The image is of legendary journalist Bill Haddad who did more to grapple with pharmaceutical corruption than anyone else.
The opening lines of A Pill for Neoliberalism, as delivered, about the job of doctors and journalists being very similar, were not part of the transcript in last week’s post.
The remarks came to me as a large crowd of media and journalism students assembled for a lecture on neo-medicalism. What I wondered is the difference between what a good journalist should do and what a doctor does or should do – very little difference it seemed to me while waiting to deliver the talk.
But this is not how it looks to most people, who see journalists perhaps investigating a topic but having to step to one side when they come up against the “science”. Their job is not to ask questions about medical science but to accept it as gospel truth and build their story around that.
Most journalists – and here I include anyone working in any media from documentary making to feature writers or newspaper reporters – are now coached from the start or else they have found the organization they work for changing around them so they now realise they need to avoid a False Balance. Just as it is not their job to present the views of Flat Earthers alongside those of real physicists, so also they should present the benefits of vaccines and drugs without question and not even begin to entertain thoughts of raising questions about hazards never mind the views of vaccine sceptics.
Miranda Spencer wrote a great article about this on Mad in America recently, where she outlined the background to and operating style of the Carter Centre for Journalism.
This increasingly it seems is the way doctors are supposed to behave also – bowing to the science that has been laid down by bodies drawn together to establish a professional consensus – bodies that never fail to reflect the interests of pharmaceutical companies.
It began in the 1990s
An effort began in the 1990s, and is still going on today, to persuade US courts to behave the same way. (Europe is irrelevant). If the science shows that antidepressants cannot cause suicide or homicide, then experts trying to tell the court that this person committed homicide because they were on drugs should simply be thrown out without being heard.
Very few doctors and almost no American doctors were able to answer the challenge they faced in court from pharmaceutical companies – you have anecdotes but we have science and to be allowed into court you have to have science and not anecdotes.
The few SSRI legal cases that happened though ended up exposing by accident that pharma’s science was ghostwritten and that there was no access to the data behind it.
With even minimal access to the data, pharma’s case began to crumble as it became clear that the science and the anecdotes lined up along with the documents showing how everything was ghostwritten.
Which brings us back full circle. The job of the courts – and journalists – is to cross-examine a case, the history of the event and any witnesses that can be brought into court in order to establish what probably happened.
If it seems the likeliest explanation is that the drug caused the event in question and this conclusion seems to be at odds with the science, the second job for the experts in court or liaising with journalists – or maybe for the journalist – is to ask why there is a mismatch in the case of medical drugs between what might seem to be a compelling individual case that this statin, antibiotic or anticonvulsant caused homicide or materially contributed to it and the literature that denies this possibility.
This is exactly the role doctors used to have. Faced with a patient mentioning some effect on treatment, their job was to examine and cross-examine the patient and work out what was likely happening. If the obvious explanation was the drug had triggered the problem, there was an onus on them to act – stopping the drug for instance. They might report the event to regulators.
If this weren’t the case, we would never know what the hazards of a drug might be. Our knowledge of these hazards does not come from controlled trials (RCTs) or the kinds of sources pharma cast as science – a game that involves money to get into and a commitment to the idea that we can’t depend on the observation of our own eyes – whether as doctors or patients or journalists – and we should not be let weigh the evidence ourselves.
Part of our current trouble is that regulators have been bamboozled by this where courts weren’t (thanks to a few brave law firms) and the regulators too now intone the anecdotes are not science mantra. Regulators like FDA rarely if ever discover or let anyone know that a drug can cause an adverse event.
The same is true of the makers of Guidelines like NICE Guidelines who operate on the basis of ghostwritten RCTs without access to the data and never discover or mention treatment related adverse events.
If instead of approaching regulators or guideline makers, we take our problems on treatment to politicians, they will say they depend on the advice they get from the bureaucrats in the regulatory and guideline apparatus. The politicians turn to bureaucrats rather than doctors.
There’s not really much point turning to doctors if all they will say in turn is that they depend on what they are told by regulators and guideline makers.
Doctors have essentially become bureaucrats, who sit even lower on the pecking order than folk in regulation and guidelines – folk who don’t really like meeting people and are happy for doctors to do this.
