What If We Had No FDA?

 

[This appeared originally in Huffington Post, 12/7/15]

Because the Food and Drug Administration forbids even terminally ill people from taking unauthorized drugs that could save their lives, twenty-four states have now passed laws to deal with the problem. They have enacted “right-to-try” legislation, which allows patients with fatal illnesses to take experimental drugs that have not received FDA approval.

Commendable as these actions are, they don’t go nearly far enough.

Most of the criticisms of the FDA focus on the agency’s delays in approving drugs. People are dying while waiting for the FDA to decide whether to give them access to vital medication. The average drug now takes fourteen years to reach the market (almost double what it took in the 1960s). New drugs are often available in other industrialized countries while they are still illegal in America.

For instance, after clinical testing showed that Provenge, a novel vaccine for advanced prostate cancer, increased patients’ survival rate, the FDA’s own advisory panel in March 2007 voted 13-4 to endorse the drug’s effectiveness, and 17-0 to endorse its safety. Nonetheless, the FDA refused to approve the drug until April 2010. During those three years, close to 100,000 people in the U.S. died of prostate cancer. Or take the case of Esbriet, designed to treat a fatal lung disease that kills 40,000 Americans yearly. It was okayed by the FDA in 2014—four-and-a-half years after its advisory panel recommended approval (and after it had been available in Europe for four years, and in Japan for seven). Obviously, no one can know precisely how many of those who died during these periods might have been saved; the only certainty is that none were allowed to find out. There are, sadly, many such examples. (And even the FDA’s “compassionate-use” program, designed to permit the terminally ill to use certain unapproved drugs, is laden with bureaucratic obstacles for patients, doctors and pharmaceutical companies.)

But these unconscionable delays are merely symptoms of the problem. The underlying cause, along with the underlying injustice, is something else–namely, the FDA’s life-and-death power over all of us.

Like any government entity, the FDA is an agent of force. It exists, not to inform or persuade us, but to legally stop us from taking a drug we think might be good for us. Here’s what the FDA typically does in prohibiting a drug. It takes a company’s research data, which identifies the drug’s risks and benefits, and decides that the statistical probability that the drug will help you is not worth the risk of unwanted side effects. This then becomes a dictatorial edict, by which you must abide.

But why shouldn’t you be permitted to make that decision? Your doctor may disagree with the FDA’s conclusions (as there is often disagreement among scientists and physicians within the FDA itself). You and your doctor may believe that, for your particular circumstances, an unapproved drug is worth the risk.

Obviously specialized knowledge is required to assess any drug. But once we remove the FDA’s coercive monopoly over the evaluations of drugs, numerous private alternatives will arise—alternatives that physicians will use in advising you. There will be competing sources of information, as there are now when it comes to assessing everything from electrical equipment to mutual funds to fire extinguishers. Your doctor will consult medical journals, private certification laboratories, professional colleagues, etc., in offering you his recommendation. Why are you not entitled to follow it?

If we live in a free society, it is you who should have the right to decide whose judgment to accept about the value of some medication—and not only if you have a terminal disease, but any affliction. Whatever your condition, it is your life and health at stake, and you should be the one making the choices. You go skiing, you ride a bicycle—you weigh risks and benefits to yourself all the time; why should the same freedom be forbidden to you with respect to something as crucial as drugs? Why should the FDA be allowed to play God?

Yes, there are risks. Some new drug may turn out to have side effects unknown when it was first released. This is what happened, for example, with thalidomide in 1961. The deformed babies born from mothers who had taken thalidomide during pregnancy were not caused by mindless “greed” on the part of the drug manufacturer. The tragedy was the result of a lack of knowledge at the time–by scientists, by pharmaceutical companies and by the FDA—about the effects of drugs passing through the placenta. The FDA’s own requirements did not include testing on pregnant subjects, neither animals nor humans. (For elaboration, see pp. 149-150 in my book In Defense of Selfishness [Palgrave Macmillan].)

The full properties of a drug are sometimes not known, and not knowable, until after a vast number of people, over a long period of time, have used it. This is part of the inherent risk one accepts if one wants the benefits of a new drug. That is, one chooses the risk of taking the drug over the risk of not taking it.

Of course, private citizens can make mistakes–but so can government bureaucrats. And of course, if left free, some people may unthinkingly endanger themselves for no good reason—just as people may thoughtlessly harm themselves, even fatally, by improperly using a drain cleaner, a ladder or a bathtub. But the actions of such people do not justify the imposition of straitjackets around the rest of us. The same principle applies to drugs. Rational people should not be forced to suffer and die needlessly, by being denied access to needed medication, simply because others may use their freedom irrationally.

