Editorial Note: This post continues Vampire Medicine and links to Reformation Day on RxISK and forthcoming posts – Here We Stand.
Between 2002 and 2004, giving antidepressants to teenagers and the risks of triggering suicidality became one of the most high profile issues in medicine. Raising a profile should be the way to put things right but things are getting much worse. The lack of access to services is leading to adolescents self-harming to such an extent this is now accepted by the British government as the area of greatest failure in Britain’s Healthcare System.
What’s gone wrong?
Blowing up the Fishpond
It was BBC’s Panorama and a Los Angeles law firm, Baum-Hedlund who initially raised concerns. Panorama threw a hand grenade into the mostly East Coast fish pond that was American medicine. This led to a series of FDA hearings in 2004, and a derailing of company plans to get their antidepressants licensed for children.
The central event was a document obtained by Panorama which revealed that Study 329, a trial comparing paroxetine, imipramine and placebo, had been negative but was going to be portrayed as positive. New York State took a fraud action against GlaxoSmithKline.
The document crystallized recognition that close to every article on every on patent drug in any area of medicine was ghostwritten and there was zero access to clinical trial data.
Faced with this crisis, there were two obvious courses of action.
One was go after the docs who were willing to let their names be put on ghostwritten articles whose data they had never seen and who presented these data at meetings – for a fee.
The other was go after the data. In 2004, the British Guideline maker, NICE, considered the second option but funked it.
New York State thought they had secured a commitment from GSK to make the data available which would set a precedent for other companies. But GSK ran rings around them, making some company authored study reports available that concealed everything about everybody that had anything to do with any of their trials.
The first was the sexy option. It offered stories the media could understand – docs on company payrolls prepared to say anything. Everyone could understand Conflict of Interest and agree it was a bad thing. Chasing this fitted a zeitgeist which said all problems could be solved with Transparency.
The second was more difficult. Unless you are involved in clinical care it sounds esoteric and geeky. It also risked blowing up a lot the guys we think of as the good guys like BMJ, Lancet, NEJM and JAMA. And it quickly became clear there would be resistance. Let’s call this Cisparency.
Stunned Amigos
When BBC threw their hand-grenade into the healthcare pond stunned fish floated to the surface. Baum-Hedlund picked the fish up and started dumping them on Congressional and Senatorial desks. Most of the fish were ugly and had thwarted data access stamped all over them. A few others were colorful eye-catching dudes.
The key desk turned out to be Senator Grassley’s, where a formidable woman, Emilia di Santo, ran the operation and an energetic staffer, Paul Thacker, got engaged.
Some colorful flashy fish called Alan, Marty and Charlie, the type to feature in Disney movies – a great title would be Three Amigos – caught senatorial or other eyes, rather than the uglier critters. There was nothing notable about the three flashy guys in terms of contributions to medical or mental health science, but at the time details about the conflicting interests of all three were tumbling into the public domain. Charlie had become the poster boy for conflict of interest across medicine.
If you’re a Senator what’s not to like about a guy who was willing to let himself be featured on the front of a glossy publication as The Boss of Bosses with a question Is Charlie Nemo the most powerful man in psychiatry. Marty was the first author on Study 329, the trial that had kicked everything off, then on its way to becoming the most famous trial in medicine.
Nemo was a Harvey Weinstein like character, capable it seems of charm with those who played ball with him and of being a thug to others. Close to the entire field of US psychiatrists enabled him.
He was probably a greater embarrassment to GSK and other companies than he was to academic psychiatry. GSK could not have wanted him to behave like a loose cannon in the way he did. He was probably central to losing them the Tobin case, which led to Panorama interest, and a bunch of dead fish, which they are still grappling with.
Enter Stage Left
Because of the Toronto episode Paul Thacker called wanting to know anything if I could tell him about Nemo. I told him – nothing much apart from what is in the public domain. I tried to persuade him Nemo was not the problem. He was irrelevant. He could even do some good if he could be turned. He and some others like Stuart Montgomery could show us where some of the bodies were buried. Chop their heads off and others would replace them.
PT wasn’t listening. Nemo had become too juicy a morsel to give up. But very little came out of his investigations beyond what was already in the public domain.
Let the Sun Shine In
The collapse in August 2007 on the grounds of pre-emption of a Baum Hedlund lawsuit, centered on the suicide of a 13-yr-old boy while taking Paxil, coincided with the introduction in September of a Physicians Payments Sunshine Act by Senators Charles Grassley (R-IA) and Herb Kohl (D-WI). This act aimed to “shine a much needed ray of sunlight on a situation that contributes to the exorbitant cost of health care”, according to co-sponsor Senator Charles Schumer (D-NY). It would require manufacturers of pharmaceuticals and medical devices with annual revenues of more than $100 million to disclose gifts or payments to physicians in any form, whether cash, trips, or other.
