Up to 1980, the pharmaceutical industry was small beer. Most of the companies had recently demerged from chemical companies, and were hiring management consultants to help them work out how to do the job.
A steady stream of life-saving drugs from the 1940s to 1960s that people and health services were willing to buy at prices greatly in excess of their costs of production gave industry time to consider the new marketplace. They faced a loss of revenue when their branded products lost patent protection and generic companies could muscle in and undercut their profits. They warned politicians things were not as rosy as they might look and not to think about interfering with the golden egg laying goose, or everyone would be worse off.
Adolf Jann, the Chairman of Hoffman la Roche in the 1970s, when Roche’s Valium was the best-selling drug in the world gave a great example of this when asked
The amount you have spent on research, especially considering the great profits you are making for example on Librium and Valium have made which you say you are spending most of it on research is giving you an immense amount of power over the direction in which pharmaceutical research around the world is going. It’s a large sum of money – don’t you think you should be accountable for that?
Jann responded: I would say no.
Interviewer: Why not?
Jann:
Because it is in my opinion absolutely logical that my task, my responsibility is to develop Hoffman La Roche. And why are we doing that? We are doing it because it is absolutely clear that the only chance for the social security or social health service is to make economies by finding new drugs.
It is worth seeing the full The Antidepressant Story from which this Adolf Jann snippet comes – starting circa 19.30 minutes in and running to 20.40.
Big Risk
In 1980 a door opened to Pharma becoming Big. Geoffrey Rose, an innocent British medical academic, floated the idea of preventive medicine – managing a person’s risks before a disease developed when putting things right would be more expensive and difficult. Lowering blood pressure is easy and cheap compared to repairing stroke damage.
Rose figured getting people to eliminate salt from their diet and stop smoking could save lives – and money. And there is no hazard to things like reducing salt or getting fit.
Neither Rose, nor many others, noticed the lemons lining up in Pharma eyes. They had just the products to manage risks – drugs to lower sugars, cholesterol and blood pressure, increase airway diameters, reduce allergic and inflammatory responses, thicken thinning bones, and nip any possible nervous problems in the bud before they developed.
Lowering blood pressure, they agreed with Rose, was more easily done than repairing stroke damage and much more efficiently done with a drug than by stopping salt.
Better again, where people only had one disease or medical emergency at a time, and that only lasted for a short time till they recovered or died, they had multiple risk factors and would have every one of them every day for the rest of their lives.
The logic was compelling. This is where the money is. The research costs for developing an antihypertensive drug were minimal compared to developing a cancer drug. Antihypertensives were pretty well certain to work, anti-cancer drugs aren’t. Doctors, patients, governments and insurers could all be persuaded to lay out money now in order to prevent paying more later.
One big risk to industry, which came into view in the 1990s, would vanish. AIDs led to intensive efforts to develop innovative new treatments that would save lives. Industry came up with antivirals that were marginally effective but for which they could charge a lot of money. Then patients discovered Triple Therapy – combining several antivirals together did save lives. All of a sudden, industry were under pressure to drastically reduce the cost of their drugs so that the poorest of the poor could afford them. When a treatment saves lives the moral pressure on industry to cut prices is huge.
Goldman Sachs commented – Saving Lives is not a good Business Model.
Industry’s turn to treating risks was cemented in place. There was no risk in treating risks. Industry could set its price and if people didn’t like it they didn’t have to pay. Those on the Left who still lobbied to get prices reduced for not so life-saving life-savers were effectively lobbying to get ever more people on ever more meds.
Better again, this opened the door to seducing parties of the left – the Democrats and European socialist parties. The lure of saving money on healthcare caught in the GSK advert above was potent.
The Labour party in Britain put in place a quality and improvement framework that aimed in the interests of equity at getting all of us treated for all our risks.
Previously we consulted doctors when we had a problem. Now doctors and clinics began to call us in for screening. They began giving us problems we never thought we had. Governments incentivized docs with bonuses to get us on meds. Industry could start thinking about disbanding its sales’ force and let governments do the selling for them.
