This week, the Department of Health and Human Services Blood Committee will review it’s policy on banning Gay men from donating blood.
Following up on a March announcement from the Department of Health and Human Services, the June meeting of the Advisory Committee on Blood Safety and Availability ”will hear presentations and engage in deliberations” on the Food and Drug Administration policy, in place in its current form since September 1985, prohibiting men who have had sex with another man ”even one time since 1977” from donating blood.
Officials at HHS and advocacy groups said that no decision on the specifics of any change – or if there even would be any change – has been made. Unlike the FDA reviews of the policy in 2000 and 2006, however, the Advisory Committee will be free to consider non-scientific factors – like societal issues and cost-benefit analysis – in its review.
The meeting, formally announced in the Federal Register on Thursday, May 20, is to take place June 10-11 at The Universities at Shady Grovein Rockville, Maryland.
Jerry A. Holmberg, the executive secretary of the Advisory Committee, said on Thursday, ”The decision has been to review the issue. The Assistant Secretary of Health wants this to be discussed in an open forum.”
The Human Rights Campaign announced in a release that the organization will offer testimony at the meeting. Spokesman Michael Cole spoke to the additional work needed to effect any policy change, saying, ”This is a long-standing policy that will take a great deal of education to help change.”
Cole noted ”the FDA’s paramount responsibility is to ensure the safety of the blood supply.” Regarding HRC and other advocates of changing the policy, Cole said, ”We must continue working to demonstrate that broadly excluding all gay and bisexual donors for life, particularly in light of tremendous advances in HIV science since the ban was adopted, does not serve that important goal.”
The lifetime ban – called a lifetime deferral by the FDA policy – often has sparked the ire of LGBT advocates in the past and also is opposed by the three main blood donations organizations – the AABB, America’s Blood Centers (ABC) and the American Red Cross.
In a 2006 statement, the three groups stated that the lifetime ban is ”medically and scientifically unwarranted.” It should be noted, however, that they ”recommend that deferral criteria be modified and made comparable with criteria for other groups at increased risk for sexual transmission of transfusion-transmitted infections,” which would be a one-year deferral. The recommendation, if implemented, would mean that only those men who have not had sex with another man for more than a year would be eligible to donate blood.
The meeting notice states that the topics to be addressed include: ”what are the most important factors (e.g. societal, scientific, and economic) to consider in making a policy change; is the currently available scientific information including risk assessments sufficient to support a policy change at this time; what studies, if any, are needed before implementing a policy change; what monitoring tools or surveillance activities would need to be in place before implementing a policy change; what additional safety measures, if any, are needed to assure blood safety under a revised deferral policy?”
The notice includes additional information, including a note that ”screening tests can be falsely negative during the ‘window period,’ defined as the interval between the time when an infected individual may transmit the disease and the time when screening tests become positive.” In agreement with the AABB, ABC and Red Cross statement, the notice states, ”A period of deferral is needed after high-risk exposure to prevent false negative tests from ‘window period’ collections.”
The June 10-11 meeting will include a period for public comment on June 11. Anyone who wishes to comment is required to register with Holmberg by June 8.
When Mark Shields started his job at the American Red Cross in Madison, Wisconsin, he rolled up his sleeve to give blood. It made sense. Part of his job was encouraging the public to donate and supporting the organization’s lifesaving mission.
Before he could give, he was told that his blood could never be accepted. Because he’s gay.
“I was 23 at the time. I was just coming out,” he said. “I was trying to be part of our organization’s mission and feeling like I can’t do this. … I certainly felt put on the spot. It was a bad feeling for a lot of reasons.”
Under Food and Drug Administration rules, men who have had sex — even once — with another man since 1977 are not permitted to give blood. The rule was implemented in 1983, sparked by concerns that HIV, the virus that causes AIDS, was tainting the blood supply. Screening tests to identify HIV-positive blood had not been developed. The policy was seen as a safety measure.
Mark Shields promoted blood
donations for two years at the
American Red Cross
But today, with the availability of more accurate testing, activists, blood organizations and several U.S. senators say the lifetime ban is “medically and scientifically unwarranted” and are calling for change.
The Federal Advisory Committee on Blood Safety and Availability will consider the issue in meetings June 10 and 11 in Rockville, Maryland. The committee makes recommendations to the secretary of the Department of Health and Human Services, which oversees the FDA.
