Centennial Speaker Series Session 6: What Are the Potential Benefits and Risks of Biotechnology?
Dr. Michelle McMurry-Heath discusses the future of biotechnology and how policymakers can best leverage scientific advances to confront 21st century challenges.
This meeting is the sixth session in CFR’s speaker series, The 21st Century World: Big Challenges & Big Ideas, which features some of today’s leading thinkers and tackles issues that will define this century.
This event series was also presented as a special podcast series, “Nine Questions for the World,” in celebration of CFR’s centennial. See the corresponding episode here.
HAASS: Well, thank you. And I often feel awkward as being introduced as Dr. Haass. I feel particularly awkward today because our speaker is Dr. Dr. She is both an M.D. and a Ph.D., or as we like to call people who are M.D.s, real doctors, unlike the academic sort the likes of me are. I’m Richard Haass, by the way. This is the Council on Foreign Relations. We are still in our 100th year. And this is a series of big ideas and big thinkers that we are bringing together to mark our 100th anniversary. If my math skills are up to speed this is our sixth in the series.
And today we are extraordinarily fortunate to have Michelle McMurry-Heath, Dr. Dr. McMurry-Heath, lead us in a conversation about biotechnology, its risks and rewards, its promise and its peril. Dr. McMurry-Heath is the president and CEO of an organization called the Biotechnology Innovation Organization. It says that on her bio, that she leads BIO. So I will just leave that as it is. She spent years in the private sector at Johnson & Johnson. She spent also years in government, in the public sector, with Senator Joe Lieberman, also with the FDA. And she is one of the prominent voices in this country and beyond on this important subject of biotechnology, which is so central to the experience we are living with and, alas, in some cases dying of, which is—which is COVID-19.
Dr. McMurry-Heath, and once we get going I will call her Michelle—it saves time and we now know each other well enough. It’s not meant in any way disrespect, just informality. We will have a conversation ourselves for a half-hour or so and then we will open it up to you, our members, for your questions. But I’m really going to lean on the membership here. As is already obvious, and if not soon will be, my expertise in this area is, shall we say, finite. I actually like doing meetings in such situations because I learn enormous amounts. And we have an extraordinarily talented teacher with us today. So, Michelle, thank you for giving us your time and your perspective.
MCMURRY-HEATH: Of course. It’s a pleasure to join you.
HAASS: So let’s start out with some basics. Let’s talk a little bit about what we mean actually by biotechnology. What is the definition? And then once we are clear about that, let’s take a step back and just give people a sense of what this field is, and where it is, and what’s going on. Let’s paint the canvas, if you will.
MCMURRY-HEATH: You know, I was reflecting on the definitions we tend to use, which is biotechnology exploits the functions and abilities of DNA. But it’s also kind of broader than that. It uses any building block of living organisms to create new solutions. And we see solutions not just in healthcare, but also in agriculture and the environment. So the applications are almost endless. And BIO tries to capture that breadth of expertise.
HAASS: Right now let’s get a sense of the dimensions of this. When we speak about biotechnology, what does it touch? What does it reach? What do we really—what are we including here?
MCMURRY-HEATH: Mmm hmm. Well, I ran across a very interesting statistic recently, which is that in the auto industry today there’s roughly 800 million Americans working in the auto industry. But there’s 1.8 million Americans working in biotechnology. So we have really grown at a rate where we touch almost every facet of life in the U.S., but also life around the globe. And the rate of increase of knowledge and the breakthroughs that are coming are just coming so fast, and it just keeps accelerating. So we have the ability to deliver so much more than we could even deliver to date.
HAASS: So when people like me hear “biotechnology” in the benign sense—and later on we’ll get to the potentially or actually malign. But let’s talk about the benign. We think of it, obviously, in terms of health care. When I talked to people in preparation for this, when I read around, what’s interesting to me is it’s got to deal with way more than that. It deals with food production, agriculture, climate change potentially. Give a sense of the reach of this field.
MCMURRY-HEATH: It’s so broad. So, for example, we have companies like LanzaTech that are developing biofuels that they hope will replace current jet fuel. If you can imagine, I know there’s lots of angst around air travel these days and not just due to COVID but before that, due to the impact on the environment. If we could create a home-grown jet fuel, imagine the democratization of air travel that we could really see going forward without impacting the environment. There’s also the ability to develop bio-based plastics. There’s ways to change the way we manufacture not just what we do in biotechnology but across many manufacturing platforms.
Then there’s the ability to address hunger. We are seeing some amazing examples of using the latest in biotechnology to deliver more nutritious, cheaper, more plentiful foods to neighborhoods around the globe. One of our companies, Benson Hill, they use CRISPR, which is a very specific gene editing technology, to be able to produce micro-crops that perhaps can grow even better than expected in hydroponic settings. Hydroponic settings are basically indoor settings where you pipe in light and water and create plants that can grow. Now, imagine that that technology is applied to every empty strip mall in the U.S., and that you’re able to engineer fruits and vegetables that taste better, are more nutritious, carry more protein, and are cheap to grow in local neighborhoods all over the U.S., and all over the globe. We would be able to boost the nutritional input of so many of our citizens. There’s so much to do. And that’s just on the broader environmental side.
