first opinion
Diversity matters in preclinical research, too
Adobe
The FDA started reporting on racial representation in clinical trials in 2015. The idea was that raising awareness of the lack of diversity would drive change. Years later, the FDA is still reporting, and the reality hasn't shifted. But in a First Opinion essay, life sciences consultant Sophie Zaaijer points to a rarely discussed representation problem even earlier in the pipeline: preclinical risk assessments.
These early evaluations are often based on human cell lines. And while the first and most famous cell line came from a Black woman (Henrietta Lacks), the majority of human cell lines come from people of European descent. "This ongoing monochromatic approach in preclinical R&D fails to capture the rich tapestry of human genetic variation, painting a portrait of humanity with a limited palette," Zaaijer writes. Read more.
cardiovascular health
Women are more likely to die of postoperative heart complication
When it comes to the most common complication after heart surgery, atrial fibrillation, a new study found that women were more likely than men to die from the condition. The research, published yesterday in JAMA Network Open, is based on data from more than 21,500 patients who developed postoperative atrial fibrillation after open heart surgery at two care centers in Massachusetts.
Postoperative atrial fibrillation occurs when a patient experiences an irregular, rapid heart rhythm. Some previous research has found that men have a greater risk of developing the complication than women, while other studies have found no difference. The lack of clarity may be due to an overall small sample size, the authors wrote. It also remains unclear why any differences in incidence or survival of the condition may differ by sex.
disability
New Alzheimer's drugs may be dangerous for this at-risk group
About 30% of people with Down syndrome in their 50s have Alzheimer's — it's the population with the highest prevalence of the disease. But anti-amyloid drugs like lecanemab and donanemab still largely aren't prescribed to them.
Ultimately, that may be for the best. In a study testing lecanemab on post-mortem brain tissue published this week, researchers determined that the population might face higher risk factors.
The conclusion comes more than a year after the FDA approval of the drug. (Donanemab was approved earlier this summer.) People with Down syndrome have historically been excluded from Alzheimer's clinical trials. More than 18,000 people have participated in trials for these types of drugs, but none of them had Down syndrome. Read more from STAT's Timmy Broderick on what makes people with this condition more susceptible, and what researchers are trying to do about it.
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