Editorial Note: This was our final letter in the correspondence that began here and ran through here. There has been no response from Dr Godlee.
28 January 2016
Dr Fiona Godlee
Editor, BMJ
Re: BMJ handling of conflict of interest
Dear Dr Godlee
Thank you for your email response of January 11 2016 to our letter of July 8 2015 about Dr Elizabeth Loder’s conflict of interest in relation to editing our Restoring Study 329 paper. However, we are disappointed with the outcome.
When Dr Loder and reviewers of our submitted paper suggested that we had conflicts of interest, we argued in our responses that conflict of interest is less important than access to data. With access to the data, others can decide whether or not perceptions of conflicting interests might have translated into actual bias. However BMJ made several more comments during the review process about our conflicts, and on July 6 2015 required that the most important part of our work, the reporting of adverse events, be independently checked because of perceived bias.
It was against this background that we wrote our letter of concern about Dr Loder’s apparent COI, intending to point out the double standards that appeared to us to be operating. We had hoped that you and Dr Loder would concede that there was indeed a perceptual issue with her organisation’s present and past relationship with GSK and that of her husband’s law firm, but would reassure us that there was no actual conflict because Dr Loder had worked hard for the publication of the paper. Instead BMJ dismissed the issues we raised as ‘so attenuated’ that requiring their declaration would be ‘absurd’, a dismissal that seemed inconsistent with BMJ’s attitude towards our perceived bias.
Study 329 will be an object of study for years to come, and it is important that the full story be available. The BMJ reviews and correspondence are the data about the handling of our paper. Reading them will make it possible for others to make a judgement as to whether any bias may have been involved. Yet these documents are not included under the ‘Peer review’ tab for our published paper http://www.bmj.com/content/351/bmj.h4320/peer-review, contrary to BMJ policy http://www.bmj.com/content/349/bmj.g5394. We request that they be posted there.
Meanwhile, the correspondence is available on the Restoring Study 329 website. We would be happy to include on that site a BMJ view as to how readers should read the various reviews and correspondence, or any other commentary that you might want to add.
Yours sincerely
Jon Jureidini
On behalf of 329 RIAT team
A couple of months ago, I was seeing Dr. David N. Hall here at Cheshire Medical Center – Dartmouth-Hitchcock-Keene(CMC/DHK)(Keene, N.H.). I asked Dr. Hall if he’d heard of “Study 329”. He hadn’t. He HAS NOW. I gave him a 3-page printout of a good over-view article on Study 329. A few days later, CMC/DHK emailed me a “termination of medical services” notice. In other words, CMC/DHK is denying me medical care, because I am an activist against MEDICAL FRAUD. It’s called “retaliation”. Spread the news – let EVERYBODY know.
The silence speaks volumes! Best of all, it lets the rest of us draw whatever conclusions we like about herr non-reply. Seems to me as if Dr. Fiona Goodlee’s bread is rather thickly buttered by someone – I wonder who? – and she’d like to make sure it stays that way thank you very much! I find this behaviour – of not replying to a formal request or explanation etc. – a perfect example of bad manners which seems to be on the increase in high places. There again, if we now draw the wrong conclusions about what has gone on, then she only has herself to blame.
On her paternal grandfather’s side, she is a great great great grand daughter of Joseph Jackson Lister, pioneer of the compound microscope and father of Joseph Lister, 1st Baron Lister.[7]
Surely no nepotism /cronyism/ kudos for thebmj from F being born in the right bed here Mary! F G has no shame – in a published piece in thebmj incredibly she told how she had heard that she had lost her bid to become editor of thebmj. Fi phoned her mum in tears. Mother was made of sterner stuff -after all F G had been sent to Bedales for goodness sake. Told her to phone as obviously a mistake had been made. F did as she had been told and lo – she had got the job after all. (She didn’t say who had been pushed out).
Another Trial
Trial By Error: A Plea to Fiona Godlee on a Familiar Topic
16 MAY 2019
By David Tuller, DrPH
On Wednesday, I sent the following to Dr Fiona Godlee, editorial director of BMJ. The topic, once again, was the ethically and methodologically challenged Lightning Process study, which was published two years ago in Archives of Disease in Childhood, a BMJ journal. My letter was prompted by the recent appearance of a review paper that cited this Archives report and called the Lightning Process “effective.”
