Sorry, but I don't know whether you've noticed a global revolution is going on. I didn't know there was an anti-intellectual movement. I just saw a growing number of people who just don't believe what they're told anymore. I'm one of those.
As for the FDA being interested in hard facts, hard evidence and scientific truth, repeating something doesn't make it true. Take statins, for example, what scientific truth are they based on? What about Vioxx that remained on the market despite adverse effects being known?
As for the gold standard double-blinded placebo controlled trials, how's that working out? I did a post on that: PEs are met through cherry picking patients, hiding adverse effects and producing a result that can't be interpreted or applied to the general population and is not what people want. Reach2 is a 'successful' RCT that met its PE but this drug has likely caused more deaths than if it had never been approved for aGvHD.
That's insane.
I don't know about the FDA being corrupt. I have a mental picture of lazy people who wave stuff through and knock off work at 5.30. As for the FDA being risk averse and careful about what's given to children, that imo is where it's worst. For one product I looked into basic safety studies were not done.
These are stem cells, something miraculous, the domain of a higher authority. The cells clearly work when you apply some basic common sense and understand that these are not drugs, have a certain way of working and need their own rules.
I watched a presentation on YT by Prof Caplan. He sounds like he really knows his stuff. He was asked if MSCs meant the end of chemo and he said, 'probably not' but he didn't sound that convinced to me. I think the battle is fierce and ugly because this is the beginning of the end of old technology - chemo, steroids and all drugs and maybe too the process of RCTs that require death to prove efficacy. I do think we could have an era of personalised medicine because of map - biomarkers that predict and confirm response.
MSB Price at posting:
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