The Foxes are Guarding the Henhouse

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…

1. 28% of advisory committee members and voting consultants had a conflict of interest.
2. 73% of meetings had at least one member or consultant that had a conflict of interest.
3. Despite these numbers, only 1% of members were recused (removed from the process) because of a conflict of interest.
4. 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.
5. For every voting member with a conflict of interest there was a 10% greater likelihood that the meeting would favor the drug being considered.
6. Speakers in public sessions were often times supported by and flown to meetings by the manufacturer of the drug under review.

We must also realize that these statistics were limited to self-reported conflicts of interest, meaning that it is likely that the actual conflicts were under-reported. That means that the numbers are probably even worse than what I just told you!! This is born out because a USA Today independent investigation from 11 years ago found that the above numbers were even worse. Isn’t the whole idea in evaluating the merits and safety of a particular drug to do so with unbiased information from unbiased sources?? Am I missing something here? What is the Actual Mission? So let’s take a look at that mission statement again. Nowhere does it mention that the FDA should be an agent for the pharmaceutical industry… and yet, that is what they appear to be. An agent is a person or entity that represents the best interests of another person or entity. If I were to write a book, I would hire a literary agent that would take my book to different publishers and find the best deal for me. He would insure that I get a nice advance and that the publisher would devote certain resources to the promotion of my book. If I were going to sell a house, I would hire a real estate agent to get me the highest possible price. The FDA has become the agent for the pharmaceutical industry. They allow outside influences into the decision-making process that work to guarantee, or at least tip the scales in favor of, the approval of drugs. Who looks to gain from that approval? It’s the pharmaceutical companies that gain… not the public. Do not allow yourself to get tricked into believing that the FDA is protecting your interests or making any progress in making your lives any better. The pharmaceutical industry has been presenting “solutions” to your ills for decades. Are those ills any better? The answer is a resounding NO!! Do we have more or less heart disease or diabetes or high blood pressure or depression or osteoporosis or cancer today than we had 10 years or 20 years or 30 years ago? The answer is more. For the first time in history, as has been mentioned in this column before, our children’s life expectancy is less than ours. That is the biggest indictment of big drug business and government involvement than could be realized. Our children are not going to live as long as we will. And what about the financial burden? I notice that in the FDA’s mission statement there is the phrase “more affordable’. That must be a joke, right? The only thing that amazes me more than the cost of a newly released drug is the fact that the next one will cost even more. Let’s look at the much bally-hoed release of the COX-2 inhibitors a while ago. I’m talking about Celebrex, Vioxx and the withdrawn drug Bextra. These are a class of drugs that supposedly will cut down on pain and inflammation without causing the stomach bleeding that Non-Steroidal Anti-inflammatory Drugs (NSAIDs) do, like Motrin or Ibuprofen. When studies were originally done, it was noticed that after being on a COX-2 inhibitor for 6 months there were less “pre-ulcerative lesions” in the stomach. Based on this information this new class of drugs was heralded as the best thing since sliced bread and that now medicine had an answer for all of those arthritis sufferers that would not cause ulcers or other stomach bleeding complications. Oh, yeah, they forgot to mention the fact that these pills would cost around $1/pill whereas the NSAIDs are more like pennies a pill. And the real kicker is that after a year of being on these COX-2 inhibitors the ulcer rate is just about the same as with the NSAIDs. Not only that… one of the COX-2 inhibitors was taken off of the market because people happened to die while taking it and another, Vioxx, is the subject of millions of law-suits against the manufacturer because of the damage that it causes to the heart. The bottom line here is that the U.S. Food and Drug Administration is doing a terrible job of living up to its mission. So, I have a few suggestions. Let’s either get the FDA to start doing what it was originally created to do… protect the public interest and help find solutions to our health ills or we should force them to change their name to better reflect what it is that they actually do… How about the Federal Dishonesty Administration or Frequently Deceptive Academy or Freaking Drug Agency. Or… we could rename them the U.S. Food and Dietary Administration and they could begin to look at how our diets are the root cause of every one of our chronic diseases and how drugs rarely fix anything!