In the beginning, randomized clinical trials were designed to move the observations made at the bench and from small clinical studies to the community at large.
One example of this transition was the Beta-Blocker Heart Attack Trial, which evolved from positive observations in small clinical studies of 100 patients or less. Because of intense skepticism, recruitment was difficult since many felt that β-blockers were dangerous. The positive benefit reported in 1982 was a surprise to everyone, including the investigators. Even though the results were replicated by at least two other RCTs, the incorporation of β-blocker therapy in post-MI patients took more than a decade to gain traction in contemporary therapy. It was difficult to get the ear of the practicing physician, but no one ever thought that one day physicians would be forced, much less given a bonus, to prescribe β-blockers after an MI.
Concern about the inconsistency of the application of beneficial therapy and in the desire to insure that every American was appropriately treated, guidelines based on RCTs were created to help physicians make the best therapeutic choices. Largely as a result of ACC/AHA guideline, β-blockers became accepted therapy following an acute myocardial infarction. From an average use of 30% in the 1990s, utilization rates began to climb 65% by the beginning of this century. Physician education was the mechanism by which this advance occurred. β-Blocker utilization became an important quality measure advanced by a variety of private and federal insurers. Now utilization rates approach 80%–85% of patients discharged after an MI, and the percent of patients receiving β-blocker therapy became part of the well-publicized quality standards that measure the performance of hospitals and clinics nationwide.
RCTs became the foundation of what is now called evidence-based medicine. We are bombarded by RCTs supporting the use of a plethora of drugs and devices that improve the lives of cardiac patients. It no longer takes a decade to incorporate these therapies into clinical practice; they are now certified within months. Guidelines committees that at one time met every 2–3 years are now in almost continuous session.
Now in the interest of uniformity, education is no longer regarded as sufficient to influence physicians, but economic incentives are proposed to prevent variation, the enemy of the “quality gurus,” in order to ensure uniformity. Physicians and their representatives are now considering accepting payment incentives in order to achieve uniformity and expedite adherence to evidence-based medicine. Variation in the application of these guidelines will lead to financial penalties.
Much of this is motivated by the idea that by achieving uniformity of care, health care costs will decrease at a time when almost 45 million Americans do not have health insurance to pay for it. In an era in which postgraduate medical education is funded largely by the pharmaceutical industry, education is no longer important. Financial incentives are the only answer to compliance. Something just doesn't sound right. Is it really no longer possible to educate physicians about how to treat their patients?