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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.

snip

To opt out of the study, contact Northfield Labs (http://www.northfieldlabs.com/...) or a participating hospital and request a blue bracelet. If worn, you will be exempt from the trial.

There is a list of actively participating hospitals on the end of the ABCnews article.

I wanted to publicize this an another failure of the Bush administration to protect people from corporate abuse.

I thought this was vital since the Food and Drug Administration approved this sellout to the pharm. companies.

http://irb.ucsd.edu/...

What is an exception from informed consent?

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.  

From an old WSJ article:
http://online.wsj.com/...

Ten in Trial Have Heart Attacks,but Data Aren't Published; FDA Allows a New Study; Doctors' Pleas Are Ignored

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.

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 10 heart attacks in their printed materials.

Here is a list of cities they tested this in.  Many of the hospitals have stopped due to the questionable ethics involved, but check with them anyway if you live in the area.

California
UC San Diego Medical Center, San Diego, Calif.
Scripps Mercy, San Diego, Calif.;

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.;

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

Pennsylvania
Lehigh Valley Hospital, Allentown, Penn.
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.;

Texas
Memorial-Hermann Hospital, Houston, Texas;
Memorial-Hermann Hospital, Houston, Texas;
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.
Virginia Commonwealth University Medical Center, Richmond, Va.
Inova Fairfax Hospital, Falls Church, Va.;

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

Originally posted to altscott on Wed Jul 12, 2006 at 08:27 AM PDT.

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Comment Preferences

  •  Please recommend (1+ / 0-)
    Recommended by:
    astoundedstill

    this is important information to get out to everyone and maybe we can stop this insanity.

    If I seem a little insensitive or clueless it is due to my having Asperger's Syndrome.

    by altscott on Wed Jul 12, 2006 at 08:24:32 AM PDT

  •  How long (0+ / 0-)

    has this been going on?  I have a family member who had surgery at the Mayo, MN about a year ago.  Any chance the blood he received was part of this?

    •  how (2+ / 0-)
      Recommended by:
      Odysseus, tamman2000

      how else would this be tested? you could never in a lot of these cases -- cases most likely to require blood infusions -- get consent. Yes it should be publicized more so people can opt-out, but at heart (hahha) this is a reality of the research.

      You have to, as i'm sure the FDA did, weigh the costs versus the benefits. If they can figure out how to make this work reliably people in emergeny situations where it's not possible to determine blood type or there isn't enough type O, could be saved.  Again, it should be publicized more, but at its core, this is not something to freak out about.

      •  You obviously aren't in an affected area n/t (0+ / 0-)

        If I seem a little insensitive or clueless it is due to my having Asperger's Syndrome.

        by altscott on Wed Jul 12, 2006 at 08:33:41 AM PDT

        [ Parent ]

      •  This is more than 10% (0+ / 0-)

        Ten of 81 patients who received the fake blood suffered a heart attack within seven days, and two of those died.

        If I seem a little insensitive or clueless it is due to my having Asperger's Syndrome.

        by altscott on Wed Jul 12, 2006 at 08:35:29 AM PDT

        [ Parent ]

        •  meaningless (1+ / 0-)
          Recommended by:
          awakenow

          unless you also provide data for deaths (and other complications) of those who recieved saline only prior to arrival at the ER after incurring similar injuries.

          "How is it pro-family to prevent people from getting married?" -Me

          by tamman2000 on Wed Jul 12, 2006 at 08:41:31 AM PDT

          [ Parent ]

          •  of the 71 people in the original study (0+ / 0-)

            who were given whole blood:

            Zero heart attacks, zero deaths

            Did you RTFA?

            If I seem a little insensitive or clueless it is due to my having Asperger's Syndrome.

            by altscott on Wed Jul 12, 2006 at 08:47:08 AM PDT

            [ Parent ]

            •  Whole blood is not the alternative (0+ / 0-)

              This is a replacement for situations in which saline is  the only treatment available.  Of course blood is the best.  The question is:

              Is fake blood better than saline?

              I have not read this particular article (yet), but I have been following the topic closely for a couple of years, personal curiosity...

              "How is it pro-family to prevent people from getting married?" -Me

              by tamman2000 on Wed Jul 12, 2006 at 10:22:33 AM PDT

              [ Parent ]

      •  I agree. (0+ / 0-)

        They should be advertising this more - and make sure that people who live around hospitals participating in the trial be aware of the trial.

        If this product is successful, it would be a boon for trauma care.  But success depends on being responsible, and Northfield Labs should be making as many people aware that they might be participants - and that does not mean just having a webpage describing the trial.

        Patient enrollment is underway in a landmark Phase III study designed to evaluate the safety and efficacy of PolyHeme® when used to treat patients in hemorrhagic shock following traumatic injuries.

        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.

        http://www.northfieldlabs.com/...

