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May 19, 2005

The FDA vs. Cancer Patients

The Wall Street Journal reports, "The American Society of Clinical Oncologists met this week in Florida, where it heard promising study results about a host of developmental cancer therapies. "Just in the last year or so there are many more options," one researcher was quoted as saying. 'None of them are FDA-approved yet. Hopefully soon they will be.'"

"The bad news is that 'hopefully' really is the operative word here. Former FDA Commissioner Mark McClellan made some progress moving the agency to speed up the drug approval process. But he was pulled away to run Medicare, and agency bureaucrats have since been working feverishly to turn back the clock. The latest evidence of backsliding was a recent vote of the Oncologic Drugs Advisory Committee (ODAC) to recommend against approving Johnson & Johnson's leukemia drug Zarnestra. The drug may not be a miracle cure -- 15% of study patients achieved complete remission. But 15% is nothing to sneeze at either, especially since the company was seeking accelerated approval for the treatment of elderly patients who might not be able to withstand the punishment of traditional chemotherapy. Yet ODAC voted against adding this weapon to the anti-cancer arsenal."

The Joint Center conference, Shortening Drug Approval Times via Industry Funding of the FDA: Did Legislation Help or Hurt?, presented and critically reviewed some of the first empirical research on the impact of the Prescription Drug User Fee Act (PDUFA) on drug approval times.

Also of interest from the Joint Center:

FDA Needs a Dose of Reform Robert Goldberg

The FDA and the First Amendment: Comments on Pharmaceutical Regulation John E. Calfee

Comments

Left out of the discussion re "breakthru" drugs is their universally staggering cost. Example: I prescribed Gleevec for a patient with metastatic chordoma based on a report from the National Tumor Institute of Italy. A one month's supply cost $6000 USD; the drug would have to be used indefinitely.

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