The Food and Drug Administration has ordered the University of California San Diego Medical Center to stop admitting patients to most of its experimental studies after finding deficiencies in procedures to protect patients.
The FDA placed temporary restrictions on the medical center after a recent audit showed a number of problems, including the failure to properly report the Medical centersdeath of a patient who hadn't given full consent for an experiment.
UC-San Diego officials said the more than 800 experimental studies under way involving thousands of patients can continue, but physicians cannot add any more patients to the trials until the FDA approves the university's plans to correct deficiencies. The studies deal with new drugs and devices.
Patients participating in experiments at UC-San Diego Medical Center in Hillcrest and campus facilities in La Jolla "are perfectly safe," said John F. Alksne, M.D., dean of the UC-San Diego School of Medicine.
"There is no evidence people in clinical trials should be alarmed," Dr. Alksne said. "We are working aggressively to respond to the questions raised by the FDA."
UC-San Diego last week released a written statement about the experiment restrictions. Three hundred physicians and faculty members whose research studies include clinical trials were notified that they can't enroll new patients until the FDA matter is cleared up.
The death that led to the FDA action involved a woman of about 500 pounds who was suffering from gallstones, UC-San Diego officials said. A team headed by Alan F. Hofmann, M.D., a professor of medicine, attempted in 1992 to use a new substance injected into the gallbladder to dissolve the stones.
UC-San Diego officials said the lead researcher for the study didn't submit the required written report of the woman's death to the correct university authorities for several months. And the patient hadn't signed the correct consent form for the experiment, they said.
The woman was reported to have died from problems with anesthesia, not the drug used on her gallstones, officials said.