Disability advocacy groups are calling into question whether researchers at a Texas psychiatric hospital violated the civil rights of people with disabilities by practicing the controversial electrotherapy treatment on patients without their consent.
The controversy centers on hospital consent forms for the treatment, which alledgedly did not spell out the potential side effects of the treatment – such as headaches, nausea, dizziness and skin irritation – or mention alternative treatments.
Additionally, there are questions of whether hospitals improperly used the treatment to research and experiment on patients with aggression issues. The Food and Drug Administration has only approved the treatment for anxiety, depression and insomnia.
The treatment, administered by a handheld device, is “designed to increase the brain waves that causes relaxation, thus easing anxiety and other ailments,” according to an Austin American-Statesman article.
“The policy implications of this are staggering,” Lee Spiller, policy director for the Citizens Commission on Human Rights, told the Austin American-Statesman. “We don’t understand how a random device was used on aggressive patients in North Texas State Hospital, and we there think there needs to be a legislative inquiry into that.”
In mid-May, in response to an investigation prompted by the Citizens Commission on Human Rights, the Texas Department of State Health Services announced that a doctor at the Northern Texas State Hospital improperly used the treatment on 120 patients between 2005 and 2007. The treatment was also improperly used at the San Antonio and Big Spring hospitals.
The research was never approved by the department’s Institutional Review Board, though there are now questions of whether the department, in fact, had knowledge of the research at the facility prior to the investigation.
The department subsequently announced that it was prohibiting the use of the treatment. But for many disability advocates, research on off-label treatments and devices should never be used on patients at state facilities, where the patient’s rights are already limited and individuals, especially those with disabilities, are more prone to abuse.
“Until there are research studies that say it’s beneficial on these patients with aggression, I don’t think it should ever be brought on campus,” said Beth Mitchell, an attorney with Disability Rights Texas. “They’re supposed to be rehabilitating them. What if it made them worse? Then you’re committing them longer.”
Disability Rights Texas is part of the federally funded protection and advocacy system and a member of the National Disability Rights Network.