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News of the Day ... In Perspective

5/24/2007

FDA rejects cancer immunotherapy agents and a new COX-2 inhibitor

On May 9, the Food and Drug Administration killed two reportedly safe, promising therapies that stimulate patients’ immune systems to attack cancers.

Dendreon’s anti-prostate cancer drug Provenge was disapproved despite a favorable (13-4) vote by an FDA Advisory Committee after discussion of the drug in a public meeting. The minority, comprised of powerful members of the oncology establishment, launched an unprecedented public relations campaign accusing the majority of incompetence and naiveté concerning cancer products.

IDM’s drug Junovan has been shown to improve survival in children with osteosarcoma. However, the FDA dismissed the evidence because the odds of efficacy were only 94% in a statistical test, rather than 95%.

“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,” writes Dr. Mark Thornton, former medical officer in the FDA Office of Oncology Products. “While our lawmakers obsess over ‘safety reforms,’ no one is holding this government agency accountable for its complicity in stalling therapies for life-threatening diseases” (Wall St J 5/14/07).

On Apr 27, the FDA rejected Arcoxia (etoricoxib), a new COX-2 inhibitor from Merck, stating that it didn’t see the need for another drug like this. Arcoxia is already in use in more than 60 countries. Merck states that there is more long-term safety data for this drug than for any other nonsteroidal antiinflammatory.

“The government is supposed to decide which drugs are ‘safe and effective,’ not which ones are better,” write David R. Henderson and Charles L. Hooper of the Hoover Institution. Approval of a drug later found to be dangerous has immediate consequences, “but if the FDA fails to approve a good drug, few bad things happen—to the FDA” (Wall St J 5/17/07).

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