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Synthetic Blood is one of the holy grails. Imagine blood that has a ultra long shelf life, can be preloaded with more than 4 molocules of oxygen and given to a hypoxic patient, Can be stored in large amounts and dropped easily into disaster zones.
Originally posted by FredT
this is what I sent her regarding why I support this...
Drug makers routinely fail to file status reports with the federal government that show what kind of progress they have made in conducting safety studies.
"Monitoring postmarketing study commitments is not a top priority at the (Food and Drug Administration)," the investigators concluded.
Such studies are considered important because they can shed light on the safety and effective use of drugs. The FDA requires all new drugs to undergo clinical testing, but trials often involve relatively small numbers of people, so the FDA frequently ask drug makers to conduct postmarketing studies.
Phase III studies are large double-blind randomized controlled trials on large patient groups (1000-3000 or more) and are aimed at being the definitive assessment of the efficacy of the new therapy, especially in comparison with currently available alternatives.
A double-blind test is a control group test where neither the evaluator nor the subject knows which items are controls. A randomized test is one that randomly assigns items to the control and the experimental groups.
To request a bracelet that exempts a trauma patient from receiving the artificial blood you must call 1 (717) 531-5829.
Originally posted by df1
The issue is "informed consent". The government has decided that "informed consent" is not required to test this product and I can not bring myself to blindly support this practice.
Regulations established by the Federal government, (21 Code of Federal Regulations 50.24) specifies the conditions under which an exception from informed consent so that in emergency situations, research can be carried out even when consent is not possible because of the nature and extent of the patient’s injuries.
Patients are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence is necessary to determine the safety and effectiveness of particular investigational interventions.
It is expected that patients will be unable to give informed consent because the extent of their injuries and the fact that they are in shock.
There won’t be time to find and ask for consent from the patient’s legally authorized representative (LAR) before beginning treatment.
The U.S. Food and Drug Administration (FDA) under regulations called 21 Code of Federal Regulations 50.24 specifies the conditions under which an exception from informed consent may be obtained. The Institutional Review Board (IRB) associated with each hospital approves its use locally.