Andrew Witty , You’re Full Of Shit…


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 heart attacks from Avanida, our lives mean zilch.

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…


http://davidhealy.org/persecution-he-who-would-do-a-great-evil/

Persecution: He Who Would Do A Great Evil

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 WhoPersecution: 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 TimeThe SUI Cide Apparatus, Professional SUI Cide.  This marks a new Pharma sub-series.

Hope Witty 3

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?

Panalba

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.

Upjohn’s Options

  1. to pull the drug immediately from the market,
  2. to stop production but let doctors use up the supplies available,
  3. to continue to produce but stop marketing,
  4. to continue to produce and to promote until it was actually banned,
  5. 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.

Business Ethics

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.

Boycott 

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.

or AbbVie

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

- See more at: http://davidhealy.org/persecution-he-who-would-do-a-great-evil/#sthash.RKbFxbPy.dpuf

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http://truthman30.wordpress.com/2014/04/08/the-funniest-joke-they-ever-heard-an-imaginary-interview-with-andrew-witty-cartoon-parodysatire/

“The Funniest Joke They Ever Heard” … An Imaginary Interview With Andrew Witty (Cartoon: Parody/Satire)

1 Vote

 “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)

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For those unfamiliar with the Seroxat Scandal,
 Shelley Jofre, and what I am satirizing in the cartoon
 see David Healy's blog here:

http://davidhealy.org/the-house-of-gsk/

You are here: Home / AbbVie / The House of GSK

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

The End Of Paxil Progress?


I’m planning on finishing up blogging by the end of this year (as I mentioned in a previous post). However, I plan to leave my blog online as I feel it is a very important resource for psychiatric drug casualties (particularly for those who took Seroxat/Paxil). It also documents GSK’s criminal history- and contains numerous other issues relating to the Seroxat scandal etc- therefore it will be left open for anyone to read.

Yesterday a website called Paxil Progress went offline suddenly and it seems that it has been taken offline permanently. The site had been running for 14 years, and there are literally tens of thousands of stories of people’s experiences with psych drugs contained in its various forums. It is (or was) an incredible resource for psych-drug users and an incredibly useful information sharing portal. When I was looking for help and guidance throughout my very difficult Seroxat withdrawal, I found the support and advice from members of Paxil Progress invaluable. It seems a terrible shame that this vital resource has now been effectively wiped from the internet. Over the years Paxil Progress gathered literally tens of thousands of members, hundreds of thousands of posts, and a huge community was created. Now it seems, that’s all gone…

I understand that the admin moderator, Scotty (Laurie Yorke), seems to have just had enough of moderating the site (running sites like that can be thankless, tiring and stressful), and it was a site which was certainly no stranger to drama and controversy, but what I don’t understand is: why was the site shut down completely? Why was is shut down so quickly? (within a day it seems) and also what will happen to the information contained in the site?

Surely there were also other people (moderators, long term members etc) who would have been willing to continue administrating the site- to keep it going?

Anyhow, we might never know the full facts, but thankfully there is another website called Surviving Antidepressants, which many of the previous Paxil Progress members seemed to  have flocked to. For those suffering from anti-depressant/psych drug withdrawal and side effect issues, it’s a site which might be worth checking out…

I sincerely hope that Laurie can maybe pass the Paxil Progress site on to others who might be interested in moderating PP, and that the information can be opened up again for people to see online, if not- it seems to me that an entire history of many people’s experiences has been needlessly erased, and that- in my opinion is a shameful travesty…

Laurie

PP

Psychiatrists learn from the experts: their patients


truthman30:

good insightful article..

Originally posted on recovery network: Toronto:

One of the great myths of what often gets called “mental illness” is that people who have been diagnosed “lack insight”.

The truth is that too many doctors lack the insight to ask – or the time to listen to insights that differ or dissent from the masses of data they have crammed into their busy brains and busy schedules.

Another  great myth is that all psychiatrists must be evil – when in fact very few are. Some are even making the time to listen and to help make space in busy training schedules for trainee psychiatrists so that they too can learn to learn not just from text books but from their patients.

