Is Vincent Browne Afraid Of The Gorilla?

6 Apr

Vincent and the GorillaReferring to the pharmaceutical industry, Marcia Angell, former editor of The New England Journal of Medicine, said “What does the eight-hundred-pound gorilla do? Anything it wants to”. 

I haven’t really mentioned the TV3 documentary, apart from my view that Patricia Casey used the exercise to contradict Professor David Healy, pushing a vendetta that she’s harboured since long before my son died. Professor Healy was expecting it so it didn’t come as a surprise, although I don’t think he’d mind me saying that he thought her posthumous diagnosis of my son was unprofessional, unprecedented and a serious abuse of her position. Protecting the drug and pushing instead the ‘psychiatric illness’ came as no surprise either – par for the course within Irish psychiatry.

It’s interesting that Patricia’s colleague, Irish psychiatrist and fellow Lundbeck supporter Ted Dinan, took a complaint to the medical council against doctor Michael Corry for commenting on Shane’s case without ever having met him; will he be doing the same with Patricia? Dr Justin Brophy, another Irish psychiatrist, also took a complaint to the BAI against Dr Corry and RTE following his Late Late Show appearance. They do protest a lot; could they possibly be right or are they just protecting their cash cow?

The debate following the documentary was supposed to be about the possible adverse effects of SSRIs and whether they can, or cannot, cause a person to become suicidal and/or homicidal. The debate, which sadly didn’t answer any questions on the drug issue can be viewed here. One of the panel, Pádraig MacLochlainn, a Sinn Féin TD, (22 mins) said that the experts need to get their facts in order, that the two experts Patricia Casey and David Healy expressed totally opposing views. He further stated that people need clarification on the effects of these drugs. Sensible man!

Now why would the debate not attempt to clarify these issues? David Healy was happy to take part and could have answered any queries put to him, but TV3 decided against it. Surely Patricia Casey would have welcomed the chance to have an open and honest discussion, considering not only does David Healy say that SSRIs including Citalopram can cause sudden death, suicide and homicide, he also says they cause miscarriages, birth defects and an increased rate of abortion due to the disinhibition effect when taking these drugs. Considering her well publicised views on abortion, she couldn’t possibly defend these drugs knowing that they actually increase the abortion rate, could she?

The only way to get any clarification on the effects of prescription drugs is to have a public debate; so why then did this promised debate not go ahead? Is it to do with the revenue that TV3 receive from its numerous pharmaceutical advertisements? Is Vincent Browne afraid to rock the boat and prod the pharma gorilla? It might be worth mentioning that Lundbeck, the inventor of the drug Citalopram, was supposed to take part in this debate but pulled out at the last minute. It might also be worth mentioning that this company has already admitted to reports of ‘self harm and harm to others’ in other countries such as Canada.

If David Healy was to be proved wrong, I’d be quite happy to admit to being misinformed, that Shane was just coincidently on this drug and I’d even apologise to Professor Casey. So how about it Vincent, will you facilitate a debate with the actual experts – or are you afraid to prod this particular gorilla?

 

 

Ejected from the European Parliament Offices

2 Apr

ADHDLast Friday Maria Bradshaw of Casper and I went to the European Parliament Offices in Dublin to meet with Nessa Childers – ‘The MEP that stands up for honesty and Transparency’.

I should point out that I had reservations about this meeting as we had contacted Ms Childers before (regarding the adverse effects of SSRIs) and were ignored. I had e-mailed her following a speech she made in UCC Cork, where she spoke about the ethical issues dealing with lobbyists, non-dislosure of funding and transparency within interest groups. She stated that she never accepted pharma hospitality and cautioned that the latter groups may unconsciously be adopting the line of thought of their funders. Anyway, Maria had organised the meeting so she dragged me along too, albeit rather reluctantly. I should also point out that while Maria is enormously clever with statistics and mind-numbing facts and despite having an MBA, her sense of direction is shocking and thus the reason I allowed myself to be roped into accompanying her to Dublin City. It might have been more productive to have let her loose on the Irish roads; I believe Galway is beautiful this time of year!

Honesty and transparency were definitely on the agenda, but it seems the honesty and transparency which Maria and I delivered were not quite so welcome. After some initial frostiness due to some Tweets which Nessa took offence to, the meeting was going quite well. That is, until we got around to the reason we were there – Shire Pharmaceuticals, ADHD and Nessa’s participation in the round table Brussels discussion and this ghost written white paper. Michael Fitzgerald from TCD and his wife Frances were mentioned, which subsequently prompted Maria to point out his links to Shire pharmaceuticals. This may, or may not, have been a turning point in the meeting.

Nessa said that she had turned down a second invitation to host a roundtable for shire pharmaceuticals. When I pointed out that what she said in Cork was a total contradiction to putting her name to a ghost written, pharma-funded paper, she said this occured whan she was a new MEP and had no idea what was happening. She also said that it was too late to do anything about it now, but when pushed on that point said she would retract her name from it if she could. At this stage, despite Maria’s best efforts to remain her usual professional self with her inherent ladylike decorum (which I don’t possess), the meeting rapidly went downhill and Nessa stood up and said “we have to go“. That was it, no niceties, no ‘Slán agus beannacht’ for us; she refused to make eye-contact and we were back on Molesworth Street before we could say the words ‘Honesty and Transparency’. After a fit of the giggles, we looked at each other dumbfounded, trying to figure out what actually happened there. It was one of the strangest experiences I have had yet, even for me!

