Since 1997
around 1300 adults “with ADHD” have been prescribed stimulants (mainly
methylphenidate, Ritalin) in Norway. The “treatment” was part of a trial project
that ended in the middle of 2003.
The main
result from this project is that around 70 % of the treated persons dropped out
– they discontinued the treatment of their own volition due to no or bad
results!
This article
is about falsified results – how to present bad results as good results!
It takes up
how the research team headed by the leading Norwegian proponent for stimulant
treatment, neurologist Nils Olav Aanonsen, has presented results in a misleading
way, and based on these false results, has recommended continued use of
stimulant treatment for adults.
The article
also takes up how the Swedish National Board of Health and Welfare has used the
false results, “the experiences” from Norway, to implement recommendations about
increased prescription of stimulants to adults in Sweden.
--------
This year Aanonsen and his team gave out
the final report from the trial project (1997-2003) [1]. The report was
immediately “released” to Norwegian media and created headlines like Ritalin
gives adults with ADHD a better life.
The report –
with its falsified results – will be used in several countries as support for
increased prescriptions of stimulants to adults “with ADHD”.
Therefore the truth about the falsifications needs to be
revealed.
The truth about the bad
results revealed in an “internal letter”
In 2001, when
the project had been ongoing 4 out of 6 years, Nils Olav Aanonsen wrote a letter
to the Swedish psychiatrist Lars-Olof Janols [2]. Aanonsen wrote about the
project and the results obtained. The letter was a good example of the sincerity
and outspokenness found only between colleagues; the content in the
letter was not at all meant to reach the public.
Lars-Olof
Janols was working with a manuscript about treatment with stimulants, for the
Swedish National Board of Health and Welfare. His data were to be included in
the book ADHD in children and adults, which the Board was about to
publish. As many more adults in Norway than in Sweden had been prescribed
stimulants, the experiences from the project were important to include in the
book.
In
the manuscript [3], sent to the National Board of Health and Welfare, Janols
gave a pithy summary of the results described in Aanonsen’s letter. He wrote:
“Insufficient treatment effects, adverse
effects, insufficient
support actions ahead and inability among the persons to take part in the
treatment and in the regular examinations are viewed as the cause for the
dropout of 70 % [of the patients].”
Aanonsen
wrote in the letter about the “dropout” of patients: “With our system of back
reporting we know from experience that only around 30 % choose to take it [the
‘medication’] one year or more.”
The
main result was that 70 % of the patients discontinued the
treatment!
The
majority of the patients received methylphenidate (Ritalin). Let’s assume for a short
while that ADHD is a real medical disorder and that Ritalin would
be a medical treatment. Let’s look at the website of Novartis, the
maker of Ritalin, where descriptions of ADHD and its treatment are to be found
[4]. It is said: “ADHD is a medical disorder associated with the balance of
chemicals (neurotransmitters) in the brain.” And about the medication:
“Stimulant medications help the brain normalize the activity of certain
chemicals that are affected by ADHD (these chemicals are known as
neurotransmitters).” It is even said: “Stimulants are designed to restore
the natural balance of the chemicals in the brain affected by ADHD.” [Emphasis
added.]
But
70 % of the patients discontinued the treatment. They did not seem to get the
“natural balance” in the brain that Novartis had promoted. On the
contrary – they fell off due to no or bad results. As Aanonsen, who thought the
activity worked well administratively, said in his letter: “The
therapeutic successes are more varying.”
The
patients who ended the treatment must have agreed to the conclusion given in the
letter that “…the effect does not seem to be of so good help on general
psychosocial ability as one could believe after the first months´ often
remarkable response on the ability to concentrate.”
Aanonsen
can’t be very pleased that the information in his letter about the insufficient
therapeutic successes has leaked out. This especially, when he, this year, has
released the official report about the project saying that treatment with
stimulants “works” – that it enhances the life quality of the
patients! (More about the report later.)
The
reason for the dropout of 70 % of the patients was, as Janols
wrote:
a)
Insufficient
treatment effects
b) Adverse
effects
c) Insufficient
support actions
d) Inability
among the persons to take part in the treatment and in the regular
examinations.
In
summary:
The project had so far proven to be a complete failure. The only possible
conclusion should have been that treatment with stimulants has no role in
“evidence-based medicine”; it does not even work as behaviour control.
How
did the Swedish National Board of Health and Welfare handle the
information?
