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Biomedical subjects

J Lexchin

Publications and source records attributed to J Lexchin.

At least 55 records · Page 3Linked to original sources
PubMed1994

Methodologic quality and relevance of references in pharmaceutical advertisements in a Canadian medical journal.

OBJECTIVE: To evaluate the methodologic quality and relevance of references in pharmaceutical advertisements in the Canadian Medical Association Journal (CMAJ). DESIGN: Analytic study. DATA SOURCE: All 114 references cited in the first 22 distinct pharmaceutical advertisements in volume 146 of CMAJ. MAIN OUTCOME MEASURES: Mean methodologic quality score (modified from the 6-point scale used to assess articles in the American College of Physicians' Journal Club) and mean relevance score (based on a new 5-point scale) for all references in each advertisement. MAIN RESULTS: Twenty of the 22 companies responded, sending 78 (90%) of the 87 references requested. The mean methodologic quality score was 58% (95% confidence limits [CL] 51% and 65%) and the mean relevance score 76% (95% CL 72% and 80%). The two mean scores were statistically lower than the acceptable score of 80% (p < 0.05), and the methodologic quality score was outside the preset clinically significant difference of 15%. The poor rating for methodologic quality was primarily because of the citation of references to low-quality review articles and "other" sources (i.e., other than reports of clinical trials). Half of the advertisements had a methodologic quality score of less than 65%, but only five had a relevance score of less than 65%. CONCLUSIONS: Although the relevance of most of the references was within minimal acceptable limits, the methodologic quality was often unacceptable. Because advertisements are an important part of pharmaceutical marketing and education, we suggest that companies develop written standards for their advertisements and monitor their advertisements for adherence to these standards. We also suggest that the Pharmaceutical Advertising Advisory Board develop more stringent guidelines for advertising and that it enforce these guidelines in a consistent, rigorous fashion.

Advertising↗
PubMed1994

Canadian marketing codes: how well are they controlling pharmaceutical promotion?

Pharmaceutical promotion in Canada is controlled by two codes: a voluntary one developed by the Pharmaceutical Advertising Advisory Board dealing mostly with printed promotional material, and one from the Pharmaceutical Manufacturers Association of Canada covering other forms of promotion. This article looks at enforcement of the provisions of these codes and at areas in which they are deficient. One of the major weaknesses in both codes is their lack of effective sanctions for companies that violate their provisions. Strong codes are necessary because many physicians rely heavily on promotional material for their source of prescribing information. However, voluntary codes or codes developed by the industry are inherently weak and lack effective enforcement mechanisms. Although the U.S. Food and Drug Administration is currently very active in curtailing promotional excesses, government control is not the solution since regulatory action will depend on the ideological position of the head of the regulatory body and/or the party in power. An independent body backed by legislative authority is preferable.

Advertising↗
PubMed1994

Who needs faster drug approval times in Canada: the public or the industry?

Over the past decade the Canadian drug approval system has come under intensive scrutiny, with the greatest amount of attention being given to the length of time required to approve new drugs. This issue has obviously also been of considerable interest to the pharmaceutical industry, and the question arises as to whether or not the concerns of the industry may be driving the proposed reforms to speed up the approval process. Both industry and government maintain that quicker approval of new drugs will ensure that Canadians have more rapid access to new medications without sacrificing safety. There are problems with these claims. The number of therapeutically important new drugs introduced annually is less than five and these are already "fast tracked," so the need to speed up approval for all products is dubious. There is also evidence that safety may be compromised with faster approvals. Industry does not need quicker approval times for its financial viability, but getting new, more expensive drugs onto the market more rapidly will increase sales and profit levels. Alternative approaches to dealing with problems such as drug approval times will only be possible when the policy-making process becomes more transparent and open.

Canada↗
PubMed1994

Agents against pediatric diarrhea. Assessing the information companies supply to Canadian physicians.