HAASS: Just to follow up on one thing, so that would suggest to me that—I actually know this, I’m almost embarrassed to say this, from golf. Where there’s certain golf courses now which are growing kinds of grass which use less water. So I assume in a world of higher temperatures, water shortages, common droughts, biotechnology then gives us something of a response for agriculture.
MCMURRY-HEATH: Yes. Yeah, unfortunately most people have heard about biotechnology in agriculture through some of the very earliest attempts. And those really got the moniker of GMOs. What we’re seeing today is so different, in part—
HAASS: Genetically modified—
MCMURRY-HEATH: Genetically modified organisms.
HAASS: Organisms, yeah.
MCMURRY-HEATH: So for example, it started with rice and corn crops that had certain resistance to pestilence, or better response to pesticides. But now, we’re able to so specifically rewrite specific genes that we are doing this with a much more delicate touch. And the applications are so much cheaper and easier to use. And so the benefits are also so much greater. So getting people to take a second look at what twenty years ago was a GMO and what today is something almost completely unrelated but is based on the technology around DNA to deliver benefits.
HAASS: One last question on the technology, then I want to get into some immediate issues dealing with COVID. When people like me hear things—anything with the word “bio” we think of high school science, we think of test tubes and laboratories. What’s the intersection between your world and things like artificial intelligence, or potentially quantum computing? To what extent does the revolution in biotechnology very much part and parcel of the revolution in artificial intelligence and computing?
MCMURRY-HEATH: They’re very much related. And you know, the advances we’ve seen in information technology has really helped us screen compounds much more quickly, to pinpoint where we need to go in identifying genes, and where in a gene we need to make a change. There’s so much at the intersection of those two disciplines that it’s almost hard to draw a boundary around them. But it’s also just exciting to see. And I think while information technology in the last decade has really transformed the way we live, and we attribute a lot of our progress to it, I think the next several decades are going to be the biotechnology decades. Where it’s not your grandfather’s test tube anymore. It’s really the ability for small groups of entrepreneurs to make major breakthroughs in health, agriculture, and the environment, and then deliver them at scale around the globe.
HAASS: Let’s talk about the immediate situation. When this crisis began, and now we’re looking at somewhere between eighteen months and two years ago, the COVID-19 crisis. And people were talking about vaccines. Even at that point Dr. Anthony Fauci was talking about the normal production or development cycle of a vaccine. And it was close to a decade. And obviously, it has been telescoped to less than a tenth of that with these so-called mRNA vaccines, which raises all sorts of questions. One is, why were we able to do it so quickly? Did the science move quickly or was the science in large part already there?
MCMURRY-HEATH: Much of the science was already there. And it was there because of twenty years of consistent investment in mRNA technology, waiting for that moment when it was really well-understood and able to be applied in lots of different settings. So that was a happy coincidence, that the intersection of a rise in understanding of mRNA coincided with COVID. But the other half of the coin is that we responded to the vaccines in a way that we don’t typically respond to other new medical breakthroughs, which was the public sector really said: We are going to partner with you.
We’re going to partner with you in making sure you’re manufacturing in a way that our regulators want to see. We’re going to help you with your clinical trials. We’re going to be in close communication and coordination between you and regulators. And we are going to make those regulatory decisions as fast as humanly possible. And that also telescoped the time in quite an incredible way. And it’s an important lesson because it says that, you know, with investment and with focus, the public sector can do a lot to accelerate innovation, much more than we’re doing on a normal day-to-day basis.
HAASS: So you’re alluding to the so-called—I think it was called, what, Operator Warp Speed? And basically the idea that the previous administration made some investments and took some risks in front-loading investments in vaccines before they actually knew they would be effective?
MCMURRY-HEATH: Well, that’s part of it. You know, even with public funding of science, public funding of the successful sciences turns out to be a very small percentage of the investment that’s needed to carry a medical product, for example, across the finish line and deliver it to patients. So while that was a happy situation, to have their cooperation there, it was really the private sector that was going to drive those solutions into real products. Where they really made a difference was on the regulatory pieces, the clinical trial pieces. The manufacturing and distribution pieces. All of those were critical. And they really accelerated the research.
HAASS: Just as an aside for a second, more traditional vaccines, like the Johnson & Johnson vaccine, are those essentially increasingly obsolete? Have we seen the end of that vaccine era at mRNA, like, genetically oriented vaccines that instruct cells what to do or don’t do, and the like? Is that a sense—have we arrived at this new era of vaccination?
