This post copies a letter sent to Michelle O’Neill and Jeffrey Donaldson, the leaders of the two largest parties in Northern Ireland. It was sent with the letters to Eluned Morgan in Wales and Johnny Mercer in England featured here and on RxISK last week.
The image is of Newgrange on the shortest day of the year – thought to be one of the most magical and hopeful symbols in Ireland. Newgrange is right beside the Boyne River a symbol of Ireland’s deepest divisions. Some references have links not in the original letter.
Michelle O’Neill MLA Jeffrey Donaldson MP
Coalisland Sinn Fein Office The Old Town Hall
Co Tyrone BT71 4LN Co Antrim BT27 4DH
August 15 2021
Let me mention before proceeding that I briefly met Ms. O’Neill on Zoom a year ago, prior to a single meeting with members of Sinn Fein instigated by me hoping to alert them to health policy issues stemming from a 2019 inquest on Stephen O’Neill, an in-law of Ms. O’Neill’s.
I had been approached over a year prior to the inquest by Colleen Bell to offer expert input. I had no idea of Stephen’s background. Bell and O’Neill are surnames from both sides of the political divide. I would have agreed to help regardless of background in this case.
The inquest pointed to significant healthcare issues that affect all of the Western World, are getting worse, and may underpin some of the political divisions we now see linked to Covid.
My post-inquest meeting with Sinn Fein was aimed at drawing out the economic implications of issues such as the ghostwriting of the medical literature and lack of access to clinical trial data that are also leading to deaths like Stephen’s. Just so you and other readers are clear on what ghostwriting means – the academic names, even from the most distinguished institutions, on the authorship lines of medical articles about current drug treatments appearing in the most prestigious journals will not have written those articles or ever have seen the data underpinning them. The ghosts will not have seen the data either.
The NHS hinges on an assumption that effective treatments that save lives and get people back to work will pay for themselves. It cannot survive if flooded with treatments that cost lives and disable people – treatments typified by the sertraline that triggered Stephen’s problems. (See Morgan vs Morgan: The Future of the NHS).
Your ability to bargain on the price of drugs hinges on pharma being able to claim the latest drug works fabulously and is free of risks. Access to trial data levels this playing field.
Given that Sinn Fein had no prior involvement in setting up the features of the system now causing problems, they seemed less likely to be hamstrung by their past. It doesn’t, however, take much exposure to the system to become an insider.
Sinn Fein’s roots in the Irish Co-operative Movement offered a further reason to hope they might engage. The issues linked to Stephen’s death are neither Right nor Left issues. They need politicians and activists to chart a path between Right and Left, as the co-operative movement once did, and AIDS activists did in the 1980s and 1990s.
Having made these points, my sense is that the DUP might have more libertarian leanings than Sinn Fein who perhaps are more authoritarian, and these leanings may play a greater part than anything else in how either of you receive this letter.
When my contact with Sinn Fein came to nothing, I reached out to Green parties also trying to chart a path between Right and Left, but whose health policies depend on technologies, which, no matter how innovative, seem at odds with their environmental policies.
The Crack of Doom forum post has my correspondence with NICE, MHRA, the four Depts. of Health in the UK, the BMA, Brenda Hale and others, linked to Stephen’s inquest. The only missing document is a May 2020 letter from Gillian Leng, the new CEO of NICE, to Ms. O’Neill. This letter confirms what I’ve been saying about NICE Guidelines being based on a ghost-written literature. Ms. Leng’s points about good practices are designed to distract.
Don’t let the silence surrounding the ghost writing of the medical literature and lack of access to trial data mislead you. Western Life Expectancies have been falling prior to Covid. A polypharmacy promoted by a ghostwritten literature that hypes the benefits and hides the harms, with no-one able to check the claims being made, plays a part in this. We are also not meeting population replacement rates owing in part for the same reasons, and specifically to drugs like those Stephen was prescribed.
The silence means that problems about ghostwriting, building guidelines based on a ghostwritten literature, and the sequestration of trial data, are more embarrassing and awkward to those in a position to make a difference than the deteriorating global climate.
When it comes to climate change, nobody thinks swapping our car for a bicycle will make much difference. When it comes to the deteriorating climate in healthcare, many talk about reversing corporate influence but as with climate change no citizens can see a way to do this. My personal view is that it is doctors more than companies who are letting us down.
Healthcare, however, does offer a way for individuals to make a difference – standing our ground on treatment related adverse events.
Hold Your Own Inquest
The possibilities become clear if you consider inquests. Getting out the far side of one is more difficult than getting out of a Maze. Like cricket perhaps, the wider inquest system as it stands embodies an English idea of Fair-Play – eleven against one. Bereaved families would be better advised to hold their own inquests.
