Should Unconscious Patients Be Used as Guinea Pigs for Medical Research?

[Ivan Seeking]

Thanks to an unusual loophole in the strict rules of medical ethics, hundreds of trauma patients in California, Texas and a few other states will be taking a gamble when ambulances come to scoop them up after accidents or acts of violence.

Without waiting to get consent, paramedics will inject a fake blood product into half of the eligible patients chosen to take part in a new study. The other half will get a routine treatment of transfusion with saline solution until they reach the hospital.

For now, the artificial blood, known as PolyHeme, isn't approved for general use. But it will still slip into the veins and arteries of unconscious patients who won't be able to say no.

"Emergency research in general creates a special set of circumstances," said Kelly Fryer-Edwards, a University of Washington medical ethicist whose colleagues across the country are divided over the wisdom of the blood study. "In a way, all of our usual approaches to research ethics -- to protecting human subjects, to trying to get informed consent -- just go out the window."

At stake is a product that could revolutionize emergency medical treatment and surgery. [continued]

http://www.wired.com/news/medtech/0,1286,62955,00.html?tw=wn_tophead_2

 

[nautica]

Research is not being done on many rare diseases due to the many restrictions, but they are allowed to do this?

Something does not seem right.

Nautica

 

[Moonbear]

I read about that a while ago and found it very disturbing that they can do a complete end-run around informed consent. Apparently, it is considered informed consent that the announcement of the trial was posted in newspapers and on TVs in the areas where the product will be tested...apparently too bad for anyone who didn't catch the news that day. People have been told if they don't want to be an unwitting participant, they should have a note with them in an obvious place (maybe taped to your arm where the vein is?) stating they don't want to be included in the trial. I just don't think that's enough. I realize they think this product will be better than saline for patients with a lot of blood loss, but it just seems they should do more to make sure the person it's being tested on is willing to take that risk. Perhaps they should limit its use to situations where a close relative is present who can provide consent for them. At least someone would be speaking for the patient's wishes that way.

 

[Monique]

PolyHeme is also thinner than regular blood, which may make it easier to use in hemorrhaging patients

Wouldn't that then just make you bleed more?

The hospitals are complying with a federal loophole created by Congress in 1996. It allows the lifting of rules about informed consent when research involves emergency medical treatment.

In 1998, a company called Baxter Healthcare launched the first major study of a blood substitute using the loophole. According to news reports, nearly half of 52 patients died and the study was halted.

In Denver, health officials allow those who don't want to take part to ask for bracelets that would let them opt out.

Or should they've been giving out bracelets for people to opt in?

 

[Monique]

But fake blood is not all that new. Don't they use starch solutions in hospitals to replace blood? Starch because it has the same high viscocity as blood.

 

[adrenaline]

But fake blood is not all that new. Don't they use starch solutions in hospitals to replace blood? Starch because it has the same high viscocity as blood.

Yes, 6% dextran solutions. http://www.infusia.cz/eng/roztok/en-plasma-in.htm Although , most trauma patients get crystalloid Lactated ringers solutions since the dextran solutions have intrinisic anticoagulant properties that would not be a good idea in hemmoraging trauma patients. Low viscosity substitutes such as this new product are probably best used for reperfusion of ischemic organs during strokes or myocardial infarctions. These products potentially can serve as an organ preservative prior to organ transplantation to decrease reperfusion injury so I see this product as a big plus in this area of medicine.

 

[Ivan Seeking]

I remember seeing a news report in the 70's about this type of technology. A mouse was place in a jar that was filled with a clear liquid. At first the mouse struggles but then starts to breathe the liquid with apparent ease. Given that the oxygen content of this fluid is similar to oxygenated blood why has this taken so long? Are previous versions toxic somehow? I was expecting to see this long ago.

 

[Monique]

I have heard of that mouse experiment too..
The point would be that the fluid has to be biologically degradable with safe byproducts. Also, it should start to coagulate. I don't really know what this new substance is, but it seems to have as the main component hemoglobin.. from an animal or from synthetic source, I don't know.. apparently not isolated from humans. That must be the reason why it is hard to manufacture.

 

[adrenaline]

I remember seeing a news report in the 70's about this type of technology. A mouse was place in a jar that was filled with a clear liquid. At first the mouse struggles but then starts to breathe the liquid with apparent ease. Given that the oxygen content of this fluid is similar to oxygenated blood why has this taken so long? Are previous versions toxic somehow? I was expecting to see this long ago.

You are referring to perfluorochemicals, also used in the movie the "Abyss." It not only transports oxygen but also CO2 for elimination by the lungs.


The mice you refer to was done in the 1960's by Clark and Gollan who demonstrated that mice immersed in oxygenated silicone oil or liquid fluorocarbon could breathe in the liquid. This exciting demonstration did not immediately lead to clinical application because the perflurochemical available at that time had a long retention time (T11/2 of more than 800 days) in the reticuloendothelial system and therefore could not be used clinically. This will potentially result in lowered resistance to infection. In addition, side effects were observed in some patients due to complement activation caused by the surfactant used as part of it.

There are newer ones with a shorter T1/2 of about a week but high O2 requirement of 70-90% inspired was required. All these I believe are still in very, very early clinical trials. i know these perfluorochemicals are derivatives of Teflon somehow and I'm worried about potential breakdown products of PFCs (but I am no chemist) and the potential for that pandora's box being opened. Remember, The Environmental Protection Agency (EPA) has classified PFCs as carcinogenic to animals. PFOA, a byproduct of many PFCs used in nonmedical uses, is suspected to cause four types of cancer - testicular, liver, breast and prostate. In laboratory studies, it also causes Hypothyroidism. PFOA is also known to damage the immune system, (probably because of its long stay in the reticuloendothelial system.)

