"The Navy ultimately hopes to use the experimental product, called Hemopure.... some studies linked the products to toxic effects, including heart and kidney damage.... potentially deadly and should not be tested in humans.... the Navy has proposed testing Hemopure in patients with severe blood loss who would otherwise likely die"
Yeah, right, support the troops -- EXPERIMENT on them after sending them into battle over DAMNABLE LIES -- so some biotech can ring the cash register!!!!!!
Now why would the Navy be worried about such things?
Related: Sailing the Seas of Afghanistan
And with MORE TROOPS HEADED THERE they NEED the STUFF?
"Navy rips FDA for blocking clinical trial; Report says agency biased on Biopure's blood substitute" by Todd Wallack, Globe Staff | April 4, 2009
An internal Navy report blasts the Food and Drug Administration for blocking clinical trials of a blood substitute manufactured by Biopure Corp., a struggling biotech company based in Cambridge.
The looters are all interlocked, aren't they?
Also see: Biotech Thiefs and Liars
The Navy ultimately hopes to use the experimental product, called Hemopure, to treat military personnel wounded in battle, where traditional blood transfusions aren't readily available. But for the past four years, the FDA has consistently rejected Biopure and the Navy's efforts to test the product in clinical trials, citing safety worries and other concerns.
And if the rubber-stamp FDA is worried about it, it must be bad!!!!
Now the Navy has commissioned a strongly worded report, obtained by the Globe, that concluded the FDA reviews were "faulty."
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FDA spokeswoman Karen Riley said some studies linked the products to toxic effects, including heart and kidney damage. Biopure declined to comment.... blood substitutes have been dogged by safety concerns.
Last year, the Journal of the American Medical Association published a study that concluded hemoglobin-based blood substitutes, such as Hemopure, are potentially deadly and should not be tested in humans. Biopure subsequently demanded a retraction and sued the coauthor of the article - a senior investigator with the National Institutes of Health - for libel, saying the study was flawed. Hemopure is manufactured from cow's blood.
Related: Dr. Moreau Operates in Massachusetts
South Africa, the only country to approve Hemopure for human use, decided to revoke its approval last year following the Journal of the American Medical Association study. The company is appealing that decision. But a coauthor of the Navy report said the safety concerns are moot, because the Navy has proposed testing Hemopure in patients with severe blood loss who would otherwise likely die. Last month, the Navy submitted a revised application to test the drug in trauma patients.
"There is a huge need," said Lewis Kaplan, associate professor of trauma surgery at the Yale School of Medicine in New Haven, adding he was baffled by the FDA's resistance. But Biopure may be running out of time. The company was forced to lay off all but five employees to conserve its dwindling cash.
In February, the company hired Newbury Piret & Co., a Boston investment banking firm, to advise on its strategic options. Biopure's stock closed at 17 cents yesterday, giving the company a market value of just $7 million. The company has also struggled to distance itself from several former executives.
In 2005, the Securities and Exchange Commission sued Biopure and several former executives for misleading investors about Hemopure's prospects for approval. The parties ultimately settled. In addition, another former Biopure executive, Howard Richman, pleaded guilty last month to pretending to be gravely ill with colon cancer to avoid a suit from securities regulators. Richman, who left the company in 2003, paid a $150,000 fine last year and faces up to 10 years in prison.
Also see: Biotech Thiefs and Liars
In October 2005, Biopure warned the FDA that the SEC probe presented a possible conflict of interest, because some of the FDA reviewers were also witnesses in the case against the company.
And that details the power relationship and who wags who.
