Three years ago, one of us (Carter) co-authored an op-ed projecting that the fiscal and humanitarian costs from a single disease, Alzheimer’s (AD), if left unchecked, would be ruinous. Last year, the other one of us (Pinkerton) authored an op-ed arguing that the U.S. Food and Drug Administration (FDA) was a hindrance to medical progress on this disease.
Now we are writing together to declare that the fiscal risk is worsening, and the FDA is still blocking it. According to the Alzheimer’s Association, AD costs the U.S. $321 billion annually, and the cost — to say nothing of the human pain — is projected to rise steadily. As a result, something must change. Everyone should hope that the “something” is a scientific breakthrough in AD that improves lives and lowers costs. After all, it’s cheaper to beat than to treat; a cure is better than care. (RELATED: Coming Soon: A Red-State Vision Of Healthcare Regulation)
The federal government spends $3.7 billion a year on AD research, and private companies and charities spend even more. Yet, despite this generous and well-intentioned input, the output — drugs that work against AD — has been deeply disappointing. In 2021, FDA approved a new AD drug, Aduhelm, the first such approval in two decades. Aduhelm costs some $28,000 per person, per year, and yet it has shown a minimal effect on AD patients — and ominous side effects.
Indeed, a House Energy and Commerce Committee report last year was very critical of the FDA’s approval process, suggesting that the agency knew all along that Aduhelm would do little good — and approved it anyway. Why the approval? One can speculate widely as to motives, but there’s one explanation that makes the most overall sense to us: the intellectually deadening hand of dogma.
For decades, the dominant school of thought on AD has been that the disease is caused by the buildup of amyloid protein plaques in the brain. So, the thinking went, get rid of the plaques to get rid of AD. As a hypothesis, that was plausible, but not all scientific hypotheses hold up under scrutiny. In fact, most don’t. And it seems clear that the amyloid theory has not been borne out, that it is little more than dogma.
This argument that we’ve hit a dead end on amyloid was articulated in a widely read article in the Free Press earlier this year, “The Reason There’s Been No Cure for Alzheimer’s.” Health journalist Joanne Silberner, whose late father had AD, quoted one expert’s opinion of the “amyloid believers” and their theory: “The exclusive focus has hurt. It pushes out other ways of thinking about the disease, and for that reason discourages innovation.”
We are not scientists, and yet we recognize the point Silberner is making about “amyloid believers” — a point well made by others before, as well — as akin to the point made by Thomas Kuhn in his classic work from 1962, The Structure of Scientific Revolutions. Instead of “believers,” Kuhn used the word “paradigm” to describe the mental model that guides scientists as they do their work.
One such model was the Ptolemaic paradigm in astronomy, which held that the sun revolves around the Earth. That was dead wrong, of course. As Kuhn put it, in light of new scientific evidence in the 16th and 17th centuries, the persistence of the Ptolemaic paradigm was “a scandal.”
And yet even as its basic fallacy was becoming obvious, Ptolemaic adherents defended it zealously. However, the obvious truth of the Copernican paradigm — that the Earth revolves around the sun — eventually won out. Thus, one of Kuhn’s “scientific revolutions” was won, and astronomy advanced. We can add that Kuhn’s point about paradigms applies to a broad spectrum of science, including medical science.
Silberner suggests that the dread malady is finally now seeing its own paradigm shift: “The Alzheimer’s research community has begun to recognize they must pursue multiple paths of unraveling this disease.”
So now, how can the rest of us help? For starters, we can recognize that the FDA is a willing victim of regulatory capture. A full 46% of FDA’s budget comes from user fees, which suggests great potential for an untoward melding of interests, public and private. This has contributed to the FDA becoming a dogmatic defender of stale orthodoxy.
So, what’s a better way? Let’s start by realizing that innovation comes from information, and information wants to be free. So that means more experimentation in the FDA, private companies and elsewhere — and less central bureaucracy trying to control the flow of ideas.
In particular, we might look beyond the paradigms of in vitro and in vivo and look to the newer paradigm of in silico — harnessing Moore’s Law to medicine. Then, beyond the basics of safety, let’s allow the medical market to decide the best path forward based on new tech wonders, including big data and artificial intelligence. If we want better health outcomes, FDA should not stand between patients and the potential cures they can learn about on a digital dashboard.
A decade ago, Silicon Valley venture capitalist Marc Andreessen observed, “software is eating the world.” He meant that, of course, in a good way, the way of frictionless progress. Meanwhile, today, AI is eating software. Yes, tech evolution is that fast.
In the meantime, everyone at risk from Alzheimer’s, which is all of us, shouldn’t worry about what does the eating, so long as it’s AD that gets eaten.
James Carter is the director of the America First Policy Institute’s Center for American Prosperity. Previously, he served as deputy undersecretary of labor under President George W. Bush and as a deputy assistant secretary for economic policy at the U.S. Treasury.
James P. Pinkerton is a Senior Fellow with the America First Policy Institute’s Center for American Prosperity. Previously, he served as a domestic policy aide in the White Houses of Presidents Ronald Reagan and George H. W. Bush. He also worked in the 1980, 1984, 1988, 1992, and 2008 presidential campaigns. From 1996 to 2016, he was a contributor to Fox News Channel.
The views and opinions expressed in this commentary are those of the author and do not reflect the official position of the Daily Caller News Foundation.
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