MedCity Influencers, BioPharma

Shining a light on gaps in breast cancer care: A call for increased equity

As an industry, we should be proud of all that we have accomplished in making precision medicine a reality, whether it has been through advances in screening, drug development, diagnostics, or delivery. However, our work has just begun.

breast cancer

When we look back on the advent of precision medicine, the health care community will reflect on a boom of high science, groundbreaking research, and a collective advancement of an industry for the benefit of each individual patient. In recent years, oncology has made significant strides as a result of this movement, with ever-advancing technologies looking deeper at the makeup and drivers of a disease, cutting-edge treatments precisely targeting those drivers, and the ripple effects of customized treatment being felt through the entire care community – pharmaceutical giants, biotechs, payers, providers, and patients are all affected.

However, not everyone has been able to benefit from the significant improvements these advances offer. We, as a society, are also grappling with how to address generations of socioeconomic inequality of all kinds – the most evident being gender and racial equity – and we see this play out in the stark example of health care access. Looking through the lens of cancer care, not everyone is given the same access to testing and treatment – which means, tragically, that not everyone is given the same access to a chance for better health and survival.

As health care industry leaders, the onus is on us to foster change – health access may be just a piece of the larger journey forward, but if these calls for equity have taught us anything, it’s that each piece matters just as much as the others and each must work together to bring about holistic change.

Increase representation in clinical trials to mirror the population
Despite the enormous growth in oncology research opportunity, not enough minority women are enrolled as participants in clinical trials. In oncology-specific trials across all cancer types, women from diverse backgrounds, the elderly, and other patients from ethnic and minority groups are less likely to be enrolled compared to younger, white males, with the proportion of enrolled African-American patients declining in recent years. We can drill down even further into breast cancer specifically, where while the majority of patients are women, these patient populations need to be more stratified, more inclusive of minority women, and further designed to study response of older patients.

The results of recent research require us to take a hard look at how this affects these patients in practice – when African American women are offered testing for breast cancer, which is already at a lower rate than white women, they are being offered a test that is shown to miss high risk determinations for women of their racial or ethnic minority group, leaving them in a dangerous position. As we design clinical trials, we must maintain as a priority their potential to help reduce real-world health disparities among minority groups.

Fewer enrollments among specific population groups result in a less clear understanding of differences in patient biology and fewer data points to inform treatment decisions or to identify areas for further research. This makes a difference for women of Latin or Asian descent, who may have different gene expressions that impact clinical outcomes, and for African-American women, who are more likely to present with difficult-to-treat breast cancers than white women and to die of their disease. If sub-populations of patients were represented in research in proportion to their prevalence in the total population, the results could improve our understanding of potentially meaningful biological differences, impact treatment decisions and make a difference to the lives of patients and their families.

Improve access to care
Another reason that patients of diverse backgrounds experience inequity in cancer care is due to lack of access to the tools of precision medicine. Some genomic risk assessment tests have lower prognostic accuracy in African American women, and research indicates that less than one-third of African-American women at hereditary risk for breast cancer receive genetic counseling and testing, with low rates for Latinas as well compared to populations like Asian Americans and Caucasians, where testing is done more frequently.

Sometimes access is a matter of geography. A 2018 paper showed that patients living closer to National Cancer Institute (NCI)-designated cancer centers were more likely to receive genomic testing compared to those who lived further away. Private insurance and Medicaid status also played a role, with lower-income patients less likely to receive genomic testing.

Other times, access is a matter of ensuring a test can work for everyone, regardless of what they look like. Some of these tests require, and must receive as a priority, model calibration in populations with greater racial or ethnic diversity.

On a global level, some countries do not allow tissue samples to be sent out of the country to get access to the latest scientific instruments and expertise. Such policies prevent patients in those countries from accessing advanced genomic testing. Without this critical information, it is impossible for patients to benefit from the advances we have made in precision medicine, to share decisions about their own treatment with their doctors, or to have confidence they are receiving the best treatment for their own biology. So, as an industry, we must look at new measures to improve access to care such as digital pathology that can be processed remotely and without tissue transfer.

Empower Patients to fight for their right to comprehensive healthcare
These disparities are discouraging, and it is incumbent on the life sciences industry to do what we can to ensure every patient has access to this fundamental human right. Every patient with cancer, regardless of background, race, or age, deserves access to the right health information so that with their doctor, they can make the best decision about their treatment journey ahead.

This is an issue on the minds of many, including our world leaders. In 2019, health leaders at the World Economic Forum called on the World Health Organization to raise the visibility and to take action to advance precision medicine approaches in an equitable and societally beneficial way around the globe.

Beyond ensuring access to better care for all patients, which includes patient education and shared decision making between a patient and his or her physician, we must also commit to greater representation in clinical trials, made even more difficult during this pandemic, to try to ensure that no matter a patient’s genetic, genomic, or hereditary background, they know that when they walk into a doctor’s office, there is an arsenal of data at their doctor’s disposal that can help them make decisions about treatment.

As life science leaders turn our attention to this issue, both at home and abroad, those who hold onto progress as a principle can and will find ways to work together and to create intersections between science and technology to push for greater equity.

Democratize Precision Care
Moving toward greater equity is already a work in progress. Some companies like Illumina are retooling their instruments to reduce costs or simplify analysis. Others like Foundation Medicine are partnering to alter current systems and workflows that challenge access. My company recently partnered with an AI-based digital diagnostics provider to make our treatment-guiding early-stage breast cancer tests more globally accessible for those who don’t happen to live close to major cancer centers in addition to committing to enrolling 30,000 breast cancer patients from a diverse demographic for an o. These are just a few examples of how we are moving forward – and we know that we can and must do more.

As an industry, we should be proud of all that we have accomplished in making precision medicine a reality, whether it has been through advances in screening, drug development, diagnostics, or delivery. However, we cannot rest on our laurels. Our work has just begun. Join me in committing to a future where our good work improves the lives of everyone equitably.

Photo: belchonock, Getty Images

Mark R. Straley joined Agendia in August 2015 as the company’s CEO, bringing more than 25 years of international experience developing and commercializing clinical diagnostics and laboratory services. Most recently he served as President, Anatomical Pathology of Thermo Fisher Scientific of Waltham, Massachusetts. Prior to this position, he was President and CEO of Metamark Genetics of Cambridge, Massachusetts, a biotech company focusing on the development of prognostic and predictive diagnostic tests for personalized treatment of patients with cancer. From 2005 to 2010, Mark held positions at Ortho Clinical Diagnostics, a J&J company, first as Worldwide Vice President of Marketing and then as Worldwide President. Prior to his assignment with J&J, Mark worked for such brand name companies as Bayer Healthcare and Abbott Laboratories where he held positions of increasing responsibility. Mark earned a Bachelor of Science degree in Marketing from Miami University.

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