Category: ben goldacre

AllTrials Is A Red Herring… We Need Access To ALL DATA…


For the red herrings see here

Sir Iain Chalmers, coordinator of the James Lind Initiative and co-founder of AllTrials:

“Among pharmaceutical companies, GSK under its current management has led the way in promoting clinical trial transparency and provides a practical mechanism to make trial re-analyses possible. The reanalysis of Study 329 illustrates the knowledge dividends from the company’s new policies and contrasts strikingly with the scientific misconduct that characterised the company’s behaviour under previous management. Today’s GSK has shown moral and scientific leadership that puts to shame many in the academic community.

Erm no Ian, today’s GSK  (2014) were recently caught bribing hundreds of Chinese doctors and fined 500 Million dollars last year.  You fail to mention this very recent moral indiscretion.

GlaxoSmithKline Found Guilty of Bribery in China

U.K. Drug Maker Handed Largest Ever Corporate Fine in China

This fine was hardly a sign of moral leadership Ian, so don’t be ridiculous..

In regards to GSK’s scientific leadership, while giving the access to data for study 329 is undoubtedly a good thing, the fact that GSK hid it for so long (and promoted Paxil/Seroxat off label to doctors/kids which resulted in kids killing themselves) is not. I am shocked that you would try to spin this as somehow good PR for GSK . Study 329 was abhorrent, Seroxat is a disgrace.

Seriously, what planet are you on Ian?

Where is GSK’s apology for all this carnage?

Publicity from Study 329 contributed to paroxetine being prescribed to “hundreds of thousands” of adolescents, Jureidini said.

Dr David Healy’s  new post, ‘Data Wars‘, raises some very important points in regards to the ‘data transparency debate’.

I have long been suspicious of Alltrials, Ben Goldacre, Simon Wessely, Sense About Science and the various other ‘movers, shakers and consensus makers’ in this debate, and I’ve written several posts about them explaining why:

See these posts of mine for further details-

https://truthman30.wordpress.com/2014/08/15/whats-the-real-story-simon-wessely/

https://truthman30.wordpress.com/2013/11/19/ben-goldacre-bad-pharma/

Call me suspicious by nature, and perhaps I am, however when you’ve been writing, and researching, about GSK’s various unethical shenanigans (for almost 9 years now) you tend to sense when something isn’t quite right. Couple that with a horrendous time on Seroxat, then finding out afterwards that it all could have been prevented if the whole psych/pharma system wasn’t so corrupt, and throw in my sheer determination -for over a decade now- to expose every corner of the Seroxat Scandal, and you end up down some very strange rabbit holes indeed.

The recent expose (restoration of Seroxat Study 329) by the RIAT team, published in the BMJ, caused quite a stir online. Not only did it make headline news, but the responses on social media could warrant many studies in themselves. Paxil/Seroxat harmed many people. These are not ‘anecdotes’, these are people’s lives-

See these posts for details of the impact of Paroxetine world-wide:

https://truthman30.wordpress.com/2015/09/22/i-knew-that-shit-was-poison-12-people-describe-their-young-lives-on-paxil-seroxataropax/

https://truthman30.wordpress.com/2015/09/19/social-media-discusses-paxil-seroxat/

The real world affects of Seroxat (Paroxetine/Aropax/Paxil) have been horrendous for those who were unfortunate enough to have been prescribed it. I’ve known that Seroxat is a dangerous drug since I was first prescribed it in 1998. It was only after I came off it, in late 2001 or thereabouts, that I discovered (courtesy of the BBC through their Panorama programme- “The Secrets of Seroxat‘ documentary) that the problems with Seroxat (of increases in suicide, self harm, akathisia, murder, aggression, withdrawal, dependence etc) were worldwide problems. There was some solace in finding this out from the BBC Seroxat series, however I won’t get those lost Seroxat years back. I won’t get my health back that I lost either, nonetheless an apology from GSK for almost killing me with their drug, lying in PIL’s, and corrupting doctors, would be nice though- but I won’t hold my breath. I was collateral damage, and harm to people like me is factored into GSK’s cost of doing business. To GSK, my life was disposable, so it’s insulting for me when I see people like Ben Goldacre and Sense About Science collude with sociopathic companies like GSK.

I find this extremely disturbing.

Alltrials is a redherring, so is Ben Goldacre’s  transparency agenda. Simon Wessely is too, as are Sense About Science.

I don’t trust any of these people/organizations. I don’t believe patients should either.

Why do I say that?

Well, hundred thousands of kids were likely put at risk from GSK’s promotion of their dangerous Seroxat/Paxil drug off label. Many high profile psychiatrists put their names to the ghost written study 329 and subsequently- the lives of hundreds of thousands of kids were put at unnecessary risk. They were prescribed a drug (Seroxat/Paxil) which has been shown to be harmful. Many died and many were damaged, plus we haven’t even begun to assess the damage to the adults who were prescribed Seroxat.

I was one of those adults. I am one of those people who suffered. What is going to be done?

Where is the outcry about Seroxat killing kids from people like Prof Simon Wessely? (the head of the UK college of Psychiatry).

Where is the utter condemnation from people Dr Ben Goldacre? (A supposed patient advocate).

Where is the press release from Sense About Science castigating GSK for this disgraceful crime?

Where are their statements expressing their utter disgust at this flagrant abuse of vulnerable people? (Depressed people prescribed Seroxat).

They’re simply not there… none of these people/organizations have condemned this scandal.

Instead what we have are organizations like Alltrials basically congratulating GSK (for giving access to a study which was fraudulent in the first place) and helping GSK spin this abhorrent Seroxat study 329 scandal into something positive (quite how they can justify this is beyond me). Notice how Alltrials fail to condemn GSK for putting kids at risk, but how they try to spin this as GSK somehow being the good guys for providing the patient level data to David Healy and the RIAT team.

What Alltrials also fail to draw attention to is- the fact that the process itself was close to impossible (it also took years), and it was through sheer determination and tenacity on behalf of the RIAT team that they got to study the data never mind the pain staking process of attempting to analyze it. Furthermore, what Alltrials also don’t mention is- the RIAT process and Rxisk are looking for the Data – Access to all the data, not just the registering of trials. What use are the trial results and what use are the trials themselves without the data which makes them? We need access to all the data. Alltrials isn’t looking for this- that’s why I don’t trust them.

Alltrials is a red herring, so are Sense About Science-  and along with the true extent of Seroxat harming kids (and adults) that’s what the RIAT team has also just exposed…

See David Healy’s Data Wars for more:

http://davidhealy.org/study-329-data-wars/

Sense about Science

Simon Wessely and Clare Gerrada are the power couple of British Medicine.  He is the current President of the Royal College of Psychiatrists, and she is a recent President of the College of General Practitioners.  When faced with questions about over-prescribing of antidepressants by GPs, she is quick to insist that GPs rarely treat distress and that almost all prescribing is for genuine illness and the drugs work well.  He gives similar messages in respect of psychiatry.

Sense about Science began in Britain 15 years ago with donations from Corporations in the Risk Management Business – from Monsanto through Nuclear Power to Pharma. These donations have vanished from sight now, replaced by endorsements from all major UK universities and journals like The BMJ and support from Charitable Foundations.

SAS’s stated mission would have appealed to someone like SW who had come under attack from a lot of fringe groups in the 1990s for taking a balanced data-driven approach to Chronic Fatigue Syndrome (M.E.).

