Should We Trust the FDA?
by Vin Miller
The United States Food and Drug Administration (FDA) was put in place to protect and support the health of the general public. Unfortunately, it’s become clear over the past few decades that the FDA is protecting and supporting something entirely different and is actually endangering our health more so than protecting it.
The modern era of the FDA began in 1906 with the introduction of the Federal Food and Drugs Act which was intended to improve the safety of foods and drugs. Despite this being a step in the right direction, there were still very few restrictions on the production of pharmaceuticals at the time. In 1937, a poorly tested medication called Elixir Sulfanilamide turned out to be poisonous to humans and caused more than 100 deaths. In response, the Federal Food, Drug, and Cosmetic Act of 1938 was created which gave the FDA much of the power that it has today. However, this power has been put to use in ways that conflict with the best interests of the general public.
The Customer is Always Right
Most businesses realize that their customers are the people who support their livelihood. Based on this, they go out of their way to keep their customers happy with top quality services and products. This is a very effective system, except when the people who should be receiving the preferential treatment are not the customers.
To accelerate the approval of new drugs, congress passed the Prescription Drug User Fee Act in 1992 which allowed the FDA to collect substantial fees from drug companies seeking approval of new products. Since then, the FDA has become very dependent on this funding which creates a significant conflict of interest. One of the primary purposes of the FDA is to protect us from any wrongdoings of the drug industry, but thanks to the Prescription Drug User Fee Act, the drug industry is now paying the FDA’s bills and the salaries of their employees. Who do you think the FDA cares about most?
The Testimony of a FDA Scientist
In 2004, David Graham, who was then the Associate Director of Science and Medicine at the FDA’s Office of Drug Safety, testified before the U.S. Senate in a case regarding the drug Vioxx. This drug is a painkiller that was removed from the market after proving to be a significant risk factor for heart disease and stroke. Vioxx was the greatest pharmaceutical disaster of all time, and according to Graham, caused 140,000 heart attacks and 60,000 deaths. This drug caused the death of more Americans than the Vietnam war!
What’s shocking about the Vioxx disaster is that the FDA was aware of the drug’s dangers for two years before finally doing something about it. In his testimony, Graham stated that “Vioxx is a terrible tragedy and a profound regulatory failure. I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.”
According to Graham, the culture within the FDA regards the drug industry as its client when it’s really the American people who should be the organization’s top priority. As such, it’s typical for the FDA to have a bias towards approving as many drugs as possible and downplaying their risks. While tens of thousands of Americans were losing their family members and friends to Vioxx, the FDA was more concerned about keeping the customer happy.
To learn more about the true nature of the FDA, I suggest that you read David Graham’s full testimony and this interview that he did nearly a year later.
Corporate Lobbying
As if the Prescription Drug User Fee Act doesn’t provide enough incentive for the FDA to favor the drug industry, corporate lobbying makes things even worse. A lobbyist is someone who uses their political connections to influence legislation on behalf of another party. According to the Center for Responsive Politics, the pharmaceutical industry has 1,659 registered lobbyists which is more than 3 lobbyists for each member of congress. In 2008, the pharmaceutical industry spent more than $230 million on lobbying and more than $29 million on contributions to political campaigns. In fact, the pharmaceutical industry spends more money on lobbying than any other industry.
In addition to pharmaceuticals, the FDA also regulates the additives used in processed foods and the labeling used to market them. This is an area of contention as well. Although the food industry isn’t as influential as the drug industry, they still have 359 registered lobbyists, and in 2008, they spent more than $33 million on lobbying and more than $12 million on campaign contributions.
Although the FDA appeared to be doing their job by taking exception to the cholesterol claims made on Cheerios boxes, they don’t seem to care about the ridiculous food labels that exist on so many other food products. Similarly, despite their approval of controversial artificial sweeteners like aspartame and Splenda, the FDA at one time banned the import of stevia which is one of the safest and most natural sweeteners available. However, once Coke and Pepsi invented Truvia and PureVia, the FDA gladly approved these stevia based sweeteners which are less natural but are patentable and therefore have much more profit potential.
FDA Scientists Continue to Speak Out
It’s been quite some time since David Graham’s testimony against the FDA and Vioxx, but unfortunately, it seems that not much has changed. I doubt that the FDA will allow another mistake as big as Vioxx, but that certainly doesn’t mean that they’re cleaning up their act for the right reasons. In fact, earlier this year, a number of FDA scientists sent letter to President Obama describing the corruption within the FDA and indicating the tremendous need for reform.
