Bush FDA Secretly allows experimenting -- without your consent !!

[Breeze54]

http://abcnews.go.com/WNT/story?id=2166058&page=1&WNT=true

Artificial Blood Experiment: Is Your City Participating?
Hospitals in Twenty Cities Take Part in Polyheme Trials

By ASA R. ESLOCKER and ASTRID HILL

July 7, 2006 —

Northfield Lab's experimental blood substitute Polyheme is currently in randomized phase III clinical trials
recruiting patients without informed consent all over the country.

At one point, it was being tested in as many as 27 cities;

it is still being tested in 23 hospitals in 20 cities.

With the FDA's approval, Northfield Lab has recruited hospitals to participate
in the trial study with exemption from informed consent requirements on study participants.
Although Northfield Lab claims that extensive information on the study has been made public,
a vast majority of the general public has never heard of the trial.

Below is a list of the cities and hospitals that are currently participating in the Polyheme trials.

Check the list to see if you live an area where you could become a trial participant without your informed consent.

To opt out of the study, contact Northfield Labs

http://www.northfieldlabs.com/contact.html

or a participating hospital and request a blue bracelet.

If worn, you will be exempt from the trial.

Polyheme© and The Newest Plastic Bracelet


California

UC San Diego Medical Center, San Diego, Calif.; No longer recruiting
Scripps Mercy, San Diego, Calif.; No longer recruiting

Colorado
Denver Health Medical Center, Denver, Colo.

Delaware
Christiana Hospital, Newark, Del.

Georgia
Medical Center of Central Georgia, Macon, Ga.

Illinois
Loyola University Medical Center, Maywood, Ill.

Indiana
Wishard Memorial Hospital, Indianapolis, Ind.
Methodist Hospital of Indiana, Indianapolis, Ind.

Kansas
University of Kansas Medical Center, Kansas City, Kan.

Kentucky
University of Kentucky Medical Center, Lexington, Ky.

Michigan
Detroit Receiving Hospital, Detroit, Mich.
Sinai Grace Hospital, Detroit, Mich.

Minnesota
The Mayo Clinic, Rochester, Minn.

New York
Albany Medical Center, Albany, N.Y.; Suspended

North Carolina
Duke University Medical Center, Durham, N.C.

Ohio
MetroHealth Medical Center, Cleveland, Ohio; Suspended
University of Cincinnati Medical Center, Cincinnati, Ohio
Miami Valley Hospital, Dayton, Ohio

(Page 2 of 2)

Pennsylvania
Lehigh Valley Hospital, Allentown, Penn.; No longer recruiting
St. Luke's Regional Resource Trauma Center, Bethlehem, Penn.
Penn State Milton S. Hershey Medical Center, Hershey, Penn.

Tennessee
University of Tennessee-Memphis, Memphis, Tenn.
Johnson City Medical Center, Johnson City, Tenn.; Suspended

Texas
Memorial-Hermann Hospital, Houston, Texas; No longer recruiting
Memorial-Hermann Hospital, Houston, Texas; No longer recruiting
University of Texas Health Science Center, San Antonio, Texas
Brooke Army Medical Center, Fort Sam, Houston, Texas

Utah
University of Utah Health Sciences Center, Salt Lake City, Utah
LDS Hospital, Salt Lake City, Utah

Virginia
Sentara Norfolk Hospital, Norfolk, Va.; No longer recruiting
Virginia Commonwealth University Medical Center, Richmond, Va.
Inova Fairfax Hospital, Falls Church, Va.; Suspended

West Virginia
West Virginia University/Jon Michael Moore Trauma Center, Morgantown, West Va.

source: www.clinicaltrials.gov where it says "Verified by Northfield Laboratories June 2006

http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1

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

http://www.acronymrequired.com/2006/03/polyheme_and_the_newest_plastic.html

The FDA is allowing Northfield to test its blood substitute without the consent
of the trauma patients, who often are unconscious.
In lieu of patient consent, the 31 medical centers testing the product are required
to carry out community-awareness campaigns about the trials.
Several hospitals have told community meetings that previous trials showed PolyHeme
to be safe, failing to mention the heart attacks,in their printed materials."

[AspenRose]

1. I wonder if you could put a clause in your medical power of attorney

as a CYA measure, in the event you are unconscious and they try to do something like this without your consent.

[Breeze54]

4. Why not?

You should ask your lawyer if you have one. And I'd get a bracelet asap!!!

I'm just floored by this but I suppose I shouldn't be. :sarcasm:

What a crock! :wtf: :grr:

[Rainscents]

2. I also heard this shit has HIV tented virus too, since they use real blood

I don't trust anything PHARMA or FDA put out. These basters wants to use people as their Ginny pigs.