But SAS has now become a node to handle any messages in the media that might hurt the interests of a company or corporate sector – such as anything to do with vaccination or my recent editorial on So Long and Thanks for all the Serotonin.  BMJ sent this article (as they send all articles) to SAS who got in touch with SW to rustle up statements from Jeff Lieberman types which can be disseminated widely to the media either for citing or as a means to close down stories:

You might not want to take Healy’s work seriously in the light of what these senior figures in the field are saying.

Sense about Science has since spread to Canada, Australia and now the United States and everywhere the mission is the same.

AllTrials & AllData

SAS was a founder of AllTrials.  This sounds like AllData – the hashtag for Restoring Study 329 – but at the moment it is quite the opposite.

There has been close to radio silence from AllTrials in the face of the call for AllData, aside from one stunning press release that more or less credits GSK with the efforts to Restore Study 329.

17th September 2015

Many supporters of AllTrials will be interested in a study published in The BMJ today, a reanalysis of previously hidden clinical trial data. The new research used data from a 1990s clinical trial of the GlaxoSmithKline (GSK) antidepressant drug paroxetine. Today’s findings contradict a 14-year-old analysis of the data referred to as Study 329, which found paroxetine to be safe and effective for treating adolescents with major depression.

The new research is the first reanalysis of a drug study under the RIAT (Restoring Invisible and Abandoned Trials) initiative, which calls on companies and academic funders to publish detailed trial information for independent scrutiny. The RIAT team was able to access the original clinical trial data using GSK’s patient-level data access portal, where researchers can request access to this information.

Tracey Brown, Director, Sense About Science and co-founder of AllTrials:

“When all trials are registered and results reported, it becomes possible for researchers to work out what data are available. GSK has gone further and made its patient level data available to researchers. It is disappointing that there are still so many companies not reporting trials. Researchers, doctors, patients and, in July, their shareholders have said they want transparency about trial results. This will confirm their views.”


Sir Iain Chalmers, coordinator of the James Lind Initiative and co-founder of AllTrials:

“Among pharmaceutical companies, GSK under its current management has led the way in promoting clinical trial transparency and provides a practical mechanism to make trial re-analyses possible. The reanalysis of Study 329 illustrates the knowledge dividends from the company’s new policies and contrasts strikingly with the scientific misconduct that characterised the company’s behaviour under previous management. Today’s GSK has shown moral and scientific leadership that puts to shame many in the academic community.”

Pontius Andrew?

Faced in 2012 with questions about the $3 Billion fine imposed on GSK, triggered by a sequence of events starting with Study 329 – is it just the cost of doing business? – Andrew Witty snapped back:

“Although corporate malfeasance cases end up looking very big, they often have their origin in just… one or two people who didn’t quite do the right thing. It’s not about the big piece. The 100,000 people who work for GSK are just like you, right? I’m sure everybody who reads the BMJ has friends who work for drug companies. They’re normal people… Many of them are doctors”.

Everything about Study 329 suggests that Andrew is comprehensively wrong. Corporate malfeasance happens when the system is set up so that the efforts of 100,000 well-meaning people get transformed into the worst of outcomes and it then takes the efforts of a few brave people within GSK to alert the outside world to how things are going wrong.


GSK 2 GSK1

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Cafe Pharma : Where GSK Drug Reps Go To Dish The Dirt On Their Employers


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I find it mildly amusing how some people- such as “Mr Bad Pharma”- Ben Goldacre– call blogs like mine- conspiracy theories. All my blog posts are backed up with research, and anyhow- most of my blog posts are news articles, and factual reporting from established news outlets (Reuters, The Guardian, Forbes etc). My contribution is usually just a commentary, an illustration of context, or an opinion on facts which have already been established. If Ben Goldacre (and others) think my posts are conspiracy theories, then they must also think that BBC Panorama generates conspiracy theories about GSK and Seroxat, or maybe they think that the US Department of Justice made up the allegations against GSK leading to the largest healthcare fraud and felony in US history? Maybe Ben (and those of his ilk) think that the whistleblowers themselves invented the allegations of mass off label prescribing, fraud and bribery of doctors and psychiatrists?

If Ben wants to research himself, and find out what GSK employees think of their employer’s behavior, he need look no further than the opinions and thoughts from GSK drug reps (and other employees) on the Cafepharma online forums:

http://www.cafepharma.com/boards/archive/index.php/t-507035.html

“… let’s talk about the since less maiming and killing of children with GSK marketing tactics. Heck even add that they were aware, bud hid the data. We could always talk about the rat infested dump in P.R. that was a GSK manufacturing facility. You could also talk about the billions of dollars GSK cheated on it’s taxes during the Zantac days. Also you could speak about the deaths of children being tested with GSK vaccines in foreign countries. There is so much evil, hiding behind, helping people to do more and live longer…”

“I agree with the central question and it makes me angry. How can AW say that all those who are guilty of past misdeeds are gone, when he, himself, was there the entire time? Furthermore, he had a high-level position in respiratory marketing.

Adding insult to injury, MB, one of the primary whistle blowers, wrote the book on questionable marketing and sales tactics. He should be in jail. It’s an absolute travesty that he will benefit financially for doing (and encouraging) the very things he accused GSK of doing.”

 http://www.cafepharma.com/boards/showthread.php?t=562567

 
Anonymous
Posts: n/a
Default FBI Interviews Glaxo Employees

Federal Bureau of Investigation agents have been interviewing current and former GlaxoSmithKline employees in connection with bribery allegations made against the drug maker in China, according to a person familiar with the matter, as fresh claims of corruption surfaced against Glaxo’s operations in Syria.

The interviews have taken place in Washington, D.C., in the past few months and are part of a Justice Department investigation into Glaxo’s activities in China, the person added.

Wall Street Journal

:

07-26-2014, 07:16 AM
Anonymous
Posts: n/a
Default Re: FBI Interviews Glaxo Employees
“Doesn’t matter. Corruption is just part of the way GSK operates. It’s amazing how long they have done it, might have to pay a few bucks in fines every now and then, and then keep on doing it! It won’t stop until the Feds put somebody in jail. But, they REAL culprits will always get away. They will sacrifice a flunky to save their own asses!”

http://www.cafepharma.com/boards/showthread.php?t=562163

“Once you don’t care anymore and you call their bluff and do nothing you realize they got nothing on you. More and more people are just not working anymore. No incentive too. GSK is helpless to stop it. Company is starting to rot from the inside out. Corruption and lies never result in success. “

 

http://www.cafepharma.com/boards/showthread.php?t=563241

“The laundry list of sins committed by GSK corporate put this company into a death spin. We got in so deep to the justice department that we had to voluntarily initiate this Patient First night mare that obviously doesn’t work. No one can claim that is succeeded on any level. As a result, we have a sales force that isn’t permitted to sell. We have no incentive to sell anything. Especially Breo which has a commanding 1% market share coming up on a year since launch.

This company has lost all ability to create success. The culture is toxic and it starts at the top. Sadly, in this job market- most of us have no where else to go so we’ll ride this out to the end. Which sadly doesn’t look like its that far away.

I wish Hollywood got to write the end of this story. The GSK executives that committed all of these crimes will end up like Gordon Gecko- In prison.”

 

“This is just another example of GSK’s complete inability act ethically on any level. It is just one embarrassing scandal after another for this management team. There have been so many now… it is hardly possible to keep track of them all.

The bottom line is that if this back alley dealing dirt bag would have kept his dick in his pants like a moral married man- there would be no way to catch him on camera taking ol’ one eye to the optometrist in China.

Sometimes karma shows up in the oddest ways.”

“You are taking it as gospel that what GSK are claiming is true. Have you not learned anything over the past 20 years about this company?

