Blood, the US Army, the US Navy and the Watchtower Society

by OrphanCrow 45 Replies latest watchtower medical

• 

  OrphanCrow

  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"?

  I apologize - I see that I didn't make myself clear. I was interested in how far down the line the idea of 'informed consent' goes when it comes to JW patients. Do they get the proper medical information that they are entitled to? Which includes the information that they are participating in a clinical trial? Along with all the risks inherent in participating? Or does that information stop at the level of the HLC?

  Informed consent is a process in which researchers provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll, or continue to participate, in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding. In general, a person must sign an informed consent document before entering a study to show that he or she was given information on risks, potential benefits, and alternatives and understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.

  https://clinicaltrials.gov/ct2/about-studies/learn#HowAreParticipants

  Do they get a chance to ask these questions?

  Questions to Ask

  Anyone interested in participating in a clinical study should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses. The following questions might be helpful during such a discussion. Answers to some of these questions are provided in the informed consent document. Many of these questions are specific to clinical trials, but some also apply to observational studies.

  • What is being studied?
  • Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?
  • What are the possible interventions that I might receive during the trial?
  • How will it be determined which interventions I receive (for example, by chance)?
  • Who will know which intervention I receive during the trial? Will I know? Will members of the research team know?
  • How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
  • What will I have to do?
  • What tests and procedures are involved?
  • How often will I have to visit the hospital or clinic?
  • Will hospitalization be required?
  • How long will the study last?
  • Who will pay for my participation?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow-up care is part of this trial?
  • If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
  • Will results of the study be provided to me?
  • Who will oversee my medical care while I am in the trial?
  • What are my options if I am injured during the study?

  https://clinicaltrials.gov/ct2/about-studies/learn#Questions
• 

  GrreatTeacher

  Is there anyone on this site that has been a member of the HLC and can give more information about the level of consent? Or would they even know?
• 

  Marvin Shilmer

  Is there anyone on this site that has been a member of the HLC and can give more information about the level of consent? Or would they even know?

  In developed societies it would be highly unethical and illegal for a medical doctor to administer experimental products to a patient without informing the patient of this fact, including answering any questions the patient might want to ask. Disclosure is essential and required. Neither the Watchtower Society nor any HLC member has ability to disconnect a treating physician from this duty.
• 

  OrphanCrow

  Zeb, you had asked:

  Hemopure? Correct me please; isnt this a derivative or bovine blood?

  For a bit more information about what Hemopure is and how it is made:

  http://www.rsc.org/chemistryworld/Issues/2010/October/ArtificialBlood.asp

  To make Hemopure 'we take bovine blood and, using filtration and chromatography, purify the haemoglobin so it is 99.9 per cent pure protein,' explains Light. But sadly it isn't as simple as just dissolving the haemoglobin in a fluid and transfusing it into the patient. Native haemoglobin is tetrameric and dissociates into dimers in the body that are excreted through the kidneys with a half life of about 30 minutes. 'Which is not a very effective therapy,' Light points out. 'You have to modify the haemoglobin so it doesn't dissociate.'

  A number of different approaches have been taken to stop this dissociation. 'What we do is polymerise with glutaraldehyde [pentane-1,5-dial] to make large polymers of haemoglobin that have a half life of between 18 and 24 hours in the body,' Light says.

  The polymerised haemoglobin is then put into a physiological buffer, which contains salts and lactates to maintain heart function. At this stage the product still contains about 30 per cent stabilised haemoglobin tetramers - and while they may not dissociate in this form, they are still problematic because they can enter blood vessel walls and scavenge nitric oxide. NO naturally causes the walls of blood vessels to relax, so if too much NO is scavenged, relaxation is prevented, making it more difficult for blood to flow, resulting in an increase in blood pressure. A final clean up stage removes most of the tetramer haemoglobin, significantly reducing the blood pressure effect, explains Light.

  Once transfused into the body, polymerised haemoglobin works in the same way as a red blood cell: it binds to oxygen in the lungs, carries it to the appropriate site in the body and then releases it. What makes it different to red blood cells is that the haemoglobin is free in the plasma - rather than bound within the cell.

  The advantage of the haemoglobin being in the plasma is that the oxygen it carries is closer to the sides of blood vessels. Oxygen binding and release in the plasma is more efficient than in the red cell, says Light, so Hemopure releases oxygen more quickly than donor blood once it gets to the target tissue. At end of its life, Hemopure is broken down by the normal biological pathway for haemoglobin.