[MadMaddie]

3. Experimenting on the unwilling and unknowing massess.....

gosh....why does this sound familiar?:think:

[Breeze54]

12. Tuskegee Syphilis Study ring any bells??

:grr: :nuke:

http://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study

[undergroundpanther]

14. Aids Study on foster kids in NY..

http://www.ahrp.org/infomail/05/05/04.php

[Breeze54]

26. Holy crap!!!

Here's a link my friend just posted. I know you mentioned this too!

"I fear that some of these experiments remind me of Josef Mengele": http://en.wikipedia.org/wiki/Josef_Mengele

[MadMaddie]

67. Yes..this is one of many...

[acmavm]

5. From the Northfield link:

<snip>
This is the first U.S. trial of a hemoglobin-based oxygen-carrying resuscitative fluid in which treatment begins in the prehospital setting. The trial will be conducted in approximately 25-30 Level 1 trauma centers throughout the U.S. 720 patients will be enrolled in the trial.

Treatment begins at the scene of injury, continues in the ambulance during transport, and for up to 12 hours post-injury or 6 units in the hospital. The trial is designed to evaluate PolyHeme® compared to the current standard of care, namely salt water in the ambulance followed in the hospital by donated blood, when needed. The primary endpoint is survival at 30 days.
<snip>

[Breeze54]

7. I think

"withput your consent" is the story here!!
And the failure of them to mention Heart Attacks!!

http://www.acronymrequired.com/2006/03/polyheme_and_the_newest_plastic.html

Media Coverage In the Past Three Years
This has been going on since:
* May 20, 2003; "Synthetic-blood testing to begin at Denver Health". The Denver Post.
* December 17,2003; "Artificial blood may get S.A. trial;
Many participants won't have given their consent." San Antonio Express-News.
* February 21, 2004; "Substitute Blood Trial Worries Ethicists", the Boston Globe.
* February 9, 2004; "Blood-substitute test skips consent" in the Chicago Sun-Times.
* February 20, 2004; "Artificial blood tested without patients' consent:
Similar tests halted in 1998 when deaths of 20 patients tied to different product".
The Ottawa Citizen.
* March 23, 2004 "An Experiment in Saving Lives.
Emergency Patients Unwittingly Get Artificial Blood": The Washington Post.

The clinical trials are done via a Food and Drug Administration *special* category of research
that makes an exception for informed consent requirements under section CFR. 50.24,
waiving consent rules for certain trauma patients so that scientists can gather,
in their words: "valid scientific evidence, which may include evidence obtained through
randomized placebo-controlled investigations, that is necessary to determine the safety
and effectiveness of particular interventions.."

Is The Blood Substitute Safe?
The company vehemantly disputed the article in a flurry of "news".
They specifically deny the Burtons's recounting of past clinical trials,

that he described this way:

"Ten of 81 patients who received the fake blood suffered a heart attack within seven days,
and two of those died. None of the 71 patients in the trial who received real blood were
found to have had a heart attack. PolyHeme's maker, Northfield Laboratories Inc.,
quietly shut down the trial and didn't publicly disclose the results..."
---------------------

This is pretty scary shit!!!

[undergroundpanther]

20. Sick fuckers they are..

FDA sanctioned Exploitation: Viagra Tested in Children Print E-mail
Sunday, 04 June 2006
The following confirms to us that the U.S. government (specifically, in this case, the FDA) and licensed academic and/or commercial laboratories that test drugs in human subjects have descended into a moral abyss.
FDA "bioethicist" Dr. Sara Bodkind, told the President's Council on Bioethics ( December 2005) that under the 1997 law--FDA Modernization Act-- "if the FDA issued a request for pediatric studies and if those studies were designed and approved by the FDA and they were completed, then the sponsor could get an additional six-month period of market protection, not only in the specific drug that they tested in children but in the entire moiety, in any preparation that used that particular chemical."

In other words, FDAMA opened the flood gates for drug testing to be done on children: the financial incentives were doubled: that is, a six month patent extension exclusivity, and the drug's market was expanded to include children.

This "public good" was "accomplished" by encouraging manufacturers and their paid academic pharmacologists to exploit children's vulnerability in mostly non-therapeutic risky drug experiments.

Dr. Bodkind stated:
"So sildenafil, for example, is now tested for pulmonary hypertension in children, but it's the compound that's known as Viagra. So if that company were to get six months of exclusivity, then it would apply to all of the products and all the uses of that moiety. So this was a very important incentive to encourage pediatric research. And that was I guess commonly called "the carrot." See: http://www.bioethics.gov/transcripts/dec05/session4.html

Fucking VIAGRA on Kids!
I Hate this shit..Sick sick souless fucking psychopath bean counters ,ceos "scientists"and so called doctors oughta be in jail or get the death penalty for this shit!!

