Hubwonk 07/02/2024
[00:00:00] Joe Selvaggi: This is Hubwonk. I’m Joe Selvaggi. Welcome to Hubwonk, a podcast of Pioneer Institute, a think tank in Boston. With nearly 600, 000 American lives lost to opioid overdoses in the past two decades, the federal government has been tirelessly working to combat the crisis. Efforts have included reducing clinical use of opioids, educating the public, and providing timely medical interventions.
[00:00:27] However, frustrations over the limitations of these interventions continue. have led policy makers in Washington to seek solutions that target the source of the addiction, the opioids themselves. Imagine a future where biopharmaceutical research discovers pain therapies that are both effective and less addictive than opioids.
[00:00:46] This vision aligns with a statement made by FDA Director Patrizia Cavazzoni in 2022, quote, preventing new addiction through fostering the development of novel non opioid analgesics
[00:00:59] However, the same year saw the introduction of the Inflation Reduction Act, which imposed price controls on small molecule drugs, thereby reducing incentives for research and development of effective, non addictive pain therapies. How can policymakers reconcile the need to address the pain and suffering caused by opioid addiction and overdose with their desire to reduce costs, which in turn reduces incentives for new therapies?
[00:01:26] My guest today is Senior Fellow and Director of Pioneer Institute’s Life Science Initiative, Dr. Bill Smith, who recently released a paper entitled, The Left Hand Doesn’t Know What The Right Hand Is Doing, The Federal Government and Opioids, which argues that though policymakers understand the severity of the opioid addiction crisis, their recent legislation stifles or extinguishes research to find non addictive alternatives.
[00:01:51] Dr. Smith will share with us why pain research is so difficult in the current regulatory regime and explain what policy changes are needed to catalyze greater investment in non addictive pain relief alternatives. When I return, I’ll be joined by Pioneer Institute’s Senior Fellow, Dr. Bill Smith. Okay, we’re back.
[00:02:11] This is Hubwonk. I’m Joe Selvaggi, and I’m now pleased to be joined by Senior Fellow and Director of Pioneer Institute’s Life Sciences Initiative, Dr. Bill Smith. Welcome back to Hubwonk, Bill.
[00:02:22] William Smith: Thank you, Joe. My pleasure.
[00:02:24] Joe Selvaggi: Well, it’s good to have you back. You’re a frequent guest on and a fan favorite on the podcast.
[00:02:30] But I want to discuss today what I think is a salient topic, which is the pain and suffering associated with opioid drug use. I use that term intentionally, ironically, in that, of course, Opioids are drugs designed to alleviate pain, but of course the abuse of those same drugs has caused a lot of pain in many other ways associated with the addiction and ultimately the death of people who abuse opioids.
[00:02:55] So, we’re going to talk about a paper that you’ve recently released for Pioneer entitled, The Left Hand Doesn’t Know What the Right Hand is Doing, the Federal Government, and Opioids. In it, you argue that our government is pursuing policies that both discourage opioid use, which I suppose is good, but also discourage the development of therapeutic alternatives, which is not so good. So I don’t want to bury the lead. Let’s start at the basics with giving our listeners a sense of why they should care about this issue. How big is our opioid addiction problem in the U.S.?
[00:03:31] William Smith: It’s huge. So, I think we’ve lost, since about 2000, we’ve lost 565,000 people to opioid overdoses. And those numbers have gone up every year to the point where we’re close to 100,000 opioid overdose deaths annually.
[00:03:48] Joe Selvaggi: Yeah, that’s a lot. That’s more than the population of Boston and just completely unnecessary. So, let’s start with the beginning and you in your paper outline the evolution of how we got where we are today, all the way back to when some of these first drugs were being developed you break it down into three discrete phases. So, for the benefit of our listeners, give us a history lesson. How did we get here?
[00:04:09] William Smith: Yeah, so, opioid pills, years ago, a decade or more ago, were very common, and pharma companies marketed them aggressively, and they were thought to be not addictive, and so there were Millions of opioid pills in circulation, and a lot of people got in trouble with them because they are highly addictive.
