September 24, 2005
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True to form, the administration picked late Friday afternoon to announce that Food and Drug Administration commissioner Lester Crawford resigned. The veterinarian in charge of the world's premier food and drug safety agency, who was confirmed for the job just two-and-a-half months ago, cited his age. He is 67.
The morning papers gave no clues as to what drove the decision, although both the New York Times and the Washington Post hinted broadly that he was forced out. But why? It couldn't have been the postponement -- again -- of approving Plan B, the morning after contraceptive pill. Crawford was doing the administration's bidding on that issue.
One possible clue to the administration's thinking comes from the appointment of Andrew von Eschenbach, head of the National Cancer Institute, as acting commissioner. Von Eschenbach, who previously ran the M.D. Anderson Cancer Center at the University of Texas, has been touting the new generation of targeted cancer drugs and in recent speeches has been confidently predicting that cancer would become a manageable disease -- like AIDS -- by 2015.
The Post story mentions that many oncologists have criticized von Eschenbach for overpromising, but ignores the back story. His prediction and embrace of the latest drugs has been prominently featured by the conservative Manhattan Institute, whose work on FDA and medical issues is conducted at its Center for Medical Progress. The Center is funded by the drug industry.
In the world of journalism, the Wall Street Journal's editorial page has been touting the new cancer therapies even when the clinical trial evidence shows they don't work or help as few as 10 percent of patients (and even then only for a few months). The Journal has been on the warpath against Richard Pazdur, who runs the FDA's oncology bureau, claiming he has slowed the pace of drug approvals.
Paul Goldberg's influential "Cancer Letter" pointed out in its August issue how a right wing "insurgency" is pushing for early approvals of cancer drugs. The insurgency includes Michael Milken (who has been treated for prostate cancer) and an all-star cast of conservative think tanks like the Manhattan Institute, the American Enterprise Institute, the Cato Institute, the Competitive Enterprise Institute, the Washington Legal Foundation and a cancer patient advocacy group known as the Abigail Alliance.
Grabbing a page from the AIDS activists of the early 1990s, their slogan is early access to experimental cancer drugs for the dying. If they can get the FDA to approve early access based on experimental data that suggests a new, experimental drug may affect the disease (usually based on some surrogate marker like tumor shrinkage, which can have no relationship to survival), they can then force insurance companies, Medicare and Medicaid to pay for the treatments.
That would be a godsend to the drug industry, which has invested billions in searching out cancer cures with marginal success. The new targeted therapies can cost anywhere from $4,000 to $10,000 a month. No wonder it has financially supported many of the conservative groups in the coalition.
Pazdur, who also came to the FDA from the M.D. Anderson Cancer Center, has fought to hold the line for the agency's traditional standard that a drug be shown to be effective before getting approved. His staff has also done a good job assessing whether a new drug's usually marginal benefits outweigh the substantial side effects and risks that are often associated with cancer therapies, including the newer targeted therapies. Just yesterday Genentech announced it had to stop a trial of its new drug Avastin for ovarian cancer after 11 percent of patients began developing holes in their stomachs and intestines.
There is a serious discussion that needs to take place at the FDA about how companies with new therapies can be encouraged to collaborate to see if in combination these drugs can have a major impact on cancer. But sophisticated scientific discussions and breaking the entrenched habits of competitive drug firms is not what the ideologues behind the anti-Pazdur campaign have in mind.
If von Eschenbach forces his former colleague out and appoint someone more malleable to run the agency's oncology division, we'll know the real reason why Crawford resigned.