Jake’s Amendment Fails. And Yet..

 

Grace McManus, John Lynch, Stephanie Lynch and Senator Pádraig Mac Lochlainn
Grace McManus, John Lynch, Stephanie Lynch and Senator Pádraig Mac Lochlainn

The only thing necessary for the triumph of evil is for good men to do nothing – Edmund Burke. I know, I know, this quote is painfully overused, but I couldn’t think of a more appropriate one here.

So, yesterday myself (and himself) went to Seanad Éireann (the Irish Senate) to witness the second stage of a bill to amend the Coroner’s Act (called Jake’s Amendment). Jake Lynch is the forever-14 year old child at the centre of all this. His parents, Stephanie and John Lynch, assisted by Senator Pádraig Mac Lochlainn, have worked tirelessly on this bill since 2015 – a proposal to amend the Coroner’s Act to include a verdict of ‘iatrogenic suicide’ (treatment-induced suicide). Sadly, the bill failed at a vote of 12-19. However, there were many surprising elements to yesterday’s Seanad Shenanigans. Firstly, few showed surprise (or denied) that antidepressants can cause suicide; that is a major shift in opinion in a few short years. Secondly, among the senators who voted for Jake’s Amendment, several were willing to put their heads above the parapet and publicly support Jake’s Amendment. Lastly, the only one who argued a ‘causal’ link was the Minister for Justice, Charlie Flanagan, and he seemed to be directly quoting from Irish Psychiatry’s statement following Shane’s inquest – so hardly a surprise. Indeed, it seems all may not be lost with him either – as following the vote, he approached Jake’s family and expressed an interest in meeting up to discuss the issue. I have a feeling that little Jake Lynch (and his parents) will make a difference – and I for one, am very proud to call them my friends.

Background:

You may remember that Jake Lynch was a 14 year old boy (diagnosed with Aspergers syndrome) who was prescribed fluoxetine, aka Prozac, to ‘help with his exams’. Five weeks after being precribed fluoxetine (where the dosage was doubled without his or his parents’ knowledge), off-label and with nil informed consent, Jake ended his own life. As his mother Stephanie said – the only thing that changed in his short life was the prescription for fluoxetine. Available literature from the Irish Drug Regulator (the HPRA), provides that ‘Prozac is not for use in children and adolescents under 18’, due to the increased risk of side effects such as ‘suicide attempt, suicidal thoughts and hostility’. However, it provides that in the case of a child aged 8-18 with ‘moderate to severe depression’, a doctor may prescribe it off-label (not licenced for that indication) – if he/she decides it is in the child’s ‘best interest’. While the pros and cons of off-label prescribing have been oft-debated, it should be remembered that Jake did not have depression and was prescribed the drug ‘to help with his junior certificate’. Clearly, as he is now dead, it seems that Prozac proved to be in ‘his worst possible interest’.

Notably, Jake had no history (or diagnosis) of depression and his death came out-of-the-blue to all who knew him – seemingly inexplicable. Indeed, after a long and protracted inquest, the coroner concluded that Jake was not in his right mind on the night he died (resulting from the prescribed fluoxetine) and returned an ‘open’ verdict. This was largely due to an email that Jake sent shortly before he died, saying he felt ‘drugged out of his mind’ and further (demonstrating a shocking lack of consent), he expressed that he was never told that the drug was an antidepressant.

While the Seanad vote was disappointing, it was hardly surprising. Although 12 Senators voted to support the bill, the majority (19) voted against. The general reasoning was that an inquest cannot apportion blame and thus, a prescribing physician might be held accountable (imagine the horror!). However, this was addressed in the proposed bill and was not the intent of Jake’s Amendment. Indeed, this particular reasoning does not explain why ‘medical misadventure’ or ‘unlawful killing’ are permitted – and surely a ‘suicide’ verdict blames the deceased? It was also mentioned that there were other alternatives in circumstances where medical treatment causes harm, such as taking the legal route. However, this failed to consider that in Ireland (and indeed, Europe), taking a case against a pharmaceutical company or medical establishment means that a plaintiff must have the means to meet the costs of the defence if the action fails. Thus, for the majority of plaintiffs with relatively ‘normal’ means (who haven’t won the lotto), a legal action is nigh on impossible. This is not justice.

