Bernie Sanders Opposes Califf for FDA Post Cites Industry Ties

Justin Karter
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Current presidential hopeful and longtime Vermont independent senator, Bernie Sanders, said that he will vote against Robert Califf’s nomination to lead the Food and Drug Administration (FDA). Sanders explained his opposition by citing Califf’s extensive ties to the pharmaceutical companies that he would be in charge of regulating.

"Bernie Sanders" by United States Congress
“Bernie Sanders” by United States Congress

“It is time for the United States to join the rest of the industrialized world by implementing prescription drug policies that work for everybody, not just the CEOs of the pharmaceutical industry,” he said.

According to Sanders’ press release, the pharmaceutical industry spent over $250 million dollars on lobbying last year while employing over 1,400 lobbyists. The three largest pharmaceutical companies, Johnson & Johnson, Novartis, and Pfizer, “made a combined $45 billion in profits last year and spent more on sales and marketing than they did on research and development.”

Robert Califf has come under renewed scrutiny for a number of issues related to his extensive record of working with medical device and pharmaceutical companies.

According to a report by the Intercept released yesterday, Califf served as a board member and consultant for a company that “specializes in helping health care companies hire faculty members and other academic researchers to influence regulatory decisions.”  In the past year alone, through his work with Faculty Connection LLC., Califf effectively augmented the lobbying efforts of Amgen, AstraZeneca, Daichi Sankyo, Medscape, Merck, Novartis, and Sanofi SA. Califf has reportedly been involved with the company since 2006.

Last week, Sheila Kaplan for the Boston Globe reported on Califf’s controversial decision to surreptitiously remove his name from a recent series of scientific papers that focused on promoting pragmatic clinical trials (PCTs) and criticized current FDA standards for informed consent and determining patient risk.

Califf was nominated by the Obama administration in September to serve as Commissioner of the FDA.  At the time, many media outlets reported that his nomination was expected to “sail through” the Senate and garner little opposition.  However, several public accountability groups strongly opposed his nomination from the start.

Immediately the administration announced the selection, Dr. Michael Carome, the director of the Public Citizen’s Health Research Group, released a statement calling on the Senate to reject Califf’s nomination.

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

The New York Times also reported in September that Califf’s “declared financial support from more than 20 companies,” has led 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.”

Speaking to the ‘Times, Daniel Carpenter, a Harvard professor who covers the FDA, called Califf “the ultimate industry insider.”

As far back as February, Diana Zuckerman, the president of the National Center for Health Research, told TIME Magazine that Califf’s ties to the industry “should be of great concern,” and that these relationships raise questions about his “objectivity and distance.”

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50 COMMENTS

  1. “It is time for the United States to join the rest of the industrialized world by implementing prescription drug policies that work for everybody, not just the CEOs of the pharmaceutical industry,” he said.

    What exactly does “work for everybody” mean ?

    “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.”

    Now with cheaper drugs we can medicate even more kids !

    These are the same ideas that give us ‘free’ mental health screening in schools, child drugging, teachers unions, standardized tests…

    Socialism sucks. “Works for everybody” Ya sure it does.

    • It’s not only about pricing – it’s also about making sure that drugs don’t get approved when they don’t work and cause harm. Like getting the FDA that does its job instead of serving as a fig leaf for pharmaceutical industry.

  2. No one took the bait so here is some more:

    How can a mental health website be in favor of all these lefty ideas ?

    The overriding problem with socialism is that it violates a fundamental principle of human nature: people respond to incentives. Incentives give people a reason to work, produce, perform, create, innovate, change, and do all of the other things necessary to improve the quality of life for themselves, their communities, and the nation. Ask me to paint your fence and you won’t even get my attention. But offer to pay me to paint your fence—provide an incentive—and not only will you get my attention I will agree to negotiate a mutually-beneficial arrangement with you. Socialism fails in part because it eliminates the incentives that are the driving forces of human nature. Theories that fail to account for human nature may sound plausible on paper, but they always fail when subjected to the practical exigencies of real life. Socialism is such a theory. http://socialismsucks.com/ LOL

    I would think a website focusing on mental health , psychology and all that would have an understanding of human nature and see the fatal flaw in all these “great ideas” from the democrats and socialists.

