Gavin (selfishgene) wrote,
Gavin
selfishgene

Organ replacement

Obtaining FDA approval is still a major hurdle, in part because cells obtained from different people may not behave alike and because recipients can have varying responses to the same kind of implant
As usual the FDA is killing people for frivolous reasons. Existing organ transplants have the same problems of variable inputs and results. To hold mechanical substitutes to a higher standard than existing therapies makes no sense. They are already an improvement due to greater availability (once in production). They don't need to justify their existence by being higher quality too.
Patients who are about to die and know that they are still months away from receiving a donor organ have nothing to lose by taking a chance on artificial replacements.
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It's the thalidomide principle. If the FDA forbids a drug or technique and people die from its lack, there's very little risk to its administrators. If it permits one and things go wrong, their careers are toast. So it makes sense for them to let ten people die through prohibition rather than one through permission.
Government is uniquely incapable of managing risk. CYA is their only mantra. Private sector has the profit motive to balance risk/reward.

Botched operations have patients who can sue; those who die on the waiting list die of 'natural causes'.
Well, there is still competition between states. Some East Asian regulatory agencies are under different political pressures, and I am guardedly optimistic about their future behavior.