[chicagomd]

42. Quick off topic point...

The lack of consent in this case is pretty appalling, but your "Fucking VIAGRA on Kids" comment is a little out of line.

As a physician I can tell you (and many of you probably already know) that prescription drugs have a lot of different effects on the body, in addition to what they are "indicated" to do. The medication with the trade name "Viagra" also happens to do good things for very sick children with certain types of congenital heart defects. For example, it may be able to keep them out of heart failure allowing them to delay their surgery.

As a Pediatrician I can tell you it is often frustrating not to have the same options available to me to help children that my adult counterparts do because there is little to no money in it for the drug companies. (That being said, because there is less money in Pediatric prescriptions, I don't have to deal with a flood of drug reps in my office.)

The FDA, without question, does some bad shit. Trying to increase accessibility of life saving medications to children (like "fucking" Viagra) is not one of them.

Proceed...

[mongo]

53. Welcome to DU chicagomd!

Stick around -- we need more voices of reason like yours.

[Straight Shooter]

54. Propulsid was another "dangerous" drug, beneficial for infants

Definitely some bad side effects for adults, including fatalities. But the hospital-based pediatricians were begging for the drug to stay available for infants with diseases related to respiratory distress. I can't remember all the particulars, but Propulsid was a lifesaver for these infants who would otherwise die without it.

[undergroundpanther]

64. Cool but

I think the kids and thier parents should have a right to refuse these tests.If a family consents than fine,but don't bribe poor people into this shit and don't violate anyones consent to test drugs dammit.

[undergroundpanther]

63. Viagra has some scary side effects

On ADULTS why are they testing it on kids for? Kids can be damaged by bad drugs alot quicker than adults.And they got a lifetime to live with the damage done. You might think it's ok to risk kids by testing on them,would you sign your own kid up as a test subject? if not why is it ok for other peoples' kids to suffer and risk? For a pediatrician you ain't that ethical are you? What part of do no harm did you ignore?
Screw your"hope" paradigm. There IS risk..If you ain't willing to sacrfice your kids for "science"..shut the fuck up.

[aikoaiko]

69. deleted - responded to wrong post.

[undergroundpanther]

17. This fake blood has killed people

Several years ago a clinical trial of a blood substitute called PolyHeme finished with worrisome results. Ten of 81 patients who received the fake blood suffered a heart attack within seven days, and two of those died. None of the 71 patients in the trial who received real blood were found to have had a heart attack.

PolyHeme's maker, Northfield Laboratories Inc., quietly shut down the trial and didn't publicly disclose the results, which are described in internal documents viewed by The Wall Street Journal. It decided the heart attacks might have been due to doctor inexperience in using PolyHeme, not a problem with the product itself.

Now Northfield is in the middle of a new trial. A Food and Drug Administration official, Jay Epstein, calls the earlier data " alarming " but not sufficient to stop Northfield from trying out its product on hundreds of trauma patients.

http://www.defrance.org/artman/publish/article_1531.shtml

Hospitals are becoming the new Death Camps ...

[bluedeminredstate]

6. There's my city right there on the list!

I was hospitalized last year with a kind of mystery illness, but luckily had no blood products. My husband was like a not so friendly check point for all the stuff that they suggested trying to make a diagnosis, and if not for him I don't know how it would have turned out. I went to the ER for a second admission in 3 days in bad condition - dehydration had me hallucinating and my friend took me to the hospital - and they put me in psych before hubby knocked some heads and got me to the ICU.
Anyone alone would be succeptible to all kinds of stuff like this product testing and who would know?

:scared:

[Breeze54]

8. Is your hospital on the list?

:shrug:

My city refused to participate, at any of the hospitals here!
To many 'unknowns'!

[bluedeminredstate]

18. No.

But for a roll of the dice in deciding where to go the first time I was admitted, I would have gone there. I weighed the teaching hospital versus non-profit hospital/higher nurse ratio and told my husband to take me to the hospital with more nurses (I'm a nurse and the lack of nurses on the floor is scary). This university, state-run, teaching hospital does work with all the hospitals in the city, though since they're the "experts."

