Negotiating Prescription Drug Prices with Prof. Aaron Kesselheim | Crooked Media
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August 16, 2022
America Dissected
Negotiating Prescription Drug Prices with Prof. Aaron Kesselheim

In This Episode

The Inflation Reduction Act of 2022 is a lot of things…including a healthcare reform bill. Along with extending healthcare subsidies for 13 million people, it also, for the first time, allows Medicare to negotiate prescription drug prices. Abdul lays out what the Inflation Reduction Act means for prescription drug prices and sits down with Prof. Aaron Kesselheim, a physician, attorney, and prescription drug policy expert, to understand what this will mean for America.

 

TRANSCRIPT

 

[AD BREAK]

 

Dr. Abdul El-Sayed, narrating: So many of us want to eat better for the planet. We’re just not always sure how to do it. There’s a lot of confusion, but there’s a podcast I’d like to recommend that can help unconfuse us. Climavores is a show for eaters trying to navigate the complex relationship between healthy food and a healthy planet. Hosted by journalist Tamar Haspel and Mike Grunwald, they explore the complicated, confusing and surprising relationship between food and the environment. And they answer all sorts of questions like, is fake meat really a good alternative to beef? Are vegetables climate friendly? Does local food actually matter? Climavores cuts through hype and empowers us to make food choices that are actually good for the environment. Listen and follow Climavores on Apple Podcasts, Spotify, or wherever you get your shows. We’ve got some fun news. Crooked Media has partnered with comfortable, sustainable shoe brand Cariuma to create two awesome pairs of shoes that listeners of America Dissected will love. One design features an all over, “I voted” sticker print, and one is a sleek white pair that says “No steps back” on the side. You can order your pairs today in the Crooked store and as always, a portion of the proceeds from these shoes and any item you buy in the Crooked store goes to VoteRiders. The leading organization focused on pushing back on voter ID laws. [music break] The CDC has revised its COVID guidelines ahead of back to school season. Meanwhile, Congress is no closer to passing COVID funding for new vaccines, treatments, or testing. The House has passed the Inflation Reduction Act 2022, sending it to President Biden’s desk for a signature. This is America Dissected. I’m your host, Dr. Abdul El-Sayed. [music break] 

 

[clip of President Joe Biden] Whether we protect the already powerful or have the courage to build a future where everybody has an even shot. That’s the America I believe in. And today, we’ve come a step closer to making that America real. 

 