Soon doctors, sitting in a sub-middle management role, will avoid meeting people also while ensuring that nurse prescribers and physician assistants who do meet people keep using drugs as per labels issued by regulators and per guidelines.
It feels like nothing short of taking a suicide bomb into a regulatory apparatus would allow a breath of air in but even then the trap would slam shut again pretty quickly.
Coming up for Air
A forthcoming Conflict of Interest conference sponsored by Johnson & Johnson has spawned debate among people I know and regard highly. Some bioethicists and others have been asked to participate but have opted not to attend – their argument being that this meeting will enable pharma to co-opt the appearances of bioethical approval.
Journalists working in the health space note that similarly they get invited to health-related meetings – on the cost of diabetes drugs for instance – sponsored by Lilly – and refuse to attend.
This has been pitched as a recent development in the tightening grip of pharma. It’s not. Bioethicists have been collaborating closely with pharma for at least two decades and journalists have been taken to health meetings for probably three or more decades.
Those who do go to the meetings have a view that is closely related to the views of the Guardian and New York Times, as well as the BBC, PBS and other media groups – that their role is not to promote a False Balance. If the science has spoken, the role of the media and journalists is to report it.
Those who don’t attend say the sponsorship necessarily vitiates the content but de facto even without attending any meetings sponsored by Pharma, or Gates or whatever, they will not report on the adverse effects of treatments or vaccines – to do so would be the equivalent of giving equal space to a bunch of Flat Earthers. The attendees and non-attendees end up in the same position.
The idea of complaining about these pharma sponsored meetings on the basis of Conflict of Interest is understandable but a weak card to play. Attending a comparable meeting without any pharma sponsorship would come up with the same results and media copy if the brief of the media is to report around the fringes of the science rather than to take issue with it.
There is a lot of low hanging fruit about ghostwriting and lack of access to the data for journalists and doctors to take issue with – in forums sponsored by pharma or not.
But the low hanging fruit is no longer the key task for journalists or doctors – the need now is to demolish an RCT/EBM ideology that stops us believing the evidence of our own eyes, and weighing the on paper “evidence” that is designed to negate our evidence.
Unless doctors do this they will be consigned to sub-bureaucratic status in the very near future. Ditto for journalists. Working for the New York Times or Guardian won’t change this reality any more than being based in Harvard or Oxford.
part of their resistance could be that our personal as well as collective data is now worth billions to such as Google It has been sold over and over without our consent. If ‘anecdotes’ receive the same acceptance as evidence as data , I guess be much more difficult for ‘them’ -whoever they are – to collect? Or use to then draw up guidelines which doctors are obliged to follow.
Anybody going to this ‘celebration’ of journalists and bureaucrats?
NICE comes of age: ready for the challenges ahead?
Wed 1 Apr 2020 from 12:45pm to 7:00pm
Location
Royal Society of Medicine
Organised by
RSM Deans Programme, NICE London ILL, BMJ Editorial
The Royal Society of Medicine and The BMJ are bringing together a multidisciplinary faculty of experts to celebrate the 21st anniversary of the National Institute for Health and Care Excellence (NICE).
Organised by the RSM and The BMJ, in collaboration with NICE, the event will review the impact that NICE has had on both the national and international healthcare landscape since launching 21 years ago.
Join us to reflect on the challenges NICE has faced along the way, the lessons that have been learned and explore the challenges that may lie ahead as we look to understand NICE’s role in the future of health.
Attendees will:
Understand the political climate into which NICE was launched and some of the resistance its formation faced
Understand the impact NICE has had on both national and international healthcare
Learn about the range of challenges NICE has faced and how the organisation has navigated them, including the use of QALYs, the economic model, battles with industry, patient involvement, conflict of interest and the production of guidelines
Discuss some of the controversies about NICE’s decisions and stances
Reflect on both the future direction of NICE and potential challenges ahead
It seems to me that, all things considered then, I guess, we should accept that we’re getting nowhere in these muddy waters! I, for one, refuse to accept that. It’s true that, for every step we take on this journey, we are knocked back two. However, to be ‘knocked back’ is not the same as being pushed to the ground. We have to keep going, keep making a noise, for our own sakes and for the sake of others. Hearing one side only, on any topic, does not broaden the mind and refusing to accept both sides of a story is unforgivable.
