Healthy Skepticism Library item: 2810

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Erill S.
Clinical pharmacology in Spain.
Clin Pharmacol Ther 1974 Sep; 16:(3):597-604

Abstract:

There are clinical pharmacology programs in three Spanish medical centers. All have developed from pharmacology departments, and joint appointments do not exist at this early stage in the development of clinical pharmacology. Recent legislation exerting increased regulatory control over drug products (specialties) has been exacted, but the challenges facing clinical pharmacology in evaluating and selecting useful and safe therapeutic agents from the myriad of new and existing preparations remains immense. [author’s abstract]
The law requires drug companies to provide protocols of clinical trials only if they are considered necessary. A 1970 modification of the law requires pharmacokinetic data and reports from clinical trials in the applications submitted for marketing new drugs. The need for more complete and updated investigational and marketing regulations is strongly felt. Most of the drug information used by physicians comes from the promotional activities of the pharmaceutical industry. The content of the Vademecum Daimon, the equivalent of the Physicians’ Desk Reference, depends solely on material supplied by the drug companies. Only 19.7% of the drugs are fully acceptable for the indications stated. For 89% of drugs, no mention is made of contraindications, and only 7% of products have accurate descriptions of the contraindications. Analysis of the clinical trials published in the 1971 and 1972 issues of the two leading Spanish medical journals found an almost total lack of adequate control data.

Keywords:
*analysis/Spain/Communication Curriculum Drug Combinations Drug Industry Drug Utilization Legislation, Drug Pharmaceutical Preparations/standards Pharmacology*/education Pharmacopoeias Schools, Medical Spain