329: The Aftermath - Karma Chameleon

It's been almost two days now since the publication of the damning 329 restoration study in the British Medical Journal (BMJ) and, as I suspected, no apology has been forthcoming from either GlaxoSmithKline, any other the original study 329 authors or the The Journal of the American Academy of Child & Adolescent Psychiatry's (JAACAP)

What we have seen, however, is a couple of quotes from spokespersons. GSK's Bernadette Murdoch and lead author of the original 329 study, Martin Keller - they make interesting reading, even though they are small musings.

First off, Bernadette Murdoch, Communications Director for GlaxoSmithKline Australasia.

On responding to the restoration study, Murdoch told ABC Australia, "We did provide an unprecedented level of data to the research team. In relation to the findings from the team's analysis, they do appear to be in line with the longstanding view that these medicines, anti-depressants like paroxetine, are not suitable for children. This is widely known and clear warnings have been placed on the product label for more than a decade."

Before offering you her small quote on the original study, let's just try and analyse her above quote. I'm no psychologist, these are just my thoughts.

"We did provide an unprecedented level of data to the research team."

This is true. In fact GSK provided over 77,000 pages of raw data to the restoration team. What Murdoch failed to mention was GSK made it difficult for the team, so difficult in fact that the restoration authors called this process of research the "periscope."

This from the authors...

"This restoring invisible and abandoned trials (RIAT) exercise proved to be extremely demanding of resources. We have logged over 250,000 words of email correspondence among the team over two years. The single screen remote desktop interface (that we called the “periscope”) proved to be an enormous challenge. The efficacy analysis required that multiple spreadsheet tables were open simultaneously, with much copying, pasting, and cross checking, and the space was highly restrictive. Gaining access to the case report forms required extensive correspondence with GSK. Although GSK ultimately provided case report forms, they were even harder to manage, given that we could see only one page at a time. It required about a thousand hours to examine only a third of the case report forms. Being unable to print them was a considerable handicap."

"In relation to the findings from the team's analysis, they do appear to be in line with the longstanding view that these medicines, anti-depressants like paroxetine, are not suitable for children."

Deflection, deflection, deflection. Here Murdoch, probably guided by GSK's attorneys, tries to let the reader know that all antidepressants, not just Paxil, are not suitable for children. She is telling us something that we already know yet, at the same time, letting the reader know that GSK are a good company and would not ever allow drugs that are not meant for children onto the market. GSK did not voluntarily offer this information, they were forced to do so after regulators found that they were lying in their original 329 study.

"This is widely known and clear warnings have been placed on the product label for more than a decade."

Again, this appears as if Murdoch is trying to undermine the restoration study, it's almost like "Oh hum, tell us something we don't know." She wants the public to know that, for almost a decade, her company have been warning the public about the dangers of paroxetine in children and adolescents. This, however, does not detract from the fact that her company tried to gain a licence for paroxetine use in children and adolescents even though they knew that..

A: It didn't work;

B: It was dangerous.


Speaking about the original 329 study (the fraudulent one) Murdoch offered this...

"These studies were conducted in the '90s, many years ago when computer systems were very different. A lot of the notes were handwritten. It's important to remember that when a medicine is approved for use, it's not just the pharmaceutical company that makes that decision. There are lots of checks and balances in between, so a regulator uses all of the data that's available on a medicine before recommending it for use for a patient,"

In essence, it appears, that Murdoch is saying, "It's not just our fault". It's almost like an admittance of guilt. We were less than fruitful with the truth but it was the job of the regulators to try and catch us out, they didn't, so they must also take the blame. In using the line, "These studies were conducted in the '90s, many years ago when computer systems were very different. A lot of the notes were handwritten," it appears Murdoch is blaming technology - ie; the RIAT team had better technology than what we did so they found stuff that we didn't...because our computers back then were not as sophisticated as what they are today.

It's interesting to note that no apology was offered by Murdoch. It's basically a rebuttal and a deflection on a calamitous scale.

Original Study 329 Lead Author Martin Keller.

This guy is priceless.

Keller, pictured above, is quoted in The Journal of Higher Education, the No. 1 source of news, information, and jobs for college and university faculty members and administrators.

Here's what he had to say...

"The 2001 results faithfully represented the best effort of the authors at the time, and that any misrepresentation of his article to help sell Paxil was the responsibility of Glaxo. Nothing was ever pinned on any of us," despite various trials and investigations, and when I say that, I’m not telling you we’re like the great escape artists, that we’re Houdinis and we did something wrong and we got away with the crime of the century. Don’t you think if there was really something wrong, some university or agency or something would have pinned something on us?"

So, it appears that Keller here is speaking on behalf of all of the original 329 authors (22 in all)

Interestingly, he lays the blame at the feet of GlaxoSmithKline, the same company who have, according to court documents, paid Keller on a number of occasions, although he denies that he, or any of the other 21 authors were paid to put their name to the 2001 JAACAP article. Keller, according to investigative journalist, Alison Bass, has in fact  "received $500,000 annually from pharmaceutical companies that manufacture the antidepressant drugs that he lauded in a series of medical research reports." ~ Boston Globe  10/04/99

It's a bizarre stance and one of complete denial. "...any misrepresentation of his article to help sell Paxil was the responsibility of Glaxo."

Key word here is 'responsibility' and Keller, it appears, seems to be shirking his. The responsibility was on Keller and his team to make sure that they read the raw data, or, at the very least, asked for the raw data.

It's a merry-go-round of buck passing akin to kids being asked, who spilled the milk?

Keller goes further, in a two page letter sent to Retraction Watch, a group of individuals that strive for celerity as much as accuracy. The letter is signed by Keller and 8 of the original article authors.

David Healy, who was one of the co-authors of the restoration study has responded to Keller here.



The letter, missing the signature of, amongst others, Karen Wagner, is regarding the science behind the two studies. I'll leave that to the experts. What I do find interesting is the claim by Keller et al that the article wasn't ghostwritten. It's just one paragraph but uses an interesting choice of words...

