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Drug Safety is Critical, So Keep Politics Out of It

Christopher Clark
Austin American-Statesman
Wednesday, December 8, 2004

I do not trust Washington politicians to decide which drugs should be available. If a drug is safe and effective, it should be on the market. Unsafe drugs should not.

But this simple distinction is becoming increasingly blurred. Activist groups are putting pressure on the FDA to approve or restrict drugs based on public opinion and political clout, rather than scientific research.

In September, outrage from activist groups led the FDA to require suicide warnings on anti-depressants, despite conflicting scientific evidence of such a risk. In May, over-the-counter "morning after" pills were deemed "unsafe" by the FDA, despite a recommendation from the FDA's own panel of scientists that the pills be approved. These birth control pills were rejected because of conservative political pressure from the White House and members of congress.

Whatever one's political leanings, these events highlight a disturbing trend: drug safety can be dictated by politics rather than science. This lets unsafe drugs be sold and keeps useful drugs from reaching the public. Furthermore, because the FDA both approves drugs and monitors their safety, it is politically risky for the agency to admit a drug is unsafe once it has already approved it for sale.

The American Medical Association recently asked for an independent government agency -- one that is separate from the FDA -- to monitor drug safety. This independence, the association says, will allow unsafe drugs to be pulled from market, even when they had previously been approved by the FDA.

This would be a step in the right direction, but it is far from adequate. Another government agency would be subject to the same political pressures as the FDA. Public outrage and political considerations could still force this new agency to take action, even when there is no scientific evidence about a drug's risk or safety.

What is needed is a truly independent group, one not subject to any government authority, to determine a drug's safety. A National Drug Safety Laboratory, perhaps operated by a top-tier research university and funded by the federal government, would have the autonomy and resources to make politically unmotivated, scientifically sound pronouncements.

This model has been successful for other national laboratories, such as the Lawrence Livermore Labs. Lengthy operations contracts and the research autonomy afforded by academe have allowed vital research to be conducted with federal money, despite changing political climates. This lack of political influence or fear of reprisal would allow a National Drug Safety Laboratory to provide accurate information about the drugs we take. Its analysis would be free from the influence of activist groups or political pressure.

Creating such an agency poses a huge challenge: it would require Congress and the White House to relinquish the political control they now exercise over the FDA. They would not be able to react to inflammatory public outrage by mandating FDA action, and they would no longer be able to pressure the FDA to approve or reject politically controversial drugs.

Despite these hurdles, an independent drug safety agency seems vitally needed. The FDA's increasing vulnerability to politics requires swift correction. A National Laboratory of Drug Safety would ensure that safe drugs can reach the market, while unsafe drugs are held back.

Even though such action might be difficult politically, we might use the same tactics to influence Congress that worked on the FDA. Educating the public about the FDA and its political bias should lead to grass-roots outrage, media coverage and calls for political action.

This, in turn, could lead to important changes in governmental drug policy -- and help ensure that all safe drugs are available, and all available drugs are safe.

Clark is a senior in computer sciences at the University of Texas. This essay was written for a Dean's Scholars Seminar on the "Interaction of Scientific and Public Perspectives" taught by Professors Adron Harris, Rick Cherwitz and Carlton Erickson. The course was developed in conjunction with UT's Intellectual Entrepreneurship initiative and the American-Statesman's Academic Engagement series.