| Comment Record|
Mr. Corey Dubin ||
2001-10-24 16:05:27 |
Committee of Ten Thousand |
Consumer Group |
| Comments for FDA General |
1. General Comments
Committee of Ten Thousand
Advocates for Persons with HIV/AIDS
236 Massachusetts Ave., NE Suite 609 · Washington, DC 20002
(800) 488-COTT · (202) 543-0988 · Fax (202) 543-6720
October 28, 2001
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
RE: Draft Guidance entitled Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD in Blood and Blood Products, Federal Register, August 29, 2001
The Committee of Ten Thousand is pleased to have this opportunity to comment on the above-referenced draft. The Committee supports the recommended new donor deferral criteria being proposed by the FDA, feeling as ever that as long as the potential for bloodborne transmission is not eliminated, strong protections are in order.
We trust the variance between these and ARC geographical donor exclusion criteria announced this summer (still more restrictive than these) will be reconciled before the final Guidance is issued, in favor of the more conservative stance, lest donors and the public become confused and any public debate generated be about this variance, not about the disease both are designed to bar from our blood. A Pilot Studies program alone may not accomplish this.
Plasma exemption: The evidence as to reduction of infectivity in the blood products manufacturing process is unclear, so we were surprised to see the exemptions granted in some cases for continued use of Source Plasma without the same geographic screens as those proposed for Whole Blood. The terms used in this discussion were of note as well. You use the term life and health-sustaining plasma derivatives. Whole blood is not? You talk about uncertain effect of a deferral on the supply of plasma derivatives as a rationale for not invoking a safety provision. Reads like an industry brochure.
[T]ransmission of vCJD by blood might be a greater risk than for CJD, you say. You point out that the risks of excepting plasma donors from the Europe-wide ban have not been established. Then you indicate the likely ability of the plasma fractionation process to reduce TSE
infectivity … and, [M]anufacturing … could lower the amount … in plasma derivatives. (emphasis added) Finally, concerning disposal of TSE-implicated product, you mention that [T]here is no current consensus on specific details of decontamination requirements for blood products … [but] methods of destruction … include steam … incineration … or treatment … These treatments are known to diminish (but may not completely eliminate) infectivity.
That is, you find both CJD and vCJD to be possibly blood transmissible, you document the relative indestructibility of infectivity, and you permit Source Plasma to be exempted from the new screens, although unclear as to its reduction in infectivity during manufacture. These are all points in the Draft Guidance that suggest a more conservative approach than that proposed. CBER more than anyone (except us) should know that inconsistency, however undesirably, is a reality in the plasma derivatives manufacturing process. Everything in that process doesn't always run right -- recalls, etc. do happen. We, who put the results in our veins, are thus less trusting than you.
Please therefore include Source Plasma in the same recommendations as for recovered plasma and whole blood. Twenty years ago we were being told that blood high in viral hepatitis antibodies was beneficial. Now we're all Hep C experts. Many deceased.
Phased Implementation: We question the continued wisdom of the proposed two-stage implementation: From 8:43 a.m. EDT on September 11, 2001, the start of a true day of infamy for this century, until the time that public announcements were being made city-wide and on all national television networks that the blood banks of New York had more than they could use, was an elapsed period of less than 72 hours. During this time Presidential leadership on the subject was very visible, including a collection at the White House. In addition, the public knows of changes in many other areas of life now necessitated; regular blood donation seems very likely to be much higher on the priority list than it was. In short, we believe the tragedy triggered a long-dormant response that can now be relied upon to meet the needs which any increase in protections for a safe blood supply might necessitate.
Also, why wait over a year for stringent Europe-wide bans, if they are justifiable today? The epidemic is moving steadily: the Japanese are now testing 1 million cattle for BSE (and fear they have a case of nvCJD), based on a case that wasn't even known when this Draft was issued for fast-track public comment -- less than a month ago. How long did it take from first suspicion until Ireland and Portugal were being singled out? What more can happen by October 2002? Indians, finding some of their sacred (and long-lived) cows infected? CWD leading to confirmed vCJD in the American west? We do not mean to add to panic, or be fear mongers, but the numbers in these related epidemics are not going down, they are going up. It is hard to imagine how prudence today will not serve us best in the coming years with this unfolding scourge.
Thank you again for this opportunity to comment. As ever, I or Dave Cavenaugh of our Washington office (contact info above) stand ready to answer any questions you may have or discuss any of these points further.
Corey S. Dubin
President, Board of Directors