“Restoring Study 329” asserts that this paper was ghostwritten, citing an early publication by one of the coauthors of that article. There was absolutely nothing about the process involved in the drafting, revision, or completion of our paper that constitutes “ghostwriting”. This study was initiated by academic investigators, undertaken as an academic / industry partnership, and the resulting report was authored mainly by the academic investigators with industry collaboration. "

 Not ghostwritten?

**Insert laughter here**

Here's Keller's letter to Sally K. Laden, the ghostwriter who worked for STI, the PR firm Glaxo hired to write the findings on their study.

"Dear Sally, you did a superb job with this.... enclosed are some rather minor changes from me, Neal and Mike."

I'm quite surprised Keller has opened up a discussion regarding the new restoration study. He's been quiet for many years regarding payments that have been made to him and his former University, Brown, in Rhode Island. By opening discussion about the new study leaves him open to questions about money he was paid but never declared, something he has remained tight-lipped about since news broke of his faux pas.

Furthermore, is Martin Keller really qualified to spot suicidal beahviour in adolescents/children, indeed, does Keller actually know the difference between males and females, come to think of it, do GlaxoSmithKline?

Alison Bass, Pulitzer Prize nominee and author of Side Effects: A Prosecutor, a Whistleblower and a Bestselling Antidepressant on Trial. She wrote on her blog back in 2008...

A memo from Keller to the IRBs at Brown and two of its affiliated hospitals, Butler and Bradley. In January 30, 1995, Keller reports (fig 1) that a teenage girl, patient #70 in study 329, ingested 82 Tylenol pills on January 19 and was hospitalized at St. Ann's Hospital. She was discontinued from the study at the end of January and coded as noncompliant according to another memo (fig 2) from Keller to Brown's IRB. Yet according to the GlaxoSmithKline's final report, (fig 3) patient #70 in the same study was a 12-year-old boy enrolled in the trial on February, 22, 1995 and withdrawn on March 24 after suffering from chest pains. This patient had been randomized to the imipramine arm of study 329.

fig 1

fig 2

fig 3

Quite remarkable. Paxil, it seems, can now give you chameleon qualities!


To date, neither GlaxoSmithKline or any of the 22 authors of the original study, or indeed, Sally K. Laden, have apologized.


Bob Fiddaman.


Back Story

Reanalysis of Glaxo's 329 Study Goes Public

Also see

RIAT Study in the media

The Seroxat Scandal - 2007

Following on from my previous posts regarding BBC TV's Panorama and their coverage of GlaxoSmithKline's Seroxat.

In 2007 they aired their 4th and final installment into the whole Seroxat scandal. 'The Secrets of the Drug Trials' focused on the infamous Paxil 329 study and showed how bosses at Glaxo knew about the suicide link with children and teenagers taking their blockbuster antidepressant - they knew yet still paid highly ranked psychiatrists to spread the word to colleagues that Seroxat was safe and effective for use in children and teenagers. Even more worrisome, GSK paid key opinion leaders huge amounts of money for writing about the benefits of Seroxat in children and teenagers, yet these same key opinion leaders didn't actually write the material - GSK hired an outside agency to ghostwrite the articles for the key opinion leaders. In essence, GSK just paid for leading psychiatrists in the field of pediatrics to add their name to the ghostwritten material and to make believe that it was their work.

The previous three Seroxat specials can be seen here, here and here.

Here's The Secrets of the Drug Trials (Starts 50 seconds in)

Bob Fiddaman.

Witty's Era Still Smells of 329 Rotten Eggs

We all remember Glaxo's CEO, Andrew Witty, 'tail between the legs' excuse when the Department of Justice handed down a $3 billion fine for his company's fraudulent activities don't we?

"It's all part of an era", or words to that effect, was the excuse Witty used. It was an excuse that distanced him from the problems of his company, although Whistleblowers in the $3 billion suit claim he knew exactly what was going on and that he even participated in the off-label promotion of Zyban when he was, at the time, VP in marketing circa 1997-2000.

Witty's 'era' excuse has never really held water with me. Here we have a boss who apparently oversees the running of his company. When his company is caught out for acting fraudulently he blames the past. More recently Glaxo have been in the news again, this time senior managers in China have [allegedly] been bribing doctor's with money and prostitutes in efforts to get them to prescribe more of GSK's drugs. Witty, being Witty, denies any knowledge of it. Turns out, if reports are correct, that GSK are not going to be charged for these crimes in China, instead Chinese authorities are going after the individuals who acted fraudulently.

Not on my watch guv.

I'm reminded of a rib-tickling scene from the movie Dumb and Dumber here.

Witty, in this scene, is played by Jim Carey.





What is it about Andrew Witty that makes him blame other people?

What does Andrew Witty fear by speaking with members of the public who have questions about his company's products?

Before I move on to the latest news about the Paxil 329 study... or rather the retraction of it, it's important to note that Glaxo's Andrew Witty has refused to meet with patient advocate Janice Simmons.

Simmons, who runs the Seroxat User Group, contacted Witty back in 2011. The Seroxat User Group had amassed over 60,000 emails from Seroxat patients, most of them were/are struggling to get off Seroxat. Janice cannot tell them how to combat the side effects such as; electric zaps, suicidal thoughts, intolerance to sudden loud noises, bouts of crying, headaches and visionary disturbances etc.

So, Janice decided to request a meeting with GlaxoSmithKline's CEO, Andrew Witty. To her surprise, GSK’s UK medical director Dr Pim Kon wrote back asking what she wished to discuss...adding that they cannot give advice to patients, they need to seek that from their healthcare professionals. [Yawn]

Janice informed Dr Kon that she wished to discuss the issue of Seroxat withdrawal. Kon wrote back telling Janice that they was not allowed to discuss personal matters with patients and that they should 'talk to their doctor'. [Another yawn]

You'll note that Witty chose not to reply to Janice Simmons, instead he, it appears, got Dr Kon to reply.

