COMMENT:TESTING THE TEST

The first signs of an incipient patients’ revolt against the controlled clinical trial (CCT) have begun to appear. Those are the supposedly airtight scientific studies in which patients are randomly selected to be given either the drug under study or

Last year, the Hastings Centre in New York, an eminent medical ethics authority, issued a 57 point table of recommendations, agreeing with the emerging healthcare activists that “there are circumstances in which other designs [radically different to the CCT] are more appropriate”. The (US) National Women’s Health Network in Washington, DC, is currently campaigning on two heavily politicized issues in women’s health. In February 1992 it lobbied the Food and Drug Administration (FDA) and Congress over the safety of breast implants, and is pointing to the inadequacies of the clinical trials that preceded this dubious procedure. In May 1992 activists were at the National Cancer Institute, voicing their well founded concern over the design of a clinical trial of a drug to prevent breast cancer in healthy women. Healthcare campaigners are getting participants in CCTs to have their tablets analyzed in order to find out whether they are getting the real drug or a placebo, and some participants then share their drugs with others.

These developments represent a concerted challenge by those who champion the rights of individuals against the collective ethic of science, represented here by the controlled clinical trial.

Behind all these individual rumblings is the first challenge to the notion, hitherto accepted as read in the medical community, that “if it’s good science, it will be ethically good as well”. Indeed, there are grave doubts that the CCT can even be regarded as “good science”.

Dr Harris L Coulter, the distinguished medical philosopher historian, addresses these sorts of issues comprehensively in a book entitled The Controlled Clinical Trial: an Analysis.

Coulter concludes that it is seriously flawed in every fundamental respect.First of all there are a variety of practical problems, for instance:

Confusion in international terminologies makes it very difficult to make comparisons in investigations.

Reliability is compromised by the enormous costs (and financial rewards) of engaging in CCTs that contribute to many inadequate protocols and the corruption of not a few investigators.

An idiosyncratic variety in the health and disease of humans presents insuperable difficulties in interpretability of CCT results.

Coulter demonstrates that the utopian ideal of the CCT is rather far removed from reality, by showing convincingly in well researched arguments that:

In practice the CCT is at best a trade off between scientific and economic restraints.

Because the CCT is incapable of precise identification, accurate prediction or valid specification at best, it manages no more than statistical correlations between the ill defined it is not ‘scientific’ in any sense of the word.

Its results do not affect physicians’ prescribing patterns the way they are supposed to do.

Although misrepresentation and concealment are fairly common,there is no fail proof method of correcting the medical literature following fraudulent publications.

The CCT is dehumanizing: patients become the objects of a scientific quest, are treated with aloofness and are seen as a source of irritation if they turn out to be individual deviants from the sample norm).

A doctor’s ability and duty to observe is consistently subverted by the assumption now in medicine that the only reliable source of information is the CCT).

Clearly, the days of trying to make all pharmacological questions fit the CCT’s unwieldy and very expensive mould are now numbered, not least by the economic reality of the horrendous cost involved for often such paltry bits of information. It is this which may hasten the displacement of the CCT in the foreseeable future.

Harald Gaier, author of The Encylopaedic Dictionary of Homoeopathy.