Won’t get fooled again? GlaxoSmithKline and access to data

November, 19, 2012 | 11 Comments

Comments

  1. Yes I believe you’re right there appears to be an effort to discount the FDA’s Black Box Warning for suicide on SSRIs. The AACAP is also doing it. The fact of the matter is here in the US there is an effort to not do the right or ethical thing for kids in general and in particular for kids who are State wards. It is as if the kids are a commodity, a source of revenue, and a pool of drug trial participants, etc.

  2. Nothing that Cochrane groups may in future do in relation to calls for access to trial data, can undo the vast harm they have already doneover (in alliance with ‘evidence-based medicine’) to propagandize and hammer-home so many ignorant and false ideas about the nature of randomized trials.

    In particular the Chchranes outrageous idea that large randomized mega-trails are intrinsically the best form of evidence concering drug effectiveness – which in practice has led to the nonsense that randomized trials are the only authoritative form of evidence concerning drug effectiveness.

  3. If you are startlingly intelligent like you are, and like I am, then there is not a chance that Sir Andrew Witty will last the course.

    I said before, I like analogies, and Sir Andy is way beyond what Sir Savile did with his own particular form of abuse. Sir Jim has now over 450 cases of abuse directed at him. He is now publicly pilloried and deried as one of the worst abusers of children this country has ever entertained.

    Sir Andy has thousands of cases of abuse from Seroxat/Paxil directed at him regarding children and adults. So what about a trial and get all the thousands who murdered themselves, their friends, their relatives, total strangers, and put Andy in the courtroom, where he has not yet appeared, in the UK.

    And let him answer the billion dollar question ‘does Seroxat cause suicide, self-harm, anger, aggression, and destruction of the will to live?’

    He will look pained, he will say, ‘Glaxo have overcome a $3 billion fine in the US, but it will not happen in the UK. We are transparent, we are cool, we are the good guys and even the drug regulators think we are the good guys.

  4. You can bet that GSK won’t grant access for patient advocates, bloggers, or lawyers! This nonsense about GSK transparency is simply untrue- the transparency is policed by GSK- therefore it’s hardly a humanitarian act on their part…

    Seems like a load of hot air to me! Makes for good PR sound bites- but in reality a bit of a damp squib …

    Rather like Glaxo’s offer of access to the MHRA in regards to the Seroxat criminal investigation some years ago. (which of course ended in no charges against GSK)

    Jean-Pierre Garnier (the former CEO of GSK) was asked my James Naughtie on BBC radio “:

    “Does this mean that all the information GSK holds on the development of Seroxat will be put in the public domain?”

    . This comprised “millions of documents, millions”, Garnier countered, “this has to be orchestrated, organized and the requests have to be specific”.

    How can the regulators, scientists or whomever needs the information, know what to ask for?

    http://seroxatsecrets.wordpress.com/2008/05/20/jp-garnier-does-what-gsk-other-employees-did-simply-refuses-to-answer-questions-about-seroxat/

  5. The transparency claim by Glaxo is nothing new. They did the same after the Spitzer settlement. Glaxo have been forced to open their doors, probably as part of their recent agreement with the Department of Justice in the States.

    Here we have a company who, at every given opportunity, like to cover themselves in garlands – they even attempt it when they are wrong – see recent excuses for their record fine.

    I’m convinced a deal was struck with the DOJ. The trial was kept under wraps for 10 years – so, we had 10 years of poor drugs being given to patients, all the time the DOJ kept quiet.

    Even more bizarre is the fact that this case had been kept sealed for 10 years during which time Eric Holder, Attorney General of the United States, became involved. Here’s where things start to get confusing and one could shout ‘conspiracy’ if they so wished but if you follow the trail you start to make sense of things a little better.

    You see Holder’s involvement in this case, some would say, stinks of something acrid, particularly when you join the dots and learn that he was once a defence attorney for Covington Burling… the very same law firm that represented Glaxo in the recent whistleblower action.

    You confused?

    What role did the US Attorney General Eric Holder play in all of this? It’s a fair enough question, given his background. No accusations here, just questions. I’ll leave US politics to those who understand the mechanics of it all.

    I wrote about this back in October, here – http://fiddaman.blogspot.co.nz/2012/10/glaxos-murky-transparency-claim.html

  6. Meant to say ..

    Excellent blog post Dr Healy,

    It is quite remarkable how the BMJ, and other media outlets, fail to see the ironies of this dafa-access situation. As you have very clearly pointed out- this is quite the coup for GSK… and whilst it provides the illusion of access (it will remain strictly under the control of GSK in regards to who gets too see the data). It also potentially shuts down the other avenues which were finally beginning to open up for independent academics – such as Goetsche’s successful appeal through the European Ombudsman..

    The devil’s in the details…
    Great insight and analysis into this data-debate Dr. Healy

    I hope that your blog is being widely read!
    It’s excellent.

