Clinical Trials Misunderstood, Panel Says

By Bob Groves

Staff Writer

NEWARK -- People who give their "informed consent" to take part in clinical trials of experimental drugs are, in fact, often misinformed, self-deluded, or too scared to focus on what they are getting into, a panel of medical experts cautioned on Monday.

"The patient and the scientist want to believe they're involved in treatment, when it's actually research," George J. Annas, a professor of health law at Boston University, said at the University of Medicine and Dentistry of New Jersey.

Clinical trials produce a "therapeutic illusion" in which people "mix up research with treatment, see scientists as doctors, and [medical study] subjects as patients," Annas said at a conference at UMDNJ-New Jersey Medical School on informed consent and human research.

About 70 physicians and other health professionals attended the event aimed at members of institutional review boards (IRBs) -- the hospital committees that oversee patient safety in clinical trials. In 1970, Congress mandated IRBs and informed-consent forms -- the agreements that volunteer subjects sign saying they understand the drug study.

The death in September at the University of Pennsylvania of an 18-year-old man enrolled in an experimental gene therapy for an inherited liver disorder was the fault of the clinical-trials system, not the school, Annas said.

"It's endemic. We don't pay attention to informed consent. We treat research as treatment," Annas said.

The father of the teenager told a Senate subcommittee hearing last week that when he permitted his son to take part in the test, he was not aware of the true medical risks or the possible serious side effects.

The death triggered a government investigation, the suspension of eight gene therapy trials in Pennsylvania, and a Senate hearing last week. This week, Beth Israel Deaconess Medical Center in Boston announced it has suspended its gene therapy tests because of safety concerns about the death.

Parents of sick children are particularly vulnerable to enrolling in studies, Annas said.

"Ninety-five percent of parents think their kids will benefit from research. The illusion is extremely powerful. We're fooling ourselves if we think we [researchers] are getting informed consent," he said.

"Subjects have to protect themselves by getting a second opinion" before becoming involved in clinical trials, Annas said.

Patients diagnosed with a fatal disease are often too traumatized to understand the experimental therapy they are signing up for, said Dr. Richard F. Levine, a professor of medicine at George Washington University.

There is a huge amount of vulnerability among patients who present themselves as subjects for clinical trials, Levine said.

"People with illness, particularly cancer, get afraid and distracted and can't pay attention. Informed consent is an illusion," said Levine, a hematologist. "As soon as you tell them they have leukemia, they think they'll die, and can't concentrate. They're not informed. They're not giving informed consent."

Informed consent also affects organ transplant recipients, said Renee Fox, a fellow with the Center For Bioethics at the University of Pennsylvania.

The fact that every organ transplant -- except in the case of identical twins -- will ultimately be rejected after a period of time "is not well understood by recipients, and is deliberately not told to them," Fox charged.

"How much and what should the recipient be told about organ rejection and serious side effects?" she asked.

This story contains material from The Associated Press.

Copyright © 2000 Bergen Record Corp.