How Biotechnology Is Helping to Stop COVID-19 and Solve the World’s Problems with James Greenwood, senior policy advisor at DLA Piper
In this episode of On Record PR, Sarah Larson goes on record with James Greenwood, senior policy advisor at DLA Piper, retired CEO of the Biotechnology Innovation Organization, and former congressman representing Bucks County, Pennsylvania.
Jim Greenwood started his career as a social worker focusing on abused and neglected children in 1980. At the age of 29, he was elected to the Pennsylvania House of Representatives and six years later to the state Senate. In 1992, he was elected to Congress and would go on to represent Pennsylvania’s eighth congressional district for six terms from 1993 to 2005. During his time in Congress, he was a senior member of the energy and commerce committee and widely viewed as a leader on healthcare and the environment. Jim crafted legislation to reform the Food and Drug Administration to create the pediatric exclusivity and pediatric autism research acts. And he led the fight in Congress to allow stem cell research to be conducted by U.S. scientists to treat disease. From 2001 to 2004, Jim served as chair of the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations. In this role, he led investigations into corporate governance at Enron, Global Crossing, and WorldCom, to reform the NIH, and into waste and fraud in federal government agencies. In 2005, Jim voluntarily left Congress to serve as the president and CEO of the Biotechnology Innovation Organization, the trade association representing 1,000 biopharmaceutical companies, academic institutions, and state biotech centers across the U.S. and in more than 30 countries. After 15 years at the helm of BIO, he recently joined DLA Piper where he now chairs the Life Sciences, Health, Policy and Regulatory Group. Jim’s hobby is photographing birds. Welcome, Jim. It is wonderful to have you with us today.
What is BIO, the Biotechnology Innovation Organization, and what does it do?
Maybe I should start with a thumbnail definition of what biotechnology is. The way I describe it is it’s understanding how life works, in humans but also in animals and in plants, and how life works at the cellular level, at the genetic level, and at the molecular level. It’s taking that profound and growing knowledge of human life functions to make medicines that will save lives, treat diseases, make farmers more productive with agricultural biotechnology and that allow us to produce fuels and materials that are more environmentally sustainable. We’re at a golden age of biotechnology where we’re using things like science techniques, like gene therapy, where you can actually take someone who’s born with a congenital defect and cure that defect by using cell immunotherapy. We do all of the things you’re seeing happening right now with treatments and vaccines for COVID-19.
So that’s what biotechnology is all about. And the Biotechnology Innovation Organization is a trade association of about a thousand biotechnology companies. Those include the biggest pharma companies like Merck, Johnson & Johnson, and Pfizer, but overwhelmingly mid-size to startup biotech companies on the cutting edge of innovation. So what BIO does is advocate for policies conducive to the success of the science and work against policies that could be disruptive to the science. As I said, the science is galloping ahead, and there’s no scientific law, no law of nature, that says we can’t eventually treat and cure every disease, but there are laws of man that can get in the way of us doing that. So that’s what I’ve been doing for the last 16 years, and I’m continuing to do with DLA Piper.
I remember you took a little bit of flack when you left Congress to, in the words of some of your critics, become a lobbyist, but I know that your interest in biotech started many years before that in Congress.
What drew you to BIO? What were you hoping to accomplish in leaving your role as a policymaker to become a policy influencer?
That’s a great question. Going back to my college years, at Dickinson College in Pennsylvania, from 1969 to 1973, it was a very tumultuous time. The Vietnam War was in full bore. Earth Day was founded in that time. There was a lot going on with racial relations, women’s rights, and so forth. That led me to say that I wanted to dedicate my life to service of some kind. I was concerned about the future of our world. I could have joined my father’s very lucrative real estate development company but instead became a house parent at the Woods Services school. I also worked from nine in the morning until two in the afternoon for a state representative named Jack Renninger from Newtown. I worked in his home where his district office was. And then Jack Renninger ran for Congress in 1976 and I was his 25-year-old campaign manager. We lost by a tiny margin. I then became a caseworker with abused and neglected children. I was unhappy with the way the state was treating kids that were troubled, so I ran for the (Pennsylvania) Legislature, got elected, and formed the Children’s Caucus. And so, I was in the state legislature for 12 years, ran for Congress, did that for 12 years, and in Congress, I did a lot of work on things like the use of reproductive cells for therapies, and a lot of work with the FDA.