MCMURRY-HEATH: Well, I don’t think it’s isolated just to vaccines. MRNA technology, for example, has so many possible applications. So as we learn more about cell and gene therapy, as we learn more about targeting specific genes to make changes, a lot of our modern medicine will seem obsolete in just a few, short years. But that’s what’s so exciting about biotechnology, because you can say that no matter where you’re sitting. If we were having this conversation in 1970s, I’d be telling you the same thing and it would be true, because our scientific understanding in biology since the early ’70s has just increased exponentially. And that’s what comes from sustained investment and the commitment and passion of great scientists.
HAASS: Just to play—to roll back history differently. If COVID-19 had broken out not roughly two years ago but twenty years ago, where would we have been? Would it have been five or ten years of an almost medieval-like situation of massive lockdowns? Would we have basically been forced to fight it with very few tools?
MCMURRY-HEATH: I hate to even guess. It would have been excruciatingly painful. We would not have been able to accelerate the timeline to the amount that you saw in this instance. The fastest vaccine production prior to COVID was six years. Six years to get through the development process as well as the regulatory process. So we did see an incredible telescoping. And I really hazard to guess as to what would have resulted without it.
HAASS: One area that seems not to have gone well, and still isn’t going well, is the global effort. And there’s an enormous gap between, how would I put it, global supply and global demand. In this country, we have the ironic, tragic, frustrating—choose your adjective—where in many cases supply exceeds demand. And what we’re trying to do is stimulate demand while we still have a quarter of our population that isn’t there. Around the rest of the world, the demand is there, the supply isn’t. Why is that? And to what extent are the companies—the Pfizers, the Modernas, the J&Js—to what extent are they responsible?
MCMURRY-HEATH: So let me start with why it is not. So it is not because of barriers to intellectual property. Moderna has made it clear that since early in the pandemic they announced that they were going to let anybody have access to their proprietary secrets, which is almost unbelievable. But I’ve spoken to many members of their board, and that was their public commitment early in the pandemic, and they’ve kept to it. What’s happened is that a few well-intentioned, but misguided, policies have just exacerbated something that was going to be difficult to do from the start. The invocation of the Defense Production Act has really turned global production of vaccines on its head.
You know, the restriction of manufacturing of the supplies, and most people don’t realize it takes almost two hundred ingredients or objects to create an mRNA vaccine. We manufacture so many of that raw material that goes into producing those vaccines, not just for the U.S. but for around the world. And the Defense Production Act restricted the exportation of those raw materials. For example, of the three hundred manufacturing partnerships that our leading vaccine manufacturers already have today in countries around the world, we saw plants ready to manufacture in India that couldn’t get the raw materials to actually produce COVID vaccine doses.
You add on top of that that the Defense Production Act mandated that vaccine manufacturers fulfill their U.S. orders before they exported any doses. And that meant that many middle-income countries—and I’m thinking of several in South America—who took the extra step to put in their orders early and be prepared for the vaccines when they came online had to then wait. And they found themselves having to double back and trying to get the Chinese vaccine, so that they’d have something in time. So we really—there was good intentions, I believe, behind that move. But it was a devastating policy move.
And we have to look, going forward, not only at how we break down the vaccine nationalism that has exacerbated the shortage, but also how we move manufacturing capacity around the globe so that we’re not waiting on either raw materials or U.S. manufacturing to make it happen. That’s going to be critically important. But despite all of that, the global vaccine manufactures are now projected to produce twelve billion doses of COVID vaccine by the end of the year, which is incredible given that we’ve never, as a globe, produced more than 2 billion doses in any year of a vaccine. So this is an incredible increase in capacity. And I think the companies should really be applauded for everything they’ve done to make that happen.
HAASS: So often in the pharmaceutical business and the rest, one always hears there’s a tension between, you know, the companies are spending decades doing research and development, massive investment on their part. They produce a successful drug. Demand grows for the drug. And the question is, how does one price it? How does one determine what’s a fair return on investment? How does one come up with adequate availability and distribution? To what extent is that a factor here?
MCMURRY-HEATH: Mmm hmm. Well, it’s very important to consider. So at the start of the pandemic, BIO started tracking all of the research and development projects targeted at COVID. And as of maybe about a month ago, that was over a thousand. So just imagine this, companies all over the world, over a thousand research and development projects, each trying to make a product that would stop or fight COVID. That includes over two hundred vaccine efforts. So that’s an amazing amount of input. You take vaccines alone, two hundred try to make the vaccine. Today we probably use five of them globally. The rest of all of that investment is sunk cost. It’s just gone. Now, some of the learnings and outcomes of those studies will be helpful in future vaccines. Some of the delivery research is going to be critically important. But we—a lot of that scientific research is just not going to be used.
So we have to pay attention to not just paying for what comes out at the end, but also making sure that we can attract the investment so that we can have those two hundred shots on goal. Because I will tell you, anyone who tried to predict which vaccines were going to be first across the finish line or which were going to work best was probably wrong in their predictions. You cannot predict ahead of time who the winners will be in a biotech race. You have to invest broadly and use every different scientific idea and approach to try to get to the finish line. So there’s a lot of—there’s a lot of angst around it. But that is really, really what’s at play.
