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 poor neighborhood, you might be an unwilling participant in medical research that was being carried out. In an almost unreal scenario that played out 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 in cities infuse PolyHeme in to trauma patients.

(Polyheme is a chemically modified blood substitue)

The practice of using unconscious patients as guinea pigs falls under an agreement the company struck with the FDA to allow testing on unconscious patients without getting the patients consent.

Are you a test subject for drugs you don’t know about? You could be, since deals with the FDA are struck to suit the drug company’s requirements for test subjects when they are required. With only little notice that it is being done. This is one story that most should read as it is almost something that is stranger then fiction, its reality.

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

Link To Story

It reads like a bad science fiction novel: A small Illinois biotech company cuts a deal with UCSD. The university agrees to test a substitute for human blood on comatose patients -- victims of gunshots and car crashes -- without the patients' consent. Within the city of San Diego, the experiment is targeted at several neighborhoods south of I-8, where many poor and minority residents are unlikely to have heard of the study and unlikelier still to have the resources to sue if something goes awry. The university conceals the identity of the city's paramedic units who carry the blood substitute. When a curious reporter asks for the names of the neighborhoods where the study is being carried out, a research coordinator working for the university tells him that the Chicago sponsor doesn't want the information made public because Wall Street moneymen -- hoping to reap a financial windfall from their investment in the company -- might sell if they discover the experiment is not going well. When the reporter asks university officials to provide details of two "adverse event" reports involving the study, the officials stonewall, saying the information is "nonpublic" because the university has signed a confidentiality agreement with the laboratory. But if Hollywood wouldn't buy that scenario, the University of California and the City of San Diego already have. A little more than two years ago, officials at UCSD signed an agreement with Northfield Laboratories for clinical trials of PolyHeme.

Gould held on, sacking the company's chief executive and eventually reaching an agreement in 2003 with the FDA to allow a new kind of clinical trial that could be run without getting the patient's consent. Employing a little-used exemption in FDA regulations, Gould proposed having paramedics in cities across America infuse PolyHeme into 360 patients. San Diego was one of those cities.

The City of San Diego moved forward with the trial in midsummer. In a memo dated August 10, 2004, the city's Emergency Medical Program manager, Donna Goldsmith, quietly informed the council that the PolyHeme trial would finally proceed. "Based upon previous trauma demographic data," the memo said, "it is projected that the San Diego region will contribute 40 patients to the study. The safety and efficacy of this artificial blood product have been demonstrated in several in-hospital studies involving more than 300 patients."

Particularly troubling to some observers are two in-house university reports of "adverse events" that have occurred.

A letter dated May 27, 2004, from Daniel Masys, M.D., then director of UCSD's Human Research Protections Program, to Hoyt discussed the first incident. "Your April 29, 2004 adverse event report for Project 030443 has been reviewed and accepted by the IRB Committee at the May 20, 2004 meeting," Masys wrote. The IRB, or Institutional Review Board, is a group set up by the university to review the ethics and integrity of research activities.

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[edit on 31-3-2006 by North Rider]

[edit on 31-3-2006 by North Rider]

:shk:

So wrong, on so many levels.



Now that I've gotten my condemnation out of the way, I can raise a question. This snippet from the article you posted made me do a double take -

But according to records obtained from the City of San Diego, at the time the U-T story appeared, city officials and UCSD administrators were still negotiating when and where the city's paramedics would use PolyHeme.

What're the legal ramifications for paramedics playing along? They'll be held liable if they use that crap without the patient's permission, and they'll be scapegoated if something goes wrong. I appreciate the fact that this stuff needs to be tested, but not like this.

[edit on 31-3-2006 by WyrdeOne]

You might want to try reading more then the first page. The article is 6 pages long and goes into great detail.

You can also edit your comments so others see the error of your ways and dont think the story is a joke.

[edit on 31-3-2006 by North Rider]

I didn't even see the page flip link down at the bottom!

Thanks dude, I'll take a little embarassment in exchange for understanding.

well, I really have read it all now. A vunerable patient who needs to be protected and guarded is used like a Jewish test subject in a camp. Cannot object or fight back? great, we'll let them use you for medical experiments.



Is there nothing that money cannot buy you in the United States? It can now buy you the right to treat people just like the Nazis treated people in ww2?? How the Japanese treated chinese in ww2?? oh man I am so canceling any future trips to the USA -The land of the living breathing Nazi overlords. The poor should be very very very afraid.

another shinning example of the great heights corporations have soared to on the backs of the masses they can do what they want when they want...
and if you are given this fake blood, polyheme, couldn't the company say that you are now thier property?? unlike an artifical heart, just a small piece in the machine so-to-speak, the fake blood permeates ALL areas of the body...i'm sure there are some crafty corporate lawyers working on that issue....'ultraviolet' here we come........

more info for those who care........
here is the loophole fed reg 50.24 code 21..actuall it is the entire 50.24 reg...interesting and disturbing

and in case you live by any of these...

