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January 2006
Preliminary findings: 2004
national sample
survey of registered nurses
HMOs earn $7 billion in first
half of 2005
Doctors: Primary care system
on verge of collapse
SMI ramps up initiative activity
Tronex Healthcare announces
contract with Consorta
Tally of human bird flu cases rises to 160
The U.N. health agency on Tuesday raised to 160 its official tally
of people worldwide who have been infected with the deadly H5N1
strain of bird flu virus after laboratory tests in London confirmed
that at least 12 people in Turkey have been infected with the
disease. The death toll from the disease has risen to 85, including
four in Turkey, the World Health Organization said. Nine further
samples, from individuals confirmed by Turkish health officials as
H5N1 positive, are still being examined in Britain to verify that
they carried the disease, said WHO spokesman Iain Simpson. The
agency does not officially update its tally of confirmed cases until
the disease has been verified in a laboratory outside the country of
the outbreak, meaning that WHO's figures often lag behind national
counts. All human cases had been restricted to eastern Asia until
the first positive test results for the virus in Turkey earlier this
year. On Monday, Iraqi officials announced that a 15-year-old girl
who died Jan. 17 had contracted bird flu, the first human case in
that country. Simpson said WHO was sending a team to northern Iraq
to investigate possible bird flu cases. (The Associated Press)
Preliminary findings: 2004 national sample
survey of registered nurses
The National Sample Survey of Registered Nurses (NSSRN) is the Nation’s most extensive and comprehensive source of statistics on registered nurses (RNs) with current licenses to practice in the United States whether or not they are employed in nursing. The Department of Health and Human Services, Health Resources and Services Administration, Bureau of Health Professions previously conducted seven sample surveys. The eighth NSSRN began data collection in March 2004 and responses were received through November 2005. The resulting database for the 2004 NSSRN is comprised of 35,724 individual licensed RNs from all 50 States and the District of Columbia. After applying weights to each response, the total number of licensed RNs living and working in the U.S. was estimated to be 2,909,467 as of March 2004, an increase of 7.9 percent or 212,927 above the 2,696,540 licensed RNs estimated in 2000. This increase is higher than the 5.2 percent increase reported between 1996 and 2000 when the RN population increased by 137,666, but lower than the estimated 14.2 percent or 319,058 increase between 1992 and 1996, which was the highest rate of growth since 1980. Of the total licensed RN population in March 2004, 83.2 percent (an estimated 2,421,461) were employed in nursing in 2004 and 16.8 percent were not employed in nursing in 2004. This estimate of the number employed in nursing represents an increase of 219,647 RNs (10 percent) over the projected 2,201,813 RNs employed in nursing in 2000. Of the total estimated population of nurses in 2004, 58.3 percent (1,696,916) were working full-time, and almost 25 percent (724,544) were working part-time in 2004. In 2004, the most common initial preparation for nursing was an associate’s degree. There has been a downward trend in the number of nurses whose initial preparation for nursing was a diploma program. An estimated 0.5 percent of RNs in 2004 (15,511) had received their initial nursing education through a master’s or doctoral degree program. The highest level of preparation for an estimated 17.5 percent of RNs is a diploma; for an estimated 33.7 percent the highest preparation is an associate degree; for 34.2 percent it is a baccalaureate degree; and for 13.0 percent it is a master’s or doctoral degree. The highest increase from 2000 to 2004 was for the number of RNs receiving their master’s or doctorate degrees (37 percent) compared to a decrease of 15.2 percent in the number of RNs whose highest degree was a diploma. Over the entire period from 1980 to 2004, there was a 43.5 percent decrease in the number whose highest level of preparation was a diploma, while the number whose highest level was a masters or doctorate increased by 339 percent. The estimated number of RNs whose highest preparation was a baccalaureate increased by 170 percent and the estimated number whose highest preparation was an associate’s degree increased by 232 percent. The trend toward more RNs in older age groups continued. The average age in each survey since 1980 has increased. In March 2004, the average age of the RN population was estimated to be 46.8 years of age, more than a year older than the average age of 45.2 years estimated in 2000; and more than 4 years greater than in 1996 when the average age was 42.3 years. In 2000, an estimated 31.7 percent of all RNs were under the age of 40; in 2004 only 26.6 percent of all RNs were estimated to be under the age of 40. Continuing the history of nursing, relatively few men are licensed as RNs, with a slight, insignificant increase estimated for 2004 from 5.4 percent in 2000 to 5.7 percent in 2004. However, it appears that the initial nursing preparation for more male RNs was an associate’s degree rather than a diploma (53.5 percent for men compared to 42.2 percent for women).
HMOs earn $7 billion in first half of 2005
The nation's HMOs1 reported a $6.98 billion profit for the first six months of
2005, representing a $1.2 billion, or 21.2 percent, increase over the $5.76
billion earned during the same period in 2004, according to Weiss Ratings Inc.,
an independent provider of ratings and analyses of financial services companies,
mutual funds, and stocks. HMOs reporting the largest year-over-year dollar
increases in net income include: Horizon Healthcare Services Inc. (Newark, NJ),
262.7% change, Oxford Health Insurance Inc. (New York, NY), 120.6% change,
Capital Advantage Insurance Co. (Harrisburg, PA), 348.3% change, Blue Cross Blue
Shield of Michigan (Detroit, MI), 27.6% change, Aetna Health Inc. (Uniondale,
NY), 83.8% change. “Despite a slowdown in earnings growth, industry
profitability remains strong," said Melissa Gannon, vice president of Weiss
Ratings Inc. “With premium rate increases leveling off, insurers will look for
more innovative cost control measures to remain competitive and financially
secure.” Of the 503 HMOs reviewed by Weiss using second quarter 2005 data, 76
were upgraded, while 12 were downgraded. Notable upgrades were: Community
Insurance Co. (Mason, OH), from B+ to A-; Mercy Health Plans of
Missouri Inc. (Chesterfield, MO), from B+ to A-; Total Health Care Inc.
(Detroit, MI), from C+ to B-. Notable downgrades include: Health First Health
Plans (Rockledge, FL), from C+ to C-; UPMC Health Plan Inc. (Pittsburgh, PA)
from B- to C; SHA LLC (Austin, TX), from C- to D+.
