May 31st, 2013

Two FDA Officials Quarrel Over Safety of Angiotensin-Receptor Blockers

Two FDA officials are quarreling in public about their different views about the safety of angiotensin-receptor blockers (ARBs), according to a story by Thomas Burton in Friday’s Wall Street Journal.

One official, Thomas Marciniak, contends that ARBs may increase the risk for cancer. Marciniak has been a vocal critic of FDA’s efforts to assess drug  safety. In the past he has raised questions about other major drugs, including prasugrel, rosiglitazone, and rivaroxaban. But Marciniak’s boss, Ellis Unger, who is the acting director of the office of new drugs, told the WSJ  that Marciniak’s concerns are a “diversion.”

In 2010 the FDA announced it was reviewing the safety of ARBs following a study that raised the possibility that the popular drugs might cause a small but significant increase in the risk for cancer. One year later the FDA said that it had concluded its review and found no evidence of an increased risk for cancer. “We have no reason to tell the public anything new,” Unger told the WSJ.

Burton reports:

In a rare rebellion by an FDA reviewer, Dr. Marciniak has clashed with his bosses over his desire to spend time on ARB safety, instead of just on new-drug applications.

Marciniak claims that the FDA review was not sufficiently rigorous because it relied on summary data provided by drug companies. On his own initiative, Marciniak analyzed patient-level data and concluded that ARBs were associated with a 24% increase in the risk for lung cancer. Marciniak,  reports Burton, “sent a memo to senior FDA officials, saying: ‘The FDA needs to inform patients and physicians about the ARB lung-cancer risks. The FDA must act now.'”

But Unger disagreed with Marciniak’s analysis and told Burton that it was not reliable. Burton reports that Unger discouraged Marciniak from working on the topic, but Marciniak refused to discontinue his investigation.



One Response to “Two FDA Officials Quarrel Over Safety of Angiotensin-Receptor Blockers”

  1. Dmitri V Vasin, MD says:

    It is obviously very disturbing.
    Especially considering quite stubborn association of ARBs with increased MI/Fatal CAD risk (LIFE, VALUE, CHARM, ROADMAP, ORIENT, etc), that FDA also dismissed couple of years ago.
    It all makes sense, however, if you follow the money trail.
    Pharma pays (a lot) for new drug applications, but safety review (and cleaning up fallout from confirmed safety risks), I am quite sure, comes from FDA budget…It may have been purely business decisions (where to get money to pay for it). And there may be nothing more sinister than that…or may be not?