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PRACTICE: Tim Kendall, Eric Taylor, Alejandra Perez, Clare Taylor on behalf of the Guideline Development Group Diagnosis and management of attention-deficit/hyperactivity disorder in children, young people, and adults: summary of NICE guidance BMJ 2008; 337: a1239 [Full text]

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NICE recommendations on ADHD are not evidence based and could expose many to unnecessary harm

Sami Timimi, Jon Jureidini, Jonathan Leo   (24 September 2008)

Diversion and abuse of Methylphenidate in light of new NICE guidance

Harry R Sumnall, Kerry Woolfall, Jon Cole, Adam Mackridge, and Jim McVeigh   (25 September 2008)

NICE should produce guidance on Infant Mental Health

Shirley A Gracias, Tim Kendall, Eric Taylor, Alejandra Perez, Clare Taylor on behalf of the Guideline Development Group   (30 September 2008)

ADHD is Neither a Disease or a Disorder

Fred A., Jr. Baughman   (1 October 2008)

NICE recommendations on ADHD are not evidence based and could expose many to unnecessary harm 24 September 2008
Sami Timimi, Consultant child and adolescent psychiatrist Lincolnshire Partnership Foundation NHS Trust, Jon Jureidini, Jonathan Leo Send response to journal: Re: NICE recommendations on ADHD are not evidence based and could expose many to unnecessary harm	We wish to point out four critical failings in the NICE recommendations on ADHD. Firstly, in examining the validity of ADHD fundamental issues such as gender distribution and cross-culturally validity were ignored. Thus, important questions such as differences in rates of diagnosis by ethnicity and the differing meanings attached to ADHD symptoms in different societies were not addressed. This creates a risk of institutional racism through imposing a certain worldview about childhood and its problems onto communities who have differing beliefs and practices. Second, although NICE recognizes that “the disorder remains one that is defined at a behavioral level, and its presence does not imply a neurological disease” (p. 17) and “The diagnosis of ADHD does not imply a medical or neurological cause” (p. 29), the review refers to ADHD as a ‘neurodevelopmental disorder’. The evidence provided does not support this view. For example, under section 5.8 “Is there consistent evidence of genetic, environmental or neurobiological risk factors associated with ADHD?” NICE note the lack of consistency found in neuroimaging studies and conclude that the following brain regions may be implicated: left prefrontal cortex, left thalamus, right paracentral lobule; frontal, temporal, and parietal lobes; the striatum; splenium of the corpus callosum; right caudate; total cerebral volume; right cerebral volume; and portions of the cerebellum. Similarly, they conclude there is a positive association with a large number of family-environmental adversity indicators. This is the equivalent of putting a bet on all horses in the race and celebrating your efficacy as a pundit! Thirdly, extending the diagnosis into adulthood is based on a lack of evidence (that ADHD has different features in adulthood compared to childhood) rather the presence of any (that, for example, ADHD can be reliably differentiated from similar presentations such as a personality disorder). Fourthly, NICE’s single most important recommendation is for medication to be used as a first line treatment in ‘severe’ ADHD. Like other systematic reviews of ADHD medication treatment, (1)(2)(3)(4)(5) NICE notes the inadequate reporting of study methodology, possible bias, limited reliability of results, and inadequate data regarding adverse events, correctly concluding that the evidence does not support using medication as a first line treatment for mild or moderate ADHD. Yet NICE concludes that medication should be used as a first line treatment in ‘severe’ ADHD with only one reference cited in support of this (which is a re-analysis of the data from the largest trial comparing medication and behavioural treatments (6)(7)(8)) that concludes that the more severe subgroup showed a larger decrease in symptoms with medication than with behaviour therapy (9). However, this data was gathered at 14 months after the beginning of the study; Swanson et al (10) analyzing the same group of patients after 36 month could not find support for beneficial long-term effects of medication over behaviour therapy, even in those with more severe symptoms, whilst finding that those exposed to medication for the longest periods were now significantly lighter and shorter. These guidelines are likely to expose many children and adults to unnecessary harm. The recommendations are not supported by the evidenc analysed by NICE. The evidence should lead to the conclusions that ADHD is not a neurodevelopmental disorder, is of questionable validity, particularly as a diagnosis for adults, and use of medication should be a ‘research only’ recommendation. References 1. Jadad AR, Boyle M, Cunningham C, Kim M, Schachar R. Treatment of attention-deficit/hyperactivity disorder. Evidence Report: Technology Assessment (Summary). 