That should have been the end of that, but alas, the experience was to get even weirder. We set off (in the right direction considering I was driving) to our next meeting, which I may tell you about sometime, whan Maria’s mobile rang. It was Nessa’s PA, who said that Nessa thinks we should contact a different MP and that we should be careful what we say and the accusations that we are making. Since when did facts equate to accusations? Strange day; I guess that Nessa can cross us off her Christmas card list! I suppose I should be thankful that last week I wasn’t aware of this other roundtable meeting that she hosted, facilitated by Lundbeck. I wonder what the chances are of us getting another meeting?

Note to self-

(1) Look up dictionary for the words Honesty and Transparency, and

(2) Buy Maria a Sat Nav!

ADHA Expert White Paper: http://www.europeanbraincouncil.org/pdfs/ADHD%20White%20Paper_15Apr13.pdf

Maria’s Blog which caused the problem: https://www.madinamerica.com/2014/02/making-invisible-visible/

Cork Conference: http://haieurope.org/wp-content/uploads/2011/08/01-Sept-2011-HAI-Europe-CVNI-Draft-Open-Seminar-Programme.pdf

John McCarty’s views on the Cork Conference: http://corkindependent.com/20110929/news/medications-can-cause-suicide-S4715.html

John McCarty speaking on 4 year old Rebecca’s death: http://healthimpactnews.com/2012/how-do-these-people-sleep-she-was-4-and-shes-dead-by-psychiatry/

 

 

Two Coroners Raising Concerns on Prescription Drug-Induced Suicide.

19 Mar
Susan Poore

Susan Poore

How many Coroners will it take?

In less than a month, two Coroners, one in the UK and one in Ireland, have raised concerns regarding prescription drug-induced suicide. There are many, many Coroners who have raised the same issues over the years and unless something is done, there will be many many more.

Norfolk

Yesterday at the inquest of Susan Poore 65, a UK Coroner Jacqueline Lake raised concerns about the suicide risk associated with antidepressant drugs.

Mrs Poore was prescribed antidepressants a month before she was killed by walking in front of a train. The Coroner voiced her concern that patients were not given enough warning of “possible side-effects of taking these medications in the initial stages”. Mrs Poore’s family said that she was acting ‘out of character’ and that the drugs had changed her personality. Her daughter stated “People think if you take anti-depressants they will make you happier - it’s such a strong drug and can have the opposite effect”.

Coroner 1 – The Coroner said she is writing to the NHS to voice her concern that patients need clearer information on the side-effects of anti-depressant drugs. She said that Mrs Poore’s mental health deteriorated and that patients were not given enough warning of the “possible side-effects of taking these medications in the initial stages”.

Sligo

Last month the at the inquest of Teresa Mulvany  70, the Coroner again raised concerns about the suicide risk associated with antidepressant drugs. Mrs Mulvaney became suicidal when her medication was changed to a generic version without her knowledge. She was subsequently prescribed more drugs to counteract the effects of the first adverse event. Shortly afterwards she booked into a hotel and took a fatal overdose. Her family described her last few days as being spent in a ‘torturous trance’; her joy was gone.

Coroner 2 - Dr Desmond Moran said that hospitals will have to take note of drugs which come with a suicide risk. He said “If the drug is adding the risk, there has to be a wonder why it’s being prescribed”. He further stated that there should be proper supervision when medications are changed.

So – how many Coroners will it take? How many more will have to die? Some more Coroner’s who expressed concerns herehere and here.

Nemo iudex in causa sua

12 Mar

PC Lundbeck

My opinion on the TV3 documentary which aired last night is irrelevant at this stage. There is one issue though which I have had from the start and which came up again last night – the Irish College of Psychiatry’s involvement in my son’s inquest. Professor Patricia Casey, who arrived at the courthouse, uninvited I might add with her legal team in tow, said she was asked by the college to represent it at the inquest. The coroner refused her request to testify, having already had his quota of experts in the form of Professor David Healy and Dr Declan Gilsenan. 

The jury at my son’s inquest found that the drug Citalopram possibly caused his death and thus rejected a suicide verdict. Professor Casey who had involved herself before, during and after Shane’s inquest, directly afterwards spoke to the Irish media stating that there were “aspects of the evidence which the college took issue with”. While undermining the jury’s verdict, she neglected to disclose her links to Lundbeck, the pharmaceutical company who made the implicated drug, Citalopram. I subsequently discovered, through a FOI request, that an internal college e-mail had been forwarded to Lundbeck pharmaceuticals from the Irish College of Psychiatry regarding this statement.