Government endorsement was more effective than Free Lunches. The only reason to keep the Free Lunches in place was so that people had something to point to and claim – there that’s the problem. Get rid of that and everything will be just fine.
Hand in hand with screening went Evidence Based Medicine (EBM). No Free Lunch was a relatively ineffective stick – refuse the carrot-cake – to beat industry with. EBM would effectively rein industry in by offering eyesight improving carrots to help doctors distinguish between reliable evidence and anecdotes. Governments and other medical bodies built these carrots into Guidelines (Sticks).
Industry trials switched to endpoints like blood sugar, lipids, or pressure, producing convincing significant changes on these – although without saving lives. The Guidelines for risk factor treatments were based on industry trials – there was nothing else they could be based on – trials that could be written up as positive even when they were negative.
And the guidelines never mentioned adverse effects. Risk controlling drugs effectively became vitamins. There might occasionally be problems but nothing significant that might warrant getting in the way of encouraging people to put their biology right. There were incentives for doctors to prescribe the drugs and no rational (evidence based) basis not to.
Willie Sutton was not a man to echo Mark Twain’s ‘There’s Gold in Them Thar Hills. There’s Gold in Them Thar Banks seemed a better bet to Willie. But given that the new blockbusters were literally worth more than their weight in gold – There’s Gold in Them Thar Pills might have given Willie pause for thought.
A Good Long-Term Model?
From a common-sense point of view, controlling a risk factor by stopping something like salt is very different to controlling it by taking a drug. Risk controlling drugs can all be expected to produce more side effects in 6-8 week trials than either nicotine or alcohol would. How sensible does it sound to get someone to take modest amounts of nicotine or alcohol every day for the rest of a life?
Twenty years into the preventive medicine era, the word polypharmacy came on our radar. But not to worry – this was just a problem among older people.
The idea that managing risks might end up disabling the young and crash social security systems lay a further 20 years in the future. Long before that, industry had moved on. Those of us fighting fires on one front rarely realize that industry have often lost interest in the fire we are fighting.
The New Prevention Racket
Even though in 1991 I had fingered Lilly’s Prozac as causing suicide, in 1993 Lilly approached me to help run a duloxetine trial. I was astonished. Prozac was just a teenager, still ascending to adult blockbuster status. Could Lilly be already planning for life after Prozac? When duloxetine crashed in early trials, it became clear it was only one of several options Lilly were working on to replace Prozac. See The Prozac Era.
Similarly I’m sure that many of ‘us’ tracking the bigger picture around 2010, watching what was now Big Pharma in action, wheeling out blockbusters like Lipitor making over $10 Billion per year, would have been brought up short by company talk about their pipelines containing 200 to 300 vaccines.
Are there that many viruses or bugs around? Even adding RSV of which there is more than one type, to hMPV or any number of coronaviruses, is this going to add up to 200? Part of the answer turned out to be that the pipelines contained vaccines for different forms of cancer. Another part was companies aimed at getting monoclonal antibodies like Beyfortus redefined as vaccines.
Yet another part was vaccines for drug abuse as well as gene therapies for genetic disorders revealed by screening. While some might find controlling drug abuse with a vaccine disturbing, it was not difficult to see the political appeal to eliminating drug abuse by vaccinating infants before the problem begins.
Still, this seemed like pharmaphantasy until recently. Bioethicists campaigning to have pregnant women included in clinical trials – in order to empower them – were among the first swallows hinting at a new Spring. Women’s need, not just rights, to be involved in trials in order to have the best possible evidence for things to take in pregnancy was spun as part of a diversity agenda – we would be recruiting pregnant people rather than women. The US government swung in behind this, pushing it as just as worthy a cause as ensuring Afghan women were not oppressed by the Taliban.
