Is FDA About to Greenlight a Drug Banned in Other Countries?

June 11, 2013
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warning-fda-approvedIf enough people raise their voices in protest, we can prevent it. Action Alert!

Remember the controversial diabetes drug Avandia? In 2010 we told you about two FDA drug safety reviewers who warned the agency that Avandia posed serious risks of heart attack and heart failure when compared with other diabetes drugs. Since then, the drug has been removed from the market in most countries and has been under severe restrictions in the US.

Last Thursday, in a combined meeting of separate FDA advisory committees, 20 of 26 panelists voted to recommend removing or modifying Avandia’s highly restrictive label and distribution system. Five voted to keep the restrictions in place, while one panelist voted to remove the product from the market altogether.

There has been only one large, randomized trial for the safety of rosiglitazone, the drug that is marketed as Avandia. That trial—sponsored by GlaxoSmithKline (GSK), the drug’s manufacturer—was called RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes). Serious flaws were found in RECORD’s methodology, its results were questioned, and the trial was widely discredited.

In 2010, FDA required GSK’s RECORD results to be reexamined and re-adjudicated. What was the FDA’s motivation for reviewing Avandia? GSK didn’t request that the drug be reviewed. Could it be, as Steve Nissen suggests in Forbes, because FDA “is seeking to avoid accountability for its role in the Avandia tragedy”? FDA’s official position is that they asked for the re-adjudication because of “the public interest in Avandia, the extensive history of the product, and the continued uncertainty of the risk surrounding this drug.”

Duke University’s Clinical Research Institute (DCRI) was selected for the re-adjudication, and they found that the risk for cardiovascular death, myocardial infarction (MI), and stroke to be virtually the same as the original study concluded. Because these new results reaffirmed GSK’s findings that the drug was no more unsafe than other diabetes products in its class, Thursday’s panelists were sufficiently reassured that the drug was safe enough to lift restrictions.

Unfortunately, other data paint a very different picture:

  • In 2005 and 2006 GSK secretly conducted an analysis of cardiovascular safety of Avandia, and concluded that the drug increased the risk of heart attacks and related events by 30%. Since two-thirds of diabetics eventually die of cardiovascular complications anyway, this 30% hike is terrifying.
  • In 2006 GSK informed the FDA’s Center for Drug Evaluation and Research (CDER) of the secret analysis, but FDA and CDER agreed to conceal this hazard from patients and practitioners.
  • During a public hearing, independent FDA statisticians reported an 80% increased risk of heart attack. Avandia is estimated to have caused 83,000 heart attacks in the United States alone.
  • Adverse effects caused by the drug are currently the subject of over 13,000 lawsuits against GSK. As of July 2010, GSK has agreed to settlements on more than 11,500 of these suits.
  • Last year, GSK pled guilty of criminal conduct, partially for concealing the hazards of Avandia. The company paid a $3 billion fine—the largest in US history.

In addition, the re-adjudication process itself was biased. GSK prepared the study materials before submitting them to Duke for analysis, rather than allowing the university to review the raw data. (On the widespread problem of publication bias, see our article in this issue.)

On top of that, key members of the 2010 advisory committee that decided to place restrictions on Avandia in the first place were not part of the 2013 meeting. Of the twenty-seven member panel, fourteen of the experts were on the panel last time, and they were the people with a more favorable attitude toward Avandia. This is in contrast to the other experts who did not serve on the panel a second time—like Steven Nissen, who was one of the most outspoken critics on the panel. FDA claims all panelists were invited, it does not appear they made a huge effort to ensure their participation; Nissen says he was not re-invited. With all of the big nay-sayers out of the picture, it’s no surprise the panel voted to lift the restrictions on this dangerous drug.

FDA should focus more on advisory panelists who have true conflicts of interest. A 2007 law placed caps on the number of waivers that could be granted allowing experts with conflicts of interest; a 2012 law removed those safeguards. When there are no restrictions on experts with conflicts of interest serving on FDA advisory panels, more drugs with dangerous side effects could certainly enter the market.

