Thursday, July 2, 2020

Racial disparities in healthcare innovation in the time of COVID-19

In previous posts, we have explored how structural racism contributes to disparities in COVID-19 cases and deaths and in access to COVID-19 treatments and preventatives. Legal institutions have also been complicit in creating a healthcare innovation system in which those receiving scientific and medical education are far from representative of the U.S. public. The resulting disparities by race, gender, and class raise substantial problems for both equity and economic growth—but these inequalities receive too little attention from most health and innovation scholars, ourselves included. This week, we examine how the COVID-19 pandemic has highlighted and exacerbated racial disparities in three slices of the healthcare innovation ecosystem: medical education, medical patenting, and clinical trials.

Racial disparities in medical education

The U.S. healthcare system is pervaded by inequality not just in access to care, but also in the profession itself. In 2008, when the American Medical Association (AMA) finally apologized for a long history of exclusionary policies, the percentage of African American physicians and medical students was just 2.2%—even worse than the 2.5% a century earlier. In the past five years, 5.7% of U.S. medical school graduates have identified as Black or African American. But there is far to go in making the profession more representative of the U.S. public.

As in other areas, the law has long enabled these disparities. In 1889, the Supreme Court upheld a West Virginia law restricting access to the profession for those without a “diploma of a reputable medical college,” and today, all state medical boards require a degree from an accredited medical school. The 1910 Flexner Report requested by the AMA—which helps accredit schools—recommended closure of five out of the seven African American medical schools operating at the time. Only Howard and Meharry remained open by 1923, and most other medical schools were closed to or skeptical of aspiring Black physicians.

In addition to creating barriers to entry into the medical profession, legal institutions have expanded the activities requiring licensure. For example, until the 1940s, Black midwives provided most prenatal and childbirth care to Black women in the United States—an essential service, at a time when many white doctors and midwives would have refused to care for them. But these midwives were regulated out of existence through state scope-of-practice laws and the Sheppard–Towner Act of 1921, which provided federal funds to states for professionalized prenatal care.

In the midst of a pandemic, a physician workforce that does not represent patients is problematic both because Black patients are less likely to face discrimination from Black doctors and because Black doctors—and other medical workers such as nurses and technicians—have been hit hardest during this crisis. They have spoken out in recent weeks about their frustration and fatigue. Professor Adia Harvey Wingfield, a sociologist who focuses on Black health care workers, fears that COVID-19 may cause “a setback of the modest advances the medical industry has made towards improving racial diversity.”

Racial disparities in medical patenting

Racial disparities in medical education parallel (and may exacerbate) similar disparities in the medical innovation ecosystem—medical patenting, in particular. Doctors tend to be user-innovators, contributing to innovations in pharmaceuticals, medical devices, and surgical methods, many of which go on to be patented (though surgical patents have legal force only in the narrowest of circumstances). A lack of Black physicians and other Black medically trained professionals means a lack of Black medical patentees—and a gap in who is likely to be remunerated from contributions to medical innovation.

To be sure, racial disparities in patenting are neither new nor limited to the medical profession. Although America has always had Black inventors, the U.S. Patent and Trademark Office specifically excluded Black inventors until Reconstruction. As recently retold by Professors Kara Swanson and Brian Frye, an enslaved man, known as Ned, invented an improved “double cotton scraper”; a slaveowner then filed a patent application for the device. In 1858, the application was rejected by the Patent Office in an odious legal opinion, Invention of a Slave, that grounded itself in the Dred Scott decision, concluding that Black people were unfit to take the inventors’ oath. Following the Civil War—up until at least 1940—non-white inventors constituted roughly 3% of patentees—while then comprising roughly 10% of the U.S. population.

Such a disparity was not merely the result of legal restrictions, but a product of systemic violence against Black Americans during the onset of the Jim Crow era. Professor Lisa Cook has meticulously constructed patenting rates of Black inventors from the Civil War until today, laboriously teasing out Black patentees from census and archival data, historical directories, obituaries, and even printed programs from Black inventor fairs. Matching patent data to lynchings and race riots common in the late-nineteenth and early-twentieth centuries, Professor Cook documented a steep decline in the rate of patenting by Black inventors as violence increased in the United States—accounting for a loss of roughly 1,100 patents from Black inventors during a 70 year period. Extrapolating a bit from Professor Cook’s data summaries, this would have meant a loss of roughly 17 drug and medical patents from Black inventors during that time—including 1918–1920 during the flu pandemic.

