Costly Lawsuits Dampen Outlook for Clinical Trials

By David Morgan

PHILADELPHIA (Reuters) Jul 01 - Human clinical trials, already under scrutiny by regulators and Congress after a spate of deaths, face a rising tide of liability lawsuits that could alter U.S. medical research, a Harvard study suggested on Monday (June 30).

Within the past three years, researchers say, legal claims including class-action suits have begun targeting universities and research institutions that recruit millions of people for clinical trials of new drugs and other medical treatments.

As a result, a team of legal experts at the Harvard School of Public Health said human-subject research costs are likely to rise as legal judgments increase, while trial methods could fall victim to tough regulation to minimize legal exposure.

"We fear that the combination of more bureaucratic regulatory oversight and significant exposure to litigation could lead to worse, not better, decision-making about the ethics of research studies," the Harvard team said in an article published in the Annals of Internal Medicine.

The National Institutes of Health say there are 6,300 clinical trials under way in the United States, involving more than 2 million people who must formally agree to participate in research overseen by institutional review boards.

The self-regulated system came into being decades ago in response to the Tuskegee syphilis experiments in which researchers withheld treatment from black participants.

Critics say the charging U.S. stock market of the 1990s helped inflame corporate demand for new drug products, leading medical researchers into potential conflicts of interest.

"There are 10 times the number of clinical trials going on today," said trial lawyer Alan Milstein, who specializes in clinical trial litigation and rejects suggestions that recent lawsuits could stifle research.

"There have been some widely publicized bad outcomes for trials at well-reputed institutions which have caught the public's attention," said Michelle Mello, assistant Harvard professor of health policy and law.

"With the growing participation of the pharmaceutical industry in trials, you have perhaps the greater perception that these are not doctors working to improve public health."

A spokesman for the U.S. pharmaceutical industry said drugmakers are victimized by a "bad perception," which he blamed on the distortions of critics.

Mello said shifting perceptions surrounding clinical trials had already raised legal risks for clinical studies.

Where lawsuits once focused on consent issues, legal claims now include fraud or even allege violations of international laws such as the Nuremberg code on human experimentation from the trials of Nazi war crimes.

Lawsuits also have come to name larger numbers of defendants, from drug company sponsors and top university officials to review board members and consulting bioethicists.