Submission regarding the proposed National Clinical Practice Points on Attention Deficit
Hyperactivity in Children and Adolescents (CPPs).
1) The CPPs do not recommend the many other alternatives which are non-harmful and many times
have been proven effective in helping a child with unwanted behaviour issues.
The following article is from the BBC website
(http://www.bbc.co.uk/science/humanbody/mind/articles/intelligenceandmemory/omega_three.shtml)
The Omega wave
Fish oils are supposed to boost our brainpower. But do the facts really stack up? We went in
search of the evidence.
Elliot is nine years old. A year ago, he was falling behind in his schoolwork, particularly reading
– which he found a struggle. He had little interest in studying and would crash on the sofa to
watch TV when he got home from school.
But over the past year, a dramatic change has taken place in Elliot. He has soared through the
Harry Potter books and now heads to the library after the school bell has sounded.
Elliot has been taking part in a scientific study on more than 100 children from 12 Durham
schools. The children were required to take a course of capsules with their meals for the
duration of six months.
"His reading jumped 18 months [over the trial period]. He’s just a lot more interested in
everything. He’s even developed an interest in classical music," says Sheila, Elliot’s mother.
Problems vanished
Over the course of the year, Elliot's academic problems disappeared.
Mark, 10, who is in the year above Elliot at Timothy Hackworth School in Shildon, Durham,
experienced similar changes.
"When I first heard about it, I didn’t think Mark had any problems. He’d only been taking
them a few weeks when I started to notice changes. His handwriting became better and his
teachers said he was joining in more in class discussions," says Mark’s mother Christine.
"At home, he started asking loads of questions. It was quite hard work for me."
The capsules given to children in the trial contained oils high in Omega 3 fats, which are found
naturally in oily fish such as mackerel, salmon and sardines and in some plant crops such as
rape seed.
Omega 3s and another group called Omega 6s belong to a family of fats known as essential fatty
acids. The right balance of these two types of fatty acids is important for the healthy functioning
of many parts of the body.
Heart of the matter
Omega 3 fatty acids are known to help prevent heart disease and they can improve the
condition of some patients with depression and bipolar disorder. But their effects on
brainpower have not been investigated in the same depth.
The Durham trial was conducted by Dr Alex Richardson, a senior research fellow in physiology
at Mansfield College, University of Oxford and Madeleine Portwood, a special educational
psychologist for Durham Local Education Authority.
The results have not yet been published, but they are expected to show a statistically significant
improvement in school performance in the group of children given Omega 3 supplements. This
does not mean that every child benefitted from the treatment – many did not. But according to
Portwood, about 40% of children showed some clear improvement.
In the dark
The children were selected on the basis that they were not fulfilling their potential at school, but
their general ability was normal. They were subjected to regular tests to measure their coordination, concentration and academic ability.
The study followed an experimental method called a randomised double-blind controlled trial.
Half the children were given capsules of Omega 3 fatty acids, and half given placebos. Neither
the children nor those evaluating their progress knew which group was taking which treatment.
Richardson believes that conditions such as dyspraxia – characterised by poor physical coordination – dyslexia and attention deficit and hyperactivity disorder (ADHD) form a spectrum
of associated conditions with some of the same underlying causes.
"Clinically, there is about 50% overlap between dyspraxia and dyslexia," says Richardson,
"and both show a similar overlap with ADHD."
The dramatic effects of Omega 3 fatty acids on the children in the Durham trial may hinge on
several functions of fatty acids in the brain.
2) The CPPs say pre-schoolers can be given stimulants despite the fact that both the drug companies
(who manufacture the main ADHD drugs, Ritalin and Concerta) and the Federal Government, say
they should not be used in children under 6 because their safety and efficacy have not been
established.
