(Courtesy of CCHR)
The Neurological Devices Advisory Panel of the U.S. Food and Drug Administration (FDA), recommended today that devices used to deliver shock treatment, also known as electroconvulsive therapy (ECT) remain in the most high-risk category (Class III), reserved for the most dangerous medical devices and not be downgraded to a lower risk category. In so doing, it recommended that the companies which manufacture ECT devices be required to prove that ECT is both effective and safe in order to remain in use.
ECT has long been known to cause serious harm to patients, including extremely severe and permanent memory loss, inability to learn and remember new events, depression, suicide, cardiovascular complications, prolonged and dangerous seizures and even death.
Patients who have undergone ECT felt vindicated by the decision, saying the ECT device is dangerous and causes irreparable harm. The chairman of the advisory panel, Dr. Thomas G. Brott, a Professor of Neurosciences, at the Mayo Clinic expressed concern about 100,000 people being given ECT each year in the U.S., yet psychiatrists had not conducted MRI scans before and after the procedure to monitor potential brain damage.
Ms. Jan Eastgate, President of the Citizens Commission on Human Rights (CCHR), a psychiatric watchdog, spoke at the hearing and was critical of the ECT device manufacturers, Mecta and Somatics, Inc. for their failure to conduct safety studies and submit a Pre-Marketing Application (PMA), while making more than $30 million from sales of the machine over the past 3 decades. She said psychiatrists claiming that a PMA would be “too expensive” the companies had “put profit above patient safety.” With ECT costing between $1,000 and $2,500 a treatment, psychiatrists had made more than $28 million during the same period.
The hearings were prompted by a GAO investigation in January 2009 resulting in a report stating the FDA must examine all devices which had remained for a substantial time in Class III without critical evaluation of safety and effectiveness. The GAO said the FDA should take steps to ensure that high-risk device types are approved through the most stringent review process reserved for new machines coming on to the market which may be potentially dangerous.
The FDA Office of Medical Device Evaluation thereafter called for hearings before a panel of experts to advise the FDA whether shock devices could be downgraded to Class II―and therefore require little review―or remain in the highest risk category with a mandated approval process with stringent clinical trials. The FDA Advisory Panel agreed that this device was sufficiently dangerous to require that it remain in Class III. It is up to the FDA whether to act on the recommendations of the panel.
Ms. Eastgate said the decision is the first step towards getting needed greater protections for patients but said there were still considerable concerns about the FDA’s handling of the safety and efficacy issues concerning ECT. She said there are potential conflicts of interest with psychiatrists helping write the FDA’s Executive Summary on ECT and advising the agency about the procedure.
CCHR, which was established by the Church of Scientology in 1969, helped obtain the first legislated informed consent laws for ECT. Texas has one of the most stringent reporting systems, including recording any death within 14 days of undergoing ECT.