Study 329 Trick, Treat or Treximet
I hadn’t seen this lecture before. It gives a really insightful and compelling perspective on the events, leading up to, and surrounding, the Seroxat Scandal, and where we are today in regards to access to data from GSK etc.
Dr Healy is outstanding, as always.
Well worth watching.
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:
“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?”
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?
This is the comment he posted, repeatedly :
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):
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
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
For more on The Ben Goldacre/GSK/Data Debacle See My Previous Posts Here: https://truthman30.wordpress.com/tag/ben-goldacre/
Lives Touched by GSK
Notes of a Paxil Guinea Pig
What does GSK owe to the youngsters in its infamous Study 329 who became suicidal while taking the company’s paroxetine (Paxil/Seroxat)?
As someone who was briefly a GSK Guinea Pig, I’d say the most important thing they’re owed is the truth. It’s a highly delinquent debt – but it’s not too late for GSK to pay up.
I took part in a study of Paxil back in 1994. Like many U.S. subjects, I signed up mainly for the free medical care: I was tired of battling my employer’s HMO which doled out mental health treatment with an eyedropper. However, having already taken Prozac with little or no effect, I was also as curious as anyone to find out if these drugs “worked” or not, according to Big Science. I was willing to be a guinea pig if it would lead to some answers.
The protocol was that everyone was put on Paxil for a number of weeks, after which half of us would be switched cold-turkey to placebos, the other half would continue on Paxil.
Supposedly, this would determine whether people with “recurrent depression” should stay on long-term Paxil maintenance therapy. Looking back, however, what the study really did was to produce drug-withdrawal distress, then interpret that as the original depression coming back.
And most likely, by 1994, GSK knew that.
Treatment Related Injury?
After the switch to either placebo or Paxil I fell asleep at the wheel of my car and had an auto accident with minor injuries. I didn’t want to drop out – I was pretty sure the cause of my accident wasn’t Paxil, but working a sixteen-hour shift. But I was told the study protocol demanded my removal. Not knowing the research design, I never found out whether they were being conscientious, or just the opposite – dropping my results to cover up problems.
The Paxil hadn’t helped me much. But after the switch, I quickly felt the ground under my feet get rockier, at least for awhile.
Well, I thought, it didn’t feel like the Paxil was doing me any good – but here I was feeling worse without it. It didn’t occur to me that this could be down to Paxil withdrawal, because I had never heard of it.
Once the blind was broken, the researchers confirmed I had indeed been switched to placebo.
I never found out if my study was published. When I finally saw a psychiatrist, his reaction was that this had been a “pretty stupid study,” because “everyone already knew” that people like me who’d had several depressive spells should be on medication for life. That makes me think there were already multiple published studies of this type – and possibly dozens more that the drug companies never bothered to publish.
GSK & Responsibility
I’m angry with GSK, not only for putting me through Paxil withdrawal, which, thank god, was not severe in my case, but also for what they later did to me and other patients by hiding the results. They and the other drug manufacturers led millions of us to believe we needed these drugs for life, “just like diabetics need insulin.”
At a minimum this deprived millions of people of a normal sex life, and may have numbed their ability to respond to life in other ways. Untold numbers of children have been exposed in utero. And I and millions of others became part of a twenty-year uncontrolled experiment on the long-term use of these drugs to control a “deficiency” that we may never have had.
For the kids in Study 329 who became suicidal on Paxil, GSK’s deception may have done much worse. To this day, I’d bet some of them don’t know the role of the drug in their suicide attempt. Being “the kid who tried to hang himself at fourteen” affected how they saw themselves, to say nothing of how their families, schools and juvenile courts may have seen them. It’s long overdue – but not too late – to tell them that “what you did was not necessarily your own doing.”
Knowing the facts about the limited effectiveness of these drugs could also open doors for those who have not responded to them. For two decades we’ve been told we were a small minority whose condition, being Treatment Resistant, must be very grave indeed. That verdict led many to accept punishing multidrug treatments, ECT, or simply becoming resigned to a life of disability.