Ritalin Acts Like 'Cocaine Dripped Through Molasses'
By Brian Vastag
Source: Journal of the American Medical Association c. 2001 American Medical Association
8-27-1
Earlier research had shown that cocaine blocks about 50% of these transporters, leading to a
surfeit of dopamine in the synapse and a hit of pleasure. Because of methylphenidate's chemical
similarities to cocaine, pharmacologists thought that it might work in the same way, only less
potently, blocking fewer transporters. Animal studies with high doses of methylphenidate
indicated that this could be the case.
Startling Results
Using a radiotracer, [11C]raclopride, that labels dopamine transporters, the team scanned 11
healthy men who took various doses of oral methylphenidate. The results were shocking. "We
were surprised as hell," said Volkow. "We didn't expect this." Instead of being a less potent
transport inhibitor than cocaine, methylphenidate was more potent. A typical dose given to
children, 0.5 mg/kg, blocked 70% of dopamine transporters. "The data clearly show that the
notion that Ritalin is a weak stimulant is completely incorrect," Volkow said.
"Hallucinations and Other Psychotic Symptoms Associated With the Use of AttentionDeficit/Hyperactivity Disorder Drugs in Children"
Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and
Drug Administration, Silver Spring, Maryland health Resources and Services Administration,
Department of Health and Human Services, Rockville, Maryland
Abstract
OBJECTIVES. To gain a better understanding of the capacity of psychostimulant medications
to induce adverse psychiatric reactions and determine the frequency of such reactions, we
analyzed postmarketing surveillance data and clinical trial data for drugs, either approved or
under development, for the treatment of attention-deficit/hyperactivity disorder.
METHODS. The US Food and Drug Administration requested manufacturers of drugs
approved for attention-deficit/hyperactivity disorder or with active clinical development
programs for that indication to search their electronic clinical trial databases for cases of
psychosis or mania using prespecified search terms. The manufacturers supplied descriptions of
clinical trials, numbers of patients exposed to study drug, and duration of exposure to permit
calculations of incidence rates. Independently, cases of psychosis or mania in children and
adults for drugs used to treat attention-deficit/hyperactivity disorder from the Food and Drug
Administration Adverse Event Reporting System safety database were analyzed. Manufacturers
were asked to conduct similar analyses of their postmarketing surveillance databases.
RESULTS. We analyzed data from 49 randomized, controlled clinical trials in the pediatric
development programs for these products. A total of 11 psychosis/mania adverse events
occurred during 743 person-years of double-blind treatment with these drugs, and no
comparable adverse events occurred in a total of 420 person-years of placebo exposure in the
same trials. The rate per 100 person-years in the pooled active drug group was 1.48. The
analysis of spontaneous postmarketing reports yielded >800 reports of adverse events related to
psychosis or mania. In 90% of the cases, there was no reported history of a similar psychiatric
condition. Hallucinations involving visual and/or tactile sensations of insects, snakes, or worms
were common in cases in children.
CONCLUSIONS. Patients and physicians should be aware that psychosis or mania arising
during drug treatment of attention-deficit/hyperactivity disorder may represent adverse drug
reactions."
The committee should note that using the above rate of 1.48 per 100 and calculating the adverse
events into the approximate 52,000 Australian children on such drugs, we work it that 780 children in
Australia will experience psychotic events such as tactile hallucinations of insects and snakes.
The following are Ritalin Side Effects taken from a well researched drug information website
(http://www.drugs.com/ritalin.html)
Ritalin side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Ritalin:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Ritalin and
call your doctor at once if you have a serious side effect such as:
fast, pounding, or uneven heartbeats;
feeling like you might pass out;
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
aggression, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches);
easy bruising, purple spots on your skin; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety,
confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious Ritalin side effects may include:
stomach pain, nausea, vomiting, loss of appetite;
vision problems, dizziness, mild headache;
sweating, mild skin rash;
numbness, tingling, or cold feeling in your hands or feet;
nervous feeling, sleep problems (insomnia); or weight loss.
This is not a complete list of side effects and others may occur.
