Debbie says:
In June of 2021, the US Food and Drug Administration (FDA) approved the first drug treatment for Alzheimer’s Disease, a leading cause of dementia in (mostly) older adults. The approval was highly controversial, and resulted in the resignation of three members of the FDA board that voted against approval. More recently, the Centers for Medicare and Medicaid Services (CMS) chose to make the drug available only for patients in clinical trials, although the FDA approval is not limited. Rachel Sachs, writing at Health Affairs this past January, has a cogent summary of the approval issues and what’s behind them. Basically, the drug has been demonstrated convincingly to reduce plaques in the brains of people with Alzheimer’s but that does not correlate to statistically reliable evidence of actual health improvement.
I had been following this very casually, until I happened to see Isadore Hall’s op-ed piece in my local Black press. Hall feels strongly about the CMS decision:
I know that CMS is fully aware that Alzheimer’s disease is a devastating disease that affects more than 6 million Americans, 80% of whom are Medicare beneficiaries. Among Americans 65 and older, Blacks have the highest percentage of Alzheimer’s disease, 13.8%, according to the Centers of Disease Control and Prevention (CDC). In fact, the Alzheimer’s Association reports that older Blacks are twice as likely to have Alzheimer’s disease than whites.
African Americans are also mostly likely to be undiagnosed for Alzheimer’s Disease, according to the National Institutes of Health. Therefore, we are also most likely to be untreated.
He goes on to explain how personal the issue is for him, as it is for so many millions of people in the United States.
Intellectually, I can understand the CMS decision; in fact, from what little I have in the way of details, it sounds like a scientifically sensible and justifiable decision.
But …
Not everything about this issue is about the science. Having Alzheimer’s in your family is devastating (often more to the family members than the person affected, particularly as the disease progresses). Aduhelm represents hope, even if that hope is tenuous. And the last thing we need as a country right now is a message that says “this particular hope, like so many others, is only available to rich people.” Add in the fact that Black people suffer more from Alzheimers and are vastly less statistically likely to be rich enough to afford it on their own. What’s more, clinical trials (where the drug will be available) are predominantly available to White patients (some estimates put it at 85% of clinical trial patients are White). The FDA is putting together guidance on how to make the trials more equitable–as of this month, that guidance is in draft and not being implemented.
CMS is legally not allowed to consider cost in their decision-making. And it’s no accident that the big insurers have been publicly thrilled with the decision, which gives them cover to refuse to make it available to their customers (of all races).
So, while Aduhelm’s effectiveness and appropriateness is important, so is the availability of hope to all, not to mention even-handed access to resources.
I’m 100% in favor of a better FDA, with a less politicized decision-making process. I would like to see the FDA revisit this approval. Meanwhile, taking this position against the CMS ruling aligns me with some uncomfortable allies, including the Wall Street Journal and many Republican politicians. But in the end I was moved by Isidore Hall. (“My grandmother lost her fight to Alzheimer’s Disease in 2017. I often watched her feeling helpless as she suffered from this horrifying and painful disease.”) I believe this medication should either be available to everyone or to no one.
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