I have a lot of political hot buttons and, while I try not to write about them all, this is one that is not particularly partisan and drives me absolutely bonkers. Yesterday at his now daily coronavirus press conference President Trump touted the possibility of people using the Right To Try legislation to access prescription treatments not approved by the Food and Drug Association (FDA). Drafted and lobbied for by the libertarian Goldwater Institute think-tank and pushed by several people with ALS (pALS) and pharma companies, Right To Try was signed into law in 2018. I was against Right To Try (RTT) before it was law, and nothing I have seen in the past two years has changed my mind. RTT was, and is, nothing more than a red herring that distracts people and politicians from the very real issues facing those of us with life-threatening illness and no options. I, more than most, understand the desperation that goes with fighting a terminal illness that has no effective treatment. I share the frustration of seeing one drug after another look promising in mouse trials and flame out in humans, doing nothing or even accelerating death. And I also chafe at FDA trials that take too long and have participation requirements that are too restrictive. Unfortunately RTT solves none of these problems. Right To Try legislation allows a person with a life-threatening illness to request of a company making a treatment that has passed FDA Phase 1 (human safety) trials access to that treatment. Proponents of RTT argue that the government, in this case the FDA, should not stand in the way of a person with informed consent trying to save their own life. The FDA drug approval process consists of three major phases, and phases 2 and 3 can take 3-10 years to complete after a drug is proven safe. The average pALS has only 2-5 years to live. The criteria for participating in a Phase 2 or 3 trial are so restrictive that finding enough qualified and willing participants with relatively rare diseases can take years. And God knows none of us want to spend precious months in a trial only to find we have been receiving a placebo. Given this situation, RTT sounds like a good idea. Bypass the FDA and go straight to the company to get an unapproved drug that just might lengthen your life. But here are the problems: |
AuthorSteve needs a creative outlet since he no longer plays instruments due to ALS. He believes there can be music in words, too. Archives
November 2018
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Oysters, Scallops, Conches
We are created to have abundant, meaningful life. Life where joy, beauty and love abound even in the most tragic of circumstances.
Find out how in Shells: Sustained by Grace Within the Tempest.