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Researchers Studied Hundreds of Pennsylvania ER Patients in Dozens of Trials

Hundreds of emergency patients across Western Pennsylvania became human guinea pigs in the past 16 years, enabling doctors to sharpen cardiac arrest, trauma and other crucial treatments in about a dozen clinical trials.

Most of those patients have no idea they are research targets until they awaken, if they regain consciousness at all, doctors said. Clinicians enrolled about 2,000 ailing subjects without receiving the patients' prior consent, a rare approach that medical scholars call a necessity of circumstance to strengthen emergency medicine and reduce fatalities.

Just this month, University of Pittsburgh and UPMC researchers announced they're looking for about 1,000 injured patients with uncontrolled bleeding for a three-year study on blood-clotting drugs.

Trials since 1998 saved an estimated 60 Western Pennsylvania patients who might have died under conventional practices, said Dr. Clifton W. Callaway, executive vice chairman for emergency medicine at Downtown-based UPMC. He said no one has died from the government-approved experiments handled by paramedics, UPMC, Allegheny Health Network, Excela Health and other health care agencies.

"We're never allowed to test something because it would be cheaper, easier or just as good" as a current procedure, said Callaway, a researcher in emergency medicine. "It has to be a better standard of care."

The Food and Drug Administration, which regulates many of the experiments, said it's fielded about 80 applications for similar trials nationwide in the past 18 years. The agency would not discuss specific studies and did not identify how many it approved, but said in a statement that the projects represent "a very small portion of the investigational new drug and device applications the FDA receives."

The unconventional research gained attention in April, when UPMC announced a study that will attempt to save critically wounded patients by suspending them near death in below-normal temperatures. Callaway said he wasn't aware of anyone who has been subjected to the space-age treatment.

"One could make the argument that the chance of survivability for these patients is not very great to start with and current options are not satisfactory," said Margaret R. McLean, the bioethics director at Santa Clara University in California.

She cast the trials as an ethical extension of accepted emergency practices, in which doctors don't need to ask for permission to save a life.

But George Annas, a bioethicist at Boston University, said the FDA needs to better shield individual rights and toughen community awareness expectations for researchers who use unsuspecting subjects. He suggested at least 50 percent of people in a target community should know about a study "” and have easier ways to opt out "” before research can begin.

"We don't draft people for research. We believe that people are sovereign in their own bodies, and no one should intrude or use their bodies for any purposes except with their consent," said Annas, who leads the BU department of health law, bioethics and human rights.

The government established rules in 1996 to regulate and monitor research that depends on unwitting patients, for whom researchers request "exceptions from informed consent." Their studies often center on heart problems and trauma in unconscious, critical patients when conventional treatments fall short, according to researchers.

Federal rules require them to show evidence, often through animal testing or observational studies, that the experiment will deliver care that is likely to be better than status quo.

Researchers gauge community input, win approval from hospital review panels, and demonstrate why pursuing standard consent would be logistically impossible. The federal review process can run six to 18 months, said Dr. Jason Sperry, a surgeon at UPMC Presbyterian.

"This type of emergency research couldn't be done any other way," said Sperry, who is working on two such trials. One examines whether blood-clotting drugs given to select patients in medical helicopters will improve survival rates. The other is reviewing whether plasma given to trauma victims in helicopters will control bleeding.

For those patients, heart attack victims and people suffering seizures, it's "essentially impossible" to ask for consent to run a medical experiment, said Dr. Arvind Venkat, vice chairman for research and faculty academic affairs in the emergency medicine department at Allegheny Health Network.

"At the same time, those are real medical conditions that we need to study to improve treatment. The only way to do that is through exceptions to informed consent," said Venkat, who acknowledged the idea makes some people queasy.

Venkat and several medical ethicists outside Pittsburgh argue it's critical to tailor studies to narrow circumstances, limiting personal intrusions and potential risks.

At New York University, bioethics professor Arthur Caplan said consent exceptions should be limited to life-or-death and other severe cases.

"You don't want to do emergency research on a person who's been sunburned and somehow is too drunk. That can wait," said Caplan, who runs the medical ethics division at the NYU School of Medicine. He said it's key for researchers to disclose the studies to surviving participants or their families.

UPMC doctors called that a standard practice in Pittsburgh. About 10 percent of 1,000 or so patients studied in the past five years regained consciousness, Callaway said. The rest died from their injuries.

Of the survivors, he estimated, fewer than 1 percent refused to continue research participation. People can opt out by adding their names to a list online at acutecareresearch.org.

Adam Smeltz is a Trib Total Media staff writer. Reach him at 412-380-5676 or asmeltz@tribweb.com


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