FDA eases restrictions on gay blood donation, but not really
The FDA announced today that they have issued final guidance on blood donation by MSM (Men who have sex with Men).
“Today [December 21], the U.S. Food and Drug Administration issued final guidance outlining updated blood donor deferral recommendations to reflect the most current scientific evidence and to help ensure continued safety of the blood supply by reducing the risk of human immunodeficiency virus (HIV) transmission by blood and blood products.
“’The FDA’s responsibility is to maintain a high level of blood product safety for people whose lives depend on it,’ said the FDA’s Acting Commissioner Stephen Ostroff, M.D. ‘We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply.’”
“As part of today’s finalized blood donor deferral guidance, the FDA is changing its recommendation that men who have sex with men (MSM) be indefinitely deferred – a policy that has been in place for approximately 30 years – to 12 months since the last sexual contact with another man.”
As can be seen, it’s okay to donate blood if you are gay or MSM, as long as you haven’t sexually acted on that orientation for at least a year. In other words, most gay men are still excluded from donating blood.
Just over a year ago, the FDA, according to Towleroad.com, had announced it “has no further plans to discuss changing its longstanding ban on gay men donating blood.
Reaction from LGBT advocates was swift, expressing frustration over the government’s refusal to update its 30-year-old policy, put in place at the beginning of the AIDS epidemic. Buzzfeed reported in December 2014: “The announcement frustrated LGBT advocates who said the unilateral ban on blood donations unfairly stigmatizes gay men. Now advocates are looking to bypass the FDA advisory panel by pressuring upper tiers of the Obama Administration.”
And apparently, that pressure began to be effective. In May, NBC news announced, “The Food and Drug Administration has formally proposed letting gay and bisexual men donate blood, so long as they've abstained from sex for a year.
“The recommendation changes the current guidance, which is that any man who has ever had sex with another man in his entire life should never be able to donate blood. It's a policy that has enraged gay rights groups and that is virtually impossible to enforce.
"’No transmissions of HIV, hepatitis B virus, or hepatitis C virus have been documented through U.S.-licensed plasma derived products in the past two decades,’ the FDA says in its recommendation.”
Now, in December, the FDA made its formal announcement. According to the Associated Press, “Gay rights activists said the new policy is a ‘step in the right direction,’ but falls short.
"’It continues to stigmatize gay and bisexual men,’ said David Stacy, of the Human Rights Campaign, the largest U.S. gay rights group. ‘It simply cannot be justified in light of current scientific research and updated blood screening technology.’"
The AP report continues, “All U.S. blood donations are screened for HIV, the virus that causes AIDS. But there is a roughly 10-day window between initial infection and when the virus can be detected in the bloodstream. The American Red Cross estimates the risk of getting an HIV-positive blood donation is 1 in 1.5 million for U.S. patients. About 15.7 million blood donations are collected in the U.S. each year.
“In 2006 the Red Cross, the American Association of Blood Banks, and America's Blood Centers called the ban ‘medically and scientifically unwarranted.’"
The FDA made Q&A about the change available on its website. Important points made by the agency include:
“The FDA has revisited its donor deferral recommendations to reduce the risk of transmitting human immunodeficiency virus (HIV) several times over the past 10 years. These reviews have been undertaken publicly at meetings of the FDA Blood Products Advisory Committee and the HHS Advisory Committee for Blood Safety and Availability (ACBSA). In 2010, the ACBSA found that the deferral policy for men who have had sex with other men (MSM) was suboptimal and it recommended that studies be conducted to better inform a potential policy change.
“Based on the evidence now available, FDA has changed its recommendation from the indefinite deferral for MSM to a 12 month blood donor deferral since last MSM contact.”
“FDA recommends that blood establishments defer potential donors as follows:
- Defer indefinitely an individual who has ever had a positive test for HIV.
- Defer indefinitely an individual who has ever exchanged sex for money or drugs.
- Defer indefinitely an individual who has ever engaged in injection drug use that was not prescribed.
- Defer for 12 months from the most recent contact any individual who has a history of sex with a person who: has ever had a positive test for HIV, ever exchanged sex for money or drugs, or ever engaged in non-prescription injection drug use.
- Defer for 12 months from the most recent transfusion any individual who has a history of receiving a transfusion of Whole Blood or blood components donated by another person (allogeneic transfusion).
- Defer for 12 months from the most recent exposure any individual who has a history of through-the-skin contact with the blood of another individual, such as a needle stick or blood contact with an open wound or mucous membrane.
- Defer for 12 months from the most recent tattoo, ear or body piercing. However, individuals who have undergone tattooing within 12 months of donation are eligible to donate if the tattoo was applied by a state regulated entity with sterile needles and non-reused ink. Individuals who have undergone ear or body piercing within 12 months of donation are eligible to donate if the piercing was done using single-use equipment.
- Defer for 12 months after completion of treatment any individual with a history of syphilis or gonorrhea or with a history of diagnosis or treatment for syphilis or gonorrhea in the past 12 months.
- Defer for 12 months from the most recent contact a man who has had sex with another man during the past 12 months.
- Defer for 12 months from the most recent contact a female who has had sex during the past 12 months with a man who has had sex with another man in the past 12 months.”
According to the AP, “While the one-year-ban has been criticized by activists it matches policies in other countries, including Australia, Japan and the U.K.”
Most advocates think the exposure window is much smaller than one year. According to the San Francisco AIDS Foundation’s website’s information on the HIV window period, “There's a period of time after a person is infected during which they won't test positive. This is called the ‘HIV window period.’
“The window period can be from 9 days to 3 months, depending on the person's body and on the HIV test that's used. During that time, you can test HIV negative even though you're HIV positive. You can still catch HIV from someone who is in the window period. In fact, there is evidence that a person in the window period is more likely to pass the virus on.”
So, despite much scientific evidence that a one year ban of men having sex with men is too long, the FDA continues to effectively ban blood donation by gay men, and other MSM.
The Gayly – December 21, 2015 @ 11:50 a.m.