Lexchin J
Emergency Department, Toronto Hospital, Ont.
CMAJ. 1993 Nov 15;149(10):1401-7.
To determine the effect of three types of interaction between physicians and the pharmaceutical industry--company-funded clinical trials, company-sponsored continuing medical education (CME) and information for physicians supplied by pharmaceutical detailers--on orientation and quality of clinical trials, content of CME courses and physicians' prescribing behaviour.
MEDLINE and HEALTH searches for English-language articles published from 1978 to 1993, supplemented by material from the author's personal collection.
A total of 227 papers from the MEDLINE and HEALTH searches and about 2000 items from the author's library were initially reviewed. The following selection criteria were used: studies conducted in Australia, Canada, New Zealand, Britain and the United States; studies conducted after 1977; quantitative surveys containing details of the survey methods; studies on the orientation and quality of company-funded clinical trials and on the content of CME courses giving explicit criteria used in the evaluation; and reports on the outcome of interactions stating how the outcomes were assessed. Thirty-six studies met these criteria.
Information was extracted on five topics: physicians' attitudes toward drug industry interactions, frequency with which physicians participate in the interactions, orientation and quality of company-funded clinical trials, content of company-sponsored CME courses and changes in physicians' prescribing behaviour as a result of an interaction.
Although most physicians participate only occasionally in company-sponsored clinical trials, most see detailers and attend company-sponsored CME courses. However, physicians do not have a very high opinion of the information from detailers or of company-sponsored CME events. Many doctors regard pharmaceutical companies as an important source of funding for clinical trials, but they also have concerns about accepting money from this source. Company funding of clinical trials may affect the quality of the trials and the types of research that physicians undertake. Company-sponsored CME courses may have a commercial bias even if conducted under guidelines designed to ensure the independence of the event. All three types of interactions affect physicians' prescribing behaviour and, in the case of obtaining information from detailers, physicians' prescribing practices are less appropriate as a result of the interaction.
Physicians are affected by their interactions with the pharmaceutical industry. Further research needs to be done in most cases to determine whether such interactions lead to more or less appropriate prescribing practices. The CMA's guidelines on this topic should be evaluated to see whether they are effective in controlling physician-industry interactions. Further measures may be necessary if the guidelines fail to prevent negative effects on prescribing practices.
确定医生与制药行业之间三种互动类型——公司资助的临床试验、公司赞助的继续医学教育(CME)以及医药代表向医生提供的信息——对临床试验的导向和质量、CME课程内容以及医生处方行为的影响。
检索MEDLINE和HEALTH数据库中1978年至1993年发表的英文文章,并补充作者个人收藏的资料。
最初对MEDLINE和HEALTH检索出的227篇论文以及作者图书馆中的约2000篇文献进行了审查。采用了以下选择标准:在澳大利亚、加拿大、新西兰、英国和美国进行的研究;1977年以后进行的研究;包含调查方法细节的定量调查;关于公司资助的临床试验的导向和质量以及CME课程内容且给出评估明确标准的研究;以及关于互动结果的报告,说明结果是如何评估的。36项研究符合这些标准。
提取了五个主题的信息:医生对与制药行业互动的态度、医生参与互动的频率、公司资助的临床试验的导向和质量、公司赞助的CME课程内容以及互动导致的医生处方行为变化。
尽管大多数医生只是偶尔参与公司赞助的临床试验,但大多数医生会见医药代表并参加公司赞助的CME课程。然而,医生对医药代表提供的信息或公司赞助的CME活动评价不高。许多医生将制药公司视为临床试验的重要资金来源,但他们也对接受该来源的资金有所顾虑。公司对临床试验的资助可能会影响试验质量以及医生开展的研究类型。即使公司赞助的CME课程是按照旨在确保活动独立性的指导方针进行的,也可能存在商业偏见。所有这三种互动类型都会影响医生的处方行为,就从医药代表处获取信息而言,互动会导致医生的处方行为不太恰当。
医生会受到与制药行业互动的影响。在大多数情况下,需要进一步研究以确定这种互动是否会导致更恰当或更不恰当的处方行为。应评估加拿大医学协会关于该主题的指导方针,看其是否能有效控制医生与行业的互动。如果这些指导方针未能防止对处方行为产生负面影响,可能需要采取进一步措施。