**********
Dear Fiona—
As you know, I have been pressing Archives of Disease in Childhood, a BMJ journal, to address problems with a 2017 paper called “Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial.” More than a year ago, I reported on Virology Blog and informed Archives of Disease in Childhood that the investigators, a team from Bristol University, recruited 56% of the participants before trial registration, swapped primary and secondary outcomes based on early results, and then failed to disclose these details in the published paper.
Last June, Archives of Disease in Childhood added an editor’s note to the published record. This editor’s note essentially confirmed the methodological and ethical lapses I had documented; it also indicated that the study investigators had provided “clarifications” and that the matter was under “editorial consideration.” It is likely that few people have seen the editor’s note, since it is not visible from the paper.
I have continued to highlight this issue publicly because I am seeking to protect children’s health and well-being. I am particularly concerned that the Lightning Process trial’s reported findings could negatively impact pediatric health policy as well as the medical care provided to this vulnerable population. Given the study’s violations of core scientific principles, the findings cannot be taken at face value. The paper should not have been published in the first place.
A recent publication illustrates and validates some of the worries about the Lightning Process paper. In late April, Current Opinion in Pediatrics published a major review called “Child and adolescent chronic fatigue syndrome/myalgic encephalomyelitis: where are we now?” Going forward, it is possible this review could influence policy-makers and medical providers. The review could, for example, influence some of those engaged in the ongoing effort by the National Institute for Health and Care Excellence to develop new clinical guidelines for the illness it now calls ME/CFS.
It is therefore troubling that this review in Current Opinion in Pediatrics touts the Lightning Process as having been shown to be “effective.” The review does not note that the investigators recruited more than half their participants before trial registration, swapped outcome measures based on the early results, and omitted key information from the published paper. The review also fails to mention the editor’s note, any reading of which should have raised questions about the reported findings. In other words, despite the Lightning Process study’s recognized deficiencies, the just-published review in Current Opinion in Pediatrics cites the findings uncritically–with unknown and possibly deleterious effects on children’s health.
It bears reiterating–and re-reiterating–that the Lightning Process is a pseudo-scientific intervention combining life-coaching, neuro-linguistic programming, positive affirmations and osteopathy. Participants are taught that they can overcome illness by controlling and changing their thought patterns. Lightning Process practitioners have declared–without citing legitimate evidence–that they can successfully treat multiple sclerosis, eating disorders and other serious conditions. Government regulators have admonished some practitioners for making misleading claims.
Phil Parker, the founder of the Lightning Process, previously taught a course on how to heal people with “divination medicine cards and tarot.” The archived website for this course explains that “divination is useful in creating a strong connection with healing/spirit guides.” The course also featured lessons in “the use of auras for diagnosis of a client’s problems” and in how to “prepare a space appropriately so that any energy polluting the room will not interfere with the work you are doing.”
Since 2017, Archives of Disease in Childhood has provided this spiritual healer with bragging rights that his commercial self-help program can be considered evidence-based. The review in Current Opinion in Pediatrics serves to perpetuate and amplify the unhelpful belief that the Lightning Process trial was robust and worthy of serious consideration.
Fiona, in the interests of preventing sick children from being subjected to questionable interventions, I am pleading with you to ensure that Archives of Disease in Childhood promptly concludes its period of “editorial consideration” and does what it needs to do about the Lightning Process study. The appearance of the new review–whose authors, I assume, did not notice the obscurely located editor’s note–has rendered the situation more urgent. When it comes to safeguarding the integrity of the medical literature, further delay in taking corrective action is unwarranted. It is also unacceptable. The Lightning Process study does not deserve BMJ’s seal of approval.
I am cc-ing several people on this e-mail: Terry Segal, the senior author of the review in Current Opinion in Pediatrics; Professor Alan Montgomery, the senior author of the Lightning Process paper; three members of Parliament who have expressed concern about the poor quality of studies in the ME/CFS domain, along with a parliamentary aide; four physicians involved with the NICE process for developing the new ME/CFS clinical guidelines; Sue Paterson, the director of legal services at Bristol University; Tom Whipple, a science reporter who has covered the illness; Professor Chris Ponting, current vice chair of the CFS/ME Research Collaborative.
Thank you for your attention to this matter.
Best–David
David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley
Affectations of W1A, the Head of Values at the BBC and the Head of Better..
a funny spoof..
http://i.dailymail.co.uk/i/pix/2014/01/24/article-2545481-1AEC506D00000578-792_306x603.jpg
1. Relationship with GlaxoSmithKline
http://www.zoominfo.com/p/Elizabeth-Loder/5968676
Consultant
GlaxoSmithKline plc
2. John M Loder
https://www.linkedin.com/in/john-m-loder-1410b014
https://www.ropesgray.com/johnloder/
3. Published Statement
GlaxoSmithKline’s leadership on data disclosure efforts stand out.
