Monday, September 05, 2005

Health Headlines - September 5

Toddler Returns to Japan Following Six-Organ Transplant

After receiving six new organs in the United States because there are no organs available in his own country, a 19-month-old Japanese boy is going home, the Associated Press reported Saturday.

In a lengthy operation on Christmas Eve at Miami Jackson Memorial Medical Center in Miami, Yosuke Ohashi received a new liver, pancreas, stomach, small and large intestines and spleen. The boy's family departs for Japan on Sunday, the wire service said.

In an effort to protect children's rights, a Japanese law states that those under the age of 15 are not allowed to be organ donors, according to the AP. It is not illegal to be an organ recipient, however.

The toddler's son, businessman Yukiho Ohashi, raised $1 million for his son's surgery in the United States, and he told the AP he plans to advocate for young Japanese patients upon his return to Japan.

Bayer Asks FDA to Reverse Animal Antibiotic Ruling

Bayer Corp. has appealed to the U.S. Food and Drug Administration over the agency's order banning the company's animal antibiotic, Baytril, the Washington Post reported Friday.

The FDA says Baytril is contributing to an increase in antibiotic-resistant bacteria that affect both people and animals. While all antibiotics eventually become less effective as bacteria adapt to them, Baytril is considered especially troublesome because it is similar to the human antibiotic ciprofloxacin, the newspaper said. The agency has ordered Baytril off the market as of Sept. 12.

Bayer has asked the FDA to postpone the ban as it fights the agency's order, which was five years in the making, the Post said.

The company's petition argues that the poultry industry needs the drug now to fight a seasonal respiratory illness that affects birds in the autumn. The petition has the backing of a number of veterinary organizations, the newspaper said, while advocacy groups like the Union of Concerned Scientists support the ban.

School Suspends Smoking Study After Information Leak

A 25-year research project thought to be among the longest-running U.S. studies on Americans' smoking attitudes and behaviors was suspended by Indiana University after personal information about the participants was disclosed to someone arranging a class reunion, the Associated Press reported Friday.

While the disclosures haven't caused any known problems, they represented what a school spokeswoman labeled "a serious breach that we're investigating." The study is expected to resume soon, although an exact date wasn't mentioned in the wire service account.

The project, when begun in 1980, involved 8,500 students in Monroe County middle schools and high schools. Believed to be the longest U.S. smoking study involving the same participants, it's exploring issues like smoking and stress, efforts to quit smoking, and teen smoking rates, the AP said.

Faulty Pool Floats Pose Drowning Hazard

Atico International has recalled 480,000 pair of inflatable arm band pool floats that pose a drowning hazard since they could tear as children use them, the U.S. Consumer Product Safety Commission says.

The company has two reports of the bands tearing at the seams, although in neither case were children hurt.

The bright orange and white arm bands have an inflation valve on each side, and are imprinted with a "Surf Club" logo. They were sold at CVS drug stories nationwide from April 2003 through August 2005 for about $1.

The products should be returned to the CVS store where purchased for a full refund. For more information, contact Atico toll-free at 1-877-546-4835.

Prominent Journal Protests FDA's 'Morning-After' Pill Delay

One of the nation's most respected medical journals issued a scathing attack Thursday on last week's decision by the U.S. Food and Drug Administration to delay allowing over-the-counter sales of the emergency contraception pill known as Plan B.

The perspective piece from the New England Journal of Medicine was released early from its Sept. 22 issue date and followed Wednesday's resignation of the FDA executive who had headed the Office of Women's Health. In announcing that she was leaving her job, Susan Wood said the Plan B delay ran "contrary to my core commitment to improving and advancing women's health."

The FDA last Friday announced that it was delaying for 60 days its long-awaited decision on whether to allow over-the-counter sales of Plan B, often called the "morning-after" pill. It can lower the risk of pregnancy by up to 89 percent if taken within 72 hours of unprotected sex.

The New England Journal piece, co-authored by the editor-in-chief Dr. Jeffrey Drazen, said postponement of the Plan B decision appeared "to reflect political meddling in the drug-approval process," especially given that an FDA expert advisory panel strongly recommended in December 2003 that Plan B be approved for over-the-counter sales. The full agency normally follows its advisory panel recommendations.

In delaying its decision, the FDA said it was comfortable allowing over-the-counter sales to adults 18 and older, but wanted more time to decide how to keep it out of the hands of young teenagers.

The New England Journal piece said that "the FDA has not pointed to any data to support" its stance questioning the safety of Plan B among younger women, "nor has the agency demanded such evidence in the case of other drugs that have been switched to over-the-counter status."

The American Academy of Pediatrics issued a statement Thursday encouraging more health professionals to discuss emergency contraception with their teen and adult patients, noting that only 20 percent to 25 percent of health care providers now do so.

"Studies show that an increase in availability of emergency contraception does not change rates of sexual activity or increase the frequency of unprotected sex among adolescents," the AAP statement said.

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