By: The Hill – December 9, 2021
To mark 50 years since the passage of the National Cancer Act of 1971, a select group of thought leaders working at the intersection of public health and oncology participated in a roundtable discussion, hosted by The Hill in partnership with Friends of Cancer Research and AstraZeneca’s YOUR Cancer Program, on expanding access to oncology precision medicine.
The September 30, 2021 discussion focused not only on how far we’ve come over the past half-century in cancer care but also how the pandemic affected access to care, the lessons learned from COVID-19, and what we can expect as oncology continues to advance over the next 50 years.
Far beyond celebrating key advancements in cancer research, screening and treatments at this milestone anniversary, the group explored both the short and long-term effects of the COVID-19 pandemic on cancer care as well as the issues of racial, socioeconomic, cultural, linguistic, and geographic disparities related to access. Specifically, the discussion focused on expanding access to biomarker testing and increasing participation in clinical trials among marginalized patient populations.
Progress Over 50 Years
In celebrating a half-century of advancement and providing historical context for the roundtable, it was noted that a similar discussion back in 1971 might have focused on radical chemotherapy or major surgical procedures used at the time to remove potentially diseased organs.
During that period, oncogenes—originally thought to be associated with viral cells—were just beginning to be discussed and studied. In the early 1970s, Michael Bishop and Harold Varmus began the research for which they would eventually win a Nobel prize, demonstrating that these oncogenes were, indeed, involved in the transformation of normal cells into cancerous cells, thus laying the foundation for many of the dozens of new targeted treatments being approved to this day.
The Significance of Biomarkers
Note was made that “nearly 60% of the cancer drugs that are included in clinical trials currently use biomarkers to target the subgroup of biologically-more-likely-to-respond patients. This has doubled the effective size of cancer treatments that are compared to unselected trials using new cancer drugs.
New therapies can harness a patient’s immune system and help recognize cancerous cells. In fact, the FDA has approved only seven different new cell and gene therapy drugs, but according to a landscaping assessment, the pipeline itself has well over 1,200 different cell and gene therapies coming down the pike and half of these are already in Phase 2 trials.
Many cancers that previously had had no treatment options now have treatments; survival rates for many cancers have significantly increased, in some cases leading to cancer being more of a chronic condition, or even, in some cases, cured. But while we’ve seen great progress, there are still cancers that have been particularly difficult to target or to reduce their devastating impact.”
In addition, credit for reduced morbidity rates was given to more personalized screening and treatment plans. The point was made that “collaboration is key” to refining and redefining cancer care in this way.
The Challenges of COVID-19
It was noted that, in the first few months of the pandemic, preventive screenings plummeted nearly 80%, posing a risk that, in the coming months, there will be a large influx of advanced cancer diagnoses. Many clinical trials came to a halt while hospitals dealt with an unknown pathogen and measures were taken to protect patients from exposure to the virus that could potentially further complicate their diseases. Perhaps most notably, shortcomings in health equity for racial and ethnic minorities and major deficiencies and accessibility for millions of Americans and people around the world became more starkly obvious.
Three Major Advancements Over Fifty Years; Three Challenges Facing Us Now
Looking back at the past half-century, one participant noted three major advances, namely the development of precision medicine, that the meaning of a cancer diagnosis has materially changed from a death sentence to a treatable, sometimes a chronic disease, and how and where cancer is treated shifting from disfiguring surgeries and often toxic therapies to a range of treatments by teams of caregivers. This same participant also noted three broad areas needing progress: ensuring access to high-quality care for everyone with a cancer diagnosis; the need for high-quality evidence and decision support, and the urgency of offering more patients the opportunity to participate in research programs when they’re treated for their cancer.
The Urgent Need for Equity
In terms of the need for high-quality care to be available to anyone with a cancer diagnosis, the group addressed the lack of equity in access to quality preventive care, targeted therapies and the latest clinical trials.
As one participant noted, “for the Hispanic community, people don’t realize that the number one cause of death is cancer. The rest of America, its heart disease,” and added, “we need more attention paid to recruiting our patients to clinical trials, recruiting the Latino and minority people to access to care programs where they meet survivors, they get trusted messengers, and they get their information with health literacy and language… and they’re not ignored. There needs to be extra outreach; our community health worker models and patient navigator models are really, really important with the minority populations.”
Pivoting off this point, another participant said,
We can’t have health equity without health literacy…Equity is great but the people that need that equity need to have their own personal empowerment to understand what’s actually happening; to be their own best advocates.”
On language barriers, another participant noted that “physician bias plays a big role recruiting minorities into clinical trials. If a patient doesn’t speak English as the first tongue, the doctor is three times less likely to invite them to our clinical trial…and this is, on many occasions, the best treatment option…we [physicians] have to take responsibility. We cannot put this on the patients that are diagnosed with cancer to advocate. It is our job to do the best treatment for our patients.”
