A state judge has ordered the state to stop drug experiments on mentally ill patients who are incapable of giving their consent to these tests.
The state Office of Mental Health said there about 20 patients (out of a total of 400 test subjects) who are so mentally disturbed that they are unable to approve or refuse experimental treatments.
But that's unethical, especially when drugs are tested without any hope of improving that patients' condition, according to advocates for the mentally ill.
At least two patients may have died and many more committed suicide, possibly as a result of these experiments, according to a lawsuit filed by three organizations and six mentally ill patients.
The lawsuit did not seek any damages for those patients and did not offer any direct evidence that the deaths resulted from the experimental drugs.
This week, a state court ordered a halt to these experiments, including drug tests on children when the treatment is only intended to test the drug and not to improve the patient's condition.
In the few cases where a patient is incapable of giving his or her permission, state officials say they seek permission from a parent or a "close friend" designated by the patient.
But State Supreme Court Justice Edward Greenfield said the state failed to get the Health Department's permission for some of the experiments on children and incompetent adults. In other cases, the state should have but did not file reports with federal officials.
Greenfield said only the state Health Department has the authority to issue regulations involving such experiments. The department, however, agreed with the state Office of Mental Health's position.
State officials said they will appeal Greenfield's ruling.
Susan Delano, the state's clinical research coordinator, said she is not aware of any patients who have died as a result of these tests. She said a few patients have suffered side effects, but the majority of tests have either helped the patients or moved drugs closer to federal approval.
Ten experiments prior to 1991 were cited in the lawsuit, including a study at Buffalo Psychiatric Center of the anti-schizophrenia drug Clozapine. It could not be determined Thursday whether any incompetent patients were involved in the Buffalo tests.