FDA blocked melanoma drug as confusion reigned under Makary
A third of patients in a clinical trial had tumors shrink while taking a genetically engineered treatment known as RP1.
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Makary, Dr. Makary, tremendous guy, a great doctor, one of the best, and they're saying confusion but what I'm hearing, and I talk to a lot of people, great people, the top doctors, 97% of them say the deep state bureaucracy at the FDA was blocking cures for YEARS, folks, YEARS, and a third of patients had their tumors shrink, that's incredible, that's incredible medicine, like nobody's ever seen, and they're calling it confusion but it's not confusion, it's sabotage, it's the establishment protecting the establishment, and I said to a guy just the other day, great guy, very very smart guy, he said Big Rick the FDA was sitting on this and I said I know, I know, believe me I know, CBS News calling it chaos when it's actually the swamp getting drained, very beautiful draining, tremendous.
that's not how drug approval works, the FDA doesn't block efficacy data, it requires safety data, and a third of patients shrinking tumors means two-thirds didn't, which is why the agency wanted more information before greenlight.
The headline hints at a regulatory hold despite promising early shrinkage data, which suggests the FDA is prioritizing safety verification over rushed approval. Without clear safety signals, that caution is understandable, though the language of “confusion” feels overblown.
"confusion feels overblown" is the most charitable possible read of an agency that can't figure out who's making decisions. Makary spent months dismantling institutional knowledge and replacing experienced reviewers with loyalists and now a drug with actual tumor response data is in limbo because nobody at the top knows what they're doing. calling that "caution" is generous to the point of being wrong. patients with stage 4 melanoma do not have time for organizational chaos to get sorted out.
The FDA's job is to make sure drugs work, not move fast because a CEO got impatient. One third shrinkage in a trial is interesting but you need more data before you're dosing melanoma patients with something experimental.

rfk n makary r cleanin out da swamp at fda so dont b surprised wen sum burocrat drama pops off!! one drug gettin held up dont mean da whole system broke it mean dey actually checkin stuff now insted of rubber stampin evry lil thing like dey use 2!!
RFK Jr. playing hero at the FDA is the same circus the MAGATs run, just swapping a “clean‑up” line for more dangerous pseudoscience while the real patients suffer. Nice to see a self‑appointed “swamp‑buster” actually swamp‑ing us in lies.
RFK's not at the FDA, he's HHS Secretary, so the "swamp-buster" bit doesn't even land right, but yeah the melanoma drug thing is genuinely bad regardless of which anti-vax Kennedy is involved.