The Zombie Apocalypse, The CDC, and The FDA

The U.S. Centers for Disease Control and Prevention, in their continuing effort to promote public health and health awareness, has outlined the basics of zombie apocalypse preparedness. Yes, for real.

As it turns out, preparing for the zombie apocalypse is similar to preparing for any other disaster: stock up on non-perishable food, water, and medications, have copies of important documents gathered together in a safe and accessible place, have a “family meeting place” picked out, and so forth. The CDC outlines emergency preparedness elsewhere on their website, but apparently no one really wants to read about preparing for a mudslide, a hurricane, or a fire evacuation. What people do want to read about, apparently, is the zombie apocalypse. Thus, figuring that getting the message out was more important than the mechanism by which they got the message out, the CDC went with a partially tongue-in-cheek, partially no-nonsense discussion of the undead and what happens when they attack. Good for them for their fun-loving and light-hearted approach to a serious matter. Particularly as, until the publication of the zombie article, “fun-loving” and “light-hearted” would not have been high on the list of adjectives I’d apply to the CDC, or any government agency, for that matter.

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 one heck of a balancing act to perform, and 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 literally can’t take action.)

In an article published in the Journal of the American Medical Association, Dr. ­Joshua Sharfstein addresses the dilemma the FDA faces. They are an organization responsible for overseeing the safety and regulating the approval of both pharmaceutical and over-the-counter drugs (as well as a large portion of the food available in the U.S., which increases their workload). On the one hand, they’re under tremendous pressure to approve drugs, both from consumers (who want to see potential treatments for diseases become available) and from pharmaceutical companies (who want to make money — more on this later). On the other hand, we live in a society that is not 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, the FDA didn’t require drug manufacturers 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, dangerous, or both), and make any claim he wished, and he wouldn’t be crosswise with the FDA. As of 1906, the FDA required that manufacturers label their wares correctly and that the medications be contaminant-free, but there were no further requirements. In 1937, a pharmaceutical company marketed sulfanilamide elixir (a solution of sulfanilamide antibiotic in diethylene glycol solvent). Diethylene glycol is sweet and did a good job of dissolving the antibiotic, which made the elixir popular with parents, since it was easy to give to children. Unfortunately, diethylene glycol is chemically similar to antifreeze, and just as toxic. Of 353 children who took the medication, 100 died of kidney failure. The public outcry was phenomenal; as a result, congress passed the 1938 Food, Drug and Cosmetic Act, which was the first legislation to require proof of safety in marketed drugs. Further acts and amendments followed, shaping the legislation that outlines the responsibilities of the FDA today.

Obviously, this legislation has 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. Take Baycol, for example (a cholesterol drug), which was pulled off the market in 2001. While Baycol appeared safe during extensive drug trials, post-marketing surveillance revealed that it increased risk of potentially fatal muscle weakness. 52 people died in all. How many total took the drug? Hard to know for sure; those are difficult numbers to come by. Maybe tens of thousands, maybe more. Regardless, compare Baycol’s “unacceptable” safety record to that of sulfanilamide elixir to 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 for marketing to the public, 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!). Oh, and 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 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 they have to recoup, 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.”

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 as tenuous as Patrick Dempsey’s in “Can’t Buy Me Love.” Now that the buzz about zombie apocalypse preparedness has died down, the CDC’s image is right back where it was beforehand: a geeky institution that we’re morosely convinced is in bed with big pharma (why else would they push all those vaccinations!?), and that overstates the danger of “routine” childhood illnesses. Oh well. I guess you can’t win. Unless you write about zombies.

 

Why do you think it’s so hard for us to believe other than the worst of government agencies?

 

References:

FDA Baycol. Accessed 14 Oct 2011.

Furberg et al. Withdrawal of cerivastatin from the world market. Curr Control Trials Cardiovasc Med. 2001;2(5):205-207.

Sharfstein, J. The FDA — A misunderstood agency. JAMA. 2001 Sept 21; 306(11): 1250-51.

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7 Comments (+add yours?)

  1. Megyn @Minimalist Mommi
    Nov 18, 2011 @ 03:05:49

    For me, it’s the business and political ties of the heads of these departments. A lot of big business men and women go from corporation to politician. It leaves a lot of questions in regards to motives. I’d like to believe that they would sever the corporate interest ties, but realistically know that there’s unfortunately more deception and filth in DC than good. Just follow the money trails :/

    Reply

    • SquintMom
      Nov 18, 2011 @ 15:54:29

      I agree that there is a revolving door between many government organizations and big business. However, academics (who do NOT make much money, and who are NOT part of that revolving door exchange) also work on drug design. This is why it’s nearly impossible to keep a drug “suppressed,” as many people like to believe the FDA does; if the drug existed, the pharm company that synthesized it wouldn’t be the only company to know about it (or at least, to get the general idea), and even if the government were (let’s assume the worst) in cahoots with big pharma to keep us all cancer-ridden, academics would reproduce the drugs and get the information out there. How can I be so sure? Because many of the drugs eventually manufactured and marketed by pharmaceutical companies were developed in whole or in part at academic institutions, and while academics will sell patents, they don’t want to see their work (or the knowledge it engendered) suppressed, for a number of reasons. To believe in a conspiracy between the government and big pharma that suppresses existing drugs, you have to believe in the ability of a multi-faceted organization to maintain absolute secrecy for decades. Simply doesn’t happen in this day and age of information overload.

      Reply

    • SquintMom
      Nov 18, 2011 @ 16:01:01

      Also, you have to ask yourself why a pharmaceutical company would suppress a drug; economically, it makes no sense. For example, there are those who claim that the CDC recommends vaccinations because they’re in bed with big pharma, who wants to profit from all the vaccinations being given. However, pharmaceutical companies (as well as medical personnel) would enjoy vastly greater profits from uncontrolled epidemics of disease than they do from vaccination. A study by Michael Kremer (Harvard / The Brookings Institute / National Bureau of Economic Research) and George Snyder (George Washington University) modeled prospective revenue for pharmaceutical manufacturers, comparing the income from vaccines to that from disease treatments. Under two different modeling scenarios, they determined that the treatments yielded greater profits than the vaccines. (Kremer and Snyder. The Revenue Consequences of Vaccines Versus Drug Treatments. Harvard, 2002.) Similarly, there’s just no good economic rationale for suppressing a drug.

      Reply

      • Megyn @Minimalist Mommi
        Nov 18, 2011 @ 17:06:07

        My concern with the ties is not of suppressing drugs, it’s more of the mentality of “let’s make a drug for EVERYTHING.” Of course, this helps pharma’s because it makes them money, and they do a lot of lobbying to ensure this trend continues. And that’s what bugs me the most-the who’s in bed with whom.

      • SquintMom
        Nov 18, 2011 @ 17:09:42

        Hmmm. But is it really big pharma that’s saying “Let’s make a drug for everything?” People with symptoms/diseases are calling for drugs, and the pharmaceutical companies are responding. If they didn’t respond — if they instead said, “Oh, well, rather than make you a drug that will help with your symptoms of, say, type 2 diabetes, how about you follow the more recommended protocol and eat a healthy diet while working toward losing weight,” people would be angry, and would turn elsewhere for their drugs (i.e., to another company), who would respond and make the drug. Basically, WE CREATE the pharmaceutical industry through our demand for relief in pill form.

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