Post-Modern Drug Evaluation: The Deconstruction of Evidence-Based Regulation.

Traditionally in medicine, nearly all prescribing decisions were made by the treating physician. The patient had relatively little input and hardly any access to alternative sources of information bearing on that decision; the cost of the prescription was covered by the patient or by an insurer, and neither was likely to provide any feedback to the physician to shape his or her decision. Now, all that has changed. Beginning with the consumerist movement of recent decades and culminating in the explosion of health-related information on the Internet, patients are increasingly vocal participants in the prescribing decision, on both clinical and economic grounds. Payers have become participants as well, and increasingly seek to influence prescribing decisions in the light of their own economic imperatives. Added to all these cross-currents is an additional wild card: the proliferation of ‘alternative medicines,’ ‘nutraceuticals’ and other nostrums that society has placed beyond the reach of the evidence-based discourse and regulations that govern conventional drug therapy. In a country where patients struggle to cover the cost of prescription therapies proven both safe and effective in rigorous clinical trials, billions of dollars per year are spent on alternative treatments in the US, unencumbered by concerns about whether they actually work or that they might be toxic. While these patterns of communication, education, disinformation and economic influence are much more chaotic than those that prevailed in the ‘good old days,’ this very ferment may also present opportunities for improvement of rational pharmacotherapy and public health. This paper briefly outlines the above changes in patterns of communication and influence as they relate to medication use in today's industrialised world (particularly the US), and suggests both hopeful and terrifying scenarios describing where these trends might lead in the coming decade. [ABSTRACT FROM AUTHOR]