Health Highlights: Jan. 13, 2009
Anti-Smoking Advocate Tapped for HHS Deputy FDA Approves Guidelines for 'Off-Label' Drug Use FDA Lax in Overseeing Doctors' Conflicts in Trials: Report Chinese Distributor Pulls Suspect Dog Food
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
Anti-Smoking Advocate Tapped for HHS Deputy
President-elect Barack Obama has nominated William V. Coor, executive director of the Campaign for Tobacco-Free Kids, a nonprofit group that seeks to reduce tobacco use among children and adults, for deputy secretary at the U.S. Department of Health and Human Services (HHS), the New York Times reported Tuesday.
If confirmed by the Senate, Coor would serve as No. 2 in the department under former Senate majority leader Sen. Tom Daschle (D-S.D.), who was selected last month by Obama to head the health agency. Coor worked as Daschle's chief counsel and policy director when Daschle was minority leader. As a member of Obama's transition team, Coor also led efforts to evaluate the department he is now nominated to join and previously had served as chief of staff at HHS under former secretary Donna Shalala in the Clinton administration, according to the Times.
"Reforming our health care system will be a top priority of my administration and key to putting our economy back on track," Obama said in a statement. "Under the leadership of Tom Daschle and Bill Corr, I am confident that my Department of Health and Human Services will bring people together to reach consensus on how to move forward with health care reform."
The new Congress is expected to aggressively pursue federal regulation of cigarettes, raising taxes on tobacco products and approving an international tobacco control treaty, the newspaper said. As a senator, Obama, an occasional smoker himself, co-sponsored a bill that would have given the U.S. Food and Drug Administration broad powers to regulate tobacco products, including cigarettes.
FDA Approves Guidelines for 'Off-Label' Drug Use
The U.S. Food and Drug Administration has OK'd guidelines that would make it easier for drug companies to use medical journal articles to promote drugs for unapproved uses, the Associated Press reported Tuesday.
While pharmaceutical firms are not allowed to advertise products for "off-label" uses, the agency has allowed salespeople to distribute articles about such uses if they have been published in a peer-reviewed medical journal. A law permitting that distribution expired in 2006, and drug makers have been lobbying for its renewal ever since. The FDA said the new guidelines, posted online Monday, are designed to discourage "ghostwriting" of medical reviews and recommended that companies disclose financial relationships with article authors, the wire service said.
The veracity of some journal articles were questioned last year when Merck & Co. was accused of ghostwriting articles about its painkiller Vioxx. The drug was withdrawn from the market in 2004 for safety reasons, the AP reported.
Companies such as Pfizer Inc. and Eli Lilly said the guidelines merely reauthorize a longstanding policy that benefits doctors and patients, but critics contend the new directives contain a loophole allowing firms to distribute product articles to doctors even when they involve uses that have not been federally approved, AP reported.
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.
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.