Preparing for the Zombie Apocalypse and the FDA

Reading time: 6 – 10 minutes

In an effort to promote public health awareness, the U.S. Centers for Disease Control and Prevention (CDC) has outlined preparation basics for the zombie apocalypse [1].

Yes, you read that right: zombie apocalypse.

As it turns out, preparing for the zombie apocalypse is similar to preparing for any other disaster: stock up on food, water and medications; have tools and supplies on hand; have items for sanitation and hygiene; etc. The CDC outlines emergency preparedness elsewhere on their website, but apparently no one really wants to read about preparing for a tornado, flood or winter weather. What people do want to read about is the zombie apocalypse. Thus, running with the idea that how you prepare is more important that what you prepare for, CDC went with a tongue-in-cheek, partially no-nonsense discussion of the undead and what happens when they attack.

If zombie preparedness made the CDC the government’s equivalent of a cool kid, the Food and Drug Administration (FDA) is the class nerd: both an object of contempt and a scapegoat. I have to admit I feel sorry for the FDA because they have quite a balancing act to perform: they’re given less credit for their actions and more credit for autonomy than they deserve (the FDA’s actions and powers are determined by congress, so where they “fail” to provide for public safety, it’s often because they truly can’t take action.)

In a recent article published in the Journal of the American Medical Association, Dr. Joshua Sharfstein from the Maryland, Baltimore Department of Health and Mental Hygiene, addresses the dilemma the FDA faces [2]. The FDA is an organization responsible for overseeing the safety and regulating the approval of both prescription drugs and over-the-counter medications, not to mention a large part of the U.S. food supply. The agency is under tremendous pressure to approve drugs, both from consumers who want to see treatments for diseases become available and from pharmaceutical companies who want to make money. We live in a society that isn’t willing to accept risk, and we find it completely unacceptable when an approved drug causes harm. The FDA thus has to balance quick drug approval with appropriate safety precautions.

Long ago, pharmaceutical manufacturers weren’t required to prove that a drug was safe or effective before bringing it to market. The proverbial “snake-oil salesman” could sell anything — even something ineffective and/or dangerous — and make any claim he wished. In 1906, prior to the creation of the FDA, the Pure Food and Drug Act only required that certain specified drugs be accurately labeled with contents and dosage. In 1937, a pharmaceutical manufacturer created a preparation of sulfanilamide, a sulfonamide antibacterial (sulfonamides are often called “sulfa drugs” or “sulpha drugs”), using diethylene glycol as a solvent. Diethylene glycol is sweet and did a good job of dissolving the antibiotic, which made the sulfanilamide elixir popular with parents, since it was easy to give to children. Unfortunately, diethylene glycol is chemically similar to antifreeze and just as toxic.

Although animal testing should have been routine, the pharmaceutical manufacturer didn’t perform any and there were no regulations requiring safety testing of new drugs before going to market. Of 353 children who took the medication, 100 died of kidney failure. The public outcry was tremendous; as a result, congress passed the 1938 Food, Drug and Cosmetic Act, which gave authority to the FDA to oversee the safety of food, drugs and cosmetics. Further acts and amendments followed, shaping the legislation that outlines the responsibilities of the FDA today.

Obviously, these laws have improved the safety of drugs brought to market. Even “failed” drugs that are pulled off the market for poor safety records do nowhere near the damage sulfanilamide elixir did. Consider Baycol (a cholesterol drug), for example, which was pulled off the market in 2001. While Baycol appeared safe during extensive drug trials, post-marketing surveillance revealed that it increased the risk of potentially fatal muscle weakness; 52 people died in all. How many people actually took the drug? It’s hard to know for sure; tens of thousands, maybe more. Regardless, compare Baycol’s “unacceptable” safety record to that of sulfanilamide elixir and you get an idea of how successful the FDA is in helping to prevent large-scale pharmaceutical disasters. The FDA did everything right. They required Bayer (the pharmaceutical company) to provide evidence of safety and efficacy in animals before the drug was even approved for human trials. They required years and years of human trials before the drug was brought to market. Everything looked good. All this to the background noise of consumers complaining that the FDA takes too long to approve new drugs, but the agency took its time and released Baycol only when it appeared truly safe and effective. And then the FDA continued to do its job; they monitored the safety of the drug post-marketing, because some side effects are so rare they don’t show up in human safety trials (even large ones), and others take years to show up. When adverse reactions to Baycol started cropping up in the public, it was removed from the market. Let me say it again: the FDA did its job. But Baycol is often cited as an example of an FDA “failure.”

We want our drugs and we want them NOW; we aren’t willing to wait years and years for testing. We also want our drugs completely safe, so FDA had better ensure that companies test for safety carefully (but quickly!). Moreover, we don’t want our drugs tested on animals (because that’s cruel), but neither do we want them tested on people (because they could be dangerous, and no one should be exposed to that. Or they could be effective, in which case it’s not fair that some people in drug trials get randomly assigned to the placebo). We’re unhappy with the FDA no matter what they do. And to boot, we’re unhappy that all the safety testing costs pharmaceutical companies millions and millions of dollars per drug, which increases drug prices. So we want our drugs SAFE, FAST and CHEAP, and we resent the FDA for “standing in the way” of our safe, fast, cheap drugs with a checklist that they insist on filling out before they allow all those (undoubtedly perfect, life-saving) drugs that they’re “withholding” to come to market. Yes, I feel sorry for the FDA. As Sharfstein astutely notes, “Some claim the FDA is captive to manufacturers … others assert the agency [moves too slowly]. Sometimes stories outlining conflicting perspectives appear on facing pages of the same newspaper” [2].

Maybe what the FDA needs is to spiff up their image a bit. They should take a lesson from the CDC and incorporate zombies into their policy statements. Or … maybe not, since ultimately, the CDC’s cool image proved tenuous at best. Now that the buzz about zombie apocalypse preparedness has died down, the CDC is right back where it was beforehand: a geeky institution that we’re convinced is on the take from big pharma (why else would they push all those vaccinations!?), and that overstates the danger of “routine” childhood illnesses. Apparently you can’t win. Unless you write about zombies.

References

1. Preparedness 101: Zombie Apocalypse. Centers for Disease Control and Prevention. Accessed 14 Oct 2011.
2. Sharfstein JM. The FDA–a misunderstood agency. JAMA. 2011 Sep 21;306(11):1250-1.
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