The 21st Century Cures Act
The GHPI supports the inclusion of cures against aging-related ill health as an indispensable part of the US medical system.
Brief: The 21st Century Cures Act
Summary:
The 21st Century Cures Act (House Resolution 6 is a bi-partisan proposal introduced by from Congressman Fred Upton (R-MI) and introduced May 19 2015 and assigned to the House Energy and Commerce Committee chaired by Rep. Upton. Representative Diana DeGette as the cosponsor and 230 cosponsors, received a favorable vote of 344 – 77 in the House and on July 13, 2015 was sent to the Senate Committee on Health, Labor and Pensions. It has been called a “breakthrough” in bi-partisan politics by none other than former House Speaker Newt Gingrich, and is designed to streamline medical interventions for cures.
What Can Be Done Generally:
Provide bi-weekly updates tracking progress of bill through Senate and Executive Office
Support recognition of degenerative aging processes as a medical condition, and as the major underlying factor of all aging-related diseases and conditions (incl. cancer, cardiovascular disease, neurodegenerative disease, pulmonary obstructive disease, type 2 diabetes, frailty) hence subject to diagnosis, development and application of “cures” and therefore an indispensable part of the Act, entitled to participate in all its programs.
Use it as a rallying call to enlist top researches of aging (from Buck Institute, Barshop Institute, Albert Einstein University, Rochester University, etc. etc) to support our coalition.
Key Point A
The 21st Century Cures Act would establish in the U.S. Treasury an NIH and Cures Innovation Fund endowed with $1.86 billion in mandatory funds per year for FY2016 through FY2020 to be disbursed across the following initiatives: biomedical research, cures development, an accelerating advancement program, high-risk high-payoff research, and special funding support for early career researchers. The fund offers encouragement to researchers seeking assurance that lack of money will not represent a prominent roadblock to the advancement of their lines of inquiry.
What Can Be Done Specifically:
Connect researchers and fellows to appropriate contact persons overseeing CI Fund.
Support dedication of funds to translational aging research within the Cures Innovation Fund.
Key Point B
The 21st Century Cures Act authorizes annual increases in NIH’s overall budget from $3.1 billion in 2016 to $3.4 billion by 2018, while directing the agency to target resources, through a “strategic plan,” which it is directed to develop to broaden its mission beyond its stronghold in crucial biomedical research and identify contributions to improving U.S. public health through biomedical research.
What Can Be Done Specifically:
Learn how we can be a part of the strategic plan, or how one of our fellows could.
Include fundamental and translational research of aging into the “strategic plan” of the NIH.
Key Point C
It accepts alternatives to multiphase clinical trials in certain circumstances, and permits accelerated approval pathways for certain classes of drugs such as novel antibiotics. Under the new criteria, the agency may consider not only randomized clinical trial data, but also, observational studies, registries and therapeutic use as evidence of efficacy for drug and device approvals.
What Can Be Done Specifically:
Create brief to distribute to fellows and labs, to enlighten on new opportunities for bringing their work to market.
Support inclusion of trials specifically directed for diagnosis and treatment of degenerative aging processes, as underlying causes of aging-related diseases.
Support increased transparency and reproducibility of studies as additional proofs of efficacy and thus additional indications for accelerated approval.
Support complementary modes of evidence (e.g. comprehensive in silico modeling) as additional proofs of efficacy and thus additional indications for accelerated approval.
Support international collaboration in the development and distribution of cures against aging-related ill health.
Key Point D
Over 250 organizations sent a letter of support to Congress.
What Can Be Done Specifically:
Contact the person who organized the sign-ons to that letter (or coalition/alliance org) and ask to sign on, and to connect to their contacts OR just go about forming strategic, PR-based partnerships with the biggest orgs listed.
In negotiations with the partners in the Act support coalition, urge them to recognize the importance of degenerative aging processes as the main underlying risk factor and often the direct cause of all aging-related non-communicable diseases, and as a strong aggravating factor in communicable infectious diseases – and therefore in need of urgent inclusion into the Act.
WHO Global Strategy and Action Plan on Ageing and Health( GSAP)
Currently, the World Health Organization develops and begins to implement the Global Strategy and Action Plan on Ageing and Health (GSAP). This is an opportunity to emphasize the importance of biological and biomedical research of aging for the development of effective health care for older persons, at the planning level and the implementation level. In particular, we support the advancement of biological and biomedical research of aging for the development of effective health care for older persons as an indispensable part of GSAP “Strategic Objective 5: Improving measurement, monitoring and research on Healthy Aging”” that should be emphasized in national policy negotiations at the stage of developing national action plans on healthy aging and their implementation.