I would love to know how the audience reacted AFTER LISTENING to your talk. Did they seem able to take on board any of the facts that you shared with them? Were they taken aback? Were they confident enough to actually share with you that maybe there were some truths in what you had to say?
Is it time to bombard the public, in all areas, with our message, in Greta style? She is on the autism spectrum herself, would she add our message to hers in some way? The fact that wildlife is affected as a result of our consumptions of psychiatric drugs, for example, would surely concern her too? Interesting, of course, to note that she, too, is now ‘upsetting the mainstream’ – what was her reaction? – “we must be doing something right”.
Whether we like it or not, our truths, just like hers,will upset many. What we must always remember is – the truth will NEVER upset ALL the people and whilst we still have a number of us who truly believe in the wrongs caused, in the name of science, hope MUST shine through.
Is it time to nationalise the pharmaceutical industry?
BMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m769 (Published 04 March
Responses
Mariana Mazzucato, founding director and professor in the economics of innovation and public value1, Henry Lishi Li, research fellow in health innovation and policy engagement1, Ara Darzi, co-director2
Author affiliations
Correspondence to: H L Li henry.li@ucl.ac.uk, A Darzi a.darzi@imperial.ac.uk
Drug companies fail to take account of the public interest and relentlessly focus on short term returns, say Mariana Mazzucato and Henry Lishi Li. But Ara Darzi argues that the profits drug companies make are vital for developing new medicines
Yes—Mariana Mazzucato, Henry Lishi Li
Do we support state ownership of the whole pharmaceutical industry? No. But do we think that the state should play a greater role in the sector? Absolutely.
The public sector is a cornerstone of the pharmaceutical industry, often taking on the highest risk in the early stage of innovation.1 It is also key to creating clusters that connect different actors in research and development (R&D), manufacturing, and health system demand, thus shaping the pharmaceutical market across its entire value chain.
Short termism and misalignment of the existing market
While the private sector is also crucial in bringing cutting edge medicines to the market, its entrenched short termism and misalignment with public interest are equally striking.2 Firstly, companies prioritise “blockbusters” at the expense of commercially unappealing medicines that are hugely important to public health.3 Secondly, the pricing of these medicines does not take into account the contribution by other actors, including public institutions.4 Thirdly, patents are often abused, being too upstream, wide, and strong,5 and high prices can persist even as generic competition kicks in, as a result of occasional cases of inefficient competition.6 Fourthly, high prices are driven by and in turn fuel the over-financialisation of parts of the industry, where share buybacks are outpacing R&D.7 These prices also lead to a drive to cut costs by outsourcing manufacturing capabilities overseas, at the expense of local capacity.8
The state should therefore govern the drug innovation process more like a market shaper: steering innovation, getting fair prices, ensuring that patents and competition work as intended, setting conditions for reinvestment, and safeguarding medicine supply. In other words, this is not about bashing big pharma—of course, it plays an important role—but about finding a way to govern a system that is not working for members of the public, who have invested in some of the riskiest stages of drug development.
In this context, where conventional policy instruments cannot effect the needed change in the pharmaceutical sector (especially where it fails), there is a strong case for a public option in pharmaceuticals: government provided, quality assured medicines that are universally available at a reasonable and fixed price, which coexist with products from the private sector.9 This requires the government to be more directly involved in coordinating and executing the full range of activities in drug innovation and manufacturing and to retain a sufficient level of control.
Nationalisation is ideally positioned to deliver this public option.10 Indeed, this is the very reason why the ex-chief economist of Goldman Sachs, Jim O’Neill, recently called for nationalisation to help solve the crisis in antibiotics innovation.
Market shaping: the entrepreneurial state
Nationalisation is not just about fixing a (private) market failure; it is about unleashing an entrepreneurial state shown to be good at developing transformative innovations.111 It equips the state with greater strategic control over long term capital allocation and the resources to strengthen dynamic capability in the public sector (such as national laboratories and strategic agencies such as the Biomedical Advanced Research and Development Authority).