1999; i-viii, 1-341 2. Klassen A, Miller A, Raina P, Lee SK, Olsen L. Attention-deficit hyperactivity disorder in children and youth: A quantitative systematic review of the efficacy of different management strategies. Can J Psychiat 1999; 44: 1007-1016. 3. Schachter HM, Pham B, King J, Langford S, Moher D. How efficacious and safe is short-acting methylphenidate for the treatment of attention- deficit disorder in children and adolescents? A meta-analysis. Can Med Assoc J 2001; 165:1475-1488. 4. McDonagh MS, Peterson K. Drug Class Review on Pharmacologic Treatments for ADHD. Oregon Health and Science University: Portland, 2005. 5. King S, Griffin S, Hodges Z, et al. A systematic review and economic model of the effectiveness and cost-effectiveness of methylphenidate, dexamfetamine and atomoxetine for the treatment of attention deficit hyperactivity disorder in children and adolescents. Health Technol Assess 2006; 10(23). 6. Jensen PS, Arnold E, Swanson JM et al. 3-year follow-up of the NIMH MTA study. J Am Acad Child Adolesc Psychiat 2007; 46:989-1002. 7. The MTA Cooperative Group. A 14-Month Randomised Clinical Trial of Treatment Strategies for Attention-Deficit/ Hyperactivity Disorder Arch Gen Psychiat 1999; 56: 1073-1086. 8. Molina BS, Flory K, Hinshaw SP, et al. Delinquent behavior and emerging substance use in the MTA at 36 months: prevalence, course, and treatment effects. J Am Acad Child Adolesc Psychiat 2007; 46: 1028-40. 9. Santosh P, Taylor E, Swanson J, et al. Refining the diagnoses of inattention and overactivity syndromes: A reanalysis of the Multimodal Treatment study of attention deficit hyperactivity disorder (ADHD) based on ICD-10 criteria for hyperkinetic disorder. Clin Neurosci Res 2005; 5: 307-314. 10. Swanson JM, Hinshaw SP, Arnold LE, et al. Secondary evaluations of MTA 36-month outcomes: propensity score and growth mixture model analyses. J Am Acad Child Adolesc Psychiat 2007; 46:1003-14. Competing interests: Sami Timimi was invited to give evidence to a one day conference organized by NICE ADHD Guidelines development group, and has commented on earlier drafts of the guideline. Jonathan Leo was a peer reviewer for the first draft of the NICE ADHD Guidelines examining the ‘validity’ of ADHD.
Diversion and abuse of Methylphenidate in light of new NICE guidance 25 September 2008
Harry R Sumnall, Reader in Substance Use Centre for Public Health, Liverpool John Moores University, Liverpool, L3 2EZ, Kerry Woolfall, Jon Cole, Adam Mackridge, and Jim McVeigh Send response to journal: Re: Diversion and abuse of Methylphenidate in light of new NICE guidance	With the publication of NICE clinical guidance (CG72: Attention deficit hyperactivity disorder: Diagnosis and management of ADHD in children, young people and adults) there has been renewed interest in the prescription of psychostimulants for the treatment of ADHD in adults and children. These treatments have already been approved for use in children (NICE, 2006) but for the first time methylphenidate, atomexetine and dexamphetamine have been recommended for adult pharmacotherapy. Whilst the identification of effective treatments for these disorders is encouraging it is noteworthy that NICE, albeit in a restricted manner, advises healthcare professionals to be aware of the potential of these drugs for misuse and diversion (Section 10.6.6). We believe that this caution is warranted. Data released by the Department of Health (2008) indicated great variation in prescribing to young people between Primary Care Trusts (PCTs); with a 23-fold difference between the highest and lowest prescribing areas. Given the short consultation time available to general practitioners and patient/carer access to information resources via the internet, there is increased scope for inappropriate prescribing through misdiagnosis, faking of symptoms, or patient pressures (e.g. Harrison et al., 2007; Mayes et al., 2008). Research conducted by our group in one of the areas with the highest rate of prescription indicated that diversion was common, and the lifetime prevalence of illicit methylphenidate use in young people (31%) was second only to cannabis (Woolfall, 2006). In adults, obtaining methylphenidate was harder but pharmaceutical preparations of stimulants such as methylphenidate and dexamphetamine were available on the illicit market for as little as £0.30 per tablet (Geraghty, 2008). A recent US review of people who had been prescribed methylphenidate found that approximately 20% had been approached to sell, give away, or trade their medication at least once in their lifetime (Wilens et al., 2008). Extending prescriptions