National Alzheimer's Project Act: Public Comments on Advisory Council Meeting, April 2012

12/28/2015

ADVISORY COUNCIL ON ALZHEIMER'S RESEARCH, CARE, AND SERVICES

Public Comments on Advisory Council Meeting, April 2012

List of Comments

   

Comments and questions, or alerts to broken links, should be sent to napa@hhs.gov.
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.


 

C. Rodgers  |  05-15-2012

I just realized I never sent you the comments I made at the April 17 meeting. Attached please find both Word and PDF files of my comments, which I am providing for the public record. Thank you,

ATTACHMENT:

Of Alzheimer's, the scientific method & educated guesses

My name is Caroline Rodgers. Some of you may recall that in January, I presented my hypothesis that Alzheimer's disease is caused by dental X-rays shortening the lifespan of the brain cells that keep sustain neurons, fatally stranding them (1). The article it was based on was reviewed by scientists specializing in Alzheimer's, neurology or radiology during manuscript development and in the course of peer review before it was published in Medical Hypothesis last July (2).

But that's not what I am here to talk about.

I am here to talk about the scientific method versus expediting answers. Thomas Edison was a great one for applying scientific method. He exemplified how persistence can conquer multiple failures when he had his lab test 10,000 different filament substances before finding tungsten. That was a great feat, but he was only looking for a way to light up the world that was already aglow with candles.

Alzheimer's is different. Darkness is descending on the minds of the elderly and the not-so-elderly with savage rapidity. Every day we fail to discover what is causing Alzheimer's and how to treat it, countless more individuals are doomed to losing their minds and ultimately, their lives in a manner that does not go gently into the night. We don't have the time to test 10,000 possibilities -- we need ask new questions and to make educated guesses that will vault us into new territory.

Clinical trials are the "gold standard" of evidence-based medicine. But when a treatment does not pass a clinical trial, it is not gold, it is lead. Recently one scientist involved with clinical trials of Alzheimer's drugs said that some 100 treatments were in the works, most of which targeted brain plaques. Since more than one clinical trial of a plaques-clearing treatment has been halted for doing more harm than good, it is time to consider that clearing plaques is not the answer and no alchemy can turn it into gold.

Meanwhile, we can't afford the time and money to be as systematic as Edison -- we need educated guesses that, like leaps of faith, close the gap quickly. The answer is probably a simple one; the very speed with which Alzheimer's has become a killer argues against a complex etiology, since the more factors required for an outcome, the more difficult it is to meet all of the conditions necessary to cause it. Plus, simple answers are easily overlooked, which is why it took nearly 300 years for scientists to discover that rickets was caused by a lack of sunshine.

Are dental X-rays causing Alzheimer's? I can't answer that question because my hypothesis has yet to be tested. But I'm told it would take only about $20,000 to launch a pilot study that could bring us closer to the truth. We need to investigate this and other out-of-the-box ideas. While the Research Subcommittee's draft recommendations call for timelines, strict metrics and cooperation among what it terms "industry players," we need to go beyond these business models and find ways to attract and fund fresh avenues of Alzheimer's research. While scientific method is important, if it is not used to explore creative educated guesses it may be a long time before we strike gold.

Thank you.

  1. See earlier comments at C. Rodgers.
  2. http://www.medical-hypotheses.com/article/S0306-9877(11)00118-6/abstract

J. Alfano  |  04-25-2012

My name is James Alfano. I am a physical therapy student at Thomas Jefferson University in Philadelphia, PA. I was recently doing some research on Alzheimer's legislation for my "Geriatrics" course when I came across the National Alzheimer's Project Act. After reading more about NAPA online, I was pleased to see that the Advisory Council welcomes public comments. While I understand that the April 17th Advisory Council meeting just passed, if it is at all possible, I would like to include the following comment for consideration at the next meeting.

Having a grandmother with Alzheimer's disease, I understand how emotionally difficult, physically taxing and financially burdensome this disease can be for a family. As my grandfather has become older and less able to take care of her, my mother and aunts have stepped up and given up much of their free time to care for her. However, with all of them working, a home health aide is needed.

Over the past couple of years, my grandmother has had numerous aides because the previous one decided that she could no longer make the commute or take care of my grandmother, among other reasons. While I understand there are legitimate reasons why an aide can no longer work with a particular patient, my family and I often felt that the aides were dictating terms to the home health agency in that they chose when and where they wanted to work and for how long. Their unreliability presented as a burden for my family and was traumatic for my grandmother who has difficulty adjusting to the new people due to her cognitive limitations.

I believe a system that makes the aides more accountable to the individuals they are assigned to care for would be beneficial, possibly through more education or training. I also believe the directors of home health agencies should be required to have a medical background so that they would be better able to understand a patient's needs and assign appropriate aides to the individuals requiring care, especially to those with dementia.

Thank you for your time and consideration of this matter.


J. Ross  |  04-20-2012

How do I reach out to Dr. William Shrank, MD at the CMMI?

Dr. Ling sent me his email but no response as of yet. I wish to apply for a demonstration project to improve the quality of care for patient with AD using a "wrap around" at risk approach which was outlined in m letter to you a few weeks back (see attached).

