Are We Guinea Pigs?

You may already be a guinea pig or you could be one in the future whether you want or not. Tests for the blood substitute were conducted in hospitals in 27 cities and the tests are on going in 20 cities. The article lists what cities and hospitals are involved and tells you what do if you want to opt out of the tests.



These tests are being conducted in a manner worthy of email spammers in that you are automatically included as a test subject unless you opt out. The hospital is not required to inform you that you are a test subject and you are not compensated for participation. I'm sure that Northfield Labs will enjoy a wind fall profit should the blood substitute work and if doesn't. Oh well whats a few lives. This is outrageous.

Related News Links:
www.wxyz.com
www.usatoday.com
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[edit on 8-7-2006 by df1]

[edit on 8/7/2006 by Mirthful Me]

[edit on 8-7-2006 by DontTreadOnMe]

I just don't know what to think about this.
Has the product been deemed safe? Well, it seems that couldn't be true, this IS the testing that is done to determine whether it is safe for human use. I have never heard of medical testing that wasn't voluntary!
Is it just the nature of the substance being tested or is this the wave of the future, where drug testing is not a volunteer situation.

Yes it is safe unless you have very specific heart or blood conditions. This is extremely old news and has been covered here a few times already.

I do not underdstand what is happening. Are the hospitals giving patients synthetic blood or are donated blood being used for experiments to create synthetic blood? This article was not very specific at all. Thankfully nothing is even going on here in Florida.

www.abovetopsecret.com...

FredT
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.

It is fully synthetic, and an extremely desirable lifesaving remedy to an ever present problem: lack of blood stocks. As far as the ethics of trial without consent, that is discussed in the other thread as well.

# that sounds pretty awesome man. Well I will continue to donate blood every few weeks because I think it is a great thing to do for people. Plus I want to eventually get that license plate that says im a 100 gallon donor sometime in my life.

While I swore I would not venture into this subject yet again, I will do so:

A fellow mod asked me my thoughts on this and this is what I sent her regarding why I support this


In a trauma victem resoring homestasis (ie blood pressure, oxygen delivery etc) is critical. We talk about the "golden Hour" of trauma. If the patient does not get to the hospital and has advanced treatment initiated within one hour, thier odds of living decrease by almost 80% in major trauma. Thats staggering. If you live in a rural area youl be lucky if first responders arrive in 45 minutes. For example we came across a major accident last year outside of Las Vegas. It occured 15 minutes before we arrived. I got out to render what aide I could. another 40 minutes went by before the first fire truck arrived. another 20 till an ambulance arrived. Thier golden hour was over. They were lucky that thier injuries while sig. were not severe.

What if the fire truck was equiped with a synthetic blood that was already laoded with oxygen could be infused and say stretch out that golden hour to say 1.5 or two?

Blood is really finiky about temperature, unless its washed (im not kidding, its an actual process where they wash the cells in sailine to get rid of the potassium) stored packed red blood cells are full of derbits from lysed cells along with thier electrolytes, and simply cannot be kept for long periods even under ideal refrideration. A synthetic product can however be kept for long periods, be dropped into disaster zones etc.

Unlike Saline or plasma or 5% Albumen which can be used in , this sythetic blood is not only a volume expander, but also can help end organ perfusion by transporting oxygen as well a carbon dioxide which the current treatments cannot.

In clinical trials, the product has proven no riskier than existing treatments and meets the FDA criteria for use in that type of setting without informed consent.

Originally posted by FredT
this is what I sent her regarding why I support this...

Who would not support and appreciate the value of this blood substitute. Research and testing are necessary to save lives, quality of life enhancement and many other things that improve the human condition.

The issue is "informed consent". The government has decided that "informed consent" is not required to test this product and I can not bring myself to blindly support this practice. Also of issue is the government giving a profit making corporation a government license without compensation to either the test subjects or american society as a whole. The medical industry not only gets to make massive profits on the backs of citizens with excessive medical costs and now american citizens are expect to be the corporate guinea pigs too.

Are americans really willing to put their lives in the hands of the faith based FDA to make their personal medical decisions?

What government agency and process was used to approve this testing?

Have other drugs been tested without "informed consent" in this manner?

Are other tests that will not require "informed consent" in the pipeline?

I dont mind being a guinea pig, as long as i know and fully understand that i am a subject of a study I think its very important that science progresses.

However, i want to be informed. I'm sure that most people appreciate that. BUT since the world is as it is these days, this is just one more liberty they take with us, one more lie.
There's no stopping it now- nobody has the you know whats to stop it.

[edit on 9-7-2006 by dgtempe]

Humm. . . this blood has Very good shelve life . . . does that means I will be able to last longer if I use it?

Truly I would not like to be use as a guinea pig without my consent . . . that is unethical.

What will the doctor tell a patient after having side effects from something that they were not aware off?

LINK

Drug makers routinely fail to file status reports with the federal government that show what kind of progress they have made in conducting safety studies.

"Monitoring postmarketing study commitments is not a top priority at the (Food and Drug Administration)," the investigators concluded.

Such studies are considered important because they can shed light on the safety and effective use of drugs. The FDA requires all new drugs to undergo clinical testing, but trials often involve relatively small numbers of people, so the FDA frequently ask drug makers to conduct postmarketing studies.

So even after a drug is approved by the FDA we are still guinea pigs.

JDub

Since I read this originally, I've been doing a lot of thinking and asked FredT for his opinion...thanks FredT!!!

We may be taking this "without consent" out of context. The article is telling us we may receive this PolyHeme. Not that we will.

According to Wiki, this substance, PolyHeme, has been around since Vietnam. Hardly new then.

It is in its Phase III trial,

Phase III studies are large double-blind randomized controlled trials on large patient groups (1000-3000 or more) and are aimed at being the definitive assessment of the efficacy of the new therapy, especially in comparison with currently available alternatives.

en.wikipedia.org...

A double-blind test is a control group test where neither the evaluator nor the subject knows which items are controls. A randomized test is one that randomly assigns items to the control and the experimental groups.

skepdic.com...

While I agree that folks should be aware that they may be receiving PolyHeme, the nature of the trials seem to indicate the subject doesn't know which blood they receive.

I urge everyone to read this Wiki article and then decide whether this is a good thing or not. Maybe our tinfoil hats are on a bit too tightly.
en.wikipedia.org...

And, finally,

To request a bracelet that exempts a trauma patient from receiving the artificial blood you must call 1 (717) 531-5829.

en.wikipedia.org...

Originally posted by df1
The issue is "informed consent". The government has decided that "informed consent" is not required to test this product and I can not bring myself to blindly support this practice.

The issue of "informed concent" is allowed to be waived in certain circumstances. For example if you are the victem of a car crash and are incapacatated you essential give concent for treatment in these cases. that is medical people will do what they need to do to save you. In the case of Polyheme, it has been denonstarated to be no more dangerous than current first responder modalities such as Normal saline, 5% Albumin, etc.

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...

It appears to me that waiving the "informed consent" of the patient and conducting human tests without any public discussion is immoral. As you pointed out emergency services can already take life saving measures without "informed consent". The systemic waiving of the "informed consent" by government imho is a different issue entirely. While you are convinced that use of the blood substitute poses little risk to the patient, apparently those doing the testing do not fully agree. These test are being conducted because some outstanding questions still remain, otherwise further testing would be unnecessary.

If this product kills a family member who is liable? The corporation? The government? The hospital? The doctor? Oh heck what does it matter, its for the good of society and it will create corporate profits & jobs.