Nominee for FDA Commissioner Has Strong Industry Ties

Justin Karter
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On Tuesday, the Obama administration nominated Dr. Robert Califf to be the new commissioner of the Food and Drug Administration (FDA). In a statement, director of the Public Citizen’s Health Research Group, Dr. Michael Carome called on the Senate to reject the nomination.  He contends that Califf “racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few.”

“Strikingly, no FDA commissioner has had such close financial relationships with industries regulated by the agency prior to being appointed,” wrote Carome.

Califf has served as the deputy commissioner for medical products and tobacco since March and is a researcher and the former director of the cardiac care unit at Duke University Medical Center.

Reuters reports that “Califf has close ties with the drug industry, having worked on myriad high-profile clinical studies, and he is also close with Dr. Janet Woodcock, the FDA’s powerful head of pharmaceuticals.”

In February, Diana Zuckerman, the president of the National Center for Health Research, told TIME that Califf’s ties to the industry “should be of great concern,” and that these relationships raise questions about his “objectivity and distance.” She cited studies suggesting that “such ties to influence the behavior and decision-making of doctors and researchers, even when the scientists don’t realize it.”

Califf graduated from the Duke School of Medicine in 1978, then completed his residency at the University of California, and a fellowship in cardiology at Duke.  Califf has had a long research career, working in both development and post-marketing surveillance.  He has also led large public–private partnerships with the FDA.

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Update 9/21/15:

New York Times: “FDA Nominee Califf’s Ties to Drug Makers Worry Some”

In Saturday’s New York Times, Sabrina Tavernise describes the close industry ties of Dr. Robert Califf, a cardiologist and researcher recently tapped by the Obama administration to head the FDA.  In a conflict of interest statement published last year, Califf “declared financial support from more than 20 companies,” leading some public health advocates to “question whether his background could tilt him in the direction of an industry he would be in charge of supervising.” Tavernise points to a presentation Califf gave on “Disrupting Clinical Research: Transforming a System” in 2014 where he singled out regulation as a barrier to research and innovation.  “I think it illuminates his thinking,” Daniel Carpenter, a Harvard professor who studies the FDA, said of the slide. “In a sense, he’s the ultimate industry insider.”

 

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Justin Karter
MIA Research News Editor: Justin Karter is a writer, researcher and community organizer with graduate degrees in both journalism and community psychology. He is a doctoral candidate in Counseling Psychology at UMass Boston, an active member of the Society for Humanistic Psychology, and is currently working on several scholarly projects at the intersection of psychology, social theory, and political philosophy.

13 COMMENTS

    • “The FDA is not the friend of the American people.” – Sounds like a libertarian argument for rescinding CFR Title 21
      “It takes its orders from Big Pharma.” – Interestingly, on some days, even big pharma recognizes there are limits. One example of a self imposed limit being the marketing of Eliquis (apixaban) to peeps recovering from heart attacks. Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome (http://www.nejm.org/doi/full/10.1056/NEJMoa1105819)

    • “The FDA is not the friend of the American people.” Indeed. The profit motive and the attendant corruption — not burning your bridges to lucrative industry employment post government service — works within the government as well as in the private sector.

      One has to go way back to find an FDA official who exemplified the necessary integrity, courage, brilliance and highest motivation to act for the public good in the execution of his/her responsibilities as an FDA official. That would be Dr. Frances Kelsey, who passed away last month, and who is largely responsible for the U.S. bypassing the Thalidomide catastrophe. As The Washington Post put it, “[the] tragedy was largely averted in the United States, with much credit due to Kelsey. … For a critical 19-month period, she fastidiously blocked its (Thalidomide’s) approval while drug company officials maligned her as a bureaucratic nitpicker.”

      One can only imagine the pressure that was brought to bear on this young doctor. At that time, the notion that drugs cross the placenta barrier was an unproven theory. But Dr. Kelsey took seriously the possibility of risk to the developing child, continued to demand more information from the company and held off approval long enough for the catastrophic effects of Thalidomide to manifest themselves. Once they did, non-approval by the FDA was a no-brainer. For the FDA to to cloak itself in her legacy as the “gold standard” government agency because of Thalidomide is false. It was Dr. Kelsey and her (sadly) unique set of attributes that averted the tragedy. Thank you, Dr. Kelsey, and RIP.

  1. This is so disheartening! Just when the corruption within the corporations is coming to rise above the societal watermark we have this appointment.
    What do the powers that be have on Obama?
    This is bad for the 99% in terms of health, nutrition, food , and family economics.

    • What do the powers that be have on Obama ?
      The robber baron families Rockefeller’s and Carnegie’s and others, their cartels and corporations demand from anyone that can be elected president the heads of the people delivered on a platter.
      See the movie “Ethos on Netflix or on Youtube for free .