The FDA has been given the power to force people to delay, whether for a day or forever, taking the medicines they believe will improve, or save, their lives. And the question we all should be asking is: By what right?

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The Collectivist Mentality

[This article appeared in Huffington Post, Nov. 9, 2015:  http://huff.to/1RINNZY]

China’s mandatory limit on the number of children a couple may have, which the communist government recently announced is being changed from one to two, attracts little support in the West. Apart from the most ardent environmentalists, people generally recognize the evil of such a policy.

But do they understand what, at root, makes it so abhorrent? Or do they tolerate, even embrace, variants of the same idea in other areas? Consider, for example, the following three positions and ask yourself whether there is a common belief underlying all of them:

  • The communist’s prohibition against having more than one (or two) children.
  • The conservative’s demand that assisted suicide be banned.
  • The liberal’s campaign against income inequality.

These seemingly diverse views are actually products of the same mindset: a collectivist mentality.

Under the collectivist philosophy, the individual has no independent existence or value. He is merely one of many indistinguishable, disposable cells within the “social organism.” It is the group that has primacy. Consequently, all important decisions must be made, not by the individual, but by society — i.e., by the state.

When it comes to child-bearing, on this view, everything you give your child — every morsel of food, every drop of water, every inch of space — represents a resource taken away from society. All acts of consumption become acts of expropriation. You therefore need public approval before having a child. You must be given permission to use up society’s scarce resources. And what about your rights? You have none, according to the doctrine of collectivism. The demands of the group, not the rights of the individual, set the standard for social policy.

Similarly, those who oppose assisted suicide believe that your life is not really your own. You are a fragment of society, they say, not an independent human being. The decision to terminate your life, no matter what agonies you may be suffering, cannot be made by you or by those who choose to assist you. Rather, it must be made by the collective. As one legal brief, written for a Supreme Court case, put it: “[Suicide] is an intensely social act . . . amenable to social control, since it has a dramatic impact on others.” It is an act “requiring the assent of society as a whole.” (And even those who oppose suicide on strictly religious grounds share the collectivist’s basic premise: the presence of some “higher power” to which the individual must subordinate himself.)

This point is articulated more starkly in an 1802 handbook of English law (cited approvingly in the aforementioned brief): “The law regards [suicide] as an heinous offence . . . for as the public have a right to every man’s assistance, he who voluntarily kills himself is with respect to the public as criminal as one who kills another.”

In other words, suicide and murder are equally objectionable since both diminish the human resources available to society. We are all supposed to accept the role of rightless serfs, serving as fodder for some “greater good.”

The same philosophy underlies the crusade for income equality. “Why should the top 1 percent own close to 50 percent of the wealth in America?” the crusaders ask. Or, looking at the issue more globally, “Why should the U.S., with under 5 percent of the world’s population, have more than 20 percent of the world’s GDP?” If your life is not yours, neither is your money. Instead it supposedly belongs to the collective, which then determines how much you should be allowed to have.

But don’t the rich have more because they have produced more? Doesn’t a Bill Gates or a Warren Buffett or a Sam Walton create his wealth through his own efforts? No, says the collectivist emphatically — no one does. This view holds not just that your money may be seized at will by society, but that you never earned it in the first place. It’s the view that your income is a collective product.

“It takes a village to raise a billionaire,” according to the organization Responsible Wealth. “You didn’t build that,” according to President Obama — society did. To the collectivist, wealth is never an individual achievement. Rather, it materializes, causelessly and anonymously, from the social organism. And since we’re all just interchangeable cells of that organism, why should any single cell receive a bigger paycheck than any other? Why shouldn’t we all be “equal”?

Exercising our rights over our lives — from keeping our own money, to bearing children, to choosing suicide — depends on a moral code of individualism. Every attack on our freedom stems from the notion that the individual must be sacrificed to the collective. These attacks will not end until the individual is upheld as an end in himself, rather than merely a means to the ends of others.♦♦

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Unsoaking the Rich

The most distressing aspect of soak-the-rich schemes is not that the left keeps pushing them-but that the right regularly fails to offers a convincing refutation.

When Democrats declare that the rich are not paying their “fair share” of taxes, the Republicans’ typical response is: Oh yes, they are; look at how much more they pay, in both absolute dollars and percentage of income, than those in lower brackets. Besides–Republicans usually add–refraining from imposing higher taxes on the rich helps “society as a whole,” because of all the jobs produced through their investment capital.

But this type of response does not address the core question. The nature of that question, as well as the absence of a compelling answer, is hinted at by James Taranto, writer of the Wall Street Journal‘s “Best of the Web” column, in his examination of a recent New York Times article. . . .

[For the full article, see “The Correct Answer to All the Soak-the-Rich Tax Schemes” at RealClearMarkets.]

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