Editorial Note: This is the first of four Trick or Treat posts. They make most sense when read in conjunction with the RxISK Prize posts especially the series of 3 posts starting tomorrow.
In 1962 RCTs were added to the regulatory requirement for marketing medicines. This looked like a definitive stake through the heart of hucksterism. No longer would we have to carry crucifixes and garlic around to ward off blood-suckers hawking ineffective remedies.
In 1962 doctors were viewed as the key element of the regulatory apparatus. A great part of their input centred on descriptions of the harms medicines could cause. In addition to news of the latest advances, medical meetings were filled with symposia and medical journals with articles on the harms of treatment and how to manage them.
Company funded RCTs, which played a minor part in clinical practice, were all done in hospitals and universities and academics had the data.
Around 1980, as new drugs got weaker and weaker, company trials became multi-centered, coordinated by CROs, written up by ghost writers, with academic names attached afterwards. Everyone seemed as happy to enable this increasingly Hollywood like remake of medicine as they were to enable Harvey Weinstein. In the process access to trial data was lost.
Richard Smith
The key event that marked a transition to the modern world came in 1990, when Teicher et al published 6 cases of people becoming suicidal on Prozac in the American Journal of Psychiatry. According to all canons of causality, this paper offered undeniable evidence SSRIs can cause suicide. Hearings were convened to discuss the need for warnings.
But coincident with these hearings, BMJ published a meta-analysis of Prozac trials which Lilly claimed showed Prozac was not linked to suicidal events. This paper had been rejected elsewhere, The BMJ reviewer was lukewarm. But Richard Smith, BMJ’s editor, perhaps spotting an opportunity to push a new kid in town, Evidence Based Medicine, and its shiny new meta-analytic machine, published.
The published data showed an increased risk on Prozac, which Lilly and BMJ ignored, claiming nothing was statistically significant. Beyond this, Lilly played some of the tricks other companies later played – the small print shows the only placebo event hadn’t happened on placebo, so that technically there was a statistically significant infinitely greater risk on Prozac.
The follow-up letters told RS he had been naïve and wrong. But no one accused him of conflict of interest. What could be wrong with letting good quality evidence (even though he got that wrong) triumph over anecdote?
The way this played in public was that the stories of suicides on Prozac were tragic but anecdotal. The scientific evidence demonstrated that patients and doctors just can’t believe the evidence of their own eyes and ears. They have to be told what’s what by experts.
This dangerous and misguided message triumphed with regulators, and later in Courts.
This message killed any interest journals like AJP and BMJ had in taking Case Reports. Besides companies didn’t buy reprints of these, whereas they handed over huge amounts of money for reprints of ghost-written fraudulent RCTs with zero access to data, and even more for the best science money could buy – meta-analyses of these trials. Evidence Based Marketing was here.
Vampire Birth
A medicine is a chemical plus information. The information about the effects of chemicals should come primarily from practice on the ground, as in the early days of antibiotic or psychotropic drug use, or street drug use now, or from use of anti-retroviral combinations for AIDS in the 1990s.
When the benefit (not the harms) of a drug is equivocal, RCTs offer a means of examining efficacy ambiguities by focusing a magnifying lens on the ambiguity. They do this at a cost – ignoring safety. They are an act of hypnosis that gets investigators to focus on one thing while ignoring everything else going on around them.
If we ignore the ignoring of safety, as we do, we compromise rather than enhance safety. The harms vanish. The drugs that come out of an RCT have no shadow – no harms. They are vampire medicines. Put another way, all clinical trials (RCTs) cause harm but some can also be helpful. They pose the same problem AI and viruses do – if you create one, can you control the consequences?
Co-incidentally around the time vampires began to flourish, companies had poison symbols removed from medicines and from discourse. Any mention of the celebrated medical wisdom that all medicines are poisons in an expert report will now be met by company motions to have the word poison struck as prejudicial.
Conflict Free Blood
If there was a conflict of interest involved in linking trials to regulation, it was born from hostility to pharmaceutical companies.
But it’s now clear that even if done by angels, RCTs are the gold standard way to hide adverse events. Their intense focus on a primary outcome rather than the overall picture means that in even the most independent of studies they necessarily neglect adverse events. Companies overlay a lot of creative hiding on this neglect but this is an extra source of difficulties not the primary problem.
It was doctors who used to go around with stakes. Regulatory bureaucrats never did. RCTs have made life easier for the bureaucrats. According to the head of Britain’s MHRA, Ian Hudson, formerly of GSK, if events are not statistically significant – and strictly speaking as no adverse event is ever a primary outcome measure, they can’t be – then they aren’t happening. BMJ helped consign stakes to the twentieth century.
If there was a conflict of interest involved in the move from RCT to Evidence Based Medicine (EBM), it was born from hostility to companies.
EBM was not unreasonable in the early 1990s but it has created a bandwagon that is now out of control contributing hugely to a conversion of poisons into fertilizers to be sprinkled as extensively as possible, from as young an age as possible.
If there was a conflict of interest involved in using trials to create Guidelines in the 1980s, it was born from hostility to pharmaceutical companies.
But now, if NICE and other Guidelines, based entirely as they are in the case of on-patent medicines, on ghostwritten articles whose data is inaccessible, hadn’t been created, Pharma would have to invent them.
Drug harms that took a year or two to come to light in the 1960s take a decade or two now. In 2003 I predicted we were on our way to having lethal and common drug harms being contested years after the drug had gone off patent. In April 2017, the Dolin case in Chicago centred on just this issue – ten years after paroxetine had gone off patent.
These problems are not being contested because it is difficult to decide if a drug is causing a harm. They are being contested because of the power of companies to shut down debate in journals like BMJ.
BMJ’s news item about the Dolin trial missed the key issues, and it wouldn’t have occurred to them they had a role in the development of the situation.
Rosemary’s Baby
If it was just one drug harm that might be fine but drug wrecks may well now be the leading source of death and disability on the planet.
