An advisory committee to the Food and Drug Administration decided that obesity drugs must undergo clinical trials to ensure they do not cause heart attacks. The 17 to 6 vote now requires studies for all obesity drugs even if no apparent cardiovascular risk exist.
The track record of weight loss drugs has not been stellar. Though the new testing requirement will require much more time and money and ultimately impede drug production, the majority felt strongly about their decision.
“Given the checkered history of weight loss drugs, I think it is better to be prudent and err on the side of caution,” Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles.
Those who oppose the vote feel a much needed treatment will now be difficult to administer.
“If the F.D.A. follows through with this vote, you’ve just added another big disincentive for the drug companies to come up with obesity drugs, and we desperately need new drugs,” said Dr. Ed J. Hendricks, an obesity specialist in Sacramento.
Currently, Xenical is the only weight loss drug that is approved for long-term use. There are two new drugs awaiting approval from the FDA: Qnexa and Lorqess. It is unclear if the vote will affect these drugs as they were submitted prior to the decision.
Many of the drugs created for obesity can elevate heart rate. Critics fear that an obese person is already at a high risk for cardiovascular problems and heart attacks and the drugs may do more harm than good. However, many doctors and obesity specialists are taking into account that one third of the adult population is obese and another one third is overweight. This statistics cause many to believe we need more drugs on the market to help remedy this increasing issue.
The vote will hinder the development of some drugs, even though the committee agreed that some testing could take place after the drug was approved.
After the horrible side effects of the popular ‘90’s weight loss drug fen-phen, it feels wise that doctors and committee members are being cautious. Fen-phen causes major heart valve damage in many users, and that sort of mistake can not be risked again.
Decisions for the pending drugs Qnexa and Lorqess will be determined this spring.
March 30th, 2012