FDA Rules Allowed Fatal Blood Trials Without Consent, Officials Say

FDA Rules Allowed Fatal Blood Trials Without Consent, Officials Say

CHICAGO (January 17, 1999 6:31 p.m. EST http://www.nandotimes.com) - A company conducted an ill-fated blood substitute trial without the informed consent of patients in the study - some of whom died, federal officials say. Baxter International Inc. was able to test the substitute known as HemAssist without consent because of a 1996 change in federal FDA regulations.

The changes broke a 50-year standard to get consent for nearly all experiments on humans. They were designed to help research in emergency medicine that could not happen if doctors took the time to get consent.

But the problems with the HemAssist trial are prompting some medical ethicists to question the rule change.

"People get involved in something to their detriment without any knowledge of it," George Annas, a professor of health law at the Boston University School of Public Health, told the Chicago Tribune. "We use people. What's the justification for that?"

No other company has conducted a no-consent experiment under the rule, FDA officials said.

Baxter officials halted their clinical trial of HemAssist last spring after reviewing data on the first 100 trauma patients enrolled in the nationwide study.

Of the 52 critically ill patients given the substitute, 24 died, representing a 46.2 percent mortality rate. The Deerfield, Ill.-based company had projected 42.6 percent mortality for critically ill patients seeking emergency treatment.

There has been an intense push to find a blood substitute because artificial blood could ease the effects of whole-blood shortages.

Researchers say it lasts longer than conventional blood, eliminates the time-consuming need to match blood types and wipes out the risk of contamination with such viruses as HIV and hepatitis.

The principle of informed consent was first articulated following the revelation that Nazi doctors performed hideous experiments during World War II. It became even more important because of U.S. -backed syphilis experiments on blacks in the South that went on for decades after a cure for the disease were revealed.

The 1996 regulations require a level of community notification that is not used in most scientific studies, including community meetings, news releases and post-study follow-up.

Some say such notification cannot replace direct consent from patients or their relatives.

"Public notification means nothing," said Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. "I know people are enamored of it, but it means nothing."

No lawsuits have arisen from the blood substitute trial, Baxter officials said.

"The regulations worked in this instance," company spokeswoman Mary Thomas said Sunday. "We voluntarily stopped the trial early on at the first sign of unexpected results to insure patient safety."