Abdul dissects the FDA’s disastrous decision to approve the new Alzheimer’s drug aducanumab despite the evidence that it fails to improve symptoms—and its aftermath and implications for the future of Big Pharma. He speaks with Professor Aaron Kesselheim, a prescription drug policy expert and a former member of the FDA Advisory Panel, who resigned at the FDA ignored the panel’s overwhelming opposition to approve it the drug.

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Transcript

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Abdul El-Sayed: New data show that US life expectancy fell dramatically in 2020. It fell three years among LatinX Americans, 2.9 years among Black Americans in a year and a half overall. France’s president Emmanuel Macron announced a plan that will require vaccine verification for access to restaurants, bars and government buildings across the nation. 1.7 million French residents signed up for vaccines the next day. The U.S. Surgeon General issued the first Surgeon General’s advisory of his tenure, calling misinformation a critical public health threat as the White House battles with Facebook over their role in spreading lies about the vaccine. This is America Dissected. I’m your host, Dr. Abdul El-Sayed. A few weeks ago, acting head of the FDA, Janet Woodcock, made an unprecedented announcement.

[news clip] Tonight, the acting head of the FDA calling for an inspector general’s investigation into approval of Aduhelm, the first Alzheimer’s drug in decades.

Abdul El-Sayed: This investigation is the latest in a long line of unprecedented events having to do with Alzheimer’s drug aducanumab, or Aduhelm, as it’s marketed by its manufacturer Biogen. Aduhelm poses a Rubicon moment for the FDA, health insurers, providers and pharma in the US. It’s forced regulators, doctors and the public, to ask basic questions about the FDA’s approval process. How little is too little scientific evidence to allow a drug with serious side effects to be marketed and sold to the American public? How much is too much to charge patients, families, and the public for a prescription drug? How often is too often to contact, cajole, pressure, and persuade regulators to approve your drug? How loud is too loud for public outcry to force you to rethink the entire system? But first, let’s talk specifics. Alzheimer’s disease is awful, it robs people of the things that make them who they are, their memories, their habits, their families and over time, their lives. Alzheimer’s disease isn’t suffered alone by the person whose brain it’s destroying. The agony is lived out by all the people who love them. It breaks minds and hearts. Until now, there hasn’t been a single Alzheimer’s medication approved by the FDA for nearly 20 years, even as rates of Alzheimer’s disease have skyrocketed. Some six million people and their families are suffering and they’re desperate for a new breakthrough. In recent years, scientists who study Alzheimer’s disease have found a remarkable thing in brains of people with Alzheimer’s, the presence of plaques of proteins that they don’t find another brains. These plaques, called beta amyloid plaques, are thought to play a role in the pathogenesis of Alzheimer’s disease. But the problem is that we don’t really know what they actually do, just that patients suffering Alzheimer’s have them in their brain. Despite not knowing the role that these plaques play in Alzheimer’s, biotech companies have been working to manufacture antibodies which attack these beta amyloid plaques, in hopes that an antibody could be the cure or at least a treatment for the disease. Biogen, the drug manufacturer behind a series of drugs that treat multiple sclerosis or MS, were able to develop, aducanumab, an antibody that does just that. But here’s the thing, it’s not clear that attacking those plaques actually addresses the symptoms of Alzheimer’s disease. But amyloid plaques have become what drug makers call a surrogate endpoint, some physiologic measure that we think is tied to the pathology we’re trying to treat, but doesn’t guarantee a direct improvement in pain, function or survival. So does treating plaques actually slow cognitive decline? That was the ultimate question Biogen wanted to answer in two large clinical trials. The results: no. Treating the plaques had little to no therapeutic effect on Alzheimer’s. In fact, independent auditors shut down both of the trials because early evidence showed that the drug didn’t appear to be helping patients and the side effects were common and serious. Patients on the drug have to have regular brain MRIs to monitor for brain swelling and bleeding. But Biogen pressed on anyway, they reanalyzed the trial findings, looking for any shred of evidence that the drug might work. They found that in one arm of one of the trials, patients on the highest dose of aducanumab, had a tiny reduction in the speed of cognitive decline. On that sliver of evidence, far short of what the FDA usually requires to approve a drug, Biogen applied for FDA approval. In the process of the application, an FDA advisory panel, a team of experts who review the evidence and advise the FDA on new approvals, voted overwhelmingly against approval 10 against, zero for, and one abstention. Another Council of FDA officials also indicated that there simply wasn’t enough evidence to warrant approving the drug. Their meeting minutes said that approval might, and I quote, “result in millions of patients taking aducanumab without any indication of actually receiving any benefit, or worse cause harm.” Two months later, the FDA ignored the recommendations of these panels, and:

