THIS ISSUE AVAILABLE ONLINE WITH EXPANDED INFORMATION AND PHOTOS
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IN THIS ISSUE:
1) HHS warns Americans about risks from ephedra
2) Nationwide cost of diabetes up $3.4 billion
3) HHS announces $20 million to develop safer smallpox vaccines
4) HHS awards $2.5 million to five states to empower more disabled
persons to work
5) Low Dose Warfarin Prevents Recurrence of Blood Clots
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HHS warns Americans about risks from ephedra
HHS Secretary Tommy G. Thompson has cautioned all Americans - particularly athletes and those who engage in strenuous activities - about using dietary supplements that contain ephedra. There continue to be serious questions about the risks surrounding this particular dietary supplement.
"There continues to be serious questions about the risks surrounding ephedra, and we therefore caution all Americans about using dietary supplements containing ephedra," Secretary Thompson said. "We believe that the current scientific evidence strongly suggests that at least some ephedra products may present an unreasonable risk."
Secretary Thompson announced a series of actions designed to protect Americans from potentially serious risks of dietary supplement products containing ephedra. The actions include:
· Seeking rapid public comment on the new evidence on health risks associated with ephedra to establish an up-to-date record as quickly as possible to support new restrictions on ephedra-containing products.
· Seeking rapid public comment on whether the currently available evidence and medical literature present a "significant or unreasonable risk of illness or injury" from dietary supplements containing ephedra.
· Seeking rapid comment on a strong new warning label on any ephedra products that continue to be marketed.
· Immediately executing a series of actions against ephedra products making unsubstantiated claims about sports performance enhancement.
· In seeking the 30-day public comment period, FDA is reopening a proposed rule entitled "Dietary Supplements Containing Ephedrine Alkaloids, which would have required a warning statement for these products, as well as restrictions on their potency and composition. FDA later withdrew parts of this proposed rule because of concerns about the specific scientific evidence, expressed by the General Accounting Office.
Ephedra is a naturally occurring substance derived from the Chinese herbal Ma Huang. While products containing natural ephedrine alkaloids have long been used to treat certain respiratory symptoms in traditional Chinese medicine, in recent years they been extensively promoted and used with the goals of aiding weight loss, enhancing sports performance, and increasing energy.
Once the 30-day comment period has ended, FDA will analyze the comments and publish its conclusions about the most appropriate approach to reducing the risk of using dietary supplement products containing ephedrine alkaloids.
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Nationwide cost of diabetes up $3.4 billion
Health and Human Services Secretary Tommy G. Thompson and American Diabetes Association President Francine R. Kaufman, M.D. announced that the annual cost of diabetes in medical expenditures and lost productivity climbed from $98 billion in 1997 to $132 billion in 2002. The direct medical costs of diabetes more than doubled in that time, from $44 billion in 1997 to $91.8 billion in 2002. The figures were revealed in a study by the American Diabetes Association (ADA) published in the March issue of Diabetes Care.
"Diabetes continues to be a huge financial burden on patients, their families and society, a burden that continues to grow in parallel with the obesity and diabetes epidemics in this country," Secretary Thompson said. "We must all work to fight this disease that touches so many of our daily lives. Fighting diabetes through research and public education on new treatments and prevention is one of our top priorities at the Department of Health and Human Services."
According to the study, the nation spends $13,243 on each person with diabetes, compared to $2,560 per person for people who don't have diabetes. The study also found that people with diabetes incur medical expenses that are about 2.4 times higher than those of people without diabetes. The figures take into account spending by individuals, employers, insurers and government programs such as Medicaid and Medicare.
The study also found:
· Direct medical expenditures of $91.8 billion included $23.2 billion
for diabetes care, $24.6 billion for chronic diabetes-related complications
and $44.1 billion for excess prevalence of general medical conditions.
· Indirect costs resulting from lost work days, restricted activity days,
mortality and permanent disabilities due to diabetes totaled $39.8 billion.
· Cardiovascular disease is the most costly complication of diabetes,
accounting for more than $17.6 billion of the $91.8 billion annual direct medical
costs for diabetes in 2002.
HHS' Centers for Disease Control and Prevention estimates that 17 million Americans have diabetes, including many who are unaware of their condition. In addition, an estimated 16 million additional Americans have pre-diabetes and can reduce their risks of developing the disease by losing a modest amount of weight and increasing their activity levels.
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HHS announces $20 million to develop safer smallpox vaccines
HHS Secretary Tommy G. Thompson announced the award of two contracts totaling up to $20 million in first-year funding to develop safer smallpox vaccines. The three-year contracts were awarded to Bavarian Nordic A/S of Copenhagen, Denmark, and Acambis Inc. of Cambridge, Mass.
"To protect ourselves from the remote but extremely grave threat of a deliberate release of smallpox virus, we need a vaccine that can be safely given to all Americans, including individuals with weakened immune systems, children and pregnant women," Secretary Thompson said. "The new contracts will help us meet this need by accelerating research on second-generation smallpox vaccines."
Acambis and Bavarian Nordic will develop, manufacture and conduct safety trials of modified vaccinia virus Ankara (MVA) vaccine candidates. Vaccinia virus, a close relative of smallpox virus, is used in traditional smallpox vaccines. A live, replicating virus, vaccinia can cause side effects, which on rare occasions can be serious and potentially life-threatening. Pregnant women and people with compromised immune systems, such as patients on chemotherapy or people with HIV/AIDS, cannot receive the current smallpox vaccine at all.