They also said Paxil was safe and effective in kids and also backed Avandia to the hilt.”

“Take off your rose tinted glasses and read between the lines.

This “We were bribed first” is nothing but a defence to keep Reilly out of jail. Follow the trail – Emails sent to top GSK execs (including Witty) – GSK hire a private detective (without actually telling him about the bribery accusations and sex tape). – Private detective investigates who GSK believe to be the whistleblower (GSK’s Head of Government Affairs, Vivian Shi) – Private detective can’t find anything on her.

GSK then tell private detective about emails and sextape – shortly after the private detective is arrested (He’s still detained in China)

Witty knew about the allegations yet decided to sanction $20,000 for Humphrey to investigate Vivian Shi (to see if she was the whistleblower)

As head of the company he should have been more concerned about the allegations of bribery,

surely $20,000 could have been spend on investigating the allegations rather than who was behind the allegations?

After they couldn’t find who the whistleblower was they decided to investigate the allegations, they found no wrong-doing – wow, that was some investigation given that the Chinese authorities found a hell of a lot of wrong-doing.

Let’s not forget Witty’s reaction when this story first broke.

“Sir Andrew Witty said bosses at the multinational pharmaceuticals company’s London headquarters knew nothing of the millions of pounds in bribes allegedly being paid to doctors and health officials to boost sales and raise prices.”

Knew nothing? He was sitting on a sextape and emails accusing his company of bribery, yet, he ‘knew nothing.

Are you following this or do you want me to draw pictures?”

http://www.cafepharma.com/boards/showthread.php?t=562704

Anonymous
Posts: n/a
Default Any other shitty 3rd world countries we can bribe?

What have you done to make yourself feel proud!! Maybe we can bribe Nigeria or Libya next? Scum execs thought they could get away with it all .. Pretend you have patients first in the us while you rape 3rd world governmens ..
Reply With Quote
  #2
Old 07-28-2014, 08:32 PM
Anonymous
Posts: n/a
Default Re: Any other shitty 3rd world countries we can bribe?

Screwing over the poor is nothing new. As a group, they are the easiest to expoit because they are desperate. GSK knows that their best return on investment with bribes is in the 3rd world. You can buy health officials for 10 to 1 over a developed nation.

If we are going to be criminals, we better damn well be the best at it!

If this is what we are getting caught doing- just think of how much more is going on that hasn’t come to light yet!?

 

Ben Goldacre Is Not Arrogant, Smug, Immature And Egotistical ..


There…

That got your attention didn’t it…

Of course, the title of this post is merely a parody and satire on the current Alltrials debate which is currently raging across the social media- blog and -twitter universe (so no need to be running to the lawyers Ben and Andrew – it’s merely black humor).

Ben is not an arrogant,.. Of course he is not…

He’s not a Pharma shill either (as some people claim)… he is NOT those things OK!..

I repeat.. Ben Goldacre is NOT those things

He’s merely a misguided geek with patient interests at heart… isn’t he?…  yes..


The following quotes from David Healy’s latest post are an illustration of why I trust that he has patient’s interests at heart and the photo after it, of Ben Goldacre , is … well… that kind of speaks for itself.. (as does Ben’s recent belittling and sarcastic comments to me, Bob Fiddaman, David Healy and others in this debate).

I don’t see Ben Goldacre or Sense About Science engaging with people like me, or Bob Fiddaman- both damaged by GSK’s Seroxat. I don’t see them highlighting the plight and the horror stories of the hundreds of thousands of people who are damaged by pharmaceutical drugs either.

In fact, the attitude from doctors like Ben seems to me to be- ‘avoid pharmaceutical drug casualties like the plague- call us conspiracy theorists if we ask questions -and deem our criticisms as mere smears- our drug horror stories as anecdotal…’…

…the game seems to be to ‘silence us with ridicule and disparagement’ or ‘ignore us and we’ll go away’…

I can guarantee Ben, that if he was prescribed a damaging drug like Seroxat, and treated the way those injured and harmed by pharmaceutical drugs are treated and if he had to endure the lies of drug companies-  he would be a little angry about it too.. and quite rightly so…

When doctors, the regulators, the medical system, and even the government abandons you, often all you have left is the ability to shout..

We stand up for ourselves, because the people we entrusted with our health and our lives refuse to…


From David Healy’s latest: 

See more at: http://davidhealy.org/sense-about-science-follow-the-patient/#sthash.5nNxDICt.dpuf

“The simple act of defining doctors or patients concerned about adverse events as “critics” is a rhetorical stroke that marginalizes concerns – makes you  a one percenter rather than one of the ninety-nine”

“Despite doctors being trained to be ever more civil, patients who have a Drug Traffic Accident become nearly invisible to their doctors.  They are just healthcare kill.”

“When something does go wrong, the patient becomes a loser and is ostracised.  The herd moves on leaving the wounded animal to the hyenas”

“In essence, doctors have a choice.  They are either the steamroller that rolls over their patient or the steamroller rolls over them. The moment needs its John Le Carre to write The Doctor who came in from the Cold.  Just as I write this, news is coming in that some senior doctors have had the temerity to go public with claims – that despite Ben Goldacre’s paper on statins – these drugs cause significant problems.  Will they be shot as they attempt to get over the Wall?”

– See more at: http://davidhealy.org/sense-about-science-follow-the-patient/#sthash.5nNxDICt.dpuf

mySuperLamePic_aac1057823597aa502aa90bf16bea63a

ImageGen

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: 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.

From 2006: A Criticism of GSK And Their Transparency Deception : “From optimism to disillusion about commitment to transparency in the medico-industrial complex” by Iain Chalmers


Following up from my post yesterday, titled ‘Ben Goldacre: Wake The Fuck Up” concerning David Healy’s article on his blog titled ‘Fucked’, I think it might be timely to post Iain Chalmers article in the JRSM from 2006, titled :

“From optimism to disillusion about commitment to transparency in the medico-industrial complex”

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1484602/

Logo of jrsocmed

J R Soc Med. Jul 2006; 99(7): 337–341.
PMCID: PMC1484602

From optimism to disillusion about commitment to transparency in the medico-industrial complex

In the mid-1970s, I was involved with others in trying to assemble evidence about the effects of care during pregnancy and childbirth. We started by searching Medline to identify reports of controlled trials that we thought might be sufficiently reliable to be taken into account in our analyses; and then searched about 70 journals by hand, page by page, back to the issues published in 1950. We found about 3500 reports of controlled trials and, with help from the World Health Organization, we published the references to these in a classified bibliography in the mid-1980s.1

But then we thought, ‘What about trials that don’t get published? If we don’t take those into account, we might reach biased conclusions’. We knew of anecdotes about researchers who had had disappointing results of trials, and had therefore never made the results public. Furthermore, in an important analysis of controlled trials of treatments for cancer of the ovary published in 1986, an Australian oncologist, John Simes, had shown how failure to publish clinical trials could lead to misleading inferences about the effects of treatments.2 So we wrote to 42 000 obstetricians, paediatricians and other clinicians around the world to try to flush out information about studies that had been done but had never been reported. It was an almost complete waste of time; we published our experience to warn others to think carefully before using the retrospective survey approach we had used in our attempt to deal with publication bias.3

Like John Simes before us, we concluded that a prerequisite for tackling the problem of biased under-reporting of research involved registering controlled trials publicly, at inception, before their results could influence whether or not the world would come to know about them. In 1990, based on a paper I had presented at the 1st Congress on Peer Review in Biomedical Publishing, I published an article with the deliberately provocative title ‘Underreporting research is scientific misconduct’. I suggested that failing to report well-conducted clinical trials was not only scientific misconduct, but also unethical; it broke an implicit contract with the patients who had participated in clinical trials. I reiterated the call for registration of trials at inception.4

As it happens, all the examples of biased under-reporting of controlled trials I gave in that paper referred to non-commercial trials. The drug industry is not very interested in perinatal healthcare, the field in which I was researching at that time, because it does not offer very rich pickings. Ten years before my article was published, however, Elina Hemminki had shown that biased under-publication of studies funded by industry might be a particular cause for concern.5 She compared the study reports submitted by pharmaceutical companies to drug licensing authorities with subsequently published reports of the same studies. From this she found that studies in which the pre-licensing records showed that researchers had looked for adverse effects were less likely to be published than studies in which adverse effects had not been sought.

