No Conflict Of Interest To See Here…


“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”

(Ben Goldacre Nov-2012)

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 ).

Ben says:

“(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
guy.)”

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?

How could Ben be so blind and naive?

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:

http://davidhealy.org/wp-content/uploads/2013/10/GSK-and-Chalmers-Lancet1.pdf


*Patrick Vallance, Iain Chalmers

Glaxosmithkline, Brentford, Middlesex TW8 9GS, UK (PV); and James Lind Initiative, Oxford, UK (IC) patrick.5.vallance@gsk.com 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…

http://www.economicvoice.com/saving-lives-after-cardiac-arrest-and-spotting-chronic-lung-disease-scoop-prizes-at-the-bmj-awards-2014/

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.

iain-chalmers2d40512a77b2b683c7b97c2f5e1cb5e1Iain Chalmers and Ben Goldacre have both been presented with awards from GSK, here is Ben’s award from 2003:

6a00d8357f3f2969e2013485f7e002970c-pi

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 :

http://allafrica.com/stories/201306061272.html?page=2

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.

http://mobile.reuters.com/article/idUSL5N0B5CV920130205?irpc=932

Top News
UPDATE 1-GSK promises to publish detailed drug trial data
Tue, Feb 05 13:23 PM EST

* 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.


Ben Goldacre: Start A Dialogue… Not A Diatribe…


I have written a few posts about Ben Goldace, Alltrials and David Healy on this blog, the most recent one- just yesterday- received yet another defensive response from Ben. Ben has responded to a few of my posts but to be honest I mostly find his responses do not address anything I raise in the posts themselves and they also quickly descend into a diatribe against David Healy. This is childish and serves no purpose considering the seriousness of what is happening. These kind of responses from Ben are not just inadequate, but often they are generic and have nothing to do with addressing the content or core of the points I am trying to get across. I did find this initially frustrating until I noticed that he doesn’t just ‘interact’ with me like that – he does it to most people- particularly those who differ with, or oppose, his views.

Take for example my post recently urging Ben to listen to David Healy’s warning about the possibility that GSK are misleading Alltrials, and thus also misleading Ben. David made some well researched, and very salient points, which also made a lot of sense. David is an extremely credible voice in this arena, he is a professor of psychiatry, a distinguished author and an expert in psycho-pharmacology- he also has extensive experience with how GSK operate- yet on my blog, on David Healy’s blog, and on another blog where David’s opinions were also being discussed, Ben posted the exact same generic response, literally copied and pasted, in the comments section of all 3 separate blogs. This is not a dialogue with Ben, this is glib diatribe. This is churlish defensiveness. If I didn’t know better, I could be mistaken for thinking that Ben is stonewalling me?

Anyhow,

This is the comment he posted, repeatedly :

Ben Goldacre on May 27, 2014 at 11:11 pm said: Edit

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Hi there,

I posted this on David Healy’s blog but it’s In Moderation so I’m posting it here too, since you’ve reproduced the same arguments.

This blog post by David Healy is absurd.

The AllTrials campaign is really simple: it calls for all trials to be registered, with their full methods and results made publicly available. Where CSRs have been made, we call for those to be placed in the public domain.

Healy says we’ve created a situation where people are withholding CSRs: that’s simply absurd, this is precisely what we campaign against.

Healy says we’ve created a situation where CSRs are inappropriately redacted: that’s absurd, again, this is specifically what we campaign against.

Healy says we have created a situation where drug companies get to choose who has access to CSRs: again, that is ridiculous, this is exactly what we campaign against.

GSK have signed up to the AllTrials campaign: they join over a hundred patient groups, more than 75,000 members of the public, NICE, Wellcome, MRC, almost all academic and medical professional bodies in the UK, and a growing number around the world. When Bad Pharma came out, industry and others were able to pretend that information about clinical trials is no longer withheld. We’ve transformed that, triggered two select committees and put the policy issue on the map, created a coalition, unpicked a web of dangerous false reassurances by professional bodies, and made it impossible for industry to engage in glib denialism.

I’m delighted that GSK have signed up to AllTrials, along with all the other organisations. There are lots of problems in medicine. There lots of people and organisations who’ve done – and continue to do – things I think are harmful to public health. But where people do the right thing, I will applaud them for it. I genuinely think that’s the right thing to do. It doesn’t mean you’re part of an elaborate and complex conspiracy with people. It doesn’t mean you approve of everything they do at work and at home.

