Frontiers in Psychiatry: Elena Vicario
Some weeks ago, following the publication of an article by Andrea Cipriani in their journal, Jim Gottstein and I wrote to the Frontiers in Psychiatry Bigwigs asking for the Cipriani article to be removed – Meta-Analytic SuperSpreader.
They have since replied Vicariously through Elena Vicario.
From: Editorial Office <editorial.office@frontiersin.org>
Date: Tue, 3 Nov 2020 at 04:34
Subject: Re: Letter re Retraction
To: David Healy <david.healy54@googlemail.com>
Dear Dr. Healy,
I am writing with an update on our investigation into the concerns raised about article “Antidepressants in Children and Adolescents: Meta-Review of Efficacy, Tolerability and Suicidality in Acute Treatment”.
Following the assessment of the journal Chief Editor, the methodology and systematic protocol used in the article is in line with PRISMA guidelines and the articles included in the systematic review are clearly outlined and available for consultation by the readers. In addition, we note that the conclusions drawn by the authors from the meta-analysis are cautious and broad.
We recognize the importance of the subject matter and thank you again for bringing this to our attention.
Best regards,
Elena Vicario, PhD
Senior Manager, Research Integrity: Elena Vicario, PhD
Frontiers | London Office
12 Moorgate
EC2R 6DA
London
Most people reviewing the issue of the journal, likely Elena too, figure matters are pretty balanced overall with all other articles skeptical about the use of antidepressants for children and teenagers and a hard hitting editorial from Michael Hengartner to make matters absolutely clear.
This not however how the system works. Decades back, at academic meetings, in what seem like more innocent times, pharmaceutical companies were good at having someone talk about CBT, or another therapy, for depression on a program mostly dedicated to selling some antidepressant.
It looked like there was a degree of balance you might expect from a scientific meeting but the idea of having a therapist in practice came closer to the vaudeville model of having a comedian come on stage in between striptease acts. The customers needed a chance to draw breath and relax and perhaps an excuse to tell people where they had been – they weren’t there for the comedian.
Its the same in this case, even though there are eight or nine comedians and only one stripper. The internet and open access makes it possible for industry to distribute the Cipriani article far and wide and for free and even to be able to point to its publication in a virtuous setting – almost nothing but comedians – while doing so. The eight or nine other pieces will go nowhere fast.
There is probably an appropriate riff on the old line about lies getting half way around the world before the truth gets its boots on.
There is another unsettling angle. The editors are essentially blaming Michael H. They’ve deferred to his judgment call as to whether there is an issue here.
It’s what Jose-Mario Bergoglio, Donald Trump, Joe Biden, Emanuel Macron and any other ‘leader’ you care to mention would do. When asked about ghost-writing combined with a lack of access to trial data, something that is not acceptable in any conceivable scientific universe, the fall-back line is ‘we’re not scientists, we will check with EMA or FDA or MHRA or whoever’ and ‘we’re sure you will understand we have no option but to do as they advise us’. See The Perfect Killing Machine.
To be absolutely clear, my problem if I were one of the comedians in this show is not that there is a paper offering another point of view, its that there is a paper masquerading as science, which is just not science. A cuckoo in the scientific nest.
Its a bit like if in the old Vaudevillian days a Drag Queen had done a striptease. The audience would likely have seen this as a comic act. These days apparently Drag Queens do striptease’s in front of children – for equality’s sake. And, besides what their advisers say, for equality’s sake Jose and Joe and Emanuel likely feel they cannot prevent a Cipriani article (of this type) being passed off as science.
In this case Michael Hengartner has no option but to take the blame. Once the requirements of the algorithm are satisfied, two positive reviews, there is no option but to publish.
There was a notable fuss last week about a Danish Mask Trial, which failed to show a convincing benefit for Masks in the current pandemic – perhaps because it didn’t ask the right questions. It was nevertheless a trial – the only trial of Masks in a time of Covid. When several doctors linked to it on Facebook pages, they found their link was blocked on the basis that they were posting misinformation.
A lot of mostly male docs were offended – how dare Facebook do this. But there is no-one doing this to anyone. The algorithm is doing it.
It hasn’t fully drawn all power to itself – there is still a missing ring, a precious, that needs retrieving. Soon now…
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Strip the Willow..
“What would have happened if this data were available 15 years ago when the study was originally published?,” he said. “Would the black box warnings from the FDA have come earlier?”
Welcome to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) website!