Four years on, Professor Casey used the TV3 documentary as an exercise to finally contradict Professor David Healy, who testified at Shane’s inquest that the drug had caused Shane’s death. Professor Healy, a psychopharmacologist, scientist and psychiatrist is an expert on psychiatric drugs. Professor Patricia Casey, who is a psychiatrist (not a psychopharmacologist or scientist) chose to contradict Professor Healy stating that the drug was not to blame, instead that it was the ‘psychiatric illness’ that he was suffering from. At one stage she contradicted Professor Healy’s description of delirium, stating that a person suffering from delirium could not possibly drive a car and would probably crash. Whether she read all the inquest testimonies is debatable considering there was one description of the drive home stating that Shane drove erratically and even hit the curb at one stage. 

I should probably point out that Professor Casey has corresponded with me before, in the form of a couple of Solicitor’s letters here and here. Shane’s inquest is not the first one involving Lundbeck where Professor Casey had issues. In this inquest of a man aged 62, again with a Lundbeck drug, Professor Casey defended the drug and said - “Scientific research indicates that children under 18 who are prescribed SSRI antidepressants were at increased risk of suicide attempts and suicidal thoughts but people of 30 years and older were not affected similarly”. 

Speaking here for Lundbeck she said “The outcome for those who get treatment is very good. It is also important to be aware too that antidepressants are not addictive”. She said “These medicines also help ‘re-wire’ the brain so that thinking processes work better.” Where is the science behind this re-wiring mechanism?

Being married to a barrister and having co-written a legal-medical book ‘Psychiatry and the law’ in conjunction with Ciaren Craven (part of her legal team at Shane’s inquest) she must be aware of the principle of ‘Perception of Bias’. This is where a decision maker must step down, not just if there is bias but even where a perception of bias may occur. Finín O’Brien - ‘The most obvious source of bias is for the decision-maker to have a financial interest in the matter to be decided.’ So should the expert witness have a similar impartiality?

There are two main rules in the perception of bias principle: Nemo iudex in causa sua; no-one should be a judge in his own cause, and audi alteram partem; hear the other side too.

In 2008 the Law Reform Commission provisionally  recommended that an expert witness should be obliged to disclose the existence of any pre-existing relationship with a party to a case or “any other potential conflict of interest”. Speaking at a person’s inquest, while simultaneously being paid by the pharmaceutical company implicated in the death, is surely a conflict of interest?

Professor Casey is no stranger to controversy as an expert witness. In this case, the High Court quashed a decision of the Irish Medical Council’s ‘Fitness to Practise Committee’ for rejecting its own expert and instead going with the opinion of Professor Casey – who had instigated the case in the first instance. The High Court quashed findings of professional misconduct against the doctor on the ground that he had not been afforded fair procedure.

In my opinion, the objectivity and impartiality of Professor Casey as an expert witness is questionable, so I’ll take her opinion that my son was suffering with a psychiatric illness with the respect it deserves. On the other hand Professor Healy’s expert report can be viewed here.

http://www.lawreform.ie/_fileupload/consultation%20papers/cpExpertEvidence.pdf

http://ijls.ie/wp-content/uploads/2013/07/IJLS_Vol_2_Issue_2_Article_2_OBrien.pdf

TV3 Documentary

8 Mar

Shane and the lads.

On Monday 10th March, TV3 will air a documentary covering the events surrounding the death of my son Shane and his killing of Sebastian Creane.

We decided to participate in this programme because it provided others with the opportunity to hear about the role that SSRI antidepressants played in the tragic deaths of both young men. This is information we wish we had known before Shane’s death and which we believe may prevent other families suffering the pain we all now live with. Vincent Browne and Lisa-Marie Berry (the Producer) assured us that the programme will be well balanced to all concerned and that we will be kept informed of everything. This TV3 Tweet shows the last recording of my son before his death, something I wasn’t aware existed and certainly wasn’t informed of.  I was assured that Shane’s friends would be interviewed for the programme. One of his friends was indeed approached by Vincent Brown; he agreed to do it but is still waiting for the call. As the programme, which I haven’t yet seen, airs in 2 days; I have concerns that I should have gone with my initial decision – to leave the other familes to it.

Maybe the documentary will be as objective as promised. Either way, I feel there are some relevant issues which I should clarify before the airing of this programme.

 

The Late Late Show:

When we were approached to do the Late Late Show some weeks after Shane died, we were absolutely terrified. The initial feeling was to run, stay away from it – I had no idea how to deal with something like that and we were still deeply in shock – we still are. Our over-riding feeling, from the very beginning, has been that if this can happen to Shane it could happen to anyone – people needed to be warned. That was the deciding factor. I informed the other families that we were appearing on the show and assumed they were asked also. We were then told that Sebastian’s family didn’t want us to do it as his month’s mind was on that weekend, so we arranged with RTE to do it the following week instead. I have never felt anything other than thankful to Ryan Tubridy and his team for allowing us (as Shane’s family) to tell our story and also for allowing Dr Michael Corry to inform the public of the dangers that these drugs can pose. It was never our intention to hurt anyone by doing this show. We felt that the only way to stop more tragedies like ours was to make the public aware of the dangers too.

