F.D.A. widens safety reviews on new drugs

U-M, Harvard team propose way to make the most of health dollars through value-based insurance design

Hospital owner to extend discounts 

Study indicates different treatment may be needed for infection-related breathing problems

‘Carestream Health Inc.’ selected as name for successor to Kodak’s Health Group

Amerinet announces agreements with Kimberly–Clark and Teleflex Medical
 

F.D.A. widens safety reviews on new drugs

The Food and Drug Administration announced changes yesterday that were intended to ensure that marketed drugs are as safe as advertised, including the first effort to do a comprehensive assessment of the safety of drugs 18 months after introduction. The agency also announced the creation of an advisory panel to improve the way it announces safety worries and a collaboration with the Veterans Health Administration to track how real patients fare after taking drugs. “We don’t see this as the only answer,” said Dr. Andrew C. von Eschenbach, the F.D.A. commissioner. “It’s merely a step as we continue a process of improvement that will be ongoing.”  Senator Christopher J. Dodd, Democrat of Connecticut, said that far greater changes were needed at the agency. Dodd promised to introduce two bills today that would reorganize the F.D.A. and require drug makers to disclose the results of all clinical trials involving humans.  

The plan does little to address a problem that nearly all agree underlies many of its woes: a chronic shortage of government money. As Dr. von Eschenbach noted, the agency has regulatory authority over about a quarter of the American economy. After the Sept. 11 attacks, the agency was asked to increase its efforts to prevent bioterrorism. Despite having greater responsibilities, its budget has remained relatively flat for years. There are now thousands of drugs in routine use. Figuring out which of these medicines may have undiscovered side effects will take a lot of money. The agency gets about $400 million of its $1.9 billion budget from fees assessed on drug makers. Under a formula negotiated with the drug industry, this money comes with strings attached. One restriction was that the F.D.A. could use little of the money to track the safety of approved drugs. That deal between the F.D.A. and drug makers expires this year, and the drug companies have agreed to allow more of their money to be used for postmarket safety assessments. Whether those fees are enough, whether there should be any strings attached to them and whether that money should be coming from drug makers at all has become the subject of fierce debate.

Dr. Scott Gottlieb, who last week left his job as the F.D.A. deputy commissioner to return to the American Enterprise Institute, a free-market research group, said the real debate unfolding around the agency is between those who believe that it needs more money and tools to assess drug risks, and those who believe that the agency should begin regulating the practice of medicine. The F.D.A. plan promises to return the agency to its scientific roots. It once had robust laboratories that conducted original studies to assess drug risks on its own. Those laboratories were largely eliminated in the past decade to apply more money to the drug-approval process and the support of a bare-bones computer program to track side effects of drugs. But in the past two years, the agency has begun an effort to improve the science of drug safety, making itself an active participant in scientific endeavors once left exclusively to drug makers and basic scientists. The efforts announced yesterday included the creation of a database of genetic codes associated with bad drug outcomes, the development of a computer model to identify patients who are most likely to suffer liver injury, and the design of screening tests that would identify patients most at risk of general drug problems. (The New York Times) To read the complete article CLICK HERE.

U-M, Harvard team propose way to make the most of health dollars through value-based insurance design

American health insurance plans charge every person the same out of pocket cost for medical services, regardless of their effect on a person’s health. American employers, and citizens, could get a lot more value out of their health insurance by abandoning the system of charging everyone the same, says a team of University of Michigan and Harvard University researchers in a paper published online in the journal Health Affairs. Instead, companies should tailor their plans so that people who can get the most benefit out of a particular drug or screening test will actually pay the least for it. By doing so, companies might not only get more for their money, they might even save money in the long run by helping their employees prevent expensive health crises. This approach, called value based insurance design or VBID, was first described by U-M professor of internal medicine and public health A. Mark Fendrick, M.D., and former U-M public health professor Michael Chernew, Ph.D., now a healthcare policy professor at Harvard. Together, they formed the U-M Center for Value Based Insurance Design. Under their approach, a person with diabetes would pay little for drugs that can delay diabetes-related health problems, and for eye and blood tests that can spot those problems early. And employees in their 50s might get free or low-cost colonoscopies, to spot pre-cancerous polyps and treat them before they become cancer. “It makes absolutely no sense to have the all patients pay the same for medical services that may have enormously different health effects. Costs should be lowest for those for whom the evidence of benefit is strongest, and vice versa, with higher costs for services where the proof of benefit isn’t strong,” said Fendrick.

In their paper, he, Chernew and U-M colleague Allison Rosen, M.D., Sc.D., describe the principle more in depth, and give examples of where it is being used. One example is the University of Michigan, where 2,200 diabetic employees and dependents are receiving free or reduced-cost medications and tests as part of a pilot project headed by Rosen, who directs the VBID center’s clinical core. Called MHealthy: Focus on Diabetes, the program is unique because it was designed to test the VBID principle rigorously, including its ability to encourage patients who aren’t yet taking beneficial medications to start taking them and to stick with them. For instance, people with diabetes are known to receive great benefit from taking inexpensive blood pressure drugs called ACE inhibitors, but most of them aren’t using the medications. The U-M project is looking at whether “free” availability of select medications will help encourage their appropriate use.

The authors acknowledge challenges to implementing VBID, including the initial short term increase in cost that would result from increased utilization of medications and tests by appropriate patients, and the lack of research on many health issues that would steer the tailoring of insurance plans to reduce costs for those who stand to benefit most from any one test or treatment. Companies would have to be careful to protect the privacy of employees who have the particular medical conditions or risk factors that would make them eligible for tailored co-pays and benefits. The authors argue that these issues can be surmounted, and that the VBID approach will lead to better health and perhaps cost savings in the long term. “The financial impact of a VBID program will depend on the level and precision of the targeting,” Chernew adds. “Most services provide significant value for a subset of patients. The better the system is at identifying those patients, and the more responsive those patients are to copayment changes, the more likely the system will be to achieve a high financial return.” For companies that are staggering under the annual increases in health insurance premiums, or trying to provide coverage to more employees to make their workplace more attractive, Fendrick says, the VBID principle could help provide a solution. “We can’t expand coverage, or maintain it at current levels, without dealing with the cost of care. VBID is a ‘fiscally responsible, clinically sensitive’ way to improve quality, access and cost-effectiveness.” For more information CLICK HERE.

Hospital owner to extend discounts 

In another sign of the change sweeping the healthcare industry, more than 600,000 uninsured patients of a Naples, FL-based company that owns hospitals in Venice, Punta Gorda and Port Charlotte, FL, could receive discounts or refunds of up to 60 percent under a legal settlement reached this month. The settlement is another in a series of legal victories for the uninsured, who for years have been charged much steeper prices than managed care providers for medical treatment. The practice has prompted dozens of class-action lawsuits and drawn threats of a congressional crackdown. Already the nation’s two largest for-profit hospital chains, HCA and Tenet Healthcare, have adopted similar discount pricing policies for uninsured patients. HMA, the third-largest chain with 61 hospitals in 14 states, settled a class-action lawsuit filed in 2004 by Jose Manuel Quintana, a Miami tow-truck driver. Quintana’s three-hour visit to HMA’s Fishermen's Hospital in Miami for chest pains landed him a $3,060 bill. 

In Florida, home to about 2.1 million of the nation’s more than 44 million uninsured, hospitals commonly charge more than 300 percent of cost, according to the suit, which called HMA “one of the worst offenders.” Some HMA hospitals charged patients between 500 percent and 600 percent of cost and in some cases garnisheed wages, seized bank accounts and placed liens on homes to collect on debts, according to the suit. The settlement guarantees discounts to uninsured patients equal to the average of what managed care providers pay at that hospital, along with rebates for about 634,397 patients who may have been overcharged during a 12-year period. HMA, whose hospitals are largely found in rural areas in the Southeast, also agreed to provide the uninsured patients estimates of expected charges in nonemergency situations, bilingual financial counseling, reasonable payment plans and a uniform credit and collection policy. Although hospitals must charge all patients the same price for identical services, uninsured patients often receive the largest bills because of the discounts hospitals extend to managed care providers whose payment, unlike those of uninsured patients, is virtually guaranteed. The practice is known as “cost-shifting.” It is unclear how much the settlement will cost the company. Since only a fraction of uninsured patients pay their bills, many of those overcharged will receive no rebate. The settlement codified an informal policy that already existed of providing discounts to uninsured patients who asked for them, said Tim Parry, HMA’s senior vice president and general counsel, noting that Quintana had qualified for a 50 percent discount under that policy. “We looked at this as, let’s be more transparent with what we’re already doing,” Parry said. (Sarasota Herald-Tribune)

Study indicates different treatment may be needed for infection-related breathing problems

New research suggests that different treatments may be needed for chronic asthma, depending on whether it results from allergies or lung infections. Previous studies have shown that certain lung infections such as Mycoplasma pneumoniae can linger on and contribute to a person later experiencing symptoms of asthma. Researchers have now identified a particular gene that influences how severe a M. pneumoniae infection may be, which in turn suggests that a different strategy might be needed for treating asthma resulting from this and similar lung infections rather than allergies. “What this shows is that infectious asthma might have a different mechanism than allergic asthma. Most people think asthma is asthma, but it may be multifaceted,” said Dr. Robert Hardy, an infectious disease specialist at UT Southwestern. That’s an important implication because the latest statistics show that asthma is on the rise. According to the U.S. Centers for Disease Control, more than 20 million Americans currently have asthma and another 10 million have been diagnosed with asthma at some point in their life. Roughly 6.5 million American children, or nearly 9 percent of the nation’s pre-adult population, have asthma, figures released in December show.

Dr. Hardy, an assistant professor of internal medicine and pediatrics, has been using mice to study how certain pneumonia bacteria contribute to chronic asthma and, in this latest study, identified how a particular gene may contribute to more severe lung infection. The research appears in the January edition of Infection and Immunity. Dr. Hardy’s research involves pneumonia caused by the bacterium M. pneumoniae, commonly called walking pneumonia. To investigate the mechanism by which M. pneumoniae causes lung disease and respiratory difficulties, the UT Southwestern researchers inoculated two different types of mice with this bacterium. The study contrasted the reaction of one normal group of mice with another group lacking a particular gene called IL-12, which is involved in immune response. The mice engineered without the gene showed significantly less lung inflammation than the mice that naturally had the gene, with some indicators showing seven times less inflammation. “M. pneumoniae might be more of a cofactor in developing chronic asthma than a direct cause, similar to how high cholesterol or diabetes makes people more vulnerable to heart attacks,” Dr. Hardy said, pointing to a number of previous studies. “It’s probably not the only thing, but it’s one of them. In some people it might incite asthma or it might exacerbate it.” Because the M. pneumoniae bacterium is difficult to kill and often remains in the lungs even after antibiotic treatment and the symptoms fade, Dr. Hardy said, it is important to find better treatments to prevent it from lingering.

‘Carestream Health Inc.’ selected as name for successor to Kodak’s Health Group 

Carestream Health Inc. is the name unveiled for the independent company that will result from the sale of Eastman Kodak Company’s Health Group to a subsidiary of Onex Corporation, Toronto, Canada. The multi-billion-dollar sale, expected to close in the first half of 2007, is subject to receipt of regulatory approvals. After closing, Carestream Health, which will have more than 8,100 employees and will immediately become a stand-alone company. In 2005, the Health Group began using the Carestream name to identify a range of digital medical imaging and IT products. Moving forward, marketing and branding efforts will focus on enhancing the Carestream brand and on building Carestream Health’s corporate identity. Kodak’s Health Group is a provider of medical and dental imaging systems and information technology solutions; molecular imaging systems; and non-destructive testing products.

 

Amerinet announces agreements with Kimberly–Clark and Teleflex Medical

Amerinet announces its agreement with Kimberly–Clark for medical products. Effective through December 31, 2009, this agreement includes exam gloves and was the result of a competitive bidding process.

Amerinet announces its agreement with Teleflex Medical for chest drainage products. Effective through November 30, 2009, this agreement includes Teleflex Medical's Chest Drainage portfolio: Pleur-evac & Sahara latex, latex-free and Autotransfusion chest drains and its Thoracic Catheters. This contract was the result of a competitive bidding process.

 

January 30, 2007

CS bill introduced in New York

Annual study finds top hospitals have 28% lower mortality rate

Neurological disease common, survey finds

Study shows stroke treatment helped brain function

Doctors sell hip resurfacing to boomers

NIH study finds MRI more sensitive than CT in diagnosing most common form of acute stroke

Institute of Healthcare Executives and Suppliers announces new member

CS bill introduced in New York  

The State of New York has introduced an act to amend the education law, in relation to central service technicians; and to amend the public health law, in relation to the provision of central supply services. Article 167 Bill A3220 for Central Service Technicians, introduced by Assemblyman Jonathan L. Bing will soon go to vote.   

According to the Bill, the practice of the profession of a Central Services Technician is defined as a person who provides the services of decontamination, preparation, packaging, sterilization, and storage of reusable medical instrumentation or devices in hospitals.  2. A Central Services Technician Overseer is an individual who is licensed as a central services technician pursuant to this article and who otherwise meets the educational, training, and experience qualifications for an overseer as determined by the commissioner. Only a person licensed or exempt under this article may perform central supply services or use the title Central Service Technician. 1. To qualify for a license as a central service technician, an applicant must fulfill the following requirements: (a) File an application with the department. (b) Receive an education in accordance with the commissioner’s regulations. (c) Have experience in accordance with the commissioner’s regulations. (d) Be of good moral character, as determined by the department. (e) Be a United States citizen or an alien lawfully admitted for permanent residence in the United States. (f) Pay an initial fee of one hundred fifty dollars, and a triennial registration fee of one hundred fifty dollars thereafter. 2. (a) To qualify as a Central Services Technician Overseer, a person must be licensed under subdivision one of this section and must meet the educational, training, and experience qualifications determined by the commissioner. (b) The commissioner shall establish minimum educational, training, and experience criteria as qualifications for a central services technician overseer.

This act shall take effect January 1, 2008, provided, however, that effective immediately the addition, amendment, and/or repeal of any rule or regulation necessary for the timely implementation of this act on its effective date is hereby authorized and directed to be made on or before such effective date. To view the complete Bill CLICK HERE.  

Annual study finds top hospitals have 28% lower mortality rate

Patients treated at top-rated hospitals nationwide are nearly one third less likely to die, on average, than those admitted to all other hospitals, according to a study released by HealthGrades, the leading independent healthcare ratings company. Patients who undergo surgery at these high-performing hospitals also have an average five percent lower risk of complications during their stay, researchers found. The annual HealthGrades Hospital Quality and Clinical Excellence study, now in its fifth year, identifies hospitals in the top five percent nationally in terms of mortality and complication rates for 26 procedures and diagnoses, from bypass surgery to stroke. Hospitals achieving this level of care are designated Distinguished Hospitals for Clinical Excellence by HealthGrades and are identified on the organization's consumer Web site, HealthGrades.com. Disparities in the care patients receive, based simply on where they choose to seek treatment, highlight a troubling phenomenon in the U.S. healthcare system: a preventable gap between high-quality hospitals and the rest of the field. The 2007 study found that 158,264 lives may have been saved and 12,410 major complications avoided during the 3 years studied, had the quality of care at all hospitals matched the level of those in the top five percent. These major complications include problems like post-op pneumonia, post-op respiratory failure, post-op bacterial infections, or post-op bleeding.  

To name hospitals in the top five percent for clinical excellence, the HealthGrades’ study analyzed nearly 39 million hospitalizations over the years 2003, 2004 and 2005 at all 4,971 of the nation’s nonfederal, nonchildren’s, short-term acute care hospitals. In comparing Distinguished Hospitals for Clinical Excellence with all other hospitals, the HealthGrades study found: On average, a 28 percent lower inhospital risk-adjusted mortality was experienced by Medicare patients at Distinguished Hospitals for Clinical Excellence in the following procedures and diagnoses: cardiac surgery, angioplasty and stent, heart attack, heart failure, atrial fibrillation, chronic obstructive pulmonary disease, community-acquired pneumonia, stroke, abdominal aortic aneurysm repair, bowel obstruction, gastrointestinal bleed, pancreatitis, diabetic acidosis and coma, pulmonary embolism and sepsis.

For those same procedures and diagnoses, Distinguished Hospitals for Clinical excellence improved at a greater rate than other hospitals, lowering inhospital risk-adjusted mortality rates over the years 2003, 2004 and 2005 by an average 11.74 percent. Medicare patients had, on average, a 5 percent lower risk of inhospital post-operative complications at a Distinguished Hospital for Clinical Excellence for diagnoses and procedures that include orthopedic and neurosurgery, vascular surgery, prostate surgery and gall bladder surgery. For those same procedures and diagnoses, Distinguished Hospitals reduced inhospital postsurgical complication rates by 3.39 percent from 2003 to 2005, more than twice as much improvement as all other hospitals. Seventy-five percent of this year’s Distinguished Hospitals for Clinical Excellence are being recognized by HealthGrades for the second consecutive year. To see how hospitals rated, CLICK HERE.

Neurological disease common, survey finds

Multiple sclerosis, Parkinson’s disease and other neurological diseases may be far more common than most people had believed, according to new estimates. Nearly one out of 1,000 Americans has multiple sclerosis or MS and one out of 100 elderly Americans has Parkinson’s disease the survey found. “Our estimate of MS prevalence is about 50 percent higher than a comprehensive review from 1982,” said Dr. Deborah Hirtz of the National Institute of Neurological Disorders and Stroke, who led the survey. It is not clear whether the disease is actually more common or if it is being diagnosed more accurately, she said. The new survey, published in the journal Neurology, also found the rate of Alzheimer’s disease was up substantially from past estimates, with 67 out of 1,000 Americans over the age of 65 affected. Nearly 10 out of 1,000 older Americans have Parkinson’s disease, and four out of every 100,000 has amyotrophic lateral sclerosis, also called ALS or Lou Gehrig's disease, the survey found. The survey projects that the number of people with Parkinson’s will double from about 4.3 million people now to 9 million people worldwide over the next 25 years. It corroborated other studies on childhood neurological disorders, finding that nearly six out of every 1,000 children has autism, and two out of every 1,000 children has cerebral palsy.

Hirtz and colleagues reviewed studies from nearly 500 medical papers published between 1990 and 2005 for their report. They found that 101 out of every 100,000 Americans has a traumatic brain injury each year, 50 percent fewer than previous estimates. More than 180 out of every 100,000 people suffer a stroke each year, and close to five out of every 100,000 have a new spinal cord injury each year. Steven Albert of the Department of Behavioral and Community Health Sciences at the University of Pittsburgh said the impact of Alzheimer’s will be substantial as the population ages. “Current projections of AD (Alzheimer’s disease) suggest that there will be about 10 million cases in the United States in 2050, of which 6 million are expected to have moderate or severe dementia,” Albert wrote in a commentary in the journal. (Reuters)

Study shows stroke treatment helped brain function

A treatment designed to clear blocked carotid arteries and prevent stroke showed signs of improving brain function in a small study, U.S. researchers said Monday. Doctors found nearly half of patients who were treated with a carotid stent to prevent a stroke showed statistically significant improvement in brain function, such as memory, judgment and reasoning. In a study of 37 patients implanted with the stents, 16 patients or 43 percent showed improved brain function a year after the stent was implanted. Doctors noted cognitive improvements at three months and those gains continued when checked at six and 12-month intervals. “Many patients have returned to a level of function they thought they had lost,” said lead researcher Dr. Rodney Raabe, chief of radiology at Sacred Heart Medical Center in Spokane, WA, where the study was conducted.

Clogged carotid arteries account for nearly one third of all strokes. Most patients with blocked carotid arteries undergo surgery to clear blockages, but recently approved carotid stents offer a less-invasive option for patients who face high risks if they undergo surgery. Several medical device makers have U.S. regulatory approval for carotid stents, including Abbott Laboratories Inc., Boston Scientific Corp. and Johnson & Johnson, Ev3 Inc. and C.R. Bard Inc. Currently the risk of stroke with either surgical or less-invasive stenting procedures is in the range of 4 to 10 percent, depending on the patient, said James Benenati, an interventional radiologist at Baptist Cardiac and Vascular Institute in Miami. That risk would prohibit doctors from treating patients to improve brain function unless they were at risk of a stroke. With better stents and more refined procedures, however, doctors ultimately could use the procedures to treat impaired brain function brought on by blocked arteries, Benenati said. The stent study did not test whether there was a similar brain benefit for patients who undergo surgery to have their carotid arteries cleared. Benenati said he assumes the same benefit would apply, but that also would need to be studied. (Reuters)

Doctors sell hip resurfacing to boomers

Doctors are beginning to offer a new alternative to hip replacement, one aimed at younger, athletic baby boomers who’ve worn out their joints too soon. Now they no longer have to wait until they hit their 60s for a fix. It’s called hip resurfacing, covering a damaged hip’s ball and socket with smooth metal rather than cutting away worn bone and replacing it. The operation hit the U.S. market last spring with Food and Drug Administration approval of the British-designed Birmingham Hip Resurfacing System. Competitors are in clinical trials, and expected to clear FDA later this year. It’s not the first time orthopedic surgeons have tried resurfacing worn-out hips. But where earlier attempts failed, data from Europe suggest this latest approach uses longer-lasting materials, with the additional promise of a joint that may hold up to the heavy recreation of today’s 40- and 50-somethings better than traditional hip implants.

Not everyone’s a good candidate, specialists caution. Resurfacing isn’t for patients with thinning bones, part of the joint could break, or those who have poorly functioning kidneys that can’t eliminate microscopic metal particles produced when the joint's reinforced pieces rub together. Moreover, while patients typically recover quickly, resurfacing is harder to perform than a hip replacement, and only a small fraction of the nation's orthopedic surgeons so far are trained to do it. But interest is growing, as evidenced by a focus on hip resurfacing at next month’s annual meeting of the American Academy of Orthopaedic Surgeons, and a growing demand for hip repair from ever-younger patients. More than 400,000 total or partial hip replacements are performed each year, a number growing as the population ages. Artificial hips can bring tremendous relief to people crippled by hip pain. But the metal-on-plastic friction means the implants can begin wearing out in about 15 years, sooner if sports or other activities increase pressure on the joint. For the average 65-year-old, that’s no problem. A 50-year-old, in contrast, could very well wear out an initial replacement and have little thigh bone left to fit another.

With resurfacing, surgeons lightly shave the damaged femoral ball and fit a metal ball snugly over it. That ball rolls in a metal cup reinforcing the socket. The idea: Metal-on-metal shouldn’t wear out as fast, and if patients do need another replacement in 15 or 20 years, the thigh bone is largely intact. “This resurfacing initiative has interest because we’re sparing bone,” explains Sheinkop, a Rush University professor and joint replacement director of the Neurologic and Orthopedic Institute of Chicago. The FDA cited studies showing the Birmingham Hip resurfacer lasted at least five years, approving its sale on condition that manufacturer Smith & Nephew Inc. continue tracking its endurance for 10 years. Doctors differ on what age is the cutoff for resurfacing, somewhere between 60 and 65, largely dependent on the patient’s bone strength. Nor do all insurers cover it. The implant costs about 20 percent more than a standard artificial hip, adding to the $35,000 tab. Complicating the choice is that surgeons call newer artificial hips, ceramic-on-ceramic balls and sockets, or tougher plastic designs, good options for even the most active person just turning 60. (The Associated Press) To read the full article CLICK HERE.

NIH study finds MRI more sensitive than CT in diagnosing most common form of acute stroke

Results from the most comprehensive study to compare two imaging techniques for the emergency diagnosis of suspected acute stroke show that magnetic resonance imaging (MRI) can provide a more sensitive diagnosis than computed tomography (CT) for acute ischemic stroke. The difference between MRI and CT was attributable to MRI’s superiority for detection of acute ischemic stroke, the most common form of stroke, caused by a blood clot. The study was conducted by physicians at the National Institute of Neurological Disorders and Stroke (NINDS), a part of the National Institutes of Health (NIH). Findings appear in the January 27, 2007 edition of The Lancet. “These NIH research findings on acute stroke imaging are directly applicable to real-world clinical practice,” said NIH Director Elias A. Zerhouni, M.D.

“The patients involved in this study were the typical cross-section of suspected stroke patients that come into emergency rooms on a daily basis.” Furthermore, the study has good news for patients, according to Walter J. Koroshetz, M.D., NINDS Deputy Director. “This study shows that approximately 25 percent of stroke patients who come to the hospital within three hours of onset, the time frame for approved clot-busting therapy, have no detectable signs of damage. In other words, brain injury may be completely avoided in some stroke victims by quick re-opening of the blocked blood vessel," said Dr. Koroshetz.  

The researchers conducted the study to determine whether MRI was superior to CT for emergency diagnosis of acute ischemic and hemorrhagic stroke. Standard CT uses X-rays which are passed through the body at different angles and processed by a computer as cross-sectional images, or slices of the internal structure of the body or organ. Standard MRI uses computer-generated radio waves and a powerful magnet to produce detailed slices or three-dimensional images of body structures and nerves. A contrast dye may be used in both imaging techniques to enhance visibility of certain areas or tissues. Study results show immediate non-contrast MRI is about five times more sensitive than and twice as accurate as immediate non-contrast CT for diagnosing ischemic stroke. Non-contrast CT and MRI were equally effective in the diagnosis of acute intracranial hemorrhage.  

Non-contrast CT has been the standard in emergency stroke treatment, primarily to exclude hemorrhagic stroke, which cannot be treated with clot-busting therapies. “Many patients who come to hospitals with a suspected stroke ultimately have a different diagnosis. Most possible stroke victims are first evaluated by non-specialists, who may be reluctant to treat a patient for stroke without greater confidence in the accuracy of the diagnosis. Our results show that MRI is twice as accurate in distinguishing stroke from non-stroke,” said Steven Warach, M.D., Ph.D., director of the NINDS Stroke Diagnostics and Therapeutic Section and senior investigator of the study. “Based on these results, MRI should become the preferred imaging technique for diagnosing patients with acute stroke.” “Although MRI is remarkably accurate in detecting early stroke damage, it can't substitute for a doctor’s clinical judgment in making a stroke diagnosis and deciding upon treatment,” said Dr. Koroshetz. “Future studies are needed to determine whether advanced contrast enhanced CT techniques can afford the same level of clinical information more quickly and with less expense,” he added.

Institute of Healthcare Executives and Suppliers announces new member

The Institute of Healthcare Executives and Suppliers announces that William C. Oliver, President and CEO of Forrest General Hospital System, has joined its organization. Oliver is in his ninth year as President and CEO of Forrest General Hospital, which is a 512-bed tertiary referral center with over 3,300 employees serving South Mississippi. He is a Certified Public Accountant and a Fellow in the Healthcare Financial Management Association. Oliver has been involved in the healthcare industry as an auditor, consultant, CFO, COO and CEO. He currently serves as chairman of the Board of Voluntary Hospitals of America (VHA), Gulf States Region; Chairman of the Board of AAA Ambulance Services; and Chairman of the Board of the Southeast Mississippi Trauma Region. For more information CLICK HERE.  

Medicare proposes payment changes for LTCHs for RY 2008,
and Medicare graduate medical education payments

Patient lives saved as performance continues to improve in
groundbreaking CMS/Premier pay-for-performance project

Japan confirms 3rd 2007 outbreak of bird flu

Virulent TB in South Africa may imperil millions

CDC: Use of mammograms among women aged 40 and older declining

New diabetes research: Half of Americans
have gene that affects how body burns sugar

Attention HPN Readers: Tell us who and what has mattered
in healthcare supply chain management, and why 

During Healthcare Purchasing News’ 30th anniversary in 2007, we’re recognizing three decades of supply chain leadership, in terms of the people, processes and products that have defined the important industry segment we cover daily online and every month in print. As part of the celebration, as well as to recognize what makes the industry we cover special, we’d like to recruit you to help us in our quest. We’d like you to reminisce through the past 30 years (whether you experienced the industry in reality or anecdotally) and vote online or via e-mail editor@hpnonline.com.

Please vote as often as you’d like for people, processes, products and concepts that rocked your world from 1977 forward. Inside each edition of Healthcare Purchasing News throughout 2007 we’ll reveal your top choices, coupled with our own in a monthly feature that should inspire conversations and debate throughout the year. To vote CLICK HERE. 

For a print version of the ballot, see HPN’s 2007 Industry Guide (published in November 2006) or CLICK HERE for a print version of the ballot.

Medicare proposes payment changes for LTCHs for RY 2008,
and Medicare graduate medical education payments

The Centers for Medicare & Medicaid Services (CMS) today issued a proposed rule designed to assure appropriate payment for services by long-term acute care hospitals (LTCHs) to severely ill or medically complex patients, while providing incentives for more efficient care for Medicare beneficiaries. Under this proposed rule, Medicare total payments to LTCHs are expected to be $4.4 billion for rate year (RY) 2008. The LTCH prospective payment system (PPS) is updated annually, effective for discharges on or after July 1 of each year. CMS analysis of the latest available LTCH claims data indicates that a significant portion of the estimated 3.49 percent increase in observed case mix between FY 2004 and FY 2005 is due to changes in coding practices and documentation rather than to the treatment of more resource intensive patients. In light of these data, CMS is proposing to update the LTCH PPS Federal rate by 0.71 percent to $38,356.45 for RY 2008. This update reflects the Rehabilitation, Psychiatric, and Long-Term Care (RPL) market basket of 3.2 percent adjusted for the difference between the reported case mix increase due to coding practices and the real case mix increase due to increases in patient severity. The proposed update is higher than the zero percent update recommended by the Medicare Payment Advisory Commission (MedPAC) earlier this year. The payment per discharge to LTCHs is also significantly higher than the Federal rate for acute care hospitals paid under the Inpatient Prospective Payment System (IPPS), which, for FY 2007, is generally about $5,300 per discharge. 

Medicare pays a LTCH an additional amount for unusually high cost cases under the high-cost outlier policy. To be eligible for this payment, the hospital’s estimated costs in treating the case must exceed the LTC-DRG payment by an outlier fixed-loss amount. The proposed rule would set the outlier fixed-loss amount for rate year 2008 at $18,477, up from $14,887 in rate year 2007. 

CMS is adopting other payment policies in the rule as well. Presently, a policy known as the “25 percent rule” governs Medicare payments to LTCHs based on the percentage of patients that were admitted from its co-located host hospital. Under this policy, if a LTC hospital-within-a-hospital or a LTCH satellite’s percentage of discharges that were admitted from its co-located host hospital exceed a given percentage (generally 25 percent) for the cost reporting period, the payment to the LTCH would be adjusted downward. CMS is proposing to extend the 25 percent threshold to certain situations not currently covered under the existing regulations. Under this proposed policy, the payment adjustment would apply to virtually all LTCHs for which more than 25 percent (or the applicable percentage in certain special circumstances) of its discharged patients were admitted from an individual hospital, regardless of whether that hospital was located in the general vicinity of the LTCH.

