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August 2006
Rising health expenses are a good value,
researchers say
FDA warns consumers about counterfeit prescription drugs from some Canadian websites
FDA forms task force on human tissue safety
DHHS announces bioshield stakeholders workshop
Nicotine levels rose 10 percent in last six years, report says
How VA hospitals became the best; No longer a nation's shame, veteran care is acing competitors
Despite dramatic increases in health expenses since 1960, the return on medical spending is high, according to a new study by researchers at Harvard University and the University of Michigan. Studying health and spending trends from 1960 to 2000, the researchers concluded that healthcare in America has been cost-effective on the whole, although ballooning costs for the elderly are a cause for concern. In an article published in the Aug. 31 New England Journal of Medicine, David M. Cutler, the Otto Eckstein Professor of Applied Economics in Harvard's Faculty of Arts and Sciences, and Allison B. Rosen and Sandeep Vijan of the University of Michigan Health System compared average per-capita spending and life expectancy of four different age groups from 1960 to 2000, analyzing increases in medical expenses versus improvements in health. “The rising cost of healthcare has been the source of a lot of saber-rattling in the media and the public square, without anyone seriously analyzing and discussing the benefits gained,” said Cutler. “But the dramatic increase in life expectancy that we've seen over the last decades shows that rising medical costs have been largely justified.” Conservatively adjusting for non-medical factors in longevity such as lower smoking prevalence and reduced death rates from accidents, suicide, and homicide, the researchers attributed 50 percent of the increase in life expectancy since 1960 to improved healthcare. Following this methodology, Cutler and colleagues estimated that from birth, the increased life expectancy since 1960, approximately seven years, from 69.90 to 76.87 years, has cost $19,900 per added year of life. Of the portion of this longevity gain attributed to improvements in healthcare, the researchers estimated that some 70 percent was due to reductions in deaths from cardiovascular disease, while reductions in infant mortality accounted for 19 percent. Comparing this $19,900 against the value of a year of life as defined by insurance companies and medical decision-makers, a figure that ranges from $50,000 to $200,000, according to different statistical estimates, Cutler and colleagues judged the increase in medical costs to be a good value. The researchers write, “The increased spending has, on average, been worth it.” By contrast, persons age 65 and older have increased their longevity by just 3.5 years since 1960, with a cost of $84,700 for each year of added life. “The foremost cause of concern posed by rising medical costs is the tremendous strain coming from increased costs for the elderly,” Cutler said. “The cost per year of life for seniors is three times higher today than it was in the 1970s.” While Cutler, Rosen, and Vijan indicate that rising costs could lead to diminishing returns as life expectancy reaches a ceiling, the researchers say greatly increased quality of life for the elderly, an important factor not considered in the current study, mitigates in favor of current levels of healthcare spending among the elderly.
DHHS announces bioshield stakeholders workshop
The US DHHS is hosting a 2-day workshop for bioshield stakeholders, in Arlington, VA, on Sept 25-26, 2006, beginning at 8 am on both days. The BioShield Stakeholders Workshop will be an open meeting for representatives from the pharmaceutical and biotech industries, professional societies, state and local public health organizations, academic R&D community, public interest groups, stakeholder federal agencies and Congress. The purpose is to accelerate the R&D, acquisition, and availability of effective medical countermeasures for chemical, biological, radiological & nuclear (CBRN) threats. Space at the Workshop is limited. There is no charge to attend. The workshop will be held on Sept. 25, from 8 am-6 pm and Sept. 26, from 8 am-5 pm at the Crystal Gateway Marriott, 1700 Jefferson Davis Hwy, Arlington, VA. Goals of the workshop include: To provide attendees with insight into the current BioShield interagency governance process; To provide individual stakeholders with an opportunity to help guide the future implementation of Project BioShield, by providing input into the draft Public Health Emergency Medical Countermeasures (PHEMC) Strategy for Chemical, Biological, Radiological, & Nuclear (CBRN) Threats. This Strategy will define the principles guiding DHHS medical countermeasure research, development and acquisition. For more information contact: Elizabeth Jarrett, DHHS Office of Public Health Emergency Medical Countermeasures at 202-260-1200. To register online CLICK HERE.
Nicotine levels rose 10 percent in last six years, report says
The level of nicotine that smokers typically consume per cigarette has risen 10 percent in the past six years, making it harder to quit and easier to be addicted, said a report that the Massachusetts Department of Health released on Tuesday. The study shows a steady increase in the amount of nicotine delivered to the smokers’ lungs regardless of brand, with overall yields increasing 10 percent. Massachusetts is one of three states to require tobacco companies to submit information on nicotine testing to its specifications and is the sole state with data as far back as 1998. The study found that the three most popular brands with young smokers, Marlboro, Newport and Camel, delivered significantly more nicotine than they did six years ago. Nicotine consumed in Kool, a popular menthol brand, rose 20 percent. The study has always measured nicotine levels based on the way smokers use cigarettes, health officials said. That includes partly covering ventilation holes while smoking and taking longer puffs. Traditional testing does not take habits into account and typically reports lower nicotine contents, researchers said. “The amount of nicotine in a cigarette has increased steadily over the past six years,” the department said, indicating in its reports that the smoking habits simulated had not changed in that period. Of the 179 brands tested in 2004, 93 percent fell into the highest range for nicotine. In 1998, 84 percent of 116 brands were in the highest range. “We want health care providers to know that smokers are getting more nicotine than in the past and may need additional help in trying to quit,” the public health commissioner, Paul Cote Jr., said. The report said that for all brands tested in 1998 and 2004 there was no significant difference in the total nicotine delivered among full flavor, medium, light or ultralight cigarettes. The finding means that agencies trying to help smokers quit may have to adjust the strength of nicotine replacement therapies like nicotine patches and gums. (The Associated Press)
How VA hospitals became the best; No longer a nation's shame, veteran care is acing competitors
Until the early 1990s, care at VA hospitals was so substandard that Congress considered shutting down the entire system and giving ex-G.I.s vouchers for treatment at private facilities. Today it's a very different story. The VA runs the largest integrated healthcare system in the country, with more than 1,400 hospitals, clinics and nursing homes employing 14,800 doctors and 61,000 nurses. And by a number of measures, this government-managed healthcare program, socialized medicine on a small scale, is beating the marketplace. For the sixth year in a row, VA hospitals last year scored higher than private facilities on the University of Michigan's American Customer Satisfaction Index, based on patient surveys on the quality of care received. The VA scored 83 out of 100; private institutions, 71. Males 65 years and older receiving VA care had about a 40% lower risk of death than those enrolled in Medicare Advantage, whose care is provided through private health plans or HMOs, according to a study published in the April edition of Medical Care. Harvard University just gave the VA its Innovations in American Government Award for the agency's work in computerizing patient records. And all that was achieved at a relatively low cost. In the past 10 years, the number of veterans receiving treatment from the VA has more than doubled, from 2.5 million to 5.3 million, but the agency has cared for them with 10,000 fewer employees. The VA’s cost per patient has remained steady during the past 10 years. The cost of private care has jumped about 40% in that same period. Vets still gripe about wading through red tape for treatment. Some 11,000 have been waiting 30 days or more for their first appointment. The Iraq and Afghanistan wars could stress the system, although for the moment VA officials say the agency can accommodate the new patients. That’s because older vets, especially those from the World War II and Korean War eras, are dying of natural causes at the rate of about 600,000 a year, whereas the Iraq and Afghanistan wars have so far created a little more than 550,000 new vets. On the other hand, because advances in body armor and field medicine have enabled soldiers to survive battlefield injuries that in earlier conflicts meant death, many of the new patients are arriving at VA hospitals with severe wounds. In response, the VA has set up four polytrauma centers around the country. The roots of the VA’s reformation go back to 1994, when Bill Clinton appointed Kenneth Kizer, a hard-charging doctor and former Navy diver, as the VA’s under secretary for health. Kizer decentralized the VA’s cumbersome health bureaucracy and held regional managers more accountable. Patient records were transferred to a system-wide computer network, which has made its way into only 3% of private hospitals. When a veteran is treated, the doctor has the vet’s complete medical history on a laptop. In the private sector, 20% of all lab tests are needlessly repeated because the doctor doesn’t have handy the results of the same test performed earlier, according to a 2004 report by the President's information technology advisory committee. Another innovation at the VA was a bar-code system for prescriptions, a system used in fewer than 5% of private hospitals. Private hospitals, which make their money treating people who come to them sick, don’t profit from heavy investments in preventive care, which keeps patients healthy. But the VA, which is funded by tax dollars, “has its patients for life,” notes Kizer, who served in his post until 1999. So to keep government spending down, “it makes economic sense to keep them healthy and out of the hospital.” Kizer eliminated more than half the system's 52,000 hospital beds and plowed the money saved into opening 300 new community clinics so vets could have easier access to family-practice-style doctors. He set strict performance standards that graded physicians on health promotion. Hundreds of thousands of veterans abandoned private physicians and enrolled in the lower-cost and higher-quality VA care. But that created a new problem. The VA’s budget from Congress (currently about $30 billion annually) couldn’t cover the influx. By January 2003, with hundreds of thousands waiting six months or more for their first appointment, the VA began limiting access to only vets with service-related injuries or illness or those with low income. Veterans’ groups understandably want the healthcare system expanded to accommodate vets with higher incomes and no service-related ailments. Tom Bock, commander of the American Legion, has another idea: allow elderly vets not in the system who are drawing Medicare payments to spend those benefits at a VA facility instead of going to a private doctor, as is now required by Medicare. “It's a win-win-win situation,” he argues. Medicare, which pays more than $6,500 per patient annually for care by private doctors, could save with the VA’s less expensive care, which costs about $5,000 per patient. The vets would receive better service at the VA’s facilities, which could treat millions more patients with Medicare’s cash infusion. But conservatives fear such an arrangement would be a Trojan horse, setting up an even larger national healthcare program and taking more business from the private sector. Congress has no plans to enlarge the scope of veterans’ healthcare, much less consider it a model for, say, a government-run system serving nonvets. But it’s becoming more and more “ideologically inconvenient for some to have such a stellar health-delivery system being run by the government,” said Margaret O'Kane, president of the National Committee for Quality Assurance, which rates health plans for businesses and individuals. If VA health care continues to be the industry leader, it may become more difficult to argue that the market can do better. (Time Inc.) To read the full article CLICK HERE.
Drug maker will pay fine for promoting off-label use
Johnson & Johnson wins antitrust suit
Transfusions of blood products might help to cut deaths in a future flu pandemic, research suggests
Hospital projects $34 million loss; However, bottom line numbers
show that it will still record
a $38 million profit
Waistlines continue to grow in U.S.
Medical errors? Patients may be the last to know
Drug maker will pay fine for promoting
off-label use
The
Schering-Plough Corporation agreed on Tuesday to
pay $435 million and plead guilty to conspiracy to settle a
federal investigation into marketing of its drugs for
unapproved uses and overcharging Medicaid for certain drugs.
Schering-Plough said it would pay $255 million to resolve
civil aspects of the previously disclosed investigation. A
subsidiary, the Schering Sales Corporation, will pay a
criminal fine of $180 million and plead guilty to one count of
conspiracy to make false statements to the government. The
agreement is subject to court approval. Schering-Plough said
the settlement resolved an investigation by the Justice
Department and the United States attorney’s office in Boston
that began before a new management team took over at the
company in April 2003. “With this agreement, we are putting
issues from the past behind us,” said Brent Saunders, senior
vice president for compliance and business practices. The
agreement comes two years after Schering-Plough agreed to pay
$346 million to settle charges that it paid a kickback to a
health insurer to protect the market for its allergy drug
Claritin. The investigation that led to Tuesday’s settlement
began in 2001. Investigators found evidence that
Schering-Plough marketed drugs for off-label uses. Off-label
uses have not been approved by government regulators, although
doctors can individually choose to prescribe drugs for those
purposes. One such drug was Temodar, which the
Food and
Drug Administration in 1999 approved to treat
anaplastic astrocytoma, a type of brain
tumor,
in patients who had not responded to other drug regimens. A
United States attorney, Michael
Sullivan, who announced Tuesday’s settlement, said Schering
promoted the drug to treat several other types of brain
cancers and
cancer
that had spread to the brain from elsewhere, uses that the FDA
had not approved. Sullivan said that Schering-Plough also
provided misleading information to the government about the
price it was charging a health maintenance organization
for Claritin RediTabs, to avoid having to pay rebates to the
Medicaid program. Medicaid is supposed to obtain the benefit
of low drug prices and drug makers are required to report
their best price on drugs supplied to commercial customers.
(The Associated Press)
Johnson & Johnson wins antitrust suit
Johnson & Johnson won an antitrust lawsuit yesterday that had accused the company of illegally using its sutures monopoly to increase sales of other surgical products. A federal jury in Santa Ana, CA, rejected claims by the Applied Medical Resources Corporation that the Ethicon unit of Johnson & Johnson had blocked competition in the market for trocars, instruments used in so-called keyhole surgery. Applied Medical, which is closely held, sued in 2003 for $54 million in damages, which could have been tripled under antitrust laws. Applied Medical, based in Rancho Santa Margarita, CA, said Ethicon had taken away its sales by offering discounts on sutures to hospitals that also bought the company’s trocars and clip appliers. Johnson & Johnson, based in New Brunswick, NJ, argued that the bundling contracts did not unfairly exclude other suppliers and were requested by hospitals that sought lower prices. The jury deliberated for 2½ days before reaching a decision. (Bloomberg News)
Transfusions of blood products might help to cut deaths in a future flu pandemic, research suggests
US researchers
examined records from the Spanish flu pandemic of 1918-1920 which killed up to
100m worldwide. They found transfusions taken from people who had recovered may
have improved the condition of others hospitalised by the virus. The study, a
joint project by various groups including the US Navy, will appear in Annals
of Internal Medicine. The latest research suggests that blood transfusions
might be an effective addition to the treatment arsenal, alongside vaccines and
anti-viral drugs. The researchers say a single recovering patient could donate
enough blood plasma to treat many others. They examined the Spanish flu outbreak
because the virus behind it is a close cousin of H5N1. However, they admit the
records on which they based their study were limited. The number of patients was
small, the work was not scientifically well controlled, and dosages were not
standardised. Disruption caused by World War 1 probably made record keeping very
difficult, and wartime censorship may have affected publication of research. The
researchers are calling for experts to examine the potential for plasma therapy,
or serotherapy, in greater detail, and to consider the benefits of drawing up
treatment guidelines. Writing in the same journal, Dr John Treanor, an expert in
infectious diseases at the University of Rochester, said a similar approach had
been used to treat other viral diseases. He said plasma therapy might pose
logistical difficulties, such as how to obtain, classify and prepare blood
materials in the midst of an outbreak. In addition, more work was needed to
refine suitable dosages. However, he added: “Although many logistical hurdles
exist, controlled clinical studies done now will probably pay a considerable
dividend when the pandemic begins. We can, should, and must explore these issues
about serotherapy now, in advance of the pandemic.” Dr John Wood, a virology
expert at the National Institute for Biological Standards and Control, said the
research was intriguing, and demanded further investigation. He said: “Our
present armoury against pandemic flu is limited. We can probably make vaccine,
but it will be five months before it is ready, and there are logistical problems
with anti-virals. It is better to have as many strings in your bow as possible.”
However, Dr Andrew Hayward, an immunologist at University College London, said
it might prove difficult to carry out research into the effectiveness of the
treatment before a pandemic strain of flu emerged. He also warned that any
treatment involving blood products carried the potential for transmission of
other infections. He said vaccines, anti-virals were likely to be the front line
defences, along with basic public health measures, such as hand washing and
wearing masks. Dr Iain Stephenson, a consultant in infectious diseases in
Leicester, said any
potential treatment for pandemic flu was worth exploring. However, he said:
“Immunotherapy is likely to work only in the very early stages of infection and
it will be difficult to identify patients that might benefit.” (BBC News)
Hospital projects $34 million loss; However, bottom line
numbers show that it will still record
a $38 million profit
How does a business lose $34 million on its day-to-day operations and still turn
a $38 million profit? Those are the bottom-line figures in Sarasota (FL)
Memorial Hospital’s proposed budget for 2007. Behind them are two trends, a
nationwide rise in bad debt, from patients who can't or don't pay their bills,
and a regional boom in property values. Hospital administrators presented the
budget last week to board members, who will conduct the first of two public
hearings on the proposal Sept. 5. The budget reflects two conflicting goals:
serving the entire community but also maintaining financial soundness. “We exist
for the public good. That's the only reason we're here,” hospital Chief
Executive Officer Gwen MacKenzie said. “We have a fiscal responsibility, too.”
The projected losses stem largely from bad debt. The hospital has seen a surge
in patients who lack insurance and insured patients who do not pay their share
of the bill. National hospital chains, including HCA and Health Management
Associates, both reported that trend in their recent financial statements.
Sarasota Memorial expects bad debt to reach $65.6 million this year, about 75
percent more than 2005's mark. It projects a smaller rise to $75.7 million next
year, still about double the 2005 total. The hospital is seeing more uninsured
patients and more patients, from many insurers, who are not paying copayments.
Bad debt is separate from charity care, which is writeoffs to patients meeting
the hospital’s poverty guidelines. That should reach $26.5 million this year and
$28.1 million next year, according to the budget. The two combine for more than
$100 million in writeoffs, about 7 percent of gross revenue. Sarasota Memorial
also is the only county hospital delivering babies, which loses money, about $4
million through nine months of fiscal 2006. The losses outpace the new
administration’s efforts to boost income and hold down salaries, benefits and
supply costs. Hospitals typically measure their performance in terms of how many
cases they handle. By that standard the hospital is holding the line. The budget
shows salary per discharge will increase less than 1 percent for the second year
in a row, after rising 6.9 percent in 2005. Fringe benefits would increase 2.6
percent in 2007, after 6 percent increases the previous two years. Supplies
would climb 4.2 percent, up from about 1 percent in 2006, but are flat as a
percentage of net revenue. The budget cites the high cost of surgical implants
as a main reason. MacKenzie said the hospital would continue the “checkbook”
approach she instituted to manage labor and supply costs. The hospital also is
holding jobs at the 2006 level and plans to recoup about $6.4 million with
better collections. To boost the revenue side, the hospital plans a 10 percent
price increase, the first in two years. The hospital also foresees the number of
outpatient cases rising 5 percent. It predicts inpatient volume will be flat.
Outpatient cases are more profitable, but generate less cash. It takes about
eight outpatient cases to make up for one inpatient case, MacKenzie said.
Meanwhile, inpatient cases are becoming harder to manage. As more surgeries
become outpatient procedures, the remaining inpatient cases tend to resemble
intensive care cases, said Michael Harrington, chief operating officer. They
tend to become more complex and require more supplies and staff time. To read
the full article,
CLICK HERE. (Sarasota Herald-Tribune)
Waistlines continue to grow in U.S.
Obesity continues to surge in the U.S., with 31 states showing an increase.
Mississippi continued to lead the way. An estimated 29.5 percent of adults there
are considered obese. That's an increase of 1.1 percentage points when compared
with last year's report, which is compiled by Trust for America's Health, an
advocacy group that promotes increased funding for public health programs.
Meanwhile, Colorado remains the leanest state. About 16.9 percent of its adults
are considered obese. That mark was also up slightly from last year's report,
but not enough to be considered statistically significant. The only state that
experienced a decrease in the percentage of obese adults last year was Nevada.
“Quick fixes and limited government programs have failed to stem the tide,” said
Dr. Jeff Levi, executive director of the trust. States have different challenges
to contend with when it comes to obesity, said Dr. Janet Collins of the Centers
for Disease Control and Prevention. “Populations are not equal in terms of
experiencing these health problems,” Collins said. “Low-income populations tend
to experience all the health problems we worry about at greater rates.” Indeed,
the five states with the highest obesity rates, Mississippi, Alabama, West
Virginia, Louisiana and Kentucky, exhibit much higher rates of poverty than the
national norm. Meanwhile, the five states with the lowest obesity have less
poverty. They are Colorado, Hawaii, Massachusetts, Rhode Island and Vermont. The
group's estimate of obesity rates is based on a three-year average, 2003-2005.
The report says health costs related to obesity are in the billions of dollars
annually. Citing a 2004 report, the advocacy group said $5.6 billion could be
saved when it comes to treating heart disease if just one-tenth of Americans
began a regular walking program. For more information
CLICK HERE. (Associated Press)
Whether or not a woman is obese will likely affect her outcome once she has been diagnosed with ovarian cancer, according to a new study from Cedars-Sinai Medical Center. The study, published online on Aug. 28 in the American Cancer Society's journal Cancer, showed that obesity affected survival rates, shortened the length of time to recurrence of the disease, and led to earlier death from the cancer than for women diagnosed at their ideal body weight. “This study is the first to identify weight as an independent factor in ovarian cancer in disease progression and overall survival, suggesting that there is an element in the fat tissue itself that influences the outcome of this disease in obese women,” said Andrew Li, M.D., the study's principal investigator at Cedars-Sinai's Women's Cancer Research Institute at the Samuel Oschin Comprehensive Cancer Institute. Ovarian cancer, one of the most lethal cancers, affects almost one in 60 women. Most will be diagnosed with advanced disease, and 70 percent will die within five years. There are several types of ovarian cancer, but tumors that begin with the surface cells of the ovary (epithelial cells) are the most common type. While previous studies have shown that obesity is a factor in the development and prognosis of cancers such as breast, uterine and colorectal, the nature of the relationship in ovarian cancers has been less well understood. In this study, Li and his colleagues examined data from 216 patients with epithelial ovarian cancer to identify relationships between obesity, ovarian cancer, tumor biology and outcome. Comparison of the obese women to ideal-weight women showed 29 percent of the obese women and 10 percent of normal-weight women had localized disease. However, obesity was shown to have a significant effect on both the recurrence and mortality of women with advanced disease. The cellular characteristics of the tumors found in the two groups also appeared to be different. “While further molecular studies are warranted, our study suggests that fat tissue excretes a hormone or protein that causes ovarian cancer cells to grow more aggressively,” said Li, who is also a physician in the Department of Obstetrics and Gynecology at Cedars-Sinai Medical Center.
Medical errors? Patients may be the last to know
.
A survey of more than 2,600 surgeons and medical
specialists reveals wide variations in doctors’ willingness to disclose errors
and in the ways they would present the details to patients. The authors of the
survey presented hypothetical but clinically realistic medical errors to the
doctors to determine how they would disclose the mistake, whether disclosure was
different if the error was less apparent to a patient and what factors were
associated with disclosure. The survey results were published Aug. 14 in The
Archives of Internal Medicine. The hypothetical errors were all mistakes
that would cause some degree of serious injury. Some were apparent, like leaving
a sponge in a surgical patient, and some were less so, like misreading chart
data. When the error was obvious, like an improperly written prescription that
led to an overdose, 81 percent of doctors said they would definitely disclose
the error to a patient. But when presented with an error less apparent, only 50
percent thought it was worth mentioning. One example was a blood chemistry
reading that had been overlooked. If it had been noticed, a serious complication
would have been prevented. “It isn’t that doctors routinely make a conscious
decision to conceal errors,” said Dr. Thomas H. Gallagher, the study’s lead
author and an associate professor of medicine at the
University of Washington.
But when an error is less obvious, he continued, “the doctor is thinking about
what the patient really needs to know to understand what happened.” “Doctors
worry about telling patients too much, scaring them unnecessarily,” Dr.
Gallagher said. Surgeons were more likely than other medical specialists to
believe that an error would result in a lawsuit, but they were also more likely
to report that they would definitely disclose an error. At the same time, they
would disclose less information than medical specialists, and they were less
inclined to use the word “error.” Over all, 56 percent of doctors would mention
the problem, but only 42 percent would disclose that the problem had been caused
by an error. Half of the doctors surveyed said they would disclose specific
information about what the error was, while 37 percent would offer only a
partial explanation. The remaining 13 percent would reveal no details at all
unless the patient asked. When presented with just the errors that were less
apparent, almost one-fifth would volunteer no information at all. Only 8 percent
would be silent about more obvious mistakes. Almost all doctors surveyed said
they would apologize, but only about one-third chose an explicit apology (“I am
so sorry that you were harmed by this error”) while two-thirds would offer a
general expression of regret (“I’m sorry about what happened”). According to the
authors, some
malpractice
insurers encourage doctors to apologize in the belief that this may help prevent
lawsuits or encourage smaller settlements when suits are filed. One problem
physicians face, Dr. Gallagher said, is that patients may fail to distinguish
errors from unavoidable medical problems. “I think that often patients assume
that any adverse event is due to error,” he said. “That’s not so. A vast
majority of such events are not errors and not preventable.” (The
New York Times)
Medline signs five-year, $75 million prime vendor distribution deal at Daughters of Charity Health System
Medline Industries Inc. announced that the company recently signed a $75 million Prime Vendor deal to provide medical supplies to Daughters of Charity Health System, a five-hospital system in California. The Daughters of Charity Health System (DCHS) is a regional healthcare system of five hospitals spanning the California coast from the Bay Area to Los Angeles. The sponsors are the Daughters of Charity of St. Vincent de Paul who, for more than 370 years, have been serving the sick and the poor through healing ministries around the world. “We look forward to implementing and establishing a long-term relationship with Daughters of Charity Health System. Our prime vendor program will provide high quality Medline brand products and distribution services with significant quantitative value. The program will also provide comprehensive logistical, standardization, and utilizations services through Medline Select,” said Tim Jacobson, vice president, Medline Corporate Sales. In the first year, Medline estimates it will save the system more than $900,000. Over the five-year term of the agreement, Medline estimates it will save the system nearly $5 million.
Colonel Marc Sager receives AHRMM’s 2006 Leadership Award
New test quickly pinpoints the most lethal avian flu; A 12-hour diagnosis allows for fast treatment
China: Tests find bird flu vaccine safe
Levels of serious mental illness in Katrina survivors doubled compared to earlier survey
13 plague cases reported in 4 states, highest in 12 years
At the request of the U.S. Food and Drug Administration (FDA), the U.S. District Court for the Southern District of California issued a warrant for seizure of Alaris Signature Edition Gold infusion pumps, model numbers 7130, 7131, 7230 and 7231. The pumps are manufactured by Cardinal Health Care 303, Inc. and the seizure occurred August 25. The seized infusion pumps have a design defect called “key bounce” that may cause potential over-infusion of medications. This seizure was intended to ensure that infusion pumps located at Alaris’ manufacturing facility are not distributed unless the problem is corrected. Infusion pumps are electronic devices intended for controlled delivery of intravenous solutions and medications to patients. Key bounce occurs when a number pressed on the pump registers twice although the operator only pressed the key once. If a key bounce occurs and is not detected during programming verification, it may result in an infusion rate at least 10 times the intended infusion rate. For example, if an infusion rate is intended to be entered as 4.8 milliliters per hour and the key bounce occurs when the 4 is pressed, the actual rate registered will be 44.8 milliliters per hour. If not detected during programming verification, key bounce events may result in serious patient harm or death. FDA inspections revealed that Alaris failed to follow FDA's medical device manufacturing regulations. The infusion pumps were seized by the U.S. Marshals Service at Alaris' manufacturing facility in San Diego, CA. The seized devices valued at more than an estimated 1.8 million dollars. Alaris has distributed these products nationally and internationally. No products were seized from healthcare facilities or individual users, and there are no plans to do so. Alaris was issued warning letters by FDA in August 1998 and October 1999 outlining the violations and was given opportunities to correct the violations, but failed to take appropriate actions. In an August 15 recall letter, Alaris informed customers that it will provide a warning label for the pumps and a permanent correction for the key bounce problem once it is available. In the letter, Alaris also provided recommendations to pump users on steps they can take to minimize key entry errors until the problem can be corrected. The steps are as follows: Proper Stance - When programming pumps, stand squarely in front of the keypad (ideally with the pump at eye level for best visibility) to facilitate proper depth of depressing each key. Listen - Focus on listening to the number of beeps while programming IV pumps; each beep will correspond to a single digit entry. Unexpected double tone could indicate an unintended entry. Verify Screen Display - When programming the pump or changing settings, always compare the patient's prescribed therapy or the medication administration record, original order, or bar code device to the displayed pump settings for verification before starting or re-starting the infusion. Independent Double Check - Request an independent double check of pump settings by another practitioner before starting or changing infusions with hospital-selected high alert drugs. Look - Before leaving the patient's room, observe the IV tubing drip chamber to see if the observed rate of infusion looks faster or slower than expected. Adjust accordingly. Healthcare facilities can continue to use pumps in their possession, guided by these and further instructions. For more information, CLICK HERE.
Colonel Marc Sager receives AHRMM’s 2006 Leadership Award
The
Association for Healthcare Resource & Materials Management (AHRMM) has named
United States Air Force Colonel Marc Sager as the recipient of the 2006 George
R. Gossett Leadership Award. The Association’s highest honor, presented in
memory of George R. Gossett, an early president of the Association, the
Leadership Award is given to an individual who has demonstrated an extraordinary
level of leadership and professional competence in the supply chain field,
advanced the state-of-the-art in healthcare materials management or made other
significant contributions to AHRMM. Col. Sager, administrator of the 59th
Medical Group of Wilford Medical Center in Lackland, TX, received the award in
recognition of his efforts to advance educational opportunities and experiences
for Air Force medical logisticians. He opened the door for materials and
services personnel to hold government contracting warrants and streamlined
acquisition processes for Air Force Medical Treatment Facilities. He has also
been a strong advocate for providing institutional memberships to AHRMM, and
introduced the Certified Materials & Resource Professional (CMRP) credential to
Air Force Medical Service Corps officers so they may further fulfill their
advancement criteria. With a military career that spans over 20 years, Col.
Sager has served the United States in a variety of U.S.-based healthcare
facility and staff positions, as well as in Korea and the Middle East (many of
these facilities were the Air Force’s front-line operations). Most notably, as
Chief of Air Force Medical Logistics, he was responsible for the development,
construction and deployment of mobile medical assemblages worldwide in support
of ongoing operations in Afghanistan, Iraq and other locations. “Col. Sager is
most deserving of the Association’s highest award. Not only is he a military
hero in every sense of the word, he has also proven that it is possible to
successfully transition from logistics and supply chain management into hospital
administration,” said AHRMM President Robert Perry. “He is living proof that a
logistician's knowledge and skills are ideal for senior leadership positions in
healthcare.”