The Covid pandemic with its redefinition of vaccines to include gene therapies and later monoclonal antibodies made it obvious that vaccines are the way forward for pharma.
You can get governments to mandate your treatments for you, without asking for any evidence of possible long-term consequences.
You can now get governments to license vaccines on the basis of antibody levels, which almost anything injected into the body can raise, rather than evidence that the vaccine has eliminated an infection or other problem.
You can produce vaccines that only give seasonal protection and need to be given every year for the rest of your life with experts claiming there is no problem with being given 1000 at a time.
You can produce experts to claim the equivalent of the earth is flat – vaccines offer better immunity than natural immunity.
Better again you can engineer a lot of this to be administered in pregnancy or in the hours or days after a birth, where it is impossible to decide between problems that might have happened anyway and problems linked to the vaccine.
There is one big snag to all this. Giving vaccines in the second half of pregnancy or early neonatal life is uncharted territory.
Back in the days of vaccine innocence, Christine Stabell-Benn and Peter Aaby showed that in children some vaccines could have non-specific beneficial effects. That is along with reducing the risks of infection with the target bug, they seemed to reduce risks from other infections. Later it became clear that other vaccines could have non-specific negative effects – they could interfere with other vaccines and lead to more infections. The good effects came from older, antediluvian, live vaccines. The not so good effects came from dead vaccines, which with DNA and mRNA compounds were becoming the norm.
This came to a head with recent RSV vaccine trials. Besides the greater number of adverse events the vaccines caused for mothers and infants, it looked like giving the RSV vaccine before other more important vaccines such as pertussis or influenza, interfered with the important vaccines so that they worked less well. Delaying the RSV vaccine until week 32 didn’t cause these problems. See It is Hard for Thee to Kick against the Pricks.
RSV is just one vaccine. What might happen when the vaccine business gets serious?
This RSV problem was one among several that revealed to regulators they were in virgin territory and had no rule book for trials of ‘vaccines’ in the second half of pregnancy or the neonatal period. Urgent harmonization meetings were convened.
The problem felt like building on Manhattan. How to concentrate so much real estate on such a small acreage – both above and below ground. Where would all the sewage and detritus go?
As all of this was happening, left to their own devices women were breast-feeding and increasingly taking care not drink alcohol, or hot drinks, not to eat soft cheeses or processed meats, not even to have hot showers for fear of harming their babies. But in the clutches of a medical Jabberwock, with not an obstetrician or neonatologist in sight, they were being signed up for an increasing number of trials, sometimes financially incentivized as never before – See It is Hard for Thee to Kick against the Pricks.
Willie S calling Wes S
Would Willie Sutton figure vaccines are a banker?
The logic of Risk Factor management might indicate what the end of this latest effort to seduce governments into continuing to pay through the nose could look like.
By 2024, there was increasing concern that not only were older folk polypharmaceuticalized, with life expectancy falling and healthcare costs going through the roof, but youngsters in the 18 to 35 age bracket were now collecting more disability payments than any other age group. To give them risk factor meds they have to be given diseases, and were now suffering from ADHD, ASD, Depression, Bipolar Disorder and PTSD, along with raised cholesterol disorder, Type 2 Diabetes, raised blood pressure and other problems. The diagnoses provide the paper basis for disability claims. The meds disable. The national debt of some Western countries was projected to triple from 100% of GDP to 300%.
Reproductive rates were plummeting primarily among the native populations in Western countries. Social systems would collapse without mass immigration.
The latest Peter Selley Research on RSV vaccines – new since last week’s post – shows pre-term births in the USA, births <37 weeks, increasing by 12% between 2014 and 2022 to 8.7%. This was before we got any RSV vaccines which cause pre-term births. Being born a few weeks earlier might sound harmless, after all we can do amazing things to keep babies alive from 28 weeks or younger. While this is true, pre-term births are still linked to neonatal deaths, poorer health in later life, and a shorter life expectancy,
There is no market, economy or business that can survive a ghostwriting of the evidence or lack of access to data from studies on which it bases important decisions. No society on earth can survive fraud on the scale that is now happening and such a loss of its bearings.
