MS-Science 2004:
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 [1] or glatimer racemate (Copraxone®) at all [2]. 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