  2. Yes, this is like hiring an oil executive for Secretary of the Interior. Sad, but not surprising. I don’t believe the tide is turning against psychiatry. I think things will get much, much worse before they become better. Many credible people who work within the system have rung the alarm bell and nobody cares. I’ve spent a lot of time visiting my loved one in the state hospital and various foster homes; I’ve witnessed hundreds of shut away people who are permanently disabled by their ‘treatment’. The response of family members is to clamor for more psychiatric beds and better chemical restraints. These parents won’t rest until big Pharma invents a depot shot of Haldol that has a half life of fifty years. We are fighting an Evil Empire of corruption and greed and this new guy at the FDA is just the new Darth Vadar.

    • Call aspersions if you must, but Duke uses industry money to finance academic studies that industry doesn’t or won’t. For examples of depression related studies, google ‘robert califf st john’s wort’ or ‘TADS depression’. For alternative medicine approaches, google ‘TACT chelation therapy’ or ‘MANTRA noetic training.’ Remember NIH awards don’t pay for the complete cost of research.

      What Justin and Sabrina don’t tell you is the public has had a direct hand in his trying to ‘transform medicine.’ The NIH has paid Duke and a number of other academic medical centers to transform the way biomedical and clinical research (bench to bed) is conducted via CTSA awards. Califf was the principle investigator for Duke’s CTSA so it was his fiduciary responsibility as a recipient of public monies to make good on the grant by offering his thoughts.

      One of Califf’s efforts to date whilst at the FDA has been to seek public input.
      FDA Announces First-ever Patient Engagement Advisory Committee (http://blogs.fda.gov/FDAvoice/index.php )
      And bless his heart, he alluded to this strategy years ago during the Vioxx scandal. (http://www.pbs.org/newshour/bb/health-july-dec04-cahill-vioxx/ )

      And as far as him being the new Darth Vader, well he likely won’t survive into the next presidency. So, that’s something for you to look forward to.

      • Remonstrance

        OK. Darth Vadar may have over the top; out of curiosity and penitence, I googled the items you suggested and here is my two cents worth: the studies you cited don’t qualify Dr. Cardiff to be a barracuda of consumer protection in this era of rampant greed and corruption.

        1) NIMH study…..I have to take it on faith that the TADS study had industry support as you inferred because the funders are not listed on the version I saw. I also have to take it on faith that Mr. Cardiff had anything to do with it because the author/director was not listed either. Most importantly, there was plenty to like about this study from industry’s perspective. Talk about dodging a bullet! If I were a Prozac salesperson, I could spin this study so quick it would make your head spin.
        The TADS study appears to provide evidence for what anyone with a modicum of lived experience knows as it relates to clinical practice (how psychiatric drugs are routinely prescribed and how patient outcomes are monitored). As one would have predicted, combination therapy—pharmacology in conjunction with CBT—is the safest short term treatment option over pharmacology monotherapy presumably because talk therapists have something useful to provide clients that prescribers don’t, i.e. they are trained to establish trust, they are less likely to use force and coercion, they are trained to observe and report behavioral changes, and they are less likely to be know-it-alls as to the origins of their client’s behavior (especially distress) a state which lends itself to open discourse and patient disclosure, things that are vital for safety.
        This is hardly the kind of study that elevates an academic researcher into being a champion of consumer safety capable of protecting people from psychiatric harm. Rather this study qualifies him to be the champion of more funding for complimentary industries that can ameliorate psychiatric harm after the fact.
        From this study, one could spin a fairly tepid policy recommendation that psychologists be involved in treatment teams to do the gumshoe work that psychiatrists usually will not or cannot do. One could also use this study to recommend to politicians that we should increase taxes to pay for CBT for all children and adolescents who are prescribed SSRI’s so that the protective factor of having a psychologist or counselor involved won’t be limited to all but the most privileged families. But you and I both know that currently, the mental health pie is divided with the lion’s share going to big Pharma; and the only thing that will change that is when expected corporate losses (liability) are in excess of anticipated corporate earnings resulting in a massive pull outs. Corporations pulling support for research and development of new psychiatric drugs who are aware of the long term negative impacts of psychiatric drug addiction will sell their sinking ships to other corporations, possibly resulting in some changes in the field. By then, however, it will be like mining companies who leave Super fund sites in their wake. By the time, the profits have been safely migrated out of the industry, the cost of psychiatric harm the extent of the corruption of the FDA will be evident but there will be no one to be held liable.
        Additionally, since the study was limited to 36 months, it does nothing to reveal the long term harm of stigmatizing of adolescents whose depression may have nothing to do with a chemical brain imbalance and have everything to do with bullying at school, dysfunction at home, unhealthy body image from advertising, etc. By the time the adolescent enters adulthood, the situational factors that may have been primary factors in the development of ‘major depression’ may have been so discounted or ignored in light of seeking remedies for the ‘chemical imbalance’ theory, that they may be forgotten entirely. After all is much easier for families to embrace the chemical imbalance theory of the diagnosed family member since it requires no work on the part of families to understand why little Johnny didn’t get the emotional support he needed to thrive. By the time five to ten years roll by, little Johnny may be on polypharmacy, always searching for just the right tweak to his cocktail as opposed to seeking alternative ways of coping with distress. The latter part of Johnny’s life will be chasing a phantom chemical brain imbalance or dealing with protracted withdrawal from multiple psychiatric drugs.
        The fittest candidate is someone who is not only willing to mitigate harm, but prevent it in the first place and holding corporations liable for future harm. By prevention I mean someone who favors policies to make it illegal to patent and market harmful drugs to treat vulnerable individuals, especially children, who are sad or depressed when safer evidence based alternatives exist. Even the TADS study shows that the CBT monotherapy ‘catches up’ with pharmacology monotherapy and combo therapy. It doesn’t take a degree in rocket science to figure out which approach is safer in the long run but it takes a barracuda to win the information war that is necessary to put safety first.
        Too bad, the adolescents who received only CBT were not followed for twenty years. I’d put my money on them having better long term outcomes, which is what really counts, especially now that the baby boomers—arguably the first generation of individuals psychiatrized for life starting in adolescence—are rapidly aging and we can see, first-hand, within our own circle of family and friends, which of us end up being the first to die—those who have been psychiatrized and medicated for life and those of us who, due to the grace of God, dodged this bullet.