These are interesting times in mental health services and it is always a pleasure to be able to spotlight an initiative within the heart of “the evil empire” that is at least partly about bringing the…

View original 1,174 more words

Consumers Deserve To Know Who’s Funding Health Research


https://hbr.org/2014/12/consumers-deserve-to-know-whos-funding-health-research

Consumers Deserve to Know Who’s Funding Health Research

December 2, 2014

The United States government is finally requiring drug and device manufacturers to disclose the payments they make to doctors and teaching hospitals. For decades these payments were largely hidden, until Senator Charles Grassley took an interest. As Grassley’s lead investigator on this issue, I spent from 2007 to 2010 uncovering industry money that academic researchers were hiding from their universities. And now the Physician Payments Sunshine Act is law, as part of the Affordable Care Act of 2010. Since then, progress has been made, but much more is needed.

Why the Sunshine Act Was Necessary

The need for full disclosure was very clear to us in the Senate. Companies were paying physicians to give speeches on behalf of their products and to publish studies (ghostwritten by the companies) that downplayed those products’ side effects. For this disgraceful behavior, companies later paid billions of dollars in fines for defrauding the federal government and selling harmful or ineffective products (witness the Paxil, Avandia, and Vioxx scandals).

Industry fumed when we proposed the Senate bill. I remember one conversation in 2007 during which a company vice president complained to me that trying to account for all the money going to doctors would be extremely costly. “Is that the story you’ll tell shareholders?” I asked him. “Do you want to admit that you can’t comply with such a law because you don’t track how much money you shovel out the door to doctors?”

I wish I could report that medical professionals embraced our efforts — but they didn’t. After we launched investigations of more than three dozen patient-advocacy groups and professional medical societies, it became clear why: Most of those organizations depended on income from industry, and many physician-leaders of these groups received large consulting fees. They fought back against our efforts to bring transparency to their financial relationships.

  • A collaboration of the editors of Harvard Business Review and the New England Journal of Medicine, exploring best practices for improving patient outcomes while reducing costs.

It was a pretty lonely battle. Our investigations exposing hidden money helped to weaken industry opposition, but passing a stand-alone bill would have been extremely difficult, perhaps impossible. Luckily the Senate was already working on health care reform, and the Sunshine Act was folded into the larger Affordable Care Act, which eventually passed in 2010.

How Transparency Has Changed Attitudes

We have come a long way since 2006, when the Wall Street Journal ran a story detailing conflicts of interest — between Cyberonics and Emory University’s Dr. Charles Nemeroff — that had not been disclosed in the journal Neuropsychopharmacology. In a letter to the WSJ, several dozen physicians, including Dr. Robert Golden, the dean of the University of Wisconsin’s medical school, defended Nemeroff. Two years later, in 2008, both Nemeroff and the University of Wisconsin came under close scrutiny for undisclosed industry money during the Senate investigations I led.

After Nemeroff was exposed for not reporting almost $2 million in received payments, he apologized in 2009, saying he would use the incident to help other doctors understand the importance of disclosure. Golden promised to clean up his own institution after investigations identified a physician there who received millions of dollars in unreported income from a device company. The 180-degree shift was complete when, writing in March 2014 in JAMA, Golden and two coauthors called for leaders at academic institutions to end most financial relationships with outside entities: “Leaders have a responsibility to set an example for others in their institution, especially for those training to be health care professionals.”

It doesn’t matter whether this shift in medical professionals’ attitudes is attributable to a change of heart or consistent outside pressure. Either way, it is now accepted that doctors are — like anyone — susceptible to money, and we are mitigating those influences by requiring transparency.

What’s Next for Transparency in Science

Despite progress, the movement toward greater disclosure has a way to go. Currently, it’s not clear how disclosure actually affects patient outcomes. Research published in the NEJM suggests it doesn’t have much impact on patient behavior. And a study in JAMA Internal Medicine shows that disclosure is unlikely to have much effect on prescribing behavior and health care costs. However, in another NEJM study, doctors judged studies more harshly when they knew they were funded by the pharmaceutical industry.

Bottom line: We honestly don’t know whether the Physician Payments Sunshine Act will make doctors think twice about taking gifts from industry — and whether people will tire of hearing about this activity and simply ignore it. We are in uncharted territory, and new laws often have unforeseen consequences. The next few years will be crucial.

One thing about the future is certain: Nobody should assume that corruption in medicine is unfixable. Medicine has been at the center of both the problems and the solutions involving science and industry. NEJM instituted the very first conflict-of-interest policy in 1984, with JAMA following a year later. The two leading science journals didn’t catch up until 1992 (Science) and 2001 (Nature). In fact, research finds that science journals have always lagged behind medical journals in addressing conflicts of interest.