  Hemopure is currently approved for use in South Africa, and has undergone some early clinical trials in the US. Production stopped, however, when Biopure went bankrupt - and OPK Biotech is currently focusing on getting production back online. Referring to the FDA's concerns over these products, Light predicts that they will be approved overseas before approval in the US. The firm's parent company, OPK, is Russian and, according to Light, 'OPK have a great interest in bringing this product to Russia.'
• 

  OrphanCrow

  And, in case anyone is interested, OPK Biotech, the Russian firm that picked up Biopure after it went bankrupt, has now been bought out by a US company:

  • August, 2014

  • HbO 2 Therapeutics LLC has acquired the manufacturing and intellectual property assets of OPK Biotech LLC. The Company is headquartered 35 miles north of Philadelphia in Souderton, Pennsylvania.

  http://hbo2therapeutics.com/
• 

  OrphanCrow

  Some more info about hemopure:

  http://hbo2therapeutics.com/overview/manufacturing.php

  HbO 2 Therapeutics' research and development laboratories, state-of-the-art bioprocessing, and purification facility are located in Souderton, Pennsylvania.

  SOURCE OF HEMOGLOBIN

  The active biological component in Hemopure® is polymerized bovine hemoglobin. Its manufacture consists of hemoglobin purification, chemical polymerization, and final packaging by sterile filtration. The Company collects fresh whole bovine blood from certified managed herds less than 30 months of age and includes documentation of the animal’s country of origin (USA) and their health monitoring. The program is under the supervision of a qualified veterinarian. Any animals sick or medically treated within 60 days before slaughter are not eligible for shipment and collection. Finally, there is a post-mortem inspection of each animal by a qualified US Department of Agriculture (USDA) inspector.

  MANUFACTURING PROCESS

  Manufacture of the products occurs in four major steps: first, bovine blood is collected and processed to remove plasma; second, the hemoglobin protein is removed from then red blood cells; third, the hemoglobin is purified of other red cell proteins; and fourth, the purified hemoglobin is stabilized by the addition of a cross-linking agent to form hemoglobin polymers, or proteins bound together. For the human product, an additional filtering step removes the unbound hemoglobin molecules. For both products, the polymers are then placed in a solution suitable for infusion. Finally, the products are put through sterilizing filters and into sterile bags.

  The company's facilities have a validated process with an annual production capacity of 100,000 hemoglobin glutamer-250 (bovine) (HBOC-201) units (250 ml/unit) or approximately 350,000 Oxyglobin® units (125 ml/unit) or 700,000 of the smaller Oxyglobin® units (60 ml/unit), or any combination thereof. Much of the engineering and design has been completed for a potential future manufacturing facility designed to produce 500,000 HBOC-201 units per year.

  VALIDATION AND PRODUCT SAFETY

  The process has been validated, in accordance with regulatory agency guidelines, to remove potential pathogens in the raw material. Examples of pathogens include bacteria, viruses, such as those leading to hepatitis and AIDS, and the transmissible spongiform encephalopathy (TSE) agents that cause rare neurological disorders, such as "mad cow disease" and its human equivalent.

  Health and regulatory authorities have given guidance directed at three factors to control these diseases: source of animals, nature of tissue used and manufacturing process. These three factors are addressed by supplier contracts that maintain traceable records on animal origin, health, feed and care, and by the validated blood collection and manufacturing processes.

  Safety assurance is provided by:

  • Managed herds in which the animals' country of origin, feed, age and 
health are monitored;
  • Clearance studies that have demonstrated that our manufacturing process removes or inactivates potential pathogens;
  • External experts' analyses of the capability of our process to remove or inactivate pathogens;
  • Adherence with worldwide industry and regulatory standards;
  • Approval of our products and the process to manufacture them by multiple regulatory agencies.
• 

  OrphanCrow

  In developed societies it would be highly unethical and illegal for a medical doctor to administer experimental products to a patient without informing the patient of this fact

  Yes.

  And that is why many clinical trials are conducted in devloping countries - it is easier to get around developed countries regulations. However, there are issues in conducting trials in developing countries and the FDA document covers those issues in a discussion starting on page 273 of that document.
• 

  OrphanCrow

  Sorry about this...I missed a little step in the history of hemopure. The world of biotech moves so quickly it is hard to keep up with the bankruptcies and shifting corporate landscape attached to artifical blood.

  http://investing.businessweek.com/research/stocks/private/snapshot.asp?privcapId=61346883

  Company Overview

  OPK Biotech, LLC was incorporated in 2009 and is based in Delaware. On April 25, 2014, an involuntary petition for liquidation under Chapter 7 was filed against OPK Biotech, LLC in the U.S. Bankruptcy Court for the District of Massachusetts. On May 20, 2014, the involuntary petition was approved by the Court.

  And then...the Hemopure company (originally Biopure) became HB02 Therapeutics.
• 

  de facto

  PAGE NOT FOUND :( Where can i find this document??? THX
  
• 

  OrphanCrow

  De facto, sorry I missed your post.

  I have searched online but cannot find the document.

  However, I learned a long time ago that downloading is important because information has a funny way of disappearing in cyberspace.

  So, if you are still interested in this document, I have it saved and can email it to you as a pdf. Just send me a pm and you can have a copy.