Mental Podcast Show

The Daily Telegraph in the UK as well as The Daily Mail carried articles this week on a paper in the journal Ethical Human Psychology and Psychiatry by John Read and colleagues that was based on the work of Brian Davy at AntidepAware.

For over a decade, AntidepAware has been cataloguing inquests in Britain where it appears likely the person was taking an antidepressant. The site gave John and colleagues access to the records.  It’s a rich treasure trove of data on the drugs people have been taking and the article in Ethical HPP helps put this on the record.

AntidepAware and I have liaised closely for years, sharing frustrations at the reluctance of, or inability of the coronial system, to tide this flood of suicides.

One of the first inquests I was involved in, in 1999, was the death by suicide of Richard Wood from Llanelli in South Wales.  It was evident to the coroner there, John Owen, and to me ,that Prozac had caused this death and Mr Owen wrote to the drugs regulator – the MHRA – but got no joy.

One of the most recent I was involved in, Samuel Morgan’s, was also in South Wales, and it was evident to the coroner, Gareth Phillips, that citalopram had caused the problem and he too wrote to the MHRA and got no joy.

Nearly 25 years later and there is no sign of movement – the MHRA may be even dug in deeper than they were in the last millenium.

There is no joy from politicians either, who seem to be waiting for MHRA to make a move – Morgan v Morgan.

The Read article highlights the stalemate.  In not a single instance among the hundreds of cases has the coroner made it absolutely clear that s/he thinks the antidepressant caused the suicide.  Britain has Open Verdicts, which to some in the outside world looks like a tacit admission of drug induced suicide – but it’s not.

The Mail and Telegraph articles take a sensible approach and have straplines mentioning that antidepressants can or might cause suicide.

Read and colleagues are a little more cautious saying that if the person committed suicide clearly the antidepressant wasn’t working – and in this sense could be said to have caused the suicide.

This framing of issues still blames the disease not the drug and leaves the door open to many doctors and huge chunks of the public to figure that the problem is our antidepressants are not strong enough. We need stronger drugs and in the meantime perhaps we need to get people on more drugs – not just one but several at the same time.

As Chance Would Have It

I was asked to review the Read article by EHPP.  As someone who has participated in British and other inquests, this gave me an opportunity to add to the data.

I was able to explain something about why in the face of these hundreds of cases not a single coroner had come out and blamed the drug.  Sure coronoers filed Regulation 28 Reports, which coroners do when there appears to be an issue that concerns the safety of others, but something is getting in the way of  these Reports leading to any movement to make things safer.

The journal editor, Don Marks, creatively opted to publish my review, expanded into article format, alongside the Read paper.  The full article Diagnosis, Verdict and Causality is here. The highlights follow.

Inquest Drama Romain and Yvonne

Case A in the article combines the case of Roman Schmitt, the 16-year old son of Yoko Motohama and Vincent Schmitt who committed suicide on paroxetine.  Romain’s case happened in France and is still in progress.

His case seques into a scene from the inquest of Yvonne Woodley in Britain, whose death on citalopram led to an inquest in 2010. Mr Cotter, the coroner called Dr.Muldoon, the medical affairs manager of Lundbeck in Britain and asked:

AC: I would like you to answer the next two questions either yes, no or I don’t know. 

CM: Ok.

AC: Do you believe that citalopram can cause somebody who would not otherwise take their own life to do so?

CM: Yes.

AC: And is that what you think happened to Yvonne Woodley?

CM: No.

After that the family doctor, Dr Rosemary Smith is asked the same questions and initially answers the same way – Yes and No.

Dr Smith is flustered and slightly all over the place. She is pushed by the coroner:

AC: And if you believe Citalopram does make people take their own life-

RS: No actually. I think I’m going to say that, because we prescribed her Citalopram to hope to make her feel better. That was the whole point of her taking it as an antidepressant, to help her to feel better. This is the risk that is reported by BNF and NICE. That is not to say that we’re actually prescribing somebody something that is going to make them kill themselves. I think if we had not prescribed her anything what would be the conclusion then if she’d hung herself? That she hadn’t been treated?

Finally Dr Gabrielle Milner, a consultant psychiatrist, having heard Dr Muldoon answer that citalopram can cause people to committ suicide  is asked the questions:

.AC: Let me ask the same questions. First do you believe that citalopram can make somebody who would not otherwise take their own life, do so?

GM: I don’t.

AC: You don’t believe it?

