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editorial comment

The Minister for Mental Health must act to protect the public — now

On Wednesday 15 April 2010, a jury in Wicklow returned a historic verdict in the Shane Clancy inquest.

The jury accepted medical evidence which implicated prescription drugs in the death of Shane Clancy and, by implication, the death of Sebastian Creane at Clancy's hands.

The drug involved was Cipramil, one of several SSRI antidepressants based on the compound citalopram, and made by Lundbeck Ireland in its Limerick plant.

Clancy had been prescribed the drug by a GP, not a psychiatrist, on 27 July 2009. Within five days, according to his mother's evidence at the inquest, he became "very agitated". On 5 August, nine days after starting the course of one month's supply, he took all the remaining pills and tried, unsuccessfully, to kill himself.

On 7 August, two days after his suicide attempt, Shane Clancy was prescribed more Cipramil, despite the doctor beiong told he had tried to kill himself. On the night of 15-16 August, he stabbed Seb Creane to death, seriously wounded Dylan Creane and Jennifer Hannigan, and then stabbed himself to death in the Creane family's garden.

The jury had a choicce of two verdicts — suicide, or an open verdict. They refused to class Shane Clancy's death as suicide, on account of the medical evidence.

This came from the Assistant Sate Pathologist, Dr Declan Gilsenan, and from Dr David Healy, an Irish psychiatrist and expert on antidepressant drugs who is Professor of Psychiatry at Cardiff University in Wales.

Dr Gilsenan testified that the concentration of citalopram in Clancy's blood was between 'toxic' and 'lethal'. He further testified that this concentration need not have been due to an overdose, but to a slow rate of metabolising the drug in Clancy.

Professor Healy agreed. He also told the court that behaviour such as suicidal or violent thinking or actions, seen in some patients prescribed SSRIs such as Cipramil, arose not from the patient's condition but from the drugs.

Professor Healy stated clearly that in a small but significant minority of patients, SSRIs can give rise to violent behaviour including self-harm, suicide and violence to others, even up to killing them. He said that this was independent of any condition the patient might have, as the same symptoms had been seen in healthy volunteers.

Professor Healy criticised the existing warnings for patients, as they give the impression that such feelings and behaviours are part of the patient's complaint, and because they are not strong enough.

Two people died on the night of 15-16 August 2009. Two others were seriously injured, one of them potentially fatally. Two families and wide circles of relatives and friends have suffered incalculable pain. Two uyoung men with bright futures had these futures snuffed out in a night of drug-induced madness.

But these were not illicit drugs. Shane Clancy's body had not a trace of other drugs, nor of alcohol — he was a non-drinker.

This was drug licensed by the Irish Medicines Board. This was a drug with a warning of potential suicidal and/or hostile and aggressive behaviour as a 'side effect'.

Yet a doctor repeated a prescription for it after a suicide attempt.

Why?

The patient warnings are too weak.

The 'Dear Doctor' prescribing information is too weak in its warnings.

Yet these dangers have been known about for many years and are warned against strongly in other jurisdictions.

In the USA and other countries the warning about possible suicidal and violent behaviour is compulsorily displayed at the top of the patient information leaflet, in large, bold type and enclosed in a black box with a heavy bold rule all round.

In Ireland the IMB allows a mild warning of suidical ideation to be included far down the text of the patient information leaflet and without any form of emphasis.

The warnings in prescribing information for doctors are equally mild, and certainly do not include a warning that the drug can cause the problem and that on account of this the patient must be monitored, especially in the early stages of taking the medication.

The format and style of such warnings is clearly inadequate — first of all, we question whether patients would read them fully, or reach the part about suicide. Second, it is patently clear that such warnings do not convey to the lay reader the level of risk involved. And it is significant.

Any day of the week, someone else may run amok on citalopram or another SSRI. More people may be killed — unnecessarily — and more families grieve, all on account of the regime of light touch regulation which rules at the Irish Medicines Board.

John Moloney, the Minister of State in charge, can do something right away.

He can instruct the Irish Medicines Board immediately to copy the US approach in relation to these warnings.

He can order them to introduce a strong Black Box warning, like those in the USA and Canada, on the patient information leaflets for all SSRIs, SNRIs, and similar antidepressants, which tell you in bold type that anyone under 25 is at particular risk of suicidal, hostile or agressive thoughts and actions when taking these drugs.

It might save other lives.

 

Professor Healy also told the court that Shane Clancy had attempted suicide soon after first being prescribed Cipramil. Despite being told this, his doctor had prescribed a further course of the same drug. In Healy's view, Clancy's doctor did not have sufficient warning that this behaviour arose from taking the medication, rather than from his depression and sadness over breaking up with his girlfriend.

