FDA in violation of Nuremberg Code?

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by Jon Airheart

It was reported on the front page of Wednesday’s Wall Street Journal that despite doctor pleas and 2 fatalities, Northfield Laboratories Inc. has been given the okay by the FDA to continue clinical trials of a blood substitute called PolyHeme. What’s worse is the manner in which the FDA is allowing it.

“The FDA is allowing Northfield to test its blood substitute without the consent of the trauma patients, who often are unconscious.”

With this appalling fact, it would appear that the FDA is in blatant violation of 3 out of the 10 principles of The Nuremberg Code’s Permissible Medical Experiments (http://www.ushmm.org/research/doctors/Nuremberg_Code.htm).

1. The voluntary consent of the human subject is absolutely essential.

5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.

The number 1 principle is self-explanatory and is the basis for which the studies are not in compliance with number 9. How can someone be at liberty to end an experiment if he/she is not made aware of said experiment?

In addition to 2 fatalities several years ago, 8 of 81 patients who received the fake blood suffered a heart attack within 7 days.
Northfield to this day has never publicly disclosed these results and fails to mention them in newly printed materials. This raises serious questions as to compliance with the number 5 principle.

The FDA has lost all credibility with this recent incident. Are they a part of our servant government or not? Are they accountable to us or not? You can give them a piece of your mind at 1-888-INFO-FDA. Lester Crawford has been the acting commissioner of the FDA since March 2004 and was confirmed the permanent head of the organization on July 17, 2005.

Jon Airheart asked me to publish this guest article for him. The photo (most embarrassing one I could find of him) is of Jon, Jessica Caplan and me and was taken in NYC in 2004.

Stephen Gordon

I like tasteful cigars, private property, American whiskey, fast cars, hot women, pre-bailout Jeeps, fine dining, worthwhile literature, low taxes, original music, personal privacy and self-defense rights -- but not necessarily in this order.

  1. 1.) While Nuremberg #1 seems to be self evident, the company appears to have adhered to Federal Regulations enacted in 1996. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.24

    2.) The WSJ article appears misleading. There is no apparent violation of Nuremberg 5. Read here: http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=820512&highlight=
    In addition, I believe subjects are permitted to withdraw from the study (Nuremberg 9).

    3.) In order to improve the care (i.e. save lives) of critically injured patients, emergency research simply must be carried out. Otherwise, physicians / scientists fail current and future patients and their families by not being allowed to test / discover potential life saving therapies for their condition.

    Question: Do you suppose that when the defibrillator was tested, the physician said “sir, I know you heart has stopped but if you would, please read this consent form”? It has saved countless lives.

  2. If Jon Airheart (read “Airhead”) and friends were actually as intelligent and informed as they attempt to sway others to believe they are, they would have already been aware of the previous Northfield Lab trials done many years ago, as I do, this is not new news. The WSJ is also guilty of ignorance on this one. And Libertarians, well, they’re just a bunch of Nazi, not too unlike the Republicans. Listen to the Libertarians long enough and soon all you will be able to listen to is German classical music. No “wunder” Jon (the pussy) Airhead (Hammer of Poop) is attempting to make a connection between the Northfield Lab clinical trials and the Nuremberg Code, Directives For Human Experimentation!!!!

    “Please stay on-topic, informative and polite. We reserve the right to remove comments for whatever vague capricious reasons seem reasonable at the time.”

    Fuck You.

  3. Consent was provided by the community on behalf of the individual, as is allowed under the very strict Federal regulation like trauma situations.

    Each individual trauma ER and hospital HAD to hold public meetings, give newspaper articles, and distribute literature in the community BEFORE this was even allowed. They had to seek input from the community, including it’s leaders before they made the decision if the trail was going to be allowed. In each case of participating trauma centers, this was done.

    Individuals or their families can opt out at any time.

    In addition, of worthy note, one state even changed it’s own LAWS to allow the hospital to participate becuase this is such a life saving product. Any hospital participating in the trial will sing it’s praises.

