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Friday, June 05, 2009

GlaxoSmithKline Exposed Part II

Following on from 'GlaxoSmithKline Exposed Part I', here comes the second installment from former Paxil activist, Rob Robinson's brilliant, groundbreaking website, Paxil Protest [now removed]

Everyone has a right to see what Rob wrote – hence the re-publishing of it on Seroxat Sufferers.



Garnier Comes Out Fighting

In this June 6th, 2004 interview with Sylvia Pfeifer and Robert Peston of the Telegraph, GSK's chief executive tells why the lawsuit filed by the New York attorney general has "made him very angry."

Jean-Pierre Garnier knows all about having to defend his reputation. The 57-yearold chief executive of GlaxoSmithKline, Europe's largest pharmaceutical group, has spent much time over the past year fending off accusations of being an excessively remunerated "fat cat."

But today Garnier and GSK face a more serious charge, having been accused of indulging in "repeated and persistent fraud" by concealing information about the company's best-selling product, the antidepressant Paxil.

In a lawsuit filed on Wednesday, Eliot Spitzer, the attorney-general of New York state, claims that GSK withheld information from doctors about the negative results of clinical trials it conducted into the use by children of Paxil.

Spitzer wants GSK to be fined the profits it made from under-18s using Paxil, a group he estimates accounted for sales of $55m (£30m) in the US in 2002. Were GSK to lose the case, analysts estimate the fine could amount to $150m – not much compared with GSK's earnings last year of £4.5bn.

Reputationally, however, the lawsuit carries much greater risk, something that Spitzer's previous targets, including some of Wall Street's finest investment banks, are acutely aware of.

And with big pharma already in the firing line for its supposedly expensive medicines ahead of this autumn's election in the US, the stage is set for battle.

Characteristically, Garnier has come out fighting. He vigorously defends GSK's record and reveals that the company had no advance warning the lawsuit was coming.

"I think this is very unfortunate because our reputation is attacked and we are not getting a fair chance to rebut because this is the almighty District Attorney office from mid-Manhattan. This is a heavyweight and I hope our voice will be heard and I hope people will not judge us on this press release from Mr Spitzer's office. It's unfair," he says.

The lawsuit alleges that GSK published and disseminated only one of five studies it conducted on the impact of the drug on children, and suppressed the negative results of the other studies "which failed to demonstrate that Paxil is effective and which suggested a possible increased risk of suicidal thinking and acts", according to Spitzer. GSK is also alleged to have failed to disclose this information in "Medical Information Letters" sent to physicians.

Is there anything GSK could have done differently? No, says Garnier, noting that people may have become confused about testing procedures. He says that results of trials to test the safety of potential new medicines are notified immediately to the Food and Drug Administration, the US regulator, if new "indications" are found. To test efficacy, companies have a series of studies done and only when all the conclusions are in are they presented to the regulator. "Our bad luck, in a way, is that the first study came in positive and we informed medical congresses because there was a lot of interest in it. The subsequent studies were negative, so once we had all the studies we told the FDA," says Garnier.

Did GSK do everything perfectly? "I'm not sure," Garnier concedes, "but you know, overall the pattern is very clear, that we did what we were supposed to do . . . Mr Spitzer makes the case that we advertised the positive studies more. That is absolutely incorrect. What happens is that if there is a positive effect, that's news. When there is a negative effect, there is no news."

But how does he explain an internal memo from 1998, first published in Britain last year, which says that GSK intended "to manage the dissemination of [the] data in order to minimise any potential negative commercial impact"?

"Here's an interesting case in point," Garnier says. "Can a company control the millions, and I mean millions, of memoranda written by, in our case, 110,000 people? What are the odds that stupid memos were written? What are the odds that memos asking the company to do things against company policy will be written? The odds are 100 percent!

"Of course we didn't follow this advice. Of course we didn't selectively publicise the data. This is not a smoking gun. It's a stupid memo and there are lots of stupid memos in every company's file and it is really unfair to look at the company's action through the small hole of one memo written among thousands and thousands in 1998. I do regret that those memos exist but I'm not going to lose sleep over the fact."

