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LATE last year, The BMJ published a systematic (Cochrane) review of the efficacy of methylphenidate for children and adolescents with a diagnosis of attention deficit hyperactivity disorder (ADHD).
The results were reported as suggesting that “methylphenidate may improve teacher-reported symptoms of ADHD and general behaviour and parent-reported quality of life”. But the authors also noted that virtually all the trials on which they based their conclusions were of very low quality and likely to be biased.
Nevertheless, many would take reassurance from the fact that this Cochrane review did not find a statistically significant increase in severe adverse outcomes. However, such conventional meta-analyses will underestimate harms because adverse events are generally poorly documented in randomised controlled trials.
This failure is one manifestation of an unacceptable lack of proper pharmacovigilance, whereby regulators, such as the Therapeutic Goods Administration (TGA) in Australia or the Food and Drug Administration (FDA) in the United States, pharmaceutical companies and doctors alike are poor at collecting and analysing adverse events from drugs.
A recent MJA article by Cairns and colleagues is therefore vital. The authors analysed intentional exposures to drugs used for ADHD (methylphenidate, dexamphetamine, modafinil and atomoxetine) reported to the New South Wales Poisons Information Centre (NSWPIC) from 2004 to 2014. During this 11-year study period, there were 1735 reports of overdoses or recreational use, 93% of which were severe enough to require hospitalisation. Increases in the rate of misuse over that decade correlated with increases in the rate of prescription. Of course, there is no evidence that the stimulant itself led to the dangerous behaviour; it may just have been the most convenient drug to hand.
- Related: MJA — ADHD and psychostimulants — overdiagnosis and overprescription
- Related: MJA InSight — ADHD meds + party drugs “complex cocktail”
- Related: MJA — ADHD medication overdose and misuse: the NSW Poisons Information Centre experience, 2004–2014
The authors made a rough distinction between likely self-injurious behaviour and illicit use (defining the latter as co-ingestion with alcohol or a street drug). While these drugs may also be part of a self-harm overdose, this approach seems reasonable.
Likely illicit use constituted 10% of intoxications overall, increasing to 20% in 2014. Furthermore, the authors provide evidence from other sources that most of the stimulants that are used as intoxicants are diverted from patients to others for whom they are not prescribed.
So how should a parent respond to a suggestion that their child has ADHD and should be treated with methylphenidate?
First, they should, with their doctor, seek a better explanation of why their child is overactive, inattentive or impulsive, rather than calling it ADHD.
That label really just amounts to a dumbed-down shorthand signalling pattern-recognition of one way in which a child can manifest or communicate that he/she is not managing.
It is far more productive to explore the child’s particular predicament and to try to intervene as appropriate with the individual, family and educational system.
Some argue that the ADHD label, while merely descriptive, confers benefit through increased access to services and a reduction in blaming the child or family for the child’s behaviour. But against this needs to be balanced the potential for the ADHD diagnosis to distract the medical system and family from seeking more meaningful explanations, and the real loss of autonomy for child and family when behaviour is framed as being outside their control.
Second, medication should only be used if it is made explicit that it is for symptomatic relief, as an adjunct to other interventions. Potential harms must be openly discussed.
While not apparently a life-threatening drug, methylphenidate slows growth, disrupts sleep and, as the NSWPIC study shows, has an association with dangerous intoxication in suicidal or recreational use, in one’s self and others. And we still don’t know what long-term impact it has on the growing brain.
All of this would be acceptable if we weren’t lacking evidence to believe that medicating ADHD has a clinically positive impact on the associated significant risks – school failure, offending and drug misuse.
As with all drug prescribing, the prescriber, in consultation with the family, needs to weigh up potential benefits against potential harms.
In doing so, the prescriber needs to take account of the fact that apparent efficacy will be exaggerated by factors such as selective reporting and publication bias, and that harms will be underreported due to poor pharmacovigilance.
Most often, the equation will not favour prescribing.
Professor Jon Jureidini is a child psychiatrist at the Women’s and Children’s Hospital, Adelaide, where he works in consultation-liaison psychiatry. He is professor in the disciplines of psychiatry and paediatrics at the University of Adelaide, where he leads the Robinson Research Institute’s Critical and Ethical Mental Health (CEMH) research group and the Paediatric Mental Health Training Unit (PMHTU).
