Brand Fascism

April, 30, 2013 | 6 Comments


  1. Hi David. Terrific, thought-provoking article. I’m interested in the points you make in (8) Propaganda 101: How do the Pharma spinners turn criticism to their advantage? Any recommended reading where I can learn more about this?
    Also, I thought the Milgram reference was most appropriate. This is precisely the response exhibited by most patients when receiving ‘advice’ from their medical practitioner. If a drug is offered, it is accepted.
    I laughed at the Vatican/Eli Lily comparison. The difference would seem to be that the Cardinals believe they have some higher authority looking over their shoulder, and Big Pharma knows that they don’t. Yet.
    All the best

  2. “We live in a Benevolent Fascism”. You are so right Dr Healy- we in the west cannot see the enemy. Your perceptive comment reminded me immediately of the letter Aldous Huxley wrote to George Orwell in 1949, soon after 1984 was published, in which Huxley argued that his imagined totalitarian future of Soma and consumerism would win out over the “boot in face” totalitarianism of Orwell. And it surely has done just that.

  3. “Anyone who has tackled pharmaceutical companies on the one hand or Dan Brown’s Angel and Demon Vatican, knows that the Vatican is kids play compared to Eli Lilly or Pfizer.” A June 14-15 conference, hosted by the Vatican,will examine the evidence for (and against) the rise of psychiatric medication and fall of psychosocial treatment for children. Does this strike anyone as a bizarre location for the discussion of what can only be described as a form of abuse of children? If we do live under Benevolent Fascism (an oxymoron if ever there was) it is perhaps fitting that the conference is being held in the land of Mussolini. Not politically correct, I know, but then I consider “political correctness” as an oxymoron too.

  4. A few hours after the last sentence in this blog was posted, Guido Rasi of EMA sent this email notifying people of a suspension of EMA’s access to clinical trial data provisions.

    ———- Forwarded message ———-
    From: Rasi Guido
    Date: 30 April 2013 12:55
    Subject: Update on EU Court interim measures decision in AbbVie and InterMune court cases
    Cc: Eichler Hans-Georg , Jablonski Tomasz , Rampal Olmedo Nathalie , Spina Alessandro , Harvey Allchurch Martin

    Dear friends and colleagues

    I write to update you on developments in the Court cases concerning the Agency’s access to documents cases.

    The President of the General Court signed interim relief orders on Friday 25 April 2013 that prevent the Agency from providing access to documents requested in the AbbVie (T-44/13) and InterMune (T-73/13) cases.
    In making the ruling, the Court has taken into account that it is the first time that the Agency’s policy is being legally challenged and that it raises difficult issues that could not be ruled on in the context of an interim ruling. As such it decided to maintain the ‘status quo’ that existed prior to our implementation of the 2010 policy.

    I am naturally disappointed by the ruling and I have asked my Legal Service to consider the possibility to appeal the interim ruling.

    I will issue a public statement on the Court rulings at 13:30 London time today, but wanted to inform you of this in advance.

    As part of the process of drafting our planned policy on proactive publication of clinical trial data, we will also publish later this afternoon (14:30 London time) the final advice from the five advisory groups which were formed to inform the Agency on specific aspects to the policy, together with a short news story.

    Finally, while we have no immediate plans to release the information, I would also like to ask whether your organisation would give permission for us to name you as having given support to us in this endeavour.
    If you are happy for us to do so, could you please contact Martin Harvey ( to let us know.

    Thank you again for your support.

    Kind regards

    Guido Rasi
    Executive Director
    European Medicines Agency
    7 Westferry Circus, Canary Wharf
    London E14 4HB
    United Kingdom
    Tel. +44 (0)20 7418 8406
    Fax +44 (0)20 7418 8409

  5. Toby Tyler Watson commenting on Facebook wrote:

    “I had Mental Health America threaten to sue me for indicating they would not attend a seminar to discuss the problems of medicating young children with SSRIs. They said by saying they would not come, it lent credibility to my claim that SSRIs posed an increasing danger to them. oh how the times have begun to change….Dr. Oz.”

  6. See Jim Murray on

    Pharma vs The European Medicines Agency – the case of InterMune

    Like AbbVie, described in my last post, a second American company, InterMune, has taken legal action to prevent or restrict the European Medicines Agency from disclosing certain clinical trial data after a medicine is approved for marketing.

    On 4th March a federal appeals court upheld the conviction of the former chief executive of InterMune, W. Scott Harkonen, relating to the dissemination of false and misleading statements about the results of a clinical trial of the medicine Actimmune. (Mr Harkonen may launch further appeals.)

