Children of the Cure has just been published – the Preface is on Samizdat. The first Chapter is on RxISK – Fear of Lying.
Children is one of several closely related books due out in the next few weeks including Paul John Scott’s The Malcharist and Jon Jureidini and Leemon McHenry’s Illusions of Evidence Based Medicine.
It would be wonderful if everyone reading this could buy a copy and one also for some doctor near you. Samizdat will publish all reviews you care to write and send in – even hostile ones. We would love if you could tweet or email or otherwise spread some of the “soundbites” below or others of your choosing – even hostile ones.
Now is the time for soundbites, in contrast to Tony Blair’s claim from one side of his mouth, when he flew in to take credit for the Northern Irish Good Friday peace agreement, that now is not the time for soundbites while claiming to feel the hand of history.
Children of the Cure tries not to take a position. It tells a story that can do with being scrutinized – for the hidden positions/motives of its authors as much as for anything else.
Children of the Cure
It’s a story that makes clear that motivation and common sense can be worth more than “expertise.” It is also a true story. Truth is stranger than fiction because fiction has to make sense. It’s a true story about lies.
After Black Box Warnings stained the SSRI antidepressants, Lady Macbeth like, senior FDA figures, working closely with trusted experts, spent over a decade trying to wash the stain away, in a manner that suggests the apparatus you think is there to look after you has no interest in truth, and many of those involved would prefer to see you dead than admit they got something wrong.
FDA to GSK
Please provide your rationale for coding suicide attempts and other forms of self-injurious behavior under the term emotional lability
We agree that the results of Study 329 failed to demonstrate the efficacy of Paroxetine in paediatric patients with MDD… we agree that it would not be useful to describe these negative trials in the labelling.
GSK to their Staff
If you are depressed who should you consult? A TV presenter or a doctor?
Judge Paroxetine on clinical trials not trial by media.
Internal GSK Document
Target: To effectively manage the dissemination of these data in order to minimise any potentially negative commercial impact.
Proposals: Positive data from Study 329 will be published
The question for every reader is: How could a journalist with no medical training, Shelley Jofre, spot the problems that the authors and reviewers of Study 329 failed to detect?
In 2016, we got fake news but as events were to reveal, medicine has been operating with fake science for thirty years. The trials we see bear as much relation to the data as what we get from politicians bears to the facts.
New York Attorney General Spitzer held a press conference at which he claimed his office’s action would change the course of medicine for ever. All pharmaceutical companies would be pressured into making their data available to doctors – as it should be.
GSK’s response “We believe that GlaxoSmithKline’s initiative to launch this register is a responsible step in ensuring transparency of our clinical trial data” left Spitzer furious.
A sensational document leading to a successful fraud case that was going to change the face of medicine, a document that opened up the prospect of investigating ghost-writing, a Black Box Warning slapped on antidepressants after nearly 15 years of campaigning, might all sound good but it didn’t feel at the time like much was really changing and it’s not clear there has been any change for the better since.
Black Box Meeting
Perceptions of the February 2 Black Box Meeting may have also been coloured by an event a few days later. On February 7 Traci Johnson, a 19-year-old college student taking part in a healthy volunteer trial for duloxetine, which Lilly was trying to rush to the market as Cymbalta to fill the void left by Prozac, was found hanging by a scarf from a shower rod in the testing facility. Her story and photogenicity became front-page news.
When researchers and the press started asking about duloxetine, the FDA didn’t scour its database and go public. It kept quiet. The FDA gave a legal rationale for its silence. Some clinical trial data are considered “trade secrets,” … and thus are exempted from release under the Freedom of Information Act
1boringoldman describing Marty Keller lead author of Study 329
There’s a deposition of Martin Keller about Study 329 available on the Internet. It’s 125 pages long, but easy to summarize: “If you think I did something wrong, you’re wrong because I’ve never done any wrong things, and I don’t specifically remember anything I’ve ever done.”
Ivan Oransky, of the Retraction Watch blog, put it trenchantly:
“GSK agreed to pay a $3bn fine and you’re [Editor of JAACAP who published 329] saying you had completely different results? Great. Show me.” Oransky described the journal’ silence as part of the “typical scientific playbook.” “It has been our experience that journals and researchers and institutions can be incredibly stubborn about failing to retract a paper”.