[news clip] The FDA just approved a new drug to fight the major cause of Alzheimer’s, despite concerns about the cost and its effectiveness.

Abdul El-Sayed: Now, why in the world against evidence and recommendations did the FDA approve Aduhelm? Let’s dissect. In 2019, Biogen kicked off a full-court press program to lobby the FDA for approval. They code named it Project Onyx. Central to the plan was a courtship of Billy Dunn, the FDA official overseeing the FDA’s Department of Neuroscience, and therefore the approval of Alzheimer’s drugs. After announcing that it had originally shelved the drug, Biogen reached out for an off-the-books meeting with Dunn to share their shred of evidence. And that’s when the drug’s destiny changed. In fact, officials within the Office of Neuroscience became so bullish on Aducanumab, they proposed approving it through a regulatory workaround called accelerated approval, which had never been used for an Alzheimer’s treatment before. Project Onyx was successful, Aducanumab was approved, and then Biogen had the gall to slap a $56,000 a year price tag on the drug. Let me say that again, $56,000 for a drug that clinical trial evidence barely showed could even work. To understand why that price point is so astounding, consider this: $56,000 isn’t even the whole cost of the treatment. Patients on Aducanumab have to get infused at a facility that has the right equipment. They also have to have regular MRIs, which can run in the thousands of dollars to monitor for brain swelling and bleeds. Then there’s the fact that the vast majority of patients who might be eligible for Aducanumab are over 65, meaning they’re insured on Medicare. Their health insurer is the US government. Right now due to a series of laws passed during the Bush administration, Medicare is legally barred from negotiating the price of prescription drugs with manufacturers. That means that the government, paid for by you and I, the taxpayer, we can’t negotiate that $56,000 price tag down as other insurers might. Instead, you and I are left paying the full price tag for a drug that barely works. If only a sixth of patients with Alzheimer’s were prescribed the drug, it would cost Medicare $50 billion a year. So let me summarize here, Biogen used underhanded tactics to get their drug approved, then they exploited suffering people desperate for treatment to push a government program into funding and all-but-ineffective drug with serious side effects that could bankrupt Medicare. But here’s the good news. There was an uproar in the Alzheimer’s community. Several medical centers, including the Cleveland Clinic, announced they wouldn’t prescribe the medication. Insurance companies have said they won’t cover it. And the Centers for Medicare and Medicaid Services who administer Medicare have kicked off an internal review process to assess whether the drug meets standards for coverage. Meanwhile, the Office of the Inspector General is investigating the FDA’s approval process. The story of Aducanumab captures so much of what’s wrong with prescription drugs in America: the blatant promotion of profit over patients, the exploitation of people desperate for some hope, the attempt to cajole, pressure and force public programs into underwriting private greed. Today, we’re diving in further. Our guest knows these contours all too well. Dr. Aaron Kesselheim was one of the members of the FDA’s initial advisory panel that voted against approving Aducanumab. After the FDA ignored the panel, Dr. Kesselheim resigned in protest. Today, he joins us to talk about Aducanumab, decision to resign, and break down pharmaceutical policy overall, as one of the nation’s leading experts in the field. After the break.

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Abdul El-Sayed: Thank you so much for taking the time. I’m really excited to have you on the pod. This is the topic that that keeps on giving, man. It’s just it’s such a fascinating story.

Dr. Aaron Kesselheim: Yeah, it has been, it has been a very interesting few weeks for sure.

Abdul El-Sayed: I can imagine your life. Well, thank you for a) your leadership b) for sharing it with us. Ready to get started?

Dr. Aaron Kesselheim: For sure. Yeah, absolutely.

