Following their Spotlight on the Troubles series, BBC ran an astonishing Behind the Scenes program that must have left even those who thought they knew what happened in the Northern Irish Troubles doubt that they really knew what was going on. The revelations turned the Troubles into a real life version of John Le Carre’s Tinker-Tailor-Soldier-Spy.
But Northern Ireland poses an extra difficulty for outsiders that even Le Carre perhaps would not be able to cope with – truth remember is stranger than fiction because fiction has to make sense.
Barring a few who have a special interest in the province, most outsiders can’t distinguish between Unionists (they’re the one’s who want to join the South aren’t they?) Nationalists, Loyalists and Republicans – and who the hell are the Alliance Party trying to ally with? Not easy for anyone on the outside to get their head around the fact that it was Loyalists who twice brought down British supported administrations in the province or the British Secret Service intervening to warn Gerry Adams about an assassination plot.
Behind the BBC Scenes
It should be rather easy for the BBC to shine a Spotlight behind the scenes of the Suicides. They could start over a coffee break, get to grips with who were the informers in house and just how high up the organisation (the BBC) had the “others” penetrated – except that height is the greatest defence the “others” have.
The Corporation played an important role in raising the issue of Antidepressants and Suicide with the 4 Panorama programs between 2002 and 2007. But BBC are now part of the problem. An insider should have a field day in working out how this happened – but would anyone broadcast the program?
In 2002, when The Secrets of Seroxat aired, the issue of suicide and dependence on antidepressants could run as a story about a cover-up of one problem on one drug – that with some skilful public relations could even be filed as a problem in just one age group.
The first two Panorama programs in 2002 and 2003 played a big part in forcing a House of Commons Select Committee hearings on the relations between the pharmaceutical industry and the health services in June 2004. And they had brought Study 329 to light.
Britain had a Labour Government at this point – a bunch of guys keenly aware of the hand of history on their shoulder, or said they were. (Or perhaps there was a Sisters in Cinderella issue – “Its on my shoulder” – Blair. “No its on mine” – Brown). (U word omitted). Some of those who knew something about the industry, e.g. Mick Behan, made this committee aware of links between New Labour and the Industry.
Behan’s written evidence was about (old-style) corruption, conflicts of interest. He missed, maybe we all missed, a new problem.
In October 2004, I gave evidence about ghost-writing of the medical literature and the lack of access to trial data.
I had been preceded by Des Spence, one of the key figures behind No Free Lunch in the UK. Alarmed by the growing power of the pharmaceutical industry, No Free Lunch, a largely physician based protest group, had been born a few years before in the US. They have unquestionably done a lot of good – as I tried to make clear – while also saying that if No Free Lunch didn’t exist the pharmaceutical industry would have had to invent them.
Des was not happy with the point being made – that industry actively want doctors and patients and the media and everyone to look at the free pens, and lunches, and undeclared or declared conflicts of interest and figure that’s where the problem lies. Eliminate these and all will be fine.
If we actually eliminate these, Industry’s worry is that we might spot where the problem really lies – which is partly (but only partly) in ghostwriting and lack of access to trial data. They agree with doctors that no-one as well educated as doctors could be corrupted by free lunches.
On the back of revelations about Study 329, in June 2004, New York State sued GSK for fraud and by August thought it had an answer that was going to solve the ghostwriting and data access problems for ever – the company and other companies would post the details of clinical trials on their website.
In September 2004, the US Congress hauled FDA over the coals about the issue of antidepressants and suicides. In September also, the head of Britain’s equivalent to FDA, Alastair Breckenridge, was cut to shreds by Shelley Jofre in a wincingly painful third Panorama program about paroxetine.
Later in the House of Commons’ Hearings Richard Horton, editor of the Lancet, and Iain Chalmers founder of the Cochrane Collaboration, weighed in – wittingly or unwittingly – on industry’s side. Horton for instance intimated that reviews and editorials might be ghostwritten and this was unfortunate but not a serious problem – the way for instance the ghostwriting of clinical trials would be. A few months earlier, in June 2004, an editorial in his journal, the Lancet, by a group working on NICE Guidelines for the treatment of pediatric depression had made it clear that the published trials in this area – most famously Study 329 – were ghostwritten.
Tanks Roll into Prague, Tiananmen & Westminster
The question of ghost-writing featured in the 4th Panorama program in 2007. After this, Shelley Joffrey and Andy Bell had their cards marked – that’s enough pharma bashing. Both were marginalised. There have to be people within the BBC well placed to shed light on what happened.
In 2008, Jon Jureidini and Leemon McHenry wrote an article for BMJ about the importance of the Study 329 story and the role of issues like ghostwriting but were shafted by the reviewers – Richard Smith, a former editor of the journal, who pooh-poohed the whole idea and a ghostwriter (sorry medical writer).
What was going on? The 2004 Lancet editorial had questioned whether any guidelines were or could be worth the paper they were written on if the situation that had come to light with children and antidepressants applied elsewhere. But its authors were silenced. The issue was not picked up. Fifteen years later, NICE clam up as rapidly about this issue as the Chinese State does if asked about Tiananmen Square. One of the significant news items of 2019 was the removal of Peter Goetzsche from Cochrane for raising concerns about just these issues.
