FDA and Red Cross Collaborate to Improve Blood Donation Policies

Kody Kinsley was so committed to increasing the blood supply in the United States when he was a high school student that he participated in and helped organize blood drives. However, Kinsley, who is now the secretary of the North Carolina Department of Health and Human Services, will be able to donate blood for the first time as an adult on Monday.

“I’m excited that I’ll get to play my small part,” he said. False. Kinsley is a gay man. Food and Drug Administration (FDA) guidance has discouraged most gay men from donating blood for nearly 40 years, despite the fact that donating blood from an individual who is not HIV positive poses no risk to the blood supply.

The Red Cross, which supplies over 40% of the blood and blood components in the United States, will begin using a risk-based individual evaluation to evaluate eligibility to donate blood on Monday that does not discriminate based on s*xual orientation. This shift is “massive,” Kinsley remarked. Men like him were looked down upon by the old advice.

It’s really not people that are at risk,” he said. “It’s about certain behaviors.” The state of North Carolina experienced a severe shortage of blood in January 2022, prompting Governor Roy Cooper to make a donation and staff to encourage Lieutenant Governor Kinsley to do the same.

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“But I had in that moment a conversation I’ve had many times in my life, which is explain to people why I can’t take part in this community service to others because of a stigma-based policy that the FDA has maintained for 40 years,” Kinsley said. When the US surgeon general first estimated that 70% of AIDS patients were gay or bis*xual men, the policy was enacted to account for that fact.

Screening for HIV antibodies in the blood was possible at the time, albeit the technique was far from foolproof and did not detect all HIV infections. Blood banks have improved their ability to screen homos*xual and bis*xual men for HIV over the years, but the FDA has maintained the same approach. It did not exclude people based on their risky behavior, but rather on their identities.

Men who were gay or bis*xual who had intercourse only with other men were initially disqualified from donating blood. The restriction has been relaxed a little over the years, but most gay men are still unable to donate. On May 11th, the FDA updated their recommendations to reflect the latest scientific findings. A person’s risk level is determined not by their personality but by their actions.

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Even though some homos*xual men will still be left out, the FDA is calling the modification a “significant milestone for the agency and the LGBTQI+ community.” According to Red Cross senior biomedical communications specialist Rodney Wilson, “the Red Cross believes this is one of the most significant changes in blood banking history.”

“It ensures the safety of the blood supply and makes blood donation more accessible to more people.” According to the Red Cross, the new recommendations will make everyone feel at home. “We know that, for many decades, the FDA’s policies have obviously caused a lot of hurt to the LGBTQ community.

And we recognize that, and we regret that that has been the case. But what we want people to know is that everyone is welcome in our mission, whether you can give blood or not,” Wilson said.

Change Coming to More Blood Banks

There had been little resistance to the more inclusive donor policies that the United Kingdom and Canada had adopted. The Red Cross isn’t the only blood bank in the United States to switch to the new system. Each blood center can determine for themselves if and when they wish to make the change.

According to Dr. Jed Gorlin, chief medical officer of America’s Blood facilities, some smaller blood facilities were able to make the adjustment rapidly. His organization represents freestanding community blood banks around the country. He claimed that it took most facilities several months to upgrade their IT infrastructure and conduct staff training.

“It takes some sensitivity training to make sure it’s rolled out in a sensitive and appropriate fashion,” Gorlin said. Most people will fill out the risk assessment electronically, “but if the computer goes down, you need staff to be ready to ask questions about anal s*x without batting an eyelash,” he said.

According to Gorlin, the new risk assessment will be used by the vast majority of facilities by the end of 2016. “I think this is a very reasonable and prudent step going forward,” he said.

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According to Susan Forbes, senior vice president of corporate communications and public relations for OneBlood, an Orlando-based nonprofit that distributes blood to hundreds of hospitals, primarily in the South, the more inclusive risk assessment will be implemented on August 21.

According to Forbes, this shift is a positive one. She recalled the pain that gay men felt following the Pulse gay nightclub shooting in 2016. Blood donations were in high demand after 49 people were killed and 53 were injured. It was forbidden for gay males to volunteer. “It was hard to see people show up who wanted to donate and were unable to because of the previous policy,” Forbes said.