Now the profession itself is under attack in Congress, accused of allowing this relationship to become too cozy. After a series of stinging investigations of individual doctors’ arrangements with drug makers, Senator Charles E. Grassley, Republican of Iowa, is demanding that the American Psychiatric Association, the field’s premier professional organization, give an accounting of its financing. NYT July 2008
The BMJ’s mission is to lead the debate on health, and to engage, inform, and stimulate doctors, researchers and other health professionals in ways that will improve outcomes for patients. We aim to help doctors to make better decisions.
I was interested to know whether the reader should just believe that the Keller 2001 paper was ghost written or whether there is some kind of proof of this? How did the authors find this out/know?
If you publish this covering letter, GSK will be put in an interesting position. If they don’t already realise it, every effort on their part to draw attention to mistakes we have made on the basis of publicly available data that others can view will draw attention to the benefits of data access and the role of companies in denying access.
“It is no longer clear to us if you still wish to publish the paper. If you are going to reject the paper, we want to know that within a week.”
In reply to BMJ claims about our “claims” made about adverse events:
Please identify any claims that we make that are not supported by the data, and we will be happy to review
In reply to BMJ claims about “the tone of the paper”:
“We think we have been extraordinarily neutral in the circumstance, but if you indicate each episode of non-neutral language, we are prepared to have a go at flattening the tone further — from pancake to Kansas. (Kansas is flatter).”
BMJ ask that we specify what was done to make the coding reliable, unbiased and reproducible … There is not a single other article about a clinical trial in the published literature that specifies these steps. BMJ have a primary concern — shielding the journal from a legal action …
BMJ 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 BMJ’s links with GSK.
New England Journal of Medicine
The aerial view of the concept of data sharing is beautiful, Jeffrey Drazen, editor of NEJM wrote.. [but] there is concern among some front-line researchers that the system will be taken over by what some researchers have characterized as “research parasites.”
The term research parasite was quickly hashtagged and became an academic social media hit. Lots of people identified as research parasites, perhaps just to annoy Drazen.
Iain Chalmers, Ben Goldacre and Sense about Science
Today’s GSK has shown moral and scientific leadership that puts to shame many in the academic community.”
Study 329 Restored
As with most scientific papers, Keller and colleagues convey an impression that “the data have spoken.” This authoritative stance is possible only in the absence of access to the data. When the data become accessible to others, it becomes clear that scientific authorship is provisional rather than authoritative.”
Superficial scratches or suicidal?
He has cut himself in response to the voice on three occasions in the past six days. On the back of his hand he has carved a cross with small adorning cuts. On his forearms he has made 10–15 cuts each about six inches long. On his upper arm are three additional cuts.
“Nothing was ever pinned on any of us,” despite various trials and investigations, he said. “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?”
“We merely supplied the patients”. This statement on the disclosure form by one of the authors of the notorious Study 329 pretty much sums up exactly what is wrong with today’s industry sponsored research.
The Bitter End
Against a background of over 30 negative RCTs, including 7 negative Prozac trials, and no positive trials, prescribing antidepressants to distressed teenagers should have come to a full-stop but, while antidepressant use for teenagers briefly stalled in 2004 by 2018, aside from contraceptives, antidepressants had become the most commonly prescribed drugs in adolescent girls generally.
Study 329 is a story of the greatest failure in medicine. But the same story can be old about almost all drugs and for people of all ages.
Pharmaceutical companies make chemicals. We are the laboratories in which medicines are made. Medicines are chemicals used for a social purpose — to treat conditions that we define as diseases. Drugs cannot come into being unless we as healthy volunteers and later as patients in clinical trials agree to take them to see what happens. Without our participation, there is no drug.
But the research in which we once participated has morphed from scientific studies whose data were in the public domain into company trials where the data have been sequestered. We are never informed about this sequestration of our data. We assume that we are participating in science, and that the data arising from the risks we take are broadly available to scientists, as they once were.
This is not just about the legal consequences of hiding data. Faced with a choice between believing you when something goes wrong on treatment or believing the scientific evidence, nine out of ten doctors will believe the “science.” And possibly because they know there is something wrong somewhere, they will get nasty with you — sometimes extremely nasty. Many of us sense this and don’t dare to raise the fact that the treatment is not suiting us. When you come up against it, it’s like the Great White shark in Jaws appearing right beside your boat – a real shock.