The problems across science loom large. Industry has funded campaigns to undermine scientific work that has major public health implications, such as secondhand smoking, obesity, regulation of chemicals, and climate change. In each case, hidden money buys off science experts, funds think-tank papers, and litters journals with ghostwritten studies.

Given medicine’s leadership position in disclosing industry funding, it’s time for physicians to lead their other colleagues in science to ensure that all scientific work remains transparent and independent. Here are some leads from the medical community that others in science could follow:

  1. The National Institutes of Health now requires grant recipients to disclose outside income and explain how they will manage conflicts during the term of the grant. Other agencies, such as the National Science Foundation and the U.S. Department of Energy (which funds scientific research), should follow suit.
  1. Standards on reporting conflicts of interest vary widely across medical journals, institutions, and professional societies, thereby creating confusion for researchers. Given that the medical research community has always led in addressing financial conflicts, it should be the first to create and adopt universal reporting standards, to simplify disclosure requirements, and to lead the way for the rest of science.
  1. For too long, companies have flooded the scientific literature with ghostwritten studies. Journals and universities should no longer tolerate hidden money that supports the publication of research. They need to require disclosure not just of the funding for the research and the financial conflicts of individual authors, but also of any financial support received for writing the study.
  1. Finally, journals should require authors to publish all research data, along with the article, online. Server space is cheap, and journals can afford to publish this information. We know that funding can bias the outcome of a study, but if the data are made public, independent researchers can verify the analyses and the conclusions.

These fixes are already being implemented or at least actively discussed by medical experts, but they are largely not on the radar in other areas of science. As medical leaders move further in adopting ethics-based changes, they are likely to influence their scientific colleagues outside medicine. In effect, the sunshine needs to become stronger in the medical community and to spread its light to the entire universe of science.

When Did The Moral Decay Begin At GSK?…


Some commentators (and ex-Glaxo employees) on Corante speculate:

http://pipeline.corante.com/archives/2014/12/02/a_sad_look_back_to_2006_at_gsk.php

10. exGlaxoid on December 2, 2014 2:22 PM writes…

Just look at where the problems for GSK have come from. Former SKB manufacturing plants, Paxil and Avandia being promoted incorrectly, buying stupid things (most pushed by former SKB managers), and many other high level decisions, almost all of which were not from former GW people. The only mistake also pushed hard by the former GW people was going into China so hard and fast, both in sales and R & D (how many drugs have come from GSK China?)

Back in 2001 – 2006, we started hearing about how outsourcing some research would so great. We started looking at the growth and predicted that by 2015 there would be 10-20% of all pharma R & D done in China and India. I think it went much faster, and produced little so far, although I do expect that eventually China will start doing much of it, as they have enough resources to make it happen now. Many of the outsourced compounds, libraries, and much of the development work has been of poor quality, slower than before, and much of the work is questionable validity. Oh well.

But here in the US, we won’t have the money to buy the latest medicines from China, since no one will have a job any more, at least in many areas. But at least the former CEOs of the pharm and biotech industry will still have their yachts.

I just hope that the industry recovered at some point and can bring back some jobs once we realize the poor quality of what we get from outsourcing to the lowest bidder. Sorry to dwell on this, but my remaining friends still at GSK are now waiting in suspense, just in time for the holidays. What a great Christmas gift.

Permalink to Comment

11. anon on December 2, 2014 2:27 PM writes…

not only have sales and developments fallen short. GSK is now in seventh place trailing: JNJ, NVS, Roche, PFE, Sanofi and MRK

12. annon 2 on December 2, 2014 3:08 PM writes…

Many in GSK R&D at the time thought these comments were overblown, hyperbola, bravo, that could never come to pass. Drug discovery & development never has, and never will be analogous to electronic chips, packaging into computers or tablets or cell phones, high volume marketing with free will purchasing (eg not regulated or filtered by doctors or insurance or providers).

And then there were all the very costly missteps, some not directly from GSK, that already forced cuts to R&D: Avandia critic Steve Nissen, Sirtis, HGS, darapladib, China GSK, many reorganizations, invisible upper management, lack of accountability for the poor decisions (promotions instead)…..

It’s tragic that such good company(ies) could be so badly managed and so quickly decimated.