Professor Healy stated categorically that "it is the drug that causes the problem", at least in susceptible patients who can form a small but significant minority. He added that the higher the dose taken, the greater the likelihood of serious adverse effects and behaviours. In Clancy's case, the post mortem had shown levels levels of citalopram which lay between 'toxic' and 'lethal'.

"My view is that there should be compulsory monitoring of patients in the initial period after starting to take the drug," he said. He explained that the danger period is generally within the first two weeks and usually within the first days of taking the drug. "As many as 50% of patients prescribed citalopram could find it is the wrong drug for them," he said. "If they react to it, if there is any kind of oddity, they should go back to their doctor and ... have the drug changed."

As in other jurisdictions, the patient should be monitored over a period of two weeks to ensure things did not go wrong. Ideally, an appointment should be made on prescription for a routine screening. As the patient could develop problematic behaviours but not link them to taking the drug, it should be a matter of calling them back to the clinic rather than leaving it up to the patient.

He felt that public awareness of these dangers is generally low and that information about the risks involved should be widely and continuously available.

 

So the Minister can do even more to protect the public. He can tell the IMB to strengthen the prescribing information for doctors to include a far stronger warning, to emphasise that the drug itself can produce these effects, and to stress the need for close monitoring of patients who are prescribed these drugs.

Mr Moloney must make it obligatory for all prescribing doctors to carefully monitor all patients prescribed these classes of drugs, including setting at least one return appointment on the date of prescription, so that the doctor can check the patient for any tell-tale signs and take corrective action.

As the danger period for such reactions can range from a few days after starting the drug up to two weeks, we recommend that the protocol should include that a date for a return visit within five days of prescribing is set by the doctor at the same time as he/she writes the prescription; and that a further doctor visit, to occur no later than 15 days after commencement of the drug, should be set at the first monitoring visit.

In addition, with regard to raising the level of public awareness, Mr Moloney can take another simple step and ensure that all patient information leaflets or package information be made available on the IMB website or on request to the IMB.

They are not publicly available at present.

 

Finally, we should recall that the present Minister chaired the Joint Oireachtas Committee on Health and Children in 2006-2007. This committee's Eighth Report in April 2007, The Adverse Side Effects of Pharmaceuticals, included a finding that the structure and funding of the Irish Medicines Board were seriously flawed.

It recommended that the IMB be broken up into two bodies, one to deal with licencing and one with pharmacovigilance or post-licencing safety monitoring.

The committee also recommended that the present funding of the IMB, by the drug companies, should end and that this body should receive its funding from central government sources.

Neither of these important recommendations has so far been implemented. The committee made other recommendations, such as the setting up of a Patient Safety Agency, none of which, to our knowledge, has been followed up.

Is it not high time that Mr Moloney implemented the recommendations which he himself made in 2007? If he had done so before now, Shane Clancy and Sebastian Creane might still be alive, and looking to their bright futures. Let's not have any more of these needless, drug-induced killings. Let's end this light touch regulation and bring in strong, effective patient safety measures.

 

 

Downloads:

Joint Oireachtas Committee report

Cipramil package information as approved by IMB

Celexa (=Cipramil) medication guide (FDA)

SSRI warning issued by the FDA in the US


'Not suicide' verdict in Shane Clancy inquest

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features

The top shock doc who now admits that ECT damages the brain

Direct HitFor more than 25 years Harold Sackeim of Columbia University has been not only the top ECT (electro-convulsive therapy) researcher in the US, but the main proponent of the controversial treatment worldwide.

He taught a generation of ECT practitioners that “permanent amnesia from ECT is so rare that it could not be studied.” He also stated that people who said the treatment erased years of memory were mentally ill and thus not credible.

The National Institute of Mental Health (NIMH) estimates that more than 3 million people have received ECT just over the course of the last generation in the US alone.

It is entirely likely that ECT could not have survived as a ‘treatment’ over this same period without the calm and authoritative voice of Harold Sackeim assuring all, including the media and judicial and legislative bodies, that passing up to 420 volts through the brain of a human being was completely safe.

Then, in January 2007, the Journal of Neuropsychopharmacology reported the results of the largest follow-up study ever done on ECT patients. Sackeim, lead author of the study, admits that the study conclusively demonstrates that ECT causes permanent amnesia and permanent deficits in cognitive abilities, which affect individuals’ ability to function:

“This study provides the first evidence in a large, prospective sample that adverse cognitive effects can persist for an extended period, and that they characterize routine treatment with ECT in community settings,”…

Doesn’t sound too bad put like that does it? See how it sounds when put into plain English: Brain Damage.