Seroxat is the UK brand name for paroxetine which is known as Paxil in the US and Canada.



Witty Sends In The Clowns


A few days ago a feature appeared in the British Medical Journal [BMJ] entitled 'Putting GlaxoSmithKline to the test over paroxetine'. [1] The feature contained  a fascinating exchange of letters between Jon Jureidini and GlaxoSmithKline between April 26 and November 8, 2013, in which Jureidini requests data from paroxetine study 329.

Please take note at who Jureidini addresses his correspondence to. Also take note that Jureidini never once gets a reply from the person he originally contacted.

Jim Carey at play again?

For those that don't know 'Paxil 329' was a study of Paroxetine vs Imipramine vs Placebo in Adolescents with Unipolar Major Depression.

The results of the study appeared in the Journal of the American Academy of Child and Adolescent Psychiatry and listed Marty Keller as the primary author. However, the study was not written by Keller at all, it was written by Sally Laden, a ghostwriter hired by GSK.

The results of the study were favourable. However, the paper was misleading in as much that it exaggerated benefit and downplayed adverse effects, including suicidal thoughts. In 2004 the Canadian Medical Association published an Editorial which showed that in 1998 an internal GSK document clearly acknowledged that GSK were aware that 329 was negative and they knew that paroxetine had no beneficial effect in treating adolescents [2]

The GSK internal document was prepared by the Central Medical Affairs team (CMAt), a division of GSK who back then were known as SmithKline Beecham.

This from the Canadian Medical Association:

The document provides guidance on how to manage the results of 2 clinical trials conducted into the efficacy of paroxetine (Seroxat). Given that the clinical trials results were, according to the document, “insufficiently robust” to support an application to regulatory authorities for a label change approving Seroxat for use in pediatric depression, CMAt recommended the firm “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.”

The CMAt document advised that “Positive data from Study 329 will be published in abstract form at the [European College of Neuropsychopharmacology] meeting” in November 1998 and that “a full manuscript ... will be progressed.” It also stated that “It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.”

Eventually GSK had to acknowledge the failure of all three of their child and adolescent paroxetine depression studies [3] but the original results [the lies] still appear in the Journal of the American Academy of Child and Adolescent Psychiatry.

Jureidini and many others have, on numerous occasions, called for the journal article to be retracted. The editor of the journal won't retract it so maybe Witty could be instrumental in its retraction?

Here's the letters:

The final exchange sees Glaxo wishing to communicate by telephone [tactics like this get rid of paper trails]

So, despite addressing Andrew Witty, Jureidini is given the runaround by GSK's Kraus and Shannon. Where was Witty in all of this, why is he, seemingly, afraid to debate with Jureidini?

Maybe Witty is still stuck in his own era and believes that the Paxil 329 study is the responsibility of his predecessor JP Garnier. Nonetheless, it's a dog shit on Witty's doorstep yet it is one that he refuses to acknowledge or is in denial about.

We all know what happens when you tread in dog shit, right?

I sincerely hope Sir Andrew knows a reputable carpet cleaner.

Bob Fiddaman

[1] BMJ 2013; 347 (Published 12 November 2013)
[2] CMAJ March 2, 2004 vol. 170 no. 5
[3] http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/GSKtoDrs.pdf

Brown University School of Medicine and the "Get Out Clause"

I always sit in bewilderment at the exemption rules and clauses that exist inside the cogs of the pharmaceutical industry and its shills. For those that don't know, a 'shill' is a person who helps a person or organisation without disclosing that he or she has a close relationship with that person or organisation [1]

So, what if one finds something that is so way off mark that it could be detrimental to the health and safety of patients worldwide?

Well, I guess the first plan of action would be to contact the person/persons who created that 'something' and to show them that what they actually created had serious safety issues regarding the safety of children and adolescents.

Scientific misconduct appears to be a noose around Brown University School of Medicine's neck, much akin to the same noose that has taken the lives of children and adolescents prescribed Paxil [known as Seroxat in the UK]

For some time now Jon Jureidini, associate professor of psychiatry at the University of Adelaide, and Leemon McHenry, a lecturer in philosophy at California State University, have been calling for a retraction of, the now infamous, Paxil 329 study, a study that has, since its publication in 2001, been discredited for its use of selective reporting and ghostwriting shenanigans.

Martin Keller

Brown University, whom, at the time, employed lead author of the Paxil 329 study, Martin Keller, were approached by McHenry and Jureidini who sought a retraction of the skewed study which, despite showing huge flaws, still appears in the Journal of the American Academy of Child and Adolescent Psychiatry [JAACAP] today and, more than likely, is still used as a guide by many prescribing physicians who will read that "Paxil is safe and effective in the use of children and adolescents."

The fact that Paxil isn't safe and effective in children does not seem to bother Brown University, whom have replied to McHenry and Jureidini with what can only be described as a "D'uh so what" type of response.

The Dean of Medicine and Biological Sciences, Edward J. Wing, writes to McHenry and Jureidini with the following excuse:

"The University will not submit a letter requesting retraction to the editor of the JAACAP for the journal article written by Dr. Keller."

The reasons being a six year statute of limitations, which basically means McHenry and Jureidini were too late in filing their complaint.

Don't you just love the way corporate entities surround themselves in that protective red-tape.

Here we have a study with Keller cited as the lead author when in fact the whole study was ghostwritten by Sally K Laden, a shill hired by GlaxoSmithKline to say nice things about Paxil and to promote it in such a way that healthcare professionals would prescribe it to children and adolescents. Keller, merely put his name to the study because...well, because that's what Glaxo paid him to do.

The wording of Edward J. Wing's response to McHenry and Jureidini is interesting in as much that it claims that Keller wrote the article.

