#desperately tempted to tag this as an analysis post but I know I shouldn’t

[petrichormore]

q!badboyhalo is like one of those giant man-eating catfish that will eat anything that can fit in their mouths and then will sometimes suffocate because they block their own damn airway trying to eat something that’s physically bigger than them. like they still kill the thing but then they also kill themselves trying to fit it down the hatch. are you hearing me? are you hearing me? it’s 3am I need you to tell me you’re hearing me.

[septiembrre]

I'm a little late but I just saw your post from a year ago about latinx rep in good girls and its sad reflecting back on it and how the show could've done better. Rio was just another stereotype, I hate how he was ambitiously latino and there was just no connection to his culture. Was he first, 2nd, or 3rd Gen? If he was 1st Gen it didn't make sense to have the family speak English. One thing that always annoyed me is how OOC he was at times and how the writers purposely made him out to be like some brown aggressive misogynistic man. They didn't bother making him complex. In a way I'm glad the show got canceled. As a Mexican woman the way Rio was written was racist.

Wah, I’ve been sitting on answering your ask. I wanted to tease your ask apart and respond to it sentence by sentence. But... my brain kept rechazandolo, so now I have feelings dump instead.

Since Good Girls ended, I have been parsing through how I feel about S4 and GG overall — sometimes more positively, sometimes more negatively. Then, I flip to reminding myself it’s not that serious (it's just tv! this is supposed to be my leisure activity!). Then, I waffle back to reflecting.

So, no textual analysis just feels and whining under the cut. I know folks are still mourning the end of the show and I don't want to yuck anyone's yum. Tagging with #ggnegativity.

My short answer is that Good Girls is my beloved, sometimes joyful, sometimes hurtful, complicated little show. Even now that we’re no longer getting new episodes I’m wary of sifting through the information we have about Rio because it’s a mess and it seems like a lot of his character was poorly thought out (ahem, all those dumb messages from Bill Krebs confirming multiple instances of lack of intentionality or care!).

I say this because I was tempted to start responding to you by riffing off of your comment with, “y'know, now that you say that, I think he’s third or fourth gen…”, pero who cares? And the point was never specifically about what gen he is, or even more specifically about... lol, I was going to say it doesn't matter what nationality he was, they just needed to pick one. Ugh, but the wording of that is too glib. The lack of intentionality behind these details feels sanitized to me, it feels very white gaze, it feels lazy.

However, I could have forgiven a lot of this weak character construction if his baseline, plot-related characterization on-screen was more consistent. But, Rio was often used as a plot device in a way that often fell flat for me, a weekly recurring bogeyman whether his antagonism made sense or not. On one hand, I feel for the creative team, because I think they were in a hard place, trying to avoid romanticizing Rio, and trying to seemingly backtrack the sexualization of him in Season 2, but... Idk, it's complicated.

Retrospectively, it’s sitting with me how much Good Girls is rooted in whiteness. While it's something I discerned before (lol, most obviously with 2x13 and in S3 with Lucy's disposability), you know how some shows get to their third or fourth season and finally start investing in their marginalized characters? It’s a crappy thing to hold out hope for, they're crumbs! But, I was. And we did get some Rio worldbuilding. But, ultimately, it felt weak to me -- under-conceptualized or under-worked.

For example, I liked Nick as a Bigger Bad who drove Rio and Beth together. I also thought that Nick's non-existent moral code was a lovely foil to Rio's, and that this contrast humanized Rio in a way that he needed. It also cast a new light on Rio's behavior of the earlier seasons, outside of Beth's perception in a way that I thought was healthy and needed. Great, meaty stuff! However, Nick and Rio's relationship came across as shallow to me. There really did not seem to be a lived-in quality to their scenes. The show really struggled with that element overall -- even with the three lead protagonists (their decades-long history with each other and interactions between their families being largely absent). I wonder why they made that choice.

It's strange because on the flip side we got a hefty amount of contextualization for MLM guy Vance and Annie's bf Kevin... Even that cop who Mick killed! All white men, too.

Me da pena.