At present, things are getting worse, not better. It’s something doctors need to realize because if drugs work marvellously well and have no side effects, there are cheaper prescribers even more likely to keep to the guidelines. Unless doctors can make a case that their job is to bring good out of the use of a poison and that this requires a good and honest relationship between us and them, they will soon be out of business in all but name.
Copyright © Data Based Medicine Americas Ltd.
I’m always keen to buy a new Healy book (I learn so much!) but wonder if this book will be made available via book depository.
Followed the links and ended up in amazon went to order two books the cost came out to $US33.50 postage for a $US16.95 book. (not including gst. )
Two books plus postage came out to $NZ134.
hmm I will have to have a think about this one. However Im sure going from past experience it will be another book I wont be able to put down.
Was aware of the shameful ‘nothing been pinned on us’ quote from Keller but didn’t know of his Houdini escape gloating quote.
Is there any way of buying ‘Children of the Cure’ online without using Amazon?
Bezos is quite rich enough already, and treats his workers (sorry, ‘associates’) appallingly
I share your view. The problem is mainstream publishers, even university press publishers, are now too scared to publish anything that covers the adverse effects of drugs. This is part of the reason for Samizdat – to ensure that books like this get published. Amazon offers a distribution platform. A lot of bookshops are tied into publishing houses and won’t take books published through Amazon but some do – or at least will order for you. I don’t have a list.
Its a case of being caught between two evils.
“A whole new group of patients – children” Shelley Jofre
The End of the Beginning …
Dear Dr. Garnier
“He was much more concerned about the welfare of the company”
“Seroxat was the main factor in the four deaths”
Trail Of Paxil Suicides Leads
By Evelyn Pringle
16 February, 2007
Because publishing the study in full would have resulted in a negative impact on Paxil profits, Glaxo decided to find other ways to market Paxil to kids. “Exit the doctors,” Ms Jofre says, “enter the spin doctors” to help promote Paxil as safe and effective for teenagers.
“The inconvenient facts,” she explained, “would be buried and the marketing people would spread the good news to doctors around the world.”
According to Ms Menzies, Glaxo found ways “to blow up out of proportion the supposed benefits in Study 329 and downplayed the negative findings.”
She explains that by using opinion leaders in the field, academics who everybody looks up to, doctors would be far more influenced to prescribe Paxil than they would be if approached by Glaxo salespersons.
Secrets of the Drug Trials
Just watch this …
I don’t buy anything on Amazon which is a conundrum in this instance One of their tricks to make money out of customers is to ‘force’ them to spend £50 before being able to write a review of a book. But, hint hint, for those who do, understandably , it is possible to write a review to promote a book or to write a critical review of books on the same page as long as keeping to their guidelines which are pretty flexible. . It is possible to do it by going into the paperback version which has a message ‘look inside!’ to get a limited but useful pre-view. I don’t think a review can be used for the kindle version but that doesn’t matter as it can still be put on the paperback version Main thing being Amazon has a customer who spends. It would be a great Samazdat action if there was a way around it – I asked some ‘alternative’ including second hand booksellers but they weren’t willing . Impossible right now anyway due to Covid.
We’re working on a work around – watch this space
Patrick D Hahn
5.0 out of 5 stars Relentless
Reviewed in the United States on May 31, 2020
GlaxoSmithKline’s Study 329 of Paxil claimed the drug was “safe and effective” for the treatment of major depression in adolescents, even though their own data — data no one else was allowed to see — showed the stuff was totally ineffective and drove the kids crazy to boot. It took fifteen years for all this to come to light, thanks to the efforts of psychiatrist David Healy and a small group of colleagues who were relentless in their drive to uncover the truth. This is a story that needs to be shared as widely as possible.
Want to read it, don’t want to buy it on Amazon.
Looking forward to the work-around.
I have perhaps ‘fallen victim’ to the hype..I have purchased two books as per Dr David Healy’s Post but I wonder are we ‘Oh Lord what fools these mortals be’ -Shakespeare
It will be interesting to see how you get on with handing one copy over to a doctor or whoever! I’m also in the process of ordering 2 copies – but a doctor will not have the pleasure of throwing a copy back in my face though!
Delivery to be 8th June 2020
Got Phone Call yesterday lunch time 5th June 2020
Delivery Driver confirming he is at Postal Address
Thanked Delivery Guy
Said I would pick up in an hour
Realised I was boxed in
191 Kia had parked into my space
Whilst his 4 x 4 Car was also parked on Yellow Lines
Had to wait whilst this Shmuck cruised slowly back to his car
His dark glasses showed – Pharma Perp!
