WASHINGTON – Critics of the revolving door between government and industry cite hundreds of legislators -turned- lobbyists as case studies in art to take advantage of years of public service one.
However, less is known about the revolving door between the Food and Drug Administration and the biopharmaceutical industry.
In a study published Tuesday in the British Medical Journal, researchers who studied the career of medical staff FDA found that more than half of the evaluators of hematology-oncology who reviewed the drug between 2001 and 2010 spent to work for the biopharmaceutical industry.
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“I think it’s staggeringly high,” said Dr. Vinay Prasad, lead author and assistant professor of medicine at Oregon Health and Science University. “When it comes to cancer drugs with high toxicity and sometimes small profit, which is a place where the trial that really matters.”
Prasad also asks whether employees can make more favorable calculations if they are looking ahead to the work of the most lucrative industry in the future.
“If we know a great post-employment opportunity is on the other side of the table, are given the benefit of the doubt,” Prasad said. “You maybe make things a little easier for businesses.”
Prasad launched the study after asking colleagues who study medical ethics if anyone knew how often employees went from the FDA for the industry.
“Those of us who follow this field of FDA regulation know stories of people who work for the FDA and immediately went to the drug industry,” Prasad said, “but nobody knew how often.”
Prasad enrolled resident physician Dr. Jeffrey Fine, serving as lead author. Well Prasad and all employees identified in the FDA hematology-oncology section who worked on applications between 2001 and 2010.
Almost half were working at the FDA. However, of the 26 who left the agency, 15, or nearly 58 percent, he had gone to work in some capacity of biopharmaceutical companies. (Thirty percent of respondents who left the FDA could not be identified.)
Genevieve Pham-Kanter, a known health economist who studies conflicts of interest in the regulatory field, praised the report.
“have not been many quantitative studies on the revolving door of the FDA, so I really have no idea of the scope and scale of these transitions to the industry before now,” Pham-Kanter, an assistant professor told the Drexel University and a senior member Leonard Davis Institute of Health Economics at the University of Pennsylvania.
“This study gives us a good start in the knowledge of the current baseline in a medical specialty that has historically had a lot of links with industry,” she said.
Pham-Kanter also warned against the assumption that the pattern members FDA staff leaving the agency to work for the industry is worrying.
“If individuals working in the industry are more informed about the regulatory process due to these transitions in employment, which is not a bad thing,” he said. “On the other hand, if former FDA employees in their current roles in the industry, try to influence their former colleagues from the FDA, we should be concerned.”
FDA spokesman Jason Young said that the dynamics of the revolving door is not exclusive to the agency.
“The FDA has a strong set of rules in place to ensure that our employees are working in the public interest, not advantage any company, organization or individual,” Young said.
After leaving the agency, Young said, are subject to additional rules that protect the confidentiality of the information they worked for the federal service, a period of reflection for senior employees, and other post-employment restrictions.
Prasad is not convinced that there is no conflict of interest.
“I’m not paranoid. These are good people,” he said. “But like all people, we are influenced.”