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Provenge FDA Rejection Sparks Call for Investigation Amid Conflict-of-Interest Concerns

Dec 24, 2007 | Parker Waichman LLP

The rejection of Provenge by the Food & Drug Administration (FDA) has some in Congress crying foul.  Shares of the Dendreon Corporation jumped sharply Thursday after lawmakers called for hearings to investigate the rejection of the company’s experimental prostate cancer drug, Provenge.  Dendreon rose from $1.34, to $6.98 and the stock almost tripled after a panel of advisers recommended that the FDA approve the treatment; the agency rejected Provenge in May.  While the FDA pointed to concerns about its potential side-effects and effectiveness, two Congressmen are concerned that one FDA advisor’s connections to competing pharmaceutical company could have doomed its approval.

Representatives Dan Burton, Michael H. Michaud, and Tim Ryan said they wanted an inquiry into potential conflicts of interest for two members of the advisory panel who had argued against approval of Provenge.  “There is reason to believe that serious ethics rules were violated” by the two advisers, the lawmakers wrote in a letter.   Dendreon won a 13-to-4 vote in favor of Provenge at the meeting of cancer advisers to the FDA in March.  While the agency usually follows the advice of its panels, it said on May 9 that Dendreon would have to produce results from another study to win approval.  Dendreon lost almost $1 billion in market value.

Dr. Howard I. Scher of Memorial Sloan-Kettering Cancer Center in New York and Dr. Maha Hussain of the University of Michigan were cited as having potential conflicts.  Dr. Scher is the lead investigator of a trial for a competing experimental drug made by Novacea and advises a venture capital firm that invests in that company, according to the letter.

Prostate cancer is cancer that grows in prostate gland, a small, walnut-sized structure that makes up part of a man's reproductive system.  The prostate wraps around the urethra, the tube that carries urine out of the body.  The cause of prostate cancer is unknown, although some studies have shown a relationship between high dietary fat intake and increased testosterone levels. When testosterone levels are lowered either by surgical removal of the testicles (castration, orchiectomy) or by medication, prostate cancer can slowly get better.  There is no known association with benign prostatic hyperplasia (BPH).  Prostate cancer is the third most common cause of death from cancer in men of all ages and is the most common cause of death from cancer in men over 75 years old.  Prostate cancer is rarely found in men younger than 40.

Men at higher risk include African-America men older than 60, farmers, tire plant workers, painters, and men exposed to cadmium. The lowest number of cases occurs in Japanese men and those who do not eat meat.  Prostate cancers are grouped according to how quickly they spread and how different they are from the surrounding prostate tissue.   Stage A:  The tumor is not felt on physical examination and is usually detected by accident after prostate surgery is conducted for other reasons.  Stage B:  The tumor is confined to the prostate and is usually detected during a physical exam or with a blood test (PSA test).  Stage C:  The tumor has spread beyond the prostate but is not in the lymph nodes.  Stage D:  The tumor has spread (metastasized) to lymph nodes or other parts of the body, such as the bone and lungs.


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