Looking for a Breakthrough in Alzheimer's as Boomers Age

More than 5 million Americans have Alzheimer’s, and that number will only climb as the baby boomer generation ages, putting increased pressure on Medicare and Medicaid—to say nothing of the toll on caregivers.

Responding to Alzheimer’s, and avoiding a federal budget catastrophe, means investing more in research and diagnostic steps, to find and treat those in the early stages of the disease, according to a 3 Democratic members of Congress who took part in “The Path Forward: An Atlantic Forum on Alzheimer’s.” The event took place Monday in Philadelphia alongside the Democratic National Convention.

In the first half of the forum, US Senator Debbie Stabenow, D-Michigan, and US Representatives Paul Tonko, D-New York, and Earl Blumenauer, D-Oregon, discussed recent legislation, as well as Blumenauer’s efforts through the bipartisan neuroscience caucus to bring awareness and resources to diseases of the brain. Steve Clemons, Washington editor-at-large for The Atlantic, served as moderator.

Alzheimer’s brings brain cell failure; researchers believe the progression results from a mix of genetic and health factors, rather than a single cause. According to the Alzheimer’s Association, the disease costs $236 billion a year in the United States, putting it on par with the cost of diabetes, which affects 6 times the number of people. Much of the cost comes in lost productivity from both patients and caregivers, often family members whose own financial safety can suffer when they must provide every basic need for a loved one.

As the members of Congress noted, the prospect of millions of baby boomers entering Medicare could put the disease’s annual cost above $1 trillion by 2050. But that number could fall significantly, they said, by funding Alzheimer’s research to achieve the therapeutic breakthroughs seen in cancer and heart disease.

“This will drown us if we don’t address it,” Tonko said. If Republicans are unwilling to fund Alzheimer’s research based on its human toll, he said, “You have to confront with the ultimate question: are you ready to take on a $1 trillion onslaught?”

Blumenauer said a generation’s worth of stalled funding for basic research means that in brain diseases, “We have made no real progress.” This happened even though “Alzheimer’s is the signature disease of the boomers,” he said. “People are more afraid of Alzheimer’s than cancer.”

Therapies that would halt progression in the newly diagnosed could have a huge impact, in both financial and human terms, he said. “We don’t even have to cure Alzheimer’s,” Blumenauer said. “If we can delay the onset for 5 years it will cut in half the suffering, the cost, the trauma.”

Stabenow said because Alzheimer’s already consumes $1 of every $5 in Medicare, research is a good investment. With a goal of getting to $2 billion research funds each year, she said the current funding is $960 million and is set to reach $1.4 billion next year.

Right now, she said, “Forty percent of doctors don’t want to make a diagnosis in their patients who have it, in part because they don’t think they can do anything about it.” Yet, prevention and early intervention are key: “The kinds of new drugs being researched work better for the early diagnosis,” she said. CMS has responded: the proposed 2017 Physician Fee Schedule would reimburse doctors for making care plans with patients.

How Should Therapies Be Evaluated?

The next speaker was Carlos Garner, senior director for Global Regulatory Affairs at Eli Lilly, which is developing solanezumab to treat Alzheimer’s. (Eli Lilly was the underwriter for the forum.) In May, Fierce Biotech’s John Carroll reported that Eli Lilly surprised investors with a request for the FDA to evaluate the drug based on its effects on cognition rather than function—in other words, to change which endpoints mattered.

Garner referenced this development, describing the need to rethink, “What’s the framework for being able to measure effectiveness?”

Measuring a drug’s value for patients whose disease has progressed to a loss of function is different, he said, than measuring efficacy earlier on, “when, actually, you’re quite normal.” Garner said drug makers and FDA need to agree on how to measure whether a drug works. “As you cure the disease, you need different endpoints,” he said. “As the science progresses, we need the regulatory environment to progress with the science.”

What’s promising, he said, is that therapies in the pipeline—which could reach patients in the next 5 years—will go beyond treating symptoms and target “the underlying pathology of the disease.”

Beyond the regulatory challenges, Garner called for more emphasis on early detection, better efforts to get patients into clinical trials, and reducing stigma, which he said, “leads physicians to not diagnose memory problems.”

A Patient Perspective

The final segment featured Pennsylvania’s Secretary on Aging, Teresa Osborne; Carol F. Lippa, MD, professor of neurology at Drexel University College of Medicine in Philadelphia; and Tom Brophy, who was diagnosed with Alzheimer’s 3 years ago.

Lippa agreed that better strategies for early detection and intervention are needed. The “plaque” associated with Alzheimer’s “starts a decade before we have any symptoms.” More work is being done with imaging to spot the early signs of trouble, and delay progression.

Osborne answered a question about the effect that managed care can have on Medicare and Medicaid beneficiaries, and the nonprofits that deal with patients. “That’s something that folks are frightened about,” she said. Provider engagement is key, Osborne said.

Brophy also called for more work on early intervention. “It’s been invaluable that I found out what is going on,” he said, adding that he’d probably had symptoms for 20 years before his diagnosis at age 61. “We have a new normal. We’re the same person, just a little different.”