Action Alert! The FDA is not obligated to follow its advisory committee’s recommendation, though they usually do so. Moreover, there is no regulatory deadline by which they have to make a decision. If there is enough public pressure, perhaps this will force the FDA to reject the advisory committee’s decision on Avandia—or at least postpone any action indefinitely. Please send your message to the FDA about the dangers of Avandia!

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26 Responses to “Is FDA About to Greenlight a Drug Banned in Other Countries?”

  1. Sharon Al-Haddad says:

    We are a nation of sheep. Most people have no idea of what is happening at the govenment level nor do they pay attention when others try to tell them. Conspiracy theories
    are so abundant that many others are sceptical of what to believe and so discount everything. And some, such as I
    once was, just find it hard to believe that our government would do these things. Once I believed the misinformation about the cannibus plant. Now I know its many benefits for human health and the environment, when used responsibly. The US government holds a patent on cannibus that states its multiple usefulness, yet the DEA
    still maintains it is a dangerous drug.

       0 likes

  2. Barb Wills says:

    I find it encouraging to hear so many like-minded people speak out – which is exactly what we need to continually do. We need to speak out to any and all government officials, friends neighbors, co-workers – anyone who will listen and join us. This is the only way we will regain “of, by and for the people”. I just watched an interview with Jeffrey Smith and a wonderful scientist. She gave all the factual, scientific data connecting GMOs to so many of (most all) the diseases we have today.

    Just continue to speak out everyone!

       0 likes

  3. Dee says:

    What WE the people are forgetting, is that WE the people hold the power.

    Don’t buy or use these drugs/GMO’s. Slam your wallets shut. That’s the only way
    to get through to these idiots.

    They can’t exist without WE the people!!

       4 likes

  4. Les says:

    60% combined risk for heart attacks? Does the FDA simply want to kill of diabetics?

    The FDA and CDER agreed to conceal this hazard from patients and practitioners? Again, I must ask, does the FDA simply want to kill off diabetics?

    Despite GSK’s wrong doing, and fines paid, this panel wants to subject diabetics to the drug. Congress should order a fine combing of their personal financial records, because they either are getting a payoff from GSK, or…they simply want to kill off diabetics.

    Apparently Europeans are not anxious to kill off their diabetics. They banned Avandia a long time ago.

    Maybe the Administration realizes the future costs of diabetics on the over burdened healthcare system, and they have partnered with GSK to lower the risks.

    If JJ Abrams made a movie out of this, we’d think it was way too far fetched…

       4 likes

  5. Martin M & Mary L Tabatcher says:

    Why is the FDA so friendly to the pharmaceutical companies and not to average Americans? It seems to us that if there is ANY DOUBT whatsoever about the safety of a drug, it should not be approved until the companies involved PROVE its safety and effectiveness. Is the FDA saying that European agencies are stupid, or is the FDA saying that, “yes, we know the drug is dangerous, but it is more important to protect company profits than protect the health and safety of Americans?”

       20 likes

  6. JOAN RUSSAK says:

    Enough is enough. We do not need to go thru another pregnant mom scare like Thalidomide or worse.

       3 likes

    • Scott B says:

      What you’re calling a “scare” is just business as usual for the big pharmaceutical corporations. They know if they throw enough of anything at a wall some of it will stick. A sufficiently large fine (for killing people, mind you–no corporation gets the death penalty for what amounts to premeditated murder, however much our warped legal system may grant them “personhood”) simply means they become desperate to sell more questionable drugs to make up the difference in the projected “cost of doing business.”

      As for the FDA (part of their acronym stands for “food,” remember, the real question is why they can’t pin down which FOODs are causing the skyrocketing statistics in adult onset diabetes which, like autism and Alzheimer’s, was virtually unheard of when I was growing up in the 50s and 60s. Between the FDA and the CDC you’d think they’d have a suspect or two in hand by now. Unless you stopped to consider who funds them.