A more proactive role includes ensuring that the results of public investments in the riskiest phase of drug research—such as that coming from the $40bn (£31bn; €36.6bn) a year invested by the US’s taxpayer funded National Institutes of Health1—are accessible only to the private companies willing and able to deliver medicines needed by the public, at a cost the public can afford. The same would apply to government and charity spending on medical R&D in the UK, which makes up 45% of the total spending.12 This is not about micromanaging companies but about ensuring a public benefit for public investment. By making sure that prices reflect the public contribution, nationalisation can be a better way to manage risk and reward.
A market creation and shaping perspective allows nationalisation to take different forms. Complete transfer of ownership is not necessarily required. Given different global contexts (such as the more stakeholder driven corporate governance in Scandinavia), the degree of ownership versus steering will differ.
Broader public interests
Nationalisation is further necessitated by broader public interests. A public option in pharmaceuticals is not only fundamental to protecting the human right to health and global health security3 but is also a strategic asset for the following:
Protecting national security. Outsourcing of manufacturing capabilities creates vulnerability in the supply chain that can lead to crippling shortages in quality assured, essential medicines. Governments should tackle this as a significant security risk.
Improving national competitiveness. The R&D of advanced biological, cell, and gene therapies requires substantial process innovation in manufacturing. Governments should take up leading roles in building the necessary “industrial commons.”8
Establishing robust market competition. Huge barriers to entry and market concentration can complicate or prevent effective competition. Governments can improve market efficiency by introducing new product options and providing transparent information on R&D and manufacturing.
No—Ara Darzi
The profit driven pharmaceutical industry is the worst system for discovering new drugs—apart from all of the others. This is a familiar trope, but it contains an important truth. There are downsides to any system. The challenge is to manage them.
Over the past 50 years, big pharma has delivered transformative improvements in global health. That is incontestable. The eradication of smallpox, the discovery of HIV drugs, the introduction of monoclonal antibodies: these three alone have saved millions of lives. The UK’s long history of drug discovery and development is the envy of the developed world. The life sciences industry employs 140 000 people in one of the most productive sectors of the economy.
Drug companies do make big profits, but these are necessary to fund the enormous costs of developing new medicines. Glaxo spent £19bn (€22.3bn; $24.4bn) on research and development (R&D) over the five years to the end of 2018.13 AstraZeneca spent nearly £30bn.14 Could a state controlled industry match these outlays? Would it?
Licensing and de-linkage
There are problems. They include “me too” drugs offering minimal gains, excessive advertising, price gouging, lack of transparency, and protectionism. During last year’s election campaign the Labour leader, Jeremy Corbyn, highlighted patients being “held to ransom” by one manufacturer, Vertex, which was locked in a battle with the National Institute for Health and Care Excellence (NICE) over Vertex’s £100 000-plus price tag for the cystic fibrosis drug Orkambi.15 It wasn’t pretty, but it was resolved by negotiation, and the drug is now available on the NHS.
Yet Mr Corbyn threatened to establish a publicly owned generics company and to strip existing drug companies of their intellectual property by introducing compulsory licensing—which would give the government the right to copy medicines deemed too expensive for the NHS.16
With Brexit done, the last thing we need is a hostile environment for intellectual property and entrepreneurship. We need to foster our innovative and competitive pharmaceutical industry, not destroy it. True, an industry that relies on profits does not work for every drug class. There is an urgent need for new last line antibiotics, but the market is too small to generate returns. Here, some form of de-linkage is required, where governments step in with financial guarantees.17
Critics of big pharma go further, favouring de-linkage more widely, whereby governments would expand direct funding of R&D.17 Yet governments already fund R&D, through our great science based universities (now doing ground breaking work on the 2019 novel coronavirus). Big pharma excels at the subsequent stage: taking the best ideas generated by scientists and bringing them to market, using its huge financial firepower to navigate the complex regulatory environment. No government could risk the huge sums involved.
Successful regulation
So, yes: British drug companies make big profits, which are necessary to fund the development of better treatments and save lives. The flipside is tough regulation to manage the downsides.
