To add to my previous post.
The availability of Hemopure is also limited to the parameters of study designs that have received approval from the FDA and to the proximity of JW patients to the hospitals where these studies are being conducted.
Currently, Hemopure has been approved for use in a clinical trial being conducted at Englewood Hospital and Medical Center in Englewood, New Jersey and the study is recruiting participants to test the efficacy of Hemopure.
Expanded Access Study of HBOC-201 (Hemopure) For The Treatment of Life-Threatening Anemia
The purpose:
The purpose of this expanded access study is to be able to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option.
HBOC-201 is not FDA approved for use in the United States, but is approved as an oxygen carrier in South Africa and Russia.
The study start date was October 2013 and the completion date is December 2016 and the estimated enrollment is 50 participants.
So, if you are a JW with anemia, you may fit the parameters of the above clinical trial being conducted in New Jersey to test if Hemopure is suitable substitute for blood in the treatment of life threatening anemia.
Another medical center that has had approval to use Hemopure is the U.S. Army Burn Center in Fort Sam Houston, Texas. The following study reveals how Hemopure is accessed by the Army doctors and the difficulty in following those steps to get FDA permission to use a product that does not yet have approval.
Experience with the use of Hemopure in the care of a massively burned adult
Abstract:
Objective: To report the use of a bovine hemoglobin-based oxygen carrier (HBOC-201) in an elderly patient sustaining extensive thermal injury unable to receive allogenic transfusion due to religious preference. Methods: Case report and literature review describing steps required for acquisition and safe infusion of HBOC-201. Results: Six units of HBOC-201 were infused in the perioperative period for anemia with signs of critically low oxygen delivery without adverse sequelae. The patient ultimately died as a result of multiple organ failure. Conclusions: Despite disappointing results of the use of HBOCs in other patient populations, there is a role for compassionate, emergency use of cell-free hemoglobin in the management of burn patients unable to receive allogenic blood products.
The Army has been using Hemopure to experimentally treat JWs for the past decade:
Over the last decade, the U.S. Army Burn Center has cared for 16 Jehovah’s Witness patients who sustained thermal or chemical cutaneous injury and experienced an overall mortality rate of 19% (n = 3). The mean TBSA burned for patients who died was 49.7% (range 25-92.5), compared to 13.8% (1-32.6) in survivors; two survivors, however, withdrew their refusal of allogenic blood and were transfused. The objective of this report is to communicate our technique in the use of HBOC-201, a bovine hemoglobin-based oxygen carrier also known as Hemopure (Biopure Corporation, Cambridge, MA) in an elderly burned male patient whose family refused transfusion based on religious preference.
The authors of the study describe the procedure they had to go through to get access to Hemopure:
Due to the large burn size and the fact that the majority of the burn wound was on the torso (where we were unable to use tourniquets as an adjunct for minimizing intraoperative blood loss during excision), we felt that the patient would not survive the perioperative period without either blood products or an HBOC. After discussion with the family, we initated steps to obtain HBOC-201. These steps included: (1) A clinician with experience using HBOC (A. P. C.) contacted Biopure Corporation; (2) A request was submitted to the Food and Drug Administration (FDA) for approval of the use of HBOC-201 as an emergency investigational new drug (E-IND); (3) A compassionate-use protocol was submitted to our local institutional review board (IRB); and (4) Informed consent was obtained from the family.
Approval was obtained based on the high likelihood for acute blood loss that would result in a critically low oxygen-carrying capacity during the perioperative period and the enhanced possibility of survival with the use of HBOC-201.
In spite of using 6 units of Hemopure, the JW patient died.
In the discussion, it is revealed why JW patients are being used to test the efficacy of artificial blood:
Cell-free HBOCs were designed to obviate the need for packed red blood cell transfusion. Their use is particularly attractive in areas where access to blood is limited such as rural communities or austere combat environments. Multiple studies report positive outcomes with the use of HBOCs in animal models of trauma, brain injury, and hemorrhage [3-5]. Despite promising results in these models, human trials of HBOCs have been disappointing. Natanson et al. published a meta-analysis of 16 randomized trials comparing HBOC infusion as a red-blood-cell substitute in the setting of trauma, orthopaedic, vascular, cardiac, elective surgery, and stroke, which demonstrated statistically significant increased mortality and risk of myocardial infarction [6].
However, the Army doctors felt that this particular study, in spite of losing the patient, was still valuable because of what they learned about the need to streamline access to the artificial blood that they are testing for the military:
Although our patient ultimately died as a result of thermal injury, our report will hopefully enhance awareness about steps needed to obtain HBOC-201. This information may expedite the acquisition of the product and minimize the period of hemoglobin deficiency; the latter is a reported contributor to mortality in the largest series reviewing HBOC use in life-threatening anemia in humans [16].
Based on our experience, we recommend the following for critically ill burn patients who refuse transfusion. A hematologist should be immediately consulted. Procedures to minimize blood loss in the ICU should be rigorously enforced. Erythropoietic agents should be considered. Adjuncts for control of blood loss during excision should be employed. If the need for a HBOC is predicted (e.g. burn > 20% TBSA), the process for obtaining the drug should be initiated as soon as possible. During infusion, ascorbic acid should be given to keep HBOC in a reduced state and to decrease methemoglobinemia. Nitric oxide donating medications (nitroprusside or nitroglycerin) and beta blockers should be used if the patient develops hypertension. Since HBOC-201 has a half-life of 19 hours, repeat doses should be given based on the initial indication for infusion. HBOC should be used with caution with expert consultation along with fully disclosing to the patient or surrogate the possibility of adverse outcomes.
The Army doctors offered this statement in conclusion:
In conclusion, despite disappointing results in human trials of HBOCs in various surgical settings, there is a potential role for compassionate, emergency use of these products in the management of burn victims unable to receive allogenic blood products.
It appears like the reason that you cannot find conclusive directives from the WTS about Hemopure approval, is simply because Hemopure doesn't have full approval from the FDA for general use. Access to Hemopure is limited to those hospitals and doctors who are using the product in either a clinical trial or for emergency use in burn, surgery and trauma situations.
So if JW is willing to be a guinea pig for the US Army, or if they are fortunate enough to access Englewood Hospital,...and if they fall into the parameters of approved studies,...and if they are willing to put up with the risks of using an experimental product, they will be able to try out Hemopure when they obediently follow their (oops...the WTS') conscience in deciding to refuse life saving blood.
Or, if a JW lives in South Africa, they will have easier access to Hemopure - it is approved for use there.
The other factor that may have disrupted the use of Hemopure in the past years that it has been being tested on humans, is the ownership and location changes that the company which produces Hempure has undergone. Biopure moved from the States to Russia at one time, and then back to the States again while undergoing ownership transfers, etc. It may finally have a stable home now that the FDA, under pressure form the US Army, has approved limited use of Hemopure in the States.
For information on some of the difficulties that Biopure has encountered in getting their product to market, this link has lots of articles on Biopure's developments and problems:
http://www.fiercebiotech.com/tags/hemopure
For all the JWs who are okay with using bovine derived blood, the US Army is on their side - they would like nothing better than to be able to develop artificial blood for use on the combat field.