New test quickly pinpoints the most lethal avian flu; A 12-hour diagnosis allows for fast treatment
In an advance that speeds up diagnosis of the most dangerous avian flu, scientists have developed a detailed influenza test that takes less than 12 hours, federal health officials said. The new technology, a microchip covered with bits of genetic material from many different flu strains, cuts the typical time needed for diagnosis of the Asian H5N1 flu to less than a day from a week or more. In addition, rather than giving just a yes-or-no result, it usually reveals which flu a human or an animal has. That means that public health officials investigating, for example, a flu outbreak in poultry or in humans in a remote Asian or African village will be able to decide quickly whether to kill thousands of birds or to treat hundreds of potentially exposed people with expensive anti-viral drugs. Right now, ascertaining whether a flu is of the lethal H5N1 strain requires that a sample be frozen and shipped to a highly secure laboratory, usually in a major city like Atlanta or Hong Kong, where the virus can be grown in eggs, isolated and genetically sequenced, a process that takes four to five days plus shipping time. The new test, called FluChip, can be performed in any laboratory that can amplify bits of genetic material; many countries have such laboratories in their national capitals. Samples need not be frozen, and because only bits of genetic material are multiplied rather than whole viruses, the work can be done in laboratories with lower biosecurity levels. Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, which announced the creation of the test, called it an “encouraging advance” that could be “invaluable to international flu surveillance efforts.” A more advanced version may be ready within two years, said Kathy L. Rowlen, the University of Colorado chemistry professor who led the team that developed the test. At present, animal and human health experts trying to fight avian flu in remote areas are forced to make important decisions based largely on guesses because it is too risky to wait a week for a laboratory to confirm that a highly dangerous virus is loose. A dipstick test done on the spot, which a veterinarian working in Indonesia said was as quick and as simple as a home pregnancy test, can tell only if a flu is type A. It also has the potential to speed up mass testing because dozens of samples can be tested on dozens of chips at once. (The New York Times)
China: Tests find bird flu vaccine safe
A Chinese-developed vaccine against the H5N1 strain of bird flu in humans has
been found safe in the first round of tests, a government news agency reported.
Researchers began work on the vaccine last year, and the government said it was
ready to start mass production. But any vaccine would face more tests before it
could be approved for human use. Tests were conducted on six human volunteers at
a Beijing hospital between November and June, the official Xinhua News Agency
said. Researchers said the vaccine “proved initially safe and effective,” the
Xinhua News Agency reported. The tests were conducted by the China Center for
Disease Control and Prevent and a Chinese drug company, Beijing Sinovac Biotech
Co., according to Xinhua. Chinese authorities say the vaccine is meant for
high-risk groups such as poultry workers. The U.S. National Institute of Allergy
and Infectious Diseases is also conducting trials on an H5N1 vaccine for humans.
(The Associated Press)
Levels of serious mental illness in
Katrina survivors doubled compared to earlier survey
According to the most comprehensive survey yet completed of mental health among
Hurricane Katrina survivors from Alabama, Louisiana, and Mississippi, the
proportion of people with a serious mental illness doubled in the months after
the hurricane compared to a survey carried out several years before the
hurricane. The study also found that thoughts of suicide did not increase
despite the dramatic increase in mental illness. The authors suggest that this
low rate of suicide thoughts is due to optimistic beliefs about the success of
future recovery efforts. The research, which was published in a special online
edition of the Bulletin of the World Health Organization, was led by researchers
from Harvard Medical School (HMS). “The increase in mental illness among Katrina
survivors is not surprising, but the low suicidality is a surprise,” said Ronald
Kessler, PhD, professor of health care policy at HMS and lead author of the
study. “Our concern, though, is that this lowering of suicidal tendencies
appears to be strongly associated with expectations for recovery efforts that
might not be realistic.” This report is the first in a planned series based on
the Hurricane Katrina Community Advisory Group, a statistically representative
sample of hurricane survivors participating in ongoing tracking surveys to
monitor the pace and mental health effects of hurricane recovery efforts. The
project is funded by the National Institute of Mental Health and the Office of
the Assistant Secretary of Health and Human Services for Planning and
Evaluation. The team discovered a strong relationship between the comparatively
low rate of suicide thoughts and the existence of positive cognitions among
Katrina survivors, especially with cognitions regarding increased sense of
meaning and purpose in life and increased realization of inner strengths.
Kessler notes that although previous studies have suggested a connection between
positive cognitions and lowered suicidality, this is the first study that offers
quantitative evidence of these psychological processes in a sample of disaster
victims. Kessler and his team believe that their findings suggest a systematic
investigation of positive cognitions might be useful in guiding public health
mass media efforts in the aftermath of future disasters, given that previous
research has shown that public health messages play an important role in
psychological reactions to disasters. “The immediate take-home message for
disaster recovery and policy makers is that communications with survivors can
sometimes build on the temporary reprieve from suicidal tendencies afforded by
these protective cognitions. Efforts on the part of public officials to control
expectations as practical recovery moves forward without destroying the positive
cognitions related to these expectations could prove crucial in the process of
continued psychological recovery,” said Kessler. For more information
CLICK HERE.
13 plague cases reported in 4 states, highest in 12 years
Thirteen cases of plague including two deaths have been reported in the Western
United States this year, the highest number of cases in 12 years, health
officials say. Seven cases were reported in New Mexico, three in Colorado, two
in California and one in Texas, according to the U.S. Centers for Disease
Control and Prevention. Two New Mexicans died, a 54-year-old woman who grew ill
in May and a 43-year-old woman who became sick in July. On average, the plague
is diagnosed in about seven people a year, CDC officials said Friday. Fourteen
cases were reported in 1994. It’s treatable with antibiotics, but health
officials stress the importance of prompt diagnosis to reduce the fatality rate.
Plague is transmitted through the bites of infected fleas, but people also can
get it by direct contact with infected rodents, wildlife and pets. Most people
become ill one to six days after being infected. The increase probably stems
from human encroachment into areas where infected rodents live, said Hannah
Gould, a CDC epidemiologist who investigated some of the cases. Plague takes
three forms: bubonic, septicemic and pneumonic. A common symptom of bubonic
plague is painful swollen lymph nodes in the groin, armpit or neck. Other
symptoms include fever, chills, and sometimes headache, vomiting, and diarrhea.
Septicemic plague can involve fever, chills, nausea, vomiting, diarrhea and
abdominal pain. Eight of the cases this year were bubonic and the other five
were septicemic. Most cases usually occur in May through September, Gould said.
(The Associated Press)
Amerinet announces agreements
Amerinet announces its agreements with First Quality
Products Inc. for adult incontinence products for acute care and non-acute care
facilities. Effective through June 30, 2009 these contracts include adult and
youth incontinence products, briefs, breathable briefs, night-time briefs,
underpads, pants, protective underwear, pant liners, cotton-snap pants,
washcloths and wet wipes.
Amerinet
announces its agreement with Cincinnati Sub-Zero Products Inc. for niche cold
therapy supplies. Effective through July 31, 2009 this contract includes Electri-Cool
II localized cold therapy systems and accessories. The Electri-Cool II is
primarily used postoperatively to deliver controlled cold therapy to the patient
and operates on thermoelectric technology, eliminating the need for a
compressor.
Amerinet announces its agreement with Tyco Healthcare Group for needles and
syringes. Effective through July 31, 2009 this contract includes needles,
syringes, flush syringes, spinal needles, bone marrow and biopsy products,
allergist trays and IV access. Tyco products offer new robust print technology,
wider finger flanges, increased peel headers and many other safety conveniences
for caregivers. This contract was the result of a competitive bidding process.
AHRQ estimates on long-term uninsured, 2001–2004
MRSA linked to nearly 14,000 PA hospitalizations in 2004
Los Angeles hospital faces possible closure
Center for Hispanic medical students loses all its U.S. aid
New compound causes cancer cell suicide
PSA predicts treatment success in advanced prostate cancer
In 2004, there were 13,722 Pennsylvania hospitalizations in which patients had a Methicillin-resistant Staphylococcus aureus (MRSA)- related infection, according to a new research brief released by the Pennsylvania Health Care Cost Containment Council (PHC4). MRSA is a more serious form of the Staphylococcus aureus (often called “staph”) bacteria and is a major health concern because of its resistance to commonly used antibiotics such as methicillin. “MRSA, a virulent form of drug-resistant bacteria, can be community-acquired or hospital-acquired,” said Marc P. Volavka, Executive Director of PHC4. “Yet no matter where MRSA is contracted, it can have significant health and financial consequences, and represents a titanic public health challenge.” PHC4's latest report does not distinguish between community and/or hospital-acquired MRSA infections. Compared to patients without a MRSA infection, patients with a MRSA infection were four times as likely to die, had hospital stays more than two and a half times longer, with hospital charges three times as much for the hospitalization. Specifically, the mortality rates for patients with and without a MRSA infection in 2004 were 8.9% and 2.1%, respectively. On average, patients with a MRSA infection stayed in the hospital eight days longer than patients without a MRSA infection. Whereas the average charge of a hospitalization with a MRSA infection was $87,990, the average charge for a hospitalization without a MRSA infection was $28,711. In July of 2005, Pennsylvania (PHC4) became the first state to publicly report hospital-acquired infection numbers, and has issued two subsequent infection reports. Those reports have focused on four types of hospital-acquired infections (central line-associated bloodstream infections, ventilator-associated pneumonia, surgical site infections, and indwelling catheter-associated urinary tract infections). PHC4 is now reporting that of the 1,932 patients identified by hospitals as having hospital-acquired bloodstream infections in year 2004, 11.2% (217) had a MRSA infection. Of the 1,335 patients with hospital-acquired pneumonia, 9.2% (123) had a MRSA infection. Of the 1,317 patients with hospital-acquired surgical site infections, 6.6% (87) had a MRSA infection. Of the 6,139 patients with hospital-acquired urinary tract infections, 3.3% (200) had a MRSA infection. It is not known if MRSA was the bacteria responsible for these hospital-acquired infections. Other findings: About half (50.9%) of all hospitalizations with MRSA infections were among patients with respiratory diseases, disorders of the circulatory system, and infectious and parasitic diseases; More than half (54%) of hospitalizations with MRSA infections were for patients age 65 and older, followed by those in the 45 to 64 age category (27%) and the 25 to 44 age category (13%). The 18 to 24 age category and the 0 to 17 age category each comprised 3% of the MRSA hospitalizations; The MRSA infection rate was similar for hospitals of all sizes; Geographic differences in the rate of MRSA-related hospital discharges were found; The Southeastern Pennsylvania region had the highest MRSA infection rate; The Southcentral Pennsylvania region had the lowest MRSA infection rate. Copies of MRSA in Pennsylvania Hospitals are free and available on the Council's Web site at http://www.phc4.org.
Los Angeles hospital faces possible closure
Investigators from the Centers for Medicare and Medicaid
Services descended on the King/Drew Medical Center in South
Central Los Angeles earlier this month and will soon determine
whether the hospital meets standards of care in 23 areas. If
it doesn't, King/Drew will lose $200 million of its $380
million budget and could face closure. Should that happen,
county officials predict a health crisis across this county of
10 million people as emergency rooms from Beverly Hills to the
middle-class San Fernando Valley are flooded with patients.
“It will set off a medical meltdown in terms of emergency
service,” predicted Zev Yaroslavsky, a member of the Los
Angeles County Board of Supervisors, which oversees the
facility. King/Drew has been out of compliance with Medicare
standards since January 2004, said Medicare and Medicaid
Services spokesman Jack Cheevers. It lost its national
accreditation in early 2005. In 2004, the Los Angeles Times
produced a series of articles on the failings of the hospital
and its affiliated medical school, Charles R. Drew University.
A public outcry followed. Between 2004 and earlier this year,
more than one in five of the hospital's 2,300 staff members
were disciplined or fired, Yaroslavsky said. The trauma center
was shut in November 2004. But when the county moved to also
cut the hospital’s obstetrics, neonatal and pediatrics wards,
Rep. Maxine Waters (D-CA) and other leaders pushed back. The
county hired a new chief executive for the hospital,
Antionette Smith Epps, who has been credited with major
improvements at the facility. Still, Epps has acknowledged
that King/Drew continues to have problems recruiting permanent
staff and improving its reputation among potential patients. A
new obstetrics ward averages 60 births a month, small compared
with the 600 born at the nearby St. Francis Medical Center.
Los Angeles police officers, sheriff's deputies and
firefighters all oppose being taken to the hospital if they
are hurt in the line of duty. While the region King/Drew
serves remains poor (It's No. 1 in Los Angeles in coronary
heart disease, diabetes, homicides, poverty, uninsured
children, teen birth rate, unvaccinated elderly and total
death rate), a demographic change has swept the community.
What was once an all-black region being served by a largely
black hospital has morphed into a predominately Hispanic area
being served by an institution that is slowly changing, too.
Thirty years ago, 85 percent of King/Drew's patients were
black. Today, 70 percent are Hispanic. “This change makes the
policies of the past untenable and has emboldened those of us
who are trying to transform King/Drew,” Yaroslavsky said.
“Whether we've done enough, we'll soon find out.” A decision
on Medicare and Medicaid funding is expected in early
September. (The Washington Post) To read the full article
CLICK HERE.
As a medical student at the
Albert
Einstein College of Medicine in the Bronx,
25-year-old Noé Romo has turned again and again to the
college’s Hispanic Center of Excellence for financial support,
friendship and guidance. The center was hailed by community
leaders when it opened in 2001 as a crucial way to address
what they saw as a disturbing, little-known trend: the
underrepresentation of Hispanics in the medical field.
According to the
American
Medical Association, only 3.2 percent of physicians
in the United States are Hispanic. The Hispanic Center of
Excellence teaches medical students and doctors of various
backgrounds about Hispanic culture and conducts research on
Latino health issues. Yet its main focus is recruiting and
encouraging Hispanic students to pursue healthcare careers.
The center does this in part by providing academic counseling,
scholarships and professional networking. But budget
cuts in Washington are threatening the future of the federally
financed center. “There’s a very strong need for physicians
who not only speak the language but understand the culture,”
said Romo, who is an American citizen of Mexican descent. The
center, the first such Hispanic center in the state, recently
lost all its financial support from the federal government. In
the fiscal year that began on Aug. 1, the cut was $700,000,
about 80 percent of the center’s operating budget. Dr. A. Hal
Strelnick, the center’s director, said that as a result of the
cut, he was forced to eliminate a two-year fellowship that
helped Hispanic faculty members at Einstein sharpen their
research skills and earn a master of science degree in
clinical research methods, to supplement their other degrees.
He fears what another cut next year will mean to the center,
though he vowed to keep it open somehow, through city, state
or private support. “The metaphor that we use is a pipeline,”
Dr. Strelnick said. “If you choke off the pipeline for
producing Hispanic health professionals, you’re going to have
consequences down the line.” Yesterday at the Albert Einstein
College of Medicine, the largest private medical school in the
state, Dr. Strelnick, Romo and other Hispanic students called
on Congress and the United States
Department
of Health and Human Services to restore the money.
They were joined by Representative Joseph Crowley, a Democrat
whose district includes parts of Queens and the Bronx. The
college in the Bronx is one of 34 institutions across the
country that had received Centers of Excellence grants from
the Department of Health and Human Services. In 2005, Congress
approved $33.6 million in grants to the 34 centers. This year,
$11.8 million was approved for four centers. Crowley has urged
the leadership of the House Appropriations Committee to
include $43 million for Centers of Excellence grants next
fiscal year. David Bowman, a spokesman for the Health
Resources and Services Administration, said the president’s
proposed budget for the 2007 fiscal year included no money for
the Centers of Excellence grants. (The
New York Times)
New compound causes
cancer cell suicide
Suicide is the regular mode of cell death. When cells reach the end of their useful life, internal mechanisms kick in and the cell automatically perishes, a process known as apoptosis. But in cancer cells this mechanism has often been genetically disabled or otherwise broken, allowing tumors to proliferate. Now researchers have found a way to reactivate programmed cell death and thereby treat cancer. In preparation for apoptosis, a chain of chemical events takes place in the cell. Near the end, the chemical procaspase-3 is activated. This chemical then transforms into caspase-3, an executioner enzyme that terminates the cell. Chemist Paul Hergenrother of the University of Illinois and an international team of colleagues realized that a compound that activated procaspase-3 might be effective in killing cancer, because many tumors show elevated levels of procaspase despite their inability to complete apoptosis. After screening 20,500 related molecules for this activation ability, the researchers narrowed it down to five likely candidates. Of these, only one showed an increasingly strong effect with increased doses: newly named procaspase activating compound, or PAC-1. “We have identified a small, synthetic compound that directly activates procaspase-3 and induces apoptosis,” Hergenrother said. “By bypassing the broken pathway, we can use the cells’ own machinery to destroy them.” The researchers tested the efficacy of PAC-1 on colon cancer cells from 23 patients. The tumors had elevated levels of procaspase-3 averaging roughly eight times as much as normal colon cells and proved more sensitive to the compound. In one case, the cancerous cells were 2,000 times more sensitive to PAC-1's enforced apoptosis than were surrounding regular cells due to their increased expression of the enzyme. Further tests in mice proved effective in treating grafted human kidney- and lung-cancer cells, and those results also indicated that PAC-1's strength correlated with procaspase-3 levels in the various cancer cells. “The potential effectiveness of compounds such as PAC-1 could be predicted in advance and patients could be selected for treatment based on the amount of procaspase-3 found in their tumor cells,” Hergenrother added. Nature Chemical Biology published the paper presenting the finding online. (Scientific American)
PSA predicts treatment success in advanced prostate cancer
A test used to detect prostate cancer can also help doctors know when treatment is working. A man’s prostate specific antigen, or PSA, level after seven months of hormone therapy for advanced prostate cancer predicted how long he would survive, according to a new multicenter study conducted by the Southwest Oncology Group and led by researchers at the University of Michigan Comprehensive Cancer Center. The study evaluated 1,345 men with prostate cancer that had spread to distant parts of the body. The men were treated with seven months of androgen deprivation therapy, a treatment designed to block the effects of hormones on the cancer. PSA levels were monitored throughout the treatment. The researchers found that men whose PSA dropped below 4.0 ng/ml had a quarter the risk of dying compared to those whose PSA was more than 4.0. Results of the study appear in the Aug. 20 issue of the Journal of Clinical Oncology. “Our analysis showed that a low or undetectable PSA after seven months of androgen deprivation therapy is a powerful predictor of risk of death in patients with new metastatic prostate cancer. This could allow oncologists to identify patients who are unlikely to do well with this treatment long before they develop clinical signs of treatment resistance,” said lead study author Maha Hussain, M.D., professor of internal medicine at the U-M Medical School. The researchers found 69 percent of the men maintained a PSA level of less than 4.0 ng/ml after seven months of treatment and 43 percent had an undetectable level of PSA at that time. Patients whose PSA was higher than 4.0 at the end of seven months survived 13 months, while patients whose PSA dropped below 4.0 but above 0.2 lived 44 months and those whose PSA was undetectable, below 0.2 ng/ml, lived 75 months. “What is attractive about using PSA to predict survival in metastatic prostate cancer is that it is an easily measurable factor. These findings could help patients avoid ineffective treatment and could help researchers design further trials,” Hussain said.
Nurses strike over health plan at hospital in New Jersey
Researchers move biotechnology closer to replacing electronic pacemakers
Cooling towers may host new pathogens
Group urges disaster planning for pregnant women, babies
Business continuity planning contracts with Tenet to supplement emergency air response service
Lawson Software passes milestone in mobile supply chain offerings
2005 medical group data finds financial losses, despite increases in physician compensation for most specialties
Nearly all of the 1,300 nurses at Robert Wood Johnson
University Hospital in New Brunswick, NJ, went on strike yesterday morning in a
contract dispute over what their health insurance plan requires them to pay for
outside medical services. The nurses on Aug. 16 rejected a proposed contract
that would have given them a 3 percent raise in each of the next three years.
But that proposal went to a vote without the backing of union leaders, said
Jeanne Clark, a radiology nurse at the 584-bed hospital and one of the
negotiators for the union. At 7 a.m. yesterday, the nurses began leaving their
jobs at the hospital with many of them joining about 400 workers on a picket
line that began forming outside. John Patella, a hospital spokesman, said that
officials who were notified of the impending strike when the proposed contract
was rejected, had arranged to bring in replacement nurses. “These nurses have
been recruited from all over the country,” he said, adding that the replacement
nurses had met
New Jersey
licensing requirements, and were experienced “in the specialty and subspecialty
services that the hospital offers and have also undergone a thorough hospital
orientation.” Under the hospital-run health insurance plan, nurses or their
family members would have to pay a fixed fee of up to $700 for each hospital
admission and each outpatient procedure performed outside of the network of
doctors and hospitals in the plan. Clark, the union representative, said the
proposed fee was different from a deductible. “This isn’t a deductible as the
hospital wants to call it, but a penalty,” she said, adding that the union had
found other plans that did not include such a feature. “Our members come from
four states in this region and cannot always get to providers that are in the
network and to the hospitals that are covered.” According to the union, nurses
at the hospital make an average annual salary of $78,000, although hospital
officials said that the average was $90,000. Both sides agree that a starting
registered nurse earns about $60,000 a year. Dr. Joshua Beshad, the hospital
medical director, conceded that the basic health plan required paying a fixed
fee outside the network, but he explained that emergency hospitalization or
emergency care outside the network was covered “100 percent.” Patella, the
hospital spokesman, disputed the union negotiators’ assertion that they had not
agreed to recommend approval of the proposed contract when it went to a
membership vote on Aug. 16. He provided a memo that he said accompanied the
proposed agreement which stated that negotiators and union leaders would
recommend its approval. (The
New York Times)
Researchers move biotechnology closer to
replacing electronic pacemakers
UC Davis researchers have
successfully used a custom designed protein and gene delivery system to restore
normal heart rhythms in pigs with electronic pacemakers, reducing their
dependence on implanted devices. This work suggests that scientists are one step
closer to making bioengineering a reality in treating the more than 2.2 million
Americans affected by irregular heartbeats. The UC Davis study, which was
co-authored by an international team that included scientists from the
University of Hong Kong and Johns Hopkins University, is published in the
current issue of the journal Circulation. The same issue also includes a
similar but independent research effort by scientists from Columbia University
and State University of New York at Stony Brook. “Our study offers positive and
direct evidence in living models that bioengineered cells can replace the
electronic pacemaker,” said Ronald Li, who leads the research team and is an
associate professor of cell biology and human anatomy at the UC Davis School of
Medicine. More than 250,000 people in the United States get artificial
pacemakers implanted each year. Researchers believe this biological approach
would provide a more permanent, reliable and less invasive alternative to
implanted electronic devices.
Cooling towers may host new
pathogens
Group urges disaster planning for pregnant women, babies
In the days after Hurricane Katrina struck Louisiana, about 125 critically ill newborn babies and 154 pregnant women were evacuated to Woman's Hospital in Baton Rouge. Some of the fragile newborns arrived without their mothers, and some of the women were already in labor. It was at least 10 days before some of the infants and mothers were reunited. Katrina focused unprecedented attention on pregnant women and newborns as an acutely vulnerable population during emergencies. A year later, those concerns are driving a push to add provisions for both groups to national preparedness guidelines for disasters, epidemics or terrorist attacks. No accurate data are available on the number of babies born during the Katrina crisis, but officials at both hospitals in Baton Rouge described vivid scenes of distraught pregnant women arriving with no records, of desperate mothers searching for their babies and of women who delivered on their way to the facility. Heidi Wigley, 26, was three months pregnant when the storm struck. She lost her home, including her medications, in St. Bernard Parish, and her doctor was evacuated to Florida. “I was evacuated to another town and could not contact my doctor, who had all the information about my pregnancy,” Wigley said from Mandeville, LA, where she now lives. “I was worried I may miscarry. The relief teams did not have any gynecologist and no prenatal vitamins. I told them I wanted more food and more money because I was pregnant, and they said no.” Two months later, Wigley developed high blood pressure, a common complication of pregnancy, and delivered prematurely in February. At 5 1/2 months, her son is now healthy. “Pregnant women face greater risks, like premature births, low-birth-weight babies and infant deaths, during the stressful conditions of a disaster. This can make delivering a child difficult and potentially life-threatening,” said Theresa Shaver, executive director of the District-based White Ribbon Alliance for Safe Motherhood. “International relief agencies have detailed guidelines for helping pregnant women, infants and new mothers in disasters around the world,” she said. “But in the United States, it is not yet integral to our preparedness plans.” The alliance has set up a working group to develop domestic guidelines in association with groups of pediatricians, gynecologists, obstetricians, nurses and midwives. Representatives from the Centers for Disease Control and Prevention and the National Association of County and City Health Officials are also taking part. Shaver noted that in the past few years, healthcare providers and officials have worked on disaster preparedness plans focusing on other vulnerable groups, including children, the elderly, heart patients, those on dialysis and disabled people. These efforts were accelerated in response to the Sept. 11, 2001, terrorist attacks and the anthrax attacks later that year, and concerns about bioterrorism and pandemic flu. But several public health advocates said it was not until Katrina exposed the lack of provisions for pregnant women and new mothers and their babies that those groups were included on the preparedness agenda. “Pregnant women and newborns are just entering the radar, and that is a post-Katrina development,” said Georges C. Benjamin, executive director of the American Public Health Association. The White Ribbon Alliance working group hopes to release by the end of August proposals to address the needs of newborn babies in disasters and present those recommendations at emergency planning meetings across the country. It is also exploring the option of introducing federal legislation. The proposed guidelines, called the Women and Infants Service Package (WISP), advocate training first responders in the special needs of pregnant and new mothers and babies, preparing birth-complication readiness packages, keeping mothers and infants together during evacuations, and setting up dedicated toll-free numbers that pregnant women can call for assistance. The guidelines also recommend that emergency teams include certified midwives and have supplies of baby formula, bottles, diapers, vaccines, and folate and iron supplements. The alliance believes that disaster situations call for a shift in the thinking of American women, who generally expect to give birth in a hospital or clinical setting. In the early phase of a disaster, officials said, births will often take place outside a health facility and without the assistance of trained health personnel. “We will be in situations where there are no healthcare facilities. In fact, if there is a pandemic flu, a hospital is not where you take a pregnant woman or an infant to,” said Robbie Prepas, a certified midwife who heads disaster preparedness at the American College of Nurse-Midwives. During Katrina, Prepas helped many pregnant women with deliveries in airports and ambulances. “We will have to retrain care providers to be comfortable with assisting deliveries outside hospitals,” she said. (The Washington Post)
Business continuity planning contracts with Tenet to
supplement emergency air response service
A Tenet Healthcare
Corporation subsidiary has contracted for a dedicated emergency air response
program as a part of its ongoing, assured response planning efforts, according
to Jeff Young of Frisco-based Business Continuity Planning Inc., whose ALERT
program will provide the services. The agreement is between Business Continuity
Planning, a subsidiary of XGL, and Tenet and supplies Tenet with the ALERT,
Aviation Logistics Emergency Response Team, program. ALERT puts in place
dedicated, pre-positioned assets to fulfill the aviation component of Tenet’s
emergency and disaster planning strategies. ALERT delivers systems necessary to
help maintain business continuity through emergency airlift, expedited cargo,
and related communications infrastructure for the duration of the contract.
Launched in 2006, ALERT evolved from the response provided by its parent company
following major natural or man-made business interruptions. During the massive
2005 hurricane cycle, for example, the company responded quickly to mobilize
rotary-wing (helicopter) assets, fixed-wing (private jet) assets, forward
operating teams, and real-time field based communications. “The ALERT program is
designed to reduce response time for customers,” he said. “The goal is to
accelerate the return to normalcy.” XGL and its subsidiaries are headquartered
in Frisco, TX, and are on the web at
http://www.xgl-air.com/.
Lawson Software passes milestone in mobile supply chain
offerings
Lawson Software says that customers like Boston Medical Center, Jewish Hospital
& St. Mary’s HealthCare, MediCorp Health System and Providence Health and
Services represent a growing number of healthcare providers that have selected
Lawson’s advanced, mobile supply chain offerings, Par and Cycle Counting,
Receiving and Delivery, and Surgical Instrument Management – to control their
supply costs by managing and tracking supplies, packages and surgical
instruments more effectively. Using bar coding, wireless and Internet
technologies, the applications enable employees to increase their productivity
via more efficient and more accurate business processes. The goal is faster
supply replenishment cycles, ensuring the right supplies are available when and
where they are needed. Providence Health and Services, an existing Lawson
Enterprise Financial Management, Human Capital Management and Supply Chain
Management customer, has licensed both Par and Cycle Counting and Receiving and
Delivery. The multi-state
healthcare network will use the mobile applications to increase
supply chain efficiencies and reduce costs by improving the accuracy and speed
with which it processes packages and moves supplies within its facilities.
Specifically, the health system wants to increase staff productivity so
employees have more time to analyze the data they collect. This analysis will
help technicians identify supply usage trends and opportunities for improving
inventory turnover. “Mobile applications were the logical next step as we sought
new ways to drive even greater benefits from our ERP system,” said Kurt Reasoner,
director, ProvConnect, Providence Health and Services. “By adding bar code
scanning and wireless technologies to our supply chain execution, we expect to
reduce both supply and staff costs. For example, the productivity gains driven
by these applications will enable us to manage supplies at growing facilities
without hiring new staff.”
