(9 of 9)
Insisting that patients be given the unvarnished truth about clinical trials might scare many away. But that doesn't bother Alan Milstein, an attorney who has represented Jesse Gelsinger's family, as well as many of the participants in McGee's study. "The biggest myth out there," Milstein says, "is that every one of these studies is essential to the advancement of medicine. That's just nonsense. Most have to do with the advancement of the researcher himself." If it were just a lawyer talking, that sentiment might be easy to dismiss. But Marcia Angell expresses a similar criticism: "We have floods of me-too drugs," she complains. "So much research is trivial duplication."
But no matter what regulations, what standardized forms, what oversight committees the government and institutions end up putting in place, in the end, it's still up to the researcher to treat his subjects with dignity and care. In fact, argues University of Virginia bioethicist Jonathan Moreno, there's a downside to stronger protectionism: "When you take away the discretion of scientists, it's possible they'll shrug their shoulders and say, 'Protecting subjects isn't my job. Someone else will have to take care of it.' And if we don't have a morally responsible community of investigators, then nothing we do will make a difference."
That said, everyone involved in an experiment has the duty to put the subjects' interests first. Says Duke's Sugarman: "The moral responsibility for the protection of patients lies with the investigator, the sponsors, the people who carry out the research: nurses, assistants, technicians, research pharmacists. You can't just say, 'The IRB said it was O.K.'"
Luckily for many of the patients in Dr. Michael McGee's vaccine trial, Cherlynn Mathias already had that attitude--though she has paid a price for her action. Facing nasty criticism from many of her colleagues at the University of Oklahoma and worried she would not be able to get decent medical treatment in Tulsa, she finally moved to Texas last August. Sometimes she wonders whether she did the right thing by sending that letter to the OHRP, but she is proud of the way the university responded.
She doesn't say the same for her former boss, though. "What hurt me so much was that McGee allowed some of the patients to believe that the only reason they were dying was that they had been forced to stop taking his drug. Many of them died," she says, "believing I was responsible for their deaths." The truth is that she was responsible only for shattering their illusions. --With reporting by Alice Park/Baltimore