BMJ helps this happen in its educational forums by making it clear for instance that giving antidepressants to minors is just fine – no mention of harms.
BMJ helps this happen in its educational forums by making it clear for instance that giving antidepressants in pregnancy – now the most commonly used drugs in pregnancy – is just fine despite a doubling the rate of birth defects and miscarriages and behavioural abnormalities in the children of those taking them.
Buffy the Vampire?
Richard Smith was succeeded by Fiona Godlee, as free of ties to industry as RS once was.
Starting with RS and then later with FG, I and others had a series of articles on drug harms rejected with an increasingly bizarre set of reasons offered for the rejections, and increasing involvement of BMJ’s legal department.
These rejections have two elements. One is that across all journals anyone interested in a drug’s harms appears to be deemed ipso facto not just biased but perverted. It’s like wanting to publish something about sex around the time Dracula was written.
The second is anyone who has ever been in any way linked to a lawsuit as an expert against a company is deemed irredeemably conflicted.
For those of us working on the Restoration of Study 329, the review process became beyond odd. BMJ editors kept raising queries that had been answered and talking about conflict of interest. To which our response was everyone is biased but the way conflicts are overcome in science is to turn to the data – it’s the data that reveals whether someone’s latent bias is operative or not.
BMJ just didn’t get it. My formulation up till then was that a belief conflict of interest is of supreme importance is incompatible with recognizing the importance of accessing the data. This is still my view in the case of most of those who champion Sunshine.
But then a predicted legal review came into the 329 frame.
BMJ’s lawyers made it clear that if the journal had anything to do with Healy and Jureidini they would be providing GSK or other companies with grounds to claim bias and to sue. This is even though BMJ and GSK are partners in AllTrials and BMJ had a short while before featured Andrew Witty on its front cover as the acceptable face of pharma, helping GSK put a $3 billion fine behind them. Partnership?
BMJ is a business that can no longer support medical practice, a key part of which is describing harms. If a doctor is not prepared to go to Court to stand up for the harms she’s put her name to, she’s writing fiction – a bit like Bram Stoker saying in real life he doesn’t believe in vampires.
That the BMJ editor handling 329 was married to a man who worked for the law firm who defended GSK against a $3 billion Department of Justice fine didn’t seem to be any kind of conflict of interest. But then patients who have committed suicide or homicide on these drugs aren’t going to sue BMJ.
When it comes to on-patent drugs, BMJ provide news stories about medicine, medical entertainment. They are less likely than the NY Times or BBC to check the integrity of their primary sources.
BMJ and all our major journals have been turned.
Oh for the Blood of a Teenage Girl!
Water and drugs flow down even the slightest gradient unless there is something in the way.
The BMJ got involved in the Tamiflu saga in 2009 making it the basis of a “transparency” campaign – see Cisparency and Transparency next week – and later AllTrials.
Tamiflu is an efficacy story not a harms story. As Peter Doshi and Tom Jefferson accessed more and more efficacy data the efficacy of Tamiflu shrank to almost nothing. But it only takes 1% efficacy to sell pills provided there are no bumps in the way, and nothing has happened to dislodge Tamiflu from the top of the guideline heap for use in cases of Flu.
The story of antidepressants and teenage girls is even more remarkable. There are now 30 RCTs of SSRIs and related antidepressants for adolescents and children – 29.5 negative. Fluoxetine/Prozac is the most negative of the lot – there are 7 trials in which it has failed to beat placebo on the primary outcome measure including the two that led to its licensing by FDA and MHRA and EMA.
Surely not – you thought Prozac worked for children. Why have you not heard of this? Same reason you never knew Harvey Weinstein was anything other than a nice guy – with the extra reason that whatever about other enablers, bureaucrats never ever admit they’ve made a mistake, and the academic media aren’t any better.
There is an excess of suicidal events on antidepressants in every one of these 30 trials. In the only notionally non-company trial, the investigators in 7 major publications in leading journals from this trial “managed to conceal” the 34 suicidal events on Fluoxetine versus 3 on placebo – this requires an Editorial Nelson to be not just blind in one eye but very short-sighted in the other.
The BMJ has done more than conceal harms. It “enabled” a transformation of these life-ending harms into a “controversy”, when in 2014 it published close to the shonkiest, most ridiculous article any major journal has ever published on anything – the Lu et al article.
There seems no point in submitting an almost entirely data-driven, opinion-free, article on what the trials in teenagers show to BMJ, even though antidepressants are now the most commonly prescribed drugs to teenage girls.
Even though last week, the British Secretary of State for Health declared adolescent mental health services the biggest single weakness in NHS provision. The great concern is that teenagers are self-harming while waiting for access to secondary services – now why would that be?
A few weeks before, the grisliest case report ever appeared in one of the few media still concerned about primary sources (Panorama). It covered the killing of twelve people in Aurora by a 24 year old on an SSRI, Black Boxed up to 25. This case report is totally backed up by the RCT data. BMJ played a stellar role in dissing any possible link to the drug – abetted by a posse of Psychiatric Association Presidents and ex-Presidents.
If on a Winter’s Night a Traveller…
With the creation of Dracula, Bram Stoker, a Dubliner, globalized the Celtic feast of Halloween. Both Dracula and Stoker left their place of origin and came to England. When last heard of, Stoker was working a few blocks down the road from the BMJ office…
To be continued
In retrospect this was, of course, the fundamental crime of Wakefield and colleagues – who have also come under Fiona’s curse – that they were prepared to consider the individual harms of MMR, although there had never even been any RCTs. Back in 2005 Ben Goldacre, in an award winning article, wrote:
“Now, even though popular belief in the MMR scare is – perhaps – starting to fade, popular understanding of it remains minimal: people periodically come up to me and say, isn’t it funny how that Wakefield MMR paper turned out to be Bad Science after all? And I say: no. The paper always was and still remains a perfectly good small case series report, but it was systematically misrepresented as being more than that, by media that are incapable of interpreting and reporting scientific data.”