GM: No.

AC: So it follows from that that you don’t think that’s what happened to Yvonne?

GM: No.

Samuel Morgan’s case may illustrate why Dr Milner is contradicting the company line in this extraordinary way.  Because these drugs come with a Black Box Warning, Chris Muldoon is pretty well legally obliged to state – yes these drugs can cause suicide.

Samuel Morgan

Samuel Morgan is as close to a healthy volunteer as you can get in clinical practice.  He has pretty well nothing wrong with him when he comes and asks for an SSRI

The doctor who reluctantly prescribes citalopram to Samuel, Richard Adams, appears to be a good doctor and decent man.  In addition to the coroner’s Regulation 28 Report sent to MHRA, Dr Adams writes to the NICE Guideline apparatus suggesting to them that their Guidance on antidepressants doesn’t adequately cover the suicide risk and may need to be revisited. This seems to indicate he believes it is possible that the citalopram he prescribed caused this death.

Long before the inquest, I contacted Dr Adams, outlining some of the background details on citalopram and SSRIs:

that SSRIs have made healthy volunteers commit suicide

that many of these healthy volunteer trials were done in Wales close to where he works

that I have written to the Minister of Health in Wales telling him about all this

that I have written to the Chief Medical Officer in Wales telling him about this

I make it clear I am happy to talk to him and his colleagues about all this without him or them having to say a word.  I also say if there are any problems, I will be happy to be an expert witness on his behalf.

He has the grace to respond but tells me that he has been advised by his medical insurer not to talk to me.

At the inquest, Dr Adams says nothing. His medical defence lawyer does the talking and blames this terrible illness depression, painting it as the only possible cause of this sad death.

Having been a doctor called to an inquest, when a patient I had seen went on to commit suicide, I know that the advice from a Defence Union is to blame the illness not the drug.  Why? Defence Unions are a business and saying the drug did it opens up the prospect of a legal action against the prescriber.

The insurance industry began life as an effort to help us take risks – like the risks of travelling. Giving us courage to do things has clearly been good for all sorts of other industries. In medicine, their business was to support doctors to take risks to help their patients. Now they will not let a doctor take the risk of conceding that a prescription drug might have caused a problem.

The right word from Dr Adams’ would not bring Samuel back from the dead but it would have brought some relief to his family, and might have saved lots of other lives.

What insurers are doing here is a serious problem, close to a scandal. When the coroner filed his Regulation 28 Report, the response from MHRA was – that Dr Adams’ had not blamed the drug and therefore they wouldn’t.

Romain Schmitt

Things are even trickier for GlaxoSmithKline in Romain Schmitt’s case.  GSK are taking great care to say they could not possibly comment on what happened to Romain on their drug.  They are able to take this position because they have not made an effort to review the records and talk to the family who lived through Romain’s time on their drug.

The classic GSK tactic, given a first airing by Ian Hudson in the Tobin v SmithKline trial, has been to say that paroxetine causes no adverse effects at all.  How is this possible – it happens because GSK take the position that if RCTs have not shown a statistically significant increase in suicidal events, there is no evidence for this.  So no matter how evident it is that the drug in fact has caused the problem, tough – this just shows people can be fooled by appearances.

The crisis about teens committing suicide on antidepressants in 2004, with the later Black Box Warning made this argument a lot more difficult.  GSK had a choice – agree the Warning was because the drug did cause suicide or argue it was because it didn’t work.

The fallback in a case like Romain’s is to argue it did not cause a suicide in this case, or that we cannot say it caused suicide in this casae – something the company can do provided it doesn’t examine this case, even when invited to do so by the family.

GSK can always say its our view that the drug didn’t cause the problem in this case – but having an individual view is not science. Science requires a consensus view. This is where a jury trial can make all the difference.

What will the doctor who prescribed the drug in Romain’s this case say?

What will the medical insurers do?

I have written to the two leading medical insurers in Britain about this problem, inviting them to comment. They have not responded.

Having made these points, a coroner in Britain has just blamed the Astra-Zeneca vaccine for the death of Stephen Wright.   How can this happen, given all the points above?  Well in this case, it is likely no doctor prescribed it – at least not in a manner that will have required medical insurer input.

The coroner also took steps not to blame Astra-Zeneca.  This death was something of an Act of God and the newspaper account stresses that these vaccines have saved millions of lives.

 

 

The post Will Medical Insurers Stop Killing People first appeared on Dr. David Healy.

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