    Conservatives are often mean and intolerant but at least they don’t sell economic bull that sounds nice but never works out.

    Politics, what a scam.

      • They also say they population needs to be disarmed so we can’t guard ourselves or our hens so the fox can do what ever it wants.

        Sanders and the others are the foxes and they don’t want any competition.

        They will through a few bones here and there taking jabs at big pharma but if they get their way there will be medical tyranny like the world has never seen.

        Electronic medical records… Just the start. They want to treat us like farm animals they “care” for. I see your EMR says ‘bipolar’ have you been taking your meds ?

        Meanwhile there was nothing on this website about Donald Trump calling out Vaccines and Autism and Ben Carson going along with it.

    • If you understand this so well why do you have to have someone else make your arguments for you?

      Unless you’re a millionaire or more no one cares whether you’re “liberal” or “conservative”; without money you’ve nothing to be liberal or conservative with.

    • The-cat

      You said: “The overriding problem with socialism is that it violates a fundamental principle of human nature: people respond to incentives. Incentives give people a reason to work, produce, perform, create, innovate, change, and do all of the other things necessary to improve the quality of life for themselves, their communities, and the nation.”

      You have turned reality on its head. Human nature is a very malleable feature of our species. It was considered human nature at one time in our history for some humans to eat other members of the species. How convenient that you have swallowed the current lie that human beings are by nature selfish and will only look out for number one and stab people in the back to get ahead; these are the incentives you are really talking about. Is this not the essence of the capitalist ethic; “expand or die and eat up your competition before they eat you up?”

      You forget that there was a time in human history when there were no classes, money, or private possessions. There were indeed incentives to cooperate out of necessity for survival. Human beings have created millions of things in this world without the type of incentives that you are talking about. It is human nature to innovate and invent things to make life easier, and also to create works of art in many forms. This has happen throughout human history when there was no direct material reward.

      Capitalism and the profit motive actually stifles creativity and the inventiveness of the human spirit by only allowing a tiny minority to engage in this type of creativity. And it only rewards discoveries that can make a profit; how narrow and limiting is this?! Just consider for a moment what inventions and creativity would be possible if more people had access to science and technology and the means to new discovery.

      There are many people who have made incredibly important discoveries in medicine and science that had no expectation of reward other than the joy of solving problems, and in many cases, the desire to help others.

      Classes and the profit motive stand as an impediment to the advance of science and human cooperation.

      Bernie Sanders is a utopian not because he believes in socialism (his own distorted version of it) but because he is deluding people into believing it is something that could be voted in within the current system.

      Richard

      • Richard, The_cat, and All ,
        There’s a film that seems to me really pertains to this discussion on youtube and/or Netflix .There are 3 parts but Richard your last comment calls out for Zeitgeist Addendum Part III to be seen first. This is a very interesting series may help stimulate new ideas .
        Fred

      • Exactly. The neoliberal doctrine fails to take into account all the non-monetary incentives such as morality, love, empathy, altruism and so on. We are so used to this kind of thinking that it’s hard to get away from this mindset and consider that most people are actually good. Sure, everyone has also some selfish in them but then the right incentives are to promote social solidarity and not individualistic greed.

        • “The neoliberal doctrine fails to take into account all the non-monetary incentives such as morality, love, empathy, altruism and so on. ”

          This is a function of culture. The success of the Scandinavian countries, which I happen to admire despite my libertarian sympathies, derives from their culture….low corruption, governing by consensus over confrontation; values that emphasize the public good; greater social integration; lack of tolerance for the excesses of unbridled capitalism (e.g., excessive, obscene executive compensation). None of that is imposed by the state; it is a function of societal values or cultures. Scandinavian countries also tend to be more homogeneous, and that promotes the “us, we all in this together” mindset as opposed to “us vs. the other.”

