Kinsley urges end to FDA policy on gay men donating blood

North Carolina’s top health official, joined by public health officials from eight other states and the District of Columbia, calls on the Food and Drug Administration to lift a three-month waiting period for gay men sexually active to donate blood.

On Thursday, Department of Health and Human Services Secretary Kody Kinsley sent a letter to FDA Commissioner Robert Califf asking the agency to remove a blood donor deferral policy that prevents men from who have had sex with another man in the past 90 days to donate blood. In addition to Kinsley and NC Director of Health Dr. Elizabeth Tilson, the letter was signed by health officials from California, Connecticut, Kentucky, Massachusetts, Minnesota, Nevada, New York, Oregon and Washington, DC.

Until a few years ago, gay and bisexual men were subject to a lifetime ban on blood donation which was put in place in 1983, at the start of the HIV/AIDS epidemic. In December 2015, the FDA lifted the ban, replacing it with a policy allowing gay and bisexual men to donate blood, but only if they hadn’t been sexually active for 12 months. The deferral period was shortened to 90 days in April 2020, shortly after the start of the coronavirus pandemic, when there was a substantial drop in the nationwide blood supply.

In the nearly 40 years since the ban was put in place, “there has been incredible progress both in the development of highly sensitive HIV diagnostic platforms and in our scientific understanding of the transmission of HIV,” Kinsley wrote in the letter.

Now all donated blood must be screened for HIV through nucleic acid testing, which can detect the virus within two weeks of infection, Kinsley wrote. This means that the risk of HIV-infected blood entering the blood supply “is negligible”.

A policy that discriminates and promotes stigmatization

Kinsley, who is the first gay person to serve as cabinet secretary in North Carolina history, said FDA policy was personal to him.

“Personally, it has been incredibly disappointing not being able to join my colleagues and loved ones in donating blood, seeing how the COVID-19 pandemic has had a significant impact on the national blood shortage, putting patient care and safety at risk,” Kinsley wrote in a Twitter post. .

Kinsey said there was no credible evidence showing the 90-day deferral period is effective in protecting the blood supply, meaning there is “no clinical reason” for the FDA keeps the “discriminatory” policy in place.

“The continuation of this policy only serves to further stigmatize an already marginalized demographic and unnecessarily restrict the eligible donor population during a time of extraordinary need in the United States,” Kinsley wrote.

Equality NC, the largest LGBTQ advocacy group in North Carolina, celebrated Kinsley’s call for an end to the policy, which the organization called “obsolete and scientifically useless”.

In an email, Kendra Johnson, the organization’s executive director, said she was pleased to see state health officials take a stand against FDA policy, adding that people “who occupy positions of power within systems are essential to advancing change”.

“Banning gay and bisexual men from donating stigmatizes a whole class of people by connecting them to HIV, a disease that potentially affects everyone,” Johnson said.

Of the several years it took the FDA to first lift its ban on donating blood to gay and bisexual men and then shorten the debarment period, Johnson said: “Unfortunately, bigotry and misinformation can take decades to overcome.”

Nationwide blood shortage exacerbated by COVID-19

Kinsley’s request to the FDA chief comes amid a nationwide blood shortage.

In January, the American Red Cross declared its first ever blood crisis. Blood donations have fallen by 10% since the start of the pandemic, the organization said, leading the Red Cross to limit the amount of blood it distributes to hospitals. Some hospitals, on certain days, lacked up to 25% of the blood products they requested.

At the time, the Red Cross said the drop in donations was exacerbated by fears about the highly transmissible variant of omicron. Low blood donor turnout had already begun in light of the spread of the delta variant in August.

FDA restrictions on when gay and bisexual men can donate blood only amplify the ongoing blood shortage, Kinsley and other health officials wrote.

The Red Cross says eligibility to donate blood should not be determined by sexual orientation and acknowledges “the harm this policy has caused many members of the LGBTQ+ community“. The removal of the postponement policy also has the support of the American Medical Association.

The Red Cross says it is helping assess other criteria that could be used to identify eligible donors, but in the meantime it cannot, as a regulated organization, ‘unilaterally enact changes to’ the policy. exclusion for gay and bisexual men.

Instead of barring all sexually active gay and bisexual men from donating blood, the FDA should supplement nucleic acid testing “with an individual risk-based assessment based on our sound knowledge of HIV transmission,” a writes Kinsley.

Assessing individual behavior means screening for “engagement in risky behaviors, such as unprotected sex,” according to the Human Rights Campaign.

The FDA is currently working on a study to determine whether individual risk assessment could replace a time-based deferment policy as an effective way to protect the blood supply. In February, the agency told WCNC that it did not have a specific timeline for the study’s completion.

The study’s organizers said they expect to recruit 2,000 gay and bisexual men from across the country who want to donate blood and who have had sex with another man in the past three months.

For more on North Carolina government and politics, listen to the Under the Dome political podcast from The News & Observer and NC Insider. You can find it at https://campsite.bio/underthedome or wherever you get your podcasts.

This story was originally published March 12, 2022 1:38 p.m.

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Avi Bajpai is a state political reporter for The News & Observer and The Herald-Sun. He previously covered breaking news and public safety. Contact him at [email protected] or (919) 346-4817.

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