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New FDA leadership

Robert Goldberg, Ph.D.
Washington Times
October 4, 2005

The departure of FDA Commissioner Lester Crawford and the appointment of the director of the National Cancer Institute, Dr. Andrew von Eschenbach, as his replacement, may prove to be a defining moment in American medicine. Those who believe that the Food and Drug Administration is placing politics above scientific review of new drugs are hailing the Crawford resignation. But whether the FDA will be allowed to reform itself with better science remains an open question. The litmus test will be if the same critics allow Dr. von Eschenbach who is widely regarded for his efforts to improve cancer care by increasing the number of treatments and tests that target specific cancers to lead the FDA in a similar mission.

Dr. von Eschenbach, who is a survivor of three types of cancer, will face yet another seemingly unconquerable challenge. Bureaucrats within the FDA, and the external critics who believe he is the drug industry's hand puppet, are undermining efforts to move the FDA into the 21st century. Rather than support scientific approaches to identify the risks and benefits of new drugs, these critics are stereotyping its proponents as pawns of the pharmaceutical industry and the Bush administration.

Take the attack on Deputy FDA commissioner Scott Gottlieb by Karen Tumulty, Mark Thompson and Mike Allen of Time magazine. This truth-twisting trio asserts that Dr. Gottlieb is merely a 33-year-old doctor turned stock picker, plucked from Wall Street by the Bush administration to shove through unsafe drugs.

In fact, Dr. Gottlieb played a major role in writing the FDA's strategic plan to use information from the Human Genome Project to make medicines safer and more effective. A drug for Parkinson's, for instance, beat the disease into remission for a small group of patients even when big studies showed no benefit, as "60 Minutes" reported. Indeed many drugs will work for 10 percent of people and not make a difference in the rest because of genetic variations. Dr. Gottlieb is working with companies and the best statisticians in the world to ensure the FDA process helps establish how genetic variations shape which groups of patients benefit from such "personalized" medicines.

In an agency rife with careerists who have never seen a patient, Dr. Gottlieb is one of the FDA's few practicing physicians, and he knows firsthand the suffering of the sick and dying. In today's FDA it is too easy and increasingly commonplace for bureaucrats to substitute statistical nitpicking for the concerns of loved ones with serious medical conditions. Dr. Gottlieb seeks to combine clinical trials with real-world measures of drug response so that people know, faster and more precisely than before, what drugs work and when.

Critics have also been quick to discredit any scientific initiatives to be undertaken by the agency or its new commissioner. Dr. von Eschenbach has mapped a vision for the NCI to eliminate death and suffering from cancer by 2015. Press reports say that "some" oncologists call that goal "wildly unrealistic." But the death rates of all cancers continue to drop, while survival rates increase. And many of the techniques he envisioned for achieving his goal such as using MRIs and genetic tests of tumors to map the progression of cancer cells are being used and shared by clinicians who are part of a cancer informatics grid he created.

Naysayers, such as Public Citizen and the so-called Center for Science in the Public Interest, imply that Dr. von Eschenbach was picked because his effort to target treatments to patients is one more way to grease the drug-approval process for industry. Public Citizen's Merrill Goozner alleges that getting targeted drugs to dying people faster is just a conservative smokescreen to enrich drug companies, and that Dr. von Eschenbach's appointment is part of that scheme.

Here, then, is what Public Citizen and Center for Science in the Public Interest and their media mouthpieces like Paul Krugman apparently oppose: genetically informed approaches to promote the faster development of safer and more effective drugs; new genetic tests to determine which cancer drugs work best for people; and better information on the relative risks and benefits of medicines.

All of that is what the new commissioner and Dr. Gottlieb stand for. And those who discredit them and feed the media misinformation about their agenda undermine medical progress and the search for cures.

Robert Goldberg is the director of Manhattan Institute's Center for Medical Progress and the chairman of the institute's 21st Century FDA Task Force.

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