[00:04:29] and that’s the first phase of the opioid epidemic. And we saw overdoses from regular prescription pills that doctors had prescribed. People began to figure out this is a problem, and they started cracking down on physician prescribing. They started limiting the pills. They tried to modify the pills, so they weren’t as addictive. And they did that just as heroin became widely available and cheap. So, what happened is, if you were, say, a kid who started abusing your parents’ opioid prescription because they got a knee replacement and it was in the medicine cabinet, you probably couldn’t get another prescription because they started limiting access.
[00:05:08] So many of these abusers turned to heroin. Which was cheap and widely available, and it’s an opioid. So, the second phase was heroin, and we saw a lot of heroin overdoses happening around the country. the third, the heroin prices then started to rise for a variety of complicated reasons, and the, so the third phase of this epidemic was fentanyl.
[00:05:31] which we know now is the most commonly prescribed, most commonly abused, opioid. and the third phase has been a terrible phase because many opioid pills come into the country disguised as something else, and people take them thinking this is perfectly fine, and they overdose and it, that creates huge problems because we used to be able to do aggressive drug education and try to convince kids, don’t take this pill, but if the pill is disguised as something else, you don’t, drug education efforts may not work in the same way.
[00:06:05] Joe Selvaggi: Yeah, it seems like, our, it’s a drug that is, we’re all working without a net. There’s no safe, dose. But so we’re talking about a, an evolution from, Let’s say more mainstream painkillers to trying to curtail the use of those painkillers to, of course, those people who are either addicted or soon to be addicted to those painkillers, find alternatives. And now we’re in this phase where the most, let’s say, ubiquitous and easy to access drug is this thing called fentanyl. How lethal is this? We’re in phase three of the three phases. How lethal is this thing called fentanyl to Americans?
[00:06:42] William Smith: It’s enormously lethal, and I talked about some of the stats on overdoses but, one of the problems is when you get a pill, and you abuse a pill, you don’t really know how powerful that pill is. You don’t know how much content is in there. So, patients take what they think is Valium, and it’s a high dose of Fentanyl, and they overdose. It’s a big problem because it’s an extremely powerful drug.
[00:07:10] Joe Selvaggi: Yeah, and of course we hear the horror stories. Your paper mentions, I thought one of the data points I found compelling is you mentioned that 7,050 American soldiers have died since post 9 11. That’s a long time ago. That’s a long time. Our nation loses 10 times that amount of people overdosing every single year.
[00:07:28] That should make the hair on the back of your neck stand up. So, one of the foundations of your paper, though, implies that, we started out with these prescription opioids and, hoping they’d be, legitimate and useful treatment for pain for people, anything from post surgeries to cancer and all kinds of horrible, painful diseases. Would you argue, that, these legal opioids have half the effect of serving as gateway drugs to these terrible alternatives like fentanyl. In other words, people start off harmless enough. using legal opioids and then find themselves addicted or using fentanyl, which can be, as we’ve established, very deadly. What evidence do you have that legal drugs are the gateway to illegal?
[00:08:16] William Smith: The evidence is not terribly strong, Joe, to be perfectly honest. there have been some studies that have done surveys where it, the evidence is very clear that prescription opioids were a gateway drug to heroin. People took prescription opioids. They couldn’t find another prescription, or they couldn’t find prescription opioids anywhere, so they turned to heroin. The data on fentanyl is not as clear. There are some studies where they survey fentanyl abusers, and they say, how do you get started? And a good percentage of them have said, I got a prescription opioid out of my father’s medicine cabinet, and then I couldn’t get it, so I turned to fentanyl. We need to study this a little more, because the data is not conclusive, but as I said, there’s some evidence that this is still the case.
[00:09:04] Joe Selvaggi: Why would someone who, let’s say, is using a legal pain drug, discard that or move to something that’s so risky and so, so illegal or so dangerous. Why are people migrating from legal to illegal deadly?
[00:09:17] William Smith: Well, the problem is they get physically and psychologically addicted to an opioid, and it may be a prescription opioid in the beginning, and then when they can’t get their hands on another prescription opioid, they try to turn to something else, because they’re addicted.