It's unknown if Wing has been on the planet Zog for the past 10 years or so or whether he is just towing the line. [self bondage in red tape]

Brown University are really showing a lack of ethics here, it's almost as if they have been skinny-dipping in icy cold waters and their balls have shrivelled to the size of peas, a great role model for students just starting out at Brown, doncha think?

They must hold Keller in high esteem to protect him so much, they must hang on to his every word regarding Paxil seeing as they claim he wrote the study.

Brown, as the name suggests, stinks like a river of floating turds, each one wrapped in red tape, each one stamped with a six year statute of limitations, each one so gut wrenchingly gaseous that nobody dare go near them for fear of seeing that sickly smile from Keller.

Swim beneath the Brown river and you'll find the voices of the dead Paxil children that Brown University wish to suppress, to ignore, to be swept into the pooper-scooper because their memories of their short lives mean absolutely nothing to Brown Uni officialdom.

Brown's reluctance to intervene is a two-finger salute to any child or adolescent being prescribed Paxil today. They should be utterly ashamed of themselves for using a statute when they knew well before the six year time limit that 329 seriously misrepresented the safety of Paxil in children and adolescents.

Unforgivable and cowardly are just two words that spring to mind...another is Karma.




Fid


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The Caspper Files [GSK's Ghostwriting Machine]

So, what exactly is CASPPER?

CASPPER stands for, Case Study Publications For Peer Review.

The fact that the name is synonymous with a ghost [Casper] is probably just down to high jinks from the Glaxo [SmithKline Beecham] team. It could also be high jinks that the name 'Paxil' could possibly be named after a toxic fungi [Paxillus involutus] although that is just supposition on my part.

Okay, let's dissect Caspper.

The Paxil Product Management launched Caspper, an apparent innovative program that was intended, it appears, to bring to the attention of 'important psychiatrists' by

**Offering assistance in the preparation and publication of case studies and other short communications relevant to the features and benefits of PAXIL.

** Encouraging the timely publication of responses to unbalanced information from competitors.

It appears the goal of Caspper was to benefit the salesforce by expanding the database of published data to support PAXIL. Furthermore, Caspper was also intended to strengthen relationships between the salesforce team [Reps] and 'key physicians and thought leaders in the psychiatric field.'

The objectives of Caspper were to 'strengthen the product positioning and overcome competitive issues.'

Some of the target areas for topic were:

**Anxiety disorders [eg; panic disorder, social anxiety disorder, and Obsessive Compulsive Disorder [OCD]

**Long term use of Paxil

**Use in the elderly

**SSRi use in women

** Successful management of sexual dysfunction


Quite ironic that they should target these particular topics. Long term use of Paxil has always been a grey area, in fact I don't even think GlaxoSmithKline have any answers to what damage prolonged use of Paxil can cause those taking it... if they do, then they are hiding it well.

Use in the elderly - hasn't there been studies that show vulnerability in children and the elderly taking Paxil?

SSRi use in women - Funny they should target this particular area. Here is a snippet from Dr. David Healy's withdrawal protocol JULY 2009 SSRI WITHDRAWAL GUIDE BY DAVID HEALY

"One of the biggest problems of SSRI dependence involves women who are on treatment and unable to stop who wish to become pregnant. Getting off an SSRI at present seems more difficult for women than men, even with the incentive of wishing to become pregnant."

Wasn't Healy the same man GSK targetted many years ago when he first spoke out against SSRi's?

I seem to recall Dr. Alastair Benbow, Head of European Psychiatry for Glaxosmithkline, claim that "Doctor Healy has made the same claims about a range of other medicines. He made the same claims about Prozac, he made the same claims about Prozac, he made the same claims about a range of other SSRIs. On every occasion he has been found to be wrong."

I think it is safe to assume now that Healy was right all along don't you Dr. Benbow?

Caspper continues to explain to the salesforce team that they should encourage physicians to author a paper regarding the benefits of Paxil. With the help of Caspper, it seems, writing a paper was never easier! In fact, Caspper seemed to do everything for the physician:

The full range of editorial assistance that CASPPER can offer contributing physicians is:

**Developing a topic

**Coordinating the editorial review process

**Submitting to the target journal

It even went as far as:

**Copy editing and proofreading

**Production of tables and graphics

** Preparation of the submission package

**Follow-up

It seems from this document that the aim was to more or less let Glaxo take control. [GHOSTWRITER]

The closing remarks of the 14 page document sums it all up.

"PAXIL Product Management has budgeted for 50 articles for 2000. Your participation in CASPPER will enable your physicians to add to the literature supporting the use of PAXIL, strengthen your relationships with key physicians and thought leaders in the psychiatric field, and ultimately, help you meet your sales goals."

The document is now hosted online.

Please disseminate.





Fid

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Possible Caspper Articles

McHenry - Industry-Sponsored Ghostwriting in Clinical Trial Reporting- A Case Study

On the Origin of Great Ideas Science in the Age of Big Pharma

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Glaxo used ghostwriting program to promote Paxil

Hat-Tip - Ruth

Source: - Associated Press

Glaxo used ghostwriting program to promote Paxil
By MATTHEW PERRONE (AP)

WASHINGTON — Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

Known as the CASPPER program, the paper explains how the company can help physicians with everything from "developing a topic," to "submitting the manuscript for publication."

The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.

A spokeswoman for London-based Glaxo said the published articles noted any assistance to the main authors.

"The program was not heavily used and was discontinued a number of years ago," said Mary Anne Rhyne.

According to the memo, which dates from April 2000, the CASPPER program was designed to "strengthen the product positioning and overcome competitive issues."

At the time, Paxil was competing with rival antidepressant blockbusters like Eli Lilly's Prozac and Pfizer's Zoloft. Paxil has since lost its patent protection and competes against cheaper generic versions. Sales of Paxil last year totaled $849 million.

Drug companies frequently hire outside firms to draft a manuscript touting a company's drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work.

