Approved Cow's Blood Product Delayed

by hawkaw 7 Replies latest jw friends

  • hawkaw
    hawkaw

    This is an important story on the "approved" cow's blood substitute (hemoglobin based blood product called Hemopure made by a company called Biopure). This "Hemopure" product was approved by the JW's Hospital Information Service back in 2000 as a substitute for red blood cell transfusions. This would help a lot of JW trauma victims who could not accept red blood cells. Of course at the time it was not approved by the FDA. The South African government supposedly gave its blessing to this product last year!!! BUT - it seems this government didn't wait until all the evidence was collected on the safety of the product. At least the FDA has not gone this far.

    Now, I would first like to apologize to this board. I have been following this product through out last year but some unknown reason I did not check up on its status in December with Adam Feuerstein. Well Adam did another story on this and I should have gotten it posted sooner - I again am sorry for the delay.

    I also recall Lee Elder's comments on the delay of another blood substitute called "polyheme". You may find the thread link here:

    ( http://www.jehovahs-witness.com/forum/thread.asp?id=15959&site=3

    So now I have, and with great sadness have to tell you folks that the cow's (or bovine) blood substitute product called "HEMOPURE" made by Biopure Inc. is not going anywhere fast. As I previously informed this board, the product has serious problems and well, I will let the article say the rest.

    You may note that below I have highlighted something in a "blue colour"for the reader. Why did I highlight it? If a company doesn't explain the safety concerns upfront then what else are they hiding?

    . http://www.thestreet.com/tech/adamfeuerstein/10005028.html

    Biopure Admits Its Blood Substitute Will Be Delayed

    By Adam Feuerstein
    Staff Reporter
    12/07/2001 10:31 AM EST

    Updated from 7:42 p.m. EST
    Biopure (BPUR:Nasdaq - news - commentary - research - analysis) admitted Thursday that problems with its human blood substitute Hemopure are forcing it to delay filing an approval application with U.S. drug regulators for at least six months.

    TheStreet.com first reported late last month that a Hemopure delay was likely. Consultants hired by Biopure to assist with its pivotal clinical trial for Hemopure noted numerous, serious problems with data collection and analysis. In addition, TheStreet also reported that a Washington, D.C., law firm was crossing the country interviewing doctors involved with the Hemopure study.

    Biopure executives had long maintained that Hemopure's filing would hit the doorsteps of the Food and Drug Administration by year-end. But late Thursday, the company acknowledged that the filing would not occur until the middle of 2002.

    In a statement, CEO Carl Rausch says the delay is being caused by FDA questions about a proposed expansion to the company's Cambridge, Mass., manufacturing plant. In his statement Rausch repeated his confidence in Hemopure and in the way Biopure conducted the trial.

    "We believe that the data [are] sound and supportive of an approvable product indication, and we continue to prepare for regulatory review and further public reporting of the Phase III data beginning in early 2002," he said.

    Safety Concerns

    Doctors and consultants familiar with Biopure say that Thursday's acknowledgement of a filing delay might be just a strategy to buy the company time while it figures out how to salvage something positive from a product with serious safety problems. TheStreet has addressed these safety issues extensively over the past several months.

    Biopure's own statement gives a hint of possible problems. In lieu of an actual approval application, the company now says that it will submit an "interim safety report for the pivotal Phase III clinical trial to the FDA by year-end."

    But Rausch and other Biopure executives said earlier that a full safety analysis of Hemopure already has been completed. On Aug. 27, the company issued a press release stating that an independent committee of experts had conducted a statistical analysis of its Phase 3 data that showed Hemopure was safe.

    That raises the following question: If the safety analysis is completed, why is the company now only able to give the FDA an "interim" safety report on Hemopure? Biopure has never released any actual safety data for review by investors or the outside medical community, and the company would not return phone calls seeking answers Thursday.

    Biopure concluded its pivotal trial for Hemopure in August 2000, which should have given it plenty of time to get all the data analyzed.

    Thursday, Biopure also said that it hopes to meet with the FDA in early 2002 to "confirm the proposed product labeling of Hemopure." The statement is confusing, according to those experienced with the process, because the seemingly positive outcome of the completed trial should have clearly dictated the product's label.

    In an earlier report, a doctor familiar with Biopure's work told TheStreet that the company could be trying to retrospectively change its plans for Hemopure by recasting results to give a more positive outlook to the data -- something the FDA frowns upon. This doctor, contacted again Thursday, says the company's statement supports his previous beliefs. This doctor has no position in Biopure.

    Cash Shortage

    The filing delay for Hemopure -- for whatever the reason -- also puts increasing pressure on Biopure to raise more cash. The company had $48 million in its coffers as of the end of July -- enough to last until July 2002 -- according to its last 10-Q filed with the Securities and Exchange Commission.

    But Wall Street sources tell TheStreet that Biopure executives have been trying to raise money since late this summer. Thursday's acknowledgment that there are problems with Hemopure's approval won't make this task any easier.

    In August, Biopure -- joined by Salomon Smith Barney bankers -- quietly made the rounds of institutional investors seeking to raise upward of $50 million in a private placement. A Wall Street money manager who was approached by Biopure says the company was able to receive commitments for only about $20 million by the second week of September.

