Rats and mice get better protection: FDA and informed consent for human subjects

The case of Audine Graybill demonstrates the flaws in the system. According to the U.S. Food and Drug Administration, in the spring of 2005, she decided to try an experimental drug to treat mania associated with bipolar disorder. The consent form that she signed on May 29 said she could change her mind at any point in the study.

She checked into High Pointe healthcare in Oklahoma City, a psychiatric center owned by a psychiatrist, Dr. David Linden. On June 3, she changed her mind and asked to leave.

Dr. Linden refused to let her go.

On June 6, she was given the experimental medicine. Her lawyer, Anthony Sykes, presented a writ of habeas corpus to High Pointe to obtain her release. But the hospital staff neither obeyed it nor gave it as requested to Dr. Linden.

More than nine months later the FDA discovered many other problems there, but only this summer finally wrote a warning letter. Meanwhile, the Oklahoma Board of Medical Licensure and Supervision suspended the doctor's license.

Dr. Linden has conducted clinical trials for most major pharmaceutical companies and continues to do research, according to his website.

According to today's front-pagestory in the New York Times, Audine's experience is quite common because of lax management by the FDA.

"Rats and mice get greater protection as research subjects in the United States than do humans," said Dr. Arthur Caplan, Chairman of the Department of Medical Ethics at the University of Pennsylvania.


Advice to human subjects in clinical trials: Talk through your rights with a patient advocate or lawyer.

Read another of our informed consent stories, or read Gardiner Harris’ source story in today’s New York Times.