Deferral of MSMby Andrew I. Dayton, M.D., Ph. D.

•The HIV epidemic in the U.S.A. is generally recognized to have started just after 1977.

•Currently MSM are deferred for MSM behavior “…even one time, since 1977…”

•In 1997 FDA presented to the BPAC an analysis of the potential effects of relaxing the MSM deferral policy to “1 year” or to “5 years.”

•Blood banking errors, poorly quantified at the time, were considered the most significant risk of changing the policy.

Deferral of MSMby Andrew I. Dayton, M.D., Ph. D.

•In November of 1998, FDA hosted a workshop on Donor Suitability.

•The highlights of this workshop were presented to the BPAC in December of 1998.

Widespread adoption of NAT for HCV and HIV, providing, amongst other benefits, redundancy.

Better understanding of blood bank error rates.

Protection of the Blood Supply

INFECTIONPOTENTIAL DONORS

BLOOD SUPPLY

TestsQuestionnaire

Undetectable Strains

Blood Bank Error

Test Failure

Window Period

Ineffective Risk Identification

Test Seeking Behavior

Peer Pressure

Misunderstanding of Questions

Self Deferral (Education)

Protection of the Blood Supply

POTENTIAL DONORS

BLOOD SUPPLY

Tests

Undetectable Strains

Blood Bank Error

Test Failure

Window Period

Prevalence

Incidence

Quantitation of Errors I:How many infectious units will “get through?”

Total Errors = P x (U + E + F ) + I x (WP/365)} x Population

Errors = P x (U + E + F ) + I x (WP/365)} x Population

Questions for the Committee:

1. Does the BPAC recommend that Men who have Sex with other Men (MSM) be deferred from donating blood for a period of five years following MSM activity, rather than being deferred for any MSM behavior since 1977?