This study measured the validity of a new instrument, the Assessment Instrument for Drug Detailing (AIDD), used by doctors to score the quality of drug detailing provided by pharmaceutical representatives in their offices. Five pharmaceutical representatives provided "good, medium, and poor" details to 135 family doctors in their offices, who were blinded to the quality of the details. A "reference standard group" constructed the details and trained the representatives. An "assessment group" trained family physicians to use the AIDD to score the details. Physicians discriminated between different quality details in all but one domain, nomenclature (P
More than 80 percent of clinical drug trials in Canada are funded by the pharmaceutical industry. This article evaluates the overall state of clinical trials in Canada and looks at the interplay between public and private interests. Health Canada has adopted standards developed by the International Conference on Harmonization, a body that is heavily influenced by industry. Commercial interests are increasingly involved in recruiting patients into clinical trials and in running these trials. It is in industry's interests to conduct drug tests on people for which it is easiest to see benefits. These interests are not fundamentally challenged by Health Canada's policy of issuing nonmandatory guidelines on who should and should not be included in clinical trials. The outcome of clinical trials is heavily influenced by commercial sponsorship, with the result that trials may favor corporate interests rather than the interests of the public. How Health Canada deals with that possibility is not known, because of its strict policy of treating clinical trial data as private property. If clinical trials are to serve the purpose for which they are designed, developing reliable and objective information about new drugs, then commercial interests cannot be allowed to take precedence over health interests.
School of Health Policy and Management, York University and Emergency Physician, University Health Network, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario. jlexchin@yorku.ca
Drug companies aggressively market their products to increase sales and economic rewards. Different countries have different regulatory regimes for controlling promotion. In the United States control rests directly with the Food and Drug Administration whereas Canada relies on a mixture of voluntary self-regulation and an autonomous agency. Each method has significant weaknesses. We examine these weaknesses by analyzing the promotion of OxyContin (the time release version of the opioid oxycodone) by Purdue in Canada and the United States. We then look at the association between promotion and the misuse and abuse of OxyContin in both countries. Finally, we advance specific recommendations for regulating promotion for drugs that may have a high abuse potential.
Prescription drugs are the fastest growing healthcare cost in Canada. Increased spending is mainly due to use of newer, more expensive medicines and a higher overall volume of prescription drug use. In the large majority of cases, empirical studies fail to support claims of a net benefit to health. Newer high-priced drugs are neither consistently safer nor more effective than older alternatives. Over 2000 new drugs and indications introduced in France from 1981-2000 were compared to existing treatments: 81% offered little to no added value and 3% were less safe or effective. In Canada, only 5% of drugs introduced from 1996-2000 offered substantial improvement to therapy. Claims linking use of newer drugs to reduced hospitalization and mortality fail to distinguish between underlying differences in disease severity and treatment outcomes. For "newer" to truly mean "better", fundamental changes are needed to the regulations governing market approval and post-approval surveillance. Such changes are possible, but would require strong political will.
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Comment On: Can J Clin Pharmacol. 2005 Winter;12(1):e10-2116055940
Patients routinely cite the media, after physicians and pharmacists, as a key source of information on new drugs, but there has been little research on the quality of drug information presented. We assessed newspaper descriptions of drug benefits and harms, the nature of the effects described and the presence or absence of other important information that can add context and balance to a report about a new drug.
We looked at newspaper coverage in the year 2000 of 5 prescription drugs launched in Canada between 1996 and 2001 that received a high degree of media attention: atorvastatin, celecoxib, donepezil, oseltamivir and raloxifene. We searched 24 of Canada's largest daily newspapers for articles reporting at least one benefit or harm of any of these 5 drugs. We recorded the benefits and harms reported and analyzed how such information was presented; we also determined whether clinical or surrogate outcomes were mentioned; if and how drug effects were quantified; whether contraindications, other treatment options and costs were mentioned; and whether any information on affiliations of quoted interviewees and potential conflicts of interest was presented.
Our search yielded 193 articles reporting at least one benefit or harm for 1 of the 5 drugs. All of the articles mentioned at least one benefit, but 68% (132/193) made no mention of possible side effects or harms. Only 24% (120/510) of mentions of drug benefits and harms presented quantitative information. In 26% (31/120) of cases in which drug benefits and harms were quantified, the magnitude was presented only in relative terms, which can be misleading. Overall, 62% (119/193) of the articles gave no quantification of the benefits or harms. Thirty-seven (19%) of the 193 articles reported only surrogate benefits. Other information needed for informed drug-related decisions was often lacking: only 7 (4%) of the articles mentioned contraindications, 61 (32%) mentioned drug costs, 89 (46%) mentioned drug alternatives, and 30 (16%) mentioned nondrug treatment options (such as exercise or diet). Sixty-two percent (120/193) of the articles quoted at least one interviewee. After exclusion of industry and government spokespeople, for only 3% (5/164) of interviewees was there any mention of potential financial conflicts of interest. Twenty-six percent (15/57) of the articles discussing a study included information on study funding.
