Editorial Note: The posts have gotten slightly out of sequence. This post should have preceded the responses from BMJ. It is the letter to which they were responding. This and other letters are on Study329.org.
8 July 2015
Dr Fiona Godlee
Dear Dr Godlee
Re: “Restoring Study 329: A randomised, controlled trial of the efficacy and harms of paroxetine and imipramine in the treatment of adolescent major depression”
I note your earlier comment about BMJ’s risks being ‘more editorial than legal’. Coincidentally when we were looking up Dr Elizabeth Loder’s profile in relation to her concerns about our handling of headache in our adverse events analysis, we became aware of a potential conflict of interest.
BMJ staff have understandably been very careful about any perceived conflict of interest on the part of our team, given that some of us have previously criticized GSK’s Study 329; we now have concerns about Dr Loder’s indirect but significant links with GSK.
(http://live.washingtonpost.com/how-serious-are-migraines.html ). This article was published just before GSK’s Treximet (combination triptan and anti-inflammatory) came on to the market.
More recently, the law firm has supported GSK with its difficulties in China
Although, as Dr Loder’s COI declaration at BMJ points out, John Loder’s work is not in the healthcare field, as a partner in Ropes & Gray, he presumably profits directly from such work.
We believe that Dr Loder’s interests have been incompletely declared and that it might have been appropriate for her to recuse herself from involvement in the assessment of our paper to avoid any perception that GSK’s interests were being considered in BMJ’s deliberations.
While the timing for bringing these concerns to your attention is not ideal, we wanted to inform you as soon as possible after we became aware of these potential conflicts.
I look forward to hearing from you soon.
On behalf of the RIAT 329 group
Copyright © Data Based Medicine Americas Ltd.
Although we can safely say that our complete misery and journey in to insanity was caused by Keller et al. telling the world Paroxetine was safe when it clearly was not.
For him and his pals to continue to say it is rather extreme and insulting to those of us who had the misfortune to fall over Seroxat/Paxil
Telling porkie pies of this calamitous nature has put K and GSK under the Spotlight of corporate manslaughter territory and it cannot be said clearer than that.
Baum Hedland Aristei Goldman Attorneys in New York were on the ball with Paxil…
K and GSK Conspiring all the dodgy results filtered right down to us
….concluding that the evidence showed that “GSK knew of the risk of pediatric suicidality as of 1998” and that “GSK documents suggest that [GSK] acted with a wanton and willful disregard for the safety of its consumers.”
………….mislead the public.
What’s missing is the Urge to Suicide when ‘the person’ has never before and never after had any thoughts of #Suicide Whatsoever..eh, Mr. A. ‘all part of an era’ Witty..
Has anyone heard Sir Andrew Witty make one remark about Paroxetine or is the sign of a great manager the ability to delegate, to others like Shannon, who is now ‘Retired at Self’ after RIAT..
Can you think of any reason that a UK Lawyer couldn’t Clean Up, no, neither can I..
Who Has the Power?
Wouldn’t it be refreshing if there was one lawyer somewhere in the world, who didn’t talk about Settlement, but, rather, Public Execution..
There’s a very clear reason why doctors aren’t litigants. And leave it to patients.
Surely, pulling the plug on this drug, like Avandia, at least in Europe, is preferable to a few K from GSK…summoned to a handshake with Sir Witty and given a cheque, for ‘services’ to the pharmaceutical industry, a curtsey and a thank you…?
Was it clever to use ‘Execution’ Twice
Was it clever to pay ‘-$Billions’
Appearing, robotic and passionless…the irony, they give us pills to look and sound just like them…devoid of any engagement?
Who is the ‘real’ one, in pharma patter..?
“and then Ben came along……..
“The BMJ has been extremely supportive…………………………………….
