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Big Pharma Officially Owns The FDA

The new FDA commissioner is a big win for big pharma

Big Pharma Officially Owns The FDA

The U.S. Food and Drug Administration has brought in a Big Pharma cheerleader to lead the agency that regulates Big Pharma.

In February, President Obama’s nominee Robert Califf sailed through the Senate approval process to be approved as the next FDA commissioner.

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Robert Califf – President Obama

Califf has financial ties and some very deep connections to the pharmaceutical industry as AlterNet reports:

Califf, chancellor of clinical and translational research at Duke University until recently, received money from 23 drug companies including the giants like Johnson & Johnson, Lilly, Merck, Schering Plough and GSK according to a disclosure statement on the website of Duke Clinical Research Institute.

Not merely receiving research funds, Califf also served as a high level Pharma officer, say press reports. Medscape, the medical website, discloses that Califf “served as a director, officer, partner, employee, advisor, consultant or trustee for Genentech.” Portola Pharmaceuticals says Califf served on its board of directors until leaving for the FDA.

In disclosure information for a 2013 article in Circulation, Califf also lists financial links to Gambro, Regeneron, Gilead, AstraZeneca, Roche and other companies and equity positions in four medical companies. Gilead is the maker of the $1000-a-pill hepatitis C drug AlterNet recently wrote about. This is FDA commissioner material?

Califf has gone on record that collaboration between industry and regulators is a good thing. He told NPR, “Many of us consult with the pharmaceutical industry, which I think is a very good thing. They need ideas and then the decision about what they do is really up to the person who is funding the study.” What?

He is known for defending Vioxx which is reported to have caused at least 50,000 heart attacks and events before its withdrawal. (Merck is said to have known about Vioxx’ cardio effects but marketed the blockbuster drug anyway.)

Califf was instrumental in the Duke drug trial of the blood thinner Xarelto and a cheerleader of the drug despite medical experts’ objections to its approval and 379 subsequent deaths. Xarelto’s serious and foreseeable risks were back in the news this week.

Duke, where Califf directed clinical research, is still recovering from a major research fraud scandal that resulted in terminated grants, retracted papers and a “60 Minutes” special. It is the least appropriate place from which to choose an FDA commissioner.

Many had high hopes for the FDA when Margaret Hamburg was confirmed as commissioner in 2009 because of her public health background. But she swiftly moved to loosen conflict-of-interest rules governing those who can serve on FDA expert advisory committees and appointed Califf the FDA deputy commissioner for medical products and tobacco as she was leaving.

Califf was also Obama’s choice for FDA Commissioner.

This is not the first time the FDA has brought in a Big Pharma cheerleader to lead the agency that regulates Big Pharma.

In 2005, a 33-year-old Wall Street insider known for recommending hot medical stocks, Scott Gottlieb, was named FDA deputy commissioner for medical and scientific affairs. When a multiple sclerosis drug trial was stopped because three people lost blood platelets and one died, Gottlieb called it “an overreaction” because the disease, not the drug, might be to blame. He rushed Chantix, Pfizer’s stop-smoking drug, varenicline, to market, which was linked to a string of 2006 suicides and the violent death of Dallas musician Carter Albrecht. Gottlieb was forced to recuse himself from planning for a possible bird flu epidemic because of his financial ties to Roche and Sanofi-Aventis and had to bow out of work related to Eli Lilly, Proctor & Gamble and five other drug companies.

Even without a Pharma-funded FDA commissioner, many dangerous drugs approved by the agency have been withdrawn due to great harm. Who remembers Vioxx, Bextra, Baycol, Trovan, Meridia, Seldane, Hismanal, Darvon, Mylotarg, Lotronex, Propulsid, Raxar or Redux?

Califf’s confirmation amounts to a handover of the agency to Big Pharma.

  • Val Zudell

    When is somebody, anybody going to step in and stop drug companies from their dangerous profiting from harmful drugs? Is there no one in command that gives a damn?

  • Marcie Evanosky Nichols

    This is bs.
    The whole industry is corrupt.
    Just keep using & abusing us regular people out here struggling to live. Keep poisoning us with your pharmaceuticals and reep all our money.
    The usa is no longer a good place to live.
    Nothing but corruption.

  • Richard Finkel

    This is like when Howard Stern called out Bush, after it was known that he LIED about Iraq. Next thing ya know the FCC commissioner, Colin Powell’s son, fined him million$ for indecency. Pure and obvious abuse of power! They don’t even try to hide it!

  • Janice

    Medicine is not needed for almost everything we Live for !!! I have MS and a Brain Tumor and medicine is not needed to keep me here !!!

  • Hazel Heal

    The 2 million global hepatitis C deaths for the past 3 years are blood on the hands of Gilead and big pharma. More die than are treated, still, and it is the biggest infectious killer of Americans, top 5 infectious disease in the world. We are tragically not deploying the cure, worldwide, that exists because these warlords are still hungry for more billions. I have, just, survived that money or your life threat by legally importing generic meds. It is a powerful global action that saves lives and directly confronts this model of unchecked greed. Please let people know, they can too.

  • Your1Friend

    Washington doesn’t just embody corruption; Washington is corruption.

  • https://www.facebook.com/pages/United-States-Kratom-United/1033017630043331?ref=bookmarks Kelly Devine

    When you separate the FDA and Big Pharma we’ll have a chance at safe medications. I was on 13 Rx and some gave me SI I tried a number of times once I was in a coma for 3 days an intentional OD of (150) amatriptaline after being on lyrica a short while I just do not trust the FDA any more that’s why I rather use natural herbs like kratom and skullcap. No side effects, no direct deaths and I know what I’m getting is safe! #KratomUnited #UnitedStatesKratomUnited #KratomLivesMatter I’d also like to mention pharmaceutical companies pushing legislators to ban the plant. Why are they so scared of kratom? Because it works!

    • BLOWFISH

      Hold on… last year someone who has been consuming for over twenty years reached out to you to warn your followers about kratom that was handled poorly during production and had confirmed toxic levels of salmonella, ecoli, listeria and mercury. You blew her off, blocked her, then went on to lie about what transpired in the very short conversation. You defamed her character, posting screenshots of what you wanted your followers to see. Edited snippets of the conversation to make this woman look bad. You block people that question your authenticity. You defame anyone who stands up to you.
      This woman had photos and thousands of messages shred between herself and this exporter. But you looked the other way, demanding she prove to you, with receipts, that she had infact been a consumer for decades. Told her she wasn’t doing her part to have band lifted. Basically, you disrespected someone’s very valid concerns and you put the whole community at risk and you continue to support the exporter even though he introduced contaminated, dangerous kratom into the American market.
      I don’t know what your hang up with head shops may be. But there is no difference between what the shops carry and what can be purchased online. Except cost. You didn’t even know the difference between a strain and a vein color a year ago and it bad to be explained to you. You are a complete mess of contradictions and blatant lies!
      You need serious help.