For those of you who, like myself, stay up until ungodly hours of the early morning, there’s always a time in which TV offers no solace: that of the infomercials. While I tend to disregard advertisements for bras that add 14 cup sizes or cooking appliances that can peel 37 apples in under a second, my curiosity’s always piqued when I hear the words “FDA approved.” Now there’s a name I trust. Those two simple words strike me with an immediate sense of relief, a steely faith in whatever product that was eligible for FDA recognition.
But recent instances of food and drug recalls throw this faith into question — how effective is the FDA? How exactly does it approve products, and what factors play into this process? I’d always thought of this as a glorified assembly line, thousands of products making their way in front of a panel of judges, metaphorically placed on some ethical “scale,” and emblazoned with a large red “yes” if the scale tipped in its favor. Now I know better.
A recent study by Yale University’s School of Medicine examined more than 200 FDA approvals between 2005 and 2012 to ascertain exactly what this process entailed. While some drugs were only approved after large clinical trials a third of the approvals were of drugs tested by a single clinical trial, others only tested by a small group of patients.
This inconsistency reveals a weakness in the system of approval. The lack of a strict rubric allows potentially beneficial drugs to fall through the cracks while passing along harmful products to be distributed to the public under the guise of being approved as “good.” The study admits that this flexibility allows for the “rapid approval” of medications for life-threatening conditions, but how often are such drugs discovered compared to the ones millions of Americans take each day? Not having a rigid enough standard leads patients to believe that the medicines they’re taking are approved of in every possible way before being placed on the market and this simply isn’t the case.
Few know of the 1980s ordeal where many hemophiliacs suffered after realizing their medication Factor VIII, a form of blood plasma, contained the AIDS virus. Plasma was harvested from the public for cash, immediately drawing in impoverished and drug addicted Americans, and contaminated blood donations were mixed with the healthy ones. The blood was filtered out for the clotting factor needed to stop many hemophiliacs’ constant “bleeds” and was shipped and marketed to the public immediately after.
At first the FDA knew little about AIDS, continuing to approve of Factor VIII because they believed hemophilia to be the more serious condition of the two. But as researchers learned more about AIDS and its crippling implications, the FDA continued to sell Factor VIII, never warning the public on the risks of using this form of medicine. Even after it was discovered that exposing the medicine to heat could reduce the probability of contracting AIDS the FDA never shared this information. And as thousands of hemophiliacs continued keeping their medication in the fridge they unknowingly continued injecting themselves with AIDS, of which 10,000 Americans died in these few years alone.
More recently carcinogens and sulfites have been found in food dyes and preservatives that caused behavioral problems and asthma attacks. The FDA didn’t warn the public, conduct further testing, or restrict the levels of these chemicals in foods. And after trans fat was discovered by the Center for Science in the Public Interest to raise the likelihood of heart disease, it took a whopping 13 years for the FDA to place this information on Nutrition Facts labels.
The purpose of the FDA according to their website is “protecting the public health” is a critical part of the medical industry but only if they’re valuing the lives of patients themselves, not focusing on profiting from those desperate to be healed.
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