It’s easy, and attractive, to scream from the sidelines, and carry on screaming forever. It’s also possible to shout out clearly and succinctly about problems, try to set out and discuss clear solutions, floodlight the path forwards, and encourage people to go down it.

Lastly, and specifically, the issue of individual personal data. The AllTrials campaign doesn’t call for all the rich individual patient data from all trials to be simply posted publicly in the public domain: that poses too much of a privacy risk, because patients are identifiable in this data. This privacy risk isn’t as big as is claimed by some of those who seek to block transparency, but we decided that the issues around graded access control to IPD are too complex for a simple headline campaign, and we didn’t want to risk industry using the issues around protecting participants’ privacy as an excuse to derail discussion on the very important separate issue of access to methods and summary results. We were absolutely right: industry have repeatedly tried to pretend that AllTrials calls for individual trial participants’ personal data to be posted online, even though AllTrials is specifically focused on registration, methods, results, and CSRs. But as David Healy knows, most of the people involved in the AllTrials campaign, myself, Iain Chalmers and the BMJ included, are closely involved in pushing for greater transparency on IPD too. It is simply absurd to claim otherwise.

The comments section on this blog is clearly the worst place to say this, but it really is a big waste of everyone’s time to have to deal with the kind of misrepresentation and abuse that David Healy keeps posting. From past experience, I don’t believe that David will engage constructively with my taking the time to correct these repeated misrepresentations, and I honestly think that’s a shame. We’re all – most of us at any rate – trying to get things improved. Everyone’s time is short, and people run things like AllTrials in their spare time. If Healy has a better way to make things better, that’s great, he should crack on with it and get others behind him. If it involves misrepresenting campaigns, smearing people, shouting abuse, and hectoring from the sidelines, then I won’t be in.

As an addendum, three brief specifics, since time is short:

David Healy, above:
“Consent processes in clinical trials were about telling you you were on a new drug that might be dangerous or might be involved in a marketing trial. Instead they have become a way for companies to justify hiding your data on the basis of a confidentiality clause they have slipped into the forms. Iain Chalmers, Ben Goldacre and AllTrials appear to have signed up to this.”
– This is complete and utter fantasy. Neither I nor AllTrials have signed up to this. David Healy will be unable to provide any evidence to show that we have. Consent forms being used to justify withholding information is exactly what I’ve campaigned against.

David Healy, above:
“That what would be put in place was a mechanism that gave the appearances of transparency but in fact would lock academics into agreeing with GSK and other companies as to what the outcomes of their trials have been.”

– This is completely bizarre. AllTrials simply calls for all trials to be registered, with their full methods and results made freely publicly available, and CSRs where they’ve been created. It is impossible to argue that this “locks academics into agreeing with GSK and other companies as to what the outcomes of their trials have been”.

David Healy, above:
“Rape is a loaded word these days”.
It’s always been a loaded word, David.
http://dictionary.cambridge.org/dictionary/british/rape_1?q=rape

 


I am not going to go into the content of Ben’s comment because it has already been responded to on David Healy’s blog- by David Healy- and I have no idea why Ben posted it on my blog because it is a response to David Healy’s post, not mine- my posts have been questioning different aspects of this and they have had a different tone. It concerns me that Ben doesn’t seem to see that there are many informed, educated and wise opinions from many different people in this debate, his opinion is not the sole authority on data transparency, the ills of the industry or the direction we should all be headed to. Ben needs to listen to others and stop dictating generic responses which do not address the concerns and opinions of others but merely inflate his own sense of ego and self-importance. It would be nice to think that we can engage with Ben and those who have differing views on the same subjects without the fear of childish retorts. I won’t hold my breath for some proper adult engagement but I will always be open to it. We desperately need dialogue here…

I will finish this post with what i think was one of the most insightful- yet also humble and intelligent- comments in this debate that I have seen so far ( copied from David Healy’s blog):

Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect. I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all. The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not. If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.” In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned. This is closer to a war than a negotiation. The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.

– See more at: http://davidhealy.org/fucked/#comments

Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect. I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all. The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not. If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.” In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned. This is closer to a war than a negotiation. The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.

