July 10, 2007   Download print version

Heart attack death rates appear lower at ‘America's best hospitals’

New way to target and kill antibiotic-resistant bacteria found

Medical sterilization systems market to reach $2.3 billion by 2010, says new report

MedAssets acquires MD-X Solutions and further expands revenue cycle offering

Amerinet expands service; partners with MEMdata to create robust capital budgeting tool

STERIS announces commercial breakthrough with selection as strategic global supplier to TetraPak
 

Heart attack death rates appear lower at ‘America's best hospitals’

Individuals admitted for heart attack to a hospital ranked as one of “America’s Best” by U.S. News & World Report are less likely to die within 30 days than those admitted to a non-ranked hospital, according to a report in the July 9 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Using a methodology that is similar to the recently released mortality measures that are publicly reported by the Centers for Medicare and Medicaid Services (CMS), the study found that ranked hospitals were also more likely to have lower-than-expected death rates, however, many unranked hospitals did as well.

Oliver J. Wang, M.D., of Yale University School of Medicine, New Haven, CT, and colleagues assessed 30-day death rates among 13,662 patients admitted to 50 hospitals ranked on the U.S. News list as the best in “Heart and Heart Surgery” and among 254,907 patients admitted to 3,813 unranked hospitals in 2003. The researchers also compared the hospitals’ standardized mortality ratios, where a ratio of greater than one indicates that the hospital had more deaths than expected and a ratio of less than one means there were fewer deaths than expected. After the researchers factored in patient characteristics, the 30-day death rates were, on average, lower in ranked hospitals vs. non-ranked hospitals (16 percent vs. 17.9 percent). When the hospitals were divided into four groups based on these rates, 35 ranked hospitals (70 percent) were in the group with the fewest deaths, 11 (22 percent) were in the middle two groups and four (8 percent) were in the worst-performing group. Eleven ranked hospitals (22 percent) and 28 non-ranked hospitals (0.73 percent) had standardized mortality ratios significantly less than one, meaning that although ranked hospitals were more likely to have lower-than-expected death rates, non-ranked hospitals with favorable ratios outnumbered ranked hospitals with similar performance by nearly three to one. “As a result, the U.S. News & World Report ranking list does not include many hospitals that have outstanding performances for the care of patients with acute myocardial infarction,” or heart attack, the authors write.

One reason for this may be the reputation component of the rankings, which accounts for one-third of the overall ranking score and is based on cardiologists’ opinions of hospitals that provide the best treatment, the authors speculate. “Citations by cardiologists likely favor tertiary centers with strong subspecialty care for the most critically ill patients while not necessarily reflecting the perceived care for the overwhelming majority of admissions for more common diagnoses, which in turn have a more substantial impact on overall hospital outcomes,” they continue. “The U.S. News & World Report ranking, which includes many of the nation’s most prestigious hospitals, did identify a group of hospitals that was much more likely than non-ranked hospitals to have superb performance on 30-day mortality after acute myocardial infarction,” the authors conclude. “However, our study also revealed that not all ranked hospitals had outstanding performance and that many non-ranked hospitals performed well. Consequently, although the U.S. News & World Report rankings provide some guidance about the performance on outcomes, they fall short of identifying all the top hospitals with respect to 30-day survival after admission for acute myocardial infarction and include a few hospitals that are actually in the lowest quartile of performance.”

New way to target and kill antibiotic-resistant bacteria found

Putting bacteria on birth control could stop the spread of drug-resistant microbes, and researchers at the University of North Carolina at Chapel Hill have found a way to do just that. The team discovered a key weakness in the enzyme that helps “fertile” bacteria swap genes for drug resistance. Drugs called bisphosphonates, widely prescribed for bone loss, block this enzyme and prevent bacteria from spreading antibiotic resistance genes, the research shows. Interfering with the enzyme has the added effect of annihilating antibiotic-resistant bacteria in laboratory cultures. Animal studies of the drugs are now underway. “Our discoveries may lead to the ability to selectively kill antibiotic-resistant bacteria in patients, and to halt the spread of resistance in clinical settings,” said Matt Redinbo, Ph.D., senior study author and professor of chemistry, biochemistry and biophysics at UNC-Chapel Hill.

The study appears online the week of July 9, 2007, in the Proceedings of the National Academy of Sciences. Funding was provided by the National Institutes of Health. In the last decade, almost every type of bacteria has become more resistant to antibiotic treatment. Every time someone takes an antibiotic, the drug kills the weakest bacteria in the bloodstream. Any bug that has a protective mutation against the antibiotic survives. These drug-resistant microbes quickly accumulate useful mutations and share them with other bacteria through conjugation, the microbe equivalent of mating. Conjugation starts when two bacteria smoosh their membranes together. After each opens a hole in their membrane, one squirts a single strand of DNA to the other. Then the two go on their way, one with new genes for traits such as drug resistance. Many highly-drug resistant bacteria rely on an enzyme, called DNA relaxase, to obtain and pass on their resistance genes. A mutation that provides antibiotic resistance can sweep through a colony quickly.

The researchers analyzed relaxase because it plays a crucial role in conjugation. The enzyme starts and stops the movement of DNA between bacteria. “Relaxase is the gatekeeper, and it is also the Achilles’ heel of the resistance process,” Redinbo said.

Led by graduate student Scott Lujan, the team suspected they could block relaxase by searching for vulnerability in a three-dimensional picture of the relaxase protein. The researchers predicted that the enzyme’s weak link is the spot where it handles DNA. Relaxase must juggle two phosphate-rich DNA strands at the same time. The team suspected a chemical decoy, a phosphate ion, could plug this dual DNA binding site. Redinbo realized that bisphosphonates were the right-size decoy. The drugs, called clodronate and etidronate, steal the DNA binding site, preventing relaxase from handling DNA. This wreaks havoc inside E. coli bacteria that are preparing to transfer their genes, the researchers found. The drugs are potent, wiping out any E. coli carrying relaxase. By targeting these bacteria, the drugs act like birth control and prevent antibiotic resistance from spreading. Redinbo, who cautions that the results only apply to E. coli, said further testing will reveal whether bisphosphonates also attack similar species like Acinetobacter baumannii (hospital-acquired pneumonia), Staphylococcus aureus (staph infections) and Burkholderia (lung infections). 