Northfield Laboratories hopes to enlist 20 hospitals in the one-year study, which will enroll 720 patients. While the company hasn't publicly listed the hospitals that are taking part or considering participation, news reports have revealed that they include the Denver Health Medical Center; University of California at San Diego Medical Center; University of Texas Medical School in Houston; Loyola University Medical Center in Maywood, Illinois; Mayo Clinic in Rochester, Minnesota; and Regional Medical Center in Memphis.

and the link

but don't worry..its all safe............right, they would lie to us...right...well???

I wonder if the CIA is involved somehow in this. After all, they are pretty well known for using front companies and experimenting on unwitting subjects. Just what do we know about polyheme and its manufacturers?

This might be a good idea for research.

This is what I said in an ATSNN article a while back on this subject



-------------------------------------------------------------------------

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.

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

Originally posted by FredT
This is what I said in an ATSNN article a while back on this subject



-------------------------------------------------------------------------

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.

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

Thanks for providing some information about this stuff. This will help in researching further.

I made an attempt to talk about this yesterday.

ATS link

Wondered if anyone in the citys testing had been notified by the media. Supposedly some minimal notification was required.

More info of those who wish to know more about this subject:

Polyheme and you

A substance called Polyheme by Northfield labs is being experimented with and used on trauma patients and the FDA has given them permission to do so, per the ABC news of July 7, 2006 (url provided below), without the patient's informed consent.

Though the experiment apparently was begun in 2003, the article quoted below indicates the product will continue to be tested in the "second quarter of 2006".

Note especially that you must "opt out" of the program in order not to be considered a candidate.

Here is a url for the article I'm copying and pasting some of below:

news.uky.edu...

from the University of Kentucky News:

Study of Blood Substitute for Trauma Patients Continues:

LEXINGTON, Ky. (May 23, 2006) – The University of Kentucky is continuing to take part in a national clinical research trial, along with 27 other trauma centers across the country, to evaluate the ability of an investigational blood substitute to reduce mortality among severely injured trauma patients......

Under the study's protocol, potential patients who do not wish to participate may opt out by obtaining a bracelet from study coordinators, similar to other medical alert identifiers.

If you want to know if your city is involved in this, you can find a list at this url:
abcnews.go.com...

While I do think the idea of something being used without a patient's consent is creepy, I think it's worth stopping a moment and really considering the situation.

That is, how many of us actually understand anything that is done to us while we are riding in an ambulance or admitted to the ER. Do you really require complete understanding of a medicine before it is used on you? Or do you nod your head slowly every time a nurse says "I'm going to give you a little ____ to help you ____."

Very few of us truly understand medicine and, if understanding becomes a mandatory precursor to treatment, then the collective health of this country is going to tumble badly.

Take a second to ask yourself if you can explain how aspirin works...or Tylenol PM, or eye drops or.... whatever. And if we can't explain what it's doing to us, is it really that different than receiving Polyheme?

I guess the question is: What exactly would you need to know about Polyheme that would raise it to the comfort level of popping antacids or getting a flu shot?

Originally posted by Essedarius
While I do think the idea of something being used without a patient's consent is creepy, I think it's worth stopping a moment and really considering the situation....

I guess the question is: What exactly would you need to know about Polyheme that would raise it to the comfort level of popping antacids or getting a flu shot?

All I need to know to NOT want it used on me is that it is synthetic blood, a substitute for the real stuff I need to live.

Informed Consent doesn't mean you understand how the stuff works in a scientific sense, it means that you are informed about the risks and advantages of its use, and it is required of medical providers that they be very candid about the risks as well as the advantages.

Being given a synthetic unproven product as a substitute for the blood flowing through your veins without your permission or at least your next of kin's permission if you are not able to hear or deal with it is NOT, imo, just "creepy" but downright Orwellian, and a gigantic breach of medical protocol.

Along those lines we have the euthanasia question which has pretty much moved from "should we" to "who do we" in a very short period, and the scandalous breaches of protocol that we all heard about happening in New Orleans, not to judge the individual practioners there, but to say that once breached ethical platforms habitually suffer ever widening gaps until it's no longer a question of whether behavior is ethical or not, but of "necessity" being the majority opinion.

I think the phrase "synthetic blood" is being misused a big here. They don't intend it to be a substitute for blood in a real, biological sense. They mean it in the same way saline could be labeled that. It's meant to keep your blood pressure and arterial volume up when you are losing a lot of blood. Polyheme just happens to contain a few important blood elements in addition to the salt water found in saline.

Mariella

Originally posted by bsl4doc
I think the phrase "synthetic blood" is being misused a big here. They don't intend it to be a substitute for blood in a real, biological sense. They mean it in the same way saline could be labeled that. It's meant to keep your blood pressure and arterial volume up when you are losing a lot of blood. Polyheme just happens to contain a few important blood elements in addition to the salt water found in saline.

Mariella

If it isn't "natural" blood created by the body itself, it is synthetic by definition.

If it is not intended to be a substitute for blood itself, why is it being used on trauma patients who've "lost a lot of blood"? Are they going to remove it as soon as they can get real blood into the patient? If you give me something to replace blood and one is real and one is lab-made, how is that not a substitute for the real?

Polyheme might contain a "few important elements of blood", but not all of them, and I sincerely doubt if science is even capable of knowing what all the "important elements" are. Or, even more importantly maybe, what the side effects will be. If they were, why would they be experimenting with this stuff? Why not just put it into use and be done with it?