International

Agnes Kant

In Tuesday's question time in Parliament an important and far from straightforward subject came up – the ethical questions surrounding medical experiments.

On Saturday De Telegraaf (1) stated that patients who take part in medical experiments are often poorly informed when they give their permission for this to occur, and that in the recent well-publicised and disastrous 'probiotica' experiments this may have been a problem (2).

As usual in De Telegraaf, the subject was somewhat sensationalised, as became clear when I read the paper that prompted its coverage, which was published in the Nederlands Tijdschrift voor Geneeskunde (Dutch Medical Journal). The observations made in the scientific medical paper were nevertheless disturbing. From 40% to 80% of patients who give their permission for inclusion in experimental trials believe that the doctor treating them will be giving the patients a treatment geared to them. Yet in a medical trial it is generally the case that the effects of two different treatments are compared, and which treatment is given to which patient is decided by lot, and therefore not by the doctor at all.

If it is a lottery and not a doctor who takes this decision, then in the judgement of scientific ethics and the directive based upon these ethics that there must be "honest uncertainty", i.e. the process is only available for use when it is in all honesty unknown which of the two treatments is the better of the two. In science this is known as the "uncertainty principle". It is a principle of importance ethically, but it does not release the researcher in any degree from the need to make certain that a patient who has given his or her permission to be included in a trial knows that their treatment will de determined by lot and not by the doctor.

A further important ethical principle is that of 'informed consent', the informed written permission of the patient in which he or she states that they are fully aware of the risks of the experiment. Especially in acute situations, and/or situations in which patients are in a very bad condition, anyone can understand that it may be extremely difficult to ensure that the patient understands what he or she is agreeing to or not agreeing to. But even this dilemma does not relieve the researcher from the duty to proceed with great care. Across the political spectrum everyone agreed that, given the conclusions of the 'Probiotica' investigation, the way in which this is done must be improved.

In a parliamentary oral question I also raised the question of the pharmaceutical sector and the huge pressure it put on the aforementioned "uncertainty principle" when it came to research in which commercial interests were involved. What came to light was that a new remedy, where the commercial interest involved was naturally keen to have it demonstrated that it received a favourable assessment, was not compared with whatever treatment was at the time the optimum available alternative, but, for example, with a dosage which was too low, or even with a placebo. This cannot in any way be allowed, but it happens all the same. The Secretary of State responsible, Jet Bussemaker, answered that it was far this reason important that research should not occur in a commercial setting but in an academic hospital.

Indeed. But unfortunately this academic setting has in recent times itself been to a large extent made into a commercial More and more, medical science is dependent on the flow of money from the pharmaceutical industry. Most pharmaceutical research departments can no longer function at all without this income and are completely dependent on it. In 2005 I wrote a report, together with Ineke Palm of the SP's research bureau and with the aid of a large number of extremely worried research scientists. The report brought together the experiences and views of twenty-five doctors who felt that the huge power of the pharmaceutical industry must be pushed back and the independence of scientific medical research strengthened.

It's clear that it's high time that this report was sent to the new Secretary of State..

(1)A popular daily newspaper.
(2)In a clinical trial of patients with acute pancreatitis, death rates amongst subjects given probiotics alongside conventional treatments were three times higher than amongst those not given the experimental treatment, consisting of introducing supposedly beneficial gut microbes.