http://www.weissratings.com/
Doctors: Primary care system on verge of collapse
Primary care, the basic medical care that people get when they visit their doctors for routine physicals and minor problems, could fall apart in the United States without immediate reforms, the American College of Physicians said. “Primary care is on the verge of collapse,” said the organization, a professional group which certifies internists, in a statement. “Very few young physicians are going into primary care and those already in practice are under such stress that they are looking for an exit strategy.” Dropping incomes coupled with difficulties in juggling patients, soaring bills and policies from insurers that encourage rushed office visits all mean that more primary care doctors are retiring than are graduating from medical school, the ACP said in its report. The group has proposed a solution, calling on federal policymakers to approve new ways of paying doctors that would put primary care doctors in charge of organizing a patient's care and giving patients more responsibility for monitoring their own health and scheduling regular visits. U.S. doctors have long complained that reimbursement policies of both Medicare and private insurers reward a “just-in-time” approach, instead of preventive care that would save money and keep patients healthier. “Medicare will pay tens of thousands of dollars ... for a limb amputation on a diabetic patient, but virtually nothing to the primary care physician for keeping the patient's diabetes under control,” said Bob Doherty, senior vice president for the ACP. The ACP plan called for innovations such as using e-mail to consult on minor and routine matters, freeing up expensive office visit time for when it is needed. Doctors would be compensated for an e-mail consultation. The proposals include incentives for doctors to work more efficiently and to provide better care, ACP President Dr. C. Anderson Hedberg said. “ACP proposals would provide patients with access to care that is coordinated by their own personal physician,” Hedberg said. The ACP cited an American Medical Association survey that found 35 percent of all physicians nationwide are over the age of 55 and will soon retire. In 2003, only 27 percent of third year internal medicine residents actually planned to practice internal medicine, the group said, with others planning to go into more lucrative specialty jobs. “Primary care physicians, the bedrock of medical care for today and the future, are at the bottom of the list of all medical specialties in median income compensation,” the ACP said. “If these reforms do not take place, within a few years there will not be enough primary care physicians to take care of an aging population with increasing incidences of chronic diseases,” said Dr. Vineet Arora, chair of the College's Council of Associates. (Reuters News Service)
SMI ramps up initiative activity
Strategic Marketplace Initiative (SMI) recently announced the appointment of Dennis P. Orthman as SMI Initiative Project Manager. Reporting to Tom Hughes the Executive Director of SMI, Orthman will be responsible for the ongoing support and coordination of SMI member-led initiatives. His role includes research, analysis, and coordination of SMI initiative team activities. Orthman has served as a consultant to the healthcare supply chain marketplace for over ten years, and brings over 25 years of industry experience. Prior to joining SMI, Dennis served as Principal Consultant with BD Healthcare Consulting and Services. There are currently six different SMI teams working on industry initiatives supported by Orthman: 1). Contract Synchronization: Working to create a new business model of collaborative data management processes aligned to reduce waste and overall expenses within the healthcare supply chain. The Team is examining the contract data loading process, with the goal of establishing a standardized process for correct contract data loading by all necessary parties by the appropriate designated effective date. 2). Perfect Order: This team is working to develop and implement a new management tool and metric for the healthcare supply chain … “Percentage of Perfect Orders.” With the creation of this tool, the team hopes to reduce operational expenses associated with today’s inefficient and time-consuming order-to-payment process. They have defined appropriate measurable elements within the supply chain that constitute a “perfect order.” 3). HIN or GLN? That is the question that this team is working to answer so that healthcare can achieve a standardized identifier for providers, manufacturers and distributors in the efforts to increase efficiencies and drive down supply chain expenses. 4). Access Guidelines: Addressing the inconsistency of practices among healthcare facilities and suppliers regarding vendor access that can lead to potential liability concerns and health and safety issues. The goals of this team are to examine regulatory requirements, search for best practices, and to establish a standardized partner access guideline, outlining minimum requirements that will ensure the health and safety of patients, partners and healthcare facility employees. 5). Measuring Effective Relationships: Organizations across the country have separately developed programs that measure the value and effectiveness of their business relationships. This initiative team is reviewing existing programs with the goal of creating a best practice that can be used by all supply chain stakeholders to measure and improve their collaborative effectiveness. The SMI team seeks to develop a flexible approach that can be used by all trading partners based on a common platform to define and measure the tangible and intangible benefits to the healthcare supply chain. 6). Supply Chain Opportunity Review: Working to identify key components, strategies, and values of the supply chain to guide and recommend future SMI initiatives, allowing all SMI Initiatives to be addressed and discussed in a unifying context and the value of the individual initiatives to be collectively defined. The team is mapping where providers and suppliers intersect, identifying significant cost drivers at each key intersection, and evaluating the value and opportunities that are present for future efforts. For more information on SMI contact Tom Hughes, Executive Director for SMI, at thughes@smisupplychain.com or info@smisupplychain.com.
Tronex Healthcare announces contract with Consorta
Tronex Healthcare Industries announces the awarding of a supply contract with Consorta Inc.’s Pharmacy Services, as the supplier of choice for Cleanroom Apparel. This contract covers a full range of head-to-toe disposable apparel including bouffant caps, beard covers, sleeve covers, face masks, shoe covers, lab coats, and jump suits. These products are available in both Cleanroom 10,000 and 100 versions and are manufactured to meet or exceed USP 797 regulations.
Iraq girl ‘died of bird flu’
First pre-birth stent implant
AAMI survey:
Salaries increase 3 percent
CHD Meridian Healthcare offers
resources to help
employers prepare for avian flu pandemic
Kimberly-Clark
Health Care joins national initiative
to reduce surgical
complications
Company-wide RFID technology
installation
is completed
by SRI/Surgical Express
FDA approves inhaled insulin for diabetics
The first inhalable version of insulin won federal approval Friday, giving millions of adult diabetics an alternative to some of the regular injections they now endure. The Food and Drug Administration said the Pfizer Inc. insulin, to be marketed as “Exubera,” is the first new way of delivering insulin since the discovery of the hormone in the 1920s. Pfizer jointly developed the drug and dispenser with Sanofi-Aventis and Nektar Therapeutics. Use of rapid-acting inhaled insulin will not replace the need to occasionally inject the hormone, according to the FDA. And diabetics will have to continue pricking their fingers to test blood sugar levels. The FDA delayed its decision by three months so it could review chemistry data on the diabetes treatment. The European Commission approved Exubera for use in adults on Thursday. Analysts have said the inhaled insulin could eventually become a $1 billion-a-year seller for Pfizer, which recently agreed to pay Sanofi-Aventis $1.3 billion to obtain full worldwide rights to the drug for use by both Type 1 and 2 adult diabetics. Clinical trials found that Exubera managed blood sugar levels just as well as injected insulin, but an independent FDA panel in September stressed that use of inhaled insulin will not mean diabetics can toss out the needles, pens or pumps used to inject the hormone. Inhalable insulin is a welcome advance, said Dr. Nathaniel Clark, the national vice president for clinical affairs for the American Diabetes Association. But he added that needles still will allow a patient to better control dosage. “Injecting insulin is far more precise in the sense of, what you want to deliver you deliver. You don't have to deal with any questions of how much is delivered through the lungs,” Clark said. The FDA review panel also expressed concern about the bulkiness of the Exubera dispenser and about some patients who experienced coughing or a slight decrease in lung capacity when using the drug. Pfizer will conduct studies on the long-term effects of Exubera on the lungs, as well as the safety and effectiveness of the drug on patients with lung disease, the FDA said. Diabetics with either type of the disease could use the rapid-acting inhaled insulin before or after meals to manage their blood sugar levels. However, the drug would not replace the longer-acting insulin injections that some diabetics, particularly those with Type 1 diabetes, need to take in the morning or before bed. “You're not going to eliminate the needles in Type 1. For Type 2, it really depends on the stage,” said Dr. Will Cefalu, a clinical investigator for both Pfizer and Eli Lilly and Co., which is developing its inhalable insulin system with Alkermes Inc. About 15 percent of diagnosed diabetics do not take the insulin or pills they should, according to American Diabetes Association estimates. The Exubera device is about the size of an eyeglass case. It delivers insulin, as a dry powder packaged in one- or three-milligram inhalable capsules, to the lungs through the mouth, according to Pfizer. Diabetics with poorly controlled or unstable lung disease, or who smoke or recently quit, shouldn't use Exubera, the FDA said. And patients should have their lungs checked before using the drug, as well as at six to 12 month intervals after that. Eli Lilly and Co., Kos Pharmaceuticals Inc., MannKind Corp. and Novo Nordisk A/S all are developing their own versions. (The Associated Press)