When a new Labour government came to power in Britain in 2024, the imminent collapse of what most Brits viewed as a jewel in Britain’s crown, its National Health Service (NHS), was high among the crises it faced.
In an effort to explain the problem to the wider public, the new health secretary, Wes Streeting, stated that Britain used to be a country, an economy, striding confidently into the future with a NHS that was no burden to it. Quite the contrary the NHS got people with serious diseases back to work.
But Britain, he said, had become a country with a heavier and heavier health service burden. It was rapidly becoming a less economically efficient country capable of supporting the burden its health service had become.
This analogy conjured up an image of the Descent of Man – slide made by Peter.
Streeting claimed more technology and more preventive medicine was the way to save Britain’s NHS. This is fine but what happens when it meets a ghostwritten and fraudulent vaccine and other medical literature? What happens if the NICE Algorithms are based on fraud?
Sounds like – Your Money and Your Life.
Patrick D Hahn says
Moderna says its mRNA platform could be used to produce hundreds of different vaccines. For once I believe Moderna.
annie says
Oh, the limitless opportunities…
Are people getting a bit sick of the offers?
The letter, with booklet, Winter Vaccines – ‘You have to get vaccinated every year because viruses change constantly and your immunity to flu and Covid-19 may have reduced since your last vaccination.’
My elderly neighbour, is one of the sheep. At 87, he gets excited to get all his jabs. In the last year he has had so many doctor and hospital visits. He is like a pin-cushion. He respects everything that is offered to him. He is of the old-school-variety, do what the doctor tells you to do. He knows nothing about pharma fraud, AstraZeneca fraud, GSK fraud, or anything else.
I don’t know any pregnant women, but Peter S is doing sterling work in that regard.
‘but what happens when it meets a ghostwritten and fraudulent vaccine and other medical literature? What happens if the NICE Algorithms are based on fraud?’
The vaccine “issue is only going to get bigger and if it doesn’t we have to make sure it does.” –
@DowdEdward
Gives you the Willies -The Collective Hoists – Hands in the Till…
Patrick D Hahn says
After my ischemic stroke (which I had less than thirty days after my booster shot, which I took on pain of losing my livelihood if I didn’t) I looked into statins for secondary prevention. The most recent meta-analysis I could find concluded that statins produced a one in sixty-seven reduction in the risk of a second ischemic stroke, but no reduction in the risk of all strokes or serious adverse events or deaths.
No thank you. I would rather not have had the shot that caused the stroke in the first place.
annie says
suggests that the deaths were caused by the vaccine.”
TGA hides from questions about sudden infant deaths after vaccination
A string of sudden unexpected deaths in infants following the Infanrix Hexa® vaccine has forced the drug regulator to go to ground.
Maryanne Demasi, PhD
Oct 28, 2024
https://blog.maryannedemasi.com/p/tga-hides-from-questions-about-sudden?utm_source=post-email-title&publication_id=1044435&post_id=150789997&utm_campaign=email-post-title&isFreemail=true&r=1q23na&triedRedirect=true&utm_medium=email
Sudden unexpected death in infancy (SUDI) and sudden infant death syndrome (SIDS) are names for the sudden and unexpected death of a baby when there is no apparent cause of death.
The Therapeutic Goods Administration (TGA) has gone to ground after being confronted with questions about a series of sudden deaths in infants who received the Infanrix-Hexa® vaccine.
The “hexavalent” vaccine protects against six diseases (diphtheria, tetanus, whooping cough, polio, hepatitis B and Hib) and is administered to infants at 2, 4 and 6 months of age.
Approved by the TGA in 2006, the vaccine lies at the heart of the National Immunisation Program, and has been administered to millions of babies across the country.
