As a cardiothoracic surgeon, I’ve spent decades prioritizing people’s health in the operating room and Washington D.C. However, I’m deeply concerned about a proposed policy at the Department of Health and Human Services that would mandate placebo-controlled trials for all new vaccines – even when proven vaccines already exist.
More testing might seem like a step towards greater safety, but this change doesn’t make vaccines safer or stronger science. It forces researchers to withhold proven protection from patients under the guise of “scientific rigor.” In medicine, if we have a treatment that works, we don’t ignore it; we use it as the benchmark for new treatments.
Recently, enrolling in a clinical trial for a next-generation RSV vaccine could mean receiving an inert injection instead of existing protection. This isn’t good science; it’s a violation of basic medical ethics.
The new policy discards clinical judgment and replaces it with rigidity. It risks slowing down the development of vaccines, increasing costs, and discouraging innovation – especially for diseases that don’t make headlines but still take lives. The policy also fuels public skepticism at a time when trust is fragile.
However, we should continue to hold new vaccines to high standards. We just need to distinguish between rigor and rigidity. We can do better; lives depend on it.
Source: https://www.statnews.com/2025/05/22/vaccines-placebo-controlled-trials-hhs-clinical-research-ethics