Healthy Skepticism Library item: 20545

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Publication type: Journal Article

Busetto D
Gangliosides regulation debacle
The Lancet 1993 Apr 10; 341:949

Abstract:

Gangliosides have been restored to the market within days of their suspension, a decision that reflects how the collapse of drug surveillance parallels that of the Government.

Despite accumulating evidence that gangliosides are of uncertain clinical value and that they may be associated with acute motor polyneuropathy (see BMJ 1992; 305, and 1330-31, and Lancet 1991; 338: 757), these substances (GM, included) are widely prescribed in Italy. Even though they have been licensed for use only for diabetic neuropathy and acute spinal cord lesions, their use has risen sharply among the general population, from 1.6 defined daily doses (DDD) per 1000 inhabitants in 1988-90 to 2.3 DDD in 1991 (see Lancet 1992; 340: 374-75). In Italy all gangliosides on the market (Cronassial, Sinassial, and Sygen) are produced by Fidia, whose profits depend largelyon these agents.

Between 1989 and 1991 eight cases of Guillain-Barre syndrome (GBS) in patients being treated with gangliosides were spontaneously reported to the health authorities. These reports, together with a study by the Instituto Superiore de Sanita, Rome, showing how widely the population in Rome was exposed to these drugs (see Lancet 1992; 340: 60), led Health Minister R. Costa to issue a ministerial decree on March 12 suspending gangliosides from the market. Gangliosides had already been withdrawn in Germany in 1989, and on March 17, the EC Committee for Proprietary Medicine Products recommended their suspension (see Lancet March 27, p 820). Yet on March 18, after an 8 hour meeting, the National Council of Health, the body that advises the minister, decided, by a 12 to 8 majority, that gangliosides are clinically useful and safe. The same day, Fidia employees were holding a public demonstration in Rome to protest against the suspension of gangliosides.

So, now, by another ministerial decree, gangliosides are back on the market, securing a bonanza for their manufacturers at the expense of the national health service. Unlike benzodiazepines are other anxiolytics, these agents are reimbursable by the state.