FOI request
A freedom of information (FOI) request for the number of deaths reported after use of the Infanrix-Hexa® vaccine has revealed some worrying data.
The Database of Adverse Event Notifications (DAEN) shows 17 reported deaths in infants.
A further 26 reported deaths exist in the TGA’s ‘internal’ database, the Adverse Event Management System (AEMS), according to a recent FOI report.
Overall, 43 sudden unexpected deaths have been reported in babies mostly under 12 months of age, which have occurred within a day or two of vaccination.
Now, after many weeks of enquiries, the TGA has gone into hiding and refuses to confirm whether it has made any attempt to investigate the deaths.
Warnings from Europe
Infanrix-Hexa® was first authorised by the European Medicines Agency (EMA) in 2000, and the public has never been alerted to any safety issues.
EMA says it monitors pharmacovigilance data in the form of Periodic Safety Update Reports (PSURs), which are submitted by the manufacturer, GlaxoSmithKline (GSK).
Essentially, PSURs describe the worldwide safety experience of the vaccine over a defined period, and are not usually available to the public for independent scrutiny.
However, a major lawsuit in Italy involving GSK, resulted in the Judge ordering the drug company to publicly release its PSURs for the Infanrix Hexa® vaccine.
Those documents were sent to Jacob Puliyel, a paediatrician and Head of the Department of Paediatrics, St Stephen’s Hospital, Delhi, who carried out an independent review.
The analysis revealed a cluster of sudden deaths among infants less than 12 months of age — 54 deaths (93%) occurred within the first 10 days of vaccination, and 4 deaths (7%) occurred within the next 10 days of vaccination.
Further, when he compared the rate of ‘expected’ sudden deaths, to the ‘actual’ rate of sudden deaths post-vaccination, there was a statistically significant increased risk of death in the first four days after vaccination, compared to the expected deaths.
The report concluded, “The clustering of deaths soon after immunisation suggests that the deaths were caused by the vaccine.”
Puliyel published the findings in the Indian Journal of Medical Ethics in 2018.
See article –
The report also showed that infant deaths, which were reported in the safety report (PSUR 16) were deleted in the PSUR 19, effectively underreporting the number of observed deaths in the final report seen by EMA.
I contacted Puliyel to ask why EMA had not raised the alarm regarding the PSUR data, and he said he thought the data were misleadingly presented to EMA.
“I wouldn’t go as far as saying that EMA colluded with GSK in the subterfuge, but I think EMA was negligent and accepted the manufacturers’ deceptive data and interpretations unquestioningly,” he said.
Puliyel criticised EMA for its lax monitoring of post-marketing adverse events and has been urging all regulators to do better.
After the publication of his findings, Puliyel said there was no excuse for EMA to ignore the data discrepancies.
“The silence suggests EMA has no defence,” he remarked.
“I think nowadays, surveillance methods are designed to protect vaccine company profits rather than the public,” he added.
When I contacted EMA, the agency denied that deaths were “deleted” from the report as Puliyel claims.
Instead, EMA said the deaths were “reclassified” after it was determined the babies died of underlying diseases, such as “viral meningitis, an inborn error of metabolism congenital hydrocephalus and congenital heart disease.”
Puliyel rejected EMA’s explanation, calling it “singularly unconvincing.”
“Viral meningitis, congenital hydrocephalus and congenital heart disease would have been obvious at the time of vaccination when the children died – not discovered many years later,” explained Puliyel.
“EMA has to explain why these obvious underlying causes were not considered causes of death when the 16thPSUR report was published and why it had to be ‘reclassified’ years later,” remarked Puliyel.
‘When the number of sudden deaths exceeded deaths expected as per the calculations in the 19th PSUR – there was this urge to ‘reclassify’ three sudden unexplained deaths as ‘deaths due to underlying causes,’” he said.
TGA enquiries continue
Efforts to compel a response from the TGA will continue, but the latest data on Infanrix-Hexa® have raised broader questions about the safety of the newer generation of vaccines designed to protect against multiple diseases within a single shot.
