FDA Official Key to Actemra Approval Now Working for Drug Maker He Regulated

Published on July 24, 2018 by Laurie Villanueva

The U.S. Food & Drug Administration (FDA) maintains that its rules and federal law prevent agency employees from leveraging their positions in the private sector.

However, a report recently published by Science Magazine suggests this may not actually be the case, noting that several former high-ranking FDA officials recently went on to do consulting work – and even accept jobs – with the very drug makers they once regulated.

These officials include Jeffrey Siegel,  the former FDA staffer who oversaw the 2010 approval of Genentech’s rheumatoid arthritis drug, Actemra. Just months later, he took a job with Genentech and its parent company, Roche, as director of the division that markets that very drug.

Just last year, he represented the pharmaceutical companies as they petitioned the FDA to expand Actemra’s approved indications.

For his part, Siegel asserts that his career change was coincidental and had nothing to do with the key role he played in the FDA’s decision to approve Actemra.

FDA and Actemra

Actemra (tocilizumab) was the first humanized interleukin-6 (IL-6) receptor inhibitor to receive approval from the FDA to treat rheumatoid arthritis. Its approved indications have since been expanded to include other autoimmune disorders.

Worldwide, more than 760,000 patients have used Actemra. The drug is Roche’s fifth highest in gross sales, having brought in $1.7 billion in 2016.

Actemra’s 2010 FDA approval was not without controversy. According to a report published by STAT last year, short-term studies indicated the drug was safe. But some FDA reviewers were troubled by data that showed “elevated levels of the blood lipids cholesterol and triglyceride, suggesting that Actemra might cause serious heart problems over time.”

“I can foresee the possibility that in five years there’s another hearing like the one on Vioxx, where the cardiologists … say to us, what were you guys thinking when you approved this drug?” Dr. David Felson, a Boston University rheumatologist and FDA reviewer, said during a 2008 meeting convened to debate Actemra’s approval.

The FDA panel did ultimately recommend that Actemra be approved, but only on the condition that Roche sponsor multi-year studies to monitor potential cardiovascular risks and other possible side effects. In the meantime, no mention of heart issues was included in the drug’s prescribing information.

Siegel, who was now working for Roche, defended Actemra in an interview with STAT, citing a recent study as “definitive” proof that the drug does not increase cardiovascular risk.

However, other experts disputed his assertions, with Felson telling STAT that Siegel “sounds like a drug company trying to defend themselves.”

Actemra Adverse Event Reports

STAT’s analysis of FDA adverse event reports uncovered more than 13,000 incidents associated with Actemra, including heart attack, interstitial lung disease, stroke, and pancreatitis. The reports also implicated Actemra in more than 1,100 deaths.

What’s more, the study cited by Siegel as “definitive” proof of the drug’s cardiovascular safety, which involved a head-to-head comparison with Enbrel, rates of stroke and heart failure were about 1.5 times higher in Actemra patients. While not statistically significant, some experts interviewed by STAT indicated that the findings are worrisome and likely warrant additional label warnings.

“Since Enbrel includes a high-profile warning and precaution in the label about heart failure, it is concerning that Actemra might be similar or worse,” said Dr. Steven Woloshin, a professor of medicine at The Dartmouth Institute and an expert on risk communication.

Genentech Resists New Actemra Warnings

Some of the FDA reviewers who voted to approve Actemra  told STAT that they did so on the condition that the findings from the long-term studies ordered by the agency would be acted on.

But so far that hasn’t happened, even though the FDA has reviewed the drug’s safety on at least three occasions. While Actemra’s label was updated in 2011 with information about fatal anaphylaxis, Genentech was able to successfully push back against agency recommendations that the drug’s safety warnings be expanded to include pancreatitis,  interstitial lung disease, and heart attacks.

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