Drugs

‘7 Deadly Sins’ at FDA Presentations: Mikkael Sekeres

Former FDA Oncologic Drugs Advisory Committee (ODAC) chairman Mikkael Sekeres, a professor of medicine at the University of Miami Sylvester Cancer Center, says he has seen repeated instances of missteps, clumsy excuses, and faulty logic in sponsor presentations to ODAC. In an online Cancer Letter guest editorial, Sekeres says the “transgressions that occur as sponsors present trial data to FDA and ODAC are common and recurring.”

What Sekeres labels as the “seven deadly sins at FDA presentations” are:

spinning trial data to make them seem better than they are;
sloth — not doing an analysis or having data that ODAC members want;
placing business objectives ahead of improving people’s lives;
wrath — responding with anger or becoming defensive when an ODAC member asks a difficult question;
misreporting negative trial results;
gluttony — overindulging use of a substance to the point of waste, such as through unneeded maintenance dosing; and
blaming trial design for a failed study.

Sekeres says much of his thinking about sponsor presentations goes back to a 2011 hearing when he was part of a panel that unanimously recommended that FDA pull the accelerated approval for Genentech’s Avastin’s (bevacizumab) metastatic breast cancer indication. He writes that at the end of the difficult meeting, angry audience members rushed to the table where the panelists sat and were intercepted by armed guards.

“Data are data and our job as clinical experts is to carefully weigh the balance of safety and efficacy of a drug in voting to improve the lives of cancer patients, or to protect the health of the public, even if that leads to unfortunate situations when angry people storm the podium,” Sekeres concludes.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome