As the delta variant ravages communities throughout the Unites States, it is important to look past the data and remember that every infection, hospitalization and death leaves an indelible mark on that patient’s family and community. And few communities have suffered as much as Black communities in the South. This week we look at this tragedy—and the strength of the people and communities left behind. We also highlight large employers working to address racial disparities in health care, how the U.S. Food and Drug Administration can increase consistency, and a doctor that discovered an entirely new class of diseases. Finally, we explore the promise and remaining challenges to making use of real-world evidence in clinical trials.
Each week we highlight five things you need to know in the life sciences industry. Here’s the latest.
1. A visual journal through the impact of COVID-19 on Southern Black communities
Black Americans and other communities of color have suffered disproportionately throughout the pandemic. This week, Stat News published visual stories exposing this suffering and highlighting the strength of these communities in the face of the pandemic: from closed medical centers, to a daughter’s struggle after her mother’s death, to rural vaccination drives and the people who staff them. With the numbing onslaught of data documenting the pandemic, it is easy to lose sight of the personal tragedy and the strength of the people behind those numbers.
2. Large employers leverage virtual care to address disparities in health care
A coalition of companies that employ over a half million African American workers has banded together in an attempt to address disparities in health care. These companies, including the likes of Walmart, Genentech and Medtronic, have partnered with virtual health care providers to ensure their workers have access to care in communities that have historically been underserved.
3. How the FDA can be more consistent when making difficult approval decisions
The FDA has faced criticism recently because of apparent inconsistency in approvals under accelerated approval pathways, most notably with its recent decision on an Alzheimer’s drug. In a study funded by the FDA and conducted by the FDA and Stanford, the findings recommended that the agency build a database of related decisions and the criteria used can allow for more transparency and consistency when they must make narrow decisions.
4. A doctor’s quest to identify and treat autoinflammatory diseases
What started as a project to understand the genetic cause of one patient’s ailment, a disease known as familial Mediterranean fever, has led one doctor to identify an entirely new class of diseases. These diseases, which are characterized by bouts of fever and inflammation, were once viewed as individual, genetic disorders. However, now that similarities have been identified, new treatments are quickly following and offering relief for patients.
5. Real-world evidence offers great promise in clinical trials, but is still difficult to get right
Modern electronic medical records and the ever-growing pool of health data collected from patients offers great promise to biopharma companies looking to understand how their drugs perform in the real world. However, this real-world evidence also presents new challenges ranging from varying demographics of patients to just the sheer volume of data to analyze and understand. This article in Clinical Leader looks at the most critical challenges that biopharma companies need to address when using real-world data.
