- © 2004 Canadian Medical Association or its licensors
Undisclosed results from clinical trials
Although the goal of evidence-based medicine is to provide physicians with an objective basis for clinical decision-making, this goal can be thwarted when evidence is suppressed. The evidence available to clinicians in published reports does not always provide an accurate profile of a drug's efficacy and safety. In a commentary, Garland decries the suppression of data from trials of selective serotonin reuptake inhibitors (SSRIs) in the treatment of childhood and adolescent depression. Negative results from SSRI trials go unpublished, while the published evidence to support their use in young people is flimsy at best. In a related commentary, Herxheimer and Mintzes point to flawed trial design, secrecy in the approvals process and inadequate systems for adverse drug reporting as the mechanisms by which ineffective and unsafe drugs secure a place in the market.
Pro-industry findings in randomized trials
The influence of industry funding on clinical trials remains a concern. Bhandari and colleagues provide evidence that this influence is not limited to trials of medical treatments but extends to trials of new surgical interventions. In a related commentary, Hirsch, a vice-president at Merck Research Laboratories, argues that pharmaceutical companies can undertake only a finite number of trials, and consequently those considered more likely to yield positive results are given higher priority. He also points out an existing bias toward the publication of positive results, regardless of the trial's source of funding.
Guinea worm disease
As part of our commitment to report on global health, we publish a review by Greenaway on the clinical aspects of dracunculiasis (guinea worm disease), endemic to 13 sub-Saharan countries. Although the disease has a low rate of mortality, the morbidity is high and its economic impact can be devastating for affected villages. The author also describes the Global Dracunculiasis Eradication Campaign and its successes to date in eradicating this disease.
See page 495
Treating urinary tract infections in older women
Urinary tract infections (UTIs) and related sepsis are common in older women. Although evidence supports short-course antibiotic therapy (e.g., 1–3 days) to treat UTIs in young women, this approach has not been well studied in older women. In a randomized controlled trial Vogel and colleagues compared a 3-day course with a 7-day course of ciprofloxacin for uncomplicated UTI in women 65 years of age and older. They found that, although both the short and the long courses had similar clinical and microbiologic outcomes, the short course was associated with fewer adverse events.
See page 469