The 4 Ps of Cancer Care: Policy, Politics, Priorities, and Prevention

[MUSIC PLAYING] Hi, everyone. I'm Dr. John Whyte, WebMD's chief medical officer. And you're watching Cancer in Context.

When I think of cancer care, I often put it in the context of four Ps-- policy, politics, priorities, and prevention. I sat down recently in Washington, DC with David Fredrickson, the executive vice president of oncology business at AstraZeneca. He explains why he's excited about some recent data around cancer deaths, as well as the innovation that he's seen in cancer research. He also shares with me what he means when he talks about cancer's fiercest opponent.

Thanks for joining me today.

John, it is absolutely a pleasure to be with you again.

We're here in Washington, DC. This is not a fake picture. We are truly in front of the Capitol. So I've got to start off and ask you, what role does politics play as we think about cancer care?

One of the big messages that we've had with governments around the globe is the importance of making sure that we are investing in national cancer strategies. The role that governments play in ensuring that not only is there access to new medicines, but that we're thinking beyond medicines, to prevention, screening, early intervention, navigation, survivorship. These are all things that require really commitment and targets and funding from governments.

And of course, politics plays into that. But I do think that one of the core messages that we're really a part of trying to move forward-- and I think that the pandemic made this clear-- is that a healthy society contributes to a thriving economy, and that this is an investment into cancer, not just a cost that society has to bear.

So we're also very close to the US Department of Health and Human Services, not too far away from the Capitol. There's the issue of regulation by the FDA, payment by CMS. Now, some people will say we're regulating drugs, it's too fast, and others will say it's too slow. So which is it? Is it too fast or is it too slow?

Well, I do think that innovation moves at its own pace. And all of the medicines bring with it a benefit/risk profile that needs to be well-understood. I think that if we also take a look at some of the remarkable innovations that are taking place-- I mean, cell therapy, gene therapy, efforts that are being made around how we better leverage identification techniques like cell-free DNA in order to identify when to intervene-- these are all technologies that do require FDA to-- or any health authority, for that matter-- to make sure that we're understanding the implications of these medicines and what we need to do to deliver them effectively.

I also think that regulatory agencies are playing a really important role, and the FDA here, as well, in ensuring that there's clinical trial diversity. I think this is a really important area where sponsors like AstraZeneca have an opportunity to create value to society by ensuring diverse populations within our studies. And regulators have an opportunity to make sure that we study in populations that are representative of the populations that will ultimately be served.

We've had some good news lately in terms of cancer deaths. Slight decrease, typically about 1% to 2%, which can be tens of thousands of lives. But we're still having more than 600,000 people die of cancer every year. You and I were talking a little earlier, the war on cancer started in 1971 here, down at the Capitol.

52 years later, it's still going on, the war. Are we having the right priorities? Is there something that we're not doing that we should be doing? Is it that we didn't quite understand cancer as a series of multiple diseases? What do you think's going on here, David?

Well, I do think that the first piece is that cancer is a complex disease. And as you highlighted at the end of the question, really understanding how deeply personal cancer is, and that what causes cancer in one person is potentially quite different-- well, will be quite different than what causes it in another. And I think that the science that we've been able to advance as a field has really allowed us to be able to make progress against that. I mean, just as a minute we think back on it, 10 years ago in lung cancer, lung cancer was seen as a single disease, or perhaps a disease that was defined by two histologies.

And I think that if we fast forward to where we are today, lung cancer has been defined by various drivers of what actually drives the tumor or mechanisms of resistance and targeted therapies, a much deeper understanding of those patients that will be receptive to immunotherapies and immunooncology agents. So the evolution that's happening in terms of our understanding of the disease has really remarkably changed.

But a war makes it sound like we're going to marshal all our resources and we're going to get this done in a relatively defined period of time.

Yeah.

We're talking half a century.

Right.

Is it the wrong term maybe, or where do you think we're going to be?

I'll certainly say that, in terms of marshaling resources, at AstraZeneca, together with my partner Susan Galbraith, who leads our research and development efforts, we spend 24/7 thinking about how we are going to eliminate cancer as a cause of death. And I think that I would say that our organizations are doing the same. The point that you're raising is an important one, but I think that, back to the point that you had raised at the beginning, American Cancer Society has estimated that we've reduced cancer deaths by a third since 1991.

And so I do think that we have to look at that as a signal of progress moving in the right direction. We're making progress with lots of different modalities, whether it's medicines or surgery or radiation, this multidisciplinary approach, which is allowing us to be able to really make sure that we're able to treat the disease. I think one of the things that's really changing, though, that we're seeing right now, and perhaps gets to one of the things that needs to be done differently, is cancer has to be identified early.

So if I look at historically how we've pursued research and development, it has been first starting in the latest lines of most advanced disease, which makes sense. The unmet need is highest there. We can understand a lot about the science. And then to gradually move it forward into earlier settings. That's been useful, but I also think doesn't bring advancements as quickly as possible into early settings. And the reason it's important to move early is that when cancer is diagnosed early, the prognosis is manyfold better. And so that's really the area that we're focused in on right now.