PRISMA is an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses. PRISMA focuses on the reporting of reviews evaluating randomized trials, but can also be used as a basis for reporting systematic reviews of other types of research, particularly evaluations of interventions.
“There is an increased risk of suicidality in pediatric and adolescent patients given antidepressants like paroxetine,” GSK said. “This is widely known and clear warnings have been in place on the product label for more than a decade.”
Doshi argued, however, that the case showed why full patient data should published alongside original scientific analyses.
Analysis of GSK’s Seroxat antidepressant
https://www.reuters.com/article/us-health-glaxosmithkline-seroxat-idUSKCN0RG33R20150916finds key data was held back
“This is fundamentally about correcting the scientific record,” said Peter Doshi of the University of Maryland School of Pharmacy in the United States, a BMJ associate editor.
The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration
https://www.bmj.com/content/339/bmj.b2700
and help editors judge the merits of publishing reports of new studies.
It’s clear to me that Frontiers would not have allowed Michael H. to publish that special issue without including a “mainstream” pro-SSRI article from the likes of Cipriani. That sucks. It also sucks that most journals would not touch those other articles, whether they were offset by a Cipriani-type piece or not.
What’s not clear to me is that Cipriani needs Frontiers to give his stuff the right touch of independence. Or that publishing in Frontiers, side-by-side with all those brave critical voices, has gotten his article noticed or respected in a way it would not be otherwise.
Face it: Guys like Cipriani can grab the megaphone any time they want it. His last article, the meta-analysis that said “Antidepressants Work?” It was trumpeted around the world. Its reach was amazing. And very few critical voices were heard, either, questioning his methods, integrity or scientific cred. In contrast, his 2020 article has barely made a peep. If not for Twitter and your column, I would never know it existed.
That’s just how Cipriani wants it, I think. He doesn’t need Frontiers at all–at least not to have his stuff read, or respected, or posted for free online. So why did he publish there? Because he WANTED this article to get as little notice as possible—while still being able to say it got published. While it carries a “respectable” message (that Prozac is proven to help kids) it also says embarrassing things about a few other products. Things he has NO urge to repeat on the Morning News.
Why does this even matter? Here’s why: Those articles by Dr. Julie Zito are important. Especially to poor kids, Black kids, kids in foster care, and any grownup who cares about any kid like that. I’m aware they will never be published in the BMJ, or talked about on CNN or NPR. But without Michael H’s effort, I would never have seen them at all. And I’m very grateful I did.
Does Dr Zito need to wake up and realize she is just being used? Does she think she’s making a difference, when really she is only making Cipriani smell a bit sweeter? Should she just stop? I say NO.
Sometimes the answer really is YES. Pharma really does need earnest psychotherapists to take the smell off its public-awareness campaigns. I would be the first to tell those therapists: Don’t do it. Don’t go on the Oprah Show with the nice doctor who shills for Pfizer or GSK. You think you’re getting this great message out, but you’re only being used.
But in this case I couldn’t honestly tell Julie Zito she’s only helping to increase drug sales or save Dr. Cipriani’s good name. Cipriani is using Frontiers to bury his article, not promote it – just like Frontiers is using Cipriani to cover its own ass. The other authors are NOT like the comics who make the strip-tease show look respectable (thus keeping the cops at bay). And they should NOT just stop. I want to hear more.
Dishes of the Day – with ‘comedic’ elements..
Royal College of Psychiatrists
@rcpsych
@ShelleyJofre, thought you’d be interested in this story today: Anti-depressants: Major study finds they work http://bbc.co.uk/news/health-43143889…
11:40 AM · Feb 22, 2018
https://fiddaman.blogspot.com/2018/02/media-frenzy-antidepressants-are-safe.html#.X7_l485xc2w
recovery&renewal
@recover2renew
·
13m
Like this perhaps?
