Category: Avandia

(2010) Will GlaxoSmithKline’s Blood Money Go Unpunished?


This article is from 2010, however I believe that its contents are just as relevant today (and perhaps more so) as they were 6 years ago…

Will GlaxoSmithKline’s Blood Money Go Unpunished?

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Shutterstock photo

Amit Chokshi submits:

In the 1970s, economist Milton Friedman penned an opinion piece in The New York Times Magazine that discussed his view on corporations’ social responsibilities. Friedman’s take on corporate social responsibility was summed up in his famous quote – “There is one and only one social responsibility of business – to use its resources and engage in activities designed to increase its profits so long as it stays within the rules of the game, which is to say, engages in open and free competition without deception or fraud.” If the recent years have demonstrated anything, it’s that without strong regulations, empowered enforcers, and lawmakers providing legitimate public service as opposed to lining their own pockets and shilling for large companies, corporations will freely and enthusiastically engage in competition utilizing deception and fraud in order to drive profits.

In a recent article in The New York Times, global pharmaceutical company GlaxoSmithKline ( GSK ) demonstrated that in its quests for profits it would have no problem at all being complicit in the deaths of its customers, not exactly a surprise given that we are in an environment with loose regulations (generally written by those that will be regulated), neutered regulating agencies, and politicians whose real constituents are corporations like GSK.

While one could point out that stocks within the sin stocks category (alcohol, tobacco, gaming) profit at their customers’ detriment, at least for the past decade if not longer, consumers have been well aware of the risks using these products carries. More importantly, these companies do not generally profess to market products that benefit the health of their customers. In contrast, GSK was pushing a product, in this case a treatment for Type II diabetes called Avandia, it knew was very risky for its patients while never disclosing material information to those using it. Even worse, GSK used its size to intimidate dissenting views and strike deals that prevented this data from reaching the public over the course of years. As a result, Avandia was linked to over 300 deaths in the third quarter of 2009 alone. In fact, as the NYT reported, government reports indicated that if every diabetic was taking a competing product known as Actos, as many as 500 heart attacks and 300 cases of heart failure could have been avoided.

In the case of Avandia, the profits secured by its billions in sales are to a great extent blood money. The question now is how policy makers respond to GSK and the executives involved and also address failures at the regulatory level. Unfortunately, GSK is likely just one of the many global pharmaceutical companies that routinely mislead patients by suppressing data and intimidating critics but there seems to be a lack of any justice carried out at any level with respect to the corporations and their executives. For example, the NYT article discusses various behaviors undertaken by GSK that should warrant serious concern:

  1. Misrepresentation of data: Some GSK studies of Avandia were considered “unethical and exploitative” by the FDA. Additionally, a GSK study on Avandia in Europe, dubbed the Record trial, was performing so poorly in 2004 (showing patients were at higher risk for heart problems) that GSK executives would never answer any questions regarding Avandia’s impact on the heart with any certainty.
  2. Intimidation: As early as 1999, medical experts were suggesting Avandia could pose a heart risk. These experts were threatened with legal action by GSK before signing documents that assured their silence.

Another failure appears to be at the various regulatory agencies. Despite having data that suggested Avandia posed significant risks, these agencies were reluctant to move quickly. Despite numerous questions regarding Avandia’s safety, these bodies held back making much of this information widely available and GSK capitalized on this silence by aggressively marketing the drug. It appears that protecting the profits and value of GSK was more critical to the regulatory agencies than protecting the lives of those using GSK products.

However, with this information now made public, what will the regulatory bodies do with GSK? What of the executives that were paid millions for running GSK that knowingly obscured or withheld life saving data? Will they be tried as criminals? Will there be significant fines levied against GSK? Will this episode help usher in new thinking at regulatory agencies where the citizens are held in higher regard than the corporations? Essentially, will there be punishment meted out that is commensurate with the deaths of possibly thousands by GSK and its executives? It’s nice to dream, but given the Orwellian world we live in and precedent set by the financial industry, it’s more probable that those executives are rewarded and receive more generous retirement pensions for the fine work they conducted.

Author’s disclosure: None.

 

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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Does Prince Harry Know About GSK’s long History Of Unethical And Immoral Behavior?


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WellChild13_L-407

GSK get a lot of publicity, and corporate brownie points, for sponsoring award ceremonies such as the BMJ lifetime achievement award, and the recent 2014 ‘Wellchild’ awards. There is nothing inherently wrong and unethical about corporate sponsorship of these types of events, but I must say, considering GSK’s appallingly unethical and sinister history (in particular in relation to harming children and babies) is there not something quite hypocritical about their sponsorship of awards relating to the well being of children?