The information from Janols, including
the summary of the catastrophic results, was sent to the National Board of
Health and Welfare and the person responsible for the editing of the book
ADHD in children and adults, the paediatrician Björn Kadesjö.
The
information was not used! In the book ADHD in children and adults
important referrals were made to the experiences in Norway but none of
the data above were taken up [5].
Primarily
one did not take up the most obvious result – that 70 % of the patients ended
the treatment because it did not work in the way Novartis and concerned
psychiatrist say!
Professor
Sten Levander, who was part of the expert group working with the ADHD book for
the National Board of Health and Welfare wrote in his manuscript [6] that
there is “no medical point in trying to discontinue the treatment each year
with the risks associated…” but “at least every fifth year one should
decide if one should reconsider the medication via a controlled discontinuing
trial.“ The patients in Norway
however found quite some medical points in ending the treatment with stimulants
long before that point – it gave no or few results but quite some adverse
effects.
Even
if Björn Kadesjö took his information about treatment of adults “with ADHD” from
Janols manuscript, he succeeded to completely omit all data about the bad
results from Norway. Instead he referred to an intermediate report issued by
Aanonsen, March 2000 [7], and said that the experiences from Norway of a group
of 39 patients treated one year showed that the treatment gave “very good
effect on at least 2 of 7 ADHD related symptoms”.
A
closer look reveals that these 39 patients were not part of a controlled trial
(as one could believe from the text). Instead they were just part of the
patients in the project. They were the patients left after a year,
of a group of 90 – where 51 persons dropped off before! For these 51 persons (57
%) no results were described.
The
final report from Norway about the trial project
Aanonsen
was very outspoken in the letter 2001 to his colleague Janols. The
insufficient therapeutic successes, the many patients choosing to end the
treatment and the threatening “demotivating” treatment situation were the things
in focus.
When Aanonsen, in February this
year,
released the final report about the project, it sounded differently. Politicians
and the public get a well-arranged story. But even if other things now came in
focus and even if well selected statistics should prove that treatment with
stimulants was a “working treatment”, it was impossible to hide the “internally”
revealed truths.
A
review of the report shows the following:
·
Aanonsen
choose to neglect that a 70 % dropout of patients due to no or bad results
is the principal experience from the trial project! Of the in total
almost 1330 patients who had got stimulant treatment, 262 patients
had got it during a period of 2 years and 1066 patients had got it a
shorter time. About the group of 1066 patients very little is said in the
report.
For
526 patients in the large group (1066 patients), who at the point of
measurement 2003 could not have got stimulants during 2 years –
they started “too late” – no results are noted.
Incredibly
enough reports from 129 patients, who started the treatment earlier, are
also missing. Aanonsen says (p. 26): “Due to lack of back reporting the
treatment process for 129 patients was uncertain.” In the claimed
administratively well functioning activity, with its “stiff routines
for quality control”, no information was reported about 129 patients – 12 %
of the remaining group. It was not known how long they had been treated and no
results were known. Probably it is not too risky to say that the results in this
group would not fit well in the final publication. The group of 129 persons
could be compared with the group of 262 persons – the persons who got stimulants
for 2 years. The difference was that the last group was described in 25
(!!) tables and graphs in the report, where also the subjective reports from the
patients were given a lot of space, while the first group got no descriptions at
all.
But
for 411 patients who had discontinued the treatment,
reports were turned in and results noted in the report – even if no graphs at
all over subjective views on “target symptoms” are available.
About
the reasons for discontinued treatment it is noted (p.
27):
·
That
43 % (n=175) of the patients ended the treatment due to adverse
effects.
·
That
36 % (n=146) ended the treatment due to “little or no effect”.
·
That
for 16 % (n=65) of the patients the treatment was ended due to “lack
of
compliance” – the patients did not take the “medication” as they should.
·
That
for 13 % (n=52) of the cases the treating physician had to end
the
treatment
due to drug abuse.
(Graph
made from the text in the report.)
There
could be more then one reason noted for discontinuing the treatment, and the
percentage exceeded 100. Under the heading “Other” 25 % was noted. The reasons
could be everything from “without noted reason” to “suicide
attempt,
other acute psychiatric disease/psychosis, criminal behaviour, serving
sentence”. No further details or numbers are noted about this in the
report.
(Graph
made from the text in the report.)
