Melissa Harris-Perry: I'm Melissa Harris-Perry, in for Tanzina Vega. This is The Takeaway. We start the show today with some big news out of the FDA. On Monday, the FDA approved a new drug to treat Alzheimer's disease, the first in nearly two decades. It's called aducanumab, and it aims to slow the cognitive decline often associated with the disease. Maria Carrillo from the nonprofit Alzheimer's Association said this about the drug.
Maria Carrillo: This is the first FDA drug approval that delays decline due to Alzheimer's disease, which means that individuals may have more time to actively participate in activities and to have sustained independence, hold on to their memories longer.
Melissa Harris-Perry: Plainly, the Alzheimer's Association and other groups are celebrating the decision. Certainly, the FDA's decision is expected to have far-reaching implications for patients, providers, caregivers, and so many others, but already, there's fierce debate over whether or not the new drug even works.
Now, my family's group text lit up with excited and worried messages as soon as news of the new drug was released. Alzheimer's is a constant theme in my family, just as it is for so many others, with more than 6 million people in the US living with the disease today. For Black families like mine, grieving during what has been called the long goodbye is complicated by the fear that medical racism will prevent our elders from receiving the best care.
While many members of our family are enthusiastic about the possibilities of this new drug, others are concerned that it could widen the already deep racial healthcare disparities that mark the experience of Alzheimer's disease. For more on the new Alzheimer's drug and what it could mean, we're joined by Jennifer Manly, a professor at the Taub Institute for Research in Aging and Alzheimer's disease at Columbia University in the Department of Neurology. Jennifer, it's lovely to have you here.
Jennifer Manly: Hi, Melissa, thanks for having me.
Melissa Harris-Perry: Absolutely. Also with us is Pam Belluck, who is health and science writer at the New York Times. Pam, welcome to the show.
Pam Belluck: Thank you, Melissa. It's great to be here.
Melissa Harris-Perry: Pam, let's start with you. Just how significant is the news of this new drug.
Pam Belluck: This is very significant. It is the first drug for Alzheimer's that's been approved in 18 years, and it is the first that goes after a key part of Alzheimer's biology, a protein called amyloid, which is the protein that clumps into plaques in the brains of people with Alzheimer's, so it is a very big deal to have this. There is a lot of controversy, as you said, about whether it works, and there are going to be a lot of implications for which patients are going to be eligible, the FDA was not clear, they didn't narrow that down.
I think there will be even more of a flood of interest in this, and clinics are going to have to manage that, and they're going to have to figure out how they're going to screen patients, and they're going to have to have enough infusion centers. This is an infusion, an intravenous infusion that patients will get once a month. They will also need to get regular brain MRIs to check for a potentially serious complication, which is, brain swelling or brain bleeding. This is really going to shake up just about everything in the Alzheimer's landscape.
Melissa Harris-Perry: Jennifer, let me come to you. I hear Pam talking about these potentially very challenging side effects, these concerns over the drug's efficacy, and yet the last time we saw a new Alzheimer's treatment was way back in 2003. There is still some level of enthusiasm, again, even in my own family that we were feeling about this yesterday, but why did it take so long to get another medication?
?Speaker: I think that's-- Part of the concern here is that there actually have been a number of amyloid clearing drugs that have come to trials over the past several years, but those drugs, just like this one, aducanumab, were not shown to improve the cognitive symptoms of Alzheimer's disease over those people who had placebo in the trial. Just to be clear, this drug approval yesterday, if you read carefully, the FDA documentation was to clear amyloid from the brain but not to treat the symptoms of Alzheimer's disease, which are cognitive impairment and dementia.
The FDA has directed Biogen, the maker of the drug, to perform additional trials to determine its efficacy in preventing decline. One reason why it's taken so long to develop these drugs is that we're targeting a protein, and this drug and others do a great job of taking it out of the brain, but it's not so clear whether this helps improve cognition.
Melissa Harris-Perry: Thank you, Pam, so much, it's so helpful for understanding what's at stake here, and it makes me want to step back just a little bit, Jennifer, and to ask you then, what is it that we know about Alzheimer's and about what causes, maybe less that question of the proteins, but those cognitive impairments, those things that take our loved ones from us little by little, what do we know about that?
Jennifer Manly: That's the key question. For me, I try to understand why those cognitive problems, the loss of memory, confusion, and the other changes that families see and people living with dementia experience. I try to figure out why that burdens some populations, some communities more than others. Very much like COVID and other diseases, Alzheimer's disease is experienced more often disproportionately by Black and Latinx or Hispanic families. There's something about our social and structural environments that raise risk for cognitive decline in Alzheimer's disease.
For a long time, we have known that amyloid and tau, which are two proteins that aggregate abnormally in the brain, are part of Alzheimer's disease but there's increasing evidence that the cognitive symptoms associated with Alzheimer's disease are also linked to cardiovascular risk and cerebrovascular disease, changes in the brain that happen because of the blood vessels and the vascular system in the brain. This drug does not treat those vascular changes. I think we're coming as a field to a realization that the neuropathology of Alzheimer's disease is more complicated than we thought before.