In the Pipeline

pipeline.corante.com/archives/2014/12/02/a_sad_look_back_to_2006_at_gsk.php

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December 2, 2014

A (Sad) Look Back to 2006 At GSK

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Posted by Derek

It’s generally painful to go back a few years and look at the large-scale pronouncements of a drug company’s upper management. Thanks to commenter Metamonad, we can, in light of tomorrow’s GlaxoSmithKline re-org, step back to 2006:

At the time of the £107bn merger of Glaxo Wellcome and SmithKline Beecham in 2000, the architect of the deal, Glaxo’s chief executive Sir Richard Sykes, spoke of creating the “Microsoft of the pharmaceuticals industry”. Now Mr Garnier, previously the head of SmithKline and the man who became the chief executive of the merged company, believes ramping up investment in the research and development of new drugs is crucial to making this vision come true.Mr Garnier said: “In terms of creating the Microsoft, this is a vision of the most R&D intensive company which I completely agree with. We have a chance to step away from the rest of our competition if we execute our plan well and we’re now in a position to do so.”

GSK is the second-largest drug company in the world, with a 7 per cent market share behind America’s Pfizer at 11 per cent. Last week Mr Garnier’s contract was extended by seven months to May 2008 so he could steer the group through a crucial year that will see the launch of several key medicines. They include Cervarix, a vaccine for cervical cancer, Tykerb, an oral treatment for breast cancer, and Eltrombopag, a blood clotting agent in the treatment of breast cancer.

These blockbuster drugs are set to bring in billions of dollars of extra revenue, enabling the company to pour large chunks into drug discovery from 2008, Mr Garnier said. This year the group is spending $4.4bn on developing new medicines, around 16 per cent of overall revenues, but the goal is to get that figure to the 20-25 per cent range over the next 10 years.

So how’d that work out? Tykerb has had a rough time of it in some clinical trials, and its revenues last year were about $340 million and falling. Ceravix brought in $270 million, down 37 per cent (although that drop was mostly due to trouble in the Japanese market). And eltrombopag, known as Promacta, was a brighter spot, with $307 million in revenues, up 46%. But you’ll note that all three of these put together did not bring in a billion dollars of revenue in 2013, which would surely not have made anyone happy if you’d told them that in 2006.

And the R&D spend last year was 15% of overall revenues – less than the starting point in the above article, and nowhere in sight of that 20 to 25%. And with the company set to cut even more tomorrow, I think we can rule that out for the near future, too.

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When The Body Says No: Mind/Body Unity and the Stress- Disease Connection


truthman30:

Amazing Lecture on the Mind/Body Connection by Gabor Maté, really struck a chord. This is the stuff that mainstream psychiatry doesn’t want you to think about…

Originally posted on Beyond Meds:

Illness and what creates illness with Gabor Maté. If you’ve been reading Beyond Meds for any length of time you’ll know that Gabor is one of my favorite human beings. He is an inspired brilliant man who is helping us change the healing climate on this planet.

Stress is ubiquitous these days — it plays a role in the workplace, in the home, and virtually everywhere that people interact. It can take a heavy toll unless it is recognized and managed effectively and insightfully. Western medicine, in theory and practice, tends to treat mind and body as separate entities. is separation, which has always gone against ancient human wisdom, has now been demonstrated by modern science to be not only artificial, but false. e brain and body systems that process emotions are intimately connected with the hormonal apparatus, the nervous system, and in particular the immune system. Emotional stress, especially…

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Glaxo’s Murky Past: ” Vaccine trials on children worse than first thought” (Irish Examiner)


Special investigation – Vaccine trials on children worse than first thought

The scale of use of children for vaccine trials is much greater than was first thought, writes Conall Ó Fátharta

THE latest revelations that another legacy company of pharmaceutical giant GlaxoSmithKline sponsored a fifth, previously undisclosed, medical trial on children in care here in the 1960s needs to result in action from the Government.

The fact is that the picture now emerging is now far more disturbing than that which compelled the then Fianna Fáil-led government to refer the matter for investigation by the Commission to Inquire into Child Abuse (CICA) in 2000.

Before that inquiry was halted following a 2002 Supreme Court ruling, GlaxoSmithKline (GSK) had confirmed just three trials in the 1960s and 1970s using over 250 children. We now know there were at least five trials in this period — the fifth exposed today by the Irish Examiner.

