There is a way of testing new medications that allows inferior drugs to come onto the market. Not inferior in the sense that the drugs help fewer people, but inferior in that the new drugs can be associated with significantly more deaths than an existing medication and still be approved.

An excellent paper in The Lancet recently explained "non-inferiority" trials, why they are unethical and why they should be banned. It is quite possible that you are taking a pill that has travelled this dubious route from laboratory to medicine cabinet.

As the name implies, a non-inferiority trial is designed to prove that the medicine being tested is no worse than an existing medication. The added value is thought to lie not in its effectiveness but in some other aspect: for example, perhaps it is chewable, it slides down more easily, it needs to be taken only once daily.

The devil, according to Professor Silvio Garattini and Dr Vittorio Bertele, from the Mario Negri Institute for Pharmacological Research in Milan, arises in the definition of "non-inferiority". The drug under investigation – let’s call it M – must produce results that fall within a prescribed limit of a standard treatment.

But if the limit is set at 7.5 per cent, it means that a death rate of 7 per cent among the patients taking M is acceptable, even if the death rate among those on the standard treatment is 5 per cent. In a trial of 1,000 patients, this amounts to an extra 20 deaths with M – yet it could still receive a regulator’s blessing. "To expose patients to such risks in the trial, and in real life, with no benefit in exchange, is clearly unethical," Garattini and Bertele fume.

The only beneficiaries of non-inferiority trials are drug companies, because of lower research and development costs; proving that M is non-inferior to the standard can be done more quickly and with fewer patients than proving its superiority. The authors ask: "Why should patients accept a treatment that, at best, is not worse, but could actually be less effective or less safe than available treatments?"

Why, indeed?

(by anjana ahuja, The Times, December 10, 2007)

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