Like the kids in Study 329, we deserve the opportunity to rewrite the life story handed to us by well-meaning professionals acting under the influence of GSK.
It’s not too late to learn something useful from the changes GSK put us all through. It might help us learn more about SSRI withdrawal and SSRI-induced agitation, including who suffers what effects and why. I have no idea what consent forms I signed 20 years ago, but I sure as hell never intended to give GSK the right to hide the results of the experiment they ran on me.
GSK owes me the truth. It owes at least as much to many others, like the kids in Study 329, who suffered far more than I did. To say nothing of the patients who never took part in research, but whose lives were altered by it nonetheless. It would have been infinitely better if they had owned up twenty years ago. But that’s no reason to write off the debt now.
– See more at: http://davidhealy.org/lives-touched-by-gsk/#comments
Three days ago I wrote a blog post titled: “Would The Real Ben Goldacre Please Stand Up?”. The gist of the blog post was a general illustration of how people (particularly doctors, psychiatrists and academics) can be seduced and manipulated by the pharmaceutical industry. I used Ben Goldacre as an example because quite frankly- his stance on the pharmaceutical industry confused me. On the one hand- he writes about drug company corruption and advocates for better access to clinical trail data- but on the other- he accepts awards from GSK (one that I am aware of anyhow) and gushes undue praise on the management of the company (GSK ) that he criticizes in his books.
I find this attitude baffling. I really do.
I understand that there are obvious overlaps within the pharmaceutical world between the industry, regulation, academia, universities, marketing and science etc. It is common for scientists and academics to receive bursaries and funding for research (particularly early on in their careers) and this doesn’t always mean that a conflict of interest, a bias, or corruption comes along with that -but what really frustrates me is how the industry (and those attached to it) doesn’t seem to see anything wrong with this generally. It’s as if there is an attitude of- “it’s so rampant and ingrained” that they wonder why anyone would question it? The attitude seems to be- “everyone has either done it- is doing it- or will do it” so what’s the problem?
And herein lies exactly the problem…
Because it is so widespread: this forms the crux of the problem! Industry has too much power and influence. That’s the problem!
Companies like GSK have their monetary tentacles in literally every facet of UK society. Globally they are powerful too- but it is on their home-turf where they are virtually untouchable. They basically operate above the law.
Why is this?
It’s simply because they are the UK’s biggest drug company (and second biggest globally)- they are massively important for the UK economy- not just in terms of jobs in research, development, factories etc- but also in terms of what they donate to, support, and sponsor in regards to universities, science, scholarship etc. They are massively influential. Too influential.
Often it is difficult to entangle who is indirectly being funded by pharmaceutical companies because they can sometimes donate to organizations (patient groups, astro-turfing) who then funnel funding through to different people and on to individuals. And then we have the problem of who owns stocks and shares in companies like GSK? How does that influence policy? How much influence and power do GSK have over politicians, the government, regulation, academia, etc etc etc.
From what I have researched- GSK have immense power in the UK. Too much power.
This wouldn’t be a problem if GSK were an ethical and moral drug company who cared about patients before profits. But, alas they are not. They are just simply not ethical and they have never given any reason for us to believe that they ever will be.
I could rattle off dozens of instances of GSK’s unethical behavior but I won’t as I have almost 500 blog posts documenting that.. and I think anyone who knows the industry would have to be aware that GSK are amongst the worst offenders of corporate crime of recent times…but anyhow all that has been documented on this blog and all over the web so I won’t talk about that now…
But what I would like to talk about is Ben Goldacre’s comments on my blog-post.
I did not expect Ben Goldacre to comment on the blog-post and I was surprised when I noticed views coming from the Guardian. I did not expect the comments after the post to turn into something of a debate either. Furthermore, I honestly have had little interest in Ben Goldacre until recently. I was aware that he was involved in Alltrials and wrote Bad Pharma, but it wasn’t until I began to think to myself that he was possibly being manipulated by GSK that I started to research stuff online.
