The Drugs and Devices Have Been on the Market for Years. But FDA-Ordered Studies Still Aren’t Done.
Summary
An investigation by KFF Health News found that nearly 600 FDA-required or voluntary postmarket studies for drugs and biologics were delayed, sometimes for years. The delays can leave patients and physicians uncertain about safety and effectiveness while manufacturers continue selling products. Tavneos is a prominent example: its 300-patient safety study had enrolled only 21 patients by fall, while the FDA identified 76 possible drug-induced liver injury cases. The FDA is now seeking to withdraw approval, alleging that pivotal efficacy results were manipulated; Amgen denies the allegation.
Watchmen Signals
Biblical Context
The strongest biblical connection is ethical rather than prophetic. The article concerns truthfulness in reporting medical evidence, responsibility toward vulnerable people, and the obligation to weigh foreseeable costs and benefits before proceeding. Scripture condemns deceptive conduct and emphasizes prudent evaluation of a project’s cost, which can be applied thematically to accurate clinical reporting, regulatory diligence, and informed medical decision-making. These are broad moral principles, not evidence that the events fulfill biblical prophecy.
Biblical Sources
Scripture references supporting the biblical context above.
Jesus uses the example of counting the cost before undertaking a project. The passage provides a broad principle relevant to evaluating medical risks, benefits, expenses, and uncertainties before approving or continuing a treatment.
The verse condemns lying and commends faithfulness. The connection is thematic: accurate reporting of clinical results and candid disclosure of risks are ethically important, particularly in the article’s disputed allegation that Tavneos results were manipulated.
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