Larry Husten (CardioBrief)

Events during and following the AC meeting were, to say the least, bizarre. The AC’s members represented two competing organizations within the FDA: the Center for Drug Evaluation and Research (CDER, which includes the FDA’s Office of Oncologic Drugs (OOD) and the Center for Biologics Evaluation and Research (CBER). The latter was selected to take the lead on the review of Provenge, something that was bitterly contested by OOD head Dr. Richard Pazdur. Two members of the AC represented CDER; Howard I. Scher, M.D., and Maha Hussain, M.D. Both were outspoken critics of Provenge at the AC meeting – some even have said that they dominated the AC meeting – and based on comments received in real time from several observers in the audience, they continually badgered and intimidated other members of the committee. Regrettably, though both had requested and received conflict of interest (COI) waivers, neither probably would have been allowed to vote, much less participate, under new draft guidelines now being considered by the FDA. (Dr. Scher, for example, is on Novacea’s scientific advisory board as lead investigator of the Asentar Phase III clinical trial in the same stage of prostate cancer as Provenge. He is also lead investigator on a clinical trial investigating the chemotherapy drug Taxotere in early-stage prostate cancer – a trial some in the prostate cancer community believe would be adversely affected by Provenge approval. How he ever was able to participate in the first place is puzzling.)

In the days that followed the AC, two members of the AC – Drs. Scher and Hussain – and a third practitioner, Dr. Thomas Fleming (who is often chosen by Dr. Pazdur to participate in OOD-sponsored advisory committees but did not participate in this AC) wrote letters, ostensibly to the FDA, protesting the AC’s recommendation to approve Provenge. All three of these letters were “leaked” to The Cancer Letter, a newsletter about oncology drug approvals that also played a key role in the Erbutix scandal. Dr. Scher has told colleagues he did not volunteer to write the letter but was asked. Additionally, substantial portions of it were written by other people. The leak and subsequent publication of the three letters was seen within the medical community as an aggressive “public relations” campaign intended to sink the approval of Provenge, despite the very favorable safety and efficacy votes of the AC. We know now, of course, that the FDA delayed the approval of Provenge by issuing a Complete Response letter, which effectively delays approval for 1-2 years. During this time, 30,000—60,000 men will die of prostate cancer, many of whom might otherwise have benefited from Provenge, which even the FDA’s own advisory committed found safe and effective.

Take, for example, the Provenge story. On March 29, 2007, the Advisory Committee voted 17-0 for its safety and 13-4 for efficiency. Two out of the four ‘no’ votes were from doctors with strong conflicts of interest. (Can you believe a doctor who vote with their wallet instead of their sworn duty to extend lives?) Even with this strong vote, the FDA issued a ‘Complete Response Letter’ to Dendreon on May 8, 2007. Provenge would have helped over 50,000 men with PCa had the FDA done their job and approved this new therapy. Incompetent, no. Conflicted, YES.

The American people need new leadership at the FDA if we are to approve new drugs that extend lives without the horrible side effects of chemo.

Politics has no place in this process. Let the scientific chips fall where they may. That does not mean a complete abandonment of common sense when looking at treatments for patients.