I don’t think that Ben Goldacre is corrupt at all. Not in the slightest bit. I think his heart is sincerely in the right place. I honestly think he is one of the good guys and I think he genuinely wants to do the right thing, but I do think he could be being misled by GSK and I think it could be precisely because of his trusting nature that GSK have endorsed him and his Alltrials organization. I also think GSK are cynically using his celebrity and popularity for PR purposes – and I hope Ben begins to see that too, or at least becomes a little aware of it…
That’s just what I think and that’s my opinion- and that was the purpose of the blog post. I hope I am proved wrong and that GSK will give access to all their trials- particularly the raw data- nobody would like that more than me- it’s what I have been calling for – for several years on this blog! I was prescribed Seroxat and I would love to know what GSK have hidden about that!
However, I have been scrutinizing GSK for a long time now- and I just do not trust them- nor will I ever -and I think it’s foolish to approach them with anything but mistrust and caution. They have broken every promise in relation to trial data so far so it is likely that they will not change their policy now, or they will find a way around all this… they always do. If they do give data it will be on their terms- they will not do anything that goes against their interest- they never do.
I could go on and on about how corrupt, fraudulent and criminal GSK are but everyone knows that- or at least they should!
But I would like to sincerely say to Ben..
and if you would like to contact Bob Fiddaman – he has information that he would like to pass on to you- it might help..
E-mail him here:
Good luck 🙂
Ben Goldacre is a doctor, journalist, blogger and writer whose media profile has risen exponentially over the past few years, particularly with the release of his last book on the pharmaceutical industry, Bad Pharma. But who is the real Ben Goldacre- and what does he really stand for?
Whilst Bad Pharma catapulted Ben Goldacre’s career firmly into the mainstream (and his trendy hip-doctor/guardian-journo persona seemed to capture the interest of the public imagination)- the content of Bad Pharma had more or less been covered already by other writers such as David Healy , Marcia Angell and others- over the years.
Actually, most of the topics and issues in Goldacre’s book had also already been covered on this blog alone – predating the content of his book by five years ( I set up this blog in 2007- Bad Pharma was published in 2012).
In other words- for a seasoned pharmaceutical industry critic, patient advocate, ex-Seroxat addict and blogger like me – what he had to ‘reveal’ about the badness and misdeeds of pharmaceutical companies was hardly revelatory at all. I could have written it myself as I was certainly familiar with most of the information.
All that aside- what interests me most about Goldacre is his association with GlaxoSmithKline.
Back in 2003- Goldacre received the GSK/ABSW award for his Guardian article ‘never mind the facts’. The article itself was basically a rebuttal piece in defense of MMR Vaccines and thus in turn- a defense of the pharmaceutical companies who make them and somewhat of an attack on those who claim that they can cause harm.
I am no expert on vaccines or their link to Autism, nor would I ever claim to be- but I am well versed in pharmaceutical misdeeds- in particular those of GSK (I have been researching and blogging about GSK related issues for over 7 years now). I am aware that one of GSK’s vaccines, Pluserix was banned in 1992 and like other GSK medicines- such as Seroxat and Avandia- not only was it causing immense harm- but GSK were allegedly aware of it.
From my own experience of Seroxat- I would like to categorically state that I believe GSK were aware that Seroxat might harm me but like many instances with many other GSK products, they failed to warn- because all that matters to GSK is the health of GSK. Profit is the bottom line. Patients- like me- are merely collateral damage. However, considering that Goldacre is a psychiatrist (a fact he seems resistant to overtly publicize) maybe he just doesn’t care much for those who claim to be harmed by psychiatric drugs like Seroxat? Nonetheless- there is surely enough quackery and pseudo-science in Seroxat marketing which could keep a self-proclaimed quack-buster like Goldacre steeped in column inches for months.