Agreeing with this, another participant added that marginalized groups “are just not being asked to participate…we talk about empowering patients and I’m all for that, but I want a system where you don’t have to be an empowered patient to get good care. Not everybody wants to be, or is able to be, when faced with the diagnosis of cancer. Sometimes they just want to say, ‘just take care of me, just do right by me, basically.’ We’ve done surveys of cancer survivors and their overwhelming preferences to defer to their physician and they want the cancer out of their body no matter what. We just need to make sure the system works for them. Right now, it doesn’t, unless they’re actively involved, and some people want to be—and that’s great they should be—but you shouldn’t have to be to get good care.”
Another participant agreed, “We cannot make this the patient’s responsibility,” adding that patients should expect to be treated with “value and respect and dignity…like their most loved person in their family. We’ve seen DEI training, cultural competency training fail for decades, which makes sense. Why should I have to know someone’s culture to give them high-quality care? I just need to treat that person like I would want to be treated.”
In Precision Medicine, What Becomes Evidence? What about Access?
This same participant added “We talk about evidence-based medicine, precision medicine. What becomes evidence depends on who’s asking the questions, who they’re asking, who’s doing the analysis and frankly who’s funding the research.”
This participant noted that “the percentage of Black and Brown physicians hasn’t changed in 50 years” and noted that less than 2% of NIH R01 investigators are Black and Brown, reiterating the fact that “the number one reason why Black and Brown people don’t participate in clinical trials is because nobody asks them. Doctors make all kinds of assumptions about what [these patients] will and will not do, and whether they’ll comply or not…If we don’t change that, then precision medicine is going to be for some people, but not for others. Yes, we’ve made progress overall, but the gap has widened. In 1982, the breast cancer incidence and mortality rates for Black and White women were the same. Now Black women die 42% more. It’s not biology; it’s not genetics. That is 100% access. If we don’t deal with the access issue, we don’t deal with the evidence issue, we don’t make it a priority to include Black and Brown people in trials and as researchers and clinicians, then in another 30 years, another group of us will be having the same conversation. That would be tragic because that means tens of thousands of people would have died unnecessarily.”
On physician bias and trial access, another participant noted “when people of color are asked to be in clinical trials, they say ‘yes’ at a much higher rate than White Americans… when they’re asked. However, from the normative bias perspective, physicians and lead investigators will say that people of color are less likely to be compliant, that they’ll drop out more quickly. And that happens to be not true.”
This participant added that
…the goal of clinical trials “isn’t to make clinical trials look like America. It’s to make clinical trials look like the disease state…”
a clinical trial for a cardiovascular medicine shouldn’t look like the American population. It should look like cardiovascular disease in the U.S. which needs to be overrepresented in for example, the African American community, and we’re not doing that.”
One participant noted “if you can talk about biomarkers, you also have to talk about validating those biomarkers…so the data becomes evidence” adding that, “there’s a misunderstanding relative to what the patient community wants, with the risks they’re willing to undertake relative to benefits and the chilling effect that slowing down accelerated approvals [at the FDA] will have, not just on patient care—a primary objective for everybody—but also on investment in new types of products. We have to be concerned, even outside of oncology, of the chilling effect that politics has on this whole process.”
What Did the Pandemic Reveal About Racial Disparities?
The pandemic exposed the stark lack of equity in healthcare along racial lines. As one participant noted, “a year and a half ago or so, a little bit longer, nobody really was thinking much about Black women. Suddenly we became essential because we were the ones who more often than not couldn’t work from home. We were the ones that had to get on public transportation, get out in public to face an often angry and unmasked public. We were the ones who had elevated risks for COVID…and we saw what happened when people of color are left out of research. Pulse oximeters didn’t work as well on people with dark skin. Corticosteroids didn’t work as well on Black people. There were lots of these examples and we see it in the cancer world. So, on top of all the other barriers that men and women of color face, they also were not going in for their screenings; they weren’t getting their screening mammograms; they were not getting their pap tests. They weren’t getting other kinds of preventive services or screening services. So, we’re beginning to see what happens. Next year we’ll see even more of these late-stage diagnoses of breast cancers and cervical cancer. Plus, people just weren’t getting the treatment for their cancers that they had.”
Another participant added that
Our healthcare system is still a legacy system that was born during a period when segregation and inequalities were accepted. We took down the facade of segregation, but the inequalities have remained.”
Our healthcare system needs to be reimagined. Yes, we can do all this great science. But the reality is that 36% of African Americans are on Medicaid. Are we going to bring all of that new science to Medicaid beneficiaries? We’re not doing it right now. The system focus is so much on financial risk that it doesn’t really think about patient risk. How are we reducing the risk for patients with cancer? We have to reimagine the system. The old system really can’t keep up with the science and the needs of a growing, diversified American community.”
