Tag Archives: FDA

“Women’s Viagra”–
Why Should Government Decide?


This was published in Huffington Post on Sept. 5, 2015   http://huff.to/1VFwzPC

In reaction to the FDA's recent decision to approve flibanserin—the so-called "women's Viagra"two camps have emerged. One argues that the drug's benefits clearly warranted approval by the agency; the other argues that the benefits are dubious and did not warrant approval. But no voices are addressing the more fundamental question: why should the government be making this decision in the first place?

When the FDA tells us which drugs we may and may not use, its purpose is not to prevent us from being defrauded. A regulatory agency is not needed for that; there are plenty of laws under which misrepresentation by drug makers can be prosecuted. Indeed, if it were concerned about fraud, the FDA would simply require a manufacturer to state a drug's true properties, including the benefits and the risks, and then leave people free to decide whether to use it.

Further, if the FDA's role is to reassure people that a drug is safe, so that they are willing to use it when they otherwise wouldn't, why is legal coercion necessary? Why doesn't the FDA just announce its evaluation of a drug and then grant everyone the right to accept or reject it? What if our doctors disagree with the FDA's conclusions (as there is often disagreement among the FDA's own medical and scientific personnel)? Why shouldn't we be free to rely on the judgment of those who arrive at a different verdict?

In fact, the FDA, like all regulatory agencies, exists essentially to say noand to force us to abide by that pronouncement. The FDA exists, not to keep us from being deceived, but to keep us from judging for ourselves what is good for us.

The debate about flibanserin, for example, centered on the risk-reward calculation. One view emphasized the negative side-effects of the drug; the other emphasized the positive effects of libido enhancement. But why shouldn't every woman have the right to make that determination for herself? Why can't she consult her doctor and then weigh the pros and cons? Why should the FDA have the power to forbid the drug, or even to place restrictions on its userestrictions such as limiting it to premenopausal women. Why can't a postmenopausal woman trust her doctor's judgment as to whether the drug is suitable for her? Why should the FDA be allowed to play God with our lives?

As laymen, we make many important decisions by consulting people with specialized knowledge. We consult mechanics to evaluate our cars, property appraisers to evaluate the worth of our homes, financial advisors to evaluate our investments, doctors to evaluate our health. We rely on private certifiers, from Underwriter Labs to Good Housekeeping, to assess the safety and the effectiveness of various products. Why can't we rely on medical sources, including our own doctors, to assess the information about a new drug? (In fact, before the FDA took over the task, drugs were privately reviewed by physicians.)

The pernicious premise underlying FDA regulation is paternalism. It's the belief that we cannot know what is really best for us, and therefore need the supervision of a "disinterested" party. We are deemed incapable of making rational judgments about our own interests. So the FDA, like a parent, must take us by the hand and lead us down the proper path. As one psychiatrist claimed, in arguing against the drug before an FDA advisory panel: "Is there a small group of women who could benefit from medical intervention–probably." Nonetheless, if flibanserin gained approval, "the much larger group of women without any medical reason for their sexual distress will inevitably be misinformed and misled into thinking that there is a pill that can get them the sex life they read about, the one they think everyone else is having."

In other words, people must be protected against their own irrationality. Even if the drug is useful for certain peoplethe argument goesthere are others who might misuse it and it therefore should be banned. But the fact that some people take a drug unthinkingly and irresponsibly cannot justify prohibiting it. Why should those who do take responsibility for their health be penalized for the sake of those don't? Why should the rational be sacrificed to the irrational?

Yes, there is a risk in taking a drug, particularly a new drug. But there can be an even greater risk in not taking it. All the FDA does is to forcibly prevent us from choosing which risk we prefer.

By treating us as helpless children, the FDA causes needless suffering and deaths. Whether someone wants a drug to increase sexual desire or to treat a deadly cancer, every day in which access to medication is legally denied represents an unnecessary evil. Studies have shown that the mere delay in approving drugs that are being safely used outside the U.S. results in numerous deaths annually—to say nothing about all the useful drugs that get developed but never approved, or all the ones that are never developed in the first place because of regulatory burdens.

I'm in favor of getting rid of the FDA entirely. But for now, at the very least, each of us should be allowed to decide whether or not to accept the agency's opinions. Those who want to categorically trust the government would still be able do so. But those who want to rely on other sources would be given the freedom to choose.♦♦