Medical sterilization systems market to reach $2.3 billion by 2010, says new report

Sterilization methods and techniques continue to evolve towards safer, speedier, and more economic processes. Innovation in sterilization is centered on improving cycle times, reducing cost and safety concerns, and designing affordable systems for in-house use. Shaped by diverse trends, the world medical sterilization systems and equipment market is expected to reach US$2.3 billion by 2010. Steam sterilization continues to be the most important and widely used procedure. Steam sterilization market is stable due to regulatory enforcements imposed on EtO sterilization, a method fraught with higher residuals. Usage of new technologies such as E-beam and X-ray, is also set to register higher growth, widening the scope of options available for sterilization procedures.

Going forwards, market share for traditional sterilization procedures such as steam, and EtO is forecast to decline, while gas plasma, gamma, are likely to strengthen. Traditional technologies including EtO gas, gamma, E-beam radiation and steam increasingly incorporate advanced features in sync with changing customer demands. Use of EtO witnessed a diminishing trend due to concerns over toxicity of residuals and chlorofluorocarbons (CFCs) issues. The overall market continues to evolve with new procedures such as Pulsed Light, Plasma and X-Ray being increasingly used for a variety of applications. Another prominent trend exerting a significant impact on the sterilization industry is the proliferation of minimally invasive therapies. This trend is necessitating the development of suitable sterilization protocols for equipment used in these procedures.

United States is the largest market for medical sterilization systems at an estimated US$955 million in 2007. Europe is the second largest market followed by Japan at third position. United States and Europe together account for about 73 percent of the global share. The global and regional markets are expected to grow at modest CAGRs ranging between 4% and 6% through 2010. Steam sterilization market is estimated at US$253 million in 2007 while the Ethylene Oxide sterilization market is projected to reach US$324 million by 2010. The sterilization supplies market is expected to reach close to US$1.1 billion in 2008.

Leading market participants include 3M, Advanced Sterilization Products, Cantel Medical, Getinge AB, Kimberly Clark, SteriGenics, STERIS, TitanScan and Tuttnauer. Sterigenics is the largest sterilization and laboratory services provider in the healthcare sector. STERIS Corp leads the worldwide market in sterilization, washer/disinfector (infection-control systems) and endoscope reprocessing segments. Getinge AB is a leading player in sterilization, disinfection and hygiene systems. “Sterilization Systems and Equipment: A Global Strategic Business Report” provides a comprehensive review of market trends, drivers, challenges, product profile, players, competition, technological developments, recent developments, mergers, acquisitions, and other strategic industry activities. Value analytics are provided in terms of product/process segments such as Steam/Autoclave, Ethylene Oxide Sterilization, Gas Plasma Sterilization, Gamma Radiation and E-Beam Radiation.

For more information, see THIS LINK.

MedAssets acquires MD-X Solutions and further expands revenue cycle offering

MedAssets Inc. announced the acquisition of MD-X Solutions Inc, a provider of revenue cycle technology and services to the healthcare industry. The acquisition expands the revenue cycle offering of MedAssets to include broad solutions for Business Office outsourcing, comprehensive Denials Management software and services, HIM compliant documentation, Point-of-Service collections improvement, and “Silent PPO” Discount Recovery.

In May 2007, MedAssets also acquired Texas-based XactiMed Inc. which offers extensive claims management solutions. The addition of MD-X and XactiMed solutions to the MedAssets Net Revenue Systems’ portfolio will offer an expanded suite of technologies and services to improve the integrity of hospital revenue cycle processes so that hospitals are paid fairly for services provided, and in a timely manner. MedAssets’ push into revenue cycle management is to further deliver on its mission to improve healthcare providers’ margin and cash flow by solving significant problems in revenue cycle and operating costs management, all through one business partner providing integrated customized program with guaranteed financial improvement.

MedAssets current revenue cycle offerings include chargemaster management, charge capture auditing, defensible pricing, as well as supply item file and chargemaster linkage. MD-X, based in Mahwah, NJ, offers web-based tools for: accounts receivable & denials management workflow technology, cash and 835 allowance posting, mapping and reconciliation, concurrent review and case management, coding clarification and optimization, risk management tracking and reporting, infectious disease tracking and reporting, quality and core measures tracking and reporting, patient access process improvement, and dynamic business intelligence reports across all MD-X applications.

Amerinet expands service; partners with MEMdata to create robust capital budgeting tool

Amerinet Inc., a national healthcare purchasing organization, announced the expansion of its BudgetMatch services through an exclusive relationship with MEMdata, Inc. to simplify and streamline the capital budgeting process. The expanded services and new BudgetMatch software have been co-developed in a unique partnership between Amerinet and MEMdata, a technology management firm that specializes in capital equipment procurement, budgeting, research, planning and related activities for health care organizations. The new Web-enabled program is designed to assist medical facilities in maximizing their capital equipment budget to ensure best practices in budgeting and procurement for a more accurate forecast.
 

“Amerinet's BudgetMatch service not only identifies the Amerinet contract matching it to an institution’s budgeted capital equipment, but also provides market-based valuations for the equipment items as well,” said Mike Reid, Amerinet senior director, construction, capital and facility services. Amerinet BudgeMatch, powered by MEMdata, features a password-protected Web site and accepts most electronic file uploads including Microsoft Excel. The system provides the ability to change a facility’s budget as many times as necessary and matches the appropriate equipment entries with Amerinet’s capital equipment portfolio. Some of the key benefits of this new program include: a central repository of provider’s capital equipment budget data in a secure online database; line item contract matching from the Amerinet capital equipment supplier portfolio; depreciation schedules of all assets in capital budget; capital allocation forecasting capabilities; the ability to update the budget, including additions and deletions of line items; automated charting and summaries by department and calendar quarter; and the ability to track actual purchases as they are made throughout the fiscal year.