In new method for stem cells, viable embryos
HHS Secretary calls for brand-new healthcare system for New Orleans
Medicare cuts payments for pharmacy-made drugs
U.S. pushing for release of flu data
FDA proposes new rule to automate drug registration and listing
Getinge acquires telemedicine growth company
In new method for stem cells, viable embryos
In
the wake of Hurricane Katrina's devastation, the country’s top
health official wants a brand-new, top-to-bottom healthcare
system for New Orleans, and he wants it to be built as soon as
possible. “What's clear to us is that there's a green-field
opportunity here,” Health and Human Services Secretary Michael
Leavitt said Wednesday in New Orleans, where Katrina tore
apart the city's healthcare network, destroying hospitals and
clinics, driving some medical personnel into permanent exile,
and forcing people remaining behind to wait hours for
emergency care in hospitals that stayed open. Those facilities
are the last remnants of a two-tier system consisting of
private medical care for people with insurance and the Charity
hospital system for people with no coverage. “The worst thing
we could do is rebuild that system,” Leavitt said. “We intend
to build a new system.” That new system is being designed by a
task force of city, state and private health experts who have
an Oct. 20 deadline to submit their plan to Leavitt, who was
in town to meet with them and encourage them. Because this is
a work in progress, no details are available yet, nor are such
data as the system’s cost or a timetable for putting it into
place. The new system will be built on prevention. “We'll try
to keep people well,” Leavitt said, “not treat them when
they're sick.” With that goal in mind, the plan will include a
network of primary-care clinics throughout the city, where
most problems can be diagnosed and treated before they become
much worse and require more expensive hospital care. “It will
require a certain amount of change,” Leavitt said, “but it'll
meet our objective of everyone having a medical home.” These
clinics will keep electronic medical records of each patient
that can be called up wherever anyone happens to show up for
an appointment. Besides being a logical next step in the
technological advancement of the practice of medicine, the
idea of providing this capability, with privacy protection,
grew out of the Katrina experience, when tens of thousands of
Louisianians lost their medical records because their doctors’
offices were drowned and their files washed away. “I see a
system where, if there's another disaster, people don’t lose
their medical records and we have to start over,” Leavitt
said. At the meeting, Leavitt asked the 40-member group to
determine by Sept. 15 what kind of computer equipment would be
required to maintain records online, and he told participants
to work out the details of the clinic network, including how
to pay for it, said Bob Johannessen, a spokesman for the state
Department of Health and Hospitals. “People need to know the
level of quality they’re receiving,” Leavitt said, “and they
need to know what the price is.” What Leavitt and the
Louisiana group are working on is complicated, he said, and it
will take a long time to realize. “It's not the thing you
build all at once and then flip the switch on,” he said.
“There'll be some bricks and mortar that’ll have to be put
into place, clinics to be built, health records to be
safeguarded, and it won't just be systems. It'll have to be
sociology that'll have to change. People have to change the
way they think. In New Orleans, they had a system for a long
time where most of the money went to institutions to pay for
care for people who were uninsured. Now the goal is to get
them insured.” (The Times-Picayune)
Medicare cuts payments for pharmacy-made
drugs
In a sweeping change, Medicare says it will significantly cut
payments to pharmacies that make their own, non-FDA-approved
versions of drugs used by asthmatics and others with
respiratory ills. The move was disclosed in a letter sent
Tuesday to Sen. Charles Grassley, R-IA. He and some consumer
advocates say patients may unknowingly get such drugs, which
have provided profits for pharmacies, but are made under
less-stringent safety and sterility rules than the government
sets for drug manufacturers. It follows action earlier this
month by the Food and Drug Administration, which warned three
large national medical-supply companies that their pharmacies
may be violating federal law by mass producing “thousands of
doses” of unapproved respiratory drugs. Starting in January,
Medicare will use special payment codes for pharmacy-made
respiratory drugs, allowing it to pay less for those products
than for brand-name formulations. For most drugs, Medicare has
until now paid the same, no matter whether the pharmacy bought
the drugs from manufacturers, or purchased raw ingredients and
made them in-house. The new payments are likely to be
“significantly lower” and will remove “any inappropriately
large financial incentives” encouraging pharmacies to make
drugs for patients, even when there is no medical reason to
switch from products made by drug manufacturers, Medicare
chief Mark McClellan said in a letter to Grassley. At issue
are liquid drugs used to treat lung conditions. The FDA says
patients are unlikely to get such drugs from national chain
pharmacies. Instead, most get them from Internet mail-order
pharmacies or firms that sell the devices used to inhale the
drugs. Pharmacists are allowed to make drugs when they have
specific prescriptions for patients who need specialized
treatments that are not available from brand-name
manufacturers. Pharmacy-made drugs are not generic drugs,
which are produced by commercial manufacturers. Both brand and
generic drugs must receive FDA approval. Pharmacy-made drugs
do not. Medicare says it is not trying to stop legitimate
pharmacy-made drugs. In July, Grassley wrote Medicare and the
FDA, saying former industry employees told his staff that some
pharmacies switch patients to pharmacy-made drugs without
telling them or their doctors. Tests conducted by
pharmaceutical companies on samples of pharmacy-made drugs
found contamination and incorrect dosage amounts, Grassley’s
letter added. Medicare now has a separate payment code for
only one pharmacy-made version of the 37 respiratory drugs it
covers. That code, for a drug called budesonide, cut payment
from $4.40 a dose to 29 cents, according to a recent
Securities and Exchange Commission filing by pharmacy Rotech
health care, one of the three firms recently warned by the
FDA. Rotech said the change could cut its revenue $30 million
this year. (USA Today)
Getinge acquires telemedicine growth company
The Getinge Group’s Medical Systems business area has
concluded an agreement regarding the acquisition of 60 percent
of the shares in the German company OTY GmbH. The agreement
also includes an option to acquire the remaining shares at a
future point in time. OTY is a rapidly expanding company
active in the telemedicine area and specializing in products
and solutions for the IT infrastructure of hospitals, with a
focus on the operation theatre. The company has developed
hardware and software that enable the integration of various
electronic data systems in the operation theatre, thus
increasing the efficiency of the communication and visibility
of patient data. The products constitute a natural complement
to the Surgical Workplace division's existing product range.
For some time, Medical Systems has been cooperating with OTY
in several markets. The market for telemedicine products
focusing on the operation theatre has expanded rapidly in
recent years and is expected to show continued favorable
growth. OTY GmbH will be incorporated in the Getinge Group as
of September 2006.
Amerinet announces its agreement with CDW Government Inc. for technology products and services. Effective through June 30, 2008, this contract includes servers, desktops, laptops, monitors, printers, digital imaging scanners, network hardware, cables, telephony and software licensing. This contract was the result of a competitive bidding process.
Amerinet announces its agreement with Attainia Inc. for software solutions. Effective through July 31, 2008, this contract includes capital budgeting and equipment planning software solutions designed for the healthcare setting. Attainia systems are secure with firewall, backup and network redundancies.
Effective through June 30, 2009, Amerinet’s agreements with First Quality Products Inc. for incontinence products for acute care and non-acute care facilities includes adult and youth incontinence products, briefs, breathable briefs, night-time briefs, underpads, pants, protective underwear, pant liners, cotton-snap pants, washcloths and wet wipes.
HealthSouth to sell its clinics and focus on inpatient care
Tissue for transplant is recalled after FDA shuts down North Carolina firm
Study shows how obesity, chronic conditions drive Medicare spending
Two studies find high weights shorten lives
Making healthcare the engine that drives the economy
Metropolitan Chicago Healthcare Council affiliates with MedAssets Supply Chain Systems
The
HealthSouth Corporation
plans to shed its outpatient rehabilitation clinics and other segments to focus
on intensive care of inpatients, the company said last week as it reported
declining revenue but a lower loss in its second quarter.
HealthSouth, which started as a chain of rehabilitation clinics and diversified through a growth period that ended in a huge accounting fraud, said in addition to the outpatient rehabilitation division, it would sell its surgery centers and its diagnostic division. The proceeds would be used to pay off debt, and HealthSouth would be left to focus on its inpatient business, which accounted for about 58 percent of its operating revenue for the last quarter. The company reported a second-quarter loss of $51.7 million, or 13 cents a share, compared with a loss of $62.4 million, or 16 cents a share, a year earlier. Second-quarter revenue fell 4 percent, to $787.5 million, down from $818.3 million in the period last year. The company said the narrower loss resulted from cost controls. A decision by HealthSouth to sell its outpatient clinics is not as radical as it might seem to some, said Derrick C. Dagnan, an analyst at Avondale Partners in Nashville. While the clinics are the most visible part of the business to the general public, he said, the medical community is more focused on HealthSouth’s post-acute-care centers, which generally specialize in intensive therapy for older patients, most of them on Medicare. “It seems like you are getting rid of your bread and butter,’’ Dagnan said. “But that inpatient rehab business to clinicians and doctors is really the business of HealthSouth.” (The Associated Press)
Joint Commission Resources (JCR) announced the appointment of two consulting practice leaders to provide innovative solutions in two critical focus areas for healthcare organizations: Accreditation improvement and infection prevention and control. JCR is an affiliate of Joint Commission on Accreditation of Healthcare Organizations. The consulting practice leaders will partner with healthcare organizations to improve strategic decision-making and enhance daily operations in a way that promotes health care quality and safety. Consulting practice leaders specializing in patient safety, the environment of care and medication safety will be available later this year. “JCR’s consulting practice leaders will skillfully guide organizations in transitioning from a culture of simply achieving standards compliance at a particular point in time to one that uses innovation to create practical and effective organization-wide solutions and fosters a continuous emphasis on performance improvement,” said Karen H. Timmons, chief executive officer, JCR. The JCR consulting practice leaders are: Stephen C. Anderson, MBA, RN – Accreditation Innovations. Anderson has more than 30 years of executive experience in healthcare, including expertise in clinical and senior management, clinical applications and information management. He is a former Joint Commission and Joint Commission International surveyor who has held leadership positions at not-for-profit, government and investor-owned healthcare delivery systems (adult and pediatric) in the United States and abroad. Barbara M. Soule, RN, MPA, CIC – Infection Prevention and Control Services. Soule has broad experience practicing and teaching infection prevention and control in the United States and internationally and has published extensively in this area, serving as editor in chief of the Association for Professionals in Infection Control’s (APIC) first Curriculum for Infection Control Practice. She is a member of the HealthCare Infection Control Practices Advisory Committee (HICPAC), which provides advice to the U.S. Office of the Surgeon General and the Centers for Disease Control and Prevention (CDC). For more information about JCR’s consulting practice leaders, please contact Nanne Finis, executive director, at nfinis@jcrinc.com.
Tissue for transplant is recalled after FDA shuts down North Carolina firm
A leading medical firm has recalled hundreds of human-tissue products destined for transplants around the nation that were supplied by a North Carolina body-parts broker. On July 6, AlloSource of Centennial, CO, began a recall of about 300 transplant parts supplied by Donor Referral Services of Raleigh, NC, an AlloSource spokeswoman said. On Friday, the Food and Drug Administration shut down Donor Referral Services, saying the company, run by Philip Guyett, had “serious deficiencies” in its processing, donor screening and record-keeping. The FDA refused to say how many people may have received potentially risky tissue. It is the second scandal in less than a year in the booming but little-regulated tissue-transplant industry. Cadaver tissue is used in more than a million transplants each year in such routine operations as back surgery and knee repairs. Improperly processed or poorly tested tissue can lead to illnesses such as hepatitis or AIDS, or even death. Last year, a scandal unfolded around Biomedical Tissue Services, a New Jersey company accused of using stolen bodies and of shipping potentially tainted body parts. (Associated Press)
Study shows how obesity, chronic conditions drive Medicare spending
A new analysis of Medicare costs and patient data by Kenneth E. Thorpe, the Robert W. Woodruff Professor and chair of the Department of Health Policy and Management, Rollins School of Public Health, Emory University (Atlanta) and David H. Howard, an assistant professor in that department, examines the impact of the rise in treated disease prevalence on the growth in Medicare beneficiaries’ healthcare spending. According to the analysis, published in the journal Health Affairs, virtually all of this spending growth is associated with patients who are under medical management for five or more conditions. This is traced to both a rise in true disease prevalence and changes in clinical treatment thresholds. Using metabolic syndrome as a case study, the authors found that the share of patients treated with medications has increased 11.5 percentage points in less than ten years. This raises important questions about the “fit” of how Medicare pays for services for complex medical management. Medicare spending is projected to nearly triple from 3 percent of U.S. gross domestic product (GDP) in 2006 to 8.8 percent by 2030. The top ten disease conditions accounted for two-thirds of the growth in spending incurred by Medicare beneficiaries between 1987 and 2002. The three conditions associated with metabolic syndrome -- hypertension, diabetes, and hyperlipidemia -- collectively accounted for 16.1 percent of the rise in spending. Virtually all of the growth in spending from 1987 to 2002 can be traced to the twenty-percentage-point increase in the share of Medicare patients receiving medical treatment for five or more conditions during a year. Overall, the prevalence of obesity among Medicare beneficiaries has doubled since 1987, but the share of spending incurred by obese beneficiaries has almost tripled, from 9.4 percent to nearly 25 percent of total spending. Efforts to control the growth in Medicare spending using lifestyle modification strategies and care coordination will require changes in the way Medicare pays for services and interacts with providers. Another implication concerns the critical need to track the future benefits associated with the more-aggressive preventive treatment of the conditions associated with metabolic syndrome. For more information CLICK HERE.
Modestly overweight baby boomers will live shorter lives, two studies will
report in The
New England Journal of
Medicine. That fits with the conventional wisdom of many public
health experts who cite the increased risk of
heart disease and
cancer. But it runs
counter to a study last year by researchers at the
Centers for Disease Control
and Prevention and the
National Cancer Institute
that found slightly overweight people had a somewhat lower risk of death. One of
the two new studies looked at more than 500,000 members of
AARP, an
organization for people 50 and older. Over 10 years, more than 61,000 of them
died. Among women, the risk of death increased for any amount of weight above
the normal range. For men, the risk was not higher for those merely overweight.
The researchers said the more telling analysis arose when they focused on
186,000 healthy men and women who had never smoked. Among men and women, being
overweight raised the risk of death 20 percent to 40 percent compared with
normal-weight people, the researchers said.
Obese people had a risk two to three times that of normal-weight people. “We found that people who are overweight had a modestly increased risk of premature death,” said Dr. Michael F. Leitzmann, an investigator at the National Cancer Institute and the senior author of the article. Because all the participants were recruited from AARP, they are not exactly representative of the population as a whole, and the participants reported their weight themselves, which contributes to some uncertainty in the results. Dr. Leitzmann said neither factor would probably skew the results considerably because “it’s a very large sample of people.” Errors in reporting weights, people sometimes say they weigh less than they actually do, would also not produce a large effect, he added. Researchers have almost universally found that obese people have considerable health risks. But there has been debate over whether someone who is less severely overweight is at a greater risk of illness. Other factors, especially smoking, can complicate analysis of the data. Smoking greatly increases the chances of deadly lung diseases, but smokers tend to weigh less.
As with most such studies, the fatness and thinness of the participants was specified by their body mass index. A second study by researchers at Yonsei University in Seoul, South Korea, and Johns Hopkins University looked at 1.2 million Koreans ages 30 to 95 and followed them for 12 years. The researchers looked at 82,372 deaths and correlated them with the body mass index. They found, too, that risk of death and cancer increased in people who were overweight, but not obese. “It’s the first time an Asian population this large has been studied,” said Dr. Eliseo Guallar, a professor of epidemiology at the Johns Hopkins School of Public Health and an author of the paper. The diet and lifestyle of Asians differ considerably from those of Americans, as does physiology. An Asian with the same body mass index as a white typically has a higher percentage of fat, so doctors recommend that Asians maintain a lower weight. The Koreans in the study were much thinner than typical Americans, with an average body mass index of 23.2 compared with 28 for Americans. The overweight category runs from 25.0 to 29.9. Dr. Guallar said the findings suggested to him that keeping weight in what is regarded as a normal range was a good idea. “That will help control a whole bunch of other big problems,” he said. As an example, according to the body mass index, someone who is 5 foot 9 would be considered overweight at 169 pounds; he would be considered obese at 203 pounds. (The New York Times)
After receiving a hip replacement last year, Angus Deaton, an economist at Princeton, wondered how much it had cost. He found out that his hospital room was $10,000 a day. “Telephone and television were extra,” he said. As for the total cost, there were so many charges associated with one service after another, anesthesia, pain management, physical therapy, the surgery itself, that he was never able to figure out how much each of them cost. All he knows for sure is that insurers say they pay, on average, $50,000 for a hip replacement. The United States already spends nearly 16 percent of its gross domestic product on healthcare, and it is almost impossible to know where all that money goes. Projections are that healthcare will take up even more of the G.D.P. as the population ages and as more expensive drugs and medical devices are developed. But a new economic approach to healthcare expenditures views costs in a very different light. Economists agree that huge increases are coming. But some say that may be just fine. By 2030, predicts Robert W. Fogel, a Nobel laureate at the University of Chicago Graduate School of Business, about 25 percent of the G.D.P. will be spent on healthcare, making it “the driving force in the economy,” just as railroads drove the economy at the start of the 20th century. Unless the current system is changed, most healthcare costs will continue to be paid by insurance, especially Medicare, which means that the taxpayers will foot the bill. But Dr. Fogel says he is not alarmed. Americans can afford it, he says, because the nation is so rich. “It takes so little of household income to satisfy expenditures on food, clothing and shelter,” he explains. “At the end of the 19th century, food, clothing and shelter accounted for 80 percent of the family budget. Today it’s about a third.” Other economists agree. “We have to spend our money on something,” said Robert E. Hall, a Stanford University economist. In a paper published in The Quarterly Journal of Economics, Dr. Hall and Charles I. Jones of the University of California, Berkeley, write: “As we get older and richer, which is more valuable: a third car, yet another television, more clothing, or an extra year of life?” David Cutler, an economist at Harvard, calculated the value of extra spending on medicine. “Take a typical person aged 45,” he said. “They will spend $30,000 more over their lifetime caring for cardiovascular disease than they would have spent in 1950. And they will live maybe three more years because of it.” He added, “Are you willing to do that? Yes, it costs a lot, but we’re rich enough where the alternative use of the money isn’t as valuable.” Still, Victor R. Fuchs, also an economist at Stanford, notes that buying healthcare is fundamentally different from buying a television or a car. “Most of it involves transfers from the young to the old,” he said. “Down the road, most medical care will be for people over age 65, and most of the payments will be from taxes on younger people.” Dr. Fuchs calls it the restaurant check problem. “You go out to a restaurant with a bunch of friends and you sort of understand that you will split the check,” he said. “The waiter comes along and says, ‘The lobster looks very good, and how about a soufflé for dessert?’ The restaurant check balloons, but you are not so careful because you figure everyone is splitting it. “That’s the way medical care gets paid for,” he said. Dr. Fuchs added, “We want to spend our money on the things that will bring the most value for the dollar. When we are spending collective money as we are in health care, then it becomes much more difficult.” The issue, he says, is not how much is being spent but whether spending more is the answer. Are those extra dollars buying marked improvements in health or are they making any difference? That, Dr. Deaton said, was the point of his exercise in trying to find out the cost of his hip replacement: “Is it worth spending all this money on a hip replacement?” In London, he said, a hip replacement costs £5,000, or about $9,500. “Don’t you think people would prefer to have it for £5,000?” Dr. Deaton said. “It is probably true that if we spent twice as much money on health care we’d be better off. But half the money we spend is wasted.” That, Dr. Hall pointed out, is an important issue. “We all know that especially in Medicare, where more and more of the spending is going to occur, there isn’t anybody who has responsibility for making sure the money gets spent well,” he said. “Some huge improvements will have to be made as the consequences of that waste get greater.” Still, the wasted money is, in a sense, a separate discussion, he said. The real questions for the future of medical spending, he said, are: “Does it make sense in terms of how we value different things? What do people think a life is worth? And what do you get?” (The New York Times)
Metropolitan Chicago Healthcare Council affiliates with MedAssets Supply Chain Systems
MedAssets Supply Chain Systems announced a new affiliation with Metropolitan Chicago Healthcare Council (MCHC), a membership and service association comprised of more than 140 member hospitals and health care organizations. The affiliate agreement between MedAssets and MCHC to enhance the financial performance and business processes of MCHC’s member organizations was effective August 1, 2006. The affiliation with MedAssets will drive supply cost savings to MCHC members through MedAssets Supply Chain Systems’ group purchasing contracts; Aspen Healthcare Metrics’ cost management programs for clinical service lines; and MedAssets Analytical Systems’ best of breed supply chain technology, data cleansing, and analytics. This affiliation also equips MCHC with the ability to offer the MedAssets Net Revenue Systems’ suite of revenue cycle management tools for linking the hospital supply chain item file to the chargemaster, defensible pricing, chargemaster management, charge capture auditing, and denials management within the Chicago health care community.
Potential J&J-Medtronic deal ‘makes sense’
says analyst
Bush to sign healthcare comparison law
Medicare posts ASC transparency information
Aetna members gain access to care price, quality data
Bird flu patients need testing before starting drugs
Medline receives American Red Cross award
for rescue efforts after hurricane Katrina
Medline awarded Premier contract for O.R.
safety products
Potential J&J-Medtronic deal ‘makes sense’ says analyst
Credit Suisse said an acquisition of Medtronic would be a logical move for healthcare giant Johnson & Johnson, which is facing a growth problem as patent expiration looms for a handful of key drugs. Shares of Medtronic, which is set to announce first-quarter results on Aug. 22, were pounded earlier this month after the company warned that quarterly sales would likely fall short of expectations due to a slowdown in sales of implantable cardiac defibrillators, or ICDs. But the stock bounced back somewhat last week amid renewed speculation Johnson & Johnson would take advantage of recent sharp declines in Medtronic's share price by making a bid for the Minneapolis-based medical device maker. A buyout of Medtronic makes “good strategic sense” for Johnson & Johnson, the analyst said Monday, since the company has long wanted to enter the pacemaker business as evidenced by its failed bid for Guidant. In order to satisfy Medtronic investors, however, the analyst said the company would likely need to offer a lofty 30% to 40% premium to the current stock price. (Forbes)
Bush to sign healthcare comparison law
An executive order being
signed today by President Bush is designed to help people make more informed
decisions about doctors and hospitals. Four federal agencies will be required to
compile information about the quality and price of care they pay for and share
that information with their customers and each other. The order directs the
agencies to: Use, where available, health
information computer systems that can talk to each other. That way, the health
records of a veteran living in Maine can be viewed by a doctor working in
California if the veteran needs emergency care there during a vacation; Enact
programs that measure the quality of care, and develop those measures with the
private sector and other government agencies; Make available to beneficiaries
the prices that agencies pay for common procedures; Develop and identify
practices that promote high-quality healthcare. The
agencies affected by the executive order are the Health and Human Services
Department, which oversees Medicare; the Defense Department, which oversees
health care for the military; the Veterans Affairs Department and the Office of
Personnel Management, which oversees the Federal Employees Health Benefit
Program. (The Associated Press)
Medicare posts ASC transparency information
To
help consumers, providers, and payers make more informed healthcare decisions,
the Centers for Medicare & Medicaid Services (CMS) is making available Medicare
payment information for 61 procedures performed in Ambulatory Surgery Centers (ASCs). President
Bush recently directed that more data be made available to all Americans as part
of the Administration’s commitment to make healthcare more affordable and
accessible. Today’s announcement is the second set of geographically-based
information made available; information on what Medicare pays for 41 procedures
performed in an inpatient hospital setting was posted at the beginning of June.
The new information posted by CMS at
http://www.cms.hhs.gov/HealthCareConInit/ will help patients undergoing
surgical procedures select the most appropriate setting for the delivery of high
quality, efficient care. The information will show “Commonly Performed
Procedures in ASCs”, and will contain charge and Medicare payment data for ASC
facility costs for a limited number of services administered in states and
counties. The data is broken down at the county, state and national level. CMS
is also concurrently releasing data on “Other Commonly Performed Procedures in
ASCs”, which contains similar charge and payment data, but for facility costs
related to services of high utilization. The department is working closely with
a number of national and local organizations toward the goal of developing more
comprehensive and personalized information on quality and cost. Building on
private sector quality measurement efforts, a new Medicare pilot project, to be
conducted initially in six geographic areas, will produce comprehensive quality
data that will help improve the quality of Medicare-covered services, and
provide information to Medicare beneficiaries that will assist them in making
more informed choices among their healthcare options. The quality information
produced under this Medicare pilot project will be based on services provided to
Medicare beneficiaries, Medicaid beneficiaries, and individuals with private
health insurance in Massachusetts, Indiana, Minnesota, Wisconsin, Arizona and
California. In making this information available to Medicare beneficiaries, it
will also be available to providers, other insurers, employers, and the public.
Aetna members gain access to care price, quality data
On Sunday, major insurer Aetna began allowing its members in the Washington area and several other markets to access prices for “30 of the most widely accessed services” and care-quality information via the company's member services site, http://www.aetna.com/. The company expects pricing information will likely be most helpful to people who have health savings accounts (HSAs) tied to high-deductible insurance plans that place more of the burden for containing health costs on consumers, rather than their employers. The posted prices are the rates that care providers have agreed to accept as payment for services to Aetna members; prices for patients who are not Aetna members may be higher. The service, begun a year ago in Cincinnati, allows the estimated 1 million Aetna members in the District, Maryland and Virginia to log on to the company's Web site, pull up a provider’s name and view price and quality information. Another 1.3 million members in other parts of the country also gained access to the new service. Aetna members in those markets can view, from any computer with Internet access, how much specific services will cost them at their provider’s office. An advisory on the site reminds members that posted rates are the “maximum amount allowed by Aetna. Depending upon your particular plan, your actual out-of-pocket costs may be less (for example, co-pays, co-insurance and/or deductibles).” Quality information is drawn from Aetna’s “Aexcel” network, described on the company’s Web site as a “designation for specialist physicians . . . who have demonstrated effectiveness in the delivery of care based on a balance of measures of clinical quality and efficiency.” Quality ratings are available for providers who specialize in 12 areas: cardiology, gastroenterology, cardiothoracic surgery, general surgery, obstetrics and gynecology, neurology, neurosurgery, orthopedics, otolaryngology, plastic surgery, vascular surgery and urology. The quality information is divided into three categories: clinical quality, volume and efficiency, according to the company. (The Washington Post)
Bird flu patients need testing before starting drugs
Bird flu cases may go undetected in patients who took antiviral drugs days before being tested because treating the virus may mask infection, said virologist Menno de Jong, whose team observed 18 cases in Vietnam. Specimens should be collected from suspected cases before or soon after medicines such as oseltamivir are administered, said de Jong, head of virology at an Oxford University clinical research unit in Ho Chi Minh City. Nasal and throat swabs from Vietnamese patients who responded well to oseltamivir, marketed by Roche Holding AG as Tamiflu, were unable to detect the virus 48-to-72 hours after beginning treatment, he said. “If a patient is on oseltamivir for three days before the first swab is taken for diagnostic testing, it's possible the result will be negative, but the patient could be infected” with the H5N1 strain of avian influenza, de Jong said. A delayed or incorrect diagnosis is a concern for disease trackers as they monitor human cases for signs H5N1 is becoming contagious to people, not just birds. Early detection and isolation of suspected cases are important to limit the spread of the virus should it begin to spread easily between people, the World Health Organization (WHO) said last year in a recommendation of strategic actions to fight a pandemic. Oseltamivir is recommended by the WHO as the first choice for doctors treating human H5N1 cases. In patients with confirmed or strongly suspected H5N1 infection, doctors should administer the drug as soon as possible, according to agency guidelines. The efficacy of oseltamivir and other antiviral drugs that work by preventing the virus from spreading from infected cells to other cells in the body “depends on their administration within 48 hours of onset of symptoms,” the WHO said. A study of H5N1 cases in Vietnam, published in the Sept. 29, 2005, edition of the New England Journal of Medicine, found the virus’s genetic material couldn’t be detected in throat-swab samples until between two and 15 days after the patient began feeling ill. The median interval from the onset of illness to the detection of viral RNA was 5.5 days, a consultative committee to the WHO wrote in the study. (Bloomberg)
Medline
receives American Red Cross award
for rescue efforts after hurricane Katrina
Medline Industries Inc. recently received one of the highest honors awarded by the American Red Cross for its efforts as a first responder to help bring in medical supplies and rescue victims of hurricane Katrina last year. “We are thankful for, and applaud, the significant contributions Medline Industries, Inc. has made to help those affected by recent hurricanes. It is through these types of generous gifts that the American Red Cross is able to continue the work we do. As we have seen with Medline Industries and others, employee initiatives, combined with support from top management, has made a remarkable impact on disaster relief efforts,” said Judith Ostronic, National Chair, Biomedical Development. In addition to donating $100,000 to the American Red Cross and an additional $100,000 to help Medline employees hit by the hurricane, Medline immediately chartered a first response helicopter rescue team that has been lauded for rescuing and coordinating the rescue of more than 1700 men, women and children from hospital and other rooftops in New Orleans. “We are so honored to be recognized by the Red Cross. We feel very fortunate that we were able to respond immediately with food, water, medical supplies and hire some of the best rescue professionals around,” said Medline CEO Charlie Mills. “It was a dangerous mission for them. There was no air traffic control, fog, downed power lines and thousands of people that needed to be rescued who were at times desperately rushing the chopper. These guys are heroes.” Mills also noted the extraordinary efforts of Medline’s Covington, LA, facility employees who came to work within 24 hours of the hurricane even though many had lost their own homes. “We were amazed by their strength of spirit and their willingness to put their own needs aside and help our customers and others who had suffered. They literally lived in the warehouse with their families and worked around the clock.”
Medline awarded Premier contract for O.R. safety products
Medline Industries Inc. recently signed a national agreement to provide operating room safety products to members of Premier Purchasing Partners, LP. The contract was developed in direct response to the Joint Commission's new national Patient Safety Goals. The multi-source agreement, to be fully implemented September 1 and effective through July 31, 2009, covers O.R. safety products including sterile standard and blank label sheets, skin markers (with rulers and labels), transfer trays, tube/cord holders and scalpel holders, important products to help hospitals with sharps safety, correct site incision and drug identification.
