Outrage: Possible Corruption at the American Heart Association

As clinical medicine has become increasingly complex, doctors ( and patients) have come to rely more and more on clinical guidelines developed by blue-ribbon panels of experts convened by the National Institutes of Health, the World Health Organization and other respected bodies. A parallel trend has been the increasing funding of biomedical research by private industry, accompanied by sporadic howls of protest as evidence piles up of drug company suppression of research results unfavorable to their products, legal threats against those guilty of simply wishing to publish their findings, creation of fake patient groups (see the November 2000 issue of the Health Letter), and ghost-writing of medical journal articles.

The two trends have now come together in the form of drug industry attempts to manipulate clinical practice guidelines. In an article in the March 23, 2002 issue of the British Medical Journal, journalist Jeanne Lenzer lays bare the evidence that the biotech firm Genentech inordinately skewed the American Heart Assoc-iationÕs (AHAÕs) guidelines on the use of Òclot-bustersÓ like GenentechÕs tPA (also known as alteplase or Activase), the only Food and Drug Administration-approved treatment for acute stroke.

       Until August 2000, the AHA maintained that the use of tPA for the most common kind of stroke was optional. However, following the publication of a National Institute for Neurological Diseases and Stroke (NINDS) trial, the AHA switched from ÒoptionalÓ to Òdefinitely recommended.Ó In that study, stroke patients receiving tPA were 1.7 to 2.1 times more likely than patients receiving an inactive placebo to have a favorable clinical outcome after three months.

       For a number of justifiable reasons, the NINDS study has not met with universal acceptance: the

placebo and treatment arms were different in critical respects at baseline and the results have not been

replicated, a practice that is generally