Dr. Abdul El-Sayed, narrating: The Inflation Reduction Act is one step closer to passing after the House of Representatives put its seal of approval on it on Friday. The bill is a hodgepodge of things that came out of the Build Back Better package, which originally contained policies that would have fundamentally changed the nature of American life. Paid family leave, universal child care, home and community based services for disabled people and seniors, extended childhood tax credits. Alas, one man, a coal baron from West Virginia, the country’s poorest state, by the way. Couldn’t quite explain it to the people of his state. But a few weeks back, in a surprise to just about everyone, Senator Joe Manchin said he could finally agree to something. And with a few tweaks, that’s what ultimately became this bill. So what’s in it? Essentially, it’s a climate tax and health care bill. The climate part is a really big deal. It spends nearly $400 billion dollars to offer critical incentives to consumers to choose renewable energy, solar or wind power, geothermal heating and cooling or electric vehicles. Estimate after estimate suggests that this will reduce greenhouse gas emissions by up to 40% by 2030. That’s 80% of the commitment that President Biden made to bring emissions down by 50% by that point. So while a tremendous investment, there still remains a lot to do. This bill is, after all, carrots and no sticks. And without those sticks, it’s going to be a lot more difficult to eke out the rest of those goals. On the tax side, the bill goes a long way to addressing the ways that corporations avoid paying taxes. First, it establishes a 15% minimum tax on corporations. Considering that this is a part of a broader minimum global tax that Treasury Secretary Janet Yellen has negotiated with over 130 countries, this will really help to address the tax havens that corporations like Apple keep, which, by the way, has them headquartered in Ireland rather than, say, Cupertino, California. It also taxes stock buybacks, gimmicks that corporations use to artificially limit the supply of their stock and therefore raise their stock prices. The final piece, as you all probably figured, is where I want to spend the rest of today’s episode. That’s health care, of course. On that front, the bill has a few moving parts. First, it extends a series of ACA subsidies established during the pandemic through to 2035. 13 million people rely on those subsidies, and extending them is unabashedly a good thing. More government health care for low income people is always good in my book. But the flashier piece of the Inflation Reduction Act is what it does for prescription drugs. First, it limits out-of-pocket spending on prescription drugs for beneficiaries on Medicare, the government insurance program for seniors and people over 65 and with certain disabilities. It limits them to $2,000 a year. It also caps out-of-pocket insulin costs to $35 a month. And those well, those are both really big deals. But the shiniest piece by far is that it finally allows Medicare, the country’s largest and most powerful insurer, to negotiate prescription drug prices. For context, before this bill, Medicare was restricted in its ability to negotiate drug prices with manufacturers at all. That means that manufacturers could basically declare a price for the new drugs and assuming they didn’t go way high and get investigated by Congress over it, which has happened. Medicare would just pay the cost, no questions asked. This offers a real change, but only just barely. First, negotiation would only start in 2026. Four years from now. And even then, it’s limited to the ten most expensive drugs. That grows to 20 within a few years. For context, there are over 10,000 drugs on the formulary. It also gives Big Pharma quite a long runway. It doesn’t allow for negotiation for the first nine years a drug is on the market. Thirteen for certain kinds of drugs. But there’s another important piece here, too. Every year, prescription drug manufacturers arbitrarily raise their prices on people, basically just because they can. This law, well, it stops them from increasing their prices by more than the rate of inflation every year. That will protect folks from having to pay exorbitant prices for lifesaving medications just because another year passed. And yet the bill has drawn all kinds of fire from Big Pharma Corps, the CEO of the lobbying group Pharma, Steve Ubl, wrote a letter to lawmakers telling them that they, quote, “won’t get a free pass if they vote for the bill”. And their argument is that this will staunch, quote, “innovation”, despite the fact that these companies spend many multiples more on marketing than they do on innovation. To get to the bottom of all this, I wanted to bring back one of the country’s leading experts on prescription drug policy, Professor Aaron Kesselheim. Aaron is a physician and researcher who spent his career researching how pharma drug pricing affects patients and elucidating policies to fix it. He joined me to talk about the Inflation Reduction Act, what it does to pharmaceuticals and what it does for patients. Here’s my conversation with Professor Aaron Kesselheim. 

 

Dr. Abdul El-Sayed: All right. Let’s hope it works. Ready to go? 

 

Professor Aaron Kesselheim: Okay. 

 

Dr. Abdul El-Sayed: All right. Can you introduce yourself for the tape? 

 

Professor Aaron Kesselheim: My name is Aaron Kesselheim. I’m a professor of medicine at Brigham and Women’s Hospital and Harvard Medical School, a primary care doctor and a lawyer. Uh and I run a research group on uh that focuses on uh pharmaceutical markets and law and regulation. 

 

Dr. Abdul El-Sayed: So I literally can’t think of anybody better to walk us through what just happened over the last uh couple of weeks. Um, The Inflation Reduction Act is, you know, sort of an oddly named uh hodgepodge of things, including climate tax and, of course, health care. And the biggest part of that that health care piece, beyond extending some ACA subsidies that’ll be really important for the 13 million people who who have them right now, is uh what has happened when it comes to  prescription drugs. Can you walk us through the top lines as you see them uh in terms of what the Inflation Reduction Act does? 

 