I will explore this in a forthcoming investigation.
annie says
You read stuff like this and you wonder, how do they have the nerve?
‘After current headwinds have been navigated’
“New approvals and data in vaccines should see growth return after the current headwinds have been navigated.”
GSK sales hampered by slump in demand for key vaccine
https://www.msn.com/en-gb/health/other/gsk-sales-hampered-by-slump-in-demand-for-key-vaccine/ar-AA1tbKqi?ocid=msedgdhp&pc=U531&cvid=57bfa05267e14343a89924b6d98008e1&ei=29
Drugmaker GSK saw a sharp drop in revenue from its blockbuster Arexvy vaccine in the third quarter, dampening overall sales growth.
Sales of the jab for respiratory syncytial virus (RSV), previously a key driver of vaccine sales which saw an extremely successful launch last year, plunged 72% year-on-year to £188 million, hit by fewer of the shots being given out in the US.
The UK’s second-biggest pharmaceutical firm still saw 2% sales growth across the business after stronger performance from its HIV and cancer treatments, with the latter category nearly doubling in sales versus the same period last year.
But the RSV jab Arexvy was hit by more restrictive recent recommendations from US health officials over administering it to older and more at-risk patients.
A resurgence of Covid-19 infection rates, and a subsequent prioritisation of vaccinations for the virus over other jabs, also caused downward pressure on Arexvy sales.
GSK said that despite the fall in sales, Arexvy still had about a two-thirds share of the retail market, where most of the doses are given.
Chief executive Dame Emma Walmsley said the strong performance in cancer treatments and HIV medicine showed “resilience we have now built into GSK’s portfolio and performance”.
She added: “Our pipeline continues to strengthen with 11 positive phase three trials reported so far this year and we are currently planning launches for five major new product approval opportunities next year.”
Blenrep, a treatment for cancer, and asthma medicine Depemokimab are among the planned new launches.
Nonetheless, shares in the company fell after it cut its outlook for its annual vaccines sales to a “low single-digit” percentage decrease, also partly driven by a smaller decline in sales for its shingles jab, Shingrix.
Derren Nathan, an analyst at Hargreaves Lansdown, said: “Just as Covid seemed to be a thing of the past, a push to drive up vaccination rates has changed clinical priorities.
“But GSK is showing strength elsewhere in its portfolio with 19% growth in speciality medicines, as the emerging cancer treatment franchise is up over 100% year to date.
“The higher margins in this division have had a positive impact on the bottom line, and full-year targets remain unchanged. New approvals and data in vaccines should see growth return after the current headwinds have been navigated.”
It comes after GSK struck a landmark 2.2 billion US dollar (£1.68 billion) settlement to resolve tens of thousands of lawsuits in the US over its discontinued heartburn drug Zantac earlier in October.
For the behemoth UnitedHealth, a new threat to Medicare profits
UnitedHealth collected $3.7 billion in dubious payments last year alone
https://www.statnews.com/2024/10/25/unitedhealth-medicare-advantage-questionable-payments-hhs-oig-audit/
For the nation’s largest health insurer, the evidence of abuse was stunning and unmistakable: UnitedHealth Group reaped billions from the federal Medicare program by diagnosing patients with serious chronic illnesses, and then delivering no follow-up care.
The findings in the federal report reveal that UnitedHealth repeatedly sent clinicians into patients’ homes and pored over their medical charts to add diagnoses for illnesses such as vascular disease, heart failure, and diabetes. The purpose was to collect more cash in Medicare Advantage — not to improve their health. The result? $3.7 billion in dubious payments last year alone.