Dear Fiona,
You asked me to respond to Dr. Jureidini’s accusations of conflict of interest regarding connections to GSK. These were 1) that my hospital, Brigham and Women’s, receives research money from GSK; 2) that my husband is a partner in the law firm Ropes & Gray, which has done work for GSK and thus he profits directly from this connection; and 3) that I have made public statements favorable to GSK products.
“The efforts of industry, too, must be acknowledged, says Loder. In particular, Medtronic’s cooperation with the Yale University Open Data project and GlaxoSmithKline’s leadership on data disclosure efforts stand out.
http://medicalxpress.com/news/2015-07-bmj-policy-clinical-trials.html
“Others lay at least some of the blame with the medical journals that publish drug trial data.
In response, the BMJ has promised to devote an entire issue to the topic next year.
BMJ Editors Dr Fiona Godlee and Dr Elizabeth Loder said: “It is time to demonstrate a shared commitment to set the record straight.”
http://www.bbc.co.uk/news/health-11521873
1. Elizabeth Loder, acting head of research ,
2. Trish Groves, deputy editor and editor in chief, BMJ Open
The efforts of industry, too, must be acknowledged, some of which caught many people by surprise. In particular, Medtronic’s cooperation with the Yale University Open Data project and GlaxoSmithKline’s leadership on data disclosure efforts stand out.6 7
http://www.bmj.com/content/350/bmj.h2373
Global Legal Post
http://www.globallegalpost.com/big-stories/ropes–gray-start-work-on-gsk-investigation-42674924/
GSK In-house Lawyer Charged by Feds
http://amlawdaily.typepad.com/amlawdaily/2010/11/ropesgsk.html
On the basis of this advice I therefore intend to take no further action on this matter.
Thank you again for raising it.
All best wishes, Fiona
Con Flicks and Interest
Then there were six……
https://pbs.twimg.com/media/A7LxmL-CUAAJc0l.png
Then there was one.
https://pbs.twimg.com/media/ChmUQOeXAAAegDq.jpg
Then
http://www.madinamerica.com/2016/05/the-fda-is-hiding-reports-linking-psych-drugs-to-homicides/
Doing their jobs properly would make David Healy Redundant and Study329 Irrelevant and Jon Juredini Quiet
“Study 329 will be an object of study for years to come, and it is important that the full story be available.
GSK @GSK May 6
.@EFPIA disclosure code means more transparency in the pharma doctor rel’ship. We’re going beyond #pharmadisclosure
https://twitter.com/hashtag/pharmadisclosure?src=hash
Repetition with Murray Stewart
https://pbs.twimg.com/media-preview/728574326023323649/4PXXuOgU.jpg
https://davidhealy.org/not-so-bad-pharma/
https://davidhealy.org/not-so-bad-pharma/#comments
“Now it is unfair to say that if Ben Goldacre didn’t exist, Andrew Witty, the CEO of GlaxoSmithKline, might have had to invent him.
Medical Kidnap: Get Out of Jail Free Report
Johanna says:
May 10, 2016 at 7:16 pm
http://www.huffingtonpost.co.uk/dr-aseem-malhotra/great-statin-con_b_9607316.html
“What is most extraordinary, however is that he has referred the editor of the BMJ, Fiona Godlee to the committee on publication ethics for the journal’s handling of an article by Harvard Medical School Lecturer John Abramson that questioned the benefits of statins in a low risk population and suggested that up to 20% of patients suffer side effects. An independent panel had already unanimously ruled that the paper didn’t require his previous calls for retraction. If found guilty this could result in her being fired.
Just maybe matters such as Study 329 are beginning to permeate into the broader medical profession…
“All in the mind”, R4 this afternoon, there is an apparent crisis in UK psychiatry, with 100 senior posts presently not filled. Apparently, most doctors have no wish to sit next to a psychiatrist at a party… Sir Si was interviewed, and he said “I don’t want to sit next to a psychiatrist neither, as they just want to talk sh** “.
His choice of final word caught me by surprise, as I thought he was about to be really honest about what his chemically-obsessed colleagues might discuss…
Sir Si also said (optimistically) that from this year onwards, half of all medical students would have to spend time in a psychiatric environment. I’ll be platting sawdust if that results in all those empty posts being taken up…
Walter
Your comment Walter is sadly true. I have just mostly met psychiatrists in the system who just don’t get it or see it and will go on to talk a load of old rubbish.
