ATS: US - Poor Trauma Victims Made Test Subjects for Medical Companies

Are you a test subject for new medical drugs? Well if you live in the US, are poor, and an unconscious trauma patient from a impoverished neighborhood, you might be an unwilling participant in medical research that was being carried out. In an almost unreal scenario in 2005, a medical research company, Northfield, paid the University of California, the City of San Diego and many other institutions an undisclosed amount of money to have paramedics infuse PolyHeme in to poor trauma patients.



I origionally posted this story in medical conspiricys but figured it wouldnt get the attention it diserved for such an important story. This is just one of those stories that is too unreal to belive but yes it does happen. Imagine what drug or procedure there testing now that we dont know about

"Give us your poor, your tired, your huddled masses" so we can use them as test subjects.


Additonal Sources:

wjla.com
cnn.com
cbsnews.com
aharp.org


[edit on 4-4-2006 by parrhesia]

This "artificial blood" has been in use quite commonly for a while now here in Kansas and Missouri. It is really only a danger to people with certain heart conditions. People are advised to get a bracelet, if they desire, dictating they do not wish to receive this treatment in the event that they are unable to decide for themselves.

While I don't necessarily approve of any subterfuge in the research of this treatment, rest assured that this was relatively benign as it was already an accepted treatment elsewhere. However, this proving method should not be allowed to become the norm.

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.

Okay back to reality. The cited sources seems more like a homeless shelter type free magazine trying to stir up drama to get people to read thier rag.

In five human trials, PolyHeme has shown:

In clinical trials to date, PolyHeme® has demonstrated no “clinically relevant” adverse effects. That is, they didn’t impact the patient’s safety or recovery.

Past studies have shown that PolyHeme® carries as much oxygen as blood, has not caused organ damage, keeps people alive who have lost all of their own blood, and can be infused up to two times a person’s entire blood volume.
irb.ucsd.edu...

In regards to the consent issue:

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.
irb.ucsd.edu...

Etc etc etc

[edit on 4/1/06 by FredT]

[edit on 4/1/06 by FredT]

BTW, it also in trials at

University of Cincinnati

Duke

University of Pennsylvania

University of Kentucky

University of Kansas GO JAYHAWKS!!!!!!!


I could go on for days here. The point is this article is nothing short of Yellow Journalism at its finest.


Okay Cue the repeditive rants against evil corporations et al......

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.

So when did regular blood transfusions become unproven or unsatisfactory? We know that properly typed and screened blood doesn't cause any negative health effects, but we don't know yet whether a chemical substitute might cause adverse reactions or long term effects.

Is this treatment being offered to all transfusion recipients at the hospitals involved in the trial, or only those that can't refuse it?

You cannot store blood in a pre hospital environment. It is very finiky in regards to temperature etc. More important, it would be difficult to crossmatch the intended recipient and infusing un-crossmatched Type O has its own pitfalls if you could get around the storage issue.

Plasma (which is the liquid portion of the blood can be given and stored for longer periods if dried) However, it is strickly a volume expander and has no ability to carry oxygen. It will help with the hypotension of shock and improve end organ perfusion, but does nothing for oxygen transmission or CO2 removal.

Synthetic blood can not only expand volume, be given to type, but also perform the function of oxygenation as well as ventalation (CO2 removal)

I think this is about informed consent.

IMHO - everyone has right to be fully informed of the risks and dangers, not just the benefits, involved in clinical tests. Even the poor.

.

Never said it was poor exclusive if I recall. AT anyrate as I posted above there are FDA exceptions for informed consent.

Ah yes.

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.

irb.ucsd.edu...

IMO - this looks like a standard medical dodge and conspiracy.

Personally, I do not want anything done to me with out my fully informed consent, ever.

It realyl doesn't matter if thise Polyheme works and is safe. If its experimental, then you can't use it on patients without their permission.

It states that these people were comatose and poor. Does that mean that they had no one as a guardian, were they, in effect, wards of the state?

Once again, you have to consider the source of the article. Its the type of rag that Soficrow likes to prop up as "conclusive evidence". Also read the FDA regulations above in regards to experimental medications.

Without actually seeing the data on the sample base, do you know it was poor etc as a fact, or are you just going with what the article says

Soficrow, if you allow nothing to be done without "informed consent" what are your expectations if you are the victem of a trauma? How exactly can informed consent be given? Do you just expect to die in that case?

[edit on 4/4/06 by FredT]

Well here are a few sources that are a bit more Credable in your view because they are main stream news sources. Why do people hear news and have to say, if cnn didnt say it its not "real" news.

WJLA News 2006

A separate journal essay by Duke University ethicist Karla FC Holloway says the study, in mostly urban hospitals, disproportionately exposes minorities to questionable science.

Cnn.com

CBS.news 2006

"There is a serious ethical flaw in this complicated and novel study," says the article to appear next week on the Web site of the American Journal of Bioethics.

Aliance for human research protection

If the purpose of developing an artificial blood product were to improve mortality by getting oxygen carrying products to trauma patients in the ambulance, why not test blood type 0-negative—which is a universal donor? There is no question that 0-negative blood is safer than any artificial product and can accomplish the same goals.

Originally posted by FredT

Once again, you have to consider the source of the article. Its the type of rag that Soficrow likes to prop up as "conclusive evidence".

Offensive and untrue. I generally quote articles from PubMed that have been peer reviewed up the wazoo. PubMed is the US database for the National Institutes of Health - but you consider PubMed a "rag"?!

The one quote I posted here came from your link.

Close-minded corporate cant and regurgitated dogma should not be the official ATS flag, IMO.







[edit on 4-4-2006 by soficrow]

I think that the article quoted was written with a heavy bias against Polyheme and the author was trying to further an agenda. If you sift thru the article a few interesting points come out.
1. The study isn't targeting the poor, it is targeting the areas that have the most trauma cases. That these happen to be the poor sections of the city says something in itself.

2. The artificial blood is not meant to be a total replacement for real blood at this time. The idea behind this is to enable paramedics to buy enough time with Polyheme to get someone to a hospital before they bleed out.

I have type AB negative blood, a rarity. As a matter of fact I only donate when it is requested because of the shelf life of blood. If I am in an accident the chances of a hospital having my type actually on hand is slim to none. I'd have to hope that saline and plasma could sustain me until whole blood could arrive. To me Polyheme and others of this type would increase my chances of survival. You can only go so far in laboratory testing and from what I've read they are at that point in the research. Something that needs to be considered is that most States have laws that allow for the treatment of incapacitated victims without their consent. I do think that this study should have recieved more publicity than was mentioned in the article. That would give people who don't want Polyheme the opportunity to make that known to their family members and to get bracelets like the ones mentioned. What I'm waiting for is a person to die because the paramedics had to use saline when Polyheme was available on other units and for the family to sue because Polyheme wasn't availible. Watch it will happen.