This post features in a series of posts on the Politics of Care Forum. It sits alongside Can Politicians Save Us, Can Politicians Save the World as well as What’s a Life Worth, Once We Were Warriors and Do Not Forsake Me Oh My Doctor. There will be a follow-up post next week.
The letter below (without the images) was sent to Eluned Morgan, Minister for Mental Health in Wales a week ago. It followed her response to a letter to her from Tania and Ian Morgan following an inquest on the death of their son Samuel in December 2020.
August 9th 2021
Eluned Morgan AS/MS
Minister for Mental Health
Welsh Assembly Government
Dear Ms. Morgan
I am writing after seeing your correspondence with Ian and Tania Morgan. Over 200 drugs can trigger suicide. If a family member of yours kills themselves (or others) as a result of one of these, what happened to the family of Samuel Morgan recently will happen you also.
There will be an inquest.
The doctor who prescribed for your son, daughter or parent may be asked to be present or to prepare a report. S/he will check with their medical insurer beforehand. The insurer will advise against conceding the drug caused the problem. At the inquest or in their report, the doctor will say s/he can’t rule out the mental disorder being treated or the one that must have been there if the suicide happens after taking an antibiotic like doxycycline or isotretinoin given for acne.
Medical insurers in this case de facto shield the pharmaceutical industry rather than support a doctor to act in the best interest of the patient’s family at a moment that calls for humanity and courage. The barrister for Dr Adams, Samuel’s prescribing doctor, pushed for an outright suicide verdict rather than an open or narrative verdict.
Dr Adams seems to be a decent man. Samuel’s case was open and shut – citalopram caused his suicide. There is no other reasonable explanation for what happened.
Dr Adams knows comparatively little about these drugs and almost nothing about Samuel, having met him perhaps only once for maybe 15 minutes. Samuel had a family and close girlfriend who knew him far better than Dr Adams could possibly ever have hoped to.
At his inquest, Samuel had input from an expert who probably knows more about these drugs than anyone else in Britain and vastly more than Dr Adams and the barrister speaking for him.
Coroners are unable to say the drug caused the suicide for two reasons. First, there is no box on their forms for this that they can tick. Second, they are semi-obliged to go by what the doctor says – s/he after all is a medical professional and coroners aren’t.
The coroner may believe however that suicide is the wrong verdict and strictly speaking if a drug triggered the death, the death cannot be suicide. In this case a coroner may return an Open Verdict, or Death by Misadventure, or a Narrative Verdict. This often feels important to a family who welcome an escape from the stigma of suicide.
If it seems obvious to the coroner that a drug caused the death of someone like Samuel Morgan or Alana Cutland whose inquest was held a year ago, who had been taking doxycycline (Appendix 1), s/he may report to the medicines’ regulator (the MHRA), as Mr. Philips did in this case and Mr. Osborne in the Cutland case.
A referral to a regulator sounds good to most people, and likely to you, but regulators are bureaucrats who never go out on a limb and say a drug has caused a problem.
Even when informed close to explicitly by a coroner of a death that looks triggered by a drug, as in Cutland case, the regulator will not agree a drug has caused or can cause a problem.
MHRA are de facto incapable of deciding if a drug has caused a problem. They are also tangled up in a web that pharmaceutical companies have spun for them.
When doctors report a problem to regulators, the regulator removes the patient’s name (usually pleading a concern about confidentiality). Once this happens no-one can establish whether a drug has caused a problem. Establishing whether a drug can cause a problem cannot be done without investigating in detail the case of the person who has been harmed. If the harm is death this means interviewing relatives. MHRA have not investigated Samuel Morgan’s death.
The doctor’s view at an inquest that a drug did not cause the problem, or failure to say it did cause the problem, is a get-out-of-jail-free card for companies and regulators. For most people, the view of a doctor who killed your family member trumps everything else.
Unlike regulators, when problems are reported on their drug pharmaceutical companies are legally obliged to investigate them. This usually means contacting the doctor who prescribed the drug and asking for the person’s medical records.