It is understandable that Wellchild probably need to take GSK money in order to keep their organization afloat, but surely the stories of the children that GSK have harmed should also be highlighted?

England’s Prince Harry attended the recent Wellchild awards, most likely in very good faith, but perhaps if he was aware of GSK’s corporate history, he might not be so eager to support it? Many people who took GSK drugs such as Avandia, and Seroxat, ended up far from well-children or well-adults. Through deception, greed, and dodgy drugs GSK has made many children and adults quite ill, and in some cases GSK drugs have led to deaths.

GSK’s Seroxat was prescribed off label to tens of thousands of children worldwide, until a series of BBC Panorama documentaries exposed its links to increases in suicide, hostility, self harm and aggression, particularly in young adults and children. We will never know how many kids killed themselves on Seroxat (Paxil) but at least now it comes with a black box warning and is banned for under-18’s. However, GSK still have yet to apologize to all those harmed from this horrific drug and as far I am aware no UK victims, or their families, have been compensated for Seroxat damage. Maybe Prince Harry would care to check out some of the BBC’s Seroxat documentary series here and he can make up his own mind about GSK’s nefarious and dubious activities :

I could list endless examples of horrendously unethical behavior by GSK over the last few decades; behaviour which damaged and killed people of all ages; and this blog alone provides ample reading on that subject.  However, I think the  US department of Justice complaint (which led to GSK’s record breaking 3 billion fine in 2012) gives more than enough scope and numeous examples of the unscrupulously evil acts that this pharmaceutical company has committed in the pursuit of profits.

Maybe Prince Harry and Wellchild could look for a more ethical sponsor, or maybe they just don’t give a damn, who knows?

See the complaint here :

http://www.justice.gov/opa/documents-and-resources-july-2-2012-glaxosmithkline-gsk-press-conference


WellChild
WellChild is the national charity for sick children and is committed to ensuring that every child in the UK, no matter what their situation, location or diagnosis, has the very best possible quality of care.
Wehave supported this organisation since 2007
During 2013:
GSK donated £380,000
for the ongoing support of the WellChild Nurse programme and
in support of the annual WellChild Awards.
During 2012:
GSK donated £165,000 in support of WellChild’s
Nurse Programme, enabling the
employment of three nurses for three years.
GSK donated £54,242, to match money raised by Senior Managers of GSK in support of
WellChild’s work.
GSK donated £30,000 to assist with the 2013 Helping Hands fundraising event.
GSK donated £100,000 to support the 2013 WellChild Awards event.
Our support represented 16.1% of their overall income.
During 2011:
GSK provided support of £165,000 for the WellChild Children’s Nurse programme.
GSK provided funding of £10,000 in
support of the Medicines for Children website.
GSK donated £10,000 to support the 2011 WellChild Awards.
GSK provided £5,000 in support of the GSK Run For Good event.
During 2010:
GSK
donated £330,000 in support of the WellChild Children’s Nurse programme
GSK
donated £10,000 in support of the Medicine’s Information for Parents Project.
GSK
donated £8,000 to support two categories at the 2010 WellChild Awards.
Our support represented 21% of their overall income.
During 2007:
GSK gave a charitable donation
of £150,000 to fund a 3 year research programme
entitled ‘Identification of Autosomal Recessive Disease Genes by Autozygosity Mapping’
with Dr Neil Morgan at the University of Birmingham
Our support represented 5% of their overall income.

UK firm tried HIV drug on orphans

GlaxoSmithKline embroiled in scandal in which babies and children were allegedly used as ‘laboratory animals’

Orphans and babies as young as three months old have been used as guinea pigs in potentially dangerous medical experiments sponsored by pharmaceutical companies, an Observer investigation has revealed.

British drug giant GlaxoSmithKline is embroiled in the scandal. The firm sponsored experiments on the children from Incarnation Children’s Centre, a New York care home that specialises in treating HIV sufferers and is run by Catholic charities.

The children had either been infected with HIV or born to HIV-positive mothers. Their parents were dead, untraceable or deemed unfit to look after them.

According to documents obtained by The Observer, Glaxo has sponsored at least four medical trials since 1995 using Hispanic and black children at Incarnation. The documents give details of all clinical trials in the US and reveal the experiments sponsored by Glaxo were designed to test the ‘safety and tolerance’ of Aids medications, some of which have potentially dangerous side effects. Glaxo manufactures a number of drugs designed to treat HIV, including AZT.

