A Closer Look at Drugs and the FDA with Mikkael Sekeres

Air Dates: July 1-July 7, 2024 

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.  

On this episode of “Story in the Public Square,” Sekeres reflects on the difficult choices made while serving on the panel that reviewed the safety and effectiveness of the drug Avastin, used to treat metastatic breast cancer. He explains that due to this experience, he has begun advocating for transparency within the FDA. He says, “I do think that’s a critical aspect of public agencies like the FDA, that they have to work on that communication to build trust in the public, so that everybody in America will trust that the medicine they’re taking out of their cabinet is both safe and effective.” 

“Story in the Public Square” broadcasts each week on public television stations across the United States. A full listing of the national television distribution is available at this link. In Rhode Island and southeastern New England, the show is broadcast on Rhode Island PBS on Sundays at 11:00 a.m. and is rebroadcast Thursdays at 7:30 p.m. An audio version of the program airs Saturdays at 8:30 a.m. and 7:30 p.m. ET, Sundays at 5:00 a.m. and 10:00 p.m. and Mondays at 2:30 a.m. ET on SiriusXM’s popular P.O.T.U.S. (Politics of the United States), channel 124. “Story in the Public Square” is a project of the Pell Center at Salve Regina University. The initiative aims to study, celebrate and tell stories that matter.