GSK have a murky history of malpractice and deception- their corporate history is littered with headline after headline of disturbing unscrupulous behavior. They are quite simply- pathologically sociopathic when it comes to harming the public. As a physician- I am surprised that Ben Goldacre would be so quick to jump to their defense- surely fraudulent clinical trials, intimidation of critics and widespread corruption resulting in damage to patients- would go entirely against the physician’s hippocratic oath?
Not so- it seems… in Ben Goldacre’s world.
Below is a picture of Goldacre receiving his BSW/GSK ‘science writers’ award from (none other than) GSK’s infamous Seroxat apologist Alastair Benbow (pictured right) in 2003. Apparently the award includes a 2000 pound bursary. (see link) http://www.badscience.net/2006/07/test-2/
Benbow was interviewed by BBC Panorama for their Seroxat documentaries and in (a diabolically delivered) defense of Seroxat he basically eventually admitted that Seroxat caused some children to commit suicide (after previously denying this in the Panorama documentary before it). Chillingly, Benbow seemed to think that this fatal side effect was almost inconsequential in the grand scheme of pharmaceutical depression treatment.
The year Mr Goldacre was receiving awards from GSK for writing articles in favor of the pharmaceutical industry, was also the year that coroners in the UK were calling for a withdrawal of GSK’s Seroxat from the market (see here).
2003 was also the year that (due to overwhelming evidence from the public) GSK were forced to abandon their no addiction claim about Seroxat. (see here)
The year that Ben was posing with an award from a GSK funded initiative is also the year that the UK regulator banned Seroxat for under-18’s due to it’s propensity to make them suicidal- a sinister fact that GSK failed to inform the public of- for years. (see here)
(Thankfully, for users of Seroxat, it was Ben Goldacre’s colleague- Sarah Boseley of the Guardian -who covered most of these stories)
According to a tweet (screen-grab below) sent in 2010 in response to Seroxat Secrets, Goldacre, knows the’ Seroxat story well‘ and apparently he thinks it’s ‘vile‘. If this is the case then perhaps he would relay his opinion on Seroxat to his chum Andrew Witty because Mr Witty doesn’t seem to give a damn about Seroxat at all. If Goldacre really thinks that the Seroxat story is so vile- then why be so chummy with GSK?
Goldacre’s stance on pharmaceutical companies seemed to take a sharp turn with the release of Bad Pharma, which on the surface paints them in a very negative light. However, since most of the content of Bad Pharma had already been covered either online, by blogs, in news-articles or in print form already- one would have to question whether it really had any negative impact at all on the reputation of the industry? Did it enlighten us to anything we did not know already?
An insightful (albeit also complex) review of Bad Pharma from David Healy (not so bad pharma) seems to conclude that the problem with Bad Pharma rests not upon the repetition of content already covered, or the many flawed arguments raised which seem to rally against the pharmaceutical industry but actually often work in their favor, “but on the premium Ben puts on controlled trials not found in other books”.
You would have to read Healy’s review a few times to understand just how flawed and -dare I say it- impotent –Bad Pharma is- particularly from a patient’s (or patient advocate’s) perspective. Perhaps it’s justified to ask- if a book highlighting the badness of Pharma actually serves to work in their favor in the long term- what use is it for the benefit of the public? Are we any safer? Possibly not.
In a video of a parliamentary discussion of clinical trial transparency in the UK parliament from April 2013- Goldacre sits alongside GSK exec- James Shannon, and William Burns from Roche (19:06:00). In this inquiry, Goldacre refers to GSK as being ‘rather badly behaved‘ in the past- he then goes on to congratulate them on their current progress towards atonement (a fairy-tale like ‘atonement agenda’ which Goldacre seems to be swallowing hook-line-and sinker). The irony of this is- GSK have no intention of giving any access to clinical trials which predate 2000- therefore trials on drugs like Seroxat will not be released for inspection (Seroxat Trials pre-date the 90’s).
