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WASHINGTON,
D.C. – In a letter to the Food and Drug Administration (FDA), U.S. Representative
Jan Schakowsky (D-IL), a member of the Energy and Commerce Committee, expressed
her concern about the “antiquated and discriminatory system of screening
for blood donors,” adding that banning gay and bisexual men from donating
blood “appears to be a case of ideology being placed before science.”
Schakowsky
questioned why a “gay man in a monogamous relationship poses the greatest
risk and should be singled out for a lifetime ban on blood donation,”
while a “heterosexual man who has visited prostitutes or has had intercourse
with an HIV positive individual, is only banned for 1 year.”
Schakowsky
called on the FDA to provide “the scientific basis upon which the FDA
is basing the lifetime ban on blood donations from HIV-negative gay and
bisexual men,” especially when Nucleic Acid Testing (NAT) for HIV has
cut the window of time between infection and detection to a matter of days.
In
the letter, Schakowsky explained that this issue was brought to her attention
by “one of my constituents, a gay HIV-negative man who has been in a
committed, monogamous relationship with another HIV-negative man for 12
years.” The constituent, who was a potential bone marrow
donor for a five-year-old boy in need of a life-saving transplant, was
turned away because he is a gay man and is banned for life from donating
blood.
“Lifting
the ban on gay and bisexual men would result in an estimated 62,300 additional
blood donors,” Schakowsky wrote. She concluded, “Unless you
can provide me with scientific data that justifies the lifetime ban on
blood donations from gay and bisexual men, I remain convinced that the
ban should be lifted so that the eligible pool of potentially life-saving
donors may be expanded. Given the urgency of this situation, I look
forward to your response by November 24, 2003.”
Below
is Schakowsky’s letter to FDA Commissioner Mark McClellan:
November
10, 2003
Mark
B. McClellan, M.D., Ph.D.
Commissioner
of Food and Drugs
U.
S. Food and Drug Administration
5600
Fishers Lane
Rockville,
MD 20857-0001
Dear
Dr. McClellan:
I
am writing to express my concern at what appears to be an antiquated and
discriminatory system of screening for blood donors. We must ensure
that our blood supply is safe, and at any time, 30-40 percent of the American
public is prohibited from donating blood during the time in which they
might pose a risk. Persons with cold or flu symptoms are banned until
symptoms abate; persons recently undergoing dental work are banned for
72 hours; persons with tattoos are banned for 12 months. One group
that is singled out and banned for life from donating blood is gay and
bisexual men. This appears to be a case of ideology being placed
before science and the result may have serious consequences for numerous
patients in need of blood product donations.
Please
provide me with the scientific basis upon which the FDA is basing the lifetime
ban on blood donations from HIV-negative gay and bisexual men. In
the absence of scientific evidence in support of this policy, I strongly
believe that the FDA should reconsider the ban so that the pool of eligible,
potentially life-saving donors can be expanded.
This
issue was brought to my attention by one of my constituents, a gay HIV-negative
man who has been in a committed, monogamous relationship with another HIV-negative
man for 12 years. He was contacted to be a potential bone marrow
donor for a five-year-old boy in need of a life-saving transplant.
He began the process of testing to determine whether he would be a match.
However, the day after filling out his health questionnaire, he was told
that no further testing would be done because he was a “man who has had
sex with another man, even once, since 1977.” Because he is a gay
man, he has been banned for life from donating blood and bone marrow.
As a result, the five-year-old boy may have to wait for the transplant
that can save his life.
I
understand the importance of ensuring a safe blood supply. During
the late 1970’s and early 1980’s, the early years of the HIV/AIDS epidemic,
gay men were discouraged from donating blood, and in 1985, the FDA turned
this recommendation into regulation. At the time, those recommendations
and regulations were prudent. Now, over two decades into the HIV/AIDS
epidemic, we have a greater understanding of HIV
and
much has changed in the ways in which we approach the epidemic. However,
the FDA’s position on blood donations from gay men has not changed.
We
are in a very different place today than we were twenty years ago.
Today, Nucleic Acid Testing (NAT) for HIV has cut the window of time between
infection and detection to a matter of days. Whereas antibody testing
can take weeks or months to detect HIV antibodies in the blood, NAT takes
as little as 4 to 5 days to detect HIV RNA. Moreover, blood banks
have been using NAT since 1999. The American Association of Blood
Banks, whose facilities collect virtually all of the blood donated in America,
requires its members to use NAT. As such, we can be certain, within
a few days, that blood donations are safe.
The
advent of NAT technology represents an important step in ensuring a safe
blood supply and an opportunity to reexamine FDA regulations that are almost
20 years old and clearly out of date. HIV is no longer a “gay disease.”
HIV affects all segments of society, with the rates of new HIV infections
rapidly increasing among heterosexuals. Every unit of blood collected
has the potential to be HIV-positive, which is why NAT is crucial.
The targeting of gay men for a lifetime ban on blood donation does not
appear to be scientifically sound at this point in time. Rather,
this ban appears discriminatory and supportive of the false stereotype
that HIV affects only gay men.
A
gay man who has consistently tested negative for HIV and who has had only
one protected sexual encounter with another man can never donate blood.
However, a heterosexual man who has visited prostitutes or has had intercourse
with an HIV positive individual, is only banned for 1 year. A woman
whose HIV serostatus is unknown and who has engaged in risky sexual acts
with multiple partners is not banned at all. I am aware of no scientific
evidence proving that, out of these three scenarios, the gay man in a monogamous
relationship poses the greatest risk and should be singled out for a lifetime
ban on blood donation.
Most
troubling is that, if there is no scientific justification for a lifetime
ban, this policy may be preventing persons in need of bone marrow transplants
from receiving available help they need to survive. It is estimated
that more than 30,000 people are diagnosed with fatal blood disorders annually.
Approximately 30 percent of those patients have compatible family donors.
The remaining 70 percent must rely on unrelated donors, and finding a match
is often difficult. As a result, patients may die due to the absence
of a compatible marrow donor. This lack of compatible donors is made
more severe by the lifetime ban on gay men. Like the five-year-old
boy who will not be able to benefit from my constituent’s bone marrow donation,
patients will continue to
search
for donors from an unnecessarily limited pool. It is this limited
pool that could be the difference between life and death for patients with
fatal blood disorders.
I
am not alone in my desire to see FDA policies changed. Both the American
Association of Blood Banks and America’s Blood Centers support lifting
the lifetime ban on donations from gay and bisexual men. FDA’s own
Blood Products Advisory Committee narrowly voted against changing the policy,
with a 7-6 vote and five members absent.
The
advances in blood-screening technology have furthered the safety of our
blood supply and we no longer need to deny those suffering from fatal blood
disorders because of unscientific bias in donor eligibility policy.
Lifting the ban on gay and bisexual men would result in an estimated 62,300
additional blood donors. This significant increase would help to
decrease our blood shortage and likely increase the pool of bone marrow
donors.
Unless
you can provide me with scientific data that justifies the lifetime ban
on blood donations from gay and bisexual men, I remain convinced that the
ban should be lifted so that the eligible pool of potentially life-saving
donors may be expanded. Given the urgency of this situation, I look
forward to your response by November 24, 2003.
Sincerely,
Jan
Schakowsky
Member
of Congress |
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