I got my package. Pleased
Second book will be part of my ‘Statement of Claim’ in High Court Proceedings that many are busy trying to silence the Truth…
If nothing else I am pleased to support the writing of This Book and support of Samizdat Health 2020.
Captivating link from Carla, over on RxISK
The killing effects of these drugs
Children and adults and the Psychotropic Drugs, which led to a violent end to themselves and others. It is certainly not typical of a teenager to become so violent. This is a short list of some of the most violent crimes worldwide. Longer lists can be found at SSRIStories, and SSRI-UKsupport.
Murder and Crimes and the drugs they were taking
A spokeswoman for GlaxoSmithKline said: ‘Violence and aggression are a feature of anxiety and depression disorders. Seroxat will reduce levels of these, and neither violence or aggression are withdrawal symptoms.’
Charges dropped after report links Seroxat (Paxil in US) to threatening behavior
August 2003 Observer
“I have personally reviewed all the data, and from my personal studies I say there is no credible evidence that Seroxat causes suicide.”
Hundreds to Sue GlaxoSmithKline in UK
Congress Hammers FDA Over Handling of SSRIs
Officials of the U.S. Food and Drug Administration (FDA) first suspected an increase in suicidal thoughts and behaviors linked to antidepressant use in children and adolescents in March 1996—eight and a half years ago. Yet no apparent action was taken by the agency until a pattern seemed to emerge in the first half of 2003.
During a dramatic pair of hearings before the House Energy and Commerce Committee’s Subcommittee on Investigations and Oversight last month, FDA officials were repeatedly put on the defensive as to whether there existed a conspiracy to cover up the link between the drugs and harmful behaviors.
Unsatisfied with answers and explanations from agency officials during the second hearing, at least two committee members, Rep. Diana DeGette (D-Colo.) and Rep. Bart Stupak (D-Mich.), threatened to introduce legislation banning the prescribing of antidepressants to anyone under age 18 “if the FDA didn’t act forcefully and swiftly to protect America’s children.”
“Just like with the S.E.C,”Mr. Spitzer said, “we’re asking where has the F.D.A. been all these years when clinical data has been hidden from public scrutiny. They have simply failed to confront the problem.”
Thanks to Carla,
The links, within the links, are definitely worth looking at …
Well researched! Thank you – I will read them all over the coming days. Evidence is suppressed & oppressed to criminal lengths in Ireland. Where do we go? Who do we trust?
The collusion betwen the two?
We are meant to report all corruption to Gardai..
But what does one do when one knows that Gardai are involved in covering up for Doctors who do harm and for Pharma who do the corruption
So we now have the THREE main oppressors in Ireland.
It will be interesting to see how far I go but Pharma & HSE are now worried how far I have got – They haves brought in the Cyberknife criminals/abusers wh can work 24/7 on your body – remember what you read about the great work that cyberknives can do – turn that into The Reverse and think how criminal they are in their torture to the Patient Whistleblower and how much can she take…Noting that Gardai at the most senior level are are involved in cover up of such torture to The Patient Whistleblower….19th June 2020
Best of luck Teri. It would be great to have another timeline, in the months to come, showing how useful your purchase of the second copy had been.
Whilst in lockdown, I’m having a serious thought about who would be likely to make best use of my second copy. My thoughts so far include using both copies on a ‘library use’ (fortnight or face fine!) type of basis. In my opinion, anyone who tunes into this book will not need anywhere near a fortnight to complete it therefore the books would soon be ready for the next couple of readers. In the meantime I shall continue adding names of readers to my list!
Any book that is privately published has to estimate a print-run, and naturally, the publisher, in this case Samizdat, would hope at least to ‘break-even’…
You have to decide if you would like to support Samizdat, then you have to decide if GlaxoSmithKline have crossed death-defying boundaries, then you have to decide if a few pounds here and there are worth disembowelling the whole false edifice of the antidepressant scandals.
This lot, for example, didn’t watch the film, and, simply put, made complete fools of themselves….
What’s going on Here?
Study 329: MK, HK, SK and GSK
The Letter below from Marty Keller and colleagues was sent to many media outlets, to retraction watch, and to professional organizations on Wednesday. Paul Basken from the Chronicle for Higher Education asked me for a response which I sent about an hour after receiving the letter. This response is from me rather than the 329 group. This and other correspondence features and will feature on Study329.org.
