02/11/2008
They are calling for an investigation of two members of the Food and Drug Administration who voted against the drug's approval, saying the academic medical oncologists may have conflicts of interest that interfered with their ability to make an unbiased decision on Provenge.
The FDA said it needed three more years of study on Provenge, although clinical trials showed it to be safe and effective in treating prostate cancer.
The FDA denied permission for the drug, in spite of two advisory committees votes that recommended the drug's approval, 17-0 and 13-4. The FDA isn't required to follow the panel's recommendation, but it almost always does.
Some 30,000 men die annually of prostate cancer. In three years, therefore, some 90,000 will be denied a drug that might have extended their lives and reduced their suffering.
The congressional hearings were called because questions of conflict of interest have arisen. Two FDA advisory committee voters allegedly are involved with drug companies that compete with Provenge.
On Jan. 11, the Supreme Court rejected a petition to hear a case, brought by the nonprofit Abigail Alliance for Better Access to Developmental Drugs, which asserted that terminal cancer patients with no options left but death have a right to assume the risk associated with taking promising investigational drugs.
Owing to the Vioxx scare, the public quite understandably wants to keep the FDA in control to ensure drug safety.
A report released on Nov. 30 by the FDA's own Science Board, however, is devastating, revealing such as: "Today, not only can the Agency not lead, it cannot even keep up with the advances in science. ... FDA's failure to retain and motivate its workforce puts FDA's mission at risk.
"Inadequately trained scientists are generally risk-averse, and tend to give no decision, a slow decision or, even worse, the wrong decision."
Michaud's focus on Provenge represents the microcosm within the larger question of whether to allow wider use of investigational drugs that in clinical trials have proven promising and safe and effective enough to continue trying on human beings.
Terminal cancer patients have a Fifth Amendment right to "life," echoing the Declaration of Independence's guarantees of the "unalienable Rights ... of Life, Liberty, and the Pursuit of Happiness."
My wife received an investigational drug which, soon after she was given it, the FDA took off the market. Yet it worked miraculously, extending her life by seven months and ridding her entirely of torturous, morphine-treated pain.
Her oncologist reported that this drug, Iressa, had been helping 15,000 cancer patients a year.
Forty percent of all Americans will get cancer. We only ask that they get the same merciful treatment my wife received.
We implore Mainers, therefore, to rally round Michaud's call for hearings on Provenge.
Ronald L. Trowbridge, Ph.D., is volunteer adjunct scholar and board director of Abigail Alliance for Better Access to Developmental Drugs. He lived in Maine before moving to Texas. Founder of the Maine Heritage Policy Center, Trowbridge can be reached at ronaldtrowbridge@yahoo.com




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