[undergroundpanther]

11. Maryland

Is not on the list,hopefully Maryland will NEVER be on that list.
It's fucking scary 'cause I gotta get a tonsillectomy done and a tonsillectomy when done to an adult can be complicated. As in if it goes wrong it can cause some profuse bleeding..So, I being a useless eater on SSI in this fucking utilitarian bean counter dominated culture run by a bunch of psychopaths with a populace playing make believe about this psychopathy in high places problem in corporations and government..I know I would be the perfect throwaway body candidate too poor to sue,so easy to be targeted for fake blood 'experiment' from these pigs..
That Tort reform law fucked us all over,it wasn't about frivolous lawsuits it was about corpoorations working to find a way to turn citizens into legally Un-consenting guinea pigs for medical/drug corporations..

A law for the thugs so we cannot fight for our own bodily consent against the predatory greedy evil elitist psychopath run companies that fucked us over when we are sick...They can KILL us legally now now in case you never THOUGHT it could happen here,it IS.

Ooops Mrs Jones was homless lady..Hmm guess that fake blood killed her off.. Oh well,Next..,Ooops old man Dan? Guess that experiamental vaccine killed him, it wasen't as safe as we thought it was fancy that..So sorry about your loss family of Dans,and Oh Don't bother suing the corporation or the hospital for letting us doing the vaccine tests,we don't need to ask anyones consent anymore, we can use whomever we want,for whatever we want,because you patients don't have rights to consent to losing anymore..Be Aware..Any lawsuit you try will be tossed out for frivoloity.
And BTW don't forget you owe the Hospital 145,000 bucks too for his "treatment" that *snort* didn't help him but gave us more information to make expensive drugs we can sell you later at 150.bucks for 20 pills...You know Bankruptcy isn't available as an option anymore..Guess we won't see you in court than.. sucker!!
Unless you don't pay up when we say so,we'll get the claims companies to harass you ,than we will bring you to court..and wring it from your skin....Bwaghahaha..

Aaargh I hate this fucking bullshit. HATE the greedy wealthy..The Top of the pyramid needs to be lopped off and crushed.People,the fish's head is long passt rotten,And it is spreading and fascism is like poison working in so many people's minds it scary as shit..They don'rt even REALIZE it..And goddammit nobody sees this, 'cause if it ain't their fucking pet issue,they think danger is far away or it isn't happening her!

What fascist psychopath needsa fucking centralized death camp anymore? We got lots of suitable places to kill and hide the numbers in labels,plenty of prisons,homes and hospitals, to diffuse the dead bodies,and we can lie through a court just to dismiss claims..All because of the wonders of "tort reform".. When alot of death is spread is over alot of places it does not look so scary and so the sheep do not revolt..This is NOT tin foil..Non consenting medical experaments..Calling Dr.Mengle??

This corporate kingdom we have become is Evil evil evil..

I so wish I could get the FUCK out of here.

[Breeze54]

13. Can you donate and store your own blood ahead of time?

Before the operation? I think you can if you ask ahead of time.
I hear your outrage!
Thanks for verbalizing it because I'm at a loss for words!! :grr:

[undergroundpanther]

15. I will ..KICK

Hopefully they won't "misplace" my blood accidentally on purpose..

You see when a person's CONSENT is violated or manipulated WE are not FREE or a Civil country anymore people! To Usurp consent of people when they are most vulnerable as in the hospital or unconscious or bleeding to death is just pure profit driven EVIL.

People give this thread 4 more votes MORE people GOT to see this!!

[Breeze54]

16. Good!!

I want everyone to see this!! Cross post this everywhere!!

I hope you can donate the blood! Maybe if you call the Red Cross??
:shrug:

[undergroundpanther]

19. I will if I don't

have to use it on myself in the tonsillectomy operation.
I'll wait a few months for my body to recoup and donate blood again too.

[Breeze54]

22. No... I mean

I think they can arrange getting and holding your blood before the operation.
So that it's there for you! I think they do that, as a service!!
They control the blood banks, most of them... I think!

[undergroundpanther]

23. I will talk to my

regular doc and the ENT and TELL them I want my own blood.TELL them to get it from the blood bank,red cross..
I will WRITE it all down.Give the papers to everyone. I want no one to play Like I was Terry Shiavo and they can read my mind or something to justify violating my consent! Besides the thread here on DU is MORE evidence to prove of what my desire is..

[REP]

31. It's Called Autologous Donation

In surgeries where a blood transfusion is expected, a patient can store their own blood for this use. It's called autologous donation. You will need to get special forms for this that specify when the surgery is to be done and how much blood is will be needed. Just donating to a blood bank and telling them to use the blood you donated won't work; it isn't stored that way unless you go through the autologous donation process. Friends and relatives of the correct blood type can also donate specifically for your use, but it needs to be done in advance with the forms. (I'm B- - I know this shit.)

Red Cross's blood screening process is a fucking joke - I'd rather take a chance bleeding out than accept a donation from them because of their poor screening. I'll die of the diseases I know I have already, thanks!