You may be surprised to know that even if the doctor has explicitly said a drug did not cause a problem, companies who work through a person’s medical records may decide their drug did cause it. This happens often in clinical trials but these conclusions are never reported in the up to 50 almost entirely ghostwritten articles that may appear in the clinical trial literature reporting the results of a single trial – articles on which NICE base their Guidelines.
How do companies come to conclusions like this? They use common sense – the problem wasn’t there before the drug was given, emerges after the drug is started or when the dose is raised, and clears if there has been a chance to stop the drug.
But in public, at court cases or inquests, the company will continue to deny a link to their drug and say that unless a randomized clinical trial (RCT) shows the problem being caused by the drug there is no proper evidence that it has been. No trials are ever done to look at a hazard and the data from the trials that are done remain inaccessible.
This speaks to the web that companies have trapped regulators in. Companies have persuaded regulators that RCTs offer gold standard evidence on what drugs do but also that a positive finding on an RCT means that the benefit-risk ratio for a drug is favourable and that warning about risks might deter people from getting that benefit.
Regulators appear incapable or unwilling to see the flaws in this argument, perhaps because it offers them a box to tick – an alibi in the event of a scandal.
RCTs can only properly investigate one of the more than 100 effects a drug has. The effect chosen is called the primary endpoint. Most people assume this is the commonest effect of the drug and other events are rare or happen if you have been the drug for a long time. This view underpins the risk-benefit argument above.
In company trials, the primary endpoint is an effect of commercial interest rather than the most common effect. In the case of SSRIs, the commonest effect is on sexual functioning. Sexual effects happen in pretty well everyone who takes these drugs, within 30 minutes of a first dose, whereas a convincing mood effect can take months to appear and is less common. Because trials are designed to focus on primary endpoints, these sexual effects of SSRIs are missed – even though companies knew they were happening from healthy volunteer trials.
In terms of risk-benefit, when companies and regulators talk about a benefit against which risks can be set, in the case of SSRIs they mean a change on depression rating scale scores. There is a minimal difference between SSRI and placebo rating scale changes that perhaps means these drugs offer a ‘X’ in the case of one person in ten who takes them.
What does offer an ‘X’ mean. No-one knows. X is a rating scale score. It does not mean get back to work or general functioning. It does not mean lives saved; more lives are lost on SSRIs than on placebo.
These drugs are now taken by roughly one in six people in Wales – not because X is a benefit but because they cause dependence and people can’t get off them. Some may think the drugs are saving their lives because they feel so bad when they miss a dose and feel so much better if they get their pills again.
In the case of women, any X there might be is likely to be wiped out by the fact they cannot function sexually, and their libido vanishes. Up to a quarter of couples in some Welsh towns are likely not making love the way they might wish.
There has been a good deal of talk about miscarriages in the UK media lately. If a woman gets pregnant, while on an SSRI, her risk of a miscarriage is doubled. If she gives birth, the risk of a birth defect is doubled, as is the risk of her child will have behavioural problems. This is all likely contributing to Welsh birth rates falling below the replacement rate.
The idea that these drugs have a positive risk-benefit balance that warrants not warning properly about their hazards is ludicrous regulatory humbug.
Your letter to the Morgan family notes the increased risk of suicide in mental illness. Samuel Morgan was not at an increased risk of suicide from any condition he had, if he had any at all. Minor nervous conditions may even protect against suicide (Appendix 2). The suicide rate in the most severe mental illness was close to zero before the introduction of psychotropic medicines in 1955 (Appendix 3).
As you should know because of studies conducted in Wales, healthy volunteers can become suicidal, engage in suicidal acts, or commit suicide linked to their intake of these drugs. I’ve invited Vaughan Gething and Frank Atherton to look into this, but it looks like neither has or, perhaps just not passed the information on to whoever wrote the letter in your name.
Another factor in Samuel’s case is that in the United States these drugs come with a Black Box Warning. Why a warning, you might ask, when regulators and companies do not want to deter people from seeking treatment?