CMS is also using this proposed rule as an opportunity to propose an unrelated change regarding Medicare’s payment policies for graduate medical education payments to a teaching hospital when its residents are being trained in a nonhospital site. Under current rules, if residents are training in a nonhospital setting, a teaching hospital may count those residents in calculating their graduate medical education payments if, in part, the teaching hospital pays “all or substantially all of the costs for the training program in the nonhospital setting.” The proposed rule would amend this, effective July 1, 2007, to require that the teaching hospital pay at least 90 percent of the total costs of training residents in the nonhospital setting (including residents’ salaries, fringe benefits, travel and lodging expenses when appropriate plus the portion of the cost of teaching physicians’ salaries attributable to direct graduate medical education). To reduce the administrative burden of documenting those costs, CMS has also proposed to allow hospitals to utilize specified proxies to determine those costs. CMS will accept comments on the proposed rule for 60 days, and will publish a final rule later this spring. The final rule will be effective for discharges occurring on or after July 1, 2007 through June 30, 2008. For more information CLICK HERE http://www.cms.hhs.gov/LongTermCareHospitalPPS/LTCHPPSRN/list.asp

Patient lives saved as performance continues to improve
in groundbreaking CMS/Premier pay-for-performance project

Patients treated at hospitals participating in a groundbreaking pay-for-performance project managed by the Premier Inc. healthcare alliance are living longer and receiving recommended treatments more frequently, according to second-year results announced by the Centers for Medicare & Medicaid Services (CMS). According to the results, more than 260 hospitals participating in the CMS/Premier Hospital Quality Incentive Demonstration (HQID) project have raised overall quality by 11.8 percent in two years, based on their delivery of 30 nationally standardized and widely accepted care measures to patients in five clinical areas. Variation between top and bottom performers continues to shrink as clinical quality improves at participating hospitals. Improvements in quality of care saved 1,284 acute myocardial infarction (heart attack) patients, according to an analysis of mortality rates at hospitals participating in the HQID project. In addition, patients received approximately 150,000 additional recommended evidence-based clinical quality measures, such as smoking cessation, discharge instructions and pneumococcal vaccination. CMS announced that it will award incentive payments of $8.7 million to 115 top-performing hospitals, representing the top 20 percent of hospitals in each of the project's five clinical areas.

When compared to the rest of the nation’s hospitals, the quality score of hospitals in the P4P project on 18 publicly reported quality indicators is significantly higher, 85 percent to 79 percent, confirming that performance incentives are effective at improving quality of care. Congress has mandated that Medicare develop a plan to implement “value-based purchasing,” which ties payment to quality of care and other outcomes, beginning with FY2009. The HQID is a test of one value-based purchasing model.

Launched in October 2003 by the Premier Inc. healthcare alliance and CMS, the pay-for-performance project involves more than 260 hospitals across the nation, which submit data to Premier for validation and analysis. In turn, Premier submits the data to CMS. The first national project of its kind, HQID is designed to determine if economic incentives to hospitals are effective at improving the quality of inpatient care. Participating hospitals report process and outcome measures in five clinical areas, acute myocardial infarction (AMI/heart attack), congestive heart failure (CHF), coronary artery bypass graft (CABG), pneumonia, and hip and knee replacement. The pay-for-performance model used in the project includes financial incentives for the top 20 percent of hospitals in each of the five clinical areas. The top 10 percent of hospitals receive a 2 percent incentive payment for patients in that clinical area. Hospitals in the second decile receive a 1 percent incentive payment. Hospitals in the top 50 percent of each clinical area receive public recognition on the CMS Web site.

Hackensack University Medical Center (HUMC) in Hackensack, NJ, was a top performer in all five areas for the second year in a row, providing high quality care for 2,853 Medicare patients. Their total award across the five clinical areas will be approximately $744,000. Charleston Area Medical Center in Charleston, WV, received the second highest incentive award, $701,000, for achieving top performance in four clinical areas. Charleston Area Medical Center also received the highest single award, $432,901, in one clinical area for providing high quality care to 883 Medicare patients who had CABG procedures. The second largest single award totals $250,775 and will be provided to the Bone and Joint Hospital in Oklahoma City, OK, a member of SSM Health Care, for exceptionally high quality of care for patients receiving hip and knee replacement procedures. For more information about the HQID project and to view those hospitals ranking in the top 50 percent in each focus area, CLICK HERE  www.premierinc.com/qualitydemo.

Japan confirms 3rd 2007 outbreak of bird flu

The H5 strain of avian influenza has been found on a local poultry farm in the western prefecture of Okayama, Japan, confirming the third outbreak this year of bird flu, according to officials. At least 39 chickens have died on the farm in the city of Takahashi, according to a statement on the prefecture’s website. The agriculture ministry said on Jan. 27 there are 12,000 chickens at the farm and that it had restricted movement of goods within a radius of 10 kilometers around it to help prevent spread of the virus. The ministry on Jan. 25 confirmed Japan’s second avian flu infection of the year at a poultry farm with 52,200 chickens in Miyazaki prefecture in the southern island of Kyushu. Birds there were infected with the H5N1 strain. (Xinhuanet)

Virulent TB in South Africa may imperil millions

More than a year after a virulent strain of tuberculosis killed 52 of 53 infected patients in a rural South African hospital, experts in Johannesburg and abroad say the disease has most likely spread to neighboring countries, and some say urgent action is essential to halt its advance. Several expressed concern at what they called South Africa’s sluggish response to a health emergency that, left unchecked, could prove hugely expensive to contain and could threaten millions across sub-Saharan Africa. The director of the government’s tuberculosis programs called those concerns unfounded and said officials were doing everything reasonable to combat the outbreak. The form of TB, known as XDR for extensively drug-resistant, cannot be effectively treated with most first- and second-line tuberculosis drugs, and some doctors consider it incurable. Since it was first detected last year in KwaZulu-Natal Province, bordering the Indian Ocean, additional cases have been found at 39 hospitals in South Africa’s other eight provinces. On Friday, several epidemiologists and TB experts said the disease had probably moved into Lesotho, Swaziland and Mozambique, countries that share borders and migrant work forces with South Africa, and perhaps to Zimbabwe, which sends hundreds of thousands of destitute refugees to and from South Africa each year. But no one can say with certainty, because none of those countries have the laboratories and clinical experts necessary to diagnose and track the disease. Ominously, none have the money and skills that would be needed to contain it should it begin to spread. Even in South Africa, where nearly 330 cases have been officially documented, evidence of the disease’s spread is mostly anecdotal, and epidemiological work needed to trace its progress is only now beginning.

Cases of XDR TB exist elsewhere, in countries like Russia and China where inadequate treatment programs have allowed drug-resistant strains of the disease to emerge. The South African outbreak is considered far more alarming than those elsewhere, however, because it is not only far larger, but has surfaced at the center of the world’s H.I.V. pandemic. Although one third of the world’s people, by W.H.O. estimates, are infected with dormant tuberculosis germs, the disease thrives when immune systems are weakened by H.I.V. At least two in three South African TB sufferers are H.I.V. positive. Should XDR TB gain a foothold in the H.I.V.-positive population, it could wreak havoc not only among the five million South Africans who carry the virus, but the tens of millions more throughout sub-Saharan Africa. (The New York Times) To read the full article CLICK HERE http://www.nytimes.com/2007/01/28/world/africa/28tuberculosis.html?
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CDC: Use of mammograms among women aged 40 and older declining

Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer-related death among women in the United States. In 2002, at least 182,125 women in the U.S. had a diagnosis of invasive breast cancer, and 41,514 died from the disease. Screening mammography can reduce mortality from breast cancer by approximately 20%-35% in women aged 50-69 years and approximately 20% in women aged 40-49 years. Organizations including the American Medical Association, American College of Obstetricians and Gynecologists, and American Cancer Society support mammography screening beginning at age 40 years. The U.S. Preventive Services Task Force recommends that women aged >40 years be screened for breast cancer with a mammogram every 1-2 years. Although mammogram use increased substantially during the 1990s, results from a recent cohort study of health maintenance organization members revealed declining screening rates during 1999-2002. This report describes Behavioral Risk Factor Surveillance System (BRFSS) findings that indicate a similar decreasing trend in self-reported use of mammograms among women aged >40 years during 2000-2005. Continued declines in mammography use might result in increased breast cancer mortality. The total age-adjusted proportion of all women aged >40 years who were asked the BRFSS mammography questions each year and reported having had a mammogram within the 2 years preceding the survey decreased significantly from 76.4% in 2000 to 74.6% in 2005.

Since 1999, U.S. women overall aged >40 years have met the Healthy People 2010 objective of 70% of women having received a mammogram in the preceding 2 years; however, the slight decline indicated by BRFSS data during 2000-2005 suggests a need to monitor mammography screening more carefully. The reason for the apparent decline in screening mammography is unclear and might be attributable to a combination of factors. One study has indicated that breast-imaging facilities face challenges such as shortages of key personnel, malpractice concerns, and financial constraints. Because the number of U.S. women aged >40 years increased by more than 24 million during 1990-2000, the number of available facilities and trained breast specialists might not be sufficient to meet the needs of the population, whose overall median age continues to increase. Previously, low mammography use has been associated with not having a usual source of health care, not having health insurance, and being a recent immigrant. However, until future studies confirm a decreasing trend in mammography rates and determine whether the trend affects all women or only certain subpopulations, determining the causes of this apparent decline will remain difficult.

New diabetes research: Half of Americans
have gene that affects how body burns sugar

A recent study by a Saint Louis University researcher confirms findings that about half of the U.S. population has a version of a gene that causes them to metabolize food differently, putting them at greater risk of developing diabetes. Edward Weiss, Ph.D., assistant professor of nutrition and dietetics at Doisy College of Health Sciences at Saint Louis University, looked at a relatively common version of a gene called FABP2, which is involved in the absorption of fat from food. Those people with the variant gene processed fat differently than those who don't have it. They burned more fat, which may have hindered their ability to remove sugar from the blood stream and burn it. Diabetes is characterized by too much sugar in the blood.

“This study adds to what was previously known about this gene variant by showing that after consuming a very rich milkshake, people with the variant gene process the fat from the drink differently than other people,” Weiss said. That is not to say that half of U.S. residents are destined to get diabetes, he adds. “While the variation of the gene appears to contribute to the diabetes risk, it does not cause diabetes by itself,” Weiss said. “Many other genes, some known and some unknown, are involved in a person's overall risk of developing diabetes. Those are things a person can't control. But there are risk factors for diabetes that a person can change, lifestyle factors, such as diet and exercise.” The study was published in the January issue of the American Journal of Clinical Nutrition. 

Suit settled over towel found in patient

Covidien selected as new name for Tyco Healthcare following separation from Tyco International

Cardinal Health to sell Pharmaceutical Technologies and Services
segment to the Blackstone Group for $3.3 billion

H2E Environmental Excellence Awards season now open

As telemedicine gains popularity, healthcare facilities must guard against risks

Common parasitic infection leads to increased risk for HIV infection

Damage to specific part of the brain may make smokers ‘forget’ to smoke

Hayes CEO to discuss evidence standards for healthcare interventions at IOM workshop

Novation announces agreements with Johnson & Johnson and Kimberly-Clark

Covidien selected as new name for Tyco Healthcare following separation from Tyco International 

Tyco Healthcare announced that Covidien will be its new name once the healthcare company separates from parent company Tyco International this spring and becomes an independent, publicly traded company. Tyco Healthcare is a global manufacturer and distributor of medical products, with annual sales of nearly $10 billion. Its product portfolio includes disposable medical supplies, monitoring equipment, medical instruments and bulk analgesic pharmaceuticals. The Covidien brand will be the master identifier that unites Tyco Healthcare’s many brand names, including Autosuture, Kendall, Mallinckrodt, Nellcor, Puritan Bennett, Syneture, and Valleylab. As Covidien, the newly independent company will embark on a distinct new direction that focuses exclusively on healthcare and benefits from increased flexibility to invest in innovation and organic growth. Covidien is an original name, inspired by themes of collaboration and life.  
 

Cardinal Health to sell Pharmaceutical Technologies and Services
segment to the Blackstone Group for $3.3 billion

Cardinal Health announced it has reached an agreement to sell its Pharmaceutical Technologies and Services (PTS) segment to The Blackstone Group for approximately $3.3 billion in cash. Cardinal Health and Blackstone have signed a definitive agreement for Blackstone to acquire the PTS businesses that develop, manufacture and package medication and other products for pharmaceutical and biotech firms, employ approximately 10,000 at more than 30 facilities worldwide and generate approximately $1.8 billion in annual revenue. Cardinal Health announced on Nov. 30, 2006 that it planned to divest the segment to focus resources on its four remaining segments serving healthcare provider customers, such as hospitals and pharmacies. The sale is expected to close early in Cardinal Health’s fiscal fourth quarter and is subject to customary closing conditions, including regulatory approvals.

Cardinal Health will retain Martindale and Beckloff Associates, two businesses that support the generic pharmaceutical market. Martindale develops generic, intravenous medicine that is complementary to Cardinal Health’s hospital business and generics strategy. Beckloff provides pharmaceutical regulatory consulting, including services for Cardinal Health generic products. PTS is a contract manufacturing and service provider for the pharmaceutical industry. Among its core offerings, it develops and manufactures oral and sterile medication in nearly all dosage forms, and holds patents for softgel and Zydis fast-dissolve technologies used in many prescription and over-the-counter medicine. The segment is also the largest contract packager of pharmaceuticals. 
 

H2E Environmental Excellence Awards season now open

Each year, Hospitals for a Healthy Environment (H2E) honors facilities and organizations with Environmental Excellence Awards recognizing their environmental performance achievements. The annual H2E Awards are the premier source of national recognition for environmental leadership and achievements in healthcare. The 2007 awards, given for work accomplished during 2006, are just around the corner. The application period is open now and will close on February 14. Through the awards process, H2E Partners gather data, set goals, and track environmental programs, highlighting the progress made by executing and integrating environmental initiatives. Leading health systems, GPOs, and hundreds of individual facilities have been honored by H2E and recognized in national and local media for their achievements. This year’s H2E Environmental Excellence Awards ceremony will take place May 14–15 in Minneapolis, in conjunction with an H2E Pharmaceutical Waste Disposal Workshop. J. Peterson (Pete) Myers, co-author of Our Stolen Future, will present the keynote speech. Attendees will celebrate H2E award winners, and learn from their success stories about proven best management approaches. For more on H2E’s Environmental Excellence Awards, CLICK HERE.
 

As telemedicine gains popularity, healthcare facilities must guard against risks

Just 20 years ago, providing healthcare services using telecommunications seemed closer to science fiction than reality. In 2007, however, many U.S. hospitals are beginning to implement telemedicine programs, allowing, for example, specialists in off-site locations to provide consulting services to onsite physicians. Providing healthcare services through telemedicine creates a unique set of challenges for healthcare organizations, including acquiring new technology and ensuring the quality of telemedicine services, according to ECRI (www.ecri.org), a non-profit healthcare research institute. Facilities that use telemedicine must have a mechanism to identify errors in transmission and to verify the appropriateness of radiology images that are transmitted, ECRI's risk management analysts say in a new 16-page report.  

The report includes recommendations on issues such as requirements for credentialing and privileging for telemedicine providers, informed consent, and liability issues arising out of the physician-patient relationship. Safeguarding the integrity, security, and privacy of healthcare information that is transmitted and stored electronically is another important aspect of providing telemedicine services that facilities must consider, according to the report. Current members of ECRI's Healthcare Risk Control (HRC) System received the Risk Analysis “Telemedicine” in their January mailing, and they can also access it on the enhanced HRC Members' Web site. Nonmembers can purchase the report for $75. The HRC System is a comprehensive resource that addresses many risk exposures for risk managers and patient safety officers involved in all areas of healthcare, from hospitals and health systems to managed care organizations and integrated delivery systems. To purchase “Telemedicine,” or for more information about becoming a member of the HRC System, contact Sharon Murphy by e-mail at smurphy@ecri.org; by telephone at (610) 825-6000, ext. 5145; by mail at ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA; or by fax at (610) 834-1275.
 

Common parasitic infection leads to increased risk for HIV infection

A new study shows a significantly increased risk of HIV infection among women with a common sexually transmitted disease, trichomoniasis. Although studies have been undertaken in the past to show the link between sexually transmitted infections and susceptibility to HIV, the study published in the March 1 issue of The Journal of Infectious Diseases, is one of the first to demonstrate a statistically significant association between trichomoniasis and HIV infection. Trichomoniasis, caused by the parasite, Trichomonas vaginalis infects more than 170 million people worldwide each year. 

The study, conducted by R. Scott McClelland, MD, MPH, and colleagues at the University of Washington in Seattle, the University of Nairobi, and the Coast Provincial General Hospital in Kenya, followed 1,335 HIV-seronegative women over the span of 11 years. Because infection with T. vaginalis is common, even a modest increase in vulnerability to HIV acquisition as a result could mean a substantial attributable risk for HIV infection overall. According to McClelland, “the modest increase in risk makes it important that studies are either very large or of long duration in order to demonstrate such an effect.” Their results showed a 1.5-fold increased risk of HIV infection among women with trichomoniasis. “What this means is that a woman with trichomoniasis is at about fifty percent greater risk for acquiring HIV than a woman without trichomoniasis, after adjusting for other differences between the women such as differences in the rates of condom use, number of sex partners, etc.,” said McClelland.

Trichomoniasis can cause tiny areas of bleeding within mucous membranes that could provide a physical pathway for HIV infection. Also, the study noted, the T. vaginalis parasite has been shown to break down an enzyme that blocks HIV attachment to cells. The findings from this study provide support for prevention and treatment of sexually transmitted diseases such as trichomoniasis as important strategies for preventing HIV infection.

Damage to specific part of the brain may make smokers ‘forget’ to smoke

Preliminary research supported by the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health, has found that some smokers with damage to a part of the brain called the insula may have their addiction to nicotine practically eliminated. The study is published in the January 26, issue of the journal Science. “The researchers found that smokers with insula lesions were 136 times more likely to have their addiction to nicotine erased than smokers with other brain injuries,” said NIDA Director Dr. Nora Volkow. “Research that identifies a way to alter the function of this area could have major implications for smokers and addiction treatment in general.”

Dr. Antoine Bechara of the University of Southern California and his colleagues identified 19 smokers who had experienced some degree of brain damage, resulting in lesions on the insula. Of these, 13 quit smoking. The scientists also identified 50 smokers whose brain injuries did not include damage to the insula. Of these, 19 quit smoking. The scientists recognized that individuals from both groups, those with damage to the insula or damage to other brain regions, were able to quit smoking. However, some smokers experienced a greater ease in quitting.

“Participants with damage to the insula were overwhelmingly more likely to experience a true disruption of the urge to smoke, characterized by an almost immediate cessation of smoking with no reported struggles to maintain their abstinence,” said Dr. Bechara. “We know that the insula plays a role in the desire to smoke by anticipating physical effects brought on by emotions such as those induced by environmental cues. Thus, damage to the insula could lead smokers to feel that their bodies have ‘forgotten’ the urge to smoke.” “Medications that target receptors within the insula may offer promise in developing more effective smoking cessation therapies in the future,” he added.

Hayes CEO to discuss evidence standards for healthcare interventions at IOM workshop

Dr. Winfred S. Hayes, president and CEO of Hayes Inc., has accepted an invitation to serve as a panelist at an upcoming workshop on Judging Results: Standards of Evidence for Healthcare Interventions. Conducted by the Institute of Medicine of the National Academies’ Roundtable on Evidence-Based Medicine, the workshop will convene at 8:30 a.m., February 5, 2007 at the Keck Center of the National Academies, 500 5th St. NW, Washington, D.C. The workshop will explore the different methods currently used in judging evidence on the effectiveness of healthcare interventions, how those methods may vary according to different factors such as burden of the disease being treated, and other issues that need to be considered when evaluating the clinical benefit of an intervention. With extensive experience in health technology assessment and public policy issues, Dr. Hayes will participate in a panel discussion of Evidence and Its Synthesis in Current Practice. Scheduled for 9:00 a.m. to 10:30 a.m., the session will examine current practices in evidence synthesis, perceived differences in evidence standards for different applications, use of different forms of evidence in synthesis, variation in how interventions are considered, and means to better harmonize approaches. For further information on the Institute of Medicine’s February 5 workshop and to register at no charge,
CLICK HERE.

Novation announces agreements with Johnson & Johnson and Kimberly-Clark

Novation has awarded an agreement to Johnson & Johnson for baby care products. The agreement is effective through December 31, 2009 and includes the following products: baby wash, baby oil, baby lotion, baby shampoo, baby powder and cornstarch and diaper rash ointment.  

Novation announces an agreement with Kimberly-Clark for facial protection products effective through Dec. 31, 2009. Product categories for this agreement include surgical masks, procedure masks, N95 respirator masks, specialty masks, eyewear and shields.    

Bonus pay by Medicare lifts quality

Flu experts call for mandatory shots for health care workers

Conflict case at hospitals is settled

Advisers oppose failure limits for the pill

Norovirus sickens hundreds aboard cruise ship

GE Healthcare receives full corporate accreditation from EHNAC

MEGADYNE to become sole provider of electrosurgical products for HealthSouth surgery centers
 

Bonus pay by Medicare lifts quality

Paying a hospital to do the right thing is a lot harder than it looks. The 266 hospitals participating in a Medicare experiment that pays them more to follow medical recommendations have steadily improved the quality of patient care. The latest results in the three-year experiment show that more heart attack patients are getting aspirin when they arrive at the hospital, for example, and more patients are getting vaccines to prevent pneumonia. But even some of the hospitals earning the largest payments say Medicare needs to develop a more sophisticated way to reward hospitals for providing better care rather than more care. The problem, they say, is that the experiment ranks hospitals and rewards only the top performers. It also tends to judge the hospitals more on whether they are offering certain treatments than on whether the care is actually benefiting patients. “This isn’t the system they will ultimately use for large-scale pay for performance,” said Dr. Charles A. Riccobono, the chief quality officer for Hackensack University Medical Center.

For the second year in a row the New Jersey hospital was the top performer in all five clinical areas that were measured by the program, and it is receiving a bonus of about $744,000. Medicare officials are expected to announce tomorrow that they are awarding performance bonuses of $8.7 million to the 115 hospitals that were the top performers for the second year, based on 30 quality measures. But the Medicare officials also emphasize that the vast majority of hospitals were able to deliver better care. “We continue to see improvement, quarter by quarter, in this cohort of hospitals,” said Herb Kuhn, the acting deputy administrator for Medicare. The hospitals experienced nearly 1,300 fewer deaths in treating heart attack patients, and they have generally been able to score higher on quality measures than the rest of the nation’s hospitals. Premier Inc., a nonprofit hospital alliance, is managing the project. Premier and Medicare are now in discussions about whether the experiment will be extended, but Congress has also asked Medicare to look into developing a new payment system that would put more emphasis on rewarding the best care. The experiment is an effort by Medicare to address a fundamental concern about the current payment system. Hospitals are not paid more when they help keep a heart-failure patient from coming back to the hospital, for example. The hospitals participating in this experiment are being measured on whether they give patients clear instructions when they leave on how best to stay healthy.

Under the experiment, hospitals can earn a bonus only if they rank among the top 20 percent in at least one of five areas of patient care: joint replacement, coronary artery bypass graft, heart attack, heart failure or pneumonia. The hospitals involved say that payment method is not the best model for a nationwide system. Hospital payments should focus on encouraging hospitals to make significant strides in improving care, and should not be based on rankings. The hospitals say they are now clustered so closely at the top that it is increasingly hard to qualify for extra payments, even if their results continue to improve. The hospitals also raise questions about the measures being used. One hospital, for example, said it found itself focusing on how it was delivering care instead of looking at how patients were actually faring. Hospitals also say that some of the measures need to change more quickly when new research shows different treatments are better. In addition to focusing on the right financial incentives, Medicare is also studying what measures to use and how hospitals will make public their progress. (The New York Times) To read the full article CLICK HERE.

Flu experts call for mandatory shots for health care workers

The top professional society of infectious diseases experts is insisting that all physicians, nurses, and other health workers caring for patients be vaccinated against influenza each year or decline in writing. It is the strongest call yet to plug a critical weakness in the nation’s flu preparations. The Infectious Diseases Society of America (IDSA) is issuing the call to Congress and the Administration as part of a new set of recommendations to better prepare the nation and the world for an inevitable influenza pandemic, as well to improve responses to the perennial threat of seasonal influenza. Health care workers caring for sick patients are routinely exposed to influenza virus and often spread it around. Yet each year fewer than two in five health care workers get a flu shot. “It’s our professional duty to first do no harm,” said Andrew T. Pavia, MD, chair of IDSA's National and Global Public Health Committee. “Voluntary systems haven’t brought immunization rates up far enough. For the sake of our patients, all health care workers must get a flu shot every year or they must be required to opt out in writing.” “Responding to the perennial threat of seasonal flu will help us prepare for an influenza pandemic, and vice versa,” said Kathleen Maletic Neuzil, MD, chair of IDSA's Pandemic Influenza Task Force. For example, she said, the yearly supply of influenza vaccine fluctuates widely because there are very few pharmaceutical companies interested in manufacturing it. A bigger and more stable market for vaccine would lure more companies into the field, improving the capacity to quickly develop a pandemic vaccine.   

As part of its own continuing commitment to assist in preparing for this serious threat, IDSA has compiled 12 principles for action on pandemic and seasonal influenza: 1.) Establish a Pandemic Influenza Vaccine Master Program. 2.) Boost R&D and stockpiling of antibiotics and antivirals. 3.) Improve diagnostic tools. 4.) Improve the financial, legal, and regulatory environment for developing anti-flu products. 5.) Update plans for distributing and prioritizing anti-flu supplies. 6.) Improve seasonal influenza response. Use seasonal flu to prepare for a pandemic. 7.) Protect Health Care Workers During a Pandemic. 8.) Build health care systems capable of responding to mass casualty events. 9.) Develop and test “community mitigation” measures: closing schools, sending workers home, isolation and quarantine, and so on. 10.  Improve and coordinate surveillance. 11.) Continue to strengthen leadership, international collaboration, and communication. 12.) Commit funding for the long term. For more information CLICK HERE. 

Conflict case at hospitals is settled

Under pressure from the Connecticut attorney general, a consulting group owned by some of the country’s most influential hospital executives agreed yesterday to stop selling marketing advice to vendors who do millions of dollars in business with nonprofit hospitals across the nation, including their own. Connecticut’s attorney general, Richard Blumenthal, said the group, the Healthcare Research and Development Institute, had undermined competition among hospital suppliers through “undue and improper influence.” Known as H.R.D.I., the group is owned by about three dozen hospital executives, but it is underwritten by 40 or so of its handpicked corporate members who sell drugs, medical devices and financial services to hospitals.  

According to a settlement agreement signed by H.R.D.I. and the state attorneys general in Connecticut and Florida, hospital members may no longer accept consulting fees and free trips to resorts from hospital suppliers. The agreement did not include any admission of wrongdoing by H.R.D.I. or its owners. The settlement, Blumenthal said, did not end his investigation of hospital vendors. H.R.D.I., which was founded five decades ago as an educational group, will change from a profit-making company into a nonprofit group financed only by hospitals or their executives. Supply companies may not initially join the new group, called the Health Education Network, nor will they be permitted to have any financial links to it.

The settlement, under which the group agreed to pay a $150,000 fine, ends a two-year investigation by Blumenthal, who found that some suppliers had increased their sales at hospitals run by H.R.D.I. members after paying consulting fees to those members, investigators said. Based in Pensacola, FL, H.RD.I. has long maintained that its sole purpose was to improve products and services in healthcare. “H.R.D.I. never has and does not now buy, sell or encourage the purchase or sale of products or services,” said Diane Appleyard, the group’s president and chief executive. “After more than 23 months of investigation, no wrongdoing was found and no charges were filed.”  

H.R.D.I.’s owners have included executives of group purchasing organizations, which negotiate millions of dollars in supply contracts on behalf of nonprofit hospitals across the country. Despite its elite membership, H.R.D.I. has maintained a low public profile. Its meetings were not open to the public or to vendors who were not members. According to H.R.D.I. rules, only two vendors in any product line could belong to the group. Under the agreement, HRDI’s successor group, the Health Education Network, may readmit vendors after three years, but only under certain conditions. Hospital executives cannot serve on a vendor’s board or receive more than $2,500 annually for work on behalf of the nonprofit group. The Health Education Network also cannot limit the number of vendors in any particular product line. (The New York Times) To read the complete article CLICK HERE.

Advisers oppose failure limits for the pill

Birth control pills sometimes fail, but setting limits on how often that could happen would put newer, low-dose contraceptives off limits to women, federal health advisers said Wednesday. The lower-dose pills are less effective at preventing pregnancy than the first oral contraceptives approved beginning in 1960. Yet the newer drugs offer other health benefits or cause fewer side effects. That has split federal health officials on the need to define a pregnancy or failure rate that would be unacceptably high for next-generation pills. Over the last decade, the FDA has approved some pills with failure rates that exceed two pregnancies per 100 woman-years of use, according to agency documents. That is twice the rate considered acceptable in the 1960s. But allowing the less-effective pills on the market can increase the options for women and their doctors, said Dr. Charles Lockwood of Yale University, acting chairman of FDA’s reproductive health drugs advisory committee. “We don’t want an arbitrary number to be ascribed,” Lockwood said after the panel declined to define a pregnancy rate that would be considered unacceptable.