[00:09:32] Joe Selvaggi: Yeah, and I, and again, it was well intentioned use. I remember all the sort of public awareness about the dangers of opioid addiction and the need to curtail doctors from prescribing too much of it, right? Where we have a large jar of it, take it till you’re done, and it sits there in the cabinet. But it seems that the desire to curtail legal use has exacerbated or aggravated the need or the danger. Migration to illegal use. Is that fair to say this was a well-intended?
[00:10:02] William Smith: That’s the irony. it’s both prescription opioids and fentanyl are dangerous but if I had to choose between the two I’d choose prescription opioids as being a little safer and the irony is that when we crack down on prescription opioids People turn to heroin and fentanyl who are which are probably more dangerous drugs They’re all dangerous, but fentanyl and heroin are probably more dangerous
[00:10:25] Joe Selvaggi: I think we’ve done a good job early on in our show here to shock people and realize that how big and how deadly the problem is, it seems that, this, the size of this problem has not escaped the notice of policymakers in D.C. I think it’s reassuring to see what the research I’ve done and from reading your paper that both sides of the aisle agree that this is a terrible problem. we do have public agencies in, in the U. S., the CDC, the NIH. What are they saying, is the possible solution? we’ve got addicted people, we’ve got deadly drugs. It’s almost impossible to, to take them all out of society. What do our public health agencies suggest as a viable path forward?
[00:11:01] William Smith: Well, most of the public agencies, the CDC, the ones that are concerned about disease prevalence warn against the use of opioids and how addictive they are. But there have been a couple agencies like the FDA and the NIH, which have actually encouraged companies to try to find pain drugs that could substitute for opioids. That would be a major breakthrough because if Patients post-surgery, for example, were not prescribed an opioid that might sit in their medicine cabinet after they only took a few days’ worth if you could prescribe them a non-addictive pain drug that was very effective that, that could replace those opioids, you’d make a significant step towards mitigating. It wouldn’t solve, but it could mitigate the, the opioid crisis.
[00:11:49] Joe Selvaggi: So, forgive me, but I don’t want to put words in your mouth, so you’re saying if we’re following the logic here, the holy grail perhaps, if I can use such a term, is that if opioid, use is in some ways addictive, and that addiction leads people down the path towards illegal or lethal alternatives. If we were to find drugs that serve the purpose of opioids, which is to reduce pain, but they were not addictive, we would effectively be attacking the problem at its root. Am I being too simplistic?
[00:12:24] William Smith: That’s precisely it. I’m just for the record, I’m a believer that this would not be a silver bullet, but I think it could significantly diminish the crisis.
[00:12:34] Joe Selvaggi: Okay. So, so let’s just put a pin in that and say at least there’s the promise, there’s the hope that there would be an alternative opioids that are not addictive. so that we have a problem, and at least on this issue, again, your paper notes that there’s bipartisan support. What kind, where then would this Holy Grail, I don’t know what we want to call it, this magic, it’s not a bullet, but it’s, easing us towards alternatives to opioids that treat pain but are not addictive. What kind of support is there for alternatives to finding this kind of therapeutic solution?
[00:13:04] William Smith: Again, the federal government for years have been giving support, so if you’re a biotech company and you’re looking for a substitute for opioids, the FDA will give you advice and counsel for free on how to structure your clinical trials, how to make it more efficient.
[00:13:21] The NIH actually will give grants out to companies that are pursuing non opioid pain substitutes. the problem is the Inflation Reduction Act came along and Discouraged research into small molecule. Drugs, and any opioid substitute is very likely to be a small molecule for complicated biological reasons. But essentially, there’s something called the blood brain barrier, where molecules that are medicines have to cross that barrier to get to the brain and get into the nervous system. So, if, for pain and neurological conditions and some other cancer to some degree, you have to cross that brain blood barrier. And small molecules do that better than large molecules. And the IRA discourages research into small molecules.
[00:14:15] Joe Selvaggi: Well, now we’re wandering into some familiar territory. You and I have discussed the problems with the disincentives for small molecule drug development in the IRA. For the benefit of our listeners who are not listening to every one of our past episodes and are unfamiliar with the distinction between small molecule and large molecule, and also what we mean by providing disincentives. I, we don’t have to rehash how drug companies make their money and what their incentives for new development are. Give us the sort of 10,000 feet view of why the IRA generally provides disincentives for those drugs that are small molecule.