Or maybe the thing that bothers me is that those scenes between Nick and Rio didn't center Rio's perspective effectively? Despite the one-on-one scenes being outside of Beth's framing (Rio being a secondary character typically tethered to Beth's story arc), there still was a lot of distance between Rio and the viewer? Like I think of Vance in his kitchen with his wife and child, and the way we as viewers were brought into that to empathize with him, and I think of the distance of Nick+Rio boxing scene or the scenes at the bar. Argh! It's hard to pinpoint without the textual analysis I feel too grumpy to do. It was such a narrative choice to keep Rio aloof and I side-eye it.

Anyway --

Overall, the writing room/show creators/decision-makers didn't seem to consider Latine/x/a/o viewers throughout the crafting of Good Girls and that sucks. It really feels like I'm being told to conform to the white gaze in watching the show, and after 2x13 that makes me feel prickly and defensive. A part of me yearns to do a rewatch to map Rio’s character (and inconsistencies) but I still yield joy from Good Girls — it’s been my main comfort story during the pandemic. I also rendered joy from Season 4 specifically — some of those scenes between the leads at the end were phenom!!

I am leaning into what's bringing me joy right now, so I feel hesitant to stew in critique, even while I also feel some sort of need to make sense of the hurtful racializations. I have a compulsion to write them all down on the same post or list -- somewhere where I can see them all at once and understand. But, at the moment, it’s not a use of my time and energy that feels good. Opting into fics and writing is bringing me a lot of joy during hard times.

I have to close with one final whine, that I am SO fatigued with television options right now. I find myself desperately wishing for more TV out there whose priority audience isn't only white folks. Good Girls isn't alone in its treatment of Latinx characters, or alone in mishandling characters of color or gay characters, or prioritization of empathy for white het male characters, but certainly, creating something more thoughtful shouldn't be so hard.

[two-are-the-trees]

31 Days of Poe Day 16: “The Imp of the Perverse”

“The Imp of the Perverse” is, in my opinion, one of Poe’s most fascinating works. It’s extremely simple in its approach; it takes one particular topic of psychology and simply gives an example of how it might affect a person. The result, however, is unforgettable, simply because the topic that Poe chooses to expand upon is one of the most strangely understandable. It is the idea of uncontrollable thoughts or impulses; the things we don’t want to think about and yet, once we begin, we simply cannot stop. Poe proves that in the wrong circumstances, this phenomenon can betray even the most cunning of criminals. 

The narrator of this story begins by explaining the concept of the perverse. He states that anything perverse is something that a person knows they shouldn’t think or do and yet their brain becomes utterly fascinated and obsessed with said subject. He then goes on to tell of a murder that he committed. He was meticulous and calculating, ensuring that there was no possible way he could be caught. The more he thinks on the murder, however, the more paranoid he becomes and the more he starts to develop some “perverse” impulsive thoughts. He soon discovers that there is only one thing that stands between himself and capture; his own mind. 

Poe develops this subject in an extremely relatable way, even for those of us who have never experienced intrusive thoughts. We’ve all been troubled by persistent thoughts that disturb us or bother us, or have been tempted to do regrettable things because of sudden impulses. It is this frantic attempt to prevent these thoughts that Poe focuses on, and it not only creates thrilling tension in the narrative, but also provokes a sympathetic response in the reader. In fact, I believe that readers of gothic literature are more familiar with this type of “perverseness” than readers of other genres. Think of the process of reading something dark or scary. The entire point of gothic literature is to disturb the reader; to take them into a narrative and show them things that are strange and frightening. Why, then, would a reader subject themselves to this, to that agonizing moment of turning the page and experiencing terror? It is because there is also a fascination and obsession with those disturbing thoughts and subjects. The reader simply must go on, impulsively, and will go back to those terrifying images later despite their best efforts to forget about them. There is a real imp of perverseness in many of us, and Poe absolutely knew it. 

Would I recommend “The Imp of the Perverse?” Yes, yes, yes, especially if you are interested in the more psychological side of Poe’s writing. This story is a fascinating exploration of the power of the human brain and how for all it’s calculating power, it is still able to fall victim to its own persuasion. The desperate struggle to actively not think of something affects us all in one way or another and the more the thoughts are repressed, the stronger they come back to haunt us. 