Iraqi and U.N. health officials said Monday that a 15-year-old girl who died this month was a victim of the deadly H5N1 strain of the bird flu virus, the first confirmed case of the disease in the Middle East. Tests were under way to determine if the girl's uncle, who lived in the same house, also died of the H5N1 virus. The uncle died a few days later after suffering the same symptoms, officials said. Iraqi health authorities began culling domestic birds in northern Iraq, which borders Turkey, where at least 21 cases of the deadly virus have been detected. Turkey and Iraq also lie on a migratory path for numerous species of birds. The girl died after contracting a severe lung infection in her village of Raniya, about 60 miles south of the Turkish border and just 15 miles west of Iran. The prospect of a bird flu outbreak in Iraq is especially alarming because the country is gripped by armed insurgency and lacks the resources of other governments in the region. Government institutions, however, are most effective in the Kurdish-run area of the north where the girl lived. Kurdistan's health minister said authorities started culling domestic birds in the village where the girl lived and nearby areas. (The Associated Press)
Salaries for professionals who service medical technology increased by 3.2% over the last year, according to the results of a new survey commissioned by the Association for the Advancement of Medical Instrumentation (AAMI). For the nine specific job title categories surveyed, the median base salary increased from $60,000 in 2004 to $62,000 in 2005, with salaries ranging from $29,700 for entry level positions to $78,000 for a department director or manager. AAMI’s 2005 Employment Survey also found that: Fewer employers today are paying the full cost of their employees’ health insurance. Only 11% of those surveyed say that their employers pay 100% of their health insurance, compared to 23% who received full healthcare insurance in AAMI’s 2003 Employment Survey; Manufacturers generally pay significantly more than hospitals or independent service organizations (ISOs), although hospitals are more apt to offer employees overtime, call-back pay, life insurance, and employer-provided pensions. On average, respondents who are certified reported earning 5.7% more than those who hold similar positions but are not certified. Biomedical equipment technicians and clinical engineers living in the western part of the United States earn more than their counterparts in other regions of the country. “Manufacturers have been increasing salaries and benefits to try to stop losing talent to the field, and to try to bring back some of the employees who left for a less-traveled lifestyle,” said Larry Hertzler, PE, CCE, vice president of program management at ARAMARK Clinical Technology Services. The median 2005 salary for certified medical technology professionals was $62,350 compared to $59,000 for someone who was not certified. The survey also found that about 78% of respondents said they receive subsidized healthcare as a fringe benefit. “Employers in all industries are asking employees to carry more of this financial load for health insurance,” said Carol Davis-Smith, CCE, senior consultant, Capital Lifecycle Solutions at Premier Inc. “Having worked in the hospital and moved outside to a consulting position, I would suspect that the actual costs paid by hospital employees are still less than those of us paying retail.” The survey results are featured in the Nov/Dec 2005 issue of AAMI’s journal, Biomedical Instrumentation & Technology, and are also available online to AAMI members at http://www.aami.org/publications/BIT. To order the survey, call (800) 332-2264, ext. 217 or visit http://marketplace.aami.org. The order code is SAL and the source code is PBFE.
Kimberly-Clark
Health Care joins national initiative
to reduce surgical
complications
Kimberly-Clark Corporation’s Health Care business announced its participation in the Surgical Care Improvement Project (SCIP), a national initiative designed to improve surgical care in hospitals. Kimberly-Clark Health Care’s involvement with SCIP continues the business’ commitment of reducing the number of healthcare associated infections in acute care and alternate site surgical settings. A partnership of leading public and private health care organizations, SCIP was created to provide hospitals, physicians, nurses and other caregivers with effective strategies to reduce four common surgical complications: surgical site infection, adverse cardiac events, deep vein thrombosis and postoperative pneumonia. SCIP is one of the first national quality improvement initiatives to unite national hospital, physician and nursing organizations; the federal government; JCAHO; and private sector experts. Under SCIP, this initiative brings together the best available science and technology to improve patient safety and well-being. www.medqic.org/scip
Company-wide RFID technology installation
is
completed
by SRI/Surgical Express
SRI/Surgical Express Inc. (SRI), a provider of products and services
supporting the healthcare industry, announced the successful
implementation of Radio Frequency Identification (RFID) Technology
in all ten of its processing facilities across the United States.
SRI will install RFID chips in over one million of its reusable
surgical gowns and drapes in this implementation. SRI believes that
this is the first full integration of RFID Technology into Class II
Medical Devices and among the largest uses to date of “Multi-Read”
applications of RFID technology. SRI incorporated “multi-read” RFID
tags into its surgical gowns and drapes, replacing its use of labor
intensive bar code scanning to track product usage. “The immediate
benefit for SRI is improved inventory control, better monitoring of
quality and a productivity enhancement of 5% over our results with
bar code scanning. As we further integrate RFID Technology into our
processes, SRI expects to virtually eliminate inaccurate shipments
of customer orders from our plants,” said Joseph A. Largey, chief
executive officer, SRI/Surgical Express.
Bird flu viruses carry unique
genes, study finds
New cancer drug approved
Statins may prevent sepsis in
heart patients
Two studies find defect in
gene for Parkinson's
Rubbermaid’s Bill Slezak
appointed to ASHES Board
of Directors
PAR Excellence and Consorta
extend their partnership
FDA sends Boston Scientific Corporate Warning Letter
On January 25, the Food and Drug Administration sent James Tobin, president and CEO, and Peter M. Nicholas, chairman of Boston Scientific Corporation, a corporate warning letter. The FDA recently performed inspections of Boston Scientific Corporation (BSC) at three separate facilities. The inspections were performed at Natick, MA on July 27 through August 26, 2005; at Maple Grove, MN on July 22 through August 25, 2005; and at Spencer, IN on August 25 through September 12, 2005. These inspections covered Vaxcel, Enteryx, and Taxus Paclitaxel drug eluting stent products and Leveen Needle Electrode product. These three FDA inspections each revealed serious regulatory problems involving the medical devices. FDA recently issued BSC three Warning Letters relating to serious deficiencies identified during inspections at three other BSC facilities. The first Warning Letter was issued on May 18, 2005, regarding Boston Scientific’s Watertown, MA facility. This Warning Letter discussed, among other items, the failure of the organization to have an adequate quality management system. The second Warning Letter was issued on August 1, 2005, for the Company’s Glens Falls, NY facility, and the third Warning Letter was issued on August 10, 2005, regarding the Quincy, MA facility. Each of these Warning Letters identified serious, systemic problems with overall corporate quality management systems. The purpose of this letter is to apprise top management of inadequate corporate-wide corrective action plan as evidenced by the continuing serious deficiencies identified at each of these facilities and to remind BSC of its responsibility to ensure that all facilities continuously comply with the Act and all pertinent regulations. The FDA requested a prompt meeting with BSC. The three most recent inspections at the Natick, MA, Maple Grove, MN and Spencer, IN facilities revealed that the devices manufactured at these sites are adulterated under section 501(h) of the Act, in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices. FDA has found ongoing systemic violations in the quality management system employed to ensure the safety and effectiveness of the medical devices BSC distributes. FDA warned BSC that these serious violations of the law may result in FDA taking regulatory action without further notice. These actions include, but are not limited to, seizing product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties.
