News: Tamara Coakley's life saved by cow's blood

by AndersonsInfo 24 Replies latest watchtower medical

  • skeeter1

    I know that the FDA wasn't "gung ho" over this product and had concerns:

    Biopure was forced into a position to continue raising money to fund the clinical trials in a variety of indications in hopes of getting Hemopure onto the market. Many of the clinical trials results were being revealed and in April 2003, the FDA put on a hold of a proposed clinical trial on Hemopure for the use in trauma patients in the hospital setting. The company did not disclose that their clinical trial was on hold to the public and tried to go for an in-hospital trauma trial designation as a separate investigational new drug application(INDA) from the pending biologic license application (BLA) for orthopedic surgery indication. In July 2003, the FDA did not approve Hemopure for orthopedic surgery and had major concerns about the materials submitted to support the BLA and safety issues. In August 2003, Biopure announces to the street through public statements that the FDA was favorable and caused the stock to go up 20%. The company continued with its misleading statements and was able to raise $35 million by December 2003 from the sales of common stock. Information was leaked about the incomplete and misleading documents between late October and end of December 2003, which led to the stock to drop by 66% from the August 1, 2003 stock price. [9]

    The people indicted were: Thomas Moore, the former CEO, for making and approving misleading statements; Howard Richman, the former head of regulatory, did the same as Moore; and Kober, member of the General Counsel, for the drafting and approving misleading statements. The charge is for violating Section 17(a) of the Securities Act of 1933 and Section 10(b) of the Securities Exchange Act of 1934 ("Exchange Act") and Rule 10b-5 thereunder and with directly or indirectly violating Section 13(a) of the Exchange Act and Rules 12b-20, 13a-1, 13a-11 and 13a-13 thereunder, and charges Moore with violating Rule 13a-14 thereunder. The Commission is seeking injunctive relief, civil penalties, and an order barring Moore, Richman and Kober from serving as officers or directors of any public company. [9]

    In April 2008, the Journal of the American Medical Association (JAMA) published a paper "Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Death," which grouped clinical trials of Biopure, Baxter, Hemosol Biopharma, Northfield Laboratories, and Sangart and argued that these clinical trials should have been stopped. The FDA received data from individual studies that demonstrated increasing risk and should have led to terminations of trials. The paper revealed that several artificial blood products increased the risk of death by 30% and almost tripled the risk of heart attacks in 16 clinical trials. The current rule is that the agency has the right to keep the information of new products confidential for competitive reasons. The JAMA paper wants Congress to review this policy for the safety of the public. Biopure refutes these findings and has been active in defending their position. [10] On Biopure’s website, they have a section dedicated to commenting on the JAMA article. [11]

  • skeeter1

    Here's the current manufacturer discussing how the blood is collected from managed herds (i.e. to reduce risk of Mad Cow's Disease). I don't see the company saying anything about FDA approval.

    Product Safety

    OPK Biotech LLC's Manufacturing Process Safeguards Against Infectious Agents

    OPK Biotech LLC's manufacturing process for its oxygen therapeutic products, Oxyglobin ® for veterinary use and Hemopure ® for human use, incorporates controls to prevent the potential introduction of pathogens and employs purification processes that have been demonstrated to remove pathogens if present. The following information is provided to address potential concerns in light of the occurrence of bovine spongiform encephalopathy (BSE), or "Mad Cow's Disease," in Canada and in the United States.

    Safety assurance is derived from:

    • health are monitored;

    • removes or inactivates potential pathogens;

    • inactivate pathogens;

    • multiple regulatory agencies.

    We have taken the necessary steps to ensure the purity and consistency of Hemopure and Oxyglobin. Our products consist of purified, chemically modified bovine hemoglobin that undergoes a pharmaceutical manufacturing process to safeguard against potential pathogens. This process employs patented purification techniques that have been demonstrated to remove or inactivate potential infectious agents, if present, including bacteria, viruses and TSE agents.

    In addition, we source our raw material only from managed herds of beef cattle from the United States. The managed herd requirements are designed to prevent the introduction of potential pathogens and include documentation of the country of origin, medical history, feed (no mammalian protein) and young age of the cattle.