What Have We Learned About Clinical Trials that Can be Applied to Cancer Research?
Given the breakneck speed at which COVID-19 vaccines were developed, are there any lessons to be applied to cancer research and treatment?
One participant answered that vaccine trials were more inclusive than a typical clinical trial and that COVID-19 presented “an entirely new scenario…data was coming from every corner and it had to be consciously captured in order to try and learn what was going on… In cancer, that rate of clinical trial participation has historically always been around 5% for all adults…that’s 95% of cancer patients that are receiving care outside of a clinical trial. We need to do a better job of putting the infrastructure in place across all communities. We need to be able to collect that information and have it be a part of research in order to make the clinical trials better and understand what’s happening to actual, real people that aren’t able to participate in clinical trials as easily.”
Another stressed the importance of collaboration and expanding clinical trial participation, saying “nowhere in time have so many pharmaceutical manufacturers come together to share manufacturing technology, share best practices, leverage each other’s experiences, expand beyond your typical clinical trial site target to look into the community where we knew patients were existing…so [the question becomes] how do we actually represent the disease at stake and go to where the patients are representing themselves?”
Late in the conversation, one participant said of the pandemic, “What we learned was that people have very short memories and the status quo is a harsh mistress…just because we’re using new data and new types of validations and new types of biomarkers doesn’t mean that the gold standard clinical trials cease to exist. These things can coexist together and move ahead a lot more quickly.”
The Role of Holistic Care and Trust in Precision Oncology
On holistic care and the toll of the pandemic in accelerating progress, one participant stressed the importance of trust in addressing people as patients [and vice-versa] and beginning that process even before they enter treatment. “The pandemic has brought about some creativity in that. I have never before received information from my OBGYN or my medical center about meditation classes, but that’s happening…we have to do more of it and our entire system has to be thinking as people without so much disease and treatment focus. It’s critically important; we [have to] move our energy and our investment earlier in the continuum.”
Regarding decision support, another participant noted a recent state of cancer survivorship survey revealing that “they’re not getting as much support on a lot of the side effects. They get support on some of the ones we know how to treat the best—like nausea, vomiting, things like that—but not some of the other things that are really their highest concerns in terms of like fatigue, depression, anxiety…I want us to think about not just making sure they get the right drug but making sure that they get holistically the right treatment that they need to address all of the burden of cancer for them, not just the physical.”
Trust between patients and clinicians surfaced as an issue more than once, with one participant articulating the need for reciprocity in this relationship.
Physicians have to trust their patients. They always want us to trust them, but physicians, as we’ve seen time and time again, don’t trust their patients…providers are going to have to trust the patients, that they know what they’re talking about; they know their bodies.”
Biomarker Testing: Are Research and Access at Odds?
The answer seemed to be that this may be, in certain cases, but needn’t be, and that biomarker testing is a good example of both where we are and where we need to be…and could be if a community of researchers, providers, and patient advocates work together.
One participant pointed out that a key term used throughout the discussion was the word “evolving” and “that’s especially true when we talk about the current biomarker testing landscape…meaning testing for cancer risk, especially hereditary cancer risk, and testing in someone who already has been diagnosed with cancer to guide an informed treatment.”
This participant also noted that “when testing is appropriate and informed by evidence, it improves overall survival and a number of other care outcomes” but pointed to major gaps in terms of insurance coverage and providers keeping up with current recommendations and evidence. “The big challenge right now—for payers, for policymakers, for advocates—is to be able to read through what the evidence is, both in the test validity that it measures, what it says it’s going to measure, and in the clinical utility. Clinical practice guidelines can be a great tool for policymakers, as we’re looking at policies that can expand access and make sure that access is appropriate. What we don’t want to do in policy is either go for blanket coverage that perhaps expands access inappropriately, or for overly restrictive coverage that then needs to be updated. So [we should be] thinking about tools we can use for continuous coverage.”
How Do We Make Precision Medicine Real? What Are Barriers?
“There absolutely are barriers,” noted one participant. “Biomarker testing is a perfect example. I think only 8% of lung cancer patients get access to biomarker comprehensive genomic testing for all seven NCCN mutations. …that is an incredibly low number with a relatively low-cost test that can prevent inefficient treatment and really get patients on the right drug at the right time. We need to have a conversation that involves payors in addressing systemic barriers.”
Another stressed the importance of “concentrating on how to improve access to biomarkers that improve outcomes for patients specifically in our underrepresented communities, where we’re currently just not getting the right tests to people where we can interpret and bring that information to better outcomes. Several of the specific examples relate to genetic testing for increased risk. It’s so much more difficult to interpret what a genetic test means in a community that has not been represented in the populations that allow us to understand risk, especially in our Latino and Native American communities.”