The NICE Guideline Apparatus had been set up by Labour and by 2004 was playing a key role in the transformation of Health Care into Health Services. In the Brave New World, managers could know what was right and proper because NICE Guidelines told them. Doctors and others could be reduced to the role of technicians – with keeping to the Guidelines written into their job contracts. This would reduce variation, improve quality and save on costs – because we would only be doing things that worked.
Pharma loved it. Why wouldn’t they – they control NICE totally, as you can do if NICE agree to work from published (ghostwritten) articles only with no access to the data. Even better the public think NICE are controlling you.
You’d expect the health services to be falling apart and life expectancy to be falling if the information on which the services depend is Fake News. Doubly so, if everyone is prohibited from looking anywhere else for reliable information – and this is what NICE delivered for industry from about 2004 onwards.
It will make little difference whether Britain’s health services remain notionally an NHS or not after this weeks election. Bureaucrats are bureaucrats, whether called managers or not, and whether they are American or British. Even when faced with an Army desperate to get trains to the Eastern front to combat the Russians, the bureaucrats running Auschwitz could be depended on not to let the trains being used to transport “workers” be diverted to anything else without the right paperwork.
Public or private the services will continue to fall apart and life expectancy will continue to fall. Britain’s Office of National Statistics reported last week that babies born today will live 3 years less than we expected them to be living less than ten years ago.
Finding Stakeknife
Codenamed, Stakeknife, it looks like Freddie Scappaticci , a confidante of Gerry Adams and Martin McGuinness, was the British Secret Services most highly placed agent within the IRA – if it wasn’t actually Adams or McGuinness.
Living now in Britain, he was arrested this year and charged with possessing (would you believe it) 329 images of extreme pornography – including with animals.
The Spotlight program raised serious questions about the legal position of the British government in the murders that Scappaticci set up. There are no Guidelines for these – no NICE legal way to dispose of them.
Did Pharma have a Scappaticci? Horton, Chalmers, Smith?
It doesn’t need one. In 2017, the Bell and Jofre (pictured) team reassembled and somehow managed to smuggle a program about James Holmes – the Batman Killer – past the Panorama censors.
They had no sense what would happen next. The Science Media Centre – a shadowy operation few had heard of in 2004 – swung into operation and the BMJ had run with an editorial dissing the program – even before it had aired. Psychiatric grandees tumbled over themselves to rubbish it.
No-one seemed able or willing to take on board the key message which was this was not about whether Zoloft caused Holmes to murder but about whether any of us, as Stephen O’Neills’ case shows, can now get a fair hearing if we are injured by a drug. In a Liberal Democracy, we give up our right to retaliate against those who have harmed us in favor of due process. But due process now seduces us into taking a drug that can cause us to kill while it actively collaborates in concealing any hints this might happen. If we try to defend ourselves in court or at an inquest, due process pits us against a ghostwritten literature with lack of access to the data that might prove our innocence. To be found not guilty, jurors or a coroner, or a GP, or hospital doctors would have to traverse an abyss few are willing to acknowledge might exist.
Another way to put it is that the media, and inquests, and courts are great at rotten apple in barrel problems but aren’t able to tackle rotten barrel problems.
Again and again I turn down media requests to get involved in programs about the industry – telling the journalists they will only increase the sales of the drugs they claim to be concerned about. Trusting in their own good intentions, journalists find it difficult to comprehend the idea they might be part of the problem.
I made an exception for Chris van Tulleken when he made a BBC program about antidepressants and children, left him amazed at evidence that the entire literature was ghostwritten, and challenged him to challenge NICE. Nice man but he funked it – see What used to be called Medicine.
I made an exception for a BBC File on Four program, also ostensibly about children and antidepressants. FF take on the Russian Mafia and some of the scariest people on the planet. And in this case the presenter, Paul Connolly, was Irish, so I was able to draw a comparison between the situation of a Stephen O’Neill for instance and the Guildford Four – to help him get the problem. He claimed to be gripped by the issues but later figured they couldn’t fit not just this but any hint of me into the program – see In the Name of the BBC.
Last week brought another Des Spence moment – an article in the BMJ to which many comments on this blog and on RxISK have drawn attention. It has a list of wonderful people on the authorship line – Fiona Godlee, Joel Lexchin, Jacob Stegenga, Lisa Bero and many others who have all done great stuff. The article however essentially makes the No Free Lunch call.
The doctors treating Stephen O’Neill will likely have read it and be pleased that someone is rooting out any corruption there might be in medicine. At the inquest, they disavowed any knowledge about medical articles being ghostwritten or any lack of access to RCT data – just as 99+% of other doctors do.
Pharma and the Science Media Centre will likely frame this BMJ piece. What better position to be in than have your enemies run your cover for you.
Beyond any kerfuffles about conflict of interest (transparency) and complete access to trial data (Cisparency) lies a deeper problem, the bedrock of Pharma’s success – our unswerving belief in randomized controlled trials (RCTs) and our willingness to set aside our own judgement and agree that black is white if authorities in the BMJ or Lancet or Cochrane or NICE tell us that this is the case.
