“AllTrials – little credibility? “What’s worse, Prof Healy says, is that the European Medicines Agency (EMA) has adopted the same scheme, placing the ‘GSK model’ firmly on the path toward respectability and universal acceptance. If true – and the EMA is denying any “change in direction” over transparency in response to concerns expressed by the European Union Ombudsman – then the credibility of AllTrials is about to crumble to nothing”
“I’ve got huge respect for Andrew Witty”
Following on from my recent post about Ben Golacre’s generic and flippant comments on my blog yesterday, here’s some more food for thought-
GSK president (of R and D), Patrick Vallance, was one of Ben Goldacre’s tutors when he was in UCL Medical School – a fact I stumbled upon because Ben Goldacre mentioned it himself in a footnote on one of his blog posts about GSK data transparency in 2012. ( see here ).
“(Oh, and footnote: Patrick Vallance, GSK’s current supreme medical
person? If you were at UCL medical school doing your clinical
training, in the late 90s, like me, then he was the clinical
pharmacology prof who taught us how to prescribe. Nice guy, smart
Ironically, it was that blog post which first brought Ben Goldacre to my attention, and it was one of the reasons why I wrote about Ben initially. I just could not comprehend why on the one hand Ben seemed to be somewhat critical of GSK, but on the other- completely enamored with GSK CEO Andrew Witty. His tweets gushed sycophantic praise like you would expect from a school boy who had just been validated by his boyhood rock idol or soccer hero. When GSK said they would sign up to Alltrials, many bloggers and patient activists were perplexed as to why this would be a ‘Cartwheel’ moment for Ben. Surely, we thought, when dealing with a drug company like GSK who are notorious for misleading and deceiving, it would be wiser to be more cautious?
Similar to his character endorsement of Vallance, Ben referred to Andrew Witty as a nice guy; as if to portray an image of Witty as someone who was innocuous and harmless. These are hardly the personality traits of someone who runs a multi-billion dollar global cut throat business – which had incidentally been fined 3 Billion for fraud by the Department of Justice the previous year. Part of the fine involved off-label prescribing of Paxil (Seroxat) which can be related back to the promotion of GSK’s infamous study 329 (A fraudulent study which has yet to be retracted and also which led to the deaths of many children).
CEO’s of pharmaceutical companies are not innocent, harmless kittens, as Ben Goldacre seems to perceive them (or at least that’s what he is maybe trying to convince us of). Pharma executives have to be utterly ruthless because their business model demands it. They cannot permit themselves to have compassion for people who are harmed by the company that they run. If they were kind, soft, humane beings they wouldn’t last a second as a pharmaceutical executive. It’s a job that requires a certain type of person (some would say maybe even only sociopaths could rise to such a high level in pharma). So either Ben really believes that Andrew Witty is a harmless kitten, with only the best of intentions for mankind, a man whose mission in life is to spread, light, love and data transparency, or something else entirely is going on… nobody could be that gullible surely? Could they?…
It all seemed very strange to me at the time, but now that I have had a few (lame but somewhat insightful) responses from Ben on my blog, and read all of David Healy’s and 1boringoldman’s posts about the Alltrails debacles, I think I have a good sense of what Alltrails and Ben Goldacre are about. I also understand now what both bloggers have been trying to draw attention to…
When I wrote my first post, I wanted to get Goldacre’s attention, because I wanted him to explain to me why – as a supposed patient advocate- which he advertises himself to be- does he consistently praise GSK? Why was he not highly critical of them? Particularly considering they have been one of the worst (or perhaps even THE worst) offenders in regards to hiding trials, manipulating evidence, harming patients (including deaths from Seroxat and Avandia etc) and a whole myriad of unethical, immoral and illegal corporate crime which has spanned decades by now. Why would Ben be so insistent on trusting them, when it was quite clear to those of us who have been documenting and researching GSK- over the years – that they are one of the most devious corporations on the planet?
Well, it seems to me that despite denying any connection to GSK- Goldacre does have some links to GSK, mainly through his association with his old tutor Pat Vallance. Vallance has worked for GSK for 8 years now and it is Vallance who is driving GSK’s transparency model- a (rather dubious) model which Goldacre and his colleague – Iain Chalmers fully support.
Goldacre denied that GSK and Alltrials are in any sort of partnership at all but this document, written by Vallance and Chalmers (and with support from Ben Goldacre), would perhaps seem to suggest otherwise:
Glaxosmithkline, Brentford, Middlesex TW8 9GS, UK (PV); and James Lind Initiative, Oxford, UK (IC) firstname.lastname@example.org PV is a President at GlaxoSmithKline, holds stock or stock options in GlaxoSmithKline, and is a board member of A*Star Board Singapore and Genome Research Limited. IC declares that he has no conflicts of interest.The authors would like to thank Martin Bobrow, Mike Clarke, and Ben Goldacre for helpful comments and critical review of this Comment.
Another interesting aspect of this involves the BMJ Lifetime Achievement Award which is of course- sponsored by GSK. (who else? .. does GSK own the UK?). This years winner was none other than (Ben Goldacre and Pat Vallance’s friend) Iain Chalmers…
The 2014 Lifetime Achievement Award, sponsored by GSK, went to Oxford-based researcher, Sir Iain Chalmers, for his contribution to evidence-based medicine.
The glittering ceremony, which took place at the Westminster Park Plaza Hotel, was hosted by actor and broadcaster Gyles Brandreth. Also attending was doctor and writer Ben Goldacre.
It is disappointing when you see someone like Ben Goldacre take a GSK sponsored award, but even more disheartening when someone like Iain Chalmers does it. Chalmers wrote of his disillusionment with GSK and their promises of Transparency 8 years ago (but it seems he has perhaps since changed his tune), time will only tell if we see similar sentiments of disillusionment eventually expressed by Ben Goldacre.