*Hey, we’ve changed the world*
Godlee or not: 28.20
“Change has happened……I’m part of the Alltrials thing”
CEBM All Trials session
‘Aye’ for Pharma
Learning to Trust: with Murray Stewart, CMO at GSK
Video with Murray Stewart “we would release the data”
GSK US @GSKUS 20h20 hours ago
Does Murray Stewart have the toughest job in Pharma? @eyeforpharma says yes in this backstage interview #efpPhilly
GSK @GSK 14h14 hours ago
“The Pharma industry knows it has to find the new high ground of innovation.” -Andrew Witty #MIglobal
The Pharma industry knows it has to find the new word ‘moral’ high ground..
“Frankly, we were offended that our work was subject to such checks when papers submitted by pharmaceutical companies with fraud convictions are not. “
“they handled it tactlessly
Jon Jureidini, MD
Healthy Skepticism: Jon Jureidini, a child psychiatrist in Australia, writes on the quality use of medicines, misleading drug promotion, suicide, medical education and child abuse.
madmom on May 3, 2016 at 3:40 pm said:
I am saddened how individuals such as Dr Fiona Godlee, seduced by money,power, and status, fail to see how deeply embedded they are in a system that puts profit above people, resulting in their dereliction of duty to protect those they are sworn to protect.
Re scripting their memoirs…
Friday, 18 June, 2004
Glaxo releases drug trials on web
Glaxo said it had previously released the results of tests on Paxil in medical journals and at scientific meetings.
GSK @GSK 8h8 hours ago
Why leave an academic career for Pharma? Prof Paul Jones tells why he did & how he brings outside views into Pharma
Do we want balding grey haired oldies dragged out in defence of the worldwide bribery of doctors……..it happened all over the world with GlaxoSmithKline bribing doctors and it is too late to paper over the cracks…
“As far as I know…..
Well, you don’t know……..
“Both the SFO and DOJ are in the middle of ongoing investigations into bribery allegations involving GSK and its associated persons not only in China but also elsewhere in the world.
The Evidence, However, Is Clear..
No time for stodgy..
Godlee points out that in medicine, facts are sometimes in short supply. She is determined to remedy that. She helped set up a campaign, known as AllTrials, to urge all clinical trial data to be publicly reported; she remains on the group’s board. And in 2013, the BMJ helped launch the RIAT initiative — which stands for Restoring Invisible and Abandoned Trials — to unearth and analyze clinical trial data that had been consigned to the desk drawer without being published.
“The bottom line with Fi is that she’s clever, she’s lovely, and she’s charming, and she has a very good strategic overview of evidence-based medicine, including its flaws,” said Dr. Ben Goldacre, a British physician, author, and an ally who has worked with Godlee on AllTrials.
The BMJ’s big target with its RIAT initiative was Study 329, which laid the groundwork for the claim that paroxetine (sold as Paxil in North America) was a safe and effective treatment for major depression in adolescents. This conclusion was soon disputed; Paxil manufacturer GlaxoSmithKline ended up paying out $3 billion in 2012 to resolve allegations of fraud and failure to report safety data relating to Paxil and other drugs.
The company released its paroxetine data as part of the settlement. A re-analysis published in the BMJ this fall showed that the drug was not effective in adolescents — indeed, that it increased harmful outcomes, such as suicidal thoughts.
The analysis “shows the extent to which drug regulation is failing us,” Godlee said at the time.
One of the corollaries of re-analyzing data from clinical trials is that it might lead to the original studies being retracted. That doesn’t concern Godlee, a former chair of the Committee on Publication Ethics, which advises journals on such issues. “Retraction shouldn’t be seen as a terrible thing,” she says. “It’s part of correcting the scientific record.”
Setting the record straight
1. Peter Doshi, postdoctoral fellow1,
2. Kay Dickersin, professor, director234,
3. David Healy, professor of psychiatry5,
4. S Swaroop Vedula, postdoctoral fellow6,
5. Tom Jefferson, researcher7
• We thank Yuko Hara, Iain Chalmers, and Betsy Humphries for many helpful conversations and comments on the idea and draft manuscript. We also wish to thank the many others who made important contributions during the peer review process: external peer reviewers James Miller, Douglas McCrory, Margaret Winker, Emma Veitch, Andrew Vickers, Deborah Zarin, and Tony Tse and the BMJ editors, particularly Elizabeth Loder.