Wednesday, March 12, 2008

FDA's Controversial Role

Today’s Wall Street Journal has another piece on potential further restrictions on anemia drugs sold by Amgen, Inc. and Johnson & Johnson (see Byron’s post for the earlier article). This piece highlights the FDA’s controversial nature. Here’s an excerpt:

Last fall, dozens of protestors gathered outside the FDA's headquarters to complain about the agency's handling of cancer medicines. Two prostate-cancer patients blamed the agency for rejecting a treatment they said helped keep them alive. Later, the group broke into a chant: "Pazdur Must Go! Pazdur Must Go!"

On the other side, cancer researchers and other patient groups say Dr. Pazdur approves drugs that work and provides a bulwark against those that are unproven and potentially dangerous.

Dr. Pazdur's role crystallizes broader questions about the FDA itself. Amid rapid changes in medical science and soaring health-care costs, Dr. Pazdur and the agency face conflicting pressures. Some want the FDA to make it easier for cancer patients and doctors to get access to drugs, by relaxing traditional standards for measuring their benefits. Others want the FDA to set a high bar to protect Americans from drugs with only limited effectiveness.

Around 1.4 million cases of cancer are expected to be diagnosed in 2008, and 565,650 Americans are expected to die of cancer this year. Still, better detection and better treatments have steadily improved the odds for many patients. For people diagnosed between 1996 and 2003, the five-year survival rate was 66%, up from 50% for those diagnosed between 1975 and 1977.


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