Professor Aaron Kesselheim: Sure. And I agree with you. I think that the this Inflation Reduction Act legislation on prescription drugs is uh really an important step um and a um and a major change. Historically in the U.S., we don’t negotiate drug prices. And for the first time now we are, we have an apparatus in place to negotiate some drug prices on behalf of Medicare. And what that’s led to is, that’s led to brand name drug prices in the U.S. being uh 2 to 4 times higher than they are in other countries. And so with this bill, Medicare is now authorized for the first time to negotiate a very small number of uh a prescription of brand name prescription drugs with respect to the prices that they would um that they would get for Medicare uh patients. That’s the, that’s the first thing it does. Um, the second thing. The second top line thing it does, which is extremely important, is that historically, pharmaceutical manufacturers are able to raise prices year over year without any restraint. And uh what the second major thing that the bill does is it limits manufacturers abilities to raise prices for Medicare beyond beyond the scope of inflation. Uh and then the third very important thing that it does is it limits out-of-pocket spending for Medicare patients. On, millions of Medicare patients spend, um you know, thousands and thousands of dollars on expensive cancer rheumatologic ophthalmologic drugs. Um and this bill would limit their, would cap their out-of-pocket spending um over the course of uh over the course of a year or 2, to $2000. And so it’s a you know really important set of uh reforms. 

 

Dr. Abdul El-Sayed: So jumping in on the uh price negotiation piece, because this really is the big top line. And you could tell by how ruffled the feathers of Steve Ubl, who is the president of uh Pharma, um the lobbying organization on behalf of the pharmaceutical industry. The letter that he sent to lawmakers saying that they wouldn’t get a free pass if they if they voted for this. You can tell that um this really is uh something that they they did not want to see happen. They’d been running ads for, frankly, a couple of years now, ever since the Biden administration existed. And uh they’re now threatening lawmakers uh around this. But it really, in my mind, my read on it is that it’s a lot more of a precedent setting function than it is a fundamental threat to to the profits of um the pharmaceutical industry. Can you walk us through um how the negotiation works when it starts, what drugs it would affect, um and how it then uh continues to proceed over time? 

 

Professor Aaron Kesselheim: Sure. And I agree with you. I think that this is a largely a, you know, an important step, but it really won’t have a substantial effect, at least in the short term, on very many drugs. Um basically, uh there are a certain small number of drugs that qualify for negotiation, in order to qualify for negotiation. For example, the drug has to have been on the market for at least nine years or at least 13 years, if it’s a biologic drug. It had to have um no generic or biosimilars on the market or with the prospect of coming onto the market. It was it’s not it’s not allowed to be a drug that’s just a drug for a single rare disease or a drug that makes, uh you know, less than $200 million dollars a year. And so it’s a relatively small number of drugs. And CMS has is uh directed to negotiate ten uh drugs by the year 2026, and that increases up to 20 per year by the year uh 2028. And so it’s a relatively small number of drugs, not for, you know, a number of years in the future does this yet get implemented. Um and of course, these are drugs that have already been on the market for you know a large, a long period of time in which they’d been making, um you know, substantial uh revenues for their manufacturers. And so when CMS negotiates those those prices, it’s supposed to negotiate them based on the benefits that the drug provides, the likelihood that the that the drug had already provided a return on investment to the manufacturer. So there are also parameters in how CMS does the negotiation to ensure that, uh you know, this is a fair negotiation process that leads to a, um you know, a reasonable value based price for the drug. 

 

Dr. Abdul El-Sayed: Do we have estimates about um how much this is going to save uh taxpayers? 

 

Professor Aaron Kesselheim: Well, the CBO scored the bill, um suggesting that it would save taxpayers about $280 billion dollars over the next ten years. Although that scoring of the bill happened before, a few parts of it were paired away during the Senate parliamentary uh review. So actually the total benefits over the next decade are probably a little bit more modest than that. So 250 or so billion dollars a year over the next uh next ten years, you know, which is, of course, you know, a relatively small percentage of overall health care and even prescription drug spending by Medicare. 

 

Dr. Abdul El-Sayed: And how much um in terms of of that savings are seniors going to experience? I know there’s the $2,000 price cap, but how much of that savings are seniors going to see? You know, let’s say you fast forward to 2026 when this actually takes place. 

