(Story updated at 7:30 p.m. ET)
Dr. Robert Califf, the White House's nominee for commissioner of the Food and Drug Administration, faces new challenges to his confirmation following the revelation that he removed his name from a series of scientific papers he co-authored that were critical of the agency.
The series explored pragmatic clinical trials, which seek to compare two or more treatments in a real-world setting instead of in a traditional clinical environment. Some of the journals criticized the FDA for having rules that make pragmatic trials difficult to conduct.
The Boston Globe first reported that Califf asked to have his name removed as author but remained as editor. Sources told the newspaper that the FDA asked Califf to make the request.
An FDA spokewoman said Califf , who joined the agency in February, "felt strongly that he should not be listed as an article's author if it was still being written or edited and he could no longer meet the criteria for authorship, or if he risked the perception that he was speaking for the FDA on a policy matter.”
Fellow clinicians, however, were surprised by the move.
“Anonymously authoring something is not necessarily illegal, but I have never heard of any scientist doing this, in the recent or distant past,” said Dr. David Gortler, a former FDA senior medical officer and a drug-safety expert at the consultation site FormerFDA.com
Experts say Califf likely will need to address the matter during his confirmation hearings, which have yet to be scheduled.
“Whatever the motivations or justifications, the perception that someone has attempted to conceal facts or be less than transparent can quickly spiral into a PR crisis,” Evan Nierman, founder of Red Banyan Group, a strategic communications firm with offices in Washington, D.C., and Florida specializing in crisis PR. “While the administration would have preferred to keep the focus on his qualifications for the job, this issue could very well become a sticking point and partisan wedge.”
Califf has been the FDA's deputy commissioner for medical products and tobacco— essentially the No. 2 role—since February. Before joining the agency, he spent more than 30 years as a prominent cardiologist and medical researcher at Duke University, including serving as vice chancellor of clinical and translational research for nine years.
A White House spokeswoman didn't immediately return a request for comment on the matter.
