Drug Safety vs. the FDA

by | Feb 20, 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 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

Alex Epstein is a philosopher who applies big-picture, humanistic thinking to industrial and environmental controversies. He founded Center for Industrial Progress (CIP), a for-profit think tank and communications consulting firm focused on energy and environmental issues, in 2011 to offer a positive, pro-human alternative to the Green movement. He is the author of The Moral Case for Fossil Fuels and Fossil Future: Why Global Human Flourishing Requires More Oil, Coal, and Natural Gas—Not Less. He is the author of EnergyTalkingPoints.com featuring hundreds of concise, powerful, well-referenced talking points on energy, environmental, and climate issues. Follow him on Twitter @AlexEpstein.

The views expressed above represent those of the author and do not necessarily represent the views of the editors and publishers of Capitalism Magazine. Capitalism Magazine sometimes publishes articles we disagree with because we think the article provides information, or a contrasting point of view, that may be of value to our readers.

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