Another self serving ‘aspirational’ revision. Count the loop holes, caveats , etc They should have had the decency to resign en masse last year when their actions were exposed. but they are obviously too useful to those who have no decency
The BMJ
Latest
Authors
Topics
Karla Soares-Weiser: Cochrane announces a new, more rigorous “conflict of interest” policy
December 3, 2019
Cochrane has a commitment to independence, transparency, and integrity in healthcare research and strives to minimize the impact of conflicts of interest in the conduct of Cochrane Reviews.
Although Cochrane’s current conflict of interest policy is stricter than most journals, over the past year we have revised our policy with the aim of strengthening our approach to financial conflicts of interest, and clarifying our position regarding non-financial interests. [1] This work was led by a panel of experts that included Cochrane’s Conflict of Interest arbiters, members of the Cochrane Governing and Editorial Boards, and other Cochrane members with expertise in conflict of interest. [2]
To inform the policy revision we:
examined conflict of interest policies from 33 healthcare-related organizations, including journals, guideline developers and research funders;
conducted an open, online survey resulting in contributions from nearly 1000 Cochrane members; and;
interviewed 16 internal and external stakeholders.
At the end of this process, we proposed a series of recommendations to strengthen Cochrane’s policy regarding financial and non-financial conflicts of interest. Cochrane’s Governing Board recently approved these recommendations, and work has begun to rewrite Cochrane’s current policy accordingly. The new policy will come into force early in 2020, and will apply to all newly registered Cochrane Reviews.
Cochrane’s new, more rigorous approach includes the following key changes:
The proportion of conflict free authors in a team will increase from a simple majority to a proportion of 66% or more.
Last authors will be treated in the same way as first authors and, therefore, must be entirely free of conflicts.
Authors of industry-funded clinical studies eligible for inclusion in a Cochrane Review will be prohibited from being the first or last author on that review.
Reviews funded by not-for-profit organizations with a specific interest in the outcome will be assessed by Cochrane’s Conflict of Interest Arbiter Panel and the Editor in Chief, who will judge whether the review is conflicted.
Cochrane authors will need to declare non-financial interests, and think critically about how these might influence the results of the review.
The board has issued a statement saying that they aspire to make Cochrane systematic reviews completely free of commercial influence, and to minimize other conflicts of interest, as soon as possible.
A recently updated Cochrane Review provided evidence that industry-sponsored studies favour the sponsor’s products disproportionally. [3] This influence can manifest at various points in the process: in the way a review question is phrased, and the way research is designed, conducted, and published. [4] Cochrane is seriously committed to mitigating the impact of financial interests in research, which is why its policy has been strengthened.
Recently, there has been debate about whether research organizations overlook personal non-financial interests, and we considered this during revision of the policy. To date, there is no empirical evidence of the influence of these interests on research results, so concerns about this potential type of conflict need to be balanced with the possibility of unfair representations concerning them. [5] Therefore, we have decided to ask review authors to declare relevant non-financial interests on the understanding that this will not restrict their participation in Cochrane Reviews.
Cochrane’s desire to increase the level of trust that readers have in Cochrane Reviews, and our support for efforts to improve integrity in healthcare research have motivated us to strengthen our conflict of interest policy, however, the ability of any new policy to effect desired change depends on how well it is implemented. To that end, we will support implementation of this policy through the appointment of a dedicated team that will include a Research Integrity Editor with expertise in the field of conflict of interest. We will re-emphasize the independence of the Conflict of Interest Arbiter Panel and initiate changes in our editorial management system to enable improved monitoring of reporting of conflicts of interest throughout the life cycle of reviews. As an organization, Cochrane looks forward to the improvements this policy will bring in keeping Cochrane Reviews demonstrably independent and impartial in their reporting and conclusions.
Read the full collection: Commercial influence in health: from transparency to independence
The programme was too convoluted for me They seemed to be out of their depth so filled it in with repeats of images and graphic descriptions of cruelty by one side then another (protestants-catholics) shocking images and thats what stuck. It also for me portrayed the Irish in a stigmatising way which still exists today For sure in parts of the UK Irish people have been subjected to ‘No Irish here’ when looking for accomodation Irish ‘navvies’ was not a term of respect for those who built the canals in UK.. Right up to now the disrespect shows in how it looks like Ireland is to be shafted over promises of ‘No Border’ after Brexit . Why the heck should Irish people not want to be independant as a whole nation is still a mystery to me. But maybe more to to the point David makes about it making no difference if health services are run by UK or USA – as there is a kuffufle going on by politicans re the intereference of USA pharma in UK I thought I might use a document David referred to me to offer an early christmas present they could use in debates rallies etc – which would help them to look like the good guys – and inform ‘the public’ atthe same time – but not a sniff from J Corbyn; Barry Gardiner; Emily Thornberry; Andy Burnham; Scottish SNP Joe Fitzpatrick; Nicola Sturgeon; Jean Freeman; Jo Swinton or the Irish health minister.
