On Dec. 21, the U.S. Food and Drug Administration (FDA) announced updated guidelines for blood donation, changing a lifelong ban on donations from gay men and other men who have sex with men (MSM) to a 12-month blood donor deferral since their last sexual contact.
"In reviewing our policies to help reduce the risk of HIV transmission through blood products, we rigorously examined several alternative options, including individual risk assessment," said Peter Marks, M.D., Ph.D., deputy director of the FDA's Center for Biologics Evaluation and Research in a press release.
He added: "Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population. We will continue to actively conduct research in this area and further revise our policies as new data emerge."
The FDA press release and fact sheet on the change did not mention the use of pre-exposure prophylaxis (PrEP) or HIV treatment in blocking HIV transmission. To date, there have been no documented cases of HIV acquisition in people taking the approved dosage of PrEP, nor of HIV transmission from people with HIV whose viral load is undetectable.
The new policy brings the U.S. in line with other countries, including Australia, France and the United Kingdom, which also have a 12-month deferral policy for MSM. However, 17 countries, including Portugal, Russia and South Africa, have no deferrals.
"Gay-rights advocates and many medical groups have been urging the FDA to lift the ban for years," KPLU reports. "They argue the policy is discriminatory because it singles out gay and bisexual men and that it is unnecessary because blood donors can be screened for HIV." One year ago, many criticized the proposed change to a 12-month deferral, saying it continued to stigmatize gay and bisexual men.
Online reaction from HIV advocates, gay men and others was swift.
As reported by MashableAsia, Marks said the FDA considered several other options before settling on the yearlong deferral period, even considering a complete reversal of the deferral. Although Marks cited concerns that the virus is undetectable via screening tests for about nine days after a person is infected, he did not explain why that would require a full year of abstinence to eliminate a false negative screening result.
Instead, according to MashableAsia, "The FDA based its decision to adopt a 12-month deferral on studies conducted in Australia, which has the same deferral period for men who have sex with other men. These studies found that switching from a total ban to a 12-month deferral period did not reduce the safety of the blood supply."
The elimination of any deferral period was "predicted to lead to a four-fold increase in HIV transmission through the blood supply," Marks said, adding that "an increase of this magnitude is not acceptable."
Medical and legal organizations that work with LGBT communities and people with HIV disagreed.
In a statement from the Gay and Lesbian Medical Association (GLMA), president Jesse Joad, M.D., M.S., and executive director Hector Vargas, J.D. said, "A one-year deferral period on blood donation for MSM does not reflect the best science on detecting HIV in the blood supply and continues to perpetuate stigma against gay and bisexual men."
"Given all we now know about HIV and the activities that do and do not present a significant risk of HIV transmission, there is simply no reason that a nondiscriminatory policy ensuring the continued safety of the blood supply could not be put in place today," said Scott Schoettes, Lambda Legal Senior Attorney and HIV Project Director, in a statement.
Many gay men and allies took to social media to express their displeasure with the FDA's decision.
Artist Jordan Eagles, who developed his Blood Eagles sculpture using, among other components, the blood of nine gay men as a comment on blood donation from non-celibate MSM, spoke out on Facebook:
Progress for heterosexual identifying men who might have messed around with another man in the past, but for gay and...Posted by Jordan Eagles on Monday, December 21, 2015
Some postings were quite blunt:
Since the introduction of a donor history questionnaire and enhanced blood testing, HIV transmission rates from blood transfusion has been reduced from 1 in 2,500 to 1 in 1.47 million, according to the FDA.
Starting in 1992, the FDA banned blood donations from MSM. Despite faster and more accurate HIV screening tests, the deferral policy continued. In 2014, the FDA began the process of updating their deferral policy.
A 2010 study from the Williams Institute at UCLA School of Law found that lifting the MSM ban entirely could increase the total annual U.S. blood supply by 0.6% to 1.4%. They explained that "while these increases in the blood supply may seem modest, they would occur in an environment where blood supply shortages are common."
The guidelines also recommend lifting the indefinite deferral on those who have hemophilia or related clotting disorders, and those who have sex with someone who uses clotting factor concentrates.