HAASS: So let me circle back though, because you mentioned before the unintended consequences of the Defense Production Act. Are there other aspects, either of domestic public policy or international policy, either what exists or what doesn’t exist, that would really help here in terms of amping up production, availability, affordability, distribution? What are—either what needs to be removed or what needs to be added to the mix nationally and internationally that would really—that would really help?
MCMURRY-HEATH: Yeah. Well, there’s a lot of efforts that have gone into addressing those issues. But they’re not actually living up to expectations. So we’re partnering and working very closely with COVAX, which was meant to be a global bank of COVID vaccines that would be distributed to countries at a price scale scaled to their ability to pay. So middle-income countries would pay a reduced price. Low-income countries would get their vaccine doses for free. But it depended on Western countries and other countries developing COVID vaccine actually prioritizing donating those doses. And that just hasn’t come to fruition.
So while the international effort and the public-private partnership was built, it’s not had the opportunity to really work at scale the way we all hoped it would be. And that—those have been political decisions not scientific decisions. And not even corporate decisions. But there’s a lot more to do there. And that’s just in affordability. Now, when it comes to manufacturing and access, there’s a lot that we need to do. We need to have manufacturing capacity, for particularly the raw materials, distributed around the globe. And at the same time, we’re facing pressure from the U.S. government to repatriate manufacturing facilities for critical drugs. So we have to strike this balance and we have to make sure that we’re allowing our companies to spread their science around the globe.
HAASS: So in the expectation that one day there’ll be a COVID-23 or a COVID-28, or some other infectious disease that spreads, should one of the things we be doing is creating what you might call production hubs around the world, so if and when these diseases break out we don’t—we don’t essentially make—run into the same set of problems?
MCMURRY-HEATH: It would be wise. You know, we’ll never know or be able to predict where we’re going to need it. We have to make sure that we’re detecting much better than we are today, detecting new outbreaks. And that detection technology needs to be spread around the globe. But we also need to be ready, willing, and able to produce. Now, one of the most heartbreaking misunderstandings in the TRIPS waiver debate around waiving IP is that if we waive IP, countries around the world would simply be able to produce COVID vaccines overnight. And actually, as a former FDA regulator, I will tell you it will take them two to three years with all of the intellectual property and all of the trade secrets, to be able to produce a single dose. So even with a TRIPS waiver enacted, we would not produce a single vaccine dose that would change the course of the pandemic.
HAASS: So that suggests that the answer, at least for the next couple of years, is less licensing, if you will, than simply going out there and creating more of the raw materials, and then wherever you create them either—if you create them here, make them available for export, or you put together the vaccines elsewhere.
Let me ask a question more broadly about competitiveness. When you think about the vaccines—and you’ve got Russian vaccines, Chinese vaccines, English, you know, British, whatever, obviously the American companies. Are you seeing real trends in competitiveness? This time, you know, Moderna and Pfizer are at the center of things today. AstraZeneca and this Chinese Sinovac less so, in terms of availability and effectiveness. Are you, though, worried when you look at the trends about American competitiveness? Or are you feeling pretty comfortable?
MCMURRY-HEATH: I’m very concerned, particularly with what’s happening on Capitol Hill over the last few weeks. Because we’re actually debating dismantling our ecosystem that has been successful, the most successful biotech ecosystem in the world. There’s a reason why our vaccines were the best and some of the first. It’s because of the long, sustained investment—not just of the public sector, but of investors, of the capital markets—in the promise of biotechnology. So that is really important for us to recognize.
The other thing we have to be worried about—
HAASS: I’m sorry. Can I just interrupt for a second?
MCMURRY-HEATH: Mmm hmm.
HAASS: What is being contemplated that would threaten, if you will, what you described as this development ecosystem? What is being contemplated that could interfere with it?
MCMURRY-HEATH: Yes, of course. I should specify. I’m so steeped in it; I focus on it too closely. So the reconciliation package that’s being debated right now in Capitol Hill contains, you know, many laudable components, particularly in the climate change area. It has some components that we’ve been fighting for for a long time. But some of the drug pricing proposals that have been suggested would have other unintended consequences on the attractiveness of the biotech sector for private investment. You cannot produce a single drug without private sector investment.
I know there’s a lot of folks bandying around the ARPA-H—Biden’s initiative to build a governmental biotech organization, might be able to do so over the period of a decade. But we have not seen that kind of effort work before. It’s been tried at the National Institutes of Health under NCATS, or the National Center for Accelerating Translational Science. And that is now a decade old and has yet to produce a single drug. So we are dependent on a whole ecosystem, not just to produce the science but also to filter out the truly promising innovations and make sure that they really rise to the top. And that is only—to date—only efficiently being done by private capital markets.
My colleague in BIO Canada likes to say that we are like a coral reef. And you can’t just take out, you know, the plankton or some of the fish and get a healthy coral reef. You need the entire ecosystem. So you can’t just remove all of—all of the attractiveness from capital markets and, you know, strike a blow to big pharma, without wiping out the small biotechs that are employing people across the country and making sure that they’re producing great science that goes around the world.
