Patients who received cranial electrotherapy stimulation at North Texas State Hospital in Vernon were not told in writing that the treatment can cause headaches, nausea, dizziness and skin irritation, said Beth Mitchell, a lawyer with Disability Rights Texas, a federally funded mental health advocacy group. The consent form — a copy of which was obtained by the Austin American-Statesman — also fails to mention alternative treatments and the condition that is being targeted.
But state officials say the form was adequate and is just one piece of the informed consent process.
"The form alone may not be the full picture," said Carrie Williams, spokeswoman for the Department of State Health Services, which oversees the 10 public psychiatric hospitals. "Risks, benefits and alternatives could have been laid out verbally and documented in the progress notes."
Challenges to the validity of the consent forms come several weeks after health department officials said they learned that a North Texas State Hospital psychiatrist had conducted unauthorized research on the use of cranial electrotherapy stimulation on violent, mentally ill patients.
The consent forms go to the heart of the questions advocates have posed on the issue: Did the patients understand and willingly agree to the treatment? Or were they being used as research subjects without regard to their civil rights?
"Honestly, I just don't understand how this could happen," Mitchell said. "I think there was a breakdown across the board here."
State officials say they are still trying to determine whether patients truly gave consent to the treatment. They have not yet spoken to any patients, Williams said.
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The Citizens Commission on Human Rights, a mental health watchdog group whose questions about the use of cranial electrotherapy stimulation sparked the health department's inquiry, says the state needs to make sure patients' rights weren't violated."What we want to see is a very thorough investigation and a formal plan of correction on any findings," said Lee Spiller, the group's policy director. "This must include actual interviews of patients to determine what their actual experiences were. That needs to be made public and reported to the Legislature. The idea here is to strengthen and protect the rights of this highly vulnerable population."
About the treatment
Cranial electrotherapy stimulation is a treatment that administers a small electrical current into a patient's brain. The concept behind it is that the current increases the brain waves that cause relaxation, thus easing anxiety and other ailments.
Although the treatment is approved by the U.S. Food and Drug Administration for anxiety, depression and insomnia, it is not approved for aggression. Physicians, however, can prescribe drugs and devices for conditions other than those for which they are approved if they believe it will help patients. The FDA and the makers of cranial electrotherapy stimulation devices are currently battling over whether the treatment is safe and effective.
Since 2001, North Texas State Hospital and two other state hospitals administered the treatment with Alpha-Stim, a hand-held device powered by a 9-volt battery that delivers the current through two electrodes clipped to the patient's earlobes. It was used on aggressive patients with schizophrenia, autism, intellectual disabilities and other disorders.
But last month, state officials said they learned that North Texas State Hospital psychiatrist Allen Childs had published research studies in 2005 and 2007 on how patients reacted to the treatment. The doctor did not have permission to conduct such research, state officials say.
Childs, who is listed as a part-time employee but who state officials said has not worked at Vernon in almost a year, did not respond to requests for comment. On May 15, the Department of State Health Services prohibited the use of the treatment, saying they wanted time to sort through the issue. Alpha-Stim had not been used at any hospital campus since February, Williams said.
The nature of consent
An informed consent form is a document that details a course of treatment and its risks, benefits and possible alternatives. In essence, it says that patients have the information they need to make an educated decision about the treatment to which they have agreed.
In general, consent can be obtained orally and documented in the physician's notes, said Rocky Wilcox, general counsel for the Texas Medical Association. In most cases, there is no requirement that all the information be listed in a form.
But state rules make a distinction for people receiving mental health treatment, said Mitchell, of Disability Rights Texas. Informed consent for that population is defined as the "knowing written consent" of information, including a description of any "discomforts and reasonably expected risks" and a disclosure of any appropriate alternative procedures, according to the Texas Administrative Code.
Written consent is required for multiple reasons, Mitchell said. Patients in psychiatric hospitals are not free to leave at any time, so a detailed consent form is an extra precaution to ensure that they have been fully briefed on their care and did not feel coerced into agreeing to treatment they did not want, she said. It's also a way to make sure that all patients get a consistent message about what treatments entail, she said.
State officials say that the consent form provided to patients was adequate, though it could have been improved with more details and clearer language.
"Informed consent is not just about a piece of paper," Williams said. "It's about the deep dialogue that happens between doctor and patient about a treatment. That's when it's determined whether the patient truly understands the risks and benefits. The form comes into play as the final, written acknowledgement."
According to the company that makes Alpha-Stim, side effects can include skin irritation, headaches, nausea and dizziness. But the four-paragraph consent form provided to patients does not mention any potential side effects. The document states that "no significant negative side effects have been reported from CES treatment since it first began in the U.S. in the late 1960s."
"I think this borders on deception if they're not spelling out what the side effects are and then just say we just chatted about it verbally," said Jim Harrington with the Texas Civil Rights Project, a nonprofit foundation that promotes civil rights and economic and racial justice. "That's nonsense."
The consent form states that the treatment reduces stress and that there have been more than 45 scientific studies of anxiety, 30 of depression and 30 of insomnia published in U.S. scientific literature. Whether doctors were prescribing cranial electrotherapy stimulation for any of those problems is unclear, as the forms do not say what problem is being treated. Childs' studies focus only on aggression.
Paul Lombardo, a Georgia State University College of Law professor who specializes in mental health law, said the consent form does contain some important elements. It describes the treatment and how it works, though not in language that most patients could understand, he said.
But parts of the document appear to be promoting the treatment, he said, particularly the mention of scientific studies.
"They are, in a consent form, essentially repeating claims that were obviously written by an advocate of this process," Lombardo said. "That's what it looks like."
Typically, state hospital consent forms are written by the agency's clinical oversight committee, whose members approve new treatments and create standardized forms for all the hospitals.
The consent form for cranial electrotherapy stimulation was not created by the committee, and the agency is still trying to determine who wrote it, Williams said.
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source: Austin American Statesmen (Ball, 5/31)
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