But the use of ghostwriting by drug companies has come under increased scrutiny by members of Congress, including Sen. Charles Grassley, R-Iowa, a longtime critic of the industry's influence over physicians. Grassley and Sen. Herb Kohl, D-Wis., are pushing a bill that would require companies to disclose all payments to physicians over $100.

According to ghostwriting expert Dr. Leemon McHenry, Glaxo's program was unusually intertwined with its internal sales and marketing department.

"We know that GSK has engaged in ghostwriting for many years," said McHenry, who works as a research consultant for Baum Hedlund. "But to create an internal ghostwriting program and have the gall to name it after a cartoon ghost demonstrates their juvenile attitude and careless disregard for patients."

McHenry acknowledged that ghostwriting is legal in principal, but said it could contribute to illegal activity if the information is misleading and causes harm.
"If these ghostwritten publications are contributing to the harm of patients because they're making false claims, then that's illegal," McHenry said.

Articles from the company's program appeared in five journals between 2000 and 2002, including the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry.

Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.

Publication in a medical journal also is a point of prestige for physicians, a fact Glaxo's memo seems to acknowledge: "Physicians will be eager to participate in CASPPER regardless of their professional stature," the brief notes.


Copyright © 2009 The Associated Press. All rights reserved.

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Ghostwriting in drug research back in the spotlight

Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial author, Alison Bass has a great post on her blog entitled, "Ghostwriting in drug research back in the spotlight."

Alison highlights New York Times journalist, Natasha Singer, who focuses on Wyeth's use of a ghostwriting firm to prepare an estimated 60 articles favorable to its hormone drugs.

Alison writes:

"Wyeth's use of ghostwriters to prepare favorable studies and then find doctors willing to put their names on them is, of course, only the latest in a long string of drug industry campaigns to present new products in the most positive light possible. The makers of the SSRI antidepressants were masters at this tactic. As I reveal in Side Effects, GlaxoSmithKline hired a ghostwriting firm, Scientific Therapeutics, to write the first draft of the controversial Paxil study 329. That draft concluded that Paxil was effective and well tolerated in adolescents, even though the actual data in the clinical trial showed otherwise. See back story here. Indeed, in its re-examination of clinical trial data for all the antidepressants, the FDA labeled study 329 a negative study, finding that Paxil was no more effective than placebo in treating depression in adolescents. Yet Martin Keller, the principal investigator of the Paxil study, and his co-authors, did not object to the ghostwritten version of the study and despite its inaccuracies (which were flagged by peer reviewers), the study was published in The Journal of the American Academy of Child and Adolescent Psychiatry in 2001 and used by GlaxoSmithKline to heavily flog the drug for use in children and adolescents."


Full article can be read HERE


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Martin Keller to step down in June

"Keller not only failed to disclose the millions of dollars he has received over the years from drug companies whose drugs he was studying and promoting in medical journals and at conferences. But there is evidence that Keller and his co-authors misrepresented data in a clinical trial of Paxil to make the antidepressant look safer and more effective than it really was. This trial, known as study 329 and funded by GlaxoSmithKline, was published in 2001 and used by the drug company to heavily market Paxil for off-label use in children and adolescents. Yet as it turns out, the data in this trial do not corroborate the company's claims that Paxil was more effective than a placebo or sugar pill in treating depression in adolescents."



'Side Effects' author, Alison Bass writes on her excellent blog, that Brown University's, Martin Keller, is to step down from his position in June of this year.

Keller's name is synonymous in the Seroxat world for his input [or rather lack of it] in the Paxil 329 studies.

Read Alison's scoop here.

Fid

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Feds probing Emory, professor on research grants

Source: The Atlanta Journal-Constitution


By CRAIG SCHNEIDER

Federal officials are investigating Emory University and one of its prominent researchers to determine if either misled government agencies about the psychiatrist’s high-paying work with drug companies, officials said.

U.S. Sen. Charles Grassley, who pressed for the investigation, sent a letter Tuesday to the inspector general of the U.S. Department of Health and Human Services outlining his concerns. He said Dr. Charles Nemeroff, an internationaly prominent psychiatrist, may have violated conflict of interest rules surrounding several grants that Emory received from the National Institutes of Health. Grassley’s letter also noted that Emory is required to report such conflicts to the NIH.

The investigation by the inspector general focuses on the concerns addressed in Grassley’s letter, said Jill Kozeny, spokeswoman for Grassley.

The probe also reflects concerns about the way in which Emory handled the reporting of Nemeroff’s earnings from drug companies and his potential conflicts of interest.

Nemeroff, an internationally known expert on depression and former chairman of Emory’s psychiatry department, was a prime target of Grassley’s congressional investigation into whether drug company payments to doctors and academics compromises medical research and scholarship.

Grassley, an Iowa Republican who is the ranking member of the U.S. Senate Finance Committee, released documents last fall indicating that Nemeroff reported little of the money he earned through speeches he delivered for drug companies. He also received payment from drug companies whose products he was evaluating, officials said.

“But I have learned from the NIH that it was generally not aware of Dr. Nemeroff’s conflicts until I made the issue public last fall,” Grassley said in his letter.

Grassley also requested that the probe focus on whether Emory misled the NIH about the nature of Nemeroff’s talks for the drug company GlaxoSmithKline, which produces the antidepressant drug Paxil. Grassley has asserted that these talks were to promote the drug, while Emory has said they were for general education.

The NIH, an arm of the federal health and human services agency, requires universities to report potential conflicts of interest to ensure unbiased research.

Schools that violate the policies can face fines, a freezing of funds and loss of future grants. Overall, the NIH awarded Emory more than $251 million in funding last year — 61 percent of its total research grants.

As a result of its own investigation, Emory in December stripped Nemeroff of his department chairmanship and placed severe restrictions on his activities. Emory found that Nemeroff had violated the university’s policies by not reporting more than $800,000 in income from speeches for GlaxoSmithKline.

Nemeroff could not be reached for comment Thursday, but he has said, according to school officials, that he believed he was following school policy and was not required to report the speaking engagements.