The inquest:

I was happy with how the inquest went. James McGuill and David Healy were great – despite the fact that Shane died from self-inflicted wounds, the jury rejected a suicide verdict. As for Professor Patricia Casey, who attended Shane’s inquest on behalf of of the Irish College of Psychiatry and who directly afterwards spoke to the media of her issues with the evidence – Professor David healy is a psychopharmacologist, scientist and the world-leading expert on the effects of psychiatric medication; Professor Patricia Casey is not. There was no issue. It is my opinion that Professor Casey undermined the inquest process and the jury’s verdict. As a direct consequence of that, the other families involved were led to believe that the process was defective and thus prevented from getting the answers they needed. We fought very hard to get answers following  the death of our son; we got those answers. Again, it was never our intention to upset the other families in doing so. At the time I was not aware that the Creane and Hannigan families had met with the Coroner Cahal Louth before Shane’s inquest. It is my opinion, held with respect for both families, that their involvement in my son’s case, along with the involvement of Professor Casey, was inherently wrong.

The jury took on board Professor Healy’s testimony on the role the prescribed drug played that night – the effect it had on my son. They returned the only other option available to them, an open verdict. This is the part which could have helped others – a change in the law to allow a verdict of ‘Iatrogenic Death’ may be more suitable. This is currently being discussed in the Seanad by another bereaved family, also SSRI drug induced. A rider would have been useful, where an investigation into this medication (or all SSRIs) could have been recommended – or at the very least caution advised. The fact is that Coroners have ordered investigations into this drug before. It comes with a black box warning in the US. In Canada the same drug company has warned clinicians of reports of ‘self harm and harm to others’. The inquest could have played a role in informing Irish people of this.

The Role the Drugs Played:

Professor  Healy said that what happened that night was caused by Shane taking the prescribed drug Citalopram. I believe if Shane had not been prescribed Citalopram, both young men would still be alive today. One issue that sometimes comes up, usually from psychiatry protecting their medical model, is that I might be doing more harm than good – possibly stopping people from taking drugs which are perfectly suited to them. These drugs are being prescribed to our children without warning that they can cause cause suicide, violence, worsening depression, mania, akathisia, birth defects and sexual dysfunction. People need to be informed – informed consent is the issue here/or lack of;  the choice is then theirs to make. I have never advised anyone not to take medication or to stop taking it – I have, if asked, given all the facts, not just the harmless effects. Irish citizens have the right to the same level of protection and informed consent as Americans and Canadians.

 

What Can The Irish Government Do?

I have been part of a delegation which met with Kathleen Lynch in Leinster House. This included Professor David Healy, Dr Declan Gilsenan and Tim O’Malley. Each one told her of their concerns that these drugs are harming people. Prof Healy told her these drugs are the leading cause of death within the mental health field while Dr Gilsenan told her that his experience as a pathologist led him to believe that the majority of suicide victims had been ‘recently introduced’ to SSRIs. Both Kathleen Lynch and Tim O’Malley acknowledged that these dangerous drugs are widely over-prescribed.

As a country we need to urgently address our high rates of suicide.  The Irish government need to start by gathering and publishing data showing how many suicides and homicides were caused by SSRIs. The investigation into the practices at Portlaoise Hospital was initiated after the death of 4 babies. Ireland has had 525 deaths by suicide last year. Preventing further deaths requires understanding the drivers behind them.

Currently those who provide us with data on the role of SSRIs in suicide and homicide have financial links with pharmaceutical companies like Lundbeck, who exert significant influence over psychiatrists, academia and our Government. Patricia Casey, who has up until this documentary rejected any claims that SSRIs can cause suicide and who has attempted to influence and discredit the verdict of the jury at Shane’s Inquest, has received payment from Lundbeck Pharmaceuticals. She is not alone.  Many of the most published academics from Irish universities and the Irish government also have financial ties to pharmaceutical companies. Sadly, the Irish College of Psychiatrists and the government are in denial about the issue of prescription drug induced suicide. For this reason, we need a fully independent inquiry into this issue, one which is not influenced by the pharmaceutical industry or conducted by those who have a vested interest in the outcome.

Lundbeck Healthcare Professionals’ Warning Letter.

Inquest of Teresa Mullaney, Age 70.

28 Feb
Teresa Mullaney

Teresa Mullaney

This week (25 Feb) The Sligo Champion reported on the inquest of Teresa Mullaney, age 70. According to the Champion, Teresa was a retired nurse who spent her life looking after others, was dearly loved by all her family and had a heart of gold.

Click on picture to see the Sligo Champion Article.

In February last year Mrs Mullaney had a knee operation. It seems that she was prescribed Venlafaxine which is known here as Effexor, possibly following the surgery. Some time later her mood worsened and she feared that her medication had been changed without her knowledge. When the family checked with the pharmacist, this was indeed found to be the case, that her usual medication had been changed to the generic version. Shortly afterwards Teresa was switched back to the original version of Effexor plus an anti-anxiety pill. Zyprexa (Olanzapine) was added into the mix, despite coming with a black-box warning in the US for  the elderly. A short time later Teresa spent 2 weeks in St Columba’s hospital in order to ‘stabilise her prescribed medication’. The family said she became deeply distressed and agitated. Her son described her last few days as being spent in a ‘torturous trance’; her joy was gone. 

