Ella Does Squamish

May 9, 2007, should be cited in the annals of cancer immunotherapy as Black Wednesday. Within an eight-hour period that day, the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient’s immune system against cancer. The FDA’s hubris will affect the lives and possibly the life spans of cancer patients from nearly every demographic, from elderly men with prostate cancer to young children with the rarest of bone cancers.

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Thus it was remarkable that in the last several months two different biotech companies, with products utilizing two completely different cancer immune approaches, came before the FDA’s Advisory Committee Meeting for judgment. The first product, Provenge, made by the Dendreon company, is a cellular therapy that tackles prostate cancer. The results of the Provenge clinical trial in men with prostate cancer who had failed all other therapies appeared before the committee that advises on cell-based cancer products for the FDA Center for Biologics. This committee was comprised of immunology and oncology experts. The second product, Junovan, made by the IDM company, was tested in children with osteosarcoma, a rare bone cancer that affects just 900 children per year. The results of the Junovan clinical trial appeared before a different committee — one that judges protein cancer agents and was comprised solely of oncologists with no immunology experts.

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However, those voting in the minority, very powerful members of the oncology community, launched an unprecedented PR campaign accusing those in the majority of incompetence and naiveté in matters relating to cancer products. The arrogance of this campaign overlooked the notion that survival data from immune-based products may be qualitatively different from, and may need to be judged by different criteria than, survival data from chemotherapy drugs.

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But such intriguing academic discussions never had a chance to take root. Instead — just a few weeks after the favorable ruling on Provenge — the Junovan product came before the FDA’s Advisory Committee for approval. Incredibly, the improvement in the survival rate of children with bone cancer who received Junovan was summarily dismissed as irrelevant by the committee. Why? The statistical data showing the odds of efficacy were 94% surety instead of the usual goal of 95% surety. This 1% difference was all the committee needed to justify a 12-2 "No" vote.

The Junovan meeting was chaired by the very physician who launched the PR campaign against Provenge.

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In the span of eight hours, the dawn of a new era in cancer immunotherapy was driven back into the night. It will be years before we know the full impact of these decisions and how many cancer patients, young and old, have had their lives cut short as a result. For now, however, one thing is clear: While our lawmakers obsess over FDA "safety reforms," no one is holding this government agency accountable for its complicity in stalling therapies for life-threatening diseases.

Dr. Thornton, a former medical officer in the FDA Office of Oncology Products, volunteers as president of the Sarcoma Foundation of America.