Indeed, recent revelations have shown that, far from carrying out just four vaccine trials on children in care here, Wellcome (now GlaxoSmithKline) sponsored trials in Ireland now span almost half a century — involving dozens of institutions and thousands of children.

The records released to CICA by GSK have now been returned to the company. The commission retained no copies. Yet, no questions have been answered.

Why are victims finding out about new trials now — through the press? Why did the short-lived inquiry not know a fourth and fifth trial had occurred?

Why did the report of Inter-Departmental Group on Mother and Baby Homes published this year still refer only to three vaccine trials — when a fourth was admitted in 2011 and the 1930-1935 trials of a Burroughs Wellcome vaccine for diphtheria carried out on 2,000 children in residential institutions were uncovered by Michael Dwyer of UCC’s School of History just a month before its publication?

Nor did it mention the 1965 trial of a 5-in-1 vaccine carried out on Philip Delaney at Bessborough mother-and-baby home in Cork. Why did this report claim a total of 123 children in institutional settings were used in the first three acknowledged trials when, in fact, 180 children were used?

The revelation that vaccine trials were carried out on children in mother-and-baby homes and other institutional settings first hit the headlines in the early 1990s.

Questions were raised in the Dáil on the subject, but it wasn’t until 1997 that then health minister Brian Cowen gave assurances that the matter would be examined.

In 2000, the Kiely report confirmed that three trials had been conducted on behalf of the pharmaceutical company the Wellcome Foundation. The institutions involved were Wellcome Laboratories in Britain, the Department of Medical Microbiology in UCD, and the Eastern Health Board.

The first trial took place between December 1960 and November 1961 in four Mother and Baby Homes — St Patrick’s on the Navan Road in Dublin (14 children), Bessborough in Cork (25 children), Castlepollard in Westmeath (six children), and Dunboyne (nine children). Four children from Stamullen baby home in Meath were also used for this trial.

The purpose of the trial was to look at the response the children would have to a 4-in-1 vaccine — diptheria, whooping cough, tetanus, and polio.

The second trial involved 69 children from St Anne’s Industrial School in Booterstown in Dublin being administered an intranasal rubella vaccine. A further 53 children from the wider community in Kilcullen in Westmeath were also used in this trial.

The first two trials were carried out by Professor Irene Hillary and Professor Patrick Meenan from the department of Microbiology in UCD, as well as other doctors.

The third trial involved 53 children in a number of residential institutions in Dublin including St Patrick’s Home, Madonna House, Bird’s Nest, and Boheenaburna. A total of 65 children living at home in Dublin also received the vaccine.

The aim of the third trial was to compare commercially available batches of the 3-in-1 vaccine — Trivax and Trivax D — with that of equivalent vaccines prepared for the trial. There is no published paper or report of this trial, but the Eastern Health Board was aware it was being conducted.

Dr Kiely’s report concluded that, given the reasons which the vaccines sought to counter, the decision to conduct the trials was “acceptable and reasonable”.

However, Dr Kiely said there was a lack of documentation available to clarify whether consent was either obtained or sought from the parents of the children or the managers of the institutions.

However, an entry in the 1962 British Medical Journal concerning the first trial seems to confirm that parental consent was not sought.

“We are indebted to the medical officers in charge of the children’s homes for permission to carry out this investigation on infants under their care,” it wrote.

Responding to the Kiely Report in 2000, Prof Hillary said it was her “invariable practice at the time to obtain consent of the competent authority”, be it the mother, the manager, or the medical officer.

However, no record of written consent has been acknowledged. The religious orders who ran the homes involved in the trials have also denied that they authorised any clinical trials.

Of the victims of the vaccine trials who have located their natural mothers, all mothers have said they were not asked for their permission.

In 2000, then minister for children Micheál Martin admitted the Kiely report was “incomplete” and raised “as many questions as it answered”.

However, despite this, Mr Martin reassured the Dáil that the trials appeared to have had no medically negative consequences for any of the children involved.

In an effort to deal with the matter, the Government decided to extend the terms of reference of the Commission to Inquire into Child Abuse. This was done despite objections that the trials could not adequately be dealt with by an inquiry looking primarily into physical and sexual abuse.

The ‘Vaccines Module’ of CICA began investigating in early 2002. It obtained documentation from GlaxoSmithKline — the successor of Wellcome — and identified the names and addresses of some of those involved in the trials.