 

Professor Aaron Kesselheim: I mean, I think that a lot of those savings are right, are directed toward seniors. I think that they’re going to see savings in a couple different ways. First off, as you mentioned, they’re going to see savings directly in the out-of-pocket costs um for their products. Um, so seniors that spend a lot of money on cancer drugs, you know, as I said, somewhere in the range of of of, you know, 1.5 million seniors um spend more than uh than the you know $2,000 a year out of pocket. The cap right now on prescription drugs and those seniors would see less out-of-pocket spending. I think the other way that seniors will see savings from this um is from the premiums that they pay for their um Medicare Part D plans, um which are restrained in their growth, um and will also, um you know, experience uh cost savings from, uh you know, paying for the non out-of-pocket percentage of the costs for prescription drugs. So I think that um seniors will see benefits both in their specific out-of-pocket costs. And I, we didn’t even get to mention the um the limitation on insulin so, you know, the insulin cap of $35 a month uh goes into effect next year. And so seniors who are paying out of pocket for insulin will see, you know, relatively immediate um cost savings. And I think they’ll also seek savings in the, you know, restraint in growth, in the fees for their premiums, for their plans. 

 

Dr. Abdul El-Sayed: And one of the interesting pieces here, you know, when you think about the the pharmaceutical profit model, is that Medicare price negotiation only really kicks in after nine uh years for most drugs and then 13 years um for certain biologics. And so the idea here is that, you know, you think about the life of a patent and the life of these things ranges. And so there’s really only a short period of time during which price negotiation could apply to a particular drug, right? After that first nine or 13 years and then before there is a biosimilar or a generic on on board. Um, and yet the pharmaceutical industry has pushed back in ways that I think are pretty profound. How do you explain it and um what do you think they’re actually trying to play for here? 

 

Professor Aaron Kesselheim: Well, first of all, I think you’re exactly right. The average market exclusivity period for a for a brand name drug is about, you know, 14 to 15 years. And for a biologic drug is, you know, according to some research that we’ve done, is more like, you know, 19 or 20 years. So this is really kicking in towards the end of market exclusivity uh for these products. And, um you know, ultimately, when a generics when generics hit the market, that is when, you know, spending on drugs tends to fall uh substantially. And, you know, these generics tend you know, if they are sufficient generic competition, they come in at much lower prices. And it’s a much more competitive market um that that, um you know, patients are used to prices falling at that time. So, yes, this is really only affecting the very last stages of market exclusivity of products. But you’re right, the pharmaceutical industry did kick up a very substantial firestorm around this. And, you know, I think that it has become sort of the knee jerk reaction of the pharmaceutical industry whenever there is any policymaking proposed around the pharmaceutical market to immediately fall back on this idea that, oh, if you change anything, then all innovation will cease and, you know, we’ll never see new drugs come out again. You know, I think that that is a is a scare tactic that the pharmaceutical industry classically uses because they are concerned about any any changes at all to, uh you know, the unrestrained pricing power that they have had up until this point in the U.S. pharmaceutical market. 

 

Dr. Abdul El-Sayed: You mentioned their principal argument that this is going to take away pharmaceutical innovation, which um is more robust in this country really than it is in in almost any other country in the world. And their argument is that, well, if you if you force uh these prescription drug manufacturers to come to the table and negotiate with Medicare, one insurer, by the way, albeit the most powerful insurer in the country, maybe the world, but one insurer. If you force them to come to the table and negotiate for the tail end of their market exclusivity, then somehow they’re not going to be able to innovate in the pharmaceutical market. But that sort of betrays the fact that they don’t actually do much um innovation. Can you walk us through uh A.) Whether or not you think that that argument holds water? And B.) Why or why not? 

 