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Dr. Jureidini’s article did not help me at all.
I certainly did not want to start medicating my son at age 4. But after 1 day at preschool we were told, basically, he was not welcome. His kindy/child care had been great – they basically had a person follow him all day, every day.
We have tried restriction diets, low salicylate, just organic home cooked no colouring/preservatives… Seen a natropath (getting desperate) been on supplements, fish oil, checked for gut parasites…
Been to dieticians, psychologists, OT’s, trainers, tutors, speachies, chiropractors (neurofeedback), physicians, psychiatrists. A lot.
So we started a stimulant. After I read all the studies that they used to get them TGA approved. In children over the age of 6 or 12 (not 4). Followed up for 6 months. In a few dozen children.
Every day I give a poorly studied psychoactive medication designed to change the function of my childs brain to my son.
Dr. Jureidini – feel free to come up with something better. I am willing to try almost anything. Until then it is continuing our 3rd/4th line medication that currently works the best.
All really good reasons to be extremely cautious before taking the long arduous process of initiating and fine-tuning meds (with particular emphasis on the “individual” nature of kids’ brains/behavior).
Naturopaths make a similar argument that their treatments cannot be properly studied because they’re individualized. Since methyl phenidate-naive patients (and parents) don’t know how it is supposed to feel to be on or to withdraw from the drug, they make perfectly fine controls in a single-blind RCT (they just can’t be their own placebo-controls in a crossover study).
As to any driving benefits of methyl phenidate, stimulants such as amphetamines have long been known to improve driving ability (my old lab did a number of such studies for the USAF back in the day), but I haven’t heard anyone advocate we prescribe truck drivers speed. A benefit or risk is what it is, whether or not the drug has been unfairly stigmatized.
The study referred to by Jon Jureidini is flawed. The conclusion to the paper is that because the trials are of not a high standard the results cannot be trusted. The gold standard they refer to is a randomised placebo controlled trial comparing medication with placebo. The criticism is that there has been no high quality trials demonstrating that methyl phenidate ,MP, is effective. By inference therefore MP is not effective. A better question is why has there been no “high quality” trials into the benefits of MP despite many people believing it works and therefore prescibing it..
It is obvious why “high quality” trials have not been done because they cannot be done for ADHD using MP. Every patient is unique and their dose must be individualised. The dosage range for MP is extemely wide but for each individual the dose is narrow. The dose must be titrated until a balance is fouind between effectiveness and side effects such as appetite and sleeping. Each day the effectiveness of the medication wears off so that the behaviour changes, often dramatically, in the evening and the next morning. The effect is so pronounced that it is not possible to hide a placebo. It is also not possible to prescibe a fixed dose that a high quality trial demands, if you do most children would either have significant/serious side effects or the medication would be ineffective. This is the implication from the cochrane reveiw alluded to above. It is obvious why they reached this conclusion.
It makes me wonder when academics comment and reference papers that are derivatives of other papers using abstract statistical techniques whether they treat many patients.
I have no hesitation in revealing my own name – previously abbreviated to Tony.
I am a general paediatrician with more than 35 years experinece under my belt and have never received any support, kickbacks, lecture opportunities, etc., etc. from any of the pharmaceutical companies. However, I have been around for long enough to see both in this country and overseas the repeated view suggesting the inappropriate use of medication in patients diagnosed as having ADHD.
I have simply worked in outer Melbloune and in regional Ausrtralia so am well aware of the lack of support services in many places. Prescribing of medication for appropriately assesssed children does not automatically mean shutting one’s mind to other contributing factors to the child’s and family’s behaviour. Not infrequently the beneficial effects of medication on a child’s behaviour has allowed a family to look more honestly at other issues in their lives that otherwise are ignored.
Why does this debate continue?
Adult ADHD drivers off medication have a documented significant increase in accidents. If the condition is missed then you can expect more accidents where the driver does not see the danger.
Stigmatising the condition and it’s treatment does not reflect well on medical practice
Again, the lack of understanding of Dr. Jureidini’s clear prose is astonishing, and telling. Are these critics junior med students?