And while China is not hampered at all by many of those same hindrances, they are so pro-innovation from a very top-down, deliberate strategy that is really being quite effective. They have grown in their ability to produce successful medicines and drugs over the last decade. And they will only continue to do so. Now, in China they have one whole province that is an innovation zone province. And that means that we can test early medical devices and medical products in that province to get the clinical data needed to get full regulatory approval. That’s a national strategy to accelerate research that we’d never be able to implement here in the U.S. And really, we don’t need to. But we also don’t need to unilaterally disarm either.
HAASS: So what you’re describing is almost the difference between China’s more top-down approach and we’ve historically had more of a bottom-up. And you’re concerned—you know, the industry is concerned that we’re introducing policies that would discourage that. I expect people will want to ask more about that. Two things in terms of competitiveness you didn’t mention, which are less immediate but longer term. One is immigration. One is the quality of public education. Are we producing or importing and retaining the talent we need, or do we have a problem there as well?
MCMURRY-HEATH: You know, the number of times I hear in a week that talent is the scarcest resource in producing new innovations is almost countless. That is definitely our scarcest resource, and I think that’s happened for several reasons.
One, because we’re not importing all the talent we need and drawing that talent to be in the U.S., and we’ve only become less attractive over the last five to ten years than we were even before.
But we also have to get better to attracting talent into biotechnology. You know, my hope now is with the power evident from the COVID vaccine effort that we will attract more young people into studying biotechnology. Now, they will have to have the educational system that fosters that interest and prepares them to really act upon it, and we don’t have that today, but it’s critically important because of all of the things that science can unlock.
You know, in bio we like to talk about just science or science that can produce justice, and I feel adamantly that science is our most powerful tool to reduce inequality and deliver justice around the globe. But it’s going to take investing in science, making sure that our scientific workforces are diverse and that they’re paying attention to diverse issues, and it’s going to take equitably distributing the benefits of that science or the end products to everyone who needs them. That is going to level the playing field more than almost any public policy could, but we need to not shy away from it.
HAASS: Thank you for that.
Let me—let me raise one last set of issues, which are negative issues. Which is, you know, my background is, obviously, foreign policy, and when issues like biotechnology come up it’s usually questions of people thinking about germ warfare, more recently it’s been bioterrorism. So the—I would think there’s—if someone were a young aspiring terrorist in any number of countries around the world, and he or she would be watching the news and looking at what has been the economic and social and political affects, dislocations, costs—use whatever you want—of COVID-19, they would say we’ve been wasting our time hijacking airplanes or even flying into buildings; we can reach—if you will, threaten the lives or livelihood of millions. So how worried should we be about the next era of terrorism really becomes bio, that one of the unintended consequences of COVID is it’s in some ways perhaps led some people down that path who might not have otherwise taken it? How real is that? Is that sci-fi or is that all too real?
MCMURRY-HEATH: Well, in terms of the possibility it is all too real, and that possibility does keep me up at night. We’ve seen that it’s possible. We’ve seen that, you know, investing in gain-of-function studies can lead to pathogens that can be quite deadly.
The one thing I think will temper it is that starting a biological fire is a fire you can’t control. COVID has shown no respect for borders or for different ethnicities. And so it’s—mutual assured destruction, which we used to discuss in the nuclear sense, is also what would be delivered from biological terrorism.
HAASS: That might—can I interrupt for a second? That might, to some extent, inhibit a government. It might not inhibit a territory-less terrorist organization. And the fact that it might be somewhat indiscriminate, that might actually make it even more tempting because they’re not worried about—mutual assured destruction is based upon the ability to retaliate, that you can attribute where a threat or an action is coming from. Could this, though, in a funny sort of way, lend itself to a very different type of threat?
MCMURRY-HEATH: Well, actually, I can understand the framing in the nuclear sense that mutual assured destruction is around retaliation, but actually biological warfare is self-retaliation. You don’t need a state actor to have retaliation in—after a bioterrorist attack. If you actually create a biological pathogen that can create the kind of damage that a terrorist would seek, it would be so dramatic that you can’t stop it from having the backlash on you itself.
So people who are not thinking through all of the steps might try it and we have to be prepared. We have to have better protection methods and modalities distributed around the globe. But I stand here warning any terrorist: If you unleash a biological pathogen, you will also fall prey to that same pathogen.
HAASS: You may well be right, but in my experience that is not necessarily a calculation or a consideration that deters certain people—
MCMURRY-HEATH: Fair enough.
HAASS: —who have made that career choice.