I find Goldacre’s choice of words also quite astounding- ‘rather badly behaved‘ really doesn’t describe the destruction of life from a defective drug like Avandia or Seroxat. “Rather badly behaved‘ doesn’t illustrate the magnitude of a 3 Billion dollar fine for fraud and corruption does it? “Rather badly behaved‘ is the kind of phrase we might use in regards to naughty children who won’t do their homework- not the UK’s biggest drug company (with the responsibility and power to enhance or extinguish human life on any given day depending on which way their ethical compass intends to sway). Goldacre then proceeds to heavily criticize Roche and their Tamiflu debacle -conveniently leaving GSK looking much more ethical by comparison.
In an interview from March 2013– Goldacre says that he met Andrew Witty, CEO of GSK, before the announcement that GSK will release all trial data relating to its current products, with older data being released over several years. “He’d obviously thought very carefully about the practicalities of it, and that reassures me – he’d thought about how to do it, what the costs would be, and I think it’s to his enormous credit.” Following the announcement Among one of many celebratory tweets, Goldacre said the news was: “Amazing. Fantastic. Historic.”
Thanking GSK for its decision, he added: “This is the beginning of the end for a dark era in medical history.” This ‘end of an era‘- and ‘the beginning of a new ethical GSK’ concept– has long been the mantra of Andrew Witty and GSK- particularly in regards to crimes that were committed prior to Andrew Witty’s tenture as CEO. I’m sure that GSK is delighted to have people like Goldacre championing (and echoing) its PR agenda- tweets from Ben Goldacre (with 250,000 followers) go far and wide. Furthermore, these are just the perfect type of glowing PR sound-bytes that- pharmaceutical reputation management consultants- can’t even buy for GSK. Goldacre’s support must therefore be -utterly invaluable to them…
And here we come back again to Ben Goldacre and his association with GSK. At every given opening in the clinical trial transparency debate- it seems Ben Goldacre just can’t resist an opportunity to lavish praise upon GSK CEO Andrew Witty. In an article from October last year (2012) he says:
“I think Andrew Witty, the current head of GSK, is a good guy, and I discuss this at length in the afterword of Bad Pharma: because I don’t realistically think that we can rely on one person in one company being nice, as a strategy to address ongoing regulatory failure in a global $600bn industry where lives are at stake.” (see here)
However, considering that Andrew Witty has worked for GSK in various high level positions for most of his adult life I think it would be safe to assume that as CEO now he would have knowledge of most things that have – and do occur -within the company- including those things which would often undoubtedly come under the banner of big bad pharma…
And Ben… “good guys don’t become CEO’s of Billion-dollar Global Pharmaceutical companies”…
“You cannot hope to bribe or twist,
Thank God, the British Journalist,
For seeing what the man will do
Unbribed, there’s no occasion to.1
What is true cannot be minted
into a falsehood, even by
the most distinguished professor. 4
4 Samuel Hahnemann.”
(Quotes Kindly Taken From http://www.whale.to/b/dwarfs01.pdf)
David Healy continues his brilliant blog posts on GSK…
Editorial Note: This post is about midway through a series of posts that are broadly part of the AbbVie series. The series began with GSK’s Ttransparency and Access Journey, moved on to The House of GSK and will have at least two more posts after this.
Reading the Minneapolis StarTribune, it was the reference to privacy that clinched it.
Facing a sexual abuse lawsuit, the archdiocese of St Paul and Minneapolis made a big deal of putting an independent panel in place to investigate. They put the Reverend Reginald Whitt in charge of appointing the panel and receiving its reports on behalf of the archdiocese.
An Independent Panel that Sticks to the Rules
Rev. Whitt told priests and deacons that the task force may review specific files to determine whether the policies of the archdiocese concerning clergy sexual misconduct were properly followed. But, he wrote, “Access to these files will be within my control, and limited only to what is necessary for the task force.”
He also wrote that he recognized that many priests and deacons “may be anxious about your right to privacy and a good reputation.” He assured them that the archdiocese will proceed according to the principles of due process and uniform application of canon policy.
This sounds terribly like the approach Sir Andrew Witty is attempting to put in place for GSK, AbbVie and the rest of the branded pharmaceutical industry vis-a-vis abuses, including child abuse committed in their name.
