- Dr. Robert Claiff is a Duke cardiologist who was named Deputy Commissioner for Medical Products and Tobacco at the FDA in Janauary, and nominated to become FDA Commissioner last month.
- Because of concerns about conflict of interest, Dr. Califf has requested that his name be removed from papers he co-authored for the October issue of Clinical Trials. The papers reportedly question certain FDA practices in clinical trial oversight and recommend certain policy changes that could prove to be controversial.
- Though the goal is to decrease any controversy, it is very unusual for an author to remove his or her name from a clinical manuscript—which is leading to a great deal of questioning about whether or Dr. Califf's move is appropriate.
This is the second incident of "controversy" surrounding Dr. Califf within the last month. In September, it was disclosed that he has close ties to the biopharma industry and has received more than $200,000 in consulting fees from major pharmaceutical companies. However, the fees collected were given to non-profits, according to a government spokesperson.
Now in his efforts to avoid additional controversy, he is removing his name from papers focusing on pragmatic, real-world clinical trials slated for publication this month. In fact, these papers were completed well before he was nominated for the commissioner position.
Although Califf declined to comment, an FDA spokesperson said, "Dr. Califf requested that his name be removed as a coauthor from these three articles out of an abundance of caution to avoid any perception that he would be commenting as an FDA official through these articles."
All told, this type of inquiry into Dr. Califf's actions is a normal part of the vetting process, though Dr. Califf, who is imminently qualified for the commissioner position, seems to have more and stronger ties to the pharma industry than his predecessors. It's also possible that Califf's criticism of the very agency he is slated to head may actually help garner support from some lawmakers who would see such critiques as demonstrating independence of thought.