This post needs to be read in conjunction with Companies and Mothers on davidhealy.org. Most people think pharmaceutical companies are evil and regulators are on our side. Both are intensely bureaucratic. They hide behind procedures. Judge for yourself which has the most humanity.
10 South Colonnade
Canary Wharf London E14 4PU
Dear Dr Raine
I am writing on behalf of families, for whom, pro bono, I’ve recently prepared inquest reports.
One mother is LC, whose 21-year-old son X was taking isotretinoin for acne, which caused his gruesome death.
Another is Tania Morgan, whose 25-year-old Samuel took citalopram for a non-existent nervous problem and died a week later in a way no parent would ever want. You are aware of his case – See High Noon and Morgan v Morgan.
Yet another is Catharine Waters, whose 22-year-old son Samuel also took an SSRI and died just over two weeks later and whose inquest is pending.
Colleen Bell’s uncle Stephen O’Neill died from problems triggered by doxycycline that treated with sertraline caused his death. Stephen’s manifestly unjust inquest put me on a road that has led to this letter. See Crack of Doom.
Finally, I include the Cutland family, whose 19-year-old daughter Alana’s horrific death was caused by doxycycline.
Not included are the parents of a 15-year-old boy, an active sportsman, and stellar student, given doxycycline for acne which caused him to hang himself 10 days later
I have added Sam Ward, who has done so much to raise the profile of isotretinoin’s problems. My understanding from Sam is that nearly 2 years ago you met her and others including Helen Wright, whose 15-year-old daughter Annabel’s isotretinoin triggered inquest is underway. I understand Helen told you she would have preferred her daughter had been murdered as that way she might have met the perpetrator in court.
Several MPs are copied in as some parents have turned to them looking for someone to help getting to grips with perhaps the most catastrophic event in a family’s life, and they, as coroners do, turn to you – unaware how pointless this is.
This letter aims at letting others see we have a system that puts everyone in the position Helen Wright is in. I would hate to mislead people and will make public any substantive errors you note.
Let me focus on the inquest system Helen Wright characterizes as pointless and demeaning.
Coroners cannot come to the often-obvious conclusion (verdict), as for instance in the Cutland case, that a prescription drug has killed a person. They cannot bring in a verdict against a prescription drug in the way they can for a street drug. There is no box to tick.
Even if there were a box to tick, it will be almost impossible to do so as medical insurers advise doctors present at, or preparing reports for, inquests not to admit anything they did, such as prescribing a medicine, could have in any way contributed to the outcome. Coroners are not going to gainsay a medical expert.
At the inquest, a lawyer with zero medical experience will often speak for a doctor, who is perhaps embarrassed at the situation, making a case the person on treatment was severely ill with a disorder that commonly results in suicide, when in the case of Samuel Morgan, for instance, such a statement was close to psychotic.
Dermatologists who never met the patient, as in the case of LC’s son, and know as much psychiatry as a sixth former are happy to opine authoritatively on a well-adjusted young man’s self-image problems – implying mental problems when the reference to self-image in his medical notes is to the correction of a physical problem.
In the case of Samuel Morgan and Samuel Waters-Rathgen, the doctor who prescribed the medicine met each of them for a maximum of 10 minutes once having had no prior contact. Are you asking these families or any sensible person, to believe these doctors knew the people for whom they prescribed better than families who had known them for a quarter century?
In the case of Stephen O’Neill, Robin Swann sent Colleen Bell the warnings on antidepressants he said MHRA put there after extensive analysis and having run independent studies.
Thoughts of suicide and worsening of your depression or anxiety disorder If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
- If you have previously had thoughts about killing or harming
- If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an
- If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Asked by Colleen to respond to Robin Swann, I suggested:
Many invited to review the warning you reproduce, however, made aware that several healthy volunteers have taken their own lives after a brief exposure to serotonin reuptake inhibiting drugs would see problems with ‘MHRA’s warning’.
It has been known for 60 years that people with no mental health history can become agitated and take their own lives on related drugs used to treat infections or hypertension.