The following paragraph is an excerpt from New Scientist Date: 31 March 2006 by Peter Aldhous
Prescribing of hyperactivity drugs is out of control
"Last week, the debate intensified, following two meetings of advisers to the US Food and Drug
Administration (FDA). First, the agency's Pediatric Advisory Committee suggested that parents
and doctors should be warned about the risk of ADHD drugs triggering hallucinations. This
followed a review of evidence of the drugs' psychiatric side effects, including disturbing
hallucinations often involving worms, snakes or insects, experienced by up to 5 per cent of
children taking the drugs. In February, a separate FDA panel recommended that they should
carry the most prominent type of safety warning, following 25 reports of sudden deaths from
heart problems (New Scientist, 18 February, p 7)."
The following is a definition taken from an on-line dictionary
(http://www.doubletongued.org/index.php/dictionary/cocaine_bugs/) the definition can be found
routinely as a slang term amongst stimulant users.
cocaine bugs: n.pl. a skin itch or the sensation that bugs are under ones skin, caused by the
hallucinatory effects of cocaine and its derivatives; formication.
The term cocaine bugs or coke bugs is a common slang term used to describe hallucinations
experienced due to cocaine and other stimulant type drugs. In view of the fact that Ritalin has been
proven to have almost carbon copy effects to cocaine and, as shown in the above article, has been
stated by psychiatric researchers to actually be more powerful than cocaine, I urge the committee to
take this information into account with regards to the legality of giving it to anyone, let alone young
children. Additionally the committee needs to reach the logical conclusion that the long term effects
of Ritalin and other such psychiatric drugs, will be much the same as the long term effects of cocaine,
speed, ecstacy etc. It should also be noted that the term "side effects" is a complete misnomer; the fact
is that these effects are the actual direct effects of such drugs, not at all side effects.
Based on the above evidence, the committee should note the following:
It is clear that such drugs are highly toxic and cause often irreversible destruction of the central
nervous system. The psychiatric community and the big pharmaceutical companies are clearly aware
of the fact that the central nervous system stymulants which are used in children are the same as
cocaine, speed, ecstacy and Ice. Despite this they persist in their attempts to administer such drugs to
young children which is extremely alarming. The long term use of cocaine and other central nervous
system stimulants causes complete and extreme physical and mental damage which is a well
documented medical fact. It needs to be taken into account that small children put on such drugs
today, may well be incapacitated both mentally and physically at some stage in their future.
It is also a well known medical fact that such drugs are addictive. The Australian TGA classes them in
the Schedule 8 category signifying their high likelihood for abuse. "As with other stimulants, the
possibility of habituation or abuse must be considered..." and "Chronic abuse of Ritalin can
lead to marked tolerance and psychic dependence with varying degrees of abnormal behaviour.
Frank psychotic episodes may occure..." (MIMS Annual 2000 page 3-317).
The key point here is that if they are addictive and given to children, the logical conclusion is that the
children will potentially become addicted. The committee needs to take into account the fact that such
drugs, due to their addictive nature, must perforce generate a lucrative business. This fact alone places
big pharmaceutical giants on par with regular illegal drug dealers who also rely on the addictive
nature of their stock-in-trade to generate business. It should be seen that legal stimulants are not any
different to highly addictive street drugs of the same nature. This being the case, it should be easy to
see that those selling the drugs may stand to profit from the addictive nature of such substances. This
potential cannot be ruled out regardless of how unsettling it is.
3) Given all of the above information it would seem that a parent's reluctance to put their child on
these drugs is in fact a rational response. To take away the parental choice for the care and well being
of their child is an extreme measure and should never be done without full evidence that it is in the
best interest of the child. At this point in time there is no evidence that putting a child on these drugs
is in their best interest, to the contrary there is much evidence to support the idea that they can cause a
great deal of harm to the child.
With all of the above in mind I submit that these New Australian Clinical Practice Points on ADHD
be reassessed and not be implemented as they have currently been put forward.