[00:14:50] William Smith: Yeah. So quite simply, small molecules are typically chemical compounds that are simple, and they come in a bottle that you pick up at CVS. They’re pills. Large molecules are much more complicated. They’re larger molecules and generally they’re infused or injected because they’re large molecules. You can’t, they don’t go work well in the digestive system. So, the IRA made a distinction about when price controls could take effect for those two types of medicines.
[00:15:19] They said for small molecules, price controls can happen after nine years on the market. For biologics, for large molecules, you could wait 13 years before price controls took effect. Now, what that does, of course, is that venture firms that want to invest in certain biotech companies or investors that want to invest in certain biotech or pharma companies are going to look at the return on investment for small molecule projects and they’re going to realize Hey, they’re cutting off four years of sales of lucrative sales, for these small molecules. I’m going to invest in large molecules. So that’s the disincentive that I’m talking about. They can slap price controls on small molecules sooner, four years sooner than large, which is going to discourage R& D investment into those molecules.
[00:16:07] Joe Selvaggi: So, okay. So, we think it’s more likely than not that the alternative to opioids would be found in small molecules. We’ve provided it, or we’ve taken away some of the incentive. It sounds almost like cutting it in half, for developing those. Ergo, there’ll be fewer small molecule trials and development. So, the odds of finding an alternative, a non-addictive alternative to opioids has gotten substantially smaller owing to the recent, well not recently at this point, the two-year-old. Inflation Reduction Act. Is that fair? I don’t want to put words in your mouth.
[00:16:41] William Smith: No, that’s fair. and compounding the problem is that pain drugs are particularly difficult to get to market. They’re, the trials are more expensive, the success rate is lower. They’re actually more expensive to, to develop than regular drugs. So, you have that factor, and you have the small molecule IRA factor. This is going to discourage R& D into these types of compounds.
[00:17:07] Joe Selvaggi: Say more, your paper references the attrition rate of these, trials, the fact that, you can be doing, I, I think of all the horrible diseases out there that they do trials on. Why is pain research such a, so fraught with, Failure. Is it simply that we already have opioids as an alternative? So, why, why come up with a better mousetrap if you already have this, albeit addictive, but useful?
[00:17:29] William Smith: Yeah, there are some medical professionals out there who say opioids are not that effective. In my experience, talking to medical professionals, they’re extremely effective, which is part of the problem. They’re very effective, which has discouraged research into other compounds, alternatives, because opioids are the, they’re the standard. If you’re, if you have surgery and you get out of the hospital and you’re going to be in pain, you’re going to get an opioid, because they work. They simply just work.
[00:17:57] Joe Selvaggi: Now again, I’m going to use the Holy Grail, analogy here. I imagine there’s some listeners out there saying, okay, these guys are imagining like the white whale or some magical, alternative to opioids that just doesn’t exist, never exist. Is there anybody out there, we have so many wonderful companies building so many great therapies, is anybody, particularly I hope maybe a local company getting any success with it, with a drug that actually addresses pain in a way that’s similar or as good or bad?
[00:18:27] William Smith: Yeah, no, I was, I’m very, one of the companies I most admire is a local company, Vertex Pharmaceuticals, which is based in Boston. And they have gone through three phases on an opioid replacement drug that showed very good effectiveness in reducing pain and didn’t have addictive qualities. The problem is if you read the data very carefully, the data was not as strong when it went head-to-head against an opioid. A traditional opioid beat out as far as reducing pain, but it did reduce pain. So, the question is there going to be uptake for a pill like that? Vertex has said they’re going to go to the FDA and seek approval, and I hope they do. And I’m hoping that it has some success in the marketplace, but we just don’t know. Because again, what is an orthopedic surgeon going to do if he sees the Vertex trials and sees that opioids were a little more effective in reducing pain. Is he going to prescribe the Vertex drug or is he going to prescribe the opioid? I don’t – I just don’t know
[00:19:26] Joe Selvaggi: Yeah, standard of care tends not to be conducive for risk or new things. It wants to rely on more familiar things. So, you have mentioned that the broadly speaking, you and I have been talking about the hazards of the IRA, the, the loss in, providing incentives to small molecule drugs.