Abdul El-Sayed: Can you introduce yourself with the tape?

Dr. Aaron Kesselheim: Sure. My name is Aaron Kesselheim. I’m an internist and lawyer and a professor of medicine at Brigham and Women’s Hospital and Harvard Medical School.

Abdul El-Sayed, narrating: Dr. Aaron Kesselheim is one of the country’s top experts on pharmaceutical policy teaching at Harvard’s Medical School and Chan School of Public Health. He sat on the FDA’s advisory panel, which overwhelmingly voted against the approval of Aduhelm months before it was approved. After the FDA ignored the panel’s decision, Dr. Kesselheim, along with two other colleagues, resigned from the panel. I reached out to him to help us understand all the contours of the decision and what it means for the future of the FDA and prescription drug affordability in the US overall.

Abdul El-Sayed: Can you tell us about how a drug usually goes through the approval process?

Dr. Aaron Kesselheim: Sure. Well, you know, about 60 or so years ago, we decided in the US that drugs, prescription drugs should be tested for their effectiveness and safety before they are allowed to be widely sold by manufacturers. And so as a result of that decision, now, drugs go through a relatively extensive testing process that starts with early testing, laboratory testing, and then eventually moves into human clinical trials. And then it goes through a process of clinical trials first, usually in healthy volunteers, to get a sense of what a safe dose of the drug might be, and then eventually gets tested in patients who have the disease in order to determine what effects the drug has and what its safety profile is. And then ultimately, that mass of data gets submitted to the FDA. And if the benefits look like they outweigh the risks, then the FDA will approve the drug for widespread use.

Abdul El-Sayed: And presumably right, when we talk about benefits, what we mean is the ability to improve symptomatology or delay the pathology of a particular disease in a person in a way that they see happening. And one of the interesting things that we’ll get to in the story is this idea of a surrogate endpoint, right? Where there’s some science that suggests that there is a measurable process in the body that itself correlates to a better outcome, but doesn’t necessarily mean a better outcome. Can you explain a little bit about how we got to the point where we’re using these sort of surrogate endpoints, and why they matter increasingly in the way that we think about what drugs get approved and what drugs don’t?

Dr. Aaron Kesselheim: Sure. And you pointed out a very important point, which is the reason that people take prescription drugs is to change their health and the way that they feel. Basically, the way that I put it is, you know, people take prescription drugs in order to change the way that they feel, function, or survive. Those are some of the key endpoints that patients really care about. A surrogate endpoint is a laboratory test or a biomarker or some kind of physical measurement that substitutes in for one of those real clinical endpoints. And some surrogate markers, some surrogate measures are very well proven to be connected to clinical endpoints. So take, for example, your LDL cholesterol level. Nobody really cares what number your LDL cholesterol actually is. That doesn’t really have any essential value. The value of the LDL cholesterol level is that we know that by treating patients with a kind of a drug called a statin and lowering that LDL cholesterol level to a certain level translates into fewer cardiovascular events, strokes, and can make you live longer. And that’s a good surrogate measure, because now that you know that that surrogate measure exists, you can develop drugs like other kinds of statins, statins that work better, to try to make that LDL cholesterol level. And you can usually determine drug’s effects on surrogate measures faster, using fewer patients, and therefore you can get drugs to the market sooner. And so that’s a good kind of surrogate measure. The problem is, is that the history of medicine is littered with all kinds of laboratory tests and other measurements that physicians thought were connected to actual clinical improvement, but turned out when they were tested in real rigorous trials not to be, because science is hard and the human body is very complicated. And, you know, drugs can have off target effects that we don’t think of or know about when you take them. And so it’s important to make sure when you use a surrogate measure that it’s validated as being connected to an actual clinical outcome. The problem is, is that over the last couple decades, the FDA has been increasingly flexible in the way that it accepts surrogate measures as the basis for approving new drugs. And so these days, about two thirds, maybe a little bit less than two thirds, of new drugs are approved based on changes to a surrogate measure. But the problem is, is that for many of those surrogate measures, they aren’t as well validated as we’d like them to be. And so then the drug reaches the market. We know that it changes the surrogate measure, we don’t know how well it affects patients’ real clinical outcomes. And so we need to do additional testing now that the drug is on the market and that becomes a lot more complicated.

