The Department for Marketing Authorisation in France has called for the ban of almost all medicinal products aimed at enhancing immunity. Starting September 30, French people have been prohibited to buy medicines like "Solutricine" , "Lysopaïne" and 10 others. On October 24, access to the market has been denied to 10 other medicines known as immunostimulant. This new application of the precautionary principle make us wonder if such a ban will not expose us to new risks.
As underlined in many press articles on the subject, “when launched, all of these medicines received a marketing authorisation from the French Health Products Safety Agency (AFSSAPS) based on clinical testing made available by the pharmaceutical company”. At that time, the tests had led to a positive evaluation of the benefit-risk balance. Since then, it appears that things have changed.
Indeed, at the beginning of 2000, 15 years after immunostimulants were put on the market, some very rare but serious adverse reactions occurred, in the form of skin rashes or allergic reactions. This led the AFSSAPS to judge that the risks were greater than the benefits, so they were banned.
The public decision of allowing or banning a medicinal product is always defended in the name of scientific knowledge available at the time. Thus, as revealed by the Journal of the American Medical Association (JAMA), the results of medical research are often contradictory: 16% of the most-quoted studies have been later contradicted, and it appears that 16% of the results of studies had been overestimated.
It is not enough to say, like Professor Jean-Paul Giroud, associated Professor of clinical pharmacology at the Cochin hospital (in Paris), that these medicines are useless (quoted in Le Figaro on Sept. 14, 2005). Such a claim does not justify a prohibition. We forget perhaps too fast that if people use medicines like " Solutricine " or any other immunostimulant, it is for the benefits they get from them, such as being less sick. Obviously, it is difficult to say that a medicine is responsible for a disease that never occurred. Nevertheless, we cannot justify calling for it to be banned simply because it is easy for us to blame it for a rash or an erythema.
As our scientific knowledge is doomed to evolve, it is likely that the AFSSAPS will later be called to re-evaluate the risks and benefits of immunostimulants. As one AFSSAPS specialist says, "the evaluation of the benefit-risk balance is never stable, it is continuous and evolves throughout the life of a product " (quoted in Le Monde on Sept. 15, 2005). However, it is difficult to imagine how this evaluation could evolve once the life of the product is put to an end. If today the AFSSAPS is able to ask for a ban, this is because immunostimulants were once allowed and their effects on patients could therefore still be observed. Banning the use of certain medicines by way of precaution can only halt the process of discovery of the benefits and risks of these products.
The measures taken in the name of the precautionary principle are always called for by authorities, which impose their judgement on us all, telling us to ignore certain risks like being sick while overestimating others. It is a dangerous principle which invites us to ruin the basis of a process of discovery essential to the healthy management of risk.
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