A pill-full of sugar helps the medicine go down

A medicine for children that has been shown to be effective in a wide range of conditions is to be released soon in the UK and is already available in the US. It has been exhaustively studied, and has no side effects. It is extremely cheap to produce, and will be readily available. Yet GPs, academics and ethicists are up in arms about the new drug. What is all the fuss about?

Obecalp is a sugar pill. The name comes from ‘placebo’ (spelled
backwards), and the idea for marketing it comes from some parents in
the US who wanted to exploit the placebo effect for their own child who
had a psychosomatic illness.

The placebo effect has been recognised for decades. In many illnesses
patients who receive a treatment that they believe will help, get
better quicker than if they had received no treatment at all. This
occurs even if the treatment that they receive contains no active
ingredients. The biological mechanism for it is still not well
understood, but there are different components to the effect (for
example, there is the effect of the doctor’s care and attention, as
well as the effect of taking a pill that you think will work).

There is some evidence that placebos may be more effective in children
than in adults. Paediatricians and GPs often implicitly rely on the
placebo effect when they treat illnesses in children that do not have
an identifiable medical cause or cure. And parents commonly use a form
of the placebo effect for a wide range of minor ailments, using ‘magic
cream’ or the ubiquitous ‘kiss and make better’.

However the central ethical quandary raised by placebo is that it is
effective only when the subject is deceived. In order to receive the
benefit of placebo we need to believe that we are receiving an active
drug. But we have a strong desire not to be deceived by our doctors, or
by our parents. So, in a sense, I was wrong in what I claimed in the
first paragraph – there is a distinctive side-effect of placebo.

It is possible that placebo pills could be prescribed to children
without requiring deception. In one intriguing study, children with
Attention Deficit Hyperactivity Disorder had their regular medication
halved, and were given placebo pills that they were told were inert.
The placebo seemed to work even though the kids knew that it was a
placebo. However it is not clear if this would be applicable in other
illnesses.

But if our concerns about deception lead us to reject placebo treatment
for children we may miss out on a significant benefit. It is sometimes
estimated that a third of patients improve with placebo, but in some
conditions the response rate may be higher. For example, half to two
thirds of children or adolescents with migraine have reduced headache
after treatment with placebo.

The controversy about Obecalp may also seem hypocritical. There would
be little outcry over the release of a new herbal medicine or
homeopathic remedy for childhood illnesses, even if there were little
or no evidence to support its use. Few would condemn parents for giving
such treatments to children. It might be felt that in such cases
parents genuinely believe that such treatments could be helpful, even
in the absence of scientific evidence. However a parent who gave their
child Obecalp for a migraine would be entirely justified in thinking
that it would be likely to be helpful, and unlikely to harm their
child. 

One solution to some of the ethical concerns that have been voiced
about placebo treatment for children would be to combine the sugar pill
with some vitamins or other micronutrients. In fact the manufacturers
wouldn’t even need to change the formulation of their pill – Obecalp
already contains homeopathic concentrations of Vitamin A, B6 and C.
Then parents and doctors could prescribe it with clear conscience –
perhaps employing that ever-useful ethical tool, the doctrine of double
effect.

Links


Doctors raise fears over new placebo pill for children
Guardian 16/06/08


Experts question placebo pills for children
New York Times 27/5/08

Placebo deception in children
Neuroethics and the Law blog 27/05/2008

For Children: a kiss on the forehead vs a placebo pill Bioethics discussion blog 28/5/08

The power of the placebo Mark’s daily apple 30/5/08

Sandler A, Glesne C, Geller G. Children’s and parents’ perspectives on open-label use of placebos in the treatment of ADHD. Child Care Health Dev. 2008 Jan;34(1):111-20.

Rothner AD, Wasiewski W, Winner P, Lewis D, Stankowski J. Zolmitriptan oral tablet in migraine treatment: high placebo responses in adolescents. Headache. 2006 Jan;46(1):101-9.

Sandler A. Placebo effects in developmental disabilities: implications for research and practice. Ment Retard Dev Disabil Res Rev. 2005;11(2):164-70.

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