ATTACHMENT:

I am Joel S Ross MD. I have provided medical care for over 10,000 victims of Alzheimer's Disease since starting my comprehensive geriatric and Alzheimer's Disease practice in 1986. I would like to present my comments on the NAPA plan. I am a member of the advisory panel of NAPA and through my organization, The Memory Enhancement of America we provide an unprecedented level of care and treatment to all those afflicted with memory loss/mild cognitive impairment and dementia due to Alzheimer's Disease.

I would desire to discuss the urgent need to open a demonstration project in our 6th congressional district.

This Memory Evaluation and Treatment Center (METC) will provide complete and comprehensive management for mild, moderate and severe stages of Alzheimer's Disease. Funded in part by the a portion of the 83 million dollars signed into law by President Obama it shall include but not limit itself to providing medical/nursing/social/psychological care of AD patients as well as offer physical and occupational therapy; address the many ethical, financial and legal challenges this deadly disease poses to patients, caregivers and society in general. This METC will show cost effectiveness by reducing unnecessary hospitalization, reducing need for emergency room visits, delay nursing home if not eliminate the need for such placement as well as be a center of excellence for all other 434 Congressional districts in our wonderful nation. Pharmaceutical research of the highest caliber testing safety and efficacy of the latest medications in development will be a further extension of METC.

All at no cost to the patient. I propose that Medicare/Medicaid and a portion of NAPA money be used to test this METC concept and in a randomized study using a group of 200 AD patients assigned to traditional (fragmented and inefficient, standard of care) and comparing them to a similarly matched group of 200 AD patients assigned to METC care.

I and my many colleagues and other professional associates and organizations believe quite strongly and will prove a METC is the only place for AD patients to receive comprehensive, compassionate and welcomed care.

My bio is attached for your review.

I welcome the opportunity to speak at the April 17th meeting on behalf of the nearly 5.5 million victims of AD as well as for those who have died from this dreadful 100% fatal disorder.

Thank you for the time to consider my suggestions,


G. MacInnes  |  04-19-2012

Thank you for the opportunity to provide comments at the meeting of the Advisory Council on Alzheimer's Research, Care, and Services on Tuesday. A hard copy of the oral comments we shared is attached as well as a copy of the written comments we submitted previously.

ATTACHMENT #1:

On behalf of the Eldercare Workforce Alliance, a coalition of 29 national organizations committed to addressing the immediate and future workforce crisis in caring for an aging America, we thank you and the Advisory Council on Alzheimer's Research, Care, and Services for your work to forumulate the Draft National Plan to Address Alzheimer's Disease.

We commend the Council for its recognition of the vital importance of a strong workforce for realizing the goals of the Plan, as demonstrated in strategies 2.A and 2.C, which call for the building of a workforce with the skills to provide high-quality care, as well as the strategies under Goal 3, in support of family caregivers.

While the action items located under Strategy 2.A are significant, we remain concerned that the essential workforce goals identified by the Council cannot be realized without the investment of additional resources. Specifically, the action items calls for additional and enhanced activities within Geriatric Education Centers (GEC), the Comprehensive Geriatric Education Program (CGEP), the Geriatric Academic Career Awards Program (GACA), the Geriatric Training for Physicians, Dentists, and Behavioral and mental Health Providers (GTPD) program, and the Direct-Care Workforce training program. These programs, which are administered through the Health Resources and Services Administration (HRSA) under the Title VII and VIII of the Public Health Service Act, are in constant danger of defunding and have experienced stagnant funding that has not kept up with the pace of inflation, even as the need for preparation to care for older adults has skyrocketed. To implement these additional and enhanced activities in order to realize the goal of enhancing care quality and efficiency for the growing number of older adults with Alzheimer's disease and other multiple chronic conditions additional funding must be invested.

We believe that access to quality health care for older adults with cognitive impairment is vital to healthy aging and we commend you for your efforts. As the work of the committee continues, we welcome opportunities to work with you.

ATTACHMENT #2:

Eldercare Workforce Alliance Comments for
The Advisory Council on Alzheimer's Research, Care, and Services
April 17, 2012

On behalf of the Eldercare Workforce Alliance, a coalition of 29 national organizations committed to addressing the immediate and future workforce crisis in caring for an aging America, thank you for your work to formulate recommendations for operationalizing the Draft National Plan to Address Alzheimer's Disease.

We commend the Council for its recognition of the vital importance of a strong workforce for realizing the goals of the Draft Plan, outlined in strategy 2.A, which calls for the building of a workforce with the skills to provide high-quality care, as well as the strategies under Goal 3, in support of family caregivers.

While the action items outlined in the Draft Plan and the recommendations you have voted on here today are significant, EWA strongly urges the Council to consider the following comments in order to achieve the essential workforce goals identified in the Draft Plan: -

