(Twilight of the Gods)

major dam of pain has broken. Last September, the COX-2 inhibitor Vioxx® was withdrawn from the market because of a study showing increased risks of heart problems. Then a few months later, similar findings were announced regarding another COX-2 inhibitor, Celebrex®. Since then, even familiar over-the-counter medications, such as naproxen, ibuprofen, and aspirin, have come under indictment. For those with crippling arthritis, splitting headaches, or other forms of chronic and intractable pain, the loss of a single dependable painkiller can be a tragedy. And now the compiled losses are becoming torrential.

In the wake of the rising floodwaters, critics are pointing their fingers:

  • Trial lawyers are beating their drums for class-action lawsuits
  • Publicity-hungry politicians are clamoring for tighter controls over the FDA
  • Editorialists are attacking the pharmaceutical industry for putting profits ahead of safety
  • Patients are badgering their doctors
  • Doctors are berating the drug companies
  • Ad nauseam

It’s a real feeding frenzy, and in all likelihood, it will only get worse.

While undoubtedly the worst thing that can be done is to increase regulatory control—the surest way to keep new painkillers off the market is by threatening, penalizing, and frightening the producers—the gods of the governmental bureaucracy are likely to do just that. They can’t just sit around and do nothing … so regulate they must, in the name of protecting us from the crisis of pain—or, should we say, the crisis of fear, a clear consequence of embracing the Precautionary Principle.*

*The Precautionary Principle is the belief, widely held by bureaucracies, that it is best to be absolutely “safe” and show no unintended and possibly dangerous side effects—thus rather sneakily shifting the burden of proof onto innovators in an entirely unreasonable way. An example of this principle in action was the FDA’s foot-dragging for many years on the approval of beta-blockers in the USA after they had been safely used in Europe for many years. Hundreds of thousands of lives could have been saved but for the use of the Precautionary Principle by the FDA.

Franklin Delano Roosevelt, certainly one of the founding fathers of the modern regulatory State, famously said, “The only thing we have to fear is fear itself.” Yet when our government turns to the manufacture of fear, as we have seen countless times, in peace as well as in war, it is clearly the government we should fear. We have witnessed this fear promulgation most recently in the nutritional supplement industry through the excesses of government campaigns against ephedra and androstenedione. In the pharmaceutical arena, it is no less the case.

Thirty-five years ago, the Italian director Luchino Visconti brought a controversial film, The Damned, to the screen. It was a story about German industrialists who played up to Hitler and the insurgent Nazis in the hope that they could be exempted from the regulatory juggernaut and could turn the State’s power to their advantage. How wrong they were. The industrialists were The Damned.

Although we have no Hitler here in America (yet), the trend in the evolution of the State regulatory apparatus is toward Fascism, whether it’s advocated and promoted by Democrats or Republicans. This system, as practiced by the Italians under Mussolini and the Germans under Hitler, imposes a rigorous economic model of total control. At the same time, deceptively, it postures itself as a friend of property, yet it severely encumbers property and the means of production with one backbreaking regulation after another—with calamitous results.

Richard Wagner’s four-part operatic cycle, The Ring of the Nibelung, has occasionally been “modernized,” touting a Marxist viewpoint, as a story of the struggle between the proletariat and their capitalist masters. So when the final curtain falls in the final opera, Götterdämmerung, it is the capitalist masters who are routed as their home, Valhalla, is burned. They are portrayed as the worn-out gods of an antiquated age. But in fact they are State capitalists, or Fascist sympathizers, as are the industrialists in The Damned. They might just as well be modern-day pharmaceutical industrialists who have sidled up to the champions of rigorous, although not yet total, economic regulation, such as the FDA.

However, there is another view, closer to Wagner’s mythos, in which the worn-out gods represent the old art, and old ideas. Following this notion and applying it to our current dilemma presents us with another possibility. The old gods are the FDA and the other bureaucrats, who are saddled with enormous conflicts of interest, ever more driven by excessive precaution, and debilitated by politically strengthened tort lawyers who invalidate their efforts.

According to some campaign promises, tort reform is supposed to be high on the administration’s agenda, as it should be, because the present system has all but destroyed any sense of reasonableness with regard to product liability. But this system shouldn’t be the only subject of reform, especially when it comes to our crises. The FDA should also be reformed and driven back, at the very least, to its original intent: a concern for safety, exclusive of efficacy. This reform would disencumber it from the conflicts of interest with the pharmaceutical industry and, provided it was accompanied by tort reform, would place the subject of liability where it really belongs: with the individual, his or her doctor, and issues of disclosure.

We should kindle Valhalla and let it burn.

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