WSJ: The Battle Over an Alzheimer’s Treatment

Wall Street Journal: The battle over an Alzheimer's treatment. Millions and millions of Americans, tens of millions probably when you think of those who are affected by those who are affected. There is little in life that is sadder than witnessing a vibrant human being become something else. What was the Nancy Reagan phrase for Ronald Reagan, one of the most vibrant human beings in modern American history, extremely witty man? The long— was it the long goodbye? I think that that was the phrase she used. As you probably know, there's not much I fear, but on the short list would be Alzheimer's. Now, there's no record of that in my genetic history, but there's no guarantee. Anyway, I care about it for others. No, not just for myself. I mentioned my own fear of it just to communicate how much I loathe that particular disease because, I'll tell you one of the reasons, I am such a believer in human dignity. It's a very keen part of my outlook on life. And dementia and Alzheimer's specifically rob you of that. So there might be a treatment, the Wall Street Journal editorial. Biogen's promising drug is caught in the FDA's political and bureaucratic limbo. That is the subtitle. The FDA has long been plagued by a culture of of bureaucratic overcaution. I'm reading to you. Biogen's Alzheimer's drug aducanumab— aducanumab— why do they give them these names? I'm good at names and this is bad. Aducanumab. Backwards, that's bamunakuda. Frankly, I find bamunakuda easier to say than Adonakumad. I'm back to the show. You mean an extended analysis of that is not warranted at this time? That's correct, for you and me only. Oh, that's bad. Biogen's Alzheimer's drug adunacomab is now ensnared in this fight. Adunacomab, a monoclonal antibody drug, is the first disease-modifying medicine to show efficacy. It works by targeting specific molecules in the amyloid to clear plaque. A late-stage trial showed a high-dose treatment removed 71% of the plaque buildup after 18 months. Yes, that is a while. And also had a significant impact on disease progression. After 78 weeks of treatment, patients received a high dose— patients receiving a high dose were 84% less of a burden to caregivers than were the controls. That's huge. They showed a 91% smaller decline in the ability to prepare a meal and 39% smaller reduction in capacity to discuss current events. In short, patients treated with high doses of Biogen's drug were much more independent and capable. Yet because of the long history of failed Alzheimer's medicines, skeptics say Biogen's promising result is a false positive. Okay, they cite a second concurrent late-stage trial by Biogen that indicated adunakumab didn't have a statistically significant benefit on symptoms. But in a post-hoc review, Biogen found the likely reason for the discordant results. The two trials had nearly identical designs, but patients in one received the high dose longer and the benefits increased with time. Now, you don't have to be a scientist to understand that the two tests are not the same. One group gets it longer than the other, and the benefits accrue over time. That would seem to me to be, as the lawyers say, dispositive. We continue. Biogen worked with FDA scientists to analyze the discrepancies between the two trials. The FDA noted in June 2019 that the evidence from the positive trial could be, quote, considered exceptionally persuasive. Get that? FDA, February 2019, exceptionally persuasive tests. All right. Biogen applied in July for drug approval. Physicians and groups that work with Alzheimer's patients have urged the agency to approve the drug. Well, yet an outside panel of scientists that the FDA convened in November to advise it, none of whom specialize in treating Alzheimer's patients, lambasted Biogen for massaging the data. They said the positive results from the one trial could be a fluke and urged the FDA to require Biogen to conduct another, which could take— are you ready— 5 more years to complete. It would be one of the most interesting tests for me personally to find out if this panel that doesn't want Biogen released and wants to wait 5 years for more tests has a completely negative view of hydroxychloroquine and zinc and ivermectin, just Positing an interesting possibility. FDA Acting Commissioner Janet Woodcock, who is now a contender to be FDA Commissioner, is under political pressure. And this is not me, this is the Wall Street Journal. She is under political pressure from the to reject Biogen's drug. The word that I skipped is either left or right. What do you think? The contender to be FDA commissioner is under political pressure from the left or the right to reject Biogen's drug. The answer, of course, is the left. Whatever the left touches, it ruins. So if you just know that, you would have known immediately from which direction this cruel idea— if— is there anyone listening who, if afflicted with Alzheimer's, or who has a loved one would not try this drug? Doing so could set back Alzheimer's drug development by years and discourage investment against an affliction that causes terrible hardship. That's right, cause terrible hardship. That's all the left does.