Dear FDA, Step Aside So We Might Live In a free society, of course, dying patients shouldn’t have to petition bureaucrats for permission to take promising new drugs, so long as they understand there are risks involved. There is no known cure for ALS. Over a period of two to five years after onset, ALS patients slowly lose the ability to speak, swallow, move, and (eventually) breathe. Riluzole, approved more than 20 years ago, is the only drug the FDA has approved to treat ALS, and it extends life expectancy by only a few months. Currently, it takes an average of twelve years for a typical new drug to move from the laboratory to the pharmacy. Without accelerated approval, GM6 faces another two and a half years of Phase 3 trials. A decision to approve or reject would come six months to two years after that. This onerous screening process admittedly keeps some unsafe drugs off the market. But it also prevents the sick and dying from using drugs that might save their lives. Such tradeoffs aside, the bigger question we need to consider is this: Why should government bureaucrats determine the risks that dying patients can take with their own lives? As Carbajal writes: “Thousands of ALS patients and myself want to be able to try this drug. I do not have any other options to fight. I don’t want to be just another statistic.”
Read more at: http://www.nationalreview.com/article/416891/dear-fda-step-aside-so-we-might-live-benjamin-powell
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Is that graph results with or without the FDA?
ReplyDeleteDear FDA, Step Aside So We Might Live
In a free society, of course, dying patients shouldn’t have to petition bureaucrats for permission to take promising new drugs, so long as they understand there are risks involved. There is no known cure for ALS. Over a period of two to five years after onset, ALS patients slowly lose the ability to speak, swallow, move, and (eventually) breathe. Riluzole, approved more than 20 years ago, is the only drug the FDA has approved to treat ALS, and it extends life expectancy by only a few months. Currently, it takes an average of twelve years for a typical new drug to move from the laboratory to the pharmacy. Without accelerated approval, GM6 faces another two and a half years of Phase 3 trials. A decision to approve or reject would come six months to two years after that. This onerous screening process admittedly keeps some unsafe drugs off the market. But it also prevents the sick and dying from using drugs that might save their lives. Such tradeoffs aside, the bigger question we need to consider is this: Why should government bureaucrats determine the risks that dying patients can take with their own lives? As Carbajal writes: “Thousands of ALS patients and myself want to be able to try this drug. I do not have any other options to fight. I don’t want to be just another statistic.”
Read more at: http://www.nationalreview.com/article/416891/dear-fda-step-aside-so-we-might-live-benjamin-powell