CHICAGO — In 1979, a man named Jerome Stone, frustrated with the lack of options and information about Alzheimer’s disease following his wife’s diagnosis, brought together experts and families affected by dementia to launch the Alzheimer’s Association. One of their goals: find a cure for the disease.
Forty years later, an estimated 5.8 million Americans have Alzheimer’s, with a new person developing the condition about every minute of every day. There is still no treatment that slows progression of the disease, let alone stops or reverses it. There are increasing doubts whether the prevailing theory explaining the foundation of Alzheimer’s is accurate.
“I would have thought we’d be further along by now,” Harry Johns, the association’s CEO, acknowledged in an interview at the group’s headquarters here.
But to listen to Johns and other association executives is to hear a message of hope: The groundwork is now, finally, being laid for future therapies. New approaches are being explored, and awareness of Alzheimer’s and other forms of dementia — and the desire to address them — has reached critical mass. The past few years have also been a boon for the association, with an increased profile and fundraising reaching a record $365 million in fiscal 2019.
“We now have momentum unlike we’ve ever had in this field before,” Johns said.
The question is whether that outlook reflects a predictably bullish view from an advocacy group — one that should be taken with a dose of skepticism — or a sign that researchers and patients might be on the precipice of progress. The first new drug for Alzheimer’s in 15 years could be approved this year. Federal funding for Alzheimer’s and dementia research has skyrocketed.
On the other hand, the Alzheimer’s Association has long touted a more positive message. When Johns joined the association in 2005 from the American Cancer Society, he called it a “time of unprecedented optimism and momentum” — using some of the same language.
Asked how he squared what he said then with what he was saying 14 years later, Johns said both sentiments were accurate. Back then, he said, a number of closely watched drugs were in pivotal clinical trials, even though they ultimately joined the heap of failed therapies.
“I believe firmly in the momentum we have today compared to what we had then, and what we had then compared to what we had before,” said Johns, whose mother and mother-in-law had Alzheimer’s. “It’s a relative reality.”
It’s not for lack of trying that the broader Alzheimer’s field has failed to find new treatments or cures; the disease has proven an intricate puzzle box to crack. For its part, the Alzheimer’s Association has been criticized for focusing too heavily on potential treatments, at the expense of providing assistance for people already living with the disease.
The association insists it can do it all, expanding its support for people with dementia while championing both basic science and translational research. And as the group enters its fifth decade, Johns sees a simple path toward therapeutic success, a strategy that he has seen work successfully in cancer: increase awareness, get people — including lawmakers — mobilized, and clear the runway for scientists to do what they need to do.
“Part of it is just being relentless,” Johns said. “You’ve gotta be relentless. We just have to get it done.”
If the Alzheimer Association’s playbook calls for rallying the public and increasing funding, there are signs that that is working.
Based on the association’s own tracking, awareness of the disease has soared over the past five years, as has awareness of the association. And in the absence of treatments, many of the association’s biggest wins have come in Washington, dating back to a 2011 law that resulted in the first federal Alzheimer’s plan.
The plan created a framework for future policy and research initiatives, and offered a way to measure progress, said Robert Egge, the association’s chief public policy officer. The first of the plan’s five goals: prevent and effectively treat Alzheimer’s by 2025.
The association also pushed the Alzheimer’s Accountability Act, signed in 2014. It required the National Institutes of Health to tell Congress every year the amount of funding it would need to meet the 2025 goal — joining cancer and HIV/AIDS as the only other diseases with hard targets for appropriators to hit.
And federal funding for Alzheimer’s and dementia has increased from roughly $500 million in 2012 to $2.8 billion in fiscal 2020, giving more scientists more opportunities to pursue a wider ranger of inquiries and potential therapeutic avenues.
Asking a member of Congress to support Alzheimer’s may seem as difficult as giving out free pie, but the challenge, Egge said, is keeping it on the front burner.
“It’s not that we have opposition,” he said. “It’s that we have to get a Congress that’s besieged by so many issues to carve out the time to focus on something. As big as this is, it’s still one of scores of issues that any given office in Congress has to think about.”
The association has also used politics to promote its work. Take, for example, an ad it aired last year during a Democratic presidential debate. It highlighted the divide between “red states” and “blue states,” before reminding viewers that the two colors, when combined, created purple — the association’s signature color and a metaphor for how to defeat Alzheimer’s: “Divided we fail but united we win.”
Another campaign from the association, “First Survivor,” was designed to signal to the public that, despite clinical setbacks, progress was still happening. The slogan: “The first person to survive Alzheimer’s disease is out there.”
“There’s momentum in the space and we don’t want people to lose hope,” said chief marketing officer Michael Carson. “We want them to know that there’s a place to go for help, that we’re there, we’re working hard on their behalf. We need their help, too, and ultimately we’re going to solve it.”
Carson said, though, that the association has been careful not to overpromise or create false hope. Some of the potential “first survivors” featured in the campaign are older people. But there are also children — indicating that it might be decades before the discovery of an actual remedy for dementia.