And he told ‘Irish Health’ even after the GMC findings:
“But you have to remember this paper didn’t actually say MMR causes autism, it didn’t even speculate on that. It was accompanied by an editorial that said by the way people should be very clear that it doesn’t mean that MMR causes autism.
“Also, this was a 12 subject case series report – it was a description of only 12 children’s clinical anecdotes, and while this is not good evidence to say MMR causes autism, it is a perfectly legitimate thing to publish.”
Meanwhile he was prepared to stake his faith in MMR safety on the back of transparently flawed epidemiological studies.
http://www.bmj.com/rapid-response/2011/11/02/re-evidence-not-bullying
But hold on, was not the basis of the UK vaccine damage payment scheme that it would award rare cases of vaccine damage, which would not be statistically significant? Not to say that Cochrane was not in a double bind too, because a reasonable inference was that if the six MMR/autism studies had been correctly performed they would have shown large population effects.
As Goldacre knew, the whole of GMC fiasco against Wakefield and colleagues was based on journalist Brian Deer’s false construct that the Wakefield “early report” of cases seen on the basis of clinical need, was an ill executed version of a research protocol to be conducted on behalf of the Legal Aid Board – a ridiculous fabrication which was dismissed in the High Court in March 2012 when Wakefield’s senior colleague Prof Walker-Smith appealed.
My best guess is that the raft of allegations made against Wakefield by Fiona et al in 2011 were made in anticipation that the GMC findings would collapse. Little wonder that Goldacre announced his sudden retirement from journalism in November 2011, following the intervention of David Lewis over Fiona’s claims, and with the High Court hearing just round the corner.
http://www.nature.com/news/2011/111109/full/479157a.html
It looks like it was just getting too complicated to explain. But perhaps even now he ought to return and set matters straight.
However much our hearts sink when reading the shocking way trust is abused in all directions those who have been silenced are making a noise. I am commenting today rather than waiting for next posts as news flies through journals too quickly to keep up with – Anybody though, who reads the BMJ cannot fail to notice it is swamped by advertisements from drug companies. On Oct 25 2017 Editors finally after much blustering and requests from readers, published ‘The Bmj declares it’s Revenues from Industry’. The criticisms can be read on the rapid responses. All five of them. The BMJ has been asked if it will give some data on the number of articles they decline to publish and some at least reason for the decision; also re rapid responses not published. So far no response. The average person will have no way of knowing what the real controversies are. We may as well not read the journals. Furthermore although the journal is promoted as open access many of the articles are via subscription only. Another recent article in the BMJ Oct 27 2017 highlights ‘Pharma Gifts Associated with Higher No. and Cost of Prescriptions’ Doctors (in USA)pocketed 3.9million dollars mainly from abusing the medicare system whereby senior citizens obtain free medications. UK doctors are no longer allowed to do this but they don’t need gifts to carry on prescribing harmful drugs obviously.there are it seems gaping loopholes when even close family members with ties to industry are not mentioned in conflict of interest statements. That would seem best practice.It is always best to be transparent as the bmj itself advocates. The editors state that ‘as part of our renumeration bonuses are linked in part to the BMJ’s financial performance’. Well that’s one way of judging a journal.
Susanne
Of course, two of the comments are mine (one merely correcting an error in the first). I would say about BMJ Rapid Responses that I have been grateful, notably this summer about the issue of compulsory vaccination, to have letters published without having to suffer harassment from trolls – it has been made actually useless posting in mainstream outlets because of the barrage of hate material which submerges intelligent comment. I imagine apart from anything that BMJ might have looked silly if they had disallowed correspondence when the the BMA had called for discussion, though it was also instructive to see how the vaccine lobbyist themselves could not be seen for dust when challenged.
However, an area where BMJ RR has become less open is that it seems unwilling to post letters documenting conflict as it used to do in the past. Perhaps the most dramatic that they won’t touch concern Prof Pollard. For instance:
http://www.ageofautism.com/2017/07/not-published-in-the-british-medical-journal-the-dangers-and-conflicts-of-infanrix-hexa.html
John…..It is some years ago since the BMJ changed it’s policy on publishing r.r.’s When Richard Smith was editor there were no restrictions on publishing r’r’s . I know from discussions that more critical views are declined. It means that although yours are published – readers do not know what is NOT published. Furthermore by excluding such a wider variety of views as published previously much useful feedback which many medics and members of the public found useful and supported is lost. Nobody is claiming that thebmj has not done some good work including via r.r.’s but effectively blacklisting those who have valuable contributions to make to knowledge and practice which impacts on members of the public via journals which to some extent provides guidance to medics is simply wrong and unethical.
Susanne
Yes, in fact, you can tell from the gaps in numbering on threads how many have been left out, although perhaps there may be others which did not even get a number for all I know.
But there is much less trolling than there was back c.2004, some of which was quite outlandish in such a place.
Susanne, in regards to The BMJ excluding comments critical of medical products, I submitted a number of critical comments on a BMJ blog article endorsing HPV vaccination published in December 2016.
Only one of my detailed comments was published, after a long delay and legal scrutiny, see this link: http://blogs.bmj.com/bmj/2016/12/05/richard-lehmans-journal-review-5-december-2016/
My other comments challenging HPV vaccination were not published, see this link: https://elizabethhart.files.wordpress.com/2013/02/e-hart-unpublished-comments-re-hpv-vax-on-richard-lehmans-bmj-blog1.pdf
In personal correspondence with Fiona Godlee, Editor-in-Chief of The BMJ, Dr Godlee responded to me: “the BMJ’s associate editor Peter Doshi is actively investigating this issue and he and others will write about it as soon as he had completed his enquiries. This cannot be done overnight. We have learnt that, to significantly influence health policy, we need to be sure of our target and on firm ground. Ensuring that this is the case is my job as editor in chief. Attacking us with emails while we do this work does not help us move forward any faster.” (15 February 2017.)
