This is the Fifteenth in the Persecution Series, after The Persecution of Heretics, The Persecution of Vulnerable Adults, Harassment from the BBC to GMC, Harassment from Rolf Harris to James Coyne to Doctor Who, Persecution: Black Riders in the Shire & Persecution: Rumbles from Mordor, of which there were eight in the SUI Cide Series SUI Cide in Betsi, SUI Cide Trick or Treat , The SUI Cide Note & SUI Cide or Homicide,SUI Cide in the OK Corral. SUI Cide & Peace in our Time, The SUI Cide Apparatus, Professional SUI Cide. This marks a new Pharma sub-series.
Considering that I’m finishing my (8th year) blogging adventure soon, I decided that I would not mince my words with my last few blog posts about Seroxat and GlaxoSmithKilne.
GSK’s CEO- ‘Sir’ Andrew Witty- is full of shit…utterly and totally -full of it…
There is no other way to describe the CEO of one of the most corrupt and devious pharmaceutical companies on the planet, and calling him that is really very tame. Dr. David Healy didn’t say that in his latest blog post, but it’s pretty much what came to mind when I read it… so why should we mince our words when it comes to these sociopaths? They don’t give a crap about people damaged by the drugs they sell, we mean nothing to them, dead babies from Paxil mean nothing, dead teenagers from suicide from Seroxat or Wellbutrin mean nothing, or patient heart attacks from Avandia, our lives mean zilch. We are disposable consumers, road kill, collateral damage.
Pharma CEO’s care nothing for damaged consumers, or the dodgy drugs their companies make because they are rolling in cash and enjoying the good life that all this blood money gives them… well enjoy the millions Mr Witty… Just like your predecessor, JP Garnier– You’re utterly full of crap and when you do retire, if your conscience doesn’t twitch because of your lifetime of service to GSK, and all the disturbing crimes which they have been involved in– (crimes which resulted in deaths of some users of your drugs) then you were well suited to the job because it’s likely you are a sociopath… However, if your conscience does twitch its likely too late to do anything about it… either way, good luck… enjoy the millions, but remember- don’t reflect- ever, don’t spend too much time alone for fear you might face yourself, and if ever you’re faced with the long night of the soul… don’t say I didn’t tell you so…
Persecution: He Who Would Do A Great Evil
He who would do a Great Evil must first persuade himself
he is doing a Great Good
Faced with questions about the $3 Billion fine imposed on GSK in 2012 – 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”.
The $3 Billion fine stemmed in the first instance from Study 329 for which New York State sued GSK for fraud. This is the study that colleagues and I are rewriting at the moment – at what risk?
Pharma has taken a regulator to Court twice. The second was in 2013 when AbbVie took the European Medicines’ Agency (EMA) to the European Court to protect Humira in 2013.
The first case happened in 1969, when Upjohn took FDA to Court over Panalba.
The 1962 amendments to the Food and Drugs Act required companies to show their drug was effective using controlled trials. For all drugs licensed prior to 1962, FDA insisted on a retrospective Drug Evaluation Study Initiative (DESI) to look at these. DESI convened panels of medical academics to adjudicate on each of the older drugs.
At the time there were many combination products – combinations of two antibiotics or an antidepressant and a tranquilizer. FDA and most academic physicians did not approve of combination products, whether antibiotics, analgesics or psychotropics. DESI recommended removing most of them from the market.
In 1969, DESI lined up Upjohn’s Panalba for the chip. Panalba was a combination of tetracycline and novobiocin. By FDA’s calculations Panalba was likely responsible for 12-15 deaths per year that would not have happened if doctors had used tetracycline alone. At the time Panalba was making $18 million per year for Upjohn – 12% of their income; $1 million per death. There was evidence that Upjohn knew of the risks the drug posed and in house evidence that Panalba was no more effective than tetracycline alone.
- to pull the drug immediately from the market,
- to stop production but let doctors use up the supplies available,
- to continue to produce but stop marketing,
- to continue to produce and to promote until it was actually banned,
- to attempt to overturn FDA’s decision using the Government and Judicial System
The company chose option 5.
Liaising with the Secretary of State for Health in the new Nixon Administration that had just taken power, Upjohn pursued a legal action all the way to the Supreme Court.
When the details of the case were presented some years later to business management students in the University of Pennsylvania, Scott Armstrong found that none of his class supported Upjohn and all bar two of the 71 found Upjohn’s behavior irresponsible.
But when he got students to role play the Upjohn Board and faced them with the decision to pull the drug or not, he found to his astonishment that 79% of respondents opted to take the same course of action as Upjohn and none withdrew the drug. This result has been widely replicated in different national groups with socialist Swedes behaving the same as capitalist Americans, and the idealistic young in just the same way as their cynical elders.
Debriefing the subjects and attempting to adjust the board and the circumstance to see if behavior could be modified, Armstrong and others were left with the conclusion that it is generally accepted that the primary duty of Board members is to stockholders rather than to society at large. Board behavior can be modified by appointing stakeholders but even then few Boards opt to remove Panalba from the market.
