The Food and Drug Administration said Tuesday it will recommend lifting the lifetime ban early next year, replacing it with a policy barring donations from men who have had sex with another man in the previous 12 months. The change would overturn a 31-year-old policy that many medical groups and gay activists say is no longer justified, given advances in HIV testing.
But activists questioned whether requiring a year of celibacy from gay men amounted to a significant policy shift.
"Some may believe this is a step forward, but in reality, requiring celibacy for a year is a de facto lifetime ban," Gay Men's Health Crisis, a New York-based non-profit that supports AIDS prevention and care, said after the announcement.
The blanket ban dates from the early years of the AIDS crisis and was intended to protect the blood supply from what was a then little-understood disease. But many medical groups, including the American Medical Association, say the policy is no longer supported by science. Australia, Japan, the U.K. and many other countries previously moved to a one-year period.
The agency will recommend the switch in draft guidelines early next year and move to finalize them after taking comments from the public, FDA officials told reporters. FDA Deputy Director Dr. Peter Marks declined to give a timeframe for completing the process but said, "we commit to working as quickly as possible on this issue."
Marks said some of the most compelling evidence for changing the policy comes from Australia, which put in place a one-year ban on donations over a decade ago. Recently published studies showed no change in the safety of the blood supply after making the switch.
Additionally, studies conducted by the U.S. government suggest gay and bisexual men are actually more likely to abide by donation guidelines under a 12-month prohibition period. All blood donors take a questionnaire about their health and sexual behaviour, but some gay men reportedly answer inaccurately to donate blood.
All U.S. blood donations are screened for HIV but the testing only detects the virus after it's been in the bloodstream about 10 days. Still, FDA officials said current research does not support reducing the donation ban below the one-year mark, though the agency may consider changing the timeframe.
"We're committed to re-evaluating the blood donor deferral policy in the future as new scientific evidence becomes available, but at this time we simply don't have the evidence," Marks said in a teleconference with reporters.
According to government figures, men who have had sex with other men represent about 2 per cent of the U.S. population, yet account for at least 62 per cent of all new HIV infections in the U.S.
The American Red Cross estimates the risk of getting an HIV-positive blood donation is one in 1.5 million. About 15.7 million blood donations are collected in the U.S. each year.
Despite the shift in approach from the federal government, gay advocates said Tuesday that requiring a year of abstinence from gay and bisexual men was unrealistic and not supported by science.
"This new policy cannot be justified in light of current scientific research and updated blood screening technology," said David Stacy of Human Rights Campaign, the largest U.S. gay rights group.
The U.S. blood banking system already bars donations from people who have had sex with a prostitute or an intravenous drug user in the past 12 months.
The FDA implemented the lifetime ban on donations from men who have sex with men in 1983, when health officials were first recognizing the risk of contracting AIDS via blood transfusions. Under the policy, blood donations are barred from any man who has had sex with another man at any time since 1977 — the start of the AIDS epidemic in the U.S.
The push for a new policy gained momentum in 2006, when the Red Cross, the American Association of Blood Banks, and America's Blood Centers called the ban "medically and scientifically unwarranted." Last year the American Medical Association voted to oppose the policy.
Patient groups that rely on a safe blood supply, including the National Hemophilia Foundation, have also voiced support for dropping the ban.
The switch in policy could increase the U.S. blood supply by 2 to 4 per cent by making 2 million additional men eligible to donate, according to researchers at UCLA's Williams Institute.Suggest a correction