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The FDA heard testimony in March from the American Red Cross, the American Association of Blood Banks and America’s Blood Centers that the ban on blood from men who have sex with men is unnecessary because blood-screening methods are more advanced and accurate today than when the ban was first implemented.
san diego
Call for blood donors excludes gay, bisexual men
S.D. County experiencing ‘dangerously low blood levels,’ San Diego Blood Bank says
Published Thursday, 20-Jul-2006 in issue 969
In the midst of a countywide blood shortage, recruitment efforts exclude roughly half of the GLBT community as a result of the Food and Drug Administration’s (FDA) ban prohibiting men who have sex with men (MSM) from donating blood.
Lynn Stedd, director of community relations and marketing at the San Diego Blood Bank, said a serious blood shortage in San Diego became evident after July 4, and the San Diego Blood Bank issued an appeal for blood donations.
“One of the reasons we issued that appeal was because I checked nationally, and more than half of the blood centers across the country were at dangerously low blood levels,” she said. “So I knew that we really didn’t have anywhere to turn to bring blood from another area, so we really had to depend on our own community to come in and donate.”
In order to be adequately prepared for any disaster or emergency, the San Diego Blood Bank must maintain a five- to seven-day supply at all times. Currently, the A-positive (4.2 days), B-positive (4.7 days) and O-positive (3.4 days) blood types are at urgent levels.
Stedd said the San Diego Blood Bank agrees with America’s Blood Centers, the American Red Cross and the American Association of Blood Banks’ efforts to influence the FDA to re-evaluate their existing policy on MSM.
In March, the FDA held a workshop at the National Institutes of Health that revisited the scientific basis of what are termed as “deferral” policies, including the policy related to MSM in the era of sophisticated blood testing. The FDA heard testimony from the American Red Cross, the American Association of Blood Banks and America’s Blood Centers that said the MSM blood ban is unnecessary because blood-screening methods are more advanced and accurate today than when the ban was first implemented. The groups also recommended that MSM should be barred for only one year after having sex with another man and should be treated equally to other groups at risk for spreading STDs through donated blood.
Sharon Pavlovsky, America’s Blood Centers manager of government and public relations, said she does not think the FDA will change its policy in the immediate future. “It’s still under consideration and it’s still being discussed,” she said. “If it comes back up at a BPAC [Blood Products Advisory Committee] meeting, it will be more of a discussion.”
The ban was initiated in the mid-1980s when fear about the spread of HIV and AIDS was at an all-time high. In 1983, the FDA recommended donor-screening procedures to exclude individuals at increased risk for HIV.
The FDA’s BPAC, a committee of the Center for Biologics Evaluation and Research, which regulates the collection of blood and blood components used for transfusions, frequently discussed the exclusion of potential donors based on certain sexual histories and continues to recommend the deferral of MSM and their recent partners from donating blood.
“In the early ’80s, in the early years of the AIDS crisis, the blood banks were reluctant to defer MSM because it was perceived to be discriminatory,” said Stephen Whitburn, public affairs manager for American Red Cross Blood Services Southern California region. “Then there were a number of documented cases of HIV being transmitted through the blood supply. Since there wasn’t a test for HIV in the blood supply at that time, the Food and Drug Administration implemented the deferral for men who had sex with other men even once since 1977.”
The first official antibody test for HIV was developed and implemented in 1985.
Dr. David Oh, San Diego Blood Bank chief medical officer/medical director, said an HIV antibody-based test and nucleic acid testing (NAT) are performed on all donated blood. Aside from HIV, the blood is tested for hepatitis B, C, West Nile Virus, syphilis and Human T-cell Lymphotropic Virus.
“They are incredibly sensitive. I can’t say they are 100-percent accurate,” Oh said. “The major concern in terms of missing an infection would be during the window period. That would be the time between exposure to the infectious agent and the time it would be detectable with the test.”
Oh said the window period for an antibody-based test is around 22 days, while the window period for the more sensitive NAT is about 10 days.
“That’s the concern – somebody who before they donate has engaged in a high-risk activity with somebody who’s infected,” he said. “If the donation occurs within 10 days of that activity, then it’s very likely that the testing wouldn’t pick up on that.”
Dr. Louis Katz, former president of America’s Blood Centers, agreed testing is not 100-percent accurate but said it’s extremely rare for infected blood to reach a transfusion recipient.
The risk that a transfusion will transmit the hepatitis B virus is around one in 350,000, with hepatitis C at one in 1.5 million and HIV at one in 2 million, Katz said.
“That’s the reason for the behavioral deferrals. [It’s] because the tests are not perfect, and so that’s really where all the controversy comes from,” Katz said. “If the tests were 100 percent, there would be no reason to ask anybody anything, you would just draw the unit and just test it. But the idea is that those very rare occasions when the test is not yet positive, which is literally a few days after an infection, that’s where the need to continue screening for behaviors is felt to come from.”
FDA spokesperson Stephen King told the Washington Post in March that the agency would convene a meeting later this year of its BPAC to formally reconsider revising the policy.
Katz said the recommendation that MSM can donate blood if they have not had sexual relations with another man for a period of one year is not completely arbitrary – the same one-year recommendation applies to other risk groups such as intravenous drug users and men who have had sex with a sex worker.
“Those of us who advocated for a relaxation of the rules understand that most gay men aren’t going to quit having sex for a year at a time so they can go donate blood,” he said.
“… At this point, I don’t get the impression that the FDA is willing to accept any additional risk, even though whatever the additional risk is [is] far below what we accept all the time – getting in a car without buckling a seatbelt, walking across the street at night. They may be more dangerous things, but I think there’s a certain sensitivity about the safety of the blood supply that is making it hard for the FDA to find a way to say, ‘We can accept additional risk even if it’s a tiny risk.’”
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