The most bizarre aspect of this was the idea that letting the Sunshine in would bring down drug costs – See Raiders.
But the Bill fit the perceptions of many ethicists, journalists and others that the root of the healthcare problem lay in payments to opinion leaders. Transparency was crowned king despite a complete lack of evidence of opinions being changed by payments.
This model locates opinion leaders as experts – the cream of the profession. They are only the cream in the sense of being rich and thick. No pharmaceutical company wants someone who can think. The first qualification for being picked by pharma is to be mediocre, and the second is to remain on message.
The model views other doctors and patients as airheads who will rely on a few puppets made over as smart dudes to tell them what to think. No one would pay any heed to what some cartoon puppets were saying were it not for the iron fist inside the puppets that has all too obviously silenced BMJ, JAMA, Lancet and NEJM – see Vampire Medicines.
The Benefits of Transparency
Baum Hedlund contacted Emilia di Santo again in 2007. It put the Ugly Fish back on her desk. While Grassley wrote to the Department of Health and FDA raising cisparency issues, the die was already cast. The transparency fish were already sitting in their bowl, scales glinting in the bright sun light. Rather than chase cisparency, Grassley continued with the low hanging fruit of transparency, scooping up a number of other prominent psychiatric academics on the way none of whom seem to have been harmed by the attention.
Just this year Karen Wagner, one of those named and supposedly shamed became the current President of the American Association of Child and Adolescent Psychiatry, despite multiple depositions conceding her articles are all ghost-written and she wouldn’t know what to do with data even if she saw it.
On July 12, 2008, the New York Times reported:
“But now the profession itself is under attack in Congress, accused of allowing this relationship to become too cozy. After a series of stinging investigations of individual doctors’ arrangements with drug makers, Senator Charles E. Grassley, Republican of Iowa, is demanding that the American Psychiatric Association, the field’s premier professional organization, give an accounting of its financing.”
The following year APA voted Alan Schatzberg in as its President.
After a brief period under a cloud, Nemo moved from Emory to Miami and was welcomed into the bosom of places like London’s Institute of Psychiatry who know a thing or two about supporting people who have been vilified by the enemies of psychiatry. A President of the World Psychiatric Association in waiting?
On March 23 2010 Grassley and Kohl’s Physician Payment Sunshine Act was enacted as part of the Patient Protection and Affordable Care Act.
Sidelining Cisparency
The resolution of New York States’ fraud action against them in 2004 involved an agreement by GSK to post details of their clinical trials on their website. This led to a set of Clinical Study Reports (CSRs) for paroxetine trials in children being posted.
GSK also posted 3-7 page summary reports of trials in other therapeutic areas, including trials of their blood sugar lowering blockbuster, rosiglitazone (Avandia). Reviewing these summaries Steven Nissen, from the Cleveland Clinic, found an increased rate of mortality on Avandia compared to placebo. Avandia was withdrawn from the European market and restricted in the US. These data laid the basis for the Department of Justice to pursue GSK for both Paxil and Avandia.
In 2009. Peter Doshi from Johns Hopkins and Tom Jefferson from Rome, working with colleagues on a review of Tamiflu, Roche’s antiviral drug for influenza, became headline news, when the data they assembled suggested Tamiflu didn’t work.
Governments around the world had stockpiled billions of dollars’ worth of Tamiflu having been told it saved lives by reducing transmission of the virus, kept people out of hospital and got them back to work faster. Fiona Godlee and BMJ helped make Tamiflu a campaign for transparency.
Then in October 2012, facing criminal charges for promoting its antidepressants for unapproved uses and failing to report safety data about Avandia, GSK accepted a $3 Billion fine, then the largest settlement in a Department of Justice lawsuit.
Far from being on the back foot, just as they had out-maneuvered New York State in 2004, GSK took the initiative. They announced plans to make their clinical trial data available to researchers on a secure website, if an independent panel of experts agreed the research proposal met a scientific need – mature transparency.
A few weeks later, AllTrials was born. The idea might have begun with Fiona Godlee. The family present at the birth included Sense about Science, the Cochrane Collaboration, the Centre for Evidence Based Medicine, Iain Chalmers, along with BMJ and PLoS, with the lot now fronted by Ben Goldacre.
