Medical tests given without consent; 24 die

Without knowing what was being done or consenting to it, 52 critically ill patients received a blood substitute as part of a medical experiment. Twenty four of them died.

Shockingly, the experiment was performed with the full knowledge and approval of the federal government.

In 1996, the Food and Drug Administration (FDA) set aside a long-standing policy which prohibited any medical test or treatment without the patient's informed consent. That policy was a direct result of Nazi atrocities during WWII.

During the war crimes trials held after WWII, the world was shocked by reports that Nazi doctors had administered medical tests and treatments to unwilling patients. As a result, American judges at the Nuremberg trials wrote a code of ethics called the Nuremberg Code.

The first principle of that code was that no human being should ever be forced to take part in a medical experiment without his or her consent.

"The voluntary consent of the human subject is essential," states the code. "This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice ... and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision."

In November 1996, however, the FDA decided that the Nazi approach of conducting medical experiments on people without their knowledge or consent was permissible in certain situations.

That change in regulations opened the door for Baxter International Inc. to test their blood substitute -- known as HemAssist -- on unwitting patients. Baxter officials halted their clinical trial of HemAssist, however, after 24 of the 52 critically ill patients (more than 46%) given the substitute died.

According to the 1996 regulations, medical researchers and companies must make public announcements of the upcoming tests. The "public notification" clause isn't good enough, say some critics.

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

"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 Tribune. "We use people. What's the justification for that?"

SOURCES: "Blood Trials Done Without Consent," Associated Press, January 18, 1999.