the one to get behind…

Posted on Monday 30 September 2013

by David Healy
September 29, 2013

Two years ago, the European Ombudsman ruled that the European Medicines Agency should open up access to Clinical Trial Data for anyone who applied from anywhere in the world. Six months ago two US pharmaceutical companies AbbVie and InterMune took a legal action against EMA that has closed down access to all trial data for all drugs for all doctors and researchers anywhere in the world. Most people have not heard of AbbVie. Until recently they were Abbott Laboratories, one of the biggest pharmaceutical companies in the world. They make Humira, a monoclonal antibody used for Rheumatoid Arthritis, Crohn’s Disease, Psoriasis and other conditions. It is the best selling drug in the world today, and projected to be the best selling drug of all time.

This is one of the most important legal actions in Healthcare ever. At a recent meeting in Bruxelles AbbVie made it clear that a main reason to keep clinical trial data confidential was to hide adverse event data, although there may be other issues like a Trade War with China. You can read about this and see the whole video here. Essentially AbbVie are asking the Courts to grant their Corporation the privacy rights of an individual – a very powerful wealthy individual.  If this legal action succeeds Adverse Event data will be hidden forever. Hence RxISK launched a petition calling on Richard Gonzalez, the CEO of AbbVie to drop his legal action against the EMA’s policy of open access to clinical trial data. The petition is here or in other languages from Spanish to Chinese on Rxisk here.

This petition is as much for anyone who may be prescribed drugs as for those prescribing them – so we are hoping to spread word about it generally. We are trying to get every country in the world to sign. We have 75 of the 180 countries in the world signed up but would love to have all. We only have 3 weeks to get this done. All help would really be appreciated.

No single example comes close to making what’s awry right now so clear as the suit by AbbVie and InterMune. They are shutting down the European Medicines Agency’s policy for drug transparency for no reason other than to hide the downside of their drug, Humira. The irony is that the people who take this drug know they are playing with fire, but their conditions are such that many are willing to take the risk. They need to know exactly what they’re facing. These companies want to increase their profit margins by hiding the magnitude of that risk, and the fact that they’re blocking the most important reform program in medicine so far this century is apparently immaterial. If you’re ever going to sign a petition or send a plea to your email list, this is the one to get behind…

And it’s not lost on us that the House Republicans are about to shut down the US government over two issues – Affordable Healthcare and a tax on medical devices [speaking of priorities]…
    September 30, 2013 | 10:03 AM

    Thanks for doing this Dr. Mickey! And for fellow blog-fans, if you missed that link it’s here:

    This is about our right to know the facts on all drugs, of course. Peter Gotzsche has been on a quest to get all the clinical trial data on duloxetine (Cymbalta for depression or Yentreve for bladder control). The shutdown triggered by AbbVie’s suit has blocked his access to the last few studies. And that’s important: apparently he’s figured out that the rate of suicide attempts was doubled on duloxetine, even for middle-aged women taking it to control bladder problems! Lord only knows what else is hidden …

    But as for AbbVie’s Humira and other TNF-blockers: I only wish its use was confined to people with devastating conditions who were taking these drugs with full knowledge of the risks. AbbVie and Pfizer (Enbrel) have both been aggressively campaigning to get these drugs prescribed for psoriasis — and targeting women whose psoriasis is embarrassing and frustrating but hardly a disability! To see how gross this gets, take a look at AbbVie’s latest ad which positions this VERY hazardous drug as a beauty product:

    That’s the world AbbVie wants. Need I say more?

    Nick Stuart
    September 30, 2013 | 10:53 AM

    Oh my Lord. These people are criminals. Pure and simple.

    Nick Stuart
    September 30, 2013 | 11:04 AM

    Actually..thinking about it…. ‘pure’ and ‘simple’ are probably not apt metaphors to use when describing this kind of behaviour…

    September 30, 2013 | 1:41 PM

    AllTrials and RIAT are not identical but they seem allied. I do wish that RxISK and AllTrials were playing nicer with each other. Does RxISK reference AllTrials at all? Is AllTrials highlighting RxISK’s petition? They do not have to entirely agree on all points, but if they do make sufficient common cause that would seem ill-advised.

    Jan Crouch
    September 30, 2013 | 4:44 PM

    Thank you David for doing this I have brought it to the attention of as many people I can think of. We all have a RIGHT to know the true outcome of drug trials. It seems to me that the pharmaceutical companies are a law unto their selves, and yes put profit before people, I really do not know how they sleep at night. Yes, and I would call them criminals, it is about time that they were exposed to what they truly are. We must not ever give up campaigning for transparency..

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