Both Effexor and Zyprexa come with a US black box warning and both are associated with an increased risk of suicide. The ‘anti-anxiety’ pill most likely does too. Sadly, but not surprisingly, 4 days after leaving St Columba’s hospital, Teresa checked into the Great Southern Hotel and took an overdose, which resulted in her death. The family have raised a number of issues:

1. The total lack of communication between the doctors and the family.

2. Questions need to be asked about generic versions of prescription drugs.

3. The level of ‘care’ Teresa received in her last few months.

4. How could Teresa, who was recently released from hospital, be allowed access to a months supply of medication.

The Coroner, Dr Desmond Moran, said that St Columba’s will have to take note of drugs coming with a suicide risk. He said “If the drug is adding the risk, there has to be a wonder why it’s being prescribed”. He further stated that there should be proper supervision when medications are changed.

The jury at Teresa’s inquest made a number of recommendations, including:

1. That generic drugs should not be prescribed without proper communication and

2. That appropriate supervision should be maintained where medication has been changed, particularly in psychiatric illness cases.

Sadly for Teresa and her family, the Irish Human Rights Commission made similar recommendations following Shane’s death, which if acted upon by the medical profession in this country, would probably have saved her life! Let’s hope that Teresa’s death can influence doctors when prescribing these highly dangerous drugs in others. Condolences to the family of the lovely Teresa.

Nessa Childers, ADHD and Some Inconveniently Dead Children.

16 Feb

Nessa ChildersI have copied Maria’s blog verbatim from the ‘Mad In America’ website. I thought it might be more relevant here in Ireland as it concerns Nessa Childers. Just to explain; in 2012 myself and the poor long suffering husband went to this conference in Cork entitled ‘Mad Medicine: Do conflicts of interest drive you crazy?’ Among the speakers was the late John McCarthy who spoke about the tragic death of four-year old Rebecca Riley as a direct consequence of being medicated for ADHD. He speaks about Rebecca here.

Nessa Childers, a former psychotherapist and MEP, also spoke at the conference and presumably listened intently to John McCarthy. Her pitch was certainly impressive. She spoke on a number of healthcare issues: the ethical issues that arise from dealing with lobbyists, conflicts of interest within medicines regulation, non-dislosure of funding within patient organisations and transparency within interest groups. She stated that she never accepted pharma hospitality and cautioned that the latter groups may unconsciously be adopting the line of thought of their funders. Hmm.

Maria’s Blog -Brought to you by the good people of Shire Pharmaceuticals (No, not really).

Making the Invisible, Visible

Maria Bradshaw

February 12, 2014

A couple of weeks ago I received a memorandum submitted on the Children And Families Bill by the UK ADHD Partnership (UKAP). The memorandum recommended that regulations issued to accompany the Children and Families Bill should include a requirement that “all children who receive two fixed term exclusions from school are screened for ADHD and, if appropriate, an assessment process for ADHD initiated.” [1]

The key points of their submission are

  • That ADHD is “a clinically distinct neurobiological condition that is caused by an imbalance of chemicals affecting specific parts of the brain responsible for behavior”
  • That children with ADHD are at a 100 times greater risk of being excluded from school than children without the condition
  • That school exclusion is associated with an increased likelihood of antisocial and criminal behaviour; and
  • That ADHD is under-diagnosed in the UK.

The UK ADHD Partnership (UKAP) claims to be

. . . A group of medical and educational specialists with experience of working with children with Attention Deficit Hyperactivity Disorder ( ADHD) and Special Educational Needs (SEN), committed to helping drive better access for children to the diagnosis, support and management of ADHD to build better futures for children with the condition. [1]

They certainly appear to be a group the UK parliament should trust and, on the face of it, there is no reason that parliament should not adopt their recommendation that

The SEN Code of Practice and relevant regulations and guidance issued to accompany the Children and Families Bill should include UKAP ’s Call To Action: that all children who receive two fixed term exclusions from school are screened for ADHD and, if appropriate, an assessment process for ADHD initiated.” [1]

Except that the UKAP appears to be a front group for pharmaceutical company Shire, who manufacture the ADHD drug marketed as Vyvanase in the US and Elvanse in the UK.  The UKAP call to action is exactly the same as the call to action by the Better Futures Group, initiated and funded by Shire Pharmaceuticals. [2]  The majority of the members of UKAP are members of the Better Futures Group and many of those who are not have financial ties to Shire.

A couple of weeks ago I emailed UKAP and asked them to clarify the extent of the relationship between UKAP and Shire:

Could you please advise what proportion of UKAP’s funding is received from Shire and what your other funding sources are. Could you also advise whether your team members are paid by UKAP.

They responded.

Dear Maria,

‘Better Futures’ is a campaign initiated and funded by Shire Pharmaceuticals UK, but implemented by an expert Better Futures Group. The group consists of health and educational specialists with experience of working with children with ADHD. The Group’s aim is to improve the identification of ADHD in school-age children with a view to establishing a positive path forward for them. UKAP endorses both the NICE and SEN guidelines and have clearly stated aims which are consistent with nationally agreed recommendations.  Most of the committee are not prescribers and so do not feel they have a conflict of interest.  In addition, no UKAP member currently receives any payment or remuneration for the work undertaken.

