Test Of Blood From Cows Approved

[OhioChick]

POSTED: 1:24 pm EST December 14, 2006

The Navy's latest proposal to test a blood substitute on 1,100 trauma victims appears more likely to earn a go-ahead from regulators who had blocked the experiment over safety concerns.

The Navy wants to test the product, derived from cow blood, on civilian trauma victims in emergency situations. It proposes doing so without obtaining their consent in advance, as is customary in clinical trials.

The substitute blood, called Hemopure, would be given on the way to the hospital to patients ages 18 to 69 who have lost dangerous amounts of blood. It would substitute the saline fluids typically given in ambulances when donated blood is unavailable for transfusion.

Three times since June 2005, the Food and Drug Administration has blocked Hemopure trials from starting. Each time, it has cited safety concerns. Its manufacturer, Biopure Corp., based in Cambridge, Mass., contends that the benefits of Hemopure outweigh its risks.
http://www.newsnet5.com/health/10534985/detail.html

<snip> Researchers say blood substitutes can both counter a dangerous drop in blood pressure in bleeding victims and carry oxygen from the lungs to the body. Saline fluids can do the former but not the latter. While blood can do both, it has its own limitations. Unlike blood, blood substitutes theoretically could be stored for years and then used without concern for infection or blood type.

[babylonsister]

1. Without patients' knowledge? Will the blood be tested for 'mad cow'?

The passage has been blocked 3 times for safety; what politician is involved in the Hemopure co.?

[intheozone]

5. Mad Cow will not be a problem

Biopure uses blood from cows that are grown specifically for this process. The cows' diet and envirnoment are very controlled so that there is no exposure to the disease. Also, the cow blood is broken down to its many components and only some of those components are used in Hemopure. And those components goes through very refined sterilization processes.
Biopure makes the same type product for use veterinary use. Animals do very well when treated with it and the Vets love it.
This produce truly does save lives, not only people who are bleeding to death due to trauma but it has been used in Sickle Cell anemia patient and for people who can't or won't accept blood transfusions when needed to save their lives.
I have been following this product and investing in this company since 1998. I wish the FDA would get it shit together and approve this product.

[babylonsister]

12. Can you elaborate on why this product has been blocked 3 times? nt

[OhioChick]

13. Interesting Read:

http://www.acronymrequired.com/2006/07/polyhemecopy_hemopurecopy_life.html

[babylonsister]

14. Wow. I just skimmed that, but with the help of the Navy? I again

would like to know, who's awarding this contract, who has fingers in this pie? And I resent someone who has money invested in this coming on here hawking this company when so many questions are outstanding.

[intheozone]

18. Excuse me, but "coming on here" ?

I have been registered on DU since early 2001 when there were less than 27,000 people registered. Just because I don't post a lot, don't assume that I am not on this board every single day for hours.
I am not hawking this company, I am simply telling readers what I know about it after following it for years. I also know people who have used the company's animal product extensively and have done work for this company.
The Navy and the rest of the military would love to have this product. See my other posts about no blood typing needed, no refrigeration needed and shelf life of 3 years.

[babylonsister]

20. I mean no disrespect, and

I understand the potential, fantastic ramifications of a source like this for blood. But color me skeptical until it comes back with a clean bill of health from multiple sources. And your investment in this company doesn't make you unbiased. :hi:

[confludemocrat]

16. But they cannot implement similar management to reduce mad cow hazard?

They will allow the testing of cows in a process that benefits the drug companies capacity to produce this stuff, but no control of the raising and the testing of individual cows in protocols that shield the great mass of us from mad cow. The politicians are owned by one or the other oif drug companies and/or beef industry, it's clear.

[Kutjara]

2. So experimenting on people without their consent is ok now?

Welcome to the Corporated States of America.

[intheozone]

6. See my response to earlier post above. This product has saved many lives, one in the

city I live in. In trauma cases, the patient may not be able to give consent. You if were bleeding to death from an auto accident, would you want to the paramedic to give you something that could keep you alive until you get to the hospital or would you rather he want for someone's consent (which would probably come after you have already bleed out and died?

[Kutjara]

11. Personally, I would want them to fully test the product and get...

...the necessary approvals, before routinely pumping it into people. I would certainly be grateful if it saved my life after an accident, but less so five years later when I learn I have organ damage or some other debilitating side-effect. While it can be argued that prolonged illness is better than sudden death, there are many people who would disagree.

I take your point that dying accident victims aren't usually in a position to provide consent, but that doesn't mean they're fair game for experimentation and drug testing.

My point isn't really about Hemopure, per say, it's more about the setting of a precedent for bypassing the appoval process. Just because a drug or other product saves lives today, it doesn't mean they are safe. Testing potentially unsafe products on unconsenting people is unethical.

[intheozone]

19. I understand your concern. Hemopure is not a drug,

it is an oxygen delivery solution that is given like saline solution. It doesn't stay in the body long-term to cause long-term effects.

[CrispyQ]

25. Very well said & I agree completely.

:thumbsup:

[valerief]

3. I really really really really hope the evil tailgaters don't put me in

a car crash and I get pumped up with mad cow blood.