Stories that run and run …
Harriet Vogt says
I just found myself idly typing – ‘why is Wes Streeting such a ******* idiot?’ into the search bar (possibly not the only person to be doing this) and up came this fabulous piece by Kathleen Stock.
https://unherd.com/2024/10/wes-streeting-wants-to-experiment-on-you/
What I hadn’t realised – slow on the uptake – is that Eli Lilly are actually putting money into the coffers of UK Inc to pay for the privilege of what is effectively a national test market of Mounjaro – and its ability to deliver us from fatness unto neoliberal productive functionality. (Apparently it’s undershot its ‘bullish’ sales’ projections and the stock’s a bit wobbly so this seems like a smart idea):
‘The five-year experiment is part of a £279 million deal struck with Lilly, the world’s biggest drug company, and aims to determine whether giving weight-loss injections to the obese will boost the economy. It will have two prongs. On one side, the NHS will identify potential participants for its trial on the basis of obesity, plus some combination of “hypertension, sleep apnea, cardiovascular disorders and unhealthy levels of … cholesterol”. It will then dose them with Mounjaro, Lilly’s competitor to Novo Nordisk’s Wegovy (better known as Ozempic). Meanwhile academics at the University of Manchester will be collecting data about the effects of the drug on “health-related quality of life and changes in participants’ employment status and sick days from work”. Accustomed as we are to seeing the nation’s relatively poor health as a terrible financial burden, effectively Streeting is urging us to flip the script and see it as a possible goldmine.’
I particularly loved this moment in KS’s piece – hasn’t she risen like a phoenix since escaping my old university, that used to be radically open-minded and is now just a wokerati fascist establishment – or another scared little business that fails to protect its academics and their freedom to think and speak for themselves:
‘In Streeting’s imagination, perhaps, biotech companies will start flocking to our shores, lured by the juicy prospect of exclusive access to a centralised pool of patients. Lazarus-like, the NHS will eventually stagger out of the tomb, throwing off its bandages. The economy will boom, replete with newly svelte and mentally balanced workers. Government ministers will dance nimbly in celebration to the sounds of Taylor Swift .’
The Wesbot is alarming for all of us concerned about society’s pharmacological destruction. He’s a sort of ‘painting by numbers’ instrumentalist – got a weight problem, drug it, got a waiting list problem, double the number of appointments. How? – send in the trusts who seem to know and they’ll sort it. In fact, diagnostic hubs do help speed up throughput – we’ re talking mass production here. which for some routine interventions like cataract surgery is fairly appropriate – but where are you going to get the staff, Wes? No answer – not in his software programme.
The Wesbot manifests zero awareness of drug harms. He’s ordered another review:
‘Patient safety at heart of government’s plans for healthcare reform as Health and Social Care Secretary orders action to improve regulator performance’
https://www.gov.uk/government/news/government-pledges-further-action-to-strengthen-patient-safety
And the organisations included are:
CQC
National Guardian’s Office
Healthwatch
Health Services Safety Investigations Body
Patient Safety Commissioner
NHS Resolution (quality and safety functions only)
Fair enough, the CQC does need an overhaul – as the Dash review confirmed. And he does need to try and get his seemingly flow chart head around the respective roles of these overlapping organisations – several of which are focussed on ‘after the event’ harms – not risk prevention.
What is particularly striking is the absence of the MHRA and NICE – arguably the pivotal organisations that should be driving patient safety in medicines and medical devices. But I fully expect that Wes sees them as profit centres – as they appear to see themselves. https://assets.publishing.service.gov.uk/media/653be2e9d10f35000d9a6b0f/3948_MHRA_Annual_Report_2023_A4_PRINT-271023.pdf
I was under the impression, originally, that the Patient Safety Commissioner was going to be the voice of harmed patients. Apparently she is aware of far more than she can handle, with a tellingly small department. If I were her, I’d be making a bid for far greater power in the Wesbot review. But who knows – plenty for you, David Alton et al and patient advocacy groups do to push the MHRA to focus on more than defensive, ‘risk-to-self’ comms.
Dr. David Healy says
Great comment – will add to the Prozac Era post on DH also where it is just as pertinent and there are other examples of this happening across Europe also.