    According to an earlier statement from the FBI:
    “Evidence at trial further showed that Harkonen caused InterMune to issue a false and misleading press release publicly announcing the results of a clinical trial of Actimmune for the treatment of IPF on Aug. 28, 2002. Although the clinical trial had failed, InterMune’s press release falsely stated that the results of the clinical trial established that Actimmune helped IPF patients live longer. The headline of the press release read, “InterMune Announces Phase III Data Demonstrating Survival Benefit of Actimmune in IPF,” with the subheading “Reduces Mortality by 70% in Patients with Mild to Moderate Disease.”

    In 2006, the company itself had reached a Deferred Prosecution Agreement with the Department of Justice and agreed to paid fines and penalties of $36 million. One clause in the agreement states that it “does not provide any protection to any former employee of InterMune”. Mr Harkonen had left the company in 2003.

    Actimmune was promoted as treatment for idiopathic pulmonary fibrosis (IPF), a rare but fatal disease. Treatment cost around $50,000 per annum, generating revenue of over $100 million, mostly for treatment of IPF. (Doctors may prescribe but companies may not promote medicines for uses for which they have not received an authorisation. )

    In so far as the offending press release had a basis it seems to have come from the selective use of the data from a clinical trial labelled GIPF-001 – a practice sometimes known as data mining or data dredging. From the beginning, there were some sceptical voices about the company’s claims and in January 2004 an article in the New England Journal of Medicine concluded that Actimmune “did not affect progression-free survival, pulmonary function, or the quality of life”.

    Another case for timely and full disclosure.

    On the indictment of Mr Harkonen, Intermune issued a press release, of which this is an extract:
    “Since 2004, InterMune has been a transformed company with a new management team, a rigorous compliance program and a promising pipeline focused on serious pulmonary and hepatic diseases.”

    Still, it’s a pity that the earlier experiences of InterMune and AbbVie/Abbott have not convinced them of the merits of more transparency on the part of the European Medicines Agency… END

    Pharma vs the European Medicines Agency- the case of AbbVie(Abbott)

    Posted by jim on 01/05/13

    Two American pharmaceutical companies, AbbVie and Intermune, have taken legal action to prevent or restrict the European Medicines Agency from disclosing certain clinical trial data after a medicine is approved for marketing.

    In my opinion, both companies have been involved in activities that seem to prove the need for more transparency and not less.

    AbbVie is a new company founded to carry on the work of most of the former medicines division of Abbott Laboratories. This was not a third party takeover, but a split of one company into two separate entities. AbbVie is basically the old medicines division of Abbott and therefore inherited the Corporate Integrity Agreement signed between Abbott and the US Government last October.

    In October 2012, Abbott was required to pay $1.5 billion in criminal fines and civil settlements for promoting a medicine, Depakote, to treat dementia and schizophrenia. The medicine was not authorised for these indications.

    According to the US Dept of Justice:
    “Abbott has pleaded guilty to misbranding Depakote by promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was FDA approved. In an agreed statement of facts filed in the criminal action, Abbott admits that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use. In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use”.

    According to the Agreed Statementof Facts, Abbott delayed for years in disclosing the full results of clinical trials showing that Depakote was no more effective than a placebo, and aggressively promoted Depakote through its sales force, special “educational” material, speakers fees, and selective use of study results.

    For schizophrenia, Abbott submitted to the FDA in January 2002 the results of a trial described as “negative” by the company itself. (This was a trial of Depakote combined with another medicine.) Patients showed some improvement up to 21 days, but not up to 28 days – the primary “endpoint” of the study. However, Abbott used the 21 day results, the “secondary endpoints to promote Depakote to health care providers as a treatment for schizophrenia” at least up to 2006. The promotion was expensive and intensive and is described in the Agreed Statement.

    Abbott carried out a second study on Depakote and had concluded by January 2005 that the results were negative. However, they continued for a very long time to use the first study in their promotion and did not disclose, even to their own reps, the results of the second study. In August 2006 they published a synopsis of the second study, which spoke of the Depakote combination as being “well tolerated”. It did not mention that patients treated with Depakote were more than twice as likely to suffer from “somnolence” than those treated with the alternative.

    If the company had made a full and timely disclosure of their clinical trial results in this case they could not have continued to misbrand this medicine for as long as they did.

    I will say something, also interesting, about the other company, InterMune, in a later post. END

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