"Volume expanders had been developed back in the 60s by using JW subjects in research facillitated by the Army. (yes...I can back that up...I have the study that shows that...)"
I wouldn't mind seeing that.
Blood, the US Army, the US Navy and the Watchtower Society
by OrphanCrow 45 Replies latest watchtower medical
-
-
Marvin Shilmer
This discussion from 2008 is not particularly revealing. Participants openly discuss how the JW patient population has been and can be useful in analyzing various novel hematological strategies and products against current treatment options when a current treatment option is not considered optional by that patient population.
The long and short of it is Watchtower has and asserts a doctrinal position with a consequence that a substantial population of JWs refuse particular current treatment options even when it might lead to avoidable mortality or morbidity. Researchers do not create this scenario, and most vehemently reject it as irrational. But on the other hand researchers are willing to exploit this reality in order to learn what they can of novel strategies and/or products the same patient population will accept as an option. By "exploit" I do not suggest researchers unethically expose patients to needless hazard. Rather, researchers see patients that are likely to die if something is not done and they offer an option that though experimental is no more likely to lead to mortality or morbidity than refusing whatever treatment option is being refused.
It just happens to be the case that when it comes to hematological medical strategies and products, military institutions are very interested for obvious reasons. Soldiers in combat are subject to hemoragh and military institutions want to keep solders alive to fight another day, and hopefully go home to famlies when the fighting is over.
-
OrphanCrow
they were desperately looking for a way to reverse out of their murderous Blood policy.
Actually, their 'murderous blood policy' was a benefit in this situation. It is that policy that makes for the control group and also creates a 'compassionate' group that speeds the process of approval up. Compassionate use serves a distinct purpose for the pharma companies, in addition to being used for 'patients who are going to die anyways'. If the blood ban was given up, there would no longer be a pressing 'need' to get some products on the market. Compassionate use is often the toehold that is needed by some companies.
I had said earlier that the WTS approved Hemopure in 2000 but there is evidence in the literature that JWs were being given Hemopure before the 'official approval'. The medical literature, at least those studies and trials which have made it to publication, has examples of procedures being done on JW patients long before the Society gave approval on the procedures.
"Volume expanders had been developed back in the 60s by using JW subjects in research facillitated by the Army. (yes...I can back that up...I have the study that shows that...)"
I wouldn't mind seeing that.
The study can be found in this book here:
The book was published by the Watchtower Society and placed with medical professionals across Canada. I don't know if it was used in any other country.
I don't know if you can access this study digitally, but a hard copy would certainly be found in the Society's library.
Electrolyte Solution in Surgical Patients Refusing Transfusion
Seymour Gollub, PhD, MD; Robert Svigals, MD; Charles P. Bailey, MD; Teruo Hirose, MD; and Clara Schaefer
(from St. Barnabas Hospital, Bronx, NY)Originally published in The Journal of American Medical Association, March 29, 1971, Vol. 215, no. 13
Abstract:
Major blood loss in 13 surgical patients was treated by infusion of crystalloid solution alone, supplemented by colloid plasma expander when necessary. Neither whole blood nor any of its components or fractions was employed at any time. For losses of 21% to 66% of blood volume, Ringer’s solution administered in three to five times the volume of blood loss, produced significant intravascular fluid increments equaling one fifth to three fifths of the shed blood. Colloid solutions were required to sustain blood volumes or blood pressure for patients with blood losses in excess of 1,200 ml, otherwise clinically significant edema was manifested. One week after surgery, blood volumes averaged 90% of original values. The death rate was three thirteenths. The average hospital stay was prolonged 3.4 days.
And this small note just prior to the reference list at the end of the article:
This investigation was supported by the John A. Hartford Foundation and aided by the US Army Surgical Research and Development Command.
about the study:
This communication presents a body of clinical experience with exclusive use of crystalloid solution as alternate therapy to blood transfusion in cases of high-trauma surgery with major blood loss. Though it describes, in many ways, extremes of clinical practice, it may contribute to a clearer understanding of results of nonhemic fluid resuscitation, and help to define safe limits of its employment.
The subjects:
Thirteen consecutively studied cases of a group of surgical patients subjected to a wide range of traumatice procedures are presented. All sustained major blood loss. None received blood or any blood fraction at any time. All were members of the Jehovah’s Witness faith.
I have the entire study scanned, if you are interested. But the quality isn't great.
-
OrphanCrow
I knew i was getting into a lot of work when I posted the link to the FDA document.
Crazyguy, you asked for pages where the JWs are mentioned. this following quote(s) come from near the end of the document...I have somehow ended up with more than one copy and the one I took this from is over 600 pages long...so I don't know exactly which page it is from.
This is following many pages of opinion on safety, efficacy, compassionae use, study design, etc...and the opinions are divided - some actively support the WTS supplying the control group and compassionate use subjects. The following speaker gives his rationale for using artifical blood for the JW community ("a control that's not getting anything" means...JWs) - he thinks it would be good to at least know if artifical blood will work:
Mr. Carson:
So you’ve just described the first study. Okay, but the first study is to have a control that’s not getting anything. And if you can’t show it works there, then you wouldn’t go and do another study. So it’s a proof of concept, and it would benefit that small group of people and there are more and more people, you know, who are not from a religious point of view, but have other reasons why they would prefer not to have blood.