The FDA is looking at how well studies done before approval of new birth control pills reflected their “real-world” use. Typically, that use is less consistent and reliable than it is in clinical studies. Also, newer versions of the pill aren’t being tested on women who reflect the broader population. The women in clinical trials are younger, skinnier and healthier than are U.S. women on average, panelists and other experts said. The more clinical trials can mimic real-world use, the more confident women will be that the pills both work and are safe, Kirsten Moore, president of the Reproductive Health Technologies Project, a nonprofit advocacy group, told panelists. The exclusion of smokers, obese and older women from clinical trials also underscores the need for large follow-up studies that assess the real-world safety and effectiveness of the oral contraceptives, advisers said. (The Associated Press)

Norovirus sickens hundreds aboard cruise ship

A highly contagious form of stomach flu sickened hundreds of passengers during a worldwide voyage on the Queen Elizabeth 2 cruise ship in what health officials called an unusually large outbreak. The Centers for Disease Control and Prevention reported 276 passengers and 28 crew members had come down with norovirus by the time the ship docked Wednesday in San Francisco, CA, for a regularly scheduled stop, though only four passengers remained sick. The CDC boarded the QE2 on Friday in Acapulco, Mexico, to investigate the outbreak. Investigators determined the emergency sanitation measures put in place by the ship’s crew, from disinfecting casino chips to halting self-service at the ship's buffet, were containing the outbreak. “This one was a good example where they had a lot of cases but they did gain control over the spread of infection,” Ames said. The infections affected nearly 17 percent of the ship’s 1,652 passengers, a particularly high percentage, said Jaret Ames, acting chief of the CDC’s vessel sanitation program. (Associated Press)

GE Healthcare receives full corporate accreditation from EHNAC

GE Healthcare announced that the company joins a group of healthcare firms that have received full corporate accreditation by the Electronic Healthcare Network Accreditation Commission (EHNAC). The commission is an independent, not-for-profit accrediting agency for entities that send or receive HIPAA transactions or that transport or process EDI (Electronic Data Interchange) transactions between two or more trading partners in the healthcare community. EHNAC’s site reviewer worked with GE Healthcare’s clearinghouse staff to review the commission’s comprehensive accreditation criteria, including validation of GE’s security and privacy policies and production services. The accreditation, based upon supplied documentation and site visit evaluation, is granted for a two-year period. According to EHNAC’s website, 25 healthcare organizations, including GE Healthcare Integrated IT Solutions, are currently fully accredited. 

MEGADYNE to become sole provider of electrosurgical products for HealthSouth surgery centers

MEGADYNE and HealthSouth Corporation have entered into an exclusive agreement for HealthSouth to use MEGADYNE’s complete circuit of electrosurgical products and educational support in its nationwide network of surgery centers. Effective immediately, MEGADYNE’s entire product line of electrosurgery products will be integrated into HealthSouth’s surgery centers, with a goal of 90 percent compliance after implementation. Under the three-year agreement, HealthSouth will offer MEGADYNE’s complete circuit of electrosurgical care products: Mega Power electrosurgical generator; E-Z Clean line of non-stick electrosurgical tips; Mega Soft reusable Patient Return Electrode; E-Z Pen Electrosurgical Pencil; Resposable Laparoscopic Electrodes with MegaTip and Indicator Shaft technology; Ultravac smoke evacuator, and additional electrosurgical peripherals and accessories.    

January 24, 2007

Bush’s health plan proposal provides tax incentives to the uninsured, could tax those already covered

Medical ads aim straight for the heart

L.A. hospital cited by health officials

RX for wrong-site surgery: Two minutes of conversation

ACS recommends HPV vaccine; but cervical cancer screening still necessary

New rules for birth control are examined

Amerinet announces agreements to Ansell Healthcare and ErgoSafe Products

Novation awards agreements to Becton Dickinson and Smiths Medical for I.V. catheters

Bush’s health plan proposal provides tax incentives to the uninsured, could tax those already covered

President Bush’s new health plan could either put more money in or take more money out of your pocket. The uninsured will get tax breaks to entice them to buy their own insurance, while those who spend too much on their coverage may get hit with taxes. Bush’s proposal, which he described in last night’s State of the Union address, would remove income or payroll taxes on the first $15,000 each family spends on healthcare, while single people would be allotted a $7,500 tax break. But any spending that overreaches this amount will be taxed, and that will most affect those already covered by their employers. Although most of the 160 million people insured through work will initially get a tax break, they’ll end up paying taxes if the cost of their plan exceeds the deduction cap. By managing federal healthcare funding more effectively and by offering tax benefits, the White House promises to make healthcare more available and affordable. The plan “will level the playing field for those who do not get health insurance through their job,” said Bush. The plan to revamp the way Americans are taxed for healthcare is getting a mixed reaction from doctors and health insurance experts. In effect, the tax breaks could create “an incentive for individual folks and families to purchase some health insurance,” said Dr. John Sbarbaro, professor of medicine and preventive medicine at the University of Colorado at Denver. “They would get a tax break of $15,000 even if their insurance only costs $10,000” he added, “That alone could reduce the rolls of the uninsured.” Nearly 80 percent of the 47 million uninsured are in the working class but are not offered insurance through their employers. The president said these tax breaks will allow 3 to 5 million more Americans to buy health insurance. 

Taxing healthcare spending over the capped amount “punishes people who suffer from one or more chronic illness,” said Alan Sager, director of the health reform program at Boston University School of Public Health. Other critics worry the plan will create a financial barrier, and preventive healthcare measures including screenings, vaccines and checkups may end up getting sacrificed. These services have been proven to save money in the long run by preventing problems or solving them early. But if the patient exceeds his deductible, he may not be able to spend the money himself. The president’s plan “fails to address the fact that out-of-pocket expenditure will lead to a decrease in essential healthcare services,” said A. Mark Fredrick, co-director of the Center for Value Based Insurance Design at the University of Michigan. The more money people have to pay on their own to get such care, the less likely they are to do it, and that increases the risk of more expensive and preventable problems down the line. The president’s proposal also affects federal funding within the states, helping them in their efforts to provide insurance to the poor or those hard to insure. Ideally, states across the nation could use the funding to experiment with plans that might successfully decrease the uninsured population. “That allows for creativity and an opportunity to determine what works and what doesn't work,” said Sbarbaro. (ABC News)

Publisher’s Note: As the mother of a practically uninsurable chronically ill child, who is currently paying more than the proposed family maximum insurance payment of $15,000 a year for her – I agree with Mr. Sager wholeheartedly. This proposed health insurance plan has certainly forgotten about a large number of the Nation’s critically ill who are ineligible for Medicare/Medicaid assistance, yet need critical healthcare services. 

Medical ads aim straight for the heart

An outcry over ads nudging consumers to ask their doctors for purple pills, depression remedies or other brand-name prescription drugs hasn’t stopped an escalation of direct-to-consumer marketing in healthcare. In fact, as spending on such ads continues to climb, a new television commercial has introduced an entirely new category in the mix. Now showing: TV ads aimed at consumers touting a $30,000 heart defibrillator that must be surgically implanted. Medtronic Inc., maker of an implantable cardioverter defibrillator, has launched a national $100 million campaign to raise awareness of sudden cardiac arrest. The blitz includes marketing materials for physicians and also television and print ads directed at consumers, representing a shift away from doctors initiating the discussion about such devices.

Executives at companies like Medtronic say that advertising new procedures as well as prescription drugs direct to consumers imparts valuable information and potentially saves lives. But critics say ads like Medtronic’s campaign for its defibrillator could lead to a new burst of spending on medical care, just as the barrage of prescription drug ads has been blamed for part of the increase in healthcare costs to employers and taxpayers. Since 1998, the year after the FDA eased restrictions on consumer drug ads, spending on brand-name drug advertising has quadrupled to more than $4 billion a year and some insurers have reported their prescription cost increases have gone up by double digits under the more lax FDA rules. “The industry is now pushing the envelope on even implantable devices,” said Dr. James Rohack, an American Medical Association board member and Texas cardiologist who saw a Medtronic TV ad last week. “You need to have a good discussion with your doctor before you go down that road.” Some say it could spur unnecessary and expensive surgeries if worried heart patients demand doctors implant such a device. Physicians fearful of malpractice suits may find it hard to deny patients what they ask for.

The new wave of drug and device ads comes as the new Democratic-controlled Congress is expected to hold hearings and potentially introduce legislation regulating the advertising of prescription drugs, which continues to grow. Congress is particularly interested now that the Medicare program offers a popular drug benefit. Spending on consumer drug ads rose more than 8 percent, to $3.3 billion, in the first nine months of 2006, according to TNS Media Intelligence, which tracks such marketing. The AMA has long criticized prescription drug ads that target consumers, saying they create demand based on wants instead of needs. Rohack said the association more recently has taken notice of the introduction of device ads, such as one recent campaign for an artificial hip endorsed by golfer Jack Nicklaus. While devicemakers have traditionally limited their advertising to trade journals targeted at physicians, market research firm Cutting Edge Information said consumer ad spending on medical devices grew to nearly $50 million in 2005 from practically “nothing” a decade ago.  

Medtronic believes its campaign is the first for a heart device, in terms of reaching out to consumers. Executives at Medtronic said the ad campaign is designed to reach 850,000 people in the United States the company believes would benefit from a defibrillator, arguing that neither consumers nor physicians are fully informed about the device or its benefits. Most people don’t know the difference between cardiac arrest and a heart attack, Medtronic says. The Medtronic device can cost $20,000 to $30,000, not including the cost of surgery and hospitalization. In the campaign, dubbed “What’s inside,” a soft voice tells viewers they will find inside the device “10,000 more kisses ... 200 more football wins,” saying it will “always be there for you, close to your heart with the power to restart it in case of sudden cardiac arrest.” Dr. Sidney Wolfe, head of consumer group Public Citizen’s Health Research Group, said he considers the ad highly misleading. “This is trying to frighten people and you are going to have people who are scared and uniformed saying, ‘Let's not take a chance,’” Wolfe said. Similar to the way it handles drug ads, the FDA said it does not pre-approve advertisements for devices. When it comes to devices, the agency said it has “a very small unit in our compliance area,” to review device ads, agency spokeswoman Karen Riley said.

Medtronic’s ad blitz comes with sales growth slowing in the $5 billion defibrillator business since some models were recalled in 2005 by a Medtronic rival. Industry defibrillator sales that had been rising 15 to 20 percent annually before it slowed to flat growth last year. Cowen & Co. expects defibrillator sales to increase nearly 6 percent this year, to $5.85 billion, compared to the investment firm's earlier 2007 forecast of 3.6 percent growth, to $5.73 billion, due in part to the Medtronic campaign. Those questioning campaigns like the one from Medtronic say the issue is that they do not discuss other potential options, including those that could be less expensive or less risky to patients, such as medication. But Medtronic says the ad strongly encourages patients to see their doctor and includes a toll-free telephone number in the consumer ads and pieces aimed at doctors. (Chicago Tribune)

 
L.A. hospital cited by health officials

Hospital staff did not properly clean medical instruments linked to a deadly bacterial outbreak at a neonatal intensive care unit, state regulators have concluded. White Memorial Medical Center, in Los Angeles, CA, closed the unit Dec. 4 after an outbreak of Pseudomonas aeruginosa sickened five infants. Two of the babies died, and their deaths were believed to have caused by the pathogen. In a report issued Tuesday, inspectors from the California Department of Health Services faulted hospital staff for not following manufacturer’s recommendations for sterilizing laryngoscope blades, which are used to insert breathing tubes. The report said the respiratory therapy staff simply wiped the blades with soap, tap water and alcohol wipes. A White Memorial statement said the report “confirms the hospital’s preliminary findings.” The neonatal unit has been reopened and officials said there have been no new infections. Of the roughly two million hospital-acquired infections each year, about 10 percent are caused by P. aeruginosa, a common bacterium that can be spread by healthcare workers, medical instruments, disinfectant solutions and food. (Associated Press)

RX for wrong-site surgery: Two minutes of conversation

A study of Johns Hopkins surgeons, anesthesiologists and nurses suggests that hospital policies requiring a brief preoperation “team meeting” to make sure surgery is performed on the right patient and the right part of the body could decrease errors. In the study, which will appear in the February issue of the Journal of the American College of Surgeons, Hopkins OR personnel were “very positive” about the briefings, according to surgeon Martin Makary, M.D., M.P.H., director of the Johns Hopkins Center for Surgical Outcomes Research and lead author of the study. “Although we lack systems for uniform reporting of wrong-site surgeries to understand the extent of the problem, we observed team meetings increase the awareness of OR personnel with regard to the site and procedure and their perceptions of operating rooms safety,” said Makary. He stressed that wrong-site surgery is exceptionally rare but entirely preventable.

A study published last year in the Archives of Surgery that looked at 2.8 million operations in Massachusetts over a 20-year period suggests that the rate of “wrong-site” surgery anywhere other than the spine is 1 in every 112,994 operations. The Joint Commission requires hospitals to have a presurgical conversation in the OR before every surgery. Although Makary says no national standard was set by the Joint Commission, he and others led efforts at Hopkins to enforce the mandate, developing a standardized OR briefing program that became Hopkins Hospital policy in June 2006. Since then, he has collaborated with Rochester University, Yale, Columbia and Cornell and the World Health Organization to broaden the use and reach of the Hopkins program.

The briefing consists of a two-minute meeting during which all members of the OR team state their name and role, and the lead surgeon identifies and verifies such critical components of the operation as the patient’s identity, the surgical site and other patient safety concerns. The briefing is performed after anesthesia is administered and prior to incision. A survey, among 147 surgeons, 59 anesthesiologists, 187 nurses and 29 other OR staff, was given twice - before implementing the policy and after it had been in effect for three-months. After training, a 13.2 percent increase in those who believed the policy would be effective was recorded among the OR personnel. And more than 90 percent agreed that “a team discussion before a surgical procedure is important for patient safety.” “The Joint Commission identified communication breakdowns as the most common root cause of wrong-site surgeries,” said Makary. The survey is based on a similar questionnaire designed by the airline industry to assess programs designed to reduce safety errors.  

ACS recommends HPV vaccine; but cervical cancer screening still necessary

Girls should get the new vaccine for human papilloma virus (HPV) at age 11-12, the American Cancer Society says in new guidelines issued Friday. HPV is a very common virus. Some types of HPV are sexually transmitted, and these can cause cervical cancer and other types of cancer, as well as genital warts. The vaccine currently available, called Gardasil, protects against 2 types of HPV that cause about 70% of cervical cancers, and 2 other types that cause 90% of genital warts. It is given as a series of 3 shots over the course of 6 months. Other HPV vaccines are also being tested. But screening will still be an important part of cervical cancer prevention, even in people who have been vaccinated, the guidelines say. They are published in the latest issue of the ACS journal CA: A Cancer Journal for Clinicians. The complete ACS recommendations address several different groups: Routine HPV vaccination is recommended for girls aged 11-12 years. Girls as young as 9 years old may be vaccinated. The vaccine is also recommended for girls 13-18 years old to catch up on missed shots or to complete the series of shots. There is not yet enough information to recommend for or against vaccinating women 19-26 years old, so these women should discuss vaccination with their doctor. The HPV vaccine is not recommended at this time for women over age 26. Women should continue to be screened for cervical cancer according to ACS guidelines, regardless of whether they have gotten the HPV vaccine. The new recommendations are in line with those issued by federal health officials after the vaccine was approved last summer.

New rules for birth control are examined

The government is considering raising standards for birth control drugs, saying new pills appear to be less effective at preventing pregnancy than those approved decades ago. The Food and Drug Administration asked a panel of experts on Tuesday whether it should require new contraceptive drugs to meet a standard of effectiveness before approving them for sale. The panel is to meet again on Wednesday. In documents on its Web site, the F.D.A. says newer contraceptives appear to be less effective, with twice the failure rate at times, than previous products, most likely because manufacturers have started using lower doses of hormones that stop ovulation. “The very first pills were very high dose and carried risks of blood clots and cardiovascular problems that would be unacceptable to most women,” Amy Allina, program director of the National Women’s Health Network, said. “Today, most birth control pills are very safe for the vast majority of women.” The original pills approved in the 1960s allowed on average fewer than one pregnancy for every 100 women taking the pill for at least a year, the drug agency said. But in the last decade, the government has approved pills allowing more than two pregnancies for every 100 women. (Associated Press)

Amerinet announces agreements to Ansell Healthcare and ErgoSafe Products

Amerinet announces its agreement with Ansell Healthcare Products LLC for medical supplies. Effective through December 31, 2009, this agreement provides savings to Amerinet members for Ansell Healthcare’s full line of examination gloves, and additional savings with their private label offering through Amerinet Choice. This contract was the result of a competitive bidding process.

Amerinet announces its agreement with ErgoSafe Products for medical supplies. Effective through December 31, 2009, this agreement includes EgroSafe's line of patient handling, positioning, and transferring products. ErgoSafe products are designed to reduce injuries to staff, as well as, improve the quality of care by reducing skin sheer and injuries while providing pain and sore management. This agreement was the result of a competitive bidding process.

Novation awards agreements to Becton Dickinson and Smiths Medical for I.V. catheters

Novation has awarded dual-source agreements to Becton, Dickinson and Co. and Smiths Medical Inc. for I.V. catheters, effective through December 31, 2009. Product categories include safety I.V. catheters, conventional I.V. catheters and other related products.  

FAO: Many global bird flu outbreaks unreported

Avian Flu Talk: Suspected bird flu patients continue to rise

Rapid flu tests may reduce threat of antibiotic resistance

Drug resistance in an influenza pandemic

Abbott to sell its core laboratory diagnostics business, including point of care, to GE for $8.13 billion

FDA Commissioner announces important personnel changes

Novation offers Disaster Supply Needs Assessment Tool

FAO: Many global bird flu outbreaks unreported

Many countries are doing a better job fighting the H5N1 bird flu virus, yet many outbreaks are not reported, Food and Agriculture Organization (FAO) officials said on Tuesday. Absolute transparency about disease outbreaks, involving farmers directly in surveillance and reporting as well as compensation were key to make the global fight against bird flu successful, they said. “So far, many countries have managed to progressively control the virus and the global situation has improved tremendously,” Juan Lubroth, a senior FAO infectious diseases official said. “Unfortunately, at the global scale, many outbreaks remain under reported or unreported. National or international bodies are often not in a position to immediately verify rumors or reports about unconfirmed outbreaks,” Lubroth said. The number of outbreaks in the first weeks of 2007 had been significantly lower than the epidemic waves of last year despite new flare-ups of the virus so far in eight countries, including Indonesia, China, Egypt, Japan and South Korea, FAO officials said. “The virus continues to persist in several Asian countries, as well as in Egypt and Nigeria,” said Hiroyuki Konuma, the FAO’s deputy regional representative for Asia and the Pacific. “Other countries may have been affected but have yet to report.”  

The FAO said there had been no reports of new outbreaks in secretive military-ruled Myanmar or Laos and Cambodia, all neighboring Thailand, which had its first outbreak in six months earlier in January. The spread of the virus by migrating wild birds from Asia to Europe and Africa had not taken place during this autumn/winter season at the same level as it had in 2005, the officials said. But the poultry trade and the transport of live birds could still spread the virus and strong vigilance was needed. “Recent outbreaks are following a seasonal pattern and do not come as a great surprise,” Lubroth said. “But we should remain alert as the recent outbreaks show. It is crucial that countries themselves set up their surveillance, detection and rapid-response measures,” he added. “Only immediate reporting of any suspected bird flu outbreak makes possible rapid intervention by farmers and veterinarians.” The officials also expressed concerns about bird flu spreading in Vietnam ahead the Tet Lunar New Year festival in mid-February when poultry is part of traditional feasts. Vietnam has had no human H5N1 cases since November 2005 but the virus that first hit Southeast Asia in late 2003 returned to the Mekong Delta last month and has spread to a number of provinces. (Reuters)

Avian Flu Talk: Suspected bird flu patients continue to rise

The most recent reports in Indonesia indicate that the number of suspected cases is still increasing, but the Public Health Ministry has been slow to confirm these reports. There has been a lot of discussion lately on the Avian Flu Talk message board regarding reports from national media sources, which are now indicating that the number of bird flu patients is continuing to rise since the avian flu virus re-emerged last month after a near 6 week hiatus. There have been a total of 8 confirmed human deaths in the last 30 days spanning from Egypt to Indonesia. The most recent reports in Indonesia indicate that the number of suspected cases is still increasing, but the Public Health Ministry has been slow to confirm these reports. The number of confirmed cases in Indonesia over the last two weeks equals approximately 10% of their total cases since 1993. Vietnam, South Korea and Hong Kong have also experienced a surge in poultry outbreaks over the last month. The bird flu virus appears to have now become easier to transmit from birds to humans, which has sparked a mass culling campaign in the backyards of Indonesia. Experts fear that this sudden increase of outbreaks will substantially increase the chances of the bird flu virus evolving into a human flu pandemic. For more information regarding the latest bird flu news, or to see what others are saying online, we would encourage all of those who have not already done so to visit the following Internet based discussion forum at THIS LINK.

Rapid flu tests may reduce threat of antibiotic resistance

New tests to rapidly detect the flu are allowing doctors to cut down on the number of hospital patients who receive antibiotics, helping soften the rapidly worsening threat of antibiotic resistance, according to a study to appear in the Feb. 26 issue of the Archives of Internal Medicine. The study was posted online by the journal Jan. 22 because of the importance of the findings to public health. The research was done by infection control experts at Rochester General Hospital in Rochester, NY, who are on the faculty at the University of Rochester Medical Center. “Rapid testing does give physicians evidence to discontinue antibiotics, and some physicians are responding to the evidence,” said Ann Falsey, M.D., who led the study.

Falsey's team analyzed the records of 166 patients who definitely had the flu when hospitalized. Eighty-six of the patients tested positive with the rapid test, which gives an answer within minutes, while the 80 others either did not have the rapid test done, or they tested negative at the time but were later found to have the flu. The team checked the subsequent treatment to see if there was a difference in the use of antibiotics, which aren’t effective or useful against viruses like the flu. They found that 86 percent of the patients whose flu was confirmed early on were treated with antibiotics, compared to 99 percent of the patients whose flu wasn’t identified immediately. It’s not a huge difference in numbers, but the study showed that the difference is significant, demonstrating that the rapid test does reduce the use of antibiotics in the hospital. “At least some proportion of doctors is willing to stop antibiotics when patients have a documented viral infection,” said Falsey.

The issue is important, says Falsey, because the over-use of antibiotics makes patients and the community more vulnerable to dangerous microbes resistant to most treatments. It’s particularly important in hospitals, where people most prone to infection are treated. Yet, Falsey noted in the study that 61 percent of patients who were generally at low risk for bacterial infection continued to receive antibiotics. She says that the prescription of antibiotics to patients with a viral infection is often done by doctors who believe that their patient may also have a bacterial infection or that antibiotics will prevent subsequent bacterial infections that could occur while the person is weak with the flu or another virus. In the current study, for instance, those patients with the flu who were still receiving antibiotics tended to be older, smokers, and have breathing difficulties. In other words, they were the ones most vulnerable to such an infection. Nevertheless, Falsey notes that there have been no studies proving that such a practice is effective at preventing infections. “Doctors are trying to do the right thing by their patients. Sometimes they perceive antibiotics as the safest choice, even though a virus may be the cause of their patient’s illness,” said Falsey, noting that 90 percent of people with the flu who see a doctor are given antibiotics, even though the drugs won’t help.  

Drug resistance in an influenza pandemic

Stockpiling large amounts of oseltamivir (Tamiflu) and related antiviral drugs with the intent to treat a large fraction of the population is a key part of pandemic preparedness of many countries. However, it is known that influenza viruses can develop resistance to these drugs. New research by Marc Lipsitch and colleagues (Harvard University) suggests that wide-spread use of antiviral drugs during a pandemic carries a substantial risk of resistance emerging and resistant influenza strains causing illness in a substantial number of people. This would counteract the benefits of antiviral drugs but is not likely to eliminate those benefits entirely. These researchers set up a mathematical model to mimic the spread of influenza. They then fed a set of assumptions into the computer. These included information about the rate of transmission of influenza from one person to another; what proportion of people would receive antiviral drugs for prophylaxis or treatment; how likely the drugs would be to successfully treat or prevent infection; and in what proportion of people the virus might become resistant to drugs.

The modeling led to three main predictions. First, it predicted that widespread use of antiviral drugs such as oseltamivir would quickly lead to the spread of resistant viruses, even if resistant strains emerged only rarely. Second, even with resistant strains circulating, prophylaxis and treatment with oseltamivir would still delay the onset of the pandemic and reduce its total size. Third, non-drug interventions (such as social isolation and school closures) would further reduce the number of cases, but a higher proportion of cases would be caused by resistant strains if these control measures were used. (Public Library of Science) For more information CLICK HERE.

Abbott to sell its core laboratory diagnostics business, including point of care, to GE for $8.13 billion

Abbott announced that it will sell its core laboratory diagnostics business included in the Abbott Diagnostics Division and Abbott Point of Care (formerly known as i-STAT) to GE for $8.13 billion in cash. Abbott’s Molecular Diagnostics and Diabetes Care (glucose monitoring) businesses are not part of the transaction and will remain part of Abbott. Over the past several years, Abbott has made a number of acquisitions and completed other strategic actions that have transformed the company and positioned it for higher growth by strengthening the mix of its medical and pharmaceutical portfolio toward innovation and technology-driven businesses in emerging therapeutic areas. These include: Knoll Pharmaceuticals in 2001, TheraSense (blood glucose monitoring) in 2004, and Guidant's vascular business and Kos Pharmaceuticals (lipid management medicines), both in 2006. Additionally, Abbott spun off its hospital products business into a separate NYSE-traded company named Hospira in 2004. The sale of Abbott’s core laboratory diagnostics business to GE is expected to close in the first half of 2007 and is subject to customary closing conditions, including regulatory approvals.

FDA Commissioner announces important personnel changes

U.S. Food and Drug Administration (FDA) Commissioner Dr. Andrew C. von Eschenbach announces two new personnel changes at the Agency; the creation of the Office of the Chief Medical Officer which will be overseen by Deputy Commissioner Dr. Janet Woodcock and the appointment of John R. Dyer, MPH, as the agency’s Deputy Commissioner for Operations and the Chief Operating Officer (COO).  

As the Deputy Commissioner and the Chief Medical Officer, Dr. Woodcock will oversee scientific and planning-related operations for FDA. In this capacity, Dr. Woodcock shares responsibility and collaboration with the Commissioner of FDA in planning, organizing, directing, staffing, coordinating, controlling, and evaluating the agency's scientific and medical regulatory activities in order to achieve the mission of FDA. Dr. Woodcock most recently served as the Deputy Commissioner for Operations. An internist and rheumatologist, Dr. Woodcock was previously the Director of the FDA’s Center for Drug Evaluation and Research (CDER) and also has significant experience working in the Center for Biologics Evaluation and Research (CBER).  

Dyer will be a part of the senior management of the agency that supports the Commissioner in advancing his priority initiatives. Specifically, Dyer will concentrate on strengthening the management, business processes, and information technology of the agency. In addition, Dyer will work with the other Deputy Commissioners and the Chief of Staff to provide management leadership and oversight to FDA. “With almost 24 percent of the products in the marketplace regulated by FDA it is imperative we apply and incorporate modern management tools and techniques to our regulatory decisions. Dyer’s deep experience in management is ideally suited to meet the emerging challenges and opportunities involved in protecting and promoting the health of the American public in the 21st century,” said Dr. von Eschenbach. Dyer most recently served as the Chief Operating Officer for the Centers for Medicare & Medicaid Services (CMS). In that capacity, he led the implementation of the Medicare Modernization Act (MMA) and was responsible for the overall day to day operations of the agency.    

Novation offers Disaster Supply Needs Assessment Tool

Novation has released its Disaster Supply Needs Assessment Tool to assist alliance members in their preparation for disasters. The tool allows healthcare facilities to calculate the amount of supplies and pharmaceuticals needed in the event of a disaster. Having the quantity of products estimated based on usage per patient is a key element when considering a supply list for disaster preparedness. The tool auto calculates supplies needed on hand based on bed count and/or surge capacity to care for patients for one week. In addition to the assessment tool, Novation has also created a Disaster Preparation Resource Guide, which provides resources to assist members in preparing to treat patients and protect health care workers in the event of a disaster.  

Norovirus strikes 100 guests, closes Dulles hotel

Rush researchers identify antihypertensive drugs that facilitate and/or prevent diabetes

Mayo selects point-of-use solutions from PAR Excellence

Study on nicotine levels stirs calls for new controls

FDA approves shelf life longer than any competing drug-eluting
stent product

FDA issues correction on patient examination and surgeons' gloves test procedures and acceptance criteria

Showdown looms in congress over drug advertising on TV

Norovirus strikes 100 guests, closes Dulles hotel

The Hilton Washington Dulles Airport hotel closed for the weekend so crews could scrub and sanitize every surface after about 120 employees and guests were sickened by the highly contagious norovirus. Workers from a professional cleaning company prepared to scrub every nightstand and counter twice with a chlorine bleach solution. The crew will also clean carpets and drapes and mist each room with a disinfectant. Even a very small amount of the virus can cause infection. It survives prolonged periods on such surfaces as counters and door handles, and it can become airborne under some circumstances. Some common disinfectants -- such as alcohol-based waterless hand scrubs -- won't kill it. The sickened guests and employees complained of gastrointestinal distress, including nausea, vomiting and diarrhea. The Virginia Department of Health said it could have come from one person mingling with others or from an infected worker touching food. Norovirus is named after Norwalk, Ohio, where it sickened numerous elementary school students in 1968. In November, it sickened more than 300 people on a Miami-based cruise liner. Last month, the virus laid low scores of students at Catholic University.

Marc-Alain Widdowson, a medical epidemiologist at CDC, said that "this winter season seems to be worse than previous winter seasons. The last time we had things this bad was 2002-03." Current estimates are that at least half of the more than 75 million annual cases of food-borne illness in the United States are caused by norovirus. About 20 percent of people who go to a doctor because of acute diarrhea are infected with it. The virus is believed to cause 10 times as many cases of diarrhea-and-vomiting illness as the next-most commonly implicated microbe.

Lucy Caldwell, a Virginia Department of Health spokeswoman, said the best way to avoid the misery of norovirus is frequent hand-washing. If you do become ill, disinfect everything you've touched. "Spend time cleaning the toilet, including the handle," Caldwell said. "Clean anything you touch. The soap dish, your phone, the remote control." Norovirus is almost always passed through vomitus or feces. Perhaps as few as 10 virions -- individual virus particles -- are enough to cause infection. The incubation period is usually a day or more. Three-quarters of people report vomiting and diarrhea, although only one-third have fever, and symptoms usually last about five days. (Washington Post)

Rush researchers identify antihypertensive drugs that facilitate and/or prevent diabetes

Patients with high blood pressure are more likely to develop new-onset diabetes than those who don't have hypertension, but this tendency is often attributed to higher weight, recent weight gain, or stronger family history of diabetes among those with high blood pressure. Doctors have known since 1958 that some drugs used to control high blood pressure have the side effect of increasing blood sugar and causing new-onset diabetes.