Emory spokesman Ron Sauder said, “Emory has been fully cooperative with the National Institutes of Health and Sen. Grassley, and we will continue to be.”

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Interview with Shelley Jofre

Here we have an Interview with Panorama investigative reporter, Shelley Jofre.

Shelley was instrumental in exposing GlaxoSmithKline and the MHRA plus fraudulant psychiatrists with her reports concerning Seroxat.

The first documentary, 'The Secrets of Seroxat' was aired in 2002 and saw 65,000 people ring the BBC helpline and they received over 1,500 emails. This prompted Shelley to make a follow-up programme called 'Emails from the Edge', which was broadcast on BBC TV on the 11th May 2003. 'Taken on Trust', her third investigation in to Seroxat, shook the foundations of the MHRA to the core as she exposed how they had failed the British public regarding thier ignorance and incompetence. Her fourth and final installment [thus far] of the whole Seroxat scandal was called 'Secrets of the Drug Trials', she showed how GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials. This was aired in 2007.

On November the 1st, 2007, Shelley shed further light on her investigations into Seroxat when she was interviewed at Coventry University as part of the 'Coventry Conversations' series. The interview is available for download and is over an hour in length.

The interview with Shelley is a pretty amazing insight into how GlaxoSmithKline saw her as a major nuisance as she kept chipping away at them, digging for answers.

Shelley Jofre is a terrific reporter, a constant thorn in the side of GlaxoSmithKline and the MHRA. If there were any justice in this world then Shelley should recieve all the accolades. She put the dangers of Seroxat on the map here in the UK, she exposed the clandestine goings-on at the world's second largest pharmaceutical company and the body that regulate them, the MHRA.

A key point in these four documentaries was when she asked Head of European Psychiatry , for GlaxoSmithKline, Alistair Benbow, if Seroxat could be safe in children. His reply still baffles me to this day, he answered, "Absolutely. It could be. We haven't got a license in children yet..."

Quite why Benbow would suggest that Seroxat could be safe in children and would suggest that they hadn't got a license in children 'yet', is quite revealing. His company, GlaxoSmithKline, had documents from 1998 that showed that medication for adolescent depression failed to demonstrate any benefit for paroxetine over placebo in adolescents and demonstrated a worrying profile of adverse events for paroxetine.

I think it is fair to assume that Benbow was either lying or he didn't know that his company knew Seroxat was not beneficial to children, in fact it was quite the reverse. If the latter is true then Benbow as Head of European Psychiatry , at GlaxoSmithKline should ask himself why his employers never told him.

I got myself in to hot water when I created a video with comments from Benbow and juxtaposed them with comments from patients and the mainstream media. Apparently I had caused Benbow distress. Surely, as a consumer of their product, Seroxat, I had every right to question Benbow? Glaxo's lawyers were not happy with a comment I made regarding Benbow, I likened him to a Nazi dictator. In hindsight that was wrong, however, the question of whether Benbow lied on national TV has still not been answered.

Here is the interview with Shelley. It was conducted by John Mair and recorded in front of an audience at Coventry University.

It is an audio recording and not a video.

Right click and 'save as'

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The Doctors Lounge - Information about very long term use of paroxetine

Can anyone answer the age-old question about the very long term use of paroxetine?

Glaxo can't

The MHRA can't

Is there anyone that can or were we merely all lab rats whilst GSK earned millions?

This from the Doctors Lounge:

Currently there doesn't seem to be enough information on the effects of long term use of paroxetine (Seroxat).

There have been reports of some abnormal movements resulting from SSRIs; e. g., muscle twitches or stiffness. In theory, long-term use of these agents might--I emphasize might--predispose some individuals to such abnormal movements. But this theoretical risk, in my opinion, must be weighed against the debilitating effects of severe (major) Depression--which has a 15% mortality rate. Of course, there are other classes of Antidepressants that have been around much longer, and which do not seem to pose these theoretical risks--I. e., tricyclic Antidepressants. But these are also much more potentially toxic than the SSRIs, and have their own side effects.

Having said that, it must be conceded that we do not yet know the long-term effects of Paxil or related agents (called SSRIs, and include Prozac and Zoloft), if by long-term, you mean, "after 10 or more years of use." These agents are still too "new" to generate that kind of data. So far as I am aware, there are no convincing studies showing any serious long-term effects from the chronic use of Prozac, which is a closely related medication used since about 1988. So, all in all, I think the risks of taking Paxil indefinitely are probably quite small, but the jury is still out.

Dr. Tamer Fouad.


How reassuring. I like his opinion on risks: "I think the risks of taking Paxil indefinitely are probably quite small" - quite an opinion considering Dr Tamer Fouad said earlier in the same paragraph, "...we do not yet know the long-term effects of Paxil or related agents."

So, who do we get the answer from, Benbow, Andrew Witty, Martin Keller?

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A story worth telling

"To be a journalist," says Alison Bass (AMST), "you've got to have thick skin."

Bass' first book, Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial, published in June, details her in-depth investigation of corruption in the pharmaceutical industry. The book marks the continuation of a diverse journalistic career that Bass launched writing theater reviews for the Justice while a Brandeis student.

Side Effects follows the lives of Rose Firestein, the lead attorney in the New York State attorney general's lawsuit against the pharmaceutical company GlaxoSmithKline, and Donna Howard, former assistant administrator in the department of psychiatry at Brown University. The two women exposed years of corruption and deception at GlaxoSmithKline, the company that manufactures Paxil, an anti-depressant prescribed to children and adults across the United States.

Bass describes the unlikely series of events that led her to unearth a history of corrupt practices at GlaxoSmithKline. While a medical and mental health columnist for the Boston Globe during the 1990s, Bass would periodically receive tips from people wanting to report unethical medical practices.

"I first made the acquaintance with Donna Howard when she came forward as an anonymous source," Bass says.