“Ultimately, we make sure that we’ll never come out and say there is a specific timeline on a cure,” he said. “Don’t know it. Can’t say, basically, there’s going to be a cure for this family.”
A few years ago, the association consolidated, bringing local chapters, which had been affiliated but largely independent, into the national organization. The shift was not seamless.
Instead of being subsumed, a number of chapters broke off, arguing that they didn’t want to send their local dollars to a national organization that spent millions on salaries and that was focused more on lobbying and marketing than on curating programs for their communities.
The rifts were exacerbated by subsequent fights over fundraising dollars, trademarks, and the establishment of new chapters by the national association in areas where the local organizations chose to strike out on their own, according to people who work in the Alzheimer’s field. In interviews with other Alzheimer’s organizations, more than one person referred to the association as the 800-pound gorilla, while declining to criticize it on the record. (The Alzheimer’s Association is one of a handful of groups for the disease, including UsAgainstAlzheimer’s and the Alzheimer’s Drug Discovery Foundation.)
Critics accuse the Alzheimer’s Association — whose mission statement includes supporting patients and caregivers and promoting brain health along with eliminating the disease — of sidelining people living with dementia in its single-minded pursuit of treatments.
“It is fair to say that the currently stated ‘dual mission’ of the U.S. Alzheimer’s Association is technically correct but de facto grossly unbalanced as it is substantially closer in reality to a single mission,” Eilon Caspi, a gerontologist and critic of the association, argued in a 2017 paper in Dementia. Describing the millions of people living with dementia and their caregivers, Caspi wrote: “These individuals desperately need fundamentally higher level and quality of timely support, education, and training, evidence-based and innovative services and programs, and psychosocial personalized interventions.”
Association executives dismiss the criticism, and seem confounded by assertions that it has neglected people with the disease.
“I would emphatically disagree with that opinion,” said Joanne Pike, the association’s chief program officer. “We’ve done nothing but increase the numbers that we have served and the number of services that we have been providing.”
Johns argued that the “unification,” as association executives call it, led to a more cohesive structure with a streamlined fundraising apparatus, instead of the national organization competing with its own chapters for donations. He said it was a key driver in the group’s spike in fundraising, from $160 million in fiscal 2016 to $365 million in fiscal 2019, which has allowed the association to contribute to more research directly and expand its care and support services.
Pike said being one organization also helps programs that have been successful in one region get implemented in another. The association has been holding more community forums and increasing opportunities for volunteers. It also rolled out recommendations for long-term care providers for dementia care in 2018 and is developing guidelines for primary care providers. The association wants these clinicians to able to help diagnose dementia early and for patients and families to feel comfortable talking with their general clinicians about cognitive issues.
Because the treatment options are so limited, Pike said, “physicians report that they don’t feel like there’s something they can do, so it’s not something they broach as quickly. Cancer and diabetes, heart disease, have a treatment, and so health systems are able to have an actionable item where they see value from that.”
The association also runs a 24-hour helpline service from its Chicago headquarters that receives 300,000 calls a year, the majority from caregivers. One day in December, the staff had taken 644 calls by 3:53 p.m., as a screen tracked incoming calls and how quickly they were answered. On the wall is a painted message in capital letters: “Making that call is not a sign of weakness.”
For decades, the underlying hypothesis in the Alzheimer’s field has been that the buildup of plaques of beta-amyloid protein in the brain drives the death of neurons and cognitive issues that are hallmarks of the disease. But of scores of amyloid-targeting drugs that have been tested, none has been definitely determined to slow the disease.
“I don’t think that there’s anyone out there today who thinks [amyloid] is exclusively the answer,” Johns said. The association has diversified the types of research it funds for several years now.
Still, the amyloid-targeting drug aducanumab, from drug maker Biogen, is expected to be reviewed by the Food and Drug Administration this year. Biogen believes it works, but because the clinical trial results were ambiguous, some experts have argued the drug should be tested in another trial before approval. Johns declined to say whether he thought the FDA should approve aducanumab.
He also dismissed questions about the potential cost of an Alzheimer’s therapy. Back-of-the-envelope calculations have pegged the cost of a monthly infusion like aducanumab at $40,000 a year (though Biogen has said nothing about how it would price aducanumab if it were approved). With 2 million to 3 million potential customers, that’s $100 billion annually — more than the entire Medicare prescription drug benefit in 2018.
Johns argued that the association’s focus would be on access to any approved treatment, irrespective of the price. Asking a question about how the association would advocate around access despite how many billions of dollars the drug might cost was “almost rationing it from the outset,” Johns said. A spokeswoman later sent over a 2015 report from the association that found that a treatment arriving in 2025 that pushed back the onset of Alzheimer’s by five years would save payers $220 billion over five years — though it didn’t account for the price of that drug.
“It’s not our choice what the company charges or what’s paid for it,” Johns said. “Our interest is access, when there is a drug available that can make a difference in people’s lives. That’s real for people.”
Nicholas Florko contributed reporting from Washington.