Professor Aaron Kesselheim: Well, I mean, I think that this idea that all innovation will cease because of, you know, fair drug prices is one of the uh is a is a boogeyman. That argument that the pharmaceutical industry does pull out uh in all of these discussions. And I think that it’s wrong on a number of different levels. You know, I think that, first of all, um when we’re talking about negotiating prices, we’re talking about negotiating prices based on the clinical benefits that drugs provide. And so we might very well expect to still pay high amounts of money for drugs that offer real clinical benefits to patients. And what we won’t do is we won’t pay a lot of money for drugs that don’t offer a lot of clinical benefits or, you know, are the eighth drug in a particular class or something like that. Unfortunately, uh that’s what we do right now. And so I think that this new system might actually be even better for innovation because we will be incentivizing, you know, important, you know, new products that actually demonstrate real clinical benefits because we will still pay, um you know, a substantial premium for those products. You know, in addition to that, I think it’s important to recognize that a lot of the most transformative innovation in this country comes out of government funded research that happens in academic medical centers and government laboratories before the pharmaceutical industry ultimately gets involved later in the stages of the development of those products. And, you know, pharmaceutical many large pharmaceutical manufacturers um only spend about 10 to 20% of their revenues on uh research and development as compared to, you know, closer to 30% on marketing and administration and 30% on return to shareholders. So funneling a lot of money uh to the large pharmaceutical companies is not necessarily the most efficient way of trying to incentivize needed research and development uh spending. The best way to do that would be to directly invest in it through uh through the NIH or, you know, as in the case of, um you know, Operation Warp Speed, where the government, you know, invested a substantial amount of money in the development of of of COVID vaccines. You know, we got a really successful product in a relatively short period of time, and that was through, you know, direct investment. So, I mean, I think that I think that the system that that it was implemented in a very small way in the Inflation Reduction Act um is not a threat to uh real innovation. As long as we keep up investment in the NIH and, you know, research, upfront research and development and also because this is really about, you know, negotiating prices based on their clinical benefits, uh which is, you know, may still lead to uh important drugs being paid uh and being paid, you know, quite high prices for those um but, but not paying for uh for drugs that don’t offer a lot of clinical benefit. [music break] 

 

[AD BREAK] 

 

Dr. Abdul El-Sayed: Maybe uh an upshot of this uh of this legislation is that we may be subjected to fewer pharmaceutical commercials. Uh maybe maybe they’ll trim their marketing budgets a little bit and uh and keep investing in their pipeline. But, of course, they did kick up a storm and um and even though the argument that they’re using is a canard, uh they’re making the argument anyway. And and in my mind, this has a lot more to do with potential and precedent. You and I worked together and you helped advise me when I was working um to advise the writing of the Biden Unity Health Care Task Force Democratic platform and on health care. And we all agreed, in fact, that the platform that President Biden ran on was that uh Medicare would be able to negotiate prescription drugs on behalf of everyone in this country. You know, right now, this is very thin. It only applies to people who are Medicare beneficiaries, people over the age of 65 and with certain disabilities. My sense is that pharma sees the writing on the wall and they’re trying to advocate now to protect themselves from the precedent that this sets that there is the possibility for drug price negotiation. How plausible do you think that argument is? How likely do you think that we’re going to see an expansion of this in the future? 

 

Professor Aaron Kesselheim: Well, I mean, I do think that if this uh goes well and is successful, then, you know, then I think that that future administrations in Congresses may be emboldened to expand this. I mean, I think that the goal here was to try to allow the private market to obtain the same prices uh that Medicare was able to negotiate. And that ultimately got um stripped out of the bill in order to try to make it more politically feasible in the current Congress. Um, so I would imagine that, uh you know, future administrations and, you know, people running for Congress in the future will, uh you know, run on the idea that, uh you know, if Medicare is getting these prices, why shouldn’t patients in the private market get these prices? And I think that ultimately, if we can show that we can negotiate prices fairly and arrive at uh at reasonable prices that also provide for fair compensation for for manufacturers and innovation doesn’t stop. I you know, I think that we will show that this can be done in a you know, in a reasonable, rigorous and transparent way, just like it’s done in every other industrialized country around the world. And I think that the prospect for expanding it is um is a real possibility. 

 

Dr. Abdul El-Sayed: I really appreciate you making that point. Right. This this brings the United States forward to the standard that has been set in every other high income country in the world. No other high income country does it like we do. And what that means is that the American taxpayer, in effect, ends up subsidizing the pharmaceutical manufacturer for the rest of the world. And what we’re saying now is that, no, actually, there needs to be an effort to bring down the prices. Runaway prices for uh folks across our country, too, and um that these corporations cannot continue to throw their weight around politically and think that they’re going to be able to use that to, you know, what economists call rent seek to be able to just command whatever profits that they want or their on their prescription drugs. There’s another piece of this, too, which is limiting the increasing of of pharmaceutical prices uh to the rate of inflation. Can you talk about what that does, why that’s so important, and how that contrasts to what prescription drug manufacturers do right now? 