[00:19:44] Just to put a, underline on this, you and I have talked, arguably for two years about it, saying that it is likely, based on our knowledge of economics and incentives, to discourage, development of small molecule drugs. We say that’s probable. Now, we have two years of, retrospective. Have you been able to measure the degree to which the IRA has discouraged, not just what we’re talking about, small molecule.
[00:20:07] opioid alternatives, but all those other small molecule targets like cancer and Alzheimer’s, all these horrible diseases that can really only be addressed with small molecules. So, say more about that.
[00:20:17] William Smith: We have some anecdotal evidence that companies are cancelling trials for small molecules and investors are paying attention to that.
[00:20:24] Pulling back from investments in small molecule research, there’s a biotech investor named Steven Potts, who’s a doctor, who sent out a survey to a hundred, a hundred venture capital firms and asked if they were, Pulling back on small molecule investments and 90 percent of them said that they were so there’s some evidence out there I don’t think we’re gonna have the real evidence until after September. On September 1 They announced what the prices are gonna be for the 10 drugs that have been put on the price control list at CMS and if those prices are very low, it seems likely to me that we’re going to see some fallout from that.
[00:21:05] Joe Selvaggi: Indeed. Again, one does not need to be an economist to know that price drives new research into new drugs that can also command similar prices.
[00:21:15] William Smith: So, yeah, so if the average price reduction that shows up on September 1 for those 10 drugs is 90 percent reduction, that number is going to be plugged into every return-on-investment analysis done by a venture capital firm on promising drugs in the pipeline and they’re going to, they’re going to know exactly what the numbers are and how much revenue is going to be lost because of the IRA and you would think that there’ll be fallout. they’ll invest in an alternative fashion.
[00:21:46] Joe Selvaggi: Indeed, these investors do not invest merely to save lives, they invest for return. So, I want to say, of course, I want to acknowledge, of course, the logic of the IRA of setting prices for certain drugs or limiting patent protection for certain therapies was to reduce costs of health care. So ultimately, it’s a value equation. We want to reduce costs and improve people’s lives.
[00:22:12] Do you have any, I think in your paper, you do mention some comparison between the money that’s likely to be saved with the IRA, which is, money we’re not spending on expensive drugs relative to the cost of not developing. opioid alternatives. In other words, the cost of opioid death and abuse is, if you care to, you can somewhat measure it. And the savings that is realized by passing RA, just compare the scale and scope of, did we save a little bit relative to what the costs were likely to incur? What can you say about that?
[00:22:46] William Smith: Well, we didn’t do a full economic analysis of this, but if we were to discover a replacement for opioids. That would save billions if not trillions of dollars. There’s just no doubt about that. the amount of medical care that’s going into things like NARCAN and other, procedures to treat opioid addiction, that’s substantial, and the prospect of finding an alternative treatment would be substantial.
[00:23:18] Joe Selvaggi: Yeah, you in your paper, I’m going to quote from you or cite some of your data. The Congressional Budget Office estimates that, well, you say that the estimated four-year cost of, opioid addiction in the ballpark was 631 billion. The CBO estimates the savings from the IRA to be 129 billion during the 10-year period. So, 4 years of opioid addiction, 631 billion. 10 years of IRA implementation, 129 billion. Seems like a false economy. Again, I don’t want to impose my own, judgment here, but to me, that’s, what’s the term? Pennywise, Dollar, Foolish,
[00:23:54] William Smith: Yeah, and that’s just considering the impact on opioids. What about the impacts on cancer and heart disease and many other things that aren’t going to get invented? which would prolong longevity, reduce healthcare costs. The IRA is going to be a very costly piece of legislation.
[00:24:12] Joe Selvaggi: So, I want to keep our focus on the opioid alternative, the possibility for an opioid alternative. I’m imagining listeners saying, look, okay, criticize the IRA all you want. It’s trying to save drugs broadly. Why don’t we, if we all agree, and I think, this is not, this has no, Ideological or political valence. We all agree that opioid addiction affects everyone, and it’s terrible. Couldn’t we have some sort of, like, moonshot program where we say, okay, small molecule, big molecule, don’t bother me with the details. Whoever gets to the holy grail first, gets this, opioid alternative first, we’ll give them, 50 billion dollars or something. Why don’t we provide incentives for that particular research given its importance?
