Tag Archives: FDA

The FDA, Opioids and Altruism

An opioid pill (Opana ER) that successfully relieves pain is being removed from the market by the FDA—not because of any claims of unsafety or inefficacy, but because people have found a way to pulverize the drug and inject it to get “high.” Since such people risk contracting HIV or hepatitis C through the sharing of needles, no one—the FDA declares—should be allowed to take the medication: “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”

Obviously, this action is another demonstration that the purpose of the government’s regulatory apparatus is not to keep people from being defrauded, but to prevent them from exercising their own judgment about what is good for them.

More broadly, though, this is a demonstration of the power of the altruist creed. When the desperate sufferer of pain is to be sacrificed to the mindless drug addict—when a productive pharmaceutical manufacturer is to be sacrificed in order to keep people from indulging in self-destructive behavior—when the rational are to be sacrificed for the sake of the irrational—what could possibly underlie such injustice except a code that preaches self-sacrifice as everyone’s moral duty?

As I wrote in IN DEFENSE OF SELFISHNESS:

“If the FDA were worried that people lacked accurate information about a drug, it would simply publicize its own findings and allow patients and their doctors to make an informed judgment about whether to use the medicine. But the doctrine of altruism does not permit this. After all, if people are merely provided with medical information, the demands of the needy are not being fully met. The FDA can describe what a particular drug is and is not supposed to do, it can present the consequences of misuse, it can explain the need to consult a physician—but what if people refuse to listen? What if they ignore the evidence? . . . As long as people are allowed any freedom to make their own choices, there will always be some unmet needs—i.e., the needs of those who do not wish to make rational choices. . . .

“This argument can be made, of course, not just about medications but about everything—which is precisely what the collectivist does. Any product, from mousetraps to mutual funds, can be improperly used, particularly by those who do not care to acquire the requisite knowledge. Nothing, therefore, is exempt from the tentacles of the regulatory state. To protect the ‘needy,’ the government must control everyone’s actions.”

“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.♦♦