Traumas Create Unwitting Test Subjects

As Hilary Williams hung from her seat belt in the overturned wreckage of her truck -- legs broken, colon ruptured and lung bruised -- blood oozed from torn arteries and veins.

Hilary, 27, and her sister, Holly, 25, who was injured less severely in the crash, waited half an hour for medical help to arrive. By the time an air ambulance reached them at the crash site, about 45 miles south of Memphis, it was midday onMarch 15. Hilary's face was pale, her lips were blue, her faint pulse was fast, and her blood pressure was 55/0. She was in shock.

Because she was close to death, she instantly became eligible for enrollment in a controversial clinical trial. But because she was in no shape to consider the risks, the flight nurses did not have to obtain her consent before giving her an experimental blood substitute.

Within moments, fluid the color of merlot was dripping into her veins. Hilary, a singer/songwriter and the daughter of country singer Hank Williams Jr., became one of thousands of people across the nation who, while fighting for their lives over the past 10 years, unknowingly became test subjects in medical trials.

With waived-consent studies becoming more prevalent, critics question whether the public understands how they work and whether test subjects get adequate protection.

Although the study that included Hilary Williams has brought criticism, she believes the infusion of blood substitute helped save her. "I thought I was going blind," she says as she recovers in Nashville. "Everything was dark. My eyes were open but I couldn't see anything. I felt at peace. I kept wanting to fall asleep, but a truck driver who stopped kept telling me to wake up and to hang on."

But another trial, which is reported in today's Journal of the American Medical Association (JAMA), was halted because a device called the AutoPulse, which was used to revive cardiac-arrest victims, failed to save more lives than when rescuers performed cardiopulmonary resuscitation.

According to the study, as many as 10 people in one city may not have been revived because of their participation. The JAMA study does not identify the city. But doctors have identified the site as Seattle -- which has one of the highest resuscitation rates in the nation -- in discussions at medical meetings since the AutoPulse trial was halted in March 2005.

Patients in these types of studies -- often financed by manufacturers of the tested product -- are treated under a broad federal rule that allows researchers to test emergency treatments on patients with specific, life-threatening medical conditions without their explicit consent as long as they remain under close watch of independent reviewers.

Federal officials and medical researchers say there is no substitute for this testing of emergency treatments for the leading causes of death: trauma and cardiac arrest, which claim hundreds of thousands of lives in the USA each year. To the researchers, studies with negative findings are as important as successful trials in their search for the best treatments.

Studies have included large, multi-city, randomized trials, which scientists consider the gold standard for medical research. One study that ended in October 2003 compared ways to revive patients in cardiac arrest and taught doctors and city leaders how to deploy automated external defibrillators.

Federal officials say such research is key because emergency treatments are largely untested. "Many of the treatments that are currently used in life-threatening circumstances have not been formally studied," says Sara Goldkind, a Food and Drug Administration (FDA) bioethicist. "They have not come to be standard-of-care based upon rigorous scientific data."