Normally trials on children would require parental consent but, as the infants are in care, New York’s authorities hold that role.

The city health department has launched an investigation into claims that more than 100 children at Incarnation were used in 36 experiments – at least four co-sponsored by Glaxo. Some of these trials were designed to test the ‘toxicity’ of Aids medications. One involved giving children as young as four a high-dosage cocktail of seven drugs at one time. Another looked at the reaction in six-month-old babies to a double dose of measles vaccine.


http://www.independent.ie/irish-news/victim-reveals-horror-of-vaccine-trials-secret-legacy-26674008.html

Hundreds of children are feared to have been subjected to the experimental trials while in the care of the Catholic Church.

Now the victims’ cases could be reopened, as calls for the Government to deal with the scandal intensifies.

Legal action is being planned against GlaxoSmithKline and the Sacred Heart Order, which allowed the tests at the Bessborough Mother and Baby Home in Cork.

Campaigner and abuse survivor John Barrett, who was born at the home outside Cork city, was used as a ‘human guinea pig’ while in Lota industrial school, also in Cork.

“We didn’t have a clue what was being done to us at the time,” he said. “We only found out years later.”

John, now 58, wants to know the truth behind the children’s ordeal, who conducted the tests and why such experiments were allowed.

Hundreds of youngsters in children’s homes are believed to have been used in trials in the Sixties and Seventies to improve vaccines for tetanus, diphtheria and whooping cough.

John was used in four different experiments when he was aged 12 and 13 at the Lota home.

He said: “All of the boys of my age were taken off and given tests, X-rays and general examinations.

“Lists were made of those deemed to be ‘healthy’ and we would sometimes be lined up in one of the dormitories and given massive injections.

“We didn’t know what we were being given. Later blood tests would be taken and those whose scars from the first injection had disappeared were given a second dose.

“Over a couple of years, this happened about four times. I don’t think they were the normal injections you would expect.

“There is a major inquiry into child abuse so there should be a similar inquiry set up alongside it into medical experiments on children.”

More than 25,000 youngsters spent time in Irish orphanages between 1960 and 1975, the period when the controversial one-in-four trials are believed to have taken place.

Kevin Cooney of the Adopted And Fostered Persons’ Association said: “These orphans were society’s most innocent and vulnerable people.

“The State participated in abusing the rights of children in their care. That is indefensible. There must be a full disclosure.”

Meanwhile Health Minister Mary Harney has been called on to instruct her officials to make available all relevant information regarding the ongoing vaccine trials.

The call comes following Mari Steed, 50, breaking her silence on Friday, in the Irish Independent, into how she was subjected to a controversial vaccine trial as a baby without her mother’s consent.

She said she the trial were carried out on her between December 1960 and October 1961, when she was between nine and 18 months old.

Ms Steed, who now lives in the US, and three others, are preparing to take legal action in US courts against the drugs company, GlaxoSmithKline.

Leas Ceann Comhairle Brendan Howlin, who was health minister in 1993, assured victims that an inquiry had found they suffered no ill effects from the experimental medical tests.

He admitted he did not remember the probe or its findings. The Department of Health said it was searching department archives in a bid to locate the documents.

Mr Reilly said yesterday that all the facts must be put on the table.

“It is totally unacceptable for children in the care of the State to be involved in a vaccine trial without proper information being made available, or the full consent of their parents or guardians.”

Sunday Independent

– See more at: http://www.independent.ie/irish-news/victim-reveals-horror-of-vaccine-trials-secret-legacy-26674008.html#sthash.XEdUjOqq.dpuf


 http://www.theargus.co.uk/archive/2003/09/24/5103769.Happy_pill_girl_s_suicide_tragedy/

Happy pill girl’s suicide tragedy

A brilliant young artist killed herself after taking the controversial anti-depressant Seroxat.

Sharise Gatchell, 18, had been prescribed the drug without her parents’ knowledge.

They found her body when they returned home after a weekend away.

Sharise had hanged herself. A packet of Seroxat, with 30 empty blisters, was lying on her bed.

Today her father Alfred said he blamed the so-called wonder drug for her death.

He and wife Stephanie, of Lawes Avenue, Newhaven, have joined calls for it to be banned.

A coroner at Eastbourne yesterday stopped short of making a definite link.

But he said he would pass the findings of the inquest to the Committee on the Safety of Medicines, the Government’s advisory body on pharmaceuticals.