For the reasons already mentioned, I had had little contact with the pharmaceutical industry while I was a perinatal researcher. In 1992, however, I moved to the UK Cochrane Centre. As the Centre and then the Cochrane Collaboration began to become known to people in industry, representatives of the Association of the British Pharmaceutical Industry asked to meet with me. A delegation came to the UK Cochrane Centre, led by Frank Wells, the medical director of the ABPI. Our discussion lasted for about 3 h, during which I emphasized the openness with which the Cochrane Collaboration did its work: protocols for Cochrane reviews and completed reviews were published in electronic form, and could be criticized publicly, and readily amended if necessary.

After I had explained this, I felt it reasonable to suggest to my ABPI visitors that industry should be more open about its clinical research, because biased under-reporting could harm patients. Encouragingly, Frank Wells subsequently wrote in the preface of a book he had co-authored on fraud and misconduct in medical research: ‘Under-reporting of research is (another) form of misconduct, given that this can lead to seriously misleading recommendations for clinical practice and for new research’.6

The same year that this book was published, Mike Wallace, another member of the ABPI delegation and at that time the chief executive of Schering Healthcare Ltd (the British subsidiary of Schering AG), told me that he realized that biased under-reporting of research was ethically and scientifically indefensible. He felt that unless the pharmaceutical industry started to take an initiative to confront this issue voluntarily it would end up being forced to do so—probably in ways that it would rather not be. Mike Wallace said that he had decided to provide information about all his company’s controlled trials for publication in the Cochrane Controlled Trials Register. I know that he was reprimanded for breaking ranks in this way, in particular, by colleagues from other member companies of the ABPI. I am glad to be able to pay tribute to a senior nonmedical executive in the industry who stepped out of line to do something which he thought was morally correct.

Mike Wallace was not the only person within the British pharmaceutical industry taking steps towards greater openness, however. In particular, David Jackson, medical director of the British holding company of GlaxoWellcome, had persuaded his colleagues in the international parent company that the company should adopt a more open policy. The new policy was announced at the end 1997, and I was pleased to be quoted in the press release welcoming it. The following year, the chief executive of the company, Richard Sykes, wrote a landmark editorial in the BMJ entitled ‘Being a modern pharmaceutical company involves making information available on clinical trials programmes’. He made clear that one reason for Glaxo Wellcome’s new disclosure policy was ‘… to help those undertaking systematic reviews of clinical data and to help reduce the impact of publication bias’.7

GlaxoWellcome implemented the trials registration policy it had announced, and two of the people who were involved—Trevor Gibbs and Elizabeth Wager—later published an account of the challenges this had presented.8 Elizabeth Wager was head of the writers’ group within the company and she convened a group of her colleagues in other companies to agree and then publish guidelines for good publication practice. They noted that ‘… the aim of the guidelines is to ensure that clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner. The guidelines cover companies’ responsibilities to endeavour to publish results of all studies’.9,10

Things were stirring among pharmaceutical physicians more widely. In 1998 the Ethics Committee of the Faculty of Pharmaceutical Medicine declared that:

‘Pharmaceutical physicians have a particular ethical responsibility to ensure that the evidence on which doctors should make their prescribing decisions is freely available… the outcome of all clinical trials on a medicine should be reported’.11

Two years later they reiterated the ethical principle: ‘Studies are performed to increase knowledge in some way, and this knowledge should be shared with the wider world. Study findings should be communicated, whatever the outcome, for the benefit of the community at large’.12

Presumably because the ABPI felt that it could not really sit by while one of its major members, GlaxoWellcome, and the Ethics Committee of the Faculty of Pharmaceutical Medicine were showing a moral lead in this way, the Association decided to commend Glaxo Wellcome’s policy to other member companies. I was on the ABPI side of the table at the press conference announcing this policy, and I welcomed it wholeheartedly. In brief, I had become optimistic that the industry really was beginning to address the problems that I had urged should be addressed at our meeting eight years previously. Although the response was not nearly as good as the ABPI had hoped, AstraZeneca, Aventis, MSD, Novartis, Roche, Schering Healthcare and Wyeth did begin registering retrospectively those of their trials that had involved UK patients.

However, these hopeful signs were not sustained during subsequent developments. In the same year that the ABPI announced that it was leading the world in registering clinical trials, Glaxo Wellcome merged with Smith Kline Beecham. Initially, my optimism that the new company would maintain Glaxo Wellcome’s policies on trial registration seemed justified: the new company’s logo had replaced the Glaxo Wellcome logo on the trials register. I wrote to the chief executive of the merged company, Jean-Paul Garnier, to express my pleasure at this. I also mentioned that I was delighted that Elizabeth Wager and her six colleagues in the former. Glaxo Wellcome writing department, and their association with the Good Publication Practice for Pharmaceutical Companies Guidelines, continued to be supported by the new company. I never received a reply to my letter; the company abandoned the trial registration process and abolished its publications departments in the USA and the UK, headed by Elizabeth Wager and Elizabeth Field, respectively—both co-authors of the Good Publication Practice Guidelines for Pharmaceutical Companies.9,10

It was round about that time that increasing amounts of empirical evidence began to confirm doubts about the trustworthiness of research sponsored by industry. As I have noted already, Elina Hemminki had produced evidence of based under-reporting of industry research 20 years earlier: reports of studies submitted in support of new drug licences in which adverse effects had been sought were less likely subsequently to be published.5 A study using similar methods was reported in 2003 by Melander and his colleagues.13 Their paper entitled ‘Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry’ demonstrated result-dependent over-reporting and under-reporting of industry studies of new drugs. They concluded that any attempt to develop treatment recommendations using analyses based only on publicly available data were likely to be based on biased evidence.

Other evidence reported over the past 5 years has demonstrated associations between industry-sponsorship and research results favouring products made by the companies funding the research. As well as biased under-reporting of research, the associations observed may also reflect inappropriate comparison of new products with comparators of existing products in doses too low to be effective or higher than necessary, with consequent higher incidence of adverse effects.1417 Neither of these possible explanations is morally or scientifically defensible. In addition, there is evidence of more subtle forms of industry bias in the way that data are interpreted,18,19 for example, by putting a biased spin on the evidence. The title of a recent report20 says it all: ‘Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head to head comparison studies of second generation anti-psychotics’. One of the five key points emerging from the evidence presented at the 5th Congress on Peer Review in Biomedical Publishing was that ‘… the drug industry is successfully skewing the literature in its favour’.21

By now the public was starting to get interested in these matters. I was asked to write an article about under-reporting of research for the popular weekly journal New Scientist.22 In fact, I had co-authored a piece on the topic in the same journal 8 years previously.23 But now, something happened which made a real difference to the likelihood of the message about publication bias being taken seriously. Eliot Spitzer, the attorney general for New York State, took GlaxoSmithKline to court for withholding information about important possible adverse effects of drugs taken by children for depression.