I do not consider my emails to Dr Godlee containing valid concerns about HPV vaccination to be an ‘attack’.
I have patiently waited for The BMJ to take action on this matter. It is now the end of October, and I have seen no results of Peter Doshi’s investigation.
Meanwhile, lucrative HPV vaccine products continue to be promoted around the globe, with parents and their children failing to be properly informed about the many uncertainties of these over-hyped still experimental vaccine products.
For more background, see this webpage: https://over-vaccination.net/cochrane-collaboration/
Thanks very much Elizabeth – I knew some were not being published but we can’t know why and how many unless Fiona and colleagues become more transparent about that . Her response to you is actually more of an ‘attack’ than your unpublished response . Fiona by the way published an article in thebmj describing how she was told she had failed in her bid to become editor. She phoned her mother in tears – was told ‘not to be so wet’ and contact the bmj to check – was then told she had the job. Sorry can’t be bothered to trawl through for her embarrassing article – but thing is -How do Editors get appointed?
When last heard of, Stoker was working a few blocks down the road from the BMJ office…
a ha ha .. ending on a titter ..
So as England goes in to overdrive on ‘Sex Pests’ in Westminster and/or all the prudes come out and all the pests come out .. titter again ..
The ‘drug pests’ are rife as described, none more so than Pests in Positions of Authority.
I understand you have submitted a paper on PSSD to the BMJ .. how will that go down .. it’s that Pesky Oirishman again pushing us. But, we have his number .. 329 and all that ..
http://www.straitstimes.com/business/companies-markets/pharma-giant-gsks-regional-hq-in-singapore-will-nurture-asia-talent-for
The Straits Times features a futuristic building full of Straits .. a power hub .. breeding for the future
To save a lot of mental energy, this post and comments, cover this Breeding Ground with some surprising guest comments ..
https://davidhealy.org/not-so-bad-pharma/
Swept Aside:
http://www.ageofautism.com/2012/12/leveson-inquiry-submission.html
this also seems particularly appropriate ..
When last heard of, Andrew Witty was working a few blocks down the road from the Venture Capital office ..
Reading the support for RxISK Prize from whocaresinsweden, their comment seems better placed on Vampire Medicines than on the Rxisk.org page as a Swedish Social Comment ..
Whocaresinsweden.com
5 hrs
RxISK Prize Campaign
Post-SSRI Sexual Dysfunction (PSSD)
De flesta vet att SSRI (antidepressiva medel) skapar sexuella biverkningar men nästan ingen känner till att dessa kan bli permanenta efter avslutad behandling.
Translate this page
Post-SSRI Sexual Dysfunction (PSSD)
Most people know that ssris (antidepressants) create sexual side effects, but almost no one knows that these can become permanent after cessation of treatment.
Rxisk is an international organisation consisting of recognised researchers who are in favour of medicines but who work to highlight serious adverse reactions such as the pharmaceutical industry for economic reasons, do anything to hide.
In The Swedish documentary who cares in Sweden there are several of these researchers and testify to how ssris create serious side effects. In addition to sexual side effects, there are also aggression and the feeling of wanting to kill others and themselves. This is denied in the documentary by Swedish researchers who both cooperate with pharmaceutical companies and act “Informers” to the Swedish media.
The problem is that these media informants are not reviewed or questioned by the media.
Unfortunately, the safety of the public on medicines is, unfortunately, in the hands of a virtually absent Swedish Medicinjournalistik. It should, of course, call into question instead of politely reading the marknadsföringstext that the pharmaceutical companies send to the journalists.
Clip..Dee Mangin, David Healy and Others
https://www.bing.com/videos/search?q=who+cares+in+sweden+david+healy&&view=detail&mid=25559F6B19D1708556CA25559F6B19D1708556CA&FORM=VRDGAR
“just what is happening and what the appropriate levels of responsibility” ……. “are” (the Swedish candle must have gone out)
I hope everyone has watched these 3 docu films.
https://www.artimus.se/whocaresinsweden.php
Nobody in these 3 films disappoints and when I watched all those years ago, it set me up for several rounds of total disbelief – Vampire Vignette …
I wonder how doctors managed to learn about serotonin syndrome (how this got past the filtering from ghost written articles and other pharm influence). It seems like the only adverse drug reaction they have learned about. When I tell them my story and symptoms, with some regularly this is what they said. Which is then followed by the advice to abruptly discontinue all of my psych drugs (ignoring how I can’t do that because I don’t want to end up further maimed or worse).
David, you say: “In 1962 doctors were viewed as the key element of the regulatory apparatus. A great part of their input centred on descriptions of the harms medicines could cause.”
What role do doctors play in the regulatory process now? It seems to me many are only too happy to prescribe a plethora of medical products. Our society is grossly over-medicated, this is not healthy.
Now the consequences are coming to light, e.g. the fallout from the opioid, antibiotic and antidepressant epidemics.
Isn’t it ironic that doctors are in the frontline of creating these epidemics of over-use of medical products, causing untold harm…
The vaccine epidemic promises to be the biggest disaster of them all. It staggers me that the medical profession has sat back while international vaccine schedules have swelled to gross proportions, including multiple revaccinations with now obviously defective vaccines such as pertussis, and highly questionable vaccine products such as HPV vaccines.
There are currently at least 46 doses of vaccines on the children’s schedule in Australia, and there is intensive industry lobbying to add more products to the schedule, e.g. meningococcal B and annual flu vaccines. Big Pharma has hijacked vaccination policy, and the community is being exploited with the over-use of vaccine products.
Recently I forwarded an email to Dr Joanna Flynn, Chair of the Medical Board of Australia, challenging her about over-vaccination, which can also be added to the problems of over-diagnosis, over-prescribing, over-treatment and over-servicing by the medical profession.