The participant also noted that more genetic testing for inherited susceptibility to cancer in Black communities could help clinicians understand how to serve that patient and their family members and improve outcomes. “Germline genetic testing is now driving therapeutic decision making,” he noted. “So together, as a community, we’ve got to figure out better ways to improve access to germline genetic testing for these communities and make sure that we’re making precision medicine more precise for diverse communities.”
Creating Digital Cancer Pathways
Another participant noted that “cancer care actually has three different components. It starts with prevention, and 42% of cancers in the United States are preventable. A town the size of Seattle can be saved from cancer every year in the United States if we do good prevention. And then we move to diagnosis, and then we move to treatment that is becoming so complex…the FDA approved more than 160 genomic tests over the last few years and is approving about a drug or two a month for hematology and oncology… the frontline physicians and teams need help.” She cited the creation of digital cancer pathways that make sure that at the beginning from prevention, members or the public are automatically enrolled in certain digital prevention pathways.
“If you have a BRCA1 mutation, you are automatically enrolled and you get automated reminders [about] when and what you need to do, so you don’t fall through the cracks. The problem is a lot of people want to fall through the cracks right now. When we go to diagnostics and treatment, I’m always blown away that the United States we spend more for low-value care than for the military or for education. So, on one hand, a lot of people do not get the tests. On the other hand, we have so much low-value care, we need create digital tools for frontline physicians to have at their fingertips, so at any moment they’ll able to order the right tests and the right treatments…using this system of cancer pathways, oncologists can recommend the treatment that is most cutting edge.”
Is Personalized Medicine a Public Good? If so, We Need Improved Implementation
One participant said, “It’s fantastic that we’ve invested so much in R&D and developing new drugs and developing new biomarker-driven drugs…but there is not enough investment on the implementation side of things” pointing to issues of health literacy and the lack of minority patients in clinical trials due, as noted, to a dearth of minority physicians to offer those clinical trials.
He added that if “we just compare the amount of investment on the R&D side of things and the amount of investment on solving implementation challenges, there is a huge, huge, huge imbalance there. We are at that inflection point where we made a lot of progress but if we don’t fix the current implementation challenges right now in a fashion that’s scalable and replicable, I feel that these challenges will continue to get amplified.”
Conclusion
Over the course of the discussion, a number of areas of progress in cancer research and treatment were examined as well as the road ahead for patients. Participants agreed that victories secured in the past half-century have laid the groundwork for advances yet to come. But in order for steady gains to be made, some core areas will need greater attention, like expanding access to high-quality care, improving patient engagement through clinical trials, equipping physicians with the tools needed to treat patients in a tailored manner and doing all of the above in a way that does not create barriers for underserved groups.
As one participant noted, the discussion had focused on issues of disparities, access, and sharing data, and care, “all of the things that we didn’t necessarily think about when the National Cancer Act was put forward, when it was all research and more research.”
Another concluded “All of this science is really fantastic and important. We love the breakthroughs. The real challenge is that our healthcare finance and delivery systems can’t keep up and it leads to disparities. We need to have a very long conversation about our healthcare delivery and financing system. We bring new therapies online and then patients can’t get access to them…It’s time that we really think about how we can reimagine our healthcare system so that it can keep pace with the science so that we can get cure to patients as quickly as possible.”
Roundtables Attendees
- Jeff Allen – President & CEO, Friends of Cancer Research
- Linda Goler Blount – President & CEO, Black Women’s Health Imperative
- Narjust Duma – Associate Director, Cancer Care Equity Program and Thoracic Medical Oncologist, Dana-Farber Cancer Institute/Harvard Cancer Center
- Nicolas Ferreyros – Director of Communications, Community Oncology Alliance
- Stephen Gruber – Director, Center for Precision Medicine, City of Hope
- Ryan Hohman – VP, Public Affairs, Friends of Cancer Research
- Jody Hoyos – President & COO, Prevent Cancer Foundation®
- Tatjana Kolevska – Medical Director, Kaiser Permanente’s National Excellence in Cancer Care Program; Chair, Oncology and Hematology, The Permanente Medical Group
- Neal Meropol – Vice President of Research Oncology, Flatiron Health
- Shelley Fuld Nasso – CEO, National Coalition for Cancer Survivorship
- Omar Perez – Head of Medical Diagnostics, U.S. Medical Affairs Oncology, AstraZeneca
- Peter Pitts – President and Co-founder, Center for Medicine in the Public Interest
- Gary Puckrein – President and CEO, National Minority Quality Forum
- Jon Retzla – Chief Policy Officer and Vice President, Science Policy and Government Affairs, The American Association for Cancer Research (AACR)
- Elena Rios – President and CEO, Hispanic Medical Association
- Upal Basu Roy – Executive Director, LUNGevity Research
- Alyssa Schatz – Senior Director, Policy and Advocacy, National Comprehensive Cancer Network®
- Moderator: Steve Clemons – Editor-at-Large, The Hill
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