For more analysis (which contains spoilers!!!) please read below the cut!

The brilliance of this story really shines through in the narrator, as he is the perfect candidate to fall victim to impulsive thoughts. He is clearly very smart, as he demonstrates in the thoroughness of his murder plan. He thinks very long and clearly about things and runs through every possible answer before acting, such as when he explains his deliberation about which murder method to use before deciding on a poisoned candle. This brain power becomes a double-edged sword, however, when his tendency to overthink continues even after the murder has been carried out. With nothing else to do, the narrator quickly becomes paranoid that somehow, something will go wrong even though he took all the necessary steps to ensure his safety. This is all the fault of his active mind; when left to idle, it simply keeps on planning even when, at that point, his thinking becomes a problem rather than an asset.

This is also where the narrator’s problem with perverseness comes into play. The narrator states that he is extremely susceptible to impulsive thoughts. I believe this is all because of his intelligence and his active mind, similarly to how he is prone to paranoia. Those who tend to be planners and overthinkers will understand this perfectly. Once his brain becomes focused on a subject, he becomes locked onto it and cannot think of anything else until his impulses are satisfied. This becomes a major problem when the thought he locks onto is the fact that he will only be caught for the murder if he confesses himself. The way Poe writes this sequence where the narrator realizes he is going to impulsively confess is perfect; the anxiety and tension is palpable as the narrator frantically tries to control his thoughts, but of course that only makes it worse. We can only read on in horror as his own mind betrays him and he reveals all without hesitation. 

There could also be a moral aspect to this story. One might argue that it is because the deed the narrator carried out was so horrible that guilt simply caught up with him and he could contain it no longer. I think that is also an interesting angle for the story, as it implies that sooner or later, guilt or at least some sense of moral obligation will catch up with everyone in the end. However, I think I prefer to think that the narrator would have gone his whole life without confessing had he somehow just been able to avoid that one thought forever. But, alas, sometimes the brain is too powerful even for itself and it cannot stop the uncontrollable rush of impulses that stem from a seemingly harmless idea. 

So, what did y’all think? Was there any way the narrator could have avoided confessing? Do you believe it was guilt that led him to confess? Do you find yourself obsessively engaging in media that scares you? If you have something to add, please comment on this post or send me an ask! You can also use the tag #31daysofpoe to write your own response post!

[gordonwilliamsweb]

FDA Weighs Approval of a Lucrative Alzheimer’s Drug, but Benefits Are Iffy

The Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits as well as criticism about the integrity of the FDA approval process.

This story also ran on The Daily Beast. It can be republished for free.

The agency said it will decide by June 7 the fate of Biogen’s drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November. Doubts were raised when, in 2019, Biogen halted two large clinical trials of the drug after determining it wouldn’t reach its targets for efficacy. But the drugmaker later revised that assessment, stating that one trial showed the drug reduced the decline in patients’ cognitive and functional ability by 22%.

Some FDA scientists in November joined with the company to present a document praising the intravenous drug. But other FDA officials and many outside experts say the evidence for the drug is shaky at best and that another large clinical trial is needed. A consumer advocacy group has called for a federal investigation into the FDA’s handling of the approval process for the product.

A lot is riding on the drug for Biogen. It is projected to carry a $50,000-a-year price tag and would be worth billions of dollars in revenue to the Cambridge, Massachusetts, company.

The FDA is under pressure because an estimated 6 million Americans are diagnosed with Alzheimer’s, a debilitating and ultimately fatal form of dementia, and there are no drugs on the market to treat the underlying disease. Although some drugs slightly mitigate symptoms, patients and their families are desperate for a medication that even modestly slows its progression.

Aducanumab helps the body produce antibodies that remove amyloid plaques from the brain, which has been associated with Alzheimer’s. It’s designed for patients with mild-to-moderate cognitive decline from Alzheimer’s, of which there are an estimated 2 million Americans. But it’s not clear whether eliminating the plaque improves brain function in Alzheimer’s patients. So far, nearly two dozen drugs based on the so-called amyloid hypothesis have failed in clinical trials.