Sharise’s death is the latest in a series of cases brought to the attention of the pill’s Crawley-based manufacturer, GlaxoSmithKline (GSK). It insists the drug, which has become the most heavily-prescribed anti-depressant since it was first licensed in 1990, is safe.

The inquest heard Sharise, an “extremely talented” art foundation student at City College, Brighton, was initially prescribed Seroxat to help her battle shyness and depression.

But her condition deepened and she experienced dramatic mood swings, withdrawing into herself.

She agreed with her parents to come off the drug.

However, shortly before her death she was given a new prescription without the knowledge of her parents.

Mr and Mrs Gatchell went away on Friday, May 23, believing Sharise’s best friend was staying for the weekend.

Her parents returned early on Monday, May 26, to find their daughter’s body.

The empty pack of pills, dated May 7, a blood-stained craft knife and a note were on her bed.

Mrs Gatchell told the inquest: “I had no idea she was on Seroxat but she was definitely behaving very strangely. Had we known she was taking it we would never have gone away.

“She was aggressive, hostile and very depressed.

“We feel cheated that as a family we didn’t know she had been prescribed Seroxat just because she was over 16.

“We as parents should have been able to have had some input even if we could not have stopped her. With all the controversy surrounding it, why take the risk?”

Sharise’s GP, Dr Zoe Nunn, of the Quayside Medical Practice in Chapel Street, Newhaven, said she had no fears about prescribing Sharise Seroxat.

She said: “I felt she was quite chirpy and didn’t have any serious concerns.

“If I had had concerns she was at risk of self-harm or suicide I would have made sure she was followed up more closely.”

East Sussex coroner Alan Craze recorded a verdict of suicide.

Cut The Bullshit GSK…


d56d9999977b6b65bc2d2cffbd18faee

http://www.pinterest.com/pin/22025485650742329/

http://pharmamkting.blogspot.ie/

just that simple…

Posted on Sunday 13 October 2013


[SmithKlineFrench in former days]

The corporate history of GlaxoSmithKline [GSK] starts with a Drug Store in Philadelphia [1830] and a Trading Company in New Zealand [1873], a history sketched through the many mergers on their website. But the parts that are of current interest were the acquisition of SmithKlineBeecham by GlaxoWelcome in 2000 and the coming of Andrew Witty as CEO in 2008. Witty has been with Glaxo since 1985, straight from university at age 21 – rising through the ranks.

Eliot Spitzer and Andrew WittyThe story would be incomplete without yet another character, Eliot Spitzer, then Attorney General of New York who settled a lawsuit against GSK in 2004 over false claims about using their antidepressant Paxil in children and adolescents [Study 329]. The financial part of the settlement was insignificant, but this part wasn’t at all trivial:
In addition to the monetary portion of the settlement, GSK has also agreed to publicly disclose all of its clinical drug trials about the safety of an antidepressant for children. The company will put summaries of all of its studies since December 2000 in a clinical trial registry on its Web site…
Witty took over in 2008 and set about to restore GSK’s tarnished image. In 2008, he announced that GSK would publish their payments to physicians [after they were revealed in Senator Grassley’s investigations of academic psychiatrists]. But the sins of the past continued to haunt GSK, culminating in a record breaking $3 B settlement in July 2012 for improprieties involving multiple drugs. Then, a year ago, we heard this:
Forbes
by Matthew Herper
10/12/2012

In an unprecedented move that could signal dramatic changes in the drug industry, GlaxoSmithKline is promising to make detailed data from its clinical trials available to independent researchers so that scientists can draw their own conclusions about the safety and effectiveness of its new drugs. The change, which has yet to be implemented, is being announced at a speech in London at the Wellcome Trust, where Glaxo chief executive Andrew Witty is also detailing how the British drug giant has made its chemical libraries available to researchers working on drugs against tuberculosis and malaria. It could be a dramatic change for a company that has been dogged by scandal over lack of disclosure.

“Because of our unique role, we recognize that society holds us to higher standards than for other industries,” Witty says in his prepared remarks, which may change. “This is how it should be. Over the last four or so years we at GSK have been working hard to be more open and transparent. As I have shown these new approaches are helping to provide new solutions for serious global health issues. They will also help build society’s trust.”