Garnier is adamant too that commercially it would simply have made no sense to break the rules. "Some people say this is a commercial pressure. This is 3 per cent of the depression market. Do you think you are going to put your reputation at stake to gain something there?" he thunders.

So what happens next? Analysts are not ruling out other states jumping on the bandwagon, nor the possibility of class action lawsuits being filed in the US. So far, says Garnier, there are no signs of that but the industry as a whole is becoming too easy a target.

"It's becoming too easy for many people to attack the pharma industry and hold the pharma industry to standards that are higher than anywhere else. I don't have a problem with the standards but I do have a problem with extortion."


In the latter part of August, 2005 GlaxoSmithKline paid a $2.5 million dollar fine to the state of New York and further agreed to set up a Internet-based clinical trials registry — thus avoiding trial. However, according to Mr. Spitzer, GSK and J.P. Garnier, its chief executive, appeared unrepentant with regard to changing behaviour over disclosure of adverse clinical data. He warned that GSK was still being watched, as were all other pharmaceuticals companies. “The arrogance of the (GSK) commentary is offensive and problematic,” Spitzer said. “We are going to be watching them with a hawk’s eye to see that they have abided by the terms of the settlement.” Spitzer went on to say GSK’s comments following the settlement characterized the settlement as another legal annoyance, and showed too little contrition for the substantive evidence he had against it.

In the end, however, Mr. Spitzer's lawsuit turned out to be the least of GlaxoSmithKline's legal concerns. On April 12, 2005, a shareholders' class actionsuit was filed against GSK on behalf of company stockholders. In an interesting twist, Mr. Garnier was named as a defendant. Here follows a large excerpt from that lawsuit.

More Than Just 'One Stupid Memo'
Garnier acted as a controlling person of GlaxoSmithKline (within the meaning of §20(a) of the 1934 Act). By virtue of his high-level position, participation in and/or awareness of GSK’s operations and/or intimate knowledge of its internal financial condition and business practices, Garnier had the power to influence and control and did influence and control, directly or indirectly, the decision-making of GlaxoSmithKline, including the content and dissemination of the various statements which GlaxoSmithKline contends are false and misleading.

GlaxoSmithKline controlled Garnier and all of its employees. Garnier was provided with or had unlimited access to copies of GlaxoSmithKline’s internal studies, reports, press releases, public filings and other statements alleged by GlaxoSmithKline to be misleading prior to and/or shortly after these statements were issued and had the ability to prevent the issuance of the statements or cause the statements to be corrected.

In particular, Garnier had direct involvement in or intimate knowledge of the day-today operations of GlaxoSmithKline and therefore is presumed to have had the power to control or influence the particular transactions giving rise to the securities violations as alleged herein, and exercised the same.

We missed something big —
we missed the fact that the public wasn't going to necessarily trust us.
— Jean-Pierre Garnier
CEO of GlaxoSmithKline
(8/13/2005)


The fact is GlaxoSmithKline selectively released only data from favorable studies regarding Paxil and concealed data from unfavorable studies, using its employees, paid consultants, and unwitting researchers as conduits to disseminate the misleading information from these studies to the public and investors, as follows:

On 5/30/98-6/4/98, Drs. M.B. Keller, N.D. Ryan and B. Birmaher, et al., presented a poster at the American Psychiatric Association (“APA”) Annual Meeting in Toronto, Canada, entitled “Efficacy of {Paxil} in adolescent depression.” This poster found Paxil efficacious in children and adolescents.

In 98, Drs. K.D. Wagner, B. Birmaher and G. Carlson, et al., presented a poster at the New Clinical Drug Evaluation Unit (“NCDEU”) Annual Meeting in Boca Raton, Florida, entitled “Safety of [Paxil] and imipramine in the treatment of adolescent depression.” This poster found Paxil efficacious in children and adolescents.

In 10/98, Drs. R. Berard and N. Ryan presented a poster at the European College of Neuropsychopharmacology Annual Meeting in Paris, France, entitled “Adolescent depression: Efficacy of [Paxil].” This poster found Paxil efficacious in children and adolescents.

In 8/99, Dr. C. Gagiano presented a poster at the World Congress of Psychiatry Meeting in Hamburg, Germany, entitled “[Paxil] in adolescent depression.” This poster found Paxil efficacious in children and adolescents.

