Pharmaceuticals as a market for "lemons": Theory and practice.

Drawing on economic theory and institutional analysis, this paper reframes Akerlof's theory of how a market for lemons operates and argues that each of the many markets for lemons must be studied empirically to document how different stakeholders cope with the problems of information asymmetry, secrecy, and power. Such markets are a new field for sociological analysis. To illustrate, the paper characterizes pharmaceuticals as a multi-tier market of information asymmetry in which actors in each tier have substantial control over how much they disclose about hidden risks of harm. Such a market rewards the production and sale of "lemons." Current incentives and institutional practices reward developing a large number of barely therapeutically innovative drugs and ignoring their often hidden or understated harmful side effects. They reward designing and executing substandard, biased trials that mislead the FDA and regulators abroad to approve new drugs without clear evidence of their degree of harm. Approved drugs are likely to be "lemons" but promoted as "safe and effective." The result is substantial hospitalizations and deaths from adverse drug reactions. A "risk proliferation syndrome" of institutional practices maximizes sales, profits, and exposure to toxic side effects. An "inverse benefit law" of marketing operates as companies try to maximize sales. The probability of benefits decreases but the chances of lemons adverse events do not. The details presented here deepen understanding of how markets for lemons thrive on information asymmetry, secrecy, and power. Lessons can be applied to other markets.

The Need to Systematically Evaluate Clinical Practice Guidelines.

Clinical practice guidelines abound. The recommendations contained in these guidelines are used not only to make decisions about the care of individual patients but also as practice standards to rate physician "quality." Physicians' confidence in guidelines is based on the supposition that there is a rigorous, objective process for developing recommendations based on the best available evidence. Though voluntary standards for the development of guidelines exist, the process of guideline development is unregulated and the quality of many guidelines is low. In addition, the few tools available to assess the quality of guidelines are time consuming and designed for researchers, not clinicians. Few guidelines are evaluated, either before or after their dissemination, for their impact on patient outcomes. Just as with pharmaceuticals and other products that can affect patients for better or worse, perhaps it is time to develop more standardized ways to evaluate the development and dissemination of clinical practice guidelines to ensure a similar balance between risk and benefit.

Implications of pharmaceutical industry funding on clinical research.

This commentary explores the influence of industry funding and offers suggestions for overcoming some of the problems. First, it is difficult to obtain funding from some sources for research with limited commercial value. Second, lack of communication among researchers can impede scientific progress. Stopping research before meaningful results are available is another area of concern. Next, suppressed or delayed publication of data may bias the results of meta-analyses, resulting in incorrect risk-benefit profiles for drugs. Finally, commercially funded clinical research is more likely to yield positive results than when funding comes from other sources. Possible solutions are explored.