I answered at length in the other of your replies.
Sure, your scenario is heartbreaking. But guess what... heartbreak is happening every day on all kinds of illnesses/trauma while trials are being done in properly controlled FULLY patient-informed setups. Hell, there are even drugs that have been trialed that work well but their population of affliction is so low that there's no money in making the drugs so they are shelved anyway!
You can bet that more drug companies will use this as the model for their next drug trials. Not only that, but other businesses will jump on the 'need to opt out' to change their business practises.
Here's the obverse of what you say is OK... let the drug company in question and/or the FDA inform the population potentially involved in the trial 6 months before the trial starts, and frequently during the 6 month prior advertise the availability of bracelets AUTHORIZING use in case of trauma, even giving a "prize" of $20. or something like that for signing up??????
Methinks that's very easy to do BUT involves publicity and it sounds to me like the main objective was to have a QUIET TRIAL.
I wonder if anyone who had it administered died anyway? I wonder, if so, if their next-of-kin were informed of the administration? I wonder, too, if this type of trial allows such deaths to be written off as "the trauma was too severe and they would have died anyway???
I WONDER HOW ANY SUCH "TRIAL" CAN ACTUALLY PROVE (repeat: PROVE) **ANYTHING**? The scheme offers built-in excuses for all failures!!!!!
WRONG with a capital W.
>>In other words, EVERYONE is "in" unless they specifically opt out!
>>
>>I wonder how many people know of the availability of such bracelets and exactly where to get them?
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>Alternative scenario:
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>a little girl is hit by a bus. she's lost a lot of blood. the ambulance has arrived. the medics note they she doesn't have a bracelet.
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>in this alternative scenario, only those with a bracelet can receive the PolyHeme.
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>the little girl is then rushed to the hospital for a real blood transfusion. she hast lost too much blood and doesn't receive the new blood in time.
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>she dies. all the while, PolyHeme sat in the ambulance.
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>I see a bigger problem with the alternative problem than with the situation as it is.
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>Here's a PolyHeme FAQ I found:
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http://irb.ucsd.edu/notices/polyheme/FAQs.htm>
>Thanks for pointing this out. It is an interesting technology.
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>But I can not find fault with the related FDA policies as you have.
