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PubMed1978

Ethical problems in clinical psychopharmacology.

The present article originates from some intriguing problems which the author, working as a clinical pharmacologist and psychiatrist, was faced with during clinical investigations. Practical difficulties appearing at first glance as of a rather methodological nature often reveal themselves as ethical questions. Investigation of psychotropic drugs in normal volunteers as well as in psychiatric patients is taken as a model to exemplify certain fundamental ethical aspects of medical research. It is emphasized that the "solution" of ethical problems cannot be achieved by referring to a given code of norms which themselves depend on certain historical circumstances, but rather by recognizing and reasoning the conflicts which result from various moral maxims. Clinical psychopharmacology should not only be conscious of its methodological shortcomings and future goals but also accept the justification of discussions about the ethical and legal questions involved in its dealings and take an active part in these debates. With regard to the relationship between patient and investigator, "solidarity" [23] instead of ongoing paternalism or legal formalism, appears to be a realistic goal. This is also true in the area of psychopharmacological research.

Disclosure↗
PubMed1981

[Drug testing today].

According to the new West German drug legislation, new drugs will only be registered if their quality, effectiveness and safety is ensured. Safety means a favourable ratio of therapeutic value and risk of side-effects. Effectiveness can usually be verified most objectively in adequate and well-controlled clinical investigations (phase II and phase III of drug evaluation), which are preceded by pharmacological and toxicological experiments in animals and preliminary pharmakokinetic and pharmakodynamic studies in volunteers (phase I). In phase III and IV, rare but important adverse drug effects are looked for.

Animals↗
PubMed1980

"Ethical" drugs.

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PubMedDate not supplied

Bioequivalence and narrow therapeutic index drugs.

Every prescription written for a generic drug requires an act of faith by the prescriber that any one of the several available products will be therapeutically equivalent to the innovator (brand name) products. Concerns about this act of faith have been expressed for many years, particularly in the wake of the generic scandals that occurred in 1989-1990, and especially relative to the drugs with a narrow therapeutic range. We contend that these drugs are actually the least likely to pose problems in ensuring therapeutic equivalence, but that new criteria must be established for bioequivalence because the present system is wasteful and is stifling innovation in the industry. We propose four suggestions to the scientific and regulatory communities that we believe could assist in modifying the process such that innovation is encouraged and practitioners are reassured relative to the appropriateness of using generic drugs.

Drug Industry↗
PubMedDate not supplied

[Determination of drug posology in pediatrics].

The dosage of drugs which might be used in children must be determined to avoid empirical use, even when no application has been submitted for a paediatric licence. Toxicological evaluation and assessment of the effects on growth, an adapted pharmaceutical form and paediatric pharmacokinetic and adult clinical data are essential before conducting trials designed to determine the paediatric dosage. The dose used during preliminary studies is extrapolated from the adult dose expressed in relation to weight, tested in a dose-effect study, and then more accurately defined on the basis of pharmacokinetic data in different age groups. Obtaining consent from both parents for studies whose direct benefit is not always obvious, as well as the global cost of these studies, constitute drawbacks to paediatric drug development. Incentives to determine a paediatric dosage could consist of public participation in funding, prolongation of the patent, and granting an advantageous price for a specifically paediatric pharmaceutical form or indication.

Age Factors↗