Prepared Remarks of George Vradenburg
Before the National Alzheimer's Advisory Council Inaugural Meeting
I speak today as the Co-Founder and Chairman of USAgainstAlzheimer’s, a national advocacy campaign and network committed to mobilizing the national political will to tackle Alzheimer’s disease. I also serve as the co-convener of Leaders Engaged in Alzheimer’s Disease, a network of over 20 Alzheimer’s-serving organizations serving millions of Americans affected by Alzheimer’s.
As all of us know, the trend lines of Alzheimer’s disease are all moving in the wrong direction. Prevalence is rising rapidly as Baby Boomers turn 65 at the rate of 10,000 per day; mortality rates are up dramatically with an estimated 10 million Baby Boomers expected to die with this disease; the costs of Alzheimer’s care are now estimated to balloon to over $1 trillion in 2050.
Prevalence up, mortality up, costs of care up.
More than one million residents now live in nursing facilities, a figure that will sharply increase as the nation ages. But, to paraphrase Jonas Salk talking about polio, ‘We don’t need more iron lungs, we need a cure.’ Yet, public investment in an Alzheimer’s cure – already anemic compared to cancer, heart or HIV/AIDS – is dropping; private investment in Alzheimer's drug discovery – from both venture capital and public companies alike – is pulling back due to the high risk, lengthy time cycles, and cost burdens of getting a product through a sluggish, silo-ed and unpredictable therapeutic pipeline. These trend lines – rising prevalence, mortality and costs versus declining investment in a cure – describe nothing less than a public health and fiscal crisis. This is simply unacceptable, and our national plan should say so.
All of us in this room fought hard for the creation of a national Alzheimer’s plan. It is long overdue. Now that we will help to develop a national strategy, it is incumbent that we get it right. It is vital that our National Plan commit our nation to ‘transforming the trajectory of Alzheimer’s.’Business as usual merely will continue us on a path toward public health and fiscal disaster. Marginal improvements are not enough. We should develop and execute a transformational national plan to defeat Alzheimer’s.
How? By establishing a clear, quantifiable, and accountable national ‘reach’ goal to flatten Alzheimer’s mortality and cost curves which would lead to massive reductions in government and private spending on healthcare for Alzheimer’s victims. We should fashion a plan to achieve spending reductions through innovative treatments for Alzheimer’s. One might call this the SPRINT approach.
Today, I recommend we establish a national goal to stop Alzheimer’s by 2020. Many in the research community believe that with a well-funded aggressive plan, we can prevent or control Alzheimer’s within the decade. And, over the last few weeks I have heard from hundreds of Americans in the Alzheimer’s community who share this goal.
Achieving this goal, in my view, will force us to think ‘out-of-the-box’ and avoid the comfort of incremental or marginal tweaks to our current research, drug discovery, and delivery systems. Particularly in times of fiscal stress, we must embrace innovations in technology, policy, industry practices, regulatory work processes, and public-private work relationships. This challenge is far from easy, but as urban planner Daniel Burnham said, “Make no little plans, they have no magic to stir men's blood”. The national goals we set must have the power to ‘stir’ our blood and inspire us to transformative thinking.
What do I mean by stopping Alzheimer’s? While none of us will rest until we have developed a therapy or therapies to prevent or cure Alzheimer's, I submit to you that for the purposes of our work, we establish our goal to mean the availability, by 2020, of a therapy or therapies able to prevent or control the cognitive and functional disabilities of Alzheimer's disease. According to the Trajectory Report prepared by the Alzheimer’s Association with support from Dartmouth University and the Lewin Group, were a therapy available today that would delay onset of Alzheimer’s simply by five years, it would reduce the estimated number of patients dying with Alzheimer's in this decade from 5.6 million to 4 million and, by 2050, reduce the number of Alzheimer’s victims by close to 6 million. Importantly, such a therapy or therapies would save our nation several trillion dollars in healthcare costs in the coming decades, dwarfing the savings estimated from any brand of healthcare reform in the current political dialogue.
I have no delusions that achieving this goal will be easy. It is very ambitious; we must all recognize this at the outset. But, as JFK said in 1962, “We choose to go to the moon in this decade … not because [it is] easy, but because [it is] hard, because that goal will serve to organize and measure the best of our energies and skills …”
Our SPRINT recommendations should seek to accelerate drug discovery, First, we must reduce the time and cost of moving potential Alzheimer’s ‘targets’ discovered in basic research to therapies widely accessible to patients in the market. This means not just a greater investment in basic research to generate more ‘targets,’ a critical priority; but it also means new translational science and practices to de-risk potential molecular ‘shots on goal.’ It means targeted public investments in the ‘valley of death’ through proven solution-oriented investment vehicles such as DARPA and In-Q-Tel in order to attract many times the levels of private venture investment in Phase 1 and 2 trials. It means mitigating the cost and time of Phase 3 clinical trials through large-scale patient registries, biomarker research, standardization and qualification, and adaptive trial designs; and it means a continuing public-private-philanthropic outcome-oriented dialogue on other pipeline reforms. In sum, we must improve the performance of each stage of the therapeutic pipeline. If retail customers can expect the Wal-Mart supply chain to respond quickly to their product and price preferences, should Alzheimer’s patients expect any less?
In addition to improving each stage of the therapeutic pipeline, we must, in my opinion, employ new technology and communication tools and protocols in new ‘open innovation systems’ and ‘learning networks’ that empower not the center but the ‘edge of the network’ so that all of ‘us’ are enlisted in the challenge of Alzheimer’s: Researchers talking to researchers to crowd source solutions to challenging problems using open data standards and rapid data transfer; clinicians talking to clinicians to share insights regarding earlier detection of Alzheimer’s symptoms and more effective family care planning so as to shift the locus of care from institution to home; and victims and caregivers sharing their experiences in order to reduce social isolation, improve coping strategies, and fighting against the stigma of this disease. And we must find new and sustainable ways of working together across boundaries through public-private-philanthropic partnerships and collaborative problem-solving.
Beyond this acceleration of the science of discovery and drug development, we must also reform our drug review and approval process so all novel therapies for Alzheimer's receive the full benefit of accelerated review, so all trial sponsors have the clear and complete guidance they need as early in the review process as possible, so FDA review itself is timely, predictable, and consistent. Through additional FDA authorities and otherwise, we must provide enhanced incentives to private venture firms and public companies to invest in drug discovery through extended market exclusivity for Alzheimer’s-indication drug candidates where patent life is short or non-existent and through adequate reimbursement practices.
Setting a faster pace from basic research to therapies for patients using new tools and problem-solving processes is the SPRINT Difference. We should be SPRINTing, not slow-walking, to stop Alzheimer’s by 2020.
Stopping Alzheimer’s by 2020 is a big goal, but I submit that it is the right goal to force the development of a transformative national Alzheimer’s plan. And with the right plan and the innovative application of ‘the best of our energies and skills’, we can transform the trajectory of Alzheimer’s.