Researchers at Rush University Medical Center have found significant differences between antihypertensive drugs. ACE-inhibitors and the newer angiotensin receptor blockers, or ARBs prevent people from getting diabetes, and the older diuretics or beta-blockers, increase the chance that a person becomes diabetic, compared to either placebo or calcium channel blockers according to a study published in the January 20, 2007 issue of The Lancet. Their analysis found that the lowest risk of new-onset diabetes occurred with ARBs or ACE-inhibitors, followed by calcium channel blockers or, and highest with beta-blockers or diuretics.

The study is expected to be of greater interest in the United Kingdom than the United States, because the British National Institute of Health and Clinical Excellence issued a new set of guidelines about hypertension treatment for primary care physicians in June 2006 that are based on economic considerations. Because diabetics generate about 4 times the healthcare expenditures as non-diabetics, the new British guidelines recommend against using both a diuretic and a beta-blocker for the routine treatment of hypertension. In the United States, however, tradition and the 2003 national hypertension guidelines still recommend a diuretic as first-line treatment, and a beta-blocker only one of several acceptable second-line options.

Mayo selects point-of-use solutions from PAR Excellence

PAR Excellence Systems Inc. announced that they have signed an agreement with the Mayo Clinic, Rochester, MN, making PAR Excellence the point-of-use solutions provider for Mayo. Point-of-use solutions allow hospitals to capture supply usage when dispensed. PAR Excellence has been providing technology based and customizable supply chain solutions in the healthcare industry for the last fourteen years. www.parexcellencesystems.com

Study on nicotine levels stirs calls for new controls

A Harvard study concluding that cigarette makers have for years deliberately increased nicotine levels in cigarettes to make them more addictive led to renewed calls Thursday for greater federal oversight of the industry. Senator Edward M. Kennedy, the Massachusetts Democrat who is now chairman of the Senate Health, Education, Labor and Pensions Committee, promised to reintroduce within weeks a bill that would allow the Food and Drug Administration to regulate cigarettes. Mr. Kennedy said the Harvard study, which was released last week, “is dramatic new proof that Big Tobacco is addicted to addicting millions of young smokers.” (see HPN’s Daily Update for the original study http://hpnonline.com/dailyupdates/January_07.html)

Philip Morris, the nation’s largest cigarette maker, released a statement last Wednesday taking issue with the Harvard study but saying the company supported Mr. Kennedy’s bill. The company, which is owned by the Altria Group, said its own reports showed that nicotine yields for its top-selling Marlboro brand were the same in 2006 as they were in 1997. Changes between those years, it said, “reflect that there are random variations in cigarette nicotine yields.” The Harvard researchers analyzed data only through 2005, although they promised to include 2006 figures in future analyses. Dr. Gregory Connolly, a professor at the Harvard School of Public Health who was a leader of the study, said there was nothing random about the growth in nicotine yields, which occurred across all cigarette brands and makers.

Cigarette makers have for decades denounced scientific efforts to measure the byproducts and effects of cigarette smoking. And for decades, experts have been arguing over the best ways to measure smoke from smoking. One common way has been to use machines to mimic smoking. For years, these tests were done at the Federal Trade Commission. In recent years, however, government regulators have asked cigarette makers to do these machine tests themselves. And beginning in 1997, Massachusetts regulations required cigarette makers to file an annual report with health regulators on the results of these tests.

The Harvard group found that nicotine yields from smoking had increased each year from 1998 through 2005, by about 11 percent altogether. In August, in a racketeering suit brought by the Justice Department against the tobacco industry, a federal judge found that tobacco companies had for decades “manipulated the use of nicotine so as to increase and perpetuate addiction.”

In ordering strict new limitations on tobacco marketing, the judge, Gladys Kessler of Federal District Court for the District of Columbia, also said that for decades, tobacco companies had “lied, misrepresented and deceived the American public.” Dr. Richard Hurt, director of the Mayo Clinic’s nicotine dependence program, said he had reviewed the Harvard analysis and found it credible. And Dr. Hurt said documents disclosed in litigation against the industry showed that cigarette makers closely controlled the nicotine content of their products. “If anyone thinks that tobacco companies have changed for the better and are now reformed, I have some beachfront property in Nebraska I’d like to sell them,” he said. (New York Times)

FDA approves shelf life longer than any competing drug-eluting
stent product

Boston Scientific Corporation has announced that the U.S. Food and Drug Administration (FDA) has approved extending the shelf life of its TAXUSR Express(2)T paclitaxel-eluting coronary stent system in the United States to 18 months from the current shelf life of 12 months. The decision was based on data submitted by Boston Scientific to the FDA that demonstrated the performance of the TAXUS Stent -- in particular the drug content, drug degradation profile and drug-release -- was maintained within FDA-approved specifications at 18 months. The newly approved TAXUS Stent U.S. shelf life is longer than any competing drug-eluting stent product. The extended expiration date applies to all available sizes of the TAXUS Stent for sale in the United States. The Company said it would immediately begin updating labels to reflect the 18-month expiration date. The shelf life for the TAXUS Stent outside the United States remains unchanged at 18 months. Click here for the complete story.

FDA issues correction on patient examination and surgeons' gloves test procedures and acceptance criteria

The Food and Drug Administration (FDA) is correcting a final regulation that appeared in the Federal Register of December 19, 2006 (71 FR 75865). The document issued a final regulation that improves the barrier quality of medical gloves marketed in the United States (U.S.). The rule will accomplish this by reducing the current acceptable quality levels (AQLs) for leaks and visual defects observed during FDA testing of medical gloves. The document was published with some errors in the use of references. This document corrects those errors. The objective of the final rule is to reduce the risk of transmission of blood-borne pathogens (particularly human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infections). The rule accomplishes this objective by ensuring that medical gloves (surgeons' and patient examination gloves) maintain a high level of quality with respect to the level of noted defects.

The CDC reported that between 1992 and 2002 there had been 56 identified incidents of occupational transmission of the HIV pathogen and all but 7 of these cases (12.5 percent) were due to percutaneous cuts or needlesticks. In addition, there were 138 other cases of HIV infection or AIDS among health care workers with occupational exposures to blood who had not reported other risk factors for HIV infection. Assuming the same 12.5-percent rate for these workers implies that 17 additional cases of HIV transmission to health care workers during this period might have been caused by cutaneous contact in an occupational setting. Consequently, a total of 24 incidents of occupational transmission of HIV to health care personnel may have occurred over the 10-year period (or 2.4 per year) due to problems with the barrier protection properties of gloves used in health care settings. CDC analyses communicate that a large portion of HBV infections in health care personnel are the result of direct or indirect blood or bodily fluid exposures that inoculated HBV into cutaneous scratches, abrasions, burns, other lesions, or on mucosal surfaces. Because 2.4 of the 7.3 annual HIV cutaneous contact transmissions (33 percent) were believed to be attributable to glove defects, FDA similarly expects about one-third of the 140 annual occupational transmissions of HBV infections (approximately 40 cases) may potentially be associated with the current quality level of medical gloves. If only 6 percent of these cases develop chronic conditions, then an average of 2.4 annual cases of chronic HBV are associated with defective medical gloves.

The previous AQL (being replaced by this rule) for medical gloves allowed a defect rate of 4.0 percent for patient examination gloves and 2.5 percent for surgeons' gloves. The AQL represents the proportion of sampled gloves from a given lot that may include defects such as leaks or foreign material and still be accepted for entry into the marketplace. Currently, if more than 4 percent of the sampled patient examination gloves exhibit defects in accordance with the sampling criteria, the entire lot of gloves is considered adulterated. Surgeons' gloves are sampled to a higher quality level (lower AQL requires a higher proportion of non-defective gloves in order to pass inspection), because these products have a higher likelihood of contact with bodily fluids. Of course, medical glove lots that fail to meet the AQL may be marketed as household or other products. Lots initially found to be out of compliance are either resampled and subsequently offered as medical devices after meeting the current AQL, offered as nonmedical gloves, or sold in foreign markets.

Approximately 39.5 billion medical gloves were imported into the United States during 2004. According to FDA records, there are over 400 manufacturers of medical gloves. Malaysian manufacturers supply almost 40 percent of the medical gloves in the United States while Thailand manufacturers supply approximately 30 percent. Surgeons' gloves accounted for only about 15 percent of all imported medical gloves during 2004. FDA expects the demand for medical gloves to increase by the same rate as employment in the medical services industry. The Bureau of Labor Statistics has projected annual employment growth of 2.6 percent for this industry, which implies an annual volume of over 50 billion medical gloves in 10 years. (A 2.6 annual growth rate results in an expected increase of 29.3 percent in 10 years.)
Click here for the complete story.

Showdown looms in congress over drug advertising on TV

Drug advertising aimed at consumers, a fast-growing category that reached $4.5 billion last year, will face hard scrutiny in the new Congress, according to industry critics in both the House and Senate. The consumer ads will be on the griddle early in this session at hearings on the user fees that manufacturers pay to speed the reviewing of new drugs by the Food and Drug Administration. The user fee law will die in the fall unless Congress acts to renew it. The pharmaceutical industry, which often gets what it asks for from Congress and the executive branch, seeks to renew the law and add a new set of user fees that would be pay salaries for additional F.D.A. employees to evaluate all consumer drug ads, before they are shown on television. Both the industry and its critics agree that there should be a pause before the advertising starts — to allow time for doctors to learn about a new drug. The companies want the delay to be left up to them, but critics say the FDA should require a wait of up to two years. Criticism of direct-to-consumer advertising has intensified since 2004, after Merck withdrew Vioxx, a heavily advertised painkiller, after a clinical trial showed that it sharply increased the risk of heart attacks and strokes.

Spending on consumer drug advertising, meanwhile, has been growing, from $1.1 billion in 1997 to $4.2 billion in 2005, according to a recent report to Congress by the Government Accountability Office(GAO). In the first nine months of 2006, spending rose 8.4 percent to $3.29 billion, on track toward $4.5 billion for the year, according to TNS Media Intelligence, an advertising research firm. Two independent government watchdog groups sharply criticized consumer drug advertising recently, and a separate survey Jan. 9 commissioned by the PricewaterhouseCoopers accounting and consulting firm indicated that skepticism is widespread among the public, too. Only 1 in 10 consumers said the direct-to-consumer, or D.T.C., ads could provide useful information to a large audience, the survey said. (Consumer drug advertising is not permitted in most of the world, except New Zealand and the United States.)

Voluntary guidelines for consumer ads took effect last year. Under the guidelines, the companies have promised to hold off on consumer advertising of a new medicine for an unspecified “appropriate” period. That would allow time to tell doctors about risks and benefits, before television and Web site viewers see an ad and demand a prescription. Twenty-seven members of the pharmaceutical manufacturers organization have endorsed the guidelines, but it is hard to figure exactly how long the delays in advertising will run. Bristol-Myers Squibb has said that it would delay for 12 months. Johnson & Johnson and Pfizer said they would wait six months. The manufacturers group cannot say how other companies have interpreted the guidelines, a spokesman said. Critics say that even after FDA approval, the full safety profile of a new drug cannot be known until it has been widely used for a number of years. But the manufacturers’ guidelines have to be voluntary, said Daniel E. Troy, a former chief counsel of the FDA, because the Supreme Court has “struck down restrictions on advertising of tobacco, alcohol, gambling and unapproved compounded drugs.” Corporate lawyers say such advertising is protected by the First Amendment under a doctrine of commercial free speech. But some experts say the limits of the protection are murky.

“It is a giant game of chicken between the government and the industry,” said R. Alta Charo, a law professor and bioethics specialist at the University of Wisconsin in Madison. “I don’t believe either side really wants to see a definitive case go to the Supreme Court because neither side is willing to take the risk that they will lose.” Professor Charo was a member of a committee of experts of the Institute of Medicine, which examined drug safety issues at the request of the FDA. Last fall, the committee called on Congress to give the FDA new authority over advertising, including the power to require a two-year moratorium on advertising before approving a new drug. FDA regulators would be granted the power to require moratoriums under a bill sponsored by Senators Edward M. Kennedy and Michael B. Enzi, the chairman and ranking Republican member of the Senate Health, Labor, Education and Pensions Committee. The GAO said last November that the FDA should be doing a better job of overseeing consumer drug ads. Now, the FDA reviews only a small fraction of the advertising, picking and choosing without proper priorities, the GAO said. The GAO report had been requested by three influential senators: Bill Frist, a doctor, before he stepped down as Republican leader of the Senate; Charles E. Grassley, now the ranking Republican on the finance committee, and Herb Kohl, a Democrat who heads an appropriations subcommittee that oversees the FDA. FDA officials said they had to deal with 54,000 drug promotions each year, aimed at both doctors and consumers. Click here for the complete story. (New York Times)  

Measles deaths fall by 60 per cent

Hayes CEO to discuss evidence standards for healthcare interventions at IOM workshop

New hand sanitizing wipes help kids stay healthy

FDA Warns Doctor Over Stem Cell Implants

Survey:  Hospital overcrowding issues increased over last year creating patient flow

Gene map unraveling tricks of trichomoniasis

Simple diagnostic test detects genetic signs of lung cancer in a patient's sputum
 

Measles deaths fall by 60 per cent

Measles deaths have fallen by 60% worldwide since 1999 – a major public health success. This exceeds the United Nations goal to halve measles deaths between 1999 and 2005 and is largely due to an unprecedented decline in measles deaths in the African region. The progress was announced today by partners in the Measles Initiative: the American Red Cross, the United States Centers for Disease Control and Prevention (CDC), the United Nations Foundation, UNICEF and the World Health Organization (WHO). According to new data from WHO, global measles deaths fell from an estimated 873 000 deaths in 1999 to 345 000 in 2005. In Africa, the progress has been even greater, with measles deaths falling by 75%, from an estimated 506 000 to 126 000. The data will be published in this week’s edition of The Lancet.

The 75% reduction in measles deaths in Africa is due to the firm commitment and resources of national governments, and support from the Measles Initiative. It is described as “a spectacular achievement,” by Mr U Olanguena Awono, Minister of Public Health, Cameroon. “We are winning the fight against measles, which has long killed, sickened and disabled our children. Our determination is stronger than ever to make measles history by further strengthening our measles control activities, working in concert with our international partners and setting aside resources.”

A strategy to reduce measles mortality, consisting of four components, has been key to ensuring the massive global decrease in measles deaths. The strategy calls for the provision of one dose of measles vaccine for all infants via routine health services; a second opportunity for measles immunization for all children, generally through mass vaccination campaigns; effective surveillance for measles; and enhanced care, including the provision of supplemental vitamin A. As a result of this strategy, between 1999 and 2005 global measles immunization coverage with the first routine dose increased from 71% to 77%, and more than 360 million children aged nine months to 15 years received measles vaccine through immunization campaigns.

“One of the clearest messages from this achievement is that with the right strategies and a strong partnership of committed governments and organizations, you can rapidly reduce child deaths in developing countries," said Dr Julie Gerberding, Director, United States Centers for Disease Control and Prevention (CDC). Accelerated measles control activities are contributing to the development of health infrastructure to support routine immunization and other health services through promotion of safe injection practices, increased ‘cold chain’ capacity for vaccines storage, and the development of a global public health laboratory network. In addition, measles vaccination campaigns are contributing to the reduction of child deaths from other causes. They have become a channel for the delivery of other life-saving interventions, such as bednets to protect against malaria, de-worming medicine and vitamin A supplements. Combining measles immunization with other health interventions is a contribution to the achievement of Millennium Development Goal Number 4: a two thirds reduction in child deaths between 1990 and 2015.

There is still some way to go in the fight against one of the world’s most contagious diseases. Of the estimated 345 000 measles deaths in 2005, 90% were among children under the age of five – many dying as a result of complications related to severe diarrhoea, pneumonia and encephalitis. The challenge now is to reach a new global goal: the reduction of global measles deaths by 90% by 2010, compared to 2000 levels. This means that the gains made in countries that have implemented accelerated measles control strategies must be sustained, and similar strategies must be implemented in countries with high numbers of measles deaths, such as India and Pakistan.

Hayes CEO to discuss evidence standards for healthcare interventions at IOM workshop

Dr. Winfred S. Hayes, president and CEO of Hayes Inc., has accepted an invitation to serve as a panelist at an upcoming workshop on Judging Results: Standards of Evidence for Healthcare Interventions. Conducted by the prestigious Institute of Medicine of the National Academies’ Roundtable on Evidence-Based Medicine, the workshop will convene at 8:30 a.m., February 5, 2007 at the Keck Center of the National Academies, 500 5th St. NW, Washington, D.C. The workshop will explore the different methods currently used in judging evidence on the effectiveness of healthcare interventions, how those methods may vary according to different factors such as burden of the disease being treated, and other issues that need to be considered when evaluating the clinical benefit of an intervention. With extensive experience in health technology assessment and public policy issues, Dr. Hayes will participate in a panel discussion of Evidence and Its Synthesis in Current Practice. Scheduled for 9:00 a.m. to 10:30 a.m., the session will examine current practices in evidence synthesis, perceived differences in evidence standards for different applications, use of different forms of evidence in synthesis, variation in how interventions are considered, and means to better harmonize approaches. For further information on the Institute of Medicine’s February 5 workshop and to register at no charge, CLICK HERE.

New hand sanitizing wipes help kids stay healthy

In an effort to promote the importance of hand hygiene and reduce absenteeism, PDI, the healthcare division of Nice-Pak Products Inc. introduces Sani-Hands for Kids Instant Hand Sanitizing Wipes. “Proper hand hygiene for children is the single most important mean for preventing the spread of infection in schools and healthcare facilities,” states Jean Fleming, R.N., MPM, CIC - Infection Prevention Education Manager for PDI. Sani-Hands for Kids pre-moistened wipes kill 99.99% of germs, more than gels or rub-in alcohol handwashes. “As children and adults use the wipes,” explains Fleming, “the friction caused by wiping physically removes bacteria and dirt on the surface of hands, which gels don’t do.” Sani-Hands for Kids Instant Hand Sanitizing Wipes are now available to schools, childcare facilities, childrens' hospitals and pediatric and dental offices. To minimize the drying effects of alcohol and moisturize the skin, the pre-moistened wipes contain emollients such as aloe, glycerin and vitamin E. Easy and fun to use, Sani-Hands for Kids wipes are available in 220-count and 135-count canisters as well as individual “on-the-go” packets.

FDA Warns Doctor Over Stem Cell Implants

A Las Vegas doctor has been implanting stem cells harvested from placentas into patients with multiple sclerosis, muscular dystrophy and other diseases in violation of federal law, according to a warning letter released by health officials Thursday. Dr. Alfred Sapse failed to properly obtain, store, test and process the placentas, as well as screen both the suitability of the donors and the patients given the human tissue, according to the Food and Drug Administration letter. At least 16 patients received the stem cells, the FDA said. Sapse also failed to obtain or even seek federal approval to carry out the procedures, done by at least one doctor under his direction, according to the FDA.

Oversight of implants of stem cells and other types of tissue is important to avoid infecting patients with viruses or bacteria. Furthermore, Sapse didn't allow an FDA investigator to see and copy records on his implant patients during a July 6, 2006, agency inspection of his firm, Stem Cell Pharma Inc., the letter said in part. The FDA released the letter, dated Nov. 22, 2006, on Thursday. The letter demands that Sapse outline what steps he has taken or will take to correct the violations and prevent them from recurring.

Sapse claims on his Web site to have carried out 42 stem cell implants on patients with MS, Alzheimer's, muscular dystrophy, cerebral palsy and other disorders, as well as to combat the effects of aging. Sapse, a Romanian-trained ophthalmologist, charges $6,000 per procedure. He touts "70 percent improvements, some very impressive."

Since the late 1980s, doctors have used blood from the placenta and umbilical cord as a source of adult stem cells. The cells develop to form the major components of blood: infection-fighting white blood cells, oxygen-carrying red blood cells and clot-forming platelets. Because of that ability, they're frequently transplanted, typically in children, to treat blood disorders like leukemia and lymphoma. Adult stem cells are not the same as embryonic stem cells, which can form any type of cell in the body.

 

Survey:  Hospital overcrowding issues increased over last year creating patient flow

A new survey of top hospital executives, administrators and managers across North America reports that seven out of every eight believe that overcrowding has failed to improve at their facilities in the last year. The overcrowding, according to a majority (60%) of more than 200 survey respondents, continues to force hospitals to divert patients needing urgent medical care to other facilities. The survey, commissioned last month by TeleTracking Technologies and the American College of Emergency Physicians (ACEP), reports more than 80 percent of respondents say overcrowding is one of their top five management concerns. It also reveals that more than 70 percent of the administrators who responded say that while their facilities have a stated goal of admitting patients from their Emergency Department within two hours of arrival, almost half (48%) fail to meet that goal more than half the time.

The good news, according to the survey results, is that the executives and administrators say they are increasingly optimistic about their organizations’ ability to manage the flow of patients through their hospital, to reduce overcrowding and manage costs. An overwhelming majority (94%) said they believe that technology, either by itself or in combination with changes in staff and processes, can reduce overcrowding. “While the challenges facing health care organizations continue to grow, we are seeing positive signs that the organizations are working to bring those challenges under control,” said Anthony Sanzo, Tele-Tracking’s Chief Executive Officer. “An increased focus on ensuring that patient flow issues are aggressively addressed gives hospitals the ability to relieve overcrowding in a timely manner.”

Sanzo noted, however, that 57 percent of survey respondents said they are considering expanding bed capacity to relieve patient flow challenges, with a virtually identical number (58%) saying added capacity is either at the top or near the top of their priority list. “While there is no question that we will need increased capacity to meet the future needs of our healthcare system, technology-based solutions can lessen long-term capital expenditures and have an immediate positive impact on patient flow,” Sanzo added. Adding bed capacity through “brick and mortar” expansion can be especially costly for health care organizations, which consistently face financial challenges. By contrast, an Advisory Board study states that “a typical 300 bed hospital moving from the bottom quartile of Average Annual Bed Turns (annual admission divided by average staffed beds) to the top quartile in bed efficiency could yield 4,500 additional admissions and well over $10 million in revenue annually.”  The survey also reveals that: 28 percent of respondents said their organizations have had to postpone or cancel surgeries because of bed shortages; and; 80 percent of reporting organizations said they have a standing committee that addresses patient flow issues, underscoring its importance.

Gene map unraveling tricks of trichomoniasis

The tiny parasite undulates under the microscope like some creature from a sci-fi movie, but this one is all too real, latching onto the sexually unwary with tentacle-like probes. Now scientists have mapped the genes of the nasty little bug that causes one of the world’s most common, and arguably least recognized, sexually transmitted infections, one with the tongue-twisting name of trichomoniasis. Researchers hope the work will bring new attention to a parasite estimated to infect 170 million people a year worldwide, including 8 million in North America, and one emerging as a player in the spread of the AIDS virus. “There are a huge number of people infected out there, but they don't know it so you don’t know it,” warned Dr. Jane Carlton, a parasite specialist who led the four-year effort by The Institute for Genomic Research to crack the bug's genome. The work is published in the journal Science. Most sexually transmitted infections are caused by viruses or bacteria. A microscopic, single-celled protozoan named Trichomonas vaginalis causes this one. The good news: "Trich," as it's short-handed, is easily curable, with a drug called Flagyl. The bad news: Many cases go undiagnosed and thus continue spreading trich, plus the parasite is starting to develop resistance to the drug. Both men and women can be infected, although trich is more common in women. But men usually suffer no symptoms, while about half of women do, reporting such problems as vaginal itching and a fishy-smelling frothy discharge. During pregnancy, trich can cause premature birth or low-weight babies. It's linked to pelvic inflammatory disease. But trich's real threat is that it quietly increases women's vulnerability to HIV, by altering the lining of the vagina so that it's easier for the AIDS virus to sneak in. Trich also seems to increase the chances that people who already have HIV spread it, enhancing that virus in different ways. “It is a bad actor,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which funded the genome work. The genetic mapping “is a very strong step in the right direction with regard to a parasite we still have not fully appreciated,” he added. (The Associated Press)

Simple diagnostic test detects genetic signs of lung cancer in a patient's sputum

DNA coughed up along with phlegm could point to lung cancer, say researchers at the University of Maryland School of Medicine who are developing an inexpensive and non-invasive gene probe to help diagnose early stage lung cancer in current and former smokers. In the January 15 issue of Clinical Cancer Research, the researchers report that their fledgling test, designed to check whether two genes believed to be tumor suppressors are deleted in cells found in sputum, identified 76 percent of stage I lung cancer patients whose tumors also showed the same genetic loss. Existing sputum "cytology" tests, which look for changes in cell structure, identified only 47 percent of the patients, they say. While no other simple sputum analysis has found such a high correlation with lung cancer, it is not yet good enough for the clinic, researchers say, and so they are now expanding their test to screen for up to eight genes.

"There is an urgent need to develop reliable early diagnostic biomarkers for lung cancer that can be detected non-invasively, and these two genes look to be great candidate markers for such a test," said Feng Jiang, M.D., Ph.D., assistant professor of pathology at the University of Maryland School of Medicine. "We need to validate our findings, of course, but we have shown that the genetic aberrations seen in sputum reflect the same genetic aberrations found in lung tumors, and that these molecular changes occur before any morphological changes can be seen in a cytology test. Most heavy smokers never develop lung cancer, even though cells in their airways show genetic damage," Jiang said. "The trick is to find the genes that are only cancer related." He went on to say, "As a diagnostic tool to identify early stage lung cancer patients who would then benefit most from curative therapies, FISH is very cheap and convenient. The technique may be also useful in monitoring lung cancer patients for response to treatment, disease progression and early evidence of relapse in the future."  

Second drop in cancer deaths could point to a trend

New software could help people with multiple prescriptions

More aid required for chronic conditions in low income countries

Risk of stroke expected to decrease with new screening guidelines

Study uncovers a lethal secret of 1918 influenza virus

Reanalysis of cigarettes confirms tobacco companies increased addictive nicotine 11 percent

Pap Test, a mainstay against cervical cancer, may be fading
 

Second drop in cancer deaths could point to a trend  

The number of cancer deaths in the United States has dropped for the second year in a row, the American Cancer Society reported yesterday. The finding suggests that the small drop reported last year — the first in more than 70 years — was real, possibly the start of a continuing decrease and not merely a statistical fluke, researchers said. Much of the decrease is due to smoking cessation and improved detection and treatment of colorectal, breast and prostate cancers. But it has taken enormous efforts and ingenuity to produce relatively small gains.

From 2003 to 2004, cancer deaths fell by 3,014, considerably more than the previous year’s decline, 369. (These are the latest years for which figures are available.) Although the drop is notable, it still pales in comparison with the number of cancer deaths, 553,888 in 2004. Cancer is the second leading cause of death in the United States, after heart disease. By far the greatest decreases in mortality have been in colorectal cancer — 1,110 fewer deaths in men, 1,094 fewer in women.

Dr. Alfred I. Neugut, the director of cancer prevention and control at Columbia University Medical Center, said colorectal screening was comparable to the Pap test, which led to an 85 percent decrease in the incidence of cervical cancer in this country. Improved treatment has also played a part in lowering the death rate from colorectal cancer, Dr. Neugut said. “There was a revolution in treatment between 1998 and 2000, and revolution is a mild word,” he said. “We went from having one drug to having six or seven good drugs. The cure and survival rates have increased dramatically as a result. The cost of care has also gone up, but you get what you pay for.”

One great concern, Dr. Ward said, is that African-Americans have markedly higher death rates than whites from nearly every type of cancer. Researchers do not fully understand why. Having less income, education and access to health care account for much of the difference, but not all of it, researchers say. The report also notes differences with other racial groups. American Indians and Alaska natives have the highest incidence and death rates from kidney cancer, but the reason is not known. Compared with whites, Pacific Islanders and Asian-Americans have a higher incidence and death rate from stomach and liver cancers. The main reason is that they are more likely to be exposed to the hepatitis B virus, which can cause a chronic liver infection that leads to cancer, and to the bacterium Helicobacter pylori, which can lead to ulcers and stomach cancer.

Lung cancer is still the leading cause of cancer mortality in the United States, with 160,390 deaths expected in 2007. In men, deaths have been decreasing, but in women they are still increasing slightly, because women quit smoking later.

Breast cancer incidence, which had been climbing steadily for decades, has leveled off. One reason may be that many women abandoned menopausal hormone treatment after a major study in 2002 found that it increased the risk of breast cancer. Another reason may be that rates of mammography — and therefore of new diagnoses — have also leveled off. Death rates have been decreasing, but in women ages 20 to 59, breast cancer is still the leading cause of cancer death.

Death rates from a few other cancers have increased. One is esophageal cancer in men, an increase Dr. Ward said was probably linked to obesity. Being overweight increases the risk of acid reflux, in which stomach acid backs up into the esophagus, causing a chronic inflammation that can eventually lead to cancer. Liver cancer has also increased in both men and women, almost certainly because of hepatitis viruses; about 3 million people in the United States have chronic hepatitis C infections, and 1.25 million have chronic hepatitis B. Hepatitis B is especially common among Asian immigrants, many of whom were infected at birth. But obesity may also raise liver cancer rates, Dr. Ward said. CLICK HERE for the complete story. (New York Times)

New software could help people with multiple prescriptions

Multiple prescriptions can be confusing: knowing which pill is which, when to take what medication and what pills have special instructions. A Medical College of Georgia physical therapist and associate dean wants to reduce consumer confusion with software that creates a calendar-like printout every time a prescription is filled.

Medication errors lead to an increase in doctor's visits and hospitalizations, which drive up health care costs. With $25,000 in VentureLab funding from the Georgia Research Alliance, Dr. Guion is working with an independent consultant to test and market a program that allows patients to print out a "calendar-type" listing of their current medications. The goal is to help them remember often-complicated prescription schedules. "The printout also shows warnings about similar-looking pills to protect patients from taking the wrong medication," he says. The computer program interfaces with computer software at major pharmacies.

"The idea is that pharmacists won't have to do any extra work," Dr. Guion says. "When the prescription comes in, they can scan it and the calendar printout will automatically generate. It won't require any extra keystrokes."

He is testing an early version of the program in an independent North Carolina pharmacy.  Eventually, Dr. Guion says, the program could be tailored to online pharmacies where 20 percent of Americans now fill their prescriptions, or targeted toward individuals who could use the program on their home computers.

