Tag Archives: Esbriet

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?