Califf Removes His Name as Author of Scientific Paper Critical of FDA | Pharmaguy's Insights Into Drug Industry News | Scoop.it
President Obama’s nominee to lead the Food and Drug Administration recently coauthored a series of scientific papers but asked that his name be removed before publication.


Dr. Robert Califf, the Duke cardiologist first named a deputy commissioner in January and then nominated for the top post last month, was the driving force behind the series, which was published in the October issue of the journal Clinical Trials.


The heart of the series is an examination of what are known as pragmatic clinical trials — an increasingly popular type of study that seeks to compare two or more treatments in a real-world setting instead of in a traditional clinical environment. Portions of the papers are critical of the agency and recommend policy changes that would be highly divisive.

It’s unclear what prompted Califf to remove his name — a decision that could raise ethical concerns. It is highly unusual for authors of scientific papers to have their names removed before publication.


A spokeswoman for Califf said he declined to comment. A coauthor on one paper, speaking on condition of anonymity because of the sensitivity of the matter, said Califf had been told to mask his authorship by the FDA.

 

A spokeswoman for the agency suggested it was his decision.


One of the papers — which focus largely on clinical trials and deal only partially with the FDA and regulation — coauthored by Califf pushes back against skepticism.


“We are concerned that current Food and Drug Administration requirements for obtaining individual informed consent may deter or delay the conduct of pragmatic clinical trials intended to develop reliable evidence of comparative safety and effectiveness of approved medical products,” the paper says.


Another passage from that article discusses ways to make it easier for researchers to gain consent from study participants — a process critics say has become too cumbersome and confusing for potential enrollees. “We believe that the FDA should have the explicit authority to consider alteration or waiver of individual informed consent when deemed appropriate,” the article notes.