Right now, Glaxo publishes results from its clinical trials on its own Web site and on another site run by the National Institutes of Health, and it says it tries to publish scientific papers on every study in research journals. But doctors outside the company don’t have access to vast databases of how each patient in a clinical trial did. What Glaxo is promising to do is to create a process through which researchers can request this raw data and use it to do new analyses…

Witty, who became Glaxo’s chief executive in 2008, has tried to distance the company from the Avandia controversy, focusing attention on the company’s efforts in the developing world, including research to create the first vaccine for malaria and now, announced today, new initiatives against tuberculosis and other emerging diseases. In Glaxo’s press release announcing the settlement with the feds, he said that the Avandia and Paxil controversies “originate in a different era for the company” and expressed his “regret” and said that his company had learned from its mistakes.

What Witty is saying he will do now goes way beyond anything even Eliot Spitzer asked for. Glaxo would put in place a system by which independent researchers could request the data about what happened to individual patients in its clinical trials, and would be granted access if an independent group of experts thought the idea had scientific merit.

“We think that it’s the right thing to do for patients, we think it’s the right thing to do for understanding our medicines,” says Patrick Vallance, the senior vice president in charge of drug research at Glaxo. “I think if you volunteered to be in a clinical trial, your legitimate expectation is that your data will be used to insure that future generations of patients get the maximal advantage.” Vallance denied that the initiative was a response to past scandals. “It’s absolutely what I’ve believed for a long time. It’s what Andrew believed. It’s what many people in the company believed”…
This story has as many individual ripples as a mountain stream, and it’s easy to get lost in the blather that surrounds every twist and turn. I’m going to skip over all the rhetoric, like GSK’s very public signing up for AllTrials and the media blitz in places like the Huffington Post and elsewhere. I don’t mind their public sainthood so long as it’s matched by pious actions – but I’m not so sure the good works yet live up to the spoken gospel. The details of GSK’s offer were announced in August in the New England Journal of Medicine [article behind a paywall]. :
Access to Patient-Level Data from GlaxoSmithKline Clinical Trials
by Perry Nisen, M.D., Ph.D., and Frank Rockhold, Ph.D.
New England Journal of Medicine. 2013 369:475-78.
What information will be made available?
GlaxoSmithKline will provide the raw data set [the data collected for each patient in the clinical study] and the analysis-ready data set [the data set analyzed by GlaxoSmithKline and provided to regulatory authorities]…
What information will investigators be required to submit?
It is important that the analyses proposed by investigators petitioning to access a data set have scientific credibility. We believe that there are public health risks if the proposed analyses are not scientifically robust and give rise to erroneous concerns about safety or false hopes of a potential benefit for patients. Therefore, in accordance with the expectations of usual good scientific practice,investigators will be required to submit a brief research proposal with the use of an online form [Section 2 in the Supplementary Appendix], describing their analysis and publication plans, their management of potential conflicts of interest, and the qualifications and experience of their search team [which should include a statistician]
How will research proposals be reviewed?
After they have been processed to ensure that the submitted information is complete, proposals will be reviewed by an independent review panel. The panel will initially comprise external experts appointed by GlaxoSmithKline. The independent review panel will accept or reject proposals on the basis of their scientific rationale and relevance to medical science or patient care.The panel will also consider the qualifications of the investigators and the management of potential conflicts of interest. To make the decision-making process fully transparent, we provide a list of the members of the independent review panel and their charter on the website…
What are the conditions on which access will be provided?
Investigators will be responsible for obtaining any other approval that may be required for their research [e.g., from ethics committees, institutional review boards, relevant research institutions, or funding bodies]. They will also be required to sign a data-sharing agreement that commits them to use the data only for the research purpose described in the accepted research proposal
My complaint, recurrently voiced ad nauseum, has to do with the conditions for access to this data. To quote Andrew Witty from a few days ago [see trojan horse or real reform? the jury’s still out… ]:
[beginning at 1:37] “Well what we’ve done – well sequentially we’ve been increasing the level of data transparency around the data we generate on clinical trials. So we’ve been publishing clinical trials summaries for a while. We’ve now committed the publish all of our clinical trial reports that are detailed reports of those trials, and also the patient level data. Now nobody else in the world is committed to doing that…
[beginning at 2:02] “And we’re not simply going to publish data on trials still to come, but we’re going to go back and we’re going to publish all the data for all the trials that have been done since the company was formed… since 2000.”
[beginning at 2:33] “We’re doing it because we think it’s in the interest of patient safety, first of all, so that it gives as many people as want to look at the data a chance to make sure that absolutely the right conclusions have been drawn. If we’ve missed something, we want to hear about it…”
Sir Andrew and I are on the exact same page in this latter comment [in red]. And it highlights that complaint of mine. I consider myself a solid member of the domain of as many people as want to look at the data. And it’s because I want to make sure that absolutely the right conclusions have been drawn. That’s me in a nutshell – a practicing physician who is considering prescribing Andrew Witty’s medication to a patient. So I want to see if they proved the efficacy of the drug and if the adverse effects have been reported accurately. You’d think I should be able to tell that from the published article, but that hasn’t been the case for a pretty good while, at least in psychiatry. So I want to look for myself.