New treatment, first in years, demonstrated
for dangerous staph infections
Families troubled by healthcare costs
Children slip through cracks of AIDS efforts
Healing potential discovered in everyday human brain cells
Doctors warn of powerful and resistant tuberculosis strain
Adverse effects and costs of chemotherapy greater than previously thought
FDA, MIT to work on tracking drug side effects
Duke University Medical Center (Durham, NC) researchers have demonstrated in an international clinical trial the effectiveness and safety of a new drug for treating bloodstream and heart infections caused by Staphylococcus aureus bacteria. Based on the trial, the Food and Drug Administration already has approved the drug, daptomycin, for treating heart infections and bacteremia, also known as bloodstream infection or blood poisoning, caused by S. aureus, according to Vance G. Fowler Jr., M.D., an associate professor of infectious diseases who participated in the study. “This is the first new drug the FDA has approved in two decades for treating these types of potentially life-threatening infections,” Fowler said. “This advance adds a new weapon to our dwindling arsenal of antibiotics against these difficult-to-treat infections.” Daptomycin had been approved by the FDA in 2003 for treating skin infections caused by S. aureus. But until now, Fowler said, no one knew definitively whether the drug would be effective against the more serious bloodstream and heart infections. The researchers published their findings in the August 17, 2006, issue of the New England Journal of Medicine. Cubist Pharmaceuticals, which manufactures daptomycin, funded the study. S. aureus now causes up to 2 million infections and 90,000 deaths per year worldwide, most of them in healthcare settings, Fowler said. Treating S. aureus infections is difficult because many strains have developed resistance to all penicillin-related antibiotics, according to the researchers. For these highly resistant strains, called methicillin-resistant S. aureus, or MRSA, the drug vancomycin has been the only consistently reliable treatment alternative. Recently, however, MRSA strains with resistance to vancomycin have appeared. “The rising prevalence of S. aureus infections and the organism's increasing resistance to drugs make these bacteria a growing threat to medical care throughout the world,” said Ralph Corey, M.D., a professor of infectious diseases who participated in the study. In the study, the research team tested daptomycin's ability to combat two specific types of infection caused by S. aureus, including MRSA strains. The first type was bacteremia, or bloodstream infection. The second was infective endocarditis, which is an infection of the inside lining of the heart. Endocarditis due to S. aureus is a particularly severe form of the infection. It can involve either the tricuspid, mitral, or aortic valves and often occurs in patients with pre-existing heart disease. The results showed daptomycin was as effective as standard therapy, Fowler said. Daptomycin was more successful at eliminating drug-resistant S. aureus, at 44.4 percent success versus 31.8 percent. However, the standard therapy slightly outperformed daptomycin for S. aureus without drug resistance, at 48.6 percent success versus 44.6 percent. Both types of treatment took roughly the same amount of time, eight or nine days, to clear an MRSA infection. “Having another drug in our armamentarium against S. aureus not only will give physicians a new treatment option, but also may help slow the current troubling spread of drug resistance among these bacteria,” Fowler said.
Families
troubled by healthcare costs
About half of adults in middle-income families reported serious problems in
paying for their healthcare while even those in more affluent circumstances said
they had troubles with medical bills, a new survey found. Forty-eight percent of
individuals in families earnings between $35,000 and $49,999 said they had
either a somewhat serious or very serious problem paying their medical bills in
the last two years, according to a study by The Commonwealth Fund. Meanwhile, 50
percent of adults in that income bracket said they had difficulties affording
their health insurance. Meanwhile, 33 percent of individual in families earning
between $50,000 and $74,999 a year said they had trouble paying for medical
bills while 21 percent of people in families earning $75,000 or more reported
such a dilemma. Fifty percent of individuals in families earnings less than
$35,000 annually reported such a problem. Thirty-five percent of people in
families with an annual income of between $50,000 to $74,999 reported they had
trouble paying for health insurance while 23 percent of those in families
earning $75,000 or more said the same. Forty-eight percent of those in families
with incomes of less than $35,000 said the premium cost represented a problem.
Karen Davis, president of the Commonwealth Fund, said she was surprised that
people earning more than $50,000 were having difficulties affording healthcare,
and that it signals that the high costs are affecting more people. The study
also found that 48 percent of those surveyed worried that wouldn't be able to
pay their medical bills in the event of a serious illness, regardless of their
income. The study also found that while people are having difficulties paying
for their health services, they are also unsatisfied with them. Forty-two
percent of people surveyed said they had experienced poorly coordinated,
inefficient or unsafe care at some points during the past two years. Their
experiences included a medical error, a duplicate test or the failure to provide
important test results to doctors or nurses. Three-quarters of the adults
surveyed said the healthcare system needs fundamental change or a complete
rebuilding. The Commonwealth Fund is a New York-based private foundation that
aims to promote better health care. The study contacted 1,023 adults by phone in
early June. For more information on the Commonwealth Fund,
CLICK HERE. (The Associated Press)
Children slip through cracks of AIDS efforts
Efforts to greatly
expand antiretroviral treatment for
AIDS in poor
countries are not reaching a vast majority of children who need it, a
World Health Organization
official said in Toronto. The official, Dr. Kevin M. De Cock, who directs the
organization’s AIDS program, said that an estimated 2.3 million children 15 and
under around the world are infected with H.I.V., the
virus that causes
AIDS, and that 800,000 of them needed antiretroviral drugs to stay alive. Of the
800,000, only 60,000 to 100,000 are receiving therapy. While the children
account for 14 percent of AIDS deaths, they make up only 6 percent of recipients
of antiretroviral drug therapy. Many of the children are orphans. “We must
conclude that scale-up has so far left children behind,” Dr. De Cock said at the
16th International Conference on AIDS, which has attracted 24,000 participants.
His comments drew on an extensive review of progress in efforts to step up
antiretroviral treatment. At the same time, Dr. De Cock said, fewer than 10
percent of pregnant women with H.I.V. in poor and middle-income countries are
receiving the simple regimen of pills that can prevent the transmission of the
AIDS virus to their newborns. By contrast, rich countries have virtually
eliminated pediatric AIDS. Dr. De Cock also described an inequity in
antiretroviral treatment for injecting drug users, particularly in Eastern
Europe and Central Asia. There, these users account for more than 70 percent of
people infected with H.I.V. but about a quarter of those receiving treatment.
“An urgent priority is improving access to antiretroviral therapy for children,
especially in sub-Saharan Africa, and for injecting drug users everywhere,” Dr.
De Cock said. (The
New York Times)
Healing potential discovered in everyday human brain cells
University of Florida (Gainesville) researchers have shown ordinary human brain cells may share the prized qualities of self-renewal and adaptability normally associated with stem cells. Writing online Aug. 16 in Development, scientists from UF’s McKnight Brain Institute describe how they used mature human brain cells taken from epilepsy patients to generate new brain tissue in mice. Furthermore, they can coax these pedestrian human cells to produce large amounts of new brain cells in culture, with one cell theoretically able to begin a cycle of cell division that does not stop until the cells number about 10 to the 16th power. “We can theoretically take a single brain cell out of a human being and, with just this one cell, generate enough brain cells to replace every cell of the donor’s brain and conceivably those of 50 million other people,” said Dennis Steindler, Ph.D., executive director of UF's McKnight Brain Institute. “This is a completely new source of human brain cells that can potentially be used to fight Parkinson's disease, Alzheimer's disease, stroke and a host of other brain disorders. It would probably only take months to get enough material for a human transplant operation.” The findings document for the first time the ability of common human brain cells to morph into different cell types, a previously unknown characteristic, and are the result of the research team's long-term investigations of adult human stem cells and rodent embryonic stem cells. Last year, the researchers published details about how they used stem-like brain cells from rodents to duplicate neurogenesis, the process of generating new brain cells, in a dish. The latest findings go further, showing common human brain cells can generate different cell types in cell cultures. In addition, when researchers transplanted these human cells into mice, the cells effectively incorporated in a variety of brain regions. The human cells were acquired from patients who had undergone surgical treatment for epilepsy and were extracted from support tissue within the gray matter, which is not known for harboring stem cells. When the donor cells were subjected to a bath of growth agents within cell cultures, a type of cell emerged that behaves like something called a neural progenitor, a cell that is a bit further along in development than a stem cell but shares a stem cell's vaunted ability to divide and transform into different types of brain cells. Even when the cells from the epilepsy patients were transplanted into mice, bypassing any growth enhancements, they were able to take cues from their surroundings and produce new neurons. Scientists speculate a small amount of existing progenitors may be emerging from the gray matter of the brain and multiplying in torrents, or perhaps the aging clock of the mature cells actually turns backward when the donor cells are in a new environment, returning them to past lives as progenitors or as stem cells. In addition to using the cells in treatments to repair or replace damaged brain tissue, the ability to massively expand cell populations could prove useful in efforts to test the safety and efficacy of new drugs. It is also possible to genetically modify the cells to produce neurotrophins, substances that help brain tissue survive, researchers said. The research was supported by grants from the National Institute of Neurological Disorders and Stroke and the National Heart, Lung and Blood Institute of the National Institutes of Health. Steindler and co-senior author Bjorn Scheffler, M.D., a UF neuroscientist, are involved with RegenMed Inc., a biotechnology company that seeks to use stem cell technology to develop human therapeutics.
Doctors warn of powerful and resistant tuberculosis
strain
Virulent strains of tuberculosis resistant to all standard drugs have killed 52
of 53 patients in a rural hospital in South Africa in recent months, a team of
researchers reported in Toronto. The patients, who were also infected with the
virus that causes AIDS, were resistant to all first- and second-line drugs for
tuberculosis, Dr. Neel R. Gandhi told the 16th International Conference on AIDS.
“It’s essentially not treatable,” said Dr. Gerald Friedland, an AIDS specialist
at Yale who worked in the South African hospital and was an author of the study.
“There’s quite a lot out there. We don’t know the whole extent.” The illness was
rapidly fatal. About half the patients died within 30 days of the time their
sputum was collected and sent to a laboratory. Officials from South Africa, the
World Health Organization in Geneva and other public health agencies will meet
in South Africa in the next few weeks to come up with a strategy, he said. The
drug-resistant strains killed two healthcare workers and were suspected in the
deaths of four others. Of the 536 patients studied, 221, or 41 percent, had
tuberculosis strains resistant to at least two drugs. In 2004, only 128 such
cases were found in the whole United States. More important, 53 of the residents
of the area had what was called an XDR, for “extremely drug-resistant” strain.
Dr. Friedland estimated that half the patients had picked up their infections at
hospitals or clinics. Most of those who died were in the advanced stages of
AIDS, he said. Many were relatively young, the median age was 35, and had never
been treated for tuberculosis, so they presumably had not developed resistance
slowly in themselves, but had caught the extremely resistant strains from
someone else. Dr. Gandhi, of the Albert Einstein College of Medicine at Yeshiva
University in the Bronx, said 26 of 30 isolates were genetically similar,
suggesting that their infection was acquired shortly before patients developed
cough, fever, weight loss and other problems. Tuberculosis and infection with
the AIDS virus have long been known to be closely intertwined. This year, the
Centers for Disease Control and Prevention in Atlanta reported a total of 347
cases worldwide in which the agency found tuberculosis bacteria resistant to all
first- and second-line drugs, including isoniazid, rifampin, ethambutol,
streptomycin, kanamycin and ciprofloxacin. But there has been little data about
such strains in Africa or among H.I.V. patients, Dr. Gandhi said. About 80
percent of new tuberculosis cases in KwaZulu Natal are also infected with H.I.V.,
Dr. Gandhi said. The annual death rate among such patients was 40 percent before
the introduction of antiretroviral drugs, Dr. Gandhi said. The death rate then
fell to 12 percent. Dr. Gandhi’s report was based on information that became
available after the deadline for submission for the main papers presented at the
conference and was made in what is termed a “late breaker” session. Dr. Gandhi
led a team that included scientists from Yale and the Nelson R. Mandela School
of Medicine in Durban. (The New York Times)
Adverse effects and costs of chemotherapy greater
than previously thought
Researchers at Dana-Farber Cancer Institute and Harvard Medical School have
found that breast cancer patients 63 years of age or younger may experience more
chemotherapy-related serious adverse effects than reported in clinical trials,
according to a study in the August 16 issue of the Journal of the National
Cancer Institute. Led by Michael J. Hassett, MD, MPH, of Dana-Farber,
researchers studied a database of medical claims made by women with newly
diagnosed breast cancer who had employer-provided health insurance between
January 1998 and December 2002. “This is the first study, to our knowledge, of
chemotherapy-related serious adverse effects in a population-based sample of
younger women with breast cancer,” said Hassett, who is also an instructor in
medicine at Harvard Medical School. “We found that eight chemotherapy-related
serious adverse effects may be more common than reported in large clinical
trials, and, therefore, these adverse effects may be responsible for more
patient suffering and higher healthcare expenditures than currently predicted.”
Doctors often prescribe chemotherapy to eliminate residual cancer cells in women
who have undergone surgery for breast cancer. Women who received chemotherapy
were more likely to be hospitalized or visit emergency rooms for problems that
are typically related to chemotherapy, including fever or infection, low white
blood cell or platelet count, nausea, diarrhea, malnutrition, or dehydration.
Researchers studied 7,052 women from a database of claims made to health plans
that contract with large employers in the U.S. The group was equally divided
into two cohorts of 3,526: those who received chemotherapy within 12 months of
their first breast cancer diagnosis, and those who did not. In addition to more
incidents of chemotherapy-related adverse effects, women undergoing chemotherapy
for breast cancer also experienced increased healthcare costs: $1,271 more per
year for hospitalizations and emergency room visits and $17,617 more per year
for ambulatory care than women who did not receive chemotherapy.
FDA, MIT to work on tracking drug side effects
Methods used to track disease outbreaks also may be used to help spot side effects from prescription drugs after they hit the market, U.S. health officials said. The Food and Drug Administration agreed to work with the Massachusetts Institute of Technology on adapting technology to detect side effects earlier than current FDA monitoring systems. The project will involve automated scanning of databases for unusual patterns of health problems that could be drug-related, said Dr. Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs. It will build on computerized systems public health officials use to spot infectious disease outbreaks, follow the spread of influenza or detect a bioterrorist attack, he said. The partnership with MIT is the latest step to strengthen post-approval oversight of medicines, Gottlieb said. The efforts “will also require continued support by Congress,” Gottlieb said. (Reuters)
FDA approves new medical use for Plavix; Drug benefits patients with common form of heart attack
New details in reported secret deal over generic drug
New bird flu drugs possible, study says
WHO Update: Avian influenza situation in Indonesia
Nonin Medical acquires MedAir AB; Adds carbon dioxide monitoring technology to Nonin product line
People with blocked coronary arteries can typically choose among drugs, bypass surgery and vessel-clearing procedures like angioplasty. But in the small, aging industrial city of Elyria in northeast Ohio, doctors are much more likely than those anywhere else in the country to steer patients toward angioplasty. No one has accused the doctors involved of any wrongdoing. But the statistics are so far off the charts, Medicare patients in Elyria receive angioplasties at a rate nearly four times the national average, that Medicare and at least one commercial insurer are starting to ask questions. And the hospital where most of the procedures take place says it plans to conduct an independent review. Dr. Elliott S. Fisher, a researcher at Dartmouth Medical School, analyzed Medicare data and found Elyria to be an outlier. Nearly all the procedures at the Elyria hospital are performed by a group of cardiologists who dominate coronary care in this city and have an unabashed enthusiasm for angioplasties, the highly profitable procedure in which they specialize. The cardiology group’s leader says the high rate of angioplasties is simply a function of his doctors’ detecting disease more often in their patients than physicians elsewhere might spot, and being quicker to intervene. “We do manage very aggressively the patients we care for,” said Dr. John W. Schaeffer, the founder and president of the group, the North Ohio Heart Center, which employs 31 cardiologists. But some outside experts say they are concerned that Elyria is an example, albeit an extreme one, of how medical decisions in this country can be influenced by financial incentives and professional training more than by solid evidence of what works best for a particular patient. Medicare pays Elyria’s community hospital, EMH Regional Medical Center, about $11,000 for an angioplasty involving use of a drug-coated stent. The cardiologist might be paid an additional $800 for the work. That is well above the fees for seeing patients in the office. And with the North Ohio doctors performing thousands of angioplasties a year, about 3,400 in 2004, for example, the dollars can quickly add up. Some medical experts say Elyria’s high rate of angioplasties, three times the rate of Cleveland, just 30 miles away, raises the question of whether some patients may be getting procedures they do not need or whether some could have been treated just as effectively and at lower cost and less risk through heart drugs that may cost only several hundred dollars a year. Or whether, in some cases, patients might be even better off with bypass surgery, even though a bypass is a riskier, more invasive and more expensive procedure. At EMH Regional, Medicare pays the hospital about $25,000 for a bypass operation, and as much as $2,200 to the surgeon. The Elyria cardiologists do not perform bypasses. Because they are not surgeons, the North Ohio cardiologists must refer a patient to another doctor if they conclude that bypass surgery is that patient’s best option. The bypasses are performed at the Elyria hospital by surgeons from the Cleveland Clinic who have operating privileges there. But even in cases of extensive disease where other doctors might typically recommend bypass surgery, the Elyria doctors say they frequently favor the use of stents. For patients with less serious disease, the doctors say they do prescribe drug-only treatment. When it comes to treating blocked arteries, there are no definitive studies showing which approach most benefits patients in the long term. And some local insurers agree that the Elyria hospital provides high-quality care. But there is little doubt that hundreds of Elyria patients each year are getting angioplasties that they might not be getting if they lived elsewhere, at a cost of millions of dollars a year to Medicare. Experts know that changing the financial incentives can change the way medicine is practiced. For example, Kaiser Permanente, which employs its own doctors, says its patients in Ohio, including some in Elyria, are slightly less likely than the national average to undergo the type of cardiac procedures the North Ohio Heart Center doctors perform so prolifically. Kaiser’s cardiologists, who work on salary instead of being paid by the procedure, typically treat patients in that region at the Cleveland Clinic, where they have hospital privileges. And they follow established protocols about when a patient should undergo an angioplasty, when drugs might suffice and when bypass surgery might be the best resort. “We believe we’re doing a good job,” said Dr. Donald Sheldon, the hospital’s vice president for medical affairs. But he conceded that the high rates raise questions. He said the hospital had decided to ask a professional society of heart specialists to review the cardiac program and “give us an honest and objective outside look.” Experts say that cardiac care is one of the most lucrative areas of medicine. EMH Regional says it generates nearly half its profit from cardiac services. The high rates do not have “a good explanation,” said Dr. Eric J. Topol, a nationally known cardiologist at Case Western Reserve University in Cleveland. He said Elyria did not appear to have significant differences in risk factors and demographics from Cleveland and the rest of Ohio that would explain the sharply higher rates. One clear reason for the high number of angioplasties in Elyria, though, is the way the doctors tend to perform the procedures. In many other parts of the country, doctors who perform angioplasties try to unblock all of the blood vessels during a single session. Or they may elect not to put a stent in another vessel that might require an additional session because there is only a minor blockage. But in Elyria, patients are more likely to undergo two or more procedures, sometimes requiring separate hospital stays and additional bills. As many as 31 percent of patients there who receive treatment undergo additional procedures, according to Dr. Scott Sheldon, a North Ohio Heart Center cardiologists, who is not related to the hospital’s Dr. Sheldon. That would be three times the national average. No one has accused the North Ohio doctors of inappropriate conduct. But there have been cases in which unusual patterns of medical activity that also showed up in the Dartmouth data have prompted federal law enforcement investigators to look into whether unnecessary procedures have been performed. Experts say it can be difficult to detect cases in which doctors cross a medical line and are clearly performing unnecessary treatments. In the absence of any real monitoring or oversight, doctors in most places have few incentives not to favor the treatments that provide them the most reimbursement. Dr. David D. Waters, chief of cardiology at San Francisco General Hospital, who is currently studying the effectiveness of different kinds of treatment for heart disease, said that the way physicians are typically paid, more money for more procedures, results in too many decisions to give a patient a stent. “You can’t be paying people large sums of money to do things without checks and balances,” he said. To read the entire article CLICK HERE. (The New York Times)
The Food and Drug
Administration (FDA) approved the use of Plavix (clopidogrel bisulfate) for
patients who have had a type of heart attack called acute ST-segment elevation
myocardial infarction (STEMI), who are not going to have coronary artery repair
(angioplasty). A STEMI is a severe heart attack caused by the sudden, total
blockage of an artery. In STEMI patients, Plavix prevents subsequent blockage in
the already-damaged heart vessel, which could lead to more heart attacks,
stroke, and possibly death. FDA approved Plavix in November 1997 to decrease
platelet function in people who suffer from acute coronary syndrome (ACS).
According to the American Heart Association, each year an estimated 500,000
Americans have a STEMI heart attack. “Plavix has demonstrated that it can help
reduce these post-STEMI events for patients who suffer certain kinds of heart
attacks," said Steven Galson, MD, Director of FDA's Center for Drug Evaluation
and Research. Two studies support the effectiveness of Plavix in treating STEMI
heart attack patients. A large trial, the Clopidogrel and Metoprolol in
Myocardial Infarction Trial (COMMIT) study, demonstrated that Plavix, when
combined with other standard treatments including thrombolysis, a procedure to
dissolve clots, reduced mortality and also reduced the combined number of
recurrent heart attacks, strokes and deaths. COMMIT was a randomized,
double-blind, placebo-controlled trial of 46,000 patients conducted in China.
The findings in COMMIT in China are supported by the results of the Clopidogrel
as Adjunctive Reperfusion Therapy (CLARITY) study. CLARITY was a clinical trial
of 3,500 patients undergoing thrombolysis for STEMI heart attacks. CLARITY
showed that the coronary artery blood flow was better with clopidogrel treatment
compared to placebo. Serious side effects of Plavix include bleeding and,
rarely, low white blood cell counts or thrombotic thrombocytopenic purpura (low
platelet counts with spontaneous bleeding and clotting). Plavix is manufactured
by Sanofi Aventis of Bridgewater, NJ.
New details in reported secret deal over generic drug
A federal court filing provided new details about accusations that a Bristol-Myers Squibb executive entered a secret side deal with a generic drug maker in hopes of preserving the lucrative monopoly over the anticlotting drug Plavix. Those accusations are thought to be the focus of a Justice Department investigation of Bristol-Myers and the French company Sanofi-Aventis, its marketing partner for Plavix. The filing, made in Federal District Court in Manhattan by lawyers for the Canadian generic drug maker Apotex, asserts that Bristol-Myers made the secret agreement as part of a proposed settlement with Apotex of a patent lawsuit. The secret deal, Apotex asserts, was an effort to evade the scrutiny of the federal and state regulators who were reviewing the settlement. Although the Food and Drug Administration approved Apotex’s generic version of Plavix earlier this year, the settlement would have delayed the introduction of the generic drug until 2011, several months before the Plavix patent is scheduled to expire. Apotex’s filing asserts that Dr. Andrew G. Bodnar, a top assistant to Bristol-Myers’s chief executive, Peter R. Dolan, negotiated the secret deal after regulators objected to an earlier version of the patent settlement because it would have restricted competition. The side deal, the filing said, contained two provisions that had been in the original version of the settlement agreement but that were not included when the companies formally submitted their revised version. One provision called for Bristol-Myers and Sanofi to give Apotex a six-month head start to introduce its generic version of Plavix in 2011 before the two big companies would introduce their own generic, according to today’s court filing. Under the other provision, Bristol-Myers and Sanofi would secretly give Apotex a $60 million fee that had been part of the original settlement agreement. After regulators rejected the revised settlement agreement late last month, Apotex began shipping its generic version of Plavix, known as clopidogrel bisulfate. The company has flooded the United States market with millions of pills priced 10 to 20 percent below the $4-a-day price of brand-name Plavix. Plavix, used to prevent the recurrence of heart attack and stroke, had United States sales last year of $3.5 billion and is one of Bristol-Myers’s top products. Worldwide, the Plavix franchise is worth more than $6 billion. Apotex has said that it negotiated the settlement on the assumption that regulators would reject it, but conducted the discussions to win concessions from Bristol-Myers and Sanofi that have made it easier to introduce its generic drug in defiance of the big companies’ patent claims. It is unclear whether Apotex is a subject of the Justice Department investigation. Yesterday’s filing was made ahead of a hearing scheduled for today in Federal District Court in Manhattan. There, Judge Sidney H. Stein is to consider a request by Bristol-Myers and Sanofi to block further sales of the generic drug until after a patent trial, now expected to begin in January. Tony Plohoros, a Bristol-Myers spokesman, said that an internal investigation by the company’s outside lawyers had found no evidence of unlawful conduct by Bristol-Myers employees. In a hearing before Judge Stein earlier this month, a lawyer for Bristol and Sanofi asserted that Apotex’s chief executive, Bernard C. Sherman, had lied to the federal government about the secret agreement to sabotage the settlement agreement and clear the way for his company’s sales of the product. Sherman has denied that accusation. To read the entire article, CLICK HERE. (The New York Times)
New bird flu drugs possible, study says
Advanced X-ray technology has helped scientists spot a new target that drug designers might use to attack the bird flu virus. Though a new drug would still be years off, the new research offers hope of a fresh way to fight a disease that health experts fear could one day evolve into a deadly human flu pandemic. “This gives us a new target that we didn't know we had before," said Dr. Michael Perdue, a flu expert at the World Health Organization, who had no role in the study. Researchers used advanced X-ray technology to provide an “atomic picture” of the atoms and molecules that comprise one of the two surface proteins in the H5N1 virus. Neuraminidase, the “N” in H5N1, is the protein in bird flu that allows the virus to spread to other cells in the body. Drugs currently used to treat bird flu are based on other neuraminidase models that are not specific to H5N1. By identifying H5N1's unique blueprint, researchers may one day be able to use drugs that home in on the strain that has killed 139 people in the past three years. New drugs targeting H5N1 could potentially be used in combination with the current leading bird flu medication, Tamiflu, to reduce the risk of the virus mutating into a resistant form, said John Skehel, lead author of the paper appearing in the journal Nature. Drug combinations can reduce the risk of a virus becoming resistant to one drug, a lesson learned in the fight against AIDS, noted Skehel, director of the National Institute for Medical Research in London. Research into new flu drugs has traditionally focused on the neuraminidase protein because flu’s other surface protein, hemagglutinin, the “H” in H5N1, has proven harder to attack. To date, Tamiflu, which was developed to treat human flu, is the only drug shown in lab studies to be somewhat effective against H5N1. However, there have been isolated instances of strains resistant to Tamiflu. Experts agree on the importance of having more drugs in the arsenal to fight bird flu. “Right now, our options are really quite limited,” said Dr. Fred Hayden, an antivirals and influenza expert at the WHO. “We're really down to Tamiflu and Relenza, so there is a need for an alternative.” Though the timeline for producing a new drug usually takes between three to five years, it could potentially be shortened as countries accelerate their pandemic preparedness plans. “Since drug companies have already attacked neuraminidase before, they should already have a lot of information on how to build compounds that would work in attacking it,” said Perdue, who cautioned that the process of conducting clinical trials in humans could still take years. (The Associated Press)
WHO Update: Avian influenza situation
in Indonesia
In an
update of August 17, 2006, the World Health Organization (WHO) reports that the
Ministry of Health in Indonesia has confirmed the country’s 58th case of human
infection with the H5N1 avian influenza virus. The case occurred in a 9-year-old
girl from a remote village in Garut district, West Java Province. She developed
symptoms on August 1, was hospitalized on August 14, and died on August 15.
Recent chicken deaths were reported in her household. Three hamlets within the
village are currently under investigation. An
additional case
from the village, but from another hamlet, was confirmed by the Ministry of
Health on August 14. This 17-year-old male developed symptoms on July 26 and is
now recovering. Another death from severe respiratory disease occurred on August
5 in a 20-year-old neighbor, who is also now known to be a cousin. As no samples
were taken for testing, the cause of his illness remains uncertain. Based on
epidemiological and clinical findings, however, infection with the H5N1 virus is
strongly suspected. As both young men developed symptoms on the same day (July
26), epidemiologists assume that they acquired their infection from a shared
environmental source. The currently recognized incubation period for H5N1
infection of 2 to 8 days makes human-human transmission between the two highly
improbable. Teams from local health authorities, the Ministry of Health, and WHO
are currently in the three hamlets investigating these cases and assessing the
overall situation. Team members include experts in animal health. Recent
die-offs of poultry are known to have occurred in the village, and all three
cases described above had documented exposure to diseased chickens. Heightened
awareness in the hamlets, supported by the presence of well-equipped teams, has
led to the presentation of additional persons for medical evaluation. Rumors of
additional deaths from respiratory disease in the hamlets in late July and early
August are also being investigated. Although the village is remote and access by
road is difficult, good communications from the field have been established with
the Ministry of Health and WHO. Of the 58 cases confirmed to date in Indonesia,
45 have been fatal.
Nonin Medical acquires MedAir AB; Adds carbon dioxide
monitoring technology to Nonin product line
Nonin
Medical Inc. announced the acquisition of Swedish medical technology company
MedAir AB. With the acquisition, MedAir, which specializes in developing and
manufacturing optical equipment for medical gas analysis, has become a wholly
owned subsidiary of Nonin Medical. Medair AB management and employees are not
affected by the acquisition, the terms of which were undisclosed. The future
plan calls for the expansion of Medair AB. Minneapolis-based Nonin Medical
designs, manufactures and distributes a broad spectrum of physiological
monitoring devices
Study finds MRSA most common cause of skin infections in patients presenting in nation's ER's
Cancer Institute’s new chief talks of cutbacks
Projected costs of stroke highlight need for increased NIH funding
VHA’s global spend analysis debuts at AHRMM Conference
After nearly a two-year head start,
Johnson & Johnson
is about to face competition in the market for artificial spinal disks. Synthes,
a Swiss orthopedic devices company, told investors after European stock markets
closed Tuesday that it had received regulatory approval to sell its Prodisc
lumbar disk replacement in the United States. For now, only surgeons at the 19
hospitals that participated in the Prodisc’s clinical trials will be implanting
the device in this country. But Synthes plans to start a training program next
month for others who want to do the implants, Peter Fehlmann, a Synthes
spokesman, said. Synthes is just one of several large device companies,
including
Medtronic,
Abbott Laboratories
and Stryker, that expect to compete with Johnson & Johnson’s DePuy Spine
subsidiary for a share of what analysts believe will be a billion-dollar segment
of the orthopedics industry. Implanting the Prodisc, thousands of which have
already been implanted in patients in Europe, could be an alternative to spinal
fusion surgery for as many as 25 percent of the 220,000 Americans who undergo
fusion annually. The companies are also racing to develop cervical disks for the
neck and upper spine. Johnson & Johnson’s disk, known as the Charité, was
approved in October 2004. But sales have been disappointing. Insurers have
continued to classify the disk as experimental, and many refuse to cover the
cost of the implant procedure, which can cost more than $10,000 per disk and
several times that amount in hospital and doctors’ fees. Like the Charité, the
Prodisc consists of metal end plates around a hard plastic core. But backers of
the Prodisc say that differences in the design make it easier to implant the
disk accurately and keep it firmly anchored. That may make it harder to remove
if necessary, but could also make the Prodisc less prone to wear and to
displacements requiring remedial surgery. Unlike the Charité, the Prodisc
demonstrated superior results to spinal fusion in its clinical trials, according
to Dr. Rick B. Delamarter, a spinal surgeon who participated in Prodisc’s trials
and will work for Synthes training other surgeons. “We’ve gotten inundated today
with calls from patients who want to proceed with it,” said Dr. Delamarter, who
practices at the Saint John’s Health Center in Santa Monica, CA. (The New York
Times)
Study finds MRSA most common cause of skin infections in
patients presenting in nation's ER's
UCLA researchers report in
the Aug. 17 issue of The New England Journal of Medicine that Methicillin-resistant
Staphylococcus aureus, or MRSA, is the most common cause of skin and soft-tissue
infections among patients presenting in emergency rooms across the country. MRSA
is resistant to the antibiotics used for years to treat these skin conditions,
such as cephalexin and dicloxacillin. “The study points to the rising prevalence
of this type of MRSA and the need for clinicians to culture infections and make
sure the proper antibiotic is administered to treat MRSA,” said Dr. Gregory J.