My email also raised the issue of conflicts of interest in vaccination policy, i.e. that academics associated with industry are influencing vaccination policy.
My email to Dr Flynn can be accessed via this link: https://elizabethhart.files.wordpress.com/2014/12/over-vaccination-legally-valid-consent-and-conflicts-of-interest-in-vaccination-policy-email-to-the-chair-of-the-medical-board-of-australia.pdf
L’Affaire Wakefield: Shades of Dreyfus and BMJ’s Descent into Tabloid Science
Vera Sharav’s monumental exposé now on AHRP
http://ahrp.org/laffaire-wakefield-shades-of-dreyfus-bmjs-descent-into-tabloid-science/
My personal opinion is that the accumulated behaviour of pharmaceutical companies, concerning SSRI-type medicines, constitutes to ‘crimes to humanity’.
From the very basic research in “5ht” in mice (or whatever you scholared call it), onwards to human trials with the enormous misconducts that we can read about on this blog. Lieing and misrepresenting “scientific data”. Using marketing to push these pills to an overprescription, where 9 out of 10 patients cannot benefit over the harms.
The failure, from the companies themselves, to forcefully regulate the use in under 18’s. Which leaves millions of young adults ‘absent’ during the very important adolescence years, 12 to 21 years of age, where a large portion of our emotional development occurs. Leaving them unable, and even unaware, to form emotions that guide (and mislead, for learning) and forms the adult human being.
The failure, from regulatory agencies, to force responsible investigations to be conducted in the very serious allogations of sideeffects. Instead we have the exact same suspicions as Teicher et al had back in 1990. 30 years of allowing the pharmaceutical companies have ‘the benefit of the doubt’.
Are we, absolutely sure, that the ‘benefit of the doubt’, should not be in FAVOUR OF THE PATIENT???????
Ove2017
Ove
Companies didn’t created RCTs and EBM – they didn’t like them. They didn’t create Guidelines – they didn’t like them. They didn’t create anti-overmedication campaigns.
Doctors don’t have to prescribe drugs for which they have no access to the data. BMJ and other journals don’t have to publish articles for which they have no access to the data.
Very little that companies do breaks the law. I think a better case could be made that its doctors who are failing us. Its their complicity that is the problem.
David
D I noticed that some of the many adverts on the BMJ site included reference to advice re adverse effects although I haven’t checked these = some of which included a reference to the Yellow Card Scheme. Have had reply from them via ‘What do they know’ site which advises on Freedom of Information requests Made FOI requesting how many reports they have received about adverse effects to anti depressants by name. I should have included a request for a breakdown of reports by doctors and others but should have a reply by 28th nov. which may give this but can follow up anyway
There must be some question whether their advertising of pharmaceutical products on the web is legal.
Well, for starters, the companies produce a product. The producer of any sort of product is liable to its safety. If you get caught cheating with the safety of your product, as they have been, time and time again, how come the patient is the one we doubt?
No, I’m not saying the companies created the ‘game’ or its ‘rules’, but they exploit it in every which way they can.
And you DH, know very well how utterly impossible it is for us patients to confront our doctors. It is not a level playing field. In Britain you have the debate on the patient consulting “dr. Google”, and how doctors want to be able to turn down patients that question them.
The root cause behind doctors and medical journals are the companies.
“Volkswagen tampered with their exhaust data, we didn’t blame the car dealer or the salesman, the producer is liable”
Ove
I am not blaming patients. I’m blaming doctors. You’d be safer with one of these robots that can learn – and the first thing a robot that can learn would do is to pay no heed to guidelines. It would take note of the injuries and deaths and change prescribing accordingly. Unless doctors wake up and realise keeping us safe is where there future lies – they are toast, because the current state of affairs cannot continue.
D
And I’m not defending doctors, I agree that they can turn the tide. And so could real ethical medical journals. And even mainstream media must stop boosting flawed science.
And if the sideeffects they hide would’ve been rashing of the armpit, I would let the manufacturers pass, but this is pills that kill and maim.
(Off topic, Swedish media reports tonight that prescribing of ADHD medicines have risen 600% over the last decade, that should reassure future psychiatrists a busy schedule)
David
No, the doctors shouldn’t be prescribing without access to the data but the drugs are being offered to them by the companies on false or ‘economic with the truth’ data, and we learn today (ITV ‘This Morning’ programme in UK) that GPs are now so exhausted and over stretched that many are suicidal and are packing in their jobs because they can’t handle the stress. The ratio of patients to doctors is becoming untenable.
So, if things are that bad, when, realistically, will the doctors get the time to root out hidden data from elusive companies. I guess a lot of them are fire fighting. This doesn’t excuse them, but when confronted with a patient desperate for help, and the prospect of an 18 month wait for NHS psychological therapies, isn’t it human nature to be brainwashed by the blurb in the BMJ when feeling exhausted, and hand out a prescription?
Of course surely we need a turnaround – the money going towards social prescribing and mentoring and psychological therapies and away from the drugs’ bills, keeping medications only for those who really do need and benefit from them, but GPs insurance will mostly not cover them if they offer social prescribing in case they get sued because they recommended a walking club in good faith, say, and someone tripped in a pothole and broke their leg.
So the downward spiral continues, till we hit the bottom.
H
Companies only get away with it because doctors and BMJ and all medical journals and all guidelines bodies like NICE have been spineless. Doctors don’t have to spend time chasing. They just stop prescribing and companies will do the work pretty quickly.