Let me—you mentioned gain-of-function research. I might ask you to spend thirty seconds explaining it because, obviously, it’s become a controversial subject thanks to Senator Rand Paul and Dr. Fauci and their multiple exchanges on the subject. But it raises another issue, which is not terrorism but the question of monitoring/supervising research. And accidental leaks—for all we know, COVID-19 came out of a lab in Wuhan. The Chinese are not helping us, to say the least, get to the bottom of it. But to what extent do we have a real problem with these—you mentioned there’s two hundred vaccines or whatever being developed around the world, whatever. I would think the chances of some of the research having consequences that were truly unintended is not negligible. How much of a problem do we have in the business you’re in, there’s—that you represent all these companies and all these countries that, as benign as the effort might be intended to be, we simply have too many people playing with—in a different generation I would say too much dynamite? And what can we do about it?
MCMURRY-HEATH: I think we do have to be a lot more intentional. You know, I’ve been in the public sector. I, of course, was in academia when I was going through my training and have been in the private sector. And I will say the private sector does the best job of keeping people focused on the outcome—that you’re trying to get a specific product, that you’re trying to cure a certain disease or create a certain crop. And that focuses the scientific efforts on things that are actually useful in getting to that goal.
We have a lot of science for science’s sake in both our public sector and our academic sectors, and I think it’s time for us to ask: Is that the best use of even our raw material efforts? So of course we need academic partnerships. Of course we need public-sector interest and investment in science. But maybe we need to start thinking about whether or not the balance has tipped too far and we need to be much more accountable for what comes out of the research.
You know, the reason I actually left academia for science policy was because I was always bothered by the fact that I would get calls in my graduate immunology lab from people who had read about a latest scientific advance in a newspapers, usually from an academic source, and they would call and say: Can you give me that technology? Because it can cure my child. But that technology was really just a discovery for discovery’s sake. And while that serves some purposes, we also have to think about being more accountable for how we spend our scientific time and more judicious with it.
Initiatives like the TRIPS waiver would be giving away some of the most competitively valued research—mRNA technology—to any entity that wanted it in a way that you could not control around borders or it falling into the wrong hands. We have to be responsible and intentional, but I think it’s possible for us to be good stewards of the science.
HAASS: I guess I’m slightly skeptical, only because with nuclear weapons usually there’s a scale of production. Even the Irans and North Koreas, we had warnings. We chose in some cases not to act on them. My concern about this is it may not necessarily be in a bathtub in a basement, but the scale could be such that—easier to hide. We learned that in some ways in Iraq—
HAASS: —at certain points. A lot of scientists might have certain capabilities that either well-intentioned or anything but well-intentioned individuals and groups, it seems to me, have a potential to cause real damage. And again, the lack of the ability of governments to police the world here; that even if tomorrow we all said this type of research on—you mentioned CRISPR before or gain-of-function research is—the downsides are too great, it’s too risky, my guess is it would be very hard to implement such a ban simply because this is a world of distributed capability. Which leads me to think that we’re going to be dealing with both naturally but also unnaturally occurring challenges from biotechnology for some time to come.
MCMURRY-HEATH: Well, I won’t disagree. I will not stand here and say we should not have some sleepless nights over the potential of misuse of biotechnology. That is, of course, possible, and we have to be on guard against it at all times.
But we also have to strike the balance that, you know, I mentioned that one-in-a-hundred chance of success for most biotechnology efforts. Those hundred efforts have to come from very diverse and geopolitically, politically, geographically, ethnically diverse scientists all trying to answer a question. That is what’s going to get us to cures for patients, for example, much faster.
HAASS: That is why the word “dilemma” was invented.
HAASS: So let’s make that our transition point. Let’s now open it up to our members to press you with some informed questions, unlike what you’ve been fielding for the last half-hour here.
OPERATOR: (Gives queuing instructions.)
We’ll take the first question from Jay Markowitz.
Q: Thank you, Michelle, for participating in this. And Richard, I find that when non-experts lead discussions like this they ask the most interesting questions, so thank you for leading it.
HAASS: (Laughs.) Thank you.
Q: I can only imagine what it must be like, Michelle, for you to be heading an organization with so many—so many different members that are all struggling with the same thing that has touched on a number of the issues that you’ve discussed this afternoon, and that has to do with pricing. And one of the big issues—I mean, this is like a classic tragedy of the commons where all of your members would agree that one of the reasons why the industry is considered at such a low level by so much of the population despite coming up with these amazing drugs and vaccines that, you know, have basically put an end to a devastating pandemic is that they have to—they feel they have to pay too much money for them. It also results in some of these talented people that you have identified, Michelle, as being reluctant, perhaps, to join an industry that is considered so greedy and in many cases evil. So I’m curious if you can discuss what it is that the biotechnology industry, the biopharma industry in general, and perhaps you as a leader of this organization can do to help control some of the egregious behavior and also help inform the public. Thank you.
MCMURRY-HEATH: Look, there are changes and adjustments that have to be made to the way the U.S. system deals with the pricing of drugs and biologicals, and I will say one of the most important ones to make is to reduce or eliminate the financial disincentive for patients to follow their doctor’s advice. So right now a patient goes in to a doctor, they get a prescription. That is what their clinician thinks is the best course of treatment and therapy for them. And yet, they face copays, they face deductibles, they face lack of insurance, and all of those are hurdles deliberately placed in their path to cut down on the number of times a patient follows their doctor’s advice.