STERIS announces commercial breakthrough with selection as strategic global supplier to TetraPak

STERIS Corporation announced that Tetra Pak, a provider of food processing and packaging solutions, has selected the Company as a strategic global supplier for the provision of sterilization systems on a Tetra Pak beverage filling platform currently in the final stage of development. The selection follows several years of joint development between the companies resulting in the creation of a unique aseptic beverage filling platform that uses a proprietary STERIS vapor sterilization system and represents an advancement over traditional package sterilization methods. The new sterilization system provides a technology that permits continuous optimization of this core process and contributes to improved capacity and flexibility on Tetra Pak’s next filling platform.   

July 9, 2007   Download print version

CMS publishes new Medicaid drug payment rule

Heart therapy strains efforts to limit costs

PricewaterhouseCoopers agrees to $225 million settlement related to Tyco class action
 

Chromosome linked to colorectal cancer identified

GAO reports on Medicare ultrasound procedures

Study advances vCJD prion detection
 

CMS publishes new Medicaid drug payment rule  

A new method of setting limits on what the federal government will reimburse state Medicaid agencies for prescription drug payments, aimed at reigning in inflated drug product payments, was announced in a final rule put on display at the Federal Register. “This new payment formula allows Medicaid to pay more appropriately for prescription drugs dispensed to Medicaid beneficiaries,” said Leslie V. Norwalk, Esq., acting administrator of the Centers for Medicare & Medicaid Services (CMS). The new regulation is expected to save states and the federal government $8.4 billion over the next five years. Even with this change, the Medicaid program is still expected to spend $140 billion for drugs over the same time period, fiscal years 2007 through 2011. 

The change, part of the Deficit Reduction Act (DRA) of 2005, is in part a reaction to a series of reports issued in 2004 by both the Government Accountability Office (GAO) and the HHS Office of the Inspector General (OIG) showing that Medicaid payments to pharmacies for generic drugs were much higher than what pharmacies were actually paying for those drugs. Both the GAO and the OIG found that states were overpaying for drugs because they were using commercial drug pricing guides as the basis for setting state reimbursement levels. The investigation of these drug “compendia” documented that these prices were artificially inflated, especially for generic drugs. Pharmacies, the reports showed, made the most profit on those generic drugs with the highest mark-up, creating an incentive to dispense those drugs. Prior to the DRA, Federal Upper Limits (FULs), which capped federal matching payments to states for generic drugs, were based on artificially inflated prices reported in the commercial pricing compendia. “These prices (FULs) were so high that most states set their own upper limits on allowable drug costs that were generally far less than the federal FUL,” Norwalk said. Prior to the DRA, many drug companies reported prices to the compendia that bore little relationship to the drug’s cost. Actual drug costs were considered proprietary information that was kept secret. CMS was prohibited by law from disclosing Average Manufacturers Price (AMP).

The DRA also makes an important change to healthcare purchasing by introducing transparency in Medicaid prescription drug pricing and requiring that for the first time, AMPs be publicly reported on the Internet. States will now be able to use actual AMP information as the basis for setting drug reimbursement. Drug makers will also have to report AMPs monthly, as well as quarterly, as was the practice prior to DRA. More frequent reporting will allow states to make timely adjustments to reimbursement rates. The rule will also require states to collect information from physicians on drugs they administer in their offices. Although being published as a final rule, CMS does solicit additional comments on two key areas: (1) the so-called “outlier policy” that eliminates from AMP calculations any drug in an FUL that is priced significantly lower than other drugs in that category and (2) definition of AMP. This will allow CMS the benefit of further public comment as actual AMP numbers become available and the FULs are developed. Interested parties will have 180 days to submit comments. The rule can be viewed at http://www.cms.hhs.gov/MedicaidGenInfo/Downloads/CMS2238FC.pdf.

Heart therapy strains efforts to limit costs

The nation’s most common cardiac malfunction, once thought harmless but now seen as a potential killer, is testing the ability of regulators to keep up with medical treatments being carried out with scant evidence of long-term effectiveness. With its episodes of rapid and irregular heartbeats, the condition, atrial fibrillation, afflicts at least 2.2 million people in the United States, according to government estimates. While some experience no symptoms and most others seem to suffer little more than weakness or shortness of breath, the condition is now recognized as a major source of strokes and a precursor to potentially fatal deterioration of the heart. Already, Medicare and private insurers are spending billions of dollars annually to cope with atrial fibrillation, mostly on hospitalizations, tests and drugs unapproved for such patients. The number of patients is forecast to soar, and spending could climb even more rapidly if many of them receive what many doctors say is now their best hope for a cure, an expensive procedure known as catheter-based ablation. Advocates of the procedure say it is less invasive than open-heart surgery, the only proven method for curing many patients, and in the long run more cost-effective than drugs, which generally offer temporary relief. Thousands of patients worldwide are estimated to have had the procedure done since 2000.

Federal regulators, however, have not approved as safe and effective any of the devices used. So hospitals and doctors are finding it difficult to be fully reimbursed for the procedure’s cost, which is generally calculated at $25,000 to $50,000. “This is one of those areas where the practice of medicine has moved faster than the approval process,” said Daniel G. Schultz, head of the Center for Devices and Radiological Health at the Food and Drug Administration. “This is very high on our list of areas that need concerted attention.” Dr. Schultz said the F.D.A. would soon schedule a public meeting with medical and industry experts to discuss what is known, and still needs to be known, about the welter of drugs and devices now being used without approval to treat atrial fibrillation.

Some of the biggest questions focus on ablation, which involves burning, freezing, or otherwise neutralizing the portions of the heart muscle where abnormal electrical pulses set off the irregular heartbeats. Last month at a medical meeting in Denver, heart rhythm specialists distributed a statement endorsed by the American Heart Association, the American College of Cardiology and four other big American and European doctors’ groups that recommended atrial ablation as standard care for patients who do not respond to drug therapy. Each catheter-based procedure requires disposable equipment that can cost $4,000 to $5,000 a patient. According to Alexander K. Arrow, an analyst at Lazard Capital Markets, atrial fibrillation ablation procedures already account for more than $200 million of the $1 billion annual market for cardiac ablation equipment, which is also used for other kinds of arrhythmia. Companies in the field range from small start-ups to industry giants like St. Jude Medical and Johnson & Johnson. Estimates of the potential market for atrial ablation devices in the next decade range from $1.5 billion to nearly $5 billion, according to Medtech Insight, a market research company in Newport Beach, CA. Those projections include sophisticated diagnostic and computerized-mapping equipment, which is often sold by the same companies. Some leading medical centers also use expensive robotic guidance systems from companies like Hansen Medical and Stereotaxis. (The New York Times) To read the original article see THIS LINK
 

