To the Editor — On Memorial Day this year, the senseless murder of another unarmed black man in Minneapolis, Minnesota, touched off days of protest against police brutality and racial inequality. In the ensuing months, disturbing videos of George Floyd and other minorities killed and mistreated by police have filled our television screens and stirred the American conscience. Meanwhile, the worst pandemic in a century rages unchecked across the globe, hitting communities of color the hardest because COVID-19 preys on the immunocompromised in a time when too many African Americans struggle to access quality healthcare.
The world is waking up to the reality that this new, cutting-edge industry called biotechnology is humanity’s best and only hope to eradicate the COVID-19 threat. Biotechnology is also the most powerful tool we have to broaden access to clean air and water, nutritious foods, breakthrough medicines and sustainably made consumer products.
At this galvanizing moment of national awakening, the Biotechnology Innovation Organization (BIO) is challenging our industry and its members to walk the walk of racial equity in hiring and promotions, clinical trial enrollment and the bioeconomy.
We believe that the biotech industry can not only save lives, but also advance equal opportunity and social justice by creating more entry points for minority scientists and more advancement into leadership positions. We also have an obligation to make sure our transformative scientific breakthroughs are accessible and affordable to under-represented communities.
BIO recognizes that these are not overnight fixes and that to be successful we need an actionable plan. So last month, as the world’s largest biotechnology advocacy association, we rolled out our BIOEquality Agenda. We are leading a national effort in collaboration with our partners and member organizations in the biotechnology sector to support stronger and healthier communities. The effort will be organized around three pillars (Box 1): health equity, investment in current and future researchers, and expanded opportunities for women and other under-represented populations.
I took over as BIO’s president and CEO on 1 June of this year. A decade earlier, I was a newly appointed associate science director at the US Food and Drug Administration (FDA) when the Office of Minority Health was launched. A white paper at that time noted that African Americans represented 12% of the US population, but only 5% of clinical trial participants. Hispanics were 16% of the population, but only 1% of trial participants.
Ten years later, we continue to see substantial under-representation in phase 3 trials, where thousands must enroll before a medicine is approved. According to a disheartening report press-released by Tufts University, although the level of data available on participant representation by sex and age showed notable improvement from 2007 to 2017, participant representation by race and ethnicity did not. Black participants were under-represented by more than 20% relative to proportionate levels in clinical trials for 80% of all drugs and biologics approved by the FDA during 2007–2017. Hispanic or Latinx were under-represented by 62%.
BIO has already begun working with organizations outside our industry who really understand these under-represented communities, including the National Association of Black Churches and the National Urban League. Together, we will develop and implement strategies that seek to better educate those who enroll participants and build bridges in the African American community.
There is an understandable legacy of mistrust when it comes to medical testing and trials. The Tuskegee study on syphilis in black men took place without participants’ informed consent for more than 40 years while many went untreated. Even once it became clear that penicillin was effective, many were not given adequate treatment for their disease.
To make sure the treatments for COVID-19 and other illnesses are safe and effective on members of minority and vulnerable populations, it is important to have their participation in clinical trials. So we need to build confidence, have an open and honest dialogue about the past, and work with local community leaders who can be that trusted voice.
While the BIOEquality Agenda will address inequities in healthcare delivery, STEM (science, technology, engineering and math) programs and minority entrepreneurship, BIOEquality complements the Right Mix Matters initiative we launched last year to accelerate gender, racial, ethnic and LGBTQ (lesbian, gay, bisexual, transgender and queer or questioning) representation on biotech company boards, in C-suites and in functional leadership positions.
BIO is deeply committed to both BIOEquality and the Right Mix Matters campaign. In these difficult and uncertain times, we will continue to build support for a more equitable future for the biotech sector and the millions of patients across the world who depend on our success.
M.M.-H. works for industry trade organization the Biotechnology Innovation Organization (BIO). She was employed by Johnson & Johnson and holds stock in Johnson & Johnson.
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McMurry-Heath, M. BIO’s plan to promote opportunity and access for the underserved. Nat Biotechnol 38, 1123–1124 (2020). https://doi.org/10.1038/s41587-020-0688-8