Moran, the study's principal investigator and a clinical professor of medicine
in the department of emergency medicine and the Division of Infectious Diseases
at Olive View–UCLA Medical Center. Since the 1960s, MRSA has been found in
healthcare settings, generally among patients who have been hospitalized or are
in nursing homes. In the last few years, however, a new type of MRSA has
emerged, affecting people with no connection to health care settings. Outbreaks
of these new strains of MRSA have been reported among athletes, correctional
facility inmates and military recruits. Still, the UCLA study demonstrates that
the infections appear to be common in people who are not connected to any
particular risk group. “We noticed more patients showing up in our emergency
room with infections that turned out to be community-associated MRSA and wanted
to see if this was the case nationwide,” said Dr. David Talan, an author of the
study and a professor of medicine in the Division of Infectious Diseases and
chief of the department of emergency medicine at Olive View–UCLA Medical Center.
Community-associated MRSA most often manifests itself on the skin as a boil or
pimple that can be swollen, red and painful, and have discharge. Researchers
cultured the acute skin or soft-tissue infections of 422 patients seen at 11
metropolitan emergency rooms in the United States during August 2004. Out of
those patients, 249, or 59 percent, were found to have MRSA. The proportion of
infections caused by MRSA in various cities ranged from 15 to 74 percent.
Further characterization of the MRSA samples, performed at the Centers for
Disease Control and Prevention, revealed that one genetic type accounted for 97
percent of the samples. “This one genetic type of MRSA is appearing in
metropolitan areas across the country,” Moran said. “More research will
determine how prevalent it is in other parts of the nation.” Researchers tested
the antibiotic resistance of the isolated MRSA samples and found that in 57
percent of cases, doctors had prescribed an antibiotic to which the bacteria
were resistant. “Doctors need to change what they've done for decades, since
traditional antibiotics don't work against MRSA,” Talan said. “We encourage
physicians to reconsider antibiotic choices for skin and soft-tissue infections
in areas where MRSA is prevalent in the community.” Talan notes that most MRSA
cases are mild, and having the infection drained and keeping it clean resolves
the problem. But when antibiotics are needed, it's important to prescribe an
effective medication. Sometimes these infections may require hospitalization
and, in rare cases, may even be life-threatening. Researchers tested the
effectiveness of different types of antibiotics on the MRSA samples and found
that 95 percent were susceptible to clindamycin, 6 percent to erythromycin, 60
percent to fluoroquinolones, 100 percent to rifampin and
trimethoprim-sulfamethoxazole, and 92 percent to tetracycline. The next step,
according to Moran, is to compare these different antibiotics in real patients
in order to identify an optimal treatment. The study revealed several potential
risk factors for community-associated MRSA. Patients with MRSA were more likely
to report a spider bite as the reason for the skin lesion, perhaps thinking it
was a bite in absence of other skin problems. Those with MRSA also were more
likely to have close contact with a person with a similar infection. “However,
none of these risk factors were consistent enough to help doctors identify cases
of MRSA; it appears now that everyone is at risk,” Moran said. Dr. Rachel J.
Gorwitz, an author of the study and a medical epidemiologist at the Centers for
Disease Control and Prevention, noted the importance of educating patients in
order to avoid transmission. She offered the following guidance: Wash hands
often with soap and water to keep them clean, or use an alcohol-based hand
sanitizer (if hands are not visibly soiled); Don't share towels, razors or other
personal items; Avoid contact with other people's wounds or bandages; Keep
breaks in your skin clean and covered and watch for signs of infection, such as
redness, warmth and swelling; See your doctor if you notice signs of infection;
don't try to drain a boil yourself at home; If you have a skin infection, keep
the infected area covered with a clean, dry bandage until it is healed; wash
your hands thoroughly after changing the bandage and put used bandages in the
trash. For more information,
CLICK HERE.
VHA’s global spend analysis debuts at AHRMM Conference
The University of Pittsburgh Medical Center based in Pittsburgh, PA, announced its success to further drive corporate transparency and internal controls process enhancements using supply chain management technology offered by MedAssets Analytical Systems. Although not required by law, UPMC, a not-for-profit organization, initiated a project in June 2004 to comply with regulations set forth by the Sarbanes-Oxley Act of 2002. Subsequently, UPMC’s supply chain function, a department managing an approximately $1 billion supply spend, was identified as an area of focus for improving data integrity, streamlining business processes, and enhancing internal controls in financial reporting. MedAssets Analytical Systems’ Client Item File Services standardizes and normalizes the supply chain data in 19 facilities across the UPMC enterprise. By continuously cleansing the supply item file, a database housing items routinely purchased by UPMC, the foundation for accurate purchasing and analytics is established. MedAssets’ Strategic Information service and technology allows UPMC to aggregate the normalized purchasing data across multiple facilities, analyze purchasing activities, and make informed and accurate decisions to reduce costs, streamline business processes, and report on total supply procurement across the enterprise. A customized, Web-based contract catalog warehouses UPMC’s entire contract portfolio, including all local, regional and national agreements. An executive dashboard provides key performance metrics to consistently and accurately measure supply chain performance.
Experts cite distribution as key in fighting H.I.V.
Treatments for cancer are linked to heart ills
FDA forms internal nanotechnology task force
Ekahau and St. Croix Systems team up to integrate RTLS and asset management
Rotech won't make copies of drugs after FDA warning
One of the nation's largest respiratory therapy companies on Monday said it would stop making unapproved copies of drugs and distributing them to patients, days after receiving a warning from the FDA. Rotech health care, while saying it disagreed with the Food and Drug Administration's stance, said in a release that it will no longer accept new prescriptions for some of its pharmacy-made drugs and begin switching 30,000 patients to brand-name formulations. At issue are drugs used by asthmatics and others with respiratory conditions. The drugs are inhaled using a table-top device called a nebulizer. The company was one of three targeted by the FDA for scrutiny last week, with the agency saying the pharmacies were mass-producing respiratory drugs in violation of federal law. The FDA says some pharmacies are making large amounts of unapproved copies of brand -name drugs. Drugs made in pharmacies are held to less-stringent safety and sterility rules than the agency sets for drugmakers. The FDA allows pharmacies to make drugs for patients, a process called compounding, but only if they have valid individual prescriptions from doctors saying their patients need treatments, dosages or formulations that aren't made by commercial manufacturers. Last week, the FDA said the three, Rotech, CCS Medical and Reliant Pharmacy Services, owned by home oxygen company Lincare, had crossed into mass-producing their own versions of the drugs. "There is no demonstrated medical need for your compounding of these products that are essentially copies of commercially available drugs," the FDA said in a warning Wednesday to Orlando-based Rotech. Generally, states oversee the practice of pharmacies, but the FDA steps in when problems arise, such as product contamination or when pharmacies cross into manufacturing. Rotech's statement Monday that it supplies 30,000 patients with compounded respiratory drugs is a rare look at the size of some drugma k ing pharmacies. Generally, the number of customers or doses supplied is kept secret by the FDA and the companies. A Rotech subsidiary, Pulmo-Dose, makes the drugs for asthma and other respiratory conditions. Rotech is of the nation's largest respiratory therapy and home medical equipment firms, with $533 million in revenue last year. But it is struggling, particularly after Medicare lowered payments in the past two years for oxygen and some inhalation drugs. For just one product, a pharmacy-made drug called budesonide, the company said in a recent Securities & Exchange Commission filing, the lower payments may result in a $30 million drop in revenue this year. Medicare now pays abou t $4.40 a 0.5 milligram dose for the commercially prepared drug, the SEC filing says, but dropped payment to 29 cents for a pharmacy-made product. Ro tech on Monday said its decision to switch patients back to commercially prepared products, which it said would take several months, woul d increase its annual revenue by about $60 million and its projected annual pretax profit to about $10 million. (USA Today)
Experts cite distribution as key in fighting H.I.V.
Large studies of an array of promising new ways to prevent H.I.V. are nearing completion, but the world is unprepared to make them widely available to the hundreds of millions of people at risk of becoming infected, an international panel of experts reported in Toronto. Findings from some studies, like those assessing the effectiveness of microbicides and male circumcision, are expected within the next five years, some possibly in about a year, the panel said at the 16th International Conference on AIDS. The studies are vastly complex, there will be no magic bullet to prevent the disease, and whatever new methods work will have to be combined with existing preventions, the panel of 50 international experts said. It urged the world to address a significa nt number of practical and ethical challenges that it said threaten to slow or derail critical research projects concerning many prevention measures. In addition to microbicides, male circumcision and vaccines, the report focused on three other H.I.V. prevention methods: Diaphragms and other cervical barriers that could help protect women from H.I.V. and other sexually transmitted diseases; A drug to suppress herpes, which infects up to 70 percent of people in some parts of Africa, microbicides, and vaccines;&nbs p;Antiretroviral pills like tenofovir to prevent infection among prostitutes, drug injectors and other people at high risk of becoming infected before and after exposures. The need is urgent to make prevention measures of proved effectiveness widely available because four million people are becoming infected each year and fewer than one in five people at high risk for H.I.V. have access to such preventions. As treatments have proved effective, “the harsh reality is we are quickly falling behind in H.I.V. prevention,” Dr. Helene Gayle, the president of the International AIDS Society, which is the main organizer of the conference, said. No new prevention method under study is likely to be 100 percent effective, which will increase the difficulty of putting them into practice, the panel said, adding that educational campaigns will be needed to integrate the new met h ods with effective older ones. The panel cautioned against the complacency about risk behavior that could follow bro ader use of effective preventions. More donor funding will be needed to introduce and deliver the new preventions, said the panel, known as the Global H.I.V. Prevention Working Group. It made a number of recommendations, including one to find ways to help poor countries train enough health workers to carry out male circumcision safely. Last year, a study in South Africa found that circumcised men were 60 percent less likely than noncircumcised men to become infected with H.I.V. by female sex partners. (The New York Times) For more info, CLICK HERE.
Treatments for cancer are linked to heart ills
Two widely used treatments for breast cancer, radiation and the drug Herceptin, can cause heart problems, researchers are reporting. But the problems can usually be treated or prevented, and they should not scare women away from needed cancer therapies, the doctors say. The findings, from two studies being published in The J ournal of Clinical Oncology, expand on earlier research linking the treatments to heart trouble. The first study involved 961 women with early-stage breast cancer who were treated from 1977 to 1994 at the University of Pennsylvania; 477 had cancer in the right breast, and 484 in the left. Those who had radiation to the left breast had an increased risk of heart disease up to 20 years later, apparently bec ause the radiation hit parts of the heart and coronary arteries. The women’s risk of coronary artery disease was 25 percent, compared with 10 percent in the women who had radiation on the right. Similarly, 15 percent of the women treated on the left side had heart attacks, compared with only 5 percent treated on the right. The problems did not usually show up until 10 or more years after the radiation. Women who already had heart disease, hypertension or high cholesterol before starting cancer treatment had the greatest risk. Despite th e problems, the women did not have higher death rates from heart disease. Dr. Eleanor E. R. Harris, the lead author of the study, said that in one sense, the findings reflected good news: many women with breast cancer are now living long enough to be concerned about the long-term effects of treatment. Dr. Harris, who has moved from Pennsylvania to the H. Lee Moffitt Cancer and Research Institute in Tampa, said her study was more important for women who had radiation in the past than for those being treated today. Those treated five or more years ago need to be especially careful about treating high blood pressure and cholesterol, she said. Nationwide, researchers estimate that there are about 370,000 women who had radiation to the left side of the chest for breast cancer more than 10 years ago. Women today have less risk, Dr. Harris said, because improved radiation techniques and equipment have made it possible to avoid exposing the heart in nearly every case. But she said it was i m portant for women to be treated at centers with the most advanced techniques. Some women who have the breast removed completely do not need radiation. Those who have lumpectomies, removing just the tumor, almost always need it. But Dr. Harris said she would not recommend that women choose mastectomy just to avoid radiation and its risks. The operation has complications of its own, and patients sometimes need radiation anyway. She said the first priority should be picking the most effective treatment for the cancer. Dr. Larry Norton, a breast cancer expert at Memorial Sloan-Kettering Cancer Center in New York, who was not involved in the study, said the effects of radiation on the coronary arteries were relatively small but of concern to cancer doctors. He said more data and recommendations about the problem would become available later this year. The second study, at the M. D. Anderson Cancer Center in Houston, involved 173 women with cancer that had spread beyond the breast. The women had tumors that were sensitive to the drug Herceptin, which can help 20 percent to 25 percent of patients but is known to cause heart problems in some. The patients took the drug for at least a year; in 49 women, or 28 percent, the heart lost some of its pumping ability, usually while they were still taking the drug. More than half had no symptoms, but some felt short of b rea th. But the pr oblem co u l d usually be reversed with medicines like beta blockers and ACE inhibitors. Most of the women recovered fully, but a few had lingering problems, and one died from heart failure. The director of the study, Dr. Francisco J. Esteva, said that over all, the findings were encouraging because the heart problems were reversible and women could even take the drug again once their hearts recovered. But women who have already had heart failure may need to avoid Herceptin. Dr. Esteva said: “Patients need a baseline cardiac evaluation, and need to be seen by a cardiologist if they develop a decline in cardiac function or cardiac symptoms. And they need a cardiologist who is familiar and has experience with this problem.” (The New York Times) For the entire article, CLICK HERE.
FDA forms internal nanotechnology task force
Acting Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., announced the formation of an internal FDA Nanotechnology Task Force. The new task force is charged with determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials. The task force will identify and recommend ways to address any knowledge or policy gaps that exist so as to better enable the agency to evaluate possible adverse health effects from FDA-regulated products that use nanotechnology materials. FDA will continue to address product-specific nanotechnology-related issues on an ongoing basis. Specifically, the task force will: Chair a public meeting to help FDA further its understanding of developments in nanotechnology materials that pertain to FDA-regulated products, including new and emerging scientific issues such as those pertaining to biological interactions that may lead to eith er beneficial or adverse health effects. This public meeting is scheduled for October 10; Assess the current state of scientific knowledge pertaining to nanotechnology materials for purposes of carrying out FDA's mission; Evaluate the effectiveness of the agency's regulatory approaches and authorities to meet any unique challenge that may be presented by the use of nanotechnology materials in FDA-regulated products; Explore opportunities to foster innovation using nanotechnology materials to develop safe and effective drugs, biologics and devices, and to develop safe foods, feeds, and cosmetics; Continue to strengthen FDA's collaborative relationships with other federal agencies, including the agencies participating in the National Nanotechnology Initiative such as the National Institutes of Health (NIH), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA), as well as with foreign government regulatory bodies, international organizatio n s, healthcare professionals, industry, consumers, and other stakeholders to gather information regarding nanotechnology materials used or that could be used in FDA-regulated products; Consider appropriate vehicles for communicating with the public about the use of nanotechnology materials in FDA-regulated products; Submit its initial findings and recommendations to the Acting Commissioner within nine months of the public meeting. The National Nanotechnology Initiative (a United States government research and development coordinating program,) refers to nanotechnology as "the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications." A nanometer is a billionth of a meter. A human hair is about 80,000 nanometers in width. Materials made in the nanoscale size range can often have chemical or physical properties that are different from those of their larger counterparts. Such differences include altered magnet i c properties, altered electrical or optical activity, increased structural integrity, and increased chemical and biological activity. Because of these properties, nanotechnology materials have great potential for use in a vast array of products. Also because of some of their special properties, they may pose different safety issues than their larger counterparts. For additional information about FDA's Public Meeting scheduled for October 10, CLICK HERE.
Ekahau and St. Croix Systems team up to integrate RTLS and asset management
Ekahau Inc., a provider of Wi-Fi-based Real Time Location Systems (RTLS), announced that it is collaborating with St. Croix Systems Corp. to deliver a combined asset management, maintenance and real-time location solution for the health care industry. The Ekahau RTLS now integrates with St. Croix Systems’ Capital Asset Lifecycle Management software. The combined solution enables health care facilities to use their existing campus-wide wireless infrastructures to track historical and real-time locations of their assets and equipment. The addition of location tracking capabilities adds value to existing asset management solutions by providing documentation of maintenance status, condition, and availability for use, as well as exact life-to-date usage and costs patterns of critical assets. Effective asset management in a health care organization depends on the interplay of people and t echnology. The combined management and tracking solution will enhance coordination and communication between care givers and hospital support services leading to a safer more efficient environment of care.
Why the U.S. has not stemmed HIV
Cardinal Health & Mecmesin develop new syringe pump calibrator
Omnicell launches ProServ 1 Services Program, announces OptiFlex system enhancements at AHRMM
Aeroscout enhances its Wi-Fi based active RFID tag
USDA says Michigan bird flu case no risk
to humans
The bird flu virus has been found in a pair of wild swans in
Michigan, but U.S. officials said on Monday the birds have not
contracted the deadly H5N1 strain that has spread through
birds in Asia, Europe and Africa, killing more than 135
people. Routine tests conducted in a Michigan gaming area
found two of 20 swans have what government officials believe
is likely a low-pathogenic strain of H5N1. Confirmatory test
results are underway and will be available in about two weeks,
but officials stressed there is no threat to human health. "We
can definitely say this is not the H5N1 highly pathogenic
virus that's been found in Asia and other parts of the world,"
said the U.S. Agriculture Department's Ron DeHaven, head of
the Animal and Plant Health Inspection Service. "It's not the
introduction of that virus into North America." The swans had
shown no sign of sickness and test results indicate this is
low pathogenicity avian influenza. Pathogenicity refers to the
ability of the virus to produce a disease. A low-pathogenic
strain produces less disease and mortality in birds than does
a high-pathogenic version. Health officials and industry
analysts said they do not believe the infected swans came in
contact with U..S. commercial poultry. The low-pathogenic
strain of H5N1 has been found before in wild birds in the
United States, in 1975 and 1986. A similar low-pathogenic
strain was found in Canada last year. It is common for mild
and low pathogenic strains of bird flu to appear in the United
States and other countries. The infected swans were found as
part of an increased surveillance program put in place after
Congress approved a $29 million request by the Bush
administration in December. So far, more than 10,000 wild
birds have been tested. Just last week, the program was
expanded beyond Alaska, targeted because of its close
proximity to the Pacific Flyway with Asia, to the rest of the
country. "We see no cause for public hea lth and medical
authorities to take any special actions as a result of this
information," said Bill Raub, science advisor to the
Department of Health and Human Services. (Reuters)
Why the U.S. has not stemmed HIV
The number of new HIV infections in the United States has been about 40,000 a
year for the past decade and a half. It has not budged, not with new drugs, new
prevention strategies or new administrations. Five years ago, the Centers for
Disease Control and Prevention launched an effort to cut it in half. It did not
move. The intransigence of the AIDS epidemic in the place where it emerged, and
where many of the strategies against it have been developed, will be on the
minds of many this week as 20,000 people gather in Toronto for the 16th
International AIDS Conference. There is little question that, for public health
experts and AIDS activists, the fact that the HIV infection rate has not changed
since 1990 is an embarrassment. At the same time, it is a testament to a
victory, albeit one that happened long ago. AIDS was first recognized in June
1981. I ncidence of the disease, the number of new cases in a period, generally
a year, peaked at 160,000 in the mid-1980s. With intensive effort to reduce
risky behavior in gay men and, to a lesser extent in injecting drug users, it
fell to 40,000 by 1990. It has remained there since. The number of new HIV cases
each year has not changed despite a dramatic increase in HIV prevalence, the
number of Americans infected at a given time. That number stands at 1.1 million
and is growing as people on combination antiretroviral therapy live
far longer than AIDS patients used to. Deaths from AIDS in the United States
dropped from 52,000 in 1995 to 15,800 in 2004. Normally, a rising number of
infected people would lead to a rising number of new infections each year, as
more people are able to transmit the virus. But that is not happening. One of
the main reasons is that HIV-positive people today are more likely to know they
are infected, and t o know to take precautions, than was the case in the past.
Consequently, a stable rate of 40,000 new cases a year is a "very, very
significant finding," Ronald O. Valdiserri, deputy director of the CDC's HIV and
AIDS activities, said last week.. "We think it represents some level of success
in HIV prevention. We will not deny that we have a ways to go." Holtgrave, who
worked at the CDC and at Emory University before moving to Johns Hopkins, tried
to answer that in 2002 and recently updated his calculations. He estimates that
the number of new infections could be cut in half if the 5 million Americans at
highest risk of HIV, 4 million because of sexual activity and 1 million because
of drug use, received the full battery of proven interventions. Those include
HIV counseling and testing, free condoms, one-on-one or small-group counseling
sessions, and
needle exchange. The CDC now spends $720 million a year on HIV prevention. It
would need to spend $415 million more to reduce new cases by 50 percent,
according to Holtgrave's calculations. He and his collaborators further
estimated that the country would need to prevent 12,000 infections each year
to save money in the long run. HIV infection is expensive to treat, and newly
infected people will need to be treated for decades, a huge cost to the
health-care system. "I think it's fair and certainly honest to say that over the
past several years we've gotten more stringent with our funding," Valdiserri, of
the CDC, said last week. The CDC estimates that 17 percent of new infections
each year come from contaminated needles. Evidence suggests that 65 percent of
those could be prevented if every addict had access to a clean needle. However,
federal law prohibits using federal money for that purpose. (The Washington
Post)
Cardinal Health & Mecmesin develop new syringe pump
calibrator
Mecmesin, global supplier of force and torque testing systems, have recently worked with Cardinal Health in joint development of an instrument to calibrate the occlusion monitoring function of their syringe pump infusion systems. The automatic detection of a blockage, or ‘occlusion’, which may halt infusion of a drug to the patient, is a critical safety feature of a syringe pump. The occlusion will present itself as a build-up of excess pressure behind the syringe plunger, detectable by an integrated pressure sensor. An alarm is triggered if the pressure exceeds a pre-defined safety level. The accuracy of this sensor is therefore vital to ensure early occlusion detection, and guarantee consistent drug dosage; hence regular calibration of the sensor is a necessity. Working closely together, Cardinal Health and Mecmesin developed a custom-engineered ‘occlusion tester’, comprised of a CFG 100N digital force gauge with a special fixture designed to fit comfortably into the syringe seat.
Omnicell launches ProServ 1 Services Program, announces OptiFlex system enhancements at AHRMM
At the AHRMM 44th Annual Conference & Exhibition at the Gaylord Palms Resort & Convention Center in Orlando this week, Omnicell Inc. introduced its new Omnicell ProServ 1 program of professional services to help customers maximize their investment in Omnicell automation solutions. Omnicell ProServ 1 offerings include the following categories of support: Omnicell OnSite consulting services - Three levels of on-premises support provide day-to-day operational management, periodic review, and custom engagement assistance; Reporting services - A series of flexible reporting packages and services, available at various frequencies (one-time, monthly or quarterly) and with summary and detailed data options leverage the information generated from the use of Omnicell automation systems. In addition, a comprehensive executive dashboard, capturing critical operational and financial metrics, is offered; Benchmarking services - Available on a quarterly basis, Omn icell ProServ 1 benchmarking services enable healthcare facilities to compare themselves against other similar Omnicell customers on a variety of key operational and financial metrics; Database services - Assistance in diagnosing and/or cleansing databases is offered to help healthcare facilities manage their systems; Operational services - Secure hosted operational services, such as OmniBuyer, Omnicell's Web-based requisitioning and purchasing system, are available.Omnicell also. introduced new management, security and tracking enhancements to its OptiFlex SS supply management system for hospital surgical services units. OptiFlex SS is a physician preference card system as well as a perpetual inventory management system for all supply management requirements of the surgical services department. New enhancements to OptiFlex SS include: The ability to globally manage items across pre ference cards and physicians, ensurin g accuracy and eliminating manual work; Security improvements, including bolstered system password and user timeout features a s required by HIPAA; Track expiration date, lot number, and serial numbers easily via bar code scanning, eliminating manual tracking.Omnicell introduced new inventory management, cost tracking and usability enhancements to its OptiFlex MS supply management system for hospital medical-surgical units. OptiFlex MS is a complete, integrated system for managing supplies in closed cabinets and open shelves in medical-surgical nursing units. New enhancements to OptiFlex MS include: Expansion of inventory control reporting capability, allowing inclusion of multiple departments/pars; Security improvements, including bolstered system password and user timeout feature s as required by HIPAA; central management of user credential authentication; and expanded availability of the magnetic card reader feature for improved system access control; Inventory management and cost tracking for temporary patients; Improved cost tracking and inventory management features, including the ability to store purchase unit of measure information at the item level and the true cost of item at time of issue to patients, improving accuracy of cost analysis; Additional user-friendly features, including improved guiding light functionality, making it easier for users to locate needed inventory items. Omnicell introduced new case, product and patient tracking enhancements to its OptiFlex CL supply management system for hospital cath labs, endoscopy and other special procedure units. OptiFlex CL is a specialty area management system with real-time point-of-use data collection that tracks supplies and procedures to the physician for cost management and automated charge capture. New enhancements to OptiFlex CL include: Track case costs via user defined case types (e.g., diagnostic and interventional radiology, endoscopy, electrophysiology) back to the case, physician, patient and technician, ensuring accuracy and cost control; Track expiration date, lot number, and serial numbers easily via bar code scanning, eliminating manual tracking; Inventory management and cost tracking for temporary patients. The enhanced versions of the OptiFlex systems were successfully beta tested at St. Patrick Hospital and Health Sciences Center in Missoula, MT.
Aeroscout enhances its Wi-Fi based active RFID tag
AeroScout Inc., a provider of Wi-Fi-based Active RFID visibility
solutions, announced several enhanced features and capabilities for its
AeroScout T2 Tag. The T2 tag is the industry's leading Wi-Fi-based Active RFID
tag for asset tracking and management, with tens of thousands of units being
shipped each month to customers around the globe.
New
features on the AeroScout T2 Tag include a built-in temperature monitor and
motion sensor, for unmatched asset management capabilities. The motion sensor
provides transmission control based on movement of the tag, improving real-time
location accuracy and enabling a 4+ year battery life in most customer
environments. The temperature sensor provides an additional stream of asset
management data for environment-sensitive assets, enabling the tag to wirelessly
trigger a remote alert if the temperature goes above or below a certain
threshold. In addition, advanced call button and LED functions, intrinsically
safe and electromagnetic certifications on the tag, and extendable battery life
(up to 8 years) all enable customers to further enhance their asset management
capabilities.
Built-in motion sensor gives greater efficiency to the tag's performance and
advanced real-time visibility. The tag can be configured for different
transmission rates when static or in motion. For example, an infusion pump in a
hospital can be set to transmit every ten seconds while in motion, updating its
location in real-time, but will transmit only once an hour while stationary to
conserve energy and reduce network overhead. Using the AeroScout MobileView
software application, users can confirm whether an asset is in motion or
stationary. Optional built-in temperature sensor is a valuable tool which can be
programmed to wirelessly report its temperature, enabling customers to view both
the asset's location and its temperature from the Web-based MobileView
interface. In addition, customers can enable automated temperature-based alerts.
For example, a refrigerated trailer in a shipping yard can trigger an alert to
the yard manager's pager, if the internal temperature in the trailer is too high
and threatens spoilage. Advanced call button functionality enables the tag's
call button to be used for multiple business purposes simultaneously. Customers
can configure different patterns, such as multiple clicks or long-versus-short
clicks, to represent different assets statuses or alerts. Electromagnetic
compatibility certification ensures that the T2 tag is safe for use within
environments with other critical electronic devices, such as hospitals. This
certification ,
IEC
60601-1-2,
is recognized by the FDA in the United States, as well as all EU nations and
several other countries worldwide. Optional intrinsically safe tags ensure
safety for customers in explosion-prone environments such as mining and oil
refineries. The Intrinsically Safe T2 Tag follows the same dimensions as the
standard tag, and is available with or without the call button. Expanded LED
functionality adds the option for up to three different colored LED lights on
the tag when unique visual identification is needed for large inventory
settings. Optional extended battery life configuration enables to extend tag
battery life for up to 8 years. The T2 tags are a key component of the AeroScout
Visibility System, a complete suite of products utilizing Wi-Fi standards for
asset visibility and process improvement. The system can employ existing
wireless access points to act as Active RFID readers, without needing additional
networking equipment or disrupting voice and data communications.