– See more at: http://davidhealy.org/fucked/#comments


Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect. I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all. The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not. If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.” In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned. This is closer to a war than a negotiation. The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.

– See more at: http://davidhealy.org/fucked/#comments

Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect. I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all. The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not. If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.” In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned. This is closer to a war than a negotiation. The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.

– See more at: http://davidhealy.org/fucked/#comments

http://davidhealy.org/fucked/#comments

 1boringoldman says:

May 29, 2014 at 12:14 am

Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect.

I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all.

The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not.

If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.

In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned.

This is closer to a war than a negotiation.

The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.
– See more at: http://davidhealy.org/fucked/#comments

ben-goldacre-1

GSK’s Seroxat For Sale As Part Of Drug Portfolio Offloading Scheme



 

http://news.sky.com/story/1271423/glaxo-tempts-bidders-with-7-5bn-drugs-sale

Glaxo Tempts Bidders With £7.5bn Drugs Sale

Buyout giants are examining offers for GSK drugs such as the antidepressant Seroxat, Sky News has learnt.

GSK Brentford headquarters

GlaxoSmithKline is based in Brentford in west London

GlaxoSmithKline (GSK), Britain’s biggest pharmaceuticals company, has approached potential buyers of brands including the ulcer remedy Zantac and Seroxat, a well-known antidepressant.

Sky News has learnt that GSK has invited a small number of private equity firms, including Advent International, Blackstone and KKR, to consider making offers for some or all of the roughly 50 medicines in its Established Products Portfolio.

Based on a frequently used valuation multiple of two times’ annual sales, the assets could be worth as much as £7.5bn in total, according to one source.

It is unclear how interested the private equity firms are in pursuing any deal with GSK.

GSK is highly unlikely to offload the portfolio, which also includes Imitrex, a migraine treatment, and Zofran, which is prescribed to combat symptoms of nausea, as a single entity.

The company is more likely to sell the rights to bundles of the products or individual medicines in order to maximise the value it can generate from any disposals, the source added.

Transactions may focus on licensing deals in the US or Western Europe rather than emerging markets.

News of the approach to prospective private equity buyers comes in the same week that GSK disclosed that it was the subject of a formal Serious Fraud Office probe into its “commercial practices” following allegations that its staff bribed doctors to prescribe its products in China and other overseas markets.

A spokesman for GSK echoed recent comments made by Sir Andrew Witty, its chief executive, that it was open-minded about the future of the established products portfolio.

“We continue to evaluate options to maximise the value of our portfolio and are currently reviewing [it], he said.

Lazard, the investment bank, has been appointed to oversee discussions with potential buyers.

At GSK’s first-quarter results announced last month, it said that sales from the non-core portfolio fell by 11% to £814m “principally reflecting lower sales of Lovaza, down 25%, and continuing generic competition to a number of products across the portfolio, including Seroxat/Paxil, down 15%, and Malarone, down 34%”.

The company has already begun selling some non-core products, announcing an agreement last September to sell thrombosis brands Arixtra and Fraxiparine to Aspen, the South African drugs group, for £700m. GSK owns an 18.6% stake in Aspen.

GSK has been active in reshaping its business in recent months, unveiling a three-part transaction with Novartis which involved the British company acquiring its Swiss rival’s vaccines arm and its oncology division moving in the opposite direction.

Sir Andrew effectively ruled out acting as a ‘white knight’ during Pfizer’s recent pursuit of AstraZeneca, which ended – at least temporarily – on Monday.

GSK And The British Establishment: How Deep Does The Corruption Go?


Quite deep it seems..

I have been drawing attention to this for several years, however it’s great to see the mainstream slowly wakening up…


http://www.morningstaronline.co.uk/a-522b-Drugs-Scandal-Under-the-Influence#.U4ctDi_c2pK

Drugs Scandal: Under the Influence


Apr
2014
Friday 25th
posted by Morning Star in Britain

The well-connected people on the board of GlaxoSmithKline did not stop a series of bribery scandals, writes SOLOMON HUGHES


BBC’s Panorama dedicated last week’s show to exposing how big British drug firms like GlaxoSmithKline (GSK) regularly made bribes and other payments to doctors to encourage them to prescribe their pills.