  • EWA strongly supports the Clinical Care Subcommittee's Recommendation #8 to invest additional funding in multidisciplinary geriatrics education and training programs under Title VII and VIII of the Public Health Service Act. Action items under Strategy 2.A of the Draft Plan call for additional and enhanced activities within these programs; however, they have experienced stagnant funding and constant threats of defunding, even as the need for preparation to care for older adults has skyrocketed. Some of the programs authorized in the Affordable Care Act have yet to receive appropriations. To implement the additional activities called for in the Draft Plan to enhance care quality and efficiency for the growing number of older adults with Alzheimer's disease and other multiple chronic conditions, additional funding must be invested.
  • EWA strongly supports the Clinical Care Subcommittee's recommendation to increase funding for loan repayments and other incentives for those who study geriatrics and gerontology. We recommend that geriatrics and gerontology be made permanently eligible via statute for federal loan forgiveness and other efforts to boost enrollment in these medical disciplines.
  • EWA strongly supports the Council's recommendations with regard to promotion of geriatric education offerings and the dissemination of information about Alzheimer's disease, dementia care, and support systems. EWA believes that geriatric competencies and dementia training should be included in training for all primary care clinicians and staff to improve detection, treatment and care for people with Alzheimer's disease.
  • EWA strongly supports the Long-Term Services and Supports Subcommittee's recommendations for health care provider training and for adequate training and compensation for paraprofessional caregivers. More specifically, we recommend that certified nursing aides and home care aides and their supervisors be required to take at least 120 of training, including explicit geriatric care and gerontological content; and that minimum training standards/competencies for non-clinical direct-care workers should be created and that they should be adequately compensated.
  • EWA urges the Council to consider more specific recommendations on improving access to Medicare and Medicaid funded home- and community-based care services to allow individuals with Alzheimer's disease to stay in their homes as long as possible.
  • EWA strongly supports the Council's recommendations to expand and increase funding for AoA programs such family planning and social services, research and development projects, and training in the field of aging; respite care; support services for family caregivers that can help reduce their burden.

We believe that access to quality health care for older adults with cognitive impairment is vital to healthy aging and we commend you for your efforts. As the work of the Council continues, we welcome opportunities to work with you to achieve the goals of the National Plan.


M. Harpold  |  04-18-2012

I am writing to follow up on my previous email below that included attached comments concerning the Draft National Alzheimer's Plan, to make sure that you did receive my email & comments (I have also attached another copy to this email). I understand that the next NA Plan Advisory Council meeting is scheduled for tomorrow, April 17, and also wanted to be sure the copy of my comments was submitted to the Advisory Council for consideration and appropriate discussion.

Could you confirm?

I understand the Advisory Council meeting tomorrow will be available for live streaming via the internet; am I correct that there will be no teleconference of the meeting or opportunities for external input?

Are there other recipients (or postings) relevant to the development of the Plan to which it would be appropriate to provide these comments?

==========

From: Michael Harpold

[Link to comments -- M. Harpold]


M. Ellenbogen  |  04-15-2012

Attached is my letter to be read at the NAPA April 17 meeting. I tried to keep it as short as possible, but I was afraid I would lose part of the message I was trying to convey. I would have liked to focus on only one or two points, but I felt they were all very important. Maybe some were in the middle of reading you can slam a book down to get everyone's attention to refocus at my request since I am not there to get their attention. I'll be watching.

Is there a way I can send you an email to a blackberry or something if I hear something that I would like to bring up last minute as I attend the meeting from home?

Thank you again for all this. You have no idea what it means to me to be able to be a participant in this project.

ATTACHMENT:

I cannot express enough the Urgency and need for interim goal at 2020 or earlier, victims cannot wait for treatment.

Resources ... 2020/2025 is goal critical but we need to mobilize the will, the plan and the resource to get there as quickly.

Save time, money and lives, by not reinventing the wheel. Use the finished HIV model. I am a firm believer that the people before us have laid the framework needed to get started so we are not wasting a lot of time on the basics. The only approach I always followed along with that is, to delete, enhance and critique to make the plan even better. Ask the previous plan makers what they did wrong and what would they do different. Ninety percent of that framework came from the best of many minds. I really believe the input and suggestions made by Bruce Lamb, in his letter from January 13, 2012 should be discussed when building this framework.

One thing that keeps coming to mind is the disparity issue related to AD. Am I the only one that sees this, or do we all just not want to talk about it? For example, AD was first identified and named in 1906, while AIDS was identified in 1981. I see us now in the same stages as HIV was in 1988, when a focused effort was begun towards treatment or cure, with the creation of The Office of AIDS Research. It took an additional 5 years to strengthen this OAR (The NIH Revitalization Act), which really made a huge difference. Within three years of that day and by 1996 we started to finally have an impact on AIDS.

Let's not make a similar mistake as we did with HIV. Let's create a diseased focused agency for AD, with all the necessary strength, as of day one. Just think you can make up for the disparity that has been created and just maybe we could have a cure in less than 5 years.

Leadership ... the President himself needs to speak out because we need everybody at the table -- not just Federal government, but industry, research community, victims and affected families, people of all ages -- and only he is in a position to provide that leadership.

Government should consider offering a large sum of money to anyone who can come up with the cure for this disease first. While I am not sure what that amount should be, it can be in cash and partial tax credits. I think that will drive many more into this arena and more efforts if the pie is big enough.

Bruce Lamb shared his viewpoints on January 13, 2012, which were very interesting. I really like these paragraphs below and we should all learn from them. Bruce makes very good points on how to evaluate the adequacy of Alzheimer's funding.

If one assumes that funding for HIV/AIDS was right sized to enable translation of basic discoveries to successful therapies, then given the lack of effective AD therapies, one possible implication is that funding for AD has been insufficient. A quick comparison of funding levels for HIV/AIDs relative to AD in the United States suggests this may be at least one factor that has hindered the translation of AD discovery to effective therapies. Based on publicly available data, National Institute of Health funding for HIV/AIDS in the United States is currently approximately $3 billion [5]. With approximately 1 million HIV-positive subjects in the United States, this equates to $3,000 of NIH funding per person with HIV/AIDs. In contrast, current NIH funding for AD is at a level of approximately $450 million [5], with perhaps another approximately $100 million to $200 million in NIH funding that might have some relevance to the study of AD (cognitive decline in aging, related neuro degenerative conditions). With a current prevalence of approximately 5 million individuals affected with AD in the United States, this equates to a maximum of $130 of NIH funding per person affected with the disease. So, on a per affected individual basis, NIH funding for HIV/AIDs is 23 times the level of that for AD.