Fiona Godlee could take a stand for all of us but doesn’t. Simon Wessely could but doesn’t
D
Isn’t it high time to fight back then? Set up peer support groups for a variety of different issues – not for anyone’s glory but simply to provide a chance to ‘share thoughts that worry us’ -” do I need a pill to help me through or would talking to others at that group do the trick?”, “is my meds. really making me feel like this as Rxisk says – would someone know at that group I wonder?”, ” Am I REALLY supposed to feel like this, for this long, just because I’ve stopped taking that tiny tablet – wonder if someone else has felt like this?”, “these voices are driving me mad – how can I learn to cope with them?”. As things stand, all of these type of questions find their way to the doctor’s desk and the answer will be found via the prescription pad. If they – the doctors – refuse to change, then let us become more ‘community centred’ and do it for them. They’ll probably find our ideas hilarious – but, if successful, we would have calmer surroundings at their surgeries and calmer patients who really need their doctors’ support occasionally. Isn’t it worth a try? With emptier surgeries, they might even have a spare room to offer us for our peer support activities – for free of course, for services rendered!
Mary, the struggle to get some GPs to socially prescribe, as you suggest they should and could, is very wearing. They cite their insurance cover, the cost, or they kick the idea into the jungle of bureaucracy and forgetfulness.
But if we look at the work of Dr Simon Opher whose idea first reported on BBC
(bbc.news.co.uk) 5th April 2005 was that ‘Art proves an effective medicine’ reported by Jane Elliott, at the time BBC News Health Reporter.
‘An innovative scheme to use art to cut unnecessary medical consultations is proving such a success that other surgeries are looking at taking on the idea.’
Fast forward to 12 years on, ‘ArtLift’ (as his idea has now become known) is now so successful it runs throughout Gloucestershire. Described as ‘The bridge between arts and health’. ‘Our artists bring a range of techniques to their sessions and are skilled at involving people who may not have tried anything like this before, as well as those with more experience. So even though a session might be called ‘Poetry’ or ‘Printmaking’ you’ll all be experiencing and working with colour and imagination and there’s something for everyone.’
Picking up Spruce’s point about being ignored, I drew our local large GP practice’s attention to Dr Opher’s work back in 2007. As a professional artist/writer/lecturer of many years’ experience, I offered to set one up with them. They ignored my submitted comprehensive proposals for over a year. Then my GP, to whom I’d offered them, was retiring, so I asked yet again what the outcome was. It took him another several weeks to find the information I’d given him, and then said the Panel weren’t interested as it would cost too much. I had already pointed out that there was Arts Council funding available as the Uni of West of England has surveyed Dr Opher’s results and found that patient consultations had reduced by 75% for anxiety! depression! Parkinson’s and even terminal illness coping strategies.
So, it never happened there. But in November I am glad to say I am starting one at a local horticultural therapy centre, which the NHS have ceased to be involved with, and we shall assess what difference anxiety and stroke recovery patients feel after a few sessions. I will report back! So, keep plugging away Mary and Shane, persistence in a good cause wins in the end. Same to you Spruce. They bank on you getting tied and dispirited and giving up. But you won’t!
If Shane and I are lucky enough to get this support group off the ground, I would like to point out that we would not be in any way connected to a group of doctors. We contacted out own group merely to see if we could distribute the questionnaire there – to get a feel of the relevance of what would be offered. If we could stop people in their tracks before they make their appointment with a doctor, we would lighten the doctor’s load. If we could get patients to consider the possibility of medication withdrawal to give better health, then we would save money in the long run. If patients are returning to doctors with unexplained symptoms and nothing seems to make them better, maybe, eventually, doctors might start to believe in peer support groups?
We all acknowledge the fact that visits to doctors are of real importance and that their prescribing of medications can be vital to our wellbeing. Having said that, we all also know that, at times, just a listening ear and a reassuring word will do the trick. More and more, people are turning to their doctors with issues that do not require medicating but, without intervention, will be difficult to overcome. Since the answer, in the eyes of so many doctors, lies with the prescription pad and a repeat slip, we have ended up with ever more cases appearing at the receptionist’s desk pleading for an appointment due to a variety of problems connected to their medications. To my mind, it makes sense to find some way of supporting many of these patients who are either wrongly medicated or suffering conditions which can be helped without strong medications.
Just over two years ago, Shane had his first appointment with David. Shane wanted to reduce his medications as he felt that they were providing very little support for the voices and other hallucinations which had been problematic since he was put on Seroxat all those years ago. He’d gone through twelve years of changes of medications or higher dosages. At that first meeting, David suggested that Shane may find being part of a Hearing Voices group useful in coming to terms with his hallucinations. On his return home, Shane (whose energy level at that point was zero!) immediately set about finding a local HV group. He has attended regularly every fortnight ever since. The difference that it’s made to his life is mind blowing.
Earlier this week, I was allowed to observe at the HV group which Shane attends. I wanted to be sure that I had the correct picture in my mind of how a peer support group is run before we, hopefully set up the withdrawal one of our own. Words fail me in my attempt to give a true picture of my experience during those two hours. It was the most worthwhile two hours that I’ve spent for a very long time. One outstanding point is the way that the group accepted my presence. There they were, confident enough to discuss their issues with a total stranger – except that she was ‘Shane’s mum’ – I felt so humbled. The two facilitators were also welcoming and their relaxed attitude certainly supported the whole little group. Now, what did they do during those two hours? Well, actually, they did exactly what appointments with doctors are unable to do – they took their time! They had a short Mindfulness session – then they each explained how that had been for them and their voices. They then had a break for a cuppa. When settled back again it was time for each to say how things had been for them since the last meeting. The facilitators LISTENED and offered reassurance periodically. It ended with them deciding which comment from them would be used as their focal point at the next session. THAT WAS IT!
Obviously, in dealing with hallucinations, the facilitators need to have knowledge in that area – but, in the main, it was the experience of each other that carried the day.
To cap it all, speaking about our intentions with the two facilitators afterwards, I mentioned David and RxISK and one of them knew and admired David’s work. That was the icing on the cake! She is now aware of the campaign too.
Art, music, exercise and many other things undoubtedly have their place but ,to me, it was just the relaxed easy-going atmosphere that made this the ideal situation for the needs of the group participants.