However, the probe was hit with a Supreme Court ruling which upheld Prof Meenan’s challenge against a High Court order directing him to give evidence before the inquiry.

The court also criticised the decision to ask the commission to examine the vaccine trials in the first place, stating they had “only the most tenuous connection, if any, with the appalling social evil of the sexual and physical abuse of children in institutions, which was the specific area into which the commission was established to inquire”.

Mr Justice Hardiman stated that Prof Meenan’s involvement in vaccine trials related only to one trial in 1960/61 and that the issue of the “reputational damage” associated with being involved with a Commission primarily looking at sexual abuse had to be considered.

Following this, Prof Hillary challenged the Government’s order directing an investigation into the vaccine trials. The Government did not appeal this decision. As a result, the work of the Vaccines Module’ ceased in November 2003.

However, those who suspected they were victims of the trials continued to claim that there were far more than three trials carried out by Wellcome here.

The Third Interim Report from CICA in December 2003 confirmed as much when it stated that the documentation it received from GSK “disclosed a considerable amount of information in relation to other vaccine trials conducted in the State”.

When RTÉ’s Prime Time asked the pharmaceutical giant about this statement, it confirmed a fourth trial had taken place in 1965. This trial involved giving differing doses of the measles vaccine to 12 babies aged between nine and 19 months in the Sean Ross Abbey mother-and-baby home in Tipperary.

The firm stated that this fourth trial was the only other clinical trial sponsored by Burroughs Wellcome using children in institutions in Ireland.

However, as the Irish Examiner reveals today, a fifth trial also occurred during this period.

An article in The Lancet in August 1965, discovered by Michael Dwyer of UCC’s School of History, confirms that Glaxo Laboratories Ltd carried out yet another measles vaccine trial on 34 children aged between eight months and just over two years. The trial was carried out by Prof Hillary and Prof Meenan of UCD and AJ Beale of Glaxo Laboratories. It is also the first trial which confirms Glaxo Laboratories involvement in a vaccine trial. All of the other trials were carried out by Wellcome.

Although the report does not mention an institution, it makes reference to the fact that the reaction to the children were monitored by “the adults looking after the children”. It also says examinations were done on the children from day six to 14 at the same time — 6pm — indicating the children were in a group setting.

The Irish Examiner put questions to GSK concerning this trial, what institution it was carried out in and why it failed to disclose this trial in 2011.

The company did not agree that the references in The Lancet amounted to evidence that the trial was carried out on children in care, stating that, in other papers by the same investigator, the author explicitly stated that the study was carried out on children in care. GSK said if it had any evidence that this trial was carried out on children in care, it would have handed it over to the CICA.

On the issue of whether consent was either sought or obtained for this study, GSK stated that any studies were done to the highest ethical and safety standards as a fundamental part of developing and delivering new vaccines to treat and prevent illnesses that were a major public health risk at that time.

“The studies of The Wellcome Foundation vaccines were conducted by independent healthcare professionals. The children who participated in the trials were recruited from the community and those living in children’s homes. The methodology and results of at least two of the studies were published in respected journals,” said a statement.

GSK said it had “limited archived documentation” given the trials happened decades ago, but was seeking to investigate the facts. It also confirmed it would fully co-operate with any Government investigation into the issue.

The upcoming Mother and Baby Homes inquiry cannot ignore the issue. Many victims were resident in these homes and deserve answers, justice and all of the information held on them by GSK. Otherwise this state really does view them, even now, as was said in the Dáil in 2000 as “children of a lesser god”.

Vaccine trial confirmed by data request

Mari Steedsays media interview transcripts were kept on her GSK files

In 2011, GlaxoSmithKline released a data protection request to vaccine trial victim Mari Steed which confirmed she was part of a vaccine trial it carried out half a century earlier.

It also released a dossier indicating that it had been monitoring statements she had been making to the media on the vaccine trials going back almost a decade.

Ms Steed, who was adopted to the US from Bessborough, discovered she was a victim of the trials in the late 1990s when she was trying to trace her natural mother.

A handwritten note on her medical file released to Ms Steed — the Sacred Heart order then ran the home — confirms she was given three injections for the 4-in-1 vaccine, the third of which was “given by Prof Hillary”. This entry is immediately followed by: “Baby to America.”

Ms Steed’s natural mother Josephine, who passed away last year, always stated that she was never asked for her permission, nor was she aware that vaccines were being trialled on her daughter during her time in Bessborough.