So we need to get frank about that and we need to do everything we can to eliminate those hurdles because it’s not just a question for that individual patient. As we’ve seen with COVID, our health is all interrelated. We need to be a healthier society. And we can’t just look at the two- to three-year insurance window—that’s the average length of time an American stays with one insurer—and try to save money just in that window. We need to think about the long-term impact.
At the same time, we need to have a frank conversation about what investment is needed to produce the types of scientific breakthroughs that Americans in particular demand, and we can’t shortchange that effort. I would hazard a guess that if this time last year someone had said, well, the U.S. government has to invest two more billion dollars in getting a COVID vaccine across the finish line, there was no price tag that our country would have said was too high. That was not the case. Obviously, it was not necessary. But we have to realize that there are patients all over the world in every disease class and type who are just as desperate for their solution and their cure, and we forget that when we’re having our policy dialogues.
So we have to make sure we keep the innovations going, and that means having a better pricing system to incentivize new innovations. We want to make sure that those new innovations are always stimulated. And we have to make sure that investors are always investing in them. And we have to make sure that large pharmaceutical companies who bring a specific expertise to that—and that is the ability to manufacture at scale, deliver around the world, and navigate the vast regulatory complexities that are needed around the world to even access patients—that is the type of capability that we don’t want to necessarily replicate in every small biotech, but we have to understand it for what it is, make sure that we’re considering all the development costs in place, and then set fair prices and make sure that we have a price structure that stimulates more innovation and comes along over time.
Now, on the backend of that, we also have to make sure that as these drugs mature that they’re moving into generic form so that after a time that technology, once it’s paid for, is more accessible to a greater number. That is the only way currently within our current paradigm that we can do both, stimulate the investment and get more solutions to more patients.
I would like to know if that actually answered your question because I’m sure there’s a lot there and I’m sure there’s many others who have a lot of questions in this sphere as well.
HAASS: Well, we’ll give them a chance.
HAASS: Thank you, Jay.
OPERATOR: We’ll take our next question from Joel Cohen. (Pause.) Mr. Cohen, please accept the “unmute now” button. (Pause.)
All right. We’ll go to our next questioner, from Brett Lambert.
Q: Hi. Thank you for that. It’s a great conversation.
And having been following this when I was in the department, the issue of biotechnology for quite some time, I’m interested in your thoughts about global standards. Where America does best is when we lead, and we saw that with 5G. Could you give us some of your thoughts about how we set global behavior and how we can better inform the global community about standards as a basis for these developments, which are both exciting and frightening?
MCMURRY-HEATH: Well, you know, one of the areas that I’m passionate about as a former regulator is making sure that our regulatory systems are robust and globally coordinated. That’s going to be critically important. We shortchange regulation at every turn.
The U.S. Food and Drug Administration regulates thirty cents on every dollar of the U.S. economy, and yet it is short-staffed, it is plagued by poor morale, and it has been leaderless for nine months now. That is very, very disturbing to me because that means just at the time when we should be setting standards for what we do about boosters and what we do about variants and what we do about not neglecting the other areas of health and disease that are so important to pay attention to, we are not speaking with the loudest voice we can.
So it starts, from a standards point of view, with regulators that are equipped and staffed to do the job. And one of the things the vaccine effort showed us is that even our previous level of staffing for FDA, for example, is not what’s needed. What’s needed was the intense support and coordination that we saw between regulators and innovators during the vaccine effort. And so our target should not be just getting FDA back to what it was three or five years ago; it should really be to grow it into a robust agency that can really have the scientific muscle to partner with innovators in every sphere and coordinate with their counterparts around the globe.
HAASS: Just to follow up on that, do we need new mechanisms or we just need to better use existing mechanisms?
MCMURRY-HEATH: Well, it varies depending on the medical area. So in biotechnology, I think there are a lot of great mechanisms. There’s a lot of global harmonization. There’s a lot of coordination. We don’t exactly have the same regulations in every country, but we are pretty far down the line. And that’s incredibly important because that means that there’s very little delay between an innovation becoming available in one country versus another.
In the med tech sector, we are not that close. So when my team, for example, used to disseminate a technology across 150 countries, we would count on a seven-year lag for complex medical technology to get from the first country approved for the last. Can you imagine waiting seven years for an innovation that is already available elsewhere? So there’s more to do.
HAASS: Another question, please.
OPERATOR: We’ll take our next question from Cathy Taylor.
Corporations in the U.S. particularly have traditionally defined ethics in terms of business and professional ethics. And while we’re seeing the conversation start to focus also on ethical tech, we haven’t really seen widespread thought leadership around ethics—corporate ethics from a societal and community impact. Do we need to be thinking differently in the corporate setting about ethics? And do we need a new framework for that?
MCMURRY-HEATH: You know, we do, and I think it’s more about the conversation we have around mission and living into mission.