Besides questions about whether the drug works, there also are safety issues. More than one-third of patients in one of the trials experienced brain swelling and nearly 20% had brain bleeding, though those symptoms generally were mild and controllable. Because of those risks, patients receiving aducanumab have to undergo regular brain monitoring through expensive PET scans and MRI tests.

Some physicians who treat Alzheimer’s patients say they won’t prescribe the drug even if it’s approved.

“There’s a lot of hope among my patients that this is going to be a game changer,” said Dr. Matthew Schrag, an assistant professor of neurology at Vanderbilt University. “But the cognitive benefits of this drug are quite small, we don’t know the long-term safety risks, and there will be a lot of practical issues in deploying this therapy. We have to wait until we’re certain we’re doing the right thing for patients.”

Many aspects of aducanumab’s journey through the FDA approval process have been unusual. It’s ���vanishingly rare” for a drug to continue on toward approval after its clinical trial was halted because unfavorable results showed that further testing was futile, said Dr. Peter Lurie, president of the Center for Science in the Public Interest and a former FDA associate commissioner. And it’s “mind-boggling,” he added, for the FDA to collaborate with a drugmaker in presenting a joint briefing document to an FDA advisory committee.

“A joint briefing document strikes me as completely inappropriate and an abdication of the FDA’s claim to being the best regulatory agency in the world,” Lurie said.

Three FDA advisory committee members who voted in November against approving the drug wrote in a recent JAMA commentary that the FDA’s “unusual degree of collaboration” with Biogen led to criticism that it “potentially compromised the FDA’s objectivity.” They cast doubt on both the drug’s safety and the revised efficacy data.

The FDA and Biogen declined to comment for this article.

Despite the uncertainties, the Alzheimer’s Association, the nation’s largest Alzheimer’s patient advocacy group, has pushed hard for FDA approval of aducanumab, mounting a major print and online ad campaign last month. The “More Time” campaign featured personal stories from patients and family members. In one ad, actor Samuel L. Jackson posted on Twitter, “If a drug could slow Alzheimer’s, giving me more time with my mom, I would have read to her more.”

But the association has drawn criticism for having its representatives testify before the FDA in support of the drug without disclosing that it received $525,000 in contributions last year from Biogen and its partner company, Eisai, and hundreds of thousands of dollars more in previous years. Other people who testified stated upfront whether or not they had financial conflicts.

Dr. Leslie Norins, founder of a group called Alzheimer’s Germ Quest that supports research, said the lack of disclosure hurts the Alzheimer’s Association’s credibility. “When the association asks the FDA to approve a drug, shouldn’t it have to reveal that it received millions of dollars from the drug company?” he asked.

But Joanne Pike, the Alzheimer’s Association’s chief strategy officer, who testified before the FDA advisory committee about aducanumab without disclosing the contributions, denied that the association was hiding anything or that it supported the drug’s approval because of the drugmakers’ money. Anyone can search the association’s website to find all corporate contributions, she said in an interview.

Pike said her association backs the drug’s approval because its potential to slow patients’ cognitive and functional decline offers substantial benefits to patients and their caregivers, its side effects are “manageable,” and it will spur the development of other, more effective Alzheimer’s treatments.

“History has shown that approvals of first drugs in a category benefit people because they invigorate the pipeline,” she said. “The first drug is a start, and the second and third and fourth treatment could do even better.”

Lurie disputed that. He said lowering the FDA’s standards and approving an ineffective or marginally effective drug merely encourages other manufacturers to develop similar, “me too” drugs that also don’t work well.

The Public Citizen Health Research Group, which opposes approval of aducanumab, has called for an investigation of the FDA’s “unprecedented and inappropriate close collaboration” with Biogen. It asked the inspector general of the Department of Health and Human Services to probe the approval process, which that office said it would consider.

The group also urged the acting FDA commissioner, Dr. Janet Woodcock, to remove Dr. Billy Dunn, an aducanumab advocate who testified about it to the advisory committee, from his position as director of the FDA’s Office of Neuroscience and hand over review of the drug to staffers who weren’t involved in the Biogen collaboration.