PricewaterhouseCoopers agrees to $225 million settlement related to Tyco class action

PricewaterhouseCoopers LLP (PwC) has agreed to pay $225 million to settle securities and accounting fraud claims relating to the Tyco International Ltd. securities class action, presently pending in the United States District Court for the District of New Hampshire before Judge Paul Barbadoro. This settlement with PwC, combined with the recent settlement with Tyco, the largest ever by a single corporate defendant, will bring the total settlement to more than $3.2 billion by the time it is presented to the court for final distribution, inclusive of interest. The settlement with PwC, reached after four years of litigation and extensive mediation, represents one of the largest recoveries on record from an outside auditor in the history of securities class action litigation. Investors who purchased or acquired Tyco securities from December 13, 1999 through and including June 7, 2002 are covered by the settlement. 

Shareholders alleged that as Tyco’s auditor, PwC was in a unique position to uncover the fraud and to prevent the damages to Tyco’s shareholders. However, PwC is alleged to have failed in its duties as a corporate watchdog at a time when Tyco is alleged to have overstated its income during the class period by $5.8 billion. Defendants Dennis Kozlowski (Tyco’s former CEO) and Mark Swartz (former CFO) have been sentenced to up to 25 years in prison after being convicted of grand larceny, falsification of business records and conspiracy for their roles in the alleged scheme to defraud investors. Former Tyco board member Frank Walsh has also pled guilty to committing fraud.  

Chromosome linked to colorectal cancer identified

Researchers at the Ontario Institute for Cancer Research and Cancer Care Ontario have successfully identified a specific genetic variation on chromosome 8 that is associated with colorectal cancer. This is the first genetic predictor that has been identified for the most common forms of colorectal cancer to date and may play a significant role in how people are screened for the disease. The study was published in Nature Genetics reporting the work of the Assessment of Risk for Colorectal Tumours in Canada (ARCTIC) project. The project involved researchers from around the world including the U.S., France, England and Scotland who analyzed more than 100,000 genetic elements from 10,000 people, including 2,400 Ontarians from the Ontario Familial Colorectal Cancer Registry. Previous research on this chromosome has linked it to other forms of cancer, including prostate cancer, suggesting that individuals with this newly discovered variation may be at risk for a broad spectrum of cancers. “This discovery will lead to better understanding of colorectal cancer biology and the cause of this disease,” said Dr. Tom Hudson, co-principal investigator and president and scientific director of the Ontario Institute for Cancer Research. “This information can be used to identify those at risk of colorectal cancer and direct them to screening at an earlier age.” (News-Medical.net) For more information, see THIS LINK

GAO reports on Medicare ultrasound procedures

Medicare spending on imaging services, among which are ultrasound procedures that use sound waves to facilitate diagnosis, nearly doubled from 1999 to 2004. The Congress required the United States Government Accountability Office (GAO) to examine Medicare’s payment methods for ultrasound procedures and whether the technicians that conduct them, called sonographers, should be subject to qualification standards, such as having to undergo a certification process called credentialing. This report addresses (1) the ultrasound procedures commonly used to diagnose medical conditions of Medicare beneficiaries, particularly for beneficiaries in a skilled nursing facility (SNF), (2) the financial impact of changing how Medicare pays for ultrasound exams and associated equipment and ambulance transportation for beneficiaries in a SNF, and (3) the factors for the Centers for Medicare & Medicaid Services (CMS) to consider in determining whether to establish credentialing or other requirements for sonographers.

Three-fourths of the approximately 41 million ultrasound procedures provided to Medicare beneficiaries in 2005 in any setting were one of two types: (1) echocardiograms to diagnose heart conditions or (2) noninvasive vascular procedures used to monitor blood flow and detect blockage or injury in veins and arteries. Ultrasound procedures consist of the ultrasound exam itself and the physician’s interpretation of the exam. Nearly all of the ultrasound exams provided under Medicare Part B, which covers physician, hospital outpatient, diagnostic testing, and certain other services, were performed in physicians’ offices and hospital outpatient departments.

Two ultrasound procedure payment changes affecting SNF beneficiaries that GAO examined would likely increase expenditures and beneficiary cost sharing. If CMS had paid to transport ultrasound equipment to beneficiaries in SNF stays not covered by Medicare, which is not currently done, Medicare expenditures could have increased by an estimated $9.8 million and beneficiary cost sharing could have been about $2.6 million higher in 2005, assuming the number and location of services would not change in response to this policy. Moreover, paying separately for ultrasound exams and related transportation during beneficiaries’ Medicare-covered SNF stays, as opposed to bundling these and other services into a single daily payment as CMS currently does, could have increased Medicare payments by about $22.0 million and beneficiary cost sharing by about $13.4 million in 2005, assuming no change in service use due to the revised policy.

The skill of the sonographer conducting an ultrasound is critical for its use to support a physician’s correct diagnosis; poorly captured images can lead to misdiagnoses or unnecessarily repeated exams. Findings from several peer-reviewed studies, the Medicare Payment Advisory Commission, and ultrasound-related professional organizations support requiring that sonographers either have credentials or operate in facilities that are accredited, where specific quality standards apply. CMS stated that it would consider this recommendation. To view the report see THIS LINK

Study advances vCJD prion detection

Scientists have made significant advances towards the development of a technique that could be used to confirm whether someone is infected with variant CJD. The technique, which has so far been used mainly in animal models, works by mimicking and accelerating the replication of prions, abnormal proteins that progressively kill off brain tissue and are thought to cause the disease. The method, known as known as Protein Misfolding Cyclic Amplification (PMCA), enables the level of prions to be increased so that they can be recognised by existing detection methods. Researchers have shown for the first time that the number of vCJD prions can be amplified from infected human brain tissue extracts prepared from normal human platelets, a type of blood cell essential for clotting. The sample is incubated and exposed to repeated rounds of ultrasound, which break the prions up into more numerous smaller particles. However, more research is urgently needed to ensure that the technique, which has been applied to brain tissue, can be applied to other tissues, such as blood, that might be used in tests for vCJD.