Melissa Harris-Perry: Pam, despite these deep complications that Jennifer is laying out for us here, there is still so much enthusiasm about this. Is that about kind of the desperation so many of us feel for any treatment at this point?
Pam Belluck: Yes, I think so. This is a very serious disease, obviously, it's very widespread, 6 million in the United States, 30 million worldwide. As our population is aging rapidly, that's going to probably double in the next 30 years, so there is a desperation for treatment. I'd like to say I agree with everything that Jennifer has said here and explained. I think it's really important to kind of counterbalance the enthusiasm for some new approved drug with expectations for what it might or might not be able to do.
This was a drug that, as Jennifer said, there's a long history, I think, 25 years worth of clinical trials of drugs that have successfully lowered the levels of this amyloid protein and yet not shown any effect at all, any benefit at all on the memory and thinking problems that characterize Alzheimer's. This one was-- There were two clinical trials that were essentially identical that were conducted with this drug.
They were both stopped early because a safety monitoring committee said, "This doesn't look like it's working," so about more than a third of the patients who were trial participants didn't actually complete the trial, so you have a smaller amount of data than you expected. Then, one of those trials didn't show any benefit at all. The other one showed in one dose, in the high dose, really a very slight benefit, and we're talking about perhaps slowing decline of memory and thinking problems by maybe four months over 18 months or about two and a half months in a year.
Well, on the one hand, you have the patient population and the family population totally understandably saying, "Well, any kind of delay in decline could be meaningful." On the other hand, you have the scientific community in large part saying, "This evidence isn't convincing." Even the FDA kind of said, "This evidence isn't really that convincing. That's why we're asking for another trial." Even if it was convincing, the potential is pretty slight for benefit and may not outweigh the risks.
I guess one other thing that I wanted to say, and Jennifer mentioned, the clinical trial that the FDA is requiring Biogen to do to confirm whether or not they get the same degree of benefit in that trial. That's because the evidence wasn't convincing, but the thing with the clinical trial is that that's going to take probably four or five years. While that trial is running and trying to recruit patients who will participate, which is hard to do in Alzheimer's trials as it is, this drug is available for a number of years when we don't really have a conclusive answer.
Melissa Harris-Perry: Pam, let's talk more about these questions of racial disparities relative to Alzheimer's. Help me to understand if this is, as we sometimes see in health disparities, truly along the lines of race or if this seems to be actually race standing in for a variety of socioeconomic status questions, which one does this look like from your research?
Pam Belluck: I think Jennifer may be better placed to answer that. There certainly is a disparate effect. Populations from BIPOC communities are disproportionately at risk for Alzheimer's. I think there's a variety of reasons for that. They also, unfortunately, have disproportionate access to care and to memory clinics.
Interestingly, in these clinical trials, as I mentioned, it's really hard to recruit patients to participate, to begin with, the participant base tends to be overwhelmingly white, at least in this country. They usually do have participants from many other countries, but this is a problem that we've seen in many clinical trials for many different diseases, you don't get a good representation of the United States population so whatever effect you're seeing in the drug may not generalize to the entire population.
Jennifer Manly: I can add to that a little bit. I think just going from what Pam was saying about the trials, we know that only about 1% of participants in Alzheimer's disease clinical trials identify as Black and about 3.4% only identify as Hispanic or Latino. This is no different in the trial that we're talking about right now. I think that the primary concern about this is some of those side effects that were mentioned before by Pam, the brain swelling and brain bleeding.
Those side effects impacted about 35% in terms of the brain swelling and about 17% had brain bleeding. Because so few people from my community and your community, Melissa, participated in these trials, we don't know what the frequency of those side effects would be in those groups.
I think the other big deal here is that overall, Alzheimer's disease is an underdiagnosed condition. Only about half of the people in the US who have Alzheimer's disease, dementia, ever receive a formal diagnosis by their doctors, and this is even lower, significantly lower among African Americans and Hispanic people. The diagnosis and the identification is part of why we have concerns about access, access to this drug and access to treatment.
My research shows that there are life course social and structural risks that increase the risk for Alzheimer's disease and dementia and that these are modifiable because we have ways in our country of investing in neighborhoods and investing in schools and investing in health care among people who wouldn't normally have the opportunity to get that. Just from a population or public health perspective, my focus has been on increasing access to diagnosis, increasing the utility of the tools that we use to diagnose and also trying to find out why we have these disparities in dementia.
Melissa Harris-Perry: Jennifer, tell me if I'm overstating this, are you suggesting that Alzheimer's, like diabetes, like asthma, like maternal and infant mortality, is in part a result of structural and systemic racism, as well as these kinds of plaques on the brain or other physiological characteristics?
Jennifer Manly: Yes, though structural and systemic racism are the fundamental causes of some of the disproportionate investment in education, for example. What we're finding is that schools that serve Black children have less investment, federal and state investment. By following people over the course of their lives in these big national studies, we can trace that level of investment to their risk for dementia and cognitive impairment later in life. Absolutely, like COVID, like diabetes, like hypertension, there are these links to racism that need to get explored. Now, that doesn't mean that the disease itself is different in terms of the neuropathology, that means that there are other ways to modify the disease.