 

Professor Aaron Kesselheim: Sure. Yeah. So we’ve spent our time talking about negotiation. But another uh another very important pillar of this is the limits on price increases over time. And so basically, again, in in the US, drug manufacturers can raise prices year over year um freely and that again contrasts with restrictions and rules in place in other industrialized countries around the world where manufacturers are not allowed to raise prices above inflation without bringing new information to the market. And so what this bill does is this brings um rules relating to Medicare in line with that and says, look, Medicare, unless manufacturers get a new, you know, indication or some other or some other information comes out that, you know, changes the value proposition for these drugs, manufacturers are not able to raise prices year over year beyond the scope of inflation. And I think that that’s a very important part of this in terms of helping uh restrain price growth after a drug is launched. And I think, quite honestly, even though this only applies to Medicare, I think this will have spillover effects for price increases in the private market as well, um because Medicare is such a major component of the market and such a big buyer of prescription drugs that manufacturers are going to think twice about raising prices in the private market, knowing that um such a large fraction of their sales is going to Medicare and they’re going to have to pay back um those price increases to Medicare. So I think that this this other part of the bill may actually, even though it’s only directed at Medicare, um manufacturers may respond by uh restraining price increases that have been um rampant in the United States without uh these rules in place. 

 

Dr. Abdul El-Sayed: Yeah, I really appreciate that point. And just for listeners to understand, these kinds of price increases happen all the time and they happen on medications that don’t substantially change. And all of that kind of goes back to the the business model of big pharma companies. So much of their financials operate, varies in almost every public corporation on the quarterly stock price. And there are a whole group of analysts and a whole industry of analysts who will uh advise um  investors as to whether or not they want to buy stock from a particular company. And for a lot of companies, they can innovate their their product line. But for pharma, a lot of these companies don’t necessarily come out with a new prescription drug every single year. And so when they’re forecasting their potential growth, i.e., whether or not their stock price is going to increase, the only thing that they can really do to make that stock price increase if they don’t have new prescription drugs uh in the pipeline, is just to raise the prices of the ones they already have. And so they do this year after year. And of course, who suffers right? For that CEO trying to increase their their stock value. His, is are the people who are uh required to take this drug, and they know they can get away with it because well these are prescription drugs we’re talking about, we’re not talking about, you know, fancy cars or, you know, nice, uh nice blenders. These these are things that people fundamentally have to have. And so if you raise the price on them, they’ll buy it anyway. Um and so that’s exactly what they do. And it’s such a part of uh the financialized model of um of the pharmaceutical industry and it’s really quite pernicious. And so this really is a really big deal. It’s, it’s kind of wonky. Um so it hasn’t really gotten the same kind of top line treatment as as the price negotiation has, which is a lot easier to understand, but it is still really, really quite critical in terms of being able to lasso down the pharmaceutical industry. I want to ask you, you know, as you think about where this has gone and where it has yet to go, you know, what are the two or three things um you would have liked to see uh in this bill to really capture or address some of the biggest challenges that that we have right now? 

 

Professor Aaron Kesselheim: Well, I mean, I think that one of the major gaps in the bill is the fact that negotiation starts, you know, so far down the line, you know, 9 to 13 years after initial drug approval. And again, in most other industrialized countries, negotiation happens within the first year after a drug is approved. And so I think I personally would have liked to have seen negotiations start sooner, closer to the to the launch of the drug. I think that one of the dangers of this model is that uh manufacturers might respond by trying to increase their launch prices more than even more than they have already. And so, you know, establishing a baseline, you know, that Medicare will pay or, you know, for the first X number of years without uh without negotiation. So I think that one of the things that that was originally in the Cummings bill that passed the House of Representatives a few years ago, um you know, was this idea that negotiation would happen closer to the time of a of drug approval. So I think that that’s uh I think that’s one of the biggest gaps right now in the bill. And, you know, again, we’ll just have to see going forward if that you know does turn out to be a problem and uh and if it needs additional legislative fixing. 