This is not a matter of Black Box Warnings being a thing we don’t do in Britain. The FDA took the step they did because there was no benefit to the drugs for those 25 years old and under – as Samuel was. The lack of benefit in this age group came to light after GlaxoSmithKline was charged with fraud for claiming paroxetine was effective and safe in minors, and later fined $3 billion. (Many of the paroxetine healthy volunteer studies prior to its launch were done in Wales).
Samuel was on citalopram which is equally ineffective in his age group. The first citalopram trial done in minors had one of the highest suicidal act rates. Forrest Laboratories marketing it in the US were fined nearly $400 million.
But not even Black Box Warnings make it clear that these drugs can cause suicide in healthy volunteers. There is nothing in the UK or US labels of these drugs to tell doctors what to do if a drug is causing a problem. Instead of stopping treatment, they routinely double the dose, as Dr Adams would likely have done had an agitated Samuel come back to him.
I routinely tell people that MHRA don’t see study data. MHRA say they do. We can agree they see figures – from a selected set of company trials. In addition, in the case of Eluned Morgan’s file let’s say, MHRA will see figures from an EM file but are unaware there may be up to four alternate EM files differing in length by several hundred pages in some cases (See Children of the Cure).
If someone dies in a trial or has to go to hospital because of an adverse event, companies must fill out a serious adverse event form. Or once had to. They have discovered that if investigators decide a person dropped out of the drug or vaccine study because s/he had an intercurrent illness, no report is needed.
In one paroxetine study (Study 329), four teenagers dropped out with intercurrent illness, all taking paroxetine. One of these, a 15-year-old boy, was arrested by police for brandishing a gun in a public place threatening to shoot people. He was taken to hospital. This was likely a serious paroxetine adverse event, but GSK gave him an intercurrent illness and didn’t fill any paperwork. MHRA have no idea what happened here or to the others with intercurrent illness. Access to the data really means being able to investigate what happened – that is have access to the people in a trial. MHRA have access to NONE of the data from any study they review.
There is a link between this 15-year-old boy and Samuel. There have been 45 antidepressant RCTs in supposedly depressed minors – all 45 negative, but many written up as positive. This is the greatest concentration of negative trials ever. Yet antidepressants now appear to be the second most commonly taken drugs by teenage girls and their use is fast growing.
This isn’t just a matter of doctors inappropriately pushing these drugs. Greta Thunberg’s generation have transformed our awareness of the chemicals being pumped into the environment, but they are pumping more chemicals into themselves than any previous generation. Samuel was a case in point. He pressed Dr Adams to prescribe, as do an increasing number of young people you know. Laying on therapy is not the answer because therapists routinely pressure people to get on meds.
While deferring to MHRA or NICE might look appealing, most people in Wales reading this will spot the irrelevance of MHRA, NICE, BMA or BMJ. They:
The National Health System (NHS) came from Wales. It hinged on the idea that effective treatments could be delivered for free paid for from the money saved by reducing premature mortality and disability. It cannot survive delivering ineffective and dangerous treatments.
Healthcare was once the badge of honour for progressive politicians. But the Labour party now plays into pharmaceutical company hands. It champions universal health coverage rather than universal healthcare and nowhere does this show more than with the SSRI group of drugs and what happens as a consequence to people like Samuel Morgan. Labour’s healthcare policies went out of date around 1990 when the SSRI drugs came on stream.
A year ago, the Conservative MP, Johnny Mercer, resigned from the Cabinet on a point of principle. You and I may not agree with the principle, but we can respect his view that it was a matter of honour for him. I mention Mr Mercer, as, triggered by one of his constituents, I have presented him with the same gauntlet I now present you. See What’s a Life Worth?
It’s difficult to believe there isn’t a matter of honour here for you. Can you really tolerate a total lack of access to study data and an almost complete ghostwriting of the medical literature in respect of on-patent drugs with NICE, MHRA, BMA, BMJ all saying it’s not their problem?
I will post my letters to Mr. Mercer and to you online next week. I enclose a series of links to posts that include the prior correspondence to NICE, Welsh Government and others and you are welcome to show this letter to anyone you wish to show it to.
David Healy MD FRCPsych