Dr. Califf, a cardiologist, has been serving as the FDA’s deputy commissioner for medical products and tobacco since he joined the agency in February, divesting interest in his pre-FDA activity. Although he has donated his proceeds from private industry to nonprofit groups since the mid-2000s, Dr. Califf has taken some form of financial support from over 20 companies according to a disclaimer added to the end of a European Heart Journal article he penned last year. His financial disclosure form for 2014 alone lists consulting fees provided to him from seven companies, and his salary at Duke was funded in part by drugmakers Merck, Novartis and Eli Lilly.
Even many people with conservative or anti-government leanings acknowledge that the U.S. Food and Drug Administration (FDA) is among the most vital agencies for ensuring public health and safety. The FDA regulates roughly a quarter of every dollar that is spent in the U.S., with approval decisions that could have life-or-death consequences for thousands of citizens as well as for the companies who need FDA approval in order to survive. This is why the Obama administration’s Tuesday nomination of Dr. Robert M. Califf to serve as the next FDA commissioner may not lead to confirmation as a mere formality in the Senate. The nomination follows Dr. Margaret A. Hamburg’s resignation in March from the position she held since 2009. As a groundbreaking clinical researcher, Dr. Califf help to found the $200 million Duke University Clinical Research Institute, turning it into one of the leading research facilities in the country. The institute, however, has received 63 percent of its funding through private industry. This fact, along with other notable ties between Califf and the pharmaceutical industry, has led some advocates to question whether or not these connections will ultimately influence Califf’s regulatory judgment.
Dr. Califf, a cardiologist, has been serving as the FDA’s deputy commissioner for medical products and tobacco since he joined the agency in February, divesting interest in his pre-FDA activity. Although he has donated his proceeds from private industry to nonprofit groups since the mid-2000s, Dr. Califf has taken some form of financial support from over 20 companies according to a disclaimer added to the end of a European Heart Journal article he penned last year. His financial disclosure form for 2014 alone lists consulting fees provided to him from seven companies, and his salary at Duke was funded in part by drugmakers Merck, Novartis and Eli Lilly. According to the Wall Street Journal, Dr. Cardiff has received over $200,000 from corporations between 2009 and 2015. Perhaps most notably and potentially concerning is the clinical trial that he led in 2011 for Johnson & Johnson’s blood-thinner Xarelto, in which the report of the study was used for an FDA recommendation panel’s evaluation of the drug, leading to its approval. Johnson & Johnson paid Califf $48,560 for consulting fees in 2011. Despite widespread commercial success, Xarelto has been the subject of widespread multidistrict litigation due to severe bleeding side-effects.
Cardiff’s supporters note that his activity with industry is beneficial and should exemplify his experience and understanding of the process. Harvard political science professor and FDA expert Daniel Carpenter, says “In a sense, he’s the ultimate industry insider.” Dr. Caleb Alexander, co-director of Johns Hopkins University Center for Drug Safety and Effectiveness responded warmly to the nomination in an interview, saying “He has a very good understanding of industry and academia, and think that will serve him well.” His supporters also note anti-industry stands he has taken while at Duke, including his advocacy that study results be published independently and without companies reviewing or approving the manuscript reports, against the desires of the drugmakers. Stanford professor and chair of the medical department Dr. Robert Harrington, who worked with Califf at Duke recalled, “This is a long-held, steadfast position that has cost his groups research in the past.” Another former colleague at Duke, Dr. Adrian Hernandez also credited Califf for his impartiality, saying “He was really passionate about ensuring we were independent. I’ve seen plenty of times when a company wanted to do something in a certain way and his answer was no.”
Even in light of the support, the industry ties weigh heavily on advocacy group Public Citizen’s Dr. Michael Carome, who said “He has amassed an extensive record of close collaboration with industry, through consulting fees, speaking fees and research grants supporting his salary.” This will color his views when it comes to making regulatory decisions.” It should be noted that former FDA chief Hamburg served on the board of medical supplier Henry Schein from 2003 until her appointment in 2009. Hamburg divested her interest in the company, including future stock options, prior to assuming the position. Also in 2005, Lester Crawford resigned abruptly from the position two months after his confirmation after it was discovered that he owned stock options from companies under FDA regulation. Although Crawford pleaded guilty to the offense, he continues to claim that it was an act of carelessness, and not a result of intentional wrongdoing. While there has been interplay in the past between industry and FDA administrators, Califf’s ties are likely unprecedented, although financial disclosures between pharmaceutical companies and doctors only began in recent years, making comparisons to past commissioners difficult. Even though the administration nominated Califf, a registered Democrat whose conservative leanings also make him popular among Republicans, to be a compromise candidate to prevent a lengthy fight over his confirmation, it remains to be seen his ties become a source for alarm among some lawmakers.
MedPage Today – Shannon Firth
New York Times – Sabrina Tavernise
Wall Street Journal – Joseph Walker and Christopher Weaver