Bird flu viruses carry unique genes, study finds
Scientists may have found out what makes the H5N1 influenza virus so deadly: bird flu viruses have a gene that may make them especially destructive to cells, U.S. researchers reported on Thursday. All the bird flu viruses studied by the team at St. Jude Children's Research Hospital in Memphis had the gene and none of the human influenza viruses did, they said. People infected with the H5N1 bird flu virus in Vietnam and Thailand had the “avian” version of the flu virus, as did the victims of the 1918 influenza pandemic, which killed tens of millions of people globally, the researchers said. But the influenza viruses that cause the normal seasonal flu, and those that caused the less deadly 1957 and 1968 human flu pandemics, do not carry the avian genes. The finding, published in the journal Science, may provide a way to identify the more dangerous viruses and may also help companies trying to make better flu drugs, said St. Jude's Clayton Naeve. “We documented a clear difference between bird viruses and human viruses. You need much more work to demonstrate this actually contributes to virulence in nature,” Naeve said. Naeve and his colleagues have been working to sequence the genomes of all known influenza viruses. No one has done this, even though flu viruses have just eight genes and are relatively simple organisms, the researchers said. “This is information we expect will be very important in understanding the attributes of this virus, how it will cross from birds to humans. We are releasing this data so that other investigators worldwide can mine it for information,” he said. The researchers used a collection of samples of 11,000 influenza viruses, including 7,000 avian influenza viruses, assembled by St. Jude's Dr. Robert Webster over 30 years. Naeve's team may have identified a protein to watch. It is called NS, for non-structural protein, and is only made once the virus has infected a cell. The avian versions seem to allow the virus to do much more damage to a cell than the human versions of NS, Naeve said. It is possible that a mutation that would allow a flu virus to more easily infect people will weaken the NS protein, Naeve said. (Reuters)
For
the first time, the Food and Drug Administration has approved a new cancer drug
for use in two different diseases, advanced kidney tumors and rare abdominal
malignancies. Sutent, made by Pfizer, is the second drug in only about a month
to treat advanced kidney cancer, a disease for which there were no new therapies
for more a decade, according to the FDA, which approved a Bayer drug called
Nexavar in December. Although studies have not yet shown that Sutent improves
survival, the agency granted Sutent accelerated approval because kidney cancer
is so deadly. Sutent shrank tumors in 26% to 37% of patients, according to the
FDA. That makes it far safer and more effective than older drugs for the
disease, which are so risky that they are often given in an intensive care unit.
About 36,000 cases of kidney cancer are diagnosed each year and 12,600 die of
it, according to the American Cancer Society. Pfizer plans to continue studying
Sutent, and is testing it in cancers of the breast, colon, lung and other
organs, says Joseph Feczko, the company's chief medical officer. Sutent belongs
to a new wave of “smart drugs,” said George Demetri, who helped develop Sutent
and directs the Center for Sarcoma and Bone Oncology at the Dana-Farber Cancer
Institute in Boston. Sutent is able to combat two types of tumors because both
cancers are fueled by the same defective proteins, Demetri said. Unlike
chemotherapy, which poisons all growing cells, drugs such as Sutent are designed
to block the spread of tumors but largely spare healthy tissue, said Demetri.
Sutent also combines two powerful strategies to fight cancer, Demetri said. It
silences growth signals inside cancer cells and also also cuts off their blood
supply. In addition to kidney cancer, the FDA approved Sutent for patients with
gastrointestinal stromal tumors, or GIST, whose disease is no longer controlled
by a drug called Gleevec, or who had rare but severe reactions to it. Sutent
works by blocking the proteins that make tumor cells immune to Gleevec, Demetri
said. In a carefully designed trial of more than 300 patients, in which some got
Sutent and some took placebos, Sutent cut the risk of death by more than half,
according to Demetri's study. Researchers at the medical conference in San
Francisco also presented promising news about esophageal cancer, a disease that
kills 85% of patients within five years. Patients with early-stage disease who
underwent surgery, chemotherapy and radiation lived more than twice as long as
those treated with surgery alone, said Mark Krasna, a professor at the
University of Maryland. Those who got the triple therapy lived about 4.5 years,
while other patients survived only 1.8 years. Only about one-third of esophageal
cancer patients today receive the combination. Another third of patients today
are treated with surgery alone, Krasna said. (USA Today)
Statins
may prevent sepsis in heart patients
The cholesterol-lowering drugs, statins may lower the risk of developing sepsis,
a potentially fatal reaction to infection, by 19 percent in patients with heart
disease, a new Canadian study suggests. “Patients
who are treated with statins enjoy not only a reduction in their risk of heart
attack and strokes, but a reduced risk of sepsis,” said lead researcher by Dr.
Donald Redelmeier, from Sunnybrook and Women's Hospital, in Ontario.
The findings appear in the Jan. 25 early online edition of The Lancet.
More than two people die every minute from severe sepsis in the United States.
It is the leading cause of death among patients in intensive care units, and is
responsible for more deaths than breast, colorectal, pancreatic and prostate
cancer combined, according to the Society of Critical Care Medicine.
For the new study, Redelmeier's group collected data on 69,168 patients over age
65 with heart disease. All had been hospitalized for acute coronary syndrome,
stroke or a revascularization procedure. Half of the patients had been
prescribed statins after discharge, and half had not.
The researchers found that after two years, 551 patients taking statins were
hospitalized for sepsis, compared with 667 patients not taking these drugs. That
represented a 19 percent reduction in the risk of sepsis among those taking
statins, Redelmeier's team noted.
If the finding is
replicated in other trials, Redelmeier believes the use of statins may be
important in reducing the risk of sepsis in any patient undergoing complex
surgery. “Patients who are at risk for sepsis should not have their statin
discontinued, contrary to standard therapy in intensive-care units,” he said.
In addition, patients undergoing high-risk surgery should consider taking
statins to prevent sepsis, Redelmeier said. “Patients with high degree of
immunocompromise may want to consider statins for primary prevention,” he noted.
Some experts thinks additional studies are needed to prove whether statins
really do reduce the risk of sepsis.
