Cancer Center Sued on Clinical Trial

The Associated Press

Tuesday, March 27, 2001; 6:12 PM

SEATTLE -- A leading cancer institute has been accused of violating medical standards on ethics and human research while conducting a blood cancer experiment.

A lawsuit was filed Monday on behalf of the families of the 82 patients who participated in Protocol 126 at the Fred Hutchinson Cancer Research Center.

If certified as a class action, the case would represent the broadest damage suit to date stemming from clinical trials, according to Alan Milstein, the plaintiffs' chief attorney.

Center officials declined comment Tuesday, saying the facility does not comment on lawsuits.

The lead plaintiff is William Wright Sr., of Heflin, Ala., whose wife Becky died of leukemia after participating in Protocol 126, which was conducted from 1981 to 1993.

The goal was to eliminate graft-versus-host-disease, in which the new blood begins to attack the body. Instead, there was a dramatic increase in rejection of donated marrow and cancer relapse. Eighty of the 82 participants have since died.

In a recent five-part series, The Seattle Times maintained at least 20 of them died of graft failures associated with the experiment.

The lawsuit, which draws from material in the Times' series, alleges that researchers continued the trials even when it became evident the treatment wasn't working. Patients were not alerted to a safer alternative, neither were they told about financial incentives to the center and staff involved with the test, the lawsuit said.

Individual defendants include Drs. E. Donnall Thomas, a 1990 Nobel laureate and former clinical division chief; Robert Day, former center president; and John Hansen and Paul Martin, who were principal investigators in the trials.

Also named as defendants are Genetic Systems, a biotechnology company that bought exclusive licensing rights to three of the eight drugs in an "antibody cocktail" tested in Protocol 126, and its successor corporation.

The company also gave stock and positions to Hansen, Martin and Thomas, the lawsuit said.

"Hopefully the result of this lawsuit ... will be a change in the way clinical trials are conducted in this country and a refocus on the health and protection of the patients," Milstein said Tuesday.

The Seattle-based center has the world's leading bone-marrow transplant program and is the No. 1 recipient of research funds from the National Cancer Institute.

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(c) 2001 The Associated Press