Nihilism and nonethical studies prevail
After seven years of my studying the medical literature on MS, a sad conclusion emerges: the euphoria of 1996 (when it was felt that MS was standing shortly before an important therapeutical breakthrough) has not been given satisfaction. Simultaneously, unethical studies are publshed in an increasing number annually. Or is there a contradiction to be found here? Perhaps these studies, after all, are not so unethical at all, once the basis of existant therapy has been reevaluated.
If you believe the Cochrane reviews on randomised controlled trials [RCT], you may approach in that direction. Recent publications did not leave any good reputation on the scientific basis for the treatment with interferon-beta above one year  or glatimer racemate (Copraxone®) at all . Now, one should not sink into despair over such a message: the Cochrane-reviews, after sorting out the majority of studies for not meeting their sincere criteria, are almost always reaching a nihilistic conclusion, upon which the stereotypical demand for further studies is raised. On the contrary, one could claim the bunch of Cochrane-studies an indication that RCTs, in spite of all standardization, may yield controversial conclusions and do not contribute to any positive changes in therapies.
Should the physicians indeed believe in these nihilism, the way would be paved for any new RCT, since you could now tell the patient (and believe it yourself) that the tested substance was not obviously different from placebo and there was now no therapy which had better been used for, e.g. the coming two years. The problem is, however, that this attitude is not met among the most active MS-researchers. They have usually contributed to studies which have shown advantage to the test substance towards placebo. How, else, could they tell most of their patients that they had a cure that worked, and how tell the health insurances that it was worth paying the huge sum for, if a cheap placebo-preparation could do the same? It must be assumed that these physicians must suffer deep ethical problems when speaking with one tongue to some patients and with another to others. Obviously, the publication-obsession and its occupational importance make this dual approach seem necessary to many physicians. It does certainly emphasize my claim elsewhere that physicians are incompetent for dealing with the ethical questions of medical studies. Unfortunately, this aspect has not been given appropriate attention in the society.
In a positive sense, some progress has been made for identifying physiological substances which signal neuronal destruction and thus measure the activity of disease. These can be used as parameters for new approaches to the therapy of MS – when new drugs become available. Such need not necessary be carried out in a doubble-blind fashion but it will probably be necessary for getting the resulting article printed. My advice to patients and doctors is the same: stay away from RCTs. Better a good consciousness in meager results than … this alternative, you must imagine for yourself.
John Schou, M.D.
1. : Rice G PA, Incorvaia B, Munari L, Ebers G, Polman C, D'Amico R, Filippini G. Interferon in relapsing-remitting multiple sclerosis (Cochrane Review). In: The Cochrane Library, 4, 2001. Oxford: Update Software.
2. : Munari L, Lovati R, Boiko A. Therapy with glatiramer acetate for multiple sclerosis (Cochrane Review). In: The Cochrane Library, Issue 1, 2004. Chichester, UK: John Wiley & Sons, Ltd.
Inserted February 29, 2004