Transplant
I didn’t know this: the use of organs from brain-dead infants for transplants is not legal (I can only assume that’s what “not approved” effectively means). A Japanese national who works in Chile therefore had to send his 10-month-old son to Miami to get a multiple-organ transplant. It looks as if the surgery was successful.
“Not approved” is a lot more complicated than illegal. In the medical community, it means that the FDA, or Koseirodosho, or whatever, has not officially put its stamp of approval on something, usually because of lack of data. That being said, “not approved” automatically means experimental, and if that also meant “illegal” medical science would never advance. A doctor has the right to engage in experiments, but can do so if and only if the patient or guardian can comprehend the risk / benefit and signs papers to that effect. However, insurers have the right not to cover unapproved procedures.
In Japan “not approved” takes on greater nuances. In the US, docs prescribe pharmaceuticals off label all the time. For instance, if one SSRI had a label for both depresion and anxiety, while the rest had only depression in the label, most docs would use all drugs in the class for both indications. In Japan, only the SSRI with the anxiety label would get used for anxiety. Although Japan is less litigious than the US, Koseirodosho and the JMA have made it clear that a doc not follwing the letter of the law and labeling is on his own and will be thrown to the wolves if something goes wrong.
On top of this, not only are not-approved or not covered drug costs are borne by the patient, but also the cost of the visit is borne by the patient. Normally doctors visits in Japan are freee, and getting hit with a $500 office visit out-of-pocket is a severe shock to most Japanese.
Viagara is approved for ED in Japan, but not covered by the NHS, so the patient pays not only for the drug, but also the visit if the only complaint was ED. Thus the rash of mail-orders of Viagara to shady mail-order pharmacies in Claifornia and Hawaii who have docs on staff who unethically diagnose Japanese patients via the internet.
I can see several reasons for not doing thr transplant procedure in Japan:
1) Not enough (or even any) experienced docs for this type of operation – always a possibility in multi-organ transplants.
2) Because of the above-mentioned liability policy, even a qualified doc might hesitate to perform it in Japan.
3) Since it might not be covered by the NHS (I’m just guessing here), financial aid might be available in the US that’s not available in Japan.
4) Koseirodosho might be leaning on Japanese docs not to do this because of the ethical implications – but they will be happy to pick up on rhe proceedure in a decade or two, after the West has worked out all the ethical details – just like they lagged behind the West for more than a decade (albeit for very different reasons)in approving low-dose oral contraceptives, which BTW were approved after women’s geoups howled at the unheard-of 6 month quickie approval for Viagara.
Thanks for the explanation, John. Oddly, I think if it had been a drug, the word 認められる would have clicked with the English approved in my head, since you hear that word discussed in relation to new drugs and the FDA all the time. With surgery, I didn’t make the connection, and obviously, I know way less about this sort of thing than you.
I do remember the Viagra controversy–lots and lots of complaining about the men in their twilight years who run the government (not that it was misplaced, necessarily). You do hear a lot less here about controversial surgery; most of the shady liposuction stories and such seem to come from Southeast Asia.
Such familiarity with surgery here as I have is, thankfully, not personal. I just know from foreign friends who have had very tricky procedures done that, by their account, the care they got was at the level they would have expected in other First World countries. (Not that there aren’t screw-ups–there was that whoops! story in Yokohama a few years ago where two patients were mixed up and got each other’s…was it a heart bypass for one and a liver transplant for the other, something like that? I think one or both may have died. Also, while National Health does cover things, it’s not unheard of for people to be semi-covertly shaken down for “thank-you” money to the tune of a few thousand dollars’ worth.)
If the multiple-organ transplant (even trickier than usual on an infant?) isn’t done here, though, that would explain the story. I’m glad things have worked out for the family so far.