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12-09-2016, 03:52 PM | #1 | |||
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Building a 21st Century FDA - Reason.com
Would you support these changes in the FDA's drug approval process if it meant substantially cheaper medicines brought to market much quicker?
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Born 1948. Diagnosed 2011. DBS ON 7/17. Taking cd/ld 200 MG at 6 am, 9 am, 12 pm, 3 pm, 6 pm and 9 pm. Finasteride 5 mg, Life Extension Mix and Once-Daily Health Booster, Mitochondrial Energy Optimizer with BioPQQ, Optimized Curcumin (longvida), Triple Action Cruciferous Vegetable Extract with Resveratrol, Vectomega-3, Vit D3 5000U,Lithium orotate 5 mg, AMPK Activator, Kefiran, N-Acetyl-L- Cysteine (NAC), Tri-Magnesium, Advanced NeuroPro, Duozyme, Palmitoylethanolamide (PEA) Updated 9/21/17. |
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"Thanks for this!" says: | johnt (12-09-2016) |
12-10-2016, 05:56 AM | #2 | ||
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GerryW asks:
"Would you support these changes in the FDA's drug approval process if it meant substantially cheaper medicines brought to market much quicker?" Yes, but the devil is in the detail. Let's look at just one of the issues raised: the delay in getting a therapy to market caused by having to climb over regulatory hurdles. Just suppose, and I know it's not possible, that you knew a therapy was safe and efficacious without testing it, then not only are the direct costs of testing wasted, but the delay caused by the testing costs lives. But, is the years of extra life a suitable metric for PD therapies? Using the wrong metric can lead to the wrong decisions being made. I think for PD that quality of life needs to be taken into account. Would you accept a drug that reduced your life expectancy, but increased your quality of life? John
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Born 1955. Diagnosed PD 2005. Meds 2010-Nov 2016: Stalevo(75 mg) x 4, ropinirole xl 16 mg, rasagiline 1 mg Current meds: Stalevo(75 mg) x 5, ropinirole xl 8 mg, rasagiline 1 mg |
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