      • “It is human nature to innovate and invent things to make life easier, and also to create works of art in many forms.”

        Yes it is, but not in the absence of freedom. How much freedom — where does regulation/taxation get oppressive and stifling — is where the debate needs to be. I am not here to defend the excesses of capitalism or capitalists who behave badly I certainly do not subscribe to the idea that all rich or successful people are job creators or have earned their success through hard work and innovation, but the entrepreneurs (those who take the risk and create something out of nothing) have and we all are better off because of them. We as customers, voters and shareholders already have a lot of power to hold corporations/executives accountable (they do care about reputations and opprobrium/shaming can be quite effective in policing shameful behavior), if we would only use it.

      • As to incentives, who said Socialism is averse to incentives? I think most social democrats would agree that incentives to, say, invest in green energy are good, while incentives like cleaning up oil spills without charging the company who spilled the oil are bad. I think they’d just advocate for different incentives.

        Additionally, as B says somewhere below, I think socialistic structures in a capitalistic economy actually encourage innovation by allowing small entrepreneurs to make money more easily, while creating barriers to large corporate entities to dominating markets and suppressing wages and suchlike. I have no doubt that small businesses feel oppressed by regulations. But how many of those regulations are advocated for by Big Businesses themselves in order to assure their control of the markets?

        The problem is not socialism, but corruption. Any government can be corrupt, but a combination socialistic/capitalistic political economy appears to minimize the incentives for corruption by assuring that beyond a certain point, trying to squeeze more money out of the workers and consumers of the country no longer really pays a big dividend, while investing in the community starts to look more appealing.

        If you have doubts about this, look at how the city of Burlington, VT did under Bernie’s leadership. The business community did everything they could to keep him out at first, but in the end, they saw that their businesses thrived under his approach to government. That’s why he keeps getting re-elected – he really does know what he’s doing.

    • The_cat – having lived in a few different countries so far the more “socialistic” ones (I mean social-democratic European countries) do much better than more capitalist ones. Also in terms of actual free market. You can call it a paradox but having the state regulate market in a more socially just direction actually promotes genuine competition between small businesses as opposed to hegemony of big business and cronies.
      I think you should listen more to what Mr Sanders says instead of looking at the label (we should be used to that approach here I suppose ;P). I don’t agree with a lot of things, especially on foreign policy, but he’s not crazy.

      • “You can call it a paradox but having the state regulate market in a more socially just direction actually promotes genuine competition between small businesses as opposed to hegemony of big business and cronies.”

        It is not a paradox. It works where it does (e.g., Scandinavia, Germany) because of that society’s culture. Try that in the U.S. (a high corruption/low competence society) and you end up with a man-made disaster like the State of Illinois.

          • “Somehow I don’t think social democracy has been tried recently in Illinois.”

            Actually, the ruling party maintains that it is trying to do just that, even as it enriches itself and its favorite constituents. How do you propose implementing social democracy in Illinois? Vacuum out Illinois’ entire population and settle it with Scandinavian? Sorry, culture and customs matter. A lot. Much more than the law or a particular political system.

          • Hello B:
            I am not saying that the Germans are better people. I am saying that cultural differences are real, they matter, and countries like, say, Scandinavia (very low on the corruption scale, government by consensus instead of confrontation) are different from the U.S. And, of course, culture changes over time.

          • “I seriously don’t get people’s obsession with Jobs. He was an extraordinarily good salesman and a***ole at the same time, bordering on a sociopath.:

            Job was much more than a great salesman. He was an authentic genius and visionary; there is no getting around that. As an entreprenurial genius (only in that narrow sense), he was one of the heroes of capitalism. I am not making any comment about his personal character, conduct, mental state or suggesting that he was an admirable sort or worth emulating as a person. I was making a limited reference to his role as an entrepreneur.

  3. Fascism: By vague analogy, any system of strong autocracy or OLIGARCHY usually to the extent of bending and breaking the law, race-baiting and violence against largely unarmed populations.