Leemon McHenry says:
September 18, 2015 at 1:42 pm
Reply to Keller et al.
If Dr. Keller was principal investigator in study 329, wasn’t he responsible for verifying the data? Dr. Keller stated in his sworn deposition that he did not do so because he doesn’t like to review pages and pages of numbers. This, of course, distinguishes the authors of the 2001 JAACAP paper from those who devoted themselves to the reanalysis of study 329. At least, Le Noury et al. studied the patient-level data rather than trusting GSK’s statisticians. The RIAT reanalysis is a pioneering work that paves the way for similar treatment of all industry-sponsored clinical trials published in the medical journals.
‘a real piece of work’ …
Starting at the beginning just picking out a few things 208 young people were left in the trial
as a high number had withdrawn .plus I person was withdrawn by the researchers. leaving 207 not 275 – a tiny number considering the intention of massively using the drug and the chaos they caused.. Of these %24 on placebo dropped out with the researchers claiming the reasons for some to be having adverse effects to the placebo was mysterious to them – so why did’t they ask? And include the results. I don’t understand why a placebo was necessary when the investigation was between two drugs. To me it means there were even fewer in a genuine trial.
It’s shame the youngsters themselves were not involved in the write up so they could verify or not the codes assigned to them when they could so easily be skewed by corrupted researchers or simply incorrect in the young persons’ view.instead they were being used just as research fodder.
Even if other researchers are given access to data subsequently there is no guarantee that it will be honest unless ‘participants’ are asked to consent or not to it’s use after having validated it – and are proactively given copies of any publication to make sure it isn’t altered for any reason – . And who can give consent to being contacted individually again. People are less trusting these days maybe but there are still high levels of altruism regarding research – more openess would make it more appealing maybe and certainly more ethical..
The thought of ‘research parasites’ is interesting , it is similar to something Ii have picked up on whereby psychoanalysists are attching themselved to neuropsychiatry -some retired ex clinicians are conducting pseudo research really as a hobby – and being referred to as ‘theorists’. They have access to their old departments and friends and colleagues who share research and so on with them and then provide useful references to back what are amateur publications. It’s shabby.
To get nowhere near the end of the astonishing book – the issue of reviewing is interesting. How many reviewers does it take before a paper is no longer authentic. If authors comply with so many requests to make changes how reliable can it be One way around it might be for the original submission to be published – then or together with the reviewers desired amendments – let readers make up their minds. The BMJ it seems did’nt like the ‘tone’ of some letters exchanged – they were used to most who make submissions being submissive I guess – bu they come across likecall handlers who attempt to push callers into compliance or they’ll put the phone down on us – or in the case of journals make sure you don’t get published.
Looks like many of those who have been exposing the truth are getting older – hopefully there will be enough of the next generation to carry on the baton (Not writing anybody off just yet of course!)
Have just finished reading – such a detailed account. The patience needed to keep the BMJ sweet for all those months must have been very trying indeed. Many would have given up and taken their work away! So many snatches of stories already heard, names that we’ve heard over the years, all came together to make complete sense. A complicated, tense situation which ended with the desired outcome.
Over all, I’m not sure how many will labour through the detailed ‘329’ sections unless they have prior knowledge/interest in that particular issue. I hope that no one gives up without reading the remaining chapters of the book ( even if they leave out the ‘329 section’) as the information either side of that are well worth reading.
On page 245, you state that the “usual” way of dealing with a suicidal person ( of thoughts and actions being the individual’s responsibility) is not the correct reaction when SSRIs are in the picture. I found that to be a very important couple of sentences. However, I would like to know what IS the correct reaction in such cases – a change of SSRI with a month’s supply handed out? An increased dose – again handed out as a month’s supply? That, unfortunately, in my experience is how it does happen and obviously CANNOT be the right answer. Decreasing the dose slowly, I assume, would be the way forward, coupled with an explanation that the medication is creating the situation. From our experience, the individual is way beyond being responsible for their own thoughts and actions at that stage. Keeping the person and others safe becomes a full-time job during such an episode. Generally speaking, doctors have such a problem accepting the awful reactions SSRIs can create and always turn the responsibility inwards to the person’s ‘personality’. Is it possible that doctors need better guidance on seeing and understanding the difference between suicidality in depression and SSRI – induced suicidality? I cannot see a way forward in getting doctors to support in withdrawal if they don’t even understand that everything about SSRI reactions take such a different path.
