In this series, we explain why we invested in our current portfolio companies. In the process, we hope to highlight the white spaces in women’s health and the life sciences — as well as the people, products, and companies working to fill those gaps. The name “Under the Microscope” refers both to our extensive due diligence process and our investment focus on healthcare and the life sciences.
When individuals use a healthcare product, they’re assuming the product will work safely and effectively. For white men, those assumptions are usually a reality.
The ethnic makeup of participants in clinical trials, which test healthcare products before they become commercially available, remains around 86% white and usually male. However, white men can have entirely different experiences with the same product from women and/or people of color; carbamazepine, for example, can treat epilepsy but can also cause a severe skin disorder in patients of Asian heritage with a particular gene variant: one that white patients don’t share. Without proportional minority enrollment in clinical trials, though, researchers don’t always have the data to identify any race- or sex-based differences in the side effects, safety, or even efficacy of a certain product
This data gap persists across trials for nearly all medical fields, including oncology drug trials and COVID-19 vaccine clinical trials. In its Phase I coronavirus vaccine trial, Moderna, for instance, had only ten people of color out of 45 total participants — though people of color in the United States are more likely to be infected with, be hospitalized due to, and die from COVID-19 than white Americans are. (In a later-stage study, Moderna did temporarily pause trials to enroll a proportionate number of people of color.)
This underrepresentation is not new. In 1993, Congress passed the National Institutes of Health Revitalization Act, requiring NIH-funded research to include a certain percentage of both women and people of color. The law was a positive step forward, but NIH-funded research trials make up only 6% of all clinical trials. In contrast, 40% of the population is a racial/ethnic minority.
Various barriers to entry for possible participants of color help perpetuate this underrepresentation. They often don’t have the same access as whites do to health systems connected with clinical trials, to health insurance, which may be a prerequisite for clinical trial participation, or to healthcare providers they trust. A 2011 study, which focused on Black Americans specifically, found 25% of survey responders expressed a high level of doubt that their physician would be forthcoming with them or would even would stop their participation in a clinical trial if serious harm were anticipated.
This distrust is not without precedent. In the Tuskegee Syphilis Experiment, which started in 1932, poor black men with syphilis went untreated, left to die, go blind or insane, or experience other severe health issues. Another example is Henrietta Lacks whose cells were taken in 1951 — without her consent or knowledge or her family’s — and were subsequently used to enable cloning, gene mapping, in vitro fertilization, the polio vaccine, and cancer research while Lacks’ family remained in poverty. Lacks’ name was first leaked in the 1970s, but she remained mostly invisible until a book sharing her story was published in 2010. Recently, one out of three Black people expressed hesitation about one of the latest scientific developments: the COVID-19 vaccines. In January 2021, Tyler Perry, an actor, director, and studio head, received a vaccine publicly both to encourage others to receive it and to alleviate collective worry about further exploitation of Black bodies.
Without communities, medical experts, and even celebrities to change it, the the discrepancy between the clinical trial participants and the general population continues to grow — and at a cost. Research published in 2018 found that eliminating race-based health disparities could save $135 billion per year: $93 billion in excess costs for medical care and $42 billion in “otherwise hampered productivity”.
DrugViu, a real-world evidence (RWE) company and clinical research platform, is reaching communities of color and collecting data on their experiences in a way that clinical trials historically haven’t.
DrugViu has built a platform through which, with permission, the company collects, abstracts and combines all the user’s medical records on one platform and provides it back to the user in a chronological and easy to navigate way on their own secure portal. Users upload their self-reported health outcomes, medication efficacy and side effects tied to their medical records to create a new data asset and a symbiotic relationship: the medical records validate the patient-reported outcomes while the patient-reported outcomes enrich the medical records.
Interested parties can search based on specific aspects, such age, sex, race or all the above, to see how others like them reacted to a specific medication, including side effects, safety, and outcome. DrugViu, as a result, has the potential to become the go-to for communities of color who don’t see their experiences currently represented in clinical trials but who want to educate themselves and make the best healthcare decisions possible.
DrugViu can also benefit these individuals long-term by helping researchers recruit clinical trial participants that are proportionally reflective of the product’s target population, saving distrust, money, wariness, and unexpected health issues in the future. The company’s first focus is improving recruitment specifically for clinical trials for autoimmune disease (AID), which affects over 23 million Americans. About 80% of those diagnosed are women. Black individuals, meanwhile, have the greatest chance of being diagnosed with specific types of autoimmune diseases, such as systematic lupus erythematosus (SLE), but, while they make up 43% of prevalent SLE cases, they represent only 14% of enrollees for randomized clinical trials. Whites, Hispanics, and Asians, respectively, represent 33%, 16%, and 13% of prevalent cases while they compromise 51%, 21%, and 10% of clinical trial participants.
DrugViu can help change these numbers to be representative: fueling the work that the 1993 NIH Revitalization Act started, expanding it to trials outside the NIH’s jurisdiction, and starting to eliminate the physical, mental, and economic costs that come with a non-proportional clinical trial population. We believe that DrugViu’s work can readjust the status quo for clinical trials so that, in the future, white men won’t be the only individuals who will be able to trust that a healthcare product will work for them safely and effectively.
At Avestria Ventures, we look for early-stage women’s health and female-led life science companies with products or technologies that improve healthcare quality and/or access, lower costs, induce clinical or behavioral change, are evidence based, have scalable commercialization plans, and have a sustainable competitive advantage. Know one? Contact us via our website, LinkedIn, or Twitter.