EU Draft Drug Safety Laws A “Disaster” – Congratulations To Dr Ben Goldacre & AllTrials On Undermining Drug Safety Worldwide

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Dr Ben Goldacre’s involving himself in drug safety regulation looks like turning into a nightmare for everyone except the drug industry.  When we look at who is really behind his AllTrials Campaign, there is good reason to be worried.

Dr Ben Goldacre, as a seeming new convert to drug safety regulation, published a book “Bad Pharma” last August about the drug industry.  He also took it seemingly upon himself to found the AllTrials campaign with great public fanfare to get drug industry clinical trial data opened up to scientific scrutiny.

The most recent outcomes have been described as a “disaster” by internationally respected expert Dr David HealyMaking Medicine More Dangerous for You and Your Children – Drug Industry Wins System Which Hides Drug Hazards  

Others also are concerned about the fallout and effects of Dr Goldacre’s meddling.  CHS reports on some of those further concerns here. We specifically quote below Trudo Lemmens of the University of Toronto.  Trudo Lemmens is Associate Professor and Scholl Chair in Health Law and Policy at the University of Toronto Faculty of Law, with cross appointments in the Faculty of Medicine and the Joint Centre for Bioethics.

Trudo Lemmens observations are most revealing about the disaster Dr Ben Goldacre and his playmates have been instrumental in unfolding.  In short Dr Goldacre has been instrumental in building a platform of political pressure for change of drug regulation with the drug industry taking over the impetus to manipulate regulation favourable to it and get its own way to the detriment of you, your family and children.

Well done Dr Ben Goldacre.

Dr Ben Goldacre’s response to criticism is to use his extensive BadScience Forum network and social media to stir up bullying, abuse and harassment on the internet of anyone who dares criticise him: Dr Ben Goldacre Forced By CHS to Answer Criticism Over Drug Safety – But Not Before Goldacre’s Usual Response – Bullying, Abuse & Harassment.

But first CHS directs your attention to The AllTrials Campaign.  Who is really behind it? 

It is run for Dr Ben Goldacre by lobby front group Sense About Science. That Sense About Science are behind Dr Goldacre’s campaigning is more than a little troubling. 

Sense About Science were first exposed by journalist George Monbiot writing in the UK’s Guardian newspaper in 2003: Invasion of the entryists How did a cultish political network become the public face of the scientific establishment? 9 December 2003 The Guardian.

Sense About Science were also exposed by Lobby Watch as having strong links to the GMO industry, the Living Marxism group and Spiked.

Sense About Science are listed under “Contact Info” buried at the end of a very long page as the only contact point for AllTrials on the AllTrials website:

c/o Sense About Science, 14A Clerkenwell Green, London, UK, EC1R 0DP. Phone: +44 (0) 20 7490 9590 Email: alltrials@senseaboutscience.org  Web: Contact form

Quite why a bunch of British Marxists should also suddenly espouse capitalistic ideals of industrial and commercial science after the Berlin Wall came down following “Glasnost” and “Perestroika” in the former Sovier Union is something which defies belief.  It is almost as if whatever their old job was as Cold War Warriors, there was a new job to do and they just jumped from their Marxist horses mid gallop for capitalist ones to ride off in a completely different direction.

Here are some of the entries on Lobby Watch’s website under the heading “LIVING MARXISM LINKS”

Living Marxism

Sense About Science

Genetic Interest Group

Science Media Centre

Fiona Fox

Spiked-online

Frank Furedi (Click & then see Living Marxism profile)

Getting drug trial data opened up for scientific scrutiny is something many many others have been working at for decades, having to counter the manipulations of the drug industry to avoid that happening.

So how come no-longer-so-fresh-baby-faced Dr Ben Goldacre with his new friends thought he could succeed in a few months where others have toiled for decades and continue to do so against the well greased wheels of the drug industry in political life?  Or was that ever a  serious consideration?  Is it all smoke and mirrors? 

The involvement of Sense About Science and its history suggests it is and always was.  On the most favourable view we at CHS can take, at the very least Dr Goldacre has been unwise in his choice of friends.  And at the most one can only speculate. 

Dr Goldacre also enlisted the help of Dr Fiona Godlee, the editor of a leading medical journal, the British Medical Journal.  The BMJ has close ties to the drug industry.  It makes millions of dollars annually from drug industry advertising and promotion worldwide.