[undergroundpanther]

32. Thanks for the info

I will ask about the autologous donation papers and get it done. If I do an autologous donation can the fuckers wiggle out of using my blood after I do that process? Or is it binding legally?

[REP]

35. Yes, Sort Of - If They Need More than Has Been Stored

But the chances of needing any during a tonsillectectomy, assuming you have a normal PT (no clotting disorders) are remote. Autologous donations are usually required for major surgeries, like hysterectomies, oophorectomies, renal surgery, etc or for those with delayed PT times.

[Breeze54]

36. Thanks for clarifying and the needed info!

:thumbsup: ;)

[wiley]

56. Consider storing naive lympocytes

You'll want them when you get older. If exposed to an antigen in the future, they could be a personalized treatment for many diseases.

[Breeze54]

61. How and where can one do that?

:shrug:

[wiley]

71. Ask your local blood bank. If they don't do it, a specialty lab

will do it or refer you to the nearest location. Hospital research centers MAY do it for you, or you may have to go to the specialty lab center. You're may have to negotiate the price for procedure and storage if it's not research related. If it's research related, make sure to find out what will happen if that research project is defunded or stopped. Make sure that you know what you are consenting to if participating in a research protocol. I'd also recommend storing eggs or sperm when you are very young, as the older you get (over 40) the more chance that birth defects or things like autism, etc. will occur in your offspring - if conception is something you are interested in.

[KoKo]

9. Why am I not surprised to see Duke on that list.........

The more I know about Duke the less I ever want to have to be hospitalized there....sheesh.

[undergroundpanther]

10. Fuckers..

Don't y'all get it? We are just unwashed masses of fodder for the rich criminal 'elitists' to use,bodies and minds for them to exploit in one way or another in their insane quest to live forever,never suffer,get whatever they want,play their fucking games, and rule the world as lord and master.
Goddammit I really do not trust this government now, With this kind of sickening games going on with consent. This is what happens when you let a bunch of fucking sociopaths rule a nation,run a corporation and control a culture. They destroy people and manipulate and lie and harm and mutilate and scam...AAaargh..
I HATE the rich pig,corporate fucking bullies,exploiters and elitist thugs...And their fucking little Eichmann enablers..better wake the fuck uP!!

[undergroundpanther]

21. Get this on the greatest

Page..it needs to be seen!
Needs 4 reccomends!

[alfredo]

24. This is pretty scary. K&R

It was on TV tonight. Something like 10 people have died.

[Maraya1969]

25. I swear the blood in my body just rushed out of my face. This is

terrifying. I am sending this around in an email. K&R also.

[arikara]

27. Must read article: BAD BLOOD

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.

Despite repeated studies, PolyHeme has yet to be approved by the Food and Drug Administration, and this May, Forbes magazine told its predominantly Wall Street audience that researchers at Walter Reed Army Institute of Research had "published a study suggesting PolyHeme might not be so safe after all. Comparing resuscitative fluids, it found that hemorrhaging lab rats treated with PolyHeme experienced higher mortality rates than those that received two commonly used solutions."

The founder of Northfield labs is Steven Gould, a 57-year-old physician from Chicago who has worked on blood substitutes for more than 25 years. In 1979, after obtaining a grant from the Army, he and several other doctors at the University of Chicago developed a technique to separate hemoglobin, the oxygen-carrying protein, from blood, then link the hemoglobin molecules together into polymers, hence the name PolyHeme.

<snip>

http://www.sdreader.com/php/cover.php?mode=article&showpg=1&id=20050728

[Breeze54]

28. argh!!!!

snip-->

Northfield's Restraining Order Against the San Diego Reader

According to the Reader, contrary to the requirements of the trials and Dr. Gould and Northfield's indignant defense, the city of San Diego produced scant information about the trials. What was publicized leaned more towards marketing and recruiting material, as opposed to than the balanced public information that was required in lieu of patient consent. Contrary to the company's claims
to transparency, information was tightly controlled - if not censored - by Northfield Laboratories. In a memo sent from Gould to the principal investigator of the UCSD study, published by the Reader, he wrote:

"I urge you to remind your study coordinator and all others associated with the trial that information about patients and the details of the trial at your site are not to be shared with anyone outside the study team." UCSD sent the request on to the City of San Diego, who agreed,
"not to disclose to any third party any Confidential information,"
defined as "all information, data, materials, in whatever form or medium,
that treats as confidential and proprietary information."
:grr:

snip-->
But this may be just the tip of the ethical allegations iceberg.
The Reader's thorough, interesting, and potentially damaging report investigated participant recruitment for the trials, hospital and doctor compensation for the study,
as well as adverse events that occurred in the Polyheme© trial.
The San Diego Reader found that only a few ambulances servicing only select areas of the city
were participating: "...paramedic units in three of the city's poorest communities
-- Oak Park, Nestor, and San Ysidro --
had been chosen for the trial because those areas generate the largest number of severe trauma patients..."

http://www.acronymrequired.com/2006/03/polyheme_and_the_newest_plastic.html
=============================

They are using it "in the field" in Iraq also!!!!

