FDA doc takes heat for strict standards on new cancer drugs

 I had a long wait for the Red Line and a gratis NY Times from the BU Comm school. So, I read this piece about the FDA doc who is trying to protect patients from marginally useful cancer drugs.

Dr. Richard Pazdur, director of the Food and Drug Administration’s cancer drug office “has helped to loosen approval standards for cancer medicines and made it easier for dying patients to get experimental drugs. But he demands that drug makers prove with near certainty that their products are beneficial…Some, say this has “has cost thousands of lives and set back the pace of discoveries….”

Dr. Bruce A. Chabner, clinical director of the Massachusetts General Hospital Cancer Center was quoted in the story:

“…(S)ome cancer specialists say that Dr. Pazdur, after pushing for years to lower approval standards, has toughened them recently after being criticized for approving drugs that were later shown to have few benefits.’I’m worried there’s been a change in his thinking that could be adverse for the field,’ (Chabner) said.”

The Times article noted that Chabner is “a member of the board of directors of PharmaMar, a Spanish biotech company whose drug Yondelis is approved in Europe but was rejected in July by the F.D.A.’s cancer advisory board after a critical introduction by Dr. Pazdur.”

Others think Pazdur’s approach keeps toxic, high-priced, barely effective drugs off the market.  

He also “has a lot of support within the mainstream cancer community,” said Dr. Otis W. Brawley, chief medical officer of the American Cancer Society. In May, the oncologists’ society gave him a special recognition award for “his outstanding service to the oncology community.”

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