The company settled out of court for a couple of million dollars, but the charge laid against it had the effect of increasing the pressure to deal with publication bias. It provoked the International Committee of Medical Journal Editors to do what the Committee should have done years earlier. It announced that the authors of any reports of clinical trials that had begun recruitment after the middle of 2005 would have to confirm that the studies had been registered publicly, at inception.

Only then did the drug industry start to try to limit the damage caused by its failure to follow the lead given by Schering Healthcare and Glaxo Wellcome nearly a decade earlier. In a press release issued in June 2004, GlaxoSmithKline announced that it would make the results of all its clinical trials publicly available. The company did not explain how, given that its trials register had been allowed to fall into disrepair, the public would know whether all results were being made available. A BMJeditorialist commented thus:

‘Last month GlaxoSmithKline announced that it would publish summaries of all its clinical trials of a new product once it had been launched. The decision followed news of a lawsuit brought by New York State alleging that the company had concealed the results of paroxetine because they might have spoiled marketing plans. GSK said it had been considering the move for some months. A similar sounding policy was announced by Glaxo Wellcome in 1998, but seems to have been quietly abandoned in 2000 after the merger with SmithKlineBeecham.’24

Industry’s attempts at damage limitation continue. Speaking on the BBC Radio 4 programme In Business on 24 June 2005, Jean-Pierre Garnier said: ‘We have responsibilities beyond those to our shareholders’, and ‘… we must be completely transparent with the public about what we do’. The gap between this statement and an analysis of the records submitted by his company (and other pharmaceutical companies) to the National Institutes of Health trials register25 suggests that GlaxoSmithKline’s understanding of what transparency implies may leave many people disappointed and cynical about the company’s expressed commitment to greater openness.

If GlaxoSmithKline really is committed to the kind of openness the public has come to realise is needed, one might have expected it to have endorsed the Good Publication Practice for Pharmaceutical Companies Guidelines developed by its dismissed former employees and colleagues in other companies.9 It has not. Indeed, at the time of writing, only six pharmaceutical companies have endorsed the guidelines—Aventis, Amgen, LEO Pharma, Otsuka, Serono and 3M Pharmaceuticals.10

The public is beginning to demand stronger sanctions. During 2004 and 2005, the Health Committee of the House of Commons held an enquiry into the influence of the pharmaceutical industry. The Committee drew attention to the problem of biased under-reporting of research and recommended registration of trials at inception.26 Richard Sykes, previously chief executive of Glaxo Wellcome, now rector of Imperial College London, gave oral evidence to the Committee which clearly impressed the members. In its report, the Committee’s recommendations began by noting Richard Sykes’ view that:

‘Today the industry has got a very bad name. That is very unfortunate for an industry that we should look up to and believe in, and that we should be supporting. I think there have to be some big changes.’

On 6 January 2005, the industry announced a global commitment to clinical trial registration and publication. Whether this commitment amounts to the‘big changes’ that Richard Sykes judges are needed is an open question. First, the commitment applies to only a tiny proportion of the clinical trials which should be informing prescribing practices because it is not being applied to trials conducted in the past. Second, there is a continuing flow of empirical evidence of biased reporting and interpretation of industry trials. My judgement is, therefore, that industry’s actions are simply too little and too late to deal with its current reputation for being less than honest with its research—just as Mike Wallace feared might be the case in his conversations with me a decade ago.

Biased under-reporting of research harms and sometimes kills patients, quite apart from the waste of resources that results from this form of scientific and ethical misconduct. In 2004, a former editor of the New England Journal of Medicine published a book entitled The Truth About The Drug Companies: How They Deceive Us and What To Do About It.27. How can we expect the public to trust the pharmaceutical industry and clinical researchers who work with it while we acquiesce in this state of affairs?

Jan Vandenbroucke has noted how science as an errordetecting process simply ceases to exist in these circumstances:

‘In all scientific debates all sides always have their own biases: we have no other way to look at data but to interpret them. However, in usual clinical or epidemiologic research, studies are repeated by others, in different settings and by different means, looking for biases, flaws, and ways of remedying them, endlessly arguing whether the biases are remedied or not. That is the essence of open scientific debate and criticism, which is the only guarantee for progress. That is no longer possible with pharmaceutical products because the monopoly of the pharmaceutical industry of studies of its own products leads to persistently one-sided studies that can no longer be questioned by studies from other sides. Moreover, the one-sidedness cannot be seen from the public record, that is the published papers. Without the possibility of open debate, science simply ceases to exist’.28

Careful thought needs to be given to this analysis by governments, public and charitable organizations, and individuals who promote research collaboration with industry while remaining silent about the unethical and unscientific behaviours alluded to above. As I have made clear, biased reporting and lack of transparency is not limited to commercially-sponsored research; but the empirical evidence makes clear that it is a particularly noticeable problem in that sphere. Those who collaborate with industry need to be clear that their acquiescence in these forms of scientific misconduct inevitably casts doubt on their integrity, as reflected in the title of a book by another former editor of the New England Journal of Medicine—On The Take: How Medicine’s Complicity With Big Business Can Endanger Your Health.29 The responsibilities of doctors should be unambiguously to their patients. Yet some clinician researchers (with plenty of encouragement from government and the institutions with which they are associated) appear to have become so seduced by the financial rewards resulting from collusion with industry’s agenda and practices that they have forgotten this most fundamental of their professional duties. Indeed, that is the most depressing cause of my optimism of a decade ago becoming disillusionment today.

A few weeks before finalizing a draft of this essay for submission to the Journal of the Royal Society of Medicine I was invited by Richard Tiner, medical director of the ABPI, to address a meeting of 60 or so members of medical departments of member companies on the topic of ‘clinical trial transparency’. In response I suggested that, rather than give a talk, it might be a more useful to pre-circulate the above text so that it could be discussed at the meeting, and Dr Tiner accepted this proposal.

It came as a bit of a surprise to me that there was no serious challenge to the facts I had assembled to explain why my earlier optimism had turned to disillusion. This may have been partly because it was clear that I have tried to work with industry over the past decade to increase transparency, and to commend publicly the positive steps that some individuals, companies and the ABPI had taken in that direction. Instead of giving me the rough ride that I had been expecting, participants at the meeting asked me for suggestions about what could be done to deal with the bad reputation to which Richard Sykes had referred in his evidence to the Health Committee of the House of Commons.

Although I made one or two off the cuff suggestions at the meeting, I realized that I needed to add to this essay some suggestions for steps that might go some way to increasing confidence in the scientific integrity of the industry. So, in conclusion, here are three practical suggestions:

  1. All pharmaceutical companies should join Aventis, Amgen, LEO Pharma, Otsuka, Serono and 3M Pharmaceuticals in publicly endorsing the Good Publication Practice Guidelines for Pharmaceutical Companies9,10
  2. Industry as a whole should put in place mechanisms for promoting and monitoring adherence to these guidelines, thus making clear to the public that it regards under-reporting of research as just as serious a form of scientific misconduct as fabrication of data
  3. Industry should voluntarily take steps that go beyond the minimum currently being required for clinical trial registration,30 for example, by publishing full protocols at the inception of all randomized trials.

 

I hope that I may be able to write another essay in 5 years’ time entitled ‘From disillusion to optimism about the scientific integrity of the pharmaceutical industry and the people collaborating with it.’

