Let’s go through the FDA’s revolving door

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    Companies often hire agency staffers who managed their successful drug reviews

    The Food and Drug Administration (FDA) says its rules, along with federal laws, stop employees from improperly cashing in on their government service. But how adequate are those revolving door controls? Science has found that much like outside advisers, regular employees at the agency, headquartered in Silver Spring, Maryland, often reap later rewards—jobs or consulting work—from the makers of the drugs they previously regulated.

    FDA staffers play a pivotal role in drug approvals, presenting evidence to the agency’s advisory panels and influencing or making approval decisions. They are free to move to jobs in pharma, and many do; in a 2016 study in The BMJ, researchers examined the job histories of 55 FDA staff who had conducted drug reviews over a 9-year period in the hematologyoncology field. They found that 15 of the 26 employees who left the agency later worked or consulted for the biopharmaceutical industry. More here at Science.org.

    In 2009, for example, an FDA panel weighed whether the agency should approve AstraZeneca’s widely prescribed antipsychotic drug quetiapine (Seroquel) for a wider range of conditions. The panel heard from health policy expert Wayne Ray of Vanderbilt University in Nashville, who described his research linking the drug to sudden cardiac death when used with certain other medications. Ray recalls “an FDA staff member who gave a very negative presentation on our paper.” And according to the meeting transcript, the agency’s then-Director of Psychiatric Products Thomas Laughren, who was instrumental in shepherding Seroquel and similar drugs through the review process and personally signed their FDA approvals, also challenged Ray’s results and defended AstraZeneca’s clinical trial findings in the discussion that followed. The company’s “analysis should have been able to pick up a difference in sudden cardiac death, and they didn’t find any difference between drug and placebo,” he said.

    Ray told Laughren and the panel that AstraZeneca had pooled data from all its trials as though the data were one data set, causing a well-known statistical error called Simpson’s paradox. To take the company’s conclusion “as definitive” would be “very dangerous,” Ray said, according to the transcript. Laughren responded by calling sudden death “a pretty definitive event.””