Here, Britain also has a proud record of success. This is the country that developed NICE to ensure that only cost effective drugs were prescribed on the NHS—a model since copied around the world. The consumer regulator, the Competition and Markets Authority, has shown its mettle against big pharma by winning an £8m refund for the NHS last October from Aspen, a company accused of anti-competitive behaviour.18 And the NHS successfully struck a deal with the industry last year—the voluntary pricing and access scheme—under which the growth in NHS sales of branded medicines will be capped at no more than 2% a year for five years from 2019.19
The result? Our spending on drugs is lower than most of our European neighbours, amounting to just 12% of total health spending and placing the UK in the bottom quarter of OECD countries.20 The upshot is that we get excellent value from the pharmaceutical industry, and the downsides of its profit driven nature can be managed. We should support, monitor, and regulate it—not kill it.
Footnotes
MM is professor in the economics of innovation and public value at University College London (UCL), where she is founding director of the UCL Institute for Innovation & Public Purpose (IIPP). HLL is research fellow in health innovation and policy engagement at IIPP.
AD is a surgeon and director of the Institute of Global Health Innovation at Imperial College London. He was a Labour health minister from 2007 to 2009.
Competing interests: All authors have read and understood BMJ policy on declaration of interests. MM and HLL have no relevant interests to declare.
AD declares the following interests: chair of the Accelerated Access Collaborative; honorary consultant surgeon, Imperial College Healthcare NHS Trust and the Royal Marsden Hospital; co-director of the Institute of Global Health Innovation; co-director of the Cancer Research UK Convergence Science Centre at the Institute of Cancer Research and Imperial College London; non-executive director of NHS England and Improvement.
Provenance and peer review: Commissioned; not externally peer reviewed.
A different tack – journalists and doctors …
It is always useful to provide an example of ‘Good Journalism’ with all the facts of the medication involved in a death.
This rarely happens in mainstream media and we can assume this doesn’t give a ‘fair balance’..
Luckily we have lucid, and clear writing, as provided, here –
Journalism should take note, and, more to the point, the prescriptions – speak for themselves …
Charlotte: SADS or Polypharmacy?
Posted on March 4, 2020 by Brian — No Comments ↓
http://antidepaware.co.uk/charlotte-sads-or-polypharmacy/
The inquest into her death began in October last year. The family hoped to finally have answers as to how Charlotte died, and had secured an expert psychiatric report that examined the impact of the medication Charlotte was prescribed. But the inquest was adjourned until February 2020, because the NHS Trust asked for this evidence to be excluded from the inquest.
The coroner denied this request but gave the Trust time to produce their own report. Charlotte’s mother Sue said that when the inquest was delayed, she couldn’t stop crying. She said: “To me, it feels more like a trial than an inquest.”
In October 2014, while at Bronzefield Prison, she was prescribed: “Diazepam (for anxiety), Depakote (for mania symptoms), Mirtazapine (an antidepressant), Beclomethasone and Salbutamol (for asthma), Mebeverine (for abdominal cramps), Nafarelin and Tibolone (synthetic female hormones for PMDD symptoms), Omeprazole (to treat excess stomach acid), and Paracetamol (for pain relief).”
In July 2015, “the consultant forensic psychiatrist prescribed Trifluoperazine (an antipsychotic medication that can be used to treat certain types of anxiety).”
Ms Nokes received 200mg of Zuclopenthixol (an anti-psychotic medication) and the next day, the psychiatrist spoke to Ms Nokes by phone and prescribed 5mg of Diazepam.”
Woman serving ‘never-ending’ jail term suffered ‘sudden unexpected death’
https://www.theguardian.com/society/2020/mar/03/woman-serving-never-ending-jail-term-suffered-sudden-unexpected-death
Long gone are the days when Sarah Boseley, Health Editor, The Guardian, wrote seriously explicit articles, regularly, about Seroxat …
‘…but I’m afraid that is the way it is. …
My god another horrendous story. I can’t believe she was in prison for eight and a half years for what she done?.
She was kept in because of her mental state I bet which was probably bought on by all the drugs she was on. She was “in prison within another medicated prison that put her there in the first place”.
I want to swear out loud but won’t but this is all so wrong. She should not have even been put into prison in the first place. Sounds to me as if she needed healthcare urgently but if a crime is involved that takes priority over the cause in this backward corrupt country.