Abdul El-Sayed: So it really is about the quality of the validation between that surrogate endpoint and how a patient feels, functions, and survives, as you very eloquently put it. In a lot of cases, that evidence is just not as well validated. Interesting point here, right, is also a question of where research goes. There’s a lot more money in generating some sort of biopharmaceutical that you can take to trial based on some questionably validated surrogate, than there is in actually validating the surrogate endpoint. And so you have this mismatch of where the research actually goes. You touched on this in your last, in your last answer, but the idea of these independent review panels—can you talk to us about why they’re so important in the drug approval process?

Dr. Aaron Kesselheim: Well, the FDA is the center for drug approval in the U.S. and sometimes the FDA has questions about a particular point in data that they receive as part of a new drug application that’s a controversial point. And if they have a question about that, then they can bring in an outside advisory committee to help them answer that question. And advisory committees are usually made up of experts in a wide range of subject matter, you know, the clinical field itself, epidemiology, biostatistics. These advisory committees may even have a, will have a consumer representative, they even may have an industry representative who doesn’t usually vote. But nonetheless, they bring together this panel of outside experts and present this controversial point to them and get some outside advice on what to do. And then the FDA can decide what to do with that advice. And about 75% of the time, the FDA follows the advice of the advisory committee. But, you know, I think the advisory committee process is really important because if, so, first of all, it gives the, it gives the FDA access to outside expertise on a particular question, if it needs it. And second of all, it provides, you know, an independent review of controversial questions so that when the FDA makes a decision, they can say, look, you know, in addition to thinking about this ourselves, we also brought it before this independent panel and they said X, Y or Z. And that can help provide support for the FDA’s decision or trust in the FDA’s decision.

Abdul El-Sayed: Now, let’s get to the matter at hand. The FDA approved a drug called, aducanumab, traded as Aduhelm, which is an Alzheimer’s drug that is specific for people with early-stage Alzheimer’s dementia that is focused on addressing this, the surrogate endpoint of beta amyloid plaques. And in several trials showed very limited actual impact on patients’ symptoms, though it was successful in maneuvering that surrogate endpoint. You were on the independent review panel that voted 10 against approval, zero for approval and one abstention. Can you tell us a little bit about a) top line, what happened with the approval of Aduhelm, and b), why it was so clear to you that this drug shouldn’t be approved?

Dr. Aaron Kesselheim: Sure. So this is a, you know, Alzheimer’s disease, obviously a really, really problematic disease that affects a lot of people. There aren’t really good therapies out there and a lot of people suffer from from this disease. And it affects not only the patients themselves, but also the family members and just a really, really tough disease. And Biogen had a monoclonal antibody that they had helped develop. It was, you know, had its origins in academic research science in university in Europe. But Biogen had this monoclonal antibody. And to Biogen’s credit, they organized two very large, what are called phase three clinical trials, which is the sort of the largest and most rigorous type of clinical trial. They were placebo-controlled clinical trials. Two that were done with the exact same methodology to them. And about halfway through the trials, the trials were designed to have a stopping point where the independent Data Safety Monitoring Board would review the data and evaluate whether or not it looked like it was promising, to continue. And when the monitoring board did that, they thought, they concluded that it was futile, that if they were to continue finishing up these trials, that the drug would have shown no effect. And so Biogen shut down the trials and after they shut down the trials, a little bit more data came in. Biogen went back and they analyzed the two trials separately, and they found that in one of the trials in one of the arms, in the high-dose arm, that it looked like there was an impact that the drug had where it did alter the course of Alzheimer’s disease a little bit now. It didn’t cure Alzheimer’s disease, it didn’t improve patient’s cognitive function, but it did slow the decline a very little bit. And then Biogen went to the FDA and worked with the FDA to try to understand why the negative trial failed and why the positive trial was the right one, which we can talk about later. But it’s not exactly what you’re supposed to do, you know, in terms of making a conclusion, because it kind of assumes that the answer that you want is the right answer. And then the FDA brought this question to the advisory committee and said, advisory committee, what do you think? Does the existence of one positive arm in one of the two trials, whereas the other arm in the other trial was totally negative, does that provide substantial evidence that the drug looks like it affects people’s cognitive function? And as you pointed out in your description, we voted almost unanimously that it did not provide substantial evidence. That it may be that the drug works, but there’s also just as good evidence that the drug doesn’t work. And in that situation, what you should do is just do another trial and test the drug again and see if it actually does work. So that was what we said. And then what happened was, was that after we met in back in November of 2020, the FDA then went back to the drawing board with the company and in June, they approved the drug. Now, importantly, they basically changed the whole premise on which they were going to approve the drug. In November, we talked about the effect of the drug on cognitive function with patients with Alzheimer’s disease. But then when they approved the drug, they approved the drug saying that, well, the drug changes your amyloid plaque levels, which is a surrogate measure and we assume that changing amyloid plaque levels will affect your cognitive function. So they ended up approving the drug on the basis of the surrogate measure, which we didn’t discuss back in back in November at the advisory committee meeting.