Then I got a call from a headhunter saying, ” There’s this organization called BIO. They’d love to interview you for the position of president.” And I had to think long and hard about whether I considered that service because it was my first time in the private sector. When I looked around, I thought, “Well, you know, maybe I don’t want to be in Congress for the rest of my life. Maybe I’d like to do something different.” A trade association made sense because I didn’t want just to be one of these “eat what you kill” lobbyists, where you’re “a hired gun,” and you work for whoever pays you. But I looked at biotechnology, and I thought that this is the most profound thing humans can do — reach into your body, pull out your DNA, put it under a microscope, and from what you learn, you can prevent a couple from burying its child. And not only can you cure diseases with this science, but as I said, enhance our agriculture productivity and improve the environment. So it seemed like a good thing to do, and so I did. And yes, I was accused of going to the dark side and the revolving door of paid lobbyists. I often said, there wasn’t enough money in the world that would cause me to leave Congress to run the cement lobby or something that I didn’t believe in, but I did believe in this cause. And I still do.
If my research is correct, you were the second CEO of BIO. And you grew it. You almost tripled it in size up to about 176 employees or so.
Yes, there were something like 70 employees when I arrived, and I boosted it up to about 180 and made it a world-class organization. Besides the work that we do in advocacy for policy, we also put together conferences and conventions all over the world where scientists can meet with investors and learn all kinds of things about the science and the policy. We had those meetings in California every year, in New York, a couple of times in Europe, Brazil, China, and Japan. It’s quite a thriving organization.
You’ve left BIO but you’re still going to be involved in the life sciences through your role with DLA Piper. As you mentioned earlier, we have seen perhaps the largest mobilization of scientists and scientific minds around the world over the last year to try to come up with treatments and vaccines for the coronavirus pandemic.
Tell us a little bit about what you saw happening over the last year, both things that encouraged you and perhaps things that may have given you a little bit of pause.
When the pandemic hit and I was still at BIO in the spring, we immediately swung into action. I sent a memo out to every one of the thousand biotech companies and asked, “Can you help develop either diagnostics or treatments or vaccines for COVID? We have to get beyond business as usual. We have to make deals quickly. We have to be thinking less about profit and more about saving the world.” This is a global pandemic, and we’ve all seen the horrible results in disease and death and ruinous economic outcomes. We put that together very quickly. We’ve seen it’s quite stunning in terms of the scientists’ and the companies’ ability to figure out a way to make hundreds of treatments and maybe a hundred vaccine candidates, of which two treatments have been approved and now three with J&J’s Novavax coming on board quickly. That’s been quite astonishing. On the other side of the coin, while the science is doing better than ever, the political headwinds are more severe than they’ve ever been before, and we can go into that. It’s for a lot of reasons. Too many people can’t afford their medicines. On the one hand we’re showing what the industry can do. On the other hand, a lot of proposed legislation at the state and federal level, which is well-intended to help people afford their drugs, could be ruinous to our ability to keep innovating.
The price of medications is a huge issue for a lot of people, but at the same time, we need to incentivize our scientists. With your background and experience, how do you say we balance those two competing societal needs to continue to support the industry so it continues to make these lifesaving medications and then make sure that people can afford them?
I’ve come up with two moral principles that should guide us as a society on these issues. The first is no patient should ever have to do without the medicine they need because they cannot afford what’s required to come from their pocket. And from the patient’s point of view, it’s all about out of pocket costs, not so much the drug’s price. What do they pay? People are paying more and more because they have these high deductible insurance plans, including in the Medicare program. So that’s a problem we have to solve, and we can solve. The second moral principle is no policy should be acceptable if it drives investment away from this science. If you’re going to impose rigid price controls, what happens is the venture capitalists and other investors in these companies say, “Oh, well, if you’re going to impose price controls, I have no guarantee I would get my money back. I’ll put my money into some new app or some other sector of the economy.” So we can put caps on out-of-pocket costs for patients. And we should. There’s good reason to do that. And we should make sure that we don’t dis-incentivize investment.
Talk a little bit for our listeners, including myself, who don’t necessarily know how a drug goes from the laboratory to the shelf and what exactly that costs the companies.
What do you wish people understood better about the process of discovering and then creating a lifesaving medication?
