Exclusive Interview: Biopharma And A Biden Administration

A Biden administration, if elected, would protect biopharmaceutical innovation, tackle the rising costs of cancer drugs and “promote science, without politics.”

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The top two health care priorities for US presidential candidate and former Vice President Joe Biden, should he win the election, would be to implement a national COVID-19 plan, and to protect insurance coverage for Americans, said Greg Simon, a former Biden political aid. A “reinvigoration” of the Cancer Moonshot program, and dealing with drug pricing, could be next on Biden’s list. Simon spoke with In Vivo about his personal experiences; he is not officially part of Biden’s 2020 presidential campaign.

Greg Simon, Former Executive Director Of The Obama Administration’s Cancer Moonshot Initiative Greg Simon

In Vivo: You worked closely with Joe Biden on the Cancer Moonshot and the Biden Cancer Initiative. What are Biden's greatest strengths and greatest weaknesses when it comes to US health care, and working with the biopharma industry?

Greg Simon: His greatest strength in general is his enormous sense of empathy. When you lose someone to cancer you have a choice, you can retreat or you can go forward to help other people, and that's what he chose to do. No one would have blamed him if he had chosen not to that. Losing a son at [a young] age and deciding that he would turn that into an effort to help everybody facing cancer requires a lot of empathy and personal courage, because you have to relive that experience every time you talk about cancer. There is a speech that Joe Biden gave at the World Affairs Council in Philadelphia [in 2016], and he insisted that he wanted to explain CAR-T therapy to a group of public policy experts. So he read up, met with people, talked to people, we briefed him, and he gave a speech in which he explained the history of immunotherapy, how CAR-T [therapies] were developed, what they do, and what it means for patients. How many politicians do you know who would do that? It was an amazing thing. That is the energy he brought to the Moonshot, and to the Biden Cancer Initiative. He knew what he did not know. He did not know all of the innerworkings of the National Institutes of Health (NIH) and the National Cancer Institute (NCI), he did not know the science of immunotherapy when all this started. He knew what every family facing cancer knew: he couldn't move his son's medical records from one institution to another, he couldn't get images sent from one institution to another, he had no idea where to turn when they decided that Beau [Biden]'s cancer was glioblastoma, and he had to start asking every doctor he knew – including his son-in-law, who was a plastic surgeon for recovering cancer patients. That's what he knew, which is what every family facing cancer knows, that you have no idea how to navigate it, you have no idea what the science is that could save your relative. And he knew that he didn't know how the system was working, and that's what we spent a lot of time on at the beginning.

What do we do in cancer research, how does it work, what are the facts, what are the cultural barriers? And you can go back and look at the first speech he gave to the American Association for Cancer Research (AACR) meeting in New Orleans. He gave a talk where he put his head in the lion's mouth and said, part of the problem is the way you do what you do. It's not because you invented it, it's because it's the system that you inherited, the system that funds you, the system that publishes you, the system that gives you tenure, and we're focused on all of those things instead of curing cancer. And the young scientists in the room stood up and gave him a standing ovation. As he likes to tell it, all the leaders in the front row sat there rather silent because they knew it was true, but they didn't want to hear it. A year later, he gave another speech to the same group in Washington. And when he was introduced, the leadership said, Joe Biden gave us a lot of hard truths last time, and we are working to change that reality. And it was a completely different response from the entire organization, when he was asking them to share data, fund young people, fund more diverse people, take your chances, listen to patients. It was unlike the year before, when you could see the split between the lab rats and the lab bosses. That's who Joe Biden is. I would say his greatest weakness is impatience, and that's the right one to have. I always joked that, when we were in meetings with the medical record companies, or the pharma companies, that my goal was that everybody leave the meeting at the same time. Because if he thought he was getting BS-ed by any of those groups, he would just get up and leave, rather than lose his temper. Certainly, that was true with the medical records companies. When the CEO of Epic asked him, “Why do you even want your medical records, they are 1,000 pages long and you won't understand them past the first two pages?” I thought the room was going to freeze, I mean literally everybody froze, I thought we'd never get out of there. And he said the only answer that's right: ‘It's none of your business why I want my medical records. They are mine, give them to me.’ That was the right answer. Thank goodness he gave that answer, rather than leaving the room, which I was tempted to do.  