 

[Monique]

So regarding the ethics: shouldn't they have mailed out opt-out bands/ registration papers to all the citizens instead of giving a newscast? I mean, no one assumes they will be in an accident so doesn't feel like they are at risk for being part of the experiment. If this is the way the law works for emergency medicine, I think they are on shaky ground.

 

[Moonbear]

I agree, I think it would have been much better to have an opt-in rather than opt-out arrangement. Afterall, what happens to the out-of-state traveler who winds up in an accident and never had the choice to opt-out? And who wants to have to wear a bracelet all the time just so they don't accidentally become a guinea pig?

 

[wasteofo2]

They're just setting themselves up for major lawsuits if anyone dies who receives this blood.

 

[Evo]

They're just setting themselves up for major lawsuits if anyone dies who receives this blood.

If anyone even guesses that the deceased was a guinea pig. They probably aren't going to announce it. It will look like a death resulting from the accident/injury.

That's just plain scary.

I also saw the mouse in the liquid on tv YEARS ago, I am sure in the late 60's, if it is the same thing. It was a 3M announcement and it blew my mind. The announcer said that their scientists had discovered a liquid that did "nothing". The guy had a book of matches and submerged them and then lit them, it looked like water, it was in what looked like a rectangular fish tank. Then they put the mouse in it (looked like my pet hampster ) and it continued to breath and didn't appear wet. It was so weird I never forgot. I never heard anything about the liquid again.

 

[wasteofo2]

I don't buy that they'll be able to explain away the deaths. Even if the person did die due to a totally unrelated thing, having the fake blood in the without anyone consenting would be grounds enough for a lawsuit. Hell, people have sued cigarette companies for getting cancer, sued McDonald's for getting fat from eating there, sued cable companies because they're addicted to tv/fat/lazy. People will sue for most anything these days, and if a relative died and there's even a question whether or not the fake blood contributed in any way, people are going to be taking this to court or getting huge out of court settlements.

 

[Evo]

My question is, if you didn't know about the fake blood trial and a relative died from a car crash in Colorado, would it even occur to you to investigate anything? I wouldn't if I hadn't read this thread. It may have already happened multiple times, but no one was aware that something like this may have occured. How can you question what you don't know if the death seems to be the result of injuries? Know what I mean? That is what makes it so atrocious. Unless they tell everyone related to someone that died after receiving the fake blood that "oh by the way, they received experimental fake blood, so maybe they didn't really die from their injuries, we might have accidently killed them".

 

[hitssquad]

Chilled perfluorocarbons for rapid cooling of vital organs

I remember seeing a news report in the 70's about this type of technology. A mouse was place in a jar that was filled with a clear liquid.

Steven B. Harris researches this full time at his company Critical Care Research.

• Packing a patient in ice, for instance, cools the skin but doesn't extract heat quickly enough from inside the body. Thus, for more than a decade, no one could see a way to apply Safar's remarkable discovery that the onset of brain death could be delayed simply by reducing body temperature.
  
  In 1997 a researcher named Michael Darwin had an idea: Why not use the lungs to cool a patient? Darwin at that time was director of research at 21st Century Medicine, a company largely financed by Life Extension Foundation. He saw that since the lungs are subdivided into tiny compartments (alveoli) and densely wrapped in blood vessels, they provide an excellent opportunity to cool the blood, which can then cool the brain after the heart has been restarted with a defibrillator. Using cold air to cool the lungs isn't practical, because gases don't transport heat rapidly enough. But a cold breathable liquid could do the job, and Darwin knew that a whole chemical family, called perfluorocarbons, has the unique ability to transport oxygen and carbon dioxide.

 

[Moonbear]

My question is, if you didn't know about the fake blood trial and a relative died from a car crash in Colorado, would it even occur to you to investigate anything? I wouldn't if I hadn't read this thread. It may have already happened multiple times, but no one was aware that something like this may have occured. How can you question what you don't know if the death seems to be the result of injuries? Know what I mean? That is what makes it so atrocious. Unless they tell everyone related to someone that died after receiving the fake blood that "oh by the way, they received experimental fake blood, so maybe they didn't really die from their injuries, we might have accidently killed them".

My bet will go with the car insurance companies being the first to dig this up. With something like a car accident, there would be an autopsy and investigation into fault, so if the auto insurers can pin the blame on some fake blood as contributing to the cause of death rather than the injuries sustained in the accident, then they can avoid payouts. Plus, all procedures followed by the paramedics need to be documented, so it would show up there too. That's the thing with this; a high percentage of the patients are likely to die no matter what treatment they receive, so it just seems like opening the door to lawsuits by relatives who just want to blame someone. There just has to be a better way and closing the loophole in the law seems to be the only thing that will force discussion of this among those who need to find that better way and use it.

 

[Pattonias]

Is it really appropriate to refer to this PolyHeme as "fake blood." You make it sound like their using baby oil with food coloring. Perhaps artificial blood would be more appropriate.

 

[hypatia]

What odd necropsy-posting lately.
Ok you could also call it...bogus, fake, false, mock, phony, pretended or pseudo. Feel free to take your pick.

 

[Pattonias]

Wow, not sure how I didn't catch the old thread date...