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)
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
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