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“ he FDA has carefully examined
T
and considered the available scientific evidence relevant to its
blood donor deferral policy and
now will take the necessary steps
to recommend a change to the
blood donor deferral period.”
—MARGARET A. HAMBURG
FDA Plans to Lift Ban on Blood Donations
from Gay Men
In 1983, shortly after the onset of the
AIDS epidemic, the U.S. Food and Drug
Administration (FDA) advised blood
centers to refuse blood donations from
gay men for fear of contaminating the
blood supply. However, the FDA recently
concluded that contemporary practices
of blood screening render the ban unnecessary.
In a formal proposal issued on May
12, 2 015, the FDA recommended ending
the 32-year-old ban on blood donations from men who have sex with men
(MSM), provided they haven’t had such
sex in the previous 12 months.
This proposal is a follow-up to the
agency’s announcement last December
that it intended to issue a proposal to lift
the ban in 2015. Last year, two separate
14
ASH Clinical News
federal advisory committees recommended this one-year deferral policy
as safe, based partly on the experience
of the United Kingdom, Sweden, Japan,
Australia, and other countries that already had adopted it.
However, groups in the lesbian-gaybisexual-transgender (LGBT) community object to the requirement that MSM
must be sexually abstinent 12 months
prior to donating blood, contending that
current blood donation testing detects
all known serious blood-borne pathogens, including HIV, within 45 days
of exposure. A shorter deferral, of two
months or less, may be appropriate, they
suggested.
The American Civil Liberties Union
also took issue with the FDA plan. “The
FDA’s proposal must be seen as part of a
continuing process and not an endpoint,”
said Ian Thompson, ACLU legislative
representative. “The reality for most gay
and bisexual men – including those in
committed, monogamous relationships
– is that this proposal will continue to
function as a de facto lifetime ban.”
Peter Marks, MD, PhD, deputy
director of the FDA’s center for biologics evaluation and research, said that
compelling scientific evidence to shorten
the deferral policy to less than one
year is not yet available. Furthermore,
medical data from other countries with
the 12-month deferral policy in effect
demonstrate that the limit does not lower
the safety of the blood supply. He also
described the policy as being consistent
with other limits. For instance, there is a
one-year deferral for men or women who
have had sex with someone who is HIVpositive and for men or women who had
sex with an intravenous drug user.
“The FDA has carefully examined
and considered the available scientific
evidence relevant to its blood donor
deferral policy,” said FDA Commissioner
Margaret A. Hamburg. Now, she said,
the FDA “will take the necessary steps to
recommend a change to the blood donor
deferral period.”
The FDA did note that this new
proposal does not reflect any shortage
of blood donations, and there is not an
urgent need to increase the number of
eligible blood donors.
The proposed FDA guidance to blood
centers was officially published in the
Federal Register on May 15 and is now
open for public comment. When the 60day window for public comment closes,
the FDA will issue a final version of the
recommendations.
Sources: The Wall Street Journal and the FDA’s “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus
Transmission by Blood and Blood Products: Draft Guidance for Industry”
Researchers Make
Progress in Making All
Blood Types Universally Accepted
Scientists have made promising progress
in developing a method for transforming any type of donated blood into type
O – the universal blood type that can
safely be given to any patient – according to research published in the Journal
of the American Chemical Society. Led by
David H. Kwan, PhD, a team of scientists
created a special enzyme that can shear off
the substances on red blood cells that are
responsible for potentially fatal immune
reactions if a patient receives the wrong
type of blood.
The enzyme is not yet effective enough
to allow for large-scale processing to
convert type A or type B blood into type
O, said Dr. Kwan, a postdoctoral fellow
of chemistry at the University of British
Columbia’s Centre for Blood Research in
Vancouver, Canada. “We’re not there yet.
This is a step toward that,” Mr. Kwan said.
“The big thing is that we’ve shown that it’s
feasible to improve these enzymes.”
The enzymes used in the study strip
away antigens that determine blood
type; while the methodology has been
around for about 15 years, this is the first
promising report of its effectiveness. Mr.
Kwan and his colleagues performed what’s
called “directed evolution” on the enzyme,
generating mutant versions and selecting
the ones that did the best job of stripping
away blood antigens. In just five generations, the enzyme became 170 times more
effective – not yet effective enough to
solve the problem of ABO mismatch, the
researchers said, but improved enough to
show that the process of enhancing the
enzyme does work.
June 2015