Woodcock refused, saying in a letter that FDA “interactions” with drugmakers make drug development “more efficient and more effective” and “do not interfere with the FDA’s independent perspective.”

Although it would be unusual for the FDA to approve a drug after rejection by an FDA advisory committee, it’s not unprecedented, Lurie said. Alternatively, the agency could approve it on a restricted basis, limiting it to a segment of the Alzheimer’s patient population and/or requiring Biogen to monitor patients.

“That will be tempting but shouldn’t be the way the problem is solved,” he said. “If the product doesn’t work, it doesn’t work. Once it’s on the market, it’s very difficult to get it off.”

If the drug is approved, Alzheimer’s patients and their families will have to make a difficult calculation, balancing the limited potential benefits with proven safety issues.

Anne Saint, whose husband, Mike, had Alzheimer’s for a decade and died in September at age 71, said that based on what she’s read about aducanumab, she wouldn’t have put him on the drug.

“Mike was having brain bleeds anyway, and I wouldn’t have risked him having any more side effects, with no sure positive outcome,” said Saint, who lives in Franklin, Tennessee. “It sounds like maybe that drug’s not going to work, for a lot of money.”

Their adult daughter, Sarah Riley Saint, feels differently. “If this is the only hope, why not try it and see if it helps?” she said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

USE OUR CONTENT

This story can be republished for free (details).

FDA Weighs Approval of a Lucrative Alzheimer’s Drug, but Benefits Are Iffy published first on https://nootropicspowdersupplier.tumblr.com/

[stephenmccull]

FDA Weighs Approval of a Lucrative Alzheimer’s Drug but Benefits Are Iffy

The Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits as well as criticism about the integrity of the FDA approval process.

This story also ran on The Daily Beast. It can be republished for free.

The agency said it will decide by June 7 the fate of Biogen’s drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November. Doubts were raised when, in 2019, Biogen halted two large clinical trials of the drug after determining it wouldn’t reach its targets for efficacy. But the drugmaker later revised that assessment, stating that one trial showed the drug reduced the decline in patients’ cognitive and functional ability by 22%.

Some FDA scientists in November joined with the company to present a document praising the intravenous drug. But other FDA officials and many outside experts say the evidence for the drug is shaky at best and that another large clinical trial is needed. A consumer advocacy group has called for a federal investigation into the FDA’s handling of the approval process for the product.

A lot is riding on the drug for Biogen. It is projected to carry a $50,000-a-year price tag and would be worth billions of dollars in revenue to the Cambridge, Massachusetts, company.

The FDA is under pressure because an estimated 6 million Americans are diagnosed with Alzheimer’s, a debilitating and ultimately fatal form of dementia, and there are no drugs on the market to treat the underlying disease. Although some drugs slightly mitigate symptoms, patients and their families are desperate for a medication that even modestly slows its progression.

Aducanumab helps the body produce antibodies that remove amyloid plaques from the brain, which has been associated with Alzheimer’s. It’s designed for patients with mild-to-moderate cognitive decline from Alzheimer’s, of which there are an estimated 2 million Americans. But it’s not clear whether eliminating the plaque improves brain function in Alzheimer’s patients. So far, nearly two dozen drugs based on the so-called amyloid hypothesis have failed in clinical trials.

Besides questions about whether the drug works, there also are safety issues. More than one-third of patients in one of the trials experienced brain swelling and nearly 20% had brain bleeding, though those symptoms generally were mild and controllable. Because of those risks, patients receiving aducanumab have to undergo regular brain monitoring through expensive PET scans and MRI tests.

Some physicians who treat Alzheimer’s patients say they won’t prescribe the drug even if it’s approved.

“There’s a lot of hope among my patients that this is going to be a game changer,” said Dr. Matthew Schrag, an assistant professor of neurology at Vanderbilt University. “But the cognitive benefits of this drug are quite small, we don’t know the long-term safety risks, and there will be a lot of practical issues in deploying this therapy. We have to wait until we’re certain we’re doing the right thing for patients.”