Of course, there are many different ways to evaluate proportional or relative funding. Another one that is quite germane is economic impact. For AD in the United States this is estimated at more than $170 billion per year (and worldwide at $600 billion per year) [6]. Again focusing only on the United States, the yearly funding for research by the NIH represents 0.4% of the yearly costs of the disease in the United States. In other words, for every $2 the disease costs the United States, we spend less than 1 cent on research.

I would like to thank everyone for their hard work to date, but even more important is for you to actually follow through on the promises and plans. I am counting on you!


J. Ross  |  04-06-2012

I am Joel S Ross MD. I have provided medical care for over 10,000 victims of Alzheimer's Disease since starting my comprehensive geriatric and Alzheimer's Disease practice in 1986. I would like to present my comments on the NAPA plan. I am a member of the advisory panel of NAPA and through my organization, The Memory Enhancement of America we provide an unprecedented level of care and treatment to all those afflicted with memory loss/mild cognitive impairment and dementia due to Alzheimer's Disease.

I would desire to discuss the urgent need to open a demonstration project in our 6th congressional district. This Memory Evaluation and Treatment Center (METC) will provide complete and comprehensive management for mild, moderate and severe stages of Alzheimer's Disease. Funded in part by the a portion of the 83 million dollars signed into law by President Obama it shall include but not limit itself to providing medical/nursing/social/psychological care of AD patients as well as offer physical and occupational therapy; address the many ethical, financial and legal challenges this deadly disease poses to patients, caregivers and society in general. This METC will show cost effectiveness by reducing unnecessary hospitalization, reducing need for emergency room visits, delay nursing home if not eliminate the need for such placement as well as be a center of excellence for all other 434 Congressional districts in our wonderful nation. Pharmaceutical research of the highest caliber testing safety and efficacy of the latest medications in development will be a further extension of METC.

All at no cost to the patient. I propose that Medicare/Medicaid and a portion of NAPA money be used to test this METC concept and in a randomized study using a group of 200 AD patients assigned to traditional (fragmented and inefficient, standard of care) and comparing them to a similarly matched group of 200 AD patients assigned to METC care.

I and my many colleagues and other professional associates and organizations believe quite strongly and will prove a METC is the only place for AD patients to receive comprehensive, compassionate and welcomed care.

My bio is attached for your review.

I welcome the opportunity to speak at the April 17th meeting on behalf of the nearly 5.5 million victims of AD as well as for those who have died from this dreadful 100% fatal disorder.

ATTACHMENT:

Biographical Sketch:

Joel S Ross, M.D., FACP, AGSF, CMD CPI - Dr Ross is a Primary Care Geriatrician and Principal Investigator at Memory Enhancement Centers of America located in Eatontown, Monroe Township and Toms River, New Jersey. Dr. Ross is the Founder and Chief Executive Officer of the Memory Enhancement Centers of America which are state of the art facilities dedicated to improving the quality of lives of those struggling with dementia such as Alzheimer's Disease including the caregivers. By working closely the pharmaceutical industry and the Food and Drug Administration our centers conduct the most state of the art diagnostic and therapeutic intervention using latest medications under development.

Dr. Ross has been Principal Investigator or Sub-investigator on nearly every medications tested for Alzheimer's disease in clinical trials since 1994 including the four FDA approved medications: Aricept/Exelon/Razadyne and Namenda. Dr Ross has conducted over one hundred Alzheimer's Disease research protocols as the Principal Investigator. He has lectured worldwide on Alzheimer's Disease. Dr Ross received his medical degree from Downstate Medical Center, Brooklyn, New York, where he graduate Cum Laude. He completed his internship and residency at Nassau County Medical Center, in East Meadow, New York, where he then became Chief Resident. He is certified in Geriatric Medicine, Internal Medicine and a Certified Physician Investigator by the Association of Clinical Research Professionals. He was the founding member of the geriatric fellowship program at Jersey Shore Medical University and in 2000 was recognized as an "advocate for excellence" as program director-Geriatric Residency at Jersey Shore Medical University. Dr Ross was awarded the "top doctor" in the field of Geriatric Medicine in New Jersey by his peers.

Dr. Ross has an adjunct Associated Professor of Medicine appointment to Mount Sinai Medical School New York, New York since 2002 and is a Clinical Associate Professor of Medicine at UMDNJ-School of Osteopathic Medicine, Stratford, New Jersey since 1996. Dr Ross was appointed to the Drexel University School of Medicine as a Clinical Adjunct Professor of Medicine in 2009. He is on the staff of Monmouth Medical Center, Long Branch, NJ.

Dr Ross received the Humanitarian of Year Award in 2011 from the Alzheimer's Disease Caregivers of Central NJ.


M. Harpold  |  03-29-2012

I am uncertain whether my comments on the Draft National Plan to Address Alzheimer's Disease (see attached) are most appropriate to be sent to you, as liaison with the Advisory Council, and/or napa@hhs.gov (representing address for public comments), as I am unclear whether there is a distinction. I believe my comments may be most appropriate and relevant for the Advisory Council and their considerations, and therefore sending to you. Please let me know if I should also send directly to napa@hhs.gov.