Of
the 411 patients 175 had directly noted adverse effects as the
reason for discontinuing the treatment. In Aanonsen’s text one can see that
these patients had got the adverse effects illustrated in the above diagram. (The persons had noted more than one adverse
effect; the sum is more than 100
%.)
43
% of the 411 patients discontinued the treatment due to adverse effects.
Estimating that the 129 patients, not accounted for, have ended the treatment
and that 70 % of the 526 patients not included at the point of registration
2003, have done the same or will do so, (70 % is the estimated figure earlier
reported by Aanonsen), means that another 500 patients have ended the treatment
(or will soon do so). It is reasonable to assume that the figure 43 % is
representative also for this group, which would mean that close to 400 patients
ended/will end the treatment due to the type of adverse effects illustrated
above. Around 150 of these can be expected to suffer from depressive mood and
anxiety as a direct effect of the stimulants.
In
the report Aanonsen is not at all considering these adverse effects as a
problem. He writes (p. 55): “All
in all the above experiences do not give reason for worry about considerable
adverse effects or serious complications in the treatment of adults with
hyperkinetic disorder/ADHD with stimulant medication.”
One
can ask what is needed regarding adverse effects for “worry” to arise! Compared
to the group of 262 persons taking stimulants for 2 years it is probably almost
the double amount of persons, around 400, who has ended/will end the
treatment due to adverse effects.
The “risk-benefit balance” for amphetamine is hardly favourable!
Over
92 % of the patients discontinuing the treatment did this for “negative reasons”
(see above). But Aanonsen is in the report more interested in the 5,6 % (23
persons!) ending the treatment due to not “needing” the drug any more
(1,9 % ended due to pregnancy). The fact that 23 patients discontinued the
treatment for this reason, leads to the following incredible conclusion
(p. 55):”…some patients who have chosen to end the treatment have stated
as reason for this that they have achieved a good enough functioning.” “This can
indicate that the starting of treatment with stimulant medication for
hyperkinetic disorder/ADHD in adults, not necessarily means a life long
treatment. A shorter or longer period with drug treatment can be assumed to help
a person turn a negative situation, get on a better track and manage to benefit
better from other treatment.” That 380 persons ended the treatment for
“negative reasons” did not lead to any general conclusion about the workability
of the treatment, but the 23 patients who could do without the drug, lead to the
above!
·
One
of eight persons, 12,5 %, ended the treatment due to drug abuse.
52
persons out of the group of 411 were taken off the treatment due to abuse. It
has been said that drug abuse is a form of “self medication” for persons “with
ADHD”, who have been “denied” treatment with stimulants. When the correct
treatment now is given; the treatment that according to Novartis restores “the
natural balance” in the brain, the result is that 12,5 % of the patients in this
group starts or continues to abuse drugs. Considering the insufficient follow-up
procedures (see example about the 129 patients) the actual amount of persons
abusing the prescribed “medication” and other drugs, is very likely much
higher,
as Aanonsen also says, p. 52: “here it can be a matter of
underreporting”.
On page 19 in the report one can
see that around 25 % of all persons who have been prescribed stimulants also
have got the same “medication” earlier, based on an ADHD diagnosis or similar
(MBD). This is also true for the persons who now have been prescribed stimulants
for 2 years (p. 31). An interesting question is if the group of persons that
earlier (as children) got stimulants, in a high or low degree corresponds with
the group that have developed a later addiction. If a high degree of
correspondence exists it would be a powerful contribution to the theory that
early treatment with stimulants leads to later drug abuse. Aanonsen writes
nothing about this but should absolutely get the chance to account for this
relation.
·
It
is very clear in the report that the treatment does not “work” at all for
“difficult cases”, for criminals and for persons who quite recently have abused
drugs. This
must be a big problem for Aanonsen and other proponents of stimulant treatment.
It is not possible – or at least should not be – to prescribe drugs classed as
narcotics with a high potential of abuse to persons with “mild problems”. The
very reason for prescribing narcotics is the really difficult
problems: “other measures have not been enough”; as a last measure a trial
with stimulant treatment is needed; a group of persons with very severe problems
makes it necessary to…
It
is certainly primarily these persons Aanonsen described in his internal letter
to Janols 2001, when he in a complaining voice wrote that there was an
“inability among the persons to take part in the treatment and the regular
examinations” and “for some patients one can get the impression that they
need a doctor full time to function in an acceptable way.” It was also about the treatment of these
persons that Aanonsen wrote that many physicians did find the treatment
situation “demotivating” as “many of the patients (20-30%?)” were
unusually “conflict oriented”, complained to representatives and reported
the doctors to the police!