The AllTrials ask was for access to the protocols for all clinical trials. The impression given was that AllTrials was seeking access to clinical trial data. It wasn’t. It was named AllTrials rather than AllData. It supported proposals that might enable some investigators, approved by companies, to access certain efficacy data. Exactly what GSK were proposing.
GSK promptly signed up to AllTrials. Within a few months of a record fine in the US, Andrew Witty, GSK’s CEO, featured on the March 9 2013 cover of the BMJ hailed as the acceptable face of the pharmaceutical industry.
Spearing Nemo?
A few years later the time came to dump fish in a Chicago jury box in the Dolin case. Trying to spear Nemo wasn’t going to get anyone anywhere with a Windy City jury – he mightn’t have been visible in a Green River anyway.
It was the ugly brutes the jury got told about. GSK’s lawyers spent their time desperately trying to block any mention of Study 329 and trying to stop jurors seeing the harms data from paroxetine trials, or hearing about the ways the company had tried to thwart access to data.
GSK’ s lawyers went apoplectic at a mention of the idea that if you owe a bank a million dollars, you have a problem but if you owe a billion, the bank has a problem. This could be reprized as – if Senator Grassley catches GSK out in a little lie – hidden payments to Nemo – GSK has a problem but if the entire thing is a lie Senator Grassley is fucked.
Transparency, efficacy and Nemo were irrelevant in Chicago. Its the Great White Lies about Harms that count, not a few little tiddlers.
To be continued..
A big factor in this is the people who turn up on the scene – in the case of All Trials people like Fiona and Ben – who pose as honest brokers on behalf of the public: I am sure they more than half believe it themselves. But who asked them?
Back in 2011 when we had the public crisis in investigative journalism and the behaviour of the Murdoch empire the government appointed Lord Leveson, and in case you didn’t trust Lord Leveson the self-appointed defender of public interest, Hacked-Off, appeared from nowhere as apparently friendly gatekeeper. What no one realised at the time and even I didn’t for many months was that the Leveson inquiry was really at least half about burying the Wakefield affair in which the state and the Murdoch press had connived to obtain for reporting purposes information from private medical records and legal documents, not to mention various other illicit manoeuvres.
In fact Leveson ended up hearing evidence against Wakefield, which was not part of the public brief at all, and condemning him again in his first report while recommending bureaucratic controls on reporting. In fact, Leveson allowed the Murdochs to veto inquiry into their Wakefield investigation and remarkably both Leveson and the inquiry’s lead QC Robert Jay had already been involved in denying claims in the MMR litigation. Meanwhile, Hacked Off included as an adviser Evan Harris who had been part of the Sunday Times ambush on Wakefield and had made allegations against him in the House of Commons under privilege. The coincidences were quite remarkable.
http://www.ageofautism.com/2016/05/best-of-watch-dog-boss-martin-moore-sat-on-uk-government-panel-with-editor-who-hired-brian-deer.html
http://www.ageofautism.com/2016/05/best-of-uk-inquiry-cuts-deal-with-new-international-not-to-investigate-brian-deer.html
http://www.ageofautism.com/2012/12/leveson-inquiry-submission.html
Of course, this is not entirely parallel to the issue of Study 329 but it does involve some of the same people and it also poses the problem of the difficulty of reading what is actually going on in public events. The conclusion of Leveson was that it was alright for the state and media to use dirty tactics against citizens in support of government policy.
Don’t miss btw Vera Sharav’s new investigation into the Wakefield affair:
http://ahrp.org/laffaire-wakefield-shades-of-dreyfus-bmjs-descent-into-tabloid-science/
Here btw is Goldacre trying to save Evan Harris in the 2010 election:
“Keep Evan Harris in parliament, Oxford West and Abingdon
“May 5th, 2010 by Ben Goldacre in bad science | 48 Comments »
“It’s the election tomorrow and I want to ask your help to get one MP re-elected for the good of science in the UK. In an era when so many of our elected politicians have acted out of self-interest, dipping their fingers in the till, Evan Harris has stood out by being smart, hard-working and informed, but more than that, by being genuinely brave in taking on causes in science and human rights that many believe in, but few would have the guts to stand up for.
