FDA official: “clinical trial system is broken”

BMJ: 12/5/13

FDA investigator Thomas Marciniak has spoken out over drug companies and missing or “bad” data, most famously over rosiglitazone. He tells Deborah Cohenhow he believes the current research and development process is broken

The clinical trial system is broken and it’s getting worse, according to longstanding Food and Drug Administration investigator, Thomas Marciniak.

For seasoned observers of the drug approval process, Marciniak will be a familiar name and his comments will come as little surprise. In his 11 years at the US federal agency, Marciniak has been embroiled in high profile controversies that have pitted him against his employer—most notably in his assessment of the diabetes drug rosiglitazone (Avandia). This particular battle is one that he may have lost. The FDA has just decided to reverse restrictions placed on the drug that it had introduced in 2010 partly as a result of his assessment of a trial assessing the cardiovascular risks of rosiglitazone (see box). Read More