Abdul El-Sayed: So there’s that issue of that surrogate endpoint issue again. There’s also a really important societal perspective here, which is that the majority of patients who are going to be eligible for this medication are going to be people who are insured on Medicare. And Medicare is a public insurance system that, of course, is legally barred from negotiating the price of these medications. And this means that covering all of the eligible people could put Medicare at serious risk of insolvency. The other piece of this is that there hasn’t been a Alzheimer’s drug that is approved since 2003 and there are a lot of people suffering. And in some respects, it’s like the company has free-rided on the immense need and hope for a new Alzheimer’s drug, and is asking the federal government to pay for it, despite the fact that there is not strong evidence that it works. You ultimately decided to resign from that advisory panel. Can you speak to the kind of societal quandary that this drug and its approval puts us in, and what it tells us about the FDA’s function moving forward?

Dr. Aaron Kesselheim: Yeah, it is a really important point. And the the drug was approved using a very problematic process. The drug was approved after, you know, an independent advisory committee said nearly unanimously that it shouldn’t have been approved, and it was approved on the basis of a totally different premise than we discussed. And so the FDA basically changed its approach in the last few months to approve the drug on the basis of the surrogate measure, saying that the drug’s ability to remove amyloid plaque would be reasonably likely to affect cognitive function in patients. And I just don’t think there’s any basis in the testing of this drug to make that conclusion. Nonetheless, by virtue of the FDA approving the drug, now there’s an assumption that Medicare is going to cover the drug, that Medicaid is going to cover the drug, that private insurance companies are going to cover the drug. And as you pointed out, in the U.S., we allow pharmaceutical companies to charge whatever price they want and the company in this case set the price at approximately $56,0000 a year for annual treatment for which there is no necessarily endpoint, like a person could theoretically be on this drug for a long time. And, you know, given how many patients have Alzheimer’s disease, the amount of money that we spend on just this one drug could eclipse the annual budget of NASA, for example. And it will draw a lot of resources away from other potential investment in other ways that we do know can actually help patients with Alzheimer’s disease in paying for this drug, which, for which there is no good evidence. And we didn’t actually even talk about this, for which there is major risks associated with the drug as well, there’s a risk of brain bleeding and hemorrhage that will require constant sort of frequent monitoring with MRI scans, which also cost a lot of money, potentially hospitalization if you have a severe brain bleed, which can also cost money. So there will be a lot of spending associated with this drug on the basis of extremely flimsy evidence in support of it. And again, you know that draws money away from other places where we could be spending money in a more, in a more cost effective way. It will put a burden on individual patients who will have to decide if they want to spend money on their co-pays and deductibles to pay for this drug or do other things that could try to help their family members with Alzheimer’s disease. So I think that it does put patients and society in a very difficult situation.

Abdul El-Sayed: All while exploiting a certain hopelessness about this disease to offer what is ultimately based in the evidence, a relatively false hope about whether or not this will work. The other thing that’s come out recently is the kind of full-court press lobbying that Biogen put in to get their approval. And, you know, there is a bigger, broader conversation about the impact of pharma and the $4.3 billion dollars they’ve spent over the last 20 years to shape the prescription drug market in this country. But zooming in on this particular medication, in this particular case, what were the kinds of things that Biogen did and how did it potentially impact the FDA’s decision?