Recently we were comparing hate mail, and it occurred to me that you could only really pay tribute to the vital contribution Evan has made by listing all the groups who despise him, and the vicious hate campaigns they have mounted. The antivaccination conspiracy theorists hate him, because he drove for more and better evidence on the MMR and autism hoax, and helped expose it through the GMC.”
https://web.archive.org/web/20100508052703/http://www.badscience.net/2010/05/keep-evan-harris-in-parliament-oxford-west-and-abingdon/
As far as I know I was the only person to raise publicly Harris’s involvement in the MMR business during the 2010 election and I don’t even know whether anyone in the constituency saw my Age of Autism blogs or cared: it is true, however, that the constituency swung on less than 100 votes so it is just remotely possible that I made a difference.
The other thing to remark is that it was manifestly Goldacre who was dealing in “hate” whereas I was dealing in specifics. All those bad MMR people again, and even Goldacre could not keep a straight story on the Wakefield Lancet paper!!!
http://www.ageofautism.com/2016/08/guardian-health-editor-sarah-boselys-little-problem.html
Much more Witty and Pithy than Yale – GSK feature heavily – Alltrials get a mention .. on the same page ..
Promoting Transparency in Clinical Research
Why and How A Policy Paper
By the Yale Collaboration for Research Integrity and Transparency
November 2017
In the Aquarium ..
https://law.yale.edu/system/files/area/center/crit/document/crit_white_paper_november_2017_best_.pdf
CRIT
All those ‘Big’ Fish leaving us Little Fish – Floundering in the Shallow End – as only a Paroxetine swimmer can know ..
Paxil Injuries/GSK Video depositions
https://www.baumhedlundlaw.com/prescription-drugs/paxil-injuries/
“It wasn’t part of my job” – J-PG
In the first video, former GSK CEO Jean-Pierre Garnier says in his testimony that GSK’s way of counting suicidal behavior events in GSK’s Paxil clinical trials was incorrect.
In the next deposition, GlaxoSmithKline biostatistician John Davies is questioned about GSK’s improperly counting suicidal behavior and its effect on calculating suicide risk rates during Paxil clinical trials.
Lastly, former GlaxoSmithKline executive Dr. Geoffrey Dunbar says in his testimony that he helped author the drafts of the Paxil suicide report that the U.S. Food and Drug Administration (FDA) asked for in 1991. The calculations in this report showed and suggested that instead of Paxil increasing the suicide risk by nearly nine times, the drug decreased suicidal behavior. He admits in his deposition that his reports include improperly counted suicidal behavior events and that publications in which he participated in writing, had incorrectly conveyed that Paxil reduced suicidal behavior.
The Feeding Frenzy in the Seaquarium has starved us of oxygen in the thick and creamy salty seas and without Shaley Joffe all could have been lost .. it took a Peter Pan and Wendy .. to cast all doubts and fly away .. without the satisfaction of Spearing any Nemos ..
From being the CEO of GSK , and being at the helm of GSK when they were fined the largest health care fine/fraud in US history and weathering several corruption investigations during his tenure- Andrew Witty- has now been rewarded with a government job by the UK establishment!
You really couldn’t make this stuff up if you tried!
https://truthman30.wordpress.com/2017/11/06/jobs-for-the-boys-gsks-andrew-witty-and-gsks-patrick-vallance-fly-though-the-revolving-doors/
November 6, 2017
Jobs For The Boys? :GSK’s Andrew Witty And GSK’s Patrick Vallance Fly Though The Revolving Doors…
Andrew Witty was the recent CEO of GSK. He was at the helm of GSK when they were fined the largest health care fine/fraud in US history (in 2012) and weathered several corruption investigations (including the 2014 China Bribe scandal) during his tenure. You would think that this kind of thing wouldn’t look good on his CV wouldn’t you? You’d think that presiding over a company that has one of the worst corporate reputations (and image problems) of the FTSE 500 would look bad for future roles and jobs wouldn’t you?
Not so- it seems- when it comes to the stomach churning revolving door of the British business and political class.
http://www.fiercebiotech.com/biotech/sir-andrew-witty-to-head-up-new-uk-speedy-drug-review-system
“….The U.K. government has announced that former GlaxoSmithKline chief Sir Andrew Witty is to head up its new pathway that aims to get a handful of drugs and medical technologies to patients quicker than ever before….”
The plans for the so-called Accelerated Access Review (AAR) will see Sir Andrew, once on the other side of the fence trying to get new drugs onto the market, decide which set of medications and devices can get through to U.K. patients at a much speedier rate. This also comes two months after he was hired by venture capital firm Hatteras Venture Partners; the firm tells me he will be staying on there, but did not answer questions about any potential conflicts of interest….”
So Sir Andrew Witty of the corporate pharmafioso outfit of GSK will now head the UK governments fast-track process for new drugs? Does that make you feel safe in the drug approval process?