You know, most people who go into biotechnology go into it not only because they’re passionate about doing science and assisting science, but because they’re passionate about serving patients, ending hunger, attacking climate change. And if we can just remind everyone at every juncture about what—the importance of their work in achieving that mission, that will drive commitment not just to the science, but to the ethical production of that science and the just distribution of that science on the other end. And all three of those are key.
And I see a lot of it every day in our member companies. I just met with one of our member companies this morning and it was hundred biotech professionals on the line, and their commitment and excitement around the ability of biotechnology to create a more sustainable world was palpable. So we just have to harness those good intentions that are already there and then make sure we live up to them.
HAASS: Another question, please.
OPERATOR: (Gives queuing instructions.)
At this time, we don’t have any hands raised.
HAASS: OK. Then I’ll raise my hand. (Laughter.) The presider’s privilege.
One area we haven’t talked about specifically is trade. We’ve got the WTO and so forth. Is the global trading system what it needs to be? I expect the answer is not. So what could usefully be done in order to use the trading system to facilitate, among other things, the spread of treatments and the like that would be useful?
MCMURRY-HEATH: Yeah. Well, we need more governmental advocacy for science and less political nationalism. You know, nationalism just stands in our way of being able to have global supply chains that deliver innovation everywhere it’s needed. But at the same time, our governments have to stand up for the importance of the technology not just for economic/trade reasons, but also for its ability to deliver so many amazing innovations.
Right now we’re facing an issue with Mexico where they’re throwing up barriers to importing any types of agricultural technologies that are based upon DNA. And the little-known fact is we have such porous borders when it comes to agriculture and it’s so difficult to segregate crops that one country standing in the way of a biotechnology means that that biotechnology does not get developed for anywhere in the world.
So we have to realize that when it comes to biotech, we’re all in this together. And we have to fight trade barriers with that in mind.
HAASS: Speaking about barriers, one of the barriers—and I alluded to it before—is China’s refusal to allow an independent investigation of what happened in Wuhan. Is there anything from your perspective that could be done that could induce the Chinese to act responsibly here? Or, basically, is this just an area where governments trump all else and all others?
MCMURRY-HEATH: Well, there have been so many roadblocks put in the way of that investigation that while I know we are all desperate for the answer of the origin, I’m personally doubtful we’ll get there. That being said, we need to keep demanding it and we need to keep making it clear that not sharing the origin means we can’t prevent the origin of any similar types of pathogens breaking out elsewhere in the world. We need that line of sight. And it’s not something that can be done, I think, within just one country. If the origin had been within the U.S., it would take international experts to dispassionately consider the evidence and come up with a scenario for the production. So I hope that eventually our Chinese colleagues will be persuaded with that—by that because I think it’s critically important, but I’m not sure we’ll get there.
HAASS: I’m not sure either. So what about the idea of—you’ve got the WHO. Could we get where we need to get perhaps better by taking it outside the U.N. system and having some sort of an international NGO that we would have scientists and others—I mean, there’s people who monitor human rights. There’s people who monitor other developments within countries. Is there a place here for something that’s, if you will, international civil society that could perhaps do things that governments are unable or unwilling to do?
MCMURRY-HEATH: I love that idea, and it’s probably the only answer that is pragmatic and workable. It’s so important for scientists to be able to be not because they’re pursuing a national agenda, but because they’re sharing science and approaches to scientific questions. And that is the only type of gathering that can get to the bottom of the question, first of all, and can actually break down some of the broader self-protection. So I think it’s very important for us to pursue something like that.
HAASS: And the last question, because you’ve raised it: How does one, then, square that circle? Because you’ve got industrial competitiveness and national competitiveness, you’ve got elements of national security here, yet you just talked about the sharing of information. So you’ve got elements of community and we’ve, obviously, got elements of anything but. Is that just one of those realities and we constantly work it and massage it, or can you actually imagine any sort of a decisive breakthrough?
MCMURRY-HEATH: Well, that’s the beauty of intellectual property protections because it says once you collaborate on an idea you own that idea. And for many of our companies that don’t have any products yet on the market, the only thing they have of value if their intellectual property.
But that being so, that does not stop them from collaborating actively around the globe and sharing the ownership of that intellectual property with their collaborators. The amount of collaboration we saw during COVID was huge, and we’re—even in the midst of a world in which we could not travel. So scientists are breaking down those barriers. What we know now about Wuhan has actually come from scientists in China sharing their knowledge around the globe. So there is already that international network and we just have to invoke it.
HAASS: Dr. Michelle McMurry-Heath, I want to thank you for all you’ve done in the course of your career, I want to thank you in advance for all you are going to do, and I want to thank you for giving us an hour of your time and the benefit of all your—all your experience and knowledge. So thank you on behalf of everyone associated with the Council on Foreign Relations. Thank you very much.
MCMURRY-HEATH: Thank you. And I’ll just add as a new CFR member I would love to meet other members as well, so I look forward to meeting many of you at upcoming events.
HAASS: Great. We look forward to it as well.
Thank you. And thank you all for joining us for the past hour.