Notes

Acknowledgments I am grateful to Richard Sykes, Richard Tiner, Elizabeth Wager, Mike Wallace, Frank Wells, Jan Vandenbroucke, and participants at the ABPI meeting held at BMA House on 28 February 2006, for helping me to ensure that this account is accurate.

Competing interests None declared.

Note Listen to an audio interview with Iain Chalmers on [http://www.jrsm.org]

References

1. National Perinatal Epidemiology Unit. A Classified Bibliography of Controlled Trials In Perinatal Medicine 1940-1984. Oxford: Oxford University Press (for the World Health Organization), 1985
2. Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncology1986;4: 1529-41 [PubMed]
3. Hetherington J, Dickersin K, Chalmers I, Meinert CL. Retrospective and prospective identification of unpublished controlled trials: lessons from a survey of obstetricians and pediatricians. Pediatrics1989;84: 374-80 [PubMed]
4. Chalmers I. Under-reporting research is scientific misconduct. JAMA 1990;263: 1405-8 [PubMed]
5. Hemminki E. Study of information submitted by drug companies to licensing authorities. BMJ1980;280: 833-6 [PMC free article] [PubMed]
6. Lock S, Wells F. Preface to the second edition. In: Lock S, Wells F, eds. Fraud and Misconduct In Medical Research. London: BMJ Publishing Group, 1996: xi-xii
7. Sykes R. Being a modern pharmaceutical company. BMJ 1998; 317: 1172. [PMC free article][PubMed]
8. Gibbs T, Wager E. Realities of trial registration: the Glaxo Wellcome experience. Int J Pharmaceut Med 2000;14: 203-5
9. Wager E, Field EA, Grossman L. Good Publication Practice for pharmaceutical companies. Curr Med Res Opinion 2003;19: 149-54 [PubMed]
11. Faculty of Pharmaceutical Medicine. Ethical Issues Working Group. Ethics in pharmaceutical medicine. Int J Pharmaceut Med 1998;12: 193-8
12. Wells F, Lunnon MW. First Report of the Ethics Sub-Group. Society of Pharmaceutical Medicine. Int J Pharmaceut Med 2000;14: 58-64
13. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003;326: 1171-3 [PMC free article] [PubMed]
14. Djulbegovic B, Lacevic M, Cantor A, et al. The uncertainty principle and industry-sponsored research. Lancet 2000;356: 635-8 [PubMed]
15. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003;326: 1167-70 [PMC free article] [PubMed]
16. Bhandari M, Busse JW, Jackowski D, et al. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. Can Med Assoc J 2004;170: 477-80 [PMC free article] [PubMed]
17. Gardner W, Lidz CW. Failures to publish pharmaceutical clinical trials. Proceedings of The 5th International Congress On Peer Review and Biomedical Publication, Chicago, September2005.
18. Yank V, Rennie D, Bero L. Are authors’ financial ties with pharmaceutical companies associated with positive results or conclusions in metaanalyses on antihypertensive medications? Proceedings of The 5th International Congress On Peer Review and Biomedical Publication, Chicago, September2005.
19. Jørgensen AW, Gøtzche P. Sponsorship, bias, and methodology: Cochrane reviews compared with industry-sponsored meta-analyses of the same drugs. Proceedings of The 5th International Congress On Peer Review and Biomedical Publication, Chicago, September2005.
20. Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S. Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head to head comparison studies of second generation anti-psychotics. Am J Psychiat 2006;163: 185-94 [PubMed]
21. Fisğter K. At the frontier of biomedical publication: Chicago 2005. BMJ 2006;331: 838-40[PMC free article] [PubMed]
22. Chalmers I. In the dark. Drug companies should be forced to publish all the results of clinical trials. How else can we know the truth about their products. New Scientist 6 March 2004: 19[PubMed]
23. Pearn J, Chalmers I. Publish and be applauded. New Scientist 6 January 1996: 40.
24. Herxheimer A. Open access to industry’s clinically relevant data. BMJ 2004;329: 64-5[PMC free article] [PubMed]
25. Zarin DA, Tse T, Ide NC. Trial registration at ClinicalTrials.gov between May and October 2005. N Engl J Med 2006;353:2779-87 [PMC free article] [PubMed]
26. House of Commons Health Committee. The Influence of The Pharmaceutical Industry, 4th Report of Session 2004-05. London: Stationery Office, 2005
27. Angell M. The Truth About The Drug Companies: How They Deceive Us and What To Do About It. New York: Random House, 2004
28. Vandenbroucke JP. Without new rules for industry-sponsored research, science will cease to exist. Rapid response on bmj.com, posted 14 December 2005 [http://bmj.bmjjournals.com/cgi/eletters/331/7529/1350]
29. Kassirer J. On The Take: How Medicine’s Complicity With Big Business Can Endanger Your Health. New York: Oxford University Press, 2004
30. Sim I, Chan A-W, Gülmezogğlu AM, Evans T, Pang T. Clinical trial registration: transparency is the watchword. Lancet 2006;367: 1631-3 [PubMed]

Articles from Journal of the Royal Society of Medicine are provided here courtesy of Royal Society of Medicine Press
Iain Chalmers

Ben Goldacre: Wake The Fuck Up!



“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” (David Healy).

“Clinical trials are the gold standard way to hide adverse events” (David Healy).

“it would be better for mankind if all clinical trial data were sunk to the bottom of the sea rather than being made visible to academics stuck in a submarine and only able to view things through a periscope, which is what the GSMA-ESK system offers”. (David Healy).


bggHEALU
1362503627273.cachedI was supposed to be taking a break from blogging but reading David Healy’s latest blog post (titled ‘fucked‘ ) this morning made me very annoyed. I won’t go into detail about the post here, but I will post it in its entirety, because personally I think that David Healy is one of the few commentators out there worth listening to; particularly in matters regarding GSK and their so called ‘Transparency’ era. I seriously hope Ben Goldacre begins to wake up and smell the coffee, because if what David (and others) have observed comes to fruition and patients and consumers of pharmaceutical drugs are put at even greater risk, than they are already- because of this sham ‘transparency’ smokescreen– then Goldacre and his cohorts will be partly responsible. The sub- title of Ben’s book is ‘how drug companies mislead doctors and harm patients’. Isn’t this ironic considering GSK are misleading Dr. Ben Goldacre, and in the process- this is inevitably going to harm more patients?

If Goldacre really wants to help patients and hold pharmaceutical companies to account (as he claims) then he needs to begin to listen to people like David Healy, or at the very least begin a dialogue. So far, all I have seen and heard from his direction is arrogance and hubris. As I have said before on this blog: Would The Real Ben Goldacre Please Stand Up?

And if you can’t get real and stand up Ben, please- for the sake of those who are trying to get through to you- just maybe do yourself a favor and wake the fuck up!…


http://davidhealy.org/fucked/#comment-105798

Fucked

Editorial Note: Apologies for the Language

A year and a half ago this blog ran a series of posts about access to clinical trial data – reporting on how industry were going to engineer the appearances of transparency.  See Won’t get Fooled AgainAccess to Clinical Trial Data, and  The Data Access Wars.

Do Academics have Wild Dreams?

Several months later, soon after being fined $3 Billion, GSK trumpeted their endorsement of transparency by signing up to the AllTrials campaign and declaring their intention to put in place a method to allow researchers access to clinical trial data that would go beyond the wildest dreams of researchers.  See April Fool in Harlow, and GSK’s Journey.

Its all to easy to imagine a marketing department figuring that academics don’t have very wild dreams.

When GSK signed up to AllTrials Ben Goldacre rolled over and purred.  The BMJ featured Andrew Witty on their front cover as the candidate of hope.