Even a lay person informed of this will be able to see that the words MHRA have put in place, if you look at them, appear designed to conceal the fact that the drugs, quite independently of any underlying disorder, can cause suicide.
What lay people may not know is that there is no basis for MHRA to say that anyone taking these drugs is more at risk if they have previously had suicidal thoughts. A good case can be made that such people may be less at risk.
Finally, there is no basis to say that younger people are more at risk. The important point about under 25s is that 45 out of 45 clinical trials for antidepressants in depressed minors say these drugs don’t work. Younger people should rarely be put on them, but they are now the second most commonly taken drugs by teenage girls. If you believed MHRA that young people are more at risk, given that the drugs don’t work for this age group, then ‘Stormont we have a problem’ seems the appropriate phrase.
So why do we have the words we currently have on the label for these drugs. I put ‘MHRA’s warning’ in quotation marks, for a reason. It is pharmaceutical companies who write the label, not MHRA. MHRA have a role in harmonising labels across different drugs from the same group but not much more. Companies are allergic to the word cause, and this can be seen in the words we have in the label. MHRA are allergic to the word cause in sympathy.
Later in my response to Mr. Swann, I indicate that MHRA’s scrutiny of licensing applications amounts to reading the case the company presents. You do not have access to the data from trials and blithely tolerate companies publishing studies they have told you are negative, but then report in the best journals as positive and free of harms.
When the coroner in the Cutland case sent you a Regulation 28 Report, in which he mentioned the word psychosis to characterize the reaction Alana Cutland had to doxycycline, your response was that MHRA has so few reports of psychosis on doxycycline it was difficult to come to a view.
You could readily have had my entire report in this case, which makes it completely clear that, whatever word we use, doxycycline caused Alana Cutland’s death.
Accepting that Alana’s death was triggered by doxycycline might have been inconvenient for MHRA. Currently MHRA’s position that there is no problem on isotretinoin hinges on a Swedish study apparently demonstrating people put on isotretinoin are not much more likely to commit suicide than they were prior to this prescription. This study, however, ignores the fact that most of those given isotretinoin almost certainly had been on doxycycline or related drugs, which unquestionably cause suicide, prior to starting isotretinoin.
It is difficult to sense from your response to the Morgan or Cutland inquests or MHRA’s review of isotretinoin any interest to safeguard people or their children. MHRA’s response to letters from coroners after SSRI inquests has remained the same for over 20 years.
I finished my letter to Mr. Swann by offering a few conclusions that my work on SSRIs and isotretinoin has led me to:
- There is no access to clinical trial data on medicines.
- Close to all of the medical literature reporting trial results for on-patent drugs is ghostwritten, hyping the benefits and hiding the harms.
- Clinical trials of these treatments that are negative on their primary or their most common outcomes are often reported as positive.
- Clinical trials that have a significantly increased occurrence of harms have their harms airbrushed out of ghostwritten publications.
- Regulators (FDA, MHRA, EMA) do not get to see the full trial data.
- Regulators approve treatments as working even when more people die on active treatment than on placebo.
- Regulators approve medicines on the basis of negative studies and agree not to let the wider world know about this.
- Regulators say nothing when companies publish negative studies as positive and make adverse effects of treatment, including death, vanish.
- For many trials there are more deaths on active treatment than on placebo, but this does not lead regulators to warn about hazards as to do so would in their stated view deter people from seeking a benefit (that is a commercial benefit to companies rather than lives saved or a restoration of function).
You have never contested any of these points. Nor have NICE. Nor have any Ministers of Health in any of the four UK jurisdictions. Nor have the BMA. Nor has a House of Commons Select Committee in 2004. They all reach for a lifeline I offer them, namely that it’s not their role to police the medical literature. The medical journals don’t contest it either.
Everyone else, though, thinks you have seen the data, when we both know you neither have it, nor have seen it, nor could give it to Boris Johnson were he to be tempted to withhold it from the French for not giving vaccine passports to people who have participated in Novavax trials.
