Patient's survivors sue The Hutch
Seattle Times staff reporters
The husband of a breast-cancer patient who died as a result of a clinical trial is suing the Fred Hutchinson Cancer Research Center, its former director and three of its doctors, alleging they misled his wife about drugs they were testing.
The patient, Kathryn Hamilton, was featured in a recent Seattle Times investigative series on human experiments at "The Hutch."
Hamilton, a hospital administrator from Spokane, died in February 1993 from the toxic effects of high-dose chemotherapy. She had agreed to experimental treatment, taking drugs that were supposed to protect her body against the ravages of those chemicals.
But in the lawsuit filed yesterday in federal court in Seattle, Hamilton's family alleges that her decision to enroll in the clinical trial was based on incomplete and false information. Specifically, the suit alleges, the doctors knew or should have known that drugs used in the trial would not work.
Named as defendants in the lawsuit were Dr. Robert Day, the former director of The Hutch; Dr. William Bensinger, who was in charge of the experiment; Dr. C. Dean Buckner, Hamilton's doctor; and Dr. Frederick Appelbaum, whose job was to inform Hamilton about the risks of the experiment.
Hutchinson Center officials said late yesterday that they had not seen the lawsuit and could not comment on it.
Hamilton's husband, Allan Berman of Spokane, said he decided to file the lawsuit after reading the story about his wife's experiment. He said he was previously unaware there were questions about the drugs being tested.
Hamilton's son, Chris Addicott, is a Seattle attorney who went public with his mother's story.
"I didn't file a lawsuit because I knew that it wouldn't bring her back," he said yesterday. "But having watched The Hutch continue to deny any wrongdoing in the face of overwhelming evidence that it misled and kept critical information from my mother, I am fully supportive of the lawsuit filed by my stepfather on her behalf. Perhaps it will force The Hutch to account for and acknowledge the gravity of its actions."
Hamilton was 48 when doctors detected breast cancer for the third time in 13 years. She was told she would live only another year or two with conventional chemotherapy.
She chose instead to enroll in the clinical trial - and died 44 days after beginning the treatment.
In an earlier experiment with the same chemotherapy drugs, two of the first four patients had died from the effects of the chemotherapy. In Hamilton's trial, doctors were testing experimental drugs to try to counter those deadly side effects.
In the informed-consent papers given to Hamilton, she was told that one drug, pentoxifylline (PTX), was found to be effective at making high-dose chemotherapy safer. However, the lawsuit alleges that doctors knew about more recent experiments - including one on which they were about to publish a medical-journal article - that showed PTX was a failure.
In Hamilton's experiment, doctors mixed PTX with another drug in hopes that the combination would be effective even though PTX alone wasn't. The suit alleges the doctors should have known the drug combination also wouldn't work.
A doctor who had left The Hutch to develop the drug combination commercially had himself already abandoned the drugs. That doctor was James Bianco, who founded Cell Therapeutics.
The Hutch owned stock in Cell Therapeutics and had a licensing agreement with the company. Buckner, Hamilton's doctor, and E. Donnall Thomas, a Nobel Prize laureate at the Hutch, were both on the company's scientific advisory board and had stock options in the company.
The suit also alleges that doctors failed to give Hamilton an intravenous form of PTX even though her informed-consent papers said an IV form was available. Hamilton had repeatedly had trouble keeping down orally administered drugs, and her son said family members would never have agreed to the experiment had they known an IV form was unavailable.
Since The Times series was published in March, The Hutch has admitted that this was a mistake on their part. They had lost the Food and Drug Administration approval to use the IV form and hadn't told Hamilton.
The suit accuses The Hutch and its doctors of fraud, assault and battery, being responsible for product liability and violating consumer-protection laws. It also argues some novel legal theories, including the accusation that the experiment violated "the right to be treated with dignity" as stated in the Nuremberg Code of 1949 and the 1964 Declaration of Helsinki from the World Medical Association.
Three attorneys in the case, Alan Milstein of Pennsauken, N.J., and David Breskin and Thomas Dreiling of Seattle, are also representing other families in a separate class-action lawsuit drawn from the same Times series. Those families are survivors of some of the patients who died in another clinical trial.
In that trial, called Protocol 126, 80 of 82 participants died - at least 20 of them from causes directly attributable to the treatment. Many of those had a good likelihood of survival with conventional treatments.
That experiment used eight antibodies to kill white-blood T-cells in bone marrow donated by tissue-matched siblings. The researchers thought that eradicating the T-cells would eliminate a condition called graft-versus-host-disease, thus making transplants more successful. In fact, though, with the T-cell eradication, the rate of rejection of donated marrow and of relapse of cancer increased dramatically.
The Hutch and some of the doctors involved in Protocol 126 had financial interests in some of the antibodies used in that clinical trial.