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The FDA vs. Cancer Patients
The Journal takes issue with recent changes at the FDA that indicate that the agency is backing away from “accelerated approvals” for new cancer drugs. (For more detail on these policies, see this week’s Spotlight by Scott Gottlieb.)
The latest evidence of backsliding was a recent vote of the Oncologic Drugs Advisory Committee (ODAC) to recommend against approving Johnson & Johnson's leukemia drug Zarnestra. The drug may not be a miracle cure -- 15% of study patients achieved complete remission. But 15% is nothing to sneeze at either, especially since the company was seeking accelerated approval for the treatment of elderly patients who might not be able to withstand the punishment of traditional chemotherapy. Yet ODAC voted against adding this weapon to the anti-cancer arsenal.
This is a special shame because ODAC used to be a bastion of common sense, wherein clinicians who treat cancer patients would often buck FDA statisticians to approve new drugs. But ODAC is now chaired by osteopath Silvana Martino, who is notably hostile to the drug industry, and so it is unlikely to continue to be an independent check on the FDA.
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