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Informed Consent

 
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jbrown34
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PostPosted: Wed Dec 22, 2004 3:24 pm    Post subject: Informed Consent Reply with quote

Gary,

I was deployed during the 1st Gulf War and I did receive this particular vaccine under an umbrella of Secrecy. You put alot of faith in the fact that these vaccinations were given without each individuals consent. I know that when I was given these vaccinations, that I had to sign a form acknowledging the fact that I was given the vaccine. It has also occurred to me, that most of the personnel in the military in general, do not always read what they sign. The long and short of this is simply, if pressed hard enough, I believe that the government will eventaully fess up, if you will, to the use of this particular vaccine. But, I also should let everyone know, that they will probably be able to produce the forms that we signed, as proof that we were informed. I know that if I were involved in something like this, I would definetly want to cover my six, the forms would provide that cover. It does not change the fact that these vaccinations took place, nor will it effect the actual outcome of those personnel who have been affected, to include myself. Having said that, I hope that you will keep digging, perhaps, there will be those personnel who did not sign any of the forms that I mentioned, but I wouldn't count on it.

Semper Fidelis - Always Faithful - too bad our governemnt was not always faithful to us in return.
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madmmom
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PostPosted: Wed Dec 22, 2004 3:37 pm    Post subject: informed consent Reply with quote

I would liken informed consent under duress, as may have been the case when my son was administered his first innoculation in Afghanistan in late October, to a forced confession. Under orders, with threat of reprisal, there is little a "good soldier" has control over. If the innoculations resume, I would be more proud of him for accepting punishment that would include court martial and dishonorable discharge. There aren't many youngsters capable of making that choice. That's why WE must find a way to halt this injustice!!!
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Gary M - Author
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PostPosted: Wed Dec 22, 2004 4:55 pm    Post subject: Reply to jbrown34, RE: Informed Consent Reply with quote

Dear jbrown34: Anthrax Vaccine Adsorbed, aka BioThrax®, was a licensed vaccine. The Division of Biologics Standards (DBS) - at the time under the jurisdiction of the NIH and later transferred to the FDA - licensed the anthrax vaccine in November 1970. Therefore, the military did not in 1990 require your consent to give you this vaccine.

So what were the forms for? They were not consent forms. These forms secured your pledge not to disclose that you were a recipient of the only "Secret" immunization administered in the Gulf.

Ostensibly, this was to maintain Op-Sec. In theory, if Saddam knew U.S. forces were immunized against anthrax, Saddam might switch to another BW agent (assuming that he had the alternate agent and the capability of delivering it). On the other hand, you could argue that if you immunized troops against anthrax, and telegraphed that fact, it might have deterred Saddam from using anthrax (especially since the U.S. and British military weren't advertising the fact that the licensed U.S. and U.K. anthrax vaccines probably wouldn't protect recently immunized troops).

In any case, if you were given one of the prototype second generation anthrax vaccines that contained squalene, then you were given an IND (investigational new drug). At least one Army Reserve major has publicly confirmed that he oversaw the administration of the new vanthrax vaccine to Gulf War troops; the anti-squalene antibodies in sick Gulf War veterans is consistent with that assertion.

Your "informed" consent to receiving an IND vaccine, would have required someone making it plain to you that you were getting an experimental vaccine, not the licensed one. It also would have been incumbent upon the person giving you the IND to explain the risks of taking it (i.e., squalene has caused the animal version of multiple sclerosis in rats). Had this person failed to do so, then you did not give your "informed" consent. You couldn't have. You were not informed.

If someone approved the administration of the new and improved anthrax vaccine to Gulf War troops in 1990 and 1991, and subsequent clinical trials with the new vaccine during AVIP and Operations Enduring Freedom and Iraqi Freedom, then their "six," in my view, is most definitely exposed.

I hope you are well and that your holiday is a truly happy one.

Sincerely,
Gary Matsumoto
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DKehl



Joined: 13 Nov 2004
Posts: 8

PostPosted: Thu Dec 23, 2004 1:27 pm    Post subject: Reply with quote

The document I received for my records asked two questions requiring a Yes or No answer.

1. I have been given an anthrax vaccination brochure. Yes/No

2. I have been given the opportunity to ask questions about the anthrax vaccine prior to receiving the immunization. Yes/No

* SF 601 Overprint 2/03, Immunizations Record, Standard Form 601

We were handed a pamphlet, this sheet and told to answer yes to both questions. We were stood in formation and read a direct order to receive the vaccine. When questions were asked whether the vaccine was safe we were told, "The Marine Corps says it's safe, therefore, it is."
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jbrown34
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PostPosted: Thu Dec 23, 2004 2:13 pm    Post subject: RE: Reply Reply with quote

