Rebellious FDA Reviewer Insists ARB Heart Drugs Have Cancer Risk
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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. 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.
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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. 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.
Help employers find you! Check out all the jobs and post your resume.