    Our process has been validated, in accordance with regulatory agency guidelines, to remove potential pathogens in the raw material. Validation requires repeated testing to document that the process consistently meets performance requirements. 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. We comply with, and believe we exceed, all current guidelines regarding such risks for human pharmaceutical products, including raw material safeguards proposed by the FDA in January 2007. In addition, the European Directorate for the Quality of Medicines (EDQM) granted a "Certification of Suitability of Monographs of the European Pharmacopoeia" for our veterinary product, Oxyglobin, in 2001 and for Hemopure in fiscal 2003. In August 2005, the European Directorate issued updated certificates for both products. This certification is required for all human and veterinary medicinal products that are manufactured from ruminant materials and marketed in the European Union, and it represents the Council of Europe's official acknowledgment of the acceptability of Oxyglobin and Hemopure with regard to TSE agents"

  • skeeter1
  • AndersonsInfo
  • alamb

    Exactly. How are they not seeing the hypocrisy. Growing up with sportsmen JW's, they made a HUGE deal out of bleeding meat. Spill the blood on the ground stuff. And the blood sausage horror stories. We couldn't even buy Revlon lipstick because of the pigments supposedly from blood and we had to watch out for lecithin additives too. How are they wrapping their minds around this?

  • Refriedtruth

    Must read vote too comments by mostly objective non apostate worldly common sense readers

  • Timothy Riches
    Timothy Riches

    On the whole, a positive outcome, both for the woman and for the JWs that will almost certainly be aware of this product now. They won't die out of ignorance. Damn! 2,350ml is almost half the blood in her body! Astonishing!

  • Quandry

    Remember when they used to say that taking blood you would/could take on the personality of the individual?(or was that transplants?) Anyway, I still don't get how using animal blood is ok with them.

    I'm with you, Carla.Anyway, blood is considered an analogous to a transplant.

    I wonder if this woman is now in a field somewhere chewing on grass, or walking to the nearest barn asking to be milked?

  • willyloman

    This is a big step towards realization of what the WTS has been counting on, a synthetic product renders their controversial blood transfusion issue moot. They want it so bad they'll ignore that it's made from cows' blood.

    Watch for these talking points soon, in a WT (study edition) near you:

    1. Faithful dubs followed the Bible prohibition on blood for many years, despite ridicule.

    2. Wordly scientists, impressed by the steadfastness of these lovers of Jehovah, set out to solve the problem.

    3. Now they've created a synthetic substance designed to save the live's of faithful witnesses everywhere.

    4. You see, friends? You just have to wait on Jehovah.

    They'll have to spin it for the smarter ones among the faithful, but they've been infecting the ranks with cognitive dissonance for decades. They experimented with the "generation" doctrine and got away with that and to most dubs, the generation teaching had been sacred. Nevertheless, the rank and file were generally willing to look the other way when it mutated into something no one quite understands.

    Meanwhile, no one ever really understood the blood transfusion doctrine, so this should be easier for them.

  • BluesBrother

    Sis Coakley evidently has a broad "Christian conscience" if she accepted Hemo based transfusion..

    The Awake that Skeeter quoted a while back (August 2006 page 11) said

    "However, compared with other blood fractions, the HBOC presents more challenges to conscientious Christians, who seek to obey God’s law on blood. Why? As long as the HBOC is derived from blood, there are two objections that may be raised. One, the HBOC carries out the key function of a primary component of blood, the red cells. Two, hemoglobin, from which the HBOC is derived, makes up a significant portion of that component. Regarding this and similar products, then, Christians face a very serious decision. They must carefully and prayerfully meditate on Bible principles concerning the sacredness of blood. With a keen desire to maintain a good relationship with Jehovah, each must be guided by his Bible-trained conscience"

    So they say that although this is not a banned treatment, but we do not fully approve of it.....A lot of dubs would not accept it.

    In my opinion I cannot see that this is really "synthetic blood"..The word implies something made up from chemicals like synthetic fibres. This stuff uses cows blood as a basis , which is still blood, isn't it?

    [Edited...OK I have now found TD's excellent comment further up this thread, which explains the nature of it]

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