(HealthDay News)
Two
studies find defect in gene for Parkinson's
An error in a single gene might cause many cases of Parkinson's disease in certain groups, including Ashkenazi Jews and Arabs, two studies report. Previously, genes for Parkinson's disease have been identified only in rare cases. But findings from the scientific papers, both of which were published in the New England Journal of Medicine, suggest that for certain ethnic groups, the disease could carry a substantial genetic component. Identification of the genetic mutation might help scientists better understand how Parkinson's damages the brain and causes symptoms of the disease, says J. William Langston of the Parkinson's Institute in Sunnyvale, CA. The discovery also might lead to better therapies for Parkinson's, he said. Susan Bressman, a neurologist at New York's Beth Israel Medical Center, Laurie Ozelius, a molecular geneticist at the Albert Einstein College of Medicine in New York, and their colleagues studied 120 Parkinson's patients and 317 healthy people. All were Ashkenazi, or Eastern European, Jews. The team zeroed in on a gene called LRRK2 that previously has been shown to have mutations that cause Parkinson's in some families. When the team looked for one of the more common mutations, they found it in 18% of the Jewish patients. When they looked only at patients who had a family history of the disease, they got a more dramatic result: The mutation was found in nearly 30% of such cases. The researchers also found the mutation in 1% of controls: Ashkenazi Jews in their 70s who remained healthy. The team estimates that about 70,000 Ashkenazi Jews in the USA could be carriers of the mutation; they might escape the disease, or they could develop symptoms late in life, Bressman says. She and other experts believe people with an inherited vulnerability also might need exposure to an environmental factor to get the disease. The second study suggests the same mutation frequently can be found in Parkinson's patients of Arab descent. The studies might change the way people of Jewish or Arab descent are diagnosed, Bressman says. But she doesn't recommend widespread testing just yet. “We don't have a cure for Parkinson's right now,” she said, and there also is no known way to prevent it. A positive test in family members might simply raise worries about developing the disease in the future, says Robin Elliott of the Parkinson Disease Foundation. (USA Today)
Rubbermaid’s Bill Slezak appointed to ASHES Board
of Directors
Following the annual ASHES conference and exposition, Bill Slezak, Healthcare Industry Manager at Rubbermaid Commercial Products, was appointed to a three year term on the American Society for Healthcare Environmental Services (ASHES) Board of Directors. Slezak brings over 20 years of healthcare, business and IT experience, including his current responsibilities with Rubbermaid Commercial Products, located in Winchester, VA. Slezak will contribute the perspective of the supplier and manufacturing community and their constituents to ASHES strategic, procedural and policy-making decisions.
PAR Excellence and Consorta extend their partnership
PAR Excellence Systems, Cincinnati, OH, which provides innovative and affordable
products and services to automate the health care supply chain, and Consorta,
Schaumburg, IL, announced they had extended their original agreement for open,
point-of use systems for an additional two years. Recently, PAR Excellence added
PAR Vision, a browser-based data analysis tool. All of these are now available
to the Consorta shareholders and individual hospitals. “Because PAR Excellence
offers such a wide variety of solutions, we are a good fit for the Consorta
membership with their many different budgetary, inventory, and supply billing
requirements,” said Dick Felger, VP of Sales for PAR Excellence.
CDC considers flu vaccine
for millions more children
Joint Commission issues alert
to improve medication safety
National evaluation of the
effect of trauma-center care
on mortality
Clotting drug linked to kidney
damage
Medline adds
antimicrobial lab coat to its Omega line
Glaxo to begin bird flu clinical trials
Drug maker GlaxoSmithKline PLC hopes to start clinical trials in early April for its vaccine against the deadly H5N1 bird flu strain, a company executive said. The London-based company would test the vaccine with two different boosters and the first results should come about three months later, said David Stout, president of the company's pharmaceutical operations. Production is slated to start by year's end, he said. GlaxoSmithKline has submitted a mock-up dossier to the European Agency for the Evaluation of Medicinal Products, or EMEA, seeking an outline approval to market a vaccine against pandemic flu. The mock-up process requires companies to conduct clinical trials for safety and to establish the dosage and schedule for core compounds to obtain quick authorization for pandemic vaccines. The company submitted an adjuvant tested in the mock-up file the company has submitted to the European regulator, Stout said. An adjuvant stimulates a person's immune response to an infection to help make a vaccine work. “We know one adjuvant works, and we have a second adjuvant,” Stout said. “We are going to take both formulations in the clinic in early April, so that we will know we'll be able to pick between the two, and should be able to start production by the end of the year,” Stout added. The company is starting production of its traditional flu vaccine in the next couple of weeks for the next influenza season, Stout said. “If a pandemic breaks out, we would be able to stop production of the traditional flu vaccine and start production of the pandemic vaccine,” he said. “We could start production on a risk basis (without regulatory approval) if that was necessary.” (The Associated Press)
Federal disease specialists are considering whether to routinely vaccinate millions more children against the flu, a measure designed to protect children and the adults they might expose to the virus. A decision on whether to give flu shots to children 2 to 6 years old is expected by the end of the year, disease trackers from the US Centers for Disease Control and Prevention said at a flu vaccine summit. Already, federal guidelines advise flu immunizations for children 6 months to 23 months old because they are especially prone to complications from the respiratory illness. Doctors and public health authorities also discussed making shots an annual ritual for all Americans. “'But if we were to say we want universal vaccination, that doesn't happen overnight,” said Nicole Smith, an epidemiologist in the CDC's flu branch. US health guidelines strongly urge that senior citizens, the very young, and the chronically ill be vaccinated against seasonal flu. (The flu vaccine is not considered safe for infants under 6 months.) Although that policy does not recommend shots for healthy adults under 65 and children over 2, there's no medical reason in most cases that they can't receive vaccine. Instead, the current recommendations reflect a desire to get a limited supply of vaccine to patients who need it most. This year, about 86 million doses of vaccine are expected to be produced, but the CDC estimates that 180 million Americans are either at serious risk of complications from the flu, or have contact with those high-risk patients. But with vaccine manufacturers promising to substantially increase the number of shots they make for future flu seasons, disease specialists are reviewing research to determine whether vaccinating children ages 2 to 6 makes sense. Among the studies the federal specialists said they will review: a Harvard Medical School report that suggests 3- and 4-year-olds often spur flu outbreaks, showing respiratory symptoms weeks earlier than other children. The Harvard and Children's Hospital Boston researchers have said they believe 3- and 4-year-olds should be routinely vaccinated to prevent spreading flu to older children and adults. If federal specialists go along with that recommendation, the new policy would not go into effect until the 2007-2008 flu season. (The Boston Globe)
Joint Commission issues alert to improve medication safety
The Joint Commission on Accreditation of Healthcare Organizations issued a new Sentinel Event Alert that urges intensified attention to the accuracy of medications given to patients as they transition from one care setting to another, or one practitioner to another. The failure to reconcile medications during these transitions can cause serious patient injuries and even death. According to the Alert, medication reconciliation should occur whenever a patient moves from one location to another location in a health care facility (for example, from a critical care unit to a general medical unit); or from one health care facility to another or to home; and/or when there is a change in the caregivers responsible for the patient. When effective medication reconciliation does not occur, patients may receive duplicative medications, incompatible drugs, wrong dosages, or wrong dosage forms among the array of potential errors. The medication reconciliation process also provides an important opportunity to assure that the patient is receiving all medications necessary to his or her care and to eliminate any medications that are no longer needed by the patient. Last year, United States Pharmacopeia received more than 2,000 voluntary reports of medication reconciliation errors, and a 1999 Institute of Medicine report estimated that more than 7,000 deaths occur each year in hospitals alone due to medication errors. The Joint Commission's Sentinel Event Database also identifies medication errors as one of the most frequently occurring threats to patient safety. This Database reveals that 63 percent of the reported medication errors resulting in death or serious injury were due to breakdowns in communication, and approximately half of those would have been avoided through effective medication reconciliation. The fact that medication reconciliation errors continue to occur, despite repeated warnings and rigorous standards, prompted the Joint Commission to issue the Sentinel Event Alert on medication reconciliation to the more than 15,000 health care organizations it accredits. “A systematic approach to reconciling medications must be the foundation for all efforts to prevent drug errors,” said Dennis S. O'Leary, M.D., president, Joint Commission. To reduce the risk of errors related to medication reconciliation, the Alert recommends that health care organizations: Put the list of medications in a highly visible place in the patient's chart and include essential information about dosages, drug schedules, immunizations, and drug allergies. Reconcile medications at each interface of care, specifically including admission, transfer and discharge. The patient and responsible physicians, nurses and pharmacists should be involved in this process. Provide each patient with a complete list of medications that he or she will take after being discharged from the facility, as well as instructions on how and how long to take any new medications. The patient should be encouraged to carry this list and share it with any caregivers who provide any follow-up care. In addition, as part of its current National Patient Safety Goals, the Joint Commission also specifically requires that each accredited health care organization: Implement a process for obtaining and documenting a complete list of the patient's current medications upon admission. This includes a comparison of the medications the organization provides to those on the list. The patient should be asked to describe or confirm any prescription medications, over-the-counter medications, vitamins, herbs or other supplements that he or she takes. Communicate a complete list of the patient's medications to the next service provider when the patient is referred or transferred to another setting, service, practitioner or level of care within or outside the organization. www.jcaho.org.