You couldn’t make this stuff up if you tried.
Amazingly also, on the same day that this news was reported, it was also reported that GSK have a new drug which the US regulators are designating as a ‘breakthrough’ drug.
http://www.reuters.com/article/us-gsk-cancer/gsk-gets-boost-for-early-cancer-hopes-with-breakthrough-status-idUSKBN1D20WC
“…LONDON (Reuters) – GlaxoSmithKline received a boost for its oncology research on Thursday when an experimental drug for blood cancer received a “breakthrough” designation from U.S. regulators…..”
“…The decision by the Food and Drug Administration paves the way for a speedy regulatory review of the BCMA drug for multiple myeloma. It follows similar priority treatment granted by the European Medicines Agency last month…”
Whilst Witty was swinging through his revolving door- from industry honcho to government insider- GSK’s Patrick Vallance just might be skipping through another one…
http://www.pmlive.com/pharma_news/gsks_r_and_d_head_vallance_departs,_possibly_for_government_role_1210647
“….GlaxoSmithKline’s head of R&D Patrick Vallance could be en route to a UK government position as chief scientific advisor, according to reports.
Vallance has been leading the R&D operations of GSK for more nearly six years, and his departure comes in the midst of a shake-up of the UK big pharma group under new chief executive Emma Walmsley, who took over from previous CEO Sir Andrew Witty in April.
News of the departure – reported by the Financial Times – was previously covered on the Research Fortnight website, which said Vallance had been proposed by an independent panel of scientists along with another candidate with a background in the physical sciences…..”
Of course this kind of thing is all absolutely ethical, above board and not in the slightest bit worrying. It’s just another day, another dollar isn’t it, business as usual? nothing to see here, move along…
I feel much safer knowing that these two ex GSK executives will now have an even bigger role in deciding which drugs pass from industry into patients’ mouths.
I feel so safe and comfortable knowing that the top executives from the manufacturers of Myodil, Seroxat, Pandemrix, Tafenoquine, Lamictal, Wellbutrin, Cervarix, and Dexedrine will decide on which treatments and drugs will work best for the consumer…
Yeah right…
The Foxes Own The Hen House Guys..
We’re all Fucked..
Beyond belief.
It was apparently Witty’s deal with the Italian government that led to it introducing compulsory vaccination. The CEO of GSK Italy, Daniele Finocchiaro, told an industry website:
http://www.fedaiisf.it/l-accordo-di-glaxo-con-novartis-verona-e-centrale-nello-sviluppo-gsk/
“Among the aspects, I also met with Minister Lorenzin and other members of the government who reiterated the sensitivity of the government towards those who invest, create jobs and opportunities for young people. In short, we started on the right foot.
“Such sensitivity in the Roman palaces is not to be dismissed. As for us, Andrew Witty has asked for a few things: clear rules and stability in return for strong investment in advanced research and production equipment. We were of one intent.”
Meanwhile, Lorenzin – a lady of the highest principles – was spreading the story that 270 children had died in London in a recent outbreak of measles while lamenting false stories put out on the web. (In fact, only 4 people have died in the UK with measles as an underlying cause since – only 3 when Lorenzin spoke)
http://www.bmj.com/content/358/bmj.j3429/rr-7
Truthman
Have posted a version of the story on AoA (with acknowledgements)
http://www.ageofautism.com/2017/11/the-fox-guarding-the-hen-house-outgoing-gsk-chief-to-head-new-uk-government-agency-fast-tracking-the-licensing-of-pharma-pro.html
Thanks John,
It is absolutely scandalous that Witty and Valance have been placed into such positions of power in the UK government without any public consultation (and very little in the press about it too). This is extremely undemocratic. It’s clearly nepotism, and obviously not in the public interest considering GSK’s woeful history of abuses of patient’s rights (with Seroxat/Avandia and many other GSK compounds), abuse of the law (such as fraud and bribery fines in the US, China and elsewhere) and GSK’s general lack of good governance/ethics etc. However, the sad thing is, this is the kind of news we have come to expect from GSK in the UK. I have long been drawing attention to all this on my blog, in particular the powerful influence that GSK have in the UK, upon the UK government, academia, the political and business class etc.
It’s disturbing..
but all we can do is sigh, that’s the sad thing about it.
haha, Truthman, what an awesome story, but with an evil underline.
I can almost see the “assembly line” in the future “AAR”, with conspicuous bottles of pills at one end, and mister Witty with the seal of approval in the other.
