Process
Status Items Output None Questions None Claims None Highlights Done See section below
Highlights
id577288896
aducanumab, a drug that targets a protein called β-amyloid (AKA beta-amyloid), which may be associated with the pathogenesis of Alzheimer’s disease. When it went up for approval at the Food and Drug Administration in 2021 (under the brand name Aduhelm), an advisory panel of experts recommended against its authorization, based on the lack of convincing evidence of benefit for the drug. The vote wasn’t close: 10 voted against and one was uncertain. The FDA then decided to approve the drug anyway, against the advice of its own advisers. In the wake of this decision, three members of the advisory committee resigned, with one of them calling the decision a new low for the agency. The whole saga reeked of conflict of interest and backroom deals between the company and FDA officials, leading to exposés in the press and congressional hearings.
✏️ So here we have a new drug that targets a particular protein that is thought to relate to the disease. The entire advisory panel for the FDA voted against authorizing it (10 against, 1 uncertain). FDA still approved it. 🔗 View Highlight
id577289690
Johns to make claims about equity when it comes to the marketing of a drug that many scientists and experts don’t think does very much at all for anyone and comes with serious adverse events and economic costs, while never noting the fact that just a handful of people of color were enrolled in a study of the medicine.
✏️ So, the context is that this millionaire CEO of a patient advocacy group heralded the FDA approval, and is shaming the insurance companies for not covering the drug, making claims about equity and racial discrimination. He ignores the science that is saying this drug isn’t useful, causes serious adverse effects, and is extremely expensive. But he is annoyed and calls for racial equity when it comes to marketing and selling this drug to all. 🔗 View Highlight
id577290337
The key take-home? Benefits are likely to be imperceptible and the risk of brain bleeds (ARIA) and other side effects with the drug—like with aducanumab—are substantial.
✏️ With another drug approved, the advocacy group is excited, throwing hyperbole left and right, while science says it doesn’t actually do anything and still has bad side effects. But, it costs 26,500 USD a year, plus 7k for extra tests. 🔗 View Highlight
id577290621
What is also concerning is what the new drugs—like aducanumab and lecanemab—do best: Clear β-amyloid, though with different mechanisms of action. There is thus enormous economic incentive to change the definition of the disease to target the reduction of proteins in the brain, not the clinical manifestations of the disease. It may not help patients, but it will surely enrich Biogen, Eisai, and other drug companies, and the clinical practices that prescribe these drugs.
✏️ Medical manipulation The drugs are good at doing one thing, clearing a protein. The science is still out about how much this protein actually relates to the disease though. So, what to do is change the definition of the disease in terms of reducing that protein, and you have achieved economic success for the drug companies at the expense of the people with the actual disease. 🔗 View Highlight
id577290821
β-amyloid rides on. Funders fund amyloid. Many PhD students study the effects of amyloid, their findings lead to prestigious post-doctoral positions, then senior positions and the circle remains unbroken. If you hear words like “breakthrough” about these drugs, or claims that we’re in a new era of hope for Alzheimer’s disease, it’s because of this self-perpetuating feedback loop inside the field that drives it all forward.
✏️ The destructive and manipulative feedback loop that creates the truth rather than finds the truth. 🔗 View Highlight
id577290941
A patient organization running amok, a field that is riven by controversy on basic questions of disease pathogenesis, companies looking to make a killing on drugs with little or no proven clinically meaningful benefit and real harms to patients, and an FDA willing to do their bidding. This is a race to the bottom, incentivizing the worst behavior of everyone involved.