Armstrong modified the role play experiments by introducing an Upjohn safety officer who told the Board that the company did have hidden evidence supporting the complaints – to no effect.
In real life not even the death of the CEO’s wife from suicide, from the Company’s drug Prozac, has led to a decision to pull the drug or add warnings.
Putting people in a group where the unstated assumption is they will behave like a proper Board produces a situation which has commentators reaching for comparisons with the Milgram experiment where decent ordinary people in experimental settings can be induced to give life-threatening shocks to innocent strangers simply because they are asked to do so by the conductor of the experiment.
What’s true of a pharmaceutical company Board is probably no less true of a Hospital or other Board especially when these boards see themselves as being in the business of defending brand value.
The only thing that appears to modify the likely behavior of a Board is a threat of boycott – that is if maintaining the drug on the market led to the kind of disenchantment that caused the company share price to fall, the Board would respond.
While in real life this is close to what happened when GSK threatened not to supply anti-retrovirals to South Africa, Fear not, Andrew shall never vanquished be until Great Birnam Wood to high Dunsinane Hill shall come against him.
Doctors don’t do Boycotts. Why should they? They don’t suffer the consequences of pills going wrong.
We have to accept Andrew Witty’s suggestion that he and other employees of GSK are just like us, even if few of us can imagine being party to behaviors that warrant a $3 Billion fine. But Armstrong’s study suggests we are more like him than Andrew is like what we might like to think of ourselves.
The problem is if everyone is so good, whence the growing Fascism in healthcare? We can retreat to the wilder shores of conspiracy theory and claim the problems are down to the Germans, the Jews, or a Socialist cabal. Or we (including Andrew) can attribute the problems to a few people somewhere in a pharmaceutical company who break laws.
If we accept that the Board of GSK and other companies are populated with people just like you and me, who are perhaps even less likely to break the law than you or I, the $3 Billion fine for GSK notwithstanding, then the more sensible option is that the problem must stem from the system – which is just the opposite to what Andrew is saying.
We can change systems from the top-down or the bottom up. RxISK is about bottom-up change.
If GSK loses with a Boycott, so do we. We lose access to useful treatments. This led RxISK to propose an alternative to a Boycott – an AbbVie. Rather than not speak to GSK or other companies, to AbbVie means to speak as much as possible to a company telling them and the world more about their drug – feeding back the range of effects the drug has, some good, many bad. This is a way to make drugs better – a good medicine is a chemical plus good information.
(Ditto for a hospital).
He who would do a Great Evil..
There is little doubt that people in GSK and other pharmaceutical companies have the experience of being ever more adherent to protocols for Good Laboratory Practice, Good Research Practice, Good Marketing Practice etc
They likely feel little connection with the increasing numbers of people who die a premature death because of pharmaceuticals – and why should they given that no-one in GSK ever prescribes a drug?
But still someone is responsible for all these deaths…
to be continued
“The modern pharmaceutical industry is only sixty-five years old. It has good men and women, it has achieved human and social miracles, but its collective conscience is not yet developed.”
― John le Carre (Author of the Constant Gardener)
For those unfamiliar with the Seroxat Scandal, Shelley Jofre, and what I am satirizing in the cartoon see David Healy's blog here:
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The House of GSK
November 14, 2013 6 Comments
In a just published article in the BMJ, Peter Doshi notes how in recent months the English pharmaceutical company GlaxoSmithKline (GSK) have assiduously portrayed themselves as advocates of transparency and in support of access to clinical trial data.
Well in support of ‘Responsible Access’. Responsible essentially means that a researcher commits to the primacy of RCTs and statistical significance over an analysis of adverse events. It would not for example be responsible to claim that an SSRI causes suicide, a statin muscle damage or cognitive failure, or hypoglycemics cause hypoglycemia unless a trial has shown this to happen to a Statistically Significant extent – and they never do.
This scenario suggests a variation on the old joke that Cricket is the English idea of fair-play – eleven against one. Efforts to get at the raw data are just not Cricket.
Gunfight at the GSK Corral
A failure to be converted to a Responsible way of looking at the data underpins the stand-off between GSK and the RIAT team attempting to restore Study 329 to what it should have been. Study 329 is GSK’s most famous clinical trial. RIAT stands for Restoring Invisible and Abandoned Trials (see Reading the RIAT Act).
The Doshi article along with the correspondence between GSK and the RIATers makes for eye-opening reading.
To recap, in 1998, SmithKline Beecham reviewed the final data from Study 329, a study begun in 1994, comparing Paxil, imipramine and placebo. They concluded that it demonstrated that paroxetine (Paxil-Seroxat) did not work for children. They decided they couldn’t show the data to FDA but they could go ahead and publish the “good bits” of the study.
This ultimately led to a publication in 2001 in the leading journal in the field of child psychiatry, the Journal of the American Association of Child and Adolescent Psychiatrists, with an authorship line to die for. The first author was Marty Keller of Brown University. There were over twenty others.
The article states clearly that Paxil is safe and effective in children. Most doctors eyeballing it, and its distinguished authors and the journal in which it was published, would be much more inclined to use Paxil afterwards. That so many doctors in New York State in fact went on to prescribe so much Paxil to children led New York State to take a fraud action against GSK in 2004. This study was later at the center of the US Department of Justice’s case against GSK that resulted in a $3 Billion fine.