National evaluation of the effect of trauma-center care
on mortality
Hospitals have difficulty justifying the expense of maintaining trauma centers without strong evidence of their effectiveness. To address this gap, researchers examined differences in mortality between level 1 trauma centers and hospitals without a trauma center. Mortality outcomes were compared among patients treated in 18 hospitals with a level 1 trauma center and 51 hospitals non–trauma centers located in 14 states. Patients 18 to 84 years old with a moderate-to-severe injury were eligible. Complete data were obtained for 1104 patients who died in the hospital and 4087 patients who were discharged alive. After adjustment for differences in the case mix, the in-hospital mortality rate was significantly lower at trauma centers than at non–trauma centers (7.6 percent vs. 9.5 percent), as was the one-year mortality rate (10.4 percent vs. 13.8 percent). The effects of treatment at a trauma center varied according to the severity of injury, with evidence to suggest that differences in mortality rates were primarily confined to patients with more severe injuries. The findings show that the risk of death is significantly lower when care is provided in a trauma center than in a non–trauma center and argue for continued efforts at regionalization. This research was conducted by the Johns Hopkins Bloomberg School of Public Health, Center for Injury Research and Policy, Baltimore; and the University of Washington School of Medicine, Harborview Injury Prevention and Research Center, Seattle. The Centers for Disease Control and Prevention helped fund the study, published in the New England Journal of Medicine.
A drug widely used during heart surgery to control bleeding doubles the risk of kidney damage, forcing an estimated 10,000 patients onto dialysis each year, according to a new study from a group that is calling for surgeons to abandon its use. Known as aprotinin, the drug also increases the risk of heart attack by 48 percent, heart failure by 109 percent, and stroke by 181 percent, according to a study among nearly 4,400 patients reported in The New England Journal of Medicine. The researchers added that the drug is not even needed in most cases because there are two generic drugs that cost a tenth as much and are nearly as good at stopping bleeding without increasing risks. “I wonder how we can ethically prescribe aprotinin when there are alternatives that are safer,” said Dr. Dennis T. Mangano of the Ischemia Research and Education Foundation, who led the study. The drug, which is derived from the lung tissue of cows, was approved by Food and Drug Administration in 1993. It is now used in a significant number of the 1 million heart surgeries performed worldwide each year, largely because it is slightly more effective and has been well marketed by its manufacturer, Bayer. Surgeons and anesthesiologists had suspected potential problems with the drug for many years, but the number of adverse side effects was lost among the huge number of patients given the drug. “We didn't have good, hard data to prove it,” said Dr. O. Wayne Isom, chair of the Department of Cardiac and Thoracic Surgery at New York Presbyterian Hospital/Weil Cornell Medical College. A spokesman for the FDA said the agency is reviewing the data. (Los Angeles Times)
Medline adds antimicrobial lab coat to its Omega line
Medline Industries Inc. added an antimicrobial lab coat to its Omega line of infection control products. The new antimicrobial lab coat will help prevent cross-contamination. The lab coat's HaloShield technology harnesses residual chlorine molecules from the normal laundry process and kills even the most dangerous bacteria within minutes. “Research shows that lab coats can be a major contributor to cross-contamination problems as physicians go from room to room in the hospital,” said President of Medline's Textiles Division Ron Barth. “Lab tests show that when bacteria comes into contact with chlorine bleach anchored to a HaloShield-treated fabric, 99.9 percent of the microbes are killed within minutes, including MRSA, VRE, and Klebsiella pneumoniae.” A 2005 study by Minnesota-based Ecolab found that bacteria such as MRSA could live on a bed linen for as long as five days. A study published in 2000 demonstrated that lab coats are a potential source for cross-contamination of bacteria including Staphylococcus aureus. The Omega line lab coats are infused with the same treatment introduced in Medline's HaloShield sheets and underpads. The patented technology in HaloShield is a durable coating that binds chlorine molecules, used during a regular wash cycle, to nearly any textile. The coating is rechargeable meaning the antimicrobial properties of the chlorine are renewed each time the fabric is laundered in an EPA-registered chlorine-based sanitizer. The HaloShield treatment maintains its ability to bind chlorine to the product throughout its life cycle. While chlorine is known as one of the best antimicrobial agents in the world, its power before HaloShield had been limited because it evaporates from untreated fabric soon after laundering.
Flu vaccine distribution
flawed, CDC contends
Doctors write article backing
ban on gifts from drug makers
Bush considering tax breaks
for health care;
workers who must buy coverage may be aided
DMAA launches project to
develop standards for measuring,
evaluating disease management outcomes
Thermo Asset Management Services and
Vanderbilt University
Hospital announce partnership
Guidant goes with Boston Scientific
Guidant Corp. formally ended its merger agreement with Johnson & Johnson and entered into a $27 billion accord with Boston Scientific, the medical device maker announced early Wednesday. J&J had until midnight ET Tuesday to raise its offer for Guidant, which it had agreed to buy in December 2004. Boston Scientific was offering $27 billion for Guidant, in a cash and stock deal worth $80 a share. The midnight deadline passed without any new bid from J&J, which had offered $24.2 billion for the company. Guidant said Wednesday it will pay a termination fee of $705 million to J&J. Shares of Boston Scientific rose 70 cents, or almost 3 percent, to $24.70 in pre-market trading on Inet following the announcement, while shares of Guidant slipped 68 cents to $76.10 as the potential for another round of bidding ended. Shares of Dow component J&J were not trading on Inet, but were up slightly in Frankfurt trading. J&J issued a statement early Wednesday saying simply that increasing its latest offer “would not have been in the best interest of its shareholders.” The Boston Scientific-Guidant deal still needs the approval of antitrust regulators in the United States and Europe, who had already cleared the potential deal between J&J and Guidant. (CNN)
Flu
vaccine distribution flawed, CDC contends
The nation's top disease tracker Tuesday acknowledged that there are significant
flaws in the flu vaccine-distribution system in the United States and pledged to
consider expanding the federal government's role in buying and tracking shots.