-all leaders who have all been sounding off about the issue,
Sadly no response from ‘Keep Our NHS Public’ doctors’ campaigning group
or the Independant; the Guardian; The Irish Telegraph; The Daily Telegraph; The courier.
I was not being naive – just think it;s worth a try sometimes – this document included a catalogue evidence of corruption and succesful legal cases again USA pharma companies.
To be fair Scotland Health Minister was prepared to give an answer – ambiguous though
Our Reference: 201900008321
17 December 2019
Thank you for your email of 1 December addressed to Jeane Freeman MSP, the Cabinet Secretary
for Health and Sport, regarding the practices of the pharmaceutical industry. I am responding on her
behalf.
It may be helpful if I clarify that the pricing of medicines is a matter reserved to the UK Government.
There are UK wide system of regulations to which pharmaceutical companies must conform. The
Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), introduced in January 2019,
places a 2% cap on the growth in sales of branded medicines to the NHS for each year of the
scheme, from 2019-2023. Pharmaceutical companies are required to repay the NHS for spending
above the cap. Any companies not wishing to opt in to the voluntary scheme are automatically subject
to the provisions of the statutory scheme, as set out in the Branded Health Service Medicines (Costs)
Regulations 2018.
We are aware of recent reports suggesting that the UK Government has been contemplating a trade
deal with the US that may include medicine pricing. As highlighted above, medicine pricing is subject
to strong regulation in the UK. What the potential cost may be in relation to medicine pricing would be
subject to the terms of the deal entered into however, it will continue to be the view of the Scottish
Government that patients in Scotland should have access to clinically effective medicines at a cost-
effective price.
I hope that you find this information helpful.
Yours sincerely
Scottish Ministers, special advisers and the Permanent Secretary
are covered by the terms of the Lobbying (Scotland) Act 2016. See
http://www.lobbying.scot
St Andrew”s House, Regent Road, Edinburgh EH1 3DG
http://www.gov.scot
Elliot Paton
I remember contacting Des quite a few years ago asking whether No Free Lunch would take up an issue and found out he was no longer bothering – said also the issues were now covered by the BMJ (though not clear from whose side)?
I always suspected that a critical moment in the final moral collapse of the BBC was the Dr Kelly affair. Lord Hutton (from Northern Ireland?) found that Blair was telling the truth (technically) and Gilligan, the BBC journalist, not telling the truth (technically) whereupon the Chairman and Director-General resigned. After that all BBC stories had to be processed through Whitehall and often were behind everyone else by days.
– the irresponsibles – …
HIDDEN DATA
Putting GlaxoSmithKline to the test over paroxetine
Blockbuster antidepressant paroxetine is no stranger to headlines.The drug is now back centre stage as requests for clinical data from one of its trials are testing manufacturer GlaxoSmithKline’s commitment to full transparency, Peter Doshi reports
Peter Doshi associate editor
https://davidhealy.org/wp-content/uploads/2013/11/Doshi-329bmj.pdf
In 2012,GSK agreed to pay $3bn (£2bn; €2.4bn) in a fraud settlement with the United States government. In a statement connected with the lawsuit, the Department of Justice declared that “the recent centerpiece of GSK’s efforts to market Paxil for childhood depression was the GSK funded Study 329,” about which the published JAACAP “article distorted the study results and gave the false impression that the study ‘s findings were primarily positive, when they were in fact, primarily negative”
The House of GSK
https://davidhealy.org/the-house-of-gsk/
The article states clearly that Paxil is safe and effective in children. Most doctors eyeballing it, and its distinguished authors and the journal in which it was published, would be much more inclined to use Paxil afterwards. That so many doctors in New York State in fact went on to prescribe so much Paxil to children led New York State to take a fraud action against GSK in 2004. This study was later at the center of the US Department of Justice’s case against GSK that resulted in a $3 Billion fine.
The temptation is for non-academics reading this to glaze over at the sight of theologians arguing about how many angels can dance on the head of a pin. But in fact those of you who have nothing to do with healthcare – the Irresponsibles – as it turns out were then and always are better placed to know when there is a problem. It was the doctors, ethicists and theologians, the Responsible Adults, who missed it. And if this is true of 329, it is likely to be true of everything else as well.
Study 329 began to unravel because a journalist, Shelley Jofre, working for BBC’s Panorama, accidentally left to her own devices, begin to dig.
A few days after the second Panorama program, Britain’s MHRA blew a fuse and Seroxat-Paxil was on its way to being banned for children. To be continued…
That’s the Price of it.
In the early two thousands, the media was awash with Seroxat, Panorama, The Guardian’s Sarah Boseley, Social Audit, etc. etc. I was totally tuned in, so how is it, that all of a sudden, people presently involved in pharmaceuticals, don’t remember, don’t care and are now rewriting history…
https://holeousia.com/2019/12/08/turning-a-blind-eye/
It’s not for me to make moral judgements, or is it?
Resonates with what DH is saying – if only they’d have the …(what?) to do a similar piece on drug (all) trials
Surgeons withdraw support for heart disease advice
By Deborah Cohen and Ed Brown
BBC Newsnight
2 hours ago
European clinical guidelines on how to treat a major form of heart disease are under review following a BBC Newsnight investigation.
