- The Washington Times - Sunday, August 6, 2006

Acting Food and Drug Administration Commissioner Dr. Andrew von Eschenbach is clear about what the FDA is for and how it should be run. He told the Senate committee considering his nomination to be the agency’s permanent head that “millions of people are asking if there is anything else. Anything else for cancer, Alzheimer’s, AIDS, diabetes, Avian flu.” The fact is that there will not be anything else without his vision of a modern, efficient and effective FDA.

But for the mainstream media and Dr. von Eschenbach’s critics there is nothing except Plan B. It is a symbol, they claim, of how the Bush administration has compromised science for the sake of politics. And they plan to hold Dr. von Eschenbach hostage until they receive assurances that the FDA’s scientific integrity is restored. The marker for that assurance? That would be regulatory action on Plan B, the morning-after pill, in the time and under the specific conditions they demand.

Capitulation to this tactic will politicize science and the FDA forever. It will permit any politician with a pet peeve and crackpot theory to replace his or her judgment for that of the consensus of the scientific and medical communities.

Plan B is cited as an example of how politics has trumped science at the agency. But politicians are seeking to substitute the FDA’s deliberative and transparent process with their own view of what risks are acceptable and which are not. Sen. Tom Harkin wants to know why Plan B should be restricted to women 18 years of age and older while it can be purchased over the counter in Europe by anyone at any age. Does that mean the senator’s support for restricting the sale of pseudoephedrine products to minors was based on science of a purer form? Sen. Hillary Clinton claims that getting drug companies to work with pharmacists to limit the distribution of Plan B to minors is akin to holding the distillers of alcoholic beverages responsible for bartenders who serve underage drinkers. Does this mean that FDA’s pause in the approval of home HIV test kits while the manufacturer set up a program to work with doctors and pharmacists to provide adequate counseling to HIV positive patients is akin to holding the company responsible for unsafe sex?

Meanwhile Dr. von Eschenbach is the one voice in the wilderness insisting on making informed public-health and product decisions based on better science and a commitment to the canons of scientific inquiry. Until recently, the only way to limit risk was to keep medicines off the market or remove them after the public lost confidence in their safety. But, Dr. von Eschenbach told the committee, advanced technologies are allowing us to lead the FDA (and public health) “into the era of personalized medicine, where health care is tailored to each individual patient, and where the safety of medical products is enhanced by our improved understanding of how they interact with different patients, different drugs, and under different conditions.”

This is the new paradigm of medical science — biology as the new information technology — and it threatens those who have for years used rat studies and data dredging to prove that French fries, water and heart medicines cause cancer with real information for a change. Scientific integrity consists of using the most powerful search engine in pursuit of the truth or reconstruction of nature. Often, the renegade or new idea wipes away the conventional wisdom (heart experts initially scorned the idea that high blood pressure had anything to do with heart attacks).

But no one runs to a political official or uses the machinery of government to force a result or conclusion outside of the established scientific method —at least until the recent voice of the Vioxx Populi. Senator Christopher Dodd talks about restoring scientific integrity to the FDA but then entrusts David Graham to help write his own drug safety legislation. Yet Mr. Graham wants to withdraw the antibiotic Ketek despite a scientific consensus that it keeps kids from dying from pneumonia. The Enzi-Kennedy bill, which at first was an elegant roadmap for promoting dynamic risk evaluation, now requires the FDA to treat all medicines as equally dangerous. Every drug could be so tightly restricted without regard to science that it would make the FDA’s limits on Plan B look like fluoridation.

Mrs. Clinton says that “‘Once we start politicizing the Food and Drug Administration, there is no stopping.” She should know. She wants an FDA that acts on the political whims and media-driven factoids of politicians. Andrew von Eschenbach, with the voices of patients still fresh in his heart and mind, regards science as a source of human empowerment and redemption. For his courage to continue on that path, the president should make him FDA commissioner over the ignorant objections of those that would politicize science and call it truth.

Robert Goldberg is vice president for strategic initiatives for the Center for Medicine in the Public Interest. Peter Pitts is president of the Center for Medicine in the Public Interest and former associate commissioner for external affairs for the FDA.

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