For the current flu season, the U.S. Centers for Disease Control and Prevention
bought about 11.5 million doses, out of 86 million produced by private
manufacturers, with much of it then resold to state health departments. “Since
we don't own the supply, it's very difficult for us to put our weight behind
supporting appropriate distribution,” said Julie Gerberding, CDC director,
speaking at a major summit on the flu vaccine supply and its distribution.
“Certainly,” she said, “government could purchase more vaccine.” Next year,
manufacturers are likely to produce as many as 120 million shots, company
representatives disclosed at the Atlanta summit. But doctors and public health
authorities voiced continued concern about the patchwork system of public
agencies and private doctors, pharmacies, and big-box retailers that now provide
flu vaccine. Health authorities said they are particularly dismayed by the
failure to establish a network that would follow every shot from the time it
left a manufacturer to the time it was administered. A detailed tracking system,
public health officials and doctors said, has the potential to ease a persistent
supply-demand mismatch that results most years in millions of vaccine doses
being squandered. The CDC is studying such a tracking system, and summit
participants are expected to offer recommendations on how a network could be
structured. But Dr. Raymond Strikas, a leading flu vaccine specialist at the
agency, acknowledged that further discussions with vaccine makers and
distributors are necessary before a registry could be implemented.
Pharmaceutical industry executives have long expressed fears that providing the
CDC with too much information might jeopardize their competitive edge. Jennifer
Alfisi, an executive with the Health Industry Distributors Association, said her
industry is concerned that providing information to the CDC could breach
confidentiality agreements with doctors, who may not want details of their
practice disclosed to the government. But association members are discussing how
they can be more helpful. (The
Boston
Globe)
The gifts, drugs and classes that makers of pharmaceuticals and medical devices routinely give doctors undermine medical care, hurt patients and should be banned, a group of influential doctors say in The Journal of the American Medical Association. Medical schools and teaching hospitals should be the first to establish a comprehensive ban, the group writes. But the authors argue that all doctors should eventually follow suit. Broadly adopted, the recommendations would transform doctors’ day-to-day lives and shut off the focus of drug makers’ biggest expenditures. But Dr. David Blumenthal, an author of the article, said it was “not very likely” that many in medicine would listen to the group. Federal law forbids companies from paying doctors to prescribe drugs or devices, but gifts and consulting arrangements are almost entirely unregulated. Voluntary professional guidelines suggest that doctors refuse gifts of greater than “modest” value. Sanctions against doctors who accept gifts of great value are extremely rare. The drug industry spends tens of billions of dollars a year to woo doctors, far more than it spends on research or consumer advertising. Some doctors receive a significant part of their income from consulting arrangements with drug and device makers. Others take regular vacations and golfing trips that are paid for by companies. While such rich arrangements are often restricted to specialists, most physicians routinely accept small gifts from drug salespeople. Surveys show that most doctors do not believe that these gifts influence their medical decisions, although most believe that they do affect their colleagues’ medical judgment. But even small gifts can lead to profound changes in doctors’ prescribing behavior, with “negative results on clinical care,” the article states. As a result, all gifts should be banned, the authors conclude. Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America, said the drug industry had a voluntary code of marketing conduct. “Only practices that do not compromise independent judgments of health providers, such as modest working meals, gifts of minimal value that support the medical practice, and distribution of free samples, are permitted,” Johnson said in a statement. Dr. Duane M. Cady, board chairman of the American Medical Association, said in a statement that “drug and medical device makers can play a role in educating physicians about new products.” He said the organization was “in the process of examining and updating its policy on gifts to physicians from industry.” (The New York Times)
Bush considering tax breaks for health care;
workers who must buy coverage may be aided
President Bush is weighing proposals for new tax breaks for health care costs, which will be a major topic of next week's State of the Union address, a top economic adviser to the president said Tuesday. “People are very, very frustrated about the cost of health care,” said Allan Hubbard, director of the National Economic Council. Hubbard told reporters at USA TODAY and Gannett News Service that the tax code offers advantages when a company buys health coverage for its employees but doesn't do the same for employees who have to buy coverage on their own. “The president's very concerned about the unfairness of the tax code,” Hubbard said. Bush himself has discussed some other health care ideas, including expansion of health savings accounts. Bush has also talked about providing consumers with more information about medical costs, to enable them to be better shoppers. Hubbard said Bush will discuss that topic, but he declined to say whether Bush would propose that the government require doctors to post their fees, or simply encourage patients to ask. Hubbard said Bush will also devote part of Tuesday's speech to higher energy prices and the rising costs of entitlement programs such as Medicare and Social Security. Sen. Edward Kennedy, D-MA, said the administration's health care approach does not address the increasing numbers of uninsured Americans, or problems with Medicare's new prescription-drug plan. In recent appearances, Bush has indicated he will revive past health care proposals. They include allowing businesses to pool their health insurance costs across state boundaries and restricting what Bush calls “junk lawsuits” that drive up medical costs. The president and aides will also promote health insurance “portability” in an increasingly mobile society. “People should be able to leave their jobs and keep their insurance,” Hubbard said. (USA Today)
DMAA launches project to develop standards for measuring,
evaluating disease management outcomes
The Disease Management Association of America (DMAA) announced the launch of an
ambitious project to develop by year’s end a uniform method for measuring and
evaluating outcomes in disease and care management programs. Don Fetterolf, MD,
chair of the DMAA Quality and Research Committee will lead the DMAA Outcomes
Steering Committee’s stewardship of the standards development project. The
committee expects to present a final, uniform evaluation methodology during the
DMAA’s 2006 Disease Management Leadership Forum, Dec. 3 to 5, in Denver.
Underscoring the importance of this effort is agreement among the companies and
individuals involved to support the final methodology and to put on hold
independent standards development projects already underway. Initial work on the
project will involve a survey of the disease management community to collect
data on how disease management organizations and others now measure outcomes.
The steering committee established sound criteria for a survey instrument, using
a process that examined questions of scope, statistical and actuarial
considerations, collection methods and other issues. “The DMAA recognized that a
gap exists in our understanding of best practices for evaluating disease and
care management programs,” DMAA Executive Director Tracey Moorhead said. “Our
experience shows disease management works, but lack of agreement on how to
measure that success has hampered our ability to convince skeptics. Through the
leadership of the DMAA and its members, we will develop the tools we need to
erase any doubt that disease management benefits patients and payers alike.” The
DMAA will reach out to a broad coalition of public and private quality and
standards-setting entities to enlist their assistance and support as the project
moves forward. Relationships already established include those with URAC, the
National Association of Manufacturers and third-party evaluators and
researchers.
Thermo Asset Management Services and
Vanderbilt University
Hospital announce partnership
Thermo Asset Management Services, Brookfield, WI, and Vanderbilt University Hospital, Nashville, TN, have announced an agreement for the hospital to implement Thermo AMS’ LIFECYCLE Program. The program creates effective management and operational tools designed specifically for Vanderbilt University Hospital.