Oddly enough that accords with the American Journal of Psychiatry (1973) which stated: “the ECT patients’ inferior (test) performance does suggest that ECT causes permanent brain damage.”

Neurosurgeons agreed. Frank Vertosick equated ECT to repairing a computer with a chainsaw. Sidney Samant said that ECT produced effects identical to those of a head injury. John Friedberg said that ECT caused brain damage and memory loss.

Why then did psychiatrists continue to administer ECT for at least thirty-four years past the point where they knew it was causing brain damage, and why did society tolerate it? Because Harold Sackeim, the world famous ECT research expert, stated right up until January 2007 that ECT definitely didn’t cause brain damage.

Dr. John Read of the University of Auckland said: “This study proves what critics and recipients of shock therapies have been saying for years and shows that the Ministry of Health and the Royal College of Australian and New Zealand Psychiatrists have been misleading parliament and the public.”

The results of the study were picked up by news wires around the world. Sackeim’s admission, though long overdue and falling somewhat short of a full Mea Culpa, was still welcomed by those dedicated groups and individuals who have fought against this barbaric and primitive practice.

ECT has been around for almost 70 years now and has never been absent from controversy. Numerous websites detail harrowing stories of electro-shock induced brain damage by survivors and their families.

Articles were written and research papers published. Lobby groups were established. Survivors formed themselves into groups to protest their situation. There were even a very few courageous psychiatric insiders who blew the whistle.

Few listened. Fewer cared.

To be labeled as mentally ill is to be stigmatised. Open your mouth and people wonder whether you are making it up as you go along. Your every utterance has doubt cast upon it by virtue of the fact that you have been labeled ‘mentally ill’.

Nothing that the ‘mentally ill’ person says or does can be taken in without it first being filtered through the perception that at best the person is incompetent and irrational and at worst violent.

These unspoken generalisations and perceptions though entirely erroneous are rife, especially in the media. While most people are uncomfortable with the idea of physical coercion, there is a tacit and convenient agreement that in the case of the mentally ill it is ‘probably in their own best interests”. Considerations of human rights are put aside because these people are ‘different’.

The forced application of ECT to millions of people ranks alongside the worst atrocities of the twentieth century. Coursing high voltage electricity through the brains of unwilling recipients was a blatant and barbaric disregard for human rights plain and simple. It happened because decent people chose to disregard the evidence of their own ears and eyes, not to say common sense, in favour of the soothing voice of experts like Harold Sackeim.

The lesson to be learned is that human rights are too important to be allowed to moulder in the bin of meaningless slogans. A genuine understanding and respect for human rights would have stopped involuntary ECT happening in the first place. Human rights must become widely and well known and to this end should be taught in schools. Do you, or any of your family or friends, know Article 1 of the UN Declaration of Human Rights — or any of the Articles?

Human rights are for all people at all times and under all circumstances. There are no exceptions and can never be any exceptions. If there are exceptions to human rights then such ‘Rights’ by definition degenerate to the status of ‘Privileges’.

It has now been revealed that the inspiration for Sackeim’s support of ECT for all those years was the fact that he was quietly on the payroll of Mecta Corporation, the manufacturer of ECT machines. Just as it was money that provided the quasi-legitimacy for ECT, so it was the highly profitable nature of ETC that kept psychiatrists enthusiastically pulling the switch. And now it will again be money, or more precisely the fear of losing money through litigation, that will bring about the end of the practice. Not remorse or pity, nor even common decency or respect for human rights, just money.

We are on the cusp of an avalanche of court cases on behalf of the recipients of ECT. No amount of money can ever compensate for the willful and unnecessary damage that has been done these people, or the indignities that they have had to suffer to even be listened to. There is also no price that compensates for the injustice and shame of having been legally defined as unworthy of human rights and, ipso facto, classified as less than human. Such court cases will though serve to focus attention on the importance of paying more than lip-service to human rights.

Genuine human rights for all can only be attained when our media realise that alongside their disseminative power comes an intellectual responsibility.

It is not just the media, though. It is time for society at large to take a good hard look at itself. The truth is that we all knew what was happening; we all knew that it was completely wrong and yet very few did a damn thing about it. Why was that?

Possibly Ayn Rand explains the problem best: “The hardest thing to explain is the glaringly evident which everybody has decided not to see.”

 

Philip Barton 2008

 

Philip's blog is here

 


 

features

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