More aid required for chronic conditions in low income countries

In an article published in the January 18, 2007, issue of the New England Journal of Medicine, Gerard Anderson, PhD, professor in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health, highlights the need for more international assistance to address chronic non-communicable conditions affecting people living in low and middle income countries. According to Anderson, chronic conditions such as cardiovascular disease and cancer result in more deaths and account for more years of healthy life lost than most communicable diseases, and yet little international aid is focused on preventing or treating these conditions. For instance, cardiovascular disease is the cause of 30 percent of all deaths globally and 27 percent of deaths in low income countries. By comparison, HIV/AIDS, tuberculosis and malaria, combined, account for 10 percent of all deaths globally and 11 percent of death in developing countries. Prevention and treatment programs for non-communicable chronic diseases are possible at relatively low cost-per-life saved or disability prevented.

"It's a myth that chronic diseases affect only rich countries. Despite the fact that a substantial burden of disease in the world's poorer countries is caused by non-communicable chronic diseases, most international aid is focused primarily on preventing and treating infectious diseases," said Anderson, author of the article, which he co-authored with Ed Chu, a medical student at the Johns Hopkins School of Medicine. "Treating infectious diseases must remain a priority, but additional resources should be committed towards treating and preventing non-communicable chronic conditions if we want to address global health needs effectively and address the major reasons for premature mortality in the world."

Anderson suggests a number of reasons why international aid has historically focused on controlling infectious diseases. For one, infectious diseases pose an international threat if they spread uncontrolled. Another is that many donors want a permanent solution such as a vaccine that may not be possible with non-communicable chronic diseases. Also, chronic conditions are rarely viewed as urgent problems in low income countries and generally do not attract the attention of celebrities.

Risk of stroke expected to decrease with new screening guidelines

For the first time, a set of screening guidelines for the detection of carotid stenosis, the thickening of the blood vessel that supplies blood to the brain and a leading cause of stroke, has been developed by a multidisciplinary committee of internationally recognized neurologists and surgeons. These guidelines will help reduce the death and disability rates associated with stroke by identifying carotid stenosis in a timely manner, allowing treatment before a stroke occurs. These guidelines appear in the latest issue of Journal of Neuroimaging.

Approximately two million people living in North America and Europe are currently at risk for stroke and could dramatically benefit from a thorough and effective screening procedure. "The guidelines will help to reduce the incidence of stroke through early detection in up to one-fifth of the high risk patients who undergo screening procedures as outlined," says Dr. Adnan I. Qureshi, lead author of the guidelines.

Screening recommendations are provided for high risk persons in the general population; patients undergoing open heart surgery including coronary artery bypass surgery; patients with peripheral vascular diseases, abdominal aortic aneurysms, and renal artery stenosis; patients after radiotherapy for head and neck malignancies; patients following carotid endarterectomy, or carotid artery stent placement; patients with retinal ischemic syndromes; patients with syncope, dizziness, vertigo or tinnitus; and patients with family history of vascular diseases and hyperhomocysteinemia.

Study uncovers a lethal secret of 1918 influenza virus

In a study of non-human primates infected with the influenza virus that killed 50 million people in 1918, an international team of scientists has found a critical clue to how the virus killed so quickly and efficiently. A team led by University of Wisconsin-Madison virologist Yoshihiro Kawaoka reveals how the 1918 virus - modern history's most savage influenza strain - unleashes an immune response that destroys the lungs in a matter of days, leading to death. The finding is important because it provides insight into how the virus that swept the world in the closing days of World War I was so efficiently deadly, claiming many of its victims people in the prime of life. The work suggests that it may be possible in future outbreaks of highly pathogenic flu to stem the tide of death through early intervention.

The study "proves the 1918 virus was indeed different from all of the other flu viruses we know of," says Kawaoka, a professor in the UW-Madison School of Veterinary Medicine and at the University of Tokyo. By infecting monkeys with the virus, the team was able to show that the 1918 virus prompted a deadly respiratory infection that echoed historical accounts of how the disease claimed its victims. Importantly, the new work shows that infection with the virus prompted an immune response that seems to derail the body's typical reaction to viral infection and instead unleashes an attack by the immune system on the lungs. As immune cells attack the respiratory system, the lungs fill with fluid and victims, in essence, drown. The mechanisms that contribute to the lethality of the virus were uncovered by University of Washington researchers using functional genomics, a technique in which researchers analyze the gene functions and interactions. Learning more about the virulence mechanisms of the 1918 flu virus may help researchers understand how to keep the virus from causing such a severe immune response.

The same excessive immune reaction is characteristic of the deadly complications of H5N1 avian influenza, the strain of bird flu present in Asia and which has claimed nearly 150 human lives but has not yet shown a capacity to spread easily among people. "What we see with the 1918 virus in infected monkeys is also what we see with H5N1 viruses," Kawaoka says, suggesting that the ability to modulate immune response may be a shared feature of the most virulent influenza viruses. Knowing that the virus does something early in infection to trigger such a devastating immune response may provide biomedical researchers with clues about how to intervene and stop or mitigate the virus' potentially lethal effects, Kawaoka says.

Reanalysis of cigarettes confirms tobacco companies increased addictive nicotine 11 percent

A reanalysis of nicotine yield from major brand name cigarettes sold in Massachusetts from 1997 to 2005 has confirmed that manufacturers have steadily increased the levels of this agent in cigarettes. This independent analysis, based on data submitted to the Massachusetts Department of Public Health (MDPH) by the manufacturers, found that increases in smoke nicotine yield per cigarette averaged 1.6 percent each year, or about 11 percent over a seven-year period (1998-2005). Nicotine is the primary addictive agent in cigarettes. In addition to confirming the magnitude of the increase, first reported in August, 2006 by MDPH, researchers from the Harvard School of Public Health (HSPH) analyzed how manufacturers accomplished the increase -- not only by intensifying the concentration of nicotine in the tobacco but also by modifying several design features of cigarettes to increase the number of puffs per cigarette resulting in a product that is potentially more addictive. They also discovered that smoke nicotine yields were increased in the cigarettes of each of the four major manufacturers and across all the major cigarette market categories (e.g. mentholated, non-mentholated, full-flavor, light, ultralight).

Tobacco Control Research Program at HSPH led by program director Gregory Connolly said, "Our findings call into serious question whether the tobacco industry has changed at all in its pursuit of addicting smokers since signing the Master Settlement Agreement of 1998 with the State Attorneys General. Our analysis shows that the companies have been subtly increasing the drug nicotine year by year in their cigarettes, without any warning to consumers, since the settlement. Scrutiny by the Attorneys General is imperative. Proposed federal legislation has been filed by Senator Edward Kennedy (D-Ma.) that would address this abuse and bring the tobacco industry under the rules that regulate other manufacturers of drugs."

The discovery of an 11 percent increase in nicotine content, said Connolly, confirms recent statements by the US District Court for the District of Columbia that manufacturers have the ability to manipulate addictive additives, and, he said, "it underscores the need for continued surveillance of nicotine delivery in products created by an unregulated industry."

Pap Test, a mainstay against cervical cancer, may be fading

The big news in the war on cervical cancer is the new vaccine recently approved to prevent the disease. But another major change that will affect millions of women is also under way, though more slowly and quietly. The Pap smear, an annual ritual for many women and the mainstay of cervical cancer prevention for more than half a century, may start to fade in importance. It will not disappear for many more years, if ever. But a newer genetic test that detects human papillomavirus, or HPV, which causes cervical cancer, is starting to play a bigger role in screening. And other genetic tests are being developed. At the least, some experts say, women will no longer need Pap smears as often.

The new vaccine could also deal a longer-term blow to Pap testing, which works by detecting abnormal cells from the cervix that could be on their way to becoming cancerous. It is not that women would no longer need screening because they had been vaccinated. The vaccine, approved only for girls and women 9 to 26 years old, does not protect against all strains of HPV that cause cancer. If a precancerous lesion is present, the Pap test will detect it only 50 percent to 80 percent of the time. Pap testing is effective only because it is done often; a lesion can take 10 years to turn into a cancer, so a yearly test will probably find it in time. As more women get the HPV vaccine, however, the number of lesions will decline, making the Pap test more costly per cancer case detected. And with fewer problems to detect, said Dr. Eduardo L. Franco, a professor of epidemiology and oncology at McGill University, the technicians who read Pap smears may lower their guard — and their accuracy.

Some gynecologists say having women come for annual Pap testing brings them in for other needed examinations.

The HPV genetic test looks for the DNA of 13 of the cancer-causing strains of the virus. Experts say this test can detect more than 90 percent of precancerous lesions. It is also easier to automate and far less likely to produce ambiguous results. The samples are taken the same way as for a Pap test, meaning women still need to get into stirrups. But since the genetic test is less prone to error, experts say it is possible that in the future women will be able to take their own samples. The test was first approved by the Food and Drug Administration in 1999, and its use has grown steadily, partly spurred by advertising by the test’s manufacturer, Digene, based in Gaithersburg, MD.

Dr. George Sawaya, an associate professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, says about 2,500 to 3,000 cervical cancer cases in the United States each year are in women with normal Pap tests. Digene says it hopes that European countries, which place more limits on medical spending than the United States, will make HPV testing the standard in place of the Pap. European experts disagree on whether that will happen. But Pap testing is likely to be displaced in developing countries, which account for more than 80 percent of the roughly 500,000 new cases of cervical cancer and 275,000 deaths each year. Those countries cannot do efficient Pap screening for lack of laboratories and technicians and difficulty in getting women, who might have to walk miles to a clinic, to come for testing every year. In the developing world, Pap testing has had “basically no impact on cervical cancer rates in any country, ever,” said Jacqueline Sherris, a strategic program leader for reproductive health at PATH, a nonprofit organization in Seattle.

PATH is working with Digene to develop a simpler and cheaper version of the HPV test for developing countries. Women might be tested only once or twice during their 30s but would get fairly good protection, Sherris said. Still other tests are in development. One would determine the specific strain of HPV infecting a woman. Types 16 and 18 account for most cancers (and are the cancer-causing types targeted by the new vaccine). So having one of them would be considered more worrisome. Yet another test would look for the activation of two genes, called E6 and E7. Such activation is believed to be required for a precancerous lesion to turn into cancer. “Looking forward,” said Dr. Wright of Columbia, “the molecular tests are becoming so good that we can see a time when cytology is no longer used as the primary screening test.” (The New York Times)  

January 17, 2007

Link found between periodontal disease and pancreatic cancer

Chemotherapy appears to delay cancer recurrence following surgery for pancreatic cancer

Antivirals effectively curb influenza virus

Study shows a new fat replacement for trans fat raises blood sugar in humans

Advisory: Patients who receive drug-eluting stents should continue antiplatelet medications

Indonesia plans to slaughter hundreds of thousands of chickens to stem H5N1 outbreak

Genesis HealthCare to Be Sold and Taken Private

Link found between periodontal disease and pancreatic cancer

Pancreatic cancer is the fourth leading cause of cancer death in the U.S.; more than 30,000 Americans are expected to die from the disease this year. It is an extremely difficult cancer to treat and little is known about what causes it. One established risk factor in pancreatic cancer is cigarette smoking; other links have been made to obesity, diabetes type 2 and insulin resistance. In a new study, researchers at the Harvard School of Public Health (HSPH) and Dana-Farber Cancer Institute found that periodontal disease was associated with an increased risk of cancer of the pancreas. The study will appear in the January 17, 2007 issue of the Journal of the National Cancer Institute.

"Our study provides the first strong evidence that periodontal disease may increase the risk of pancreatic cancer. This finding is of significance as it may provide some new insights into the mechanism of this highly fatal disease," said lead author Dominique Michaud, assistant professor of epidemiology at HSPH. Periodontal disease is caused by bacterial infection and inflammation of the gums that over time causes loss of bone that supports the teeth; tooth loss is a consequence of severe periodontal disease. Two previous studies had found a link between tooth loss or periodontitis and pancreatic cancer, but one consisted of all smokers and the other did not control for smoking in the analysis, and therefore no firm conclusions could be drawn from these studies.

The results showed that, after adjusting for age, smoking, diabetes, body mass index and a number of other factors, men with periodontal disease had a 63% higher risk of developing pancreatic cancer compared to those reporting no periodontal disease. "Most convincing was our finding that never-smokers had a two-fold increase in risk of pancreatic cancer," said Michaud. One possible explanation for the results is that inflammation from periodontal disease may promote cancer of the pancreas. "Individuals with periodontal disease have elevated serum biomarkers of systemic inflammation, such as C-reactive protein, and these may somehow contribute to the promotion of cancer cells," she said. Another explanation is that periodontal disease could lead to increased pancreatic carcinogenesis because individuals with periodontal disease have higher levels of oral bacteria and higher levels of nitrosamines, which are carcinogens, in their oral cavity. Prior studies have shown that nitrosamines and gastric acidity may play a role in pancreatic cancer.

Chemotherapy appears to delay cancer recurrence following surgery for pancreatic cancer

Use of the drug gemcitabine for chemotherapy significantly delays the recurrence of cancer, compared to no chemotherapy, for patients following pancreatic cancer surgery, according to a study in the January 17 issue of JAMA. With an estimated 232,000 new cases per year, pancreatic cancer is among the most common malignancies worldwide. It is also one of the most lethal cancers, with a mortality incidence ratio of 98 percent, according to background information in the article. Surgery is the only curative treatment option for this type of cancer, though the prognosis still often remains poor. Therefore, surgery alone is an inadequate approach to achieve long-term disease control in patients with resectable (surgically remove a part of an organ) pancreatic cancer.

Helmut Oettle, M.D., Ph.D., of Charite School of Medicine, Campus Virchow-Klinikum, Berlin, Germany, and colleagues conducted a study (CONKO-001) comparing use of the drug gemcitabine with no anticancer drug therapy in patients who had undergone complete resection of pancreatic cancer. Recurrent cancer developed in 74.3 percent in the gemcitabine group and 92 percent in the control group. The estimated median disease-free survival was 13.4 months in the gemcitabine group compared with 6.9 months in the control group.

Antivirals effectively curb influenza virus

Two antiviral drugs, oseltamivir and zanamivir, are highly effective when given as a preventive measure to reduce the spread of the influenza virus, according to an analysis of household-based studies by researchers at Fred Hutchinson Cancer Research Center, University of Michigan and University of Virginia, published in the current print edition of the American Journal of Epidemiology. The analysis also suggests that treatment with oseltamivir may reduce the infectiousness of influenza patients, although further studies are needed to provide a definitive conclusion.

"Preventing the spread of influenza within families is an essential part of influenza management, regardless of the strain. This study shows that there is a clear benefit to be gained by giving antivirals to people who have been exposed to the virus to prevent the onset of symptomatic illness," said lead author M. Elizabeth (Betz) Halloran, M.D., D.Sc., a Hutchinson Center-based biostatistician.

The authors reviewed the effects of each antiviral on infectiousness and pathogenicity – the ability of the influenza virus to cause overt disease. The researchers found that both drugs were highly preventive against influenza illness, with oseltamivir at 81 percent efficacy and zanamivir at 75 percent. Thus, the preventive use of either product reduced by 75 percent to 81 percent the chance that an exposed person would become ill with influenza.

Study shows a new fat replacement for trans fat raises blood sugar in humans

Last month, New York City outlawed the use of partially hydrogenated oils, known as trans fats, in restaurants, a ban now under consideration in other cities, including Boston and Chicago. But novel research conducted in Malaysia and at Brandeis University shows that a new method of modifying fat in commercial products to replace unhealthy trans fats raises blood glucose and depresses insulin in humans, common precursors to diabetes. Furthermore, like trans fat, it still adversely depressed the beneficial HDL-cholesterol. The study demonstrates that an interesterified fat--(a modified fat that includes hydrogenation followed by rearrangements of fats molecules by the process called interesterification) enriched with saturated stearic acid--adversely affected human metabolism of lipoproteins and glucose, compared to an unmodified, natural saturated fat. Interesterification to generate a stearic acid-rich fat that is fast becoming the method of choice to modify fats in foods that require a longer shelf life because this process hardens fat similar to oils containing trans-fatty acids, but the new study shows it can alter metabolism in humans.

"One of the most interesting aspects of these findings is the implication that our time-honored focus on fat saturation may tell only part of the story," explained biologist and nutritionist K.C. Hayes, who collaborated on the research with Dr. Kalyana Sundram, nutrition director for palm oil research at the Malaysian Palm Oil Board in Kuala Lampur. The Malaysian-Brandeis collaboration compared trans-rich and interesterified fats with an unmodified saturated fat, palm olein, for their relative impact on blood lipids and plasma glucose.

"This is the first human study to examine simultaneously the metabolic effects of the two most common replacement fats for a natural saturated fat widely incorporated in foods. As such, it is somewhat alarming that both modified fats failed to pass the sniff test for metabolic performance relative to palm olein itself," noted Sundram. "Whether this reflects the amount of test fat consumed, underlying genetics of the specific population examined, or some unknown factor, requires further study because the apparent adverse impact on insulin metabolism is a troubling finding," he added. For the complete CLICK HERE.

Advisory: Patients who receive drug-eluting stents should continue antiplatelet medications

Patients who have had drug-eluting stents inserted to prop open blocked coronary arteries should continue to take medications to reduce the risk of blood clots for at least one year after the stent is inserted, a new scientific advisory recommends. The American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons and American Dental Association issued the joint advisory today. It will be published in Circulation: Journal of the American Heart Association, Journal of the American College of Cardiology and Catheterization and Cardiovascular Interventions (CCI): Journal of the Society for Cardiovascular Angiography and Interventions.

The medications clopidogrel and ticlopidine are in a class of prescription drugs called thienopyridines. Thienopyridines and aspirin are known as antiplatelet agents. They are begun before stent insertion to reduce the chance of clotting within the stent, which may result in heart attack or death. "Despite this benefit, antiplatelet therapy is sometimes prematurely discontinued within the first year after stent implantation," the advisory warns. This practice is potentially deadly. Stopping antiplatelet therapy too early after a stent is placed is the leading independent predictor of stent thrombosis – blood clots that frequently lead to heart attack and/or death. "Death rates due to presumed or documented stent thrombosis range from 20 percent to 45 percent," the advisory reports.

"We want to alert patients and healthcare professionals that this is a serious medical issue; they shouldn't even think about stopping antiplatelet therapy because it could result in heart attack or death," said Cindy Grines, M.D., chair of the advisory writing committee and a cardiologist at William Beaumont Hospital in Royal Oak, Mich. "If a physician, dentist or surgeon feels that stopping these medicines is absolutely necessary, the patient's cardiologist should be consulted, and the medications should be re-started as soon as possible. Patients are advised to postpone elective procedures if the physician or dentist doing it isn't comfortable with continuing antiplatelet medicine."

The advisory group made the following recommendations to eliminate early discontinuation of dual antiplatelet therapy:  Before implanting a stent, the physician should discuss the need for antiplatelet therapy with the patient. In patients not expected to comply with 12 months of thienopyridine therapy, for whatever reasons, a bare metal stent should be strongly considered.; In patients who are likely to require surgery within 12 months of receiving a stent, a bare metal stent or balloon angioplasty with a provisional stent should be considered instead of routinely using a drug-eluting stent.; Healthcare professionals must make a greater effort to educate patients before hospital discharge about the reasons for prescribing thienopyridines and for taking the dual antiplatelet therapy, as well as the risks for stopping it early.; Patients should be specifically instructed before hospital discharge to contact their cardiologist before stopping any antiplatelet therapy, even if instructed to do so by another healthcare provider.;Healthcare providers who perform invasive or surgical procedures should be made aware of the potentially catastrophic risks of prematurely stopping thienopyridine therapy, and should contact the patient's cardiologist to discuss optimal patient management.;Elective procedures that carry a risk of bleeding should be delayed until a month after the patient has completed an appropriate course of thienopyridine therapy, which is ideally 12 months after receiving a drug-eluting stent in patients who are not at high risk of bleeding, and at least one month after a bare metal stent.; For patients who receive a drug-eluting stent and who must have procedures that mandate stopping thienopyridine therapy, aspirin should be continued if at all possible, and the thienopyridine restarted as soon as possible after the procedure.; The healthcare industry, insurers, congress and pharmaceutical industry should insure that issues such as drug cost do not cause patients to prematurely discontinue thienopyridine therapy and incur catastrophic cardiovascular complications.

Indonesia plans to slaughter hundreds of thousands of chickens to stem H5N1 outbreak

Indonesia plans to slaughter hundreds of thousands of backyard chickens over the next few weeks in a bid to stem a surge in human deaths from the H5N1 virus, the health minister and other officials said today. Indonesia has recorded 61 deaths from bird flu, including four in the last week. Siti Fadilah Supari said local governments would issue regulations banning the rearing of poultry in residential areas, signaling a more forceful approach in the nation worst hit by the virus. She said owners of chickens, ducks and other fowl would receive compensation of just under $1.50 per bird, with the main focus in the capital, Jakarta, and densely populated areas to the west where most of Indonesia's human infections have occurred. The country's cash-strapped government has come under fire for failing to take steps to stamp out the virus and has largely failed to follow through on earlier promises to stamp out the virus through mass slaughters. In an early sign of possible confusion about the campaign, Supari said it would occur within the next week, but Jakarta Governor Sutiyoso said residents would in the capital would have two weeks before officials began forcefully slaughtering birds. Until last week, Indonesia had not recorded any cases for six weeks - a lull that led some Indonesian officials to say they were succeeding in beating the disease. The World Health Organization cautioned that it was too soon to draw that conclusion. (Associated Press)

Genesis HealthCare to Be Sold and Taken Private

The Genesis HealthCare Corporation, which runs long-term care centers, said Tuesday that it would go private in a $1.25 billion deal. A joint venture formed by the private equity firms Formation Capital and JER Partners will acquire the company, based in Kennett Square, Pa. The buyers also will assume $450 million in debt. The deal is expected to close in four to eight months, a spokeswoman said. Genesis HealthCare operates more than 200 skilled nursing centers and assisted living centers in 13 eastern states. It also provides contract rehabilitation therapy to over 600 health care providers in 20 states and Washington. Formation Capital invests in the senior housing and long-term care industry. It is based in Alpharetta, Ga., and has an office in the Philadelphia suburb of Jenkintown. JER is a private equity and real estate management company in McLean, Va. (NY Times) 

Bird flu reports spreading in Asia

Bird flu will challenge to U.S. health system, expert predicts

National Patient Safety Initiative launched to provide free electronic
prescribing to every physician in America

Store clinics tap a public need, but many doctors call the care inferior

One-time melanoma screening of older adults appears to be
cost-effective

Broadlane announces membership with
Health Industry Group Purchasing Association

The Council of Supply Chain Executives announces
new corporate member Caduceus Systems

Nonin signs agreement with MedAssets to supply pulse oximeters

Bird flu reports spreading in Asia

An Indonesian hospital was on Monday overwhelmed with patients suffering bird flu symptoms while the virus spread further among flocks in Vietnam and flared anew in Thailand. A recent spurt of human infections with the H5N1 bird flu virus, which re-emerged in Asia in late 2003, has alarmed health officials. Four Indonesians have died this year after a six-week lull in cases, taking the number of people killed by bird flu in the country to 61, the highest in the world. At Jakarta’s Persahabatan hospital, where doctors were treating 9 people with bird flu symptoms, including a 5-year-old girl in intensive care, its isolation wards were overwhelmed. “If we get more patients, we will send them to Sulianti Saroso,” Muchtar Ichsan, the head of the bird flu ward, said, referring the country’s main bird flu treatment centre in North Jakarta. The patients included the son and husband of a woman who died of bird flu last week. The 18-year-old son has been confirmed to have the disease, although tests so far on the husband show he does not have the virus. In a bid to stem the spread of the virus, Indonesia plans to prohibit people from keeping backyard fowl in three high-risk provinces. Adding to regional worries, a senior Thai agriculture official said on Monday that 1,900 ducks had been culled in the northern province of Phitsanulok after some of the birds had tested positive for H5N1. The case is Thailand's first in birds since last July. The last human death, the country’s 17^th, occurred in August.

The World Health Organization (WHO) says the spike in cases in the northern hemisphere winter follows a similar pattern to that seen over the past three years and was to be expected. But it was encouraging that outbreaks were being quickly reported and dealt with, a senior WHO official said. “It is not surprising that we are seeing an increase (in cases) ... but we are seeing much more effective responses than we were a few years ago,” Keiji Fukuda, WHO’s coordinator for the global influenza program, told journalists. In Vietnam, where bird flu has killed 42 of the 93 people infected since 2003, the virus appeared to be spreading fast among fowl in the country’s southern Mekong Delta, threatening to engulf the major rice-growing region. The Animal Health Department said in a report seen on Monday that tests showed H5N1 had killed ducks in the province of Soc Trang, just a day after bird flu was found in the neighboring province of Tra Vinh. The Agriculture Ministry has ordered an additional poultry vaccination campaign in the Mekong Delta area and requested reinforcement of animal health teams to contain the spread. Farm ministry officials in Japan said there was no evidence of the disease spreading there following confirmation at the weekend of a bird flu outbreak at a poultry farm in the southwest in which 3,800 chickens died. (Reuters)

Bird flu will challenge to U.S. health system, expert predicts

A bird flu pandemic remains a threat that the U.S. healthcare system must take seriously despite less frequent media coverage and the absence so far of human cases in the United States, experts warned. John Bartlett, an infectious disease expert at John Hopkins University, said the decentralized U.S. health system will make it more difficult to get ready for a possible human pandemic of H5N1 avian virus, or anything else. He disagreed with the suggestion that the bird flu threat has been overstated by the media. “The number of cases in 2006 was more than it was in 2005, which is more than it was in 2004 ... so it continues to go up in people,” he said. “And it continues to be just as lethal as it was in the beginning,” Bartlett said at a conference aimed at helping U.S. hospital administrators prepare for a pandemic. The virus mainly affects birds but the deaths of two Indonesian women last week brought the worldwide death toll among people from the virus to 159, out of a total of 256 infected since 2003. “It’s there to stay in birds, which means it is just waiting for the opportunity to make the mutation,” Bartlett said. The H5N1 virus is steadily changing and could at any time acquire the changes it needs to be easily transmitted from human to human. It would then spark a pandemic that could kill millions within months. Bird flu as an issue in the United States suffered from “press fatigue” in the absence of new things to say about the health threat, he said.

Bartlett was echoed by David Nabarro, bird flu coordinator for the United Nations, who said fewer headlines were a result of increased familiarity with the disease rather than a diminished threat. “It is incredibly infectious virus and it has not gone away. It is very much there, lurking at all times ready to strike,” Nabarro said. At last week’s conference at Johns Hopkins School of Medicine in Baltimore, Bartlett and other experts debated how U.S. hospitals would struggle with expected shortfalls of medicine, hospital beds, respirators and health care workers. “What we learn about flu ... (can) prepare you for natural disasters, bio-terrorism or another pandemic,” Bartlett said. Thomas Inglesby of the Center for Biosecurity at the University of Pittsburgh told the panel “the time line has already begun to slip a little bit” on the U.S. goal for 2011 of having enough vaccine for the entire population within six months of the identification of a pandemic influenza virus. Hospitals “have to plan that there’ll be no vaccine,” he said, urging administrators to start “speaking collectively about the need for a much more ambitious and aggressive vaccine strategy.” With no federal guidance on who will receive pandemic vaccine once it is developed and manufactured, Inglesby said, state and local health authorities will have trouble making and enforcing decisions. Bartlett and Inglesby said the absence of clear guidelines on an avian flu pandemic would pose ethical challenges when it came to choosing who would receive scarce treatments. (Reuters)

National Patient Safety Initiative launched to provide free electronic prescribing to every physician in America

A coalition of the nation’s most prominent technology companies and leading healthcare organizations announced a national initiative to provide free electronic prescribing for every physician in America. The National ePrescribing Patient Safety Initiative (NEPSI) is the first nationwide effort to improve patient safety by offering a solution to the medication errors that harm millions of people each year. Preventable medication errors injure at least 1.5 million Americans and claim more than 7,000 lives each year, according to a July 2006 study by the Institute of Medicine (IOM) of the National Academy of Sciences. In an effort to reduce these errors, the IOM has called on all of the nation's physicians to adopt electronic prescribing by 2010.

“While medication errors and adverse drug events can be common and serious, electronic prescribing is clearly a tool that can dramatically reduce errors and improve patient safety,” said Nancy W. Dickey, currently President of the Health Science Center and Vice Chancellor for Health Affairs at the Texas A&M University System and formerly President of the American Medical Association. “Yet despite the many benefits of electronic prescribing, physician adoption is still modest. The situation calls for a solution that will overcome the barriers many physicians face in adopting this life-saving technology.” The challenge, according to the eHealth Initiative, is that fewer than 1 in 5 of the nation’s practicing physicians currently process prescriptions electronically. Studies indicate that most physicians have been reluctant to adopt electronic prescribing largely because of the cost of the systems, and a perception that the technology requires too much time to learn and install.

NEPSI will help address those barriers by providing physicians simple, safe and secure electronic prescribing at no cost. NEPSI is led by Allscripts, a provider of clinical software, information and connectivity solutions that physicians use to improve healthcare, and by national sponsor Dell Computers, Inc. Other technology companies sponsoring NEPSI are Cisco Systems Corp., Fujitsu Computers of America, Inc., Google Inc., the coalition’s Search Sponsor, Microsoft, Corp., Sprint Nextel Corp., SureScripts Inc., and Wolters Kluwer Health Inc.

The backbone of the NEPSI program is eRx NOW, web-based software from Allscripts powered by the same engine used today by more than 20,000 physicians to write millions of electronic prescriptions each year. The eRx NOW is available free to any healthcare provider with legal authority to prescribe medications, and requires no download, no new hardware, and minimal training. The product includes the ability to quickly generate secure electronic prescriptions that can be sent computer-to-computer or via electronic fax to 55,000 retail pharmacies, more than 95 percent of all U.S. pharmacies, via SureScripts. All prescriptions are instantly checked for potentially harmful interactions with a patient’s other medications using a real-time complete medication database provided by Wolters Kluwer Health, as well as real-time notification of insurance formulary status from leading payers, plans and pharmacy benefit managers. The product also includes the ability for physicians to search and find targeted health-related information for themselves or patients using a custom search engine from Google and offers physicians and patients the highest levels of security available. Interested physicians can visit the NEPSI web site, http://www.nationalerx.com/home.htm to register for the program. The solution is currently being used by physicians and will begin national deployment within 30 days.