FDA announces new program to
transform
and strengthen medical device safety
APIC, IDSA, SHEA develop model
legislation
on public reporting of healthcare-associated infections
China reports 10th bird flu
case
MedAssets Net Revenue Systems
enhances Crosswalk,
offering improved data integrity
A prominent surgeon in Wisconsin was paid $400,000 a year by Medtronic for a consulting contract requiring him to work just eight days. Another doctor in Virginia received nearly $700,000 in consulting fees from Medtronic for the first nine months of 2005. These doctors work in a growing field, complex back surgery, and this makes them particularly valuable to the spinal-implant division of Medtronic. In recent years, the company has spent tens of millions of dollars on consulting contracts and other types of payments to them and numerous other prominent surgeons, according to papers filed as part of a whistle-blower lawsuit. The suit contends that some of these payments were made to attract or retain the doctors’ business. Medtronic, based in Minneapolis, is one of the country's largest medical device makers, with $10 billion in annual sales. The documents shed new light on a matter that has troubled the medical device industry for years: the assertion that companies employ a variety of financial ruses to pay doctors who use their devices, a practice that medical and legal experts say is unethical and possibly illegal. But despite industry efforts to clean up such practices, the documents and accusations made by former Medtronic employees suggest that the problem persists and may have gotten worse. The lawsuit, filed in United States District Court in Memphis two years ago and since amended, was brought by the whistle-blower, a former Medtronic employee. The Justice Department, which has the right to intervene in the case but has not yet done so, is seeking to recover Medicare funds. According to legal filings, it proposes that Medtronic settle the matter by paying $40 million. The suit accuses Medtronic of giving spine surgeons “excessive remuneration, unlawful perquisites and bribes in other forms for purchasing goods and medical devices.” The plaintiff, Jacqueline Kay Poteet, a senior manager of travel services for Medtronic until 2003, has also accused the company in a supplemental complaint of continuing these improper payments in 2004 and 2005. Her lawyer has objected to the proposed settlement offer as too low. All the doctors involved in the lawsuit who were reached for comment said that the payments to them were appropriate and fair compensation for work done for Medtronic. The company, which said it continues to cooperate fully with the government to resolve the case, declined to comment directly on the accusations, saying they remained the subject of litigation. In a written response, a spokesman, Rob Clark, said, “We take these allegations very seriously and we do not tolerate conduct that is illegal or unethical.” Consulting arrangements with doctors to improve devices, he said, “are critical, in our view, to the delivery of state-of-the-art health care and are perfectly legal.” The internal Medtronic documents filed as part of the suit show that Medtronic spent at least $50 million on payments to doctors over some four years, through June or later in 2005. Such payments can become illegal when they are linked to a doctor's use of a particular device and violate the federal law against kickbacks, which says that payments and other benefits cannot be provided to doctors if the payments are intended to induce them to use the company's products. In addition to consulting fees and other payments, the lawsuit said, Medtronic played host at medical conferences where the “principal objective” was to “induce the physician, through any financial means necessary” to use its devices. According to the Medtronic documents, the company closely tracked the use of its devices by the doctors who attended the conferences, choosing some for “special attention.” Poteet, the whistle-blower, worked for Medtronic until an injury forced her to leave in 2003. At Medtronic, she arranged trips for doctors to the company’s conferences and became familiar with attempts to win the doctors’ favor. Medtronic is also the target of another whistle-blower lawsuit in Memphis, where its spine division is based; that suit also accuses it of making improper payments to doctors. Medtronic’s “bribery program,” as it was described in the suit, “has not only failed to cease, but continues unabated with increased payments made to many physicians,” the suit said. A doctor in Virginia, for example, made $300,000 in consulting fees in 2003 but only $75,000 in 2004. Last year, the company paid him nearly $700,000 for his consulting work through September. The doctor, who was not named as a defendant in the suit, said the spike in payments was a result of a change in how he was paid, requiring him to document his work before he received any money and therefore increasing the amount he received last year. The company commonly paid for doctors to attend any of 200 professional meetings a year. If the doctors wanted to go snorkeling or play golf, the sales representatives or Medtronic employees almost invariably paid for the expense, she said. When the doctors visited Memphis, she said, Medtronic employees would take them to a local strip club, disguising the expenses as an evening at the ballet. A Medtronic lawyer raised concerns in 2003 about whether the company should pay to take doctors sailing or fishing, or ask for contributions, according to a company e-mail message that is part of the legal filings. “When we are sending scores of doctors to a nice resort like this under the guise of training and education on our products,” he said, “I think we need to be more careful and stick to the limits of our rules as best we can.” A spreadsheet compiled by Medtronic for a June 2003 meeting indicated what Medtronic hoped to accomplish with each doctor attending an event, Poteet said. This list of 230 or so doctors included an estimate of the dollar value of the devices each doctor used in surgery, including the value of the devices made by Medtronic. One doctor is described as “a 100 percent compliant M.S.D. customer,” while others were cited for “special attention.” M.S.D. referred to Medtronic Sofamor Danek, the largest competitor in the spinal device market. The notes for one doctor suggested an expectation that those offered an arrangement where they helped design a device would become loyal users. (The New York Times) http://www.nytimes.com/2006/01/24/business/24device.html?emc=eta1
FDA announces new program to transform
and strengthen medical device safety
The U.S. Food and Drug Administration (FDA) is launching a new program to
transform and strengthen the way it currently monitors the safety of medical
devices after they reach the market, both new technology and existing products.
The FDA Center for Devices and Radiological Health's (CDRH) Postmarket
Transformation Initiative will better protect the public health by allowing the
FDA to identify, analyze and act on problems more quickly, including alerting
the public sooner of potential medical device issues. “Over the next decade,
medical technology innovations will fundamentally transform the health care and
delivery system, providing new solutions with medical devices that will
challenge existing paradigms and revolutionize the way treatments are
administered,” said Dr. Scott Gottlieb, FDA's Deputy Commissioner for Medical
and Scientific Affairs. “Under the leadership of our device center's expert
staff, we are working to develop even better ways to evaluate new technologies
to maximize benefits and minimize risk, including more efficient ways to develop
more effective post-market systems that can support safer medical practices as
well as continued innovation.” Areas in which this initiative will focus
include: Working toward an electronic reporting system for adverse medical
device events;
Unique ways
to identify medical devices including standardized and globally accepted names;
ways to improve device information in patient records; improved internal
collaboration on post market safety issues; and identifying opportunities to
improve the safety of medical devices through collaborative efforts with
professional organizations and the medical device industry. The FDA undertook
this initiative after a comprehensive, year-long internal inventory of the tools
used to monitor the safety of medical devices after they are approved. This
inventory identified many areas that are working well; however, it also
identified challenges associated with medical devices after they reach the
market. To obtain a copy of CDRH's Medical Device Postmarket Safety Program or
Medical Device Postmarket Safety Program – Synopsis and Recommendations, see:
www.fda.gov/cdrh/postmarket/mdpi.html
APIC, IDSA, SHEA develop model legislation
on public reporting of healthcare-associated infections
The Association for Professionals in Infection Control and Epidemiology (APIC), the Infectious Diseases Society of America (IDSA), and the Society for Healthcare Epidemiology of America (SHEA) has released model legislation to assist patient safety initiatives by giving state legislatures a template to use when adopting legislation for the collection and reporting of healthcare-associated infection rates. “Our organizations recognize the challenges to the states of public reporting,” said Michael L. Tapper, MD, chair of SHEA’s Public Policy and Governmental Affairs Committee. “Sound science and appropriate methodologies are integral to states’ successful institution of reporting requirements. APIC, IDSA, and SHEA have worked together to provide a comprehensive document based on these principles.” “Currently, there is no uniform national standard for surveillance of healthc