Our successes to date with the campaign relate to educational achievements. This can be seen in the C&F bill and the SEN Code of Practice that have now included that FTE from school should trigger a process to determine whether there are underlying functional or cognitive difficulties that are hampering the child’s progress being. (sic)

Kind Regards

UKAP

I emailed them back asking for clarification of the relationship between the Better Futures Group and UKAP.

Thanks for your response. I understand however that the Better Futures Group was “initiated and funded by Shire Pharmaceuticals” (http://www.lanc.org.uk/the-better-futures-group/) and that the UKAP website states “Financial support for the development of UKAP was made possible through a grant from Shire Pharmaceutical Ltd.” Is this information correct?

I received no response. And the link I cited has been removed.

A Shire Pharmaceuticals flyer for a talk by UKAP and Better Futures Group members Susan Young and Fintan O’Regan confirms that “The Better Futures Group, initiated and funded by Shire Pharmaceuticals, is a group of medical and educational specialists working towards improving provision for children with ADHD in the UK by helping drive better access to identification, diagnosis, support and management,” [3] as does the section on the Shire website which states “The Better Futures Group — a group of UK medical and educational experts in ADHD, initiated and funded by Shire — held a parliamentary reception to raise ADHD on the political agenda, attracting over 80 attendees.” [4]

So who are the members of the UKAP?

Dr Susan Young, President of UKAP, was employed by Shire in 2012 as lead author of a White Paper on ADHD [5] and provided with a medical writer, also funded by Shire. The paper’s disclosure statement reveals she is the Vice President of UK Adult ADHD Network (UKAAN), funded by Shire.  It states she received speaker fees from Shire to present data at the European Expert Roundtable, the meeting which gathered the data on which the white paper was based.  In her disclosure statement she reports having been a consultant for Janssen-Cilag, Eli-Lilly and Shire, having given educational talks at meetings sponsored by Janssen-Cilag, Shire, Novatis, Eli-Lilly and Flynn-Pharma and having received research grants from Janssen-Cilag, Eli-Lilly, and Shire.

Fintan O’Regan, the Vice Chair of UKAP is a member of the European ADHD Alliance initiated, developed and funded by Shire and former chairperson of the European ADHD Taskforce established and funded by Shire. [6]  He is the author of a number of parent and teacher resources funded by Shire and available on their website ADHDandYou[7]

Both are members of the Better Futures Group, as are Dr Peter Hill and Valerie Ivens. [8]

UKAP member Bill Colley is listed on the submission as an educational consultant. His CV identifies he is a paid consultant for Shire. [9]  In an ADHD journal sponsored by Shire, UKAP member Dr Philip Kewley discloses he has lectured at and attended meetings sponsored by Shire. [10] He is also a member of the Better Futures Group.

He makes his views on ADHD drugs very clear on his website:

There is absolutely no doubt that the reality of ADHD and its impact on the child and family have tended to be very significantly under-rated in the press, whereas the alleged side effects of medication have been exaggerated. As with any medication there can be some short term side effects, especially involving appetite suppression or sleep difficulty, but there is no evidence of long term side effects with the use of such medications.

UKAP member Sheila Keeting works for Add+Up (Attention Deficit Disorders Uniting Parents) which is funded by Shire.

Although the members of UKAP are closely aligned with Shire, their submission is fully referenced, and so seemingly represents current research on ADHD and provides parliament with good evidence on which to develop policy. A review of the evidence cited in support of the submission though shows that is not the case

The source of the claim that ADHD is caused by a chemical imbalance is not a meta analysis published in a peer reviewed journal but the book Understanding ADHD – A Parents Guide to Attention Deficit Hyperactivity Disorder in Children by Dr Christopher Green, author of Toddler Taming.

The claim that ADHD is underdiagnosed in the UK is referenced to a report written by ADHD-Europe which collaborated with Shire Pharmaceuticals on the parent and teacher resource authored by UKAP member Fintan O’Regan. [11]  The report states

It is commonly accepted that ADHD is under diagnosed and under treated in Europe; this being supported by literature from the Netherlands and the United Kingdom which show problems with assessment, referral rates and diagnosis.[12]

No references are provided to these studies.

The reference to ADHD children being 100 times more likely to be excluded from school than other children is from a survey conducted by Attention Deficit Disorder Information and Support Service (ADDISS), an organisation providing “people-friendly information and resources” which receives funding from Janssen-Cilag, UCB Pharma, and Eli Lilly, who all make ADHD drugs. [13]  ADDISS also wrote the report which associates ADHD with antisocial and criminal behavior – a report funded by Eli Lily. UKAP member Prof Peter Hill is a member of the ADDISS board. [14]

The members of UKAP are undoubtedly respected academics, but none of the sources referenced here meet the standard of evidence that we should expect when research is being cited as the basis for government regulations.  As such, the UKAP members’ academic credibility is being expended here to augment the significance of dubious references, rather than the opposite – and what it should be – that the responsible and rigorous reference to credible research augments the members’ credibility.

