Psych Drugs of 4 patients switched without OK

A follow up to the earlier story:

A doctor at a state mental health facility changed patients' medications last year so that they would be eligible for a study of a new psychiatric drug, violating basic guidelines for research on human subjects and causing dangerous side effects in a 43-year-old man with schizophrenia, a state investigation has found.

The Disabled Persons Protection Commission uncovered numerous ethical violations at the Solomon Carter Fuller Mental Health Center by Boston Medical Center physicians contracted to treat patients there.

According to a DPPC report, patients' medications were switched without informed consent and without a clear medical need, the changes were made more than two months before the human-studies review boards approved the research protocol, and the patients involved were clearly not eligible under the criteria for the study, which specified that subjects be outpatients.

One of the four patients whose medication was switched, a man who had been stable for 10 years on the drug Clozaril, became so ill and acutely psychotic that he spent months in and out of hospital wards. He was diagnosed with neuroleptic malignant syndrome, a rare, sometimes lethal side effect of medication changes, according to the commission's report.

The names of doctors involved were deleted from the commission report, but Department of Mental Health officials and Hughes acknowledged their identities. According to the Globe story the Doctors involved are Dr. Douglas Hughes and Dr. Valentina Jalynytchev.