Store clinics tap a public need, but many doctors call the care inferior

Some of the newest players in healthcare are rubbing doctors the wrong way. You may know them: those small clinics at your neighborhood Wal-Mart, Target or CVS that promise quick attention for routine visits such as sore throats, minor aches and pains, flu shots, with no appointments needed. The clinics, which go by such names as MinuteClinic, RediClinic, QuickClinic, Medpoint Express, Curaquick and MediMin, offer convenience and low price, scarce commodities in today’s medical marketplace. But while consumers are taking to the concept, physician resistance is building. “The quickest, most convenient medical care is not always the best,” said Caroline Van Vleck, a Washington pediatrician. Particularly, she and a growing chorus of primary care physicians contend, when it comes to children. Within the past six months, the American Medical Association and the American Academy of Pediatrics have both decried it. “Convenience is not enough,” the AMA said in a recent editorial. The AMA complained these new services are spreading too far, too fast. In a policy statement issued this fall, the AAP “opposes retail-based clinics as an appropriate source of medical care for infants, children, and adolescents and strongly discourages their use.” As traditional medicine sees it, when a young patient gets hurry-up treatment for a single symptom at a retail-based clinic (RBC), also known as a convenient care clinic (CCC), the process leads to “fragmentation of care.”

James Woodburn, chief medical officer of MinuteClinic, emphatically disagrees: “We’ve been around for nearly seven years now . . . with almost no adverse events,” he said. “We have a long track record of quality medical care,” he continues, expressing pride "with our ability to provide convenient and extremely high-quality and cost-effective care.” From a business point of view, RBCs look like a success story. Five years after the first RBC was founded by a Minnesota doctor, there are now about 200 nationwide. A survey last summer by the California HealthCare Foundation projected the number will reach several thousand by the end of 2007. Fueling this growth, says Anne Pohnert, MinuteClinic’s manager of operations for the Washington area, is the appeal of lower cost, speed, convenience and after-hours availability. “Many patients would like to get in to see their primary care physician, but when they call, there is no appointment available,” she said. Choosing an urgent care center or emergency facility may involve “a long wait and considerably more cost,” she adds. “We believe that a visit to MinuteClinic instead of an ER on a Friday evening for a five-minute strep test is a win-win for patients and insurers trying to save time and healthcare costs.” To contain costs, the typical retail clinic is a bare-bones affair, usually a small room with a few chairs, a cabinet or two and perhaps, but not always, an examining table. On-site medical staff usually consists of a single nurse practitioner or physician assistant. A doctor is generally available for phone consults only. Prices are posted for all to see. Some typical fees in Maryland’s MinuteClinics: $30 for a flu shot, $59 for a strep test, $49 to diagnose and prescribe treatment for an ear infection. The American Academy of Family Physicians has launched a national project (http://www.transformed.com) to test new ways to improve care and make primary care practices more welcoming to patients. (The Washington Post) To read the full article CLICK HERE.

One-time melanoma screening of older adults appears to be cost-effective

One-time melanoma screening of adults age 50 or older appears to be as cost-effective as other nationally recommended cancer screening programs, according to an article in the January issue of Archives of Dermatology, one of the JAMA/Archives journals. Melanoma is the only cancer for which incidence and death rates continue to increase in the United States, while screening continues to be underused, according to background information in the article. Treating melanoma costs more than $740 million each year in the United States. Older patients and those who have immediate relatives with melanoma are at higher risk. Knowledge regarding risk factors and the availability of treatment has spurred greater interest in screening; however, the lack of a large randomized trial proving screening efficacy has been cited as an obstacle preventing its widespread implementation.

Elena Losina, Ph.D., Boston University School of Public Health, and colleagues constructed a mathematical model to simulate the melanoma events that occur in a population, including disease occurrence, progression, detection with and without a screening program, treatment and death. The authors projected the additional costs of screening and the additional survival attributable to earlier detection. They then assessed the cost in dollars for every extra year of life gained (the cost-effectiveness) from melanoma screening by a dermatologist. “We considered the following four screening strategies: background screening only; that is, skin examination at a routine non-dermatologist physician visit, followed by referral to a dermatologist, on average, once every five years; and one-time, every two years and annual screening by a dermatologist, all beginning at age 50 years,” the authors write.

In the model analysis, the cost-effectiveness of screening was about $10,100 per quality-adjusted life year gained for one-time screening compared with current practice. In other words, for every $10,100 in costs associated with one-time screening, one individual would have one additional year of life because of the screening. In addition, costs totaled $80,700 per quality-adjusted life year gained for screening every two years compared with one-time screening, and $586,800 per quality-adjusted life year gained for annual screening compared with screening every two years. Among siblings of patients with melanoma, one-time screening cost $4,000 per quality-adjusted life year gained compared with current practice, screening every two years cost an additional $35,500 per quality-adjusted life year gained, and annual screening cost an additional $257,800 per quality-adjusted life year gained. Cost-effectiveness analyses are typically used when large randomized trials of screening procedures cannot be done for either logistical or ethical reasons, the authors write. “Using this method, interventions in the United States are generally considered cost-effective at less than $50,000 per quality-adjusted life year gained or less than $100,000 per quality-adjusted life year gained,” they continue. “This study suggests that one-time screening of the general U.S. population at age 50 years for malignant melanoma is very cost-effective and that screening every two years of siblings of patients with melanoma may also be cost-effective, depending on disease progression rates,” according to the authors. “Either screening programs should be expanded or efforts to perform a definitive efficacy trial should be initiated.”  

Broadlane announces membership with
Health Industry Group Purchasing Association

Broadlane recently announced its decision to become a member of the Health Industry Group Purchasing Association (HIGPA). In addition to membership, Broadlane will also be given a seat on HIGPA’s Board, which will be filled by Charles E. Saunders, MD, Broadlane’s chairman and chief executive officer. “HIGPA is excited to welcome Broadlane to our membership and Board,” said HIGPA’s Chair Darrel Weatherford. “Broadlane is a well-known force in our industry. The wide range of services offered by Broadlane provides a positive impact on the healthcare supply chain, specifically providers and the patients they serve. We are certain that this new partnership with Broadlane will strengthen our efforts to fulfill HIGPA's mission and vision.” Saunders added: “Broadlane looks forward to actively participating in HIGPA. The association’s new governance structure will ensure that HIGPA’s public policy and advocacy are free of any perceived conflicts of interest with suppliers. HIGPA’s mission of helping healthcare providers offer the highest-quality and most cost-effective patient-centered care possible mirrors our own.”

The Council of Supply Chain Executives announces
new corporate member Caduceus Systems

The Council of Supply Chain Executives (The Council), a division of the Institute of Healthcare Executives and Suppliers (IHES), announces the addition of Caduceus Systems to its list of healthcare supplier clients. The Council provides consulting, insight and educational networking opportunities for leading healthcare suppliers of products and services utilizing a roster of the brightest supply chain executives in the country. “As the Council of Supply Chain Executives continues to expand, we are pleased to gain the participation and commitment from Caduceus Systems. Caduceus has excellent management, reputation and technology and our network of supply chain executives are looking forward to providing their years of industry experience and advice to them”, said W. Hays Waldrop, President and CEO of The Council of Supply Chain Executives. Caduceus Systems LLC is dedicated to providing inventory management and e-procurement software solutions and related services to hospitals and the healthcare industry.

Nonin signs agreement with MedAssets to supply pulse oximeters

Nonin Medical Inc. announced that it has entered into an agreement with MedAssets Supply Chain Systems to make its comprehensive line of pulse oximeters and sensors, including the only wireless oximeter based on Bluetooth technology, available to MedAssets customers. Under the multi-year agreement with NONIN, MedAssets customers will have access to these pulse oximeters and sensors. 

Consorta joins forces with MedAssets Analytical Systems to decrease costs and improve efficiencies for its members

HPN creates new surgical supply innovators award

New gene uncovered for late-onset Alzheimer’s;
Findings replicated in four different ethnic groups

Japan starts incinerating chickens

Do statin users risk Parkinson's?

Drugs show promise against kidney cancer

Medline ready for possible pandemic, has significantly increased its inventory

Amerinet announces agreements
 

Consorta joins forces with MedAssets Analytical Systems to decrease costs and improve efficiencies for its members

On the heels of its decision to become an equity shareholder in HealthTrust Purchasing Group, Consorta Inc. signed a separate supply chain management services and technology deal with MedAssets Analytical Systems, a unit of MedAssets Inc., to provide Consorta shareholders and participants nationwide with MedAssets Analytical Systems’ supply chain management services and technology. MedAssets Analytical Systems tools will offer Consorta and its members increased transparency into their supply chain operations in order to enhance decision making, improve contract compliance, and aid Consorta in attracting new shareholders. The agreement is effective February 1, 2007.

“Our new relationship with MedAssets Analytical Systems will greatly benefit our shareholders and Consorta,” said Joseph Ciccolo, Senior Vice President, Support Services, Caritas Christi Health Care System and member of Consorta’s Executive Committee. “It will not only help us meet our system’s goals to reduce supply chain costs by rendering our spend data in a more usable and actionable state, but it will also assist Consorta in developing a program that the shareholders view as essential for Consorta’s continued success and growth.”

MedAssets Analytical Systems’ Strategic Information Services aggregates, normalizes and analyzes supply chain data from single or multiple facilities and provides greater transparency and control of the total supply spend. Information is compiled and provided in actionable formats such as opportunity analyses and executive summaries to clearly identify specific courses of action. Strategic Information monitors and maintains the accuracy and compliance levels of Consorta’s national group purchasing and members’ locally negotiated contracts. Additionally, on an “as-requested” basis, MedAssets Analytical Systems’ Client Item File Services can be engaged to assist in standardization and maintenance of individual shareholders’ supply item files.

“The objective of the MedAssets and Consorta collaboration is to help our shareholders and their members reach their savings goals faster,” explained Anna Fox, Vice President, Contract Operations and Data Management at Consorta. “Without tools and processes to normalize spend data, it becomes nearly impossible to identify timely opportunities. By offering established and proven supply chain services and technology to our members, we will increase contract compliance and capture the fees and rebates that are owed to our shareholders.”

HPN creates new surgical supply innovators award

You may have heard horror stories about surgical services departments that simply won’t work with materials management, either because of personality conflicts (e.g., doctors get what they want with the C-suite’s blessing) or a lack of respect for the MM department’s capabilities (e.g., the O.R. director doesn’t believe a non-clinical department truly understands clinical needs). In fact, you may have experienced one yourself.

Until the advent of DRGs for reimbursement in the early 1980s, and the subsequent emergence of managed care, materials management took more of a hands-off approach with the O.R., which typically didn’t know who or what materials management was. But that started changing in the 1990s. Market conditions were forcing clinicians to understand the business, finance and operational aspects of the facilities in which they practiced while the materials managers were forced to learn about clinical needs and how to speak clinical language. As a result, a growing number of doctors added MBAs to their M.D.s and O.R.s added business and materials management expertise to their ranks. Meanwhile, materials management departments started pursuing concepts like value analysis, and installing nurses and related clinicians as departmental liaisons.

Call it a meeting of the minds as both pursued the bottom line from different directions. However, this remains a developing trend that hasn’t yet infiltrated the majority of healthcare facilities. So while challenges between MM and the O.R. may continue as common occurrences in many facilities – even those that have implemented noticeable and noteworthy improvements – success stories between the clinical and supply chain management areas to reduce expenses and improve efficiency without negatively impacting patient care do exist.

Healthcare Purchasing News would like to find them and share them with you. But we need your help. We’ve created a new award that recognizes those facilities, surgical services departments or specific O.R. management professionals that have identified problems, developed workable solutions and effectively worked together with materials management, thereby improving patient care. We'd like to honor and profile the facility that offers the optimal, if not best, solution to a lingering supply management challenge in the O.R. with the “HPN Award for Surgical Supply Innovation.”

Applying is simple: Please submit a brief nomination of no more than 750 words max that highlights and outlines what the problem was, how it was solved and who collaborated on/contributed to developing and implementing the solution. Email applications to editor@hpnonline.com or send to: HPN’s Surgical Supply Innovators Award, 7650 So. Tamiami Trail, Ste 10, Sarasota, FL 34231.Deadline: Monday, January 22. HPN will feature the winning facility in the March 2007 edition, as well as at the 2007 Association for periOperative Nursing (AORN) Congress in Orlando, FL, March 11-15.

New gene uncovered for late-onset Alzheimer’s;
Findings replicated in four different ethnic groups

An international team of researchers, led by Columbia University Medical Center, Boston University School of Medicine and the University of Toronto, has uncovered a major new gene, SORL1, implicated in late-onset Alzheimer’s disease. Replicated in four distinct ethnic groups, SORL1 is only the second genetic variant for late-onset Alzheimer’s, the type of Alzheimer’s found in 90 percent of people with this devastating disease. ApoE4, the first, was identified in 1993. In an article published in the Jan. 14 advance on-line edition of Nature Genetics (February print edition), researchers describe how variants in the SORL1 gene were found to be more common in people with late-onset Alzheimer’s than in healthy people the same age. The authors believe that these genetic variants alter the normal function of SORL1, sending amyloid precursor protein (APP) down a pathway that increases the production of the toxic amyloid beta peptides in the brain resulting in Alzheimer’s.

When the SORL1 gene works properly, it sends APP along recycling pathways, preventing it from being cut into toxic forms. People with these genetic variants may not produce normal amounts of SORL1, suggesting that this gene has protective function when working properly. The researchers believe that the reduction of SORL1 in the brain increases the likelihood of developing Alzheimer’s disease. An important aspect of their findings was that the association between Alzheimer’s disease and SORL1 was replicated in four distinct ethnic groups: Caribbean-Hispanics, North Europeans, African-Americans and Israeli-Arabs. Many previous studies on the genetics of Alzheimer’s used data from mostly white populations of American and European ancestry. In total, the five-year federally- and internationally-funded study involved DNA samples from 6,000 volunteers. The team at the University of Toronto was led by Peter St. George-Hyslop, M.D., director of the Centre for Research in Neurodegenerative Diseases, and the Boston University team by Lindsay Farrer, Ph.D., chief of the Genetics Program.

“The importance of the finding is that it opens new pathways to explore the cause and as well as potential targets for treatment of this devastating disease,” said Richard Mayeux, M.D., co-director of the Taub Institute for Research on Alzheimer’s Disease and the Aging Brain and leader of the research team at Columbia University Medical Center. “SORL1 represents another critical piece of the Alzheimer’s disease puzzle. This appears to be the fifth Alzheimer’s disease gene, and there are likely to be other important genetic variants that need to be identified before the entire picture is complete.” “Now that we know that variants in SORL1 are associated with late-onset Alzheimer's disease and we know the specific regions of the gene involved, our next step is to determine which of the variants contain the specific disease causing alteration,” said Dr. Mayeux. Another next step is to determine how many cases of late-onset Alzheimer’s are caused by these SORL1 variants; it is known that ApoE4 explains approximately 20 percent of all cases of late-onset Alzheimer’s. Studies are planned to investigate how many Alzheimer's cases are attributable to SORL1. The hope is that this information will help develop accurate screening for this gene.

Japan starts incinerating chickens

Japanese authorities on Monday began incinerating more than 10,000 chickens that have either died of bird flu at a southern Japanese poultry farm recently or culled there, officials said. Separately, the Environment Ministry said that there were no signs of wild birds indicating a possible link to a pathogenic strain of the bird flu virus in last week’s outbreak of the disease. About 4,000 chickens died at a farm in the town of Kiyotake in Japan’s southern state of Miyazaki last week, and local officials late Saturday said that the virus belonged to the broad H5 family. Over the weekend, another 8,000 chickens at the firm were culled to prevent the spread of the nation's latest outbreak of the bird flu. Japanese agricultural officials have confirmed that the virus is a broad H5 family. Experts at the National Institute of Animal Health near Tokyo are still conducting close examination on samples to determine whether the virus was the H5N1 strain, said Makoto Takahashi, a Miyazaki official.  

Meanwhile, a group of Environment Ministry officials have conducted on-spot examination on droppings from wild birds found around the affected farm, but found “nothing unusual,” said ministry official Yoshifumi Kubo. A total of 31 kinds of birds, including 16 kinds of migratory birds like blue herons and wild ducks, were confirmed in an area of a 1.9 mile radius of the affected farm, Kubo said. Kubo said the farm is surrounded by farm land and housing areas and that there are no large ponds or rivers nearby inhabitable for wild birds. The government has banned shipments of eggs and 330,000 chickens at 16 poultry farms within a 6.2-mile radius of the farm. The compound of the farm involved has been disinfected following the outbreak of the disease. Japan has confirmed one human case involving the H5N1 virus but reported no human deaths. Japan’s most recent H5N1 outbreak occurred in Kyoto in 2004. Miyazaki, about 560 miles southwest of Tokyo, is the country’s largest poultry producing region. (Associated Press)

Do statin users risk Parkinson's?

Statins are used by millions of people to prevent heart attacks and stroke by lowering harmful blood cholesterol. But U.S. scientists are concerned after a small study found people with low cholesterol upped their risk of developing Parkinson’s disease. Now the University of North Carolina team is to study 16,000 people to see if the link is real and causal. If it is, a surge in Parkinson’s cases is imminent they say. But experts argue statins may in fact protect against it. Dr Xuemei Huang’s group discovered themselves that people on statins were less likely to have Parkinson’s disease. Their study, published in Movement Disorders, included 124 patients with Parkinson’s and 112 of the patients’ partners, who acted as controls. They found that patients with lower “bad” LDL cholesterol levels were more than three times more likely to have Parkinson’s than those with higher LDL cholesterol levels. Paradoxically, those on statins were less likely to have the condition. Dr. Huang says this could be because those who develop Parkinson’s have had low LDL cholesterol all their life and so have never needed to take statins. She told Chemistry & Industry that past studies linking Parkinson’s with a gene (apoE2) associated with lower cholesterol support her theory that low LDL is the culprit. Because statins lower LDL cholesterol, the concern is they may trigger Parkinson’s. Dr. Huang said: “I’m definitely concerned which is why I’m conducting a prospective study of 16,000 people.”

But Dr David Dexter, senior lecturer in neuropharmacology at Imperial College, London, said: “With the evidence we have at the moment, I would say there is not much cause for concern that statin use may cause Parkinson’s disease.” He said previous studies had demonstrated that statins can increase brain dopamine concentration, the chemical transmitter deficient in Parkinson’s, and that statins protect nerve cells. “Also one of the secondary symptoms some patients with Parkinson's experience is dementia, similar to Alzheimer’s disease, which may result from vascular changes in the brain. Statins would be expected to protect the brain against such vascular changes,” he explained. Dr. Huang agreed that the medical value of statins far exceeded any possible additional risk of Parkinson’s. Professor Yoav Ben-Shlomo, professor of clinical epidemiology at Bristol University, said patients had a right to know the risks of any medication they were taking. He said a prospective study, tracking the lifestyle of people before Parkinson’s develops, should help provide more answers. (BBC NEWS)

Drugs show promise against kidney cancer

Two new drugs help slow the growth of the most common form of kidney cancer, two studies published by the companies said. The biotech drugs, called Sutent and Nexavar, “are a major step forward in our struggle against kidney cancer,” said Dr. James Brugarolas of the University of Texas Southwestern Medical Center in Dallas, TX. “Both (drugs) delay the growth of kidney cancer by 3 to 6 months,” Brugarolas wrote in a commentary on the results, published in the New England Journal of Medicine. About 30,000 cases of renal cell carcinoma, involving the outer cells of the kidney, are diagnosed in the U.S. each year. It is responsible for up to 90 percent of all kidney cancers, and accounts for 1.5 percent of cancer deaths. Patients typically survive for just a year. Interleukin-2 and interferon alfa are often given to treat it. But they work in only about 5 percent of patients whose tumors have spread. Only interleukin is approved for that use in the U.S.

In the test of sunitinib, a drug marketed under the brand name Sutent, the response rate was 31 percent versus a rate of 6 percent for treatment with interferon alfa, said the team led by Robert Motzer of the Memorial Sloan-Kettering Cancer Center in New York. The 375 who received the Pfizer drug as part of the test involving researchers from the U.S., France and Poland typically went for 11 months without having their tumor progress, compared to five months for an equal number of volunteers receiving interferon. However, the drug also produced more side effects such as diarrhea and vomiting, and initial results showed no clear increase in survival. Motzer called treatment with Sutent a new standard of care for advanced kidney cancer. The test of sorafenib, sold as Nexavar, did not compare the drug with any established treatment. Response to the drug was so strong that the research team, headed by Bernard Escudier of the Gustave Roussy Institute in Villejuif, France, allowed placebo recipients to begin taking Nexavar. While patients who received the placebo went an average of 2.8 months without their tumor progressing, the delay was 5.5 months for those getting Nexavar. The drug affected the tumors of 10 percent of the volunteers, compared with just 2 percent among placebo recipients. But the initial results did not yet show that patients given the drug lived any longer, and Nexavar produced side effects such as skin problems and diarrhea. Brugarolas said the side effects of both drugs can be severe in 10 percent of patients. He said until the two drugs are compared in a head-to-head test, nobody will know which is better. Both drugs work by inhibiting tumor growth and limiting the amount of blood going to a tumor. (Reuters)

Medline ready for possible pandemic, has significantly increased its inventory

While threats of a potential outbreak of avian flu has major manufacturers allocating and on backorder for essential medical supplies, Medline Industries Inc., has significantly increased its raw and finished materials inventory, readying it to immediately help healthcare professionals in a time of crisis. “The bottom line is that manufacturers have a responsibility to help healthcare professionals be ready. Allocating medical supplies in today’s world is just not good for our customers and their patients,” said Medline President Andy Mills. “Healthcare facilities can depend on Medline for isolation gowns, N95 masks, gloves and all other necessary protective apparel because since the outbreak of SARS in 2003, we’ve taken considerable steps to prepare for a possible pandemic. We've not only significantly increased our inventory, we have developed programs to help hospitals overcome the financial and logistical challenges they face in stockpiling for a potential disaster.” Mills notes that Medline is in a unique position to help because the company stocks more than $100 million of personal protective products. Medline also has eight production facilities strategically located on three continents. As part of its Pandemic Preparedness Program Medline has: increased its finished goods inventory by 50 percent; doubled its raw materials inventory; increased its offering of N95 particulate respirator masks; and introduced a new line of isolation gowns that are the only gowns on the market offering protection that exceed the new Association for the Advancement of Medical Instrumentation (AAMI) guidelines.

Medline also offers two approaches to help meet the individual needs of its customers and ease the financial and logistical burden of stockpiling supplies. Consignment allows the customer to order product with no up-front cost. Medline ships the product to the facility and structures a program to bill the facility as the product is used. Its Guaranteed, On-Demand Inventory allows the customer to order as much product as it needs. Medline stores the product in one of the company’s secured warehouses and ships it as needed. (For both Consignment and Guaranteed, On-Demand Inventory, there is a minimum order of 500 cases of any mixture of products.) Medline has a full supply of National Institute for Occupational Safety and Health (NIOSH) -approved N95 particulate respirator masks in stock. These masks have been specifically recommended for use by the Centers for Disease Control and Prevention (CDC) as Personal Protective Equipment (PPE) for healthcare workers exposed to patients with known or suspected avian influenza. A properly fit-tested, NIOSH-approved, N95 particulate respirator filters at least 95 percent of solid and liquid airborne particles not resistant to oil. The company has introduced an additional three N95 NIOSH approved particulate respirators and has four options for isolation gowns.

Amerinet announces agreements

Amerinet announces its agreement with CompView Medical for medical supplies. Effective through November 30, 2009, this agreement includes CompView Medical’s all-in-one equipment management boom and visualization system.

Amerinet announces a new agreement with Cardinal Health for medical supplies. Effective through December 31, 2009, this agreement includes Cardinal’s line of latex, synthetic, powdered or powder-free medical exam gloves.

Amerinet Choice, LLC announces its agreement with R&K Laboratory Packaging Technologies to supply laboratory packaging for fluid and specimen transport, processing and storage. Effective through December 31, 2009, this agreement includes Lab specimen bags with biohazard symbol, disposable tube racks and tube rack covers, urine container kits and specimen shipper containers. The above agreements were the result of competitive bidding processes. 

Indonesian bird flu death toll hits 59

Indonesian bird flu death toll hits 59

One of two Indonesian women diagnosed with bird flu died and the other was reported in critical condition on Friday, part of an outbreak that has ended a lull in the country where the virus has claimed the most lives. A teenage boy also died of the disease earlier in the week, the first fatality in six weeks. The deaths brought the number of people killed by bird flu in Indonesia to at least 59 since the virus began ravaging Asian poultry stocks in 2003. The Indonesian deaths account for more than a third of the world’s total. “Indonesia has been on the right track in handling the bird flu, but the danger still exists,” said Bayu Krisnamurthi, head of the country’s bird flu commission. All three cases occurred in the industrial town of Tangerang to the west of the capital, Jakarta. The 37-year-old woman died late Thursday in a Jakarta hospital that is also treating her husband and 18-year-old son for symptoms of the H5N1 virus, said Haris Sugiantoro of the Health Ministry’s bird flu information center. Tests have confirmed that a 22-year-old woman also is suffering from the virus, said Joko Suyono, another official at the center. Neighbors said they saw her pick up a chicken that had died nearby. “She is now in critical condition in an intensive care unit of the hospital,” Suyono said. On Wednesday, a 14-year-old boy also from Tangerang died after being treated for four days at the same hospital. His death ended a pause that had led Indonesian officials to say they were making progress in the fight against the disease. (Associated Press)

House passes bill relaxing limits on stem cell research

The House yesterday overwhelmingly approved a bill that would loosen the restrictions on human embryonic stem cell research imposed by President Bush in 2001, inaugurating the second such assault on the administration’s stem cell policy in as many years. Thirty-seven Republicans joined 216 Democrats to pass the Stem Cell Research Enhancement Act, which would allow federal funding of research on stem cells from embryos slated for destruction at fertility clinics. The 253 to 174 vote fell 37 votes short of what it would take to override the veto that Bush yesterday promised would be forthcoming, assuming the Senate passes the same bill, as expected. Bush vetoed the legislation after it passed last year. But buoyant research proponents said they still have several options and promised to persevere until the legislation becomes law. “While it’s not enough to override a veto, it's enough to show we have tremendous momentum,” said Rep. Diana DeGette (D-CO), who led the House effort with Rep. Michael N. Castle (R-DE). With the Senate already within one vote of having the two-thirds majority it needs for an override, and with the Democrats now in a majority position that will allow them to use procedural rules in their favor, DeGette suggested that it is time for the president to begin negotiating with Congress over compromise language. Under the existing policy, federal funds may be used to study only those stem cells taken from embryos destroyed by Aug. 9, 2001, or about 21 of the nearly 400 stem cell colonies created since 1998. The House-based bill would expand that pool of available cells to include those from any of the thousands of embryos that are discarded by fertility clinics each year, as long as those cells were freely donated for research by the parents. It would also impose some of the country’s first ethics rules on embryo research. (Washington Post)

House set to vote on forcing Medicare to negotiate drug prices

The Democratic-led House is poised today to pass legislation requiring Medicare to negotiate drug prices in defiance of Bush administration opposition. Supporters say the government could save $96 billion over 10 years by negotiating for drugs bought in bulk. Opponents call it a “bumper sticker” policy that sounds good even as government studies show it won’t produce any savings. The measure is the fifth of seven Democratic legislative initiatives that House Speaker Nancy Pelosi, a California Democrat, is working to push through the chamber by the end of next week. “It is clear that Medicare can do better, and we are insisting that they do so,'' said House Energy and Commerce Committee Chairman John Dingell, a Michigan Democrat.  Even if Democrats get the measure through the House and Senate, President George W. Bush is prepared to veto it. “The administration strongly opposes'' the legislation, said a statement released yesterday by the Office of Management and Budget. If Congress were to pass it, Bush “would veto the bill,” the statement said. The Medicare program currently has a clause that expressly prevents Health and Human Services Secretary Michael Leavitt from interfering in negotiations between insurers and drugmakers.

Democrats want to force Leavitt to negotiate drug prices instead of leaving it to the insurers. Prices for drugs purchased under the Medicare plan are more than 80 percent higher than for other federal programs that negotiate with drugmakers, according to Dingell. The average monthly premium has gone down to $22 from $38 since the program started, Leavitt wrote in the Washington Post yesterday. The Congressional Budget Office estimated this week that the legislation “would have a negligible effect on federal spending because we anticipate that the secretary would be unable to negotiate prices across the broad range of covered drugs that are more favorable than those obtained” under current law. In addition, “competition among plans has lowered costs for taxpayers and beneficiaries,” Senator Charles Grassley of Iowa said yesterday at a Senate Finance Committee hearing on the program.

While the legislation, written by Dingell, offers no advice on how Leavitt should execute bulk negotiations, Democrats have long cited the Veterans Administration as a model. The cheapest Medicare price for 20 milligram of the cholesterol drug Zocor tablets was $1,485.96 a year, more than 10 times the lowest VA price of $127.44, according to a report by Washington-based consumer advocacy group Families USA. Medicare’s lowest price for Pfizer Inc.’s cholesterol drug Lipitor was 51 percent higher than the VA would pay. “But you can't use the VA model under this bill,” said Mark McClellan, former head of the Centers for Medicare and Medicaid. The VA has limited the list of drugs it buys, and negotiates lower prices directly from drugmakers that want their drugs on that list. Medicare would have to make available a wider range of drugs so it would have limited leverage in negotiations for lower prices. The VA, for example, excludes some of the most expensive treatments. The program won’t pay the $3.40-a-day price for Lipitor. Patients are instead prescribed Zocor, sold by Whitehouse Station, NJ-based Merck & Co., which costs less, and are only given Lipitor if they apply for a special waiver. (Bloomberg)

GAO: Overview of approaches to negotiate drug prices
used by other countries, U.S. private payers & federal programs

Rising prescription drug spending has led the United States and other countries to seek ways to negotiate lower prices with drug manufacturers. Currently, the Medicare Part D benefit comprises competing prescription drug plans overseen by the Centers for Medicare & Medicaid Services. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 prohibits the Secretary of Health and Human Services from interfering with price negotiations between Part D plan sponsors and drug manufacturers and pharmacies. The U.S. Government Accountability Office (GAO) was asked to describe how prescription drug prices are negotiated. This testimony provides an overview of such efforts (1) by governments in other countries; (2) by U.S. private payers, such as employer-based health plans; and (3) by federal programs other than Medicare Part D.

Governments in other countries use a range of approaches to limit the amount they pay to acquire drugs: Ceiling prices establish a maximum price manufacturers may charge for their products. Purchasers may sometimes negotiate more favorable prices directly with drug manufacturers; Reference prices use local or international price comparisons of drugs classified in a group as therapeutically similar to determine a single or maximum price for all drugs in that group; Profit limits control how much profit a drug manufacturer may earn per product or within a specified period of time. Other factors, such as scope of coverage and national formularies, which are generally lists of preferred drugs, influence drug price negotiations.