Who to Trust?
It’s abundantly clear that we can’t trust the drug industry, and the food industry isn’t very trustworthy either. The government agency appointed to protect us from these industries simply isn’t doing its job. With the right perspective, however, this could be a blessing in disguise because it requires us to take responsibility for our health which is something that we should be doing anyway. The best way to do this is to educate yourself, commit to a healthy lifestyle, and when in doubt, abide by the laws of nature. Unlike big industry and the FDA, nature has no lobbyists, is completely impartial, and will never lie.
If you’d like to learn more about the FDA and what you can do to promote change, visit the American Association for Health Freedom’s site about Reforming the FDA.
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Excellent! I hope everyone who reads this passes it along to others. It’s clear that our political system (ie lobbyists) will never change, so it is up to all of us to educate each other and to ‘lobby’ our representative ourselves (even though that has become less effective over the years, as we don’t control their purse strings any longer [now that they voted themselves lifetime salaries, and aren't afraid of not being re-elected])
Hi Jon, thanks for your comment! Although the odds are against us, I’d like to think that there is hope for change. In fact, if you read more about the Vioxx disaster, you’ll see that David Graham’s testimony was made possible by a senator who was looking to do the right thing.
A sobering post, Vin. Given that we recognize the problem, educating others with such posts is crucial, and I think the American Association for Health Freedom’s site is a vital first step in effecting such change!
Hi Phil, thanks for your comment! Yes, it’s sobering indeed. It really angers me that the very same agency that was put in place to protect us has little regard for our welfare. Hopefully the American Association for Health Freedom will help to change this.
I find myself really conflicted about the issue of the federal government regulating food and drugs because I’m not convinced that it’s within their constitutional authority to do so.
There are a few practical problems with the notion of the FDA as well:
1) It creates a moral hazard where people think that anything FDA approved must be safe and therefore they aren’t as cautious about putting things into their body as they ought to be.
2) It leaves an unelected government bureaucracy as the first and only word on the safety of food and medicine which makes it unaccountable to the people.
If the FDA didn’t exist, what would happen? I’m willing to bet that there would be numerous consumer advocacy organizations that would step up to the plate, and just like everything should be in a free society we would have a choice of many sources of information and be free to decide what we believe is safe and healthy and what is not. The FDA doesn’t strictly regulate nutritional supplements but there is an organization called consumerlab that takes products and tests them for purity, lead contamination, etc. and for a fee you can access the results through their website. I think there would be a lot more such organizations if people didn’t have the misconception that the FDA was looking out for them.
If there were a thriving industry of consumer watchdog groups that replaced the FDA what would happen if one of them screwed up? Obviously they would lose public confidence and would risk going out of business. What happens when the FDA screws up? The politicians try to sweep it under the rug as quickly and quietly as possible so as to avoid political ramifications but nothing changes, and there is no recourse. Anyone who thinks we would be less safe under a regulatory system driven by the free markets rather than government intervention should give this some serious thought.
What’s really amazing is seeing the extreme arrogance of some doctors and scientists who criticize the value of natural remedies while at the same time peddling concentrated forms of natural remedies that do a lot to upset the delicate chemical balance inside the human body. I believe that doctors would be less gung-ho about handing out these unnatural pills if they didn’t have political cover from the FDA. As long as they “follow the guidelines” they don’t have to worry about whether their actions destroy the lives of their patients. In fact they don’t even really have to worry that much about their patients at all since the patients usually aren’t the ones paying the bills, but that’s a different topic.
Hi Dave, thanks for your thoughtful comment!
I think you have an interesting idea regarding consumer advocate organizations. One thing I’d be worried about with a model like this is the lack of a required approval process. Although the FDA isn’t doing it’s job well enough, I think it’s a good practice to have an approval process that requires research to support the safety of a new product. Of course, it would be much better for the research to be independent and unbiased which often isn’t the case today. I don’t know if private organizations could possibly have the authority to require such an approval process, and without it, we’d all be test subjects until a new product has been in circulation long enough for its effects to be known.
One thing I especially agree with is that the FDA, or any agency, organization, or industry that would hypothetically take its place, needs to be much more accountable for their actions.