        January 20. 2009 cannot come soon enough.

        by Crisis Corps Volunteer on Wed Jul 12, 2006 at 08:38:59 AM PDT

        [ Parent ]

      •  But shouldn't they tell (0+ / 0-)

        you at least after the fact?  Without some sort of reasonable follow-up system the result information would be pretty random.  That is, only those who go back to the same facility and told of any side affects would be included in follow-up results.  Even then, if the facility didn't have a good method for collecting such data, the results couldn't be considered statistically significant.  Giving people something without knowing it, with know formal follow-up is not proper protocal for a double blind placebo challenge.  I am ALL for research but something seems strange about this.

    •  As far as I know (1+ / 0-)
      Recommended by:
      tamman2000

      it is limited to trauma patients who can't give consent due to the emergency. Presumably because if you could give imformed consent, you wouldn't.  Call the hospital.

      If I seem a little insensitive or clueless it is due to my having Asperger's Syndrome.

      by altscott on Wed Jul 12, 2006 at 08:32:30 AM PDT

      [ Parent ]

  •  What's the alternative? (2+ / 0-)
    Recommended by:
    Odysseus, yellowdog

    Could you propose a different way to test artificial blood intended for use in situations where only saline is normally administered?

    Personally I view it as my responsibility to humanity to participate in this trial if I am the victim of a traumatic injury.  People will survive far more accidents if an artificial O- that doesn't need to be refrigerated can be administered in the ambulance instead of waiting for the ER.  It will not be widely available unless it is first tested.  This is the test.

    Awareness is one thing, and local news outlets should cover this in affected areas, but this isn't a sellout to big pharma, it is the only way to determine if an artificial blood product works...

    "How is it pro-family to prevent people from getting married?" -Me

    by tamman2000 on Wed Jul 12, 2006 at 08:39:13 AM PDT

  •  errm (0+ / 0-)

    Medical experiments without explicit informed consent is a violation of the Nuremburg Code.

    A rabid lamb bowing to Dear Kingpin in the land of the Lilliputians

    by tvb on Wed Jul 12, 2006 at 08:58:23 AM PDT

    •  So POWs are protected, just not citizens (0+ / 0-)

      If I seem a little insensitive or clueless it is due to my having Asperger's Syndrome.

      by altscott on Wed Jul 12, 2006 at 09:03:27 AM PDT

      [ Parent ]

      •  not quite (0+ / 0-)

        It doesn't differentiate, nor does the similar Declaration of Human Rights.

        A rabid lamb bowing to Dear Kingpin in the land of the Lilliputians

        by tvb on Wed Jul 12, 2006 at 09:06:38 AM PDT

        [ Parent ]

        •  speaking of the Germans... (0+ / 0-)

          They use, or used to use, prisoners for medical and crash testings (the prisoners are volunteers and get a reduced sentence for their public service).

          That's one way to clear death row-- test stuff like this on death row inmates.  If they survive the medical testing, commute their sentence to life without parole.
          And if they don't survive the testing, they go on to the next world knowing they helped society.

  •  Sent this to my family and friends.. (1+ / 0-)
    Recommended by:
    altscott

    If I ever find out, that , me ,or my family has been experimented on without my consent I will sue them for everything they have...I saw this and I couldnt believe that our govt. cares so little about us that they think they can use us like this, without our permission.. Thank you altscott for bringing this to our attention..

  •  My husband (0+ / 0-)

    works in the medical field and we had a conversation about this just the other day.  He didn't have a problem with it, I did.  Now, usually, I am very "pro-science" and behind most studies.  This, however, is different.  If it were me or my family member, there is no way I would give consent.  If it isn't something I would personally do, I can't expect it to be all right for it to be tried on others, especially without consent. Besides, is there really a need for this product?  I know that there are drawbacks from human donations, but its a system that really has worked quite well.  

    My husband, on the other hand, doesn't have a problem with it.  Ofcourse, like many people in the medical field, he has a bit of "de-personalization" going on and just sees the value of the testing and possible development of the product.  I know that many things go on in medicine that most never realize much less understand, but its an attitude I find troublesome.

  •  I think Portland, OR (0+ / 0-)

    is participating also. I read something awhile back in our paper, The Oregonian and saw a couple of tv news blips about it.

    Spiritual people inspire me; Religious people frighten me.

    by Esjaydee on Wed Jul 12, 2006 at 09:29:25 AM PDT

  •  I am on the IRB (1+ / 0-)
    Recommended by:
    tjb22

    at my institution.

    We examine clinical trials and grant approval.  My IRB panel includes 15 MDs, several public members, 2 lawyers, a pharmacist, myself (status not identified) and others.

    Consent is mandatory.  In one case in 10 years, we have waived consent.

    In a case like this, I would not waive consent.  This would not get thru my IRB.  NO WAY.  If we don't approve, you don't do your research.  NO APPROVE, NO STUDY.

    My institution, a very important one, has one of the biggest med research programs in the country.  We are #3 or #4 in all surveys.  Unlike many big programs, we have never been closed down for IRB and HIPAA violations.

    For those who think I'm bluffing here, we have strung out MDs for 3-4 months until they satisfy us.  Their research must be clear.   They must have adequate power.

    So, I don't believe this, not for a minute.

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