Professor James Ironside, of the National CJD Surveillance Unit at the University of Edinburgh, said: “While this method, due to the length of time it takes to carry out, is unlikely to produce a rapid screening test that could be implemented in blood donation centres it may well be suitable as a confirmatory test that could be conducted at a national centre. “Work is currently ongoing to develop a screening test for vCJD but one of the issues common to various screening tests is that of “false” positive results. By developing a reliable confirmatory test, such as this one, the impact of these false positives can be minimized. However, the ethical dilemma remains over screening and testing for a disease for which there is no cure.” A total of 161 people have died from variant CJD since the disease emerged in early 1990, including three people who received blood transfusions from donors who later developed the disease. There is therefore an urgent need to develop tests that may be used to screen blood donations for vCJD infectivity, backed up with confirmatory tests, to prevent further examples of disease spread through infected blood.

July 6, 2007   Download print version

Farmed in China's foul waters, imported fish treated with drugs

SPSmedical announces monthly audio seminars for healthcare facility
in-services

Periodontal bacteria found in amniotic fluid

Catastrophic head injury three times greater in high school vs. collegiate football players

New medical implants should react with the body, not seek to be inert

New 'asthma gene' could lead to new therapies

Amerinet signs exclusive agreement with ASCA
 

Farmed in China's foul waters, imported fish treated with drugs

Perched above the banks of the catfish farm he owns is Zhu Zhiqiu's secret weapon for breeding healthy fish: the medicine shed. Inside are iodine bottles, vitamin packets and Chinese herbal concoctions that he claims substitute for antibiotics. Zhu's fish farm, in a village on the lower reaches of the Yangtze River, sends about 2.7 million catfish fillets each year to the United States through an importer in Virginia. Despite his best efforts -- he has dozens of employees clearing trash from the water each day, and the fish are fed sacks of fish meal more expensive than rice -- Zhu's fish sometimes get sick. Then he brings out the drugs.

Chinese exporters like him have seized much of the U.S. market, accounting for 22 percent of all imports, because their fish are cheaper to raise. The fish are being raised, however, in a country whose waterways are an ongoing environmental problem, tainted by sewage, pesticides, heavy metals and other pollutants. The situation is worst in the southern half of the country, where Zhu's farm is and where industrial runoff accumulates. Like other fish farmers throughout the world, catfish growers in China turn to a variety of potions. But the extent to which they use traditional Chinese medicine, which cannot be tested for as easily in the Western countries that import fish, is unusual. Zhu claims to use only safe and legal drugs, but it was clear that some of his competitors have not been so scrupulous.

The competitors spike the water with banned substances to keep their farmed fish alive. Batches of seafood traded at the Shanghai fish market this week, for example, carried the tell-tale greenish tinge of malachite green, a disinfectant powder that has been banned in China for five years because it is a suspected carcinogen but is still commonly used. Illegal substances like malachite green keep showing up in Chinese seafood shipped to the United States, provoking a partial U.S. ban on such shipments last week. It was the latest development in an ongoing global awakening about the risks of Chinese-made products, from toys tainted with lead paint to pet-food ingredients containing a deadly industrial chemical. Many of the "Southern-style" catfish fillets on U.S. grocery shelves these days are indeed from the south -- of China.

The Chinese government's own reports express alarm that many rivers in this region are so contaminated with heavy metals from industrial byproducts and pesticides, including DDT, that they are too dangerous to touch, much less raise fish in. In the city of Wuxi this month, for example, blue green algae, exacerbated by factories dumping waste, infested several nearby lakes that provide drinking water to the point where the government had to shut off the water supply. Outside of Qingdao, pollutants from nearby liquor and leather factories have turned streams a murky gray. And in Nanjing, the river that cuts through the city is full of urban trash such as twisted metal and clothing. Chinese food producers' reliance on chemicals, whether as a means to increase prices of their wares by tricking importers or as a way to inexpensively keep food fresh, has come under increasing scrutiny in recent months.

Zhu says that all the quality-control tests of his fish have shown no illegal substances and that the traditional Chinese medicines are safer because they are normally used to treat human illnesses. Instead of using antibiotics, Zhu regularly gives his fish Gandankang, a Tibetan blend that people take for liver and gall bladder problems. He also sometimes uses a "magic grass pill" made from a root used to treat diarrhea or dysentery and help stop miscarriages in humans. The claim that giving fish traditional Chinese medicine is safe is backed up by China Catfish Institute, a research group affiliated with the Ministry of Agriculture.

But Cao Yulin, general manager of the Jiangsu Baolong Group, which exports catfish and uses some herbal medicines in his own fish farms, said that even traditional Chinese medicines can pose a threat. While in general they are safer than other chemicals because there is less residue, he said, some smaller farmers are not well trained and may not prepare the medicines -- some of which need to be boiled or mixed -- properly. Even the Chinese government's own reports are damning, describing how industrial and urban sewage forces farmers to use chemicals to keep the fish alive.

Tom Sherman, vice president of marketing for Icelandic USA of Newport News, Va., which imports catfish from Zhu's farm through an exporter, said he was not aware that traditional Chinese medicine was used in raising the fish the company brings to the United States.

Zhu's is one of eight fisheries in the area that sells to the Xiajiang Agricultural Industry Development, a processing company that fillets and freezes the fish. It is a high-risk but lucrative industry for the region, with a profit margin that can be as much as 40 percent for farmers and 30 percent for processors. Liu Tianyuan, factory manager for the processing company, said profit would be even greater, even 20 percent more, if the plants were not so concerned about quality. He said the company spends a lot of money each year training its farmers on how to best use drugs safely and tests each batch of fish for illegal contaminants three times during its seven- to eight-month growing cycle. Xiajiang sells the fish to Icelandic USA, which breads the fillets and sells them to food-service companies or through its own retail brand as "Southern-Style Biscuit Battered Catfish Fillets" at grocery stores.

In a statement, Icelandic said it supports the FDA restrictions and that it ensures quality by boarding vessels with its seafood, and checking the farms and production facilities. All of its suppliers are "required to test their products for all banned substances by an official certified laboratory," it said.