How
should Aanonsen, in his position, describe the fact that the treatment of these
persons with stimulants is a complete failure – without saying so? He
uses some well-proven measures, the foremost being to blame the patients.
He says (p. 54) about the persons who were socially maladjusted: “Often there
has been unrealistic expectancies that stimulant medication will lead to big
changes in behaviour, something which in practice not often has been the
case.”
Also
the persons who not too long ago had been abusing drugs and alcohol (p. 52)
“had unrealistic expectancies that stimulant medication should contribute to
a lowered urge for drugs or remedy a difficult situation.”
The
persons had “unrealistic expectancies” – maybe they had read the “facts”
about Ritalin published by Novartis or simply had read to many articles in
medical journals or in newspapers that Ritalin gives adults with ADHD a
better life!
Now at least they know that this
was not true.
·
In
the report the subjective evaluations for the large group that ended the
treatment have been completely omitted, while the results for the group that got
stimulants for 2 years have been exaggerated in all possible ways.
One
must assume that also the patients who discontinued the treatment made a
subjective evaluation of the effects from this, after 6 weeks, 6 months and 1
year (if still there). We know from Aanonsen’s internal letter that these
evaluations must have been very negative. How do Aanonsen and colleagues handle
this situation to not “disturb” the presentation? They simply omit these
evaluations, they do not describe them at all! Instead they choose to describe
at length the group that did not drop out with well-chosen
diagrams.
In
the report there is a diagram (p. 42) that shows that the life situation has
become better for those succeeding to take stimulants for 2 years, “more
positive after starting treatment with stimulant medication”. In an
extremely one-sided article in the Norwegian newspaper Aftenposten (Ritalin
gives adults with ADHD a better life, 15th of March 2004),
Aanonsen says: “Quite some persons experienced a marked increase in life
quality.” Looking in the report (p. 42) there is a graph moving in a
positive direction, from 3 to 2. If one reads the text to see what these figures
stand for it is hard to understand that statements about “a marked increase
in life quality” is a fitting description. The figure 3 stands for
“moderate maladjustment” and the figure 2 for “mild
maladjustment”. The starting point was “moderate maladjustment” and
the end result after 2 years, one step better, “mild maladjustment”. The
impression is that huge efforts have been made to present some form of
social betterment. Behind this presentation lies the true picture about the
treatment in general; as Aanonsen said in his internal letter: “…the effect
does not seem to be of so good help on general psychosocial ability…” The
treatment did not in other words better the life situation in general – and
absolutely not for those with big problems.
·
In
the end of the report (p. 54) there is a passage with the very important
conclusion: “However
many of the patients got treatment measures in addition to the purely medical.
Better life quality therefore can have more explanations in this group and can
not offhand be attributed to the stimulant medication.”
The slightly rising graphs presented for this group could have been caused by
other measures then the “medication”. With this in mind it is fascinating to
read the descriptions about the good effect of the stimulants, on the group
treated for 2 years, in the newspaper article – it was the drug that
caused the betterment. In media it is obviously possible to “offhand” attribute
the better life quality to the treatment with Ritalin.
·
It
is also said (p. 29) that the report neither is planned to be nor designed as a
scientific investigation
and that all “evaluations of effects, numbers, or conclusions below do not
claim to have scientific universality exceeding this
material.”
The
two points above could have been a fitting, humble framing of the report
if the head of the project himself took them seriously. But these
limitations, these fitting explanations, were not thought to be true in practice. In the “press release” in media (Aftenposten), the trial project was
transformed into a “unique Norwegian study” and the heading Ritalin
gives adults with ADHD a better life, did fit well with Aanonsen’s
statements. It was no longer any problem to “offhand” attribute all
betterment to the treatment with Ritalin, and the “conclusions” suddenly
got “scientific universality”.
·
“If
the treatment of children was decided from the children’s own motivation, the
compliance could turn out to be of the same magnitude.”