    I’ll take hints of Socialism over that any day. I suggest you look at who proposed the bill on mental health and his supporters. Trolls should at least be able to present the illusion that they know about the subject they are using as bait.

    • The Nanny state is 100 times more dangerous than the police state.

      “Of all tyrannies, a tyranny exercised for the good of its victims may be the most oppressive….”

      “Fascist”

      The Libertarian Party is for all who don’t want to push other people around and don’t want to be pushed around themselves. Live and let live is the Libertarian way. http://www.lp.org/introduction/what-is-the-libertarian-party

      At least label your trolls correctly.

      • If you haven’t noticed the scapegoating and open discrimination and fear mongering of the Republicans, I don’t know how to make it much clearer.
        Regardless, you want to argue politics, but this site is not about politics. They merely form a backdrop in this specific instance for the larger issue.

          • “The term Liberal is closely tied to individual rights, and the majority of survivor’s want human and civil rights.”

            Acidprops

            it would be more correct to say that “liberal” (i.e., classical liberalism) USED to be closely associated with individual rights and personal autonomy. Today, the commitment to individual autonomy and personal freedom is the hallmark of libertarianism. Modern-day liberalism has devolved into group-think, identity politics, group grievance-mongering, political correctness and statism. A state, by definition, means coercion, and I can’t think of a group less in need of state-supplied coercion than people who have been through the coercive mental health system.

      • Thanks but I’ll take living in today’s Sweden over living in Nazi Germany.

        I don’t think you use the word socialism in the same way as people who actually describe themselves as such understand.

        Please, to begin with – read Marx’s Communist Manifesto and then come back to comment. I’d bet you’ll find this book stunningly reasonable. Or at least you’ll know what you’re criticizing.

  4. Liberals and conservatives, as the terms are understood in the US, are two sides of the capitalist coin. They exist to provide the illusion of democratic debate. Liberals are at least as bad as conservatives regarding the issues we care about, so I’m afraid that to take a “side” here would be falling into the trap.

    • Admittedly, since everyone gets paid in the end, the concept as it applied to parties is true. However, my own tendency towards liberal ideals remains. I do view politics as a backdrop to what is more a question of profit versus human rights. I don’t believe politicians care one way or another about mental illness. as far as the impact on this country or on those diagnosed with a mental illness. I am not sure how your question about letting someone make my argument applies though.

      • Sorry, no, that comment was addressed “the cat” regarding his needing to post someone else’s argument against “socialism” instead of using his own.

        So, I think where we might appear to differ is more that we mean different things by the same terms. For example I think you interpret “politics” narrowly to refer to the bickering that goes on between Democrats and Republicans over how best to administer their shared turf. But this is only the internal politics of the ruling class; revolutionary politics has to do with the struggles between the ruling class (popularly referred to as the 1%), the working class and the completely disenfranchised.

        Among that 1% are quite a few liberals and Democrats. Liberals are good talkers when it comes to “ideals,” not so good at putting them into practice. In my view liberal Democrats are more dangerous than straight-up racists and reactionaries because they prey upon the idealism of people who might otherwise be involved in more fundamental activism, but end up making phone calls and handing out leaflets for milquetoast candidates who are hopelessly compromised before the election has even begun.

        • That is an excellent point. In fact the current political elites are not divided into left and right but just less and more extreme representatives of the ruling class.

          In other words – we need to change the system completely. And indeed it’s a class war alive and well.

          • A “class war”
            People chose to be low class.

            I just saw another young man new to addiction recovery goto the tattoo shop and cover his arms with those opportunity removers.

            “Freedom of expression” Great but that doesn’t help when you go for a job and they don’t hire you.

            The system is kind of corrupt and all that but in America you can still make it if you try and are smart about it.

            I don’t want an omnipotent nanny state making everything “fair” for everyone even if it did lift me a little.

  5. Following current logic foxes are ideal candidates for guardians of a henhouse – they are experts on poultry afterall.
    It seems like from the psychiatric surviviour perspective Sanders is the best candidate so far. Hardly perfect but that may be the best there is.