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Based on your experience, what do you think a Biden administration’s top priorities would be, with respect to health care policy? What does he think needs to change most urgently?

I am not officially on the campaign, so let me make that really clear. I'm not privy to his day to day conversations about anything, much less health care and COVID. But there are some pretty obvious priorities based on what he has said, and what I know he's done. Number one, you can't talk about anything in health without talking about COVID. The first priority is to implement the plan. Everybody knows what the plan needs to be, except the Trump administration. The plan has to be massive testing, massive contact tracing, wearing of masks, social distancing, and preventing an epidemic of enormous proportions from reemerging or continuing to emerge as we enter the winter and the flu season. We are starting to have cases that are at the highest we've had in many states since the beginning of the pandemic. There is no corner, there is no rounding the corner, we are on a downward slope, and if we do not take the steps that everyone should know we need to take, nothing else will matter.

The pandemic is causing people to die from cancer, who aren't getting treated, or checked or diagnosed. It is causing people to die from heart attacks, it is causing all kinds of ancillary deaths, we have got to put the clamp on the epidemic, that's number one. Number two, we have to protect insurance. If the court strikes down Obamacare, we have to pass it again. If the court doesn't strike it down, we need to undo all of the booby traps the Trump administration has put in the way of people getting insurance. Allowing people to sell bad insurance policies that do not cover you when you need them, that do not cover pre-existing conditions, that do not have limits on your catastrophic cost, this is what the Trump administration has allowed. Obamacare disallowed that, and we have to go back to that, we have to provide a public option for people who do not want or cannot afford the private option. This is very straightforward stuff. The biggest determinant of who lives and dies from cancer is who has insurance. If you don't have insurance, you don't go to the doctor, you don't get checked, you don't get diagnosed, and you die from a cancer that is treatable. I have no doubt that after those two things, [Biden] will reinvigorate the Cancer Moonshot. I would point out that the Cancer Moonshot did not end when we left the White House, it was a seven-year program funded by a Republican Congress, that continues today. The NCI is continuing the Cancer Moonshot agenda, agencies around the country that were part of the Moonshot are doing what they said they would do. So that continues. [Biden] would provide the thing that has been missing for four years, which is presidential leadership: bringing people around the table to do things faster, better and cheaper.

The overarching goal of the Cancer Moonshot was to achieve a decade’s worth of progress in five years. Was that goal accomplished? If a Biden administration decided to continue the Cancer Moonshot, as you’ve suggested, would the five strategic goals outlined in the original Task Force report (Also see "Cancer 'Moonshot' Recommendations On R&D Have Strong Patient Focus" - Pink Sheet, 10 Sep, 2016.) remain the same, or would there be new goals?

The Cancer Moonshot was not monolithic, so you had 80-something different projects that came out of the Cancer Moonshot. A good 20 or 30 of those were government partnerships. Many of them were government/private sector or private sector/private sector partnerships. All of those have made progress to one degree or another. In exchange for all of the NCI research dollars [provided under the Cancer Moonshot], any data coming out of that research has to be published in open-access journals. I know that some of the more detailed scientific projects, like the proteomic projects, have made progress in drug discovery and proteome discovery, because I get updates about those. I know that the private sector has taken up many of the Moonshot’s goals, and continues to move them forward. For example, I am a consultant to MITRE, a non-profit that contracts with the government. But they also have their own internal research budget. And they’ve used their internal research budget to pick up a project called mCODE, or minimum common oncology data elements, which is designed to get every cancer center, every hospital and research organization to use the same words to describe cancer. That effort is growing and spreading around the country. But if you start the Moonshot as we did, when you only have nine months in the White House, that was the agenda we thought we could achieve in nine months, to light a fire under the community, for people to start working more together, sharing data more openly, funding in a different way. If you have a four-year agenda in a new administration, you can have a different set of goals, which I wouldn't hazard a guess as to what whoever is going to run that would want to do. If you have a four-year runway, you can get much deeper into all of the things that we only had nine months to do.