Study: 4-Drug AIDS cocktail no advantage
Abbott expands its AIDS program; 45 countries to get drug at lower price
GOJO hand cleaners EcoLogo and Green Seal certified
Kelsey-Seybold Clinic chooses MedAsets Supply Chain Systems for Pharmacy Purchasing Solutions
Aethon redefines hospital asset tracking with HOMER
Study: 4-Drug AIDS cocktail no advantage
A four-drug cocktail isn't any better for treating newly diagnosed HIV infection than the standard three-drug regimen, according to a study that followed 765 patients for three years. The finding is welcome news to patient advocates, despite the lack of a step forward in treatment. Adding a fourth drug would have raised costs in an already overburdened system in which some states report waiting lists of uninsured patients who need help paying for their HIV drugs. The annual cost per person for antiretroviral drug therapy in 2001 was about $11,000 a year, according to a previous study. Murray Penner of the National Alliance of State and Territorial AIDS Directors estimated that adding more drugs to already complex regimens could cost health systems millions of dollars more. Adding a drug to the cocktail also could increase side effects and the potential for dangerous drug interactions, said Jim Pickett of the AIDS Foundation of Chicago. The new study clears up a ling ering question posed by the conflicting results of prior studies. Some smaller studies had found a quicker effect at beating back the virus when more drugs were added to the cocktail, while others found no added benefit. "Triple drug therapy has been the standard approach to treatment of HIV infection for a decade or so, but there's always been a question about whether we could do better with more drugs," said study co-author Dr. Dan Kuritzkes of Harvard's Brigham and Women's Hospital. "This reaffirms the potency of the current standard of care," Kuritzkes said. Researchers made the two drug cocktails equally easy for patients to take, delivering both in five pills taken daily. Patients and their doctors didn't know which cocktail they were getting. The study will appear in Wednesday's Journal of the American Medical Association and was released Sunday to coincide with the opening of the 16th International AIDS Conference. Researchers found that the four-drug cocktail, which a dded the HIV drug abacavir, had no advantage in reducing the amount of virus in patients' blood. Compared with standard therapy, it also didn't increase levels of CD4 cells that fight infection. "Over the entire course of the study, at no point did there seem to be an advantage of the four-drug regimen," Kuritzkes said. Supported by grants from the National Institutes of Health, the research was conducted at more than 40 U.S. sites. Several pharmaceutical companies provided drugs. Some of the researchers, including Kuritzkes, reported financial ties with the makers of HIV drugs. More than half the patients in the study were black or Hispanic and almost 20 percent were female. "It was a pretty diverse population that reflects the epidemic today," Kuritzkes said. Black patients who took the drugs as directed did as well as white patients, but blacks who did not adhere precisely to the drug routine returned to high virus levels quicker than whites who didn't take the drugs as prescr ib ed. The reason for the difference wasn't clear, Kuritzkes said. For more on the International AIDS Conference CLICK HERE. (The Associated Press)
Abbott expands its AIDS program; 45 countries to get drug at lower price
Under criticism for pricing of its AIDS drugs, Abbott Laboratories has added 45 countries to its preferential pricing program, reaching beyond just the poorest of nations in the world to the "low- to low-middle income." The Chicago-based drug giant already makes its blockbuster AIDS pill Kaletra available for $500 per patient per year in 69 of the poorest countries, including all of Africa. In the United States, Kaletra costs more than $7,500 a year per patient. In expanding the program Abbott said it would add countries considered "low income," such as India, Vietnam and Pakistan, as well as "lower middle income" economies, including China, Syria, Jordan and several countries in South America and Asia. These additional 45 countries will pay $2,200 a year per patient, reduced from the $3,300 or $5,000 a year they had been paying, an Abbott spokeswoman said. (Chicago Tribune)
GOJO hand cleaners EcoLogo and Green Seal certified
GOJO is proud to be the first to provide a family of environmentally preferable
products that meet the new EcoLogo (Environmental Choice) and Green Seal
certifications (CCD-104/GS-41) for Hand Cleaners and Hand Soaps. The family of
products, which will be available in early Fall 2006, includes GOJO’s Green
Certified Foam Hand Cleaner and Green Certified Lotion Hand Cleaner. Once a
manufacturer attains certification from one of these organizations, the company
may place the widely recognized EcoLogo and/or Green Seal logo on the product.
This helps buyers, both consumer and corporate, select sustainable products that
help protect the environment. EcoLogo categorizes hand cleaners as “those
products designed to remove both organic and inorganic soil from skin”. They
usually fall into two specific categories: industrial and institutional.
Industrial hand cleaners are usually found in such places as auto manufacturing
and repair facilities, factories, print shops, and similar industrial settings.
Institutional hand cleaners are most often found in the public washrooms of
airports, restaurants, retail stores, educational facilities, and office
buildings. “Hand soaps and similar cleaners can negatively impact indoor air
quality and often contain ingredients that irritate the skin and eyes,” said
Scott McDougall, President of EcoLogo. “And when the active ingredients in these
products are washed down drains, they have the potential to harm waterways and
aquatic ecosystems. We commend GOJO on their products and ongoing efforts to
help protect our environment.”
In order to attain EcoLogo’s CCD-104 certification for hand cleaners, the
manufacturer must
demonstrate
environmental leadership throughout the product’s life cycle. Additionally,
they
must
meet requirements such as: Perform as well as or better than conventional hand
cleaners; Have limited toxicity, helping protect waterways, aquatic life, and
other organisms; Are biodegradable, producing minimal waste; Have eliminated or
reduced ingredients considered likely to negatively impact h ealth a nd th e
environment; Are derived from sustainable sources. For more information, contact
EcoLogo toll-free at 1-800-478-0399 or visit
www.ecologo.org.
Kelsey-Seybold Clinic chooses MedAsets Supply Chain Systems for Pharmacy Purchasing Solutions
MedAssets announced that Kelsey-Seybold Clinic, based in Houston, TX, has selected MedAssets Supply Chain Systems to implement supply chain solutions for pharmacy. The multi-year relationship was effective February 2006. Kelsey-Seybold Clinic was previously affiliated with Premier for pharmacy purchasing services. Through the agreement, Kelsey-Seybold Clinic will be utilizing MedAssets’ contract portfolio and CDQuick on-line catalog. Access to the MedAssets’ contracts and supply chain technology will provide cost savings and improved operational efficiencies for the organization’s 18 clinics and ambulatory surgery center. Kelsey-Seybold Clinic will be taking part in MedAssets’ Clinical Pharmacy Consulting Program which includes the Pharmacy Audit tool, a disease state management program which supports Kelsey-Seybold’s own physician-drive n programs via clinical information; a comprehensive professional educational program; and other decision support tools.
Aethon redefines hospital asset tracking with HOMER
At AHRMM's Annual Conference & Exhibition - August 13, 2006, in Orlando, FL, Aethon Inc., a provider of practical robotics, introduced HOMER, an asset management solution designed to locate and recover hospital equipment. HOMER, a fast growing Radio Frequency Identification (RFID)-based asset tracking system, also allows hospitals to avoid major infrastructure investments. In the fast-paced hospital environment, equipment is constantly moving and often hard to find. By tracking the location of assets, hospitals can improve staff efficiency and satisfaction, increase asset utilization, decrease equipment rentals, and improve regulatory compliance. "HOMER increases confidence that equipment will be in the right place at the right time," said Aldo Zini, Chief Executive Officer, Aethon. "It is a complete solution, which improves workflow dynamics in hospitals, because it's the only asset tracking system capable of automated transportation." HOMER's unique asset tracking capabilities are an outgrowth of technology made possible by TUGTM, a robotic hospital delivery system. Leveraging the TUG platform and employing a single mobile antenna eliminates the typical infrastructure hurdles of competitors' systems. This translates into more efficient organization and location of pumps, wheelchairs, monitors, respirators, beds and virtually any other assets hospitals are interested in tracking. A cost-effective and nimble solution, HOMER can seamlessly merge with existing hospital systems and requires minimal installation. HOMER works with active RFID tags (unique identifiers). Because it can use any third-party tag, HOMER is tag independent. Furthermore, HOMER can be integrated into existing asset management software. Aethon provides installation, tag selection and setup, software integration, training and support.
GlaxoSmithKline settles claim of inflating prices on cancer drugs
FDA statement on JAMA article on recalls and safety alerts affecting AEDs
FDA warns three pharmacies to stop mass-producing unapproved inhalation drugs
Study finds that a type of cancer in dogs is contagious
Battling breast cancer with The Pink Glove
GlaxoSmithKline settles claim of inflating prices on cancer drugs
GlaxoSmithKline Inc. has agreed to pay more than $41 million in restitution to end claims by more than 40 states that it inflated the prices of drugs used by cancer patients and others. The settlement announced Thursday with the U.S. Justice Department, National Association of Medicaid Fraud Control Units and New York Attorney General Eliot Spitzer will include more than $1.5 million in restitution to New York state's Medicaid program for cancer drugs and $940,000 in connection with pricing of an antibiotic, Spitzer said. With some state lawsuits still pending on behalf of consumers and government health plans, the company expects eventually to pay a total of $70 million, said Mary Anne Rhyne, spokeswoman for the British company. They include civil actions by the attorneys general of New York, California, Connecticut, Nevada, Montana and Arizona. The cost will be covered by the company's existing legal reserve, she said. She said testimony showed states and health plans chose to use the company’s drugs at the set prices “although it has been widely known for years that (average wholesale price) exceeds the prices actually paid by physicians, pharmacies and others,” according to the company's prepared statement. “Nevertheless, GSK has agreed to settle the cases, without admitting wrongdoing, to put this historical matter behind it,” the company stated. Connecticut Attorney General Richard Bluementhal called it a “brazen scheme.” “The fraud is especially shameful because the company sought to increase sales by manipulating prices instead of competing honestly,” he said. In a separate settlement of a private class action lawsuit, the drug company will also fund a $40 million restitution fund for the poor and needy who use the Medicaid health care system nationwide and New York's Elderly Pharmaceutical Insurance Coverage plan, Spitzer said. That suit was settled in federal court in Boston. “Our lawsuit helped stop a long-standing practice that inflated the cost of drugs for people suffering from cancer and cheated the Medicaid system” Spitzer said. “Today's settlement provides significant restitution for consumers and the Medicaid program.” Spitzer had accused the company of inflating average wholesale prices of drugs in the class “anti-emetics” that help patients overcome the nausea and other effects of chemotherapy to fight cancer. In turn, health plans and consumers overpaid and government health plans reimbursed drug stores and physicians based on the inflated prices. People on Medicare, the health plan for the elderly, also overpaid because they allegedly paid a percentage of the inflated prices, Spitzer said. An inflated average wholesale price also allowed the company to market the drugs to health care providers as coming with a “spread” between the wholesale price and actual price that could be pocketed by doctors and others to choose the GlaxoSmithKline product, Spitzer said. The company also paid the New York Attorney General's Office $750,000 for the cost of the investigation. (Associated Press, Newsday Inc.)
Automatic external defibrillators (AEDs) are important medical devices. Numerous
studies have shown that thousands of lives are saved each year using these
devices to treat patients in sudden cardiac arrest. In the past decade, these
devices have become simpler to use and have been placed in more public places
like airports and schools. A recent article in the Journal of American Medical
Association (JAMA) titled Recalls and Safety Alerts Affecting Automated External
Defibrillators helps inform the public about the safety of AEDs. FDA supports
the kind of research and most of the conclusions reached in the JAMA article are
consistent with FDA's own findings. However, there are a few points on which the
agency differs. First, the authors assert that manufacturers are unable to track
AED units, making it impossible to know how many AED units were actually fixed
or taken out of service. However, under FDA regulations, manufacturers are
required to track AEDs and are doing so with processes in place to identify the
location of a device in the event of a recall. Our records show that these
devices are being tracked with a high level of accuracy. In fact, more than 95
percent of the AEDs affected by Class I recalls in 2005 were returned to the
manufacturers or taken out of service. Fewer than three percent were lost or
stolen. Second, the authors state that there has been an increase in the number
of AEDs affected by advisories during the study period. This is true, however,
FDA believes that improvements in the devices' ability to self-diagnose hardware
and software problems may contribute to this trend. This capability may result
in users reporting problems before a device is ever used on a patient. Also,
while more than 21 percent of AEDs were affected by an advisory, it does not
necessarily mean that they malfunctioned. A device advisory is issued when a
medical device has the potential
to exhibit a certain failure mode, not only when a device has, in fact, failed.
We continue to depend on our ability to work with owners of AEDs when these
devices are subject to a recall and have taken steps in recent months to improve
our communication and collaboration with the broader community. AED users should
continue to report device malfunctions to the manufacturer and to FDA. In
addition, users should heed device error messages and warnings during regular
device self-checks and respond appropriately to recall notices and safety
alerts. For more information, visit
www.fda.gov.
The Food and Drug Administration (FDA) has warned three firms, RoTech Healthcare, Inc., CCS Medical, and Reliant Pharmacy Services, to stop manufacturing and distributing thousands of doses of compounded, unapproved inhalation drugs nation-wide. Responsible officials at firms that do not properly address violations identified in FDA warning letters risk further enforcement, including injunctions that prevent further violations and seizure of their products that violate the law. The three firms warned by FDA say that they produce inhalation drugs as part of the practice of pharmacy compounding. Traditional pharmacy compounding typically involves pharmacies preparing drugs that are not commercially available, such as a unique medicine for a patient who is allergic to an ingredient in a FDA-approved drug. This kind of compounding follows a physician's decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs. FDA normally permits traditional pharmacy compounding and the agency's action is not targeting this practice. Inhalation drugs are used to treat diseases including asthma, emphysema, bronchitis, and cystic fibrosis. Compounded inhalation drugs may be distributed to patients in multiple states, and patients and their doctors may not know that they are receiving compounded products. FDA urges consumers using inhalation drugs to discuss their medications with their physicians and verify with their pharmacists that the medications they received are what their physicians ordered. “Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness, often are not produced according to good drug manufacturing practice, and typically are not sterile. This may expose patients to unnecessary risk,” said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. “To avoid these risks, we encourage patients to use FDA-approved drugs whenever possible.” FDA believes that, in compounding mass amounts of inhalation drugs, a number of pharmacies go well beyond traditional compounding. FDA is aware of certain pharmacies compounding millions of doses of inhalation drugs per year. These compounded drugs often simply copy FDA-approved, commercially available drugs, and any differences from FDA-approved drugs do not appear to be related to patients' medical needs. Consumers and health care professionals should notify FDA of any complaints or problems associated with compounded drugs. These reports may be made to MedWatch, FDA's voluntary reporting program, by phone at 1-800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.
Study finds that a type of cancer in dogs is contagious
Scientists in England have gathered definitive evidence that a kind of cancer in dogs is contagious, a peculiar exception to the age-old medical wisdom that you can't “catch” cancer. Although no human cancer is known to spread naturally from person to person, the finding of such a disease in dogs, and emerging evidence that a different contagious cancer is spreading among marsupials in Tasmania, is a reminder, scientists said, that under the rules of evolution, DNA will try anything to perpetuate itself. Cancer-causing viruses may spread from person to person, but the cancer does not. But the dog cancer, known as Sticker's sarcoma, is spread by tumor cells getting passed from dog to dog through sex or from animals biting or licking each other. Because Sticker's sarcoma is usually not fatal, and because some of the tumor cells reside in the dogs' genital tracts, today's worldwide distribution of Sticker's tumors represents a single colony of cancer cells, the new research concludes. Indeed, scientists suspect that the colony, distributed among countless dogs, may be the longest in the world. Scientists have suspected for decades that Sticker’s was being passed directly from dog to dog, but doubts persisted because no other naturally transmitted cancers were known. Rarely, recipients of human organ transplants have “caught” cancer from tumor cells hiding in the organs they received. Weiss and his colleagues did genetic studies on the tumor cells from 40 dogs with Sticker's sarcoma, collected from five continents. The researchers showed that the cells are not genetically related to the dogs they are in, proof that they did not arise from the dogs’ own cells. Further genetic studies by Weiss's team suggested that the parent cell probably arose in a domesticated dog of Asian origin, perhaps a husky, hundreds of years ago, and perhaps more than 1,000 years ago. Since then, the cancer has perpetuated itself by jumping from one dog to another. For the whole story CLICK HERE (The Washington Post)
International spa products distributor Universal Companies has joined hands with Intrinsics single-use essentials, and ERGO styling tools to fight breast cancer with The Pink Glove project. Available beginning in September, $5.50 from the sale of each box of pink vinyl gloves will be donated to City of Hope, a leading Southern California biomedical research and treatment center and hospital for cancer and other life-threatening diseases. “We are very hopeful that people will want to partner with us in this effort to increase funding to battle breast cancer,” said Universal Founder and CEO Marti Morenings. “All of us have been touched either personally or by a friend or loved one suffering from breast cancer. City of Hope is doing amazing research on fighting breast cancer, and we’re privileged to be a part of that work.” When spas, salons, and healthcare providers purchase and use the pink vinyl gloves while performing services, they are not only donating to City of Hope, but also demonstrating their support and building awareness of breast cancer research, treatment, and education among their clients. The Pink Glove is lightly powdered and available in small and medium sizes. A box of 100 latex-free gloves may be purchased for $9.99. To order, please visit http://www.thepinkglove.com/.
FDA seeking comments on use of Identifier System for medical
devices
Reaction mixed to latest round of CMS Regs
Bird flu monitoring expands nationally
Genetic test aids lung cancer fight
High-dose statins following a stroke can prevent a second
SCCM to host new conference on quality and safety; pre-course to highlight rapid response teams
U.K.-based Radal Technology introduces risk management products to the U.S.
FDA seeking comments on use of Identifier System for medical devices
The Food and Drug Administration (FDA) is seeking information for the next 90 days, on how the use of a unique identifier system for medical devices may reduce medical errors, facilitate device recalls and improve medical device adverse event reporting. The comments will be used to help the agency determine what next steps the agency should take related to a unique device identifier (UDI) system for medical devices. "Much like the bar code rule for drugs and biological products, unique identifiers for medical devices could have many potential benefits for improving the quality of care for patients," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA. "A unique device identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting and encouraging cost effectiveness by improving delivery and supply chain efficiency." The number and complexity of medical devices is growing. It is important for FDA to quickly identify new risks and work with industry and device users to manage these risks appropriately. A UDI system may be used to identify a device and the information associated with that device throughout its lifetime. For example, a UDI could identify which devices are compatible, such as implanted devices being used safely with magnetic resonance imaging (MRI) systems.FDA also commissioned two reports from outside experts on automatic and unique identification of medical devices. The reports identified several potential benefits of a UDI system, including identifying incompatibility with devices or potential allergic reactions. In addition, FDA has been working with the Agency for Healthcare Research and Quality (AHRQ) in the U.S. Department of Health and Human Services (HHS) and with other federal partners to better understand the issues with the development, implementation and use of a UDI system. During the comment period, FDA wants to learn about the feasibility, utility, benefits and costs associated with developing and implementing a UDI system for medical devices. In addition, the agency wants to hear about various automatic identification technologies, such as bar code and radiofrequency, which could be used with a UDI system. A list of questions as well as what a UDI could look like, are included in the Federal Register notice. To submit electronic comments, visit www.fda.gov/dockets/ecomments. For more information, visit www.fda.gov/cdrh/ocd/udi/index.html.
Reaction mixed to latest round of CMS Regs
Critics of doctor-owned specialty hospitals reacted favorably to aspects of a plan issued late Tuesday by the Medicare program to tighten oversight of the facilities, but they stuck to their view that the facilities should be banned. The plan “is important,” said Senate Finance Chairman Charles E. Grassley, R-Iowa, but “these steps alone won’t unravel the web of conflicts that have been created by these limited-service hospitals, which cherry-pick patients based on dollars rather than diagnosis and put the well-being of both individual patients and the health care delivery system at risk.” Doctor-owned specialty hospitals limit themselves to certain procedures — cardiovascular surgery, for example — that according to critics are highly lucrative and siphon off patients from traditional hospitals they need to be able to offer services with low or no profit margins. Similarly, the American Hospital Association, which depicts doctor-owned specialty hospitals as a threat to the survival of the traditional hospital, praised the plan’s requirement that physician-owners disclose to patients their financial interest in the facilities. “Patients have a right to know whether a conflict of interest may affect their care,” said Thomas Nickels, AHA senior vice president. Nickels also praised the Centers for Medicare and Medicaid Services plan for requiring the facilities to disclose what percentage each physician-investor owns and how much he or she is being paid. In cases where the percentage of profits received by a physician exceeds the percentage representing his or her ownership stake, CMS could prosecute the specialty hospital for violating laws barring kickbacks for referrals. But “given the growing evidence that financial interest may be overtaking patient interest, the AHA continues to believe physician self-referral to limited-service hospitals they own should be banned,” he said. Grassley and top Finance Committee Democrat Max Baucus of Montana had urged CMS to delay issuance of the regulatory plan, citing flaws in a survey on which the plan was based. Delaying the plan would have extended a CMS administrative moratorium on enrolling new doctor-owned specialty hospitals as Medicare providers. But CMS Administrator Mark B. McClellan defended the survey in a letter Tuesday to the two senators, blaming problems in the survey in part on a low response rate by hospitals. CMS declined to extend the moratorium. (CQ Healthbeat)
Monitoring of wild migratory birds to prevent a deadly
bird flu
virus is expanding
to cover the entire nation and U.S. territories in the Pacific. The stepped-up
testing will be done by scientists in the lower 48 states, Hawaii and other
Pacific islands. They will begin keeping an eye out for the deadly H5N1 strain
of the avian flu that has killed more than 100 people, mostly in Asia. In
Alaska, where the first migratory birds began arriving, monitoring started just
before summer. “This move to test thousands more wild birds throughout the
country will help us to quickly identify, respond and control the virus if it
arrives in the United States,” Agriculture Secretary Mike Johanns said. “Because
we cannot control wild birds, our best protection is an early warning system.”
Interior Secretary Dirk Kempthorne said more coordinated monitoring by federal
agencies, states and universities “will be important this fall as birds now
nesting in Alaska and Canada begin their migration south through the continental
United States.” The Agriculture and Interior departments are providing $4
million to state agencies to collect samples from specific species of migratory
birds winging along four major U.S. migratory bird flyways. Congress budgeted
$29 million for monitoring for the highly pathogenic strain of bird flu. Feces
or tissue samples from 75,000 to 100,000 wild birds will be collected, along
with 50,000 samples of the water and ground that birds come into contact with.
Locations where the samples will be collected will vary depending on weather and
habitat conditions. Likely sites include national and state wildlife refuges and
parks, city ponds and parks, and private lands where owners have given approval.
(The Associated Press)
Genetic test aids lung cancer fight
Scientists have developed a powerful new genetic test to determine which lung cancer patients should get chemotherapy, saying the advance could save thousands of lives every year and heralds the growing importance of genetic profiling in cancer care. Patients whose lung cancer is caught at the earliest stage typically do not get chemotherapy, because the benefits outweigh the toxic side effects of the drugs only for a subset of patients likely to suffer a recurrence. The new test allows doctors for the first time to identify which patients are at greatest risk for a recurrence, an almost certain death sentence, and then give them chemotherapy. The results, described in the New England Journal of Medicine, are so promising that researchers are launching a broad, government-funded clinical trial of the test within the next six months, including some 1,200 patients at about 60 sites in the United States and Canada. Using new genetic tools, doctors are learning how to measure the characteristics of a particular patient’s tumor and use this information to mount a more effective counterattack. This “personalized medicine” is already saving lives of patients with breast cancer and leukemia, and the list of diseases is now expected to grow. Similar tests are being developed for colon, prostate, and other cancers. One of the great frustrations of cancer medicine is that tumors that look the same do not always act the same, leaving doctors unsure how to treat patients. Now, scientists are learning to distinguish cancers by the genetic machinery at work in the tumors. Some tumors may have distinctive mutations in their DNA. Tumors may also have telltale patterns of genes that are active. At any given moment, some genes in a tumor are turned on, making proteins, and others are turned off. Identifying the “on” genes is known as measuring “gene expression,” and this is the method used in the lung cancer study, which was led by scientists at Duke University. The scientists at Duke identified patterns of active genes typical of more lethal tumors. The work could provide pharmaceutical companies clues that will help develop drugs and help scientists understand the disease's inner workings, according to Tyler Jacks, a lung cancer researcher who is also director of the MIT Center for Cancer Research. The test could also have broad clinical applications, according to Dr. Anil Potti, who led the study and is an assistant professor at Duke. Initially, it will be used to identify patients with stage 1 non-small cell lung cancer, a common form of the disease, who would benefit from chemotherapy. The team also hopes to identify patients with later stages of the disease who are unlikely to benefit from chemotherapy, saving them the rigors of the drugs. And, Potti said, the team has early data that suggest the same genetic tools can identify which chemotherapy drug will work best on which patient's tumors. This could also have applications in the treatment of breast cancer, where doctors use some of the same chemotherapy drugs, he said. Between 40,000 and 45,000 patients are diagnosed with stage 1 non-small cell lung cancer every year in North America, Potti said. Typically, a surgeon will remove the tumor, but the patient is not given chemotherapy. Between 40 percent and 50 percent of patients will have a recurrence, and virtually all of these patients die. Preventing even some of these deaths would mean thousands of lives saved every year, Potti said. (Boston Globe)
High-dose statins following a stroke can prevent a second
Loading up on a statin
within six months of a stroke or transient ischemic attack reduced the risk of
recurrent stroke or TIA, according to results of a major trial. Lipitor (atorvastatin)
at 80 mg/day begun during that period was associated with 2.2% five-year
absolute reduction in risk of stroke and a 16% relative reduction in risk of
fatal or nonfatal stroke, found the SPARCL (Stroke Prevention by Aggressive
Reduction in Cholesterol Levels) trial, reported K. Michael Welch, M.B., Ch.B.,
of Rosalind Franklin University of Medicine and Science, and colleagues, in the
Aug. 10 issue of the New England Journal of Medicine. It's not news that
patients with established cardiovascular disease are less likely to have a
stroke if they are taking statins, but Dr. Welch and colleagues wrote that it
was unknown whether statins could reduce stroke risk in the absence of
established heart disease. SPARCL, they contend, answered that lingering
question. In an accompanying editorial, David M. Kent, M.D., of the Institute
for Clinical Research and Health Policy Studies at Tufts-New England Medical
Center in Boston wrote that the case for a change in recommendations is not so
clear cut. He pointed out that “the relative risk of hemorrhagic stroke was
increased by 66% among patients in the [Lipitor arm], an effect that is likely
to be of some import among patients presenting with a hemorrhagic stroke.”
Although Dr. Kent was not persuaded that high dose Lipitor should be recommended
for all stroke or TIA survivors, he predicted that the SPARCL trial results are
likely to add to the “gathering momentum favoring the promotion of ischemic
stroke to a ‘coronary heart disease risk equivalent,’ the adoption of statin
therapy on discharge as a ‘quality indicator,’ and the inclusion of statins in
preprinted stroke orders to improve adherence by physicians.” The SPARCL trial
was supported by Pfizer, maker of Lipitor. Dr. Welch reported having received
consulting fees from Eisai, GlaxoSmithKline, Medpointe, AstraZeneca, NMT
Medical, and Ortho-McNeil; lecture fees from GlaxoSmithKline; and grant support
from Pfizer. Dr. Kent reported having received grant support from Pfizer. (MedPage
Today)
SCCM to host new conference on quality and safety; pre-course
to highlight rapid response teams
Initiating a rapid response team (RRT) in the hospital setting can decrease
patient deaths, according to the Institute for Healthcare Improvement’s 100,000
Lives Campaign. Hospitals that participated in the Campaign implemented up to
six evidence-based and lifesaving interventions, including initiating an RRT, to
prevent an estimated 122,300 avoidable deaths. The Society of Critical Care
Medicine (SCCM) is a Scientific Partner to the Campaign and recognizes the
importance of RRTs in the hospital setting. As a result, SCCM developed the
Rapid Response System Training for First Responders course, to be held on
September 21, 2006, in Baltimore, MD. The Rapid Response System Training for
First Responders course will offer an international perspective on how to train
team members while affording smaller group discussions to analyze real-world
case studies. Participants will receive the paper, “Findings of the First
Consensus Conference on Medical Emergency Teams,” by Michael A. DeVita, MD, from
the University of Pittsburgh. This paper addresses questions regarding benefit,
design elements, and advisability of implementing an RRT system. The paper will
be published in the September issue of Critical Care Medicine. Rapid
Response System Training for First Responders is a pre-course to SCCM’s new
conference Excellence in Quality and Safety in Critical Care, to be held
September 22 and 23, 2006, in Baltimore, MD. Clinical shortages, coupled with
diminishing resources and rising medical costs, are straining healthcare
organizations as well as personnel. This multifaceted dilemma can impede the
practitioners’ ability to deliver high-quality patient care. To assist
healthcare professionals, SCCM developed the progressive conference,
Excellence in Quality and Safety in Critical Care. The conference will
address administrative and clinical problem areas to identify everyday solutions
that critical care professionals can use in their practices. For more
information, CLICK HERE.
U.K.-based Radal Technology introduces risk management products to the U.S.
Radal Technology Limited, a U.K.- based company specializing in the design,
manufacture and distribution of risk management products, announced its
expansion into the North American market. Radal Technology provides sensor
technology specifically aimed at reducing facility risks associated with
cigarette smoking, slip-and-fall accidents and hygiene. The company’s speech
messaging unit can be programmed to verbally alert occupants of wet or slippery
floors or remind employees to wash their hands, for example. For more
information CLICK HERE.
ARAMARK announces signing of merger agreement
CMS
announces payment revisions
Appropriateness criteria issued for cardiac computed tomography,
cardiac magnetic resonance imaging
Doubt is raised on defibrillators;
Devices do save lives
but can sometimes fail
Number of uninsured children declines as
enrollees
in state health insurance programs increase
ARAMARK announces signing of merger agreement
ARAMARK Corporation announced Tuesday, that it has signed a definitive merger agreement under which Joseph Neubauer and investment funds managed by GS Capital Partners, CCMP Capital Advisors and J.P. Morgan Partners, Thomas H. Lee Partners and Warburg Pincus LLC will acquire ARAMARK in a transaction valued at approximately $8.3 billion, including the assumption or repayment of approximately $2.0 billion of debt. ARAMARK is a leader in professional services, providing food services, facilities management, and uniform and career apparel to health care institutions, universities and school districts, stadiums and arenas, and businesses around the world. The Board of Directors of ARAMARK, on the unanimous recommendation of a special committee comprised entirely of independent directors, has approved the agreement and will recommend that ARAMARK’s stockholders approve the merger. The transaction is expected to be completed by late 2006 or early 2007, subject to receipt of stockholder approval and regulatory approvals, as well as satisfaction of other customary closing conditions. Joseph Neubauer, ARAMARK Chairman and Chief Executive Officer, said, “We are proud to partner with this distinguished group of private equity firms, all of which have outstanding reputations and proven records of success. They are committed to working with us in building long-term solutions that deliver the most value for our clients and customers. They understand our business, share our mindset, and will be strong partners moving forward.” www.aramark.com
CMS announces payment revisions
Centers for Medicare and Medicaid Services has released proposed major payment revisions for physician, hospital outpatient, imaging, specialty hospital and ambulatory surgery center services. Among the surprises: a proposal for quality measures for hospital outpatient care that would lessen payment increases next year if data on quality isn’t reported. Under a proposed regulation for Medicare physician payments in 2007, doctors are scheduled to take a 5.1 percent cut on Jan. 1, rather than the original CMS estimate of 4.6 percent. The higher-than-expected payment cut to physicians means that the cost of legislation to block that reduction, widely expected at the end of this year, will be more than $1 billion more expensive than expected. That puts other types of providers in line to see cuts to come up with that extra money. CMS Administrator Mark B. McClellan emphasized new coverage of preventive services in the payment rule. For example, the proposal would implement a statutory requirement that Medicare’s colorectal screening benefit is no longer subject to the Part B deductible in Medicare. McClellan also highlighted the fact that doctors would receive payment incentives to spend more time with their patients. The proposed rule would continue to impose a 25 percent reduction in payment for preparing additional medical images of contiguous body parts. CMS said last year that it would slice payments by half in 2007, not 25 percent, for the added images, but the latest proposal retreats on that prediction. The proposed rule also would implement a statutory requirement that payments for certain types of medical imaging in the doctor’s office be capped at the same amount paid to hospital outpatient departments. By applying those caps after making the reductions for multiple images, imaging payments will be higher, McClellan said.