That’s a great question, because society is filled with disinformation and misinformation and lack of information. We start with, “Why is it that the United States leads the world in biotechnology innovation?” We innovate, every year, more new medicines than the rest of the world combined, about 57%. So that’s astonishing. We’ve done a number of things to make that work. First off, we invest something like $35 to $40 billion a year at the National Institutes of Health (NIH), most of which goes to universities for basic research. It’s not so much that the universities are trying to figure out how to make medicines. They’re trying to figure out, How does this gene work? How does that cell work? What goes on inside the cell to make all of these amazing, intricate facets of life all coordinate and work together to produce functional humans and animals and plants? That knowledge then often leads to patents. Universities will patent certain discoveries, and then frequently lease or license those patents or sell those patents to biotechnology companies who then use that basic knowledge to do all the difficult work of actually trying to develop a medicine. And that’s a high-risk proposition; 90% of the projects that biopharmaceutical companies undertake, whether it’s a small biotech company or a big pharmaceutical company, fail.
Look at Alzheimer’s disease, for instance, which costs us almost $300 billion a year now, headed to a trillion dollars a year as baby boomers encounter this terrible disease. The failure rate has been about 100%. After the expenditures of billions and billions of dollars, we still haven’t found a cure. So, it’s very, very risky. But once in a great while, after spending what could be $2 billion to develop a new medicine, one of these drugs gets approved by the FDA and becomes available to treat a disease. In the rare case where that happens, the company needs to be able to set the price on what the market would bear, what the insurance companies are willing to pay, not what is set by some bureaucrat in government, because otherwise, nobody will invest in the first place. The small companies rely on venture capital firms, and those firms take money from either wealthy individuals or institutions and put it in these high-risk ventures, knowing that they’re going to lose their shirts nine times out of 10, but find success on the 10th one. Price controls will kill that because it takes 10 to 12 years even to bring a drug to market. Nobody can risk that much money for that period of time unless they know they can set the price.
I think I saw a comment in one piece that I read somewhere that “the second pill costs $10, the first pill cost $3 billion.”
Right. For the most part, it’s not the manufacturing costs [that drive drug prices], and that’s what gets people confused. They’ll say, well, you know, why are you charging $1,000 for this bottle of pills? It can’t cost you more than $15 to make it. Well, that’s true, but as you said, it’s the billions of dollars that were invested. Think about why patients have to pay anything for drugs in out-of-pocket costs. The high- deductible plans have resulted in the fact that employers hear from their health insurer who says premiums are going to go up, and very frequently, the employer, whether it’s General Motors or a mom and pop, says “We just can’t afford to pay that much more for healthcare. What can we do?” And the insurance company usually responds, “Well, you can raise the deductible and the employees will have to pay more out of their pocket.”
In some ways, that works to hold a lid on healthcare expenditures, because there’s an old saying, “We’ll all spend as much money for healthcare as someone else is willing to pay.” So if I twist my ankle and need an x-ray, do I call an ambulance to take me to an emergency room, which might cost $3,000? If I’ve got a big deductible out of pocket, maybe I’ll call my neighbor and ask him or her to take me to the local urgent care center, which might cost me a couple of hundred bucks. That makes sense. But when you think about applying that to prescription medicines, let’s say you’re sick, and it could be anything from a minor disease or sickness to cancer, and you get your prescription, you need that prescription. That’s what your doctor says you need. So you’re not making a decision between an ambulance versus driving yourself, or between an emergency room versus an urgent care center. You need that medicine. So when you go to the drug store and you put your prescription on the desk and come back and they want $800 that you don’t have, what happens? About 30% of the time, people just leave their drugs on the counter. They don’t adhere to their medicine. They get sicker, they wind up in the hospital, and that’s more expensive. So, I don’t think it makes sense to have any kind of out-of-pocket costs for medicine, except for the case where you have a choice between a generic and a brand drug. Then if they’re considered to be equally effective, it’s okay to make the patient pay an extra $25 or $30 bucks out of pocket. Otherwise, we’re far better off not having the out-of-pocket costs, so the patients all get their medicine and get better soon, which costs the healthcare system less money.
Is there any appetite for that change in the insurance industry?
When I came up with this idea a few years ago, we started with Medicare because there are about 45 million people on the Medicare Part D prescription drug program, which I helped create when I was in Congress. And of those 45 million, about 1 million of them are paying more than $3,000 a year out of pocket. And some of them are paying $6,000, $9,000, $12,000 a year out of pocket, and I think that’s immoral. I believe that people work all their lives, pay into Medicare, they get the benefit, need the medicine, and then they get charged an arm and a leg for it, and it’s wrong.