In fact I’ve been laughed at sneered at (very unprofessional) but I have learnt not to bite back, your only give yourself a headache.
I once heard a hospital Dr years ago say “A lot of psychiatrists are just failed medical students that couldn’t make it in med school) so chose either psychiatry or dermatology. It’s sad comments are made like that because they should all be as good as the best Dr,s out there.
I have met some very bad ones unfortunately and think it’s those who give the proffesion a bad name.
The last one I saw was hissing through her teeth looking like she wanted to knock me out for saying Ssris can cause intense alcohol cravings. I wanted to explain to her but she was too angry and didn’t look like she wanted to listen so I didn’t bother.
That is part of the problem not wanting to listen.
Anne-Marie,
Lets all buy it..
http://www.hive.co.uk/Product/Katinka-Blackford-Newman/The-Pill-That-Steals-Lives–One-Womans-Terrifying-Journey/19188924
I’m interested in your comment that many psychiatrists don’t seem to listen, and some laugh at you in an unprofessional way. Also, today on the BBC Breakfast show, Mental Health First Aid programme is being taught to hairdressers so that they can listen to customers if they feel low and want help. All this is giving the impression that if you are feeling suicidal and can talk about it and be referred for professional help, it is ready and waiting out there for you. Our son died, but had been rubbished and humiliated in front of a Home Treatment team by an NHS psychiatrist who also works as a Head Trainer in NLP (neurolinguistic programming) who told him he might as well stop taking his Venlafaxine AT ONCE as he didn’t consider him to be depressed ( no suggestion of tailing it off, also advised to stop Zopliclone at once). He got terrible withdrawal symptoms, reported feeling dreadfully much worse head pain and anxiety, and was shouted at in front of the team for being attention seeking. The psychiatrist wouldn’t listen to us or him about his 11 year history of struggle with OCD and anxiety after first taking RoAccutane, the acne drug, when he was 21. The psychiatrist then put him on Olanzapine, Sertralne was added, and he experienced such voids in his thinking that he ended his life. The psychiatrist would not listen to us at all. He told our son he would probably end his life but would rather he did it in hospital than out in the community, but he was withdrawing treatment anyway ‘because he had not co-operated’, presumably because he said he felt so suicidal. So no hospital care was being offered, and in a way we were relieved because this man had been up before the GMC over safety issues and a death in his hospital some time before. We feel NLP is being used, even covertly, for a quick fix to get immediate results, which can be dire, and then when deaths occur, it is denied that it was used. You cannot suddenly stop a drug like Venlafaxine because hypnotically you feel you know best what is wrong with a patient after 2 short meetings with him, and then rubbish him for reporting feeling terrible. This man we feel should not be practising psychiatry in the NHS, or even in his several private practices. Our son explained how suicidal he felt, but was derided for it. I don’t think his experience is unique.
w-n-m-f-w/
http://1boringoldman.com/index.php/2014/09/19/weep-no-more-for-witty/
“if you try to publish criticism of a fraudulent article, what you’re going to find is that you are certainly not getting published in one of the high-impact medical journals, like BMJ
http://www.madinamerica.com/2016/05/researchers-deconstruct-ghostwritten-industry-trial-for-antidepressant/
“a considerable conflict of interest when it comes to editorial decisions on critical manuscripts submitted to the journals.
“a pilot that can’t trust the instruments on his airplane
http://1boringoldman.com/index.php/2016/05/14/this-tawdry-era/
”yet the authors had one hell of a time getting it published
“persisted until they found a journal that would accept the article as it should’ve been written.
………………”insure that all this dedicated work is rewarded with a wide readership, one that helps us move closer to putting this tawdry era behind us…
w.n.m.f.w…. http://1boringoldman.com/index.php/2013/07/28/a-closing-argument/
•
Johanna
July 29, 2013 | 7:11 PM
I ran across this joint statement on “responsible” data-sharing practices from PhRMA and its European cousin EFPIA. It is a real piece of poop, of course … we will share data only with “responsible” parties in a “responsible” format. In other words, we are committed to telling you everything we think you need to know. Trust us.