The 4-in-1 trial took place between December 1960 and November 1961 in four mother-and-baby homes. The purpose of the trial was to look at the response the children would have to a 4-in-1 vaccine — diptheria, whooping cough, tetanus, and polio.

Following her data protection request, Ms Steed was astounded to discover that GSK had kept a substantial file on her — and not all of it related to her medical records.

Referred to as “GSK 36” in parts of the documents released to her by the pharmaceutical firm, the records confirm her participation in the trial. However, she was astounded to discover the firm also had a file monitoring media appearances she made talking about the issue.

This included press cuttings from a range of newspaper interviews given by Ms Steed — some almost a decade apart.

Also included were typed transcripts from a number of different radio interviews. These included an interview with PJ Coogan on Cork radio station 96FM and an extract from a news bulletin on the station where she was quoted.

Ms Steed said the fact that the pharmaceutical giant was monitoring her public statements was “shocking”, although “not entirely surprising”.

“It was somewhat shocking to realise that GSK had been keeping such data on me, although not entirely surprising,” she says. “Just prior to receiving my DPA reply from GSK, I had received my entire file from the HSE South, which included a six-page dossier that Sister Sarto of Bessborough had kept on me, noting similar media references and untoward comments regarding my search for my mother.”

Ms Steed said she was aware of a number of Bessborough adoptees who had made DPA requests from GSK, but said she was not aware of anyone else that has had their participation in a vaccine trial formally confirmed by the company.

“I personally know one individual who came forward as part of the initial Laffoy investigation, but has not filed a request under DPA as far as I know; and of course, one other who participated in the Prime Time investigation,” says Ms Steed. “Many more have unexplained marks and scarring on their bodies, including outside areas where vaccines would typically be given.

“And every person I know, among hundreds, who were adopted from Ireland to the US, reported that as children we all came up as testing positive for TB during routine childhood doctor visits, despite not actually suffering from it. This anomaly has never been able to be explained by our family practitioners here in the US.”

The Philadelphia woman said the fact that the vaccine issue has never been fully investigated defied belief, and said many US adoptees were considering going to the courts unless the issue was included in the upcoming Mother and Baby Home inquiry.

“Failing that, I believe there are enough of us to move forward through the courts on the matter, including the EU court and potentially the UN,” says Ms Steed.

“There seems to be an inexplicable reluctance on the part of the Irish legal community to represent victims of such trials and proceed with cases. Although we are now making inroads to US law firms who have handled legal cases against GlaxoSmithKline and may be willing to provide representation.”

Waiting for some answers

Mari Steed is one of the few people that knows she was used in a vaccine trial. Others are not so lucky.

For people such as Christopher Kirwan, the wait for answers goes on.

He has written to numerous ministers of children to no avail. He has also written to GSK and to the Sacred Heart Sister — both of which have told him he was not used in any vaccine trial carried out in Bessborough.

A investigation by the Data Protection Commissioner in 2011 also confirmed that neither GSK nor the records then held at Bessborough indicated that he was part of a vaccine trial. That would be fine if the Cork man didn’t have eight unexplained scars on his arms and legs.

Mr Kirwan was born in Bessborough in November 1960 and was adopted the following June. He was in Bessborough during the period of the first Burroughs Wellcome vaccine trial, and even had his photo taken with Mari Steed as a baby.

Despite his scars, his records simply state that he was inoculated for the BCG and smallpox and that no documentation indicating he was part of those trials.

Mr Kirwan believes he was involved in a vaccine trial of some form as the marks on his body do not make sense for someone who just received two inoculations. His adoptive mother told him that when he left Bessborough as a child he had bandages on his arms. “I just want answers,” he says.

Philip Delaney has also been told he was not part of any vaccine trial, despite his medical records indicating he was give three injections of a 5-in-1 vaccine for polio, measles, diptheria, whooping cough, and tetanus. Beneath the record showing this injection, the words “Contact Dr Hillary, Dublin” are crossed out.

His adoptive mother told Prime Time in 2011 that she was told by a doctor who came to take the blood in a follow-up visit that Mr Delaney was one of 20 babies used for a trial for a 5-in-1 vaccine and that the babies were not supposed to have been given up for adoption.

“The Government are saying there have been no ill effects,” says Mr Delaney. “How do they know? Because they don’t know about this trial.”