posted
Blood Substitute Necessary On Battlefield, Military Says
By Associated Press
A blood substitute the military wants to test on civilian trauma victims is urgently needed to save lives on the battlefield in places such as Iraq, a Navy official told federal advisers yesterday.
The Navy wants to test the product, derived from cow blood, on roughly 1,100 trauma victims in emergency situations. It proposes doing so without obtaining the customary informed consent of patients.
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 for the saline fluids typically given in ambulances when donated blood is unavailable for transfusion.
In Iraq, 68 percent of the U.S. troops who die of trauma before reaching a hospital experience severe bleeding as part of their injuries, the Navy's deputy surgeon general, Rear Adm. John Mateczun, told a panel of federal health advisers. An available blood substitute could save many of those lives, he said.
"We urgently need an oxygen-carrying capability that does not require refrigeration, is universally compatible and can be readily administered in a field setting," Adm. Mateczun said in remarks to a Food and Drug Administration (FDA) panel convened to consider whether the agency should lift a hold on the experiment. The FDA isn't required to follow the recommendations of its advisory committees but usually does.
Three times since June 2005, the FDA has blocked Hemopure trials from starting. Each time, it has cited safety concerns. Hemopure's manufacturer, Biopure Corp., based in Cambridge, Mass., says the product's benefits outweigh its risks. The Navy agrees.
The Naval Medical Research Center, which is overseeing the government-funded study, has since revised its design for the experiment. It now says the product won't be given to patients 70 or older, and it is limiting the amount of Hemopure that would be given to trauma victims. Many of them are expected to be young men under the influence of alcohol. The battlefield is too uncontrolled to do the research, an FDA spokeswoman said.
The proposed changes have moved the FDA closer to giving its go-ahead to the experiment, which is required for the product to eventually win approval, according to agency review documents. Still, the proposed experiment came under sharp questioning yesterday by agency staffers, who said it was hard to determine whether the trial's benefits outweighed its risks, the agency spokeswoman said.
One critic said the proposed trial is unethical and the FDA's previous reasons for blocking the trial remain valid.
"Human subjects would be exposed to an unreasonable and significant risk," said Dr. Sidney Wolfe of the watchdog group Public Citizen. Yesterday's meeting originally was to have been held in secret in July, but the FDA postponed it at the last minute after Public Citizen sued.
-------------------- We all need someone to lean on! Posts: 418 | From: Nashville, Tennessee | Registered: Jul 2006
| IP: Logged |
posted
More I think about this article the more I want to tell these guys if they want experiment on people do it on themselves first. First they all got get regular infusions of the crap and wait say 2 years before starting an outside trial. This includes all excutives working in the company. That way if it's another freaking anthrax vaccine disaster the louse's get it as well. Show others it's safe by taking it yourself first for and extended basis. I am sure they can come up with some excuse for not dosing themselves with this substutite first. Tell us some crap how it can save lives, anything that gets it out for the free human guinea pigs in military service. After all there is the Fere's doctrine that protects them if something goes wrong badly.
Posts: 269 | From: Fla | Registered: Oct 2006
| IP: Logged |
(c) 1999-2005. INDIVIDUAL MEMBERS RESERVE ALL RIGHTS TO THEIR POSTINGS ON THIS BULLETIN BOARD WHERE COPYRIGHT IS NOT EXPLICITLY DISCLAIMED. (KANSAS CITY, MO.) *** Junior members, members, moderators, and administrators reserve common-law copyright privileges and rights to their own individual postings, unless expressly disclaimed. By using this bulletin board and in consideration for the privileges of such use, all guests, junior members, members, moderators, and administrators irrevocably agree to grant AGWVA permission and consent to use, store, retrieve, copy, distribute, and edit such message postings without limitation or exception, and irrevocably appoints AGWVA as agent for the purpose of execting any document or instrument necessary to effectuate this agreement. Furthermore, by using this bulletin board and in consideration therefor, all authorized or unauthorized guests, junior members, members, moderators, and administrators agree that the controlling jurisdiction over any dispute or controversy arising from the use or access of this bulletin board shall be governed under the laws of the State of Missouri and jurisdiction of the Circuit Court of Clay County, Missouri. *** While we encourage private messages to be posted in private forums requiring special authorization to enter, some messages on this bulletin board are protected by attorney-client privilege, doctor-patient privilege, and/or priest-penitent privilege, and such messages are intended solely for the use of those posting those messages, the intended recipient of that message, and AGWVA Bulletin Board's management - any disclosure beyond these parties is unintentional. The voluntary provision of medical, regulatory services/VA-representation, or religious services to members of the AGWVA Bulletin Board shall be limited by the case-by-case circumstances of each situation and shall be provided or not provided at the sole discretion of the person providing such services with the understanding that such services may stop or be limited at any time. Voluntary provision of any such service does not guarantee or assure any person a future or further right to such services. *** For posting messages to or from this bulletin board, AGWVA's management (moderators and administrators) are not compensated, directly or indirectly. *** Unauthorized use, copying, or distribution of material posted to this bulletin board is prohibited. Unauthorized access to this bulletin board is illegal and AGWVA reserves the right to prosecute anyone attempting to illegally access this bulletin board. AGWVA has stated explicit rules of conduct for its members posting on this bulletin board and all such rules are incorporated herein by reference as if fully set out hereinbelow. ***
UBBFriend: Email this page to someone!
Printer-friendly view of this topic