In ensuring there is close scrutiny of groups like UPAK who are key opinion leaders with financial ties to industry, we may think we can rely on politicians like Nessa Childers, member of the Irish and European parliament, who presents as being aware of pharmaceutical company lobbying:

I can assure you that the pharmaceutical industry is a very strong lobbying force in the corridors of power in Brussels. And as we know, many patient groups are of course funded by industry which complicates matters for decision makers greatly. [15]

And prepared to resist them:

. . .  Speaking in Strasbourg, Labour MEP Nessa Childers urged her government colleagues not to put the interests of big business before public health concerns.“You could say that people have the right to lobby but we have the right not to listen. I will say…that this is a public health issue and we should not be listening to these kind of threats. “It’s very common for large industries to do it and you have got to learn to put your foot down.” [16]

Nessa Childers, however, wrote the introduction to the White Paper on ADHD funded by Shire and authored by Susan Young and Michael Fitzgerald, who she identifies as “a colleague”[17] in a video she filmed with Mary Baker of the European Brain Council which receives funding from Shire.[18]

On 30 January I wrote to Nessa Childers

Dear Nessa

I am aware that you have expressed strong views about honesty and transparency and the need for politicians to be wary of, and disclose dealings, with lobbyists.

I am writing to ask whether you are aware of the fact that the European Expert Roundtable on ADHD and the White Paper arising from it, were initiated and funded by Shire Pharmaceuticals who have been very overt about their agenda to increase diagnosis of ADHD in Europe in order to increase revenues from the drugs they manufacture to treat this condition. I wonder if you are aware that Dr Susan Young has received signficant funding from Shire and other pharmaceutical companies and of research showing that despite their best intentions, such funding influences the views of researchers.

I wonder if you are aware that the ‘call to action’ from the UKAP for mandatory ADHD screening for children excluded from school on two occaisons is in fact a call to action from the Better Futures Group, initiated and funded by Shire Pharmaceuticals?

Finally I wonder if you are aware that the Australian medicines regulator has recently issued a warning in respect of methylphenidate and its causal association with suicide following the suicide death of a 9 year old and attempted suicides of two other children of similar ages.

If you are aware of these issues, I would be grateful if you could advise me how you manage them to ensure that UK and European regulation and policy are informed by robust, independent science rather than by the agendas of pharmaceutical companies.

I received a reply from Nessa Childers’ parliamentary assistant advising that Ms Childers would reply to me personally but two weeks later have not heard from her.

Ironically, it appears the only party in the current push for mandatory screening of children for ADHD who is being in any way transparent is Shire Pharmaceuticals.

In an interview with Bloomberg Business Week discussing the shift in perception of childhood lack of attentiveness from “bad behavior” to a mental disorder, Bloomberg comments:

That’s been great news for Shire, the world’s biggest seller of ADHD drugs. More than 90 percent of the Dublin-based company’s sales of ADHD medicines are in the U.S., where brisk demand since 2007 helped fuel a more than doubling in U.S. annual revenue for the class of stimulants used to treat the condition. The drugmaker would like to duplicate that success closer to home. But as Shire tries to roll out its flagship ADHD pill, Vyvanse, in eight European countries, it faces an unfamiliar hurdle: convincing people the condition exists. ADHD is diagnosed about 25 times more often in the U.S. than in the U.K. And while attitudes vary by country, many European parents, teachers, and doctors are reluctant to use medication to treat what they see as routine childhood behavioral problems.

CEO of Shire tells Bloomberg that

Called Elvanse in Europe, Vyvanse became available this year in the U.K., Ireland, Denmark, and Germany, and will enter the markets in Spain, Finland, Sweden, and Norway in early 2014 as Shire reaches agreements with governments on pricing and reimbursement. One challenge will be fueling demand without advertising to parents. Such direct-to-consumer ads, a mainstay of drug marketing in the U.S., are banned in Europe. Instead, Shire is discussing the prevalence of the illness with doctors at psychiatry conferences across the continent. “The next year to two years is going to be a significant educational effort on our part,” says Chief Executive Officer Flemming Ornskov. “The climate in Europe is a bit more negative. It will take us some time.”

Bloomberg goes on to say

Increasing the diagnosis rate in Europe — and the subsequent drug sales that often follow — would be lucrative for Shire, which had $1.8 billion in ADHD drug revenue last year. Vyvanse contributed $1 billion of that, surging 28 percent, and analysts predict the pill’s sales will reach $1.77 billion in 2016, according to the average of analyst estimates compiled by Bloomberg.[19]

Bloomberg reports that in 2007 the US accounted for 83% of ADHD consumption, but by 2013 that had fallen to 66 percent with Scandinavian countries exceeding the U.S. in growth of ADHD prescriptions.

A recent FDA review of suicidality associated with the use of Shire’s ADHD drug (ingredient name lisdexamfetamine) found no need to warn of suicide associated with the drug despite a number of suicide related events in clinical trials and completed suicides of children prescribed the drug in post marketing studies.[20] The following is a summary of fatal cases reviewed.

8.5 APPENDIX F. DETAILED SUMMARY OF FATAL CASES (N=12)

Suicide

ISR #6679980; US; 2010: A13-year-old male hung himself in the family barn 20 months after initiating treatment with lisdexamfetamine 50 mg “on school days” for ADHD. He did not have a personal or family history of psychiatric illnesses, including suicidal thoughts or attempts, completed suicides, or drug or alcohol abuse. However, he experienced “extreme bullying” by his classmates for “some time” due to his facial scar and small stature. His physician recommended counseling and addressing bullying at school, but his recommendations were not carried out.

