Patients in Cancer Trial Sue Tulsa Researcher, IRB


NEW YORK (Reuters Health) Jan 31 - Patients who participated in a melanoma vaccine clinical trial are suing the project's principal investigator, the members of the research center's institutional review board (IRB), and the company that supplied the drug used in the vaccine for fraud and failure to protect them.

The 7-count complaint, filed on Monday in US District Court in Tulsa, Oklahoma, is believed to be the first such lawsuit to hold individual members of an IRB accountable for their alleged actions. Cancer patients and their families contend that researchers at the University of Oklahoma Health Sciences Center at Tulsa failed to properly notify patients of the risks involved in the study and to follow trial procedures. They also contend that the defendants intentionally defrauded the US Food and Drug Administration (FDA) to obtain approval to conduct the trial.

The suit also names Immunex Corporation as a defendant, saying that it supplied the vaccine and continued to co-sponsor the trial although "no studies of any kind" supported the vaccine in humans. Immunex spokeswoman Kris Greco said that the company had yet to review the allegations in the lawsuit. The Seattle, Washington-based company did provide the granulocyte macrophage-colony stimulating factor used in the trial, she confirmed.

University officials terminated the trial in March based on findings of an audit by a contract research organization.

"I think one of the significant aspects of this case is that the IRB members are individually sued and this is a case in which the FDA and governing agencies made specific complaints against the IRB," said Alan C. Milstein, the plaintiffs' attorney.

In a letter last June, the federal Office for Human Research Protections (OHRP) ordered the university to stop all government-supported clinical research involving human subjects because of serious breaches of patient safety (see Reuters Health report, July 11, 2000).

The university subsequently disbanded its IRB and removed as chairman Dr. Daniel C. Plunket, a defendant in the suit.

OHRP's letter to university officials also faulted Dr. Michael McGee, the project's principal investigator and a defendant in the suit, for making substantial changes to the project without IRB approval. "The IRBs have got to realize that they have a lot of work to do and they've got to do it diligently," Milstein told Reuters Health. "Someone's got to be out there protecting these vulnerable patients to make sure they don't get sucked into a clinical trial that isn't based on sound [science] and is in accordance with federal regulations," he continued. Lynn Mattson, who is representing Dr. McGee on administrative claims against the university over tenure issues, contends that the lawsuit is based largely on allegations made by a former university employee. Mattson said that he has "no reason to disbelieve" the testimony of scientists who made and tested the vaccine and who vouch for its safety. "Nobody ever came to Dr. McGee or any of the people that were either asked to resign or let go and specifically acquainted them with the supposed allegations of wrongdoing," Mattson said.

Milstein also represented the family of Jesse Gelsinger, whose death in 1999 following an experimental gene therapy treatment at the University of Pennsylvania sparked a federal crackdown against patient safety violations in clinical trials.

Gelsinger's parents filed a wrongful death suit against the University in September of that year. Penn officials settled the suit for an undisclosed amount. Milstein now commends University officials in that case for acting very quickly to resolve the situation and remedy the problems that gave rise to the law