      And speaking of things unheard of when I was a kid, I remember when nearly every neighborhood had a fat kid (it was the Dark Ages of political correctness, we used words like “fat” and “stupid” to describe certain physical and mental conditions). Nowadays it seems nearly every neighborhood is lucky if it has a skinny kid. In other words it would be unheard of to live in a neighborhood or go to a school where being overweight was not pretty much an accepted norm. In fact, it would surprise no one if Social Services didn’t show up at the skinny kid’s house to determine if the parents weren’t starving their children. Imagine if they found only whole grains, organic vegetables and fruit, range-grown animal products, natural sweeteners–but no Pop Tarts, frosted flakes, sodas, Spaghettios, cake mixes, Kraft mac & cheese, bleached table salt, hot dogs and luncheon “meats, bleached white bread, corn syrup, sugar, MSG or canola cooking oil? That the kids didn’t get vaccinated, take behavioral drugs, or brush, gargle and rinse with fluoride? Talk about living in the Dark Ages!

      Then again, might be something in there for the FDA and CDC to look into, in their never-ending search for the cures for diabetes, autism, breast cancer, ADD, and a host of maladies people didn’t used to hear much about.

         3 likes

  7. Frances says:

    Would it surprise anyone if they did approve it. The FDA (federal death agency) only cares about the companies, NOT the people they harm. Remember that the doctor may right the prescription, it is up to you if you fill it and use it. Be informed and there is nothing wrong in telling a doctor you will not use a certain drug. If the doctor does not respect your wishes, and insist you take a drug that can do you really bad harm, it is time to find another doctor.

       10 likes

  8. T. J. Irving says:

    This report is horrifying and the facts portray these, so called, expert panellists as some sort of zombies with the same thought processed individuals. I presume they make their decisions on the facts presented and then decide to send millions of people to their deaths. Are they the same category of “expert” who decide that vitamin and mineral supplements are “dangerous” and should be heavily restricted?
    I hope to Goodness I never have to resort to medical treatment to try to maintain health because I fear it will amount to a death sentence.

       5 likes

  9. Faye Nieuwendorp says:

    silly FDA–just show them (fda)the money and no more danger.

       2 likes

  10. Caren Grabinsky says:

    I have friends who are diabetic. I am concerned for their safety. This drug is BANNED in other countries, and definitely needs further investigation before approving Avandia.

    Please take heed and do not rush this through.

    Thank you, Caren Grabinsky

       3 likes

  11. Kevin Lawrence says:

    Congress needs to stop this type of criminal behavior at the FDA and CDER.

       6 likes

  12. americanuser says:

    What IS this? are all g’ment agencies conspiring against the American public? If it’s not one it’s another and each seem to be doing the exact opposite of what we elected them to do. I really don’t think we should worry about terrorists thousands of miles away, I think we should begin to worry about our domestic terrorists.. The United States Government. The FDA has turned into a militant group, intent on spreading their idea of what this nation should be and their God? Money of course.

       5 likes

  13. Nicolo Oggiano says:

    Be nice and great if FDA would notice what is going on in other markets.Several countries have decided against GMO crops .The USA has allowed them.No wonder there are so many allergiesto foods and other health complications in this country.

       7 likes

  14. MareCadTITANIC says:

    Get rid of the fda & this drug !!!

       5 likes

  15. Judith Mitchell says:

    My husband is diabetic and it is good to learn about what he ought NOT to take. I am forwarding this article to him in case his doctor recommends AVANDIA. What a disgraceful, murderous, scam.

       4 likes

  16. Craig Garcia says:

    Poisoning Americans for economic gain!

       4 likes

  17. John G. Valenti says:

    “Last year, GSK pled guilty of criminal conduct, partially for concealing the hazards of Avandia. The company paid a $3 billion fine—the largest in US history.” Quoted from the above article. My question is: who gets that 3 billion dollars? I hope it is the survivors of those heart attacks or the families of those who did not survive. Thanks.

       5 likes

  18. The FDA needs to sued along with GSK,

       4 likes

  19. J. Covey says:

    Oppose approval of drugs that pose more harm than benefits.

       4 likes

  20. Patricia Reed says:

    We need less harmful drugs and more prevention of health problems.

       5 likes

  21. Janet Tice says:

    I find it alarming and very sad that America is falling so far behind other countries in health, drugs, and accepting science over profits.

    Avandia is a dangerous, unproven drug and should be treated as such.

       2 likes

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