For the complete story see: THIS LINK.

SPSmedical announces monthly audio seminars for healthcare facility
in-services

SPSmedical announces monthly Audio Seminars on a variety of infection prevention and sterilization topics to health care facilities. This new educational service assists health care facilities comply with educational training and provides certified staff with CEUs. Charles Hughes, Lead Educator of SPSmedical provides a one hour CE presentation, pre-approved through both IAHCSMM and CBSPD. Each seminar allows time for Q & A at the end of the presentation. For those unable to attend the live broadcast, a recording will be available for 30 days via the internet. SPSmedical provides handouts prior to each Audio Seminar and a post seminar notification is sent including audio file, certificate of participation and evaluation form. There is no cost to each attendees; however, the health care facility is charged a small fee for each phone connection. For a complete listing of seminar objectives visit: THIS LINK.

Periodontal bacteria found in amniotic fluid

A study appearing in the July issue of the Journal of Periodontology found bacteria commonly found in the mouth and associated with periodontal diseases in the amniotic fluid of some pregnant women. The study, which evaluated 26 pregnant women with a diagnosis of threatened premature labor, found the presence of periodontal bacteria, P. Gingivalis, in both the oral cavity and amniotic fluid in 30% of the women. Amniotic fluid is a liquid that surrounds an unborn baby during pregnancy. Any disruptions in the amniotic fluid, such as a bacterial infection, could potentially be dangerous to both the mother and baby.

 “While this study’s findings do not show a direct causal relationship between periodontal diseases and adverse pregnancy outcomes, it is still important for women to pay special attention to their oral health during pregnancy,” explained Preston D. Miller, Jr., DDS, President of the American Academy of Periodontology. “Woman who are pregnant or considering becoming pregnant should speak with their dental and health care professionals about their oral health during pregnancy.”

The Academy has a risk assessment test and information available online at www.perio.org.

Catastrophic head injury three times greater in high school vs. collegiate football players

The incidence of catastrophic head injuries in football is dramatically higher at the high school level than at the college level, according to a study published in the July issue of The American Journal of Sports Medicine. Catastrophic head injuries, which include brain bleeding and swelling, are rare and can be devastating. Athletes with major brain injuries may be left with permanent brain damage.

“High school football players have more than three times the risk of a catastrophic head injury than their college peers,” says lead author, Barry P. Boden, M.D., from the Orthopedic Center in Rockville, Md., and adjunct associate professor at the Uniform Services University of the Health Science in Bethesda, Md. Boden and coauthors also found a high percentage of high school athletes playing with neurologic symptoms from a previous head injury at the time they sustained a catastrophic injury. Football has more direct catastrophic injuries than any other sport tracked by the National Center for Catastrophic Sports Injury Research (NCCSIR). More than 1.2 million high school athletes played football during the 2001-2002 academic year.

“The incidence of injury is higher at the high school level compared to the college level, which may indicate that the younger brain is more susceptible to a brain injury,” explains Dr. Boden. “Many of the players who had a severe head injury were playing with minor neurological symptoms from a previous head injury such as a concussion.” Dr. Boden suggests that players should be discouraged from using their heads to tackle, since 81% of the injuries were caused by helmet-to-helmet collisions (16/37) and helmet-to-body collisions (14/37).

“The single most important piece of advice that I can give is to never let an athlete play football if he has any neurological symptoms whatsoever, says Dr. Boden. Those symptoms may include amnesia, dizziness, headache, irritability, and personality change. Of the difference in catastrophic head injuries between high school and college players, Boden theorizes: “High school students might take longer to recover from a concussion than college players. Another possible reason for these reported injuries may be that there aren’t as many team physicians covering high school games as college games. Consequently, some high school athletes may not be properly evaluated or receive medical attention.”

New medical implants should react with the body, not seek to be inert

A world leader in medical implants calls for a rethink in our approach to building medical implants. Currently so-called biomaterials are chosen because they are reasonably successful at hiding from the body’s immune system, and are consequently not rejected. All the same, within a month of implanting them, the body isolates implants by wrapping them in a collagenous, avascular sac. Materials are considered to be ‘biocompatible’ if this sac is not too thick.

“That’s not very clever,” says Professor Buddy Ratner, Director of the University of Washington Engineered Biomaterials, in Seattle, USA. In a commentary published in Polymer International, he says that it is time to take a more intelligent approach. Rather than building implants out of materials that try to hide from the body’s systems, he believes that we should be creating them from materials that are specifically designed to engage with biological processes. This could take the form of materials made with specifically sized pores that encourage small blood vessels to actively grow through the implant, or implants coated with DNA that specifically prevents formation of the collagenous capsule. Both of these let the implant and the body actively work together, rather than simply try to prevent them fighting against each other.

New 'asthma gene' could lead to new therapies

A gene that is strongly associated with a risk of developing childhood onset asthma was identified by an international team of scientists, whose findings are published July 5th in the journal Nature.

In a genetic study of more than 2,000 children, scientists from the University of Michigan and colleagues from London, France and Germany found genetic markers that dramatically increase a child's risk for asthma. These markers are located on chromosome 17, and children with this marker had higher levels of a new gene called ORMDL3 in their blood, which occurs in higher amounts in children with asthma. The presence of the disease-associated version of ORMDL3 increases the risk of asthma by 60-70 percent, the study suggests.

"In terms of an asthma gene, there have been quite a few reports but not one that can be clearly reproduced in samples," said Goncalo Abecasis, associate professor at the U-M School of Public Health. "I think eventually it will lead to new therapies because it points to a specific biological molecular pathway. Once we understand the biology and we know the players, it's possible to target with specific drugs."

Childhood asthma treatments are heavily focused on allergic responses, since most children with asthma also have many allergies. The discovery of a so-called 'asthma gene' would provide a new set of mechanisms to try and modify and manage childhood asthma, Abecasis said.

Asthma, a complex disease caused by a combination of genetic and environmental factors, is the most common chronic disease of childhood. Asthma occurs in 7-10 percent of children in the United States and one child in seven in the United Kingdom.

