FDA Lax in Overseeing Doctors' Conflicts in Trials: Report

The U.S. Food and Drug Administration does little to oversee financial conflicts that doctors involved in clinical trials of drugs and medical devices may have, government investigators said Monday.

In 42 percent of trials, the FDA failed to receive disclosure forms from physicians and said that efforts to police such disclosures weren't worth the effort, The New York Times reported. Results of the investigation, conducted by the U.S. Department of Health and Human Services, were expected to be released Monday and fuel an ongoing debate about how money that doctors receive for this research could skew study results, the newspaper said.

Fewer than 1 percent of the doctors helping oversee clinical trials registered with the agency -- about 206 of the 29,691 clinical investigators listed. And those who filed the required disclosures reported that they had a significant conflict of interest, the Times said. Since the FDA does not have a complete list of these physicians, the agency has no way of knowing whether every doctor required to file actually did so, the newspaper said.

Doctors have been required by the FDA since 1999 to reveal such conflicts, and companies are required to collect and to consult with the agency before trials begin to resolve outstanding problems. Previous studies have found that one-fifth to one-third of all doctors have such conflicts, according to the Times.

FDA spokeswoman Karen Riley told the newspaper that the agency opposed reviewing doctors' financial conflicts before trials because they represented just one possible source of bias.

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Chinese Distributor Pulls Suspect Dog Food

A Chinese distributor has pulled a popular dog food brand from its pipeline following reports that about 10 dogs got sick after eating the product, two had died, and a third was gravely ill, the Associated Press reported Monday.

Shanghai Yidi Pet Co. said it stopped selling Optima brand dog food last week and notified its customers not to feed it to their pets. The sickened dogs were believed to be suffering from aflatoxin poisoning. Aflatoxin is a naturally occurring chemical in a fungus sometimes found on corn and other grains that can cause liver damage. The company said it was unclear how the dog food might have been contaminated, but indicated that it might have spoiled in storage before reaching shops, AP said.

While Optima is the name of an American dog food brand, it was unclear if the food sold in China came from the United States. In the United States, Optima products are made by Nashville, Tenn.-based Doane Pet Care Co., which was bought in 2006 by Mars Inc., makers of Pedigree brand pet foods. Mars' Web site does not list any international operations, and it was unclear if Doane was the manufacturer of the brand sold in China. Calls for more information to the American and the Chinese companies went unanswered before business hours Monday, the wire service reported.

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106 Major League Baseball Players Got Exemptions for ADHD Drugs

Almost 8 percent of all Major League Baseball players used drugs to treat attention deficit hyperactivity disorder (ADHD) during the 2008 season, almost twice the percentage of the general population.

The drugs -- usually stimulants -- to treat ADHD are among those banned for general use in the major leagues, according to the Associated Press. The 106 exemptions -- 7.86 percent of all major league players -- are actually three more than granted during the 2007 season, the wire service reported.

The U.S. National Institute of Mental health estimates that 3 to 5 percent of American children have ADHD.

A Major League Baseball spokesman told the AP that making that sort of comparison might not be a fair one. "We are far younger than the general population," Rob Manfred, baseball's executive vice president of labor relations, was quoted as saying, "and we have far better access to medical care than the general population."

But Dr. Gary Wadler, chairman of the committee that creates a list of banned drugs for sports organizations, told the wire service he was concerned about the percentage exemptions for ADHD drugs in professional baseball.

"I've been in private practice for a lot of years," Wadler told the AP. "I can count on one hand the number of individuals that have ADD. To say that (7.86 percent) of major league baseball players have attention deficit disorder is crying out for an explanation."