Pariante’s Dish of the Day
https://fiddaman.blogspot.com/2019/04/pariantes-dish-of-day.html#.X7_fsc5xc2x
@samizdathealth
@DrDavidHealy
·
22 Feb 2018
The Cipriani paper discussed today is junk. It is based on ghostwritten papers with no access to the data. No one – not MHRA or FDA have had access – none of the notional authors of these papers have had access – none can let an independent expert see what the data shows
‘Here’s the death warrant …
in Psychiatry
THIS ARTICLE IS PART OF THE RESEARCH TOPIC
Antidepressant Prescriptions in Children and Adolescents View all 9 Articles
SYSTEMATIC REVIEW ARTICLE
Front. Psychiatry, 02 September 2020 | https://doi.org/10.3389/fpsyt.2020.00717
Antidepressants in Children and Adolescents: Meta-Review of Efficacy, Tolerability and Suicidality in Acute Treatmen
Katharine Boaden1, Anneka Tomlinson1,2, Samuele Cortese3,4,5,6 and Andrea Cipriani1,2*
1Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, United Kingdom
2Department of Psychiatry, University of Oxford, Oxford, United Kingdom
3Center for Innovation in Mental Health, Faculty of Environmental and Life Sciences and Clinical and Experimental Sciences (CNS and Psychiatry), Faculty of Medicine, School of Psychology, University of Southampton, Southampton, United Kingdom
4Solent NHS Trust, Southampton, United Kingdom
5Division of Psychiatry and Applied Psychology, School of Medicine and National Institute for Health Research MindTech Mental Health MedTech Cooperative and Centre for ADHD and Neurodevelopmental Disorders Across the Lifespan,
We conducted a meta-review of the existing literature on RCTs in children and adolescents across a number of disorders (see list below). We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) approach (5). The protocol of this meta-review is available online (https://www.psych.ox.ac.uk/team/andrea-cipriani).
In conclusion, the results from our analysis of aggregate data should be contextualized, incorporating patient’s values and preferences (50). Treatment decisions should be tailored to patients on an individual basis, so we recommend clinicians, patients and policy makers to refer to the evidence provided in the present meta-review and make decisions about the use of antidepressants in children and adolescents taking into account a number of clinical and personal variables (51). The available evidence base is not enough and randomised data should probably not be the only source of information. One way forward is to use comparative analysis of individual patient data in combination with high-quality real-world data to identify effect modifiers and prognostic factors that can inform tailored treatments and shared clinical decision making across a number of psychiatric conditions and interventions (52). This will be a material move towards a real precision-psychiatry approach that may improve the clinical outcome (and quality of life) of our patients (53).
Data Availability Statement
The datasets generated for this study are available on request to the corresponding author
Received: 17 January 2020; Accepted: 07 July 2020;
Published: 02 September 2020.
Edited by:
Michael P. Hengartner, Zurich University of Applied Sciences, Switzerland
*Correspondence: Andrea Cipriani, andrea.cipriani@psych.ox.ac.uk
1 Comments – Susanne.
There are so many serious limitations to this study as highlighted by one of it’s critics Professor David Healy (see David Healy blog) and the reviewers editor . And indeed the authors of the article themselves. The study was passed although it deviated even from the tight PRISMA guidelines in some respects. Would it not be better for the reputation of Frontiers and trust in published research to retract the paper? The very serious potential harms to the young people are so well documented by now any publication needs to be open to critical appraisal and revision . Their is no shame to admitting errors have been made in either the research itself or the decision to publish – if remedial action is taken, That’s ‘good’ science’. An issue which may have profound consequences is that GPs are the people who do most of the prescibing. Very few have deep understanding of drugs and rely on research which in turn informs NICE. Poor research can have serious impacts on real lives.
Where does he find the time?
Andeas Cipriani retweeted –
The Mental Elf
@Mental_Elf
·
Nov 24
Fluoxetine & fluoxetine with CBT were more effective than placebo controls in young people with depression.
‘I have been working closely with world class academic institutions (Universities of Bristol, Cambridge and York in the UK; Universities of Ulm and Munich in Germany; University of Ioannina in Greece; Universities of Nagoya and Kyoto in Japan; University of Cape Town in South Africa) and important organisations, such as the National Institute for Health and Clinical Excellence in the UK, the Istituto Superiore di Sanità in Italy and the World Health Organization (WHO) in Geneva. Together with the Department of Mental Health and Substance Abuse at WHO I have co-authored a manual on psychopharmacology, which provided evidence-based information to health care professionals in primary care especially in low- and middle-income countries. This manual is part of the Gap Action Programme of the WHO and is distributed by WHO as a reference source to assist physicians working in the primary health care through increasing their knowledge and improving their routine clinical practice in using evidence-based medicines for mental disorders.’
I am currently Editor in Chief of Evidence-Based Mental Health. I am also on the Editorial Board of the Lancet Psychiatry and the Australian and New Zealand Journal or Psychiatry.
(Evidence-Based Mental Health is a quarterly peer-reviewed medical journal covering all aspects of mental health. It is co-owned by the BMJ Group, the Royal College of Psychiatrists, and the British Psychological Society.)
