We all want to help people with critical illnesses, but we should get beyond the slogans and hyperbole. I don't have access to the latest version (it keeps changing) but i'm worried by what i see.https://twitter.com/califf001/status/973515426859814912 …
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4. 90% of drugs entering phase 1 don't make it to market either because they don't work or excess toxicity. Even if restricted to "beyond phase 1" drugs, over half have net negative effects (M Hay, Nature Biotech 2014). Most experimental drugs will hurt and may do harm
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5. Critically ill patients are vulnerable. its critical that if this bill goes through, there is a process for consent to experimentation. Even then extra care is required to make sure desperate people and families understand.
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6. Who will pay? if this opens up a "cash and carry" business for these patients it will recapitulate previous "snake oil" experiences in the US. This is especially concerning for cell tx and regen medicine where unproven therapies are already being peddled for cash.
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7. FDA policy already recommends access when a pt can't participate in a trial. We should focus on access in the context of learning which treatments work. The results of uncontrolled cash access to experimental tx are predictable. there is a history here worth reading
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8. in summary we should continue to strive to find the right match for experimental therapies for critically ill patients that also informs future generations so they can benefit with evidence that enables coverage. This bill doesn't seem to do that.
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