Massachusetts

Watchdog group Public Citizen names Massachusetts-based health research director – The Boston Globe

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Steinbrook, 70, who most recently served as editor-at-large at the medical journal JAMA Internal Medicine and deputy editor at the New England Journal of Medicine, said he’ll be dividing his time between Massachusetts and Washington, D.C., in his new role.

“We have to be nimble,” Steinbrook said. “And when new drugs and issues emerge, we have to be able to approach them in a rigorous and thoughtful way with the public’s interest at heart.”

Public Citizen founded in 1971 by political activist Ralph Nader, has long sought to hold accountable businesses ranging from automakers to pharmaceutical giants. Another one of its research groups has been a leading voice for access to medicines and lowering drug prices.

The health research group headed by Steinbrook focuses, among other things, on keeping the Food and Drug Administration independent of special interests and assuring that state medical boards take disciplinary actions against doctors’ malpractice. It has criticized the FDA for watering down its standards by speeding up approval of some drugs.

Last month, the group opposed the FDA’s approval of the first gene therapy for Duchenne muscular dystrophy, a $3.2 million one-time treatment from a Cambridge biotech, Sarepta Therapeutics. Public Citizen cited safety risks and argued that the clinical data presented to FDA reviewers failed to show that the drug provided significant benefits.

“We are not opposed to the premise of accelerated approval in terms of getting effective drugs more quickly to patients who can benefit from them,” Steinbrook said. “We are concerned about the execution [of the approval process] and industry influence” as well as making sure that drug makers generate post-approval data on a drug’s performance.

Steinbrook, who is also an adjunct professor of internal medicine at the Yale School of Medicine, is only the third director of Public Citizen’s health research group in its more than half-century history. The group was founded by Dr. Sidney Wolfe. Steinbrook takes over from Dr. Michael Carome, who led the group for the past decade.

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Steinbrook said he sees his role less as confronting industry than as protecting patients and assuring the integrity of the drug approval process. He criticized the FDA’s user fees, paid by drug makers whose experimental therapies are evaluated by the agency’s reviewers.

“Going forward, an independent FDA would be best if it was paid for by the taxpayers,” he said. “But user fees are the world in which we live.”

Steinbrook said his group will also monitor emerging artificial intelligence technologies to make sure they’re used in a way that benefits patients and doesn’t compromise privacy or lead to faulty diagnoses.

“It’s something that we’ll be looking at carefully,” he said.


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Robert Weisman can be reached at robert.weisman@globe.com.





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