UNSOUND REGULATiOi\iS FOR DRUG DEVELOPMENT

Time for Scientists to Make Their Voices Heard

... academicians can and must help to create sound legislation and assume authority in public matters. But it is a mistake to blame excesses of the past on sCientists when in fact they have been largely excluded from the decision process.' Drug testing carries the·same obligations as other areas of human experimentation for the optimal use of human resources, safety and quality of research, but these obligations have not always been fully met. Animals and humans have been used wastefully. There has been a proliferation of animal models for toxicology studies even though animal tests cannot usually predict the effects of a drug in man. Standards for toxicology are often set by officials in response to pressures from legislators or consumer groups- people often not fully conversant with the ·subject. This makes drugs more costly, limits the range of discovery (and at times may even prevent it), and unnecessarily delays release of some drugs.

Scientific decisions must be made not by self-interested political

groups~

but by scientists - - -

Misusing human subjects to test trivial drugs ofien erodes scientific credibility, but political demands to discontinue testing can affect legitimate human experimentation. This may in the long run be more damaging. Good data related to new drugs or new uses for old drugs is often underused, as in the delays by the FDA to approve propranolol for angina (recently approved) and hypertension (unapproved). There should be checks and controls, but the tendency is to play it too safe .

. . . Scientists by-passed Although scientists have not dealt effectively with the problems of drug development, they are socially responsive and responsible. This is shown by their presence on many boards which have commented on matters of social concern. They do not, however, often take the initiative in regulating drug development - maybe because they have been bypassed owing to the political importance of the issue. The advice necessary to create reasonable drug testing legislation could have been, but was not, gleaned from scientists. Decisions about the kind of testing necessary to 'prove' safety and efficacy were left to lay personnel 'who created regulations that were cumbersome, rigid, and costly in terms of time and number of subjects'. A concurrent rise in concern about human experimentation creates a contradictory situation - proof of absolute safety is required, but the requisite testing is frowned on. Scientists do realise that some risk in drug taking is inevitable and that drugs often may best be evaluated by close surveillance after release. This allows 'those with the most to gain from efficacy to accept the largest burden of risk'. The raised voices of consumer groups, however, have forced them back into their laboratories and left drug testing to people of sometimes dubious integrity. The present shoddy and unnecessary testing could lead legislators to rule out all" human experimentation. • Scientists must improve their communication with the public through the media by commenting as much, as often and as widely as possible. • They 'must become active members of society so that no one will use [them] as their dupes, court jesters, or window trappings', • They must be given power to. translate suggestions into action or, at least, access to the public when their suggestions are ignored. • They must be willing to revamp suggestions when mistakes are made and to follow up on mistaken hypotheses. • Scientists will generally accept responsibility for their decisions if they can be assured of a reasonable evaluation and a competent adoption of them. Melmon, K.L.: Oinical Pharmacology and Therapeutics 20: 125 (Aug 1976) l.NPHARMA 28th August, 1976 p4