In 12/99, Drs. G.J. Emslie, K.D. Wagner and M.A. Riddle, et al., presented a poster at the American College of Neuropsychopharmacology (“ACNP”) Annual Meeting in Acapulco, Mexico, entitled “Efficacy and safety of [Paxil] in the treatment of children and adolescents with OCD [obsessive compulsive disorder].” This poster found Paxil efficacious in children and adolescents.
In 12/99, Dr. Karen Wagner, one of the authors listed on the published article concerning GSK’s study to assess the safety and efficacy of Paxil in treating children and adolescents, Study 329, spoke at a meeting of GSK Neuroscience consultants, at which she discussed Study 329. She was quoted by an internal GSK newsletter as having said: “We can say that [Paxil] has both efficacy and safety data for treating depression in adolescents.”

On 5/13/00-18/00, Drs. B. Birmaher, J.P. McCafferty and K.M. Bellew, et al., presented a poster at the APA Annual Meeting in Chicago, Illinois, entitled “Comorbid ADHD and disruptive behavior disorders as predictors of response in adolescents treated for major depression.” This poster found Paxil efficacious in children and adolescents.

On 5/30/00-6/2/00, Drs. K.D. Wagner, G.J. Emslie and B. Birmaher, et al., presented a poster at the NCDEU in Boca Raton, Florida, entitled “Safety of [Paxil] in the treatment of children and adolescents with OCD.” This poster found Paxil efficacious in children and adolescents.

On 5/5/01-5/10/01, Drs. D.A. Geller, J. Biederman and D.J. Carpenter, et al., presented a poster at the APA Annual Meeting in New Orleans, Louisiana, entitled “Comorbid psychiatric illness and response to treatment in pediatric OCD.” This poster found Paxil efficacious in children and adolescents.

On 5/28/01-31/01, Drs. D.A. Geller, J. Biederman and K.D. Wagner, et al. presented a poster at the NCDEU Annual Meeting in Phoenix, Arizona, entitled “Comorbid psychiatric illness and response to treatment, relapse rates, and behavioral adverse event incidence in pediatric OCD.” This poster found Paxil efficacious in children and adolescents.

GlaxoSmithKline commissioned Drs. M.B. Keller, N.D. Ryan and M. Strober, et al., to write an article about one of GSK’s successful Paxil studies. It was published in an article in the Journal of the American Academy of Child and Adolescent Psychiatry, entitled “Efficacy of [Paxil] in the treatment of adolescent major depression: A randomized, controlled trial.” This article found Paxil efficacious in children and adolescents.

In 11/01, GlaxoSmithKline issued a Medical Information Letter regarding the use of Paxil to treat major depressive disorder (“MDD”) in children and adolescents, which reported studies with positive efficacy results. GlaxoSmithKline also enclosed a published article regarding its favorable study with the Medical Information Letter.

On 5/19-23/02, Drs. D. Gallagher, C. Gardiner and D.J. Carpenter presented a poster at the APA Annual Meeting in Philadelphia, Pennsylvania, entitled “Interim Results: Long-term safety of [Paxil] in pediatric patients.” This poster found Paxil efficacious in children and adolescents.

In 6/02, Drs. D.A. Geller, K.D. Wagner and G.J. Emslie, et al., presented a poster at the NCDEU Annual Meeting in Boca Raton, Florida, entitled “Efficacy of [Paxil] in pediatric OCD: Results of a multicenter study.” This poster found Paxil efficacious in children and adolescents.

In 6/02, Drs. K.D. Wagner, E. Wetherhold and D.J. Carpenter, et al., presented a poster at the NCDEU Annual Meeting in Boca Raton, Florida, entitled “Safety and tolerability of [Paxil] in children and adolescents: Pooled results from four multicenter, placebo-controlled trials.” This poster found Paxil efficacious in children and adolescents.

