ADVISORY COUNCIL ON ALZHEIMER'S RESEARCH, CARE, AND SERVICES
Public Comments on Advisory Council Meeting, April 2014
List of Comments
Comments and questions, or alerts to broken links, should be sent to email@example.com.
Also contact us if you would like a topic added here.
PLEASE NOTE: The Public Comments included here are not an endorsement of the views or information by National Alzheimer's Project Act, its Advisory Council members, the Administration or the federal agencies involved in this project.
R Richards | 04-28-2014
Attached are written comments from AARP for the Advisory Council on Alzheimer's Research, Care and Services for their April 29 meeting tomorrow. We understand these comments will be shared with the Advisory Council. Please let us know if you have any questions or if there is anything else we need to do for submission of these comments.
STATEMENT FOR THE RECORD SUBMITTED TO THE
April 29, 2014
AARP appreciates the opportunity to comment as the Advisory Council prepares to make 2014 recommendations to the Secretary of Health and Human Services (HHS) on the National Plan to Address Alzheimer's Disease (National Plan). AARP's mission is to enhance the quality of life for all as we age. Living independently, connected to family, friends and community is key to a high quality of life. As we age, a decline in cognitive health is not only one of people's greatest fears, but it is also one of the greatest threats to living independently and a high quality of life. As with all family caregivers and the loved ones they are helping, tangible steps can be taken to improve the quality of care, quality of outcomes, and quality of life for people living with dementia and their family caregivers. As this country moves forward with the National Plan goal of preventing and effectively treating Alzheimer's by 2025, we also need to move forward with more effective care for those already affected by dementia, including better care coordination and planning, better access to affordable care, and support for family caregivers who take care of their loved ones.
A. Translate evidence-based, person and family-centered care into widespread practice.
It is important to expand person and family-centered care models broadly to reach the tens of millions of people and their families who could benefit from them. We know that person and family-centered models of dementia care that emphasize continuity of care and coordinate across settings and providers can also improve outcomes. Thanks to academic researchers across the country and the support from federal agencies who are represented on the Advisory Council such as the National Institutes of Health, the Administration for Community Living, the Centers for Medicare & Medicaid Services, and the Department of Veterans Affairs, we have developed an evidence-base from which we can implement better care.1 In some cases, in addition to improving individual outcomes, we can even deter or delay expensive, disruptive, unwanted hospitalization and institutionalization.2 Both domestically and internationally, models of care exist which demonstrate interventions that preserve abilities, improve behaviors, and reduce caregiver burden. These models show that we can do more to help those with a diagnosis of dementia -- and find ways to do it in responsible, cost-effective ways.3
Despite the evidence that we can improve outcomes for people with dementia, these models of care are unfortunately neither widely known nor widely adopted. All too often, people either go untreated, or even after diagnosis, think there is nothing that can be done. It is important to educate people with dementia and their family caregivers that medical, social and behavioral interventions can help even while we struggle to find a cure for the future. 4
That is why AARP urges the Council to redouble their efforts around goals 2 and 3 of the plan:
More broadly, individuals and their family caregivers should be made aware of interventions that can help them.
B. Apply evidence-based quality of care across all settings -- for those living at home receiving care through primary care settings, as well as in residential and institutional settings.
Individuals should receive quality care no matter where they live. As the Advisory Council considers how to achieve the goal of enhanced quality and efficiency of care for those with dementia, it is critical to think about the care provided for those with dementia living in different types of settings. People often live with dementia for long periods of time -- and dementia manifests itself over a continuum of time and abilities. Therefore, quality care needs to adapt over a continuum as well.
AARP is striving to make it easier for older people to live with independence and remain in their homes and communities for as long as they can, surrounded by family and friends. People with dementia are often happier and have more control in their own familiar home, and with the right help and support, they too can continue to live independently.5
While we want people to have the option of living in their homes as long as possible, for some people, particularly those who face advanced stages of dementia, living in a residential setting or nursing home may be the best option for them. Clearly these people still want and deserve to live life on their terms, with dignity and respect, and need high quality care that is affordable and sustainable. Our emphasis on promoting independent living applies to people living in nursing homes and assisted living facilities as well as in home or other smaller community settings.
