Why the FDA requires 12 months' abstinence before gay men can donate blood

In the days after the Orlando shooting, we showed you lines of people trying to donate blood nationwide. But a huge portion of that group was turned away.

Seattle — Viral hepatitis, which is of particular concern in the gay male population, can take as long as three months after exposure to show up in a blood test.

Even so, the U.S. Food and Drug Administration’s current restrictions on blood donations from gay men require abstinence for 12 months.

KIRO 7 looked into the basis of this policy decision, tracing the steps from a blood donation through the testing process.

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The process of having blood banks adopt this policy has taken months, as many of them are still waiting on FDA approval of their new questionnaires. In the meantime, men who have had sex with other men would still be barred from donating blood entirely.

This has left many people in the LGBTQ community unable to donate blood in the wake of the Orlando shooting, which affected that population so deeply.

Restrictions on giving blood

In December of 2015, the FDA announced the lifetime ban on blood donations from men who have had sex with other men had been changed to a ban on men who have had sex with other men in the 12 months prior to the blood donation.

Rep. Adam Smith (D – Seattle) was among the lawmakers who asked the federal government to do research and gather data, to inform better policy.

“I think there are some built-in biases, against the LGBT community and not a full understanding of how the disease is transmitted,” Smith said.

Smith told KIRO 7 he still feels the 12-month deferral is too long.

Christopher Peguero, a city of Seattle employee, is married with children.

At the very moment when Peguero felt he needed to do something to help the people of Orlando, he couldn't participate.
How a blood donation is screened

Each donation of blood goes through 14 tests, according to Mark Destree, the donor testing director at Bloodworks Northwest.

Destree showed KIRO 7 that each blood donation is run through machines to separate blood components for the recipient. At the same time, that donor’s blood is also put into four small vials to be run through those 14 tests.

Those tests include two for detecting HIV. There have been five generations of HIV tests, including a new version that is about to be used starting the final week of June.

One of the HIV tests looks for antibodies, which can turn the test positive for HIV within three to four weeks after the donor contracted it. The other test is a nucleic acid test, or a NAT test, which looks for the genetic material of the HIV virus. The NAT test turns positive within 12 to 14 days after the donor is exposed to the disease.
Viral hepatitis however, takes longer to show up.

Dr. James AuBuchon, the president and CEO of Bloodworks Northwest, said that for hepatitis B or hepatitis C,

“It could be anywhere from 60 to 90 days, or perhaps even longer.”

When KIRO 7 asked why the FDA would then require 12 months of abstinence rather than three months, AuBuchon said, “The FDA is by nature, very cautious. They too, appreciate the safety of the blood supply that we have been able to achieve. They do not want to take steps that endanger the blood supply.”

AuBuchon said he believes the FDA may eventually shorten this deferral period even further, when more data becomes available.

Why men who have had sex with men are considered to be higher risk donors

"This deferral has nothing to do with one's sexual orientation, and has only to do with exposure to a virus that has devastating consequences in a recipient," AuBuchon said.

The most recent data from the Centers for Disease Control show that in 2013, 81 percent of the U.S. population with an HIV positive diagnosis is among gay and bisexual men ages 13 and above.

That population also made up 65 percent of new diagnoses in 2013.

There is a higher risk of getting HIV if one has sexual contact with people who are disproportionately burdened with the disease.

In addition, the act of anal sex is also more likely to transmit diseases than other forms of sex.

The screening questionnaire for all blood donors seeks out risky behaviors, which include male-and-male sexual contact, sharing of needles, sex with a prostitute, and travels to places where certain diseases are prevalent.

For example, those who have been to countries where there was an outbreak of the Zika virus are asked to defer giving blood for four weeks.

While Peguero’s sexual behavior may be considered by the government to be higher risk, he said other high-risk behaviors do not immediately disqualify those donors.

“If a woman were to have multiple partners, unprotected, she would be eligible to give. And they would still screen the woman and use the technology that’s available,” Peguero said.

The chances of contracting HIV from a blood transfusion

AuBuchon said approximately one person per decade in the U.S. has contracted HIV through a blood transfusion. That comes out to about 1 in 150 million.

“It happens when someone who has recently been exposed to the virus, then donates blood within a few days, less than two weeks, after their exposure,” AuBuchon said.

This low rate has been a result of using a group of donors that has a low probability of having HIV in the first place.

The FDA has been cautious, because any change in the questions or tests can be a concern. The agency recently published a study, showing that if there were no deferral criteria, the risk of HIV transmission would at least quadruple.

Deferral criteria include not only men who have had sex with other men, but also anyone who has traveled to places where certain diseases are prevalent, and anyone who has had a piercing.

Australia adopted a similar 12-month deferral for men who have had sex with other men. Studies have shown that risk of HIV transfusion has not increased after this policy was put into place.

However, Australia adds a sworn statement to the donor questionnaire, stating that lying on any of the answers could result in fines or imprisonment. There is no such sworn statement in the U.S.