Residents Need Training to Assess Drug Company Influence

Recently actor Tom Cruise's opposition to pharmacotherapy for mental illness received attention in the media. Although the majority of the public likely disagrees with this extreme viewpoint, there has been some concern about the safety of various medications, such as the SSRIs in children and atypical antipsychotics. Thus, public education about their appropriate use in psychiatry is imperative, so those with mental disorders do not forego a potentially important aspect of treatment.

With increasing medication options available (CNS drugs now account for the largest category of U.S. pharmaceutical sales), it is sometimes a challenge to stay abreast of their best applications. At a time when the number of pharmaceutical sales visits and industry sponsorship of educational programs are high, maintaining a rigorous critical mindset about presented drug-related information has become increasingly important for physicians.

Research indicates that heavily promoted agents are often selectively prescribed, despite an absence of scientific evidence for greater efficacy or a more favorable side-effect profile. Industry promotion has also been associated with higher prescribing costs and decreased use of generic medication, which can be as effective as their brand-name counterparts.

Some residency programs restrict pharmaceutical drug representatives from interacting with trainees to avoid biased prescription practices. Most physicians would likely agree that if resident contact with representatives occurs, there should be balance among the different companies. Opinions vary, however, about the extent of restriction that is ideal for those in training. Residents restricted by policy from seeing sales representatives do not appear to see them any less when they later enter practice, but the extent of their skepticism may differ.

Medication marketing to physicians is likely to remain a fixture in office practice, so learning to scrutinize the presented information appropriately and resist gratuitous prescribing is essential. Some physicians believe that it is better to let residents meet drug representatives while they are under supervision and critical thinking can be taught. Although residency programs may not be able to match industry marketing resources, faculty can provide balance, criticisms, and structured interactions, which should lessen abuse potential.

Residency programs could benefit from innovative curricula addressing issues regarding the pharmaceutical industry. These would include guidance on appropriate conduct with drug representatives and regular group evaluations of the distributed literature and brochures. Courses should also include information on the drug-development process, including clinical trials and the role of the Food and Drug Administration (FDA), drug pricing, and the impact of marketing on prescribing practices.

To benefit fully from the literature on drug trials, physicians need to develop skills that allow them to evaluate published studies in terms of design, validity, and applicability of conclusions. In residency, this would require training on how to assess a paper critically, including potential problems with demographics and sample size, type I or II error, statistical analysis issues, and placebo effect in clinical trials, for example.

Meta-analyses, used to assess data across multiple studies, can be helpful in evaluating the clinical effects of medications. However, they are often subject to publication biases toward favorable results and should therefore be evaluated cautiously. In comparison studies, ensuring that medications were administered in clinical doses and with similar adjunctive treatments can also help in validating the literature.

The FDA and drug makers are not required by law to make drug trials public. The Pharmaceutical Research and Manufacturers of America's Web site at<www.clinicalstudyresults.org> includes medication studies sponsored by its member pharmaceutical companies. However, this is a voluntary registry, and companies may decide not to publicize individual study results.

To avert this problem, APA and other medical organizations have advocated for a mandatory, centralized, drug-trial registry. The Fair Access to Clinical Trials (FACT) Act, introduced this year in Congress, would require registering all publicly and privately sponsored trials and results with a government database, which would be easily accessible through the Web site<www.ClinicalTrials.gov>.

Industry support of educational programs can be essential, particularly as funding from other private and government sources becomes increasingly uncertain. However, monitoring of content by CME providers and academic institutions should be relentless, with emphasis on accuracy and variation in treatment modalities covered.

There needs to be balance in sources presenting medication-related information. Multiple educational forums free of industry influence should be made available by academic institutions and professional organizations. A regularly updated Web site xdisplaying psychiatric medications with related information and references could help ensure that less publicized and generic medications are equally considered when deciding on treatment.

The pharmaceutical industry will continue to exert an influence on the medical community, and it is important to be able to adapt to the associated challenges. It is likely that those able to assess research evidence objectively will be in the best position to make use of all therapeutic options. ▪