Summary
An updated “Global strategy and Action Plan (GSAP) on Ageing and Health” will be presented to the 138th session of the WHO Executive Board, in January 2016, under Agenda Item 7.4 Multisectoral action for a life course approach to healthy ageing: draft global strategy and plan of action on ageing and health. This will be distributed by WHO Governing Bodies through the usual channels.
What Can Be Done Generally
The final ratification will be in January 2016 by the WHO executive board. So it may be already too late to weigh in on the actual formulations. But even the current formulations can be used in advocacy in particular national contexts, during the planning of national action plans and during the various stages of the Global Action Plan implementation, to emphasize the importance of biological and biomedical research of aging for the development of effective health care for older persons. Especially encouraging for the biomedical and biological research of aging is “Strategic Objective 5: Improving measuring, monitoring and understanding” [of healthy aging] that should be emphasized in national policy negotiations at the stage of developing national action plans and their implementation.
http://www.who.int/ageing/consultation-strategic-objective5/en/
Key Point A
There may be several quite encouraging elements in the existing draft of the Action Plan, that can be interpreted for the advantage of longevity research. In particular, Strategic Objective 5: “Improving measuring, monitoring and understanding”, includes Action 1 – “Agreeing on metrics, measures and analytical approaches for Healthy Ageing” – may be conveniently interpreted as a strategic objective for biomedical aging research!
What Can Be Done Specifically
Most importantly, it is necessary to indeed infuse and emphasize a more biomedical/biological interpretation, as the text allows for different kinds of interpretation.
Key Point B
Strategic objective 5 proposes:
- “developing and reaching consensus on metrics, measurement strategies, instruments, tests and biomarkers for key concepts related to healthy ageing including functional ability, intrinsic capacity, subjective well-being, health characteristics, personal and environmental characteristics, genetic inheritance, multimorbidity and the need for care”
- “reaching consensus on approaches for the assessment and interpretation of trajectories of these metrics and measures over the life course. It will be important to demonstrate how the information generated serves as inputs to policy, monitoring, evaluation, clinical or public health decisions, and their link to the need for health and long-term care and broader environmental change”
AND
- “developing and applying improved approaches for the testing of clinical interventions and population based approaches that take account of the different physiology of older people and multimorbidity” [!]
The Action Plan also includes actions for:
- “developing evidence informed national Healthy Ageing strategies or plans that are part of overall national plans through a process that involves all stakeholders” (“Strategic Objective 1: Fostering healthy ageing in every country” Action 1)
AND
- “including core geriatric and gerontological competencies in all health curriculums” (Strategic Objective 2: Aligning health systems to the needs of the older populations. Action 3).
What can be done specifically
All these objectives and actions can be interpreted to support biomedical research of aging *if* emphasizing the correct biological/biomedical aspects. For example “national healthy aging strategies” must be understood to include biomedical research. And “gerontological competencies” should also be understood as including biogerontology. Otherwise the biological and biomedical interpretation of these objectives can be overwhelmed by conventional social, psychological, assistive technological or lifestyle approaches. The latter approaches are important, but need not exclude the biomedical therapeutic approaches. Still, the basis for a biomedical interpretation exists in these documents, but needs to be emphasized and made more explicit.
Two points need to be emphasized particularly:
- “Elucidating basic mechanisms and processes of aging, their relation to disease, and mechanisms of their amelioration for the development of therapies to achieve healthy longevity.”
- “Extensive research is still needed for the formal, measurable and diagnosable definition of the aging process, not only on the functional, but also on the fundamental biological level.”
These points were already sent to WHO during the consultation on GSAP, and I am happy to report they have apparently been noticed. See “WHO Global Strategy and Action Plan on Ageing and Health: Briefing note on consultation process and web based survey, August – November 2015” that quotes the above suggestions, with reference to Strategic objective 5, as “They emphasized the need for better terms and methods, spanning and combining biologic and social issues, such a formal, measurable definition of the ageing process.” (page 15 http://www.who.int/ageing/ageing-global-strategy-survey-report-en.pdf?ua=1 ) It should be seen if they are reflected in the final text. But in any case, they can always be emphasized in basically any particular national aging policy discussions and programs for healthy aging.
Key Point B
There are also some encouraging elements in the recently issued “World Report on Aging and Health” (October 1, 2015)
http://www.who.int/ageing/events/world-report-2015-launch/en/
http://apps.who.int/iris/bitstream/10665/186463/1/9789240694811_eng.pdf?ua=1
For example the report includes a section entitled “Reframing medical research” (pp. 113-114). It has such pro-biomedical-research statements as:
“Much medical research is focused on disease. This prevents a better understanding of the subtle changes in intrinsic function that occur both before and after the onset of disease and the factors that influence these changes…. Specifically, more research is needed that looks at how commonly prescribed medications affect people with multimorbidity, which is a departure from the typical default assumption that the optimal treatment of someone with more than one health issue is to add together different interventions. And outcomes need to be considered not only in terms of disease markers but also in terms of intrinsic capacity.”