Dr. Aaron Kesselheim: Well, so it is well known that Biogen worked closely with the FDA in reexamining the data, you know, leading up to the advisory committee meeting, to try to get a better handle on the data. And to be honest, I think it’s not necessarily a bad thing when, you know, for companies to have an open line of communication with the FDA because, you know, I think that that helps drug development move forward in a more efficient way. I think that what we’ve also learned by virtue of some excellent investigative reporting is that there were other off-the-books meetings between Biogen and folks at the FDA and that is, you know, potentially problematic. And, you know, I think that in addition to that, Biogen also supports the Alzheimer’s Association and the Alzheimer’s Association put pressure on the FDA to approve the drug. And now, of course, there have been a lot of statements that you’ve heard about the drug in the press and online that provide an overly rosy, optimistic picture of what this drug might do that aren’t consistent with the underlying evidence. And again, if there are, you know, I don’t know if those are are supported by the company or whatever, but I think that it’s really important that we have some way of trying to get, you know, more realistic communication out there about the basis for which this drug was approved and the, you know, the lack of any good convincing evidence of benefits, the really strong evidence that it has potential harms that are associated with it, the potential pricing issues associated with this drug. I think that it’s really important to make all of those things as clear as possible for patients who are now faced with the decision of whether or not they’re going to take it.

Abdul El-Sayed: The FDA has announced an investigation into this particular case. And stepping back for a minute, do you see this kind of situation being more of a signal of a new norm about the way that the FDA operates, or an outlier, and why?

Dr. Aaron Kesselheim: Well, I do think that the FDA has taken an increasingly flexible approach towards approving new drugs. And in recent years and again, I think that it is important and in certain circumstances for the FDA to be flexible in the type of data it accepts. You know, there might be rare diseases where you can’t do the kinds of trials that we might sort of ideally want. You know, there might be a serious disease that we need to try to speed things up with. And I think that in those cases, flexibility is extremely is extremely important. I think that unfortunately, in this case, there was flexibility applied in a circumstance where there really isn’t good evidence that this drug is effective and it really does need more testing in order to show whether or not it actually works. And in those cases, you know, in those cases, I think that the flexibility, that the flexibility goes too far. I think that this decision does set a precedent. Well, first of all, it sets a precedent around other Alzheimer’s disease drugs. So, for example, there was another drug made by Lilly that is in an earlier stage of testing that reported that it, too, removed amyloid plaques from the brain. And in the trial in which it reported that, the conclusion was, hey, it’s exciting need to show that this drug removes amyloid plaques in the brain, we look forward to testing this drug to see whether or not this drug actually affects cognition, because there have been decades of drugs that affect amyloid plaques in the brain and don’t impact cognition. And so Lily appear to be poised to do the more formal testing of this drug to show whether or not the drug actually would affect clinical behavior. And in fact, in the wake of the Aducanumab approval, now, Lilly says that they’re just going to try to get approval for the drug without doing that additional testing. So I think that this decision does set an important precedent in terms of limiting companies’ willingness to do this sort of rigorous testing that drugs need before they before they reach the market. And it sets a precedent for other diseases as well that say, well, we have surrogate measures that aren’t very well validated, why can’t our drugs be approved on the basis of those surrogate measures, just like Aducanumab was approved? So I do think the concern is, is that this will set a precedent that will continue to move the amount of testing that drugs have done before they’re able to be widely sold further and further away from what patients and clinicians really want, which is to know that a drug actually has some benefit before they, before they start prescribing it.

Abdul El-Sayed: Yeah, it’s created a real disincentive in the scientific community for fully proving out and characterizing what the long term consequences of a particular medication may be for those endpoints: how you feel, how you function, and whether or not you survive. Well, we really appreciate you, Dr. Kesselheim, for joining us today and sharing your perspective on this. And we appreciate your leadership in being out there and advocating for a better, safer FDA, and a better experience when it comes to prescription drugs for our patients and providers. And thank you again for for your insights and your wisdom.

Dr. Aaron Kesselheim: Thanks for having me. It’s been a lot of fun.