 

Dr. Abdul El-Sayed: I really appreciate that point. And that’s, you know, a recognition that the um the opponent in these negotiations is pretty wily. And they’ve got a lot of power and they know that they are providing a good that people fundamentally need and deserve. Um and they’re going to engage, uh as they always have to, to maximize their profits. As as we think about other exciting aspects on the horizon, there’s been a massive increase in scientific funding. Uh, during this administration, whether it’s all the fallout from, you know, the race to a vaccine and COVID, uh whether it is this new CHIPS and science bill that was just signed into law, what do you think is the future for for science innovation and um the real kind of government funded pharmaceutical innovation uh that is the lifeblood of uh the industry here? What do you, what do you look at on the horizon? Um and and uh that gives you hope? 

 

Professor Aaron Kesselheim: Well, I think there are a lot of really exciting things on the horizon and a lot of hope, uh you know, out there for for the future. I think that, uh you know, for example, I think that there have been there are a lot of really important new potential uh gene therapies for for diseases like uh hemophilia or sickle cell disease that have been, um you know, historically under uh under-funded and undertreated. And, you know, I think that those kinds of things are, you know, are not yet not yet shown uh to work. But I think that they are, you know, right, you know, in the in the in the um near future, I think that we’ll see uh those kinds of treatments come out. Uh, there is, you know, there’s been a lot of research around uh neurologic diseases like Alzheimer’s disease and ALS. And, you know, unfortunately, some of the um first drugs that that are being discussed right now, you know, don’t look very don’t look very good. But I think that there is still a lot of promise and future products um that are in the pipeline that will come out. Um, you know, I so I think that there is there’s a lot of research and a lot of, you know, important new new drugs that are and treatments that are being developed. Um and, you know, a lot of there are things like like CAR T therapies that recently came out that are being tested and shown to work  in certain areas that are now being tested in a whole bunch of other areas of cancer, uh you know, that that can be very useful. So uh I think that there is a lot of good promise out there. And, uh you know, I think that that’s another reason why these kinds of systems are important to have in place, so that when those when those new products come out, um there can be a, you know, a process in place for ensuring that they’re priced fairly and available to the people who need it, you know, providing a reasonable return for the for the people who invested in it so that, uh you know, as many people as possible can uh benefit from them. 

 

Dr. Abdul El-Sayed: I really appreciate that point. Right. Because, you know, so often when we talk about uh the amazing science that gets done in labs across the country, you think about the upper reaches of what science can offer. And there really are some amazing things. But the critical work is also about making sure that the people who need them get them. And, um you know, the COVID vaccines are such an amazing uh example of that. And, you know, this is this is a great leap forward in science that was made free of charge for every single American. Um and it really has made a gigantic difference, saved uh thousands of lives, if not millions. And so much of this was about making sure that it wasn’t just the scientific pipeline, but it was also the policy pipeline that they guaranteed access. And we cannot forget the the hope of that kind of example when we think about all of the other diseases out there um that are on the cusp of being treatable because of the amazing research and science that is being done, but also making sure that these are available to people because uh we are we are we are thinking about the public policies that um hold the pharmaceutical manufacturers, who tend to buy access to these drugs to sell them. We’re holding them accountable. And I really appreciate you being a leader um in that respect. Uh that was friend of the pod, second time guest, Professor Aaron Kesselheim. He is, of course, professor of medicine at Harvard Medical School and faculty in the Division of Pharmacoepidemiology and Pharmaco Economics in the Department of Medicine at Brigham and Women’s Hospital. And he is uh both the creator and the leader of the Program on Regulation, Therapeutics and Law, otherwise known as Portal. Um, Aaron, we really appreciate you making the time on short notice to walk us through uh the Inflation Reduction Act, what it does, what it doesn’t do, uh and the hope that you have in the future. 

 

Professor Aaron Kesselheim: My pleasure. It’s a it’s a, um you know, really great week. 

 

Dr. Abdul El-Sayed: It really is. Thank you again. 