God im just an ameatur but even I can see what’s wrong here. So much for living in the 21st Century.
Moving On or Leading them Astray?
Richard Smith: The case for workshops on publication and research ethics (and an invitation)
March 6, 2020
“Imagine that you write a scientific paper on the influence of various factors on drug compliance. You are not writing about a specific drug, but a student who is working with you has a small grant from a drug company. Should you declare this as a conflict of interest?”
This is a case that I have been using for years in a workshop on publication and research ethics.
Many people will think that there’s no point in declaring something so trivial that could not possibly have affected your judgement. It’s not clear if the student is a co-author, but even if she or he is it could not have affected your judgement. It’s a general subject, nothing specifically related to the company. Plus, you are aware of evidence that if you do declare a conflict of interest readers will think less of your paper, which seems unfair.
Others take the view that all conflicts of interest should be declared no matter how minor. As an author you cannot know if the conflict of interest has affected your judgement: the bias operates unconsciously. We have to do double blind randomised trials to evaluate interventions not because people are consciously fiddling results, but because bias is subtle and pervasive. We have lots of evidence that conflicts of interest do affect judgements. The policy should be “if in doubt declare” or “declare everything even something that seems irrelevant.” One reason for such a policy is that if you don’t declare a conflict of interest and later an editor or reader makes you do so it looks as if you have been dishonest, hiding something.
The point of the case is that there is no “right” answer and that people make different decisions. After people in the workshop have read the case I ask them to vote, and often the vote is split 50:50. I then get people from each side to try and convince those from the other side that they are right.
Then I ask questions like: What if it’s a large grant rather than a small one? What if the student is a co-author? What if the person is not a student but a shareholder, employee, adviser to the company, somebody who has been paid by the company to give a talk, or somebody who attended the talk given by somebody paid by the company and was given a glass of indifferent red wine and two pens?
My point is that publication and research ethics (like all ethics) cannot be reduced to a set of rules that you simply memorise and follow. There is no substitute for thought and judgement. (Having said that, I do share with the people in the workshop links to the guidelines of the Committee on Publication Ethics and the International Committee of Medical Journal Editors).
I have a dozen cases that I use, all of which are designed to divide opinion. But often these days I don’t use them at all—because I start by asking if anybody has had a problem. Years ago people would share problems with me after the workshop, but these days somebody usually volunteers a problem at the beginning. The commonest problems relate to authorship, and the single commonest problem is senior colleagues, often supervisors, insisting on being authors on papers where they have done little or nothing. In many cultures it is impossible for a younger researcher to resist this demand. We often conduct a role play with me playing the demanding, unreasonable senior (a role I enjoy and find embarrassingly easy).
Stephen Lock, my predecessor as editor of The BMJ, was one of the first people in Britain to become concerned about research fraud or misconduct—back in the 1980s. The establishment dismissed his concerns by arguing that misconduct was rare, nobody was harmed, and science was anyway self-correcting. We now have ample evidence that all these arguments are fallacious. Misconduct is common, and it’s important that anybody conducting research has some chance to learn about publication and research ethics and recognise the scrape that they might fall into inadvertently. In the US all PhD candidates have to do online courses on misconduct, but there are worries that these have degenerated to “tick box exercises.”
I think that it’s important to discuss cases and reflect on the difficulties, which is why I run my workshops. I’m not looking for more work (and am happy to share my cases with anybody), but I am running a workshop with Sara Schroter from The BMJ, who has done more research into scientific publication than perhaps anybody else.at the London School of Hygiene and Tropical Medicine on 25 March from 2-4pm—and it’s open to doctoral students and staff at LSHTM and doctoral students from the Bloomsbury Postgraduate Skills Network (see below for list of members). If you are eligible, please come. Contact transferableskills@lshtm.ac.uk to book your place. I promise you’ll have fun.
Bloomsbury Postgraduate Skills Network
University College London (founding member
Richard Smith was the editor of The BMJ until 2004.
Competing interest: RS has run his workshop in many countries and institutions. Usually he is not paid, but he has been paid intermittently by the London School of Hygiene and Tropical Medicine, where he has been running the course for around 15 years.