[undergroundpanther]

30. The Death camps

Are hidden in plain sight. I said this MONTHS ago and everyone yelled Tin Foil! NOT..anymore..shit.

[undergroundpanther]

29. I read it..

All I can say is..As citizens we MUST put an END to this Corporate SECRECY and proprietary information twisting of words,and laws bullshit RIGHT NOW.The Corporations have gone TOO FAR,

Somehow some way all corporations must be forced to stop this. We must MAKE THEM stop using a claim to secrecy when the cry"corporate"secrets is being used to keep a bunch of ceo thugs and dr mengele assholes and greedy hospital administrators from ever facing criminal charges of murder, genocide or worse .
The Wealthy corporate thugs and their enablers MUST be made accountable even if it's not through courts if it comes to that,the corporates are forcing the issue..We have to do Something.. or they'll kill us one by one,when we get hurt sick or are most vulnerable...Without our consent. With this shit we are in danger,especially if you are poor,a person of color,gay/trans,disabled,or any of those "useless eater" categories in standard bean counter mentalities, or an inferior race as declared by Eugenicists and NAZIS who pay the utilitarian bean counters to put a price tag on your head...

I wish there was a way to say, NO MORE of this hiding under the fucking excuse of corporate secrets. FUCK THE CORPORATIONS ,they are NOT PEOPLE,they have NO RIGHTS of persons,No rights at all,Murder is not a corporate privilege!! FUCK their corrupt "bio-ethicists"who are just criminals beholden to the psychopath Ceos,.. most of all FUCK all their whining over their 'profits.. every.last.cent take it from them ..These fuckers are KILLING people because they can get away with it..Why why do we let this shit go on? Why do tolerate and let congress,violate our consent and force us to TRUST and tolerate these big pharmacy monsters and give them more power to destroy OUR lives?? No fucking re-thug senators kid will EVER get Polyheme.. that's for sure,..so why are black poor people? Are some citizens ok to throw away. A lesser class?

Fuck the corporate machines and their corporate person hood scam and their secrecy!

I am Sooo PISSED OFF.

[Rainscents]

34. I agree...

This shit have to stop! What else these basters up to that we don't know about? It's fucking scary!

[Auntie Bush]

62. "I am Sooo PISSED OFF." Glad you explained that...I hadn't noticed.

Thanks for the rant! :pals: You speak for both of us...only I'm not so eloquent at expressing myself.

[GuvWurld]

33. We Do Not Consent

We Do Not Consent (.pdf)

[Breeze54]

37. Thank you for the link

and the free download of the book! Awesome! ;)

I DO NOT CONSENT...either!! :scared:

[earth mom]

38. I HATE the Pharma Giants! They are pure evil!

:grr:

[pecwae]

39. Have just written to Northfield

and Duke to opt out. I don't need anything else to complicate my health! Thanks for this info.

[niallmac]

40. Hard to believe but I guess it's true.

Is it because the product is so important to our War on Terra?
Guess this is what happens when the public is focused on the
price of gas and stirred up by the latest manufactured terror plot story.

I still can't believe this was OK'd.
Where are our courts?
Where are our representatives?
Bought up by the Corporations
Every one.
Long time ago.

Edit to :kick:

[mom cat]

41. Thanks! I just sent them the following e-mail:

I do not wish to participate in the polyheme study. Please provide me with the blue bracelet that I can wear in the event that I might be hospitalized that indicated my refusal to be part of your experiment.
If this e-mail has reached the wrong department, please forward it to the correct one.

[Breeze54]

43. They're still not upfront about it

I can't believe they don't have a form just for the Opt Out Option.
That's because they don't want to make it easy for anybody to opt out!!
People traveling this summer would fit their "random test subject" category nicely!

Here's the address: Contact Information

Northfield Laboratories Inc.
1560 Sherman Avenue
Evanston, Illinois 60201-4800
847.864.3500
http://www.northfieldlabs.com/contact.html

I don't know that I would trust them to take my name off the list!! Would you?

Who the hell is going to check with Northfield Labs database, as you're being whisked away in an ambulance? :shrug:

People have to fight for a DNR order to be honored, at times, right IN the hospital!!

That blue bracelet should be more easily available, IMHO, to EVERYONE in the USA!!