I appreciate the opportunity to participate in the March 14 Advisory Council teleconference as well as the opportunity to submit my comments on the Draft National Plan to Address Alzheimer's Disease and its importance for the more than 400,000 individuals with Down syndrome in the US and their families and caregivers as well as associated stakeholders. More explicit inclusion of Down syndrome as integral to the Plan, particular concerning fundamental, translational and clinical research, will be important for accelerating progress and success not only for individuals with Down syndrome, and associated very high Alzheimer's disease neuropathology and dementia, but also for the entire population that will develop or currently have Alzheimer's disease.

Should you have any additional questions etc., please do not hesitate to contact me.

ATTACHMENT:

Comments Regarding Draft National Plan To Address Alzheimer's Disease
March, 2012

Thank you for the development of the Draft National Plan to Address Alzheimer's Disease, and for the opportunity to submit comments.

The Down Syndrome Research and Treatment Foundation is a national/international 501(c)(3) nonprofit organization with the mission to stimulate and support biomedical research that will accelerate development of treatments to significantly improve cognition, including memory, learning and speech, for children and adults with Down syndrome. The major objectives include creating new opportunities for all Individuals with Down Syndrome to: 1) Lead more independent lives; 2) Participate more successfully in schools & employment; and 3) Prevent additional early cognitive decline with aging & Alzheimer's disease. Since its founding in 2004, DSRTF, through its novel research strategy and grants program, has identified and substantively supported much of the research that has led to the recent rapid and unprecedented advances in Down syndrome cognition research and the first clinical trial with a novel drug candidate to focus on as a primary indication and specifically address overcoming cognitive and behavioral impairments in individuals with Down syndrome by a major international pharmaceutical company, Roche.

We acknowledge and appreciate the explicit recognition, inclusion and designation of attention to intellectual disabilities populations as unequally burdened by Alzheimer's disease within Strategy 2.H: Improve care for populations disproportionally affected by Alzheimer's disease and for populations facing care challenges. However, this is far too limited within the overall plan; it is more than just initiatives addressing only care. As discussed further below, there is a very strong rationale to explicitly include Down syndrome in each of the strategies, and designated strategic sub-actions, comprising the National Alzheimer's Plan and resulting initiatives, and Strategy 1 involving fundamental, translational and clinical research in particular.

As research has documented, virtually all individuals with Down syndrome, now numbering more than 400,000 individuals in the US, develop the characteristic neuropathology associated with Alzheimer's disease by age 40. Research has also shown that, very conservatively, at least 25% increasing to 75% or more of the individuals with Down syndrome between the ages of 40-60 develop the signs and symptoms of Alzheimer's-type dementia and the percentage increases with age. These facts underscore the very significant and important relevance of this population as a key and explicit element to be included not only in the National Alzheimer's Plan but also in the development and implementation of all aspects of the Plan, including research (fundamental, translational, and clinical) to effectively prevent and treat Alzheimer's disease, enhancing care quality and delivery, and expanding supports for people with Alzheimer's disease and their families. Given these facts, explicit and integral inclusion and consideration of Down syndrome in the Plan and associated initiatives can not only significantly address the significant number of individuals with Down syndrome but also the larger non-Down syndrome population developing or with Alzheimer's disease. This requires significant increases in awareness and rational considerations among researchers and clinicians, which can be partly addressed through explicitly including Down syndrome more prominently in the Plan as well as in resulting initiatives and increased proportional funding.

Given the significant size of the Down syndrome population (>400,000 in the US, and up to 10-times that number worldwide) and the virtual certainty that the individuals will develop the characteristic neuropathology of Alzheimer's disease and ultimately the associated dementia further compromising their cognition and life, inclusion of Down syndrome, particularly in the research initiatives (fundamental, translational, and clinical) would significantly contribute important novelty, unavailable otherwise, to as well as enhance and accelerate essentially all aspects of the major objectives specified under Goal 1: Prevent and Effectively Treat Alzheimer's Disease by 2025 as well as Goal 2. NIH grants and funding for all of Down syndrome research have remained disproportionately very low, e.g. $20M in FY 2011. This includes a much smaller and too limited subset of research grants investigating the aspects of Alzheimer's disease associated with Down syndrome. As only one contrasting example, explicit and significant attention and funding by NIH and its Alzheimer's disease research initiatives, both basic and translational, have been targeted to so-called dominantly inherited Alzheimer's disease, both basic and translational (see e.g., the DIAN initiative) that is much more rare and with a much smaller population. In both Down syndrome and dominantly inherited Alzheimer's disease myriad research has confirmed the significant involvement of the same gene, APP, and its products (The APP gene is located on human chromosome 21, the chromosome trisomic in Down syndrome, as are a number of additional genes demonstrated to be involved in mechanisms associated with Alzheimer's disease.). Through more detailed and sufficient investigations in the Down syndrome population, researchers can obtain invaluable insight into how and why Alzheimer's disease develops, and can compare and extend their findings to the much more common late-onset sporadic Alzheimer's disease as well as enhance and accelerate development of new therapeutics. The relevant trajectory to Alzheimer's disease and size of the Down syndrome population provides a strong rationale for greater recognition and explicit inclusion in the National Alzheimer's Disease Plan and resulting Alzheimer's disease fundamental, translational and clinical research initiatives.