It was a good show, but didn’t say how deeply the British Establishment was implicated in these corrupt practices.

All the time GSK was involved in the bribery and questionable payments, they were directed by a board that included James Murdoch, son of Rupert, and Chris Gent, a Tory donor and adviser to David Cameron.

As Panorama revealed, GSK is facing charges of bribing doctors to prescribe their medicines in Poland between 2010 and 2012.

As readers of my column know, this is one of many doctor-bribing charges faces by GSK — Chinese authorities accused GSK of using a network of middlemen and travel agents to pay doctors to prescribe their drugs in a £2 billion scheme between 2007 and the present.

GSK admitted some of its Chinese executives had misbehaved. The Chinese case is ongoing.

GSK is also investigating claims that in 2012 it paid 16 state-employed doctors and pharmacists in Iraq to act as sales representatives.

These are all allegations, but there is a very strong reason to believe they are true.

In 2012 GSK agreed to pay a $3 billion (£1.7 billion) fine in the US for the illegal promotion of prescription medicine, including bribing doctors.

The Philadelphia Inquirer bluntly described GSK’s behaviour as “organised crime.” Its scams included entertaining doctors and paying them “advisory fees” to persuade them to prescribe drugs.

GSK also tried to get drugs prescribed for conditions not approved by regulators, like selling anti-depressants as slimming aids.

The charges also included fraudulent pricing of drugs to cheat Medicaid, the US healthcare scheme for the poor.

So the firm itself, and regulators, are taking the Chinese, Polish and Iraqi bribery charges seriously. If it did that kind of thing in the heavily regulated US, it seems likely it would have been as reckless elsewhere.

Fish rot from the head. If GSK was up to no good, its leadership must take responsibility.

This leadership are not anonymous bureacrats, they are men at the heart of the British Establishment.

For the past 10 years Sir Christopher Gent has been chairman of GSK. In 2009 David Cameron announced Gent would sit on the  Tory leader’s personal “economic recovery committee.”

Gent is a long-term Tory activist who has given the Conservative Party around £110,000.

From 2009 to 2012 GSK had a new director looking at the firm’s ethics — James Murdoch.  Announcing his appointment in February 2009, Sir Chris said he was “delighted to welcome James to the board of GSK.

His experience of global business, marketing and communications will bring a unique and alternative perspective to the board.

“He will also be an excellent addition to the board’s corporate responsibility committee, an area where he has shown particular leadership at BSkyB and News Corporation.”

So thanks to James Murdoch’s ethical leadership at NewsCorp, he was put onto the companies corporate responsibility committee — which would deal with issues of irresponsible behaviour, like, er bribery.

Murdoch quietly slipped off the board in 2012 “to focus on his current duties” at NewsCorp — duties which needed a lot of focus because of the scandal over payments to officials by News International staff.

Last week I said the British establishment was a bit like the Belgian thriller Salamander.

In this TV show, a top cop Paul Gerardi stumbles onto a secret organisation called Salamander, bringing politicians, businessmen and security officials together around a private bank.

A senator’s wife explains that Salamander is “a sort of interest group. They arrange appointments to high office [and] ensure each other’s companies win government contracts.”

The difference between the real Britain and fictional Belgium is our corporations buy friendship with politicians in the open.

Instead of having to run a conspiracy in secret, they just rely on their corporate takeover of politics being ignored.

British Olympic Diver, Tom Daley, and GlaxoSmithKline


GSK are a massively wealthy corporation with a huge influence over the entire UK economy, therefore it is not surprising that they spend a lot of money on corporate sponsorship initiatives, which give good publicity, and create a positive image for their profitable pharmaceutical brand.

The English Olympic diver, Tom Daley, has become an extremely popular celebrity in the UK, and I have no doubt Tom is a genuinely good guy, but I have to wonder- are these GSK sponsored sportsmen and women aware of GSK’s long, disturbing, history of bad pharmaceutical practice?

If not, they should be.

http://www.gskhpl.com/our-science/


 

 

Tom dPeflab


GSK’s Cover Up Of Suicide Link With Seroxat In Teenagers

GSK’s Avandia Causes Tens Of Thousands Of Deaths And Heart Attacks

GSK Corruption Of Doctors (BBC Panorama)

GSK Bribery, Fraud, 3 Billion Dollar Fine

 

GSK: How To Provide Access To Data Without Revealing Anything At All


“The process of using this interface for analysis is unnecessarily maddening and a severe obstruction to the task”..