It was both humbling and inspiring to see ordinary extraordinary family members, stand firm with the courage of their convictions, in the face of any establishment. Senators like David Norris, Francis Black, (the very kind) Maire Devine, Trevor Ó Clochartaigh and Rose Conway-Walsh, were all thoroughly inspiring.

Contraindication?

While Senator (and doctor) James Reilly was among the opposers – it was hardly a revelation. Indeed, he took umbrage with Senator Norris stating that Prozac was contraindicated in ‘those with Aspergers’ – which he said was untrue. Hmm, let’s see, shall we?

Definition of contraindicate – To indicate the inadvisability of something, such as a medical treatment. 

According to a 2010 Cochrane literature review Selective serotonin reuptake inhibitors (SSRIs) for autism spectrum disorders (ASD)’There is no evidence of effect of SSRIs in children and emerging evidence of harm (I have full text if required).

According to the NICE guidelines (section 1.4.22) – Do not use antidepressant medication for the routine management of core symptoms of autism in adults.

And again, per NICE (reviewed in 2016) – Do not use antidepressants for the management of core features of autism in children and young people. 

It seems pretty clear to me that Senator Norris was actually correct when he said that the SSRI prozac was contraindicated for ‘those with Aspergers’. What is not clear, is why Dr Reilly was unaware of the NICE guidelines or the Cochrane review.

So, back to business as usual, the families fight on for justice and Jake, the 14 year old child at the centre of all this, remains irrevocably and needlessly dead. There is little doubt that this is not over – at least until the fat skinny lady sings (aka Stephanie).

The recording of the Seanad can be seen here from 26 minutes and concludes here.

GSK’s Dirty Little Secret

Stewart
Dolin v SmithKline Beecham

So, myself and my friend Stephanie were in Chicago this week. We had traveled across the Atlantic to hear the opening arguments of Dolin v. Smithkline Beecham Corp (now GlaxoSmithKline – GSK). For more background to this case, see here.

We arrived straight into an unprecedented weather event, Storm Stella – described in the media as a weather bomb, having undergone bombogenesis (haven’t a clue either). Thus, while we were a little worried that the trial might be postponed, we were more concerned with the liklihood of two Irish females freezing to death. However, despite hitting a cool minus-8, with some pretty bizarre white-out conditions, we survived and the trial went ahead as planned (with the Hon. William T. Hart presiding).

This case centers on Wendy Dolin, the plaintiff, alleging that her husband’s death in 2010 was drug-induced and that GSK failed to warn of the increased risk of suicide in older adults taking the antidepressant Paroxetine. Her lawyers, Baum Hedlund, contend that GSK hid a ‘dirty little secret’ – that the drug can cause akathisia, often coded under the innocuously-sounding ‘inner turmoil’. However, this drug-induced condition is far from harmless and injury to oneself and/or others, can quickly follow. Furthermore, as alleged in this case, it can often prove fatal; see here.

At the time of his death, Stewart Dolin was 57 and was a corporate lawyer with ReidSmith. While suffering from work-related stress, he was prescribed Paroxetine by his physician, Dr. Martin Sachman – a family friend. Paroxetine is perhaps more widely recognised by its trade name Paxil, or Seroxat in Europe. Six days after being prescribed a generic form of the drug, Stewart died by jumping in front of a Chicago train. He was affluent, well-liked by colleagues and well-loved by his family. Per one of his colleagues “Stu Dolin was a close personal friend, valued colleague and a great leader in our firm. His energy and spirit benefited everyone around him. The lawsuit claims that GSK failed to adequately warn doctors (including Dr. Sachman) of the increased risk of suicidal behavior in adults. Indeed, GSK’s opening argument proclaimed that ‘Paxil does not cause suicide’. That was then contradicted by GSK’s very own literature, where a 2006 analysis showed a 6.7 times greater risk of suicidal behaviour in adults (of all ages) taking Paxil, over placebo.