Letting you off the hook, I put it to Mr. Swann that these matters need leadership from politicians – characterizing you as a good bureaucrat in the process, who will do all you can to keep to the wording of the regulations currently in place but not someone in a position to lead them or anyone else out of the bind Helen Wright has characterized so well (other than perhaps in a Yes Minister fashion). Mr. Swann and colleagues need to change the regulations rather than wait for MHRA to take initiatives it was never designed to take.
Then, attempting to bring this issue home to him. I added one more point for Mr. Swann:
- There are certainly a great number of deaths from Covid. These occur primarily in hospital settings and allow us to link many to Covid and to register these deaths and maintain figures that have some validity.
Deaths from the vaccine happen at home and in settings other than hospitals. No attempts are made to link the deaths to the vaccine (other than in Norway where 10% were likely linked to the vaccine and 26% possibly linked.) No register of deaths lets us know how common vaccine deaths are relative to Covid deaths.
In addition, points 1-9 above apply to these recent company vaccines just as much as they do to medicines like antidepressants.
I imagine all of the families on whose behalf I am writing are pro-vaccine, possibly intensely so, as am I, and they may be disturbed by this point and the figures for the vaccines I reproduce below. These are a month out of date – the totals now are quite a bit higher.
Covid Vaccine Yellow Card Side Effects 26 August 2021
|Heart Attack & Heart Failure||705|
|Nervous System Disorders||226,745|
|Joint & Muscle Problems||68,901|
|Pulmonary Embolus and DVT||3,170|
|Vertigo & Tinnitus||8,852|
|Reproductive & Breast||32,337|
The point I want to make is that you essentially are making no effort to establish a causal link between the vaccines and the above events. The public may see apparent efforts to do so but these are rather a case of firefighting media reports of thrombosis or myocarditis, which you know cannot be put out and must be accepted in a seemly fashion.
As a colleague put it, the public get the impression you are painstakingly searching for vaccine needles in a haystack, when actually you are doing little in the face of a haystack of needles.
Besides it not being MHRA’s job to establish a causal link, you would have to interview the person or their families to have any chance of establishing causality and I am not aware of MHRA for instance getting in touch with any of the families whose loss has led to this letter. You haven’t requested records. You haven’t been in contact with me. I can put you in touch with people who have been seriously injured in some of the vaccine trials if you are interested, whose injuries have likely been hidden under some innocent coding rubric.
If only a third of the cases above are linked to the vaccine as the Norway investigation suggested, this is still a huge amount of death and injury, with an even greater toll if we take the likely under-reporting into account.
Given that so few myocarditis and thrombosis cases are listed here, the close to a quarter of a million nervous system/psychiatric reports, issues that have not featured in the media, suggest a huge toll of problems and an effort to pass many of them off as functional or anxiety – an experience that takers of SSRIs, isotretinoin and doxycycline will be very familiar with.
Many of these people have been badly disabled. Most of them are gaslighted by doctors, regulators, medical bodies, politicians, the media, and others.
We are told we are at War with the Virus, but we don’t have a Red Cross in the field to pick up even our own troops who are wounded, never mind enemy combatants (the unvaccinated, who doctors openly suggest irritate them and they feel inclined to let die), no convalescent hospitals or rehabilitation facilities for our troops to go to, no effort to sustain the population’s morale by treating our troops decently.
It’s somewhat like the way Britain treated the Gurkhas or other Commonwealth soldiers in two World Wars.
It’s the way Britain is treating the families on whose behalf I am writing.
Professor David Healy MD FRCPsych
cc. LC, Tania Morgan, Catharine Waters, Colleen Bell, Neil Cutland, Sam Ward,
Robin Swann, Eluned Morgan, Daisy Cooper
 BMJ https://doi.org/10.1136/bmj.n1372 ; Norway study: https://doi.org/10.4045/tidsskr.21.0383; Norway regulator press release: https://legemiddelverket.no/nyheter/expert-group-has-assessed-deaths-amongst-the-frail-elderly-following-covid-19-vaccination
Eluned Morgan and Robin Swann wrote letters in response neither denying the ghostwriting and lack of access points and praising MHRA to the skies. On October 5, Eluned Morgan, or more probably her office, sent a bizarre response to Mr Healy which is attached HERE.
