Feud At FDA As Staffer's Safety Review Bucks Agency Line

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Feud At FDA As Staffer's Safety Review Bucks Agency Line
May 31, 2013 | By Tracy Staton


Outspoken FDA scientist Thomas Marciniak is stirring the pot again. This time, his target is angiotensin receptor blockers, or ARBs, taken by millions of people for high blood pressure, The Wall Street Journal reports. And his superiors at the agency are having none of it.

Here's the background: A 2010 study concluded that ARBs, which include Novartis' ($NVS) Diovan and Merck's ($MRK) Cozaar, increased patients' cancer risk markedly. The red flag flew highest in lung cancer; The Lancet's study concluded that ARB users had a 25% greater risk of that type of cancer.

FDA commenced its own safety review. By 2011, it had concluded that ARBs did not cause an increase in cancer risk. But Marciniak disputed that conclusion, saying it was based on data summaries provided by the drugmakers. He dug into patient-level data on his own initiative--and found an increase in lung cancer risk of 24%, about the same as The Lancet study.

"The FDA needs to inform patients and physicians about the ARB lung-cancer risks," Marciniak told senior agency officials in a memo (as quoted by the WSJ). "The FDA must act now."

Agency brass are telling Marciniak to leave it alone. But he's not one to keep silent about perceived safety risks. He went maverick at a hearing on the now-resctricted diabetes drug Avandia, questioning the RECORD safety study that comes up for another airing next week. He pointed out a potential link between the bloodthinner Effient and cancer; in that case agency reviewers also disagreed, and the potential risks were chalked up to chance. A subsequent Archives of Internal Medicine study found Effient users saw higher rates of cancer than Plavix patients did.

Now, Marciniak's boss, Ellis Unger, tells the WSJ that there's nothing new to tell the public about ARB safety. Unger disputes Marciniak's methods, too; he told the WSJ that using patient-level data may lead to overcounting cancer cases, because some ailments that weren't actually cancer could be included.

The ARB class is a big one, with more than $7 billion in 2012 sales. Several of its members, including Diovan and Forest Laboratories' ($FRX) Benicar, made FiercePharma's recent ranking of top cardio drugs. They've also been on the market long enough for some patents to have expired. With so much history under their belts, ARBs might seem an unlikely target.

As the WSJ points out, FDA's reluctance to allow Marciniak to dig through the ARB data, couched as it was as a time-constraint issue, raises the question of whether the agency is too focused on newer drugs' safety.

With another FDA panel hearing next week on Avandia, whose safety saga stretches back more than 5 years, that's debatable. The agency itself has been working on some database-monitoring programs to help flag safety problems in older meds. But those are in their early stages. And for now, FDA's attention--and limited resources--may gravitate toward big public scandals, like Avandia, taking efforts away from routine investigation of long-marketed drugs. With more budget cuts likely on their way, under a newly unveiled White House budget report, the FDA's resources will be in even shorter supply.

- see the WSJ story
- get more from Forbes

Special Report: Top 10 Cardio Drugs 2012
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Live from FDA: Nissen speaks on Avandia


Thank You FiercePharma and Ms Staton