C. Recognize that quality of care also must include family caregiver support.
In 2009, about 42 million family caregivers in the United States provided care to an adult with limitations in daily activities at any given point in time. They provided unpaid care valued at $450 billion that year, more than total Medicaid spending in 2009 and more than twice the total for paid services and supports, according to AARP's Public Policy Institute.6 The Alzheimer's Association estimates that more than 15 million of those caregivers are providing care for someone with Alzheimer's disease or other dementia.7
While this concept is important in family caregiving broadly, best practices of care for those with dementia recognize caregiver well-being is essential to maintaining the well-being and abilities of the individual as well.8 It has been clearly established that counseling and support for spousal caregivers of those with dementia benefit the individual, family caregiver and society. Individuals whose family caregivers received the counseling and support interventions designed by the New York University Caregiver Intervention Study compared to usual care experienced a 28.3% reduction in the rate of nursing home placement.9 A 2012 report released by AARP's Public Policy Institute and the United Hospital Fund also found that almost half of family caregivers perform medical/nursing tasks for care recipients, such as managing multiple medications and helping with assistive devices for mobility.10 Families generally do not receive training and other assistance to help them provide care. Such training and supports also benefit the person receiving the assistance.
We need to help the millions of family caregivers navigate the confusing care systems to provide assistance for their loved ones and otherwise support them in their caregiving roles. Family caregivers should be given an assessment of their needs and then receive help based on the assessment, especially when a care or discharge plan depends on a family caregiver voluntarily providing services to an individual. Such assistance should include information, training, counseling, links to community resources, help locating services, respite care, or other supports. In September, a federally appointed Commission on Long-Term Care released a report with important bipartisan recommendations to help build a better system to support individuals and their family caregivers nationwide. 11 Importantly, the Commission called for a national strategy to address the needs of family caregivers. The Commission specifically recommended assessing family caregivers and their needs in the care planning process, including family caregivers in patients' health records and as members of care teams, ensuring family caregivers have access to relevant information technology and, importantly, encouraging family caregiver interventions, including respite, training, and other supportive services. We need to provide the support and tools to all family caregivers so that both the recipient and provider of care can sustain themselves.
AARP is dedicated to improving the quality of care to all individuals who need long-term services and supports (LTSS) and supporting creative, innovative mechanisms by which that care can be personalized, delivered, evaluated and financed. We know that older adults with end stage dementia are some of the most complicated and expensive individuals with LTSS needs. They often are living with multiple chronic conditions -- and if we can improve the quality of care for those with dementia, we can use those lessons to improve the care for all people with LTSS needs. Focusing on concrete steps to deliver on goals 2 and 3 of the plan could help make significant strides to assist all older adults and their families.
C. Rodgers | 04-18-2014
Attached please find written comments I am submitting for consideration at the April 29 Advisory Council Meeting. I am also mailing a hard copy to the address provided.
Kindly verify by email that you have received the attached and that it will be included in the materials you provide to Council members.
Additional evidence that ionizing radiation causes Alzheimer's
In 2011, Medical Hypotheses published my paper proposing that Alzheimer's disease (AD) is a long-term consequence of ionizing radiation (IR) due to dental X-rays.1 Since then, three more articles have been published in scientific journals raising concerns that ionizing radiation may be a cause of Alzheimer's disease.
All four papers propose different pathways to neurodegeneration via ionizing radiation, with some overlap, yet with all of the scientific literature on the subject -- each review has well over 100 citations, many of which relate specifically to radiation-induced effects -- why has the possibility that ionizing radiation may be a major cause of dementia not been properly addressed?
Traditionally, radiation experts, doctors and dentists have compared low levels of medical radiation to a single airplane flight or an extra day of environmental exposure. They point out that we are naturally exposed to low levels of ionizing radiation arising from the ground and descending from the sky, called "background radiation," without apparent ill effect. However, it is only within the last 100 years that frequent, lifelong head exposure to X-rays from dental visits has become "normal."