Far from the sick and the needy, a fast approval, and onwards to the unsuspecting patient. (and physician)
New pills, new miracles.
In the background the silent majority wonders why they keep getting ill.
I’m sure the heads that rolled, if they did, when BP lost a barrel or two in the Gulf of Mexico, aren’t holding up the line at your local soup-kitchen either?
-“if you owe the bank a million, you are in trouble. If you owe the bank a billion, they are….”
Yes indeed..
It’s quite creepy when you look at what’s happening here.
If Andrew Witty and Patrick Vallance have GSK shares then surely these new positions bestowed upon them by the UK establishment invoke concerns of serious conflicts of interest?
Particularly, when you consider that Witty’s new job will effectively entail deciding which new drugs are to be ‘fast-tracked’ to market.
The Foxes Own The Hen House Guys..
That’s a MAY BE ..
‘Several Group Actions have been settled in the US following Court proceedings related to harm caused to individuals who had become dependent upon Paxil (Seroxat in the UK) – an FDA approved and prescribed antidepressant.
“It is ironic” says Claimant Bob Fiddaman “this British company has compensated Americans for the harm caused to adults and children who became dependent upon its antidepressant Paxil (Seroxat) yet UK citizens have had to fight for years to have their case heard. We may now only be a group of 105 Claimants but we are determined to gain compensation for the harm caused to us.”
To see the genesis of this litigation, which first commenced with the BBC’s Panorama Programme ‘Secrets of Seroxat’ first shown in 2002,
visit news.bbc.co.uk/2/hi/programmes/panorama/2310197.stm
http://www.fortitudelaw.uk/product-liability/seroxat-group-action/
A UK Legal Action of this magnitude might cause some Regulators, Government, Government Advisors for their hearts to stop..
It is not beyond reasoning for Andrew Witty and Team to be called to give Depositions.
There is no one left to ask to Take The Stand who hasn’t given some sort of testimony in the US.
MHRA and Ian Hudson, spring to mind.
It doesn’t surprise me that potential litigation can take years to get off the ground in the UK and no litigation will take place unless there is every chance of winning.
The Case Against Seroxat and GlaxoSmithKline is one of those Patient Games that will go on and on but most Paroxetine Experts know that the Case for launching Seroxat into the UK was deeply flawed and deeply misrepresented and Andrew Witty knows all this.
I don’t think its a coincidence that GSK Team Seroxat have all left their posts, even Murray Stewart ..
https://www.linkedin.com/in/murray-stewart-90704b5
This narrowing of focus already claimed the scalp of one senior member of the medical team, with Murray Stewart, formerly Chief Medical Officer, left his position to join Novelion Therapeutics – a biotech focused on developing treatments for rare metabolic diseases.
http://www.pharmafile.com/news/515563/gsk-s-rd-head-move-after-shift-focus
GSK Chairman appointed Emma Walmsley for a total shift and a new clean face, that was pretty obvious ..
Litigation has become more of a “what can we get thrown out” rather than, “What can we include in”, for GSK’s team of legal experts.
During the Dolin trial, King & Spalding’s duo of Bayman and Davis were often standing opposing what expert witnesses had to say – in the hope that the presiding judge would “strike out” any mention of withdrawal, homicide, birth defects and other serious adverse reactions associated with their client’s drug.
They thought by focusing the jury’s attention on the generic aspect they could side-step all other related ADRs associated with Paxil. They (King & Spalding) wrongfully assumed that jurors are human too – every human has the need to feed their inquisitive minds, the jurors, in this case, were no exception. I think K&S erred when treating the jury as if they were from the planet Zog and had never heard, or read, a bad thing a bad Paxil, or indeed GSK.
King & Spalding, just like GSK, walk through life with blinkers on. They actually believe they do no wrong, cause no harm. This probably has been borne out of all the litigation they have been involved in – and all the corruption during the days of Monty Burns look-a-like, JP Garnier.
They feel as if people are ganging up on them because, in their eyes, they see their products as helping millions of people – they can’t get beyond this and any criticism of their products are more often than not defended by saying, “Our drugs have helped millions of people worldwide.”
One can associate this with a chairman of a football club. He takes over a struggling team then wins trophies, a result of which sees money coming into the club. Some years later, the club hits hard times and the fans call for the Chairman’s head. He’s astounded because he’s given the fans what they wanted – he ends up resenting them.
GSK, and K&S, resent the consumers because it’s the consumers who are now seeing through them. They resent the lawsuits because their drugs (apparently) help millions of people worldwide. As I said, they cannot get beyond this.