Melissa Harris-Perry: Pam, can you give me some hope? Are there other medications in trial that might be even more promising than this one that we received approval on?
Pam Belluck: Yes. Actually, there are two medications that also attack amyloid and seem to do a better job of that, actually. They have had more promising results from their mid-stage trial, their Phase II trials, and they're now in the larger Phase III trials.
Melissa Harris-Perry: Pam Belluck is a health and science writer at the New York Times, and Jennifer Manly is an associate professor at the Taub Institute for Research in Aging and Alzheimer's at Columbia University. Thank you both.
Jennifer Manly: Thank you, Melissa.
Pam Belluck: Thanks for having me.
Melissa Harris-Perry: Now, we've been talking about the new drug approved by the FDA for treatment of Alzheimer's. With more than 6 million Americans living with Alzheimer's, this news is personal to so many families, including mine. For the past two years, my big sister has provided round-the-clock care and companionship for her mother, who we all call Nana. Nana's Alzheimer's advanced swiftly during the pandemic. While I only live a few blocks away, COVID-19 meant I couldn't provide much help. I spoke to my sister, and she told me what the hardest part of last year was for her and Nana.
?Speaker: It was difficult as it was-- Not having home health care, most difficult for not being able to take her out. Because you're concerned about them losing their ability to walk, you want them walking every single day, and we would take her to Walmart or to the mall and just walk, just walk. She would associate getting in that car, "she is going to someplace." [unintelligible 00:20:19] take her out to eat pre-COVID and then all of a sudden, that comes to an end, and she doesn't understand why.
Melissa Harris-Perry: We asked you to share your experiences with us, and here's what you had to say.
Greg: Your question was about Alzheimer's. I could share with you that our wonderfully bright mom at the age of 90, she was a 26 year elected councilwoman, got to spend the last four months waking every morning and asking us, "Why am I sleeping downstairs? What's going on?" We got to tell her for the first time each day that she had incurable brain cancer. Then watch her taking that difficult news with total surprise and dismay. This Alzheimer's is a cruel disease, and its cure deserves a relentless pursuit. This is Greg Keenan from Stamford, Connecticut.
Jackie: Our biggest emotional challenge caring for our mother with dementia is constantly listening to what we call [unintelligible 00:21:34], this particular loop she's stuck on, which is, "What am I doing? Tell me what to do?" Our friend's mom with dementia has her own loop, which is, "Why am I here?" It would be interesting to predict what your loop might someday be. This is Jackie from Greenbrae, California.
Karen: This is Karen from Forest Park, Oklahoma. I once worked as an unskilled caretaker for a woman with Alzheimer's. It was really sad to see how just lost she felt in her day. It's a totally brutal disease, and I am optimistic about future treatments because the alternative isn't bearable.
Sue Leone: Hi, this is Sue Leone from Raleigh, North Carolina. Alzheimer's is shitty. There is no other way to describe it. Prevention or cure, great, but in my opinion, treatment just prolongs the agony for everyone.
Barbara Anderson: Hi, this is Barbara Anderson. I live in Brownsville, Oregon. I'm 67 years old and have generations of Alzheimer's victims on both sides of my family. I'm really counting on effective treatments being found before I start feeling its effect. It's a fear I live with. It's a brutal disease for both the sufferer and those who care for them. I've been through it many times with people I love dearly. I'm counting on the scientists.
Mary: Hi, this is Mary from Philadelphia. I suspect that I may have the early stages of Alzheimer's disease. I'm 77. My sense of smell is not nearly what it once was, and in the past two years, I find that I'm being more forgetful. As far as cures or treatments for Alzheimer's, I don't see that happening in my lifetime, although we may learn more about prevention and the causes of Alzheimer's. Thank you.
Todd: Hi, my name is Todd, and I'm calling from Philadelphia, Pennsylvania. My wife's aunt lived with us for 10 years after she was diagnosed with Alzheimer's. My wife was her main, her only caretaker until she was placed on hospice. We got no help from family or friends financially or otherwise; helping out my wife to give her a break or anything of that nature.
My wife actually ended up having to stop working to stay home and care for her. She did pass away at our house at 90 years of age. Both my kids were minors at that time. It was dramatic, traumatic, and difficult, but I think on the back end, my wife felt obligated and not so much enjoyed taking care of her aunt but felt like it was her duty to do so rather than put her in a rehab facility.
Elizabeth: Hi, this is Elizabeth from Napa, California. My mother died of Alzheimer's last year, her father died of Alzheimer's 25 years before that. I'm terrified of the disease. I am really [inaudible 00:24:48] new drug. I will check it out, and I'm also interested in death with dignity law for people with Alzheimer's because right now, even though the disease is fatal, once you have Alzheimer's, you're not considered competent to make the decision to end your own life. It's devastating for families, it's devastating for finances, and it's not a great quality of life for people at their end of life. That's my opinion about it. Thank you so much. Bye-bye.
Melissa Harris-Perry: Thank you so much as always for sharing your thoughts with us. The number to call is 877-869-8253. You can also always send us a voice memo to firstname.lastname@example.org.
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