If we can provide a similar atmosphere for others troubled by their life circumstances, then I feel that Shane’s suffering will not have been in vain.
Doctors used to think alcoholism was a lost cause. In that case, at least they recognized a problem, but they still had next to nothing to offer and people were routinely sent home to die.
Then AA got busy.
It took a while but now doctors refer people to 12-step groups. To my knowledge, there has never been an adversarial relationship between the two. AA calls this “cooperation with the professional community (CPC) and strives to be helpful to doctors by offering what they have.
In our attempts to get a medication support group going here in Ohio, we have had a lot of interest online, but few in attendance so far. This was in contrast to a Grief Recovery group that I started around that the same time where I had to turn people away. It could have been the way we presented the information, so we are going to shift from calling ourselves a general “Rx Medication Support” group to being strictly about withdrawal for now.
But Fiona French mentioned something that gave me pause, about people not being well enough to even leave the house to attend a meeting. To that effect, the online support groups are indispensable, and maybe this is partly why some people who were interested in our group didn’t come.
Mary, as you have said, the healing effect of physical presence and the listening compassion of others have great value. I’m also thinking that physical meetings in our communities might make our need for assistance increasingly REAL in the minds of everyone, including our doctors (who as of now don’t really care what we found on the internet.)
I’ll be lighting my candle at 5 EST.
Heather – can’t agree with you on this – doctors are in the best position to change things .They are not a group with no influence – they are not forced to prescribe harmful drugs . They should seek other sources of revenue other than use human beings as cash incentives. If this happened in any other sphere of medicine they could be sued/brought under the scrutiny of GMC. If the care for those they care for does not a have remedy available prescribing something which has such a potential for harm is simply not the answer. Doctors have a moral and legal obligation to do no harm.
Susanne, in principle you and David Healy are of course bang on correct about doctors having power etc re prescribing, but if we don’t look at the practicality of WHY they are lobbing out the medications so freely and in many cases irresponsibly, we are living in cloud cuckoo land. I don’t mean to sound rude, but to effectively make a difference and change things, surely we need to honestly accept the baseline we are starting from. A friend in Mi6 once told me that wars are won by whoever controls the propaganda at the crucial time and hoodwinks the opponent that they are in control. Then the other side loses their resolve because they believe they are on a hiding to nothing.
Why have prescriptions for RoAccutane-isotretinoin for acne risen by 650% in the last few years! despite constant rumours about dire side effects linked to suicide? (Only very recently has more come out about the PRSD it can cause, which was never on the PIL, by the way).
Suggested answer – The dermatologists are so thin on the ground, 20% of posts unfilled, that this immediate seemingly ‘quick fix’ gets them through their long waiting lists, no doubt aware, especially in today’s ‘importance of your skin appearance’ culture, young people can be feeling suicidal anyway about how they look, so they need help quickly. One prescription and hopefully dermatologist’s role over. (Could add, roll over too here). But next stop GP for low mood and maybe psychiatrist for depression. Dermatologist is well out of it now, it’s someone else’s problem….’most likely all the fault of the patient anyway who ‘may have been depressed in the first place’. Buck successfully passed and the Perfect Circle begins.
34 years of raising alarm about this drug have not prevented dermatologists believing it is a magnificent tool in their armoury, reassured by BMJ articles, and yes, it can be, for getting rid of acne, (often not for long) and getting rid of skin patients from their lists, but the other mental and physical problems that mushroom from it can be very costly to the NHS, and can end up costing the patient their life.
The BMJ does carry a lot of the blame I feel, as the propagandist. A very experienced physician who worked with us to enable us to meet our NHS Trust CEO after our son’s death, and knew Olly’s story and did his very best to help our case, did add, sometime later, that he’d suddenly seen there was ‘a recent good piece in the BMJ about RoAccutane-isotretinoin having not been found to have a proven link with suicides’. My point is not that the BMJ printed this, (because of course this bears out how they are influenced by Big Pharma’s own evidence), but that this very thoughtful, activist physician of so MANY years’ experience, was obviously taken aback a little in his resolve purely because he read a report in the BMJ. Don’t other doctors, short of time, do exactly the same? Reassured, they prescribe.
We need to get our propaganda machine exerting the influence of truth much more strongly to the doctors. Spreading the word about RxISK is doing this.
Heather – I can accept different views without thinking them rude! And on this we disagree. Doctors have a duty to know what they are prescribing and to inform those they are prescribing to – so that informed choices can be made. Too many are neglecting to do that. There is enough information out there that they should be taking note. Rxisk can take the credit for doing much of it.
Continuing with the Halloween theme its a tangled web we weave when first we practice to deceive.
First let me say I have no medical background or training. But I lost my husband to SSRI’s …death by suicide. At his inquest in his honour I tried to get the fact acknowledged. David had offered to write a report but the coroner would not allow it .She said he had ‘a drum to beat’ When as David himself said in an earlier post he would have cited data. As it happened she commissioned a report which was farcical I am happy to share if anyone is interested. And when I asked what percentage of people taking SSRI’s have adverse effect he replied ‘ I don’t know ‘
It was my wish that lessons be learned from my the death of my husband by collecting data on medication being taken from all deaths by suicide. Unfortunately even though the coroner said she would make recommendations to NICE I have as yet been unable to obtain a copy even though I believe this information should be available to me. I do have a recording of the inquest and interestingly the GP’s so!icitor interrupted the coroner in her summing up to advise caution about how much she said .
So basically the information that would help is not being used during trials or even after fatalities.
Horror stories
I agree with the spinelessness of most physicians. I also have been thinking lately about their lack of interest or curiosity in something they don’t understand. They don’t know how to think anymore. I don’t think this can all be expanded by arrogance and greed either.
I remember some very bad nutritional advice my GP gave me several months ago. “Go on a CARB FREE diet. Only eat meats, fruits and vegetables.” Last I checked fruit had plenty of carbohydrates.
