On Monday, November 27, the Food and Drug Administration (FDA) released documents on its assessment of the risk of acquiring variant Creutzfeld-Jakob disease (vCJD), a human form of mad cow disease, for people with bleeding disorders who have used US-licensed plasma-derived factor VIII products (pdFVIII). Although there are still too many uncertainties to allow it to make a precise calculation of theoretical risk without further study of this issue, FDA officials and other experts continue to believe that this risk is exceedingly low, but possibly not zero. It is important to note that there have been no known cases of vCJD in users of pdFVIII products worldwide, including in the United Kingdom where the prevalence of vCJD in the general population is the highest in the world. The National Hemophilia Foundation (NHF) issued Medical Advisory #406 informing the community of the release of the FDA documents and their implications.
On December 15, the agency’s Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC) met. Transmissible spongiform encephalopathies, or TSEs, are a group of rare, progressive neurological diseases caused by prions, infectious agents composed of proteins. TSEs include both vCJD and the bovine form, bovine spongiform encephalopathy (BSE). The purpose of the meeting was to receive the advice of a panel of consumers, medical professionals and other experts on how best to broadly communicate this information to the public. Val Bias, who co-chairs NHF’s Blood and Product Safety Working Group, represented the organization on the panel. Click here to read Mr. Bias’ testimony.
The committee also considered whether a minimum standard could be set to remove vCJD prions and others from plasma-derived clotting factor. The committee decided that although current methods of clearance were an important factor in keeping the risk very low, it was not currently possible to determine an appropriate standard.
NHF will continue to work closely with the FDA and other government agencies to ensure that the community receives complete, accurate and timely information on this subject.
For more information about the FDA risk assessment and related information, please visit the TSEAC section of the FDA Web site at: http://www.fda.gov/cber/advisory/tse/tsemain.htm