to adults will mean that access to illicit stimulants will be made easier. That methylphenidate is misused is unsurprising; it is a Class B drug in the UK, and subjective effects are described as ‘cocaine-like’ at supratherapeutic doses (Swanson & Volkow, 2002). We believe that without adequate monitoring of prescription rates and compliance, and appropriate investigation of anomalies, it is likely that with the introduction of NICE guidance, misuse of these drugs in both adults and young people will increase. This has implications for both treatment services for drug misuse (for which non-prescribed stimulant use is a risk factor), and also for clinicians. Sustained release formulations of methylphenidate are popular as they are clinically effective, and produce high treatment adherence (Sanchez et al., 2005; Lage & Hwang, 2005). However, as with immediate release preparations, pre-chewing of sustained release tablets results in Cmax and Tmax that are higher than both conventionally administered immediate and sustained release preparations (Kimko et al., 1999). Sustained release formulations may therefore hold higher abuse potential. ADHD is a strong risk factor for adult substance use disorders, but stimulant therapy is protective against this outcome (Wilens et al., 2008). Disruption of treatment regimens through diversion of tablets (whether voluntarily or through coercion) into a vibrant illicit market may therefore not only affect psychopathological outcomes in ADHD patients, but may also increase vulnerability to substance use disorders, particularly in young people without ADHD. In line with NICE guidance we support prescription by experienced clinicians after clear diagnostic criteria have been met. Furthermore we would also argue that Drug (and Alcohol) Action Teams, which are local partnerships representing local authorities, health, criminal justice and the voluntary sector, are made fully aware of local prescribing and diversion rates and have in place appropriate responses to misuse. Department of Health. Table showing data on methylphenidate items dispensed for each year from 2003 to 2008, broken down by age and PCT. DEP2008-1888 House of Commons Library 2008, 10/07/2008. Geraghty, O (2008) An Exploration of the Black Market Availability and Costs of Licensed Medicines in the North West. Liverpool, Liverpool John Moores University School of Pharmacy and Chemistry. Harrison AG, Edwards MJ, Parker KCH (2007) Identifying students faking ADHD: Preliminary findings and strategies for detection. Archives of Clinical Neuropsychology 22: 577-588 Kimki HC, Cross JT, Abernethy DR (1999) Pharmacokinetics and Clinical Effectiveness of Methylphenidate. Clinical Pharmacokinetics 37: 457-470 Lage M, Hwang P (2004) Effect of methylphenidate formulation for attention deficit hyperactivity disorder on patterns and outcomes of treatment. Journal of Child and Adolescent Psychopharmacology 14: 575-581 Mayes R, Bagwell C, Erkulwater J (2008) ADHD and the rise of stimulant use among children. Harvard Review of Psychiatry 16: 151-166 National Institute for Health and Clinical Excellence. Methylphenidate, atomoxetine and dexamfetamine for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Review of Technology Appraisal 13 2006 Sanchez RJ, Crismon ML, Barner JC, Bettinger T, Wilson JP (2005) Assessment of adherence measures with different stimulants among children and adolescents. Pharmacotherapy 25:909-917 Swanson JM, Volkow ND (2003) Serum and brain concentrations of methylphenidate: Implications for use and abuse. Neuroscience and Biobehavioral Reviews 27: 615-621 Wilens, T.E., Faraone, S.V., Biederman, J.,Gunawardene, S. Does Stimulant Therapy of Attention- Deficit/Hypercativity Disorder Beget Later Substance Abuse? A Meta- analytic Review of the Literature. Pediatrics 2003; 111: 179-185. Woolfall K (2006) Substance use among young people in Wirral, Merseyside. Liverpool, Liverpool John Moores University. Competing interests: None declared
NICE should produce guidance on Infant Mental Health 30 September 2008
Shirley A Gracias, Consultant Psychiatrist, Chair of AIMH UK CAMHS, Family Health Centre, The Halve, Trowbridge, Wilts BA14 8SA, Tim Kendall, Eric Taylor, Alejandra Perez, Clare Taylor on behalf of the Guideline Development Group Send response to journal: Re: NICE should produce guidance on Infant Mental Health	I read the summary of the latest NICE guidance on ADHD and accompanying commentary with a mounting sense of dismay. While not wishing to diminish the impact of severe ADHD on a child’s development, I would like to highlight the increasing evidence from neuroscience of the impact a child’s early environment, particularly within the context of the developing attachment relationships with caregivers, has on their developing brain. What happens interactionally between babies and their parents will have