I'm glad you wrote to them! I'd suggest keeping a copy with a friend, on you and in your car!

And get a bracelet!!

I'm going to get one for myself and my three kids too!!

:grr:

[mom cat]

65. And then wear the bracelet at all times. Use it to start conversations

about this "study".

[GeorgeGist]

44. Well there is this to remember...

"This study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting.
...
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria

Inclusion Criteria:

* Adult patients following trauma who have sustained blood loss and are in shock

Exclusion Criteria:

* Patients who have sustained unsurvivable injuries
* Patients who have severe head injury
* Pregnant females
* Patients found in cardiac arrest
* Patients who object to participation (e.g., religious grounds, wearing exclusion bracelet).



emphasis mine

http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1

[Breeze54]

47. Patients who object to participation

How do they object if they're unconscious?? :shrug:

How far from a hospital are they?

Did you read where they are targeting poor neighborhoods/area's??

This is UNETHICAL!!!!!! :grr:

You are the guinea pig... whether you like it or not!! :nuke:

[IndyOp]

57. I think they can still test you even if blood is available at the hospital

The purpose of the study is to test a product that will be used "where blood is not available" -- just describes the future use of the product, not the conditions under which it will be tested. They could still very well be giving the product to people for testing even when blood is available.

"This study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting."

[Breeze54]

59. You got it!

http://www.acronymrequired.com/2006/03/polyheme_and_the_newest_plastic.html

Northfield's Restraining Order Against the San Diego Reader

snip-->
"More troubling, Northfield paid the hospital and principals per patient
who "completed" the study, which could financially motivate doctors to continue
with Polyheme© even if the patient would have benefited from donor blood.

One of the most ethically contentious aspects of the trial is that it requires
patients to be treated with Polyheme© for 12 hours, longer than what would be
medically necessary in a city hospital where donor blood is available." <--snip

[Deja Q]

45. Why don't they just ask? I would be inclined to say 'yes, I will help!'

Depending on the issue, but I'll generally an accomodating fellow. Underused and misunderstood, but definitely accomodating.

[Breeze54]

50. Maybe A.C* could volunteer?

How about Cheney? He's in the hospital a lot!
I think all the Dr's and FDA board members, hospital admin. that approved this
should be the guinea pigs! Don't you? How about the b* family? The GOP, at large?

Rush? Hannity and his followers!! ;) yeah!! Let them volunteer!

Besides, if you sign up, they may cause you to have a life-threatening trauma!
They need "volunteers', don't ya know? :sarcasm:

Ever read or seen the movie, "Coma"? :scared:

[Breeze54]

46. Northfield Responds to ABC 20/20 segment

http://www.northfieldlabs.com/2020.html

snip-->

ABC’s 20/20 report on Northfield’s pivotal Phase III study with PolyHeme® lacked balance.
It failed to note the following key points:

• It is critical to conduct rigorous scientific research to improve patient care and outcomes in emergencies.
The PolyHeme study is designed to address the critical, unmet need for an alternative to blood
when blood may not be immediately available. In the case of a man-made or natural disaster,
PolyHeme represents a potential life-saving resource to sustain lives that otherwise might be lost.

• This study is being conducted under a federal regulation passed in 1996.
The regulation allows a waiver of informed consent when patients are in a life-threatening situation,
when obtaining individual informed consent is impossible,
and when current therapy is unproven or unsatisfactory.

The most critical stipulation is that there is the potential for direct benefit to the patients enrolled:
a survival benefit.

Northfield’s trauma study meets these criteria.

• The study protocol was approved by FDA and by 32 institutional review boards at
Level I trauma centers across the country.

• Extensive community consultation was conducted by participating centers,
using print and electronic media, as well as community meetings.

Over 60 million media impressions were created by these efforts.

• An Independent Data Monitoring Committee is charged with overseeing patient safety in this study.
After reviewing the data on the first 60, 120, 250, and 500 of the planned 720 patients to be enrolled in the study,
the IDMC four times recommended that the study continue without modification.

Following the 500 patient review, the IDMC recommended that the study go to completion.

• Northfield recently announced that the study has passed the 700 patient mark.

I don't care if 32 institutions...er...Hospitals & Doctors PAID to participate, approved it!!!

:grr:

And what ARE the "SURVIVAL BENEFITS"?? They pay the family off, of the deceased?? :shrug:

"Extensive community consultation"?? :wtf: How many here have ever heard of this experiment??

Northfield Labs is basically telling 20/20 and YOU to go F*ck yourselves!!
We're going to keep doing this...BECAUSE WE CAN!!!!
:grr:

[lonestarnot]

48. Janet Napalitano probably stopped them! Yeah Janet!

These fucking people are monsters!