So we want that earlier diagnosis. We want those targeted therapies. We want that precision medicine that you and I have talked about before. So what's the role of biomarkers in all of this, and why is it so challenging to make sure that that's democratized? So when you talk about disparities, we know there's differences in terms of who might get biomarkers, irrespective of their tumor type, based on race, ethnicity, sometimes based on gender. What's the challenges here, David?

Well, so biomarkers are absolutely essential. I think that, again, back to the notion of how deeply personal cancer is, personalized treatments that are tailored to address the specific cancer that somebody might have is absolutely where cutting-edge science is happening right now. You raise an important piece in terms of, well, how does that affect actually disparity? What I think we've seen with biomarkers, whether it's immunohistochemistry, which is a long-existing approach, all the way to next-generation sequencing, which is the most cutting-edge, and all the things that are in between, that the cost of delivering those is coming down.

And what I also see as an important phenomena is we're seeing decentralization of the delivery of those biomarkers. And so what we're seeing is that technology and data and AI are allowing us to be able to deliver precision medicine and biomarkers across the globe at a cost that is much lower than what we were seeing when it was all done through central labs that were predominantly in wealthy nations. And I think this is a phenomena that's going to continue to help to open up access to patients across the globe.

One of the things that we saw during the pandemic was that, as people stayed indoors, that they were not actually going to get their colonoscopy, their mammograms, their regular checkups, and that, as a result of this, we really saw cancer diagnoses decline. This is not a good thing. Those declines were not a result of patients not having disease. It was a result of--

They didn't come in.

They weren't coming in.

How concerned are you we're going to see that later, at more advanced stage?

Well, we were very concerned about it, I would say, 18 months ago, and it was one of the reasons that we worked together with many, many different advocacy groups on a campaign called New Normal, Same Cancer to try to create awareness around this. I'm pleased to say that right now-- and we follow this, as you can imagine, quite closely-- I do think diagnosis rates are getting pretty back to where they were at pre-COVID levels. So it's encouraging to see that. I do think that the impact of those missed diagnoses during those last couple of years is something that we may see as we move forward.

I think that what I would say here is that there are a lot of educational resources that are available. There are a lot of advocacy groups doing a lot of remarkable work. Cancers that used to have stigmas don't have stigmas associated with them anymore.

And I think that there is a tremendous amount of resource that exists out for people to be able to educate themselves. And I think that my experience has been that, yes, second opinions are always good to get. Educating oneself and really having a conversation with your care team to understand the options that are in front of you is really the best way to be able to arms oneself to be able to tackle this.

Now, you've been quoted-- so I'm looking at my notes because I don't want to misspeak-- you say you want AstraZeneca to be cancer's fiercest opponent. What does that mean, practically speaking?

Well, the origin of cancer's fiercest opponent was that the late Jose Baselga, who passed away in 2021, he was a colleague of ours. And as we lost him, we mourned that cancer had lost its fiercest opponent. And so Susan Galbraith and I, as we led from those days going forward together, it became a rallying cry for our organization. It became a rallying cry to say that we know that cancer is a disease that we believe can be defeated.

We believe that what it's going to take is really harnessing what is coming out of science, technology, data, and bringing this together, and bringing it together, as you've just described, practically in the tumor types that are the highest causes of mortality across the globe and the highest incidences across the globe, and a recognition that we need to be doing the work to invest in the research and development and the delivery that's required in order to be able to bring these therapies to patients across the globe.

I want to focus a little more about diversity of clinical trials, and specifically talk about cancer care. So when we talk about trials in novel anticoagulants or cardiology trials, there are tens of thousands of people around the world. Cancer trials typically aren't the same scale.

And we know that many cancer trials are truly global in nature. 60% of them may be conducted outside the United States. And our framework of diversity typically is from the American perspective. So how do we address that in terms of the composition of clinical trials when you're looking at it from a global perspective?

It's a very good question. I would say that while maybe the sort of lay discourse is from a US perspective that, when I look at the way in which we approach clinical trial enrollment and what health agencies require, in Japan, Japanese patients are essential to be studied in order to be able to file in Japan. The same is true with the China FDA.

And Korea. But their regulators have stipulated that.

And they have stipulated, but it does create, therefore, at least a global lens that we are looking through for how we think about the development of our medicines. And I do think that this is beneficial, actually, towards the broader effort of clinical trial diversity that we've got. I think that you're right. I mean, cancer studies probably have anywhere between 300 to say 1,200 patients in each one of those studies.

And so it's not the same kind of population that you've got the ability to be able to kind of get to the same level of numbers that you might in the large studies. With that said, we have specific efforts that are underway to, one, work together with policymakers here and through efforts like Cancer Moonshots, where we've been participating actively in the clinical trial diversity work, together with FDA and with Moonshots, to try to really make sure that we put into place guidelines around what clinical trial diversity means and what it would look like.

I think the second piece is that we are building actively out plans so that we can actually enroll diverse populations into the studies. It's not enough just to say that you've got the goal. The reality is that we've got to then make sure that we've got sites across the globe that we can get high-quality participation in and be able to bring those patients in.