In the U.S. private health insurance market, health plans typically contract with pharmacy benefit managers (PBM) to help manage their prescription drug benefits. PBMs negotiate rebates or payments with drug manufacturers, encourage substitution of generic drugs for therapeutically similar brand drugs, and negotiate discounted prices with networks of retail and mail-order pharmacies, passing along at least some of the savings to health plans and enrollees. PBMs influence price negotiations with manufacturers through formulary development and management and through the large market share they often represent. Approaches for negotiating drug prices vary among federal programs in the U.S. In part, these approaches depend on whether the programs purchase and distribute drugs directly or reimburse retail pharmacies or other providers for dispensing or delivering drugs. While the approaches used by federal programs in the U.S. reflect U.S. laws, markets, and healthcare delivery and financing, there are also elements common to some of the approaches used by other countries and by private payers.

Some federal programs set ceiling prices, others establish prices by referencing prices negotiated by private payers in the commercial market, and still others rely on negotiations with manufacturers, directly or through private health plans. For example, the Departments of Veterans Affairs’s and Defense’s prices for a prescription drug may be the lowest of a ceiling price, other established price, or a price negotiated with the manufacturer. State Medicaid programs, joint federal-state programs that finance medical services for certain low-income adults and children, reimburse retail pharmacies for drugs dispensed to beneficiaries at set prices. The programs receive rebates from manufacturers that are meant to take advantage of the prices for drugs in the commercial market and are required to reflect discounts and rebates negotiated by private payers with manufacturers. For health benefits offered to federal employees, retirees, and dependents, rather than negotiating with manufacturers, the government contracts with participating health plans that typically use PBMs to negotiate drug prices and offer other pharmacy benefit, administrative, and clinical services. For more information CLICK HERE http://www.gao.gov/new.items/d07358t.pdf

 

Obesity operations jump in United States

More than 120,000 obese Americans had some kind of surgery to help them lose weight in 2004, with the biggest increase among middle-aged people, according to a study released Wednesday. In 1998, 772 people aged 55 to 64 had gastric bypass, stapling or some similar procedure known as bariatric surgery to help weight loss. But that number ballooned to 15,086 in 2004, according to the Agency for Healthcare Research and Quality. “Among the reasons for the extremely dramatic increases is that the mortality outcomes from obesity surgery have improved greatly,” the agency said. “The national death rate for patients hospitalized for bariatric surgery declined 78 percent, from 0.9 percent in 1998 to 0.2 percent in 2004.” Agency director Dr. Carolyn Clancy said the report shows “more Americans are turning to obesity surgery and that an increasing number of younger people are undergoing these procedures.” More than 103,000 of the 2004 operations were on patients aged 18 to 54, the study found, and 349 were performed on youngsters aged 12 to 17. “As the rate of obesity continues to climb, the healthcare system needs to be prepared for continued escalation in the rate of this surgery and its potential complications,” she said. The average hospital cost for an obesity surgery patient stay, excluding physician fees, was $10,395 in 2004 as compared with $10,970 in 1998, adjusted for inflation, according to the report. (Reuters)

Cold remedies cause three infant deaths

Prescription and over-the-counter cough and cold remedies have been linked to the deaths of three infants, according to CDC researchers in Atlanta. The infants, two boys and a girl from the ages of one to six months, were all found to have high levels of the nasal decongestant pseudoephedrine in their blood at autopsy, reported Arjun Srinivasan, M.D., and colleagues, in the Jan. 12 issue of Morbidity and Mortality Weekly Report. Two of the children had detectable blood levels of the cough suppressant dextromethorphan and Tylenol (acetaminophen), the investigators added. The blood levels of pseudoephedrine in the children were nine to 14 times higher than those resulting from the recommended doses of the decongestant in children who are ages two to 12 years. “Because of the risks for toxicity, absence of dosing recommendations, and limited published evidence of effectiveness of these medications in children ages younger than 2 years, parents and other caregivers should not administer cough and cold medications to children in this age group without first consulting a health-care provider and should follow the provider’s instructions precisely,” the investigators wrote. “Clinicians should use caution when prescribing cough and cold medications to children ages younger than two years,” they added. “Moreover, clinicians should always ask caregivers about their use of over-the-counter combination medications to avoid overdose in children from multiple medications that contain the same ingredient.” Although the occurrence of adverse events associated with the use of cough and cold remedies in children is low, “an estimated 1,519 children ages younger than two years were treated for adverse events from such medications during 2004-2005,” the MMWR editors wrote in a note accompanying the report. No one is sure what constitutes a safe dose of cough and cold medications in infants and toddlers under two years old, and there are no FDA recommendations for clinicians who prescribe for young children. (MedPage Today)

FDA proposes new measures to strengthen drug safety
under PDUFA reauthorized User Fee Program

The Food and Drug Administration (FDA) proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program which, if adopted, would significantly broaden and upgrade the agency’s drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public. To achieve these public health benefits, the agency proposes to recommend, as part of the reauthorization of the program, that annual user fee collections be increased to $392.8 million, an $87.4 million increase over the current base line. For more information, CLICK HERE http://www.fda.gov/OHRMS/DOCKETS/98fr/07n-0005-nm00001.pdf.

UK government to miss MRSA superbug target

The British government will not meet its target to halve the number of cases of the deadly superbug MRSA by 2008, according to a leaked government memo. The memo sent to ministers in October by Department of Health Director of Health Protection Liz Woodeson said experts believed the goal set in 2004 may never be met. “We have a three-year target to halve the number of MRSA bloodstream infections by April 2008. Although the numbers are coming down, we are not on course to hit the target and there is some doubt about whether it is in fact achievable,” Woodeson said in the memo published by the Health Service Journal. The memo said it could be possible to cut infections by a third over a longer period of time but it may not be possible to get it down to a half.

MRSA is a growing public health problem in Britain and other nations. Britain has the worst record for MRSA infections among major European countries. In England and Wales, deaths linked to MRSA increased 22 percent between 2003 and 2004. Overuse of antibiotics is blamed for the development of superbugs such as MRSA. Poor hygiene and cleanliness standards contribute to its spread. The memo also warns that another superbug called Clostridium difficile is now endemic and a “far bigger problem” than MRSA for the health service. There were twice as many deaths linked Clostridium difficile in 2004 as there were to MRSA, according to the document. “The fact that MRSA infections are out of control should come as no surprise. Targeting the rise and fall of MRSA bacteraemias only covers a small part of the problem,” said Dr Ronald Cutler, an expert on infectious disease and pathology, from the University of East London. “More action should be taken to investigate and develop new methods particularly to control spread in hospitals and nursing homes,” he said. Health Minister Andy Burnham told the Health Service Journal that he would urge Prime Minister Tony Blair to encourage hospitals to bring cleaning services back in house instead of using private companies to try to tackle the problem. (Reuters)

Deadly Rift Valley fever may be spreading in Horn of Africa

A Rift Valley fever outbreak that killed at least 75 people in Kenya the past month may be spreading in the Horn of Africa, aided by floodwaters harboring mosquitoes that carry the viral disease. Seven people may have died from the disease in an area of southern Somalia 11 miles north of the Kenyan border, where conflict between Islamist fighters and a transitional Somali government is hampering efforts to investigate suspected cases, the United Nations Integrated Regional Information Network reported yesterday. (Bloomberg)

SCAI issues clinical alert on drug-eluting stents and late thrombosis

Hospital death rate study reveals wide variations

FDA eyes drug tests done by Canadian lab

You still can’t drink the water, but now you can touch it;
technique kills 100% of microbes from Katrina water

AIDS drug study offers hope for pregnant women

Bridling at insulin’s cost, states push for generics

Study finds major variation in Medicare Rx drug costs across states
 

SCAI issues clinical alert on drug-eluting stents and late thrombosis

The Society for Cardiovascular Angiography and Interventions (SCAI) today released a clinical alert advising physicians on practical steps for reducing the risk of a rare but serious complication associated with the use of drug-eluting stents. The document follows hearings held by the Food and Drug Administration’s Circulatory Systems Device Panel regarding the use of these devices. The panel supported the continued use of these devices but also suggested more research to determine whether the devices contribute to an increased likelihood of heart attack and death in complex heart disease patients who receive these stents. SCAI’s clinical alert, published online in SCAI’s official journal, Catheterization and Cardiovascular Interventions, focuses on the importance of careful patient selection, meticulous stent implantation, and consistent use of medications to prevent the delayed formation of blood clots that can block blood flow to the heart, a condition known as late stent thrombosis. “Practicing physicians and their patients are naturally concerned by the recent finding of a very small, but important risk of very late stent thrombosis. Since SCAI’s membership includes the vast majority of practicing interventional cardiologists, we felt it was critical to give some practical advice and guidance in an attempt to ensure optimal outcomes for our patients with coronary artery disease. Coronary artery disease is still the number one cause of death in the Western world, and anything we can do to maximize therapy while minimizing risk is welcome,” said John McB. Hodgson, M.D., FSCAI, the lead author of the clinical alert, a Past President of SCAI, and Chief of Academic Cardiology at St. Joseph’s Hospital and Medical Center in Phoenix, AZ.

This clinical alert has been designed to provide interventional cardiologists with practical advice on how to evaluate and minimize the risk of late stent thrombosis. Its recommendations include the following: Prior to any stent implantation, patients should meet accepted criteria for coronary intervention as described in guidelines jointly published by the ACC, AHA, and SCAI; The decision to treat a patient with a drug-eluting stent, rather than a bare metal stent or bypass surgery, must be made on an individual patient basis, considering the relative risks and benefits of each therapy. This determination will vary according to each patient’s medical history, coexisting illnesses, and lesion characteristics; Patients must be carefully evaluated for their ability to adhere to long-term therapy with dual anti-clotting medications; Careful attention must be paid to stent implantation technique, including the use of intravascular ultrasound, screening for arterial calcification, and pretreatment of complex lesions in some cases; Patients should take dual anti-clotting medication for at least three to six months, preferably for 12 months unless there is a high risk for bleeding. In patients with a higher-than-average risk for late stent thrombosis, for example, those with diabetes, physicians should consider not only continuing dual anti-clotting medication for longer than 12 months, but also testing responsiveness to these medications and adjusting dosages as needed; Discontinuation of dual anti-clotting medication requires careful consideration and must be individualized for each patient. Several large multicenter trials to better define the risk of late stent thrombosis and assess strategies to prevent this complication are in progress or will soon begin enrolling patients. In the meantime, “patients should be reassured that the implantation of a drug-eluting stent, after careful consideration with their physician, remains a very effective method for the treatment for symptoms associated with the disabling problem of coronary artery disease,” Dr. Hodgson said.

Hospital death rate study reveals wide variations

Hospital death rates can be reduced by employing more Registered Nurses and the routine use of care maps or protocols, according to a study in the latest UK-based Journal of Advanced Nursing. A research team from the University of Toronto and the Institute for Clinical Evaluative Sciences in Ontario, Canada, studied 46,993 patients admitted to hospital with heart attacks, stroke, pneumonia and blood poisoning. They discovered that deaths within 30 days of admission varied considerably between the 75 hospitals in the study, ranging from 10 percent to 28 percent and averaging just under 17 percent. When they added in the survey results from 3,886 nurses at the hospitals, together with official discharge and death rates, population statistics and insurance plan data, they discovered that a number of factors accounted for 45 percent of the variation in death rates. “Our research underlines the need for hospitals to look as carefully at staffing structures and care processes as they already do at accurate diagnosis and appropriate and effective interventions,” said lead author Dr. Ann Tourangeau. 19 variables were examined to gauge their effect on 30-day death rates. Key findings included: A 10 percent increase in the proportion of Registered Nurses employed was associated with six fewer deaths per 1,000 discharged patients; The death rate also went down by nine per 1,000 discharged patients when the number of Baccalaureate-prepared (university graduate rather than diploma qualified) nurses went up by 10 percent; A 10 percent increase in adequate staffing and resources (as reported by nurses) was associated with 17 fewer deaths per 1,000 discharged patients.

“An important finding of our study was the effect that the routine use of care maps or protocols had on lowering 30-day death rates,” adds Dr. Tourangeau. “A ten percent increase in the use of care maps in hospitals, as reported by nurses, was associated with ten fewer deaths for every 1,000 patients. Our findings contribute to the mounting evidence that structures and processes in hospital nursing care have an impact on patient mortality and survival. They clearly have implications for hospital management, clinical practice and future research,” she adds. “We specifically recommend greater use of care maps or protocols to guide patient care during their time in hospital. These could be shared, as a matter of good practice, on the Internet and adapted around the world to provide patients with culturally sensitive services. Although we were able to identify what caused 45 percent of the variance in 30-day death rates, more than half of the variance remains unexplained. Death rates are a complex issue and nursing care is just one factor that influences survival rates. Future research should look at elements such as access to in-patient and out-patient care, the healthcare environment and the impact of hospital management and leadership on outcomes.”

Other study findings included: The percentage of Registered Nurses ranged from 36 percent to 100 percent, with an average of 66 percent; Full-time nursing staff ranged from 35 and 92 percent, with an average of 61 percent; Nurses had spent between three and a half and fourteen and a half years on their current clinical unit, with an average of just over eight years; On average, 13 percent were Baccalaureate-prepared (graduate) nurses. This ranged from zero to 62 percent across the hospitals; The use of care maps and protocols varied from 29 percent to 85 percent, averaging 63 percent; An average of 40 percent of nurses felt their staffing and resources were adequate, with figures ranging from 19 to 52 percent.

FDA eyes drug tests done by Canadian lab

Health officials said Wednesday that inspections revealed serious concerns about drug testing done by a Canadian company that underpinned the applications of potentially hundreds of medicines pending federal approval or already on the market. The concerns could compel some drug companies to either confirm or repeat certain tests their products underwent required to win federal approval, Food and Drug Administration officials said. While the work won’t result in the removal of any drugs from the market, it could slow the approval of some drugs awaiting federal clearance. The FDA stressed it has no evidence of problems with the quality, purity or potency of the affected drugs. Still, the agency is sending more than 1,000 letters to drug companies asking them to reevaluate the results of tests performed by MDS Pharma Services between 2000 and 2004 and included in their applications to the agency. Companies have six months to comply.

Ultimately, the request likely will affect only a small percentage of the drug applications submitted since 2000, FDA officials said. “The FDA is taking this precautionary measure to make sure the data submitted to the agency is of the highest quality,” said Joseph Famulare, deputy director of the office of compliance in the agency’s drug evaluation and research division. FDA inspections of two of MDS Pharma Services’ facilities in Canada revealed a variety of problems with its testing procedures. The contract company, part of MDS Inc. of Mississauga, Ontario, originally agreed to audit its own work, but that failed to satisfy the FDA and prompted the agency to appeal directly to drug makers. The FDA said MDS Pharma Services failed to identify and fix sources of contamination in the tests, which measured drug levels in the blood of patients. The company also failed to validate and document the accuracy of the testing methods it used, the FDA said.

In a statement, MDS Inc. said it has taken numerous corrective actions to meet the FDA’s requirements but hadn’t been able to fully satisfy the FDA. It planned to redirect efforts to support its clients with independent audit activities, the company said. “While we are disappointed in the time and effort that it has taken to get to this course of action, we believe that it will benefit everyone involved to have a crisp path forward to resolve this issue,” said Stephen P. DeFalco, president and CEO of MDS Inc. “We will fully support our clients with data and information from their studies to help bring this issue to a rapid and complete resolution.” Agency officials have identified all 217 generic drugs that either have won or are seeking federal approval and that included MDS Pharma studies in their applications. For brand-name drugs, FDA isn’t as sure which companies relied on testing done by MDS Pharma Services. As a result, it is notifying all brand-name drug makers that submitted the more than 900 applications received since 2000 to comb through their files to find out. The FDA declined to identify the drug companies known to have contracted with MDS for testing. (The Associated Press)

You still can’t drink the water, but now you can touch it;
technique kills 100% of microbes from Katrina water

Engineers have developed a system that uses a simple water purification technique that can eliminate 100 percent of the microbes in New Orleans water samples left from Hurricane Katrina. The technique makes use of specialized resins, copper and hydrogen peroxide to purify tainted water. The system, safer, cheaper and simpler to use than many other methods, breaks down a range of toxic chemicals. While the method cleans the water, it doesn’t yet make the water drinkable. However, the method may eventually prove critical for limiting the spread of disease at disaster sites around the world. National Science Foundation-funded researchers Vishal Shah and Shreya Shah of Dowling College in Long Island, NY, collaborated with Boris Dzikovski of Cornell University and Jose Pinto of New York’s Polytechnic University in Brooklyn to develop the technique. They will publish their findings in Environmental Pollution. “After the disaster of Hurricane Katrina, scientists have had their backs against the wall trying to develop safeguards,” said Shah. “No one knows when a similar situation may arise. We need to develop a treatment for decontaminating flood water before it either comes in contact with humans or is pumped into natural reservoirs.”

The treatment system that the researchers are developing is simple: a polymer sheet of resins containing copper is immersed in the contaminated flood water. The addition of hydrogen peroxide generates free radicals on the polymer. The free radicals remain bound to the sheet, where they come in contact with bacteria and kill them. The researchers are working to lower the amount of copper in the treated water end product and improving the system’s impact on chemical toxins. Shah believes it could be ready for emergency use within five to seven years. Applying their technique to water from the Industrial and 17th Street canals in New Orleans, the researchers were able to destroy all of the bacteria within 15 minutes. In tests with laboratory water samples containing even higher bacterial concentrations, the exact same process killed at least 99 percent of the bacteria in 90 minutes.

AIDS drug study offers hope for pregnant women

Women can take the anti-AIDS drug nevirapine to protect their unborn children without endangering their ability to undergo life-saving antiretroviral treatment later on, a new study has found. The results are good news for poor women in Africa, Asia and Latin America who must take nevirapine, an inexpensive first-line drug that often prevents the transmission of H.I.V. from mother to child. The drug lingers in the blood up to three weeks, and if the mother has the AIDS virus, its presence encourages the growth of nevirapine-resistant strains. That has led to fears that any antiretroviral drug cocktail containing nevirapine would be useless. But the new study, being published on Thursday in The New England Journal of Medicine, finds that such a cocktail is still effective if women simply delay it for six months after taking the protective dose of nevirapine. The study was done by Harvard researchers working in Botswana, but has implications for poor women everywhere. Early reports of data gathered in the study, along with evidence from similar ones, influenced the World Health Organization’s new AIDS treatment guidelines last year, helping keep nevirapine in the arsenal of first-line AIDS drugs.

Nevirapine has never been a perfect drug; in prolonged use, it can poison the liver and cause rashes, and the AIDS virus only needs to make a single mutation to develop resistance to it. In wealthy countries, women are usually given a short course of two or three antiretroviral drugs late in the pregnancy to prevent passing the virus to their babies, and birth infections are now rare in the West. But in poor countries, many women in rural villages give birth without ever seeing a doctor, or make the trek to hospitals or clinics only when they are in labor, leaving medical workers with little choice but single-dose nevirapine. The drug is so simple and effective that health workers in small clinics often leave pregnant women one pill to take when labor starts and a syringe full of liquid nevirapine to squirt into the newborn’s mouth, said Dr. Shahin Lockman, a researcher for the Harvard School of Public Health’s AIDS Initiative and author of the study. In some cases, she said, they must do this without even knowing whether the mother is infected. Under those circumstances, nevirapine is usually harmless, and cuts in half the chance that the baby will get infected. The drug is also a cornerstone of antiretroviral AIDS treatment in poor countries. The Botswana study concludes that waiting six months after single-dose nevirapine allows the nevirapine-resistant strains to disappear from the body. For 70 to 80 percent of mothers infected with H.I.V., waiting that long is safe, said Dr. Catherine M. Wilfert, scientific director of the Elizabeth Glaser Pediatric AIDS Foundation. Women healthy enough to carry a pregnancy to term are usually not yet so sick that they need AIDS cocktails immediately, she said. Although her foundation prefers to offer mothers more than just single-dose nevirapine, Dr. Wilfert said, she was glad to see that potential resistance to it could be overcome. (The New York Times)

Bridling at insulin’s cost, states push for generics

As they examine their state healthcare budgets, 11 of the nation’s governors have identified one big-ticket item they think should cost less: insulin. The drug cost state Medicaid programs $500 million in 2005. And in the face of an epidemic of diabetes, the governors are asking why there is no cheaper generic version of a drug that, in one form or another, has been used since the 1920s. The issue involves questions of politics and profits, as well as science. Insulin is caught in a commercial tug of war between brand-name drug companies that want to protect their franchises and generic drug makers that want to produce their own insulin products. Recently, each side has stepped up efforts to advance its side of the argument, and there are signs that Congress is ready to make life easier for generic drug companies. People with diabetes in this country, as well as government and private insurers, spend a combined $3.3 billion a year on insulin. Analysts say the price of insulin might drop by 25 percent if generic versions became available.

Gov. Haley Barbour of Mississippi, a Republican, and 10 other governors have asked the F.D.A. to ease the way for generic insulin. In Congress, some members see the generic-insulin issue as having implications for the nation’s healthcare bill that go well beyond diabetes treatments. Insulin is one of the most widely used of a growing category of drugs known as biologics, medicines, made from living organisms, that are the fastest-growing segment of pharmaceutical spending. Many believe that if generic insulin is approved, that would open the door to development of generic versions of other, more complex biologics. Some include popular and expensive treatments for rheumatoid arthritis, cancer and other diseases that cost tens of thousands of dollars a year. Some generic drug manufacturers say that a first step would be for the F.D.A. to adopt guidelines explaining the testing and documentation that would be required for the approval of insulin.

The 11 governors from states with high Medicaid spending on insulin are pressing for such guidelines, and generic drug manufacturers say they need them to proceed with applications for insulin. The F.D.A. announced in 2001 that it was developing guidelines for approving generic insulin and human growth hormone, another widely used and long available biologic. Those guidelines have never been released, however, partly, critics say, because of pressure from the Biotechnology Industry Organization, which represents the brand-name makers of biologic drugs. The association argues that the same shortcuts to approval that are granted for conventional generic drugs are not applicable to biologics, even simple ones like insulin. Those shortcuts include an exemption from the long clinical testing required for approval of brand-name drugs. The trade group has been working to make sure generic drug companies cannot piggyback on the clinical studies done by drug innovators. The F.D.A. says that it is studying the issue, but believes that it is more appropriate to develop guidelines that would apply to all biologics rather than to issue guidelines for individual products like insulin and human growth hormone. The agency has said it will release a scientific background paper this spring that examines the issue. To read the full article CLICK HERE. (The New York Times)

Study finds major variation in Medicare Rx drug costs across states

Soon, Congress may vote on whether to require the Medicare system to negotiate lower prices for medicines taken by millions of seniors enrolled in Medicare Part D prescription drug plans. That change and others might save some seniors a lot of money, suggests a new study from the University of Michigan Medical School. It finds tremendous variation in what Medicare enrollees in different states pay for the same medications, even with the lowest-cost Part D plans. In fact, two people taking the same drugs but living in different states could face costs that differed by thousands of dollars, even if each had chosen the lowest-cost plan available to them. And within a state, the difference in a person’s costs for the same drugs could top $10,000 a year or more, depending on which plan he or she chose.

Such wide variation in prices means that Medicare prescription drug plans are substantially more affordable in some states than in others, the authors conclude. In all, depending on which medicines they’re taking and which plan they’re in, people in one state might spend 10 percent of their annual income to pay for prescription drug coverage premiums and co-pays, while someone taking the same medicines in another state would spend 20 percent of their income, the study finds. The difference in plan costs appears to have little to do with the cost of living in different states, the researchers found. In fact, some of the states with the lowest cost-of-living-adjusted average incomes had some of the highest drug plan costs.

The researchers, led by U-M physician and healthcare policy researcher Matthew Davis, M.D., M.A.P.P., made the findings using Medicare’s own Web-based calculator for prescription drug plan costs. They analyzed every plan in every state for four real patients who had typical ailments and medication regimens, and looked at what the plans would cost, considering plan premiums, coinsurance, and copays each time a prescription was filled. The results, published in the January Journal of General Internal Medicine, may help inform the Congressional effort to reform the Medicare drug benefit, including bulk purchasing. Currently, individual Part D plans offered by commercial insurers acquire their own drug supplies at the prices they are able to negotiate with pharmaceutical manufacturers and distributors, and set their own drug lists, premiums and co-pays.

January 10, 2007

Canadian report on SARS cites health system failures

CDC awards $3.7 million to improve public health
and healthcare information sharing for disease detection

Bird flu resurfaces in Vietnam

Kodak to sell health group to Onex for up to $2.55 billion

Blood test predicts cardiac events and death in heart patients

Improved adherence to certain medications associated
with longer survival following heart attack

MedAssets Net Revenue Systems enhances Medgician Online
to meet needs of critical access hospitals 
 

Canadian report on SARS cites health system failures

The SARS epidemic that killed 44 people in Ontario in 2003 spread because of a shoddy public health system and inadequate safety practices, according to an investigative commission report released Tuesday. The disease infected nearly three-fourths of its victims at clinics and hospitals, facilities that should have prevented its spread, the report said. But the epidemic was finally stopped by health employees who worked despite wrenching fears of a then-unknown killer. “Nurses lived daily with the fear that they would die or infect their families with a fatal disease,” said the report, the last of three volumes produced in an exhaustive inquiry headed by Ontario Superior Court Justice Archie Campbell. “The surprise is not that Ontario's response to SARS worked so badly, but that it worked at all,” Campbell said in the 1,204-page report.

The outbreak of SARS, severe acute respiratory syndrome, hit Toronto area hospitals in two waves in the spring of 2003. The illness, eventually traced to central China and brought unwittingly to Canada by an elderly woman who had visited Hong Kong, closed hospitals, brought routine healthcare in the province to a halt and prompted visitors to Toronto to be quarantined. It was an “economic disaster,” the report noted, and infected more than 330 people with serious lung disease in four months, in addition to those who died. The disease also killed hundreds of people in other countries, mostly in Asia. Throughout much of the epidemic, Canadian authorities assured the public and health workers that precautions were being taken to prevent the disease’s spread.

“This was a system failure,” the report said. “The lack of preparation against infectious disease, the decline of public health, the failure of systems that should protect nurses and paramedics and others from infection at work” all failed. “The only thing that saved us from a worse disaster was the courage and sacrifice and personal initiative of those who stepped up, the nurses, doctors, paramedics and all the others, sometimes at great personal risk, to get us through a crisis that never should have happened,” the report said. Reacting to the report, medical authorities noted improvements made in the system since 2003. “You have to remember we were in the fog of war when SARS came to Ontario,” Tony Clement, the federal health minister now and health minister of Ontario at the time, said. “We didn’t know what it was, how it was transmitted. We didn’t know how to deal with it. In terms of infectious disease controls in hospitals, we are much better prepared,” he said. “I would argue we have the best infectious disease control in the world now.” (Washington Post)

CDC awards $3.7 million to improve public health and healthcare information sharing for disease detection

The Centers for Disease Control and Prevention (CDC) has announced $3.7 million in new grants designed to enhance healthcare information in an effort to improve the detection and response to emerging public health threats. The new grants will fund studies at three new Centers of Excellence in Public Health Informatics located at New York City Department of Health and Hygiene; the University of Utah, Salt Lake City; and Johns Hopkins University, Baltimore, MD. “The goal of this funding will be identifying new tools and methods to enhance health information sharing and ultimately lead to the adoption of a nationwide, technology-based, integrated healthcare surveillance system. We hope we’ll be able to detect emerging public health threats earlier and more efficiently,” said Dr. Steve Solomon, director of the Coordinating Center for Health Information and Service at CDC.

These Centers of Excellence will be designing new tools and methods to assist and enhance CDC’s BioSense program. BioSense provides real-time biosurveillance for potential health threats through immediate access to data from hospitals and healthcare systems in major metropolitan cities across the nation. The studies will involve a variety public and private sector partners, including universities, health departments and research organizations. Studies include: investigating new technologies which will improve the timeliness and accuracy of electronic disease surveillance systems and enhance the development of a national disease surveillance network; implementing and evaluating a model Electronic Health Record (EHR) system that incorporates public health priorities and epidemiological data; and enhancing the use of electronic medical surveillance in detecting and investigating public health threats.

Bird flu resurfaces in Vietnam

Bird flu is popping up after a yearlong hiatus in Vietnam and elsewhere in Asia, and experts are warning now is the time for the H5N1 virus to flourish. The big question: Just how far will it go this winter? As temperatures drop during traditional flu season, bird flu typically spreads. A year ago, the virus swept across countries in Africa, the Middle East, Central Asia and into Europe. Even so, officials say it’s hard to predict what such an unpredictable virus will do. “We’re braced for basically a repeat of what we saw last year,” Peter Cordingley, spokesman for the World Health Organization’s Western Pacific region, said. “We’re expecting more problems through the colder months as we head into February and March.”

Last winter, a wave of bird flu was reported in many countries where the H5N1 virus was detected for the first time, including India, Iraq, Azerbaijan, Niger and France. Turkey was particularly hard hit last January when 12 people were infected, four of whom died. Since December, flare-ups have caused the death or slaughter of 30,000 birds in Vietnam after no poultry outbreaks or human cases had been reported for a year. South Korea, which had not battled the disease in three years, also has slaughtered more than 1 million birds since the virus erupted in November. Egypt last month reported three human deaths from the H5N1 virus, while Indonesia, the country hardest hit by the virus with 58 deaths, continues to report human cases. On Wednesday, a 14-year-old Indonesian boy died from bird flu, just days after being hospitalized, a health official said. New fears also have surfaced in Hong Kong after a wild bird found dead tested positive for the virus on Saturday, and mainland China on Wednesday reported that the virus had last month infected a farmer, who has since fully recovered.