None of the apparent authors, it transpired, were authors in the sense people in the street would be likely to understand authorship. The real author – Sally Laden – appeared nowhere on the authorship line. The story behind the publication of 329 is laid out on Healthy Skepticism along with the efforts by Leemon McHenry and Jon Jureidini to get the “authors”, or the cuckolded institutions who lent their prestige to this ghostwritten article, or JAACAP, the journal in which it was published, to retract.
Which all refuse to do. And GSK as of a few weeks ago state that “GSK does not believe the article is false, fraudulent or misleading” (see GSK to RIATers).
Enter Stage Left
This is astonishing but there is another equally astonishing story to tell.
The temptation is for non-academics reading this to glaze over at the sight of theologians arguing about how many angels can dance on the head of a pin.
But in fact those of you who have nothing to do with healthcare – the Irresponsibles – as it turns out were then and always are better placed to know when there is a problem. It was the doctors, ethicists and theologians, the Responsible Adults, who missed it. And if this is true of 329, it is likely to be true of everything else as well.
Study 329 began to unravel because a journalist, Shelley Jofre, working for BBC’s Panorama, accidentally left to her own devices, begin to dig. She went to the American Psychiatric Association Meeting in Philadelphia in May 2002, clutching the Keller-Laden paper. She was interested to interview some of the “authors”. One of her questions was “What is emotional lability?” There was a surprising number of children in 329 who became emotionally labile – what’s this? she asked. No-one seemed to know.
At APA, she approached one of the 329 authors Neal Ryan, who gave a non-answer and quickly got in touch with GSK to let them know a journalist was asking questions.
A few weeks later in July and again in August, GSK send a dossier to FDA seeking approval for Paxil for children.
A few weeks after that, on October 7th, to coincide with World Mental Health day (October 10th), Newsweek hit the streets featuring a depressed teenager on the front cover and a strapline Teen Depression: 3 million kids suffer from it. What you can do. The message inside was that Prozac was already being marketing for children and Paxil and Zoloft were about to be. What you can do – is get children on Prozac, Paxil and Zoloft.
Celebrating World Mental Health Day
Three days later, on October 10th, World Mental Health Day, and the 40th anniversary of the passage of the 1962 amendments to the Food and Drugs Act, FDA sent GSK a letter saying Paxil was approvable for kids.
Among other things, the letter notes that GSK had already told FDA that Study 329 showed that Paxil doesn’t work for depressed children. FDA were happy to go along with GSK’s suggestion that this should not be mentioned in the labeling of the drug. Given that the Study 329 publication majored on how effective Paxil was, it would have been inconvenient if the label said otherwise.
There are many notable things in this approvable letter. Perhaps the most interesting is FDA asking GSK to clarify just what emotional lability meant.
FDA have later spun this into a story that their reviewers detected there was an increase of emotional lability events in Study 329 that needed looking at. In fact this idea came on their radar after conversations between Jofre and third parties led to a visit to FDA on August 28th and a suggestion to FDA that they explore the issue of emotional lability.
FDA at the time had a few weeks to respond to GSK’s request to market Paxil for children. Neither Jofre nor the third parties knew at the time that GSK were seeking pediatric approval for Paxil.
The Secrets of Seroxat – The Perils of Paxil
On October 13th Jofre’s program, The Secrets of Seroxat aired on BBC. This led to one of the biggest responses the BBC had ever had to a Panorama program – 65,000 calls and over 1000 emails.
Panorama had never repeated a topic before. Jofre and Panorama have revisited paroxetine and GSK a further four times – each time demonstrating that when it comes to the blindingly obvious sometimes what you need is plain Curiosity rather than Responsibility.
In dealing with the RIAT team, GSK still insist there is nothing wrong with the Keller-Laden paper and show no interest to co-operate with setting the record right, even though the “fraudulent” version is still the only one on the public record. As such it is still being built into guidelines on the management of children who are depressed – a trial that showed paroxetine doesn’t work and leads to a statistically significant excess of suicidality (emotional lability).
When facing requests from others such as Peter Goetzsche to be Responsible (see GSK’s Transparency and Access Journey), GSK have typically invited them to meet GSK experts in GSK House. This is more awkward with a RIAT team that is dispersed from Atlanta to Adelaide.
It’s a lot more awkward with a journalist like Jofre, who asks herself along to GSK House with a list of questions in need of an answer.
Despite a haircut between programs, Jofre and Andy Bell produced a second Panorama program, in May 2003, Emails from the Edge that brought the walls of the Temple down. A few days after the second Panorama program, Britain’s MHRA blew a fuse and Seroxat-Paxil was on its way to being banned for children. To be continued…
The moral of the story perhaps is GSK figure letting Responsible adults in to the Club is no problem, but they recognize that a motivated lay-person, particularly a woman spells trouble.
– See more at: http://davidhealy.org/the-house-of-gsk/#sthash.1K8jexcJ.dpuf