Although by no means an attempt to thoroughly include detailed or exhaustive rationale and recommendations in these comments here, in addition to the suggestions and requests above with respect to more prominent and explicit integral recognition and inclusion of Down syndrome in the ultimate version of the National Alzheimer's plan, I submit the following recommendations for further consideration:

  • Explicitly recognize and include discussion and components specifically involving Down syndrome in Goal 1 as well as each of the proposed "Actions" under Strategy 1A, including Actions 1.A.1-5.
  • Explicitly recognize and include discussion and components specifically involving Down syndrome in Strategy 1.B. including Actions 1.B.1-6. This would include not only research in animal models of Down syndrome, but with respect to human clinical studies explicit designation and inclusion of relevant and appropriate cohorts of individuals with Down syndrome, together with and/or in parallel/addition to those clinical studies initiatives involving non-Down syndrome cohorts. The results would be expected to be mutually informative and beneficial.
  • Explicitly recognize and include discussion and components specifically involving Down syndrome in Strategy 1.C. including Actions 1.C.1-2. Again, given that essentially every individual with Down syndrome develops the characteristic neuropathology associated with Alzheimer's disease by age 40 with a significant proportion also developing the signs and symptoms of Alzheimer's-type dementia and further increases with age earlier, inclusion of relevant and appropriate cohorts of individuals with Down syndrome, together with and/or in parallel/addition to these research initiatives involving non-Down syndrome cohorts would uniquely provide important relevant and additional information, insights, direction and acceleration of success.
  • As is true for Alzheimer's disease research and development, relevant Down syndrome research is ongoing, and increasing, internationally. It will be important to coordinate with and expand relevant Down syndrome research internationally and collaboratively. Therefore, explicitly recognize and include discussion and components specifically involving Down syndrome in Strategy 1.D. including Actions 1.D.1-2.
  • Explicitly recognize and include discussion and components specifically involving Down syndrome in Strategy 1.E. including Actions 1.E.1-3. With respect to Action 1.E.1., again, given that essentially every individual with Down syndrome develops the characteristic neuropathology associated with Alzheimer's disease by age 40 with a significant proportion also developing the signs and symptoms of Alzheimer's-type dementia and further increases with age earlier, inclusion of relevant and appropriate cohorts of individuals with Down syndrome, together with and/or in parallel/addition to these research initiatives involving non-Down syndrome cohorts would uniquely provide important relevant and additional information, insights, direction and acceleration of success. With respect to Action 1.E.2., inclusion of private-public collaborations and partnerships between Federal entities such as NIH and non-governmental nonprofit organizations such as DSRTF with its focus on Down syndrome cognition research will enhance productivity, accelerate significant progress and success as well as minimize duplications of efforts and resources. With respect to Action 1.E.3., the critical importance of the increasing development and very significant impact of Alzheimer's disease on individual with Down syndrome and their families and care givers underscores the importance of involvement and communication with this community and associated stakeholders.
  • As indicated above, given the particular and significant relevance and importance of and impact of Alzheimer's disease on the relatively large population of individuals with Down syndrome, their families and caregivers as well as the healthcare system, it is not sufficient to generally designate "intellectual disabilities" in only Strategy 2.H. "Down syndrome" should be explicitly included in proposed Strategies 2.A.-H., 3.A.-E., 4.A.-B. and each of the Actions included under those strategies. Therefore, explicitly recognize and include discussion and components specifically involving Down syndrome in Strategies 2.A.-H., 3.A.-E., 4.A.-B. and each of the Actions included under those strategies.
  • Finally, based on the comments, rationale and recommendations outlined above, we would encourage and recommend that a representative from the Down syndrome community be added to the National Alzheimer's Project Act (NAPA) Advisory Council, as the important deliberations, priorities and implementation will have mutual benefits to science/research, clinical care, and long term care not just additionally for individuals with Down syndrome and associated Alzheimer's disease but also for the broader population and research efforts involving Alzheimer's disease.

I would be very pleased to further discuss, as may be helpful and informative, any aspects of the above concerning the importance of explicit inclusion and considerations of Down syndrome relating to Alzheimer's disease in further detail with those involved in developing the National Plan, including members of the Advisory Committee. I have registered for and plan to attend the upcoming May 14-15 NAPA/NIH Alzheimer's Disease Research Summit in Bethesda, and look forward to the opportunity for further discussion of the importance and relevance of Down syndrome for the Plan and its successful implementation as outlined above.


C. Rodgers  |  01-20-2012

Attached please find a PDF of the PowerPoint I prepared for the 1-17-2012 public comments. I am also attaching a Word file and a PDF of the text to the presentation. Both files the PowerPoint and text files contain more information than time allowed me to present in person.

Thank you in advance for posting both the PowerPoint and text file on the website.

ATTACHMENT #1:

Are Dental X-rays Causing the Alzheimer's Epidemic? [Available as a separate link: http://aspe.hhs.gov/daltcp/napa/Comments/cmtach34.pdf]

ATTACHMENT #2:

Are dental X-rays causing Alzheimer's disease?

Good afternoon. My name is Caroline Rodgers. I am a researcher and writer specializing in public health issues.

I am sure that everyone here would agree that Alzheimer's disease has turned the prospect of aging into a scary and uncertain future that will rob many of us of our memories, our dignity and even our lives. I am here because I envision a world in which Alzheimer's is once again a rarity and our senior years are a true Golden Age.