[00:24:53] William Smith: Well, the federal government has done it on a modest level, NIH, as I said, will give grants to companies that are researching opioid alternatives. There hasn’t been a moonshot, so to speak, and I’m not sure it’s a wise investment because the prospects of finding one of these, I think, are very slim. Despite Vertex’s success, I think the prospects of finding one are really small. For example, in our analysis, we looked at every possible, opioid replacement therapy that was small molecule. And we only discovered nine clinical trials in the whole country, for potential. And as for RT therapies, which are cancer therapies, there are hundreds of trials. So, the prospect of finding the, these, this pill, I think the industry thinks is remote. And the number of trials would indicate that case.
[00:25:46] Joe Selvaggi: Yeah, and frequent listeners, those who have caught you on the show before, understand that many times, therapies are discovered not deliberately or intentionally, they’re often stumbled across when you’re looking for a cure for one disease, but suddenly you find it effective for another disease. We see this all the time, if you’re not doing any research in this area, in other words, if all small molecule, research comes to a grinding halt, the odds of stumbling across this wonderful alternative to opioids becomes substantially less or even zero. Is that fair?
[00:26:15] William Smith: Yeah, that’s fair. And the most famous example of what you’re describing is Viagra, which was in clinical trials for angina, the heart condition. And if the patients in the trial discovered it had some other side effects, Pfizer turned it around and put it into another trial and got this blockbuster drug. So, yeah, that happens all the time, but I think it’s very slim in the finding an alternative to, an opioid, I think, is a slim possibility.
[00:26:44] Joe Selvaggi: Yeah, indeed. So, again, I maintain that this doesn’t have a political valence. It’s not a contentious issue, between parties or anything like that. But we’re in an election year, lots of turmoil, there’s very good possibility we see a different person in the White House, next year, the Senate and the House are up for grabs.
[00:27:01] I’m gonna ask you two parts. If you were king for a day, what would you do? And what do you think the prospects of that sort of, change or that sort of, embrace of a better alternative is likely to happen given, a shakeup? Either in the White House, the Senate, or all three.
[00:27:18] William Smith: I’m cynic about this.
[00:27:19] I think there’s a lot of bipartisan blame to go around on the opioid epidemic. We’ve seen opioid overdose deaths grow through Democrat administrations, Republican administrations, Democrat administrations, and it’s just a straight line up. And nobody in Washington seems to be, as you said, advocating a moonshot or treating this crisis with the, the respect that it deserves this is a major hundred thousand people a year dying of overdoses and the stuff is being, made with chemicals that go into Mexico from China and Nobody’s really doing anything about it. It’s, it’s very disturbing to me, and I think I would condemn both parties and their reaction to this because, I haven’t seen any party that has, either party has an effective strategy.
[00:28:08] Joe Selvaggi: But do you imagine a policy intervention, let’s say, again, the king for a day, were we to re incentivize or, say, protect, the patent protection of, or increase the patent protection of small molecules, or encourage or compensate? research firms for developing these alternatives. I’m going to ask the obvious, that would have to help. Is that enough? Is that what you imagine the solution to be, if it were possible?
[00:28:34] William Smith: I think you’d have to have very strong incentives in place for companies to undertake this risky research. You would start with, even in a modest way, exempting Small molecule pain drugs that could substitute for opioids from the IRA’s nine year price control regime.
[00:28:56] Just exempt those projects. I’d like to change the IRA so that all small molecule research is equal in patent life to large molecules. But if you want to start small, yes, just change it. Change it to 13 years for non opioid R& D projects and then provide other incentives, tax incentives. We’ve seen how effective the Orphan Drug Act and other federal pieces of legislation that incentivize certain types of drug research.
[00:29:28] And you could do the same thing. I don’t know enough about the science to know whether it’s a possibility, but I do know Vertex has had some success and you could build upon that success.
[00:29:39] Joe Selvaggi: Yeah, I think we also have to attack the rhetoric that attends, drug companies. It’s, the popular mythology is that drug companies are wearing the black hat and they’re shaking us all down and there’s the cause of the high cost of health care.
