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March 2, 2006Want Real blood? Wear a Bracelet…Medical ethicists are raising concerns about a study of blood substitute being used on trauma patients without their consent. Northfield Laboratories got federal approval for its study of the blood substitute Polyheme back in 2004 but the debate was reignited by a recent Wall Street Journal story suggesting the company tried to hide some crucial details about a previous blood substitute study. In the current study, trauma victims get Polyheme or saline fluid in the ambulance on the way to the hospital. Those given the Polyheme treatment continue to receive it for up to 12 hours, while those on saline get blood transfusions. Ethicists say the problem is that the testing should be done separately in patients who can give consent or who have family members who can consent. Although “informed consent” has become a standard bioethical consideration, the trauma study was approved under a federal exemption that applies to emergency research. Rather than requiring informed consent when needed, community briefings are offered in which residents can “opt out” of the research by wearing plastic hospital-style bracelets in case they are injured and unconscious. Rather than opt out of such research, the requirement should be that people opt in by wearing a bracelet only if they are willing to participate in the study. Requiring citizens who live near urban hospitals to wear an identifying tag in order not to be experimented on is an absurd an unnecessary burden. 3 Responses to “Want Real blood? Wear a Bracelet…”Leave a Reply
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March 5th, 2006 at 10:41 am
If there were a requirement that a bracelet be worn before participation there would be no trial for polyheme or any blood substitute because there would never be enough people in the trial.
In order to participate, you have to be a hemodynamically unstable trauma patient. The chances of the few people who opt in to actually become trauma patients are slim to none. I think that the current set up is satisfactory.
There is a clear need in the emergency medical field for a viable blood substitute that is shelf stable, able to be used safely in the field by EMS crews, and is more effective than current fluid replacement therapies which merely maintain blood pressure but not the other life sustaining aspects of blood.
March 5th, 2006 at 10:48 am
[...] hen I record the MedicCast tonight but I commented on an entry at this Bio ethics site: http://bioethicsnews.com/?p=207 Check back soon for the MedicCast: Episode 5 This e [...]
March 17th, 2006 at 5:59 pm
I think that research is important but not very many people know about this new research. I have just now become aware of this via a news blog. I do not like the risks associated with blood transfusions and unknowingly I could have gotten blood via this new product and some disease. AIDS takes up to six months to show up for those that are donating blood. Some people unknowingly donate blood with AIDS that have contracted it recently prior to donating and it is undetectable in some cases. This is why a lot of people will store their own blood before a surgury. This new product may be less risky in that it is more filtered but it definately has risks that are attached to it. An unconsious trauma patient with a no blood card may get this product and get some disease that goes along with it. My feelings are mixed on this but I tend to side on the conservative side of the issue. I think that those that wish to participate in the study should wear braclets. This would ensure that they have knowledge of this new product that is being tested in the field and that consent is given for treatment and all the associated risks that go with that alternative treatment. Additionally AIDS is not the only virus or harmful thing that blood carries either there are hundreds of risk factors associated with transfusions and quite a few can be headed off with saline which carries oxegen to the brain until the body has sufficient time to replentish the blood.