    After Sept. 11, the deal was taken off the table. In the following weeks, Biopure and Salomon went their separate ways. Biopure then hired Shoreline Pacific, a boutique investment bank based in Sausalito, Calif., to pick up the fund-raising hunt. But these efforts haven't yielded any results.

    Biopure can fall back on a $75 million equity line of credit it has with French bank Societe Generale. But the company has been reluctant to go this route because any money it raises by selling stock to Societe Generale comes with significant costs. The French bank gets the stock at a discount, which it then will sell for a quick profit. But the bank also is allowed to bolster its gains using various shorting strategies that could put even more downward pressure on the stock, according to SEC documents filed that explain the agreement.

    Biopure can take down money from the agreement in installments of only about $3 million each.

    "This [equity line] agreement is really a fund-raising strategy of last resort," says one fund manager familiar with its details. "Biopure is reluctant to use it, especially given the company's weak stock price." This fund manager is short Biopure.

    Shares of Biopure were trading down more than 11% Friday. Since Oct. 11, Biopure shares have fallen 23%, while the American Stock Exchange Biotech Index has risen 22%.

    Now I know people are going to post stuff on this thread saying I am again jumping the gun and I have no merit in my concerns. BUT and a big BUT this whole issue with Biopure just stinks.

    Maybe the technology invented by Biopure may help in obtain future blood substitutes but other than that this product, as is, looks dead in the water.

    hawk

  • LDH
    LDH

    Goddamnit, lost my long reply. I'll paraphrase.

    Hawk, what I find most interesting is how a bunch of GD yahoos can give their 'approval' to a product that the FDA hasn't even said is safe.

    More evidence that they don't know what the hell they are doing.

    Lisa

  • jayhawk1
    jayhawk1

    Thanks Hawkaw,
    Sounds like Biopure has a bad product. Or at least has more work to do. To echo what Lisa said, those fools in the Society have jumped the gun on aproving something that could be unfit to use.
    I am having trouble with this though. Why is a bovine blood product okay, and a human blood product not? It seems to me that the Bible calls blood, blood, without making a distinction. If this is a doctrine that the JWs want to subscribe to, then do so and stop splitting hairs about it.

    "Hand me that whiskey, I need to consult the spirit."-J.F. Rutherford

    Jeremy's Hate Mail Hall Of Fame.
    http://hometown.aol.com/onjehovahside/ and Kylishhlee@aol.com

  • hawkaw
    hawkaw

    You can read about the approval of hemopure by the WTS's HLC at ....

    ( http://www.ajwrb.org/basics/hemopure.shtml

    Why is a bovine blood product okay, and a human blood product not?
    Hemoglobin oxygen carrier product from human blood (one product is called polyheme) is also okay (according to WTS as of 06/01/00) to be taken as well (conscience permitting of course). But both products are not approved by the FDA and both are having problems getting approved.

    hawk

  • hawkaw
    hawkaw

    Lee Elder put it this way wrt this issue:

    The Watchtower Society's blood policy has swiftly mutated into a deadly shell game. The policy aims to permit artificial blood (hemoglobin solutions like HemoPure and PolyHeme). While the leadership waits for the new blood products to hit the market, members continue to reject medically necessary transfusions of red cells and discontinue their chemotherapy treatments when platelet transfusions are needed even though platelets comprise less than 1/5 of 1% of blood volume. The average Jehovah's Witness has little or no realization of what is taking place. Those that do are frightened by the implications and effectively silenced by fear of Watchtower sanctions that would require their JW family members and friends to shun them.
    .

    hawk

  • LDH
    LDH

    I'm surprised that this topic has seen so little activity, while once again that asshole You Know chews up the valuable resources of the board.

    It's fun to chat, but it seems many have forgotten why we're here.

    Lisa

    Thanks Hawk. Good Catch

  • Naeblis
    Naeblis

    Why are we here?

  • hawkaw
    hawkaw
    Why are we here?

    Could you please get a little more specific with me Naeblis. I would like to help you with my thread.

    If you don't know why I started this thread - well, according to AJWRB.org's statistics, I could probably give you about 900 reasons per year as to why.

    So what is it you don't understand sir?

    LDH (Lisa)

    I start the threads and go from there. If people don't want to discuss them well that is okay with me. If they want to discuss them that is okay too. I know Marvin Shilmer has an opinion on this issue which is much different than mine when it comes to whether HemoPure (as it is) will get approved by the FDA or not. Marvin believes I am jumping the "gun" and I don't. But it is good we air our opinions and make everyone aware what is going on in the industry.

    Keeping in mind that I am not a JW or exJW I do find it interesting as to what "takes off" and what doesn't on this board. I remember starting a thread on what the Watchtower quoted from the Federal Council of Churches of Christ a few weeks back and I really wanted and asked for a lot of input and posts on it. I think I noted - oh - maybe only 25 or 30 posts. I guess I just report it and it is up to you people whether you find it interesting and want to keep the thread alive.

    I guess I am happy if I can just help one or two people to stop the needless killing and hurt that goes on in this Borg. I can think of Old Happy Day's comment a few weeks ago when he told me that thanks to the UN information, he had gotten a few of his family members out. That to me is amasing that I was part of an unique team (that included people like you) to get people actually out of this organization.

    In any event your comments, Lisa, are very welcome and nice, and I thank you kindly for your input.

    hawk

    p.s. - Naeblis - where about in Canada are you? I forget. I am a Kingston dude.

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