McClellan said that
because of fast-rising spending on hospital outpatient care, the status quo must
not continue. “Doing nothing is not sustainable from the standpoint of Medicare
costs and beneficiary premiums, and we want public input on the best approaches
to promoting high-quality, affordable care,” he said. Citing what he called
Medicare’s “equitable adjustment authority,” McClellan said the proposal would
require hospitals to report data on quality performance measures starting in
2007. If hospitals next year failed to report the inpatient quality-of-care data
necessary to receive a full payment increase, the update they receive for
outpatient care would be two percentage points lower, CMS said. Thus instead of
receiving an increase next year of about three percent for outpatient care,
facilities would get an increase of about one percent. CMS said that pending the
development of quality measures specific to outpatient care, something CMS plans
to do, it’s fair to tie payments to reporting of data on inpatient measures
because they cover many of the same activities as in outpatient care. The
outpatient rule also expands the set of quality measures on which hospitals must
report data to receive a full payment update for inpatient care in fiscal 2008.
Added measures assess the satisfaction of patients with the care they get at a
facility, post-surgical complications, and death rates at a facility for heart
attack, heart failure and pneumonia patients within 30 days of receiving
treatment.
CMS also is proposing a new payment system for ambulatory surgery centers that
would take effect in 2008. CMS said the proposed rule would “allow payment to an
ASC for any surgical procedure that does not pose a significant safety risk,
greatly expanding the list of surgical procedures for which Medicare pays an ASC
facility fee.” But payments to the surgery centers would be tied for the first
time to the “Ambulatory Payment Classifications” (APCs) used for payment of
hospital outpatient departments. The proposal calls for ambulatory surgery
centers to receive 62 percent of the APC level, a relatively low percentage,
analysts said. McClellan also announced the release of a regulatory plan for
doctor-owned specialty hospitals. Release of the plan effectively lifts a CMS
administrative moratorium on the enrollment of new specialty hospitals as
Medicare providers. But CMS will require facilities to disclose the percentage
that individual doctors own of a facility and the terms of their compensation.
Specialty hospitals also will be required to inform patients before they receive
care that staff physicians have an investment interest in the hospital.
Hospitals may be found in violation of anti-kickback regulations if the
compensation of doctors is out of proportion to the percentage of the facility
they own. And hospitals that fail to report physician investment and
compensation arrangements will face fines of up to $10,000 a day. That
enforcement effort will begin with specialty hospitals that did not fully
respond to a recent CMS survey to determine their investment and compensation
arrangements. The hospitals that responded reported compensation proportional to
investment percentages, but 53 percent of the specialty hospitals polled did not
provide the requested data. CMS noted that traditional hospitals have complained
that specialty hospitals can better coordinate the delivery of care with staff
doctors because of the opportunity for physician ownership. To “level the
playing field,” CMS said it will do a pilot test easing hospital-doctor
collaboration on more efficient care, including a “gain-sharing” demonstration
in which traditional hospitals can share profits with doctors from increased
efficiency. (Congressional Quarterly)
The American College of Cardiology Foundation (ACCF) along with key specialty and subspecialty societies have released Appropriateness Criteria for two relatively new clinical cardiac imaging modalities, cardiac computed tomography (CCT) and cardiac magnetic resonance imaging (CMR). These Criteria were developed in order to address the growth in biomedical imaging to ensure that it is appropriate to patient needs. “In response to the need for guidance in ordering and performing advance cardiac imaging procedures, such as CT and CMR, the ACCF has focused a great deal of resources in helping to determine if it is ‘reasonable’ or appropriate to perform a test for a specific indication. We aim to assist patients, clinicians, and payers when determining how best to use cardiac tests and procedures. It is now widely apparent that these imaging studies should be used only when the information provided will have a direct impact on patient care, as medical imaging has undergone tremendous growth in recent years,” said Robert Hendel, M.D., F.A.C.C., chair of the writing group for the Appropriateness Criteria for CCT and CMR. “It is also our hope that the criteria will generate discussion between physicians and payers regarding reimbursement,” added Dr. Hendel. An appropriate imaging study is defined as one in which the expected incremental information combined with clinical judgment, exceeds the expected negative consequences by a sufficiently wide margin for a specific indication that the procedure is generally considered acceptable care and a reasonable approach for the indication. Negative consequences include the risks of the procedure (i.e., radiation or contrast exposure) and the downstream impact of poor test performance such as the delay in diagnosis (false negatives) or inappropriate diagnosis (false positives). The 39 CCT and 33 CMR indications rated by a technical panel of experts encompassed the majority of clinical scenarios referred for CCT and CMR, respectively. These appropriateness reviews assessed the risks and benefits of the imaging tests for several indications or clinical scenarios and scored them based on a scale of 1-9, where the upper range (7-9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1-3) implies that the test is generally not acceptable and is not a reasonable approach. The mid range (4-6) indicates an uncertain clinical scenario. “We recommend that cardiovascular professionals use the CCT and CMR Appropriateness Criteria to avoid ordering tests deemed inappropriate in the clinical setting unless there are very unusual circumstances. In addition, clinical scenarios rated uncertain require more research before we understand whether a given test is appropriate or inappropriate for that particular scenario,” said Michael Poon, M.D., F.A.C.C., a member of the writing group for the Appropriateness Criteria for CCT and CMR. www.acc.org.
A
review of safety data raises questions about the reliability of the automated
external defibrillators (AEDs) that hang on the walls of airports, shopping
malls and health clubs. Harvard Medical School researchers found that over the
past decade, 1 in 5 automated external defibrillators were recalled because of
the potential for malfunction, and devices that failed were associated with 370
deaths. Nonetheless, the devices have saved tens of thousands of lives, and the
benefits outweigh the risk of malfunctions, said study author Dr. William Maisel.
“The number of malfunctions may be alarming to some, but you have to take it in
the context of the large number of patients saved by these devices,” he said. He
said the study, the first comprehensive look at safety data on the devices,
underscores the importance of properly maintaining the defibrillators. The study
appears in Wednesday's Journal of the American Medical Association. The
American Heart Association estimates that 900 Americans die each day from sudden
cardiac arrest. Combined with cardiopulmonary resuscitation, AEDs can keep
victims alive until emergency crews arrive. In a 2004 study, the devices helped
raise the cardiac arrest survival rate to 23 percent, compared with 14 percent
with CPR alone. Some states have passed laws requiring defibrillators in public
buildings, and Congress has approved money for rural communities to buy them.
The devices cost around $700 to $1,200; nearly 200,000 are distributed a year.
The study found that most of the recalls were for electrical or software
problems. The findings were based on reports to the Food and Drug Administration
from 1996 through 2005. The FDA issued 52 advisories about automated external
defibrillators or crucial components during that period. (Associated Press)
Number of uninsured children declines as enrollees
in state health insurance programs increase
Even though the total number of Americans without health insurance is on the rise, a new study analyzing government data suggests good news for the nation’s children. The percentage of uninsured kids in America has decreased by 20 percent since the government-funded State Children’s Health Insurance Program (SCHIP) was approved by Congress in 1997. The State of Kids’ Coverage was released by the Robert Wood Johnson Foundation (RWJF) to kick off the Covering Kids & Families’ Back-to-School Campaign, a nationwide effort to enroll eligible children in public health coverage programs during the back-to-school season. The report shows that the number of uninsured children has decreased by 2 million since the creation of SCHIP and recent expansions in public programs. In the same period, the number of uninsured Americans has increased by nearly 5 million people. States with the biggest decline in the percentage of uninsured kids are Arkansas (-60 percent), Maine (-50 percent), Alabama (-47 percent), South Carolina (-46 percent) and North Dakota (-44 percent). The report also shows that fewer children are receiving private health insurance, which is supplied mostly through their parents’ employer-sponsored health plans. The percentage of children who have private health insurance has fallen by five percent since 1997-98. That means 1.4 million fewer kids have private health insurance. States with the biggest decline in percentage of children having private health insurance include New Mexico (-23 percent), Mississippi (-23 percent), Alaska, (-23 percent), Oklahoma (-19 percent) and Wyoming (-17 percent). The reports shows that even though the number of kids with private insurance is declining, public coverage programs have expanded, resulting in more kids being insured. The percentage of kids enrolled in public health coverage programs has increased by 31 percent since SCHIP programs began, meaning at least 5 million more kids now have public coverage. States with the greatest increase in percentage of kids enrolled in public coverage (e.g., SCHIP or Medicaid) since 1997-98 are Alaska (+139 percent), Maryland (+139 percent), Indiana (+132 percent), Wyoming (+114 percent) and Arkansas (+109 percent). Despite the success of public programs, millions of children remain uninsured. The latest Census data show that nearly 8.3 million children remain uninsured nationwide. Experts say that more than 70 percent of these children are likely eligible for low-cost or free health care coverage through SCHIP or Medicaid, but have not yet enrolled.
Deaths spur debate about drugs made in pharmacies;
Experts seek stricter
oversight
WHO: Fuel shortages in Lebanon a grave threat to health
Docs: 5% Medicare cut would hurt patient care
Journal won't bar authors on drug makers payrolls;
Fear of
antitrust lawsuits cited by JAMA editor
FCC begins
rulemaking to establish a new “MedRadio”
service for medical radio communication
devices
Amerinet announces agreement with Nonin Medical Inc.
Deaths spur debate about drugs made in
pharmacies; Experts seek stricter oversight
In eight days last summer, the same dangerous inflammation
struck three cardiac surgery patients at Mary Washington
Hospital within hours of their operations. On Sept. 2, one man
died. The unusual cluster of cases alarmed chief cardiac
surgeon John Armitage, who feared a contaminant was in the
surgery center. Tests confirmed it: Bacteria were found in a
solution injected into patients’ hearts during surgery. The
Fredericksburg, VA, hospital shut down its cardiac surgery
program the next day and called state health officials, who
brought in the Food and Drug Administration and the Centers
for Disease Control and Prevention. Within days, the FDA and
the CDC confirmed the presence of several types of bacteria in
opened and unopened bags of the cardiac surgery solution, a
state report later showed. The hospital later determined that
at least 11 cardiac surgery patients were stricken during a
10-month period from the end of December 2004 to September
2005, and three died. The illnesses and deaths drew attention
to a practice few patients know about: Some drugs, including
high-risk sterile preparations, are made in pharmacies under
less-restrictive rules than those that drug companies follow.
The troubles at Mary Washington raise questions about the
oversight of such pharmacies by hospitals, state regulators
and the FDA. Almost all hospital pharmacies do some type of
drug making, called compounding, ranging from low-risk
procedures, such as adding medications to intravenous
solutions, to high-risk work, such as making sterile
treatments from scratch. In most states, hospitals are not
required to test the sterility or potency of products made in
their own pharmacies or purchased from outside pharmacies. The
frequency and thoroughness of state inspections of the
pharmacies vary widely, and the FDA's role in oversight is
sometimes hampered by questions over whether it has
jurisdiction over what generally is a state matter. Scrutiny
of the pharmacy that served Mary Washington and 45 other
mid-Atlantic medical facilities set off a cascade of actions:
Virginia health officials pegged the contaminated solution as
the likely culprit in the cluster of patient illnesses. All
injectable medications made by the pharmacy during a six-week
period were recalled, the pharmacy lost its Maryland license
temporarily, and its parent company received an eight-page
letter from the FDA outlining problems in five of its
facilities nationwide. The hospital was cleared to reopen its
surgery program two weeks after the testing. The pharmacy,
owned by one of the nation's largest such firms, regained its
state license in January. Before the rise of large drug
companies, most prescriptions were made in pharmacies. Now,
the National Association of Boards of Pharmacy estimates that
pharmacy-made compounds account for 1% to 5% of all
prescriptions. Time pressure, or the cost of having the staff
and equipment to mix drugs, leads some hospitals to hire
outside pharmacies to make compounded products, including
difficult-to-prepare sterile drugs. In 2003, Mary Washington
hired Central Admixture Pharmacy Services (CAPS) in Lanham,
MD, to produce a blended cardiac surgery drug called
cardioplegia, the hospital said. The solution stops the heart
from beating during bypass surgery and must be sterile because
it is infused directly into the heart. CAPS, owned by B. Braun
Medical, has 20 locations across the country and supplies 400
medical facilities, according to its website. Because of its
size, it is one of a few pharmacies that fall under regular
FDA oversight, with routine inspections scheduled about every
two years. Most pharmacies, even those that make sterile
products, are smaller and are overseen by state inspectors,
not the FDA. Rules governing such pharmacies vary by state. In
Maryland, where CAPS has one pharmacy, regulators are updating
rules governing preparation of sterile drugs in pharmacies,
said John Balch, president of the Maryland Board of Pharmacy.
Despite efforts to beef up oversight of sterile-drug making by
pharmacies, only 12 states have adopted new standards set in
2004 by U.S. Pharmacopeia, a non-profit drug-safety
organization. Some hospitals have updated their pharmacies to
meet the standards, which can mean buying expensive equipment,
but many others have not.
The
standards were created partly in response to two separate incidents a few years
earlier, when contaminated, pharmacy-made medicines killed three people in
California and one in South Carolina. Pharmacy board attorney Louis Ling says
the new rules will require any pharmacy making compounded batches of drugs to
test them for sterility and potency. Special “clean rooms” and equipment will be
required, and employees will have to don protective clothing to make sterile
drugs. CAPS' website advertises that it meets the new standards, and the company
runs programs that teach other pharmacies how to comply with the rules. But FDA
investigators found some of CAPS' facilities falling short of good manufacturing
practices. “Sterility is an area that we're very concerned about,” said Steve
Silverman, acting assistant director at an FDA compliance office. “So we closely
monitor firms like CAPS, which train their personnel and have procedures
designed to minimize risk. If these firms were to disappear, then sterile
compounding likely would return to hospital and local pharmacies that may be
less-well-equipped.” (USA TODAY) To read the entire article,
CLICK HERE.
WHO: Fuel shortages in Lebanon a grave threat to health
WHO warns that if fuel is not delivered this week, 60% of all hospitals in Lebanon, in addition to other health facilities will simply cease to function. WHO urges all parties to ensure the safe passage of fuel, as a matter of priority. Due to the damage to infrastructure in the conflict-affected areas of Lebanon, hospitals and other health centres are relying on fuel to run generators. Power is essential to run operating theatres, life-saving equipment including incubators for newborns, refrigeration for vaccines and treatments including insulin. It is also essential for safe water provision and hygiene. WHO has received reports that fuel supplies are running dangerously low. One hospital in Marjayoun, for example, reports that it will run out of fuel by Wednesday. “Based on available information, if there is no fuel delivered in the next few days, more than half of the hospitals will not be able to operate by the end of this week and the situation will be much worse next week,” warned Dr. Ala Alwan, Representative of the WHO Director-General for Health Action in Crises. Lebanon has 12 000 hospital beds. A reasonable estimate is that, in order to function, each hospital bed needs 80 litres of fuel per week for electric power. Up until now, fuel deliveries have been severely hampered because of the ongoing military operations. “Fuel is key in any basic infrastructure. The provision of fuel is a matter of life or death in a hospital setting. We urge all parties to ensure safe passage of fuel supplies to hospitals,” said Dr. Alwan. Fuel shipments are ready to be sent to Lebanon as soon as the security situation allows. Fuel tanks are also ready to be sent from Beirut to other areas in Lebanon in convoys, provided security is ensured.
The Ministry of
Public Health in Thailand has confirmed the country’s 24th case of human
infection with the H5N1 avian influenza virus. The case, which was fatal,
occurred in a 27-year-old man from the central province of Uthai Thani. He
developed symptoms on 24 July, was hospitalized on 30 July, and died on 3
August. Investigation of his source of infection revealed contact with household
chickens, which began dying around one week prior to symptom onset. This is the
country’s second case of H5N1 infection, and second fatality, within the past
two weeks. Confirmation of these cases follows an 8-month period in which no
human cases were reported in the country. Recent outbreaks in poultry have been
officially reported in two provinces, Phichit and Nakhon Phanom, located in the
northern and north-eastern parts of the country. The World Health Organization
(WHO) has issued an update on the cumulative number of Avian Influenza
A/(H5N1) reported to WHO. As of August 7, 2006, there have
been a total of 233 cases of Avian Influenza A/(H5N1) and a total of 136 deaths.
Vietnam and Indonesia have both reported 42 deaths due to Avian Influenza. To
view the table,
CLICK HERE.
Docs: 5% Medicare cut would hurt patient care
Medicare reimbursements to doctors are set to drop by nearly 5 percent next year, an amount that physicians say could make it harder for elderly patients to see a doctor. Mark McClellan, administrator for the Centers for Medicare and Medicaid Services, said Monday that the agency would soon issue new regulations updating reimbursement rates for physicians. He did not provide an exact amount the rates would change in 2007, but trustees for the Medicare program projected in May that the cut would be 4.7 percent. The reimbursement rates are established by formula, which sets annual and cumulative spending targets for physician reimbursements. When spending increases exceed economic growth, payments to doctors are supposed to be cut. McClellan attributed proposed payment reductions to a “vicious cycle” in health care. Doctors provide more and more services per patient, which drives up Medicare spending faster than the overall economy. However, Congress in the past has headed off similar reductions called for by federal regulation, and it's expected to step in again this year once lawmakers return from their August recess. Already, 80 senators wrote their respective leaders in that chamber last month to say they believe the Senate should increase the reimbursement rates for doctors before Congress adjourns in October. McClellan said he was optimistic that the federal government could also make some structural changes as soon as this year in the way doctors are reimbursed. Those changes would focus more on paying doctors when they provide services proven to improve patient outcomes rather than just reimbursing doctors for more care. He said he is seeing more leadership from physician groups this year when it comes to providing guidance on how the government could undertake such a transformation. (The Associated Press)
The Journal of the American Medical Association said it and other
periodicals would be sued by the pharmaceutical industry if they banned authors
who fail to reveal financial ties to drug makers. “There's a risk for antitrust
suits,” said Catherine DeAngelis, editor in chief of Chicago-based JAMA. “I've
talked to lawyers, and so have other journals.” Last month, JAMA said doctors
failed to disclose their ties to drug makers in two separate studies, including
one that linked migraines to heart attacks in women. The journal, which has the
largest circulation of any medical periodical, published corrections in both
cases. Researchers who flout disclosure rules can expect “appropriate corrective
actions” from their universities, DeAngelis said in an editorial published
yesterday. DeAngelis rejected suggestions that JAMA ban authors who are revealed
to have undisclosed financial ties to drug makers. That “would only encourage
that author to send his or her articles to another journal; it cleans our house
by messing others,” DeAngelis wrote. If all medical journals agreed to ban such
authors, antitrust issues would arise, she said. While a collective agreement
might be unlawful, there's nothing stopping JAMA and other journals from sharing
the names of authors who've broken the rules, said Stephen Ross, a former lawyer
for the Federal Trade Commission and a law professor at Pennsylvania State
University. “They could even jointly observe that particular journals published
a certain researcher” despite past problems with disclosure, said Ross. In the
study linking migraines and heart disease, the study's six authors had all
worked as consultants or paid speakers for companies that make drugs to treat
headaches or heart disease. Last month, JAMA also corrected a February study on
depression, noting that more than half the authors were paid speakers or
consultants for antidepressant makers. (Bloomberg News)
FCC begins rulemaking to establish a new “MedRadio” service for medical radio communication devices
The FCC has initiated a proceeding to establish a new service for advanced medical radio communication (“MedRadio”) devices in the 401-406 MHz band. The FCC noted that an ever-increasing number of medical devices are coming to rely upon radio transmissions for critical aspects of their functionality. In this Notice of Proposed Rule Making, the FCC proposed designating an additional two-megahertz of spectrum for these devices, at 401-402 MHz and 405-406 MHz, adjacent to the existing Medical Implant Communications Service (MICS) band at 402-405 MHz, for a total of 5 megahertz specifically designated for medical device radiocommunications. Underscoring the flexibility and scope of potential uses under this new service, the FCC proposed to revise its nomenclature and designate the entire 401-406 MHz band as MedRadio service. To accommodate a wider variety of devices than the current MICS service, which is limited to use of implant devices, the FCC proposed allowing the use of body-worn transmitting devices in the MedRadio service. The FCC also proposed increased flexibility for the newly designated 401-402 MHz and 405-406 MHz bands to allow the use of low power, low duty cycle MedRadio devices without requiring the frequency agility capability required by the current MICS rules. The FCC proposed that frequency agility would continue to be required of devices in the core 402-405 MHz band to accommodate devices that might be used for more critical purposes and which might be less compatible with non-frequency-agile devices, and sought comment on this point. Additionally, in the Notice of Inquiry, the FCC sought comment on information concerning developments that are anticipated in the medical devices field and their likely spectrum requirements. Among other matters, the inquiry sought comment on: New implant and body-worn medical radiocommunication technologies and how the Commission could anticipate and proactively address the challenging array of RF spectrum issues; The relative benefits and tradeoffs that should be considered with respect to both licensed and unlicensed approaches to authorizing the operation of these devices; and collaborative efforts between this Commission (FCC) and the U.S. Food and Drug Administration (FDA) regarding options for better educating device manufacturing industry leaders about medical radio device electromagnetic immunity issues in an RF environment. For more information CLICK HERE.
Amerinet announces agreement with Nonin Medical Inc.
Amerinet announces that it has entered into an agreement with Nonin Medical Inc,
a U.S. health care manufacturer of physiological monitoring devices, to make
Nonin's line of wrist, fingertip, and MRI compatible pulse oximeters and
applicable sensors available to Amerinet's members, including a wireless
oximeter based on Bluetooth technology. Under the three-year agreement
Amerinet's members will have access to these pulse oximeters and applicable
sensors.
Administration aims to set health care standards
Blue Cross and Blue Shield plans unveil Blue Health Intelligence
TB diagnosis sometimes delayed by unfamiliarity in the U.S.
Diabetic blacks, hispanics face more hospitalizations
US Surgical takes measures to acquire Confluent Surgical for $245 million
Fuji receives FDA clearance for Obliquus 3D Software
A 27-year-old Thai man has died of
bird flu, the
country’s second death from the disease this year, officials said Saturday, as
they put eight more provinces, including the Bangkok area, on a watch list. The
man died on Thursday after the A(H5N1)
virus killed
chickens on his backyard farm in Uthai Thani Province, 135 miles north of
Bangkok, and the third province to have an outbreak since the virus re-emerged
in July after an eight-month lull. “He buried them without any protection, and
that’s why he caught bird flu,” Thawat Suntrajarn, chief of the Department of
Disease Control, said of
Thailand’s 16th
victim since the disease swept through parts of Asia in late 2003. Bird flu
killed at least 134 people worldwide before this latest death, according to the
World Health Organization.
Since the death of a Thai teenager in late July, Thailand has rushed to plug
gaps in its bird flu defenses. The area around the sprawling Thai capital was
among eight provinces declared bird flu risk zones on Saturday, increasing the
total to 29 of Thailand’s 76 provinces. Agriculture Minister Sudarat Keyuraphan
said local officials would go on a door-to-door campaign to educate villagers on
how to handle sick or dead poultry. A new call center will take reports of
suspicious poultry deaths and answer questions about the disease. The government
has threatened fines of up to about $100 or two months in jail for failing to
report sick or dead birds. The outbreaks in Thailand and neighboring Laos, where
bird flu was found on a farm last month, renewed fears that the disease is
flaring up again in Asia. In Vietnam, where no cases have been confirmed in
poultry or humans this year, the authorities are taking no chances. Animal
health workers slaughtered 53 wild storks at a theme park in Ho Chi Minh City on
Saturday after random tests showed H5, part of the A (H5N1) virus, in two birds.
In Indonesia, tests confirmed six suspected human cases were not bird flu, an
official said. (Reuters)
Administration aims to set health care standards
The Bush administration will soon launch an ambitious effort to require that all providers of federally financed health care adopt quality-measurement tools and uniform standards for their information technology, Health and Human Services Secretary Mike Leavitt said Sunday. Leavitt told a session of the National Governors Association's annual meeting that “in a matter of weeks,” President Bush will sign an executive order setting the new requirements. He promised that by year's end, a majority of the 100 largest private employers will sign similar contracts with the hospitals and doctors they use to care for their workers. He urged the governors to follow suit by signing up the groups that take care of state employees and Medicaid recipients. The goal of the initiative, Leavitt said, is to reduce health-care cost inflation while increasing the quality of medical services individuals receive. The executive order would affect doctors and hospitals serving the Medicare population of elderly Americans and people served by any other federally financed service. It would require those health providers to join with the government to standardize the requirements for information technology systems coming into their facilities; set standards for care of specific health problems; and develop uniform methods of measuring and reporting the outcomes of treatments. Leavitt cautioned that the first standards in all three areas would be “pretty basic,” but said they would provide a foundation for a future system in which patients could make “much more informed decisions” about where to go for treatment and what it is likely to cost. Leavitt said that the demand for such information is large and that tools are becoming available to supply it. He said he had contacted executives of 21 of the 100 largest private employers and “21 of 21” are ready to sign such contracts with their own suppliers. That number will grow rapidly in coming weeks, he said. Governors expressed interest in using Leavitt's model in their states but voiced some skepticism about the readiness of doctors to have their work evaluated. Leavitt insisted that the physicians with whom he has met “want the standards” set for care in their specialties, in part because they want to evaluate their own performance against that of their peers, and in part because rewards for quality, which Leavitt said these measurements would make possible, might offset the loss of income threatened as budget pressures reduce their reimbursements for Medicare patients. Leavitt conceded that many of the doctors are “skeptical we can create a system that measures quality accurately,” but he said some specialties are already developing such standards and more can be nudged into doing so. As for the standardization of information technology, now moving in rather haphazard fashion into hospitals and doctors' practices, Leavitt said HHS teams have finished drafting recommended standards for four basic functions: registering patients, reporting lab results, writing prescriptions, and providing secure communication channels between patients and doctors and among health-care providers. Those standards will also be written into the proposed executive order, he said. (The Washington Post)
Blue Cross and Blue Shield plans unveil Blue Health Intelligence
Blue Cross and Blue Shield Plans announced the creation of Blue Health Intelligence (BHI), a resource designed to help improve healthcare quality through opportunities to share critical health information initially with employers, and in the future, with consumers and providers. BHI as a health intelligence resource will strengthen the movement to greater healthcare transparency by ultimately providing unmatched detail about healthcare trends and best practices. The secure, HIPAA-compliant database is comprised of claims information (with no personal identifiers) from 79 million lives, significantly larger than existing healthcare databases. Twenty Blue Cross and Blue Shield Plans currently are participating in BHI. Access to the aggregate data will be available only to the participating Plans. The development of BHI over the last several years responds to the demands of employers, consumers, and providers who are calling for credible and actionable data to drive informed, evidence-based decision making. BHI is currently being pilot-tested and will be operational by 2007. As BHI evolves, the resource will provide a number of benefits to employers, consumers, providers and other stakeholders, such as: Sharper insight into healthcare trends and best clinical practices; information about the efficacy of certain treatments and new medical technologies as well as emerging trends in healthcare practice and delivery; benchmarking data to assist in conducting comparative analyses across a number of healthcare components; and opportunities for health services research. For more information CLICK HERE.
Fuji receives FDA clearance for Obliquus 3D Software
FUJIFILM Medical Systems USA has received FDA 510(k) clearance of Obliquus, an integrated 3D software package providing diagnostic MIP (Maximum Intensity Projection) and MPR (Multiplanar Reconstruction) functionality that is important to the radiologist’s diagnostic process. A software option for Fuji PACS facilities using Synapse version 3.1.1 and higher, Obliquus was designed to reduce facilities’ requirements to integrate a third party 3D solution for basic, commonly-used functions. Because the Obliquus software was written and developed by Fuji and is a direct component of Fuji’s Synapse PACS, it offers a number of advantages to both radiologists and their facilities over the use of a third party 3D solution. Radiologists benefit from the availability of Obliquus anywhere on the network that Synapse is available, even from remote locations since it works with compressed studies. It also allows users to maintain productivity by seamlessly displaying any cross-sectional study while within the Synapse application; there is no need to exit to a new application. Facilities benefit from the ability to leverage the use of existing Synapse workstations, as well as from the ease of deployment.