Dear Gary,

What myself and others signed during the 1st Gulf War, had SECRET in the appropriate position on the top and bottom of the form (SF-600). The form was a single sheet of paper that had plenty of room for addition's in the center. I knew what you meant by Informed Consent and I do not believe that the middle section of the form that we signed is still blank. If there is or was a plan to do something that could be construed as less than forthcoming, I know that they covered their six. It would not be the first time that forms have been completed after the individual signed them. I know that little fact from over twenty years of dealing with the everyday functions of the military. I absolutely hope that I am wrong and the people that are responsbile for this situation are held accountable. For those of us that are still here and especially for those who can no longer question for themselves. The real loss are to those that remain, fathers, mothers, brothers, sisters, wives and children, because no explanation is going to be good enough for them, nor should it be! I know it will not be enough for my family.
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Gary M - Author
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PostPosted: Fri Dec 24, 2004 2:25 pm    Post subject: Reply to DKehl & jbrown34, RE: Secret Immunizations Reply with quote

Gentlemen: What DKehl describes in his new posting is, in my view, coercion not consent. And, again, I pose the question to you both: Why did you have to consent to getting a licensed vaccine? Anthrax Vaccine Adsorbed (AVA) was licensed in November 1970 by the Division of Biologics Standards, which was then part of the National Institutes of Health (it is now part of FDA). So why did Army or Marine Corps medics give you a brochure for this shot? In 1990, this vaccine had already been licensed for 20 years. Why did the military go out of its way to ask troops if you were given an opportunity to ask questions about it? Did you have to give your consent to get gammaglobulin? How about the flu shot? Tetanus and typhoid? Did you get a brochure for those? No? Well, like the anthrax vaccine, those vaccines and toxoids were licensed too. So why was anthrax vaccine such a conspicuous exception?

jbrown23: Under different circumstances, I would say that you might be letting your suspicions get the better of you over the blank space. Regrettably, I think the military has given you too many reasons to be this suspicious. From whom were you supposed to keep the fact that you received this shot a secret? Places like Log Base Alpha, out in the middle of the Saudi desert, were hardly crawling with Iraqi fifth columnists (I certainly didn't see any). And why were medics instructed not to annotate the anthrax shot in your WHO immunization cards? Failing to do so meant the only record proving that you received this shot was in the hands of the military alone, and the military told the media for years that all the shot records were missing (they were not). Why did the military say that if all the records (the immunization rosters) were intact, and sent, initially, to FORSCOM and then the Army Surgeon General's office?

Well, one possible answer is this: if you thought your illness could have resulted from this shot, there would be no way for you to even begin to prove that without being able to verify that you received the shot. If the illnesses occurred in clusters, among a specific population of troops (say, Air Force personnel at Al Kharj) who got anthrax immunizations and were no where near the Khamisiyah dump from 10-13 March 1991, then the available evidence would raise questions about the anthrax vaccine, not chemical weapons, as a potential problem. Without units having records of having gotten this shot, they couldn't connect any problem to the vaccines either. Any effort to trace a possible link between illness and the vaccines would be stymied by these gaps in the evidentiary trail.

Botulinum toxoid was experimental. Troops receiving it were asked to consent to getting that shot, but it was not a secret. Why not? Botulinum toxoid, sometimes annotated in WHO shot cards as "Vac B," was meant to protect troops from an Iraqi biological weapon. Why wasn't Vac B a Secret then?

If the military kept the anthrax shots a Secret for operational security, then this secrecy was inconsistently applied. Pyridostigmine bromide was a licensed drug being used in a novel application to protect troops from the effects of a possible chemical weapons attack with the nerve agent soman. Why wasn't the PB pill a secret?

If U.S. intelligence concluded that Saddam had probably weaponized anthrax, and that anthrax was the BW agent he was most likely to use (affirmative on both counts), then why not deter Saddam from using this weapon by advertising as widely as possible that U.S. forces were immunized against it? Concealing this fact would only encourage its use. And my question is, did someone want to encourage Saddam to use it? Because if he did, the U.S. Army Medical Command would have gotten a de facto Phase III (I think it's Phase III, not II) clinical trial to prove the vaccine(s)'s efficacy against inhalation anthrax.

This is the type of trial requiring that immunized subjects be exposed to the agent from which the vaccine is supposed to protect. A Phase III trial is designed, then, to specifically prove whether or not a vaccine works. No one had ever done this with anthrax vaccine because the FDA would never approve an efficacy trial in which human subjects were deliberately exposed to potentially fatal doses of anthrax. Had Saddam attacked U.S. forces with anthrax, the Army would get the "data points" that it could never hope to get in peacetime.

As Navy Captain W. M. Parsons, Ph.D., from the Armed Forces Epidemiological Board wrote on 4 September 1990, Operation Desert Shield presented "unique research opportunities." The question is how unique?

I don't want to be too harsh on the military for its illogic and inconsistency on this particular point, but the military was, in fact, undeniably illogical and inconsistent in maintaining secrecy over it use of BW and CW countermeasures during the first Gulf War. The excuse that you were given to keep the anthrax shot a secret - preventing word of the immunizations getting back to Saddam - is so lame, it's almost laughable. I would laugh, except the most likely explanation for why the anthrax shots were kept a secret makes me want to cry.

Sincerely,
Gary Matsumoto
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