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FDA could lift archaic blood donation restrictions for gay and bi men with groundbreaking new study

Lily Wakefield December 16, 2020
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A phlebotomist takes blood donation samples

The pilot study will assess whether individual questionairres could replace discriminatory blood donation restrictions for gay and bisexual men. (Getty/ ALEX EDELMAN/AFP)

The US Food and Drug Administration (FDA) has launched a study which could finally remove discriminatory blood donation restrictions for gay and bisexual men.

Gay and bisexual men were banned for life from donating blood in the US at the height of the AIDS epidemic in 1985, and for 30 years afterwards.

In 2015, the FDA amended its rules, allowing queer men who had been celibate for 12 months to give blood.

In April this year, the FDA further relaxed these restrictions in response to blood shortages caused by the pandemic, meaning queer men must now abstain from sex for three months instead of 12 in order to be eligible.

But now a pilot study, named Assessing Donor Variability And New Concepts in Eligibility (ADVANCE), has been funded through an FDA contract and could do away with the blanket restrictions altogether.

The ADVANCE study is being carried out by three of the largest blood centres in the US – Vitalant, OneBlood and the American Red Cross – and will work with LGBT+ community centres across the country.

According to the study’s website: “The purpose of the study is to determine whether a different donor deferral can be used at blood centres nationwide while maintaining the safety of the blood supply.

“For this to be possible, a change would need to be made to the donor history questionnaire, and this study is the first step in assessing the safety of a change.”

An individual blood donation questionnaire “to assess risk factors that could indicate possible infection with a transfusion transmissible infection, including HIV” could then potentially replace blanket restrictions for gay and bisexual men.

LGBT+ centres in the US will be assisting the blood centres in enrolling 2,000 gay and bisexual men for the research.

The results are expected late next year and will be submitted to the FDA, which will then decide the next steps.

The FDA ADVANCE study has been revealed in the same week that the UK announced a “landmark change” to its blood donation rules, no longer requiring gay and bisexual men to abstain from sex.

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