Had anyone done any research on what is now available in the US or exactly what the US armed forces are using? Hemopure isnt avaliable except in rare cases.
Blood, the US Army, the US Navy and the Watchtower Society
by OrphanCrow 45 Replies latest watchtower medical
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Lee Elder
Hemopure is being used by JWs on a compassionate usage basis in the U.S. in some situations. The Boston bombing comes to mind. If you use the "find" function in Adobe and type in "Jehovah's" you can quickly view all of the citations in the FDA's pdf. -
Pistoff
The link mentioned in the OP is dead, does anyone have the document? -
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OrphanCrow
Thank you for posting a link to the FDA document, wifibandit. Much appreciated.
crazyguy:
Had anyone done any research on what is now available in the US or exactly what the US armed forces are using? Hemopure isnt avaliable except in rare cases.Hemopure is rarely spoken of using its brand name anymore - the product is now more commonly referred to as HBOC-201.
There is one clinical trial listed online.
The study is currently underway and it is targeting trauma patients who cannot have blood. Exclusion criteria is patients who can receive blood - therefore...an ideal parameter for Jehovah's Witnesses. And, of course it is the JW population that is being targeted - the study is being conducted by Aryeh Shander from the Englewood hospital and the primary outcome measure is "survival". Shander's practice is almost exclusively the JW population and the only group of patients who will consent to "death" as a possible outcome are JWs.
https://clinicaltrials.gov/ct2/show/NCT01881503
Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia
This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Englewood Hospital and Medical Center
Sponsor:
Englewood Hospital and Medical Center
Collaborator:
HBO2 THERAPEUTICS
Information provided by (Responsible Party):
Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier:
NCT01881503
First received: June 14, 2013
Last updated: December 21, 2015
Last verified: December 2015
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
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.(more at link)
There are also some clinical trials being conducted in Europe - and again...targeting patients who refuse blood.
HBOC-201 (Hemopure) is manufactured by HBO2 Therapeutics. The history of the ownership and scandals associated with this company is lengthy and can be easily researched. This is a thumbnail overview of the shenanigans that the artificial blood manufacturer has undergone most recently:
http://www.biospace.com/News/walking-dead-biotech-zombie-companies-and-why-they/349901
In the second part of BioSpace’s four-part Halloween series, we take a look at some of the biggest Biotech Zombies in recent years. A “zombie company” is media parlance for a firm that either exists solely on government or venture capital bailouts to exist, or a heavily indebted company that is able to repay the interest on its debts but not reduce its debts. In many cases, these biotechs have been forced into bankruptcy—or sold for parts to larger, hungrier acquirers.
Biotech is listed fourth:
Last, and certainly least, on our list is OPK Biotech . The now-deceased Cambridge, Mass.-based company was a storied chronicle of how not to succeed in business when you’re trying, despite a supportive local business community and regular infusions of capital.
OPK had started out strong, developing an anemia drug, Oxyglobin, as recently as February 2013, and poaching former EMD Serono and Merck & Co. (MRK) exec Yaniv Glazer to serve as chief executive.
But OPK spent most of 2014 fending off angry creditors, who eventually forced the firm into bankruptcy to collect on several million dollars of outstanding debt. In April, OPK was named in an involuntary petition in Boston’s U.S. Bankruptcy Court, but at the time was not even in operation, having shuttered most processes earlier that month.
During that time, the company allowed creditors and vendors to go unpaid—and employees to go uncompensated—as it stonewalled in an attempt to buy time to find a suitor.
OPK was eventually rewarded when HbO2 Therapeutics bought the firm for undisclosed terms, including all assets and intellectual property, in August. The company will now be headquartered outside Philadelphia, but its dealing during the rough times left many longtime staff and partners with a sour taste in their mouths.
In an ironic twist, OPK had played the opposing vulture role before. In 2009, OPK $4 million for the assets of blood-technology developer Biopure Corporation (BPUR), along with a 50/50 partnership with the group that owns the company’s headquarters and some lab space. Biopure had filed for bankruptcy only months prior.HBOC-201 (Hemopure) is not available in the USA except for clinical trial that is dependent upon the participants qualifying for its use under the Expanded Access Program (compassionate).
However, the same product is approved for veterinary use. The FDA has declared it unsafe for humans but okay for animal use....and Jehovah's Witnesses.
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OrphanCrow
Pardon me. I have to make a correction.
I had said in my previous post: "There are also some clinical trials being conducted in Europe - and again...targeting patients who refuse blood."
That is incorrect - I was confused with the clinical trials in Germany for the implementation of blood management programs.
The news about the world of artificial blood is rather quiet at the moment.
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OrphanCrow
In spite of Hemopure being made available for human use in South Africa since 2001, it is no longer available in that country.
http://hemopure.hbo2therapeutics.com/ordering.php
Hemopure is currently unavailable. Please check back for updates.
The company that manufactures HBOC-210 (hemopure), Hbo2Therapeutics, has not posted news updates since April of 2015.
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OrphanCrow
Some background on how the clinical trial of Hemopure that is being conducted by Aryeh Shander (SABM) at Englewood Hospital came about. The trial only lists the manufacturer, HBO2 Theapeutics, as a sponsor. But, the US Navy was involved in the applications for approval.
http://www.acsh.org/wp-content/uploads/2012/04/20090721_blood_substitutes.pdf
This was written in 2009:
The U.S. Navy and the manufacturer of Hemopure had submitted to the FDA another proposed trial in trauma patients. In December 2006, the FDA's Blood Products Advisory Committee voted eleven to eight that the benefits of this proposed phase 3 trial did not outweigh the risks for individual patients (http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4270B1-index.htm). The Navy Medical Research Center and the manufacturers of Hemopure have since submitted a new protocol for a phase 2 out-of-hospital trauma study, but the FDA has placed this trial on clinical hold.34
And for some context to the FDA 2006 hearing, this is an interesting document (pdf download):
Naval Medical Research Center’s Briefing Book for the 14 December 2006
Blood Products Advisory Committee (BPAC) Meeting
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Pistoff
Thanks, Orphan Crow and wifibandit
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OrphanCrow
You are welcome, pistoff.
By the way...I would think that anyone who had thought, back in the late 90s and early 2000s, that Hemopure was the way of the future, and invested heavily into that company, through all its twists and turns, flips and flops, and re-locations, would be taking a big hit right about now.
*edit to add - just another thought...if you check out the last pdf I linked to, you can find out why that Advance Directive is SO important to the WT right now and why it so critical for them to have it on file, readily accessible