But I think that it starts with setting the goal and the objective. And this is a place where I think that our interests as the maker of these medicines and the innovators is very much consistent with the interests of society and the interests of policymakers to create diversity. And so this is something we want to do.

People are saying we want accountability. Right? We want to know that you decided upfront you're going to meet these goals and you're going to use every effort to do it, and if they're not met, there's going to be some accountability at an executive level.

So right now at AstraZeneca, we are working on the ambition portion that is around health equity. So we do have aspirations as it--

That's a good thing.

--as it relates to health equity, which are really around how do we drive equity in outcomes and access for patients living with the diseases that we treat across the globe. That will likely be an evergreen ambition. That said, we have then very practical goals that we are setting in order to be able to make progress against that ambition. Clinical trial diversity and really building equity into the R&D process as early as possible, specific goals.

One of the things that's going to start with is that we will soon be releasing a publication that shows how we're doing on clinical trial diversity. So we've done an audit of all of our trials across the oncology organization. That's something that we will produce a report on. We have a Health Equity Advisory Council here in the US that is not made up of health care experts. It's actually made up of equity experts that have served as peer review on that report.

And we have set a specific corporate goal internally for a percentage of patients that need to be both from the United States and the diversity of that population. And it's in line with the discussions that we've been having with the agency here. And we are really working hard to make sure that it's something that we've got a target and we can measure ourselves against it.

A big discussion in Washington is around payment. What do you say to those folks who say drugs are just too high, in terms of the cost?

Well, I think that the discussion that we always force ourselves to have and that we want to have with society is a value discussion. Medicines that are dramatically moving the needle on overall survival or long-term durable outcomes are ones that are creating value, and we think are ones that should be recognized as such as we start thinking about the value of the medicines. We strive as a result to really focus in on medicines that are moving standard of care, that we think can actually transform the landscape, not to be playing in areas that are me too, that already are addressing a need that exists.

And so I think that, so long as we're able to focus in on really going early stages of disease, where outcomes are best, we know-- and this is something that I think is really well seen across the globe-- if we are able to drive towards long-term, durable outcomes for cancer patients that result in lowering of premature deaths, that is something that we consistently hear that society values. And that value math works out. And so that's really why we're focused in on trying to move everything as early as we can into the treatment algorithm.

So we've talked about politics. We've talked about priorities. We've talked about payment. I want to talk and end with prevention. And maybe we should have talked about prevention first, right? If we could prevent a cancer in the first place, that'd make everyone's lives much better. Are we not focused enough on prevention? What's your role in terms of thinking about prevention, in terms of treatment?

Yeah. Well, so there's no question that prevention is the best way to avoid disease, have lower costs, healthy society, et cetera. And I think that we know that, frankly, across so many different walks of life. In terms of what's our role, I think that there's two parts to it. First, we have been leading efforts to really make sure that, beyond our medicines, that we are focusing on early screening, early detection, early diagnosis. These are all ways to take at-risk populations and make sure that investments are being made, time is being committed, resources, goals are being set to identify cancer early so that it can then be treated and addressed early.

Now, obviously, the best part would be to say how do we even prevent it all together. One of the things that we've been working with through things like the Lung Ambition Alliance, which is some really outstanding work that we've been doing with other partners to try to really drive screening, diagnosis, and identification of lung cancer, is we set up things like mobile CT scan units for high-risk patients. We've also been able to attach to that smoking cessation education. So as we identify high-risk patients that make sense to be screened for lung cancer, if they're still smokers, it also represents an intervention point for prevention.

I think also the other important piece is that we really believe that national cancer strategies is an absolutely critical component to health care moving forward, and important to countries across the globe. 80% of countries have some kind of cancer strategy, but very few of them have actually put the dollars and the effort behind it in order to make sure that it's actually going to be able to meet its objectives. And I think that prevention plays a very important role in terms of those policies and those standards. And so as we have conversations with governments about how they can really tackle particular cancer types, prevention within that, shaping dialogue also plays an important role.

What are you most excited about in terms of cancer care over the next, let's just say, three years? And only give me one answer. Is it biomarkers? Is it in terms of innovative therapies? What would it be?

Right now, next three years, antibody drug conjugates is what excites me the most in the next three years. Two reasons. The first one is that antibody drug conjugates represent the potential to replace classical chemotherapy in a number of different tumor types. Unfortunately, for all of the progress that we've made with cancer, so many patients ultimately are treated with classical, traditional chemotherapy. And while there's benefit that comes from that, systemic chemotherapy brings a lot of side effects. Antibody drug conjugates is a way of delivering more precise chemotherapy that isn't systemic. It's not throughout the whole body. It's being delivered specifically to a tumor type. This is, I would say, the number one area.

And the second part of antibody drug conjugates, it's opening up the ability to be able to treat cancers that we didn't actually know that we could treat before. Within HER2, it's opened up a whole new area of breast cancer to be able to treat a group of patients that previously we wouldn't have thought would have been able to be treated with the type of therapy that we're using.

David, thanks for joining me today. Always good to see you.

It was absolutely my pleasure. Thanks for having me. And what a beautiful setting we're in.

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