Last year my article proposing that dental X-rays are causing Alzheimer's disease was published in the Journal of Medical Hypotheses1. I also made a poster presentation on the subject at the 2011 Alzheimer's Association International Conference2.

The technical explanation of my hypothesis is:

Ionizing radiation from dental X-rays shortens the telomeres of microglia, which are critical to maintaining neuronal health. This reduces the lifespan of microglia, stranding neurons. Stranded neurons subsequently die, causing irreversible dementia.

More simply stated:

Head exposure to low-dose ionizing radiation is causing us to outlive the brain cells designed to support our neurons all lifelong.

NOTE: Dental X-rays are the only form of ionizing radiation that virtually all Americans are routinely exposed to at regular intervals throughout their entire lives, starting in early childhood. Although low-dose ionizing radiation amounts have been compared to background radiation exposure received during long airline flights, the amount of whole-body ionizing radiation received cannot be fairly compared to the amount beamed directly into the head.

It is not realistic to believe that decades of dental X-ray exposure would be without consequence for all people. The question is not, "Why should we consider whether dental X-rays are causing Alzheimer's," but rather, "Why didn't we think of this sooner?"

Hypothesis foundation:

  1. Alzheimer's prevalence data
  2. Population-based dental care information
  3. Scientific studies1-4

Dental care & dementia: A sampling of countries

INDIA

67% have never visited a dentist5
Dementia prevalence estimated at 1/5 -1/4 that of Europe's6

CHINA

30% to 43% adults have never visited a dentist7
Dementia prevalence about half of Europe's6

UNITED STATES

1% have never visited a dentist8
13% of people 65 and older have AD9

Let's test this hypothesis against the facts

FACT: The emergence of AD symptoms is delayed 10 or more years following the presence of AD brain pathology.

Microglial telomere shortening would have a delayed effect on neurons because it reduces microglial lifespan, not function.

FACT: AD mortality increased rapidly after 1979, making it the sixth leading cause of death by 2000.

Since AD symptoms are delayed by 10 or more years, it is worthwhile to look at health trends taking place in the decades before the surge in AD mortality. This was a time of major changes in the nation's dental health habits.

1940 it wasn't until the '40s that X-ray machines were common in America's dental offices10. However, nearly two decades later, in 1954 . . .
1957 only 37% had visited a dentist within the year, while 18% reported never visiting a dentist11.
2008 59% had visited a dentist within the year, with only 1% never having visited a dentist8.
2010 The national average that had been to a dentist or dental clinic within the year was 69.7%9

FACT: The hippocampus is one of the first brain regions to suffer AD-related damage.

It contains both microglia and neural progenitor cells which -unlike other mature brain cells -- keep dividing, making them more susceptible to radiation-induced damage.

FACT: Men die sooner than women following an AD diagnosis12.

Older men have shorter telomeres than women the same age13, so they would have less time if their microglia telomeres were prematurely shortened.

FACT: Virtually all people with Down syndrome have AD brain pathology by age 40 -- but there is a wide variance in the onset of dementia14,15.

People with Down syndrome lose telomere length faster than the general population, but just like others, there is variation in newborn telomere length16,13. Also, people with Down syndrome are subject to many genetic dental anomalies that could entail additional X-ray exposure.

FACT: AD prevalence is higher in urban areas17.

City dwellers make more dental visits18.

FACT: AD is increasing most rapidly in developing countries -- especially Latin America6.

In the last few decades, many countries started providing free dental care to all citizens, such as Cuba in 1976, Venezuela in 1999 and Brazil in 2004,.

FACT: AD does not respond to anti-inflammatory or cholesterol-lowering drugs -- even though AD is associated with brain inflammation and high cholesterol19,20 .

Neither treatment can help neurons that have lost their support system.

FACT: Mentally stimulating activities initially delay AD, yet ultimately accelerate it21.

Additional brain growth would eventually overwhelm microglia struggling to support existing neuronal networks.

If dental X-rays are causing Alzheimer's, it raises new questions and concerns, such as:

  • Could diligent dental care explain the increase in non-familial early-onset AD?
  • At what price, a smile: What are the long-term risks for orthodontia patients exposed to cone-beam CT scanners that create 3-D images -- at much higher radiation levels?
  • Could head X-rays after sports injuries contribute to early-onset dementia?
  • If dental X-rays pose risks, could brain imaging utilizing ionizing radiation to monitor AD accelerate disease progression?
  • Do plateaus in declining cognition relate to intervals between X-ray exposures?
  • Could the ratio of dental professionals to population be used to create accurate algorithms to predict dementia trends?

What are the prospects for Alzheimer's prevention, treatment or cure?

If dental X-rays are causing Alzheimer's disease, future cases can be decreased by eliminating or strictly limiting dental X-rays. Dentists can also turn to alternative imaging technologies already developed, yet not in common use. Interventions for people already exposed to dental X-rays yet without AD symptoms could include developing ways to safely transplant self-donated bone marrow or dental stem cells to replenish microglia populations. Other possibilities would be to develop ways to preserve or even lengthen microglia telomere length or to selectively remove permanently senescent microglia cells to stimulate replacement microglia that would actively provide neuroprotection. Sadly, there is no evident cure for people who have already lost their microglial support system to the point where enough neurons have died to cause symptoms.

