Nessa Childers, ADHD and Some Inconveniently Dead Children.

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.

2 thoughts on “Nessa Childers, ADHD and Some Inconveniently Dead Children.

  1. As soon as my blog was published and you tweeted it to Nessa, I received a reply from her. Am writing a blog post which looks at her response and will publish in a couple of days.

    Like

  2. Keep up the excellent reporting, it is hugely important that these relationships are made fully public. These representatives work for the “state”, which is the people. I applaud your diligence and courage, and along with countless others, am very supportive of the quality work you and Maria are doing. Keep the faith.

    Like

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