Europe’s professional body for heart surgeons has withdrawn support for the guidelines, saying it was “a matter of serious concern” that some patients may have had the wrong advice.
Guidelines recommended both stents and heart surgery for low-risk patients.
But trial data leaked to Newsnight raises doubts about this conclusion.
Thousands of people in the UK and hundreds of thousands worldwide will be treated for left main coronary artery disease each year. This is a narrowing of one of the main arteries in the heart.
The guidelines on how to treat it were largely based on a three-year trial to compare whether heart surgery or stents – a tiny tube inserted into a blocked blood vessel to keep it open – was more effective.
‘Check your cholesterol from age 25’
Inequalities in heart attack care ‘costing women’s lives’
My ‘anxiety’ was actually a rare heart condition
The trial called Excel started in 2010 and was sponsored by big US stent maker, Abbott.
It was led by eminent US doctor Gregg Stone and aimed to recruit 2,000 patients. Half were given stents and the other half open heart surgery.
Success of the treatments was measured by adding together the number of patients that had heart attacks, strokes, or had died.
The research team used an unusual definition of a heart attack, but had said that they would also publish data for the more common “Universal” definition of a heart attack alongside it. There is debate around which is a better measure and the investigators stand by their choice.
In 2016, the results of the trial for patients three years after their treatments were published in the prestigious New England Journal of Medicine. The article concluded stents and heart surgery were equally effective for people with left main coronary artery disease.
But researchers had failed to publish data for the common, “Universal” definition of a heart attack.
Newsnight has seen that unpublished data and it shows that under the universal definition, patients in the trial that had received stents had 80% more heart attacks than those who had open heart surgery.
The lead researchers on the trial have told Newsnight that this is “fake information”. But Newsnight has spoken to experts who say they believe the data is credible.
Image caption
Stents are a less invasive option for patients too ill to have surgery
Prof Rod Stables, clinical lead for research at the British Heart Foundation, said this information should have been published and knowing it would have made a “substantial contribution to our ability to appreciate the nuances of the results”.
Shortly after Excel was published, the professional bodies for heart surgeons and cardiologists got together to write a new set of guidelines.
But they had not seen the unpublished Universal definition data.
Currently, European guidelines recommend either a stent or open heart surgery for people who have less severe forms of this disease.
The European Association for Cardio-thoracic Surgery (EACTS), which helped draw up the guidelines, told Newsnight if the information on the trial is proven to be correct, “the recommendation is unsafe”.
“It is a matter of serious concern to us that some results in the Excel trial appear to have been concealed and that some patients may therefore have received the wrong clinical advice,” Prof Domenico Pagano, EACTS secretary general, said.
Newsnight has also learned that as the guidelines were being drawn up, the trial’s Data Safety Monitoring Board – an independent body that looks after the interests of patients – was raising concerns.
Newsnight has seen emails where they raised concerns about the higher mortality rate amongst those patients who were receiving stents.
The board thought this information should be made public, as they were aware new guidelines were being drawn up that would recommend stents or surgery.
However, the main investigators chose not to do so at the time. They point out that the board allowed the trial to continue unchanged.
Prof Nick Freemantle worked on the guidelines. He told Newsnight he would “never” have agreed the treatments were interchangeable if he had seen the leaked data.
He said that the result of making the “wrong recommendation” is that “patients who have received stents [for left main coronary artery disease] will have died who otherwise would have lived for longer, survived for longer, if they’d had open heart surgery”.
The European Society of Cardiology, the other professional body involved in writing the guidelines, rejected the claim that the guidelines may have caused harm to patients. They stand by the guidelines, which they say were based on more than the Excel trial.
‘Dangerous for patients’
This year the trial published a further set of its results, showing what had happened to the patients five years after their treatment.
This found for every 100 who died after having open heart surgery, 135 people with stents died. Overall, 10% of people who had surgery died in the trial compared with 13% who had stents.
Prof David Taggart, a surgeon at Oxford University, resigned from the trial. He says he “had no choice” as he believed the academic paper describing the five-year results did not give enough prominence to the mortality data in the trial.
The NEJM had recommended that the researchers should give it greater prominence too.
Prof Taggart said he believed the paper’s final paragraph, which concluded that there was “no significant difference” between stents and open heart surgery was “dangerous for patients”.
When challenged by Newsnight, the trial’s principal investigator, Dr Gregg Stone, said he believed that it had been given sufficient prominence and had been considered to meet NEJM’s standards.
Sponsors of trials like this are also responsible for making sure all results are published.
When Newsnight contacted Abbott, the sponsors of the trial, they directed the BBC towards the trial’s main researchers.
The EACTS has now urged their members to “disregard the guidelines relating to left main disease for the time being”.
“We recommend that patients seek the advice of the multidisciplinary heart team at their hospital before deciding which treatment option is most appropriate for them,” said Prof Domenico Pagano.
Conflicts of interest
In the course of the investigation, Newsnight found a larger debate within the medical community about the way that conflicts of interest are handled.
There is one school of thought that says they raise questions and need to be carefully managed because of potential bias – conscious or unconscious.
