A Closer Look at Drugs and the FDA with Mikkael Sekeres

Story in the Public Square

In 2011, the Food and Drug Administration held a hearing to review a drug previously approved for the treatment of metastatic breast cancer. The hearing was fraught with concerns over the drug’s safety competing with cancer patients who felt they were alive because of the drug. Dr. Mikkael Sekeres was on the panel receiving testimony, and weighing what he heard against the long history of the FDA to make sure drugs are safe AND effective.

Mikkael Sekeres is a professor of medicine and chief of the division of Hematology at the Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine. He earned a master’s and medical degree in clinical epidemiology from the University of Pennsylvania School of Medicine before completing his postgraduate training at Harvard University. He has served as Director of the Leukemia Program and Vice-chair for Clinical Research at the Cleveland Clinic Cancer Center. Sekeres’ new book, “Drugs and the FDA,” is set in the context of the FDA's 2011 trial for the drug Avastin. There, he examines the ways the FDA became the sole authority on medicine in the United States and the process of approving drugs.

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