    :)

  7. Since 1997, EMA is talking about transparency.
    In november 2010, I have asked EMA for some raw data about a product approved on one clinical trial which I think was biased. (I had already sent a short paper to EMA about my doubts on this trial in 2009)
    I did not get the data and lodged a complaint with the European ombudsman in April 2011. (0693/2011/(ELB)RA)
    Unfortunately, EMA “could not retrieve the document from the archives”
    I finally decided to published my doubts : http://www.la-press.com/redirect_file.php?fileId=4504&filename=Approved-Beta-Interferons-in-Relapsing-Remitting-Multiple-Sclerosis_Odd_One_Out2&fileType=pdf

    4 of the speakers of tomorrow EMA workshop are aware of this case of unsuccessful data request.
    Let us hope that in a few hours workshop, they will fix a 15-year long problem

  8. Another example of what you often write about:

    “Roche Pharmaceuticals, manufacturer of Tamiflu (oseltamivir phosphate) – marketed as ‘a prescription drug…an oral antiviral treatment (not a vaccine!) for influenza, belong(ing) to a class of medicines called neuraminidase inhibitors (NAI) ostensibly designed to be active against all clinically relevant influenza virus strains…proven to be effective in the treatment and for the prevention of influenza in adults and in children 1 year and older’, are currently facing intense scrutiny in Medical circles, for deliberately withholding primary Clinical Trial data on Tamiflu. Under pressure from a UK Government led commission investigating the safety & efficacy of neuraminidase inhibitors, the British Medical Journal (BMJ), backed by the Cochrane Collaboration (a non-profit international organization comprised of the world’s leading Medical researchers & practitioners) have jointly accused Roche of deliberately withholding the majority of “full study reports” pertaining to the anti-viral drug Tamiflu, including suppressing potentially damning evidence of adverse side effects.

    “8 of the 10 RCT’s (randomized controlled trials), on which effectivcness claims (of Tamiflu) were based, were never published, and the only 2 that had been published were funded by Roche and authored by Roche employees and Roche-paid external experts…The Cochrane reviewers now know that there are at least 123 trials of Tamilfu and that the majority (60%) of patient data from Roche Phase 3 completed treatment trials remains unpublished. There are concerns on a number of fronts: the likely overstating of effectiveness and the apparent under-reporting of potentially serious adverse effects.”

    http://vaccineresistancemovement.org/?page_id=11240

  9. Robert Gibbons has been well rewarded, at least. After thirty years at UIC, he is movin’ on up … In November of 2010, he and his entire “Center for Health Statistics” moved to the University of Chicago, Pritzker School of Medicine. In March 2011 Greenhouse and Sharon-Lise Normand joined the Center. And a month later Gibbons was named a Pritzker Scholar for 2011. What’s that, you ask?

    “The Pritzker family of Chicago, widely known philanthropists whose many business ventures include the Hyatt Hotel chain, made a gift of $30 million to the University of Chicago in 2002. The gift has been used to recruit outstanding new faculty to the Biological Sciences Division of The Pritzker School of Medicine. These Pritzker scholars form uniquely synergistic and powerful groups of investigators. To date, there have been 18 Pritzker Scholars.”

    You won’t be too surprised to learn that a lot of the Pritzker family capital is tied up in pharma and biotech these days. Or that family spokesperson Penny Pritzker was and is Obama’s top fundraiser. The relationship between Pharma and both parties remains pretty “synergistic and powerful.”

    Lately Gibbons has coauthored several articles casting doubt on the link between leukotriene-modifying asthma medications (like Singulair) and suicide:

    http://www.ncbi.nlm.nih.gov/pubmed/21663330
    http://www.ncbi.nlm.nih.gov/pubmed/22698520
    http://www.ncbi.nlm.nih.gov/pubmed/2204610

    The first one includes a bit of finagling crude enough for even me to catch: It examines reports “between 1995 and 2010” although 96% of these reports came in the past two years! (It also claims both asthma and allergic rhinitis are themselves “associated with suicide” which is news to me.) The last one speculates that these meds may even lower suicide rates. Keep a close watch on your children, folks, and when they sneeze … Ask Your Doctor.

  10. Colour me cynical but even if the doors are thrown open to inspection of the raw data, there is no guarantee that what will be revealed actually shows the real problem. Having been a whistleblower I know this intimately. The situation was that the raw data, on paper could have been viewed by anyone and nothing untoward seen. The real problem was that the study involved extensive psychological testing that had been performed while the building was undergoing construction with hammering, circular saws, nail guns going off constantly. This, of course, invalidated all of the data obtained under such conditions. So, even if it seems to be transparent, I’d be more than reluctant to accept any of it. Even NIH studies conducted with objective oversight teams can’t guarantee that the “oversight” will be constant. If it were, I’d be more inclined to accept that what you see is was what was obtained.

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