Rogue FDA Reviewer Insists that ARB Heart Drugs Can Cause Cancer

Rogue FDA Reviewer Insists that ARB Heart Drugs Can Cause Cancer

May 31st, 2013 // 5:10 pm @

Latest FDA and cGMP Compliance News

We are now seeing another instance of a medical reviewer at FDA clashing with his superiors over drugs known as angiotension receptor blockers. These are taken by 20 million people to help to stop strokes and heart attacks. But, they were linked to a high cancer risk in 2010. FDA later determined that there was not a higher risk and cleared the medicines to be used the next year. However, FDA reviewer Tom Marciniak has disagreed with the agency’s assessment and states that more warnings are necessary.

To come to its conclusion, FDA did a meta analysis of all existing studies on the drugs. Marciniak is a cancer expert and thinks some of the studies are flawed and make the outcome unreliable. For example, the analysis did not account for cases of lung carcinomas as actual lung cancer.

He figured that the risk for lung cancer increased 24% in ARB patients when they were compared to others taking a placebo. He believes that this is a statistically significant finding. In 10 of the 11 studies, there were more cases in those who took ARBs than in control groups.

Marciniak stated in agency documents, “Garbage in, garbage out,’ according to documents in the paper. In an memo that he wrote to top FDAers, he said that FDA needs to tell patients and doctors about the risk of lung cancer.

What is FDA doing on this? Nothing at this time. The head of the Office of Drug Evaluation has informed the paper that these complaints are not important and that FDA has nothing new to share with the public. He noted that using raw patient data can include some illnesses that are not actually cancer.

This is far from the first time that reviewers at FDA have fought with FDA officials over matters of drug safety. Another issue was 5 years ago when there were problems with antidepressants causing suicidal tendencies in young people.

Marciniak also helped to lead the agency review of the Avandia pill for diabetes by GSK. A 2007 meta analysis determined that there were serious heart risks. FDA held a meeting on this and restricted its use. FDA was still divided on the data and next week, there will be an unusual meeting to reassess one of the important clinical trials in this case.

In the ARB fight, Ellis Unger, the head of Office of Drug Evaluation, noted in a letter to Marciniak that his analysis would show he spent a lot of time on this. So, he said, he assumes that there has not been much work done in the cardio renal area at this time, or he is doing most of this work off the clock.

Marciniak stated, you are looking at a serious question about whether a drug that was taken by millions of citizens can increase cancer risk, and you are criticizing me for the man hours I spent on the analysis?

Unger also wrote that even if there were a 30% increse in risk, he didn’t think there was much chance that there would be a new regulatory decision on the matter. Marciniak was shocked that FDA would not make an updated decision on the drugs if there was such a large increase in cancer risk.

 

 


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