(1boringoldman-blog- http://1boringoldman.com/index.php/2014/05/25/a-decision-to-reconsider/)


 

 

Does Ben Goldacre really believe that a multi-billion dollar corporation like GSK can’t provide an easier, more technologically advanced, and productive route- for researchers to access their data?

GSK are taking the absolute piss out of Alltrials, the BMJ, the entire scientific and medical community, and the public at large, with their ‘transparency charade’ but most of all they are harming patients -and that is utterly indefensible… the system GSK have in place is obviously a deliberate attempt to block researchers gathering data properly…

 


 

http://1boringoldman.com/index.php/2014/05/25/a-decision-to-reconsider/

 

…as a member of the RIAT team who was granted access to the Data from Paxil Study 329 to do an independent reanalysis by GSK, we’ve now had months of experience working with their “remote desktop” interface as a portal to their information. It is a single windowed multiple document interface, totally self contained that can’t be accessed by any software other than that provided inside the window. Multiple passwords are required multiple times for access, and on some days, one is frequently thrown from the system without warning, necessitating repeated logins. There’s another internal window from SAS that contains the data and allows one to run SAS programs to analyze the data. The data is also provided as text-based CSV files that can be moved outside the internal SAS window and displayed in spreadsheets [Open Office is provided]. The open source statistical program, “R” is also provided. In our case having no-one fluent in SAS procedures and programming, we are using “R” which has the necessary statistical functions. Getting the data into the proper format required by “R” means using multiple spreadsheets – which is very difficult in the cramped space provided – sometimes taking days and involving many “start-overs.” Once the data is analyzed, one can only export non-data containing files with results, and that’s only by application for approval. Using the primitive graphing functions of Open Office or “R’ in the “remote desktop” is very difficult and the graphs can’t be exported. That finally lead us to copy the information for the graphs by hand to get it into the computer proper to create our images. The process of using this interface for analysis is unnecessarily maddening and a severe obstruction to the task.

The original hand written CRFs are provided as PDF documents. In our case, there are some 275 subjects, many with several pdfs, each pdf containing 200+pages. In the interface provided, we can see only one page at a time of the nearly 60,000 pages. Tallying the adverse events from the pdfs is hard enough work, but doing to without being able to make printed copies and referring back and forth is a double nightmare, requiring days of wasted time, and delegation is impossible. Working inside of this little window brings home how important it is to have a workspace that allows simultaneous display of lots of information, and this isn’t it. One of our team has lost one assistant already over this interface. The EMA’s decision to even consider using this kind of interface is at best, ill advised, and a negation of the initial promise of Data Transparency. If I weren’t retired and instead had a job to do, I don’t think I could do it. If I were a graduate student given the task, I might go to the chairman of the department and ask for another major professor. It’s impossible to imagine that anyone contemplating this decision who knows the ins and outs of data analysis has tried it out in this kind of environment. As I said before, it’s like going to sea to see the world in a submarine, looking through a periscope.

I expect the EMA means well, and may think that since the data is available in this system, it should be okay.. But they apparently don’t realize the practical burden that it inflicts on anyone trying to have a serious look at a clinical trial. At the least, I would hope they would sit someone down in front of a computer using such a system so they can see with hands-on what I’m talking about – that I’m not being melodramatic.

Unbelieveable: GSK Sales Reps In China Want To Be Reimbursed For Bribes!


From Bob Fiddaman’s blog:

 http://www.networkedblogs.com/Xh0Ty

Thursday, May 29, 2014

GSK’s Sales Reps Want Their Money Back

Where’s John Grisham when you need him?

Seriously, you really couldn’t make this shit up.

The Financial Times are running with a story that’s as jaw-dropping as anything I’ve read thus far regarding the bribery scandal in China. I had to do a double-take, had I fallen asleep last night and somehow travelled back in time to April 1st? There were no skid marks from DeLorean tyres in my bedroom and my computer told me it was 29/05/2014.

“GSK salesmen want ‘bribes’ reimbursed” is the headline, what follows is pure Grishamism.

