FDA Advisers Have Financial Ties to Stent Makers: Report
Six doctors with financial ties to companies that make heart devices will serve this week on an U.S. Food and Drug Administration panel reviewing the safety of drug-coated stents that are used to prop open arteries. The stents have been linked with an increased risk of blood clots that can cause heart attacks and strokes.
Critics have condemned the FDA for allowing the doctors to serve on the panel, which will make recommendations that could influence FDA guidelines involving drug-coated stents, Bloomberg News reported.
To clear the way for the six doctors to take part in the review, the FDA has waived rules that prohibit experts from involvement in matters that affect companies with which the experts have consulting contracts or in which they own stock.
The fact that the six doctors hold shares in, or receive fees from, companies that make stents is outweighed by their expertise on heart disease, Randall Lutter, the agency's associate commissioner for policy and planning, noted in a posting on the FDA's Web site.
A number of studies have suggested that drug-coated stents increase the risk of blood clots, Bloomberg reported. That includes a Cleveland Clinic Foundation study released in late November that said heart patients who receive drug-coated stents are five times more likely to develop blood clots than patients who receive bare metal stents.
Blood clots caused by drug-coated stents may cause an extra 2,160 deaths each year in the United States, according to an editorial by U.S. cardiology experts posted online Oct. 11 by the American College of Cardiology.
-----
Norovirus Sickens Hundreds on Caribbean Cruise
An outbreak of norovirus sickened 338 passengers and 46 crew members on the Royal Caribbean's ship Freedom of the Seas during a seven-day Caribbean cruise.
The sick passengers and crew were treated with over-the-counter medications during the cruise, and crew members sanitized railings, elevator buttons, door handles and other frequently touched surfaces, the Associated Press reported.
The Freedom of the Seas, which was carrying about 3,800 passengers and 1,300 crew members, returned Sunday as scheduled to the Port of Miami. It's believed that a passenger previously exposed to the norovirus brought it on board Nov. 26, Royal Caribbean said.
Last month, about 700 passengers and crew were affected by a norovirus outbreak during a trans-Atlantic cruise by the Carnival Cruise Line's Liberty, the AP reported.
Norovirus, which causes stomach flu-like symptoms, affects about 23 million Americans each year, according to the U.S. Centers for Disease Control and Prevention.
-----
Exercise Boosts Health of Obese Women
If they exercise, obese women may not need to diet to improve their health, a study by British researchers suggests.
The team from Leeds Metropolitan University and the University of Hull found that encouraging obese women to exercise for four hours a week led to significant improvements in their health and mental well-being, BBC News reported.
The 62 women, ages 24 to 55, weren't encouraged to diet but were taught about good eating habits, including how to read food labels and to cook healthy meals. They also received behavioral therapy to help them understand and respond to body cues such as hunger and feeling full, BBC News reported.
After one year, the women had lost only a few pounds but were much fitter and happier with themselves. Their respiratory fitness increased and their blood pressure, cholesterol and heart rate levels declined, the study said.
The findings were presented at a meeting of the U.K. Society of Behavioral Medicine. |
