UsAgainstAlzheimer’s Board Member Testifies on Alzheimer’s-Related Psychosis Before FDA Advisory Committee
Washington, DC (June 17, 2022)— Today, UsAgainstAlzheimer’s Board Member Meryl Comer provided testimony to the Federal Drug Administration’s Psychopharmacologic Drug Advisory Committee on her experience as the wife and daughter of Alzheimer’s patients who experienced Alzheimer’s-related psychosis. The advisory committee is discussing the application by Acadia Pharmaceuticals to use pimavanserin for the proposed treatment of hallucinations and delusions associated with Alzheimer's disease psychosis. Below is Comer’s testimony as prepared for delivery and submitted in the public record.
FDA Public Hearing: Docket # FDA-2022-N-0557
Psychopharmacologic Drug Advisory Committee
Written Submission and Request to Speak
My name is Meryl Comer. I am a co-founder and board member of the non-profit organization, UsAgainstAlzheimer’s. I have lived deep inside the labyrinth of Alzheimer’s disease 24/7 for more than two decades, caring for my husband and my mother, both exhibiting a range of psychoses that put them in harm’s way and complicated care. I hope the observations I offer today are useful to this panel’s deliberations.
The delusions and distortions of reality suffered by those living with early to mid- stage Alzheimer’s, who act out from psychosis, are not uncommon and among the most difficult challenges encountered across the arc of this fatal neurodegenerative disease. No one, even those aware at some level that their intellect is being eroded, wants to be told that what they perceive in the world around them… is either not real, inaccurate, or distorted.
The lack of appropriate or re-purposed therapies to manage symptomatic behaviors associated with psychosis, takes an indelible toll on those living with dementia and those who care for them. I know.
I watched my 57-year-old husband… a respected physician and then chief of hematology/oncology at NIH... be misdiagnosed for four years with everything from depression to pernicious anemia and even mad cow’s disease, while we were privately held captive to his paranoia, hallucinations, and delusions. The private advice from his psychiatrist was “you may want to get out while you can.” His other advice “Call 911 if he gets too dangerous.”
Several months later my husband, who paced incessantly and with whom I walked 6 miles a day to manage episodes of sundowning, was admitted to Johns Hopkins for evaluation. I was denied my request to stay to comfort him in an unfamiliar environment. Early the next morning I arrived to find him in a zombie-like stupor from an inappropriate dose of a widely prescribed antipsychotic given to quiet my anxious husband as a PRN. For the next two and a half months, he was confined to a locked ward where every available anti-psychotic was tried, slowly titrated, and then discarded.
My husband’s final diagnosis read "Alzheimer's disease with a behavior disorder" and deemed too dangerous to come home. He was discharged with prescriptions that included 16 Depakote (an anti-seizure medication), and 4 Ativan a day. There was nothing left to try. The damage had been done. No facility would take him. I brought him home and slowly weaned him off all the medications, that in turn put me in harm's way due to his psychosis, aggravated by agitation.
Please consider that with psychosis, the demons and terror are the pendulum along which our lives swing. Any challenge is self-defeating. Traumatic psychotic episodes, punctuated with aggressive agitation, were followed by long plateaus as he sunk deeper into the disease. I buried him two years ago - 24 years later.
My other experience is the garden variety psychosis suffered by my prim and proper 80-year-old mother, who valued her independence and lived alone. During her early Alzheimer’s paranoia, she was insistent that she was being spied on by neighbors and that her personal items were being stolen, though she let no one in her house. She had bizarre conversations with the TV, would scream out the window to strangers to rescue her, and even called 911 to report she was being held against her will. The doctor’s prescription for Seroquel – never filled because we feared the long list of potential side effects more.
The reality is that whatever the FDA approves and doctors prescribe, we are left to manage the consequences. Unfortunately, the real numbers and societal impact of psychoses and dementia are masked. As family caregivers, we keep the secret about these aberrant behaviors to support and protect our loved one’s dignity…even from our adult children.
An FDA-approved drug for Parkinson’s disease with a demonstrated safety profile in elderly populations, if deemed effective by this panel in treating Alzheimer’s related psychosis, will ease the patient’s torment and help us support them at the intersection where the scaffolding of their identity begins to fall apart due to the ravages of a disease with no cure.
Thank you for your time and consideration.