Do I have the credentials they might find suitable? Would my primitive statistical expertise stand their test? Am I capable of tallying up the adverse events appropriately? And what’s my research proposal? All I want is to make sure that absolutely the right conclusions have been drawn. In fact, I did that with their Study 329 data when it finally showed up on their website last year [some eleven years after they published the article, some seven years after they were court ordered to post the data publicly – see the lesson of Study 329: an unfinished symphony…]. The data was in a text format so I had to copy the values by hand to a spread sheet. And as you know, that study was negative every which way but Sunday, unlike the published article’s conclusions.

So when I read this as a condition of access to the data …
It is important that the analyses proposed by investigators petitioning to access a data set have scientific credibility. We believe that there are public health risks if the proposed analyses are not scientifically robust and give rise to erroneous concerns about safety or false hopes of a potential benefit for patients. Therefore, in accordance with the expectations of usual good scientific practice, investigators will be required to submit a brief research proposal with the use of an online form, describing their analysis and publication plans, their management of potential conflicts of interest, and the qualifications and experience of their search team [which should include a statistician].
… it pisses me off. The authors of that paper gave false hopes of a potential benefit for patients and didn’t give enough rise to concerns about safety, not only with GSKs safe passage but with their help, including their paying the real author, Sally Laden. And management of potential conflicts of interest? Out the window. So that’s why I’m not ready to make nice [see the wisdom of the Dixie Chicks…]. They want to check my credentials? Well I want to check theirs.

This blog and many others are full of similar examples – unpublished studies, studies with biased design, statistical manipulations, omissions, creative graphs, etc. There’s even a growing field in medicine of people who spend their time using creative but indirect methods to find all the games being played to distort the Clinical Trial results. The record speaks for itself, and GlaxoSmithKline is prominently represented. I really like and respect the work Iain Chalmers and Ben Goldacre have done. I fully support AllTrials. I own Bad Science and two versions of Bad Pharma. I even think I might like Andrew Witty if he lived on my street. But, if he’s going to say he has a policy that gives as many people as want to look at the data a chance to make sure that absolutely the right conclusions have been drawn, he’s going to have to make his company’s actual policy match the words.

My point is easy. If the journal article is in the public domain, it’s only a proxy for the data – a wrapper. The data needs to be there too. It’s just that simple…

3 Comments for ‘just that simple…’

  1. October 13, 2013 | 6:20 PM

    A 50-something psychiatrist told me that the people running SmithKlineBeecham had been psychopaths and Glaxo bought their messes.

    But since then, GSK has hardly distinguished itself as a beacon of trustworthiness.

  2. Annonymous
    October 14, 2013 | 12:18 AM
  3. October 14, 2013 | 5:07 AM

    Here’s a little twist. The descendent of the family who owned the Trading Company in New Zealand is now our Prime Minister’s Chief Science Advisor and an avid supporter of drug treatment for suicidal kids.

Remembering GSK’s Cidra Disaster, Ian Mc Cubbin and Courageous Whistleblower Cheryl Eckard


http://pharmagossip.blogspot.ie/2011/01/gsk-whistleblower-cheryl-eckard-vs-gsks.html

MONDAY, JANUARY 03, 2011

GSK whistleblower Cheryl Eckard vs GSK’s Ian McCubbin on 60 Minutes

Back story here and here.

So. How does one defend the indefensible?

Here’s GSK’s Ian McCubbin’s (pic) attempt:

Ian McCubbin is a senior vice president from Glaxo headquarters in London.

“We regret what happened in Cidra. But we’ve worked really, really hard to resolve those issues. We spend $600 million every year on make sure that our plant and equipment is state of the art,” McCubbin said.

“Would you say that the company was chastened by all of this?” Pelley asked.

“No, I’d say the company was very disappointed that this occurred and that we regret that this occurred. But we’ve learned from it. And what you learn from, you become stronger,” McCubbin replied.

McCubbin told Pelley the company has about 80 plants around the world. When asked if any of them operate the way Cidra did, he said, “Absolutely not.”

“So how did Cidra go wrong?” Pelley asked.