Before proceeding further, it is important to note that the three latest papers only suggest that ionizing radiation could be causing dementia and do not venture that dental X-rays are the source. Begum et al clarify that by "relatively low doses," they are referring to computed tomography (CT) scans (versus Caroline Rodgers • Advisory Council on Alzheimer's Research, Care and Services 4/29/14 • 2 | P a g e oncological doses); Kempf et al do not address dental X-ray exposure beyond noting that together, diagnostic medical and dental radiation exposures have increased significantly in recent years. Cherry et al only consider the possible consequences of space travel, not oral health as it is practiced today.
Dental X-rays, unlike comparable levels of background radiation that occurs over several hours or days, can involve multiple head exposures in quick succession, which could overwhelm cellular recovery mechanisms. Consider that a full mouth series usually involves between 14 and 21 individual X-ray images; a panoramic X-ray systematically scans the jaws, jaw joints, nasal area, sinuses and teeth; bitewings expose upper and lower back teeth at the same time and usually are done in pairs; and occlusal X-rays aim at the floor or roof of the mouth. Can we really state with confidence that this increase in head exposure to ionizing radiation, which starts in early childhood and continues throughout adulthood, is unrelated to the increase in dementia? Alzheimer's is distinct from age-related cognitive loss both in terms of brain pathology and symptoms and has become a major killer within the same 100 years that has brought us this array of common dental X-ray procedures.
If the answer to stopping the Alzheimer's epidemic is not drug or therapy development but simply taking many fewer X-rays with head involvement, the kind of market-driven research that America is good at and has yielded results in cancer treatment will not work. That is why we need government and/or academic leadership to form and fund research teams that will properly investigate the effects of ionizing radiation on the brain.
Caroline Rodgers is the author of "Dental X-ray exposure and Alzheimer's disease: a potential etiological association," which was published in Medical Hypotheses in 2011. She gave a poster presentation of her peer-reviewed hypothesis at the Alzheimer's Association International Conference in Paris (ICAD 2011) and has presented her work as a member of the public at meetings of the Advisory Council on Alzheimer's Research, Care and Services in Washington, DC. In 2012 she made a presentation as a member of the public at the FDA Guidance and Workshop on Pediatric X-Ray Imaging Devices. She also attended a 2012 Institute of Medicine workshop exploring commonalities across four neurodegenerative diseases.
M. Adams-Cooley | 04-09-2014
Dr. Norman Foster has prepared a statement he would like to be read at the Council meeting on 4/29. I sent a paper copy in the USPS mail to Rohini Khillan for the record. I'm hoping you can clarify how I should submit the attached PDF online. (He cannot attend the meeting in person, so I'm not sure what to put in the subject line or if this email will suffice.)
I am submitting the enclosed 5-page statement to be read at the April 29, 2014 meeting of the Advisory Council on Alzheimer's Research, Care and Services. My statement addresses the importance of determining the cause of dementia when it is recognized in medical practice.
I am a geriatric and cognitive neurologist. My clinical activities primarily involve the evaluation and care of patients with cognitive deficits. I wish to provide greater insight from the perspectives of practicing clinicians, patients, and their families. I propose that the Council adopt two recommendations as outlined in my statement:
Public Comments to the Advisory Council on Alzheimer's Research, Care, and Services
Thank you for the opportunity to provide public comments to the Advisory Council. I am unable to attend today's meeting in person so I request that this statement be read to the Council. The content and motivations for this statement are entirely my own. Citations and conflicts of interest are listed in the written version of these comments I have submitted.
Thank you for the opportunity to provide public comments to the Advisory Council. I am a board-certified geriatric neurologist, Professor of Neurology and Senior Investigator in The Brain Institute at the University of Utah in Salt Lake City. I direct the Center for Alzheimer's Care, Imaging and Research and I am Chief of the Division of Cognitive Neurology. Over the past 30 years I have maintained an active clinical practice as a cognitive neurologist. My clinical activities primarily involve the evaluation and care of patients with cognitive deficits. Our Center has a unique role. We are the sole academic dementia program in the Intermountain West, and our Cognitive Disorders Clinic is the primary referral center for 10% of the geographic United States. This provides a unique perspective I hope you will find helpful in your deliberations.
