Complaint: Drug studies done on mentally ill without consent
A patients’ rights group has filed a complaint with the U.S. Department of Health and Human Services saying the state of Texas gave drug companies access to files of mentally ill patients and permission to conduct studies without patient consent.
A representative of the Texas Department of State Health Services said the claim is not true, and that the state adheres to all legal and ethical considerations when allowing access to patients in its care.
Deborah Peel, president of the Austin-based Patient Privacy Rights Foundation, filed the complaint on behalf of patients in the state’s mental hospitals anytime since 2000 who were subjects of studies by major drug companies, according to the complaint.
“Last week, based on documents I was provided, I became aware of long-standing systemic practices by drug company researchers working hand in glove with state officials and physicians working for the state to coerce mentally ill hospitalized patients in several state mental hospitals to participate in drug research trials,” Peel wrote in the complaint.
Peel said she was made aware of the situation by a reporter from K-EYE news in Austin. She said she investigated the situation and is confident that the problems exist.
The complaint is not valid and the state has not and does not coerce patients into participating in studies, said Doug McBride, spokesman for DSHS.
Before they closed for lack of funding in 2003, the state had research units attached to its mental hospitals in San Antonio and Terrell, east of Dallas, McBride said. Some research continues at hospitals around the state, but researchers from drug companies or any other organization are not allowed to use patients without their permission, he said.
“The implication is that somebody was using patients in mental hospitals as unwilling and unwitting guinea pigs, and that is not the case,” McBride said.
Peel said some patients who were involuntarily admitted to state hospitals were told they could have their admission status changed to voluntary if they agreed to participate in drug studies. Peel, a psychiatrist, questioned whether patients admitted involuntarily are alert enough to make such decisions.
Patients are never released from a state mental hospital unless they are medically ready to leave, regardless of whether they have been in studies, McBride said.
Peel also alleges that researchers paid by drug companies were allowed to “go fishing” for test subjects by looking at patient files without their permission.
“What was clearly in the records of several of the studies was they allowed drug company representatives to read people’s charts and sit in on rounds, the treatment team meetings,” Peel said. “That’s a complete outrage.”
McBride said he does not know whether drug companies are allowed access to patient files without explicit permission from patients. Some researchers may be able to look at patient files with identifying information withheld, he said.
“I don’t know the parts of every case,” he said. “I can tell you that if someone is looking at a medical record for a patient then all the “I”s have been dotted and the “T”s have been crossed as far as honoring confidentiality requirements and research requirements,” he said.