Middle Ground in VA Reform

Times reporter Terence Monmaney last week unveiled compelling evidence that Philip T. Sager, a cardiology researcher at the West Los Angeles Veterans Affairs Medical Center, performed risky experiments on at least four patients without first obtaining their written permission or informed consent. Noting Sager’s actions, as well as similar failures by other VA researchers, federal regulators rightly began overhauling the hospital’s management.

Unfortunately, they halted not just the suspect research but virtually all cell, animal and human experiments at the West Los Angeles VA as well as those at the loosely affiliated Sepulveda VA Medical Center in the San Fernando Valley. They did so while acknowledging they had no reason to suspect these researchers had done anything wrong.

Federal inspectors would do better to focus instead on errant researchers and on beefing up the hospital’s lax enforcement of the federal government’s so-called 14 principles of informed consent, at least some of which Sager seems to have violated.

Perhaps most important, Washington needs to recognize that informed consent procedures are often skirted at hospitals throughout the country. A 1997 federal report found informed consent “deficiencies” in 38% of the 194 American hospitals it studied. Washington also needs to explore underlying issues, like whether some human experiments should be banned even when a patient gives informed consent.

The West Los Angeles VA is one of several hospitals where patients with severe psychoses were taken off medications known to control their mental illnesses and put on placebos--dummy sugar pills--instead. Earlier this year, the National Bioethics Advisory Commission rightly questioned this practice and called on President Clinton to order the federal Institute of Medicine to review alternatives, such as testing newer psychiatric drugs against older psychiatric drugs, instead of against nothing.

Washington needs to recognize that it’s not likely to solve widespread medical ethics problems simply by indiscriminately banning research at a particular hospital. Federal officials should aim for something sharper: a reexamination of principles for safeguarding patients and of mechanisms for ensuring that those principles are put into practice.