3. I worked in critical care for several decades. Critically ill people need clinicians who understand their illness and their wishes. Matching an experimental therapy to a patient's biology and illness requires time and skill. The FDA paperwork is the least time issue.
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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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Dr. Califf; as a 30 year long patient with incurable illness and a patient advocate, I really wish that we didn't have to be on the other side of this discussion.
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But March 30, 2007, was the start of more than a decade's worth of difficulties for the Digestive Tract Paralysis community, the withdrawal of Zelnorm, the last of 3 remaining drugs capable of regenerating the nerve and muscle tissue of the digestive tract.
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I'm clearly an ancedote; Zelnorm helped to save my life after properly restoring digestive tract function in a manner in which I am forever grateful.
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