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News of the Day ... In Perspective5/24/2007
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 naivet� 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). Additional information:
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