Many aspects of aducanumab’s journey through the FDA approval process have been unusual. It’s “vanishingly rare” for a drug to continue on toward approval after its clinical trial was halted because unfavorable results showed that further testing was futile, said Dr. Peter Lurie, president of the Center for Science in the Public Interest and a former FDA associate commissioner. And it’s “mind-boggling,” he added, for the FDA to collaborate with a drugmaker in presenting a joint briefing document to an FDA advisory committee.

“A joint briefing document strikes me as completely inappropriate and an abdication of the FDA’s claim to being the best regulatory agency in the world,” Lurie said.

Three FDA advisory committee members who voted in November against approving the drug wrote in a recent JAMA commentary that the FDA’s “unusual degree of collaboration” with Biogen led to criticism that it “potentially compromised the FDA’s objectivity.” They cast doubt on both the drug’s safety and the revised efficacy data.

The FDA and Biogen declined to comment for this article.

Despite the uncertainties, the Alzheimer’s Association, the nation’s largest Alzheimer’s patient advocacy group, has pushed hard for FDA approval of aducanumab, mounting a major print and online ad campaign last month. The “More Time” campaign featured personal stories from patients and family members. In one ad, actor Samuel L. Jackson posted on Twitter, “If a drug could slow Alzheimer’s, giving me more time with my mom, I would have read to her more.”

But the association has drawn criticism for having its representatives testify before the FDA in support of the drug without disclosing that it received $525,000 in contributions last year from Biogen and its partner company, Eisai, and hundreds of thousands of dollars more in previous years. Other people who testified stated upfront whether or not they had financial conflicts.

Dr. Leslie Norins, founder of a group called Alzheimer’s Germ Quest that supports research, said the lack of disclosure hurts the Alzheimer’s Association’s credibility. “When the association asks the FDA to approve a drug, shouldn’t it have to reveal that it received millions of dollars from the drug company?” he asked.

But Joanne Pike, the Alzheimer’s Association’s chief strategy officer, who testified before the FDA advisory committee about aducanumab without disclosing the contributions, denied that the association was hiding anything or that it supported the drug’s approval because of the drugmakers’ money. Anyone can search the association’s website to find all corporate contributions, she said in an interview.

Pike said her association backs the drug’s approval because its potential to slow patients’ cognitive and functional decline offers substantial benefits to patients and their caregivers, its side effects are “manageable,” and it will spur the development of other, more effective Alzheimer’s treatments.

“History has shown that approvals of first drugs in a category benefit people because they invigorate the pipeline,” she said. “The first drug is a start, and the second and third and fourth treatment could do even better.”

Lurie disputed that. He said lowering the FDA’s standards and approving an ineffective or marginally effective drug merely encourages other manufacturers to develop similar, “me too” drugs that also don’t work well.

The Public Citizen Health Research Group, which opposes approval of aducanumab, has called for an investigation of the FDA’s “unprecedented and inappropriate close collaboration” with Biogen. It asked the inspector general of the Department of Health and Human Services to probe the approval process, which that office said it would consider.

The group also urged the acting FDA commissioner, Dr. Janet Woodcock, to remove Dr. Billy Dunn, an aducanumab advocate who testified about it to the advisory committee, from his position as director of the FDA’s Office of Neuroscience and hand over review of the drug to staffers who weren’t involved in the Biogen collaboration.

Woodcock refused, saying in a letter that FDA “interactions” with drugmakers make drug development “more efficient and more effective” and “do not interfere with the FDA’s independent perspective.”

Although it would be unusual for the FDA to approve a drug after rejection by an FDA advisory committee, it’s not unprecedented, Lurie said. Alternatively, the agency could approve it on a restricted basis, limiting it to a segment of the Alzheimer’s patient population and/or requiring Biogen to monitor patients.

“That will be tempting but shouldn’t be the way the problem is solved,” he said. “If the product doesn’t work, it doesn’t work. Once it’s on the market, it’s very difficult to get it off.”

If the drug is approved, Alzheimer’s patients and their families will have to make a difficult calculation, balancing the limited potential benefits with proven safety issues.