Rain on the Parade

In contrast, on this blog, 1boringoldman and on RxISK a small group have warned consistently that this was not good news.  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.

No one wanted to rain on the AllTrials parade – it never seems like a good idea to fracture a coalition. RxISK put the AllTrials logo on its front page.

Not content with a few academic ghost authors, GSK’s maneuver has put industry well on the way to making Academia a ghost, a glove puppet manipulated by company marketing departments.

Meanwhile Iain Chalmers co-wrote an editorial with GSK endorsing the GSK approach (The Attitude of Chicks to Trojans and Horses) and the British Government produced a document on clinical trial data access that could have been written in GSK central.

The GSMA-ESK Model

The great hope for those dismayed at all this lay with EMA who following Peter Gotzsche’s initiative and a European Ombudsman’s ruling looked like a beacon of hope.  But this week EMA has come out and said it is going to put in place the GSK model of data access.

Everyone is in a spin.  AllTrials are asking for more donations to continue their successful campaign.

As someone who has been working the GSK system, I can say with confidence that this is a disaster.

The key thing that companies are trying to hide are the data on adverse events.  To get to grips with the adverse events in a clinical trial is a bit like playing the children’s game Memory – where you have a bunch of cards with faces turned face down and you get to pick up two and then have to remember where in the mixture those two were when you later turn up a possible match.

Patterns of Deception

In the same way, picking up adverse events is about recognizing patterns – patterns of events, and patterns of deception.

To do this you have to be able to spread maybe a hundred documents out over a big area and dip back into them if something in one document reminds you of something in another.  The new GSMA-ESK remote access system simply won’t allow this.

Not only will it not allow this but it is about to make things far far worse than they are at present.

At the moment when it comes to studies like Study 329, GSK have been stuck by a Court order with putting the Company’s Study Reports up on the web where they can be downloaded and pored over – all 5,500 pages of them for Study 329.  They have refused to do the same for the 77,000 pages of raw data from Study 329, making it available to a small group of us through a remote desktop system.

For all other trials – future and past – investigators won’t even be able to get the Company Study Reports in usable form.  They too will only be accessed remotely.

For anyone who wants to look at the efficacy of a drug this might just about work for outcomes that involve rating scale scores or lipid levels.   The efficacy of drugs is pretty well all that most Cochrane groups, Iain Chalmers and Ben Goldacre are interested in.  The Cochrane exceptions have been Tom Jefferson, Peter Doshi and the Tamiflu group.

But this system is a bust when it comes to adverse events and it won’t work if the efficacy outcomes are in any way complex.

What can be done?

The first point to make is this.  Clinical trials are not all they are cracked up to be.  Even if well designed, not using surrogate outcomes, of sufficient duration, done on patients who actually exist, and not written up by ghostwriters, clinical trials systematically get the wrong answer, especially on adverse events.  Clinical trials are the gold standard way to hide adverse events.

One of the risks of the data access wars is that it will put an unwarranted premium on clinical trials and their data – and in this way play straight into pharma’s hands. This is what led “Crusoe” to warn Peter Gotzsche a year ago that his data access crusade might backfire – See Marilyn’s Curse.

Let’s make no mistake here – it’s morally indefensible that there is not full access to the data from scientific experiments.  In this sense Peter is right and his outrage is well-placed and close to magnificent.

But, ceteribus paribus, it would be better for mankind if all clinical trial data were sunk to the bottom of the sea rather than being made visible to academics stuck in a submarine and only able to view things through a periscope, which is what the GSMA-ESK system offers.

It might have been better if AbbVie had won their legal action.  Instead EMA’s accomodation with them has fucked us all.

Rape is a loaded word these days but in so far as what is happening is an abuse of consent and will primarily do harm to women and children it perhaps come close to being the best word.  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. See When Does Yes Mean No.   Iain Chalmers, Ben Goldacre and AllTrials appear to have signed up to this.

Whether raped or fucked, the Dan Markingson case is a stunning example of what has gone wrong – the Markingson petition is probably a much better petition to sign if you really want to save yourself and others you know and love than the AllTrials one.

Let’s Do the AbbVie Again

Second the data companies are really hiding is their adverse event data.  There are other ways to collect adverse event data.

We invited you 18 months ago to join an AbbVie – Let’s Do The AbbVie Again.  This Irish invention is the reverse of a boycott – another Irish invention.

A boycott of a company’s drug would mean you don’t get the benefit.  If you decide to AbbVie a company’s drug, you – we – can all make these drugs better by reporting on the effects they have.

Company efforts are geared more than anything else to ensuring that doctors and patients don’t report adverse events or ensuring that these events don’t register.  If you really want to get up their nose, if you really want to send the marketing departments into a spin, if you really want a company CEO to blow a fuse, this is what you need to do.

Companies want to transform adverse events into non-information.  You can stop this happening. If an event happens to you on a drug, you are in possession of the missing information.  It’s our tolerance of the patients who have Disappeared in clinical trials that is killing medicine as we have known it.

AbbVie with us and then sit back and take pleasure in a marketer who says “Thank you for helping us make our drugs better – without you we couldn’t do it“.

Now there is of course a huge conflict of interest here.  RxISK.org was set up precisely for this purpose – to register adverse events. But we will hand all events on to FDA or MHRA or whoever you want us to.  What we will also do though, and we invite any doctors or others out there with backbone to help us do it, is to decide when a drug is causing an event – this is something no regulator will ever do for you or for anyone.

Boycott

The other option is a Boycott.  Doctors could refuse to prescribe drugs for which the information was not fully available.  The Panalba and Thalidomide cases have shown that this is the one thing industry is scared of – Report to the President.

If I made claims about a drug to my colleagues but refused to show them the data, they’d have no problem telling me to get lost. I’d be boycotted from here to kingdom come.  But when it comes to industry, 99% of doctors lack balls

Doctors have been given a license to degrade us by treating us like addicts – the origins of prescription-only status.  They have been given a license to print money – we can only get our drugs through them.  The very least they could do in return is show some backbone.

But this is a decadent situation and decadence rarely breeds courage.

Emily’s Balls

The boycott was likely invented by Irish women.  The Abbvie was too.  There is one bulwark still standing in the way of GSMA-ESK.  It’s the European Ombudsman, an Irish woman – Emily o’Reilly.

– See more at: http://davidhealy.org/fucked/#comment-105798

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The Great Glaxo Transparency Swindle… Prof. David Healy says ‘now is the time of greatest peril’…


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http://davidhealy.org/welcome-to-troy/#comments

Trojan Horse

The press coverage of AbbVie’s withdrawn legal action suggests that most major companies have now embraced an option for transparency pioneered by GSK.

All Trials are among those taking credit for pressuring AbbVie into submission. They have aggressively welcomed the offer by GSK to make clinical trial data available with no questioning of the terms on which the data is being produced.

But GSK’s offer is a manoeuvre worthy of Ulysses himself. You’d never guess from company self-congratulation that it was forced on GSK by a New York Court as part of the resolution of a Fraud action. The Fraud Action happened because GSK had written up a positive portrayal of a trial when in fact the company itself thought the trial had shown their antidepressant, Paxil, did not work.

The trial – Study 329 – was test of Paxil in children. As mandated by the Courts in the wake of Study 329, GSK put up company study reports for all of their trials, Paxil and other drugs including the diabetes drug Avandia. These could be downloaded. Steve Nissen of the Cleveland Clinic did just this for the Avandia reports and was able to show that Avandia killed.  A company blockbuster was stopped in its tracks.

Poacher turned Game-Keeper?