The single most significant factor impeding the care of patients is the lack of consensus about the value of knowing the cause of dementia. The Council should unequivocally, firmly and explicitly recommend that when dementia is identified, its cause should be determined. Patients with dementia and their families deserve the dignity and respect of knowing the cause of their illness. It should no longer be acceptable to have their problems simply dismissed as "dementia".
I see in my practice daily the adverse consequences when the cause of dementia is not identified. Without a known cause, treatment is chaotic, fragmented, and ineffective. Without a known cause, prognosis is uncertain and there is little care planning or support. I recently saw a highly educated patient with diabetes that exemplifies this problem. Although his diabetes always had been well controlled with insulin, his doctors several years ago began to notice he wasn't paying attention to his blood sugars. No mental status was performed (after all cognitive screening isn't a recommended procedure). When his family became increasingly concerned about his memory problems, they were told he just had dementia and was put on Aricept. Perhaps because of his physician's uncertainty of this course of treatment, he provided no counseling about what to expect. His family discontinued this drug when his memory problems continued. Later, he was prescribed a scopolamine patch when he went on a cruise; treatment that would clearly be contraindicated in Alzheimer's disease. He became dramatically worse -- his family never understood why. Meanwhile he continued to manage his own insulin. Predictably and unnecessarily if his dementia had been recognized as due to a progressive disease, he developed hypoglycemic seizures requiring emergency treatment and hospital admission. Just before I saw him a Medicare annual wellness visit was completed, but without an assessment of cognition (this is very common, even though supposedly required). His family became uncomfortable with the lack of guidance they had received. By the time of his first visit with me, he had severe memory loss, hesitant speech, was unable to name simple objects, copy simple figures or draw a clock. Even though he had trouble dressing and became very anxious when his wife left the room, he continued to drive. (His physician hadn't restricted driving or indicated his abilities might change. His wife had no support in his care, his daughter accompanying him didn't know what she should do to help, and they had not contacted the Alzheimer's Association. My evaluation led to the conclusion that he has Alzheimer's disease dementia, but that 3 small previously unsuspected strokes also had likely contributed to his relatively rapid decline. Now we can begin appropriate care and help his family avoid future care crises and manage a progressive dementing disease.
Dementia is not a medical diagnosis; it simply describes a syndrome that can be due to any of several dozen causes. It is inconceivable that a physician today would fail to determine the cause of chest pain, stroke, shortness of breath or any symptom as serious as dementia. Yet, this is the current state of affairs with dementia. Why? It is considered axiomatic that knowing the cause of a medical problem is necessary for appropriate treatment. Why isn't doesn't this seem to apply to dementia? Physicians usually vigorously pursue an accurate and precise diagnosis.
My clinical colleagues, health systems and insurers are all well aware that no existing guidelines require determining the cause of dementia. The American Academy of Neurology provides guidelines for what testing should be performed in a dementia evaluation, but offers no opinion regarding whether or not such a diagnostic evaluation should be undertaken (Knopman et al., 2001). Reportedly, this is because there is no supportive evidence from clinical trials! Who would suggest a randomized trial where a diagnostic evaluation is withheld from half of patients? Is there really equipoise about this question? The American College of Physicians and the American Academy of Family Physicians guidelines for treatment of dementia fail to mention evaluation and seem to assume that determining causation is unexpected and unnecessary since treatment is discussed only on in the context of dementia syndrome (Qaseem et al., 2008). The Council through its recommendations and influence can begin to change expectations so that the cause of dementia always is sought.
The consequences of diagnostic nihilism are everywhere manifest. The US Prevention Services Task Force has decided not to recommend screening to detect cognitive impairment in primary care (Moyer et al., 2014). Insurers often have failed to reimburse testing shown to increase the accurate and confident understanding of causation, justifying this with the belief that the effort has no value. In this environment, the Council's important recommendation of early recognition and evaluation is unlikely to be implemented. The concept of precision care, embraced in other fields, and critical for improving quality, seems nearly unattainable unless we agree that cause of dementia is important.
