IEET > Fellows > HealthLongevity > Implants
Don’t become a Cyborg by Accident (literally) - It can be Fatal
Randall Mayes   Jul 2, 2009   Ethical Technology  

Imagine these hypothetical situations; you are injured and lying on the battlefield or are involved in a serious automobile accident and require a blood transfusion. What are the medical treatment options in these scenarios?

In the past, the standard procedure is for trauma units to use saline solution to restore blood volume and increase the likelihood of survival after traumatic injury. If organs do not receive enough oxygen, organ damage or death usually occurs.

Unfortunately, a quick blood transfusion is impossible. Blood transfusions are not readily available on the battlefield or accident sites because blood must be typed and matched to avoid fatal clotting. Also, human blood has a forty-two day shelf life and must be refrigerated.

Following the Vietnam War, researchers tested a number of blood substitutes for use on soldiers on battlefields to prevent shock resulting from low blood pressure due to large volumes of blood loss.

The Clinical Trials of Blood Substitutes

The FDA has placed a number of blood substitutes in clinical trials at selected hospitals for accident victims in the United States which are trauma victims in life threatening situations. Although blood substitutes do not have white blood cells found in whole blood, they have hemoglobin from expired human blood to carry oxygen.

Biopure’s Hemopure failed in the United States, but was approved for use in South Africa. Unfortunately, in the United States the other candidates have either failed or were withdrawn due to side effects including liver and kidney failure, irritated blood vessels, and heart attacks.

The most promising candidate, PolyHeme, was developed by Northfield Laboratories to overcome the drawbacks of working with whole blood. It has a shelf life of over twelve months while stored at room temperature, is purified it to minimize risk of viral disease transmission, and is compatible with all blood types.

In circumstances where a patient at least eighteen years old is in critical condition at the scene of the injury, random patients either received saline solution or PolyHeme for up to twelve hours as needed after transported to selected trauma centers. It was one of the few candidates to complete phase III clinical trials, but it also failed to win approval with an unfavorable risk-benefit assessment.

In 2008, the Journal of American Medical Association released the paper, Cell-Free Hemoglobin Based Blood Substitutes and Risk of Myocardial Infarction and Death, which is a meta-analysis study of 16 clinical trials of blood substitutes, including 5 products, and 3711 patients. The paper was the bearer of bad news as it revealed patients in clinical trials had a 30 percent greater chance of death when compared to a control group. 

The Informed Consent Dilemma

Humans are involuntarily used as guinea pigs for blood substitute clinical trials? In 2006, those living in 32 communities in 18 states and anyone traveling through these communities were potential guinea pigs without consent in Polyheme’s Phase III clinical trials. PolyHeme is the fifteenth experiment allowed by the FDA for emergency medical trials exempted from informed consent.

This is disconcerting since one of the distinguishing factors between eugenics and transhumanism is that the H+ movement is based on voluntary use of medical treatments and artificial human enhancements. But, what if someone is incapable of giving informed consent and a blood substitute is the only hope for survival to an accident victim or a soldier?

In order to avoid participating in the clinical trials, citizens had to inform their local testing site and wear a medical bracelet. Although I live several blocks away form the Duke University Medical Center which is one of the trauma centers across the United States which is sanctioned by the FDA, I was not aware of the clinical trials or the exemption procedures.

Even more disturbing, bioethicists Dickert and Sugarman disclosed in the Kennedy Institute of Ethics Journal that Northfield Laboratories was able to withhold proprietary data relating to the trials which remained unpublished because they had no government requirement to report problems . It wasn’t until Public Citizen filed a law suit that FDA released the data.

One solution proposed to avoid the risks to humans is to discontinue human testing and go back to animal labs. Another is to utilize other cutting edge technologies. Currently, scientists at Advanced Cell Technologies are investigating the use of type O blood, which is a universal donor, from stem cells. Also, nanotechnology researchers are investigating the use of dendrimers, a type of nanoparticle, as oxygen carriers.

Hopefully, the transparency and informed consent issues are addressed by the appropriate government regulators so that cutting edge biotechnologies such as stem cell research and bio-nanotechnology will not receive bad publicity.

Randall Mayes served as a 2009 IEET Fellow. He is a science writer and policy analyst with a focus on enhancement and emerging biotechnologies.



COMMENTS

From your article:

“In the past, the standard procedure is for trauma units to use saline solution to restore blood volume and increase the likelihood of survival after traumatic injury. If organs do not receive enough oxygen, organ damage or death usually occurs.”

“In circumstances where a patient at least eighteen years old is in critical condition at the scene of the injury, random patients either received saline solution or PolyHeme for up to twelve hours as needed after transported to selected trauma centers. It was one of the few candidates to complete phase III clinical trials, but it also failed to win approval with an unfavorable risk-benefit assessment.”

“In 2008, the Journal of American Medical Association released the paper, Cell-Free Hemoglobin Based Blood Substitutes and Risk of Myocardial Infarction and Death, which is a meta-analysis study of 16 clinical trials of blood substitutes, including 5 products, and 3711 patients. The paper was the bearer of bad news as it revealed patients in clinical trials had a 30 percent greater chance of death when compared to a control group.”

Drawing a conclusion from a meta analysis on five different products makes no sense at all. Further, it’s pretty obvious that the control group were given blood while the purpose of the blood substitutes is to provide an oxygen carrying fluid when blood is unavailable.

How could the FDA possibly come to the conclusion that they did? So if blood is unavailable and Polyheme is, the patient will probably live.  With only saline available, the patient will certainly die.  That’s an unfavorable risk-benefit?  Personally, I’d take the risk of Polyheme over the prospect of certain death or organ failure with saline. 

I’d be interested in your thoughts on this.  There must be more to the FDA’s reasoning.  What is it?

Hemoglobin Based Oxygen Carriers outside of red blood cells provide oxygen but also absorb Nitric Oxide which helps to keep arteries from constricting which causes heart attacks.

Realizing this danger should alter the thinking of HBOC researchers.
Perhaps a combination of saline solution and smaller amounts of HBOC’s might be in order.  A balance between providing oxygen and minimizing the absorption of Nitric Oxide has to be achieved if the FDA is going to approve HBOC’s.

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