Politics, Conspiracy and Drug Regulation

It's easy (and by no means invalid) to indict "big Pharma" for its marauding rapacity; but in this casehave cultivated a disease from a toxic lifestyle.
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Some Huffington Post readers may be perplexed as to why, in the recent controversy over the diabetes drug Avandia, I have twice taken a position that appears antithetical to Democrats on the Committee on Oversight and Government Reform seeking accountability from the Food and Drug Administration and the manufacturer, GlaxoSmithKline (GSK); first, by questioning the methodology behind the claim that there is a 43 percent increase in the risk of heart attack and, second, by questioning the judgment of the New England Journal of Medicine (NEJM) in promoting the study with an avidity not supported by the fragility of the data.

Indeed, the way Rep. Waxman et al, study author Dr. Steve Nissen, and NEJM seemed to synchronize led to speculation that the June 6 oversight hearings were as much about shaping FDA reform as they were about determining whether the FDA and GSK were dilatory or worse in addressing the drug's potential cardiovascular risks. As Steve Usdin wrote in BioCentury:

Alarming headlines about Avandia... served as a political defibrillator, shocking new life into congressional efforts to separate the assessment of drug efficacy and safety just weeks after they were defeated in the Senate and as the House Energy and Commerce Committee is set to begin debate on drug safety legislation.

A quick google search using the words "Avandia," "drug" and "conspiracy" grosses some 58,000 entries, many of which, it should be noted, point to a conspiracy in the other direction - that of the FDA cozying up to GSK and suppressing dissent on the drug's safety.

I have no political feelings about the partisan slugfest that took place on June 6 in response to Dr. Nissen's paper, or a stake in the matter, other than to repeat the underlying theme of my other pieces on this topic -- statistics are more useful than indignation -- and offer a crude analogy which, I hope, illuminates the deeper issues that we are overlooking in this debate.

Imagine you're a doctor, and you suddenly see a significant increase in workers from a local timber yard arriving at your surgery with cuts to their fingers. The cuts aren't deep enough to warrant sutures, so you disinfect and apply band-aids. But the increase doesn't abate, and now some of the workers are returning with infected cuts that you previously treated. Do you confine yourself to asking whether the band aid failed - was there a lack of adhesion or some other defect that suggested it didn't do what it was supposed to do? Do you demand an inquiry into whether the band-aid manufacturer misled you about its product? Do you demand the FDA issue a black-box warning about using the band-aid? Do you demand a better band-aid?

Or do you ask whether there is some underlying problem at the timber yard behind the increased injuries - and address that?

The latter course of action doesn't preclude any of the former interventions, or suggest that they aren't wise; but what of a situation where the underlying problem -- poor safety in the timber yard -- is ignored, and the public debate grows ever more shrill over the efficacy and safety of band-aids, with calls that the manufacturer is in cahoots with the FDA to minimize the risk? And what if the threat of litigation and regulation becomes so great that no-one wants to manufacture band-aids anymore?

Comparing Avandia to a band-aid is, I admit, a cartoon analogy; but the scenario cuts to the fundamental problem with diabetes: it is difficult to see how we aren't substituting a debate about how to regulate the treatment of symptoms for a debate about how to treat the underlying problem.

The unpleasant reality is that as obesity has increased, so has diabetes; and the consequences are grim. In 2002, diabetes led to 82,000 non-traumatic amputations, 153,730 cases of end-stage kidney disease, between 12,000 and 24,000 cases of blindness, and 224,092 deaths (a figure which is probably an underestimate). In 2003, health officials said New York City described the increasing rates as an "epidemic."

To put it bluntly, people are, effectively, poisoning themselves through over-eating, lack of exercise, and poor nutritional knowledge, access, and choice (yes, choice; don't think this is just a blue-collar disease). Or they are poisoning their children by allowing them unregulated access to a toxic trough of candy, chips and cookies - and an endless fountain of soda and sweetened juice (for the first time in history, a generation has been raised to dislike the taste of water).

Arguing over the motives behind treating the symptoms of this problem may prove valuable, if the risks of Avandia end up outweighing the benefits, and if the approval process for drugs results in safer treatment; but it's difficult to see it as anything other than a convenient, crowd-playing fudge when the underlying issue is vastly more complicated and getting worse.

It's easy (and by no means invalid) to indict "big Pharma" for its marauding rapacity; but in this case *we* have cultivated a disease from a toxic lifestyle, and now find ourselves in the position of needing the pharmaceutical companies to save us. The opportunities for profit are enormous, diabetes is a growing global disease with little prospect of receding; but, unlike band-aids, the drugs are imperfect, the risks are asymmetric, and the real questions defy congressional realpolitik: do you stop more people from going blind if you increase the risk of heart attack for a few?

We are partners in this mess; but, as Eli Siegel observed, "it is much easier to hate something we do not see as ourselves."

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