Class Action Suit Against Fred Hutchinson Cancer Center Sends Shock Waves Through Clinical Trials Community

An earthquake hit Seattle last month.

At the epicenter were the director of the Fred Hutchinson Research Center and several investigators who conducted cancer trials between 1981 and 1993.

The first shock wave to strike the clinical trial community was a series of reports in The Seattle Times. The newspaper alleged that patients were not given important information about risks and alternatives before consenting to participate in the cancer trials and that investigators had significant financial conflicts of interest that were not disclosed to patients. The headline for the series was explosive: "Uninformed Consent: What Patients at 'The Hutch' Weren't Told about the Experiments in Which They Died."

The aftershock was felt a few days later: Trial subjects and their relatives filed a class action lawsuit against the center, naming the co-founder, president, three investigators and study sponsor as defendants. The suit cites seven causes of action against the defendants, including breach of the right to dignity, fraud, assault and battery, product liability and violations of federal laws governing research and consumer rights.

The potential impact of the lawsuit against clinical research professionals cannot be overstated, says Alan Milstein, an attorney with Sherman, Silverstein, Kohl, Rose & Podolsky, in Pennsauken, NJ. Milstein filed the action in collaboration with the Seattle law firm of Short Cressman & Burgess and a Seattle attorney, Thomas R. Dreiling.

Milstein is familiar with clinical trials lawsuits. He's the attorney who handled the Jesse Gelsinger case against the University of Pennsylvania last year and who filed suit against the University of Oklahoma in early February. (CTA, Feb. 8, 2001.)

The stakes in the litigation are high for several reasons:

• The suit alleges serious violations of ethical rules that govern the conduct of research.
• One of the investigators is a Nobel Prize winner.
• The cancer center is the top bone marrow transplant center in the world and receives more funding from NIH/NCI than any other research institution in the country - about $140 million a year.

The lawsuit specifically alleges that, during blood cancer trials (and others involving breast cancer), in which 20 subjects died, investigators:

• Failed to inform subjects of the risks associated with participation;
• Failed to detail alternative treatments;
• Failed to abide by IRB recommendations;
• Intimidated IRB members;
• Did not follow their own internal conflict of interest policy, and instead, made millions of dollars on the study drugs.
• Did not follow their own internal conflict of interest policy, and instead, made millions of dollars on the study drugs.

The goal of the blood cancer study, called Protocol 126, was to determine whether removing or destroying T-cells would prevent graft-versus-host disease in bone marrow transplant patients.

Investigators and the Cancer Foundation were given shares of stock in the sponsor company at the beginning of the trial and investigators received a consulting fee, according to the lawsuit. The institution also signed a 20-year contract for the commercial rights to study drugs owned by the sponsor, the lawsuit claims.

There were 82 patients enrolled in Protocol 126; 80 of them are dead, with 20 deaths attributable to the treatment they received as part of the study.

Center officials have denied any wrongdoing, issuing this statement: "We at the Hutchinson Center believe our system for informing patients of the risks and anticipated benefits associated with their treatment is among the best in the country."

At the same time, however, the center announced that it is attempting to restore public confidence in its research efforts by:

• Appointing a committee comprised of community leaders, former patients and family members, to review human subjects protection;
• Inviting a national expert on informed consent to audit site practices;
• Inviting an independent national authority on protocol safety and data monitoring to audit practices and suggest improvements; and
• Reviewing conflict of interest policies and financial disclosure policies of other research centers.

Key points of contention in the lawsuit: whether the risks in the study treatment were known at the time and whether participants were appropriately informed of the risks. The lawsuit alleges that investigators did not disclose that the treatment might damage cells necessary for engraftment. The consent form was changed during the course of the trial with IRB approval, the suit notes. At first, the form stated: "To the best of our knowledge, treatment . . . does not damage the cells necessary for engraftment, but it is possible that engraftment will not occur." A later version stated: "Treatment may damage cells and failure . . . has occurred following such treatment." The consent from also stated that, if graft failure should occur, "a second bone marrow transplant would be necessary." The suit alleges that participants were not told that second transplants almost always failed.

In response to these allegations regarding informed consent, the Hutchinson Center said: "Failure to graft was not expected as an outcome at the beginning of the trial . . . Eight different trials were carried out - each with strong scientific rationale and with IRB approval." The center also asserts that "there was only limited data at that time about the effectiveness of second transplants." The site contends that subjects were not informed of these risks because they were unknown at the time of enrollment.

As for the charges of conflict of interest, the center says that a separate company owned the patent for the drugs in Protocol 126 and, therefore, the gains made by the investigators and the foundation did not flow from the trials themselves.