I notice GSK is a member of both organizations. Is this GSK’s policy on data sharing as well? If so, I think it poses a real question for the AllTrials group and particularly those who have expressed enthusiasm for GSK’s data sharing initiative. (I like a number of things Ben Goldacre has done but I am really puzzled as to why he wants to “do cartwheels” over GSK’s offerings in this field so far. And I fear he and AllTrials could get manipulated into total irrelevancy, or worse, if they get too trusting.)
So I hope they ask GSK: Are you standing behind this Orwellian piece of poop issued by your trade associations? If not, please stand up and say so. And if so, what the heck does it mean that you also “endorse” AllTrials?
http://study329.org/wp-content/uploads/2015/01/KraustoJureidiniMay32013.pdf
http://study329.org/correspondence-with-gsk/
Ben Switching..
http://1boringoldman.com/index.php/2016/05/15/captain-ben-and-his-crew/
RIAT author compares COMPare to Errol Flynn..
The BMJ/Alltrials partnership and a twelve month hurdle for Study329 to be published and then retracted
I guess the hills of Georgia are not alive to the hills of british medical journals interests and the hills of GlaxoSmithInCline..the first pharmaceutical co to sign up as they never stop telling the world
http://www.alltrials.net/supporters/organisations/gsk-statement/
Q: Was RIAT a squashbuckling doddle?
Q: Was it welcomed with Open Arms?
Q: Was GlaxoSmithKline guilty/not guilty of suppressing data?
Captain Blood
Romance
“Swashbuckling saga about a 17th Century *Irish Doctor* who’s unjustly charged with treason”
“After he treats wounded English rebels, physician Peter Blood is arrested and sentenced to slavery in Jamaica.
There he catches the eye of the governor’s daughter, *who buys him*.”
Kudos where it’s due; for half a story :
http://compare-trials.org/blog/are-your-results-unusual-or-how-often-are-outcomes-switched/
“ You need look no further than the classic example of study 329
“But the trial report in the academic journal
We hope that the journals will engage, and we hope you will help us, to help them, to do the right thing!
(Dr) Kamal Mahtani, (Dr) Ben Goldacre.
Curiouser
and curiouser..
“Share This Story, Choose Your Platform!”
http://www.alltrials.net/news/publishers-announce-new-way-to-link-clinical-trials-with-publications/
Share This Story, Choose Your ….Form!
“Dr David Healy, professor of psychiatry at the University of Bangor, and director of the patient drug safety group RxISK, says serious fluoroquinolone side-effects have been reported since they were introduced.
‘Their use was justified on the grounds that they were really strong antibiotics that could be reserved to treat serious infections,’ he says. ‘They were then used for everything, including trivial infections and even to prevent infections.
‘The problem is most members of the public regard these antibiotics as safe, and don’t connect their symptoms with them. But they’re not safe – all of them are tricky, and fluoroquinolones have the worst side-effects.’
http://www.dailymail.co.uk/health/article-3593515/Antibiotics-got-rid-chest-infection-Jane-says-destroyed-health.html
Data Based Medicine Retweeted
Harlan Krumholz @hmkyale
.@US_FDA: ‘serious side effects of fluoroquinolones generally outweigh benefits’ [why did it take so long]
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500665.htm
There is without question that the advent of some drugs have liberated many from would be incarceration which is greatly appreciated. However, in the long term, it is probable that some adverse effects can be discovered and need to be dealt with honestly.
There has been a sea change in psychiatry as a result but there still remains a huge area of misunderstanding, both by pharmaceuticals and practicing doctors. It seems to me that people don’t know whether the blurb is accurate and what is the proper dose to administer. On top of that like thalidomide the outcome of some drugs may be completely unexpected despite genuine good intentions and all the knowledge available.
Therefore, it seems it is important for everyone to be aware of the problems in trying to modify the behaviour of the mind and emotions. Patients cannot know precisely what is happening because there are, I suggest, too many complicated feelings and symptoms.
Things can go on for a long time before they are reported so it is difficult to pin-point the cause. Eventually, new facts and research may produce a better understanding and change accepted practice and wisdom. This can involve a long time scale in communicating this to everyone involved in prescribing and treating people who have serious mental health issues. Improvements are thus not immediate or well disseminated through medical practitioners. Therefore, it is imperative for everyone to be aware of the possibility of the need to revise possible negative outcomes and quickly react to bona fide findings. It seems there are many areas where there could be improvements in treatments if the existing shortcomings could be addressed. Clearly, despite great efforts there is much cause for being critical and a need for open mindedness. Do not spoil huge advances that have been made by trying to not have to rethink some apparent flagship enterprises. It is a complex area and it deserves maximum observation and care.