How would a Biden administration prioritize drug pricing? If the Democrats take control of the Senate, for example, would a Biden administration push for a Senate bill resembling the Elijah Cummings Lower Drug Costs Now Act, which included capping out-of-pocket costs in Medicare, instituting drug price inflation rebates, and Medicare price negotiation? Is that something a Biden administration would pursue in the first year?

I think they certainly would have to look at it. I have personally argued that there should be no copays in Medicare for cancer drugs. It makes no sense at all, what's the point. I think we should eventually get to the point where there are no copays in Medicare for any drugs that are necessary for a life-threatening condition. But that is Greg Simon talking. I think capping costs for patients in Medicare is a good idea. The problem we have with drug pricing is that we have this cobweb where everything effects everything else. For example, because Medicaid requires drug companies to provide their lowest offered price to Medicaid, if the drug company decides to provide that drug at a lower price than the Medicaid price for a specific population or for a specific new drug, they are basically punished for doing that, because now they have to offer that drug forever to Medicaid at the price they used for a particular group, which may not be eligible for Medicaid. We can't approach this issue one piece at a time. We have to look at the whole system. And that requires a lot more thought than some of the bumper sticker solutions that are out there. Certainly, the answer is not just importing from Canada, it's not just Medicare negotiating prices. (Also see "Biden's Drug Pricing Administrative Actions Could Focus On Medicare Demos" - Pink Sheet, 23 Sep, 2020.) I personally think that the private sector needs to redesign the financial system of how we develop drugs so that the insurance companies help to pay for the development of some drugs, to take some of the risk off the pharma industry. And in return, the pharma industry would provide lower prices long-term to the payers, in exchange for having their risk reduced in drug development. Government can't do that, that is a private sector problem. That's why in my public speeches, I am constantly pushing the idea that we need to have a cooperative approach to drug development, instead of every company for itself, where the drug company feels it has to charge a higher price early on for fear of competition. And the insurance industry tries to delay entry to the market for new drugs, to avoid paying excess costs. The person who gets squeezed in the middle is the patient.

I think the private sector needs to address the financial underpinnings of this system and then government could partake in that once the private sector has changed the way it deals with risk and reward, so that we can have those savings spread across the system. But I think the Biden administration will of necessity have to address this issue, given the fact that cancer drugs are the fastest rising costs, and the boomer population is going to be more and more of a consumer of cancer drugs, as I am myself, I'm on ibrutinib. It's a complicated problem and it will not succumb to a simple solution. (Also see "Biden, Germany And Bringing A National Drug Pricing Negotiation Process To US" - Pink Sheet, 22 Oct, 2020.) 

From a policy perspective, I think it is safe to assume that the biopharma industry will continue to focus on ‘protecting innovation.’ Should the industry feel comfortable about a Biden administration's willingness to protect innovation?

Absolutely. I hate to keep reminding the industry, but pretty much all the innovation that's going on today in biotech has been aided by Democratic administrations in the past. I used to joke when I was in the Clinton administration working for Al Gore, that I didn't get a thank you when we had the best economy and the best and longest boom market in history, and the biotech industry was booming. I didn't get any thank-you letters. I remember in the early Clinton days, after we came in during the Bush recession of 1992-1993, the biotech industry was always saying 'Woe is me, woe is me.' And when times were good, you never heard from them. And I've told them this to their face, I gave a keynote at a BIO meeting when I was in the White House in the 1990s, and I just flat out said, ‘You love to blame the government when times are bad, and give the government no credit when times are good.’ If you look at the last bill that the Republican Congress passed in the Obama administration, which had been proposed by the Obama administration, the 21st Century Cures Act [which authorized $1.8bn in funding for the Cancer Moonshot, over seven years], the BRAIN initiative, the Precision Medicine Initiative, all of these things were Democratic initiatives. They promote innovation at the highest levels in biotech. All of these things have been promoted in Democratic administrations. It was a Republican administration – President George H.W. Bush – that was going to allow patents for all of the so-called express sequence tags. And it was Senator Al Gore who went to the floor and said you cannot patent the alphabet. These are the building blocks of innovation in biotech, you cannot patent them. Imagine if that had happened, what that would have done to depress innovation in this country. So not only am I not worried about whether Biden would support innovation in biotech, I am absolutely excited about the innovation that would come out of a Biden administration.