On October 11th the letter below along with a copy of the Company Woman post was sent to EM.
Dear Ms. Morgan
Your letter to me leaves me thinking you have not understood the issues in the Morgan case.
MHRA are part of a bureaucracy that supports you and other UK ministers. They have bureaucratic expertise but little or no expertise in medicines per se.
In terms of approving drugs as efficacious:
- They do not see the data from the trials on which they base approvals.
- They routinely approve drugs as working that lead, even in the short-term trials that approval is based on, to more lives lost on active treatment than on placebo.
- When told by companies that a trial is negative, but which is published in the academic literature as positive, MHRA turn a blind eye.
- MHRA approve drugs based on negative trials.
In terms of harms, regulators:
- Say, we can’t say that thalidomide causes horrific birth defects – perhaps it prevents spontaneous abortions so babies were born that otherwise might not have been.
- Even after accessing healthy volunteer trials done in Cardiff that show suicidality, dependence and sexual dysfunction on SSRIs, do nothing.
- Even given the material on which New York State took a fraud action against GlaxoSmithKline in 2004 about an SSRI like the one that killed Samuel Morgan, and the US Department of Justice took an action against the company resolved to the tune of $3 Billion, do nothing.
MHRA spend more time thinking up responses like the thalidomide one to feed people like you who enquire about drugs than they do in getting to grips with whether thalidomide causes birth defects or SSRIs cause suicide.
Getting grips is left to doctors like me. But when close to the entire medical literature on a drug is ghostwritten with no access to clinical trial data – which your response does not dispute – most of my colleagues inevitably accept that barely effective drugs are marvelous, and the harms patients report must be in the patient’s mind.
Another problem is that when things go wrong, a doctor’s insurers will counsel against any recognition that a drug has caused a problem. Insurers essentially tell the doctor to ‘lie’.
Many years ago, I was involved in the case of a 13-year-old boy, Matt Miller, who had just moved into high school and was a bit anxious. His mother took him to the doctor who prescribed sertraline (Zoloft – an SSRI like Samuel Morgan’s). A week later he hung himself in the bathroom between his and his parents’ bedroom. Because he wasn’t hanging from a height with his feet clear of the ground, the nauseating card the lawyers played was ‘this could be auto-erotic asphyxiation gone wrong’.
If the doctor is somewhat uncomfortable about this kind of thing, as Dr. Adams may have been at the Morgan inquest, a lawyer who knows nothing about mental illness or drugs and has never met Samuel Morgan will get up and spout about how lethal the underlying illness is.
MHRA take the fact that the doctor hasn’t said the drug unquestionably caused this death – it might after all have been auto-erotic asphyxiation – as carte blanche to do nothing. Internally anyone in MHRA, in their right mind, when in a personal capacity are almost certain to view the drug as causative, as are the Lundbeck personnel, the makers of Samuel’s SSRI.
See Appendix for what goes on behind the scenes. If you look at the Company Woman or Mother post on davidhealy.org, you can see the woman in question.
It’s 22 years since my first inquest report on an SSRI death in Wales. MHRA were briefed then but did nothing. The incentives are all wrong. They are biased against safety. Hiding behind bureaucrats is not going to change this.
I think you should ask doctors to step up to the plate. Ask Dr Adams. Send this correspondence to the British Medical Association who I’ve approached previously, and to the two major medical insurers, asking them for comments.
For the public record, I will note the difficulty of your position. There are now several times more deaths being reported following Covid vaccines than from all other vaccines combined over the previous 20 years. The Norwegians have linked over one third of these to the vaccine.
How many lies are going to be told? How many families gaslit? Will a system built on lies engender trust in vaccines or foster vaccine hesitancy?
I know the response of many families you are putting in this situation is sheer disbelief at what they see unfolding in front of them. Many will surely think about taking the law into their own hands. As I mentioned in a post 6 years ago and in a deposition with GlaxoSmithKline 5 years ago, I’m surprised no-one has.
Professor David Healy MD FRCPsych