Another brave expose by Dispatches(Channel 4) Celebrities are paid loads of money to endorse, promote Charities, Thousands for an Instagram Post.. Including potentially Harry Rednapp, Caitlyn Jenner and Stanley Johnson.. #Things that make you go ummm
Students could discuss the case of Elizabeth Loder who declares no conflict of interest re her work at thebmj . That is hard to believe ,but maybe not impossible, considering her husband.s position and who his firm represents. When there are many others who could do the job – why was EL appointed.?
She currently divides her time between her position as a clinical editor at The BMJ and duties as the chief of the Division of Headache and Pain in the Department of Neurology at the Brigham and Women’s/Faulkner Hospitals in Boston. She is a professor of neurology at Harvard Medical School.
Competing interests
© I have the following interests to declare:
Personal
My husband is a partner in the law firm of Ropes & Gray. This is a large firm with offices around the world. It represents clients in the healthcare field, including academic medical centers, pharmaceutical and device companies as well as companies that invest in medical businesses. My husband’s work does not involve healthcare.
50 Shades of Gray …
‘Medication Time’
https://davidhealy.org/study-329-50-shades-of-gray/
The strongest evidence I have as to why there was such an unconscionable delay is that BMJ have been and still are scared close to shitless about publishing anything that might make a pharmaceutical company uncomfortable.
They have no problem publishing a Beasley et al paper that shows an increased risk of suicidal behavior on Prozac but claims there is no risk and that the data exonerates Prozac. They have no problem publishing Lu et al in 2014 that claims to show warnings on antidepressants cause suicide – a shoddy piece of work if ever there was one.
Ironically providing access to the data seems to have increased BMJ’s difficulties. A key message from Restoring Study 329 is that when data is made available all authorship (interpretation) becomes provisional. Despite apparent support for access to data, The BMJ want science to be authoritative – Biblical – rather than provisional. If an article offers the indisputable Word of God, they can’t get sued. If there is scope to read the matter in another way as David Linden’s Response to Restoring Study 329 indicates there is and always will be, the BMJ and their lawyers have a problem.
In my experience journals run by ex-pharmaceutical company employees have been much more courageous than BMJ on matters like this. However, while they appear to have lied at least twice in the process, BMJ are a long way from being the worst in terms of courage and integrity – they do, though, take some beating in terms of prissiness.
What was galling about the exercise was that BMJ (and everyone else who colludes to put BMJ and other journals in this position) see fit to turn their lack of guts around and blame our conflicting interests.
This is to be expected from people who have themselves been abused or are living in an abusive situation. Medication Time.
The following letter has not found favour at BMJ RR:
What is the safety threshold for a vaccine?
Dear Editor
WHO officials state [1]:
“These regulators concur in their assessment that the vaccine has an acceptable safety profile and that the benefits of the vaccine outweigh the risks”
While perhaps being more realistic than the more familiar blandishment “the benefits far outweigh the risks” it is an admission that administering the product could have considerable negative implications for a population, not to mention what might happen if you administer a large number of products where there is simply arguably a net benefit and no more. Even if there is a net benefit, which is not without ambiguity, how much harm could be delivered for small benefit by banal assurances.
How for example, do we assess the net benefit of a Meningitis B vaccine which among other listed side effects could cause Kawasaki Disease in 3 in 1,000 infants [2].
[1] Swaminathan et al, ‘The WHO Malaria Vaccine Implementation Program: clarifying misconceptions’, 2 March 2020, https://www.bmj.com/content/368/bmj.m734/rr-1
[2] John Stone, ‘An argument already lost by default?’, 22 November 2019, https://www.bmj.com/content/367/bmj.l6447/rr
The Power of the Written Word …
“We have a totally naive population that has never been exposed to it before.”
https://www.itv.com/news/2020-03-06/we-are-learning-as-we-go-with-coronavirus-government-adviser-sir-patrick-vallance/
Is he talking about Seroxat?