You have experience with telecommunications and regulatory issues, having worked to develop and pass the 1996 Telecommunications Reform Act during the Clinton administration. Now that the COVID-19 pandemic has accelerated the use of virtual communication and digital tools – for patients connecting with their health care providers, as well as for things like remote clinical trials and patient monitoring – are new regulatory changes needed, or new legislation, to build on this momentum?

Certainly, we have made 10 years of progress in telemedicine because of COVID – by necessity. It was going to be a slow slog to get doctors to do what now doctors have to do. As a leukemia patient, I have to get my blood drawn periodically, and it was a little scary at first, because I'm highly susceptible to COVID as a leukemia patient. It's hard to do a blood draw remotely and not have anybody touch you. I've had to walk the line between in-person medicine and telemedicine for other things. I had knee replacement surgery last December. I did my three-month check-up online, I held my computer camera down where [the doctor] could see me flex my knee, so he could see how I was doing in my recovery. These things people never would have done before, and now it's becoming more normal. I don’t think we need … we have plenty of privacy rules, we have plenty of ways to figure out how to compensate doctors for telemedicine, how to provide services through telemedicine.

We have been trying since 1996, as you mentioned in the telecom world, to promote broadband in hard to reach, rural areas, and urban areas that don't have good service. We were spending somewhere in the neighborhood of $2bn to $4bn a year, from the telecommunications Universal Service Fund, to spread broadband around the country. The Trump administration started to cut back on that. As did the George W. Bush administration. The Bush administration finally did not cut back on it, and the Trump administration tried to do the same thing. That’s totally mystifying to me. If we've been spending that much money, for so long, trying to make sure everybody has broadband in a changing technology environment, where it used to be that you had to wire everybody, but now you can create satellite WiFi, regional WiFi, this is a doable, physical thing. It requires – here's the punch line – infrastructure spending, which is something the Trump administration has promised every day for four years but has never put a bill on the table. So I have no doubt that a Biden administration, as part of our economic recovery, will have an infrastructure bill that will include massive help for rural areas to receive broadband communication.

As I have told people for years, the reason we need universal service isn't just so you can call your friends. It's so you can call the doctor, the policeman, the fireman, the ambulance. And now we know that is even more important than it has ever been, because of COVID-19, and it is a national priority.

How do you think a Biden administration would work to restore confidence in the nation's health care institutions, like the CDC and the FDA?

Number one, stop calling them names, that would help. Number two, show respect, by which I mean, everybody in the White House should model the behavior we need in the country. Wear a mask, be socially distanced, don't promote huge crowds. Take the advice of the scientists and do what you need to do, because we cannot grow the economy without shrinking the pandemic. We have to show that there is no political interference in FDA decision-making, we have to show there is no critical interference in CDC guidelines, we have to show there is no political game-playing with what we tell the American people. The idea that the president of the United States would lie to the public about the pandemic, because he didn't want to bother them, is obscene. People lost lives because they didn't understand the extent of this pandemic in February. It is the role of the president to tell the American people hard truths, not to baby them, to infantilize them, or to only tell them good news because you don't want the market to go down. The first rule in promoting science is to promote science, without politics. I have no doubt that the Biden administration will do that in spades.

Any final thoughts?

As I said, I'm not an official member of the Biden campaign so these are my opinions, but as a cancer patient, and as the son of a mother I cannot visit at her living facility because of COVID-19, these are highly personal issues, to everybody. I think it is incumbent on us to promote science in everything we do. We can't make improvement in cancer care unless we make improvements in COVID-19 care. What we need to do is clear. The question is, will we do it. I have no doubt that a President Biden would do it.