Visible Hands: Diversity, Equity, and Clinical Trials? 💉

Promising vaccine trial data has been announced. But what does this mean for underserved communities?

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This week, Pfizer / BioNTech announced that their COVID-19 vaccine is 95% effective, and Moderna announced 94.5% effectiveness for their vaccine. Folks trying to leave their homes without masks and the stock market rejoiced. But what does this mean in terms of vaccine delivery? What might this mean for communities disproportionately impacted by the pandemic?

Delivering vaccines, which often require storage at cold temperatures, to remote communities has required significant innovation. For example, vaccine vial monitors (aka “the world's smartest sticker”) are mandated for all UNICEF procured vaccines to monitor temperatures and differentiate between damaged versus viable vaccines. The Pfizer COVID-19 vaccine must “be stored at temperatures of about -100°F and will be delivered in dry ice-packed boxes holding 1,000 - 5,000 doses.”

It will be a logistical nightmare to get this vaccine to people far from major cities. As ProPublica uncovered, most states are underprepared: “Arizona expects the Pfizer vaccine cannot be handled by the state’s rural communities and tribal lands. North Dakota and Oregon aren’t sure how to take care of migrant workers.” Even if this vaccine gets on site, storage at hospitals won’t be easy; “the easiest option is using ultracold freezers, but not many sites have them.” According to Dr. Fauci, front-line healthcare workers are expected to get their first doses by December / January, followed by higher-risk individuals, and then the general population can expect first doses starting in April.

It’s important to remember that vaccine delivery has always been inequitable globally and domestically. But communities of color in the U.S. have had higher rates of COVID-19 infection, hospitalization, and death. There are plenty of ethical arguments why these groups should be among the first to receive a vaccine: affected communities tend to be of a lower socioeconomic status, have less ability to work remotely, and tend to live in multi-generational households. Yet, public health experts are concerned that health agencies and drug companies may “become complicit in allocation strategies that, once again, disproportionately favor the better-off, White majority.”

Racial equity in clinical trials have had a fraught history (e.g., the Tuskegee syphilis study and the story of Henrietta Lacks). Moderna slowed down its trial because its private contractor was unable to find enough Black, Latino, and Native American participants. (A month later, they had enrolled “11,000 people of color, or 37% of the trial population.”) 

Diseases that impact historically underrepresented populations have seen less resources for research and novel drug development. For instance, sickle cell disease (SCD) has received much less R&D funding compared to cystic fibrosis (CF), though both diseases are severe, rare, inherited disorders (CF is actually less common!). Notably, SCD primarily affects Black patients whereas CF primarily affects White patients. Coincidence? 

Additionally, women are underrepresented in clinical trials, and women’s health is under-researched. National Institutes of Health clinical trials didn’t require female participants until 1993, and this mandate doesn’t apply to FDA trials. According to Diana Zuckerman of the National Center for Health Research, “How does it make any sense that the agency that’s deciding which drugs and devices should be approved is the one that doesn’t have to worry if there are women or people of color or people over 65 or any other group in the clinical trials?”

Unsurprisingly, decisionmakers in the biotechnology / pharmaceutical industry are not diverse. In 2018, men named Michael outnumbered all female CEOs presenting at the largest healthcare industry conference. And biopharma management teams include very few people of color (just check out Pfizer and Moderna). 

Health inequities reflect broader societal inequities. How can healthcare companies and government agencies ensure underserved populations receive proper care and treatment? 

Actions:

 As a consumer (or in this case, patients):

• Health startups like Tia and Spora Health are “modernizing” healthcare to serve women and communities of color, respectively. If you are of these demographics and unhappy with the way your current healthcare experience, check them out.  

• DrugViu is working to increase the amount of data from patients of color, specifically for autoimmune diseases.

As a investor:

• You can make an impact on the diversity of these companies and their boardrooms. If you invest in these public companies, consider whether the board reflects the patients the companies are purporting to serve when you vote in shareholder proxies. Support proposals that increase reporting on diversity metrics and strategies that increase health equity. This Bloomberg article on diversity quotas highlighting how mandating women on board for California-based companies has led to more opportunities for previously overlooked executives. (According to this law, at the close of 2021, boards with five directors must have at least two women, and those with six or more have at least three.)

Further Reading:

 As an employee:

• If you are at a healthcare organization that needs a more representative workforce, these case studies describe what hospitals did to improve diversity. Interventions ranged from bias training to working with nonprofit community partners. 

• Quality Interactions offers healthcare-specific diversity, equity, and inclusion training and robust blog content.  

As a citizen:

• We are in the middle of a tumultuous presidential transition and a deadly pandemic. As NYMag wrote: “Without briefings on the effort with Pfizer and other firms, the incoming Biden administration fears that it will be playing catch-up on day one, rather than moving swiftly on informed policy to slow the spread of a pandemic … [A] senior adviser to Biden told the Times that they are working on figuring out the logistics themselves, including the distribution of the vaccine along racial and socioeconomic lines. As the paper notes, that is a priority of Biden’s pandemic plan, but is ‘rarely discussed by Mr. Trump.'”

  

• SEC Chairman Jay Clayton to leave agency at end of 2020: “Mr. Clayton’s successor will likely prod public companies to include more disclosures of risks related to climate change, Democratic regulators and consultants say. The commission is also likely to set clearer rules for mutual funds that emphasize companies’ environmental, social and governance-related goals.”

• The pandemic is showing us how capitalism is amazing, and inadequate: “The private sector’s capacity to develop innovative drugs is not necessarily something that happens because bold business executives manage their companies better than the less commercially minded public sector. Rather, in the United States and Europe, the progress toward virus treatment and prevention reflects an interlocking set of institutions: from the state, funding for basic research, patent enforcement and safety regulation; and from industry, the ability to turn raw ideas into a marketable product.”

• Kim Ng finally -- finally! -- lands general manager job in Major League Baseball: “In those 93 years, there were women before Ng who were qualified for the job and lost it because of fear. Not their own fear, mind you. Every woman who has worked her way up to the highest levels of a male-dominated business has been overqualified, tough as nails and afraid of nothing save perhaps the fragility of men standing in the way of her success one more time.”

• The election was a chance for Facebook and Twitter to show they could control misinformation. Now lawmakers are grilling them on it: “Lawmakers circled around important issues about how the tech companies handled misinformation during the election. But they repeatedly failed to gain new information about whether the many new interventions tech companies applied during the 2020 election were effective in cracking down on the spread of falsehoods and other inflammatory content.”

• Corporate leaders need to step up and protect Black votes: “Surveys show Americans want CEOs to play a role in protecting our democracy. They must step up. If corporate leaders—who make millions of dollars a year off of Black purchasing power—can’t defend Black votes, we cannot trust them to defend Black lives. The thousands of companies that issued statements of Black Lives Matter earlier this summer must now join us in condemning candidates who spread lies and misinformation in an attempt to undermine the election.”

• All those used delivery boxes are a hot commodity: “This surge in cardboard delivery boxes is helping to make mixed paper more valuable. The longer fibers in the cardboard make mixed-paper pulp stronger, allowing mixed paper to be used to make tissue paper and new cardboard for e-commerce boxes and other containers.”

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