January 7, 2010
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
I am writing you as executive director of the New York Association of Psychiatric Rehabilitation Services (NYAPRS) which represents a broad coalition of thousands of New Yorkers with psychiatric disabilities and over 125 community mental health recovery agencies that support them across our state.
Since 1981, NYAPRS has worked to improve services and social conditions for people with psychiatric disabilities by advancing their recovery, rehabilitation and rights through a range of grassroots advocacy, training and technical assistance and new service development activities.
Along the way, we have helped win passage of many landmark pieces of legislation and budget proposals, supported the development of numerous new service initiatives and helped support the empowerment, recovery and community integration of tens of thousands of New Yorkers.
The NYAPRS Board and Public Policy Committee has long viewed electroconvulsive treatment (ECT) as a controversial approach that, according to a range of reports, has both helped and harmed many of those who have used it.
NYAPRS has long believed that fully informed choice and appropriate government oversight is critical to ensuring that ECT use is properly treated.
As a long time advocate for informed choice and appropriate oversight over electroconvulsive therapy (ECT), NYAPRS strongly urges the Food and Drug Administration to maintain ECT devices as Class III and require the submission of a premarket approval application (PMA) and conduct a thorough review of the safety of the devices used to apply this treatment, consistent with the requirements of Class III categorization.
Moreover, we strongly question why such an examination has not been required of ECT devices in the past, given their classification and controversy.
We strongly urge you to conduct that investigation now and to reject efforts to avoid such a review by administratively reclassifying the device into Class II or Class I. Reclassification would mean the FDA would agree to accept the word of proponents that ECT is safe, without the required and appropriate scientific evidence.
While we know several individuals who have derived benefit from ECT, we also know many individuals who experienced severe memory loss, agitation, cognitive deterioration, long term brain damage and other injury, especially at the hands of equipment that was out of date and improperly inspected and maintained.
NYAPRS is particularly troubled about these reports since ECT is a treatment that is often involuntarily forced onto individuals, denying them the informed choice they have a right to have, especially regarding such a controversial and consequential treatment.
That is why NYAPRS successfully pressed state officials in 2003 to add regular inspection of ECT devices and treatment protocols to the duties of state mental health licensing and certification staff, a development that has revealed incidents of wrongful use of outdated ECT equipment and misuse.
We want to be clear: we are not advocating for the elimination of ECT but for appropriate inspection, oversight and informed consent for adults between the ages of 21 to 70, even if they are deemed incompetent by a court. Moreover, we don’t believe that that ECT should be given to children or the elderly under any circumstances as these populations are too vulnerable to usurpation by others.
We also urge the FDA to establish recommendations for treatment protocols in addition to evaluating the efficacy, safety and maintenance of the equipment both before their first use and on an ongoing basis.
As it is the FDA’s duty to assure full due diligence in its efforts to protect Americans who either consider or are required to accept ECT treatment, NYAPRS strongly urges you to conduct a comprehensive scientific investigation of the safety of the devices.
cc: NYAPRS Board of Directors, Public Policy Committee members
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