Doctor David Healy was on the stand for 2 full-days, as an expert witness for the plaintiff. His testimony included an account of how GSK had hidden suicide events from the Food and Drug Administration (FDA), thus manipulating the suicide-ratio and effectively hiding the bodies. Explaining drug-induced suicides to the jury, his world-leading expert status in psychopharmacology was unquestionable. No doubt, GSK ‘s legal team will attempt to annihilate that particular status before he exposes any more ‘dirty little secrets’. Like how 100% of Paxil consumers will experience sexual dysfunction – another life changing adverse-effect he mentioned in court, and another one not precisely admitted to by the manufacturers.

Not surprisingly, GSK’s lawyers (King and Spalding), became increasingly apoplectic, interjecting every few minutes with their objections, which proved fascinating in itself. The last hour before the court adjourned for the week-end proved to be very enlightening indeed, with their team looking increasingly agitated. Doctor Healy was then asked some questions by the plaintiff’s legal team:

(1) Do you have any doubt that Paxil can cause suicide? He answered ‘No’.

(2) In your opinion, did GSK warn doctors of the increased risk of suicide in adults? Again he answered ‘No’.

There seemed little doubt to anyone listening that Paxil could cause Akathisia and/or a drug-induced suicide. However, no doubt GSK will have many experts to refute that, whatever the evidence has shown. Having listened to this week’s testimonies, there is absolutely no doubt in my mind that Steward Dolin’s death was induced by the Paxil he was taking in the final 6 days of his life. However, the trial will most-likely go on for another few weeks when the jury will ultimately decide. Sadly, as is normal in these legal cases, every aspect of Wendy and Stewart’s private life will be publicly torn to shreds, with their every move dissected to try and put doubt into the jury’s mind. Whatever the outcome, Stewart’s wife Wendy, is one very, very brave lady.

Clearly, GSK’s lawyers are particularly polished and well used to court proceedings. That said, following the jurys’ retirement for the weekend, there was a last minute crucial objection from their legal team. One of their lawyers raised a final grievance – that a lawyer for the plaintiff’s side had the cheek to say ‘have a good weekend’ to the jury. Seriously? Drug induced suicide was the issue here and this farewell gesture caused offence to GSK’s legal team?

Anyway, if you would like to see the three video depositions that were shown to the court; they were uploaded yesterday. You really don’t need to be a body language expert to determine how truthful these GSK experts are being – or not.

GSK Biostatistician John Davies Deposition in Paxil Suicide Case:

Damning Testimony from Former GlaxoSmithKline CEO Jean-Pierre Garnier in Paxil Suicide Case:

Former Glaxo Executive Jeffrey Dunbar Deposition in Paxil Suicide Case:

When Science and Anecdote Collide

cropped-hippocrates12.jpg

For decades, declarations by perturbed relatives that a loved-one’s death was iatrogenic (induced by medical treatment), were often dismissed as anecdotal. Accounts imparted by concerned loved-ones were likely to be rejected, albeit often kindly – yet thrust aside as the demented rantings of a grieving loved-one. Placated with persuasive words, relatives often slink away, suitably chastised by the medic’s evidential superior knowledge. The rantings of the grieving widow or mother will be controlled and placated, with the vociferator patronized and often pitied as misinformed dissidents. Thus, relegated to the anecdotal tray, rather than adverse-reaction tray, the iatrogenesis will likely continue, surfacing some time later to harm another. Many feel this practice is particularly pervasive within psychiatry, where protecting the medical model seems paramount over the safeguarding of patients.

The perception of the American ‘shrink’ listening attentively, while the horizontal patient spills his innermost torment, is one that persists today. In reality, this is far from the norm, with the prescribing of psychiatric drugs taking precedence over the tedium of treating a traumatised patient. Drugs that often mask the problem with disinhibition and emotional blunting are seemingly prescribed with wild abandon, yet only the families affected can see the harms done – while medics seem oblivious. When Cochrane Scientists and expert psycho-pharmacologists, are publicly stating that antidepressants and other psychotropic drugs are causing ‘more harm than good’ and many deaths, dismissive medics who continue to recklessly prescribe are walking a fine line between acting irresponsibly and negligently. However, a vast disparity still exists between scientific findings that psychiatric drugs are the third leading cause of death in Europe (and the U.S) and psychiatry’s Key Opinion Leaders (KOLs) declaring these drugs are safe – even declaring that ‘the public should have no concerns about these drugs’. 