So I think, to know that we - - you know, we haven’t - - you know, there’s no trial on red cells that shows that it works, okay, our control group, there’s no trial in red cells against the placebo that shows that it works, and there’s no trial with these drugs that shows that it improves outcome.
I think you know, I don’t know what the regulatory part of this thing is, but it sure would contribute to the field to know that, you know, they actually do what we want them to do and they might save some lives. That - I think has value and whether or not it gets to the point whether it’s widely used or not and approved, that’s not – I think that’s a simple question.
This is responded to by the next speaker:
Mr Emmanuel:
I mean I agree with you, it’s a concept and from that standpoint it would be valuable, but it would only be commercial - - it would only interest the commercial companies in this room if there was a widespread off-label use. There is no market and no one would sink a dime into it if the market were Jehovah’s Witnesses.
Only commercial benefits.
Yes.
And the Watchtower Society was in the thick of it - providing those so valuable research subjects to get Hemopure on the market.
-
OrphanCrow
Participants openly discuss how the JW patient population has been and can be useful in analyzing various novel hematological strategies and products against current treatment options when a current treatment option is not considered optional by that patient population.
Yes, and that is exactly why this document is so valuable. The participants are named (and hence have a historical bio) and not only that, the document is a transcript - we get a word for word account - and sometimes it even has inflections - of who the players were in the game of artifical blood at the time this was recorded in 2008 and we are given a glimpse into the role of the Watchtower Society and their HLC, who emerge as significant players in this high stakes blood game.
-
redvip2000
The WTS 'approval' of Hemopure was put in place to facillitate clinical trials, not to save the lives of those they had told to refuse blood transfusions.
but facilitating clinical trials will help in the development of a drug which will save those same people. Being part of a clinical trial is not a bad thing.
So let's say a drug company approached the WT and asked if they saw an issue with members volunteering to participate in a specific clinical trial, because they fit a specific target group. Why would the WT oppose this? The effort is to develop a drug which in the long run could indeed save lives of its members. In turn the drug company would ask the WT to clarify with it's members that this is ok to do.
Perhaps the fact that the military is also a stakeholder on this can be considered troubling, but aside from that, I don't see the big deal about this.
-
OrphanCrow
but facilitating clinical trials will help in the development of a drug which will save those same people. Being part of a clinical trial is not a bad thing.
Yup, you nailed it. That is the paradox. Or dilemna. And it is a moral question that is debated and exploited all the time.
In this case, however, I am yet to be convinced that was what was going on.
Remember what the one speaker said - the only ones who would really benefit from a Hemopure trial using only JWs were those with a commercial interest in the product.
Biotech companies pay extremely well for recruiters and clinical trial subjects - and they are always on the lookout for compassionate care cases - it is how a lot of products make it to market. The hand and glove fit of pharma and biotech companies with the WTS is evident, especially when the FDA document confirms it.
Now, you may believe that the WTS is doing the one thing everybody says the WTS doesn't do - maybe everybody has really missed the point and all their 'charity work' is done with the HLCs. But, I think we would have heard about it if that were true. It is far more likely that the 'network' of bloodless centers and 'network' of HLC recruiters, receive 'compensation' for their participation in clinical trials and recommendations for 'compassionate use' of drugs not yet approved by the FDA.
-
OrphanCrow
In turn the drug company would ask the WT to clarify with it's members that this is ok to do.
In an ideal world, yes, the WT would "clarify with it's members that this is ok to do". Watchtower Land doesn't work that way.
Can I have a show of hands as to how many of you participated in that 'clarification' when it came to Hemopure? Or, were you just as surprised and a bit confused as to why it was all of a sudden okay to use cows' blood? And for all of you who got Hemopure, were you told that the risk was higher than what you would normally get? Did you know that you were participating in a clinical trial?
Of course I understand the 'informed consent' and LAR consent...but, really, what were you told about Hemopure?
And here is another thing. Study design. A great deal of the discussion in the FDA document was about study design. In addition to the JW group being an ideal control group in that they don't have a RESUS level, the same model offers drawbacks. As the one speaker I quoted above pointed out, such a study does not generalize to the larger population. The fact that a JW refuses a resusitation by alternative, already proven means (blood transfusion) makes them a poor model for predicting outcomes in other patients. Adding another arm to an internal JW clinical trial, one that would mimic external factors better, would make the trial far more benefical. The WTS needed to refine their blood doctrine just a little bit - they needed one more 'arm' to the studies.
And that happened. JWs are now given the option to sign a 'letter of understanding' for their children. I am not sure if they have that option on all the cards now.
http://www.jehovahs-witness.net/jw/friends/244052/1/Blood-transfusion-Letter-of-Understanding
The doctrine changed in response to the demands of medical research.
-
redvip2000
Remember what the one speaker said - the only ones who would really benefit from a Hemopure trial using only JWs were those with a commercial interest in the product.
Well from a commercial standpoint yes, but ultimately the patient is also a beneficiary for obvious reasons.
I don't mean to sound biased on the subject as i work for a multi-national drug making corporation, but i still don't see an issue here. Yes of course doctors need to be paid for their work in recruiting patients, since nobody does it for free. Patients on the other hand don't get paid since it is considered unethical to get paid aside from perhaps transportation expenses.
-
redvip2000
And for all of you who got Hemopure, were you told that the risk was higher than what you would normally get? Did you know that you were participating in a clinical trial?
You can't possibly be serious. How do you think clinical trials work? You think you get a random package in the mail that says " Hey, try this"?