GlaxoSmithKline, the UK pharmaceutical company at the centre of a Chinese corruption scandal, is facing protests from junior employees who say the company is refusing to reimburse them for bribes they were ordered to pay by their superiors.

Now some Chinese sales staff are complaining that GSK has denied bonuses, threatened dismissal or refused to reimburse them for bribes they say were sanctioned by their superiors to boost the company’s drug sales. In some cases, managers instructed them to purchase fake receipts that were used to cover up bribes paid in cash or gifts to doctors and hospitals, according to salesmen interviewed by the Financial Times.

In some instances, managers disguised their involvement by using their personal email address to instruct staff to pay bribes and by ordering junior staff to claim on their personal expense accounts – even if the bribe was actually paid out by the manager – according to these people.

In late March, disgruntled staff sent 25 representatives to GSK’s headquarters in Shanghai, where they unfurled a banner that read: “Return my hard-earned money.”

Cor blimey governor, can you Adam and Eve it!

So, let’s get this straight.

Glaxo’s reps paid bribes out of their own pockets that were later to be reimbursed by the company…and now they are telling Glaxo that they want reimbursing?

Here’s the Financial Times again…

“The expenses were paid with our own money, and although the receipts were not compliant, it was our managers who told us to buy the fake receipts,” said one former GSK salesman.

The FT article goes on to explain that some sales reps were warned not to implicate senior staff, in many instances, according to the FT,  management “approached each person [rep] before they were questioned and asked them not to mention his name. He even prepared a story for them to tell the investigator.”

Glaxo have denied that this is a systematic problem throughout their global operation – they’ve even denied it after other allegations of bribery have surfaced in other countries, namely Iraq, Poland, United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, Lebanon, Syria, Jordan and now the UK. [back story]

We hear the same old line from GSK when they have been caught by investigating officials, citing that they will “cooperate fully with investigators”.

I thought long and hard about this line. It’s pure psychology. By stating that they will cooperate fully with investigators eases the guilt and, at the same time, paints a picture that Glaxo were unaware what was going on. In essence, “We will cooperate fully with investigators”, actually means we’ve been caught red-handed and will answer any of your questions. We will not offer you any specific evidence unless you ask for it specifically. Glaxo do the same when faced with litigation too.

I find it laughable that reps who knowingly broke rules with their own money now want reimbursing. It’s akin to the Yorkshire Ripper billing the tool shop where he purchased his hammer from. Apologies for using such a heinous crime as an analogy – I’m referring to the Yorkshire Ripper and not Glaxo’s bribery.

It’s been alleged that female sales reps were told to offer sexual favours to doctors in efforts to get them to prescribe more of GSK’s drugs. [back story]

Are we to assume then that these female reps will be asking for reimbursement of the contraceptives and/or mouthwash they purchased?

The UK’s Serious Fraud Office recently announced that they are investigating GSK. It’s highly likely that they will just focus on GSK’s illegal activities overseas and won’t even bother to look to see if GSK reps have been doing the same here in the UK.

The FT article can be read here. You may have to subscribe to read all the content.

Bob Fiddaman

Adulterated (Contaminated) Seroxat Recalled by FDA


http://www.gmanetwork.com/news/story/362934/news/nation/fda-warns-against-recalled-anti-depression-drugs

 

Wednesday, May 28, 2014

SEVERAL batches of anti-depression medicine, paroxetine (seroxat), have been voluntarily recalled after they were found to have been “adulterated.”

According to the Food and Drug Administration (FDA), GlaxoSmithKline (GSK) Philippines Inc. is implementing a voluntary recall of paroxetine 20 milligram tablet (Seroxat) with batch numbers 601, 602M, and 603.

“Non-compliance to current good manufacturing practice (cGMP) had resulted in the voluntary recall of specific batches of paroxetine 20 mg tablet (seroxat),” said FDA Advisory 2014-038.

The FDA said the voluntary recall comes after a warning letter was sent by the US FDA to GSK USA concerning “critical deviations” made by the latter’s active pharmaceutical ingredients (API) manufacturer, SmithKline Beecham (Cork) Ltd. at Currabinny Carriagaline Cork, Ireland.

“SmithKline Beecham (Cork) Ltd. at Currabinny Carriagaline Cork, Ireland had critical deviations which caused the Paroxetine API to be adulterated,” said the advisory.