Closing comments

I don't know the answer to the questions I have raised in this short talk. I do, however, know that we have to look in new places with open minds to solve the puzzle of AD's emergence as a major killer and to restore health, dignity and luster to our "golden years."

REFERENCES

  1. Rodgers, CC. Dental X-ray exposure and Alzheimer's disease: a hypothetical etiological association. Med Hypotheses. 2011;77(1):29-34. Epub 2011 Mar 31.
  2. Alzheimer's Association International Conference (AAIC) 2011. (PA-382)
  3. Streit WJ, Braak H, Xue QS, et al. Dystrophic (senescent) rather than activated microglial cells are associated with tau pathology and likely precede neurodegeneration in Alzheimer's disease. Acta Neuropathol. 2009;118(4):475-85. Epub 2009 Jun 10.
  4. Xue QS, Streit WJ. Microglial pathology in Down syndrome. Acta Neuropathol. 2011;122(4):455-66. Epub 2011 Aug 17..
  5. Kalm M, Lannering B, et al. Irradiation-induced loss of microglia in the young brain. J Neuroimmunol. 2009;206(1-2):70-5. Epub 2008 Dec 13.
  6. Grodstein F, van Oijen M, Irizarry MC, et al. Shorter telomeres may mark early risk of dementia: preliminary analysis of 62 participants from the nurses' health study. PLoS One. 2008;3(2):e.1590.
  7. Indo-Asian News Service. 67 percent Indians have never visited a dentist: Survey. Aug 22 2009. http://www.thaindian.com/newsportal/health1/67-percent-indians-have-never-visited-a-dentist-survey_100236506.html Accessed Jul 9 2010.
  8. Llibre Rodriquez JJ, Ferri CP, Acosta D, et al. Prevalence of dementia in Latin America, India, and China: a population-based cross-sectional survey. Lancet. 2008:372(9637);464-74. Epub 2008 Jul 25.
  9. Zhu L, Peterson PE, Wang HY, et al. Oral health knowledge, attitudes and behaviour of adults in China. Int Dent J 2005;55(4):231-41.
  10. The Kaiser Family Foundation, statehealthfacts.org. Data source: The National Oral Health Surveillance System, The Centers for Disease Control and Prevention (CDC), based on the Behavioral Risk Factor Surveillance System (BRFSS). http://www.statehealthfacts.org/comparebar.jsp?ind=108&cat=2&sub=30&yr=138&typ=2&sort=a&o=a Accessed 1-20-2012.
  11. S Pleis JR, Lucas JW, Ward BW. Summary health statistics for U.S. adults: National Health Interview Survey, 2008. Vital Health Stat . 2009;10(242):1-157.
  12. Alzheimer's Association. 2011 Alzheimer's Disease Facts and Figures. http://www.alz.org/downloads/Facts_Figures_2011.pdf Accessed Jan 132012.
  13. Frommer HH. The History of Dental Radiology. Tex Dent J. 2002:119(5):416-21, 423.
  14. U.S. National Health Survey. Dental care interval and frequency of visits. United States July 1957-June 1959. Washington, U.S. Dept. of Health, Education, and Welfare, Public Health Services, Division of Public Health Methods, 1960 .
  15. Larson EB, Shadlen MF, Wang LI, et al. Survival after Initial Diagnosis of Alzheimer Disease. Ann Intern Med 2004;140(7):501-9 .
  16. Benetos A, Okuda K, Lajemi M, et al. Telomere length as an indicator of biological aging: the gender effect and relation with pulse pressure and pulse wave velocity. Hypertension 2001;37(2 Part 2):381-5.
  17. Karlinsky H. Alzheimer's disease in Down's syndrome. A review. J Am Geriatr Soc. 1986;34(10):728-34.
  18. Stanton LR, Coetzee RH. Down's syndrome and dementia. Advances in Psychiatric Treatment. 2004;10:50-8. http://apt.rcpsych.org/content/10/1/50.full.pdf+html Accessed Jan 15 2012.
  19. de Arruda Cardoso Smith M, Borsatto-Galera B, Feller RI, et al. Telomeres on chromosome 21 and aging in lymphocytes and gingival fibroblasts from individuals with Down syndrome. J Oral Sci. 2004;46(3)171-7.
  20. World Health Organization. Mental Health and Substance Abuse. Facts and Figures, Alzheimer's Disease: the Brain Killer. http://www.searo.who.int/en/Section1174/Section1199/Section1567/Section1823_8066.htm Last update Aug 18 2006. Accessed Jul 7 2010.
  21. Fos P, Hutchison L. (2003) The State of Rural Oral Health: A literature review. Rural Healthy People 2010: A companion document to Healthy People 2010. Vol. 2. College Station. TX: The Texas A&M University System Health Science Center, School of Rural public Health, Southwest Rural Health Research Center.
  22. McGuinness B, O'Hare J, Craig D, et al. Statins for the treatment of dementia. Cochrane Database Syst Rev.2010: Aug 4;(8):CD007514.
  23. ADAPT Research Group, Martin BK, Szekely C, et al. Cognitive function over time in the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT): results of a randomized, controlled trial of naproxen and celecoxib. Arch Neurol 2008;65(7):896-905. Epub 2008 May 12.
  24. Wilson RS, Barnes LL, Aggarwal NT, et al. Cognitive activity and the cognitive morbidity of Alzheimer disease. Neurology 2010;75(11):990-6. Epub 2010 Sep 1.

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