Anne Saint, whose husband, Mike, had Alzheimer’s for a decade and died in September at age 71, said that based on what she’s read about aducanumab, she wouldn’t have put him on the drug.

“Mike was having brain bleeds anyway, and I wouldn’t have risked him having any more side effects, with no sure positive outcome,” said Saint, who lives in Franklin, Tennessee. “It sounds like maybe that drug’s not going to work, for a lot of money.”

Their adult daughter, Sarah Riley Saint, feels differently. “If this is the only hope, why not try it and see if it helps?” she said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

USE OUR CONTENT

This story can be republished for free (details).

FDA Weighs Approval of a Lucrative Alzheimer’s Drug but Benefits Are Iffy published first on https://smartdrinkingweb.weebly.com/

[gordonwilliamsweb]

FDA Weighs Approval of a Lucrative Alzheimer’s Drug but Benefits Are Iffy

The Food and Drug Administration’s decision next week whether to approve the first treatment for Alzheimer’s disease highlights a deep division over the drug’s benefits as well as criticism about the integrity of the FDA approval process.

This story also ran on The Daily Beast. It can be republished for free.

The agency said it will decide by June 7 the fate of Biogen’s drug aducanumab, despite a near-unanimous rejection of the product by an FDA advisory committee of outside experts in November. Doubts were raised when, in 2019, Biogen halted two large clinical trials of the drug after determining it wouldn’t reach its targets for efficacy. But the drugmaker later revised that assessment, stating that one trial showed the drug reduced the decline in patients’ cognitive and functional ability by 22%.

Some FDA scientists in November joined with the company to present a document praising the intravenous drug. But other FDA officials and many outside experts say the evidence for the drug is shaky at best and that another large clinical trial is needed. A consumer advocacy group has called for a federal investigation into the FDA’s handling of the approval process for the product.

A lot is riding on the drug for Biogen. It is projected to carry a $50,000-a-year price tag and would be worth billions of dollars in revenue to the Cambridge, Massachusetts, company.

The FDA is under pressure because an estimated 6 million Americans are diagnosed with Alzheimer’s, a debilitating and ultimately fatal form of dementia, and there are no drugs on the market to treat the underlying disease. Although some drugs slightly mitigate symptoms, patients and their families are desperate for a medication that even modestly slows its progression.

Aducanumab helps the body produce antibodies that remove amyloid plaques from the brain, which has been associated with Alzheimer’s. It’s designed for patients with mild-to-moderate cognitive decline from Alzheimer’s, of which there are an estimated 2 million Americans. But it’s not clear whether eliminating the plaque improves brain function in Alzheimer’s patients. So far, nearly two dozen drugs based on the so-called amyloid hypothesis have failed in clinical trials.

Besides questions about whether the drug works, there also are safety issues. More than one-third of patients in one of the trials experienced brain swelling and nearly 20% had brain bleeding, though those symptoms generally were mild and controllable. Because of those risks, patients receiving aducanumab have to undergo regular brain monitoring through expensive PET scans and MRI tests.

Some physicians who treat Alzheimer’s patients say they won’t prescribe the drug even if it’s approved.

“There’s a lot of hope among my patients that this is going to be a game changer,” said Dr. Matthew Schrag, an assistant professor of neurology at Vanderbilt University. “But the cognitive benefits of this drug are quite small, we don’t know the long-term safety risks, and there will be a lot of practical issues in deploying this therapy. We have to wait until we’re certain we’re doing the right thing for patients.”

Many aspects of aducanumab’s journey through the FDA approval process have been unusual. It’s “vanishingly rare” for a drug to continue on toward approval after its clinical trial was halted because unfavorable results showed that further testing was futile, said Dr. Peter Lurie, president of the Center for Science in the Public Interest and a former FDA associate commissioner. And it’s “mind-boggling,” he added, for the FDA to collaborate with a drugmaker in presenting a joint briefing document to an FDA advisory committee.

“A joint briefing document strikes me as completely inappropriate and an abdication of the FDA’s claim to being the best regulatory agency in the world,” Lurie said.

