Artificial-Blood Study Has Critics Seeing Red

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By LILA GUTERMAN

In a dozen or so scientific studies, people have been serving as medical guinea pigs unwittingly, without giving their consent to participate. Most of those cases have provoked little public outrage. But one study of a blood substitute has raised the ire of politicians and health specialists alike.

In March the chairman of the U.S. Senate Committee on Finance rebuked the Food and Drug Administration for approving the study.

"I am personally troubled," wrote Charles E. Grassley, Republican of Iowa, "that, for all intents and purposes, the FDA allowed a clinical trial to proceed, which makes the inhabitants of 32 communities in 18 states ... potential 'guinea pigs,' without their consent."

Senator Grassley did not object to the FDA's rules that allow some studies to go forward without informed consent, to test treatments for some narrowly defined life-threatening situations. Instead, he picked up on a controversy that has simmered in the research community since the study in question began, in 2003.

The study, which looks at whether the blood substitute, called PolyHeme, can help patients who have suffered massive blood loss, has two parts. In the first, patients are randomly chosen to receive either PolyHeme or saline, the standard blood-loss treatment patients receive in ambulances. Many researchers have objected to the second part: Once the patients reach the hospital, those who received PolyHeme continue to get the artificial substance instead of blood for 12 hours.

The problem, critics say, is that FDA rules allow research without consent only when there is no effective therapy. Ambulances don't carry blood, and saline cannot carry oxygen to the brain and other parts of the body. So most agree that PolyHeme is a viable alternative in an ambulance. But the situation changes when the patient enters the ER.

Nancy M.P. King, a professor of social medicine at the University of North Carolina at Chapel Hill, and two colleagues argued in the May-June issue of The American Journal of Bioethics that the study was unethical and that once patients arrive at the hospital, they should receive blood — or be asked to consent to an in-hospital study of PolyHeme.

University Panel Said No

Leonard H. Glantz, associate dean for academic affairs and professor of health law, bioethics, and human rights at Boston University School of Public Health, agrees. He was chair of an institutional review board that rejected the proposal by BU scientists to participate in the PolyHeme trial. "The thought that blood doesn't save lives is a laugh riot," he says.

But 32 other review boards, or IRB's, accepted the proposal, as did the FDA. The Chronicle's requests for comment were met with silence from an FDA official and from researchers conducting the study at a half-dozen universities performing the clinical trial. Researchers, Ms. King says, all signed confidentiality agreements with the sponsoring company.

Susan S. Ellenberg, a professor of biostatistics and associate dean for clinical research at the University of Pennsylvania School of Medicine, worked at the FDA when it accepted the study. "This was one that FDA struggled with and ultimately decided that there was enough of a rationale for doing this that it made sense to see whether IRBs were comfortable," she says.

Attempts to reach the company sponsoring the trial, Northfield Laboratories, were unsuccessful. In news releases, the company said it had "adhered scrupulously" to FDA rules, and it added that blood can cause some problems that PolyHeme may not.

The company also said that the safety of the trial was not in question, since an independent monitoring committee had analyzed the data four times, most recently last November, after the first 500 patients had entered the trial. It did not recommend stopping the trial, which will continue until 720 patients have enrolled.

Mr. Glantz doesn't buy it. "I can't think of any circumstance in which a known beneficial treatment has been withheld from a dying person," he says. "This is a real scandal, I think. This is not going away."