Drug Safety vs. the FDA
By Alex Epstein (Orange County Register, March 22, 2005)
As studies continue to be released that explore the cardiovascular risks of Vioxx, Celebrex, Bextra, and other pharmaceuticals, the FDA has come under widespread criticism for failing to protect the public from "unsafe" drugs. The lesson commonly drawn from the studies is that the FDA needs a longer approval process and more drug bans, so as to, in the words of one "consumer advocate," "ensure that the marketplace only has safe products."
This is a deadly lesson to draw.
Consider the Vioxx study that set off the current firestorm. Many have claimed the study proves that "Vioxx causes heart attacks." What the study actually showed was that among patients taking high doses of Vioxx for 18 months, 1.5% suffered a heart attack or stroke (none fatal), as against .75% of those taking a placebo. Far from proving that Vioxx is deadly and no one should take it, the study merely gives evidence that some people should not take it--namely, those at high risk of heart disease for whom there are safer but equally effective alternatives. But others would benefit from taking Vioxx, despite the study’s findings.
Take the case of an arthritis patient profiled in the Wall Street Journal, who has no family history of heart disease, and who finds Vioxx to be the most effective form of relieving his pain. The patient judges that "If I look at the numbers, I just don't feel I'm at risk" and concludes that with Vioxx off the market he is being deprived of his best option.
Or take the many arthritis patients for whom alternative drugs like Advil and Aleve pose a major risk of stomach bleeding, a side effect from which 15,000 die annually. For these patients, any heart-related risk increase associated with Vioxx, Celebrex, or Bextra, which are designed to prevent this side effect, may be far preferable by comparison.
The lesson to be drawn here is that drugs are neither "safe" nor "unsafe" as such; they carry different risks and benefits for different people. As a result, whether an individual should take a given drug or not is a contextual issue. It depends on the available knowledge about his genetic profile, the properties of the drug he is considering, and the resulting risks and expected benefits. It depends on the risks and benefits of his other options, including the often deadly option of inaction. These are some of the factors that an individual and his doctor must take into account if they are to make an objective decision.
Unfortunately, individuals and doctors today cannot make such decisions--not consistently--due to the FDA's coercive power to keep drugs off the market. The basic premise behind this power is that individuals cannot judge for themselves what drugs to take given their individual circumstances and risk preferences, and thus the government must make collective determinations of risks and benefits--and enforce them on everyone. "To argue that people ought to be able to choose their own risks…" says former FDA commissioner David Kessler, "is to impose an unrealistic burden on people."
To prevent patients from choosing their own risks is to prevent the rational, contextual judgments that their lives require--which often means to condemn them to suffering and death. The history of the FDA is filled with bans or delays of drugs like Interleukin-2, TPa, and various beta-blockers that many would have benefited from had they been free to take them. The death toll from such bans is, according to conservative estimates, in the hundreds of thousands.
The flip side of the FDA inculcating the fiction that banned drugs are too risky for anyone to take is that it inculcates Americans with the equally fictitious idea that approved drugs are guaranteed to be risk-free and benefit-laden for everyone. If it is true, as reports suggest, that numerous people who have taken Vioxx, Celebrex, and Bextra should have stuck with cheaper, more-tested drugs, then many individuals who have suffered financial hardship or even death will have done so because of the deadly premise of collective safety.
The era of the government collectively and coercively declaring which drugs are safe for Americans to take must come to an end, to be replaced by a new era of individual judgment and liberty. Many changes must be made to achieve this, but a first step is clear. While the government must continue to prosecute fraud in the manufacturing and marketing of drugs, it must end the FDA's power to keep pharmaceuticals off the market.
Alex Epstein was a writer and a fellow on staff
at ARI between 2004 and 2011.