Today, structural barriers—a product of centuries of overt and structural racism—remain an impediment to Black medical innovation. First, patents are not cheap—they can cost tens of thousands of dollars from preparation to issuance, and actually bringing an invention to market can cost orders of magnitude more. In a world stratified by racial disparities in wealth (and access to capital), this is likely to contribute to a significant deficit of Black inventors. Second, exposure to “centers of innovation”—specifically, areas of high socioeconomic status, strong education systems, geographic areas that produce a larger number of patents—is correlated with a strong likelihood of becoming an inventor oneself. Given the racial disparities in these measures, this further contributes to the paucity of Black patentees. And third, as shown by Professor Cook, concerns over violence and personal safety—emblematic in the ongoing spate of police violence against Black citizens—have dampened innovation. Black patenting rates—even in 2010—continued to lag behind those of 1899.

Like many other illnesses, innovations to treat and diagnose COVID-19 come largely from the medical profession. With a diminished roster of Black physicians, and consequently, Black physician-innovators, a dearth of Black patentees ensures that those suffering the most from the disease have not been afforded equal opportunities to cure it.

Racial disparities in clinical trials, including for COVID-19

These racial disparities in medical education and in innovation extend to the clinical trial context as well. As we have discussed, emerging data show that communities of color, and particularly Black Americans, are being hit disproportionately hard by the COVID-19 pandemic, being more likely both to contract the disease and also to experience serious illness or death as a result.

But if history is a guide, it is unlikely that the clinical trials designed to test the efficacy of new treatments and vaccines against COVID-19 will be equally available to communities of color. Black Americans in particular are underrepresented in clinical trials of new medicines, and particularly underrepresented in certain therapeutic areas, such as oncology. Black patients made up just 4% of clinical trial participants for new oncology drugs approved in 2019, despite having higher death rates from most cancers. Clinical trials are therefore less likely to gather data on the efficacy of drugs in Black patients. As the FDA itself acknowledges, race is a social construct rather than a biological one, but many drugs do demonstrate differential efficacy in minority populations, due to environmental factors, the disproportionate burden of other chronic illnesses, and other factors.

A wide range of factors contribute to the racial disparities in clinical trial participation, but one is certainly the United States’ history of unethical medical experimentation on and exploitation of communities of color and particularly on Black people. Perhaps most notable is the Tuskegee syphilis experiment from 1932 to 1972, in which the U.S. government sought to study the course of the disease when untreated in Black men. The men never consented to the study, and perhaps most shamefully, when an effective syphilis treatment was developed, the researchers did not offer it to the men. Another prominent example is the story of Henrietta Lacks, a young Black woman undergoing treatment for cervical cancer whose tissue samples were taken and commercialized without her knowledge.

To be sure, we do not mean to ignore here the vast history of racial discrimination in medical treatment more generally. Even after the federal government used Medicare as a financial tool to force the desegregation of American hospitals (through Title VI of the Civil Rights Act), hospitals continued to turn away patients who were un- or under-insured, including women in active labor, leaving them to suffer from additional complications and mortality. A disproportionate number of these patients were minorities. It was only in 1986 that the federal government passed a law to remedy this practice, the Emergency Medical Treatment and Active Labor Act (EMTALA), to ensure that hospitals cannot reject patients in need of emergency medical treatment, but other forms of discrimination persist.

Putting it all together, not only does COVID-19 disproportionately impact Black and other minority communities—the entire medical innovation system fighting the epidemic is rife with systemic disparities. To improve disparities in the care that Black patients receive, both during the pandemic and after, policymakers should aim to increase Black participation throughout this ecosystem, including in medical education, in patenting, and in clinical trials. The NIH’s search for a COVID-19 vaccine is currently being led by a brilliant Black woman, Dr. Kizzmekia Corbett. Inequality in innovation has been framed in terms of “lost Einsteins,” but a better question might be: How many lost Dr. Corbetts are we missing out on?

This post is part of a series on COVID-19 innovation law and policy. Author order is rotated each week.

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