 

Dr. Abdul El-Sayed, narrating: As usual. Here’s what I’m watching right now. The CDC has just issued new COVID guidelines ahead of back to school season. Here are some of the headlines. The CDC no longer recommends quarantine after exposure for people who are not up to date on their vaccines. Test to stay policies and cohorting, policies designed to reduce the spread of COVID in classrooms are no longer recommended, and it does away with physical distancing the dreaded six feet apart. To be fair, the six feet apart thing was never useful. I don’t know why it got carried over for like two and a half years. Now, look, you can read more about the CDC’s new guidance on their website, but here’s my perspective. The CDC is trying to have its cake and eat it, too. It recognizes that for the most part, the country is basically done with the pandemic, however much the pandemic is not done with the country. After all, there are upwards of 100,000 new cases and nearly 500 deaths a day of COVID. This ain’t over. On the one hand, guidelines are only as good as people follow them. And right now, people just don’t follow them. For example, the new guidelines don’t change the CDC’s masking recommendations, but the vast majority of Americans just don’t wear masks in crowded indoor settings anymore. The CDC’s power, well, is in its ability to persuade. The generous interpretation here is that they’re trying to meet the population where they already are. On the other hand, the CDC is the National Public Health Department, their job isn’t to meet people where they are. Their job is to guide us to where we ought to be. The CDC stated goal is to reduce severe disease, and that’s a laudable goal, to be sure, but it’s incomplete. If I were the CDC director, I’d also add a few other goals. First would be to protect particularly vulnerable people from the ongoing threat of COVID infection itself. Second would be to encourage continued vaccination. And third would be to signal that the pandemic could get worse in the future and that we may need to adjust again. Do all of those things help the main goal of reducing severe disease? Of course. But they’re also more direct goals that the CDC just doesn’t seem to be surfacing. They’ve ramped down institutional protection, the kinds of things that vulnerable people need to be and do in public settings, do so without trying to punch up other potential opportunities to protect those vulnerable folks. Vaccinations are the most important tool we have to protect folks. And by changing their guidelines to make no clear distinction in risk protocol across vaccination status, they’re basically indicating that, well, vaccination doesn’t really change risk, which is neither true nor what the country’s most important public health agency should be implying. What’s worse, though, is that the guidelines have the feel of arguing that, yes, the pandemic is behind us, right as we’re careening into the fall, when cases have the chance of jumping dramatically and have done so every single year of the pandemic. What then does the CDC issue a new set of guidelines that’s more consistent with another rapidly spreading wave? In effect, being like, Yo, we were just kidding. Finally, the CDC is atomizing its response. What I mean by that is that they’re moving from COVID prevention as a collective goal to COVID prevention as an individual choice. I worry about that because we aren’t atomized individuals living on mountains. We’re a society, and what we do affects others. Giving up on our responsibilities to the collective means well undercutting the next public health response. Monkeypox anyone? All of this, of course, is happening in an America that has long since moved on. And what the CDC can do about it is limited at best. Congress has a huge role to play. And as exciting as the new Inflation Reduction Act is, it’s rather startling that it included almost zero funding for COVID, nothing for increasing ventilation and air purification in buildings, nothing for a new arsenal of updated vaccines. Nothing for more testing, nothing for more Paxlovid, for as much as the CDC can signal in its guidance, a signal from Congress that we still need to invest in addressing this pandemic is critical. Now, I know someone out there is probably listening skeptically to this thinking, but isn’t COVID here to stay Abdul? Yeah. Yeah, probably is. But the end game can’t be 100,000 new infections a day and nearly 500 people dead. That’s an intolerable, steady state. So while the virus, SARS-CoV-2, is probably never going to go away, the fact that it’s killing 500 people every day is a choice we’re making as a society. And I’m saying that that’s not a great choice. We can do better and we should do better. That’s it for today. On your way out. Don’t forget to rate and review. It really does go a long way. Also, if you love the show and want to rep us, I hope you’ll drop by the Crooked store for some American Dissected merch. We’ve got our logo mugs and T-shirts, “our science always wins” sweatshirts and dad caps are available on sale. [music break] America Dissected is a product of Crooked Media. Our producer is Austin Fisher. Our associate producer is Tara Terpstra. Veronica Simonetti mixes and masters the show. Production support from Ari Schwartz, Inez Maza, and Ella Price. Our theme song is by Taka Yasuzawa and Alex Sugiura. Our executive producers are Sarah Geismer, Sandy Girard, Michael Martinez and me. Dr. Abdul El-Sayed, your host. Thanks for listening.