“They all operated to the same standard, to the same quality system that we had in place. The difference between Cidra and all the rest of the plants is the effectiveness with which that quality system was implemented it was much weaker and that resulted in the compliance issues that occurred,” McCubbin said.

“Cheryl Eckard says that she was issuing warnings and no one was listening,” Pelley remarked.

“I don’t know Cheryl Eckard. And I don’t know all the details of her accusations. What I do know is that we were working with the FDA before Cheryl went to that plant,” McCubbin said.

http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195247_page2.shtml?tag=contentMain;contentBody

Nice try Ian!

But who is Ian McCubbin? And why did GSK have him speak on their behalf if he didn’t know Cheryl Eckard or all of the details of her accusations?

Ian is currently responsible for strategy development and execution within GSK’s Global Manufacturing & Supply organisation. In addition he holds responsibility for the Global Logistics organisation which delivers supply chain processes connecting the Manufacturing and Commercial organisation. Prior to rejoining GSK in July 2006 Ian undertook significant Global Operations roles in the generic Pharmaceutical sector with two of the top 10 Global generic companies. Ian is a pharmacy graduate with additional management qualifications.

http://criticaleye.net/community-profile.cfm?id=198

Glaxo pleaded guilty to a felony. It admitted it distributed “adulterated drugs Paxil CR, Avandamet (a diabetes drug), Kytril (a drug given to cancer patients), and Bactroban.” All together, the company paid $750 million to settle the criminal conviction and Eckard’s suit.

“Can anything like this happen at Glaxo again?” Pelley asked Glaxo’s Ian McCubbin.

“I absolutely hope not. We will work really hard to resolve these issues and make sure that our quality management system is in place and robust,” he replied.

http://www.cbsnews.com/stories/2010/12/29/60minutes/main7195247_page4.shtml?tag=contentMain;contentBody

Well done Ian!

Now – how many senior execs who ignored Cheryl Eckard’s pleas and tears still have jobs at GSK?

Share
Posted by at 12:54 pm

3 comments:

Anonymous said…

According to The Guardian, there were still quite a few such execs there as late as Oct 2010: http://www.guardian.co.uk/business/2010/oct/28/glaxosmithkline-executives-allegedly-ignored-eckardSurprised? Not me!

4:25 pm

AJ said…

…Now – how many senior execs who ignored Cheryl Eckard’s pleas and tears still have jobs at GSK?…I detect a trick question.

9:42 pm

Bernard Carroll said…

Dr. Jerry Avorn also delivered a body blow to GSK’s obfuscations. In the piece that ran on 60 Minutes, he dismissed talk like “… We will work really hard to resolve these issues and make sure that our quality management system is in place and robust…” Dr. Avorn reminded viewers that in medicine the standard is we get it right, as in brain surgery. Glaxo’s lame excuse that drug manufacturing is a complicated process does not hold water.And then, as so often, the subsequent coverup deepened the ethical failure.

12:43 pm

The Avandia Scandal : The Plot Thickens…


I have just done some reading on the Avandia Scandal which is just about to explode in the mainstream news. There are many aspects of this Avandia story that echo those of Seroxat. Avandia is still being prescribed in the UK despite being recommended for withdrawal two months ago, BBC Panorama has found.

GSK have released a statement similar to the one they released when the dangers of Seroxat were exposed by the BBC investigative team a few years ago.When Seroxat was first exposed by panorama there was also a call by politicians, GP’s, psychiatrists and coroners for it to be withdrawn

GSK … The Un-Constant Gardener..

See the GSK Avandia-Panaorma statement here : http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=27254

GlaxoSmithKline today issued the following statement in anticipation of the BBC Panorama programme, ‘A risk worth taking?’ which is scheduled to be aired this evening.

We are concerned that the BBC Panorama programme could alarm patients and their families about the use of Avandia (rosiglitazone) for the treatment of type 2 diabetes. This is a chronic and serious disease that if left untreated can result in serious health problems.

Patients concerned by the programme should seek advice from their doctor and not stop their medication.

The company has not seen the programme but denies any suggestions that it has put patients at risk. We consider patient safety a priority.

Avandia is currently under review by the European (EMA) and US (FDA) medicines regulatory authorities and GSK acknowledges the significant efforts these independent bodies have made to apply scientific rigour to understanding the benefit-risk profile of Avandia.

We have carried out an extensive research programme, involving more than 50,000 patients to analyse the safety and benefits of Avandia. No other diabetes medicine introduced in the last 10 years has such an extensive safety database. The results from this research programme have been given to regulatory authorities worldwide.

