https://www.levernews.com/fda-approved-and-ineffective-database-explainer/
Too long didn't read.
Certainly. Here's a paragraph-style TLDR of the “FDA Approved — And Ineffective” Database Explainer:
Over the past two years, an in-depth investigation reviewed all 429 new drug approvals granted by the FDA between 2013 and 2022, assessing whether the studies supporting those approvals met four long-established scientific standards: randomization, blinding, replication, and use of clinical (rather than surrogate) outcomes. These criteria are rooted in 1962 regulations that remain the legal foundation for proving drug efficacy in the U.S. The investigation did not examine drug safety or post-market data, but focused solely on whether the FDA had sufficient scientific evidence, at the time of approval, to assert that a drug was effective according to its own regulatory standards.
The findings are troubling: nearly three-quarters (73%) of new drug approvals failed to meet one or more of the four criteria. And because reviewers were trained to err on the side of generosity toward drug sponsors — counting borderline or partial efforts as successes — the true proportion may be even higher. Notably, the FDA has increasingly accepted surrogate endpoints (like lab tests or tumor size) instead of clinical outcomes (such as longer survival or reduced hospitalizations), despite longstanding concerns that surrogates do not reliably reflect real patient benefit. Similarly, many approvals were based on single studies or uncontrolled trials, contradicting the agency’s historic emphasis on replication and control arms.
The review highlights a broad pattern, not a few isolated lapses. High-profile controversies like those surrounding Aduhelm (Alzheimer’s) or Relyvrio (ALS) are not exceptions but examples of a larger systemic problem. While there are legitimate circumstances — such as the Ebola outbreak — in which expedited approvals based on limited data may be warranted, the investigation suggests the FDA has normalized these exceptions across a wide range of drugs, including many with less urgent clinical need. Even when randomized, controlled, blinded trials using clinical outcomes are conducted, methodological weaknesses (like unblinding, selective reporting, or biased comparators) can still undermine reliability.
In short, the FDA has shifted from being a global leader in stringent drug regulation to an agency that frequently approves drugs based on incomplete or weak evidence. This change, often justified in the name of speed or innovation, has come at the cost of scientific rigor and leaves both physicians and patients with limited assurance that newly approved drugs will truly work as claimed.