Others say that interactions between research and business are vital and there is a real public good to be gained by them.
In the Excel trial, the four main investigators all declared conflicts of interest.
Lead investigator Prof Gregg Stone declared he had received personal fees or held equity in 20 private medical companies, several of which made tools that helped with putting in stents.
He’s also the course director for TCT, an annual medical conference where the results were presented.
TCT makes money from exhibitors including some of the biggest stent makers – Abbott, who sponsored the trial, Boston Scientific and Medtronic.
Prof Pieter Kappetein, who worked on the trial and on the body that worked on the guidelines, declared that he had left the guidelines body to go and work for Medtronic, a medical device manufacturer that makes stents.
Newsnight found that he’d become chief medical officer of Medtronic Structural Heart.
By Newsnight’s count, around half of the investigators on the trial had declared personal fees from companies that made stents, and around a third of those on the taskforce writing the guidelines.
These relationships are all within the rules.
You can watch Newsnight on BBC Two at 22:30 on weekdays. Catch up on iPlayer, subscribe to the programme on YouTube and follow it on
Dare we hope that the public will, at last, believe us when we describe what’s been going on for so long in the world of psychiatry?
Fraid not. It will be more like the response to the holocaust – one of the first photographers who got there – Lee Miller – covered her photographs with a letter to the effect that I know you will find these photographs hard to believe but trust me this is real, this has been happening. She realised the enormity of the thing would be hard to accept – and perhaps hearing it from a woman wasn’t going to help.
When Jews from Europe who survived got to Israel – the response from many was not entirely sympathetic – a case of well what did you do to survive.
It was really only in 1968 that Germany began to accept what had happened. Before that the German Interior Minister, a Jew, had cut a shameful deal with the makers of Thalidomide that left the company’s victims in a bad place. Had the trial gone ahead some of the witnesses for the Company were Israeli scientists who had been collaborating with Otto Ambros from the Company – a man who was responsible for synthesising nerve gases as part of the War effort.
As long as people think the problem is just a matter of banning Free Lunches or activities to that effect, nothing is going to change.
D
Sorry Mary but after seven years of chipping away at the issue of getting people to truly believe, (not just benignly smiling weakly at me and then changing the subject to something more comfortable), I’m of the opinion that no one is EVER going to believe until it happens to them. It’s so frustrating, like watching people stumble into quicksand whilst ignoring warnings from other people who’ve already been in there, as they pass, and then expecting those same people to sympathise and pull them out. I despair.
What IS this ridiculous feeling that creeps over us as soon as we push open the door of the surgery and lower ourselves onto the chair? Do we think we are facing a magician who has powers of superior abilities not available to us? Why do we believe them without any sense of needing to check out what they are telling us? Why do we swallow anything without googling it and double checking anecdotal reports, particularly now since 2012 there is RxISK.org to refer to. I don’t know the answer, but I think it’s engrained in us since childhood, ‘Trust the nice doctor, s/he’s here to help you’. We just don’t seem to be able to wake up and get our headlights on. Not till we’ve been in the quicksand, and the damage is done. Often the doctor knows less than we do about a particular ailment because we’ve been living with it and seeking ways to manage it for some time, but STILL we blindly accept what they say. Why?
The greatest shock to me is that YOUNG people don’t want to know the risks. They will question all sorts of other areas yet blindly swallow ADs. Why? I would have thought that going along to your GP and accepting a prescription would be considered rather ‘old hat’ by teenagers – or have they somehow been fooled into thinking that ‘prescribed medication’ will give them the same ‘high moments’ as, supposedly, the drugs out there on any street of any town or village ? Having been ‘educated’ to shy away from street corners, do they seek a safer, more socially acceptable source of ‘happiness’, one which their elders will accept ( as you say) without question.
As I can sense from your comment, you are at your wits’ end wondering what on earth it is that we need to do to wake people up to the realities of prescribed drug problems. Shane and I feel exactly the same – for two years we offered a group of mutual support for those withdrawing from ADs without any success.
We contacted schools, youth clubs, youth drop-in centres etc. etc. without ever even an acknowledgement of the fact that anyone anywhere had read the leaflets. We invited the same to our two open meetings where David kindly came along as guest speaker – again no response from any of them. We cannot blame the youth when we see that their leaders are so complacent can we?
Those who attended those open meetings still refer to the shocking facts that David shared with them. In the main, they were a lot older than teenagers shall we say! They were of an age where, as you say, the doctor was held in very high regard and his word was not to be queried – and yet they believed David’s message. Unfortunately, none of them seem to have known of anyone on ADs and therefore the message failed to snowball.
I wonder if a message like this one might shock some people into the realisation of what can happen :- (taken from David’s notes to Shane’s GP less than two months ago) ‘……….as my own view is that Shane has never had a mental illness. Almost all the problems he has had have come from what we in the mental health services have done to him rather than any condition that he has had.’
Shane has been prescribed psychiatric drugs since 2002 without even a day’s break – taken from diagnosis to diagnosis accompanied by changes of medication to suit, nothing changed. The CHANGE came when David saw him, LISTENED and ADVISED according to the details that we shared with him. From that day forward, things began to improve for Shane and for his family.