Furthermore, the report states: “This will require the reallocation of budgets, which are currently relatively small in ageing-related research” and quotes Fontana et al. article in Nature (2014) “Medical research: Treat ageing” in support of that statement! (http://www.nature.com/news/medical-research-treat-ageing-1.15585)
What can be done specifically
Still, the biological and therapeutic interpretation of medical research of aging will need to be emphasized, or there is again the risk it will be pushed to the corner or even suppressed by non-biological and non-therapeutic approaches.
For example that “intrinsic function” or “intrinsic capacity” that the report wishes to improve is very vaguely defined as “the composite of all the physical and mental capacities that an individual can draw on”. This can be given to all kinds of functionalist, mentalist or even downright non-rigorous and unscientific interpretations. But it can also be given more scientific content based on biomarkers of aging and formal clinical definitions of aging. This scientific content may need to be stronger emphasized in the consultation and in the later stages of the action plan’s implementation.
Key Point C
There is also the simultaneously present, but apparently little related to the aging action plan – “International Classification of Functioning, Disability and Health (ICF)” which seems to hardly even mention aging or the “intrinsic function” in aging.
http://www.who.int/classifications/icf/en/
The ICF hypothesizes that “it is possible to see if people with similar levels of difficulty are receiving similar levels of support services irrespective of age such as when there are separate systems for aged or younger individuals with disabilities” (ICF Manual, p. 78). But the evaluation of aging-related disability is lacking.
What can be done specifically
The addition of a scientifically grounded biomedical classification of aging-related disability and function may greatly increase the utility of the ICF (currently feedback is requested by WHO on “A Practical Manual for using the International Classification of Functioning, Disability and Health (ICF)”
http://www.who.int/classifications/drafticfpracticalmanual2.pdf?ua=1
Key Point D
This addition to the ICF may be parallel to an addition of some clinically applicable, practical definition or classification of aging or senility within The International Classification of Diseases (ICD). The addition of aging to the ICF as an impairment of biological function may be actually easier than outright defining aging as a disease.
Yet “SENILITY” is already a part of the ICD, which can greatly facilitate the research, development and application of cures aging aging-related ill health! http://www.icd10data.com/ICD10CM/Codes/R00-R99/R50-R69/R54-/R54
However “senility” is currently considered a practically unapplicable “garbage code” in the ICD, due to the lack of formal and diagnosable, clinical and biological, definitions and criteria of “senility” or “degenerative aging processes” http://www.sciencedirect.com/science/article/pii/S0140673612617280 )
What can be done specifically
A major point of advocacy should be to push to develop formal and diagnosable, clinical and biological, definitions and criteria of “senility” or “degenerative aging processes” to allow evidence-based testing of anti-aging and life-extending interventions!
Key Point E
The Who seems to acknowledge the importance of public advocacy. As the global strategy and action plan (GSAP) draft states (p. 22):
“Contributions aligned to the GSAP from countries, non-state actors including older adults, civil society organizations, multilateral agencies, development partners and those who develop, manufacture and distribute aids, equipment or pharmaceuticals to improve intrinsic capacity or functional ability, can transform the action plan from a document to a movement.”
What can be done specially
So basically, all these texts and their interpretations may remain on paper, unless they are backed up by some actual local involvement, both at the grassroots and professional level, at the stage of implementation. It is very unclear how this implementation could work at the level of countries and institutions. But apparently it is at that “lower” level where the real action will need to happen.
So, in a sense, the implementation and interpretation of whatever is written in those documents will largely depend on “us”, on the individual and organizational involvements. If the longevity advocates are vocal, active and influential, the WHO authorities will need to “come to us” for the implementation of their plans..
There is little doubt that, if active enough, the longevity advocates can emphasize the importance of biomedical research of aging. There are signs of growing recognition of the importance of this issue, also at the UN. See, for example, this video on centenarians that was released by the UN Department of Economic and Social Affairs – Division for Social Policy and Development ! The authors refer to this video as a “call to action” – there is a growing realization that achieving healthy longevity is possible. But it will still be the job of longevity advocates to emphasize that in order to actually make it possible and accessible to people we need the scientific “know-how”!
https://www.youtube.com/watch?v=eBP8ycObpbU&feature=youtu.be]