OBJECTIVE: To assess information on the safety and efficacy of medications that could be used to treat children who have acute infectious diarrhea. DESIGN: Survey of product monographs. Companies were asked to supply their best evidence that products were both safe and effective for treating children who have diarrhea and to supply any information on adverse effects among Canadian children related to use of the products. PARTICIPANTS: Companies making drugs identified in the Compendium of Pharmaceuticals and Specialties as used for acute infectious diarrhea. MAIN OUTCOME MEASURES: Product monographs were reviewed for availability (over-the-counter or by prescription), mention of oral rehydration therapy, age (or weight) limit for use, and safety information. Information in the monographs was compared for completeness with a report from the World Health Organization or the American Medical Association's Drug Evaluations Annual. RESULTS: Four companies market a total of six products. Only one monograph specifically mentioned rehydration therapy. Safety information in two monographs was comparable to that in the WHO report. Safety information in two monographs was limited. None of the companies were able to provide placebo-controlled studies showing their products to be effective. CONCLUSIONS: If these products remain on the Canadian market, companies making them should cease to list them as indicated for acute infectious diarrhea among children. All company-supplied literature should unequivocally state that oral rehydration therapy is the best treatment for this condition. Safety information on some of the products should be upgraded.

Antidiarrheals↗
PubMed1993

Interactions between physicians and the pharmaceutical industry: what does the literature say?

OBJECTIVE: 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. DATA SOURCES: MEDLINE and HEALTH searches for English-language articles published from 1978 to 1993, supplemented by material from the author's personal collection. STUDY SELECTION: 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. DATA EXTRACTION: 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. DATA SYNTHESIS: 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. CONCLUSIONS: 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.

Attitude of Health Personnel↗
PubMed1993

Effect of generic drug competition on the price of prescription drugs in Ontario.

OBJECTIVE: To analyse the potential effect of generic drug competition on prices in Ontario to assess the costs and benefits associated with Bill C-22 (An Act to amend the Patent Act). DESIGN: Comparison of the cost of the least and most expensive versions of all products sold by more than one manufacturer in 1991. The number of brand-name and generic drug companies marketing each of the products was recorded. RESULTS: Of 1599 products 437 (27.3%) were made by more than one company. Almost half (44.6%) of the 437 were sold by two companies. The more companies that sold a drug the greater the difference in price between the least and most expensive versions. Similarly, as the proportion of generic drug companies in competition increased, the greater the price difference. When competition was between generic drug companies only, the price spread was smaller than when it was between brand-name drug companies only. CONCLUSIONS: Generic drug competition can result in savings to the Ontario Drug Benefit Plan. A more in-depth analysis of the potential savings is necessary to fully assess the costs and benefits associated with Bill C-22.

Drug Industry↗
PubMed1993

Pharmaceuticals, patents, and politics: Canada and Bill C-22.

In response to high drug prices, the Canadian government amended the country's patent act in 1969 to allow for compulsory licensing to import pharmaceuticals. As a result of the legislation, by 1983 drug costs in Canada were over $200 million lower than they would otherwise have been. The multinational drug industry was strongly opposed to compulsory licensing, despite any evidence that its economic position had been harmed. Restoration of patent protection for drugs was one of the key U.S. demands during free-trade negotiations between Canada and the United States in 1985-1987. The result was Bill C-22, which gave new drugs protection from compulsory licensing for seven to ten years. This article analyzes the impact of Bill C-22 on the generic industry, the creation of jobs in research and development, drug prices, and research and development expenditures. It concludes with an examination of future demands from the pharmaceutical industry.

Canada↗
PubMed1992

NSAIDs and peptic ulcer.

Explore the source record for details and available documents.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1992

Prescribing and drug costs in the province of Ontario.

The Report of the Pharmaceutical Inquiry of Ontario documented dramatic increases in the cost of the Ontario Drug Benefit (ODB) program. This article demonstrates that the rise in ODB costs for those 65 and over is due to two factors: more intensive prescribing--physicians prescribing to the elderly more often and writing more prescriptions each time they see an elderly patient--and physicians writing prescriptions for more expensive drugs. Neither of these two changes in prescribing behavior has resulted in any demonstrable improvement in the health of the elderly. Efforts to control costs through some form of copayment or by eliminating some drugs from the ODB formulary should not be undertaken since they probably will result in a reduction in the use of medically necessary drugs. Ultimately, drug costs will only be controlled by improving the appropriateness of physicians' prescribing.

Aged↗