And more recently A C is on executive cttee of coll of psychs
‘We aim to promote, facilitate, and stimulate interest in high-quality clinical research and teaching.’
Executive Committee
Member Year of joining Position
Prof. Andrea Cipriani 2020 (E) Committee Member
The Patient Experience Library
https://www.patientlibrary.net/cgi-bin/library.
https://www.patientlibrary.net/imgmag/226577.png
Anthony McQuillan and Miles Sibley – Founders
We have had many good experiences as NHS patients. A couple have been life-saving. We want the NHS to continue being the best it can be, and we believe that learning from patient experience is key to that.
The Patient Experience Library started with this thought: if clinical research databases are feasible, why not a patient experience research database?
Clinicians have access to huge databases of medical research. Their training and professional development are informed by research, and their practice is evidence-based. Historical research is held in archives, to preserve organisational memory and remind us where current knowledge comes from.
A patient-centred NHS should take patient experience evidence just as seriously. That’s why we created the Patient Experience Library as the national evidence base and archive for patient experience.
The library content relates exclusively to patient experience and public involvement in the health and care sector. For details of how we select content, please see our Terms page.
The Team
The library is hosted by Glenstall IT, a small software developer with 20 years’ experience in tailor-made information systems for the public and charitable sectors.
We also work with a small circle of freelancers who help us with cataloguing, graphic design and website development.
From a wider circle of supporters in NHS Trusts, universities and patient voice organisations, we get ideas, advice and occasional challenges. We are grateful for all of it!
Last but not least, the thousands of people who read our newsletter and visit our website help us to know that we are doing the right thing, and give us the encouragement to keep going. Thank you!
And by the way…
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Our principles
We don’t have a complicated mission statement. We just work to a few basic principles:
Learn from patients. A patient-centred NHS learns from patient experience. We don’t need to do “doctor knows best” any more. We’re in this together.
Work from the evidence. Medical evidence helps us to understand disease and how to treat it. Patient experience evidence helps us to understand service quality and how to improve it. Let’s put both sets of evidence on an equal footing.
Feedback is a gift. People share their experiences because they care, and want the NHS to be the best it can be. We should listen carefully.
Cherish it all. Patient experience evidence has been collected since Community Health Councils were set up over forty years ago. But no archive was ever created, so knowledge accumulated over decades was allowed to vanish. We’re making sure that won’t happen again.
the culture, and they need to set a lead in giving patient experience its rightful place in the evidence hierarchy.
Download report item url
Tuesday November 24th 2020
Strengthening patient experience evidence
“Patient experience must no longer be weighted least in the hierarchy of evidence-based medicine”. So said Baroness Cumberlege in First Do No Harm – the recent review of large scale avoidable harm in healthcare.
It is an important and powerful statement – but how do we push patient experience up the evidence hierarchy? Unfortunately, there seems little urgency in government, whose response has been described by Cumberlege as woeful.
Rather than wait for an official response, Care Opinion and the Patient Experience Library have decided to act on their own initiative, and act quickly. We have joined forces to integrate search functionality across both platforms – linking over 60,000 written reports on patient experience with more than 400,000 direct comments from patients.
The rationale is simple: if we want patient experience evidence to be better used, the first thing we have to do is make it easier to find.
There are longstanding barriers to getting access to patient experience evidence. These have been documented in our recent Inadmissible Evidence report. Breaking through those barriers has been a key part of the mission of both Care Opinion and the Patient Experience Library. Both teams have spent years building better, faster and more transparent ways to hear from patients. But until now, both have worked separately.
The join-up, like the rationale, is simple. Enter a search term (eg “XYZ Trust”) into Care Opinion and exactly the same term will be automatically entered into the Patient Experience Library. Users can switch between direct comments from patients, and structured reports and surveys relevant to their search term.
It works in reverse as well: a search in the Patient Experience Library brings results from both the literature and from patient comments on Care Opinion. Users can search by provider, by health condition or by service (eg maternity). Both platforms respond simultaneously to whatever search term has been entered, giving a two-way join up of direct comments and written reports.
The initiative brings together two tried and tested systems to create the UK’s biggest public evidence base on patient experience.
Baroness Cumberlege has challenged healthcare to take patient experience evidence more seriously. Government seems to be taking its time to respond. But in the meantime, Care Opinion and the Patient Experience Library are providing the basis for a joined up response right across the NHS.
Keep up to speed with the latest and best evidence on patient experience and patient/public involvement.