He also insisted on prescribing me metformin I never took. He claimed it would lower my appetite (!) Maybe the drug company offered him a nice fruit basket–woven with platinum wires–for selling X bottles?
There are several aspects to ‘doctoring’ that stick out like sore thumbs.
How was the level of prescribing allowed?
How did doctors get involved in mental health?
How did Psychiatry and General Practice become an overlap?
Why weren’t doctors reined in?
How can a President of the Royal College of Psychiatrists remain impartial when he is married to the former chair of Gps?
Being a ‘victim’ of this bat and ball situation myself when huge scribes were despatched between a psychiatrist and gps, when neither knew what the other was doing, primarily with the abuse of medications but also the abuse of the GP, I think I can speak for the patient when this sort of thing goes on.
Look how many top-notch and very public, voracious and media savvy have made a very nice living riding on the back of Psychiatry.
Simon isn’t going anywhere soon, neither is Fiona.
Simon is all over the place at present, radio and tv just this week and his new prestigious job is to reform the Mental Health Act..
He has been feted for a long time now.
I would never say to someone that they are a lifetime fraud, but, its very tempting to want to do so.
Their own agenda wouldn’t matter much to us, if it wasn’t so hedonistic and their refusal to give an inch such a danger to the likes of us who took the Seroxat and paid the very heavy penalty ..
Fiona did everything in her power to halt the publication of Study 329, until she had dotted all the i s and crossed all the t s not to protect the public but to protect her journal and editorship ..
Simon and Fiona can do what they do ad infinitum but it leaves the whole of society in a very perilous place ..
Annie, your comment reminded me of this news I read a while back. It is a Press Release from the RC Psychiatrists about the new CEO, Paul Rees, who took up his post on 28th Nov 2016.
“The Royal College of Psychiatrists is delighted to announce the appointment of Paul Rees as its incoming Chief Executive Officer.
Paul joins the College from the Royal College of General Practitioners (RCGP), where he is currently Executive Director of Policy and Engagement.”
Read more here:
http://www.rcpsych.ac.uk/mediacentre/pressreleases2016/newceo.aspx
Cisparency and Transparency ..
More on forging ahead with “breakthrough” Status .. from ex Seroxat co execs
#Business News
November 3, 2017 / 12:04 AM / Updated 7 hours ago
Former GSK boss to lead new UK accelerated drug access scheme
http://uk.reuters.com/article/uk-britain-pharmaceuticals/former-gsk-boss-to-lead-new-uk-accelerated-drug-access-scheme-idUKKBN1D3004?rpc=401&
LONDON (Reuters) – Former GlaxoSmithKline (GSK.L) boss Andrew Witty is to lead a new British scheme to accelerate access to ground-breaking medicines for conditions such as cancer, dementia and diabetes from April 2018, the government announced on Friday.
#Business News
November 3, 2017 / 7:38 AM / Updated 15 minutes ago
GSK’s R&D head to leave for top UK government job: source
http://www.reuters.com/article/us-gsk-r-d/gsks-rd-head-to-leave-for-top-uk-government-job-source-idUSKBN1D30JL
In his new job, Vallance – a one-time professor of medicine at University College London – will replace Mark Walport as the senior science adviser to the prime minister and other officials.
GSK: Vallance and ‘Good’ Science ..
Vallance has also been a key voice in the company’s push for greater clinical trial transparency, being the only pharma company to sign up to the transparency lobby group AllTrials, and has struck a different tone to many of his colleagues in the biopharma world.
Talking to me about this last year, Vallance said:
“I have been a strong advocate for this [clinical trial transparency] from my time as a clinician and academic and of course retained that commitment when I joined GSK.
Fundamentally I believe that good science demands that we must make data available for others to scrutinize: it can prevent unnecessary duplication of research and, ultimately, it has the potential to benefit patient care.
“I know concerns have been raised about greater transparency introducing a competitive disadvantage but I don’t see it. What should we be afraid of? Say a new side effect comes to light for one of our medicines, or a scientist discovers new possibilities for a medicine, why wouldn’t we want to know as soon as possible? I really do not see a competitive disadvantage and I see a compelling societal need to do it.”
If he does leave the company, it will lose a strong transparency proponent, but this could prove to be AllTrials’ gain if he does take the U.K. government role and has the ear of the prime minister.
http://www.fiercebiotech.com/biotech/glaxosmithkline-r-d-chief-vallance-to-leave-for-government-job-ft
Science Media Centre
November 3, 2017
expert reaction to reports of announcement of new Government Chief Scientific Adviser
http://www.sciencemediacentre.org/expert-reaction-to-reports-of-announcement-of-new-government-chief-scientific-adviser/
“On a personal note, it gives me great pleasure to see a colleague, who is both a Clinical Pharmacologist and Honorary Fellow of the British Pharmacological Society, contributing at the very top level of scientific strategy.”
Dr. David Healy: Seeking a Cure for Protracted, Medication-Related Sexual Dysfunction
November 4, 2017
Mad in America Podcast Today
https://www.madinamerica.com/2017/11/dr-david-healy-seeking-cure-protracted-medication-related-sexual-dysfunction/
RxISK Prize Campaign
We need your support to raise $100,000 as a Prize for a cure of one of the most debilitating side effects of modern medical treatments – the persistent loss of normal sexual functioning after stopping antidepressants, finasteride (Propecia) or isotretinoin (Accutane).
$27,749 USD
raised of $100,000 target by 72 supporters in 16 countries
https://rxisk.org/prize/
In this touchy feely society, Sexminster and all that, Psychiatrists ‘feel with their minds’ must be the most hilarious bit of misjudgement we have ever seen in our lives ..
American psychiatrists are also commenting on the Sir .. and the Slur .. if you look them up ..
Poetry in Motion ..
https://twitter.com/WesselyS/status/926567443446878210