When I was at BIO, we were able to get in legislation a cap on out-of-pocket costs. The House passed a bill with a $2,000 a year out of pocket cap. The Senate committee passed a bill with a $3,000 a year out of pocket cap. It never became law, but that’s a starting place for this new Congress and this new president to put a cap. There’s bipartisan support for it. I would like to make that cap even much smaller. I would, if I had my way, apply it to the commercial insurance sector, as well, and say to them, “You can have your high deductible plans, but you can’t apply them to prescription drugs because patients need that medicine and they don’t have many choices.” And I think, frankly if all of the insurance companies were required by law to do that, they’d all be on the same footing. Would premiums go up a little bit? Maybe a little bit, not much, but after all, that’s what insurance is for. Insurance is for when you get sick, and you need your medicine.
I want to pivot back to something you just mentioned earlier about this idea of misinformation and lack of information, and, it just seems, lack of education. Have you been disheartened or worried – I’m not sure I could find a word strong enough – at what appears to be this rising tide of anti-science attitude across the country? It’s not just policymakers, it’s the general public too. I understand this is a big question, but are we not doing a good enough job of educating our folks about basic science? Or is this all theatrics to win political points? What is happening here? I’m talking over the last 20 to 30 years.
Well, it is a big question. And are we teaching science well enough? No. We need more STEM (Science, Technology, Engineering and Mathematics) education. Having said that, you can’t expect our K through 12 school systems to be making scientists out of everyone. But what’s more important perhaps is to teach critical thinking, to educate students how to determine if something is true, or whether it’s false. What is logic? How do you discern one from the other?
When the internet came about, I thought to myself, “Oh, we’re headed to Nirvana now. The entire globe, every one of us, will be able to go online, find the truth, find the answers, and inform ourselves on everything. We’re on our way to the perfect society. What I didn’t anticipate, what few people expected, was that it would make available as much, if not more, lies and disinformation and misinformation than ever before. Now you have people who are willing to believe anything that’s on the internet. For instance, the anti-vaxxers. That came from many sources, but one was this very misguided doctor who did a study in which he claimed that there was a correlation between childhood vaccinations and autism. It just so happens that those two things kind of happened at the same time. When kids are getting their first shots is when you often begin to see the first signs of autism. That study has been thoroughly disproved.
That study was in The Lancet, and The Lancet retracted it. It was by Dr. Andrew Wakefield.
That’s exactly right. Very good. And yet, the stench of it lingers. We see this now with QAnon. You can look up anything on the internet and retrieve dead-wrong conspiracy theory information. So again, that’s why people have to learn how to use the internet. For instance, there was an urban myth proclaiming that members of Congress, when they retire, get paid their full salary for life, or some crazy stuff. There’s not a jot of truth to it, and yet I can’t tell you how many times when I was in Congress, I’d get these angry emails, “When you retire, you’re going to get all of this.” And I would say, no, no, no, here’s the truth. People don’t bother to take the time to figure out how to get to the truth.
Sometimes it feels like the truth is shouting into the abyss.
There’s an old line– a lie can get around the world before the truth can tie his shoes.
Yeah, definitely. So what other things are going to be getting around the world as far as biotech? I’ve seen references to CRISPR technology and gene editing, and the development of the COVID vaccines has been amazing. I don’t think any of us a year ago would have thought that that was even possible to do as quickly as they did. What are some of the trends you’re seeing across the industry we should be watching for?
It’s quite astonishing. Philadelphia is becoming a leader in cell therapy and gene therapy. Some people refer to Philadelphia now as the Cell-icon Valley, if you will. But let’s talk about gene therapy. Here’s an example. I met these two young boys, they might’ve been about 9 and 11, and they were both born with a congenital defect. A gene that operates the apparatus behind the eye that allows for vision to work didn’t work the way it should. These kids could barely see. Scientists discovered exactly which gene was impaired, and they were able to take the genetic sequence. When you hear about sequencing and genes, what does that mean? Our DNA is made up of four elements, and they begin with the letters A, T, G, and C. If you were to string out your DNA into a long line and count these peptides, you would see AGGTCC and various patterns. When there’s a “misspelling” in that sequence, the gene doesn’t work the way it’s supposed to. So they were able to take the correct genetic sequence and inject it into a non-harmful virus and use that to transport the correct gene into the correct cells behind the eye. And the next thing, these guys are out playing baseball. It is incredibly promising. Instead of having patients like the boys who might’ve had to have personal assistants their whole lives, learn to read braille, probably limited in their vocational capabilities; they’re going to be perfectly fine, apparently.
