Hospital's experiment draws worry Shock Trauma plans trial of new therapy without subjects' OK

FDA loosened its rules

Poppleton residents say facility should publicize test more

April 19, 1997|By Marilyn McCraven | Marilyn McCraven,SUN STAFF

Some gunshot and stabbing victims treated at Maryland Shock Trauma Center will become subjects in a medical experiment that some people say raises serious ethical issues.

The experiment begins next month and is expected to last six months, involve 25 patients and, doctors hope, save about three lives.

Selected patients will be given a blood substitute called HemAssist, which is made from human blood, apparently speeds life-giving oxygen to vital organs and raises blood pressure faster than traditional therapies of salt solutions and blood transfusions.

No time would be lost while blood-matching tests were done because HemAssist can be given to patients with any blood type.

By running the trial at Shock Trauma, the University of Maryland Medical Center will become the first local hospital to confront the ethical dilemmas of the U.S. Food and Drug Administration's decision last fall to partly lift a 50-year ban on involuntary medical testing on human subjects.

"This is the first time we will be permitted to do a research project at Shock Trauma without the patients' permission or their families' permission," said Dr. Paul Fishman, a professor of neurology and chairman of the university board that oversees medical research.

A spokeswoman for the Johns Hopkins University School of Medicine said researchers there will do human experimentation in the emergency room under the new rules, too, but they are still working on preliminary plans.

The change is restricted to federally approved experiments done on a limited number of patients who otherwise would likely die. A ban remains in effect for non-emer-gen-cy testing.

Before entering patients in a trial, the hospital is required to attempt to reach their next of kin to obtain consent that patients are unable to give.

Even with such guidelines, some medical ethicists and others are wary of using unconscious patients in tests of experimental treatments after the patients are wheeled into emergency rooms.

Dr. Arthur L. Caplan, a medical ethicist at the University of Pennsylvania, criticizes the regulations as "too broadly written and too vague. This is not adequate regulation for this sensitive and troubling kind of work."

Caplan is particularly concerned that the revised FDA regulations are vague concerning public notification.

The regulations allow public announcement, even newspaper advertisements, to substitute for informed consent -- the principle of asking prospective participants if they want to be part of a medical experiment and fully informing them of the risks and benefits before they enroll.

The difficulty in giving adequate public notification was obvious April 9, when Fishman and Dr. David Gens, an assistant professor and a surgeon at Shock Trauma, met with residents of the Poppleton neighborhood in Southwest Baltimore to announce the new regulations.

The doctors said the university had determined that Poppleton, which is across Martin Luther King Jr. Boulevard from the university's medical complex, was the hospital's "community" in terms of meeting the federal requirement for notification. They also said an advertisement spelling out the rules change would run in The Sun.

"This is the only community group we know," Fishman told community representatives in response to a question about why other community groups hadn't been contacted.

Several of the dozen or so people attending the meeting of Concerned Citizens of Poppleton said Shock Trauma officials need to go to greater lengths to notify the broader community, including addressing other community groups, running ads in free newspapers that more poor people would read and adding people from the community to the board that governs university medical research.

Gens said public notification was a key subject at two meetings of some 40 major medical centers where the FDA rules were discussed.

"At one of those meetings, I said, 'I'm from the Shock Trauma Center in Baltimore. What is my community? We receive patients from all the different counties in Maryland, even from Delaware, West Virginia and Pennsylvania. Do I have to go to every community in all these states?'

"The answer was, 'No, you don't. You should go to communities that are closest to your hospital that your [board that oversees research] feels you should.' "

For the mostly African-American audience at the Poppleton meeting, involuntary medical testing raised the specter of the notorious Tuskegee Study, in which public health officials, starting in the 1930s, did not tell poor, black Alabama men they had syphilis and withheld a cure when it was discovered.

"When you're talking about shootings and stabbings, you're talking about young black males, and we'd like to know how many of them will be affected by this," said the Rev. Edward G. Robinson, president of the Poppleton group.

Fishman and Gens tried to allay group members' fears, assuring them that only treatments already proved safe in human testing will be used. No children or pregnant women will be included.

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