The New Yorkerのインスタグラム(newyorkermag) - 6月20日 07時30分

A new A.L.S. treatment has shown promising results: according to a study published in 2020, it seemed to slow patients’ decline by about 25 per cent during the trial period. A second paper, published soon after, was even more auspicious. In the trial’s extension, those who never got the placebo survived an average of five months longer. Two outside researchers, though, advised that the “tantalizing preliminary data” be interpreted with restraint: the effect was “modest,” they wrote, in an editorial. A larger trial would be needed as confirmation—a process that could take three more years. The A.L.S. community, however, felt that there was no time to waste. The majority of current patients would be incapacitated or dead if they had to wait that long. “Please do not let another generation of A.L.S. patients die in pursuit of the perfect,” the co-founder of the organization I AM ALS told regulators. “We want to live. You have the power to make that possible.”

In March, 2022, the F.D.A. gathered an advisory committee to vote on whether the results so far “establish a conclusion” that the drug is “effective.” Agency officials, in their briefing documents, were polite, respectful, and unequivocal: the answer, as far as they were concerned, was no. But activists pushed the issue, and in September, the F.D.A. took the exceptionally unusual step of reconvening the advisory committee. This time, it voted in favor of approval. Some patients saw this as a triumph. But others weren’t sure how to feel. “If these drugs truly work, and the evidence is there, then let people have them!” one A.L.S. patient said. “But do we want a bunch of subpar therapies where the data has been sliced and diced three different ways from Sunday? And do we want to pay $160,000 a year for a therapy that has ‘eh’ benefit?”

At the link in our bio, Gideon Lewis-Kraus writes about the evolution of the F.D.A.’s drug-approval process, and the complexities of conducting trials on potentially lifesaving treatments. Illustration by @maria.chimi.

[BIHAKUEN]UVシールド(UVShield)

>> 飲む日焼け止め！「UVシールド」を購入する