        2) Per the study Duke did on St. John’s Wort (taking it on faith again that Dr. Cardiff was the lead author/director) I am not too impressed. Launching grenades against herbal supplements is a safe target for academia as it provides relatively low yielding fruit while pissing off very few financial investors. There is no reason that dietary supplements shouldn’t be held to the same vigorous testing standards as pharmacology, but I suspect that they are being held to an even higher standard, if measured by the amount of corporate media attention given to this study v.s. the amount given to the numerous studies in which SSRI’s that performed equally as bad as hypericum perforatum against placebo.
        Perhaps the focus of the study should have been which does the least amount of harm? When my adult son met most of the criteria for major depression after being discharged from the hospital for a suicide attempt, he did take St. John’s Wort and was greatly assisted by doing so. What my son did differently, (which Duke study participants probably did not) was he harvested his own St. John’s Wort in the field and produced his own hypericum perforatum tincture in our kitchen.
        The supplement didn’t have a huge effect either way but it did give him a sense of purpose, a stake in his own recovery, some sweat equity, an opportunity to be outdoors, and greater attention to his diet in general. Better than lying in bed all day waiting for a magic pill to take effect.
        Do you see the difference? The point of using herbal supplements is that individuals who are willing to pay out of pocket (they can be quite substantial in cost) or formulate their own, are more likely to make lifestyle shifts and accept greater responsibility for things within their control, such as diet. Good luck getting people to put sweat equity into their recovery once a psychiatrist fraudulently claims that they have a chemical brain imbalance that will be ‘fixed’ once they find the right cocktail of drugs. Why bother to make any effort to change if one is the passive victim of a disease, and why bother to complain about side effects if a psychiatrist thinks it’s all in your head or the only solution to obtain additional prescriptions and the original symptoms such as lethargy or agitation or irritability become indistinguishable from the side effects including compounded lethargy, agitation or irritability? Once an adolescent is in the snare of psychiatry, they are at risk of being consumers for life.

        3) Per Dr. Cardiff’s role in a major study involving noetic therapies (a term which I wasn’t familiar with until today) I couldn’t read about it because the study was behind a pay wall. And I don’t have time to read up on the benefits of public input. If the literature put out by pseudo organizations such as NAMI is any measure of the intelligence of the ‘general public’ then there is very little to be gained from public input, as the public has already been the victim of a massive fraud, subjected to decades of direct to consumer advertising and marketing campaigns instilling the chemical imbalance theory of mental illness deep into our psyche and duping us into believing in the safety of psychiatric drugs. Until the public has been educated to the contrary, there is very little to gain from public input.

  3. Yes this is bad that the FDA nominee has strong ties with the industry he is supposed to regulate, but people need to also take away from this that it was the Obama administration that nominated him. The corruption isn’t limited to Big Pharma or the FDA. It extends much further than that, to include big business, banks, and of course the government. This is just another example of how criminal and corrupt the entire system is.

    The good guys aren’t running the world. Psychopaths and criminals are running the world.

  4. I’m sure you’ve heard the slogan, “Get the Money Out of Politics”. Obama let a great many people down by, while talking about supporting the struggling middle classes, populating federal agencies with appointed officials having close ties to multinational corporations. I think we have a couple of words for that kind of thing, and those words are selling out. Psychiatry is obviously not the only profession that suffers from an excess in corruption. I would hope that there are enough reasonable and ethically responsible people around to deny this nominee this position, but we shall see. If power corrupts, and money buys power, a heck of a lot of people are going to need to be pooling their meager resources right about now in order to buy back their stolen destinies (i.e. the American dream). I suppose if we are up the river without a paddle at the present time, we don’t want to know how far up the river we could be in future if we don’t do something. Personal salvation, more and more, is going to have to rely upon collective salvation, or even the rats aren’t going to be able to escape this sinking ship. Government by, of, and for filthy rich people? Really? Maybe somebody should do something before it’s too late.

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