[00:29:51] I, I’ve pointed this out and you pointed this out in earlier episodes. The alternative to expensive drugs is not cheaper drugs. It’s no drug. It doesn’t get developed. You don’t have to pay for it because it doesn’t exist unless we provide healthy incentives. For very expensive and very, risky, research, it just won’t happen. It’s not that it’ll be developed anyway. am I,
[00:30:12] William Smith: Yeah, I don’t want to go off on a tangent, but Europe used to be the home of biopharmaceutical research in the whole world. It was the capital region. And most countries in Europe? Adopted price controls on prescription drugs, and now the Chinese have overtaken the Europeans as far as the number of trials are concerned, and they’re, the Chinese are hot on the heels of the Americans.
[00:30:36] The Americans have 24 percent of the clinical trials in the world. The Chinese now have 18 percent of the trials, and I would argue that Biopharma research and medical research is one of the premier crown jewels of the American economy and we’re frittering it away with things like the IRA.
[00:30:55] Joe Selvaggi: Yeah, indeed.
[00:30:55] It’s not just a critical, vital part of the U. S. economy. We’re talking here, in Boston. One doesn’t have to be an economist to see it has a profound influence on our local economy and the prosperity of our community. so we are the hotbed, and of course, the flip side is if we sabotage that, that development, we will suffer as a country, but particularly as a region. So, I want our listeners, of course, to read your research paper. Lots of good footnotes in there as well. Where can our listeners read your research paper?
[00:31:30] William Smith: PioneerInstitute. org, or you could just do a Google search, if you Googled my name Smith and left hand doesn’t know what the right hand is doing in Pioneer, it would come up. but it’s posted on the website also.
[00:31:41] Joe Selvaggi: Wonderful. And of course, I think your email is there, too, if somebody wants to challenge any of your observations or conclusions. It is.
[00:31:48] William Smith: My email is on the pioneerinstitute. org website, and I’m happy to reply. This is of particular interest to me because I was staff in the White House Drug Policy Office, and I worked on a congressional committee that had jurisdiction over pharmaceutical, over illegal drugs. And I’ve Spent a good deal of my life paying attention to it, and, I, I find this opioid epidemic to be just a tragedy of unimaginable proportions.
[00:32:15] Joe Selvaggi: Right, and it spares no one. It touches every community, rich and poor, rural, urban. no, no one escapes the danger, so anybody, whether it’s kids or old people or whatever, we all, are at risk.
[00:32:28] So thank you very much, Bill, for joining me again on Hubwonk. I thought your paper was provocative and interesting, and I hope our listeners did so as well. Thank you for joining me. My pleasure. This has been another episode of Hubwonk. If you enjoyed today’s show, there are several ways to support Pioneer and Hubwonk. It would be easier for you and better for us if you subscribed to Hubwonk on your iTunes Podcatcher. It would make it far easier for others to find Hubwonk if you offer a five star rating or a favorable review. We’re grateful when you share Hubwonk with friends. If you have ideas or comments or suggestions for me about future episode topics, please email me at hubwonk at pioneer institute dot org. Please join me next week for a new episode of Hubwonk.
Joe Selvaggi talks with Pioneer Institute’s Director of Healthcare Initiatives, Dr. Bill Smith, about the challenges posed by new regulations and price controls for developing alternatives to addictive opioids.
Read Dr. Bill Smith’s paper: The Left Hand Doesn’t Know What the Right Hand Is Doing: The Federal Government and Opioids
Guest:
Dr. William S. Smith is Senior Fellow & Director of Pioneer Life Sciences Initiative. Dr. Smith has 25 years of experience in government and in corporate roles. His career includes senior staff positions for the Republican House leadership on Capitol Hill, the White House Office of National Drug Control Policy, and the Massachusetts Governor’s office where he served under Governors Weld and Cellucci. He spent ten years at Pfizer Inc as Vice President of Public Affairs and Policy where he was responsible for Pfizer’s corporate strategies for the U.S. policy environment. He later served as a consultant to major pharmaceutical, biotechnology and medical device companies. Dr. Smith earned his PhD in political science with distinction at The Catholic University of America.