“Now, fast-forward seven years later, to have everybody answer the same set of questions to determine eligibility to donate blood is really a huge step in the right direction.” On September 18, the New York Blood Center announced that it will begin accepting donations from anyone who passed the new risk assessment.

The group claimed that it has “strongly” pushed for decades to have the FDA revise its stance on males who have s*x with other men based on scientific evidence. “We applaud the FDA’s final guidance that establishes a blood donor screening process based on Individual Donor Assessment, not s*xual or gender identity,” the New York Blood Center said in an email to CNN on Friday.

Critics Say it’s not Enough

Studies reveal that just about 3% of Americans actually donate blood, and that supplies are often low in the summer and around the holidays. According to Jason Cianciotto, VP of communications and policy at GMHC, the first HIV/AIDS service organization in the world, the FDA’s new advice falls short of what is needed to increase the number of donors in the United States.

There are a signficant proportion of LGBT people, particularly gay and bis*xual men who have s*x with men, who still will be excluded from donating blood, and they shouldn’t be,” he said. “This change still perpetuates the stigma and harm that the FDA policy has fomented for so many years.”

According to the new rules, anyone who has had a new s*xual partner, many partners in the past three months, or anal s*x within that time frame will be exempt from the waiting period. According to the FDA, using the three-month baseline decreases the likelihood of receiving a gift from someone who has just contracted HIV but may not know it.

FDA and Red Cross Collaborate to Improve Blood Donation Policies

Cianciotto said that the guidelines failed to account for the fact that those who used condoms in certain settings would likely be safe. Pre- and post-exposure prophylaxis (PrEP and PEP, respectively) medication users are also exempt from the policy’s immediate implementation.

The FDA acknowledges the medications’ efficacy and safety, but worries that they could falsely render an HIV test negative. According to the revised recommendations, individuals should wait three months after their final PrEP tablet or two years after a long-acting PrEP injectable before becoming pregnant. According to Cianciotto, the government’s other signals that urge the use of PrEP are being muddled by this advise.

“It’s perfectly reasonable for an individual to think, ‘OK, well, I’m taking PrEP, and I’m told that that makes it nearly impossible for me to contract HIV, and I’ve been taking it as has been prescribed, and I’ve been going to my doctor’s appointment, and that means I’m getting HIV tested at least four times a year, as well as testing for other STIs. So I know more about my health than many other people who aren’t taking PrEP, and now I can finally donate,’ and they’re going to get there, and they’re going to find out they can’t,” Cianciotto said.

When Cianciotto went to give blood for the first time in high school, he was mortified to learn that he was unable to donate since he had s*xual relations with a male in the previous 30 days. “If there was a camera watching right then, my jaw would have dropped,” he said.

“It reinforced that harmful stereotype that I had been told in my church and by my parents, that if I chose to be gay, I would be alone all my life, and eventually I would get AIDS and die. That was the message that the FDA was reinforcing to me at a very vulnerable time in my life at a young age.”

In an interview, Cianciotto noted that he now had a gay son, age 17, and that if the teen were to attend a blood drive like the one he had attended, “he could very easily be excluded.” “We raised him in a no-shame, nonstigmatized household, yet here he may be denied donating,” Cianciotto said. The FDA has stated that it will keep reviewing this regulation.

While the Red Cross welcomes the new FDA guidance, it acknowledges that the document is “not perfect.” Wilson argued that more could be done to broaden participation in blood donation. The FDA and the Red Cross will collaborate to learn more about PrEP and PEP users in particular. “Hopefully, in time, we’ll be able to eliminate that deferral, as well,” Wilson said.

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Wilson believes the existing strategy will result in increased charitable giving. On Monday, he said, several gay men had already signed up to become donors. Kinsley is rooting for himself to break the ice.

“To have someone excluded based off of a policy rooted in stigma from 40 years ago and not updated is, frankly, it hurts the community, and it lowers people’s confidence in the overall process in our commitment to one another,” Kinsley said. “I hope that gay men that are eligible to donate come forward for this.”

“I hope that we can use this moment to really educate the broad base of people who can donate about how important it is,” he added. “There’s no substitute for blood.”

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