Rebellious FDA Reviewer Insists ARB Heart Drugs Have Cancer Risk

Yet another instance of an FDA medical reviewer clashing with agency supervisors is playing out over a group of drugs called angiotension receptor blockers, which are taken by millions of people to prevent heart attacks and strokes, but were linked to a higher risk of cancer in a 2010 study in The Lancet (here is the study). Although the agency later determined there was no increased risk and cleared the drugs for continued use the following year, FDA reviewer Tom Marciniak disagreed with the agency analysis and maintains stronger warnings are needed, according to The Wall Street Journal. To reach its conclusion, the agency conducted a meta-analysis of existing studies, but Marciniak, a cancer expert, believes some of those studies had flaws that tainted the ultimate outcome, the paper reports. One example: the analysis did not count tally cases of lung carcinomas as lung cancer. Two months ago, the paper writes, he determined that the risk of lung cancer rose 24 percent in ARB patients compared with those taking a placebo or other drugs, which he maintains is statistically significant. And in 10 of 11 studies, there were more cases in ARB patients than control groups. “Garbage in, garbage out,” he wrote in agency documents that were reviewed by the paper. And in a memo sent to senior FDA officials, he wrote that the “FDA needs to inform patients and physicians about the ARB lung-cancer risks. The FDA must act now.” SHOULD THE FDA REASSESS ARBs? TAKE THE READER POLL ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs