In the wake of the Orlando shootings, local hospitals urgently needed blood donations, and the local community responded in force. But many of those most interested in donating — sexually active gay and bisexual men — were startled to learn they were not allowed to donate blood.
The Food and Drug Administration, which regulates the U.S. blood supply, does not accept blood from male donors who have had sex with a man in the previous 12 months. This has led to an ongoing debate about whether this restriction is supported by scientific evidence or, as some have argued, related to lingering stigma and discrimination related to HIV/AIDS.
Is the 12-month deferral period scientifically warranted for all men who have sex with men? When it comes to monitoring the nation's blood supply, caution may take precedence over science.
Controversy linking HIV/AIDS with blood donation is nothing new. The first documented case of HIV infection resulting from blood transfusion occurred in 1982. The following year, the FDA implemented a lifetime ban on accepting blood donations from men who have sex with men. In 1985, testing technology advanced — a commercial HIV antibody test became available to screen donated blood — meaning that for the first time HIV antibodies could be identified in donor blood to significantly reduce the risk of transmitting HIV to recipients.
The FDA, however, maintained the lifetime ban, despite mounting evidence to suggest that the policy should be changed. In 2006, a trio of organizations with vested interest in the blood supply called the lifetime ban “medically and scientifically unwarranted.” In a joint statement at the time, the American Red Cross, America's Blood Centers and the AABB (formerly known as the American Association of Blood Banks) urged the FDA to modify blood donation policies so they are “comparable with criteria for other groups at increased risk of sexual transmission of transfusion transmitted infections.”
In other words, they called for a policy in keeping with the restrictions placed on other groups engaging in high-risk sexual practices, such as individuals who have had sex with an HIV-positive individual, a group that had a 12-month deferral period. The joint statement argued that for both of these groups, available screening would accurately identify bloodborne diseases such as HIV.
Although science had shrunk the risk of transmitting HIV substantially, the FDA let the lifetime ban stand for another nine years. When the FDA relaxed the ban in 2015, it put into place the present restriction that calls for 12 months of abstaining from sexual activity among men who have sex with men. This shift was in response to substantial research documenting the risk of transmitting HIV through blood donation since the risk of HIV infection through blood transfusion had almost been eliminated, with the odds at about 1 in 1 million to 1.5 million per transfused unit. Ultimately, while the FDA acknowledges that even though the risk of transmitting HIV through blood transmission is highly unlikely, it argues that these precautionary steps are still needed to protect the nation's blood supply.
The new policy has been viewed as an improvement because it brings the requirements for blood donation by gay and bisexual men in better alignment with those for other men and women at increased risk for HIV infection. For example, there is also a 12-month deferral in place for those who report having sex with individuals who engage in sex work or use non-prescription injection drugs.
When Peter Marks, deputy director of the FDA's Center for Biologics Evaluation and Research, announced the present restriction in December, he said, “Relying on sound scientific evidence, we've taken great care to ensure the revised policy continues to protect our blood supply.” His statement reflects the FDA's desire to maintain a conservative approach despite substantial technological advances that the FDA itself has approved. For example, around the same time ban was relaxed, the FDA approved the intercept blood system — technology that can almost completely disable any HIV virus in blood samples — making the U.S. blood supply safer than ever before.
As it turns out, technology is used to screen blood, but so are words. Potential male donors must also respond to a series of questions that includes whether they had sex with another man in the last 12 months. If the answer is “yes,” they are excluded from donating blood. The self-reporting relies on honesty, and there is no way to know whether someone is telling the truth. Substantial research has documented the fact that self-reported responses often don't reflect what actually happened — especially when people are asked about what some perceive as highly stigmatized behaviors such as having sex with other men, injection drug use or engaging in sex work. Despite widespread recognition that self-reported data is flawed, it still is an integral part of the process that screens, and excludes, individuals from donating blood.
Going forward, steps need to be taken to ensure that blood donation policies are responsive to the best available evidence. Emphasizing real-time review of evidence as part of an ongoing review process would help blood donation policy keep up with the science.
Sarah MacCarthy is an associate policy analyst at the nonprofit, nonpartisan RAND Corporation and a professor at the Pardee RAND Graduate School.
This commentary originally appeared on U.S. News & World Report on July 1, 2016. Commentary gives RAND researchers a platform to convey insights based on their professional expertise and often on their peer-reviewed research and analysis.