If you look at diabetes and track the genetic cause of that disease, we will be able to eventually replace those genes to cure that disease. Think about the cost of diabetes, which is just astronomical; we’re going to be able to make that go away for people.
So it’s really quite remarkable, what the promise is. Again, the policymakers have to work with the industry to say, look, we all want the same thing. We all want the science to be able to create miraculous treatments and prevention and cures, and we all want it to be affordable to patients. We can do this. And we can do it as long as the politicians don’t say, “What we want to do is look like heroes because we’re beating up drug companies.”
Good point. I’ve got a couple of other questions that I want to make sure that we get to before our time is up. If people are interested in biotech news, are there any resources you recommend that people follow to stay up to date?
Sure. Visit the Biotechnology Innovation Organization at www.bio.org. That’s a perfect place to find all kinds of information about what biotechnology is and what’s going on with the science and what the policy issues are that can help advance the science or can prevent the science.
Second question. I know that you are an avid bird photographer. What are a few of your favorite locations to watch birds?
Well, I’ve made quite a hobby of it. I go to Central and South America a lot. I’ve been to Brazil photographing birds, Colombia, Ecuador, Peru. I photographed birds in Vancouver. For the most part, I go with a group of maybe eight of us photographers and one or two guides who are the world’s best birders and bird photographers. So they take us to these great places. They set up these two-week trips, and they constantly help us improve our photography. This summer, I’m going to be photographing birds in Zimbabwe. I’m taking my entire family, my wife, my kids and my grandchild, 10-year-old Julian. So that’s going to be a family safari. We’re going to have a lot of fun. And then by myself, I’m going to Antarctica this fall to spend two weeks photographing penguins and all kinds of wonderful species.
So out of those amazing experiences, do you have one favorite bird or a couple of favorite birds that you’ve been able to capture?
I get that question all the time, and I really can’t say that I do. I’ve had a lot of fun photographing hummingbirds because they’re extraordinarily challenging. Bird photography is extremely challenging because first off birds don’t want you near them. They fly away. And then they have to sort of stand still long enough to get a good photograph. You need to get all your lighting right, and your exposure right, and your lens right, and so forth. But hummingbirds pose a particularly difficult challenge, as you can imagine, because their wings can beat about 70 times per second. So we do this whole setup where we’ll take a flower that hummingbirds like and surround it with tripods with these flashlights and strobes on them. Then we hook that up to our cameras so that when the hummingbirds approach the flower, we push the shutter and that flashes the strobes and you’ll freeze the hummingbird’s wings and you get these spectacular pictures of the hummingbirds at the flowers.
Do you publish these photos somewhere?
When I come back from one of these trips, I might come back with 10,000 images. I’ll narrow that down to maybe the best shots of each bird and maybe have 50 images, and I’ll put them in a slide show. Then I send them out to a few dozen friends who appreciate birds and then wait for the accolades to come back in.
Wait for the praise to flow.
People say, why don’t you publish your pictures? And it’s because I hang out with really fantastic birders, and as good as I get, they’re still better than I am. So I’m not quite ready for that. But I have a thumb drive with my best shots on it, and I put it into my TV at the office and just let it run all day long. So when I’m on a long, boring phone call, I can put my feet up and watch my bird pictures.
We ask many of our guests to recommend what I call earthquake books, books that shake the foundations and help you change your life and the way you see things, whether it’s business or personal. Do you have any book recommendations to share with our listeners?
I’m reading a book about the fish owl in Russia. It’s called Owls of the Ice or something like that. (Owls of the Eastern Ice: A Quest to Find and Save the World’s Largest Owl). Nobody will read that, though. There’s a book called Zen Mind, Beginner’s Mind about Zen meditation that I recommend to people who want to learn how to meditate. And I’m just starting to read Grant, which is a huge book about President Grant. I’m pretty eclectic. I try to read some science, some history. I read almost no fiction because I just feel there’s too much real stuff from which I want to learn about how the world works.
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