Guess who turned 100 years a few years ago? Well, maybe it would be more appropriate to ask a “what” instead of a “who”. Our friends a couple of miles down the road… the U.S. Food and Drug Administration (FDA) have been around for over 100 years. It was in June 1906 that President Theodore Roosevelt signed the Food and Drugs Act and entrusted implementation of this law to the Bureau of Chemistry of the U.S. Department of Agriculture. The Bureau, the oldest U.S. consumer protection office, eventually became the FDA. As published on the FDA’s web site, this is their Mission Statement… The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. Those are pretty lofty goals; and worthy goals too, I think. Unfortunately, the FDA does not come even close to reaching them, and if we were to judge, we might assume that they are not even trying. When looked at from an unbiased perspective (yes, I can do that) we might even conclude that the FDA is much more concerned about the welfare of a certain industry than they are for the public’s welfare. Here’s an idea… let me present the facts and then you be the judge… Conflict of Interest When evaluating the merit of drug investigation data, the FDA uses a host of “experts” on outside advisory committees and FDA-invited voting consultants. The law requires that the FDA offer full disclosure for any potential conflicts of interest that their decision makers may have with the pharmaceutical industry. It took a threatened law suit from the Ralph Nader founded public-interest watchdog organization Public Citizen in 2001 to finally get the FDA to comply with the law. If the FDA were actually living up to its mandate of “protecting the public health” (or even really interested in trying) then why did it take the threat of a law suit to make them comply with a common sense law that had been on the books for years? Doesn’t it make sense to you that the people making decisions about whether or not a certain drug should get approved should not have any financial interest in, or connection to, the company that makes that drug? It certainly makes sense to me… and yet, a study that was actually published in the Journal of the American Medical Association (JAMA) gave us some interesting insights… This information covers the period from 2001 to 2004. Here are the facts…
- 28% of advisory committee members and voting consultants had a conflict of interest.
- 73% of meetings had at least one member or consultant that had a conflict of interest.
- Despite these numbers, only 1% of members were recused (removed from the process) because of a conflict of interest.
- Committee members and FDA voting consultants had conflicts that included investments, consulting arrangements and/or contracts and grants that ranged from more than $10,000 to over $100,000.
- For every voting member with a conflict of interest there was a 10% greater likelihood that the meeting would favor the drug being considered.
- Speakers in public sessions were often times supported by and flown to meetings by the manufacturer of the drug under review.