Drug Regulation

FDA official: “clinical trial system is broken”

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f6980 (Published 5 December 2013)
Cite this as: BMJ 2013;347:f6980

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  1. Deborah Cohen, investigations editor
  1. 1BMJ, London WC1H 9JR, UK
  1. dcohen{at}bmj.com

FDA investigator Thomas Marciniak has spoken out over drug companies and missing or “bad” data, most famously over rosiglitazone. He tells Deborah Cohen how 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).

His public criticism of companies and data integrity have seen him described as a rebel and a “lone wolf”—an epithet that seems to be tagged to those who voice concerns. However, the drug studies that he has reviewed and found problems with seem to have a knack of finding their way into the US Department of Justice’s investigations in-tray.1

The latest is a trial by UK drug company AstraZeneca of the antiplatelet drug ticagrelor (marketed in the United States as Brilinta and in the European Union as Brilique).2

“Drug companies have turned into marketing machines. They’ve kind of lost sight of the fact that they’re actually doing something which involves your health,” Marciniak says. “You’ve got to take away the key components of the trials from drug companies.”

Seeds of disillusion

The Mayo Clinic trained doctor is based in the FDA’s cardiovascular and renal division, …

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