The labeling issues with drugs like Paxil are perfectly designed so drug companies can defend lawsuits – attorneys argue over semantics, in fact, most of the Dolin trial was a game of semantics – one team asking why the language couldn’t be clearer, whilst the other team argued that it was clear – (We all know it wasn’t) – I’m unsure if GSK or K&S actually believe their wording was applicable for the layperson or healthcare professionals.
In their eyes, it was because the words were constructed in such a manner that they could argue the toss and show those, that they thought were from the planet Zog, just how they had done everything to raise the issue of suicide.
Having been heavily trounced they now cite that the judge was wrong, the jury was wrong, Dolin’s experts were wrong – it’s a classic case of throwing the dummy out of the pram.
GSK and King & Spalding are, in essence, spoiled little brats.
I often see the quote, “How do they sleep at night?” – they do so because they feel it is they who are the victims – they honestly believe this. How can people be so opposed to the ‘good’ that they do? Why do people focus on their ‘minor errors’ – yup, I believe they see manipulating drug trials as something minor.
One question I would like to ask King & Spalding is:
Can you provide me, and the jury, with a list of benefits of Paxil.
Then, in plain sight of the jury, I’d then ask them for a list of risks and ask if a list of risks outweigh benefits, how can they say their client’s drug is safe?
Then again, Messrs Bayman and Davis would object to my line of questioning and ask for it to be struck from the record!
If the judge were to overrule them they would then use it against him in some sort of vain attempt for a new trial.
Bayman and Davis sleep at night with no thoughts of platform jumpers, self-inflicted gunshot victims, kids hanging from ligatures or with self-inflicted fatal stab wounds because these people did what they did despite being told about warnings. In any event, it’s not GSK’s problem, it’s the problem of the prescribing doctor or the state of mind of the victims prior to taking Paxil. It’s also the FDA’s fault, they claim, for not allowing them to change the wording on the label – something that they (GSK) didn’t even need permission for. (See Garnier video from the trial)
I’ve been catapulted into their world because of my own struggles with Paxil – I see a machine that churns out defensive arguments that don’t defend but rather uses points of law designed to help corporate entities in litigation.
GSK met their match with Baum Hedlund. Brent Wisner and David Rapoport (Rapoport
Law Offices) went toe-to-toe. The pre-sparring shenanigans saw GSK (in the red corner) prance around with a cocksure attitude that they couldn’t be beaten.
Doncha just love the underdog.
“Hail, Caesar!”
“Hal has exceptional experience and a strong track record of developing significant new medicines from his time at Roche and Genentech; whilst at Calico he has helped build a research organisation that uses cutting-edge technologies in drug discovery and development. He is also very well known for his integrity, for being a clinician who is committed to always doing the best he can for patients and for building exceptional teams.”
Do we take it that Sir Witty, Dr Vallance and Dr Stewart did not have these ‘Qualities’ during their Tenure ..
https://twitter.com/GSK/status/928265476945276929
The combined statement by both Barron and Walmsley suggest an awareness that investors are beginning to become restless with GSK’s approach, with a failure to bring through the blockbusters required to drive growth. GSK’s former head of R&D looks likely to have fallen foul of this sentiment, moving on to become the UK’s Chief Scientific Adviser.
http://www.pharmafile.com/news/515613/gsk-indicates-return-oncology-appointing-roche-veteran
Fallen Foul ..
Updates/SMC
http://www.sciencemediacentre.org/expert-reaction-to-reports-of-announcement-of-new-government-chief-scientific-adviser/
of this sentiment ..
Bob, thanks for this very interesting piece of yours here;
‘They walk through life with blinkers on, they actually believe they do no harm…etc’
Why does this happen? How is this acceptable? How do they get away with it?
Surely if you look at what happens when someone, say, has suffered an overload of stress and trauma in their life, and manifests symptoms of ‘losing their normal grip’ so relatives get worried about them, you can see where GSK steps up to the plate. What happens then? Who helps the sufferer and who soothes down the worried relation/friends trying to help. Well, I guess it appears to be GSK et al with their little pill which quietens things down, takes away (at first) embarrassing (to the observers) abnormal behaviour and makes everyone feel safe again. The patient is handed over to the pill. Peace reigns.
