Drug not considered a first-line agent.
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Biomedical subjects
Publications and source records attributed to J Lexchin.
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Some or all of the promotional activities of pharmaceutical companies are typically governed through self-regulatory codes administered by industry associations. However, the conflicts between the commercial objectives and the ethical and scientific goals of promotion can potentially lead to serious weaknesses in the way in which these codes are enforced. This paper focuses on 5 critical aspects involved in the enforcement of codes governing pharmaceutical promotion: mechanisms for recognizing violations, composition of monitoring committees, sanctions for code violations, the quantity and quality of information in reports issued about complaints and code violations, and the circulation these reports receive. The Code of Marketing Practices of the Pharmaceutical Manufacturers Association of Canada (PMAC) has serious weaknesses in all of these areas. Although the Pharmaceutical Advertising Advisory Board's Code of Advertising Acceptance avoids many of the deficiencies of the PMAC code, it, too, has weaknesses. Proposals for strengthening the enforcement of both codes are offered.
Bills C-22 and C-91 eliminated compulsory licensing for pharmaceutical products in Canada. However, in the wake of these bills there are pressing issues of pharmaceutical policy that need to be decided. The value of additional spending in pharmaceutical R and D has yet to be evaluated. There needs to be a public debate about how far government policy should go in encouraging pharmaceutical R and D as opposed to investing resources in other areas. There has been a continuing escalation in the cost of the average prescription, due to the introduction of newer, but not necessarily more effective, medications. So far government has not been willing to commit resources to promote cost-effective prescribing. Pharmaceutical companies are now lobbying for more rapid approval of products and an extension to the normal patent period to make up for the time that drugs spend in the regulatory process. The process that the government uses to resolve these issues will be just as important as the ultimate decisions.
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OBJECTIVE: To assess the information pharmaceutical sales representatives provide to physicians. DATA SOURCES: A MEDLINE search from January 1966 to May 1996 was done using combinations of the terms pharmaceutical industry, drug information services, drug utilization, physician's practice patterns and prescriptions, and drugs. Studies identified from this search were supplemented by material from my personal library. STUDY SELECTION: Studies had to be conducted in industrialized countries, based on direct observations of actual physician and sales representative contacts, and reporting quantitative results on the quality of information transmitted. SYNTHESIS: Four studies were included. Representatives usually mentioned the indications for their drugs, but omitted safety information. Representatives' information frequently contained inaccuracies. CONCLUSION: Sales representatives present only selected, usually positive, information about their products. Canadian doctors should not be passive recipients of information provided by sales representatives. Physicians who choose to continue to see representatives must critically compare the information they get from them with that contained in scientific publications.
The outcome of the drug approval process plays a major role in determining how drugs will be prescribed in Canada. The objective of this paper is to examine the nature of the regulatory approval process, its decisions, how these are expressed in pharmaceutical promotion and the ultimate impact of these factors on the prescribing of psychotropic drugs in general and particularly with regard to the benzodiazepines. There is strong circumstantial evidence that the benzodiazepines were approved on the basis of inadequate clinical trials resulting in these drugs being indicated for conditions for which they were not useful and significant safety issues being ignored. These deficiencies in the regulatory process were magnified in the advertising of these products to physicians, thus contributing to inappropriate prescribing in four areas: prescribing for psychosocial problems, overprescribing for somatic complaints, overprescribing to women and overprescribing for anxiety disorders. Problems in the approval process continue to exist and these will manifest themselves in ongoing inappropriate prescribing of psychotropic, and other, medications.
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Drug therapy is an integral component of modern medical care, and practising physicians are faced with the difficult task of keeping up with rapid changes in pharmacologic treatments. Recent evidence indicates that prescribing practice is often inconsistent with criteria for safety and effectiveness. Surveys indicate that community-based physicians are not satisfied with current sources of information on prescription drugs. The dissemination of printed material alone does not lead to improved prescribing practice, but specific education and feedback strategies can. To improve prescribing practice in Canada we need to systematically evaluate strategies to change prescribing behaviour, to design quality assurance programs based on proven strategies and to develop collaboration and cooperation among providers, manufacturers, governments and the public.
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