The Wall Street Journal's Defense of Aduhelm Deserves 1.5 Cheers
Last week, the Wall Street Journal editors wrote a stirring defense of the Food and Drug Administration’s decision to approve Biogen’s new drug Aduhelm. Aduhelm was approved to treat Alzheimer’s. Critics of the federal approval argue that there is no direct evidence that Aduhelm will cure Alzheimer’s. Supporters agree.
So what’s the issue? The Journal‘s editors put it well:
Nobody has said Aduhelm is a cure, but it is the first treatment following hundreds of failures that has shown evidence in clinical trials of removing amyloid plaque—a hallmark of the disease—and slowing cognitive decline.
Critics are right that it’s not clear that amyloid causes Alzheimer’s. But the leading research hypothesis is that a buildup of harmful amyloid plaque in the brain triggers a cascade of chemical changes that interfere with neuron communication and cause brain loss. Critics also note that some two dozen drugs aimed at removing amyloid have failed to meaningfully affect the course of the disease.
The Journal continues:
Yet many trials hadn’t properly screened patients to ensure they had Alzheimer’s. Some drugs were also tested on late-stage patients who had irreversible brain loss. And some failed to clear amyloid because they didn’t target the right molecules in the brain.
Biogen learned from these failures, and the FDA noted that Aduhelm was the first drug to show “proof of concept” in an early stage trial that clearing amyloid could slow decline. This was supported by a Phase 3 trial in which patients receiving the highest dosage showed 25% to 28% less decline in memory and problem-solving compared to the placebo group after 78 weeks.
In short, there’s a good case for allowing it. As more and more people use Aduhelm, we’ll get more information. In a few years, we’re likely to know much more.
But there’s a wrinkle. If Medicare pays for this drug, whose positive effects in treating Alzheimer’s are somewhat speculative, we the taxpayers will be forced to pay. And the price is not low. The Journal quotes Senator Ron Wyden (D-Oregon):
It’s unconscionable to ask seniors and taxpayers to pay $56,000 a year for a drug that has yet to be proven effective,” Oregon Sen. Ron Wyden tweeted after the Food and Drug Administration approved Aduhelm this month.
Ask? I wish. Taxpayers don’t get “asked.”
How does the Journal deal with Wyden’s point? By claiming that having Medicare negotiate a lower price is an imposition of a price control.
It’s not. When a government negotiates a price, the other side is free to reject it. It’s not a price control. It would be a price control if the federal government said that no one–not an insurance company and not a patient–is allowed to pay more than $X for a drug. I don’t think that’s why Wyden is proposing; it’s certainly not the thinking of many of us want Medicare not to have an open-ended commitment to paying whatever a drug company charges.
For many years now, the Journal‘s editors have argued that any restriction on how much Medicare will pay amounts to a price control and they’ve repeated the argument many times. But repetition doesn’t make the argument stronger.
Here’s an earlier post where I criticized the editors on that point.