Paroxetine is used as treatment for depression, obsessive-compulsive disorder and panic disorder with or without agoraphobia.

The FDA said consumers that bought batches of seroxat that are subject of product recall may report to FDA via report@fda.gov.ph; or to GSK Philippines Inc at telephone numbers.: +6328648516 and +6328920762 ext. 8643 or mobile nos.: +639178882315 and +639178594598.

Similarly, the FDA said all consumers are being advised to buy their medicines from legitimate pharmacies and drug outlets and ask for official receipt. (HDT/Sunnex)

 

GSK Whistle Blowers? : Contact The Serious Fraud Office Confidentially And Blow That Whistle!


From Bob Fiddaman’s Blog: 

http://fiddaman.blogspot.ie/2014/05/a-message-from-uk-serious-fraud-office.html


http://www.networkedblogs.com/XfZzV

Wednesday, May 28, 2014

A Message From the UK Serious Fraud Office re GSK




GlaxoSmithKline plc investigation

27 May 2014

The Director of the SFO has opened a criminal investigation into the commercial practices of GlaxoSmithKline plc and its subsidiaries.

Whistleblowers are valuable sources of information to the SFO in its cases.  We welcome approaches from anyone with inside information on all our cases including this one – we can be contacted through our secure and confidential reporting channel, which can be accessed via the SFO website.

Notes to editors:

The SFO’s secure reporting channel can be accessed here: https://report.sfo.gov.uk/sfo-confidential—provide-information-in-confidence.aspx or via our website home page, www.sfo.gov.uk

The Serious Fraud Office is an independent government department responsible for investigating and prosecuting serious and complex fraud, bribery and corruption. It is headed by the Director, David Green CB QC, who exercises powers under the superintendence of the Attorney General. These powers are derived from the Criminal Justice Act 1987.

The SFO Press Office can be contacted on press.office@sfo.gsi.gov.uk or 020 7239 7316 / 7004 (out of hours: +44 (0) 7557 009 842)


[Source]

I actually went out and purchased a bottle of wine last night on the strength of this latest news.

The SFO may want to investigate the British drug regulator, The MHRA, too. It was they who, after a four-year investigation of GlaxoSmithKline, decided to let Glaxo off with a warning letter. No criminal charges were brought against GSK…even after the MHRA learned during their investigation that GSK had knowingly withheld safety data regarding children taking the antidepressant Seroxat [Known as Paxil in the US]

The MHRA’s four year investigation into GlaxoSmithKline failed on a catastrophic level.

Alistair Benbow, who was then Head of European Psychiatry at GSK, claimed on National TV that Seroxat could be safe in children even though his company did not have a licence to recommend it to children. [1]

All the SFO need to do is request disclosure from GSK. Emails, documents and, more importantly, the notes taken by GSK’s pharmaceutical reps during their visits to doctors and psychiatrists. Did Glaxo’s UK reps offer the same incentives to British doctors as GSK’s American, Chinese, Polish and Iraqi reps did?

Once they have these in their possession then I’m sure they will be able to retrace who said what and who they said it to.

It is imperative that the SFO obtain these documents.

The MHRA should have requested the same documents but why would they? They rely on pharmaceutical money, in fact, they are fully funded by the pharmaceutical industry.

The SFO are calling on whistleblowers – good luck. The carrot being dangled isn’t really as attractive as the carrot dangled in front of whistleblowers in the US.

I suspect the SFO are merely following up on the alleged bribery in China – they need to do more than follow-up though.

GlaxoSmithKline is infested, it’s driven by a culture where sales mean everything.

I do hope the SFO turn over every item they come across, I do hope this is not just them following up on GSK’s foreign violations.

There are plenty of experts out there who could help the SFO’s investigation, whether they choose to use them is another matter.

No stone unturned is the order of the day here. The SFO will, no doubt, face tough opposition from the current UK government. Deals may be struck given that Glaxo’s chairman, Andrew Witty, and the current Prime Minister, David Cameron, are friends and business acquaintances. [2]

One thing is certain though. The eyes of the world are watching.

 

Bob Fiddaman


[1] Seroxat – The Liars? [Video]

[2] Cronyism, Chinese Style