    The much quoted WSJ article focuses on an older trial where, due to it’s inherent design flaw of not comparing apples to apples, was discontinued.

  4. Wow Steve what an irresponsible ass. Why would you publish a guest article from an obviously uninformed individual as Airheart is on this subject? Did you bother to ask him what his background is on the subject or how much research he personally has done on the current polyheme trial? Where do you get off calling yourself the Hammer of Truth and then print this unfounded garbage. Why don’t you just go over to the Wall Street Journal and kiss Mr. Burtons ass personally. Do you think just because it was printed by the Journal makes it the truth. How much research have you personally done on the subject? Hammer of truth? What? You wouldn’t know the truth if you fell over it.

  5. How can you even begin to compare patients where one group had 60% of their blood removed with another that had 30% removed. If you research this idea further you will note that the Mayo Clinc and 30 some other prestigious institutions, which were aware of this prior study agreed to go ahead with the current study.
    If you dig a little deeper, please answer the following question honestly. Lets suppose that you or someone close to you is unfortunate enough to be in a car crash that is an hour away from a hospital? Perhaps this is in the mountains near Denver and you have already lost a lot of blood to the point of being unconscisous. Or it could be you are hiking near San Diego and have fallen and hurt yourself severely, but again 60 min away. Would you hope you had asked for that blue wirstband you heard about so you would get saline? Or assuming no wristband would you be praying that the 50/50 card the paramedic pulled said saline and not Polyhme? Sorry that was 2?s, be honest.

  6. Suggest you read the Northfield news releases http://www.northfieldlabs.com/ and the Yahoo NFLD investment board http://finance.yahoo.com/q/mb?s=NFLD for a fair but unbalanced appraisal of PolyHeme by doctors, EMTs, and knowledgeable investors. I say unbalanced because almost 100% of the comments are favorable. PolyHeme will save lives!!!!!!!!! And go get some first aid for that thumb you hit with the “hammer of truth” even if you aren’t bleeding severely enough to require PolyHeme.

  7. Polyheme was tested on 270+ patients with their consent and reduced mortality rates substantially vs historical statistics on patients receiving saline. The FDA required another trial using trauma victims before allowing Polyheme to be used in trauma situations. Obviously, you cannot get volunteers to agree to be hurt so badly that they lose 2-10 units of blood so that you can test Polyheme on them. That’s why it is being tested on trauma victims. Our representatives in Congress passed a law allowing tests such as this so that life saving medicine can be made available.

    Doctors at over 20 hospitals reviewed all the safety data from previous Polyheme trials before joining the Polyheme trial. The FDA also reviewed the data and agreed that Polyheme was most likely not the cause of the heart attacks.

    Polyheme not only saves lives, it reduces multiple organ failure, does not transmit diseases like blood sometimes does, and it lasts for a year vs 42 days for blood.

  8. You all should read Douglas Preston and Lincoln Child’s mount dragon. An artificial blood substitute figures prominently in the story.

  9. Dear Jon Airheart, as we all know, there is no such thing as bad press. I want to thank you for giving Northfield Laboratories Inc. and their life saving product PolyHeme more exposure. As a share holder and someone that has followed the developing story of potential of PolyHeme to save lives and become a block buster story stock, I can only believe that you are (in the long run) helping to make share holders wealthy. If you REALLY have some concerns about the trials, I highly suggest you request a blue bracelet from Northfield that will exempt you being treated with PolyHeme in the event you are bleeding to death and you are unconscious. If you are conscious you will NOT receive PolyHeme and will just be pumped full of salt water (saline solution) and your organs will be deprived of oxygen. You do give your consent for that right?

    Howard Jenkins

  10. Art Kulak: You forget to take your meds lately? I guess it’s that or you just need to get laid!

    Dan, I’m glad you picked up on a concern of mine that I did not blatantly mention: the American trend of valuing community over the individual. It’s also the basis for eminent domain abuse these days. I guess it is no wonder when every President since Woodrow Wilson gets on the mic to spout the wondrous benefits of “democracy.” Too bad we aren’t one. In our constitutional republic, individual rights ALWAYS trump a majority vote to take them away. Communities are an abstract concept. They wouldn’t exist without the individuals that make them up.