This
is a fantastic quote from the intermediate report about the project,
March 2000. Aanonsen is under the heading About dropouts from the
treatment speculating (p. 36) about how it would be if also children
treated with stimulants could discontinue the treatment. For adults, as
also noted in that report, it could be expected that around 70 %
discontinued the treatment themselves. Aanonsen wrote: “If the treatment of
children was decided from the children’s own motivation, the compliance could
turn out to be of the same magnitude.”
But
children cannot, as the adults, end the treatment of their own volition. If they
could, it would probably lead to that 70 % decided to quit, to no longer accept
the fact that they must take amphetamine as a “medicine”.
What
conclusions can be drawn from the experiences with stimulant treatment in
Norway?
The
conclusions and recommendations from the experiences in Norway must
be:
·
In
treating adults with stimulants one can expect that around 70 % of the patients
will discontinue the treatment;
·
The
persons ending the treatment will in 9 out of 10 cases do this due to inadequate
therapeutic success, most of them due to adverse effects, inadequate treatment
effects and inability to take part in the treatment;
·
The
persons who quite recently have abused alcohol or drugs, or committed criminal
acts, will due to the inadequate treatment effects discontinue the treatment;
they will not function better. They will, generally speaking, violate the
treatment alliance and return to drug abuse;
·
The
promises that treatment with stimulants will lead to a “restored natural
balance” of chemicals in the brain, made by Novartis, leading psychiatrists and
by “patient associations” (as CHADD), have turned out to be false. If the
“symptoms” had been caused by a “biochemical imbalance” and if stimulants had
corrected this imbalance, the “symptoms” would have disappeared. That has not
happened. Thus there is no
scientific basis for statements that this treatment is a “workable medical
treatment”.
·
There is
not any longer any reason to assume that the prescription of stimulants to
adults would work as a form of positive behaviour control. The expectancies that
narcotics should help persons to function better in society have not been
fulfilled.
·
There is
very good reason to believe that also most of the children will
choose to discontinue treatment with stimulants – if they were allowed to
choose. In accordance with the UN Convention on
the Rights of the Child, children must from here on be allowed to exercise this
right to choose.
·
The
Swedish National Board of Health and Welfare wrote in 1996 [8]: “The National
Board of Health and Welfare is in very strong doubt about widening the
indications for treatment with stimulants, even with the strict rules suggested.
The reason for our position is as follows: Many of the around 8000 drug addicts
in the country will set great hopes on ´legal´ prescription. During the 90-ties
the National Board of Health and Welfare has only for 4-5 patients supported
prescription of stimulants on license, in statements to the Medical Products
Agency. Every matter is requiring lots of resources, often followed by appeal
and sometimes even threatening calls from the persons whose applications have
been disapproved. It will be possible even for amphetamine addicts to claim that
they have a diagnosis requiring treatment and to demand analysis to get license
prescription. The boundaries will be hard to tell. Sweden will be considered a
more drug liberal country. Increased legal prescription of stimulants will
obstruct the fight against narcotics.” The experiences from Norway have
shown this to be true.
In
summary:
Stimulant treatment has been proven destructive both for the individual and
the society. It must be banned right away.
Janne Larsson,
Writer
Sweden
janne.olov.larsson@telia.com
[1]
Aanonsen et al, Utprøvende
behandling med sentralstimulerende legemidler til voksne med hyperkinetisk
forstyrrelse/ADHD,
(Trial treatment of adults with hyperkinetic disorder/ADHD), Ullevål Hospital,
Oslo, Norway, February 2004, (to my knowledge only available in
Norwegian).
[2]
Aanonsen Nils-Olav, personal letter to Lars-Olof Janols, 2001; available
from the Swedish National Board of Health, via FOI-request, (only available in
Norwegian).
[3]
Lars-Olof Janols, Pharmacological treatment of ADHD and comorbid conditions
of children, youth and adults, unpublished manuscript, 2001, (only available
in Swedish).
[4]
http://www.adhdinfo.com/info/start/about/start_adhd_information.jsp
[5]
National Board of Health, ADHD in children and adults,
2002.
[6]
Levander,
ADHD
in adults, unpublished
manuscript, 1999.
[7] Aanonsen et al,
(Rapport til Statens helsetilsyn vedrørende utprøvende behandling med
sentralstimulerende legemedler till voksne med hyperkinetisk
forstyrrelse/ADHD, March 2000, (only available
in Norwegian).
[8]
National Board of Health, letter to the Medical Product Agency, May 1996,
(only available in Swedish).