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The FDA Is Approving Drugs Without Evidence They Work
(jacobin.com)
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this post was submitted on 05 Jun 2025
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The article brings up some great points, some of which that I, an industry insider, weren't even aware of, especially the historical context surrounding the AIDS epidemic. I'll jump into the thread to critique an issue within the article.
One of the four pillars recommended by the FDA (control groups) are great in theory but can lead to very real problems in practice, specifically within indications that have an unmet treatment need or are exceptionally rare conditions.
If you have a disease that is 99% fatal but has 0 standard of care treatment options, is it ethical to ask a participant to enroll in a clinical trial and potentially not receive the study treatment/be on placebo? Or, what if the trial involves an incredibly invasive procedure like brain surgery - is it ethical for people to do a placebo procedure? Food for thought - and an explanation for why so few trials meet all four criteria proposed by the FDA.
Happy to answer questions about the industry if anyone has them.
Medicine has always relied on killing enough patients to determine how safe/effective or not a drug or procedure might be. We simply do not have the technology to provide definitive answers any other way as of yet. This is why one "practices" medicine and not "does" medicine. And administering a drug to a patient is called a "trial." There is simply no way to know the outcome until the outcome arrives. Years of experience can give you a fair indication of what to expect, but expectations are not definitive answers.
As a keynote speaker ER Doctor stated at an EMS seminar I attended, "No matter how much knowledge and skills we think we know and have, modern medicine still boils down to doing things to keep the patient amused and letting nature take it's course." As a simple medic, that was a thought that stuck with me through my 15 years in the back of the bus. It scared the bejeezus out of me.