[Breeze54]

49. Potential Battlefield Use - Iraq & Afghanistan

http://www.northfieldlabs.com/us_army.html

The Department of Defense and all branches of the military
have had a long-standing interest in the successful development of a hemoglobin
-based oxygen carrier (HBOC) to serve as a red blood cell substitute.

The ideal properties of an HBOC for military use include:

* Universal compatibility
* Long-term storage capability
* Reduction of disease transmission
* Safety during rapid, massive infusion
* The ability to support life in humans in the virtual absence
of any of the patient’s own red blood cells


Northfield’s collaboration with the U.S. Army dates back to 1969.
We are currently exploring the potential use of PolyHeme® in patients in shock
in remote battlefield settings, where red blood cells are not available.
In such circumstances, PolyHeme® has the potential to simplify and facilitate
the early treatment of such urgent blood loss by permitting immediate, rapid, and
simultaneous replacement of the lost volume and hemoglobin that occurs with hemorrhage.

How many have died on the battlefield or in the field hospital,
from being given this stuff, that we don't know about?

DU? Agent Orange? Come to mind? Ringing any bells?
I'm sure there are more!!
:evilfrown:

...fixed spelling error/typo in title...

[Breeze54]

51. They're in Phase III now! - 'treatment is given to large groups of people'

http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1

Study Phase

Most clinical trials are designated as phase I, II, or III,
based on the type of questions that study is seeking to answer:

* In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80)
for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

* In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300)
to see if it is effective and to further evaluate its safety.

* In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000)
to confirm its effectiveness, monitor side effects, compare it to commonly used treatments,
and collect information that will allow the drug or treatment to be used safely.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.

.... Without your consent!! :grr:

How come b* is against stem cell research but this is ok??? :shrug:

[knitter4democracy]

52. My husband didn't know of it, and he's an internist.

I haven't seen any of this in his journals or med lit that comes to the house, and he's never heard of it. Yeah, it's been so widely publicized. :eyes:

That's f***ing scary!!! Informed consent is the cornerstone of our medical research system. Seriously scary.

[Breeze54]

55. Is he appalled?

or not surprised? :shrug: Thanks for the info!

I'd never heard about this before last night.

http://www.theaterwissenschafterlangen.de.nyud.net:8090/images/labor_Frankenstein.jpg

[knitter4democracy]

66. He was appalled. He wasn't shocked, though.

He hates the Bush administration almost more than I do, which is saying something. He was appalled that they would endanger patients like that, especially given the last trial's outcomes. He wasn't too suprised that the FDA has become a free pass for Pharma, though. They've mucked up too many things lately. Honestly, he doesn't think much of them anymore and is just extra careful with his patients on new meds. He still trusts the CDC, but he worries that they're compromised, too.

[AirAmFan]

58. We've got 'Do Not Call'; do we need a 'DO NOT EXPERIMENT' registry?

What a concept--an "opt in" default protocol for a clinical trial. Whoever dreamed up this protocol needs to be strapped down and forced to watch footage of Dr Mengele's "expirements" in Nazi Germany.

Which Congressperson or Senator will be the first to introduce legislation to OUTLAW this and other unethical Big Money Pharma practices?

[Breeze54]

60. Agreed!

Strap them down and inject them with their own invention!! :evilfrown:

I read that Sen Grassley was pretty peeved over this but I haven't hunted down
what he had to say yet. I think there was a link to him here:
http://www.acronymrequired.com/2006/03/polyheme_and_the_newest_plastic.html

[shance]

68. Theres been speculation the Veterans Hospitals have been using Vets too

for experimentation and essentially being used as guinea pigs without their consent (obviously*).

Where is 60 Minutes when you really need them?

[wiley]

72. Last I knew, the military doesn't have to get Informed Consent for

anything they try on servicemembers. Let me know if I'm wrong about that.

[aikoaiko]

70. FDA? what about the freakin doctors.

The doctors administering these studies should lose their licenses.
The FDA and Northfield are self-serving, but the doctors know better.

[mighty]

73. Consent first

To say this scares me doesn't begin to really cover my emotions. Its reminicent of so many things including the Tuskeegee Syphillis study and even some of the stuff done by Joseph Mengela. What's really sad is it wouldn't hardly matter if there was a consent or not because people have to sign so many things when they go into a hospital they don't know what they are signing. They could be signing over body organs and most people wouldn't know. Never the less this should only be done with full consent of those being used like lab rats.

I have a feeling there would be people who would volunteer. There are many people every day that volunteer for clinical trials of things I am sure this would be no different. Why then circumvent that and do this?