May 10, 2007
Cancer patients suffered a serious setback yesterday. The Food and Drug Administration sent back Dendreon's Provenge, a development-stage drug for prostate cancer, requesting additional clinical data. The FDA rejected the drug despite an outside advisory panel's overwhelming recommendation to approve it, says Richard Miller, president and CEO of Pharmacyclics and an adjunct professor of oncology at Stanford University Medical Center.
Provenge's fate has wider implications, says Miller:
- It is the first of a growing number of therapeutic cancer vaccines to go up for approval and is emblematic of the gap between medicine and statistics that paralyzes the FDA approval process and keeps vital treatments from reaching critically ill patients.
- The FDA bases its approvals -- for everything from medications for minor ailments to new cancer treatments -- on the rigid application of the same outdated statistical standards.
- Any new drug or other form of treatment, whether it's a therapeutic treatment for infected hangnails or a cancer vaccine, must meet the FDA's standard of 95 percent certainty that any positive results claimed for its use are not due to chance.
While hangnail sufferers may be in a position to (uncomfortably) wait for such levels to be achieved, it is difficult to argue that terminally ill patients with only months to live should have to do so -- especially when more than 1,500 Americans die of some form of cancer every day. Given the choice and an understanding of known risk factors, many of these patients would prefer to accept less certainty about a new treatment's potential to extend or improve quality of life for the time that remains to them, rather than to accept the near certainty of an imminent and often uncomfortable death, says Miller.
Source: Richard Miller, "Drug Disaster," Wall Street Journal, May 10, 2007.
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