    Everyone else, the FDA IS in violation of the Nuremberg Code but I guess you are all okay with it. For those of you that think the WSJ article is biased and incorrect, I didn’t write it – take it up with Mr. Burton.

  11. Jon Airhead, you’re a fuck up and you know it, everyone knows it. You’re a fuckin’ Nazi bastard. Unintelligent, generally stupid, and obviously uninformed.

    And as far as the Nuremberg Code goes, you can stick that piece of Nazi bullshit up your ass. In fact, as far as I’m concerned you can stick all man-made laws of any kind up your ass. But then again, I suspect you love sticking pretty much anything up your ass.

  12. Imagine your in a serious automobile accident, trapped by wreckage and bleeding profusely. Your vital organs are screaming for oxygen. Life is beginning to slip away. Meanwhile, EMTs are only able to give you saline solution which can’t stop the traumatic shock that is overtaking your body. Your are about to become an ethicist’s dream….a dead person. This we are led to believe is far better than being a live guinea pig.
    Meanwhile stored in a locked refrigerator at the local trauma center, dozens of life saving units of Polyheme remain unused. They were taken off the ambulances when the FDA halted the nearly finished phase 3 trial. Hope remains that they may be used in the new trial recently designed by ethicist.
    Since the inception of the trial in April, only 1 patient has been enrolled in the trial at eh 86 sites in the country that are participating in the trial. The new trial requires that trauma victims, who have lost enough blood to have evidence of impending shock read the 14 page consent form and sign it prior to the use of polyheme. There have actually been 3 potential enrollees who could have participated but unfortunately there was not a notary present to witness the patient’s signature as required by the new trial protocol. The one enrolled patient was fortunate that the other driver who was involved in the accident in which the enrollee was injured was also a currently licensed notary.
    NFLD in it’s last conference call announced that they hope that the first look, after 60 patients will be sometime in 2014. The company hopes that an additional 45 sites will be participating in the trial and increase the present enrollment rate of 2 ½ patients a year.
    Nancy M.P. King a North Carolina ethicist who is familiar with polyheme expressed her displeasure over the length of time the trial is taking. “Northfield knows that the highest incidence of trauma occur in areas where there are large populations of minorities. It appears that there is no effort being made to get this life-saving product to market” she said. “If white affluent areas were most effected” she said, “they’d design a trial that could be completed in under 2 years.”

  13. LOL, “I am bahck”.

    Just one last (?) thought. Take a look at the pics of the schmucks running this blog. Concerned ethicists eh? Concerned about health issues are you? Stephen “the gay dude with suspenders” Gordon holding a cigar in hand, and Jon “airhead” Airheart with cigarette in mouth. And these folks are concerned about the ethical health treatment of 720 trauma patients on the brink of death? LMFAO. Let me borrow they’re own phrase “Hammer of Truth….Common Sense, Shoved Up Your…” I’ll give you a hammer, more precisely, maybe Jessica Caplan would love to get hammered, uh, up her ass (sorry Jon and Stephen, you’re not my type). And on top of all of that, are you three so fucking stupid that you haven’t yet realized that the FDA has NEVER “been accountable to us”? So why should I give them a piece of my mind? They won’t be able to figure out what to do with it anyway!!! So, you see, we actually do agree on something! I’m so ashamed. :(

  14. Art Kulak:

    You’re spouting libertarian rhetoric here (“[A]re you three so fucking stupid that you haven’t yet realized that the FDA has NEVER “been accountable to us?”), which is preaching to the chior.

    But that only tells me you’re not a complete idiot.

  15. In conclusion: debate the facts and the posts, don’t resort to attacking the messenger or other childish ad hominem attacks.

    Yes, I ban people from time to time.