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What Do We Know about FDA Commissioner Nominee Dr. Califf?

<p>Duke University researcher and cardiologist Robert Califf, M.D., is President Obama&rsquo;s nominee for the next FDA Commissioner, to replace Acting Commissioner Stephen Ostroff, M.D., who took over in 2013 when Margaret Hamburg, M.D., left the appointed post earlier this year. Califf has been deputy commissioner of tobacco and medical products since January 2015, and he was on the short list of possible commissioner nominees in 2009 when Hamburg ended up winning the nod.</p>

Duke University researcher and cardiolaogist Robert Califf, M.D., is President Obama’s nominee for the next FDA Commissioner, to replace Acting Commissioner Stephen Ostroff, M.D., who took over in 2013 when Margaret Hamburg, M.D., left the appointed post earlier this year. Califf has been deputy commissioner of tobacco and medical products since January 2015, and he was on the short list of possible commissioner nominees in 2009 when Hamburg ended up winning the nod.

Califf will need Congressional confirmation, which so far appears he will likely get without too much trouble. The Senate HELP (Health, Education, Labor and Pensions) committee said it planned to hold the confirmation hearing before Thanksgiving. While Califf enjoys decent Republican support, his confirmation hearing could be delayed by Senate Republicans who vowed a broad opposition to any Department of Health and Human Services appointment approvals until the department addresses Senate inquiries into aspects of Obamacare (the Affordable Care Act).

Califf has an extensive background in clinical research, which would be a departure from Hamburg, who came from a major public health position. In fact, lack of public health experience is among the concerns about Califf, as are his tight connections with the pharmaceutical industry.

In 2006, Califf founded and directed Duke’s Clinical Research Institute, one of the largest academic research organizations in the world, and has published hundreds of clinical studies. However, he has received a great deal of financial support from pharmaceutical companies. Presidential candidate Sen. Bernie Sanders, a Democrat from Vermont, said he’d vote against Califf’s confirmation because of the nominee’s ties to drug companies. Califf has been a consultant for a number of big pharma and medical device companies including AstraZeneca, Merck and Novartis.

“At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices," said Sanders in a press release, who sits on the HELP committee. “Unfortunately, I have come to the conclusion that Dr. Califf is not that person."

Califf’s interaction with the dietary supplement industry is more limited.

In 1996, after positive vitamin E study results were publicized, Califf told the Argus Press, “If patients want to take [vitamin E], I wouldn’t discourage it. But if patients are skeptical, I wouldn’t push them into taking it."

In 2002, Califf and researchers from Duke reported on their large published (JAMA) study that found St. John’s wort ineffective against moderately severe depression.  Califf said taking herbal remedies was potentially dangerous. “As long as these types of products remain available to the public without the protection of adequate, controlled and unbiased studies, taking them is like playing Russian roulette with your health," he said. “Just because St. John's wort was found to be ineffective for this type of depression does not mean it is harmless to the body."

On the efficacy of herbs like St. John’s wort, he reasoned there are only two kinds of therapies: those that work and those that don't work. “Until there is a reliable compound made from St. John's wort that has demonstrated efficacy for treating depression, it is very important that people think twice about taking this drug," he said.

Also in 2002, Califf commented on the results from two trials—the Heart Outcomes Prevention Evaluation trial (HOPE), and the Heart Protection Study (HPS)—that showed no benefit and a negative effect, respectively, from vitamin E supplementation. “How do you convince people that, just because somebody writes in Parade magazine that vitamins are good for you, that they shouldn't be taking them?" he said. “Most of the patients that I've seen are taking vitamins, thinking they are helping their heart . . . and yet there have been so many trials that have put the nail in the coffin for cardiovascular benefit, I don't know why the idea persists."  He further noted the HPS results may force clinicians to try to convince their patients "to not spend their money on [vitamins that have unproven cardiovascular benefit] but on things that work."

Vitamin E may not have made the Califf cut, but rising nutritional star omega-3/fish oil just might…sort of. A 2009 Forbes article reported Califf gives his cardio patients fish oil, but said he doesn’t want this to become a broad endorsement of the supplement, adding the benefits are modest. “I’m not going to go out and say everybody in the world should stock up on omega-3," he told the magazine.

The most telling statement from Califf relative to his potential impact as head of FDA may come from a November 2010 Forbes article on a study showing no benefit to a trial defibrillation from GlaxoSmithKline’s Lovanza (prescription omega-3 pills), in which Califf said “all this food supplement stuff" may need to be tested like drugs.

There is no definitive information as to how Califf would influence dietary supplement regulation, and he would have a great deal of other agency issues on his plate, including implementation of FSMA (Food Safety Modernization Act) and decisions on regulation of e-cigarettes. Despite his credentials and being widely respected as a medical professional and researcher, Califf still has to be confirmed; only then will the supplement industry begin its journey to the next chapter of FDA.

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