The FDA has a lot of blood on its hands. Everyone, especially a chronically ill person on their deathbed, should be free to choose whatever experimental medical procedure they want. Not only is this a recognition of self-ownership, but it would provide invaluable medical research and could accelerate getting effective treatments to the ill.
When the original commenters said "Everyone, especially a chronically ill person on their deathbed, should be free to choose whatever experimental medical procedure they want", it's safe to assume he meant "within reason".
The "within reason" part is very important: As in, someone on their deathbed might have to go through certain hoops to get not-yet-approved treatment X (like signing waivers saying they understand the risks, etc); and there might other minimalist safeguards in place (such as that the chemicals are manufactured at regulated facilities; that the persons involved in administering the treatment have no criminal records or major fraud convictions against them) -- but ultimately, they can get access to treatment X.
By tweaking this to an extreme absolutist position -- "there should be no regulation of end-of-life treatments, of any kind, whatsoever; even if the person offering the trade is a convicted criminal and/ con-artist" you are standing up a false argument that the original commenter wasn't making.
thank you! fda is a leading cause of death in US in my opinion; from killing off inovation that would prevent death.
I worked at a medical startup that was bought by JNJ, it was high end surgery technolgy.
We made the first gen of our product, and it took 14 months to clear fda. Even though we made lots of improvments to the devices after, we never released them; that would have caused another horible fda clearance process.
I'm similarly lazy, but hopefully this paragraph captures some of the ideas:
> Caplan suggested that giving Josh the drug through the compassionate-use protocol might endanger its approval by the FDA. In the worst case, Josh would die after taking brincidofovir, and that outcome would “be held against the drug and the company until they can show the drug did not kill him.” In the meantime, other patients would find their access to the drug severely restricted. What’s more, an online campaign powered by photographs of a sick little boy raised hard questions about fairness. “Those who are not very cute get less attention in their pursuit of unproven drugs,” Caplan wrote. “If Josh had parents who did not understand how to use social media, he would already be out of luck.”
Interesting, but does that not highlight even more so the backwardness of the FDA? If they are willing to take some anecdotal case where someone died who happened to be taking a drug--blaming it on the drug company, despite the clinical research which had been done, further delaying their going to market--that doesn't sound like a compelling argument for the efficacy of the FDA in these cases.