Underperforming transplant centers are hearing from federal regulators
Capacity cripples U.S. health system
Settlement
reached in Sutter lawsuit; Hospital group will
give refunds, discounts to former
patients
Blood clot fiber study may aid treatment
Newly
published guidelines for treatment of heart valve disease
lower recommended age
for tissue valve recipients
Five nationally renowned speakers at ASHES 21st Annual Conference
CMS isn’t planning to extend moratorium on specialty hospitals
Despite a request by the leaders of the Senate Finance Committee, the Centers for Medicare and Medicaid Services has no plans to extend by two months an administrative moratorium on approving new specialty hospitals to receive Medicare payments. The agency will issue a regulatory plan for overseeing the facilities by the deadline set in the budget savings law (PL 109-171), CMS spokesman Peter Ashkenaz said on Thursday. That measure requires that the plan be released by Aug. 8 and provides that the moratorium be lifted by then. It also allows CMS to extend the administrative moratorium for two months if the agency misses the deadline for preparing a plan. Finance Committee leaders said CMS should take the extra time to ensure that the plan is sound, asserting that there are flaws in a survey used by CMS in preparing the document. But Ashkenaz said CMS sees no evidence that an extension of the moratorium is merited. (Source: CQ HealthBeat News)
Federal regulators began sending out letters Thursday to about 35 underperforming organ transplant centers, giving them one last chance to prove their quality before taking enforcement actions against them, possibly including pulling federal funding. The move by the U.S. Centers for Medicare and Medicaid Services follows reports in The Times highlighting the agency's failure to enforce its own standards for heart, liver and lung transplant centers. The Medicare agency, which funds most of the nation's transplant centers, requires programs to achieve a specific survival rate to be certified for funding. Medicare also requires transplant programs to perform a minimum number of operations per year to ensure competency. The benchmarks vary by organ, and neither applies to kidney transplants. Last month, The Times reported that nearly 50 federally funded transplant centers, about one in five, did not meet at least one of those standards. After questions from The Times earlier this year, the Medicare agency sent letters to every certified transplant center requesting information on performance, staffing and changes that could affect patients. After reviewing results, Medicare is asking underperforming centers to verify their data and “let us know of any other information we ought to know about,” said Dr. Barry Straube, the agency's chief medical officer. “We want to make sure that there's due process here,” he said. “We'll be taking action soon.” Medicare would not identify the centers receiving the letters, but Straube said his agency would release their names if they are hit with sanctions. The federal government plans to take other steps to improve its transplant center oversight, officials said. Updated standards, which will heighten supervision of federally funded programs, will be issued before the end of the year, Straube said. They had not been expected until 2007, but the date was moved up in light of concerns. (Los Angeles Times)
Capacity
cripples U.S. health system
Demand for emergency
department (ED) services at U.S. hospitals is surging. As a result of this
upsurge, EDs are confronting a crisis. They do not have the capacity to deal
with rising demand. Due to federal regulations that require EDs to treat any
patient who enters, hospitals have struggled to manage such overcrowding.
Overcrowding is most often attributed to the inability of emergency departments
to transfer admitted patients to inpatient beds, according to a report by the
Government Accountability Office. Therefore, hospitalwide capacity problems are
driving overcrowding in EDs. There are two causes of this phenomenon: 1.
Supply-side factors have exacerbated overcrowding: In response to the pressures
of managed care and lower reimbursement from Medicare and private payers over
the past 15 years, hospitals have reduced their number of beds to improve
efficiency. Hospitals have also closed less profitable units or converted them
to specialized units, leaving less overall inpatient capacity to absorb ER
admissions. Even hospitals that have enough beds often suffer from staffing
shortages. Skilled nursing facilities and home health services have seen a
decrease in investment and are facing financial problems, resulting in fewer
discharge options. This puts further strain on inpatient capacity. 2. Factors on
the demand side are also fueling the overcrowding problem: A political backlash
against health maintenance organizations (HMOs) in the late 1990s led to a
relaxation of their policies on emergency care, which stimulated more ED use by
HMO patients. The Emergency Medical Treatment and Active Labor Act (EMTALA)
requires ambulance services and hospitals that receive Medicare reimbursement to
provide emergency care to anyone. As baby boomers grow older and sicker, demand
for emergency care is increasing. Less than half of all emergency visits are
classified as “emergent” or “urgent.” Many policymakers assume that the rising
number of uninsured people is primarily responsible for driving the crisis.
However, a recent study by the Center for Studying Health System Change
concludes that most of the increase in ED use is due to more visits by insured
patients. Overcrowded EDs have several deleterious effects on patients and
hospitals: Higher waiting times for examination and admission leave patients
less satisfied with treatment. EDs are primarily designed for emergency care and
non-emergent visits detract from this task. ED treatment is expensive, relative
to other ambulatory services. Increases in non-emergent visits to the ED raise
costs that may spill over to all patients. Capacity constraints highlight
other related challenges facing the U.S. health care system, including:
unchecked demand and overconsumption of health services among the insured; and
inadequate access to primary care for the uninsured. Individual hospitals are
attempting to address issues of overcrowding by expanding EDs and raising
efficiency. This should help in the short term. However, in the long run, more
fundamental reform will be needed. The ED experience shows that the alternative
of universal insurance coverage will not solve problems of demand.
Market-oriented approaches, in combination with government-led reforms, may
offer a more comprehensive solution. The pressure for a more concerted
legislative attempt to reform the system will grow during the 2007-2008
Congressional term. (Source:
For more information CLICK HERE.
Settlement reached in Sutter lawsuit; Hospital group will give refunds, discounts to former patients
A Sacramento judge approved an agreement Thursday that requires Northern California hospital operator Sutter Health to pay refunds and offer discounts to thousands of former patients to settle accusations that it overcharged uninsured individuals for services. An attorney representing plaintiffs said the payments could exceed $275 million. But a Sutter spokesman said that estimate appeared high. The settlement resolves a class-action lawsuit filed in 2004 that accused Sacramento's Sutter of charging uninsured patients at its high rates for services, while offering deep discounts to insurance companies and other big payers. Sutter operates 27 hospitals in the Bay Area and other Northern California locations. Sutter officials said costs could be lower than the plaintiffs’ attorneys estimate because most uninsured patients never paid their bills and therefore wouldn't be entitled to refunds. A wave of lawsuits has been filed in recent years, accusing hospitals nationwide of gouging uninsured patients by charging prices far above the rates they negotiate with insurers and other big institutions. Under the terms of the settlement, plaintiffs will receive discounts or refunds from their bills ranging from 25 to 45 percent, depending on which hospital treated them. To be eligible, claimants must have been treated at a Sutter-affiliated hospital between Sept. 3, 2000, and Aug. 3, 2006. Sutter officials said the settlement won’t change current practices. Sutter changed its billing policies in 2004 to extend discounts to all uninsured patients, regardless of income, spokesman Bill Gleeson said. Settlement claim forms must be postmarked by Jan. 17. (San Francisco Chronicle)
Blood clot fiber study may aid treatment
The fibers that make up blood clots are more elastic than rubber bands and
stretchier than spider webs. They're even tougher than doctors suspected, a
discovery that could lead to improved treatment of heart attacks and strokes.
Understanding how much these fibers can be stretched before they break should
point to better ways to bust up blood clots on demand. Made of a protein called
fibrin, the fibers are stretchier than any other naturally occurring ones, even
super-stretchy spider silk, concluded researchers who rigged up a
double-microscope to measure how tough the tiny strands, 1,000 times smaller
than a human hair, really are. The discovery, published in Friday's edition of
the journal Science, goes a long way toward explaining the dual nature of blood
clots: You need clots to seal up wounds, prevent hemorrhaging and start the
healing process. But abnormal clots can kill, blocking critical arteries to
cause strokes, heart attacks or lung-clogging pulmonary emboli. “It can be good
and bad that they're so stretchable,” noted Wake Forest University physicist
Martin Guthold, one of the lead researchers. “When they do form in the bad
places, it's kind of difficult to get rid of them. ... You can rip on them, and
they will just stretch out.” Already, he's talking with the maker of a device
that uses ultrasound to attack clots, with hopes of improving its effect. It's
an important finding, said Dr. Richard Becker, a cardiologist and hematologist
at Duke University Medical Center and a spokesman for the American Heart
Association. Aside from better clot-busting treatments, the work could lead to
better ways to prevent dangerous blood clots in the first place, and, on the
flip side, to help blood clot better in people with hemophilia and other
bleeding disorders, he said. Blood clots are a mesh of fibrin fibers bonded to
platelets, a sticky substance in blood. To heal a wound, those clots have to be
both strong and flexible, to withstand the pounding of regular blood flow,
explained study co-author Dr. Susan Lord, a pathology professor at the
University of North Carolina, Chapel Hill. But until now, the fibers’ small size
had prevented pinpointing just how strong they really are. UNC and Wake Forest
scientists came up with a solution. They dyed fibrin fibers to appear
fluorescent, and suspended them over one microscope. Then they balanced an
atomic force microscope, which senses tiny surfaces using a special tip, over
the first microscope. The second microscope's tip stretched the fibers while the
scientists measured from below, and watched as the toughest fibers stretched to
over six times their original length before breaking. On average, the fibers
stretched to about four times their length. They also contracted back to their
original size after stretching, elastic like a rubber band. But natural fibers
are far stronger than manmade rubber bands, Guthold said. (The Associated Press)
Newly published guidelines for
treatment of heart valve disease lower recommended age for tissue valve
recipients
Newly published guidelines for the diagnosis and treatment of heart valve
disease, developed by the American College of Cardiology (ACC) and the American
Heart Association (AHA) are available. A summary of the guidelines was published
in the Aug. 1, 2006, issue of the Journal of the American College of Cardiology
and Circulation. The new recommendations offer the first comprehensive update to
physician practice guidelines in this area since 1998. New data have led to more
specific guidelines for physicians to manage the complexity of heart valve
disease, including determining the severity of the disease and the appropriate
timing for heart valve surgery. An ACC-AHA joint committee revised the
guidelines for tissue valve replacement, lowering the recommended minimum age
for tissue mitral valve patients from 70 to 65 years. In changing the age
recommendations, the committee acknowledged that today's tissue valves are
demonstrating increased durability. The committee also concluded that
current-generation porcine valves have the same durability as pericardial tissue
valves.
Five
nationally renowned speakers at ASHES 21st Annual Conference
The 21st Annual Conference and Healthcare Marketplace of the
American Society for Healthcare Environmental Services (ASHES), September 24 –
28, 2006 in Nashville, TN, features well-known best selling authors, a famous
broadcaster and nationally-renowned motivational speakers.
Dr. Jerry Punch,
Physician and Broadcaster, ABC's Wide World of Sports and ESPN is the opening
keynote speaker of the conference. His session is titled, “eXceeding
eXpectations Through Teamwork!”
Mac Fulfer
Author, Amazing Face Reading, shows how this art/science of face reading
can be a means to a deeper communication with every person you meet.
Greg Blake,
Chief Encouragement Officer (CEO), PepWorks International, presents a
best-in-class, high-energy motivational session entitled “How to THRIVE and Not
Just Survive in Turbulent Times! An eXtreme Personal & Professional
Environmental Makeover”.
Ron Rosenberg,
President, Quality Talk, will hold an interactive and entertaining session
entitled, “The Hidden Secrets to Double Your Memory”.
Fred Lee,
President of Fred Lee and Associates Inc., and author of If Disney Ran Your
Hospital – 9 ½ Things You Would Do Differently, is the closing keynote
speaker. For more information about the ASHES Conference,
CLICK HERE.
FDA announces medical device user fee rates for 2007
FDA approves influenza vaccines to be manufactured for upcoming flu season
Washington Redskins take multiple precautions against dangerous MRSA
Incorrect treatment provided to one in three patients with methicillin-resistant staph infections
2006 Health Connect Partners Supply and Pharmacy Expo
Tommy G. Thompson left the Bush Cabinet nearly two years ago, but the former secretary of health and human services is trying to keep a hand in the policy mix in Washington. The former Wisconsin governor, who garnered national attention in the 1990s for his state's welfare-to-work efforts, has his eye on Medicaid. Thompson, who now works for two law and consulting firms, is set to release a white paper Friday in which he calls for overhauling Medicaid by shifting responsibility for long-term care of the burgeoning elderly population to the federal government, while leaving states to focus on acute care for those under 65, particularly children. “The federal government is the only one large enough to handle this growing problem,” said Thompson, who will address the National Governors Association on Saturday in Charleston, SC. “The states are going broke right now under the Medicaid system. Who else is going to be able to handle the elderly?” Thompson also calls for helping Medicaid recipients take a more active role in their care through new health literacy and disease-prevention efforts. As the program becomes more efficient, he argues, states could use the savings to help cover the nation's 45.8 million uninsured people, in some cases by subsidizing access to commercial health insurance. Medicaid also should adopt technology such as electronic medical records to help manage cases and improve public health information-gathering. Jeff Nelligan, a spokesman for the Centers for Medicare and Medicaid Services, said agency officials were reviewing Thompson's ideas. Thompson said that his proposals would probably increase spending initially because of start-up costs but that overall spending would be likely to decrease over time as officials learned to operate more efficiently. The federal government would not be called upon to shoulder a greater share of total Medicaid spending, he said, and states should not expect to see a decrease in their share. Rather, for both sides, savings would derive from operating more efficiently in the new system, he said. Thompson acknowledged that Medicaid funding formulas would have to be tweaked to prevent some states from reaping financial windfalls. “You want to set up almost a competitive environment where the states will strive to improve upon the healthfulness of their populations, and that will result in less costs for the states at the acute level,” he said. “And as these people get older and they move over into the federal responsibility, they will be less expensive for the federal side as well, because you're inheriting a healthier population.” (The Washington Post)
FDA announces medical device user fee
rates for 2007
The Food and Drug Administration (FDA) is publishing the fee
rates and payment procedures for medical device user fees for
fiscal year (FY) 2007. The Federal Food, Drug, and Cosmetic
Act (the act), as amended by the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA) and the Medical Device User
Fee Stabilization Act of 2005 (MDUFSA), authorizes FDA to
collect user fees for certain medical device applications. For
all applications submitted on or after October 1, 2006, and
through September 30, 2007, fees must be paid at the FY 2007
rates at the time the applications are submitted to FDA. This
notice provides details on how fees for FY 2007 were
determined and payment procedures for medical device
applications subject to user fees. Under the act, all fees are
set as a percent of the full fee for a premarket application,
and the act sets the standard fee for a premarket application
at $281,600 for FY 2007; this is referred to as the “base
fee.”' A 180-day supplement is set at 21.5 percent of the base
fee; the fee for a real-time supplement is set at 7.2 percent
of the base fee. For all applications other than premarket
notification submissions (510(k)s), the small business rate is
38 percent of the standard (full fee) rate. For 510(k)
premarket notification submissions, the fees are to be set so
that fees from all 510(k)s would produce revenue as if all
were assessed a fee of 1.42 percent of the base fee, but these
fee rates are to be adjusted so that the fee paid by a
qualifying small business is 80 percent of the full rate for a
510(k) premarket notification submission. Based on FDA's
estimates, about 19 percent of 510(k) premarket notifications
will qualify for the small business fee, and about 81 percent
will pay the standard (full) fee. The FY 2007 fee rates for
all application categories are set out in table 1 of the
following document.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-12394.htm
For more information CLICK HERE.
The Food and Drug Administration (FDA) announced that it has approved this year's seasonal influenza (flu) vaccines that include the new strains of virus judged likely to cause flu in the Northern Hemisphere in 2006-2007. Each year influenza vaccine manufacturers submit information and samples to FDA of their virus strains being manufactured for the upcoming seasonal influenza season for review and testing in FDA laboratories. Because different influenza virus strains may appear each year, one or more of the strains in the vaccine may need to be changed to protect against what public health experts think are the strains most likely to infect people that year. This season's approved formulation for the U.S. vaccine is identical to that recommended by both the World Health Organization and FDA's Advisory Committee. The formulation includes one strain that was used in last year's vaccine and two new strains. Seasonal flu vaccines do not protect against avian flu, which is caused by different viral strains. The best way to prevent influenza is by getting vaccinated. Although it is best to be immunized in the fall, getting the vaccine in the winter months when flu season often peaks is also recommended. According to the Centers for Disease Control and Prevention, every year in the United States, on average five to 20 percent of the population gets the flu, more than 200,000 people are hospitalized from its complications and approximately 36,000 people die from it. There are four vaccine manufacturers approved to market their vaccines in the United States: Chiron Vaccines, Ltd.; GlaxoSmithKline Biologicals; MedImmune Vaccines, Inc.; and Sanofi Pasteur, Inc. The manufacturers have projected making a total of about 100 million doses of influenza vaccine for the 2006–2007 season, but these projections could change as manufacturing continues.
Washington
Redskins take multiple precautions against dangerous MRSA
The Washington Redskins took steps during the offseason to
combat one of their tiniest and toughest foes, a microscopic
organism that is becoming increasingly dangerous and
potentially lethal. The microbe, methicillin-resistant
Staphylococcus aureus (MRSA), is a bacteria once relegated to
hospitals and prisons but now, because athletes are in such
close contact with one another and share Jacuzzis, whirlpools
and athletic equipment, is proliferating in locker rooms at
all levels of sports. Over the past two years, the Redskins
have had five cases of MRSA, team physician Tony Casolaro said
last year. “We're concerned about it,” aid Bubba Tyer, the
Redskins’ director of sports medicine. “We don't want to lose
any player. We don't want anything to affect their career and
we want to do all we can do. It's a terrible infection that
can cripple your team.” In addition to spending $17,000 on a
new Jacuzzi system that is equipped with an ultraviolet light
filtering system designed to kill germs, the Redskins hired
SportsCoatings Inc. to treat the training room, locker rooms
and weight rooms with an anti-microbial coating the company
claims will help kill various strains of the bacteria. Tyer
did not divulge the amount the Redskins spent, but
SportsCoatings spokeswoman Wendy Orthman said the treatment
cost roughly $1.50 per square foot. The Redskins aren’t the
first NFL team to take preventative measures where MRSA is
concerned. Some teams are doing so with different products
this year and others, such as the St. Louis Rams, have done so
in the past, using bleach. Players must also be retrained. To
Tyer, who has taken a personal interest in the prevention of
MRSA, especially at the high school and college levels, the
Redskins’ high-tech approach has little value if the team and
players do not adopt basic, low-tech methods, such as washing
hands with an alcohol-based sanitizer, avoiding sharing towels
and daily athletic gear. Last season, the Redskins’ locker
room was filled with benches. This year, each locker has its
own stool. There are signs throughout the training room,
reminding players to avoid entering the whirlpools or Jacuzzis
without first having showered. At each entrance to the
training room are oversized dispensers of antibacterial liquid
soap. In the locker room’s bathroom area is a sign adjacent to
the sink, reminding players not to share razors.
Representatives from the Centers for Disease Control and
Prevention also inspected the Redskins’ facilities, Tyer said.
Last week, the Toronto Blue Jays confirmed that the staph
infection that has kept right fielder Alex Rios on the
disabled list for the past month is a version of MRSA, which
can enter the body through a tiny opening in the skin and
spread rapidly. Blue Jays pitcher Ty Taubenheim, who is
suffering from an infection on his foot, also is on the
disabled list, but it is unclear whether the infection is MRSA.
In 2003, Jeffrey Hageman, an epidemiologist with the CDC and
expert in sports-related MRSA cases, investigated the St.
Louis Rams and found that five of 58 players developed MRSA
infections, likely from turf abrasions. In his research on the
Rams, Hageman found linebackers, linemen and players of high
body mass to be particularly susceptible. To health experts
and sports physicians alike, the reason for MRSA's growing
prevalence is confounding. According to CDC spokeswoman Nicole
Coffin, disease experts believe that MRSA has not grown in
virulence because of environmental forces, meaning that the
Redskins’ locker room is perhaps no more naturally predisposed
to MRSA today than it might have been 20 years ago. The
difference, she said, is in the need to increase prevention
methods. Staph infections have been part of the sports world
for years, but in recent years, medical experts say, the MRSA
bacteria have become highly resistant to common antibiotics,
such as penicillin. In turn, the potential for its spread,
some experts believe, has been heightened by the inappropriate
use of antibiotics, such as using antibiotics to treat viruses
and not bacteria. These misuses can increase the resistance of
bacteria. Orthman said the application of anti-microbial spray
protected a surface for life without the possibility of the
bacteria becoming resistant. Orthman also said that the
chemicals that comprise the treatment do not weaken over time.
According to Coffin, the CDC does not evaluate the efficacy of
products, nor do they test the methodology behind products.
(The Washington Post)
Incorrect treatment provided
to one in three patients with methicillin-resistant
staph
infections
Drug-resistant, hospital-acquired infections often are treated initially with ineffective antibiotics, which increases the risk of death, according to an article in the August issue of Critical Care Medicine, the journal of the Society of Critical Care Medicine.
The researchers conducted a three-year retrospective study of 549 Barnes-Jewish Hospital patients with MRSA sterile-site infection to determine the rate of appropriate initial antimicrobial administration and to evaluate the influence of this treatment on outcome. They found that nearly one in three MRSA-infected patients initially received inappropriate treatment for MRSA infection, nearly doubling their risk of death. “Physicians should deliver early appropriate antibiotic therapy,” said senior author Marin H. Kollef, M.D., professor of medicine at Washington University School of Medicine in St. Louis. “For methicillin-resistant Staphylococcus aureus (MRSA) that means treating acutely ill hospitalized patients with antibiotics that are active against MRSA instead of less effective antibiotics. The occurrence of MRSA has skyrocketed in the last five to 10 years and is now the most common hospital pathogen.” Hospital-acquired MRSA infections have serious consequences including increases in the risk of death and in healthcare costs. Patients in intensive care units are particularly vulnerable. Hospital mortality associated with MRSA sterile-site infections is reported to be greater than 20 percent. Lead author Garrett E. Schramm, PharmD, said that it is crucial for physicians to aggressively identify and treat patients at risk for sterile-site MRSA infections and for physicians to be aware of local susceptibilities for both hospital and community-acquired MRSA isolates. “In our ICUs, we automatically treat for MRSA along with other bacteria when we have a patient with hospital-acquired infection,” said Dr. Kollef. “Obviously, not everyone will have MRSA infection, but it is so common and the consequences of not treating it upfront are so high that we treat for MRSA before its presence is confirmed.” Dr. Kollef said there are no drawbacks to including MRSA treatment in initial therapy, as long as clinicians monitor the patient. If the culture results show no evidence of MRSA infection, then MRSA-related antibiotics can be stopped. In most patients, this is done within 48 hours. Dr. Schramm says that there are a variety of antibiotics that can treat MRSA infections. Many are given intravenously and are appropriate for hospital use, while some, including sulfamethoxazole-trimethoprim (Bactrim: Roche Laboratories Inc., Nutley, NJ), can be administered orally and may be used to treat community-acquired MRSA infections. Dr. Schramm is a clinical pharmacist at Mayo Clinic in Rochester, MN, and a former critical care specialty resident at Barnes-Jewish Hospital in St. Louis. “We have the antibiotics, and now we should develop optimal treatment algorithms,” concluded Dr. Kollef. “This will provide early appropriate therapy, while minimizing emergence of further resistance in MRSA and other bacteria.” In an accompanying editorial in the August issue of Critical Care Medicine, lead author Andrew F. Shorr, M.D., M.P.H., from Washington Hospital Center in Washington, DC, expands on the research of Dr. Schramm and his coauthors. “As newer tools for rapid diagnostics and organism identification become commercially available we will need to update our approach to antimicrobial prescribing generally and for MRSA specifically,” concludes Dr. Shorr. “However, in the absence of some marker that allows for accurate and reliable determination of resistant isolates, few options exist. If clinicians fail to acknowledge and adapt to the current situation surrounding infection management, patients will continue to be unnecessarily and inexcusably exposed to the risk of inadequate therapy. This simply becomes a question of ownership. If we do not act, who will?” “MRSA infection is becoming more common while remaining equally deadly,” said Joseph E. Parrillo, M.D., editor-in-chief of Critical Care Medicine. “MRSA is a changing organism and a changing type of infection. We need more clinical research in this area to optimize treatment and to better understand the epidemiology of MRSA infection.” For an audio companion to this article, CLICK HERE.
2006 Health Connect Partners Supply and
Pharmacy Expo
Time is running out to register for the 2006 HCP Supply and
Pharmacy Expo to be held at the Tampa Marriott Waterside
Resort and Marina on September 6-9, 2006. The event will
feature a “Reverse Expo” where there will be over 100 Hospital
Systems represented by VP's of Purchasing and Directors of
Pharmacy so that all vendors will have the opportunity to meet
each of the hospital executives. This will be a two and a half
day educational and networking event that you will not want to
miss. Register now before the event sells out or call Nelson
Hendry at 727-432-6931
for more Conference information
CLICK HERE.
Kimberly-Clark launches femoral angiography
drape for high-fluid diagnostic and interventional procedures
Kimberly-Clark Health Care announced the launch of an
Impervious Extra Long (XL) Femoral Angiography Drape to
deliver the fluid control required for diagnostic and
interventional procedures performed in the Catheterization lab
and interventional radiology lab, where fluid management is
critical for the protection of both patients and staff. The
Impervious XL Femoral Angiography Drape features: A film layer
that provides impervious protection against strikethrough of
blood and other body fluids, as well as dyes, Heparin and
saline solutions used for irrigation, contrast and cleaning of
guide wires; Extended length from top to bottom, as well as
improved absorbent fabric reinforcement to minimize the risk
of safety hazards from fluid pooling and running off onto
staff scrubs, shoes and the floor; Low-lint and
abrasion-resistant fabric reinforcement to reduce the risk of
lint particles adhering to guide wires, catheters or stents,
which can enter the patient’s bloodstream and can cause
significant post-procedural complications. In addition to the
Impervious XL Femoral Angiograph Drape, the KIMBERLY-CLARK
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Grassley, Baucus seek valid survey to underpin government plan for specialty hospitals
Medicare eases fee cuts, and Boston Scientific fears; agency had targeted heart-repair payments
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Grassley, Baucus seek valid survey to
underpin government plan for specialty hospitals
Sens. Chuck Grassley and Max Baucus said that Medicare
officials have made some missteps in their study of specialty
hospitals and need to take more time to collect information
about how specialty hospitals really affect local community
health care delivery. Medicare program officials have been
conducting a survey of both specialty and “competing”
hospitals as part of their effort to meet a requirement set by
Congress to develop a plan to address physician investment in
specialty hospitals. Grassley and Baucus said the trouble is
some of the hospitals selected for this survey to represent
hospitals that compete with specialty hospitals are not even
located in a state where specialty hospitals are allowed to
operate. In turn, some traditional hospitals that compete
directly with specialty hospitals have been left out of the
survey all together. The Centers for Medicare and Medicaid
Services is required by the Deficit Reduction Act of 2005 to
deliver its plan on specialty hospitals by August 8, 2006.
However, the law allows an extension of that deadline and
continuation of the moratorium on approving new specialty
hospitals for two months. “Medicare officials ought to take
that extra time to make sure the plan they will present is
credible, defensible and precise,” Grassley said. “If the
survey’s no good, or it’s skewed in any way, then it’s hard to
argue that the resulting plan will be any good. Congress
requested this plan to better understand the financial
workings of these facilities, as well as the extent to which
they provide care to Medicaid and uninsured patients. The
impact this plan will have on the long term sustainability of
Medicare underscores the need to get this right in a very
clear-cut way.” “CMS should delay issuing this particular
report, rather than risk guiding policy in the wrong direction
with erroneous information. We need to make decisions about
the expenditure of Medicare dollars based on the best data
possible,” said Baucus. Grassley is Chairman and Baucus is
Ranking Member of the Senate Committee on Finance.
Medicare eases fee cuts, and
Boston Scientific fears; agency had targeted heart-repair
payments
After three months of lobbying by
hospitals and the medical-device industry, Medicare yesterday
backed away from a plan that would have sharply reduced the
amount of money it pays for heart repair and other high-cost
procedures. The Centers for Medicare and Medicaid Services
(CMS) released a massive document dictating how much it will
reimburse hospitals for hundreds of medical procedures in
2007. The changes detailed yesterday are far less dramatic
than the federal agency first proposed in April, when it said
it was considering slashing payments for some heart-repair
procedures by one-third, and cutting reimbursement for
defibrillator implants by one-fifth. Although that document
was only a draft proposal, shares of three leading
heart-device companies,
Boston
Scientific Corp. of Natick and St. Jude Medical
Inc. and
Medtronic
Inc. of Minnesota, all sank the next day on
investor concern that less money from Medicare would cause
hospitals to use fewer of the companies’ top-selling devices,
or affect profits by pushing product prices down. Last night,
however, analysts said the new rule should relieve those
concerns. Hospitals and healthcare companies have been
watching Medicare unusually closely this year because the
agency has launched a major change to the way it pays
hospitals. Medicare pays a fixed amount for each type of
procedure, and studies had found that those payments had
become highly unbalanced. Hospitals were profiting on certain
cases, such as cardiac procedures and orthopedic surgery, but
losing money on others, such as stroke victims and lung
patients. The revision increases the amount Medicare pays
overall by $3.4 billion. But it shifts the money around in an
effort to rebalance its payment system and clamp down on a new
breed of hospitals that has emerged to take advantage of
discrepancies in the system. So-called “specialty hospitals,”
owned by doctors, concentrate on the most profitable
procedures, such as coronary angioplasty and orthopedic
surgery, leaving the bulk of less profitable medical care to
community hospitals. The steep cutbacks initially proposed
were of special concern to firms such as Boston Scientific,
because they would have significantly reduced payments for
cardiac stenting and defibrillator implants, two procedures
that involve some of the most lucrative medical devices in the
world. Costs vary at hospitals around the country, but one
financial firm estimated that under the April proposal for
cuts hospitals would have seen a 33 percent reduction in
payments for one stenting procedure, from $11,400 to $7,600,
and a 24 percent decrease in payments for one particular
defibrillator procedure, from $41,000 to $31,000. During the
60-day public comment period that ended June 12, Medicare
logged more than 2,100 comments by e-mail and letter. The
chief lobbying group for the medical-device industry, Advamed,
sent a 29-page letter to Medicare chief Mark McClellan urging
him to delay the proposed changes or make them less severe.
Boston Scientific sent its own 26-page letter by courier,
urging the agency to delay implementing the rule for at
least another year, saying it “will redistribute billions of
dollars and could substantially alter clinical practices.”
Letters signed by more than 200 US representatives and
senators, urged Medicare to delay the new rules till 2008 and
phase them in gradually, saying “the proposed rule may inhibit
adoption of new technology.” McClellan said yesterday that the
agency considered the feedback from industry and hospitals,
and was aiming for a smoother transition that would avoid
“dramatic changes” to the current system. The final changes
will reduce payments for stenting procedures, but by far less
than proposed. For one procedure, for example, the draft rule
called for a 35 percent reduction, but the new rule calls for
only a 14 percent reduction, phased in over three years.
Payment for defibrillator implants, originally scheduled to be
reduced by 21 percent, will increase by less than 1 percent.
(Boston Globe)