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Blood Safety: Satcher Remarks - January 2000



Good Morning. We have a lot to talk about today.

The first item on our agenda is the Guidance to Industry that the FDA issued on August 17. That Guidance relates to deferral of blood donors who have resided or traveled in the United Kingdom for a cumulative six months or more between January 1980 and December 1996. Let me address some of the concerns that this action has raised.

We are deferring blood donors who lived in the United Kingdom around the time of the "mad cow" epidemic. Mad cow disease first appeared there in 1985, a few years after a change had occurred in how cattle feed was prepared. In 1988, the use of certain animal products in cattle feed was banned, and the mad cow epidemic subsequently receded. It now seems clear that mad cow disease was transmitted by contaminated feed; but there may have been other ways it was transmitted as well.

New variant CJD appeared in the United Kingdom in 1995, ten years after the appearance of mad cow disease. New variant CJD is the human counterpart of mad cow disease. Forty-one of the 43 victims of new variant CJD, the total so far, have lived in the United Kingdom for at least ten years between 1980 and 1996; one other lived in France, and the last, an Irish citizen, appears to have spent substantial time in the United Kingdom. It seems likely that the agent that causes mad cow disease crossed the species barrier from cattle to humans in food; but again, there may have been other ways it was transmitted as well.

The greatest uncertainty at present is the number of United Kingdom residents who will eventually develop new variant CJD. Cattle develop symptoms about five years after exposure. If the incubation period in humans is also five years, and no further transmission takes place, there could be less than 500 cases. However, if the incubation period is much longer, far more could be affected. A test to detect individuals at risk of developing new variant CJD might settle this issue, but that test is not yet available.

There are other uncertainties as well. The new variant prion, for example, has been detected in the tonsils and the appendix of individuals before any symptoms of new variant CJD had developed. Can presymptomatic individuals transmit this disease? In the case of classic CJD, we have extensive epidemiologic evidence spanning three decades that conclusively demonstrates that this does not occur. In the case of new variant CJD, however, we do not have a corresponding assurance.

At present, the only way to reduce the possibility that the agent that causes new variant CJD might be transmitted in blood transfusions is to defer any blood donor who might be capable of transmitting this agent.

This action was first proposed by the FDA Transmissible Spongiform Encephalopathy Advisory Committee, or TSEAC, on December 18, 1998. At that time, the TSEAC recommended that this action not be implemented until its impact had been assessed. We concurred with that decision. On June 2, 1999 the TSEAC reviewed detailed estimates from the blood industry on the impact this recommendation would have. Essentially, these estimates were that a one-year residence-based deferral would eliminate 1.5% of donations, and that a six-month residence-based deferral would eliminate 2.2% of donations. TSEAC then reaffirmed its prior recommendation to defer, and polled its members individually on the duration of residence that would trigger deferral.

Because of the obvious urgency of this issue, the Department moved rapidly to consider it. The Blood Safety Committee, which I chair, met on June 8 to consider the TSEAC recommendation, and they unanimously supported it. The Blood Safety Committee also voted unanimously in favor of the six-month residency trigger. I accepted the Blood Safety Committee's recommendation, and communicated my support of it to FDA. FDA in turn announced its plan to implement this recommendation on June 17, and their Guidance to Industry was issued on August 17.

We plan to monitor the impact of this policy very carefully, and you will hear a more detailed description of our monitoring plans later this morning. We remain committed regular review of this policy, and to updating it as soon as new scientific information becomes available. We will also continue our support of research into the cause, transmission, and treatment of all the transmissible spongiform encephalopathies, including but not limited to new variant CJD. We will also continue our support of research into the most effective means of promoting blood donation. Furthermore, the senior management of the Department, myself included, are willing and in fact eager to participate in appropriate industry-sponsored programs to increase blood donations.

I appreciate the effort you made last April to examine the reserve capacity of the blood supply. We have acted on the recommendation that you made. I also appreciate the effort of the Public Health Service Working Group that I commissioned to investigate this matter, and we will act promptly on their recommendations as well. I look forward to receiving any additional suggestions that may arise from your deliberations this morning, or in the future.

This afternoon you will receive an update on the availability of plasma derivatives, and the steps that have been taken to improve this situation. I remain concerned about the quantity of these products that is available, and I would like you to consider carefully how this situation could be further improved.

You will also hear an update on the progress of the hepatitis C lookback. This update will include the revised Guidance to Industry that FDA published on June 17, and CDC plans for general notification, tracking the progress of direct notification, and evaluating the success of these efforts.

Tomorrow morning you will consider the issue of how federally mandated blood safety measures should be financed. I'm sure this discussion will be lively, and I expect it to be constructive.

As you engage in this discussion, however, I want you to remember the following point. The blood supply is as safe as it is because we have worked very hard to make it safe. We also need to remember that there is no guarantee that it will remain safe unless we maintain our vigilance.

I would be glad to answer any questions you may have.