When publicly challenged, KOLs usually retaliate with the mantra ‘correlation does not imply causation’. Pushed a bit further, their hackles will rise and they’ll state ‘these people are causing harm, by stopping people from taking life-saving medication’. Yet, even a utilitarian argument that these drugs provide ‘the greatest good for the greatest number’ has been debunked by Peter Gøtzsche (scientist and co-founder of the Cochrane Collaboration). He stated recently, to no small uproar, that these drugs are ‘doing more harm than good’ and that almost all psychotropic drug use could be stopped without deleterious effect (due to withdrawal, discontinuing is not advisable without medical supervision).

However, the problems run deeper than the KOLs defence of psychiatric drugs. An interesting article on MIA (Mad in America) tells the sorry tale of a dad who recently discovered that the American drug regulator (FDA) is ‘hiding reports linking psychiatric drugs to homicides’. It will be interesting to see what happens next within the FDA.

Furthermore, the statement that ‘the public should have no concerns about these drugs’ was made following an inquest in Ireland, where concerns were raised by the deceased’s family about a recent prescription of Sertraline (Zoloft/Lustral). However, as is common practice, the family’s concerns were dismissed. They had no way of knowing that in 1998, the Irish Drug Regulator (HPRA), following reports of Sertraline-induced suicide, had requested that the drug company in question (Pfizer) search its database for similar cases. There were 594 ‘suicide events’ reported from non-clinical sources, of which causality was not investigated. Of the 252 from clinical trial cases, Pfizer’s internal report concluded that 54 were directly related to Sertraline treatment. Interestingly, 11 of the ‘suicide events’ reported (from both sources) came from Ireland, with 2 found causally related to Sertraline. The latter were from ‘confidential’ documents released through court proceedings and provided by Kim Witczak who lost her husband Woody to Sertraline.

Nevertheless, it seems that science may be catching up with the anecdotal evidence, with some interesting studies published recently. Following the Study 329 debacle (as yet unretracted), the latest study by Jureidini et al ‘The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance’ shows how Forest Labs, through greed and fraudulent practices, actively ignored the prospective likely harms to children. The study concluded:

Deconstruction of court documents revealed that protocol-specified outcome measures showed no statistically significant difference between citalopram and placebo. However, the published article concluded that citalopram was safe and significantly more efficacious than placebo for children and adolescents, with possible adverse effects on patient safety.

Another study by Selma et al ‘The relevance of cytochrome P450 polymorphism in forensic medicine and akathisia-related violence and suicide’ expressed that a genetic predisposition to iatrogenesis can be traced back to pharmacogenetic interactions, namely the inability of some to metabolize prescribed drugs, making ordinarily ‘safe’ drugs, lethal for some. The study concluded:

“CYP450 status is an important factor that differentiates those who can tolerate a drug or combination of drugs from those who might not. Testing for cytochrome P450 identifies those at risk for such adverse drug reactions. As forensic medical and toxicology professionals become aware of the biological causes of these catastrophic side effects, they may bring justice to both perpetrators and to victims of akathisia-related violence. The medicalization of common human distress has resulted in a very large population getting medication that may do more harm than good by causing suicides, homicides and the mental states that lead up to them”.

Perhaps we will just have to wait for the hapless KOL to catch up, not only with the scientific evidence but with collective anecdotal evidence from families. It would seem that underestimating anecdotal evidence is unwise – not least as science often evolves from this very valuable source.

The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance.

The relevance of cytochrome P450 polymorphism in forensic medicine and akathisia-related violence and suicide

Family calls for more research into anti-depressants

The FDA Is Hiding Reports Linking Psych Drugs to Homicides