When I think about the Food and Drug Administration (FDA), the first thoughts that come to mind are the safety and protection of people through the testing of harmful drugs and the elimination of those that are not favorable. Before the recent egg recall, I remembered the spinach E. coli scare. I thought, “Now that is how the FDA is supposed to work” — it takes control, removes the harmful spinach from the market, and keeps people healthy and alive. Regarding pharmaceutical drugs, similar to the spinach, I thought the FDA kept drug companies and products in line. However, I discovered that the pharmaceutical aspect of the FDA is one of the most commonly misunderstood realms. In fact, instead of protecting people like you and me, the FDA is in cohorts with the drug companies. The companies that the FDA purports to protect us from are often the same companies that are in charge of the FDA itself.
Although the FDA does efficiently prosecute many drug companies, it also prosecutes people who are focused on the well being of their customers. For example, in 2005 the FDA sent multiple letters to cherry companies nationwide proposing legal action.
The rationale was that the cherry growers had published information on their website about the health benefits in cherries — their anti-inflammatory properties. The FDA had threatened the cherry companies to keep growers from promoting the healthy benefits. This seems unjust to me, but it doesn’t stop with just cherry growers. The FDA squelches the voices of the natural food and supplement proponents, and the FDA fails to provide protection to the American people due to its inability to put limits on the drug companies.
I found it shocking when I learned the Food and Drug Administration does not conduct any scientific trials on the effects of drugs. This is appalling considering that the point of the FDA is to protect us. So where is the FDA getting its information on drugs? The answer is just as surprising: the FDA gets all of its information about drugs from the companies that produce the drugs.
For the FDA to authorize a drug for the market, it needs to be given studies concerning the effectiveness of the drug. The studies are required only to provide the FDA an outline of the “successes” of the drug and how the drug hit the one positive marker that is needed for approval — even if it happened to miss twenty-five others. The report does not announce any of the failed trials and markers. The report does not recount any of the side effects. The report does not publicize any of the drawbacks. What makes me wary of this situation is that a drug as common as a very popular anti-inflammatory can slip through the research system in spite of its negative side effects. Take the over-the-counter drug Advil as an example. While it was shown to be beneficial in one area, it has the apparent side-effect of increased risk of cardiovascular disease.
Ultimately, the FDA’s drug approval system adheres to the motto: “Tell us if your drug is unsafe. Otherwise we will assume that it is safe.” However, few, if any, drug companies will ever tell the FDA their drug is unsafe — especially when a company spends around $600 million dollars in order to get one single drug on the market. No wonder the drug companies forgo mentioning the negative effects.
Ultimately, this problem can be traced back to the profit-driven ethos of the drug companies and the failure of the FDA’s drug approval system to provide support for our health and safety.
Despite the ominous nature of this situation, people are fighting back in order to ensure our rights. For example, Jonathan Emord, a lawyer from Washington, D.C., has been fighting the FDA for years. He has won seven large cases against the FDA. They range from legal arguments about labeling food and supplements — similar to the cherry grower example mentioned earlier — to the assurance that certain dietary supplements can stay on the market. Personally, I refuse to give up hope as long as people like Jonathan and the POP campaign continue to fight.