Abdul El-Sayed: As usual, here’s what I’m watching right now:

[news clip] U.S. life expectancy dropped by one and a half years in 2020, driven by the deadly virus. That’s the biggest drop since World War Two.

Abdul El-Sayed: These numbers are staggering, but beyond the 1.5 years on average, that life expectancy fell. I want to dissect three pieces that are worth paying attention to. The first is the disparity in falling life expectancy. While the country on average lost 1.5 years, Black and LatinX people lost nearly twice as much in life years on average. Though, throughout the pandemic, it was clear that Black and LatinX people were among the hardest hit in terms of overall lives lost, it’s clear now that the lives lost were younger on average than white lives lost as well. That’s part of what accounts for the higher life expectancy reduction on average. Another thing to understand here is that the life expectancy loss isn’t simply a matter of death loss to COVID, it’s also the death the pandemic took indirectly. As we discussed last week, overdose deaths went up 30% last year, a function of the livelihoods and lifelines that the pandemic also took from people. Finally, though it has never been this pronounced, falling life expectancy isn’t a new occurrence. Indeed, it’s fallen four out of the past five years now. And that reminds us that we can’t lose track of the slower moving pandemics, mental illness, addiction, gun violence, that have been destroying people’s lives and livelihoods before SARS-CoV-2 came along, even as we bring this pandemic to a close. But to do that, it’d sure be helpful if we finally ended the COVID pandemic, and numbers don’t look encouraging. New cases were up over 170% over the past two weeks, and deaths are up 42%. In response, local public health officials are doing this:

[news clip] Because of the uptick, Los Angeles County is now reinstating their indoor mask mandate. Face coverings will be required regardless of a person’s vaccination status starting midnight tomorrow.

Abdul El-Sayed: I’ll be honest with you, I think these new universal mask mandates are a step in the wrong direction. Fundamentally, we need more people to be vaccinated, and that means making being vaccinated easier, and being unvaccinated a bit harder. Reintroducing universal mask mandates only tells people who are not vaccinated that vaccines won’t protect them. Besides, the people who aren’t getting vaccinated aren’t going to be masking up anyway. This is how they’re taking it on in France:

[news clip] A health pass is now compulsory in certain cultural and leisure venues such as theme parks, museums, cinemas, theaters, gyms and libraries.

Abdul El-Sayed: In response, 1.7 million people signed up for a vaccine appointment the NEXT DAY. Though the Biden administration has said it won’t mandate verification, there’s a lot we should be doing to make it easier for employers and businesses to institute them. Check out my newsletter at Incision.substack.com for more on this. Vaccine verification is, of course, just one way to take on vaccine hesitancy that’s turned into all-out vaccine opposition. The other is to take on the misinformation that is fueling that opposition. This was President Biden on Facebook’s role in the pandemic:

[clip of reporter] What’s your message to platforms like Facebook?

[clip of President Biden] They’re killing people. I’m mean they really—look, the only pandemic we have is among the unvaccinated. And that, and they’re killing people.

Abdul El-Sayed: He backtracked his comments a bit, but honestly, he’s not wrong. The Surgeon General, Vivek Murthy, introduced the first advisory of his tenure, calling out misinformation as the grave threat to public health that it is. President Biden just connected the dots. Facebook’s pushback back, of course. But then how much more do they need to destroy to get the point? They’ve done irreparable damage to our democracy, and now our public health. When will they finally decide to stop selling people lies so that they can show them ads?

Abdul El-Sayed: That’s it for today. On your way out, do me a favor and go to your podcast app and rate and review our show. It goes a long way to getting it to other folks. And if you really like us, go on over to the Crooked Media store and pick up some merch. We’ve got a new logo Tees and mugs, our Safe and Effective Shirts, and our Science Always Wins shirts and dad caps.

America Dissected is a product of Crooked Media. Our producer is Austin Fisher. Our associate producer is Olivia Martinez. Veronica Simonetti mixes and masters the show. Production support from Tara Terpstra, Lyra Smith, and Ari Schwartz. The theme song is Taka Yasuzawa and Alex Sugiura. Our executive producers are Sarah Geismer, Sandy Girard and me: Dr. Abdul El-Sayed, your host. Thanks for listening.