NoBlood

Abishai · #1 (**permalink**) 06-24-2008, 03:05 AM

Pros and Cons of Polyheme, on the way of FDA approval...

Quote:

Dr. Dave Goes 'In Depth' On New Synthetic Blood

Prepared for cbs4denver.com by Matthew J. Buettner

DENVER (CBS4) ― A company that created a synthetic blood substitute is going to submit the results of a study to the Food and Drug Administration. It's called PolyHeme and was tested at 32 trauma centers nationwide, including Denver Health Medical Center.

Study results released Monday show little difference in survival rates among patients who received PolyHeme versus natural blood or other treatments.

A researcher at Denver Health, Dr. Gene Moore, says that despite the survival rate similarities, it has several advantages. PolyHeme has a shelf life of one year, far longer than the 42 days for human blood. It might help rural patients who live far away from a trauma center. It could also help people whose religious beliefs prevent them from receiving donated blood. Moore says PolyHeme could be useful in the event of a large terrorist attack, or in war zones like Iraq.

"These can be carried into war and used in areas where there is not blood available, taken into the field and used in these scenarios," Moore said.

The FDA could take its first look at the PolyHeme study in six months, but there are still a lot of unanswered questions.

CBS4 Medical Editor Dr. Dave Hnida said he thinks it's important for people to know PolyHeme might help if the real stuff isn't available, but those who need blood should want real blood.

"I think the best way to look at this is that it's a niche product, maybe for Jehovah's Witnesses whose religion doesn't allow for blood transfusions," Hnida said. "Also people in rural areas who may not have blood available. Possibly war; maybe in the 15 minutes it takes for a chopper ride to a combat hospital. But frankly, at a combat hospital, we would use real blood, not this product."

There has been some controversy about it for two reasons. As recently as last month, the Journal of the American Medical Association looked at all the research to date and found PolyHeme increases the risk of a heart attack. The research released Monday says otherwise, which is good since Denver Health did perhaps the best study yet on the product and finds it to be safe.

The second controversy is about testing.

"Generally you get consent to give experimental stuff to patients," Hnida said. "You're bleeding to death; it's impossible to get your signature. So the research was done without the usual consent."

Hnida said it was actually a "community agreement." The research needed to be done without consent.

Hnida also stressed that the synthetic blood will not decrease the need for blood donations.

"We are going into the slowest donation time of the year," he said. "Please roll up your sleeve. In Iraq, we saved soldiers by giving the real deal. That's the case in Denver as well."

(© MMVIII CBS Television Stations, Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.)

Source: CBS4 Denver

NoBlood

Synthetic Blood Polyheme still matter of controversy