Because of the urgent need for safer smallpox vaccines, the new contracts emphasize timely completion of predetermined objectives. For example, within the first six months the companies must produce several thousand doses of their prototype vaccine along with data indicating its effectiveness in animal models. Following approval of human study protocols, the companies will conduct tests of the vaccines' safety in healthy adults. Finally, the companies must develop a plan for large-scale manufacture of the candidate vaccines and show how they could deliver up to 30 million doses to the federal government.
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HHS awards $2.5 million to five states to empower more disabled persons to work
In promoting President Bush's New Freedom Initiative, HHS Secretary Tommy G. Thompson announced $2.5 million in grants to five states to help people with disabilities to become and stay competitively employed. Each of the states -- Indiana, Maryland, Mississippi, North Carolina and South Carolina -- will receive $500,000 to support efforts to increase services and supports to workers, as well as help others return to work without the fear of losing health coverage.
Including today's grants, HHS has awarded more than $59 million to 40 states and the District of Columbia to expand their health coverage for disabled workers through the Medicaid program. The grants support the goals of the President Bush's New Freedom Initiative, which is working to eliminate the many barriers that unnecessarily hinder Americans with disabilities as they seek to participate fully in the life of their communities.
"Already through this initiative, nearly 30,000 disabled workers have returned to work without losing their health coverage, and the number of states offering expanded health care to these workers continues to grow," Secretary Thompson said. "We must continue to work together to create these kinds of opportunities for people with disabilities so we can fulfill President Bush's promise to make life better for millions of Americans with disabilities who work."
The grants advance the goals of the Ticket to Work and Work Incentives Improvement
Act of 1999 (TWWIIA), a law passed by Congress to encourage people with disabilities
to work without fear of losing their Medicare, Medicaid or similar health benefits.
The grants will help states build the systems they need to allow individuals
with a disability to purchase health coverage through Medicaid at affordable
rates. People with a disabling condition often cite the fear of losing health
coverage as one of the major barriers to a possible return to work.
The grants can be used to support systems that provide personal assistance and supports. Such assistance can include help with bathing, dressing and other activities at home or on the job. States can also use the funds to reach out to people with a disability, train staff in new employment possibilities and improve transportation or other support programs that allow people with a disability to become productive members of the American workforce.
HHS plays a key role in implementing President Bush's New Freedom Initiative and leads inter-agency efforts to increase opportunities for community living.
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SCIENCE IN THE NEWS
Low Dose Warfarin Prevents Recurrence of Blood Clots
A study of long-term, low-dose warfarin to prevent the recurrence of the blood clotting disorders deep vein thrombosis (DVT) and pulmonary embolism resulted in such a high degree of benefit to the patients - without significant adverse effects - that HHS' National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped the study early.
The multi-center Prevention of Recurrent Venous Thromboembolism (PREVENT) trial found a 64 percent reduction in episodes of DVT and pulmonary embolism in study participants taking low-dose warfarin compared to those taking a placebo. Furthermore, there was no evidence of significant risks such as major hemorrhage or other potential side effects of warfarin, which is an anticoagulant - a drug that prevents blood clotting.
The study will be published in the April 10, 2003 issue of The New England Journal of Medicine (NEJM). Due to its importance, the NEJM posted the article online on February 24.
The trial, which began in 1998, was scheduled to run until 2005. However, at a regularly scheduled meeting of the study's independent Data and Safety Monitoring Board (DSMB) held December 4, 2002, the interim findings were reviewed and based on the strong benefit of low-dose warfarin, the DSMB recommended halting the study. The recommendation was approved by the NHLBI.
"This is an important finding for the estimated half million Americans who each year experience either deep vein thrombosis or pulmonary embolism," said NHLBI Director Claude Lenfant, M.D. "These results suggest that low dose warfarin is a safe and effective way to prevent future episodes of these potentially serious blood clotting problems," added Lenfant.
The current standard treatment for DVT and pulmonary embolism not associated with surgery or another specific cause is 5 to 10 days of intravenous or subcutaneous heparin followed by 3 to 6 months of full-dose warfarin. Therapy typically stops after the initial treatment period because long-term use of full-dose warfarin is associated with a substantial risk of major bleeding. After the initial therapy is completed, recurrent blood clots occur in 6 to 9 percent of patients each year. The new data demonstrate that these recurrent blood clots can be avoided using an inexpensive and safe therapy.
"The PREVENT results strongly suggest that long-term use of low-intensity warfarin should be considered a new standard of care for the management of venous thrombosis after stopping full-dose warfarin therapy," said Paul Ridker, M.D., the principal investigator of PREVENT and professor of medicine at Harvard and director of the Center for Cardiovascular Disease Prevention at Brigham and Women's Hospital in Boston.
In deep vein thrombosis, a blood clot develops in one of the deep veins that is surrounded by muscle near the center of the leg. The clot may partially or completely block blood flow through the vein. Symptoms include pain, sudden swelling in the leg, enlargement of the superficial veins, reddish-blue discoloration of the skin, and warm skin.
If DVT is not treated, it can lead to pulmonary embolism in which the clots detach and travel through the bloodstream to the lungs, where they may enter a pulmonary artery. Large clots that completely block the pulmonary artery can be fatal. Symptoms of pulmonary embolism include sudden shortness of breath, sharp chest pain, a cough with bloody sputum, excessive sweating, rapid pulse, and lightheadedness.
"This study gives us a new use for a 50-year-old drug," Ridker said, who added that this is a very inexpensive therapy.
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Last updated 3 March 2003
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