Good Day BIO: Inequities persist in R&D

Recent data provides more evidence of the need for equity and inclusion in clinical trials and drug development—here’s what we’re doing about it. And while we know the lame duck is busy, the Senate should add two key agriculture nominations to the agenda. (551 words, 2 minutes, 45 seconds)

Inequities persist in COVID-19 trials, rare disease research

Recent publications provide more data on the lack of racial and gender diversity in medical R&D, including for COVID-19 and rare diseases.

Female patients were underrepresented in COVID-19 treatment trials, making up 52.4% of the U.S. population with COVID-19 from October 2019 to February 2022, but only 44.6% of participants in trials for COVID-19 treatments, a JAMA study shows.

And there were racial and ethnic inequities in COVID prevention trials, with Black people making up 14.1% of the U.S. COVID-19 population but only 7.2% of prevention trial participants, and Asian people making up 5.9% of the U.S. general population but only 3.8% of prevention trial participants.

Similarly, inequities persist in rare disease R&D. Sickle cell disease affects around 100K Americans, predominantly Black and African Americans. Yet, cystic fibrosis, which affects fewer than half as many (around 40K), received 3.5 times more NIH R&D funding and 440 times as much foundation funding in 2008-2017, research shows.

Why it matters: Female and Black patients with rare diseases are found to have poorer health outcomes, found a study earlier this year.

Inequities in rare diseases show up in diagnosis, treatment, and trials,writes Alexion’s Tamar Thompson, with challenges “compounded for racial and ethnic minorities and marginalized groups.”

Solutions: “Outreach and education” and “engaging early and often with patients to understand their journeys are crucial to uncovering what health inequities they face,” says Thompson.

BIO is working to make R&D more equitable—with efforts including public information campaigns to improve clinical trial representation and the diversity and inclusivity of the industry, as well as ongoing discussions on health equity and systemic bias. And a recent I am BIO podcast addressed the under-investment in women's health, due in part to lack of representation.

BIO urges confirmation of agricultural trade officials

It’s time the Senate confirms two officials tasked with protecting America’s interests in agricultural trade, says a coalition of agriculture groups (including BIO).

The situation: Doug McKalip was nominated for Chief Agricultural Negotiator in the Office of the U.S. Trade Representative (USTR) in June, and Alexis Taylor was nominated for USDA Under Secretary for Trade and Foreign Agricultural Affairs in May. Both were approved by committee votes in September, yet a full Senate vote has not occurred.

They’re sorely needed to address barriers to ag trade—particularly with Mexico, where a presidential decree to block imports of biotech corn in 2024 has sparked a threat of U.S. legal enforcement action.

And they’re strong candidates: McKalip says biotechnology is essential to food supply and advocates using “every tool” we have under USMCA to protect it, while “Taylor is a widely recognized leader on agriculture policy and has the domestic and international experience to shepherd U.S. agriculture through growing global changes,” BIO says.

BIO’s been calling for action—joining agriculture and food groups in earlier letters to Senators to support the confirmations of McKalip and Taylor.

What needs to happen: The current Senate session ends Jan. 3. “We urge the U.S. Senate to confirm Doug McKalip and Alexis Taylor by the end of this year,” the latest letter says. “American agriculture needs experienced leaders representing us in international negotiations.”

President Biden’s Tuesday: Signing the Respect for Marriage Act at the White House.

What’s Happening on Capitol Hill: The House Committee on Veteran’s Affairs will hold a hearing on the Veterans Affairs Department’s response to the pandemic. A subcommittee of the Senate Agricultural Committee will hold a hearing on “food as medicine.”