This experimentation was ( still is?) happening in the 80’s. One of the triplets experimented on described it as ‘nazi shit’. The urge to experiment with the lives of vulnerable people seems to be ingrained in the psychiatric psyche. The mass drugging of the population is an example of the coninuation of this nazi shit mentality.
It’s been made into a film but not sure if it’s out yet.
On ITV
Triplets separated at birth didn’t know they were victims of grotesque experiment
Eddy Galland, Robert Sharfan and David Kellman were separated at birth as part of a sinister experiment – Channel 4 is telling their story in Three Identical Strangers
ByMatt RoperJane LavenderAssistant Editor
21:30, 16 DEC 2019
I think basically, Mary, that everyone is running to the wrong people.
Everyone, basically, thinks SSRIs are harmless, with maybe a bit of withdrawal and maybe, a ‘sense’ of ‘restlessness’…
‘What they have done to him’ is shockingly common
It all seemed to start when the common GP was given the god-given task of chucking SSRIs at anyone who crossed their threshold, even psychiatrists, and a lot of the blame can be attributed to the UK Royal College of Psychiatrists, whose various ‘leaders’ have totally let the side down and are still doing so, in various, ways and means..
Why they are still doing this, remains a mystery.
Shane has been led up the garden path for nigh on 18 years and how thankful you must be to have David tell those, who have done the deeds, where they have gone wrong.
Hopefully, under expert guidance, he will be free, in the true meaning, of free..
All those people out their who, for one reason or another, have been given a drug, given another drug, ceased the aforementioned drug, doubled a dose of another drug and they wonder why they have become a screwed up mess…
Some of us, have been so harmed, that we tried to take legal action; the UK, it seems, is not interested in legal action against doctors.
Many doctors, who should have been in hot-water, just carry on, doing what they do…but doing what they do, should amount to a a much greater degree of analysis, but, for some reason, no-one is interested in the plagiarism, of the common GP …
I have substantial bounty in this area, and got out of it, as soon as I realised what was going on, but, many, many, many, unedified persons are stuck in the merry-go-round, and are either dead, or, are screaming out ‘what have they done to me’
I applaud your continued vigilance
It always comes from, someone who knows …
Thank you Annie. I should just add that, although David blames the Mental Health services for Shane’s problems, it was his GP that first prescribed the Seroxat that started the journey from hell. I guess David has cleverly left out that fact since the letter was to the GP surgery!
Shane was on Seroxat for 3 months – three months during which he displayed behaviours which left his family in no doubt whatsoever as to whether there was a link between taking the ‘medication’ and his suffering. From then, until just over 3 years ago when David came on to the case, I kept repeating my mantra – ‘ having been injured by Seroxat you cannot possibly expect further psychotropic drugs to improve matters for Shane, they’re just making matters worse’ at every opportunity whether it be to Community MH psychiatrists, MH Unit psychiatrists and staff or the numerous care coordinators that we met during those years. Of course, in the main, I was seen as a troublesome parent! However, there was 1 psychiatrist who declared that Shane should be taken off his meds. – as they were not doing him any good. That person left the area two days later and that message wasn’t followed up. One care coordinator, about 4 years ago, was astounded to hear the truth of Shane’s story regarding the SSRI. He was really interested in the whole matter and realised that there was far more to this case than he’d found in the notes! No surprise there then! He was really interested in the fact that David was willing to support Shane through withdrawal – a withdrawal that no other professional seemed to believe was the correct way forward.
Shane is now taking a break from withdrawing, having successfully decreased one of his medications by almost 3/4 of his original dose and the other by 1/3. That David has been so readily available has made this possible.
Expert witness skills “should be part of doctors’ training”
14 February 2019
Posted by Neil Rose
Hendry: Much wider pool of doctors needed
Learning the skills of being an expert witness should be part of the training of GPs and consultants so they can give evidence when other doctors are under the microscope, it has been claimed.
The Medical Protection Society (MPS) set out a four-point action plan to encourage and support doctors to become expert witnesses, because it was important to “ensure that doctors have an informed hearing” when they appear before the General Medical Council (GMC) or face criminal charges.
The MPS said:
The role of expert witnesses should be looked at by the GMC as part of its drive to set up new credentials for the medical register;
GP and consultant training should include acquiring the skillset to be an expert witness;
NHS employers should make it easier for doctors to be relieved from their clinical duties so they can act as expert witnesses. This may require contractual reform to give the expert witness role greater prominence, and greater certainty for those wishing to discharge the role; and
More doctors should be encouraged to consider putting themselves forward to perform expert witness duties.
Dr Rob Hendry, medical director at MPS, said “The expert evidence of a doctor – as to the expected standard of care – can be pivotal in a tribunal hearing or in criminal trials concerning incidents that have occurred in a healthcare setting.
“This is why there needs to be a much wider pool of doctors with the right experience who are able to serve. It is a vital role that doctors can perform on behalf of and in support of their profession.
He said any doctor facing a tribunal or court would hope that the assessment of their practice has been carried out by someone respected by their peers and who can present balanced evidence “in the context of delivering healthcare in a modern-day NHS”.
