Health Headlines - September 15

FDA to Examine Drug-Coated Stents

Drug-coated stents used to open clogged arteries will be examined by an expert panel advising the U.S. Food and Drug Administration on the possibility that the devices may produce deadly blood clots, the Associated Press reported.

Nearly 6 million people worldwide have had the metal-mesh tubes inserted since they were first coated in 2002 with a drug designed to prevent arteries from re-clogging, the wire service said. Two recent studies suggested a small but significant increase in heart-attack risk and death from blood clots among stent recipients.

While the FDA said it still believes the devices are safe, it wants the additional opinion of its expert advisers about whether further study is needed, the AP said.

The agency said it's also seeking the experts' recommendations on how long stent users should take anti-clotting drugs such as Plavix or aspirin.

U.S. Obesity Rates Soaring: CDC

More than 60 percent of adults in the United States are now overweight or obese, according to a report issued Thursday by the U.S. Centers for Disease Control and Prevention.

Nearly a quarter of American adults were classified as obese last year, a problem that has increased significantly over the past decade, the agency said in its Morbidity and Mortality Weekly Report (MMWR).

While no state had an obesity rate of more than 20 percent a decade ago, 46 states reported obesity rates of 20 percent or greater last year, the agency said. And three states said 30 percent or more of its residents were considered obese.

"The magnitude of this rising obesity trend and its implications for the health of the nation calls for a strong, sustained, and effective response to alter the course of this epidemic, with the main focus being nutrition and physical activity," the report said.

Obesity has been linked to a variety of health problems, including diabetes, high blood pressure, heart disease, stroke and some cancers.

The agency evaluated statistics from the Behavioral Risk Factor Surveillance System collected from all 50 states between 1995 and 2005.

New Diabetes Drug Improves Blood Sugar, Maker Says

Merck & Co.'s experimental diabetes drug Januvia lowered blood-sugar levels when combined with another drug by an average of 2.1 points among study participants who had an average reading of 8.8 percent when the study began, the company said Thursday.

Study participants took 50 milligrams of Januvia (sitagliptin phosphate) twice daily, combined with 1,000 mg. twice daily of another drug, metformin. Januvia is the first in a new class of drugs called DPP-4 inhibitors that enhance the body's ability to lower blood sugar, Merck said in a statement.

Merck said it was testing use of Januvia by itself, and the same drug combination but with lower doses of metformin. Results from those studies will be released later this year, the company said.

Merck said it has applied for approval of Januvia by the U.S. Food and Drug Administration, and expects action on the application next month. Study results were released in Copenhagen at the annual meeting of the European Association for the Study of Diabetes.

Scooters Recalled for Dangerous Computer Glitch

Segway Inc. is recalling all 23,500 self-balancing scooters it has ever produced because a software bug can make the wheels reverse direction without notice, the Associated Press reported.

The company has six incident reports involving the Personal Transporter, including head, wrist and mouth injuries. The product was first known as the Human Transporter.

The U.S. Consumer Product Safety Commission, working with the company, said consumers should stop using the vehicles immediately. Segway is offering a free software upgrade that should end the problem, the AP said.


Some of the scooters, which hit the market in 2002, were involved in a 2003 recall to fix a battery problem. They were sold nationwide for $4,000 to $5,000.

Call Segway Inc. at 800-750-6557 for more information.

House Members Seek Probe Into 9/11 EPA Comments

House of Representatives Democrats from states surrounding New York City's Ground Zero say they want an investigation into the U.S. Environmental Protection Agency's assurances immediately following the Sept. 11, 2001, terrorist attacks that the air near the site was safe to breathe.

Congressmen Jerrold Nadler (D-N.Y.), Anthony Weiner (D-N.Y.), and Bill Pascrell Jr. (D-N.J.) denied Thursday that politics was behind their call for an investigation into comments by then-EPA chief Christie Todd Whitman that the air quality in lower Manhattan was safe for rescue workers and nearby residents, the Associated Press reported. Such an investigation, if approved by U.S. Attorney General Alberto Gonzalez, could lead to criminal charges.

Whitman, interviewed by the wire service, denied any wrongdoing. "[The EPA and I] agreed then and I reiterate now that the air on the [World Trade Center] site was not clean -- the consequence of millions of tons of burned debris from the most horrific attack in our nation's history," she said.

Whitman, a former governor of New Jersey, denied suggestions that the EPA was lax about forcing rescue and cleanup workers to protect themselves. "We were emphatic that workers needed to wear respirators, a message I repeated frequently," she told the AP.

Last week, New York City's Mount Sinai Medical Center released study results showing that about seven of 10 rescue workers suffered post-9/11 lung problems.

FDA Reminds Tissue Banks of Regulations

Companies that recover, process, store or distribute human tissue must adhere to federal guidelines to prevent possible contamination and spread of disease, the U.S. Food and Drug Administration warned Thursday, in the wake of two recent scandals involving the tissue-transplant industry.

"Patient safety is our primary concern," said a statement by Jesse Goodman, director of the agency's Center for Biologics Evaluation and Research. He said manufacturers must also ensure that contractors who work for them adhere to the same regulations.

In August, hundreds of human-tissue products destined for transplants across the United States were recalled by a Colorado provider. The products were supplied by a North Carolina body-parts broker who allegedly used an unsterile embalming room to extract tissue from dozens of corpses.

And in 2005, a New Jersey firm was accused of using stolen bodies and of shipping about 20,000 potentially tainted body parts nationwide.