ISR #6757155; US; 2010: This is a report from the South Florida Sun-Sentinel and Miami Herald newspaper articles. A 7-year-old male hung himself with a detachable shower hose approximately 2 weeks after a dose increase of lisdexamfetamine to 50 mg daily, and 4 months after initiating treatment with lisdexamfetamine 30 mg daily for ADHD. He received concomitant medications labeled for suicidality; escitalopram 5 mg daily for one month then changed to olanzapine/fluoxetine 3 mg / 25 mg for one month up to the time of death. He has a significant medical and psychosocial history of sexual abuse, living in foster care, impulse-control disorder, aggression, and self-injurious behavior. Additionally, the event occurred following an argument with his foster father’s son. The cause of death determined by autopsy was asphyxiation due to hanging.

ISR #6859748; US; 2010: A 9-year-old male hung himself in a school bathroom an unknown time after initiating treatment with an unknown dose of lisdexamfetamine for ADHD. Although he did not receive a diagnosis, his mother believed the patient was “bipolar.” Additionally, his family believed the patient was “bullied into suicide.” The autopsy reported amphetamines in his blood, but no other clinical information was provided.

ISR #7906425; US; 2011: A 16-year-old male hung himself five months after initiating treatment with an unknown dose of lisdexamfetamine for an unspecified indication. No additional clinical information was provided.

ISR #8143472; US; 2012: A 10-year-old female hung herself with a cloth belt an unknown time after initiating treatment with an unknown dose of lisdexamfetamine for ADHD; however, it was unknown if she took lisdexamfetamine up to the time of death. Additionally, she was picked on at school, was suspended from school for fighting the month prior to the event, and lost television privileges at home. She also said to her grandmother “I ought to kill myself” three months prior to the event. The cause of death by autopsy was asphyxia due to hanging.

ISR #8103103; US; 2012: This is a case report from the 2010 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS). A 16-year-old female experienced “prehospital cardiac and/or respiratory arrest” after an acute exposure of morphine solution, lisdexamfetamine, and a stimulant laxative for “intentional suicide.” No additional clinical information was provided.

Accidental Death

ISR #6262705; US; 2009: A 14-year-old male was discovered hanging from a low tree branch in the backyard by his siblings. The event occurred eight months after he initiated treatment with lisdexamfetamine 50 mg daily for ADHD. He did not have medical, psychiatric or psychosocial histories of suicidal ideation or attempts, self-injurious behaviors, depression, emotional problems, bipolar disorder, substance or alcohol abuse, family concerns, or bullying. Of note, he played with the rope for several days prior to the event. His physician felt the patient was not trying to kill himself; rather the incident was “impulsive/accidental.” No autopsy performed.

Toxicity to various agents

ISR #8066959; US; 2012: This is a case report from the 2010 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS). A 14-year-old male experienced “prehospital cardiac and/or respiratory arrest” after an “acute/chronic exposure” of codeine (primary toxic substance), stimulant laxative, quetiapine, aripiprazole, valproic acid, lisdexamfetamine, diphenhydramine, penicillin, meloxicam, and clonidine. The report listed blood or urine levels of all suspected substances or their respective metabolites. Additionally, sertraline and norsertraline levels were detected in the patient’s blood during biopsy.

Overdose

ISR #6944369; US; 2010: An 8-year-old female died “some time after” a dose increase of lisdexamfetamine from 70 mg to 100 mg daily. The event occurred an unknown time after she initiated treatment with lisdexamfetamine 70 mg daily for an unspecified indication. No additional clinical information was provided.

“Cardiac problem”

ISR #5947621; US; 2008: A 7-year-old male died while sleeping during a camping trip with his father. The event occurred 16 months after he initiated treatment with lisdexamfetamine 30 mg daily and methylphenidate 10 mg every evening for ADHD. His physician “thought” he died due to a “cardiac problem” and that the coroner had informed the physician that the patient had a structurally abnormal heart; however, further details were not provided.

Aspiration

ISR #7244207: US; 2011: Emergency medical services personnel arrived to the patient’s home, found the 8-year-old male in asystole and with emesis on his bed; thus, they believed he had aspirated. He had a history of unspecified respiratory problems and received treatment with lisdexamfetamine 70 mg and melatonin 3 mg for unspecified indications for an unknown amount of time when the event occurred. He was pronounced dead at the hospital emergency department.

Unknown

ISR # 7553409; US; 2011: A 9-year-old female experienced an unknown event resulting in death the same year she initiated treatment with lisdexamfetamine 30 mg or 40 mg daily for an unspecified indication. Her mother tried to wake her up in the morning, but she was not arousable from sleep.

The catchphrase being used by those lobbying for increased diagnosis and treatment of children with ADHD — and the title of Dr Susan Young’s White Paper — is “Making the Invisible, Visible.”

I would suggest that what needs to be made visible are the links between the UKAP, Nessa Childers, the European Brain Council and Shire Pharmaceuticals.  I would also suggest that it is the children listed above who are truly invisible in the discussions around ADHD and who — for the sake of themselves and for all other children who will be medicated in the future — need to be made highly visible.

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