The Food and Drug Administration is set to examine Friday whether plasma-derived factor VIII products pose a risk of transmitting human mad cow disease and hemophilia patient advocates are urging stricter surveillance and oversight.

The outcome of the FDA's transmissible spongiform encephalopathies advisory committee meeting Friday could have implications for several companies that manufacture factor VIII products. This includes Baxter's Hemofil and Monare, ZLB Behring's Monoclate-P and Humate-P, Grifols' Alphanate and Talecris' Koate.

The concern that human mad cow disease, an incurable, fatal brain disorder known formally as variant Creutzfeldt-Jakob disease, or vCJD, could be transmitted by these blood products was heightened in recent years by the fact that three people in the United Kingdom apparently acquired the disease through blood transfusions.

The result of the advisory committee meeting could have ramifications for other blood products, and several manufacturers not directly tied to the factor VIII issue, including Wyeth and Bayer, will be watching the meeting closely.

The FDA says the risk of vCJD being transmitted by factor VIII products is low but probably not zero. But the Committee of Ten Thousand and other hemophilia groups don't trust those odds and are urging that more be done to ensure the safety of these products.

"We're not recommending sounding the alarm, but what we want to do is increase surveillance and education," Corey Dubin, of COTT, told United Press International.

Dubin, who contracted HIV and hepatitis C via tainted blood products, noted that there are still a lot of scientific mysteries surrounding vCJD, and FDA measures that were too conservative are what allowed HIV to spread to hemophiliacs in the 1980s through infected blood.

"We're not saying the same thing is going to happen in this situation, but we don't believe the answer to ambiguity and lack of knowledge is less vigilance," he said.

Dubin said he'd like to see leukodepletion required as is done in Europe. He also wants the Centers for Disease Control and Prevention to add vCJD to its universal data collection project, which collects health information from patients who receive blood products to help detect problems with this blood supply.

However, these steps would likely raise the cost of a unit of blood or plasma and "that's part of what's at stake here," he said.

Baxter spokesman Chris Bona did not answer UPI's question of whether the company thought its plasma-derived factor VIII product posed a risk of transmitting vCJD.

"Safety is something we take very seriously," Bona responded. "We do believe that patients and the medical community deserve a scientifically rigorous base for selecting factor VIII therapy."

Bona added that there's been no reports of bloodborne pathogen transmission from any of Baxter's blood-based and non-blood-based products.

He also noted that most patients using Baxter's products receive Advate, which is a recombinant product the company developed in response to concerns from the hemophiliac community about potential pathogens in blood products.

The FDA states in documents on its website that it conducted a computer risk assessment model that concludes "that the risk of vCJD infection from U.S. manufactured (plasma-derived factor VIII) generally appears likely to be very low, but may not be zero."

The agency added, "Manufacturing processes ... likely reduce the quantity of vCJD agent, if present, but the level of reduction through manufacturing steps is not precisely known."

The FDA noted that "it is not possible for the model to provide a precise estimate of the vCJD risk in general, or of the actual risk to individual patients."

The FDA also stated that it is not aware of any cases of vCJD resulting in patients receiving plasma-derived products. "This includes patients receiving large amounts of other products manufactured from UK plasma donations over a long period of time," the agency added.

This suggests the risk is very low, but, the agency added, "the absence of cases does not rule out the possibility of exposure that could potentially result in illness in some recipients at some future point in time."

Paul Brown, a former chair of the FDA's TSE advisory committee and an expert on mad cow-like diseases, told UPI that his take on the issue is that factor VIII products carry no risk of transmitting vCJD.

"It continues to be my view that Factor VIII as currently processed includes steps that would eliminate any small level of infectivity that might have been present in the already highly diluted donor plasma pools," said Brown, who also served as former medical director of the National Institutes of Health`s Laboratory for Central Nervous System Studies.

"This is a view that is generally not accepted by the hemophiliac community, but is accepted by the medical community," he added.