On 10/11-27/02, Drs. D.A. Geller, K.D. Wagner and G.J. Emslie, et al., presented a poster at the American Academy of Children in Adolescent Psychiatry Annual Meeting in San Francisco, California, entitled “Efficacy of [Paxil] in pediatric OCD: Results of a multicenter study.” At that same meeting, Drs. K.D. Wagner, M.B. Stein and R. Berard, et al., presented a poster entitled “Efficacy of [Paxil] in childhood and adolescent social anxiety disorder.” Also at that meeting, Drs. K.D. Wagner, E. Wetherhold and D.J. Carpenter, et al., submitted an abstract entitled “Safety and tolerability of [Paxil] in children and adolescents: Pooled results from five multicenter, placebo-controlled trials.” These posters and abstract found Paxil efficacious in children and adolescents.

In 12/02, Drs. K.D. Wagner, E. Wetherhold and D.J. Carpenter, et al., published an article in the Journal of Child and Adolescent Psychopharmacology, entitled “Safety and tolerability of [Paxil] in children and adolescents: Pooled results from four multicenter, placebo-controlled trials.” This article found Paxil efficacious in children and adolescents.

In 12/02, Drs. D.A. Geller, K.D. Wagner, and G.J. Emslie published an article in the Journal of Child and Adolescent Psychopharmacology, entitled “Efficacy and safety of [Paxil] in pediatric OCD: Results of a double-blind, placebo-controlled trial.” This article found Paxil efficacious in children and adolescents.

On 12/8/02-12/12/02, Drs. K.D. Wagner, M.B. Stein and R. Berard, et al., presented a poster at the ACNP Annual Meeting in San Juan, Puerto Rico, entitled “Efficacy of [Paxil] in childhood and adolescent social anxiety disorder.” This poster found Paxil efficacious in children and adolescents.

In 1/03, Drs. A. Braconnier, R. Le Coent and D. Cohen published an article in the Journal of the American Academy of Child and Adolescent Psychiatry, entitled “[Paxil] versus clomipramine in adolescents with severe major depression: A double-blind, randomized, multicenter trial.” This article found Paxil efficacious in children and adolescents.

On 5/17-22/03, Drs. K.D. Wagner, E. Wetherhold and M. Gee, et al., presented a poster at the APA Annual Meeting in San Francisco, California, entitled “Remission of pediatric social anxiety disorder with [Paxil].” This poster found Paxil efficacious in children and adolescents.

On 5/17-22/03, Drs. R. Berard, K.D. Wagner, and D.J. Carpenter, et al., presented a poster at the APA Annual Meeting in San Francisco, California, entitled “SSRI therapy of pediatric patients with social anxiety disorder or OCD.” This poster found Paxil efficacious in children and adolescents.

In 5/03, Drs. K.D. Wagner, E. Wetherhold and M. Gee, et al. presented a poster at the NCDEU in Boca Raton, Florida, entitled “Remission of pediatric social anxiety disorder with [Paxil].” This poster found Paxil efficacious in children and adolescents.

On 6/10/03, a British agency stated that the risk of self-harm and potentially suicidal behavior of youngsters with depression was between 1.5 and 3.2 times greater when treated with Paxil than with a placebo. A British Committee on Safety of Medicines advised that Paxil “should not be used in children and adolescents under the age of 18 years to treat depressive illness.”

On 6/11/03, GlaxoSmithKline issued a statement that “not a single person committed suicide” in the study of children taking Paxil. “We don’t believe there’s any compelling evidence that Paxil causes suicide. If anything, it reduces suicidal tendencies” in patients suffering from depression. This was false because it failed to disclose a number of suicide attempts in children taking Paxil.

On 6/19/03, the FDA issued a Talk Paper in which it stated that it was reviewing data from studies of Paxil use in children and adolescents and, although the review of the safety data was not complete, “FDA is recommending that Paxil not be used in children and adolescents for the treatment of MDD.”

On 6/19/03, GlaxoSmithKline issued a press release which stated that “[i]n the company’s pediatric trials, which included more than 1000 patients treated with Paxil, not a single person committed suicide.” This was misleading because it failed to disclose suicide attempts.

On 6/2/04, the Attorney General for the State of New York sued GlaxoSmithKline based upon GSK’s suppression of adverse studies relevant to Paxil use to treat children and adolescents.

On 8/5/04, The Wall Street Journal published an article which reported that a new analysis by the FDA had confirmed the link between SSRIs and suicidal tendencies in young people.

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