"She came forward later, on the record, and told me about what was going on with Martin Keller, [chief of psychiatry] at Brown University, who was collecting hundreds of thousands of dollars coming from the state mental health agency for research that wasn't being conducted."

Not only was Keller collecting an enormous amount of money, he was also submitting data that made Paxil "look safer and more effective than it really was."

Still, Bass admits that it was several years before she recognized the import of Howard's complaint. In 2004, after she'd already left the Boston Globe, Bass read about the New York State attorney general's lawsuit against GlaxoSmithKline.

"The New York State attorney general's Office basically sued GlaxoSmithKline for deceiving doctors and consumers about the safety and effectiveness of Paxil," Bass explains, "and as it turns out one of the studies that was in the lawsuit was the study that Martin Keller had done back in the '90s that Donna Howard had told me about."

Source: The Justice

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More on Nemeroff

Loads of stories popping up about GSK's favourite MD, Charles Nemeroff. I particularly liked University Diaries take on things:

Charles Nemeroff: Lying Sleazebag

That’s harsh, isn’t it… But, you know, call him anything you like. Nothing will be done to change this professor’s disgusting behavior.

Emory University, his employer, has known for years he’s a greedy son of a bitch who doesn’t think rules apply to him, and it’s done nothing. It shares Nemeroff’s cynicism, enjoying as much as he does the corrupting pharma money the psychiatric researcher brings the school.

No conflict of interest here, in other words: It’s in Nemeroff’s interest to get rich, and it’s in Emory’s interest to get rich.

If Emory had the tiniest dose of integrity, it would fire Charles Nemeroff.

Perhaps Senator Grassley and the New York Times can have a little more success with this man, but, again, UD doubts it. The field of academic psychiatry is filthy all the way through right now, with Nemeroff and his crony, Alan Schatzberg, heading it, setting an example, showing everyone the way.

Supine universities, a nation of pill poppers… the world is their oyster.

Read more here

****

The Clinical Psychology and Psychiatry: A Closer Look blog runs with Uh-Oh Chuck, They Out To Get You, Man whilst The Carlat Psychiatry Blog goes with Curtains for Nemeroff. Phil Dawdy over at Furious Seasons entitles his post Sen. Grassley Busts Major Depression Researcher, Pharma Whore Over Pharma Money while Pharmalot runs with Why Grassley Is Investigating Emory’s Nemeroff.

All great pieces and all highlight what a scum sucking barrel of excrement this so called professor of psychiatry really is.

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Nemeroff Witholds 1/2 Million Dollars!

A prominent Emory University psychiatrist failed to tell the school about $500,000 in payments from drug maker GlaxoSmithKline while he was serving as the primary investigator for a government-funded research project studying Glaxo drugs, Sen. Charles Grassley alleged.

The payments to Charles Nemeroff, the chair of the Atlanta university's psychiatry department, were mainly for his work speaking to other doctors across the country about Glaxo drugs, including its big-selling anti-depressant Paxil, according to records Sen. Grassley obtained from Emory and Glaxo. The senator made the allegations in a letter to Emory President James W. Wagner dated Thursday.

Read full article here

Nemeroff has been mentioned on this blog countless times.

Here he is mentioned as being part of the 'board' for SAVE, the mission of SAVE is to prevent suicide through public awareness and education, reduce stigma and serve as a resource to those touched by suicide.

He is also part of the SEROXAT GUNSLINGERS, a group of men and women whom should be held accountable for their part in the Seroxat debacle, if not accountable then at least they should be interviewed for their parts played in this whole scandal.

Seroxat Secrets has many items on Nemeroff, 'Charlie “Bling Bling” Nemeroff' is a good place to start.

Nemeroff's CV can be read here

When asked: What is Cognitive Behavioral Therapy (CBT)? How does it compare to psychotherapy?

Nemeroff replied:

So of the treatments that are approved by the FDA, uh, the most effective treatment is, in the textbook at least, electroconvulsive therapy, or ECT. It's reserved for the most severe of depressions because it involves a considerable amount of medical intervention in terms of using an anesthetic, uh, and having the patient monitored closely during the treatments. It requires being done at a center. And it's often done three times a week for three or four weeks, so that it often requires an in-hospital stay.

Um, I say it's said to be the most effective because no pharmaceutical company has ever had the courage to do a study comparing an antidepressant treatment with ECT. And I think probably because they worry that they wouldn't be as effective. So I can't really say it's the most effective. Um, it's like being the heavyweight champion of the world. If no one wants to fight you, you never get the answer.

Ed Silverman over at Pharmalot has a series of emails relating to Nemeroff and what seems is his wimpering at being investigated.

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Pressured, Schools Review Ties to Drug Firms

Source: Wall Street Journal

By ALICIA MUNDY
September 11, 2008; Page B2

WASHINGTON -- Some major universities are reviewing the way they handle funding from drug companies in the wake of criticism from Sen. Chuck Grassley, who is pressing the federal agency that controls government health-research money to get tougher on universities that don't disclose ties to the industry.

Late Tuesday, Mr. Grassley (R., Iowa) fired the latest salvo, stating in a letter that a researcher for the University of Texas who worked on a National Institutes of Health study involving the GlaxoSmithKline PLC antidepressant Paxil did not disclose more than $150,000 in consulting and speaking fees paid to her by the company. Mr. Grassley has raised similar criticism of other universities, including Stanford, Harvard and University of Cincinnati.

Another 20 universities, including Brown, which was involved with a controversial study on Paxil funded by Glaxo, have been contacted by the Senate Finance committee, on which Mr. Grassley is the ranking Republican, over questions of potential conflict of interest with drug makers.

The director of NIH, Elias Zerhouni, met Tuesday with Senate Finance staff. Mr. Grassley wants NIH to start yanking grants to universities that fail to report their researchers' outside income from drug firms, as required by law.