Medical opinions vary; some experts say that lifting the ban could pose health risks to blood recipients.
The Human Rights Campaign, the American Red Cross, America’s Blood Centers and AABB, formerly known as the American Association of Blood Banks, support easing the lifetime ban to allow gay blood donors. In a joint statement, the blood organizations said that safety was the first priority and that potential donors should be screened more fairly, regardless of sexual orientation.
About three months ago, Sen. John Kerry and 17 other senators signed a letter to the FDA blasting its “outdated” policy.
Gay men, including those who are in monogamous relationships, are forbidden from contributing blood for the rest of their lives, while “a heterosexual who has had sex with a prostitute need only wait a year [before giving blood]. That does not strike me as a sound scientific conclusion,” Kerry wrote in a March 9 letter.
The FDA defended its current policy in an e-mailed statement to CNN.com: The policy, it said, is “based on scientific data that show that certain medical, behavioral and geographical factors are associated with increased risk of transfusion transmitted diseases.”
The agency has been “taking into account the current body of scientific information, and we are considering the possibility of pursuing alternative strategies that maintain blood safety,” the statement said.
The FDA retained the ban on gay blood donors after reviewing the issue in 2000 and 2006.
Other factors that would make an individual ineligible to give blood:
• Had leukemia or lymphoma, including Hodgkin’s disease and other blood cancers.
• Used needles to take drugs, steroids or anything not prescribed by a doctor.
• Born or lived in Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger or Nigeria since 1977.
• Received a tattoo in the past 12 months.
• Visited or lived in the United Kingdom for three months or more between 1980 and 1996 because of the risk of Creutzfeld-Jacob disease (mad cow disease).
Source: American Red Cross Health statistics show that men who have sex with men have a higher rate of diseases including HIV, syphilis and hepatitis B. Gay men who would be likely to donate have an HIV prevalence that is over 15 times higher than that of the general population, according to the Centers for Disease Control and Prevention.
“I do not see this being a gay rights issue,” said Dr. Jay Brooks, professor of pathology at the University of Texas Health Science Center in San Antonio, adding that he favors gay marriage and gays serving in the military.
The issue of blood donation has “nothing to do with someone being gay. Any group that’s epidemiologically at risk of making blood unsafe, it’s unfortunate. … It’s a matter of epidemiology.”
The different standards between gay and straight people exists because the risk of HIV is much lower in heterosexuals, he said.
“The interest of the recipient is greater than any donor,” Brooks said. “I’d hate to tell the one person who got HIV through a blood transfusion, ‘Sorry, we changed the regulation.’ ”
These days, blood screenings are so effective in detecting diseases that the risk of such infection is very small, said Dr. Norbert Gilmore, a professor and clinician at the McGill University Health Center in Canada.
The blood donations go through HIV antigen screening (to detect antibodies produced by the body in response to the virus) and nucleic acid testing. However, there is a “window period” for about two weeks after an individual becomes infected with HIV when these tests cannot detect the virus.
The interest of the recipient is greater than any donor.
But that risk of this infection is “so small, we should look at the day-to-day realities rather than those infinitesimal risks,” said Gilmore, whose research published this week in the Canadian Medical Association Journal criticized the ban in Canada and the U.S. as unscientific.
The most important issue in this debate should be the safety of the patients, said Mark Skinner, president of the World Federation of Hemophilia.
“This isn’t an issue just about HIV. It isn’t a gay issue,” he said. “This is an issue that relates to safety in the blood supply. Those decisions should be made on science, not based on societal concerns. We readily recognize the MSM [men who have sex with men] ban is discriminatory, but it’s discriminatory for a reason.
“What we’re looking for is a thoughtful review. We’re not opposed to the change. We want to understand what additional risks patients might be asked to accept,” he said.
Shawn Decker, a hemophiliac who contracted HIV through contaminated blood products, said he supports allowing gay men to donate blood.
Potential donors should be screened based on risky behaviors such as unprotected sex or intravenous drug use, not sexual orientation, he said.
Decker said he was looking forward to a time when “those very allies and friends” in the gay community “are allowed to pony up and give the blood that is used to create my treatments for hemophilia.”