Until we find ways of getting the public to feel supported in their care for loved ones suffering depression, anxiety etc, without sending them off to the doc for a pill, things ain’t gonna change. People need reassurance and they need to be listened to. They don’t need a doctor to unwind their worries onto, nor can they wait 18 months to go and pay forty pounds an hour to sit in front of some no doubt well trained counsellor who says little and just offers a listening ear. We all need good friends/family if lucky, who will not freak out when we’ve obviously had too much to cope with, who listen, who offer suggestions about how to cope, who help us see when we are burnt out and need a break. It’s surely society’s FEAR of mental unwellness that is the greatest gift to GSK and all the other Pharma. So how do we change that? Because a pill seems quick and painless and removes responsibility for helping from all the rest of us.
“Why does this happen? How is this acceptable? How do they get away with it?”
1. Money talks.
2. Because they are in the business of making money, whatever the cost.
3. Because laws are so perverse.
🙂
“Power tends to corrupt, and absolute power corrupts absolutely.” ~ John Emerich Edward Dalberg Acton, first Baron Acton (1834–1902)
Absolutely correct Bob.
So, how do we overturn this then, if we don’t have as much money or power as they?
Perhaps we collectively invoke something more powerful. Because that’s how we defeated Hitler, and by standing together and spreading the word, that’s how we’ll defeat all this corruption too. The walking well and the struggling unwell, the desperate carers and friends, and everybody we can spread the word to. And the Universe. And all the ones who may have left this mortal world due to what these prescribed drugs did to them, but are ever present, working their angelic socks off, to bring justice to bear. They know exactly how to do it and they will inspire us all to win. You can think me crazy to write this if you wish, but the proof will be in the mega powerful pudding, just you wait and see.
I have to add, the number of times there has been the grateful realisation spreading across the features of someone bearing about the truth of these meds and their side effects, never fails to amaze me. They tell us that AT LAST they can see what has happened and why. It won’t necessarily bring about a cure, but it does take away the agony of guilt fueled doubt.
We had a very clued-up member of the police force talking to a group of us today about ‘safe guarding’ which was enormously interesting. It was about protecting children and vulnerable adults from harm. We told her about what RoAccutane-isotretinoin and SSRIs and anti psychotics are doing to this very same set of individuals. We told her about RxISK.org and the PSSD, PGAD, PRSD and PFS horrors, and the ensuing suicides of some sufferers. She was very interested and at the same time appalled that this could be allowed to happen. I have no doubt that once she has researched it, had a look at RxISK and acne.org and read about why our son died, she will be a marvellous person to help alerting others to keep them safe. She is the kind of person who has energy and who genuinely CARES.
Civil Service ‘World’ .. Science Powerhouse ..
http://www.civilserviceworld.com/articles/news/civil-service-appoints-gsk-research-head-chief-scientific-adviser
Cabinet secretary and civil service head Sir Jeremy Heywood said Vallance was well placed to offer the best scientific advice to Theresa May.
“This is an excellent appointment for the civil service, in an important area of government business,” he said.
Also commenting on the announcement, science minister Jo Johnson said that Vallance’s extensive knowledge and experience from academia and the private sector would play a central role in government’s ambitions to build a “worldwide reputation as a science powerhouse”.
Science Translational Medicine
http://blogs.sciencemag.org/pipeline/archives/2017/11/09/more-movements-at-the-top-of-gsk
a lost decade ..
“Whaddya want” ..
J-P G ..
https://www.youtube.com/watch?v=k_p89zIddjk
2012…5.51 minutes of your valuable time ..
Alibaba ties up with GlaxoSmithKline for online HPV vaccine appointment service
Taobao users can book a vaccination appointment in more than 100 cities
PUBLISHED : Friday, 10 November, 2017, 5:43pm
UPDATED : Friday, 10 November, 2017, 7:45pm
http://www.scmp.com/tech/enterprises/article/2119348/alibaba-ties-glaxosmithkline-online-hpv-vaccine-appointment-service
Cervical cancer is the second most common cancer among women of ages between 15 to 44 years in China, with an estimated 130,000 new cases each year, or 28 per cent of the total diagnosis worldwide,
according to GSK.
Ali Baba – and the Forty Thieves ..
Jonah and the Whale….A story about God’s rebel………..
Chapter 1 v 15
‘Then they took Jonah and threw him overboard and the raging sea grew calm’
Chapter 2 v10
‘ And the Lord commanded the fish, and it vomited Jonah onto the land’
Chapter 3 v6
When Jonah’s warning reached the king of Nineveh, he rose from his throne
took off his royal robes covered himself with sack cloth and sat down in the dust..’
Chapter 4 v 11
And the Lord said should I not have concern for the great city of Nineveh in which there are more than a hundred and twenty thousand people who cannot tell their right hand from their left. And also many animals.