I wish I didn't have to drive.

[intheozone]

8. Relax, it is no mad cow blood!

See my previous post

[valerief]

21. Yeah, and hormone replacement therapy was touted as being

the answer to menopause symptoms and a preventive measure against heart disease. We know how that turned out.

Sorry, but I stopped eating beef, having soup (stock made from cow bones), and eating Jello a long time ago.

I know you're probably right and it's better than bleeding to death, but I'm still waiting for the big mad cow siege to hit America.

[rodeodance]

4. rather difficult to get "infomed" concent from captive audiance---battlefied

victim for example.

[intheozone]

7. You are right. This product is perfect for military. It does

not need to be type matched like blood, it does not need to be refrigerated, it has a 3 year shelf life. Each soldier could carry his own bag with him in combat. The military has wanted this product since early 2000.

[rodeodance]

10. yes, there are benefits to this product.

[dubykc]

24. So, why are we bothering to "test" it on the civilian population...

why not just senf it to Iraq and use our soldiers as a "test bed"?
Or are there fears of significant side effects that would be more acceptable in civilians than our military personnel?

[BlueJazz]

9. Seems like a lot of Folks could have a "Steak" in this decision.

I hope the Researchers Moove quickly on this project.

:rofl:

[babylonsister]

15. Oye, but...

:rofl:

[seafan]

17. "..Hemopure associated with higher incidence of death and cardiac arrest...."

....when compared with conventional human blood transfusions.

To add some back history on this company and its product:


http://www.boston.com/business/technology/biotechnology/articles/2005/09/15/sec_sues_biopure_and_three_executives/">SEC sues Biopure and three executives

Regulator: Group hid FDA drug concerns

By Ross Kerber, Globe Staff
September 15, 2005

Securities regulators yesterday alleged Biopure Corp. and three current and former executives schemed to hide criticism of its blood substitute even as the Cambridge biotechnology company gave investors upbeat reports to raise cash.
In a harshly worded civil complaint filed in US District Court in Boston, the Securities and Exchange Commission said Biopure, its former chief executive, Thomas Moore, current general counsel, Jane Kober, and another executive in 2003 failed to tell investors that the Food and Drug Administration had safety concerns about the company's Hemopure product.

snip

The allegations cap a long investigation and mark one of the most extensive cases filed by the SEC since it pledged with the FDA to work more closely to police the claims of drug makers. The agency wants to levy an unspecified fine against Biopure. That could be a relatively light penalty if it doesn't prevent the further development of Hemopure.
But new details of the FDA's safety concerns spelled out in the SEC complaint could make it harder for the US Navy to proceed with its plan to test the company's blood substitute on patients.

snip

According to the SEC's complaint, in March 2003 the company applied to test Hemopure on trauma patients, but the request was denied by the FDA over concerns about health risks seen in a previous trial.
In one lengthy letter the FDA told the company it couldn't conduct the new clinical trial because of ''an unreasonable and significant risk of illness or injury," according to the complaint. Later, the FDA also cited ''extensive and significant deficiencies in Biopure's application," the complaint states.

Also, the SEC said the FDA told Biopure in an April 25 letter that in an earlier clinical trial Hemopure ''was associated with a higher incidence of . . . death and cardiac arrest" compared with traditional human blood transfusions. But Biopure didn't mention the safety problems in a prospectus it filed May 6 to the SEC to sell more shares, the agency said.
And an Aug. 1, 2003, press release ''gave the false impression the company had received positive news from the FDA," the agency said. That day, the company's stock rose 22 percent, to $43.80, adjusted for reverse splits. It has fallen sharply since and fell 14 cents yesterday to close at $1.29 in Nasdaq trading.

snip

Three other individuals had received notices indicating the SEC might file actions against them as well, but they weren't named in the complaint yesterday. One was Biopure chairman Charles Sanders, who has since been told by the SEC he won't face actions, according to his attorney, Terence J. Lynam of Akin Gump in Washington, D.C. Another was former board member J. Richard Crout, who couldn't be reached for comment.

Also, there has been some discussion of an "opt-out" version of consent for the use of this product, which obviously does not protect a patient from receiving it, who is not aware of these clinical trials beforehand.

IMO, it is unethical to test any medical product, device or procedure on any patient without informed, advance consent of the patient or patient advocate. Add this to the active effort by this pharmaceutical company to conceal the documented safety concerns with this product, and there is marked diminution of ethical standards.

The Navy wants to test the product, derived from cow blood, on civilian trauma victims in emergency situations. It proposes doing so without obtaining their consent in advance, as is customary in clinical trials.

The substitute blood, called Hemopure, would be given on the way to the hospital to patients ages 18 to 69 who have lost dangerous amounts of blood. It would substitute the saline fluids typically given in ambulances when donated blood is unavailable for transfusion.

Three times since June 2005, the Food and Drug Administration has blocked Hemopure trials from starting. Each time, it has cited safety concerns. Its manufacturer, Biopure Corp., based in Cambridge, Mass., contends that the benefits of Hemopure outweigh its risks.

[donsu]

22. No to testing Navy personnel

No to cows blood

[Heidi]

23. Kick.

:kick: