PUMPING IRONY: Dementia, Redefined

A juicy conspiracy theory typically arises from rumors of comically nefarious characters toiling surreptitiously toward some obviously ridiculous objective, so I’m hesitant to compare what appears to be a clumsy crusade to promote the early testing and treatment of dementia with, say, Taylor Swift’s psyops mission to rig the presidential election. Still, a recent Big Pharma–dominated gathering in Amsterdam has raised some eyebrows.

Under the guise of championing a new preventive treatment protocol for Alzheimer’s, a panel at the Alzheimer’s Association International Conference last July concluded that public health officials should allow physicians to use a simple blood test to diagnose dementia among patients who exhibit no signs of cognitive impairment. As Melody Petersen reports in the Los Angeles Times, panelists did not seem to be fazed by, among other things, ample evidence showing that the amyloid and tau proteins the test would presumably identify have never been confidently linked to a dementia diagnosis.

“The purpose of this initiative is to advance the science of early detection and treatment,” explained panelist Maria Carrillo, PhD, chief science officer of the Alzheimer’s Association. “In order to prevent dementia, we need to detect and treat the disease before symptoms appear.”

The move would establish various new stages of the disease. If your blood test revealed elevated levels of amyloid and tau, you’d be diagnosed with Alzheimer’s Stage 1 — even if you displayed no cognitive problems. Stage 2 would describe someone whose cognitive abilities are unchanged but who begins to display signs of depression, anxiety, or apathy. Mild cognitive impairment would define Stage 3, while those diagnosed with mild, moderate, or severe dementia would land in Stages 4, 5, or 6, respectively.

It almost goes without saying that such a pivot toward “early detection” and treatment would exponentially increase the number of dementia cases, and I probably don’t need to mention that it comes at a time when the Food and Drug Administration (FDA) seems more than happy to speedily approve Alzheimer’s drugs that target amyloid and tau in the brain but deliver little noticeable relief to patients. And I suspect it surprises no one that Petersen identified at least 14 members of the 20-member panel who sport financial ties to pharmaceutical or medical testing firms.

It almost goes without saying that such a pivot toward “early detection” and treatment would exponentially increase the number of dementia cases, and I probably don’t need to mention that it comes at a time when the Food and Drug Administration (FDA) seems more than happy to speedily approve Alzheimer’s drugs that target amyloid and tau in the brain but deliver little noticeable relief to patients.

Those monetary connections, several panelists assured Petersen, did not influence their opinions.

Whether conspiratorial or not, the panel’s proposal has generated plenty of chatter among geriatricians and researchers. The American Geriatrics Society labeled the financial relationships between Big Pharma and panelists “wholly inappropriate” and argued that the move toward earlier diagnosis and treatment would offer “limited benefit and high potential for harm.”

Nor was Madhav Thambisetty, PhD, a senior researcher at the National Institute on Aging, sold on the premise. “I think this is untested, uncharted territory,” he tells Petersen. “I’m not at that stage where I would be able to make a diagnosis of Alzheimer’s disease in somebody who’s cognitively normal based on the presence of a single biomarker.”

How such a diagnosis would affect someone with no measurable cognitive difficulties — and little chance of ever developing the disease — is anybody’s guess. It’s not uncommon, though, for an Alzheimer’s diagnosis to trigger depression, anxiety, and other mental health issues. And Eric Widera, MD, a geriatrician at the University of California, San Francisco, wonders whether it might spark discriminatory actions from employers and insurance companies.

“If somebody tests positive for amyloid and they are an airplane pilot, do they have to disclose that to the airlines?” he asks. “They are not asking these questions.”

Under some pressure, the panel eventually revised the proposal and now insists that it’s not “currently” instructing physicians to use a blood test to make an Alzheimer’s diagnosis for asymptomatic patients. But Widera and others argue that the revised plan still views patients who take the blood test and are found to have the biomarkers as having Alzheimer’s — as opposed to simply being “at risk” of it.

“They are redefining what it means to have Alzheimer’s,” he argues. “You no longer need to have cognitive impairment to have this disease. You just need the positive blood test.”

“They are redefining what it means to have Alzheimer’s,” he argues. “You no longer need to have cognitive impairment to have this disease. You just need the positive blood test.”

The Alzheimer’s Association has been pushing this idea since 2011, Petersen reports, but the FDA’s recent approval of Aduhelm and Leqembi, drugs designed to delay the progression of dementia in patients with mild cognitive dysfunction, has raised the hopes of Alzheimer’s sufferers — and Big Pharma — that the time is ripe to push hard for early detection and treatment approaches.

That may explain the release last week of a new study suggesting that blood tests are just as reliable as the more invasive PET scans and cerebrospinal fluid assays in measuring levels of amyloid and tau proteins in the brain. The results were published in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association. Among the study’s more notable “collaborators” included Big Pharma heavyweights — and “outside advisors” to the Amsterdam panel — Biogen and Eli Lilly.

Conspiracy? Nah. Just business as usual.

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