Amerinet signs exclusive agreement with ASCA

Amerinet Inc., a national health care purchasing organization, recently signed an agreement to serve as the sole-source purchasing agent for the members of the Ambulatory Surgery Center Association (ASCA) (formerly Illinois Free Standing Surgery Center Association) based in Chicago, Illinois. The partnership will also focus on Total Spend Management Solutions including cost reduction, contract evaluation and implementation, and education and program coordination at all of the association’s member facilities. Amerinet will also negotiate custom contracts on behalf of ASCA, and make available an array of competitively priced, quality products and services provided by industry leaders. This three-year agreement creates a partnership of shared responsibility to reduce costs and discover new revenue streams.     

July 5, 2007   Download print version

China tightens restrictions on transplants

Sonosite files patent infringement lawsuit against GE

Visits to emergency departments jump to all-time high of 115 million

China finds poor quality on its store shelves

FDA approves a hip resurfacing implant

New standards for E-prescribing and computer-generated faxes

Consumption of small amounts of dark chocolate associated with reduction in blood pressure
 

China tightens restrictions on transplants

The Chinese government imposed new restrictions on organ transplants for foreigners Tuesday, part of an effort to curtail widely reported abuses such as selling organs and, in some hospitals, catering to foreigners looking for discount hearts, livers and kidneys. The regulations, handed down by the Health Ministry, stipulate that foreigners visiting China on tourist visas cannot receive transplants, hospitals cannot advertise abroad and any hospital planning to carry out a transplant on a foreign patient must first get authorization from Chinese health authorities.

Chinese health officials have estimated that as many as 1.5 million Chinese could benefit from transplants each year, but only about 10,000 can find compatible organs. The number of foreigners who receive transplanted organs in China has not been revealed. But some hospitals have launched advertising campaigns on the Internet to draw in foreigners, who often would face longer waits and higher prices in their own countries.

Transplants have long been a controversial issue in China because of allegations that organs are often taken from executed prisoners without their authorization, and thus are more plentiful here than abroad. Chinese officials have acknowledged that some organs used for transplants come from executed prisoners, but they say the number of such cases is low and prior authorization is required. The Epoch Times, a newspaper published overseas and linked to the banned Falun Gong movement, last year accused Chinese authorities of running a secret camp in northeastern Shenyang where Falun Gong detainees allegedly were killed to provide organs for sale. The Foreign Ministry dismissed the allegations as slander by an illegal cult, which is how authorities here have defined the Falun Gong, and foreign reporters taken to tour the facility found nothing out of the ordinary. Estimates on the number of executions range from 3,000 to 8,000 a year. International human rights groups say organs often come from executed prisoners and voice concern that the wishes of prisoners or their families are sometimes ignored. (Washington Post)

For the complete story see: THIS LINK.

Sonosite files patent infringement lawsuit against GE

SonoSite, Inc. announced it is filing today a patent infringement lawsuit against General Electric Company (GE) and certain of its affiliates in the U.S. District Court for the Western District of Wisconsin. The complaint is filed as a counterclaim to the complaint GE and its affiliates filed against SonoSite on May 15, 2007 in the same court. In parallel, SonoSite is filing its answer to the complaint denying all of GE’s claims and alleging that the asserted patents are either invalid, not infringed, or both. SonoSite’s patents cover various core ultrasound-related technologies. The complaint seeks unspecified monetary damages and a court injunction against future infringement by GE and its affiliates.

Visits to emergency departments jump to all-time high of 115 million

Visits to emergency departments increased to an all-time high of 115 million in 2005, 5 million more than in 2004, according to a new report from the Centers for Disease Control and Prevention. The American College of Emergency Physicians (ACEP) said the increase in visits combined with closures of emergency departments threaten the safety of patients and will further endanger an already fragile system. “With 315,000 people visiting emergency departments every day, the alarm bells are sounding and policymakers should heed the alert and respond,” said Brian Keaton, MD, president of ACEP. “Emergency physicians are dedicated to saving lives. We want to provide quality care to all of our patients, but we need additional resources to be able to deliver that care. That’s why we are asking Congress to pass the Access to Emergency Medical Services Act. This urgently needed legislation will help reduce the dangerous trends that are limiting the public’s access to high-quality, lifesaving medical care and stripping emergency departments of their ability to respond to disasters.”

The Access to Emergency Medical Services Act (H.R. 882 and S.1003) calls for the creation of a national bipartisan commission on access to emergency medical services which will examine factors that affect and may impede the delivery of care in U.S. emergency departments. The proposed legislation also recognizes the need for additional resources in support of care delivery. The Senate bill directs that a working group within the Centers for Medicare and Medicaid Services be convened to develop boarding and diversion standards, as well as guidelines and incentives for implementation of those standards. The House bill requires hospitals to report to the Department of Health and Human Services statistics on how many patients are boarded and for how long. The legislation is sponsored by Reps. Bart Gordon (D-TN) and Pete Sessions (R-TX) and U.S. Senators Debbie Stabenow (D-MI) and Arlen Specter (R-PA). According to the new report, nearly 42 million visits to emergency rooms were because of injuries. The leading patient complaints, accounting for nearly one-fifth of all visits, were abdominal pain, chest pain and fever. Only 13.9 percent of visits were for nonurgent medical reasons, conditions that can still need medical attention soon, such as bladder infections, high fevers, and extremity injuries that could be fractures. The new report said the closure of emergency departments combined with the overall increase in visits resulted in a 31-percent increase in visits per emergency department since 1995. There were 30,388 visits per emergency department in 2005 compared with 23,119 visits per emergency department in 1995. Medicaid recipients had the highest rate of emergency visits (88/100 persons) of all groups including Medicare enrollees and the uninsured, which indicates severe health care access problems by Medicaid patients. “Emergency departments are the nation’s health care safety net for everyone, not just the uninsured,” said Dr. Keaton. “But that safety net is breaking under the load, and we are asking the public to contact their members of Congress today by logging onto ACEP’s website at www.acep.org.

China finds poor quality on its store shelves.

China said on Wednesday that nearly a fifth of the food and consumer products that it checked in a nationwide survey this year were found to be substandard or tainted, underscoring the risk faced by its own consumers even as the country’s exports come under greater scrutiny overseas. Regulators said the broad survey of foods, agricultural tools, clothing, women and children’s products and other types of goods turned up sizable quality and safety failure rates for products that are sold domestically.