Diagnostic nihilism also breeds therapeutic nihilism. If there is a feeling of "why bother" about determining the cause of dementia, then existing treatments also become dismissed. Needed services are not offered and we hear that there is no treatment for Alzheimer's (even among some experts). This nihilism often extends to families and has huge implications for care. When causation is irrelevant dementia care becomes unlinked to medical practice. As a result doctors can feel that dementia is just a social problem not of their concern (Connell et al., 1996). They justify using drug treatments simply to "offer something" rather than treat a disease (Franz et al., 2007). Determining the cause of dementia is difficult and time consuming. As long as insurers, health systems and professional societies find it acceptable, doctors will find it easier and financially advantageous to opt out of investigating the cause of dementia. The price is paid in the quality of care patients receive. How can we expect treatment to improve when those providing care don't even know what disease they are treating? How can patients and families make difficult life-changing decisions when they are uncertain about cause of the problem and its likely course?
The Council also can begin to change expectations through its recommendations about research. The Council should prioritize research that expands the evidence base evaluating the value in clinical practice of knowing the cause of dementia. Research centers should be encouraged to begin generating data addressing the relevance of improved accuracy and specificity of diagnosis. Validated measures of high quality care outcomes relevant to clinical care are necessary to change existing practice expectations among insurers and providers. Our concept of treatment should be expanded beyond drug treatments and to populations reflecting clinical practice, rather than highly selected groups needed for mechanistic and proof-of-concept studies.
We who are most committed to improving the quality of life of patients with dementia and their families must agree on the simple proposition that determining the cause of cognitive impairment should be a fundamental expectation in clinical practice. Peer expectations are critical in clinical practice. We must help define those expectations. Otherwise, our patients will be sentenced forever to poor quality care. Caring without knowing causation is well-intentioned kindness, but it's not medicine.
Connell CM, Kole S, Avey H, Benedict CJ, Gilman S. Attitudes about Alzheimer's disease and the dementia service delivery network among family caregivers and Foster, Page 5 of 6 service providers in rural Michigan. Am J Alzheimers Care Relat Disord Res 1996;11:15-25.
Franz CE, Barker JC, Kravitz RL, Flores Y, Krishnan S, Hinton L. Nonmedical influences on the use of cholinesterase inhibitors in dementia care. Alzheimer disease and associated disorders 2007;21:241-248.
Geldmacher DS, Kirson NY, Birnbaum HG, et al. Implications of early treatment among Medicaid patients with Alzheimer's disease. Alzheimers Dement 2014;10:214-224.
Knopman DS, DeKosky ST, Cummings JL, et al. Practice parameter: diagnosis of dementia (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2001;56:1143- 1153.
Moyer VA. Screening for Cognitive Impairment in Older Adults: U.S. Preventive Services Task Force Recommendation Statement. Annals of internal medicine 2014.
Qaseem A, Snow V, Cross JT, Jr., et al. Current pharmacologic treatment of dementia: a clinical practice guideline from the American College of Physicians and the American Academy of Family Physicians. Ann Intern Med 2008;148:370-378.
Conflicts of Interest for Norman L. Foster, MD:
Dr. Foster receives a salary from the University of Utah as a faculty member through reimbursed clinical services, and for administrative and teaching activities. He provides unpaid services to the Alzheimer's Association, the American Academy of Neurology, the Society of Nuclear Medicine and Molecular Imaging, as a member of the Utah State Plan Task Force, the Working Interdisciplinary Network of Guardianship Stakeholders, and a number of other community organizations.
Within the past twelve months, Dr. Foster has received personal compensation from Bristol-Myers Squibb, GE Healthcare, the National Association for Continuing Education and Sanofi for consulting activities.
Within the past twelve months, Dr. Foster has received research support for clinical trials from GE Healthcare, the Center for Health Improvement, Merck, and Lilly.
Dr. Foster also has received research support within the past year from the National Institutes of Health, and the Veterans Affairs Office of Rural Health.
He is CEO and co-owner of Proactive Memory Services, Inc., a University of Utah forprofit start-up company developing a mobile application to improve the quality of care for cognitive concerns.