Dr Hendry continued: “Many doctors feel uncomfortable describing themselves as experts – that word carries a lot of different connotations.
“However, if a doctor is established in their speciality, and has built up expert knowledge in a particular area then it is likely that they have the necessary level of experience to act as an expert.
“Above all else, they need to be able to be able to provide informative and balanced evidence that assists the court to set a fair benchmark for the accused doctor.
“We need more doctors to be freed up by their employer as well as encouraged and trained to take on this important role.”
4
Readers Comments
Dr G Spoto says:
September 27, 2019 at 7:37 pm
I read this report with great interest. I believe this is a hugely important development.
As a Consultant Psychiatrist working in the NHS for many and as Medical Educator I have always been acutely aware of the lack of medicolegal training available to aspiring experts ,particularly with regard to supervised practice.
As Educational Supervisor for higher psychiatric trainees I was able to introduce medicolegal experience in the Job Descriptions of higher trainees in a large training scheme, something which was very successful and which I am soon hoping to be able to replicate in the private sector.
Of course the case for better access to medicolegal education could not be made more strongly than from a Medical Indemnity perspective and Psychiatrists, policy makers and NHS employers should all be united sharing Dr Hendry ‘s concerns as well as his Action Plan.
Yours faithfully,
Dr G Spoto FRCPsych MA FAcadMEd
Independent Doctors Federation
Behind the scenes, big push for ‘no more secrets’ …
Prescrire in English
24. RxISK
Nogracias Retweeted
Prof. Peter Gøtzsche
@PGtzsche1
·
15h
Advocate General of the European Court of Justice: disclosure of clinical study reports from EMA undermines companies’ commercial interests. So, let the patients die instead of telling them how dangerous many drugs are.
International protests
Juan Gérvas
@JuanGrvas
Access to clinical study reports: European Medicines Agency’s transparency policy and disclosure of vital documents should not be scaled back.
Apoyo y exigencia a la Agencia Europea del Medicamento para el acceso a datos crudos de ensayos clínicos.
Por ejemplo, lea el texto y vea la imagen sobre la #vacuna del #papiloma. Es urgente la moratoria y la transparencia en la seguridad. Vea lo que deja ver GSK (adjunto) sobre daños graves, todo tachado, en “negro”. ¿Usted se vacunaría? https://bmj.com/content/362/bmj.k3694.full…
For example, read the text and see the image about the #papilloma vaccine. Moratorium and transparency in security are urgent. See what GSK (attached) shows about serious damage, all crossed out, in “black”. Would you get vaccinated? https://www.bmj.com/content/362/bmj.k3694.full
After three years of trying to access trial data for HPV vaccines, Lars Jørgensen and colleagues find current transparency policies unfit for their purpose
A recap of actions in 2019
Access to clinical study reports: EMA’s transparency policy and disclosure of vital documents should not be scaled back (December 2019)
19 December 2019
https://english.prescrire.org/en/79/207/46302/6241/5953/SubReportDetails.aspx
Disclosure of clinical data and information, including clinical study reports, is literally of vital interest for patients, and also needed for healthcare professionals, researchers, HTA bodies, independent drug bulletins, healthcare payers, the global health community, the general interest and public health.
Full transparency – not secrecy – is the way forward!
I’m not sure whether it’s appropriate for this string, but did anyone see, and shudder with awful recognition, the Channel 4 docudrama ‘The Cure’ this last week, 9pm Wednesday, about the Staffordshire hospital scandal. Brave Julie Bailey did her best to improve standards. She’s a marvellous woman, we met with her after our son died in not dissimilar circumstances and she helped us with good advice. The portrayal of the Management team in the film was brilliant as they callously sacrifice patients’ lives to get the magical Trust status and thus to raise their salaries. If Annie could find the link and put it on here so people could see it, that would be wonderful. Sadly one hoped that after Julie Bailey’s enormous and hard won efforts (at great cost to herself and her family), and the commissioning of the Robert Francis report, things would improve. Do we think they have?……
Thanks, Heather
Stafford Hospital scandal: The real story behind Channel 4’s The Cure
It was one of the biggest scandals in the history of the NHS and saw hundreds of patients die. Now the story of Stafford Hospital, told through the eyes of campaigner Julie Bailey, is being brought to screens in new Channel 4 drama The Cure. BBC News takes a look at the Stafford Hospital scandal.
https://www.bbc.co.uk/news/uk-england-stoke-staffordshire-50836324
The Cure:
https://www.channel4.com/programmes/the-cure
The Cure: The truth behind Stafford Hospital scandal that inspired new Channel 4 drama
Tilly Pearce
19 Dec 2019 5:40 pm
https://metro.co.uk/2019/12/19/cure-truth-behind-stafford-hospital-scandal-inspired-new-channel-4-drama-11934885/
Sir Robert Francis QC, speaking in a February 2013 report, stated: ‘This is a story of appalling and unnecessary suffering of hundreds of people. ‘They were failed by a system which ignored the warning signs and put corporate self-interest and cost control ahead of patients and their safety.’