The government said, for instance, that canned and preserved fruit and dried fish contained excessive bacteria; that 20 percent of the fruit and vegetable juice surveyed was deemed substandard, and that some children’s products were defective or laced with harmful chemicals. The government also said baby formula and baby clothing did not meet the safety standards, that animal feed, fertilizer and agricultural equipment were defective and that many food items were mislabeled or heavily colored by additives.

The announcement came in the midst of a growing scandal over the quality and safety of Chinese-made exports and follows a series of international recalls involving everything from contaminated pet food ingredients and counterfeit toothpaste to toxic toys, defective tires and contaminated seafood. The announcement also suggested that Chinese consumers are at serious risk of being harmed by purchasing tainted foods, substandard goods and suspect or defective equipment. Regulators said, in effect, that goods sold in China were far more hazardous than the exports that were driving the country’s economic growth and now partly the subject of safety and quality debates.

During the last month, regulators and quality inspectors say they have discovered candied fruit with 63 times the permitted amount of sweetener; excessive additives and preservatives in nearly 40 percent of the children’s snacks surveyed in western Guangxi province; fake human blood protein at hospitals; and food tainted with formaldehyde, illegal dyes and industrial wax. Last week, the government even said it had shut about 180 food factories nationwide because of food safety violations. From December to May, regulators said they uncovered 23,000 cases involving fake or low-quality food.

Experts say aggressive and opportunistic entrepreneurs continue to take advantage of the country’s chronically weak enforcement of regulations, choosing to blend fake ingredients into products; to sign contracts agreeing to sell one product only to later switch the raw materials for something cheaper; and to doctor, adulterate or even color foods to make them look fresher or more appetizing, when in fact they might be old and stale. (NY Times)

For the complete story see: THIS LINK.

FDA approves a hip resurfacing implant

The Corin Group of Britain and Stryker said yesterday that the Food and Drug Administration (FDA)had approved the Cormet hip resurfacing implant by Corin, thus giving American consumers an alternative to another hip resurfacing system for the first time since the FDA approved that device in May 2006.

Stryker, based in Kalamazoo, Mich., has a 10-year distribution agreement with Corin covering sales of the device in the United States. Stryker said that it hoped to have enough orthopedic surgeons complete the training program agreed upon with regulators to begin marketing the Cormet by the end of September.

Although total hip replacement has become a common and exceedingly successful operation for patients whose natural hip has been irreparably damaged by illness or injury, resurfacing has attracted surgeons and many patients because it preserves more of a patient’s thigh bone. That makes it easier to replace the original implant with a total hip in the future if necessary, which is often the case for active patients who have their artificial hips for 15 or 20 years. Some hip resurfacing advocates say the procedure also leads to quicker recoveries, greater range of motion in the hip and a more natural distribution of weight and pressure on the thigh bone, or femur.

Analysts have forecast that 10 percent to 15 percent of the nearly 300,000 Americans a year who get hip replacements might be good candidates for resurfacing. Both operations cost $25,000 or more at most hospitals that offer them.

New standards for E-prescribing and computer-generated faxes

The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule on June 29, 2007, that would establish new policies and payment rates for physicians and other providers who are paid under the Medicare physician fee schedule (MPFS). Included in the proposed rule is a provision that would eliminate the exemption for computer generated faxes from the e-prescribing standards.

Computer generated faxing retains some of the disadvantages of paper prescribing. For example, the pharmacy incurs the administrative cost of keying the prescription into the pharmacy system and there is a potential for data entry errors that may have an adverse impact on patient safety. CMS believes it is important to take steps to encourage prescribers and dispensers to move toward the use of the SCRIPT standard. Therefore, CMS is proposing to eliminate the computer-generated fax exemption for all prescriber/dispenser transactions. With improved and more readily available standards based e prescribing products, CMS believes that eliminating the exemption will encourage e prescribers and dispensers to move as quickly as possible to using the SCRIPT standard. CMS expects the impact on prescribers to be minimal.

Consumption of small amounts of dark chocolate associated with reduction in blood pressure

Eating about 30 calories a day of dark chocolate (approximately 1½  Hershey’s dark chocolate kisses) was associated with a lowering of blood pressure, without weight gain or other adverse effects, according to a study in the July 4 issue of JAMA. Previous research has indicated that consumption of high amounts of cocoa-containing foods can lower blood pressure (BP), believed to be due to the action of the cocoa polyphenols (a group of chemical substances found in plants, some of which, such as the flavanols, are believed to be beneficial to health). “A particular concern is that the potential BP reduction contributed by the flavanols could be offset by the high sugar, fat and calorie intake with the cocoa products,” the authors write. The effect of low cocoa intake on BP is unclear. 

The researchers tested dark chocolate and white chocolate. They found that from baseline to 18 weeks, dark chocolate intake reduced average systolic BP by −2.9 (1.6) mm Hg and diastolic BP by −1.9 (1.0) mm Hg without changes in body weight, plasma levels of lipids or glucose. Systolic and diastolic BP remained unchanged throughout the treatment period among those in the white chocolate group. Dark chocolate consumption resulted in the short-term appearance of cocoa phenols in plasma and increased vasodilatory S-nitrosoglutathione. There was no change in plasma biomarkers in the white chocolate group.

“Although the magnitude of the BP reduction was small, the effects are clinically noteworthy. On a population basis, it has been estimated that a 3-mm Hg reduction in systolic BP would reduce the relative risk of stroke mortality by 8 percent, of coronary artery disease mortality by 5 percent, and of all-cause mortality by 4 percent,” the authors write.     

July 3, 2007   Download print version

CMS proposes policy, payment changes for physicians’ services in 2008

CMS issues final citizenship guidelines for medicaid eligibility

Fletcher Allen Health Care chooses MedAssets net revenue systems for chargemaster monitoring and management

Keeping patients’ details private, even from kin

Medicare moves to stamp out S. Fla. Fraud

Tyco becomes Covidien

Scientists discover key to manipulating fat; Pathway also explains stress-induced weight gain