FDA Advisors Found to Have Financial Ties to Product Under Review
In a recent report by Bloomberg, it was found that six doctors set to be on an FDA advisory panel, had financial ties to companies that produce stent heart devices which are currently up for FDA review. Drug coated stents that are used to prop open arteries, have been associated with an increased risk of blood clots that can cause both heart attacks and strokes.
The recent decision allows these doctors to serve on the advisory panel that could ultimately lead to the approval of rules and guidelines that would directly affect the drug coated stents, has lead to a backlash of public scrutiny.
According to Healthday, “ To clear the way for the six doctors to take part in the review, the FDA has waived rules that prohibit experts from involvement in matters that affect companies with which the experts have consulting contracts or in which they own stock.
The fact that the six doctors hold shares in, or receive fees from, companies that make stents is outweighed by their expertise on heart disease, Randall Lutter, the agency's associate commissioner for policy and planning, noted in a posting on the FDA's Web site.”
An extra 2,160 deaths a year could be avoided by not using drug coated stents according to an editorial by U.S. cardiology experts posted online Oct. 11 by the American College of Cardiology.
This would not be the first time the FDA has allowed financial ties with outside corporations to affect their decision process. A good example was Vioxx. When Vioxx along with several other COX-2 inhibitors were found to increase the risk of both heart attacks and strokes, the FDA created two advisory panels to look into the matter. The two panels concluded by a narrow margin that even though there was no doubt that the COX-2 inhibitors increased both heart attacks and strokes, the benefits outweighed the risks and all the inhibitors would be allowed to return to the market just with stronger warning labels.
After the fact, research into the FDA cases revealed that many members of the FDA advisory panels for both the original approval as well as the committees that voted to re-release the drugs back on the market, were paid consultants for the drug companies. When a member has financial ties to a company that is up for approval or review, that member is supposed to excuse themselves from the decision. In the meeting for the approval of Vioxx for of the six members including the chairman, had financial ties to Merck, the maker of Vioxx. Even more conspicuous, according to the New York Times the panel that reviewed the COX-2 inhibitors to determine if they would be placed back on the market, ten members that voted had financial ties to one manufacturer. Oddly enough, the vote was nine to one in favor of Vioxx.
It seems like to me the FDA may be protecting interests instead of our wellbeing. This article was written on behalf of FreebeeForeignPharmacy.com. For more related articles visit our blog: Foreign Pharmacy Tips.
About the Author: Cathlene Martinez has established herself in the online pharmaceutical resource industry. For more information on how to order from an online foreign pharmacies.