Despite the developments, some experts expressed optimism that the situation is improving globally and that a repeat of last year’s pattern is unlikely. The number of outbreaks among poultry today “pales by comparison” to early 2004, when bird flu first emerged in Asia, said Juan Lubroth animal health expert at the U.N. Food and Agriculture Organization in Rome. “Although we see it in different places, at least the number of outbreaks and the chickens dying ... is not what it used to be,” he said. Even as the number of poultry outbreaks declined, reports of human deaths rose in 2006, killing 79 people. Officials say the increase may be the result, in part, of better surveillance and reporting due to increased public awareness about bird flu. The disease has claimed at least 157 lives worldwide since it began ravaging Asian poultry farms in late 2003, according to the WHO. As Vietnam prepares for next month's Lunar new year holiday, known as Tet, health officials are worried human cases could follow during the busiest time for the movement of people and poultry. Vietnam was hailed for successfully beating back the virus after starting a mass national poultry vaccination program and involving the country’s top leadership in raising awareness. But even after the long lull, the virus’ resurgence has reminded everyone that it’s far from gone. “It shows that even if you take all these measures, you can’t eliminate the virus if it has been widely spread in the environment in half a year or a year,” said Hans Troedsson, WHO representative in Vietnam. (The Associated Press)

Kodak to sell health group to Onex for up to $2.55 billion

Eastman Kodak Company announced today that it has entered into an agreement to sell its Health Group to Onex Healthcare Holdings, Inc., a subsidiary of Onex Corporation, in a move that will sharpen Kodak’s strategic focus on consumer and professional imaging and the graphic communications industry. Under terms of the agreement, Kodak will sell its Health Group to Onex for up to $2.55 billion. Included in the sale are manufacturing operations focused on the production of health imaging products, as well as an office building in Rochester, NY. Kodak’s Health Group, with revenue of $2.54 billion for the latest 12 reported months (through September 30, 2006), is a provider of information technology, molecular imaging systems, medical and dental imaging, including digital x-ray capture, medical printers, and x-ray film. Onex Corporation, based in Toronto, has global operations in health care, service, manufacturing and technology industries. The healthcare operations include emergency care facilities and diagnostic imaging clinics. Subject to regulatory and other approvals, it is anticipated that the sale will close in the first half of 2007.

Blood test predicts cardiac events and death in heart patients

A simple blood test for the protein NT-proBNP accurately predicts the risk of heart attack, heart failure, stroke, and death in patients with known cardiovascular disease, according to a study led by a researcher at the San Francisco VA Medical Center. The study of 987 men and women with stable coronary heart disease revealed that the higher a patient's level of NT-proBNP, the greater the chance the patient would die or have a cardiovascular event – heart attack, heart failure, or stroke. “After adjusting for all other risk factors, it’s clear that this marker is picking up something that we are otherwise unable to detect with standard tests such as echocardiography,” said principal investigator Mary Whooley, MD, a staff physician at SFVAMC and an associate professor of medicine at the University of California, San Francisco. The study appears in the January 10, 2007 issue of Journal of the American Medical Association.

NT-proBNP is a marker in the blood for BNP, a hormone that “goes up during times of cardiac stretch or stress,” explained Whooley. “When the heart wall is over-expanded by too much blood volume, or damaged by lack of blood flow to the heart itself, BNP goes up, and NT-proBNP along with it.” Patients in the study were divided into four quartiles depending on their NT-proBNP blood levels, and followed for an average of 3.7 years each. Twenty-six percent died or had a cardiovascular event during the course of the study. The study reports that “each increasing quartile … was associated with a greater risk of cardiovascular events or death.” Patients in the quartile with the highest levels of the biomarker were 3.4 times more likely to die or have a cardiovascular event than patients in the group with the lowest levels. Whooley cautions that the NT-proBNP test is “not something that we should order on every patient who comes in for a routine checkup,” but would be most useful for patients with known coronary heart disease. “In the general population, the incidence of heart disease is so low relative to the incidence in heart disease patients that you get many more false positive results than true positives, which really lowers the value of the test,” she said. “It’s much better at predicting risk in a population with a high incidence of heart disease.” Whooley also notes that, even among heart patients, the value of the test is limited “because all of the therapies available to prevent cardiovascular events should already be used among these patients. The best it can do is help identify candidates for more aggressive therapy.” She says that one additional step for researchers is to see “whether there are therapeutic interventions that still remain to be developed that might prevent heart patients with elevated BNP from doing worse.”

Improved adherence to certain medications associated
with longer survival following heart attack

New research suggests that the pharmacological effects of taking medications such as statins and beta-blockers as prescribed following a heart attack is associated with living longer, according to a study in the January 10 issue of JAMA. Clinical trials have demonstrated that selected medications reduce the risk of cardiovascular death. However, their projected survival impact in the real world is less known, in part because of variations in drug adherence, according to background information in the article. Although it is known that adherence to evidence-based medications predicts better survival, no population outcome study has attempted to differentiate whether these associations are attributable to the drug's biological responsiveness (drug effect) or to the adoption of healthier lifestyles that often accompany adherent behaviors (healthy adherer effect).

Jeppe N. Rasmussen, M.D., of the University of Toronto, and colleagues examined the relationship between drug adherence and death following acute myocardial infarction (AMI; heart attack). To help evaluate whether this relationship was more attributable to drug effects rather than to healthy adherer effects, the researchers examined 3 medication classes, 2 of which are associated with proven mortality benefits (statins and beta-blockers); the third medication class (calcium channel blockers) was examined as a control given the absence of documented post-heart attack survival advantages. The study included 31,455 elderly heart attack survivors between 1999 and 2003 in Ontario. All patients filled a prescription for statins, beta-blockers, or calcium channel blockers. Patient adherence was subdivided into 3 categories: high (proportion of days covered, 80 percent or greater), intermediate (proportion of days covered, 40 percent - 79 percent), and low (proportion of days covered, less than 40 percent).

Among patients who used statins, mortality was greatest for low adherers (deaths in 261/1,071; 24 percent), intermediary for intermediate adherers (deaths in 472/2,407; 20 percent), and lower for high adherers (2,310/14,345; 16 percent). The researchers found that after adjustment for baseline patient characteristics, compared with those with high levels of adherence to statins, the adjusted risk of death was 12 percent higher among patients with intermediate adherence and was 25 percent higher among patients with poor adherence. A similar but less pronounced dose-response-type adherence-mortality association was observed for beta-blockers. There was no relationship between calcium channel blocker adherence and mortality.

MedAssets Net Revenue Systems enhances Medgician Online
to meet needs of critical access hospitals 

MedAssets Net Revenue Systems announced further enhancements to its Medgician Online chargemaster management software designed specifically to address coding and billing requirements unique to Critical Access Hospitals (CAH). Although critical access hospitals have many of the same chargemaster needs as other hospitals, some coding and billing requirements are unique. With Medgician Online, hospitals achieve improved compliance with regulatory requirements, reduced denials and billing rejections, and more defensible patient charging. Critical Access Hospitals often have scarce resources and fewer coding experts. With Medgician Online, the chargemaster maintenance process becomes highly automated and supporting regulatory information is readily available. Medgician Online is also integrated with MedAssets’ KnowledgeMaster or optional KnowledgeMaster Plus chargemaster best practices, benchmarking and regulatory research tool. For more information CLICK HERE.   

HPN creates new surgical supply innovators award

Healthcare spending slows again in ‘05, but still rises
at twice the rate of inflation

More adults have congenital heart disease, study finds

California plan for healthcare would cover all

Gene variant is linked to common type of stroke

Precision Dynamics Corporation and IntelliDOT Corporation
announce joint marketing agreement

Amerinet announces agreement with FDSI Logistics

HPN creates new surgical supply innovators award

You may have heard horror stories about surgical services departments that simply won’t work with materials management, either because of personality conflicts (e.g., doctors get what they want with the C-suite’s blessing) or a lack of respect for the MM department’s capabilities (e.g., the O.R. director doesn’t believe a non-clinical department truly understands clinical needs). In fact, you may have experienced one yourself.

Until the advent of DRGs for reimbursement in the early 1980s, and the subsequent emergence of managed care, materials management took more of a hands-off approach with the O.R., which typically didn’t know who or what materials management was. But that started changing in the 1990s. Market conditions were forcing clinicians to understand the business, finance and operational aspects of the facilities in which they practiced while the materials managers were forced to learn about clinical needs and how to speak clinical language. As a result, a growing number of doctors added MBAs to their M.D.s and O.R.s added business and materials management expertise to their ranks. Meanwhile, materials management departments started pursuing concepts like value analysis, and installing nurses and related clinicians as departmental liaisons.

Call it a meeting of the minds as both pursued the bottom line from different directions. However, this remains a developing trend that hasn’t yet infiltrated the majority of healthcare facilities. So while challenges between MM and the O.R. may continue as common occurrences in many facilities – even those that have implemented noticeable and noteworthy improvements – success stories between the clinical and supply chain management areas to reduce expenses and improve efficiency without negatively impacting patient care do exist.

Healthcare Purchasing News would like to find them and share them with you. But we need your help. We’ve created a new award that recognizes those facilities, surgical services departments or specific O.R. management professionals that have identified problems, developed workable solutions and effectively worked together with materials management, thereby improving patient care. We'd like to honor and profile the facility that offers the optimal, if not best, solution to a lingering supply management challenge in the O.R. with the “HPN Award for Surgical Supply Innovation.”

Applying is simple: Please submit a brief nomination of no more than 750 words max that highlights and outlines what the problem was, how it was solved and who collaborated on/contributed to developing and implementing the solution. Email applications to editor@hpnonline.com or send to: HPN’s Surgical Supply Innovators Award, 7650 So. Tamiami Trail, Ste 10, Sarasota, FL 34231.Deadline: Monday, January 22. HPN will feature the winning facility in the March 2007 edition, as well as at the 2007 Association for periOperative Nursing (AORN) Congress in Orlando, FL, March 11-15.

Healthcare spending slows again in ‘05, but still rises at twice the rate of inflation

Growth in U.S. healthcare spending slowed in 2005 for the third consecutive year, reflecting a sharp slowdown in the rise of prescription-drug spending, the federal government reported. The study, considered the most comprehensive tally of the nation’s annual health spending, found that the U.S. spent $1.988 trillion, or $6,697 per person on healthcare in 2005, the latest year for which data are available. That was a rise of 6.9%, down from 7.2% in 2004 and 8.6% in 2003, and the lowest growth rate since 1999. It isn’t clear whether the deceleration in healthcare spending is temporary or part of a longer trend, said economist Aaron Catlin, who wrote the report with colleagues at the Centers for Medicare and Medicaid Services. The study is being published in the journal Health Affairs.

The authors note that healthcare spending will be dictated by the aging of the population, the development of new technology, and utilization patterns by patients and doctors. The rise in healthcare spending was barely faster than the growth in overall economy. As a result, healthcare spending edged up to 16% of the gross domestic product from 15.9% the year before. Federal and state governments footed 40%, or $736.3 billion, of the bill for health services and supplies. The public-sector spending rose 7.8% in 2005, compared with growth of 7% for businesses and 6.2% for households. “Healthcare costs continued to grow faster than the underlying rate of inflation, faster than the rest of the economy, and faster than the growth in average wages,” said Jack Ebeler, a healthcare consultant in Washington.

The slowdown in prescription-drug spending has been notable, reported The Wall Street Journal. It increased 5.8% in 2005, down from 8.6% in 2004, and a peak of 18.2% in 1999, the report said. The drop was partly caused by a sharp deceleration in drug expenditures by Medicaid. Drug spending by Medicaid rose 2.8% in 2005, compared with annual increases of 15.4% for the program from 1994 to 2004. To restrain costs, states have worked together to get higher rebates on certain drugs and steered recipients to use those drugs. The study doesn’t include data on the effect of the Medicare drug benefit which was implemented in January 2006.

Spending for other sectors, such as hospital and physician and clinical services grew at rates similar to those of 2004, the authors said. Hospitals accounted for 31% of all dollars spent on healthcare. Despite the slowdown in healthcare spending, the percentage of personal income going for healthcare is rising. Out-of-pocket spending for healthcare grew to $249.4 billion in 2005, compared with $235.8 billion in 2004. One in five pocket dollars went to pay for prescription drugs. (The Wall Street Journal)  

More adults have congenital heart disease, study finds

Severe cases of congenital heart disease are on the rise among North American adults, but researchers say that probably means growing numbers of infants born with the condition are surviving into adulthood. “This is a real success story,” said Dr. Ariane Marelli, lead author of a new study on the trend and director of the McGill Adult Unit for Congenital Heart Disease Excellence at McGill University in Montreal, Canada. The study, which analyzed databases in the Canadian province of Quebec where access to healthcare is universal, found that severe congenital heart disease had risen among adults by 85 percent from 1985 to 2000. Among children the increase over the same time period was 22 percent, according to the study which was published on Monday in Circulation: Journal of the American Heart Association.

Congenital heart defects occur before birth and are structural problems related to the abnormal formation of the heart or major blood vessels near it. Marelli said increased survival rates for infants born with the defects were the most likely reason for increasing adult prevalence of severe CHD but more research was needed to make the link definitive. “There are many possible reasons for the increase but we think the most likely reasons are that advances in care of pediatric heart patients have allowed these infants to survive into adulthood,” she said. She said infants born with the condition before the 1960s and 1970s were less likely to survive than they are now. “To our knowledge, this is the first study to measure the changing number of patients in a North American population during a period of major progress in the management of CHD,” said Marelli. “This is the largest population study of CHD to have been performed in North America. We have no reason to believe that the predominantly Caucasian population of Quebec and Canada is different from the United States,” she said.

Extrapolating the study findings in Quebec to the U.S. population, researchers estimate that 1.8 million Americans had the disease in 2000, 900,000 adults and 900,000 children. This points to one of every 85 children having the disease in 2000 and one out of every 250 adults. “For comparison purposes, cystic fibrosis occurs in one of 4,500 live births, so there are 45 times more children with CHD than children with cystic fibrosis and most of these children are now becoming adults,” Marelli said. “The increasing prevalence of CHD means these children will live longer and acquire other forms of heart disease,” Marelli said. (Reuters)

California plan for healthcare would cover all

Gov. Arnold Schwarzenegger on Monday proposed extending healthcare coverage to all of California’s 36 million residents as part of a sweeping package of changes to the state’s huge, troubled healthcare system. A total of 6.5 million people, one-fifth of the state’s population, do not have health insurance, far more than in any other state. At least one million of the uninsured are illegal immigrants, state officials say. Under Schwarzenegger’s plan, which requires the approval of the Legislature, California would become the fourth and by far the largest state to attempt near universal health coverage for its citizens. The other three states are Maine, Massachusetts and Vermont.

The governor made it clear that a variety of mechanisms would be used to provide all Californians with insurance and that the responsibility of providing it would fall on the government, employers, healthcare providers and the uninsured themselves. The plan, which Schwarzenegger estimated would cost $12 billion, calls for many employers that do not offer health insurance to contribute to a fund that would help pay for coverage of the working uninsured. It would also require doctors to pay 2 percent and hospitals 4 percent of their revenues to help cover higher reimbursements for those who treat patients enrolled in Medi-Cal, the state’s Medicaid program. (The New York Times)

 

Gene variant is linked to common type of stroke

Japanese researchers have identified a gene variant that appears to predispose a person to strokes, but it seems more prevalent in Asians than in people of European or African descent. In a paper to be published next month in the journal Nature Genetics, researchers write that the presence of the variant raised the risk of cerebral infarction, the most common type of stroke, by 40 percent. The researchers studied 1,112 Japanese and found that the variant of the gene PRKCH turned up more often in people who had had strokes. The variant also appeared to be linked to an enzyme, rendering it more active. “The risk variant makes the enzyme more active, and that is abundantly expressed in a variety of different cell types in blocked arteries, which can ultimately lead to a stroke,” the scientists wrote, adding that arteries with more severe blockages tended to have higher enzyme levels.

The lead researcher, Michiaki Kubo of the Institute of Physical and Chemical Research in Japan, said the genetic variant was independent of other risk factors like age, sex, high blood pressure, smoking and drinking. Dr. Kubo acknowledged that many genetic and environmental factors contributed to developing atherosclerosis, the hardening of arteries that can lead to strokes, but added, “We think that this will be one of the important factors for atherosclerosis.” The identification of this variant could open the way to further studies on stroke prevention. Dr. Kubo recommended that carriers of the variant be carefully monitored. Although a standard blood pressure of 140 over 90 would be acceptable for noncarriers, for example, carriers should keep their blood pressure lower. The researchers added that the variant was extremely rare in people of European or African descent and might therefore not have significant effects on the genetic susceptibility to stroke in non-Asian populations. (Reuters)

Precision Dynamics Corporation and IntelliDOT Corporation
announce joint marketing agreement

Precision Dynamics Corporation (PDC), a provider of automatic wristband identification, and IntelliDOT Corporation, a provider of patient safety and workflow management solutions for healthcare, announce the implementation of a joint marketing agreement. In a close working relationship, the companies will be able to deliver to acute care facilities both a proven patient safety solution at the point of care, along with the convenience of patient wristbands embedded with either bar code or radio frequency identification (RFID). San Diego-based IntelliDOT develops and installs point of care bar code patient safety and documentation systems in hospitals. San Fernando-based PDC manufactures and sells bar code and radio frequency identification wristbands for hospital use. The joint agreement between IntelliDOT and PDC defines a relationship that allows both companies to deliver an even more complete solution to professionals in the acute care setting. 

Amerinet announces agreement with FDSI Logistics

Amerinet announces its agreement with FDSI Logistics for freight management. Effective through November 30, 2009, this agreement includes inbound and outbound freight management services, which includes small parcel and capital equipment (Med Surg), as well as capital equipment for construction projects. Headquartered in Agoura Hills, CA, FDSI Logistics, one of the largest non-asset based third-party logistics providers, is responding to the needs of the global marketplace by providing cost reduction programs for all modes of transportation (www.fdsi.com).  

January 8, 2007

Scientists discover new, readily available source of stem cells

Genetically altered cells may help artificial skin fight infection

A new attempt to solve one of AIDS's biggest riddles

New HIV test may predict drug resistance

Medicare drug program costing less than estimates, U.S. says

Novation announces new Anesthesia Standardization Program;
signs 25 anesthesia agreements

Case Medical awarded Premier contract
 

Scientists discover new, readily available source of stem cells

Scientists have discovered a new source of stems cells and have used them to create muscle, bone, fat, blood vessel, nerve and liver cells in the laboratory. The first report showing the isolation of broad potential stem cells from the amniotic fluid that surrounds developing embryos was published today in Nature Biotechnology. “Our hope is that these cells will provide a valuable resource for tissue repair and for engineered organs as well,” said Anthony Atala, M.D., senior researcher and director of the Institute for Regenerative Medicine at Wake Forest University School of Medicine. Atala announced the breakthrough with colleagues from Wake Forest University School of Medicine and Harvard Medical School. “It has been known for decades that both the placenta and amniotic fluid contain multiple progenitor cell types from the developing embryo, including fat, bone, and muscle,” said Atala. “We asked the question, ‘Is there a possibility that within this cell population we can capture true stem cells?’ The answer is yes.”

Atala and colleagues discovered a small number of stem cells in amniotic fluid, estimated at 1 percent, that can give rise to many of the specialized cell types found in the human body. The scientists believe the newly discovered stem cells, which they have named amniotic fluid-derived stem (AFS) cells, may represent an intermediate stage between embryonic stem cells and adult stem cells. They have markers consistent with both cell types. “It took this long to verify that we had a true stem cell,” said Atala, who began the work seven years ago. “These cells are capable of extensive self-renewal, a defining property of stem cells. They also can be used to produce a broad range of cells that may be valuable for therapy.”

An advantage of the AFS cells for potential medical applications is their ready availability. The report describes how the cells were harvested from backup amniotic fluid specimens obtained for amniocentesis, a procedure that examines cells in this fluid for prenatal diagnosis of certain genetic disorders. Similar stem cells were isolated from “afterbirth.” Atala said a bank with 100,000 specimens theoretically could supply 99 percent of the U.S. population with perfect genetic matches for transplantation. In addition to being easily obtainable, the AFS cells can be grown in large quantities because they typically double every 36 hours. They also do not require guidance from other cells (termed “feeders”) and they do not produce tumors, which can occur with certain other types of stem cells. The scientists noted that specialized cells generated from the AFS cells included all three classes of cells found in the developing embryo, termed ectoderm, mesoderm, and endoderm. In their high degree of flexibility and growth potential, the AFS cells resemble human embryonic stem cells, which are believed capable of generating every type of adult cell.

Genetically altered cells may help artificial skin fight infection

Cincinnati burn researchers have created genetically modified skin cells that, when added to cultured skin substitutes, may help fight off potentially lethal infections in patients with severe burns. Dorothy Supp, PhD, and her team found that skin cells that were genetically altered to produce higher levels of a protein known as human beta defensin 4 (HBD4) killed more bacteria than normal skin cells. HBD4 is one in a class of proteins that exist throughout the body as part of its natural defense system. Researchers have only recently begun targeting these tiny molecules as a way to combat infections. “If we can add these genetically modified cells to bioengineered skin substitutes, it would provide an important defense system boost during the initial grafting period, when the skin is most susceptible to infection,” explains Supp, an adjunct research associate professor at the University of Cincinnati (UC) and researcher at Cincinnati Shriners Hospital for Children. Supp says defensins could become an effective alternative method for burn wound care and infection control. Using them in cultured skin substitutes, she adds, could also decrease a patient's risk for infection, improve skin graft survival and reduce dependence on topical antibiotics.

UC researchers report these findings in the January issue of the Journal of Burn Care and Research. Cultured skin substitutes are grown in a laboratory using cells from a burn patient’s own skin. These cells are cultured, expanded and combined with a spongy layer of collagen to make skin grafts that are reattached to the burn wound. “Cultured skin substitutes are improving the lives of many burn patients, but they also have limitations, including an increased susceptibility to infection,” said Supp. “Because cultured skin grafts aren’t connected to the circulatory system at the time of grafting, they aren’t immediately exposed to circulating antibiotic drugs or antibodies from the body’s immune system to fight off infection.” Currently, physicians manage cultured skin graft infections during the early healing period by continually wrapping the wound in dressings soaked in antimicrobial drugs. Although this protects the grafts, Supp says, it can also contribute to the emergence of drug-resistant strains of bacteria. “When you give the patient the same drug topically and orally, the risk for drug-resistant bacteria to emerge is greatly increased,” said Supp. Researchers hope to begin testing this approach in an animal model in early 2007.

A new attempt to solve one of AIDS's biggest riddles

In the past 20 years, just about everything has changed in the treatment of HIV infection except that there is still no answer to the question: When should it start?  For most people with HIV, there are few problems and almost no symptoms for years after they acquire the virus. But the disease is incurable, and without treatment, it is eventually fatal for almost everyone who has it. Treatment consists of a combination of three or more drugs, known as antiretroviral therapy (ART). But the drugs are costly, they have side effects, and, once started, they must be taken for the rest of the patient’s life. Tens of billions of dollars in healthcare costs around the world, and in foreign aid and charity, hinge on knowing the best time to start treatment. “This is like the holy grail of AIDS research,” said Fred Gordin, an AIDS specialist at the Washington Veterans Affairs Medical Center. This month, Gordin and a group of researchers will ask the government to underwrite an audacious effort to answer the “when-to-start” question. On Jan. 17 they plan to propose to the National Institutes of Health an international study that would enroll more than 9,000 people, children and adults, from poor and rich countries. Each would be randomly assigned to start AIDS treatment either soon after infection or after the virus has begun to measurably erode their immune systems. Participants would be followed and studied for five years to see who fares best, and who dies prematurely.

The yardstick for measuring HIV’s damage to the immune system is the number of virus-fighting cells, called CD4 lymphocytes, in the bloodstream. The normal number is about 750 per microliter of blood. Years ago, research showed that a person should start ART by the time the CD4 level falls below 200. People who do not start treatment by then die sooner. The big question is, at what point above a count of 200 should therapy begin? Many guidelines (including the U.S. government’s and the World Health Organization’s) recommend that treatment start when the count falls to between 350 and 200. Some doctors think it should start even sooner, at a count of 500.  Last January, a study called SMART tested the hypothesis that periodically interrupting ART when the CD4 count rebounded might be as good as taking the treatment continuously, and possibly better if it reduced the side effects. That theory was wrong. Patients on continuous treatment not only had fewer AIDS-related illnesses, the study found, they also had fewer non-AIDS-related problems, such as heart, liver and kidney disease. It appeared that suppressing the virus in the bloodstream might benefit the entire body, not just the immune system. The study offered one more reason to consider early treatment.

The proposed new when-to-start study would actually be two studies in one. One would enroll patients with CD4 counts over 500 and randomly assign them to either start treatment immediately or to wait until they drift into the 300 to 350 range. The other would enroll people with lower counts and assign them to start immediately or to wait until their counts are 200 to 250. Most infected people there are not started on ART until their CD4 counts drop below 200, and even then many cannot get treatment. If it turns out that that threshold is indefensibly low, there would be one more impetus to bring AIDS drugs and care to the world’s poor. (Washington Post)

New HIV test may predict drug resistance

Researchers at Duke University Medical Center have developed a highly sensitive test for identifying which drug-resistant strains of HIV are harbored in a patient’s bloodstream. The test may provide physicians with a tool to guide patient treatment by predicting if a patient is likely to become resistant to a particular HIV drug, said one of its developers, Feng Gao, M.D., associate professor of medicine. Drug resistance is one of the most common reasons why therapy for HIV fails. The test, which detects genetic changes, or mutations, in HIV, also may help scientists understand how the constantly evolving virus develops drug resistance, Gao said. He said such knowledge ultimately may result in the development of new treatments designed to evade resistance. The findings will appear in the journal Nature Methods. The work was supported by the National Institutes of Health and the Duke Center for AIDS Research. Duke has filed for a provisional patent on the technology, and the researchers are considering ways to establish a new company to pursue its development or to license the technology to an existing company, Gao said.

Because HIV genes mutate so easily and the virus reproduces so rapidly, most people who are infected have many different forms of the virus in their bodies. In some cases, mutated strains take on new properties that make them more resistant to the drugs used in antiretroviral therapy. During antiretroviral therapy that does not fully suppress the virus, a strain that develops drug resistance will grow more quickly than strains lacking such resistance, and the resistant strain will replicate to become the most prominent virus in the person’s body. More than 20 drugs currently are available for treating HIV infection. All but one of the drugs target two of the genes that serve as blueprints for vital protein components of HIV: reverse transcriptase and protease. The Duke test examines the genes of HIV strains for mutations at certain positions that are known to be linked to drug resistance. For example, a change at a specific spot along the genetic code, position 46, of the protease gene results in resistance to the drug indinavir.

To assess the test, the researchers analyzed blood samples from three different groups of HIV patients. The researchers added tiny fluorescent tags designed to stick to HIV genes in particular ways. Tags designed to stick to mutated gene locations known to produce drug resistance were labeled to appear green, while tags designed to stick to the same gene locations but where the genes had not mutated were labeled to appear red. The test proved sensitive enough to detect a single mutated virus out of 10,000 nonmutated viruses in the patient samples, Gao said. “This level of sensitivity makes the assay about 1,000 times more sensitive than the most widely used assays on the market for detecting drug-resistant HIV viruses” Gao said. “Thus, the assay may permit more accurate prediction of treatment outcomes.” The test also can detect when a virus molecule has more than one mutation, a capability that no commercially available test has achieved, Gao said the test has the potential to detect mutations that confer drug resistance in infectious agents that cause other diseases besides HIV, such as hepatitis B, hepatitis C and tuberculosis.

Medicare drug program costing less than estimates, U.S. says

The Bush administration lowered its estimate of the cost of Medicare’s new prescription drug benefit, saying the price tag had come down about 10 percent in the last six months. Administration officials said they hoped the numbers would undercut support in Congress for a Democratic proposal requiring the government to negotiate with pharmaceutical makers to secure lower drug prices for Medicare beneficiaries. The 2003 Medicare law prohibits such direct negotiations, relying instead on private insurers and their agents to seek discounts on prescription drugs. Legislation to repeal that ban is a top priority for the new Democratic majority in Congress.

Michael O. Leavitt, the secretary of health and human services, said the new numbers showed that such legislation was unnecessary because competition among private plans had effectively held down costs. “Our new estimates provide clear evidence that consumer choice is working,” Leavitt said. “Government interference will result in fewer choices and less consumer satisfaction.” In July, the Bush administration estimated that payments to private plans offering the Medicare drug benefit would total $1.077 trillion from 2007 to 2016. Officials now estimate they will be $964 billion. Leslie V. Norwalk, acting administrator of the Centers for Medicare and Medicaid Services, said drug costs in general had been increasing more slowly than expected. In addition, Norwalk said, enrollment in the new Medicare program is lower than expected, because some beneficiaries found they had equivalent drug coverage from other sources. (The New York Times)

Novation announces new Anesthesia Standardization Program;
signs 25 anesthesia agreements

Novation launched its new Anesthesia Standardization Program for acute care members on Jan. 1, 2007. The program has similar categories and flexibility as the old program which expired at the end of 2006. The new program provides incentives averaging more than five percent on purchases within the portfolio, increased cooperative returns for participating members and additional savings from standardization and utilization.

The program is comprised of nine product categories: air warming, central venous catheters (CVSs) non tunneled, anesthesia masks, anesthesia circuits, endotracheal (ET) tubes, fluid warming, laryngeal mask airways, thermodilution catheters and transducers. Participating suppliers include Ambu, Arrow, Cincinnati Sub-Zero, Edwards, Gaymar, Hospira, Medline, Smiths, Tyco, and Vital Signs. Subsequently, Novation awarded 25 new anesthesia contracts in multiple product categories. The agreements which began on Jan. 1, 2007, unless otherwise noted, run through Dec. 31, 2009. Many of the new anesthesia contracts are in the new Anesthesia Standardization program.

Case Medical awarded Premier contract

Case Medical Inc., Ridgefield, NJ, has once again been awarded the Premier contract for their complete line of sterilization containers and accessories which includes all SteriTite, FlashTite and Meditray products.

January 5, 2007
 

Draft guidance on radio-frequency wireless technology in medical devices

Health groups release new immunization schedules

Lilly settles with 18,000 over Zyprexa

New U.N. health chief sets her priorities

Radiologists should discuss cardiac implant disposal with patients

NCI TALK to be recorded live at upcoming World Congress Leadership Summit;
will explore impact of P4P

Amerinet announces tri-source award for medical film and dual source for CR-DR

Med1Online enters into exclusive agreement with Pelstar LLC,
parent company of Health o meter Professional
 

Draft guidance on radio-frequency wireless technology in medical devices

The Food and Drug Administration (FDA) has developed draft guidance document to assist industry, systems and service providers, consultants, FDA staff, and others in the design, development, and evaluation of radio frequency (RF) wireless technology in medical devices. It addresses issues and concerns pertinent to the safe and effective use of RF wireless technology in medical devices, including: wireless coexistence; performance; data integrity; security and electromagnetic compatibility (EMC). Since these issues affect all stages of the product life cycle, FDA recommends they be considered in: Identification, documentation, and implementation of product design requirements; design verification and validation; and risk management processes and procedures. The document discusses considerations specific to RF wireless technology in medical devices