Putting study results up on the web must have seemed like a very bad idea to GSK. So why are they now championing data access?

GSK and other companies are reaping kudos for apparent transparency. And they can say with a straight face to any TV anchorman or Congressional committee that they are making data available.

But in fact here is what is happening. Having seen what happened with the Avandia study reports GSK now know what to do when writing a Study Report to avoid a repeat. Suitably Doctored Study Reports for other drugs will go up on their website.

The Study Reports however do not contain the data. A first approximation to the data in the case of Study 329 comes in a series of 7 appendices to the 329 Study Report – something GSK did not put up on the company website until the omission was spotted nearly 10 years later by Peter Doshi and New York State required them to do so.

In the case of Study 329, the ghostwritten article that led to GSK being sued for fraud, is 11 pages. The Study Report is over 700 pages. There are then 7 appendices that between them come close to 5500 pages. Even this however is not the raw data.The raw data lies in Clinical Report Forms.

You can Look but you cannot See

As things stood before GSK’s offer of transparency, the 5,500 page of appendices and 700+ pages of the Study Report could be downloaded and printed off. Finding what went on in a clinical trial from paperwork like this is a bit like playing Memory – where there a bunch of cards with faces or plants or whatever turned face down and if you turn one up you have to remember where the matching face you turned up before is. It can be done with 5,500 pages printed off.

But playing Memory is much harder to do now with the new improved access GSK is offering.

If you apply to access a GSK trial now you are forced to submit an analytic plan which essentially stops an applicant from accessing any adverse events on the drug. Adverse events are the material the company tries hardest to hide.

Should you get access to the full set of appendices that contain company listings of adverse events, there is almost no way to play the Memory Game because access is through a remote desktop. It may be that a younger generation used to playing Digital Memory will be able to work the system, but it’s not easy. It takes multiple passwords to access the desktop. You are logged out regularly. And while on the desktop, GSK can monitor your every keystroke.

Nightmare in Harlow

But here’s the rub. To really nail down what’s going on, you need access to the approximately 70,000 pages of patient level data. Through a remote desktop this becomes a nightmare.

This scheme to deliver frustration cloaked in the appearances of transparency was devised several years ago. 

The history of the idea was outlined two years ago in May Fool’s Day. Last year the details of GSK’s scheme were outlined in April Fool in Harlow.

– See more at: http://davidhealy.org/welcome-to-troy/#comments

Neil1Neil2

 For more on The Ben Goldacre/GSK/Data Debacle See My Previous Posts Here:
https://truthman30.wordpress.com/tag/ben-goldacre/
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Ben Goldacre Slams Roche For Tamiflu Scam, Yet No Mention of GSK for Relenza?..


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The UK government has spent £473 million on Tamiflu and £136 million on Relenza since 2006, and other countries have stockpiled it too.

When the government made the decision to stockpile the medications its medicines regulator MHRA had not seen all of the evidence” 

(From AllTrials : http://www.alltrials.net/2014/we-need-all-information-from-clinical-trials-to-make-decisions-about-medicines-tamiflu-relenza-study-shows/)

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In a recent post I drew attention to how Roche and GSK basically defrauded the UK Government/Tax Payer out of almost half a billion pounds by stockpiling the practically useless drugs, Tamiflu ( by Roche) and Relenza (by GSK).

The post was basically an article I pasted by Sarah Boseley, of the Guardian, in it she mentions how the UK wasted money on both flu drugs. See Here:

Britain had stockpiled these flu drugs in case of an outbreak and after the (media induced) hysteria about Swine Flu died down, subsequent inquiries in recent times, found that not only was the supposed epidemic merely media hype, but the supposed effectiveness of both the drugs in question were also vastly over hyped too.

It is estimated that over half a billion pounds was wasted on these drugs, with Roche’s Tamiflu costing the lions share at over 400 million while Glaxo’s Relenza cost the country almost 136 million pounds.

The vast majority of media reports about the Swine Flu Scam have included the names of both companies and both drugs, apart from,
it seems Ben Goldacre’s reporting, also, in the Guardian

I think Mr Goldacre should explain why he consistently berates Roche for Tamiflu, yet rarely challenges (or focuses his attention on) GSK about their misdeeds.(see here)

Is there a little favoritism here towards GSK on the part
of Mr Ben Goldacre perhaps?…

I have written before about his strange admiration for GSK’s Andrew Witty…

See the link-

https://truthman30.wordpress.com/2013/11/19/ben-goldacre-bad-pharma/

Here is the headline from Ben Goldacre’s spin on the
Swine flu scam:

http://www.theguardian.com/business/2014/apr/10/tamiflu-saga-drug-trials-big-pharma

“What the Tamiflu saga tells us about drug trials and big pharma

“We now know the government’s Tamiflu stockpile wouldn’t have done us much good in the event of a flu epidemic. But the secrecy surrounding clinical trials means there’s a lot we don’t know about other medicines we take”

I have read through the whole article, and although it is extremely lengthy, there is not one mention of GSK’s flu drug Relenza, or the fact that, according to the other reports (including from Ben’s Alltrials website) Relenza cost the UK almost one hundred and thirty six million pounds…

Ben does mention GSK in his report, but he mentions them in a positive context (however there is no mention of the Relenza scam, GSK’s behavior in the Swine Flu swindle, or the 136 million of their wasted stockpile).

It’s almost as if Goldacre has chosen to omit GSK’s large part in this scandal

Ben Says:

“While the battle for access to Tamiflu trials has gone on, the world of medicine has begun to shift, albeit at a painful pace, with the European Ombudsman and several British select committees joining the push for transparency.

“The AllTrials campaign, which I co-founded last year, now has the support of almost all medical and academic professional bodies in the UK, and many more worldwide, as well as more than 100 patient groups, and the drug company GSK.”

Goldacre also mentions the amount of ‘half a million’ wasted pounds, but he only mentions it in relation to Tamiflu, which gives the distinct impression than it was only Roche with Tamiflu (and not, in part, also GSK with Relenza) that defrauded the UK people and the UK government out of this money…

Make from that what you will…

Ben goes on to say:

“Should we have spent half a billion on this drug?

That’s a tricky question. If you picture yourself in a bunker, watching a catastrophic pandemic unfold, confronting the end of human civilisation, you could probably persuade yourself that Tamiflu might be worth buying anyway, even knowing the risks and benefits”.

And in any case, that £500m is the tip of the iceberg. Tamiflu is a side show, the one place where a single team of dogged academics said “enough” and the company caved in.

For a comparison  with Ben’s reporting, see some of the other headlines and articles below:

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From Alltrials:
“The UK government has spent £473 million on Tamiflu and £136 million on Relenza since 2006, and other countries have stockpiled it too. When the government made the decision to stockpile the medications its medicines regulator MHRA had not seen all of the evidence”.
“Full access has allowed us, for the first time, to quantify the harms and the lack of benefits of Tamiflu and Relenza, which have been extensively stockpiled around the world. What we need to do now, is have the courage to make all clinical study reports available for treatments that are currently available and used.”
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“Dr Ben Goldacre, author and co-founder of AllTrials:
This is a pivotal moment. Tamiflu has become the poster child for clinical trials transparency”

Whereas, presumably, now GSK have become the poster-child for ethics?..

The mind boggles…

Ben Says:
“there’s a lot we don’t know about other medicines we take”…
There certainly is a lot we don’t know about medicines  Ben.. but there’s also a lot we don’t know about the pharmaceutical companies who make them.. considering what we do know is dreadful, appalling, disturbing and sinister… then what we don’t know would likely be utterly horrifying…