A story was published in the September 5, 2012 Wall Street Journal, “Article Says Agency Let Risky Drugs Hit Market,” about a commentary in the Journal of the American Medical Association (JAMA)
, which discussed the potential safety risks associated with three recently approved drugs, and questioned the time in which new drugs are approved. Dr. Sigal’s response to that article/commentary was printed in today’s WSJ (below).
The article doesn’t provide a description of the grave alternative for patients. In the case of the drug that was approved to treat a cancer for which there were no other effective treatments, it was approved based on the drug’s effect on how long patients lived without their disease progressing. If the agency had required more data and had not approved the drug based on progression-free survival, it would likely still not be available. This potential multiyear delay equates to thousands of patients, for whom this drug may work well, not even being given the chance to fight their cancer with it.
The use of expedited approval mechanisms, including the new “Breakthrough Therapy” designation recently signed into law, isn’t about less information, but rather developing a strategy to expedite the process without compromising patient safety.
Ellen V. Sigal
Chairman and founder
Friends of Cancer Research