NIH gave more than $23 billion last year to educational institutions. Dr. Zerhouni has been publicly skeptical about NIH's ability to pull grants, but Mr. Grassley said, "Starting today, the NIH could send a signal that business as usual is over....The simple threat of losing prestigious and sizable NIH grants would force accurate financial disclosure."

Last month, Stanford announced a policy to restrict drug-company funding of continuing medical-education programs. It also removed a renowned researcher as lead investigator on an NIH project, following questions from Mr. Grassley. Harvard has said that it is reviewing its conflict-of-interest policies.

Mr. Grassley made statements about Karen Wagner based on a comparison of records from the University of Texas and from Glaxo. Between 2000 and 2008, Dr. Wagner was engaged in an NIH study on the use of Paxil to treat teenage depression and another study on teen anxiety.

The university's legal counsel said they will look for any discrepancies in Dr. Wagner's disclosure reports. Dr. Wagner did not respond to requests for comment.

The University of Texas has received more than $5 billion from NIH since 2000.

"Universities have been treading on dangerous ground with their increasingly complex financial ties to industry," said Jerome Kassirer, former editor of the New England Journal of Medicine. "They are worried that these things could ultimately affect their tax-free status," he said.

Many faculty members remain on company speakers' bureaus, he added.

Dr. Wagner was considered one of Glaxo's "opinion leaders," speaking at many medical meetings about Paxil, according to documents from civil suits. Paxil has been linked to teenage suicide and suicidal behavior. The company has said the drug is safe. Dr. Wagner was a co-author of the Brown study on Paxil that has come under attack for allegedly overstating the drug's safety.

In 2000, the first year of the NIH grant, Dr. Wagner, who is based at the University of Texas Medical Branch in Galveston, received $53,000 from Glaxo, which included a trip to Paris to speak at a company meeting, Glaxo confirmed.

From 2003 to 2004, while receiving additional funds from Glaxo, Dr. Wagner served on the university's committee policing conflict of interest.

Barry Burgdorf, the university's vice chancellor for legal affairs said there didn't appear to be a major problem with the 15-branch university's disclosure system.

Write to Alicia Mundy at alicia.mundy@wsj.com

*Hat tip: Susan (If you're going through hell keep going Blog)

Read more about the Seroxat Gunslingers here, here and here

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Glaxo Loses Preemption Ruling In Paxil Suicide

Source: Pharmalot

On September 14, 2002, 16-year-old Jake Garrison shot himself to death, eight months after first being prescribed the Paxil antidepressant. And so a lawsuit was filed against Glaxo, claiming the drugmaker knew there were risks associated with off-label use pediatric use of Paxil and, therefore, had a duty to warn of those risks.

However, Glaxo cited preemption as a reason for the suit to be dismissed. Preemption is the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness.

In this case, the drugmaker maintained that a direct conflict existed between failure-to-warn claims under New Jersey state law and the federal Food, Drug & Cosmetic Act. New Jersey law stipulates that a drugmaker must warn of all known adverse effects of a drug as soon as reasonably feasible after learning of any danger. Lawyers for the Garrison family rejected the argument in their motion.

However, Glaxo contended that, had it included warnings about an increased risk of pediatric suicide in the Paxil label, the pill would have been considered misbranded under federal law. And since Glaxo could have not remained in compliance with both state and federal law as it stood prior to September 2002, when Garrison committed suicide, Glaxo argued a conflict existed, triggering preemption of New Jersey law.

But Judge Ronald Buckwalter of the US District Court for the Eastern District of Pennsylvania rejected the argument by ruling FDA regs allow a drugmaker to “unilaterally add a warning on a drug, so long as the drug manufacturer has reasonable evidence of an association of a serious hazard with a drug.” Here is his 53-page ruling, in which he also wrote:


“Arguably, Glaxo possessed such reasonable evidence of an association between Paxil and pediatric suicidality as early as 1998, at the conclusion of their own Studies 329 and 377, the data from which initially triggered the FDA’s concerns.

“The mere fact that Glaxo elected not to submit the results of those studies until April of 2002, when it filed a supplemental NDA seeking approval of an indication for pediatric use, does not detract from the fact that it may have had reasonable evidence of a hazard prior to that time…The mere fact that the FDA had not ordered Glaxo to include this warning prior to 2002, does not mean that it could not have legally done so.”

Preemption is a hot legal topic these days. The US Supreme Court will review a case on November 3, and if you have some time on your hands, open this link to you will find background material and numerous briefs backing and opposing preemption.

By the way, this is the second Paxil case this summer in which preemption was rejected as a defense. This is the other one.

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Mail Order Academics

Simply Genius!

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GSK to report organization grants

Had to laugh when I read the latest PR exercise from GlaxoSmithKline. It makes them out to be transparent but it's oh so obvious that their hand has been forced by Sen. Grassley just as it was by Elliot Spitzer when they were forced to publish their clinical trials data online.

The latest effort to stifle bloggers, government officials and various media sources is nothing more than a publicity stunt.

We are already aware of the grants GSK have given to the likes of Keller and other Seroxat Gunslingers and also to 'experts' who 'big up' Seroxat.

I can just hear the spokesperson from GSK now... "We put all our information online that is readily available to the public."

Be nice if they put information on their website as to why they have made countless settlements out of court then placed gagging orders on those affected by Seroxat!

So next time GSK claim to be transparent, ask them why they place gagging orders on individuals they settle out of court with.

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What Are We Working For?

I just read Dr Aubrey Blumsohn's message on Scientific Misconduct entitled 'A crooked scientist'

With the current state of affairs going on at Brown University, Aubrey's message was simple:

There was a crooked man,
And he walked a crooked mile.
To confer with his crooked neighbor,
Who wore a crooked smile.
The crooked man's neighbor,
Lived in a crooked nook.
Both being crooked people,
They read a crooked book.
Inside were crooked tales,
Of other crooked men.
'Twas a crooked man's dream,
Shared with a crooked friend.

The following video by Big Country kind of sells the same message.

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

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