For non-Brits (like me) Mr Streeting had a toss away comment about putting all the umemployed on Mounjaro that the media seized on. The questioners mostly didn’t seem to know what to make of this wild comment and Wes floundered around or seemed to – it now looks much more like covering his tracks.
Between Peter Selley’s discovery that the UK was rolling over to provide free luxury accommodation to Moderna and now this, it’s hard to resist the feeling Britain is a useful colony. I another corner of the room, there is talk about reparations for slavery
David
Harriet Vogt says
In reaction to the Wesbot revelations, the words – CORPORATE CAPTURE – keep running through my mind like tickertape.
You were right to say, in a recent exchange, that I’d likely missed the earlier history of ‘The antidepressant era’. Arguably, very fortunately so. But I’m catching up…
Still on the MHRA case, I’ve been digging around in the House of Commons Health Committee report, ‘The Influence of the Pharmaceutical Industry’ 2004/5. From 20 years ago. You’ll remember it, you were there:
‘I’m not sure the industry actually are the problem. I think there are two groups , one is the MHRA, who are not doing their job all that well, and the other is the physicians generally. If I can try and bring out the nature of the problem: as regards suicide on SSRIs, both the FDA in the US – and the MHRA – clearly here thought when this issue blew up first that it was a PUBLIC RELATIONS ISSUE.(my emphasis). They took this position without any scientific input at all other than the scientific input they my have had from experts sitting on the CSM who we now know had extraordinarily close links with all of the major pharmaceutical companies. They have held to that position regardless of the scientific evidence that has come through over the course of the last 10-15 years, they have held to that point of view even though actually the scientific evidence on which they let the drugs onto the market in the first instance conclusively showed that these drugs could cause a hazard, a hazard that could be greatly reduced if the proper warning had been put on the drugs..they (MHRA) say the yellow card system is one of the best in the world in terms of trying to track hazards that may be thrown up by drugs out there in the real world, but in actual fact here in the UK we track the fate of parcels through the post 100 times more accurately than you track the fate of people killed by SSRIs or other drugs’. Professor David Healy
The ghastly truth seems to be that very little, if anything, has changed. Yes, by the looks of some historic ‘brand share’ data https://bjgpopen.org/content/5/4/BJGPO.2021.0020, it seems that you scored a direct hit on paroxetine, that has never recovered. What’s got worse is a trend for higher dosages – no wonder, thinking orthosteric effects and broken receptors (ty for that education), human beings are losing their capacity to feel.
The juggernaut (your mot juste – keen to read your next post) keeps blundering on. All the criticisms that you and others levelled at the MHRA at that meeting 20 years ago – are much the same as those covered in the letter, ‘Raising concerns about the MHRA’, from the APPG Pandemic response & recover, signed by amongst others David Alton (again) and all round decent bloke and scientist, Carl Heneghan – this year. https://appgpandemic.org/news/mhra-letter-health-select-committee
Just as an electronic yellow card was flagged as salvation in 2002, the MHRA are still banging on about their yellow card scheme, without as far as I can see, having significantly improved its reach: https://yellowcard.mhra.gov.uk/World-Patient-Safety-Day
Corporate capture? Establishment capture? Why does nothing change in the face of such ferocious – and, in fact, quite constructive criticism? Is it similar to the Sunshine Act in the US – where the declaration of ill-gotten gains by corporately captured psychiatrists is rather like an act of absolution. Guilt admitted, no need to behave any differently.
Rather than waste energy trying to improve the MHRA – for decades – it is literally impossible to embrace two polarised priorities simultaneously – mightn’t it be more realistic to set up a separate patient safety registry? The office of the Patient Safety Commissioner already exists, with the purpose of listening to the ‘patient voice’, under-staffed and bogged down with reparations (reference your last comment) for valproate and mesh harms. Add an independent research function – and could we have a patient centric oppositional force to the self-interested risk comms of the MHRA?
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