The FDA’s latest guidance imposes a one-year delay on donation.
BY JOHN TOZZI
NEW YORK — In the aftermath of the shooting at a gay nightclub in Orlando that killed 49 people and injured 53, blood centers were overwhelmed with people who wanted to donate.
Gay men, however, weren’t all allowed to do so – a policy harking back to the height of the AIDS crisis, and one that was quickly derided as discriminatory and an insult to a community under attack.
Until recently, men who had had sex with men at any point in their lives were prohibited from giving blood in the U.S., the rationale being that they were more likely to be HIV-positive.
Federal authorities have begun to loosen those restrictions, which were put in place in 1985, following years of opposition by gay rights advocates and improvements in screening technology.
In December, the Food and Drug Administration published new, voluntary guidelines for blood centers that would permit donations by gay or bisexual men who have abstained from sex for one year.
Old rule assailed
Kelsey Louie, chief executive of Gay Men’s Health Crisis (GMHC), called the new FDA guidelines “a baby step in the right direction.”
GMHC, founded in the first days of the AIDS crisis, wants the process to evaluate donor eligibility based on individual risk behavior, rather than their sexual orientation.
Advocates have repeatedly assailed the old FDA rule as a double standard, while medical professionals defended it as prudent.
Scott Schoettes, senior attorney and HIV project director at Lambda Legal, said a rigorous approach based on donor behavior, rather than identity, wouldn’t only reduce discrimination but could improve safety.
“Someone could go out and have sex with eight different people in a span of a month. As long as that was heterosexual sex, that would not ban them from giving blood,” Schoettes said. “There’s day-to-day discrimination going on against gay and bisexual men on this issue.”
The time gap
The concern about HIV in the blood supply focuses on the window between infection and when it may be detectable. Though much longer when the initial FDA rule was put in place, that gap is only nine to 11 days with the latest tests.
While all donated blood is screened, if a person who contracted HIV were to donate during that window, it might not be detected.
Even before the Orlando massacre, GMHC had been planning to hold a news conference in New York on June 14, World Blood Donor Day, to draw attention to the issue.
“This stigma perpetuates the very, very old notion that HIV is a gay disease,” Louie said. “They are taking a group of people – gay and bisexual men – and saying that only they have to have one year of celibacy.”
The FDA’s latest guidance does include other groups subject to the one-year delay on donation, regardless of sexual orientation. These include people who have been diagnosed with, or treated for, syphilis or gonorrhea, and those who got tattoos from an unregulated tattoo parlor.
Individuals engaged in sex work or injection drug use are subject to a lifetime ban.
The HIV epidemic continues to disproportionately affect gay and bisexual men, especially gay men of color. Men who have sex with men represent just 4 percent of the male population but account for 63 percent of new HIV infections and 54 percent of those currently living with HIV, according to data from the Centers for Disease Control.
‘Long time coming’
The FDA’s one-year guideline is “extremely precautionary and, in that sense, appropriate,” said Louis M. Katz, chief medical officer of America’s Blood Centers, a network of community blood centers, including the one in Orlando that put out the call for donations after Sunday’s attack.
Katz, an infectious disease specialist who has treated HIV patients, said the deferment period could probably be shortened, but even a six month or 30-day waiting period may be seen as discriminatory.
“We look at moving from permanent to one-year as a first step,” Katz said. “I think the next step’s going to be a long time coming.”
Data from Australia showed that a one-year deferment period, as opposed to a total ban, didn’t increase the number of HIV-positive donations.
No comparable evidence exists for an approach to blood screening based on individual risk assessment, according to the FDA.
“A time-based deferral for (men who have sex with men) since last sexual encounter is the one deferral policy that has been demonstrated to be effective in a setting with similar HIV epidemiology to the U.S.,” the agency wrote in its December guidelines.
Blood centers are still in the process of putting the new FDA guidelines in place, according to Katz. A spokeswoman for the American Red Cross said it is “working to change its processes and computer systems in order to implement this change.”
Both organizations supported the policy. Gay rights advocates point to policies in Argentina and Italy that take risk-based approaches.
Katz said the data on how those approaches affect the risk of infections aren’t clear-cut. Studies to detect small changes in what’s already a very small risk are difficult to perform.