Our view remains that controlled clinical trials are the most rigorous form of scientific evaluation that can be used to assess the benefits and risks of medicines.

Taken together, the data from these types of trials have shown that Avandia does not increase the overall risk of heart attack, stroke or death compared to other diabetes medicines. We continue to believe that Avandia is safe and effective when it is prescribed appropriately.

The company understands that the BBC Panorama programme will feature an audio recording of a meeting between GSK medical and clinical experts and Dr Steve Nissen. This meeting, which was hosted by Dr Nissen, took place on 10th May 2007. Four GSK scientists met with Dr Nissen to discuss the scientific data on Avandia.

The audio recording of this meeting was made covertly by Dr Nissen. At no stage before or during the meeting was GSK informed that the meeting was being recorded. Selected extracts from this audio recording have already been provided by Dr Nissen to The New York Times newspaper.

In pre-publicity materials for the programme, BBC Panorama suggests that this recording is the “secret tape the drug company would rather you didn’t hear.”

On Friday 3 September 2010, following the issuing of a subpoena (legal request) to Dr Nissen, GSK obtained a copy of the audio recording. The company today (6 September) posted the recording to its website http://www.gsk.com.

The company has taken this action so that all interested parties can hear all the comments made at this meeting in their full context.

For our part, we regret if any comments made by GSK during this meeting might be misinterpreted as seeking to stifle an independent view of the science around Avandia.

We have diligently shared our data relating to the cardiovascular safety of Avandia in a timely and transparent manner and have made extensive efforts to publish our clinical trial findings in peer review journals, at scientific meetings and via our own clinical trials website.

We remain fully committed to maintaining best practice disclosure of clinical data for all our medicines to serve the interests of patients, physicians and regulators.
GlaxoSmithKline enquiries:

GSK, Avandia and Seroxat : “It’s all just a little bit of history repeating”


Hello Readers.

I am sure some of you are as interested as I am to see the new BBC panorama documentary on GSK’s diabetes drug ‘Avandia‘, which airs this coming Monday at 8.30 on BBC 1. Panorama originally raised mainstream awareness to the hidden dangers of Seroxat and the unscrupulous dealings of GSK and the regulator back- the MHRA- in the noughties. And it seems at the beginning of a new decade Glaxosmithkline have repeated the same suspect and sinister corporate behavioral pattern with Avandia. The similarities are uncanny and they are also extremely disturbing. It seems that GSK has once again hidden negative data from the public and in the process put hundreds of thousands of lives at risk. It is seriously unbelievable how they get away with this sort of thing but I am very grateful that the BBC and Panorama are once again bringing awareness to the situation. It remains to be seen what the UK regulator (the MHRA) has to say about Avandia, but considering their inept response to people dying and being damaged from Seroxat for almost 20 years now, I wouldn’t expect much consideration (or even participation) from them in this documentary. In fact, I don’t have any faith in them whatsoever.

For more on the Avandia Scandal , check out Ed Silverman’s articles from Pharmalot :

http://www.pharmalot.com/?s=Avandia

Seroxat Secrets and Seroxat Sufferers have also written posts on the subject, check them out here:

http://seroxatsecrets.wordpress.com/2010/09/04/panorama-the-mhra-glaxosmithkline-and-avandia/

http://fiddaman.blogspot.com/2010/09/shelley-ankle-biter-jofre-is-at-them.html

GSK V’s The BBC : Panorama Exposes Avandia


News just in folks from Seroxat Sufferers. The BBC Panorama series (who also did 4 documentaries about Seroxat) have come up trumps again, this time their investigation focuses on the dodgy GSK drug Avandia. I must say Mr. Fiddaman was most certainly quick on the draw with his excellent post on this.

Check Bob’s post out here : http://fiddaman.blogspot.com/2010/09/shelley-ankle-biter-jofre-is-at-them.html

And from the BBC website : http://www.bbc.co.uk/programmes/b00tr25t

I am very impressed that Panorama and the BBC are continuing to question the dubious practices of GSK and the drugs they promotes. It seems that Avandia is becoming as much the new Seroxat Scandal as Seroxat was the new Thalidomide. Kudos and thanks also to Shelley Jofre for coming back to our screens once again to question the ethics and morality of the GSK Goliath. I recommend anyone who has been impacted by the current corrupt state of the pharmaceutical industry and ineffective regulation of drugs to watch this documentary, it will be transmitted on Monday at 8.30 and no doubt those outside of the UK will be able to access it online afterwards. Essential viewing in my opinion and I already have my VCR set to record.