Looking forward to the next book now!
I think we should spend a lot more time talking about ‘this book’.
There is no doubt that David Healy’s understanding of drugs and their histories is second to none. Plus, he has been an expert witness in high-profile court cases.
Plus he has been heralded around the world on numerous US/UK lecture tours, documentaries, and, latterly, some rather silly UK programmes, where he lands on the cutting room floor….
My doctor had her knee on my neck for over two years.
I was hyperventilating so badly, I could hardly breathe
‘an inconvenient truth’ …
Posted on Friday 21 December 2012
It’s always funny when small children try to play hide-and-go-seek by covering their eyes, but when grown-ups do it, it loses its charm. That’s what Dr. Andres Martin’s has done in his response to Dr. Juriedini’s request that the Journal of the American Academy of Child and Adolescent Psychiatry retract the 2001 Study 329 article. They had a perfect chance to do the right thing. They declined to take it.
In this particular case, there are no facts in question. It was a negative trial, declared negative by the people who did it. The paper was ghost-written and reviewed by the sponsor before any of the twenty two authors ever saw a manuscript. The science was jury-rigged to imply a positive outcome where none was supported using well-documented sleight of hand. None of that is speculative. And the article has been a centerpiece for court settlements worth billions of dollars. Yet the Journal of the American Academy of Child and Adolescent Psychiatry says “the Journal editors found no basis for retraction or other editorial action.”
One can only conclude that they found this article to be an inconvenient truth, and that Dr. Andres Martin and his colleagues in the American Academy of Child and Adolescent Psychiatry believe that acknowledging that truth would do more harm than good [or maybe even found a way not to see the truth at all, though it’s hard to imagine how]. Sooner or later, this whole tawdy saga is going to find its way out of the blogs and courtrooms and into the full light of day. And the question that’s going to be asked is why didn’t Medicine itself deal with the problem? Why didn’t the Journal itself retract the misinformation once they knew about it? Why didn’t the industry sponsor itself call for the retraction as part of their settlement with the DOJ? What possible reasonable reason could there be for leaving a paper that is a lie in their journal without even an expression of concern, much less a retraction? And there aren’t going to be any believable answers.
Hide and go seek; let’s hope this book, runs and runs ….
Thank you so much for putting Study 329 into book form! Kindle doesn’t work for me. The book was excellent as your books generally are. Panorama also did an excellent job covering Paxil/Seroxat Study 329 and it was riveting. The levels of corruption within the pharmaceutical company that goes back more than a 100 years is staggering (Pharma: Greed, Lies and the Poisoning of America). Yet, unfortunately I see nothing changing for the next hundred years, if humanity is even still intact by then. According to what I’m seeing technology/technocracy is going to make sure that the human mind, our thoughts, feelings & behaviors as we knew them will no longer belong to us, but to the big pharma cartel through the use of electroceuticals rather than pharmaceuticals. [https://www.anthonypatch.com/entangledmagazine/pdf/free/ENTANGLED_MAGAZINE_Volume4-6.pdf]
I thank you from the bottom of my heart for your Youtube videos of your many educational lectures, speeches, podcasts, and articles exposing SSRI’s countless harms, so many deadly. As a psychiatric drug survivor I too had a front row seat to the horror show that I did not sign up for, yet received, as so many others did too. The theater was filled to capacity.
You’re a very much appreciated man here in Michigan, USA.
No time for stodgy: Crusading editor aims to shake things up in science
‘She’s clever, she’s lovely, she’s charming’ – who is she? yep – Fi Godlee
It takes extraordinary expertise to avoid finding it.”
Dr Fiona Godlee, BMJ editor-in-chief, said publication of the reanalysed data from study 329 “sets the record straight” and “shows the extent to which drug regulation is failing us”. She said it also showed that the public and clinicians did not have the unbiased information they needed to make informed decisions.
She called for independent clinical trials rather than trials funded and managed by industry, as well as legislation “to ensure that the results of all clinical trials are made fully available and the individual patient data are available for legitimate independent third-party scrutiny.”
Health Minister orders review after study links antidepressants and youth suicide. The Sydney Morning Herald, 14 June 2020: