FDA’s Huge Conflicts of Interest with Big Pharma

March 13, 2012
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FDA moneyTragically, the drug they endorsed is killing the women who take it. Why is FDA doing this?

The birth control pills Yaz and Yasmin, which were endorsed by an FDA advisory committee last December, contain a drug called drospirenone. Women who take it are nearly seven times more likely to develop thromboembolism (obstruction of a blood vessel by a blood clot, which can cause deep vein thrombosis, pulmonary embolism, stroke, heart attack, and death) compared to women who do not take any contraceptive pill, and twice the risk of women who take a contraceptive pill containing levonorgestrel. Thousands of women have filed a lawsuit against Bayer, saying they were injured by Yaz or Yasmin.

Why would the FDA approve such a dangerous drug? An investigation by the Washington Monthly and the British medical journal BMJ found that at least four members of the advisory committee have either done work for the drugs’ manufacturers or licensees or received research funding from them. The members reported their industry ties to FDA, but FDA decided it didn’t matter and didn’t make the disclosures public.

Each of those four panelists who received money from the pill’s manufacturer voted in favor of the pill. Interestingly, the committee’s ruling that the drug’s benefit outweighs the risks was decided by a four-vote margin.

Ironically, while the FDA allowed voting by advisors with business connections to drospirenone, the agency barred another advisor and former researcher, Sidney M. Wolfe, on the grounds that he has an “intellectual conflict of interest.” Six years earlier, Wolfe had advised his readers not to take Yaz based on several years of data—and this was before the latest studies had been published. Because of this, he was barred from voting.

So apparently people with monetary conflicts of interest are allowed to vote, just not those with “intellectual” conflicts of interest!

FDA also didn’t provide the panel with recently unsealed court documents revealing that former FDA commissioner David Kessler had accused Bayer of hiding data on blood clot risks associated with Yaz and Yasmin. Kessler also reported that they paid $450,000 to a high profile gynecologist to sponsor the pill, including off-label use of the drug, during her book tour.

Bayer, of course, has a strong vested interest in getting endorsements for Yaz and Yasmin—in 2009 Yaz was top-selling birth control in the US.

This is not the first time that an FDA advisory panel has recommended an unsafe drug. As we reported three weeks ago, an FDA committee endorsed the weight loss drug Qnexa, a diet pill that has documented risks of causing birth defects and heart problems.

The conflicts of interest don’t stop with government bodies; they are also rampant among medical professionals of all kinds. Drug companies pay doctors, researchers, and medical experts for speaking engagements and “consulting” jobs—all of which is perfectly legal despite a blatant conflict of interest. The public interest news organization ProPublica has a Dollars for Docs database that shows more than $760 million in payments from drug companies to physicians and other healthcare providers for consulting, speaking, research, and expenses. (For more about pharmaceutical conflicts of interest, please see our other article in this issue!)

Many of these physicians and researchers are employed by the state and paid with tax dollars—and they are the ones shaping states’ health policies. In Texas alone, from 2009 through early 2011, researchers and physicians received at least $57 million in cash payments, research money, free meals, and other benefits—on top of their quite generous salaries. The Texas attorney general has sued Janssen Pharmaceuticals and its parent company, Johnson & Johnson, for offering kickbacks to state health officials to get the schizophrenia drug Risperdal on the approved list of medications paid for by the state.

A provision in the Obama healthcare reform act will require pharmaceutical companies and manufacturers of medical supplies to disclose all “payments of value” to physicians and medical professionals on a federal government website. This includes food, entertainment, gifts, travel, consulting fees, honoraria, research funding, stocks, conference funding, and royalties—anything in excess of $100 a year. Penalties for noncompliance can reach as high as $1 million.

Critics are concerned that the disclosure law won’t show context—some doctors, for example, might spend months studying the effects of the drug, but people visiting the website will assume that all such payments are payoffs, thus tarnishing the reputations of supposedly upright medical professionals. But how can one be truly independent if one takes money from a drug company? The disclosure provision merely attempts to bring greater transparency to the relationship without outlawing the practice altogether. The rule may also bring down healthcare costs if doctors stop recommending the more expensive drugs which are marketed so heavily.

50 Responses to “FDA’s Huge Conflicts of Interest with Big Pharma”

  1. Cindi says:

    As a smoker who has switched to an e-cigarette, I have seen the corruption first hand. The FDA recommended quit smoking pharma products don’t work for about 95% of people, yet when a new (non-pharma) product comes on the scene the FDA does nothing but set up road blocks and come out with a deliberately misleading study. E-cigarettes have been on the market in the US for about 5 years, with no major side effects reported. Compare that to the FDA approved quit smoking pill called Chantrix, which has been shown to lead to suicide. The FDA and major health organizations (who also just happen to have connections to pharma) repeatedly complain about the supposed lack of studies. Yet they have had 5 years to perform as many studies as they like, and have chosen not to.

       2 likes

  2. This is a beautiful article about the common family issues. My personal greif will be acrylic staining which has a hubby this is a auto mechanic, and Do-it-yourself enthusiast. Getting spots from garments is often a nightmare. Seems like your blog post is a great useful resource although and so i will be again quickly

       0 likes

  3. Kimberly Snow says:

    So who’s doing anything about this? Let’s stop whining about it and actually take action. Any links to petitions (I clicked one above but it says the server isn’t working). Any groups to join…any senators to send letter to? If someone could post that information it would be a lot more useful then just airing our grievances, which apparently for the most part everyone is in agreement on. Time for action folks.

       0 likes

  4. Cathy says:

    Thank you ANH you are doing great work and I commend you on it!! Keep going, the time for change is now. People do have the power but we need a leader.

       2 likes

  5. k.stoute says:

    occupy the FDA. Plain and simple
    The FDA & USDA no longer care about the American people. Please sign my petition and pass on to others if you agree with it
    http://www.change.org/petitions/its-time-for-us-to-take-back-the-constitutional-rights-that-our-founding-fathers

       2 likes

  6. Leticia says:

    Interesting timing. Is this why the Obama administration wants to make paying for birth control mandatory for businesses and insurance companies? Would that be a huge profit payout, I wonder? All of these feminists are up in arms over this issue and their right to take birth control when in reality they are up in arms over their “right” to poison themselves or get life-threatening blood clots with these chemicals. There are other forms of BC, should they be free as well?

       2 likes

  7. Charlotte Stubbs says:

    As a veteran who takes many medications I’d like to know WHERE my medications are being manufactured and why a specific medication is being prescribed. Many times I adjust to a medication only to have it changed to another that I can’t tolerate. WTF?.

       2 likes

    • chip d says:

      I am also a veteran and I have read that the VA buys it’s drugs from Canada even though some years back it was reported that it was illegal for american cit to get perscriptions in canada however a report of busloads of seniors went there with american perscriptions and were filled with much less cost and no problem.

         0 likes

    • Rich says:

      Charlotte, please look into safer, healthier options than Pharm DRUGS!! Chek out the book “OVER-THE-COUNTER NATURAL CURES

         0 likes

  8. Great article.
    The conspiracy FACTS- not “theories”- are exponentially being unveiled for all the world to see. Soon, We the People of Earth WILL prosecute ALL these guilty conspirators- along with their puppets- for their myriad crimes against Humanity.
    We must continue to share the Truth in this Informatio War, & even BECOME the system so we can more effectively reclaim our power. There are already many good People within the control structure that are fighting for us.
    Hillary Clinton recently said, “We’re in an information war, & we’re losing.” That’s the most honest thing I’ve ever her say, & a true sign of how far we have come.
    This is a beautiful, empowering time to be alive… to contribute to & experience this Great Awakeing of Humanity! We will soon know REAL Freedom, Peace, Prosperity & Progress!!!
    We must be vigilant… but we must also be patient. It didn’t get this bad overnight, & we can’t fix it overnight… but so long as we maintain Love & Truth on our side, VICTORY IS INEVITABLE!!!
    ON WITH THE R3V0|UTION*!*!*

       6 likes

  9. Dan Long says:

    As far as I can see, the major drug companies have enough capital to hire doctors instead of contracting them. If they want to avoid having to post their “contributions” to medical professionals, just hiring them would be cheaper than the malicious war taking place on female contraceptive practices that only serve to tear down the mandates of Obamacare.

       1 likes

  10. Dee says:

    Ummmm….Not surprised at all. It was A G Bayer that supplied the Nazi’s with
    lethal gas for their gas chambers. And to think they make aspirin for children,
    saying its an aspirin parents can TRUST!! Pathetic!!

    The war criminals are all working at big Pharma.

       3 likes

  11. Jean Leclair says:

    Oh! by the way this also goes to what goes into our food. Concerned citzen from Massachusetts

       4 likes

  12. Jean Leclair says:

    All these pharmaceuticals (or drug companies) are only out to make more money. They are just full of greed and don’t give a rats “a” about us. This also goes to the greed of the FDA and some doctors. I went through a serious operation 3 years ago this month and have not taking any treatments or perscriptions. Although it was offered, I did my research and have changed how I do with my life at this time. I have seen what has happen to my neighbor, friends and family that been through taking prescription drugs and treatments. They are only intersted in money, money and more. We need to have better monitoring of this situation.
    Keeping healthy without drugs. Thanks to people who care.

       4 likes

  13. Lawrence Jacksina says:

    Who’sinterests does the FDA protect? In the case of Yaz and Yasmin, it sounds as if Bayer is protected, but the public is not. SHAME!

       0 likes

  14. So what else is not new? These conflicts have even been reported in main stream peer reviewed medical journals in the past! Anyone with half a brain and an open mind can clearly see that the FDA is out of control. They are clearly doing what they (and the drug manufactureres) desire rather than protecting the public. In addition they are restricting our rights to natural foods (such as raw milk) and nutritional supplements, both of which are 1000’s of times less harmful than the drugs they approve every year. Until these laws and regulations are changed, so that the courageous attorneys, such as Jonathan Emord, can sue the people in charge individually, and not just the corporate FDA itself, nothing will change. When real people face jail time for what they are in charge of dictating the agency to do, they will think twice. So long as this ludicrous corporate veil says that a corportaion is able to be legally called a person, and so the real person in charge is not sued, we will continue to get nowhere. Just like the removal of our rights by the Patriot act, it is the LAWS which must be changed before we can win the battle against these corporations

       7 likes

  15. Maxine says:

    Thank you for the article.
    And now let’s also include the issue of President Obama’s broken campaign promise that he would require labeling of GM foods.
    Not only has he NOT required the labeling, the very first year he was in office he appointed former Monsanto vice-president Michael Taylor as Sr. Adviser to the FDA.
    It has become woefully clear that the FDA is not looking out for the public’s best interest and I’m wondering if it ever did.
    Here is one historical quote from a former head of the FDA, Dept. of Nutrition, Mr. Elmer M. Nelson:

    “It is wholly unscientific to state that a well-fed body is more able to resist disease than a less well-fed body.” “My overall opinion is that there hasn’t been enough experimentation to prove dietary deficiencies make one more susceptible to disease.”
    Elmer M. Nelson, M.D., head of FDA, Division of Nutrition
    October 26, 1949

    At that time, numerous brilliant doctors and researchers such as Dr. Max Gerson, Weston A. Price, Frances Pottenger, Abram Hoffer, and others had presented many studies and research, that nutrition had indeed a most powerful influence on a person’s susceptibility to disease. Most, and possibly all of the nutritional research, however, is still not indexed into the National Library of Medicine for public or professional access. Additionally, these doctors and scientists became blacklisted, ridiculed, threatened, and / or forced out of business by the AMA, Big Pharma, and the government.

    My question is, how long are we going to allow this to continue?

    I think we need to take some cues from the young people around the world and what they have done just this week to bring attention to KONY, the ruthless maniac who has been kidnapping children of Uganda for more than 20 years. His reign of terror is almost over because the young people of the world have made him “famous”.
    I think it’s time we made the FDA “famous”.
    We have the tools – we have all the information we need – and we have organizations like ANH. Let’s get started and do something out of the box, like the young people did.
    The FDA needs to be dissolved or at the very least, completely redesigned which would include firing everyone currently employed, establishing a new mission, vision, and laws prohibiting appointments and employment that would create a conflict of interest of any kind.
    After all, our tax dollars write their paychecks. We have more power than we think we do. The young people did it…

       4 likes

    • Pierre says:

      KONY was 10 years ago there is a propaganda from the US so they can attach Africa like they did for Syria, Lybia, Irak and others. You can check on Youtube there is video of people that are from Africa and they claim that happened 10 years ago and now life is good.

         0 likes

  16. Jacques Bakke says:

    Desperately need a change in the WH administration—Is it November yet?
    If we do not also change the Senate the country is headed for a Police State. We are all under assault and must aggressively confront all three branches of the gommmmment!

       2 likes

  17. Lou says:

    FDA’s Huge Conflicts of Interest with Big Pharma

    This should be obvious and incontestable to all who have observed this corrupt, criminal process for decades. Yes it is growing worse. But once we understand the flawed medical paradigm we are operating under our solution to all this medical mess is fairly simple. We can eliminate at least 99% of the big pharma drug use.

    Flawed Medical Paradigm

    1) Get sick
    2) Visit Big Medical
    3) Be Prescribed toxic Big Pharma Drug
    4) Get well

    Reality

    1) Eat toxic nutrition-less processed food, drink fluoride and sugar, get “vaccinated”, fail to live right
    2) Get sick
    3) Visit Big Medical
    4) Be Prescribed toxic Big Pharma Drug
    5) Drug at best addresses some symptoms and does not address basic life style problem
    6) Drug usually introduces NEW medical problems as it is toxic to our bodies
    7) Get sicker and repeat steps 3 – 6 until dead

    So unless you are in a car wreck et al it should be possible to almost totally eliminate big pharma from your life. The next step, one that I have taken, is unless we can find a human doctor who understands reality we must also eliminate Big Medical from our lives. This step is a little harder but not as hard as you may think. A doctor who does not understand the immense harm he is doing with these toxic drugs and lack of counseling on life style is not so hard to best.

       2 likes

  18. Richard says:

    The FDA should be investigated under the U.S. RICO laws (Racketering Influenced Corrupt Organiation). It is clearly a corrupt organization and the pharmaceutical industry is actively engaged in activities common to a criminal enterprise; bribery, witness intimidation by suppression of relevant data and excluding dissenting opinions, corruption of public officials and blantant conflict of interest in the decision making process. The FDA is also running a protection racket by suppressing the use of dietary supplements and imposing onerous penalties and regulation on supplement manufacturers in order to protect their real clients, the drug companies.

       4 likes

  19. Grace Adams says:

    Consumers might be better off with a wild woolly west of NO regulation at all–just buyer beware. Maybe some private sector vetting organization like Underwriters Laboratory or Good Housekeeping Magazine.

       0 likes

  20. jwillie6 says:

    It appears that the FDA is one of the most corrupt government agencies. It is bad enough that the government can not be trusted, but when medical scientists put money and self interest ahead of the truth and their honor, we have very few left to trust.

       0 likes

  21. bergen says:

    How true. It’s unreal that there are no rules to protect the public from such conflicts of interest. Corruption at it’s best. These are the same people that create the strict vaccination laws that our states have adding silly new vaccines, that are not deadly or that harmful, taking away rights from parents to make such decisions for our own children, forcing us to use those vaccines and drugs. Criminal and unconstitutional, all stemming from greed. And I thought we lived in a free democratic country, well beware.

       1 likes

  22. wvhillbilly says:

    Same old same old. It just gets worse and worse. The whole system is corrupt.

       1 likes

  23. John says:

    Thanks for continuing your work against the corruption in the medical industry. If it were not for the news letter, I would be completely clueless.

       2 likes

  24. Lori says:

    We allow huge companies like the pharmaceutical industry to get away with anything they want if it makes them money, whether it kills someone or not, but those same companies and the people who run them also have the clout to keep cannabis a class 1 drug. Oh, the hypocrisy of this nation! I thought the drug testing in the US was supposed to last ten years before a drug was released? Seems we have more drugs on the market that are detrimental to ones health than helpful.
    Keep up the good work in exposing these issues and problems! My only concern is that it doesn’t seem to make a difference. Capitalism is alive and well and is ruining this country!

       1 likes

  25. Helen Simonaitis says:

    So this maybe explains why my physician in an HMO is so obstinate when I report that the prescribed thyroid medication is not working, has many debilitating side effects, and leaves me worse off than before.
    He just does not listen, because he does not want to hear.
    It probably would get him in the bottom line to change the prescription. I will go to the site and try to determine if he or his company are paid to prescribe that very unsatisfactory drug when there are other drug choices available.

       1 likes

  26. john koller says:

    There should be a path to sue the insiders for fraud as well as the drug companies.

       0 likes

  27. Johann says:

    After reading this, maybe those men who are trying to deny women affordable care for things that affect only women are actually helping women.

       0 likes

  28. Gary Lampman says:

    The FDA is the Cheerleaders for Pharma and has sold out Americans to unnessary risks and deaths. It has been this relationship that has compromised the essance of this Agency. Furthermore , the same drug promoting figure heads have done their diligency to suppress drugs in this country that our neighboring Countries have used for decades but have pampered Pharma to help themselves.

    The Agency has clear conflicts of interests that fails to work in the best interests of Citizens.Instead, the FDA acts in the interests of Pharma in extending Patients far beyond the Date that Generics would be available to the Public. If investigated the FDA officials will find Prision as their first home.

       0 likes

  29. Ann Kelly says:

    My husband went on a trial of synthetic marijuana spray (inexpensive and approved in Europe and Canada) had relieved his pain from cancer treatment. Once the trial ended, a few weeks later his pain returned and all the drugs that were prescribed have had many problematic side effects and haven’t fully address his pain.

       0 likes

  30. carol reom says:

    This sounds like a license to kill , but not all, just some women

       0 likes

  31. carol reom says:

    This sounds like a license to kill ,but only some of the women. Here again feeling and associations rather than science are at the helm.

       0 likes

  32. Harish Dalal says:

    Can the opinion givers not be separated from fund receivers for any given drug?
    If a fund receiver does give a favorable opinion on a drug which turns out to be harmful, can his medical license not be revoked on the basis the person’s inability to make good medical judgement?

       1 likes

  33. Rett says:

    The world is corrupted by greed. We must pray for God’s Kingdom to come. Jesus is returning with power and with glory to rid this world of corrupt governments and false religions. May God have mercy on the sinful nation.

       0 likes

  34. Louise Esther Rothstein says:

    If Obama does prevent Big Pharma from manipulating doctors he will do great good.
    I only regret that he has allowed that behavior to infest the medical profession for so long.
    Phewww…
    I hope he can stop it.

       1 likes

  35. Stanley Foodim says:

    It is long overdo that members of the FDA disclose their relationship with drug companies and to withdraw from any evaluations of drugs from those companies.

       1 likes

  36. annie steele says:

    This is very sad. What is this oath that doctors are all suppose
    to takeabout “doing no harm”.
    Where has that gone? Some where there is a statement :
    Let your food be your medicine”.
    It is also confusing, we put elderly farmers in jail and
    harass them for selling raw milk and doctors who kill for money
    sail away on their Cruiser. There is something very wrong with this
    picture. The doctors who try to do right are not allowed to
    practice according to heart and knowledge, they take away their
    license. How can the next generation be healthy and learn
    to have any kind of values and honor if it is not practiced in front
    of them

       1 likes

  37. shorebird says:

    Absolutely on target!
    There can be no true science without independent analysis.

    This is no longer occurring,as Big Pharma controls almost all clinical trials, and they manipulate their outcomes and results by ditching the bad results.

    We are all potential guinea pigs to whatever Big Pharma decides to shove on unsuspecting Americans…greed, graft and corruption abounds as this unsustainable and high cost system gradually crumbles under its own weight. It needs far greater exposure to crumble even faster.

       0 likes

  38. Paula Landua says:

    Like myself, I hear more and more folks say they refused meds from their doctor because they are afraid of the new drugs being approved that are bad. My doctor is an older doctor and he actually told me on my last visit that he has gone back to some of the older drugs because so many on the market today damage other organs or cause other related problems that may not be reversable, but must also be treated and he doesn’t like what is happening in the medical field in today’s world. To date I have refused to take three different drugs that another younger doctor wanted to give me. Those drugs are now being reported as causing deaths and much irreversable health problems.

       0 likes

  39. Suzanne says:

    The FDA needs to be strongly reigned in about a lot of things especially trying to disallow supplements, attempting to force vaccines; approving drugs and vaccines without much long-range testing, not allowing the truth to be told about food as medicine.

       1 likes

  40. Glenn Ross says:

    YES I AM ANGRY, HOW DUMB ARE YOU PEOPLE? THIS IS SO BLATANT, WHO IS RUNNING THE FDA? THEY SHOULD BE FIRED TODAY! AND SUED FOR ALL THE PEOPLE THAT WERE HURT!

    YES I AM VERY ANGRY, YOU’RE ACTING LIKE ELEMENTARY SCHOOL CHILDREN, YOU SHOULD ALL BE FIRED! AND LOSE ALL OF YOUR GOVERNMENT BENEFITS, AND GO TO JAIL THIS IS GODDAMNED CRMINIAL!

    WOULD YOU FEED YOUR FAMILY THESE DRUGS?

       0 likes

  41. Terri Lynn Sullivan says:

    what an amazing article. Good job spreading awareness…..more people need to know the correlation between FDA “approval of drugs”, and big pharma big profits….it’s the same with so many kids “diagnosed” with fictional behavioral “disorders” and Doctor’s so quick to put those healthy, well balanced, normal kids on ADHD meds or otherwise. BTW, Love the pic of FDA/money…..could I have special permission to use the photo from your website for an article I am writing on the FDA-over proliferation of drugs crusade this industry is subjecting Americans to? thanks again

       0 likes

  42. joe says:

    it just never ends Dr. Ron Paul would have none of this just ask him

       3 likes

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