Chances are you know someone or have a loved one with Alzheimer’s disease and its slow-progressing dementia. An estimated 6.5 million Americans—and 44 million people world-wide—suffer from it. Scientists are still unsure of its causes: Amyloid protein, tau tangles, inflammation, fat protein complexes, high cholesterol and low bile acids, and even gum disease have all been conjectured. We see headlines that declare a “Cure Breakthrough” and “Reversing Dementia in Mice,” but still, if you get sick, there is no treatment. Why?
There was a glimmer of hope in June 2021, when the Food and Drug Administration approved Biogen’s drug, Aduhelm. But studies since then have been mixed, and Medicare announced that it will only pay the $28,200 annual cost for patients enrolled in clinical trials, of which there are few. This month we learned of disappointing results from a trial in Colombia for Roche’s new amyloid-protein-targeting Alzheimer’s drug, crenezumab.
Still, those I spoke with who are funding Alzheimer’s research, to a person, are surprisingly hopeful. They see a pipeline populated with potential, though they point to some flaws in the system.
My friend Elizabeth Gelfand Stearns, whose mother lived with Alzheimer’s for eight years, has raised almost $10 million over the years for the Judy Fund, which provides research funding and supports advocacy. Government spending on Alzheimer’s and related dementia research was $448 million when President Obama signed the National Alzheimer’s Project Act in January 2011, the aim of which was to “prevent and effectively treat Alzheimer’s disease and related dementia by 2025.” Ms. Stearns tells me, “Our pitch changed from ‘this is an awful disease’ to ‘90 million baby boomers are entering the prime age for Alzheimer’s and will swamp Medicare and Medicaid.’ ” It worked: This year the National Institutes of Health received $3.5 billion in research funding for the disease. Sadly, the NAPA now needs reauthorization through 2035. Patience is a virtue.
So why is there no cure after all this money has been spent on research? I could spend a dozen columns rattling off compelling theories and drugs that still need investigating. But drug approval by the FDA via trials funded by pharmaceutical companies can take eight to 10 years and cost more than $2 billion.
It turns out there is a huge flaw in the drug-discovery process—namely, a wide gap between government research funding and private pharmaceutical company spending on drug trials. Another friend, Mikey Hoag, says this is known as the “valley of death” where drugs often die. She is involved because her father showed signs of Alzheimer’s at 65 and lived with it until he was 79. A couple of months after he died, her mother showed Alzheimer’s symptoms. She lived to 88.
What is the valley of death? The Catch-22 is…