Statutory inquests mean:
- Pitting decades worth of knowledge a family has of someone against a 10-minute slot a doctor has given him or her, and having your knowledge dismissed.
- Pitting the possible bias of a family unwilling to think the worst of a child, or parent, against the undoubted bias of a doctor unwilling to contemplate their role in killing someone. The family ends up viewed as too biased to be believable.
- Pitting an Evident transformation in someone seen by many people against Evidence consisting of a ghostwritten literature denying these transformations can happen – with no-one able to check this out, not you, nor any prescribers, nor MHRA. At inquest, the ‘Evidence’ counts for more than what is screamingly Evident.
- Pitting a common-sense causality, that comes close to what the Federal Judicial Manuals in the US mandate as the way to establish causality in drug induced injury, an approach that doctors once took, and losing out to the view of a prescriber who today has no training in determining drug induced causality and is swamped by ‘Evidence’ telling him to avoid common sense.
- Pitting what the company view in private might be against what they say in public about you and your family (see Healy to Morgan).
If you want to make the Statutory System work properly and advance public health:
- You would have to enable coroners to finger a prescription drug as the obvious cause of a death, the way they can with a street drug.
- You would have to work out a way to stop medical insurers blocking doctors like Dr Brannigan in the O’Neill inquest or Dr Adams in the Morgan inquest (Appendix 1), admitting a drug caused a problem.
- You would have to provide guidance to inquest hearings that a ghostwritten literature with no access to trial data is not evidence that can be relied upon.
- You would need to review the evidence admissible at inquests. In the O’Neill inquest, the coroner mistakenly refused to admit evidence from FDA reports of harms on the medicines Stephen was given. Regulators strip names off these reports making them hearsay, but the analysis presented to O’Neill inquest wasn’t hearsay.
You can overcome the coroner’s confusion in the O’Neill case by encouraging doctors and patients to submit reports to companies (rather than regulators) with both doctor and patient names attached so that these are no longer hearsay but more reliable evidence than the current company trial evidence. (See Can Doctors Save Us). Ideally these reports is would also be lodged in a setting that can be accessed in the event of inquests and legal cases so that doctors and patients can be called as witnesses. At present there is no point in doctors or patients reporting to MHRA.
- You would need to educate coroners on the futility of sending regulation 28 reports to MHRA. Unless the regulator changes their spots, they have no role to play in public health other than their current role which is to regulate the wording of adverts. They don’t even regulate the claims made in the adverts parading as medical articles, which are ghostwritten and optimized to sell drugs rather than promote safety.
- You would need to make clear that MHRA responses telling coroners and politicians, that in addition to warnings they depend on the clinical judgment of doctors, avails of the notion of a doctor as a Learned Intermediary. This notion made sense until 1990. Since then, medical learning about drugs and devices comes from a ghostwritten literature with no chance to check the claims against the data. It is no longer clear that doctor’s judgments are worth any more than salt that has lost its saltiness.
- You would need to ensure doctors, and increasingly nurses and others who prescribe, have training in how to establish whether a treatment is causing a problem – none have any training in this basic skill at present.
As things stand every family who has a member whose death is linked to treatment in healthcare would be better off holding their own inquest rather than trying to escape a Maze, where everybody you might refer them to – NICE, MHRA, BMA, Legal Authorities – will whisper their agreement there is a problem but will say it’s not theirs to remedy.
As a woman who lost her 15-year-old daughter to a prescription drug said to June Raine of MHRA:
It would have been better if she had been murdered – that way I could face the perpetrator in court.
The problems come to a dramatic head at an inquest. The same problems hold true for all adverse events on a drug. At least at inquests, if they are damming the dead with the deceased’s family present, doctors express sympathy. Raise an adverse event in their office where no-one can see them and you will often face frank hostility or ridicule.
Still there are possibilities for significant change, which you may sense from Tracey, whose story was recently posted on RxISK.org – What’s a Life Worth?
Tracey’s MP is Johnny Mercer whose resignation as a matter of honour a year ago had an effect in Northern Ireland. I’ve challenged him to pick up these issues – see Appendix 2. As a matter of honour, tolerating deceit, indeed proven fraud, on the scale we now have without calling it out is surely not an option.
The Conservatives, like the Republicans in the US, seem to have turned to populism. This is not a bad thing. The treatment induced problems affecting Mr Mercer’s constituents offer a basis for populism 101, pitting forgotten men and women like Stephen and Tracey against an unthinking bureaucratic system.
