Put knowledge before ignorance

Should people with learning difficulties be involved in drug
trials? Researchers have been known to abuse the vulnerable
position of those with learning difficulties by persuading people
to take part in research without their informed consent. Yet too
much caution could be detrimental and result in the use of
interventions that have no scientific basis.

We became aware of the issue when we began a large controlled trial
of neuroleptics for aggressive challenging behaviour in
intellectual disability (Nachbid). Despite the fact that we had
full ethical approval, we came across a reluctance for patients to
be involved because of ethical concerns. As a result, the number of
people recruited to take part in the trial is less than a quarter
of that anticipated.

There are serious implications should the trial not be completed.
Those who think that such trials are an abuse of those with
learning difficulties may see a failure to complete the trial as a
triumph of good sense. But the likelihood is that it would also
mean that no other large-scale trials would take place in the
treatment of learning difficulties in the UK for many years.

This would mean that people with learning difficulties who take
neuroleptic drugs for aggressive challenging behaviour would be
using them without sufficient knowledge. It would not be known
whether the drugs were effective, at what dose they should be given
and for how long. As it is, many of those taking the drugs continue
to do so because those involved with their care are reluctant to
stop them, even though it is suspected that very few conditions
which present as challenging behaviour need long-term drug therapy.

The doctors prescribing these drugs would have to rely on
information from adult psychiatry as no other information would be
available, even though aggressive challenging behaviour is not
recognised as a psychiatric syndrome. Those with a learning
difficulty would be barred from benefiting from research
evidence.

Those who oppose such investigations are, in effect, opting for a
solution that leads to a greater use of drugs and promoting
ignorance about appropriate treatments.

Peter Tyrer is head of the department of psychological
medicine at Imperial College, London and Sherva Cooray is a
consultant psychiatrist in learning difficulties.