Testimony of Carol Jean Reynolds, Neurological Devices Panel of the Medical Devices Advisory Committee
PREPARED WRITTEN REMARKS
January 27, 2011
Written Testimony of National Council on Disability Member Carol Jean Reynolds1 before the Neurological Devices Panel of the Medical Devices Advisory Committee for the U.S. Food and Drug Administration
Thank you for permitting me, as well as other members of [the] public, to provide comments at this important meeting. I would first like to applaud this panel for coming together on a matter of critical importance to people with disabilities. I am here in my capacity as a board member of the National Council on Disability (NCD), an independent federal agency, which advises the President and Congress on all issues affecting people with disabilities. But I also want to let you know that I’m a psychiatric survivor myself, and therefore can speak as a person with a disability who has been impacted in a profound way by the subject at hand. I have been in recovery from bipolar disorder, alcoholism and substance abuse for 25 years. I had the privilege of having had excellent medical care when I was sick–something that so many of my brothers and sisters do not have access to. At the same time, I would like to thank the FDA for approving the medications Lamictal and Seroquel–those are the two medications I take.
Medical devices have a profound impact on the lives of people with disabilities. While many devises hold great promise for increased participation by people with disabilities in the community, their safety and effectiveness needs to be carefully studied to ensure that potential negative impacts are eliminated or mitigated. NCD wishes to specifically highlight its views regarding electroconvulsive treatment (ECT) and the classification of the devices used for ECT. I have drawn heavily from our ground-breaking report “From Privileges to Rights: People Labeled with Psychiatric Disabilities Speak for Themselves” in preparing this commentary. As noted in NCD’s report. ECT is of great concern to the disability community. As the Advisory Committee considers FDA’s role in regulating the devices used to conduct ECT, NCD wants to help inform the committee about the role these particular devices have in the lives of people who often don’t have a voice. People with psychiatric disabilities are routinely deprived of their rights in a way no other disability group has been. While I know this Committee is focusing on how to classify ECT devices, NCD believes that ECT devices are inherently inhumane, unsafe, and ineffective and should not be classified as a therapeutic device.
Public policy needs to move in the direction of a totally voluntary community-based mental health system that safeguards human dignity and respects individual autonomy. People labeled with psychiatric disabilities should have a major role in the direction and control of programs and services designed for their benefit; and most importantly and germane to this Committee meeting, public policy should move toward the elimination of electro-convulsive therapy and psycho-surgery as unproven and inherently inhumane procedures. Effective humane alternatives to these techniques exist now and should be promoted. I have concluded, from my own personal experiences, and from NCD’s policy development and research, that one of the reasons public policy concerning psychiatric disability is so different from that concerning other disabilities is the systematic exclusion of people with psychiatric disabilities from policy-making. It is rare that people with psychiatric disabilities are heard in public-policy forums, thus I want to take full advantage, as a member of the psychiatric disability community and as a presidentially-appointed member of the National Council on Disability, to urge you to carefully consider classifying EECT devices as any type of “therapeutic” device. Again, thank you for allowing me to comment.
1 Ms. Reynolds is also a Board Member for the National Council on Independent Living, and the Executive Director for a Disability Center for Independent Living.