Califf's Support for Top FDA Post Varies, NEJM Gives Thumbs-Up

November 04, 2015

BOSTON, MA — In an editorial published last week, Dr Jeffrey Drazen, the editor in chief of the venerable New England Journal of Medicine, strongly endorsed the nomination of Dr Robert Califf to head up the US Food and Drug Administration[1].

In September, President Obama nominated Califf, the current deputy commissioner for medical products and tobacco, to be the commissioner of the FDA. A cardiologist, Califf has had a long and distinguished career in academic medicine, most notably at Duke University, where he completed his undergraduate and medical degrees.

For Drazen and the New England Journal of Medicine editorial board, Califf's background make him ideally suited for his next role as the FDA chief.

"His noted strengths include his experience in the testing of new and established drugs for efficacy; his successful career at Duke University, where he was the founding director of the Duke Clinical Research Institute, by many measures one of the premier academic research organizations in the world; and until his FDA nomination, his tenure as head of the Duke Translational Medicine Institute and professor of medicine at Duke University," according to Drazen.

The editorial appears to directly challenge existing criticisms that Califf is too close to the very industry he will oversee. Some of those criticisms were recently voiced in a New York Times article looking at Califf's connection to various drug and device companies through his extensive clinical-trial work, with one expert calling Califf the "ultimate industry insider"[2].

Recently, Sen Bernie Sanders (I-VT), who is running for the Democratic presidential nomination, opposed Califf as the next FDA commissioner[3]. Sanders said he plans to vote against Califf because of his previous ties to the pharmaceutical industry and an alleged lack of commitment toward lowering the cost of medications for Americans.

Public Citizen, the consumer-advocacy group, also released a statement critical of Califf's ties to industry, saying the "nomination undoubtedly comes as welcome news to the pharmaceutical and medical-device manufacturers but is bad news for patients and consumers"[4].

Citing Califf's "extensive financial ties" to Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck, and Sanofi, Public Citizen said no former FDA commissioner has had such a close financial relationship to industry and urged the Senate to reject the nomination of Califf as the next FDA commissioner. If approved, the group argues, the appointment would "accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry, rather than those of public health and patients."

The AIDS Healthcare Foundation, an international organization that provides medical care and does advocacy work, also called on President Obama to withdraw Califf's nomination because of concerns he would weaken government regulation of the pharmaceutical industry[5].

And not to be outdone, a progressive "social-change organization" known as CREDO Action has accumulated more than 135,000 signatures as part of a petition opposing Califf as FDA commissioner[6]. Like the others, the progressive activist group alleges Califf is too allied with the pharmaceutical industry he will now be tasked to regulate.

Facts vs Innuendo

In the editorial, Drazen says such concerns about Califf's ties to industry are primarily based on innuendo rather than fact. Since 2005, he points out, Califf has served as a clinical investigator of seven major studies sponsored solely by industry. Of these trials, including IMPROVE-IT, ROCKET-AF, NAVIGATOR, EARLY-ACS, SYNERGY, and PREVENT IV, four were negative studies, two favored the intervention, and NAVIGATOR, a 2x2 factorial-designed study, had mixed results.

"Given this performance, it is impossible to argue that Califf has a proindustry bias," writes Drazen.

Moreover, Drazen points out that Califf's funded salary for the past 3 years has come largely from grants stemming from various projects, including a leadership role in the Clinical Translational Science Award from the National Institutes of Health (NIH), the NIH Collaboratory, the Patient-Centered Outcomes Research Network, and the Duke Center for Medicare and Medicaid Research Innovation project.

For Drazen and the Journal editorial board, their experience in working with Califf through the National Academy of Medicine has been positive, saying "his aim was always to find better ways to diagnose and treat illness." To do so, "he wanted well-gathered data on which to base all our clinical decisions and wanted to design and implement health systems that worked effectively to improve the outcomes of individuals and populations."

In October, Dr Kim Williams, president of the American College of Cardiology (ACC), submitted a letter on behalf of the organization's more 49,000 cardiologists and members to the Senate Committee on Health, Education, Labor, and Pensions, a committee whose jurisdiction includes the FDA, in support of Califf for FDA commissioner. Citing his long history of collaboration with the agency, including his work on the cardiovascular and renal drugs advisory committee, and his leadership roles within the Institute of Medicine, the ACC believes "Califf is the right person to lead the FDA as commissioner based on his impressive medical knowledge, clinical research experience, and visionary leadership abilities."

In September, the American Heart Association (AHA) also threw its support behind Califf, praising President Obama for the nomination and urging the US senate to confirm him "as quickly as possible"[7]. Nancy Brown, the chief executive offer of the AHA, stated the next commissioner will "need to be skilled in working with all stakeholders to protect and improve the health of all Americans" and that Califf is the "perfect person for this job."

The American Society of Clinical Oncology (ASCO) also recently endorsed Califf for commissioner, as have more than 70 patient- and disease-advocacy groups, each representing more than a dozen clinical interests[8].

Before taking the FDA post, Califf served on the advisory board of theheart.org | Medscape Cardiology. He had been a contributing editor to theheart.org since its founding in 1999 and was the host of the long-running series "Life and Times of Leading Cardiologists."

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