Award ceremonies might seem harmless and of course, anyone’s ego would be massaged from receiving an award (particularly when surrounded by one’s peers), but I can’t help thinking that GSK probably only sponsor these awards as a way of influencing how the media and the public perceives them. They want to be associated with people who are well respected in the medical profession, they want their logos in the background of the images. They want the rights to tweet the images to their followers on their twitter and share it on their facebook. They want to influence because..
Influence is power…
Undoubtedly, GSK have a massive foothold in UK academia, regulation, science, government policy, etc etc. It would be difficult to escape their influence in most facets of life in the UK medical system. But surely there should be some (deliberate and intentional) distance on the part of medical professionals, and academics? Particularly considering, as Ben Goldacre once said himself, GSK have been ‘rather badly behaved’..
And in fact, they continue to be!
This year alone has brought revelations of a massive bribery network spanning several countries, a panorama documentary exposing GSK’s influence on medical professionals, and an inquiry from the serious fraud office…. And that’s just the first 6 months of this year! Go back into the archives of this blog and you will see that every year is just as scandalous for GSK…
It’s very easy for GSK to get away with outrageous criminality over the years, without any charges brought against them in the UK, because they merely deflect the bad news and bad press they receive with corporate sponsorship, such as the award ceremonies above, and a whole myriad of other events which they sponsor, infiltrate or influence… They counter-act bad press with nice pictures at award ceremonies with familiar, smiling faces…
Doctors should be wary of this influence because at the end of the day, Companies like GSK exist solely, and ultimately, to benefit the company and their shareholders… they dish out these awards for publicity, the awards themselves have little substance really as they would not exist without corporate sponsorship.. But then again, some doctors are more aligned to establishment thinking than others.. and we all know that doctors are infamous for their big ego’s anyhow…
As I have outlined to Ben Goldacre before- Alltrials might not think they are in partnership with GSK but it seems that GSK certainly want the media to portray it as if they are… one only has to google articles like these to see that :
GSK’s clinical trial for a malaria vaccine could consolidate its position as a front-runner in neglected disease research
The history of clinical trials in developing countries is a troubled one, from controversial investigations into the contraceptive pill in 1950s Puerto Rico to Pfizer’s infamous 1996 meningitis treatment trial in Nigeria, during which several children died or acquired disabilities.
Motives for conducting trials in emerging economies range from the scientific appeal of ‘treatment naivety’ (lack of much prior drug use in participants from these countries makes it easier to isolate the effects of the candidate product) to lower costs.
Some practitioners worry that companies are seeking to evade regulation by moving to less developed countries. “One potential reason for testing an agent in a poorer country is that you don’t get hit by litigation so hard,” says Edwin Gale, emeritus professor of diabetic medicine at the University of Bristol. “If a person in Uganda is sick, no one is going to realise that what they are complaining of is because they are in a clinical trial”. And some companies are holding trials in bigger emerging markets to push products to doctors and populations rather than to advance medical knowledge – a process known as ‘seeding’ – says Professor Gale.
Tara Prasad says GSK’s clinical trial conduct in developing countries is superior to its competitors, and common criticisms directed at pharma companies running trials in developing countries do not seem to apply to GSK’s malaria investigation. It is not a ‘seeding’ attempt since trials for diseases like malaria have to be conducted where the disease burden is highest. “Testing a malaria vaccine in a malarial area is clearly appropriate, and this product is potentially a major contribution to global health,” says Ben Goldacre, author of Bad Pharma. Seeding tends to be a bigger issue in large emerging markets where the commercial landscape is more attractive.
* Drugmakers under fire for keeping medicine data secret
* New move builds on previous GSK pledge to be more open
* GSK will now publish detailed clinical study reports
* Industry critic Ben Goldacre says GSK move “excellent”
LONDON, Feb 5 (Reuters) – Britain’s largest drugmaker GlaxoSmithKline is extending a promise to make more of its pharmaceutical research data public by publishing detailed clinical study reports as well as the results of all drug trials.
The decision marks a new level of openness in the drugs industry that other companies may be under pressure to follow. Drugmakers have long been criticised for keeping important information about their medicines under wraps.
Ben Goldacre, a British doctor and author of “Bad Science” and “Bad Pharma”, who has led a campaign called AllTrials urging clinical study report (CSR) disclosure, said GSK’s support for the initiative was “excellent and amazing”.
GSK, which agreed a $3-billion U.S. settlement last year over misleading information about some of its drugs, already said in October it would make anonymised patient-level data from clinical trials available to other researchers.
“Expanding on this, GSK is committing to make CSRs publicly available through its clinical trials register,” the firm said in a statement on Tuesday.
CSRs are formal study reports that provide more detail on the design, methods and results of clinical trials and form the basis of submissions to regulators such as the U.S. Food and Drug Administration and European Medicines Agency.
Campaigners argue that CSRs are essential to assess the real value of medicines because brief summaries about trials, such as those published in academic journals, can be incomplete.
GSK said that from now on, it would publish CSRs for all of its medicines once they have been approved or discontinued from development. This would allow for the data to be first reviewed by regulators and the scientific community, it said. Patient information will be removed to ensure confidentiality.
Patrick Vallance, GSK’s president of pharmaceuticals research and development, said the promise was aimed at helping “advance scientific understanding and inform medical judgment”.
“Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research,” he added.
Demands for greater transparency by the drug industry have come to a head in Britain with the AllTrials campaign, whose supporters include the group Sense About Science, the British Medical Journal and the Centre for Evidence-based Medicine.
In an apparent effort to put its past record straight, GSK also said it intends to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of the company in 2000.