consequences for their developing emotional, social and cognitive skills (eg Fonagy and Target 2005). The strategic development of overactivity as a response to poorly developing attachment relationships has been captured on video and written about by a key researcher in the field (Crittenden 2002 & 2008). What is more the cost effectiveness of early intervention is beginning to be documented (Svanberg - in preparation for publication 2009). Finally, the quality of attachments formed in the early years are being increasingly shown to have a far reaching effect well beyond infancy, for instance on adaptation to chronic ill health and needs of care receiving in the elderly (Bradley and Cafferty 2001) Yet, despite many efforts, the Association for Infant Mental Health UK (AIMH UK)cannot persuade NICE to address the question of Infant Mental Health. Evidence presented to the panel in the development of the Antenatal and Postpartum Mental Health guidance about the impact of parental ante and post natal mental illness or stress on the infant was not accepted and incorporated. Hence the production of a guidance that is woefully inadequate from the perspective of infants. Infant Mental Health is an area where interventions could conceivably have a significant impact at relatively little cost on the future mental health of babies across their lifespan and on how they parent the next generation. However, this is little known, accepted or even understood by commissioners and providers of mental health care across the country. Like services for ADHD, mental health services for babies and their parents are patchy, often depending for their existence on the enthusiasm and interest of individual clinicians. Without a NICE guidance for Infant Mental Health we are never going to see any change or hope that in the future we may be able to prevent mental distress rather than just treat it. References Fonagy, P., Target, M.: Bridging the transmission gap: An end to an important mystery of attachment research? Attachment & Human Development, Volume 7, Number 3, September 2005 , pp. 333-343(11) Crittenden PM: Raising Parents: Attachment, parenting and child safety. Willan Publishing 2008 Crittenden, P. M.: Attachment, Information processing and psychiatric disorder. World Psychiatry, 2002, 1(2), 72-75 Svanberg, P. O. : Promoting a secure attachment through early screening and interventions: A partnership approach. In J. Barlow & P. O. Svanberg (Eds.), Keeping the baby in mind. London: Routledge due 2009 Bradley JM, Cafferty TP: Attachment among older adults: Current issues and directions for future research. Attachment & Human Development, Volume 3, Number 2, September 2001 , pp. 200-221(22) Competing interests: None declared
ADHD is Neither a Disease or a Disorder 1 October 2008
Fred A., Jr. Baughman, Neurologist, Child Neurologist 1303 Hidden Mountain Drive, El Cajon, CA, 92019 Send response to journal: Re: ADHD is Neither a Disease or a Disorder	FRED A. BAUGHMAN, JR. M.D. NEUROLOGY AND CHILD NEUROLOGY (Board Certified) FELLOW, AMERICAN ACADEMY OF NEUROLOGY fredbaughmanmd@cox.net 1303 HIDDEN MOUNTAIN DRIVE EL CAJON, CA 92019 Tele:(619) 440-8236 Fax: (619) 442-1932 Re: NICE ADHD Guidelines September 30, 2008 Ladies and Gentlemen, Please publish the following: ADHD is Neither a Disease or a Disorder Comment on NICE ADHD Guidelines By Fred A. Baughman Jr., MD We should be clear from the start that having a disease or a disorder means one has an objective physical abnormality. The first obligation of all physicians is that of diagnosis. The first question posed by the duty to diagnose is: Is there a physical abnormality—gross (a visible or palpable lump), microscopic (cancer cells of biopsy or ‘Pap’ smear), or chemical (as in diabetes, gout, phenylketonuria), yes or no? If “no,” there is no disease and the patient is medically, physically normal. It is this group, those with “no evidence of disease” (NED) from which all psychiatric and psychological patients derive. The public worldwide has been deceived and mislead for decades on this fundamental point that is well known to physicians. No patient with ADHD or with any psychological or psychiatric entity has an actual disease. Physicians telling them they do knowingly deceive them abrogate their right to informed consent, and drug normal individuals, that is, poison them. This is the standard of care in psychiatry today. NICE addresses the “disease” vs. “no disease,” physical vs. psychiatric issue stating, “the disorder remains one that is defined at a behavioral level, and its presence does not imply a neurological disease” (p. 17) [1]. Using the term “disorder” which is synonymous with disease, meaning “A disturbance of function, structure or both,” NICE sews the seeds of confusion that for decades has lead patients and the public worldwide to view ADHD and all psychiatric and psychological