I have also written to Eluned Morgan, the Welsh Labour Minister for Health, in response to the inadequate way the system, she has responsibility for, has operated in the wake of the death of Samuel Morgan, killed by an SSRI drug like Stephen (Appendix 1).
Labour in Britain and the Democrats in the US may be the biggest obstacle to the changes needed. They are still campaigning for access to drugs, not realising this is a primrose path to polypharmacy. They, and you, should be campaigning for the information that transforms chemicals into medicines, the absence of which is rapidly making prescription chemicals more dangerous that street chemicals.
With street chemicals our natural caution comes into play, no-one is going to tell us the drug didn’t harm us when we are injured, and coroners can register a street drug as a cause of death but cannot do the same for a prescription drug.
There is a wrinkle though in my hopes for action from Mr. Mercer. Women most often get put on and harmed by these drugs, but Army recruits and veterans are another badly affected group. The British Establishment has denied the risks to its troops from medical treatments, as vehemently as Mr. Mercer stone-walled Tracey. How far will his sense of duty to veterans take him?
The denial of risks starts with doxycycline, which may have initiated Stephen’s problems, followed by mefloquine (Lariam). These are used when troops are deployed to areas where malaria is common. Both commonly cause suicide – as in the horrific death of 19-year-old Amanda Cutland that featured on the front pages of most British newspapers 2 years ago. The coroner was shocked, but MHRA took the opportunity to hone their skills at denying the undeniable. (I can send you details).
Then there is sertraline, which made Stephen’s problems worse. This is dished out to Army veterans for PTSD. Neither the veterans getting it, nor the doctors dishing it out, will know that prior to its licensing for PTSD all four of the trials done were negative for men. There was a flicker of benefit for women in two of these trials – women who did not have the kind of condition soldiers have.
A previously senior FDA figure, Paul Leber, was drafted in by Pfizer to help get sertraline approved by FDA for PTSD, despite it not meeting criteria for approval. Its licensing for PTSD gave rise to a prize exhibit in my argument that the clinical trial literature is now ghost written and there is no access to trial data.
In the slide below from 1999, TBD means To Be Determined. The articles had already been written by ghosts. The Pfizer marketing department at this point needed to decide whose names, featured as authors, would sell the most sertraline (Zoloft).
In raising these issues, one or both of you could do more to reduce deaths among British Army personnel than were ever linked to the Troubles and reduce the number of homicides of innocent civilians, of which at present there are likely a greater number triggered by SSRIs every year or so among Army personnel or veterans than might have happened at the hands of the Army in Northern Ireland.
It is the best and worst of times to raise these issues. No-one wants to shake confidence in the vaccine program.
The system, however, that enables Pfizer bring a pretty ineffective drug like sertraline on the market without scrutiny of the underlying data, and can let them ghost write out of existence hazards like sertraline induced suicides and homicides, triggered both by starting it and stopping it, is the system through which we now bring vaccines to market. Nothing has changed. If anything, we have a Maze that is more difficult to escape.
Many people are clearly conflicted. Their difficulties are characterized as stemming from ignorance rather than a sense that something is amiss, even though surveys that have nothing to do with vaccines show a waning of public trust in drug regulators and the bodies representing medical professionals.
There is a lot that is amiss. The greatest concentration of fake literature on earth centres on the medicines doctors give you and your family and friends.
Two decades ago, when I became aware of the problems outlined here, I contacted MHRA suggesting I should not be saying things as serious as this if they are wrong. I offered to meet them and stop saying what I was saying if persuaded of the error of my ways. We met. They didn’t contest a single point. Soon after, a crisis blew up about these drugs that led to Black Box Warnings, and billion-dollar fines, but not the changes the crisis called for.
At a House of Commons Select Committee in mid-crisis, I repeated the points on the record, while figures like Iain Chalmers of the Cochrane Collaboration and Richard Horton, editor of the Lancet, downplayed concerns without attempting to rebut them. Neither Cochrane nor the Lancet look particularly good now.
I repeat my MHRA offer. I am happy to engage with anyone you suggest might point out the mistakes in what I am saying. If no-one is willing to engage in public on these issues, and over twenty years no-one has, I think the onus is on one of you to take a lead within the United Kingdom and the European Community not on chemicals that have to cross borders but on information critical to the safety of your constituents that should be universal.
While not without risks, this is a time when a politician who can seize the moment could exert significant leverage. Whatever about Reconciliation, a Truth Commission is called for. If either of you rises to the moment, I would be happy to help regardless of political background.
David Healy MD FRCPsych