And was it wise of British Prime Minister David Cameron to let Dr Ben Goldacre be appointed to advise in the British Cabinet Office on using randomised controlled trials in “Evidence-Based Policy.  If the drug industry can get away with manipulation of the systems of clinical trials over decades, and still do it with great success, just imagine what damage could be done in the UK and across the European Union by Dr Goldacre’s promotion of such harmful practices.  We will get political policies “proven” by controlled trials just like killer drugs like VIOXX and useless drugs like Tamiflu have been proven.  If Dr Goldacre did not foresee the issues identified by Trudo Lemmens as noted here below, then Dr Goldacre had no business advising anyone.  When we have people like Dr Ben Goldacre looking out for the public interest in Europe, we at CHS suggest the Taliban or Al Qaeda are the least of our worries. 

Dr David Healy is a serious longstanding academic and medical practitioner who is an expert in clinical trials in psychopharmacology, the history of psychopharmacology, and the impact of both trials and psychotropic drugs on our culture.  Dr Healy’s interests in and concerns for drug safety are far longer and deeper than Dr Ben Goldacre’s seemingly sudden, recent and superficial conversion to such a worthy cause.  Dr Healy’s book “Pharmageddon” is about how pharmaceutical companies have hijacked healthcare with life-threatening results set out in a riveting story that affects us all: University of California Press (2012) – available on Amazon.com.

And here are the concerns of expert Trudo Lemmens of the University of Toronto. Trudo Lemmens has just critiqued the recently distributed draft European Medicines Agency Clinical Trials Data Release Policy regarding the release and use of drug trial data:  EMA’s Proposed Data Release Policy: Promoting Transparency or Expanding Pharma Control over Data? PLOS Guest Blogger Trudo Lemmens

Trudo Lemmens is Associate Professor and Scholl Chair in Health Law and Policy at the University of Toronto Faculty of Law, with cross appointments in the Faculty of Medicine and the Joint Centre for Bioethics.

To quote extracts of Trudo Lemmens critique, this is where – and predictably where with warnings from experts like Dr Healy – that Dr Ben Goldacre’s meddling has led.  There were clear warnings.  Surely Dr Goldacre and Dr Godlee must have been aware of these issues?

Trudo Lemmens comments are also relevant to the rise of right wing anti-European Union nationalist groups in the EU.  There is considerable public disquiet about the corrupt EU political system.  It is clearly a system which cannot be fixed and is a big driver for the recent election successes in the UK and across the EU of right-wing politics.

Trudo Lemmens wrote:

In short, EMA’s approach is strengthening industry’s legal control over data, making it more difficult and legally risky for independent scientists to use them. These are in essence regulatory data, created for public interest use. For the EMA, a key public institution, to now support the privatizing of pharmaceutical knowledge through contractual affirmations of companies’ rights over these data is truly astounding. Dr. Rasi’s recent response to the Ombudsman, that EMA’s new policy is a ‘reasonable compromise’, and does not prevent researchers from asking for access to specific data sets on the basis of the existing access to information policy, does not reassure. His response does not recognize the legal concerns raised by the draft TOU and Redaction Principles, let alone justify the approach taken. And Abbvie’s withdrawal of the legal challenge of the Humira data release notwithstanding, EMA appears back in the business of imposing more extensive limits on what it gives access to in response to specific access requests.

This troubling development is not entirely surprising. Even if the transparency movement had some major victories, including the adoption of transparency requirements in the recent European Clinical Trials Regulation, opposition has been mounting. Industry may now employ other regulatory initiatives to fight transparency. The European commission recently released a draft directive aimed at streamlining and strengthening Trade Secret protection in Europe. The European Federation of Pharmaceutical Industries and Associations (EFPIA) jumped already enthusiastically on the occasion, emphasizing the need to protect the “proprietary know-how” of drug development, including in the “clinical trials phase”. In the context of ongoing and largely secret transatlantic trade negotiations between Europe and the United States and Canada, the pharmaceutical industry has also been lobbying hard to strengthen data and IP protection and to include better data protection in the package. EMA now appears to be lending a helping hand.

Extracts from:

EMA’s Proposed Data Release Policy: Promoting Transparency or Expanding Pharma Control over Data?  By PLOS Guest Blogger Trudo Lemmens

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