It should be obvious that ADHD is not an explanation. It is a descriptor, like ‘restlessness’ or ‘defiance’, that requires looking for an explanation.
It’s kinda creepy that any doctor might think, “well, you have these clusters of behaviors as defined in DSM x and so we will stop looking at why (e.g., for what could be predisposers or precipitants) but instead start medicating you …”.
This of course all presumes that there is anything objective or scientific about the evolution of the dx of ADHD across the DSMs (DSM V being panned as the worst of all). But if fhat is not common sense to anyone, they would be well-served by reading some of Frances (chair of the DSM IV taskforce; I recommend °Worried Well”) or Spitzer (DSM III). Funnily enough, I just looked at Frances’ Wikipedia entry and found this quote in the very first paragraph: “psychiatric diagnosis still relies exclusively on fallible subjective judgments rather than objective biological tests”.
Yes, ‘overactivity’, ‘inattentiveness’, and ‘impulsivivity’ require explanations above and beyond some grouping of them into yet another term.
Dr. Randal Pittelli
most peculiar for Dr Juredini to advise parents to seek a “better” explanation of why their child is overactive, inattentive or impulsive, rather than calling it ADHD. Clarifying the diagnosis should be a process of objective accuracy, not of ascribing valence(better/worse) for one diagnosis over another. By doing so, Dr Juredini reveals his prejudice against the diagnosis of ADHD which is unbefitting his stated academic background wherein objectivity should rule over subjectivity.
The naysayers don’t seem to get what Dr. Jureidini is saying.
As to why great reluctance (rather than the strawman of ‘no consideraton’) to prescribe drugs for some mental health conditions…1) MH disease definitions are inherently less objective and standardized, while their etiology and treatment outcomes are inherently less deterministic, than in other medical fields; and 2) MH too has its examples of overturned dogma (e.g., on SSRI efficacy) despite guidelines based on decades of studies with far fewer obvious issues than Dr. Jureidini brings up here. Doctors who do not understand this — those who tend to force inferred categorization of individuals based on simplistic statistics — are also those less likely to recognize subtle psychological adverse events, touting instead assumed benefits in some paper showing ‘significiant’ improvement in whatever score is myopically of interest.
As former NEJM editor Angell said, “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgement of trusted physicians or authoritative medical guidelines.” As doctors, we need ALWAYS to be reluctant to throw drugs, particularly psychoactive ones, at our patients, based on broad stroke guidelines based on incomplete study results on patients only superficially resembling our own as ‘measured’ by protractors derived from proxy models that any behaviorist would cringe at.
And without those like Dr. Jureidini questioning mental health “dogma”, deterministic nutters who project their limited inductive reasoning skills will lead to the forced medication of ADHD kids, as prominent “expert” psychiatric boards in Australia have so illiberally prescribed.
Thanks for an important article, Jon.
It concerns me that in not one of the criticisms above has the commenting author stated his or her name. Given the controversies surrounding pharmaceutical conflicts of interest when it comes to widening the diagnostic criteria for ADHD, it seems very possible that some of the comment authors may have conflicts of interest to declare with companies that profit from the sale of ADHD medication.
If those authors had had the conviction to put their real name to their opinion, this information would at least have been potentially searchable. As it is, and in the absence of any declaration either way within their comments, we readers can only guess whether ‘Dr J’, ‘Anonymous’, ‘Tony’ or ‘Doctor’ has received industry income.
A dissappointing and tendentious article in my view. Sounding to me like the anti-psychiatry guff of the 1970’s. Studies suggest the use of substances is decreased in treated as compared with untreated people with ADHD eg http://www.ncbi.nlm.nih.gov/pubmed/10429138 and http://www.ncbi.nlm.nih.gov/pubmed/12509574 . Underlying seems to be an implicit assumption that ADHD is not ‘real’. This appears to ignore the contemporary scientific evidence both genetic and brain imaging/functional imaging eg http://www.ncbi.nlm.nih.gov/pubmed/?term=adhd+and+genetics and http://www.ncbi.nlm.nih.gov/pubmed/?term=adhd+and+imaging for a sampling of the literature. http://www.ncbi.nlm.nih.gov/pubmed/24124739
An open letter International Consensus statement on ADHD signed by multiple genuinely leading scientists and clinicians in this field is linked here: http://www.addwarehouse.com/shopsite_sc/store/html/consensus.html The balance of evidence is firmly in favour of a real condition that untreated has real impacts that are not to be underestimated. The latest studies on neural networks and functional MRI and clock genes are defining this entity further .