Is Abuse too strong a word? In Study 329, a controlled trial of Paxil given to children, there was a statistically significant increase in suicidality on Paxil compared to placebo. These children were unquestionably injured but it seems about as likely that GSK have contacted the children involved to tell them what happened as the Catholic Church have voluntarily got in touch with anyone who has been affected by their priests or nuns to inquire about their wellbeing.
In Study 329, the consent form tells parents and children that the child will not be exposed to any danger or risks beyond what would be found in normal clinical practice – but the protocol for the study involved an attempt to force titrate children up to a dose of 300 mg of imipramine. This is double the standard dose used for adults – at least in Europe. One reasonable hypothesis as to why this might have been done was that it was an effort to make Paxil look good. Pretty grim if it was.
Just as the Church is insisting on the Privacy Rights of its priests, GSK, AbbVie and others have taken a legal action against the European Medicines Agency in an effort to claim Corporate Privacy Rights (See Let’s Do the AbbVie Again, Avoiding Adverse Events).
Just as we respect an individual’s right to believe what they want – to be a Muslim, Hindu, Christian or Jew – and defend a pregnant woman’s right to control what happens to her body, GSK and AbbVie are claiming a comparable right to decide what the clinical trial data they hold means.
They are asserting their right to spin their version of what it is you put in your body even though this clashes fundamentally with your right to know what you are putting in your body.
Companies operate their own version of Canon Law. Canon law is the Church’s own internal legal system that the Church insists has primacy over national judicial systems. The Bishops and Cardinals adhere to this rather than the laws of the US or other countries. Whether intended or not, this is a system that favors the clerical abusers over abused children. It is this that has fueled the anger of those who have been abused. There would be little problem if the Church’s legal system were harder on the Clerics than on Children. But using a system that defies natural justice to safeguard Clerics not unsurprisingly causes anger.
GSK and other companies run something similar. They actively attempt to over-ride the legal systems of the United States and other countries with claims that unless findings are demonstrated in controlled trials to a statistically significant extent that they simply aren’t happening.
The US Federal Judicial Manual states that convincing evidence of challenge, dechallenge and rechallenge is the way to demonstrate that a drug has caused an adverse event. No place here for statistical significance.
With a flourish worthy of the best Jesuits, internally GSK and other companies apply exactly the approach advocated by the Federal Judicial Manual when assessing whether Paxil has caused a birth defect or suicide, but even after deciding in private their drug is guilty, in public they insist there is no absolutely no evidence that their drug has caused a problem.
This can even leave GSK personnel stating in public that they are not aware of a single side effect that is caused by Paxil or likely any of their drugs. See Burn in Hell.
The US Supreme Court has weighed in on this question and decided that GSK’s model is wrong. People have a right to make up their own minds as to what an adverse event profile means. The only people who have this right at the moment though are investors. Patients and doctors have no rights – at least not established.
Church of GSKology
GSK have applied to be treated as engaged in Science. They say that what they do has all the features of Science – clinical trials, peer reviewed publications.
Ideally the Courts would decide that rather than being a Science they are a Church – they operate a system that requires belief without evidence. There is less doubt that their publications are ghost-written than the Bible is.
While they have people with great public relations skills like James Shannon who say all the right things in public, like the Catholic Church GSK appear to operate an Opus Dei like arm which enables them to place their people close to heart of Britain’s regulator the MHRA and other bodies. They are close to being the Established Church in England.
In the face of abuse, GSK make a big deal about apparent reform but the Rev Whitt described the mechanism GSK have put in place perfectly: “Access to these files will be within my control, and limited only to what is necessary for a Responsible research proposal.”
Waiting for a Frances?
When it comes to reform it seems Andrew is a Ben not a Frankie.
We need some Martin Sixsmith or Dan Brown to write a book and make a movie on the lines of The Lost Child of Philomena Lee.
Don’t hold your breath. GSK are a lot scarier than the Catholic Church.