Our results raise concerns about the completeness and quality of media reporting about new medications.
Notes
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Literature from the US has shown that brand-name manufacturers do not compete on price once generic competitors become available. This study was undertaken to investigate if this is also true in Canada.
Editions of the Ontario Drug Benefit Formulary were used to identify brand-name drugs that lacked generic competition in July 1990 but had acquired one or more generic competitors by December 1998. Prices of the brand-name drugs were compared before generic competition, at the point when generic competition started and subsequent to the initiation of competition.
Price changes for 81 different products in 144 separate presentations were analysed. There was no statistically significant change in brand-name prices when generic competition started. The movement of brand-name prices was not influenced by whether the generic was made by the company producing the brand-name product or price freezes imposed by the Ontario government. When generics first became available having four or more generics was associated with a rise in the price of the brand-name drugs compared to having one, two or three generic competitor(s).
The lack of price competition may lead to increased costs in the private market. Private insurance companies generally do not require generic substitution and some provinces do not require generic substitution for cash-paying customers. Maintaining higher prices on brand-name drugs impacts on the prices of new patented medications coming onto the Canadian market under the current pricing guidelines of the Patented Medicine Prices Review Board.
To determine the consequences of restrictive formularies in the ambulatory care setting in 4 areas: overall drug expenditures, overall healthcare spending, changes in the quality of prescribing, and health outcomes.
A MEDLINE search was conducted for English and French language articles, published between 1977-1999, that presented results in quantitative terms. Only articles from industrialized countries were used.
Information was extracted from each article in the following areas: time period of the study, geographic location and group of patients involved, outcome measurement(s), intervention, study design, and results.
Poor methodologic quality made definitive conclusions difficult to draw in most areas. Prior authorization may be effective in controlling drug costs without increasing costs in other areas. Both desirable and undesirable therapeutic substitutions may take place when drugs are delisted from formularies.
The use of restrictive formularies in the ambulatory care setting requires more rigorous research. Before changes are made in formularies, money needs to be set aside for research into short-term and long-term consequences of using restrictive formularies.
Centre for Health Services and Policy Research, and the Department of Pharmacology and Therapeutics, University of British Columbia, Vancouver, BC. bmintzes@chspr.ubc.ca
Direct-to-consumer advertising (DTCA) of prescription drugs has increased rapidly in the United States during the last decade, yet little is known about its effects on prescribing decisions in primary care. We compared prescribing decisions in a US setting with legal DTCA and a Canadian setting where DTCA of prescription drugs is illegal, but some cross-border exposure occurs.
We recruited primary care physicians working in Sacramento, California, and Vancouver, British Columbia, and their group practice partners to participate in the study. On pre- selected days, patients aged 18 years or more completed a questionnaire before seeing their physician. We asked these patients' physicians to complete a brief questionnaire immediately following the selected patient visit. By pairing individual patient and physician responses, we determined how many patients had been exposed to some form of DTCA, the frequency of patients' requests for prescriptions for advertised medicines and the frequency of prescriptions that were stimulated by the patients' requests. We measured physicians' confidence in treatment choice for each new prescription by asking them whether they would prescribe this drug to a patient with the same condition.
Seventy-eight physicians (Sacramento n = 38, Vancouver n = 40) and 1431 adult patients (Sacramento n = 683, Vancouver n = 748), or 61% of patients who consulted participating physicians on pre-set days, participated in the survey. Exposure to DTCA was higher in Sacramento, although 87.4% of Vancouver patients had seen prescription drug advertisements. Of the Sacramento patients, 7.2% requested advertised drugs as opposed to 3.3% in Vancouver (odds ratio [OR] 2.2, 95% confidence interval [CI] 1.2-4.1). Patients with higher self- reported exposure to advertising, conditions that were potentially treatable by advertised drugs, and/or greater reliance on advertising requested more advertised medicines. Physicians fulfilled most requests for DTCA drugs (for 72% of patients in Vancouver and 78% in Sacramento); this difference was not statistically significant. Patients who requested DTCA drugs were much more likely to receive 1 or more new prescriptions (for requested drugs or alternatives) than those who did not request DTCA drugs (OR 16.9, 95% CI 7.5-38.2). Physicians judged 50.0% of new prescriptions for requested DTCA drugs to be only "possible" or "unlikely" choices for other similar patients, as compared with 12.4% of new prescriptions not requested by patients (p