Three FDA advisory committee members who voted in November against approving the drug wrote in a recent JAMA commentary that the FDA’s “unusual degree of collaboration” with Biogen led to criticism that it “potentially compromised the FDA’s objectivity.” They cast doubt on both the drug’s safety and the revised efficacy data.

The FDA and Biogen declined to comment for this article.

Despite the uncertainties, the Alzheimer’s Association, the nation’s largest Alzheimer’s patient advocacy group, has pushed hard for FDA approval of aducanumab, mounting a major print and online ad campaign last month. The “More Time” campaign featured personal stories from patients and family members. In one ad, actor Samuel L. Jackson posted on Twitter, “If a drug could slow Alzheimer’s, giving me more time with my mom, I would have read to her more.”

But the association has drawn criticism for having its representatives testify before the FDA in support of the drug without disclosing that it received $525,000 in contributions last year from Biogen and its partner company, Eisai, and hundreds of thousands of dollars more in previous years. Other people who testified stated upfront whether or not they had financial conflicts.

Dr. Leslie Norins, founder of a group called Alzheimer’s Germ Quest that supports research, said the lack of disclosure hurts the Alzheimer’s Association’s credibility. “When the association asks the FDA to approve a drug, shouldn’t it have to reveal that it received millions of dollars from the drug company?” he asked.

But Joanne Pike, the Alzheimer’s Association’s chief strategy officer, who testified before the FDA advisory committee about aducanumab without disclosing the contributions, denied that the association was hiding anything or that it supported the drug’s approval because of the drugmakers’ money. Anyone can search the association’s website to find all corporate contributions, she said in an interview.

Pike said her association backs the drug’s approval because its potential to slow patients’ cognitive and functional decline offers substantial benefits to patients and their caregivers, its side effects are “manageable,” and it will spur the development of other, more effective Alzheimer’s treatments.

“History has shown that approvals of first drugs in a category benefit people because they invigorate the pipeline,” she said. “The first drug is a start, and the second and third and fourth treatment could do even better.”

Lurie disputed that. He said lowering the FDA’s standards and approving an ineffective or marginally effective drug merely encourages other manufacturers to develop similar, “me too” drugs that also don’t work well.

The Public Citizen Health Research Group, which opposes approval of aducanumab, has called for an investigation of the FDA’s “unprecedented and inappropriate close collaboration” with Biogen. It asked the inspector general of the Department of Health and Human Services to probe the approval process, which that office said it would consider.

The group also urged the acting FDA commissioner, Dr. Janet Woodcock, to remove Dr. Billy Dunn, an aducanumab advocate who testified about it to the advisory committee, from his position as director of the FDA’s Office of Neuroscience and hand over review of the drug to staffers who weren’t involved in the Biogen collaboration.

Woodcock refused, saying in a letter that FDA “interactions” with drugmakers make drug development “more efficient and more effective” and “do not interfere with the FDA’s independent perspective.”

Although it would be unusual for the FDA to approve a drug after rejection by an FDA advisory committee, it’s not unprecedented, Lurie said. Alternatively, the agency could approve it on a restricted basis, limiting it to a segment of the Alzheimer’s patient population and/or requiring Biogen to monitor patients.

“That will be tempting but shouldn’t be the way the problem is solved,” he said. “If the product doesn’t work, it doesn’t work. Once it’s on the market, it’s very difficult to get it off.”

If the drug is approved, Alzheimer’s patients and their families will have to make a difficult calculation, balancing the limited potential benefits with proven safety issues.

Anne Saint, whose husband, Mike, had Alzheimer’s for a decade and died in September at age 71, said that based on what she’s read about aducanumab, she wouldn’t have put him on the drug.

“Mike was having brain bleeds anyway, and I wouldn’t have risked him having any more side effects, with no sure positive outcome,” said Saint, who lives in Franklin, Tennessee. “It sounds like maybe that drug’s not going to work, for a lot of money.”

Their adult daughter, Sarah Riley Saint, feels differently. “If this is the only hope, why not try it and see if it helps?” she said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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