Patient Advocates Plan Protest of Dysfunctional FDA

Because about one-quarter of the goods purchased by Americans are regulated by the U.S. Food and Drug Administration (FDA), its dysfunction has a huge impact not only on the country's economy but also on the nation's equity market.

As previously pointed out on this blog ("Hey, Hey, FDA, How Many Dads Did You Kill Today?": tinyurl.com/329vlx), I was sickened by the agency's choice in May to indefinitely delay the introduction of Provenge (sipuleucel-T), an immunotherapy developed by the Dendreon Corp./DNDN as a treatment for men with asymptomatic, metastatic, androgen-independent prostate cancer.

Since Dendreon's receipt of the FDA's so-called Complete Response letter concerning Provenge on 8 May, prostate-cancer patients and their advocates have protested the agency's dubious decision in a number of ways, with both a federal lawsuit and a petition to the FDA requesting that it reconsider its position among them (CareToLive: tinyurl.com/2dqeov).

On 18 September, a coalition of these patients and advocates will continue the campaign with "A Right To Live Day" rally on the doorstep of the dysfunctional FDA in Rockville, Md. At this event, they will protest recent decisions by the FDA to deny cancer patients new, potentially lifesaving therapies, including but not limited to Provenge for patients with advanced prostate cancer (A Right To Live: tinyurl.com/2cfkzb). Among the anticipated speakers are Ray Matyshyn and Bruce Towers, who both are described as participants in Provenge clinical trials.

The stakes are high. According to the National Cancer Institute, it is estimated there will be 27,050 deaths from prostate cancer in the U.S. this year (tinyurl.com/3vecf). Moreover, the only FDA-approved treatment for men with late-stage prostate cancer is Taxotere (docetaxel), a chemotherapy marketed by sanofi-aventis/SNY. Due to Taxotere's significant side effects, it is estimated about one-half of such men refuse to use it.

As many investors and traders know, the Provenge D9901 Phase 3 clinical trial is the first randomized (two-to-one), double-blind, placebo-controlled trial of a cancer immunotherapy to show a benefit in overall survival. Equally important, this trial and others show Provenge is generally well-tolerated: Fatigue, chills, and back pain have been described as its most common side effects, with less than one-quarter of trial subjects experiencing them.

On 29 March of this year, the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) debated in open session the merits of Dendreon's Biologics License Application (BLA) for Provenge. By a unanimous 17-0 vote, the committee members found the BLA data establish that Provenge is reasonably safe. By an overwhelming 13-4 vote, they also found the BLA data provide substantial evidence that Provenge is efficacious. In addition, the FDA produced for the CTGTAC meeting an excellent "Statistical Briefing Document" (tinyurl.com/29t5xn).

Based not only on the FDA advisory committee's 13-4 vote but also on the agency's "Statistical Briefing Document," I continue to find it absurd that the FDA has chosen to indefinitely delay the introduction of Provenge because of a patently false and unjust claim it requires more than the already acknowledged substantial evidence of the product's efficacy.

Justice delayed is justice denied.

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