– government adviser Sir Patrick Vallance
(Oh, and footnote: Patrick Vallance, GSK’s current supreme medical person? If you were at UCL medical school doing your clinical training, in the late 90s, like me, then he was the clinical pharmacology prof who taught us how to prescribe. Nice guy, smart guy.)
https://www.badscience.net/2012/10/gsk-have-promised-should-we-trust-them/
Cisparency and Transparency
https://davidhealy.org/cisparency-and-transparency/
November 6, 2017
Jobs For The Boys? :GSK’s Andrew Witty And GSK’s Patrick Vallance Fly Though The Revolving Doors…
So there are two reasons behind the move to republish this study as it should’ve been reported twelve years ago:
The first is obvious – to correct the academic literature. This article shouldn’t be there. If they won’t retract it or correct it, then the only choice is to add a corrected version of the report on the clinical trial.
Second, to make the statement to future sponsors, authors, academic institutions, and journal editors that if they engage in this kind of scientific misbehavior, whatever their motive, they should be prepared for a public statement of what they did as a potential consequence.
https://1boringoldman.com/index.php/2013/10/29/an-addendum/
Why it has been reframed into a debate about GSK’s newly proposed program for data transparency is open for speculation and interpretation, but well off the actual point…
That ‘Nemo’ feeling …
Interesting that the author of the article described NICE only as a ‘cost watchdog’ in the ehadline.
Pharma
Teva’s Ajovy scores backing from England’s cost watchdogs
by Eric Sagonowsky | Mar 11, 2020 8:01pm
Ajovy
In draft guidance, Teva’s Ajovy scored a backing from England’s cost watchdog. (Teva)
Teva Pharmaceutical’s launch for migraine prevention med Ajovy has run into some tough competition in the U.S., but, across the pond, the rollout just got a big boost.
England’s cost watchdogs, the National Institute for Health and Care Excellence (NICE), endorsed the medicine in a preliminary decision that, if it stands, will allow about 10,000 patients access to the drug. Teva offered up a confidential discount to secure the agency’s backing.
The drug costs about £5,000 per year in England before any discounts.
After a review of the data, NICE experts found that Ajovy beats supportive care—typically treating acute pain—for patients who have already tried three preventive options. The experts couldn’t conclude whether it’s better than Allergan’s Botox at preventing chronic migraine, but reviewers backed the drug for patients who haven’t had success with Botox.
But NICE has conditions. Under the guidance, patients should stop taking Ajovy if their migraine frequency doesn’t improve by at least 30% following 12 weeks of treatment. The draft guidance is open to comment, and NICE says the final guidance will likely be published next month.
NICE is “pleased that the company has been able to work with us to address the concerns highlighted in the previous draft guidance,” Meindert Boysen, director of the Centre for Health Technology Evaluation, said in a statement. Last November, NICE recommended against using the med in patients who suffer at least four migraines per month.
The decision marks a win for Teva’s important Ajovy rollout,
Side Effects
Fast heartbeat.
hives, itching, skin rash.
hoarseness.
irritation.
joint pain, stiffness, or swelling.
redness of the skin.
swelling of the eyelids, face, lips, hands, or feet.
troubled breathing or swallowing.
“The documents contain verbatim emails that describe the naked ambitions of a corporation, a prominent scientific journal, colluding specious academics, ghostwriters, and pharmaceutical company marketers. The colluders reaped profits at the expense of medical and academic integrity.”
Amsterdam spent decades uncovering and publishing data about GSK’s research misconduct, especially concerning a ghostwritten, plagiarized paper to which Charles Nemeroff appended his name as the ostensible “first author.”
New Research Letter Supports Amsterdam and McHenry Against GlaxoSmithKline
Psychiatrist Edward Tobe offers support to Amsterdam and McHenry’s whistleblower complaints against GlaxoSmithKline for research misconduct.
Peter Simons
16 March, 2020
https://www.madinamerica.com/2020/03/new-research-letter-supports-amsterdam-mchenry-glaxosmithkline/
according to Tobe.
“The corrupt Nemeroff et al. paper has never been retracted. At the date of this written response, according to Google Scholar, there have been 500 citations of the Nemeroff et al. fraudulent publication, 15 citations of the 2012 Amsterdam and McHenry paper and no citation of the latest 2019 Amsterdam and McHenry paper. The editors of The American Journal of Psychiatry have elected to not inform their readers that the information in the Nemeroff et al. paper is flawed.”