There are clear clinical guidelines which include strong support for medication and choosing not to consider it when the condition is properly diagnosed appears to me to be a clear and seemingly arbitrary deviation from acceptable practice. Why is this acceptable in a mental health condition but unacceptable in oncology and diabetes?
Dr. Jureidini continues to stick to his guns on this subject and now is muddying the waters by suggesting a link between abuse of psychostimulants and its targetted prescribing to patients with ADHD. The evidence suggests that the rate of drug abuse in young adults diagnosed with ADHD is in fact lower in treated (medicated) patients compared to those untreated. Of course all prescribers will be aware that a proportion of these drugs are being mis-used and/or sold, but alert practitioners, together with the PBS Authority bureaucrats, should identify those opportunistic families and cease prescribing.
It is incumbent on paediatricians working in this field to do their very best to diligently assess such children and I would suggest that the vast majority of practitioners do so. One could argue that in the ideal world all such children would have a multi-disciplinary assessment involving a paediatrician, psychologist, speech pathologist and, for some, an occupational therapist; even occasionally a child psychiatrist.! However , that is not the real world and this demands that paediatricians must rely on their professional training and knowledge, the reports from teachers and parents and validated behaviorural questionnaires before coming to a diagnosis.
The task of us as doctors is to, our best ability, deal with “dis – ease” and families with a child with ADHD are certainly in that category. There is no argument that psycho-stimulants ideally should be part of a mulitdisciplinary approach to the problems that these children face. But denying that to them and reinforcing in the lay community the notion that we are being reckless in the use of such medications is unhelpful.
Dr Jureidini again ignores the evidence and promotes his anti ADHD agenda, at the expense of thousands of families who could benefit every single day from having a diagnosis and these life-saving medications. I hope not one family is deterred from seeking a diagnosis because of this stigmatising propaganda. ie linking drug diversion and intentional misuse to properly prescribed and medicated use (a medical intervention).
Also, please do not offer journalism where a dose diversion rate is offered in the absence of a total dose-dispensed picture. The fact is that Australians are significantly under treated for ADHD in both childhood and adulthood, in no small part due to the stigmatisation so clear in this article. The Level 1 evidence-based intervention for ADHD is medication in a context of broader psychosocial intervention, and doctors are obliged to provided evidence-based medicine.
When a trial of medication causes a significant improvement in concentration, school performance and behaviour, with side effects level only small; it is clearly to the benefit of child and family to recommend continuing medication as part of overall treatment plan.
Also I would like to know if there is any evidence for success of non-pharmacological approaches and how practical it is to “intervene in the family and educational system”.
Most parents would prefer not to have medication and in fact many would defer stimulants and try many other approaches including “alternative” therapies.
Denying children treatment because some in the community choose to misuse , doesn’t appear reasonable.
Very good article. As a paediatrician dealing with lots of neurodevelopmental “labels” I experience these above thoughts everyday. However, in poorer socio-economic locations, with minimal to no allied health support, and impossibly difficult social challenges for the family, people started prescribing stimulants for short term benefits as the only option available. Now, some allied health, social supports have become available, but the families themselves have become “EXPERTS” in diagnosing ADHD and ASD, and they threaten and demand diagnosis and medications because ” Johny’s brother / neighbour had exactly same symptoms and that other child was diagnosed so why can’t you diagnose Johny the same way?”
The proper bio-psycho-social model is too hard to implement in poorly staffed places. It is easy to rule out organic medical conditions mimicking ADHD. No wonder ASD prevalence rates have gone up to 1:50 or more in some areas, perhaps the real patients of ASD are disadvantaged due to Sunami of ASD diagnoses. Thankfully ADHD does not attract separate school or centre- link funding, otherwise the ADHD diagnosis and medication prescribing rates would be even higher.