entities as diseases when they absolutely are not [2]. Having called ADHD a “disorder” NICE stated: “The diagnosis of ADHD does not imply a medical or neurological cause” (p. 29) [1]. Given that ADHD is not a disease or a disorder, it is not appropriate to speak of it’s possible medical or neurological causes. In medicine when no disease has been found the diagnosis is “no organic disease” (NOD), or “no evidence of disease” (NED), calling for no discussion of causation. To discuss cause where no disease exists is to further mislead and confuse. If one has relinquished all claims of a physical entity and has accepted it is psychological or psychiatric, then and only then, would it be appropriate to speak of contributing psycho-social causes such as home, school, community, peer relations, etc., none physical. And yet NICE concludes that medication should be used as a first line treatment in ‘severe’ ADHD as if “severe ADHD” was a proven, diagnosable disease, when it too, along with all other classifications of ADHD, is not. The American Academy of Pediatrics (AAP) ‘ diagnostic guideline’ referred to ADHD as the most common ‘neurobehavioral’ disorder of childhood [3]. I responded “‘Neurobehavioral,’ implies an abnormality of the brain, a disease [4]. And yet, no confirmatory, diagnostic, abnormality has been found…It is apparent that virtually all professionals of the extended ADHD ‘industry’ convey to parents, and to the public-at-large, that ADHD is a ‘disease’ and that children said to have it are ‘diseased’-‘abnormal.’ This is a perversion of the scientific record and a violation of the informed consent rights of all patients and of the public-at-large. The wording of the AAP Guideline should be changed, forthwith, to reflect the scientific and medical facts of the matter.” Nor has there been proof of the existence of ADHD as a disease from that date to the present. In a letter to me of June 14, 2002, President of the Medical Board of California, Bernard Alpert, MD, wrote: “Dear Dr. Baughman, Thank you for your letter dated May 28, 2002 to Senator Liz Figueroa, relating to the mental health profession’s representation of emotional and psychological conditions as diseases of the brain…I share your concerns about the lay public’s ability to correctly process and understand the prolific media campaigns that target them for the sale of drugs and services. In my opinion it is unfortunate that such advertising is allowed, and that it often serves to mislead consumers rather than educate them…there is tremendous professional support for categorizing emotional and psychological conditions as diseases of the brain. In published materials, some quoted in your letter, you will find that support from chairs of psychiatric departments, the American Psychiatric Association and professors of major medical schools. It is clear that the psychiatric community has set their standard, and while one might disagree with it, that standard becomes the legal standard upon which the Board must base its actions. It is, therefore, the community that must change their opinion and practice for it to become the legal standard. Sincerely, Bernard Alpert, MD, Medical Board of California.” One can see here that lies have become the legal standard of practice of the psychiatric profession and of all physicians and other professionals who practice mental health. Under the circumstances, to state the truth and scientific facts of the matter would constitute medical malpractice putting a critic, such as myself, in legal jeopardy. All studies in the medical-scientific literature that have considered ADHD to be a disease or disorder and that have conveyed this belief to participating researchers, subjects and their families are invalid, should be acknowledged as such, and should be withdrawn. Pam issued such a challenge in 1990 when he wrote: “…any studies that do not meet standards for proper research procedures or interpretation of data must not be accepted for publication, or if already published must be discredited within the professional literature” [5]. References. 1. NICE ADHD Guidelines: http://www.nice.org.uk/guidance/index.jsp?action=byID&o=12061 2. Stedman’s Medical Dictionary, 25th Edition, Williams and Wilkins, Baltimore, MD, 1990. 3. American Academy of Pediatrics, Committee on Quality Improvement and Subcommittee on Attention-Deficit/Hyperactivity Disorder Clinical practice: diagnosis and evaluation of the child with attention- deficit/hyperactivity disorder. Pediatrics. 2000; 105:1158-1170 [Abstract/Free Full Text] 4. Baughman, FA, Diagnosis and Evaluation of the Child With Attention -Deficit/Hyperactivity Disorder (letter) PEDIATRICS Vol. 107 No. 5 May 2001, pp. 1239 5. Pam, A. A critique of the scientific status of biological psychiatry. Acta Psychiatricia Scandinavica, 82 (Suppl. 362), 1-35. Competing interests: None declared