Healthy Skepticism Library item: 13014

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Greenland P, Lloyd-jones D.
Critical Lessons From the ENHANCE Trial
JAMA 2008 Feb 27; 299:(8):953-5
http://jama.ama-assn.org/cgi/content/extract/299/8/953

Abstract:

The unusual release on January 14, 2008, in the news media and on a drug company Web site,1 of a
portion of the Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE) trial data resulted in numerous articles and commentaries in the lay media. The availability of only fragmentary information created massive confusion and raised many more questions than answers for patients, physicians, pharmaceutical companies, and regulators. A full report of the ENHANCE trial in a peerreviewed medical journal is not expected for months, and
the first public presentation of the study’s findings in a medical setting will not occur before late March 2008.

The purpose of this Commentary is to review key features of the ENHANCE study and to point to lessons that should be learned by drug companies, clinical researchers, clinicians, and health agencies…

Background on the ENHANCE Trial

Lesson 1: Drug Trials Should Not Be Done for Marketing Purposes Only

Lesson 2: The News Media Must Be Sure to Get the Facts Straight. Errors in Reporting Can Cause Serious Damage, and Patients May Be Harmed or Become Distressed From the Resulting Confusion

Lesson 3: Leading Scientific, Patient-Oriented, and Disease-Oriented Organizations Must Scrupulously Avoid Conflict of Interest