The FDA’s New ‘Don’t Say Gay’ Policy for Blood Donation

For decades now, gay men have been banned from donating blood. In 2015, what had been a lifetime ban was relaxed, so that gay men can become donors if they abstain from sex for at least a year. This was later shortened to three months. Last week, the US Food and Drug Administration (FDA) laid out a new, more comprehensive plan: Gay and bisexual people will be allowed to donate as long as they have not recently engaged in anal sex with new or multiple partners. Assistant Secretary of Health Rachel Levin, the first transgender official confirmed by the United States Senate, issued a statement applauding the proposal “Payment of property rights. She treats everyone equally,” she said, “regardless of gender and sexual orientation.”

As a member of the small but honorable Association of Homosexual Pathologists, I have been more affected by these proposed policy changes than most Americans. I am subject to restrictions on donating blood, and I am also responsible for monitoring complications that can arise from transfusions of infected blood. I am very concerned about HIV, given that MSM are more likely to contract the virus than people of other groups. But it wasn’t bloodborne disease that I feared most as a doctor. Common bacteria cause far more transfusion-borne infections in the United States than any virus, and most of these cause severe or fatal illness. The virus risk is extraordinarily low — not a single case of transfusion-related HIV has been reported in the United States since 2008 — because laboratories now use high-accuracy testing to screen all donors and ensure the safety of our blood supply. This test is so accurate that banning a person from donating based on their sexual behavior no longer makes sense. Meanwhile, new diktats around anal sex, such as those explicitly targeting MSM, continue to discriminate against the gay community — the FDA is simply struggling to find the most socially acceptable way to follow a policy it should have abandoned long ago. .

Strict precautions made more sense 30 years ago, when screening wasn’t as good as it is today. Hemophilia patients, many of whom depend on blood products to live, were high-profile and early victims of our inability to keep HIV out of the blood supply. He lamented one of the patients who contracted the virus through a blood transfusion New York times In 1993 he had already watched his uncle and cousin die of AIDS. Those days of “shock and denial,” like times They called it, thank God it’s behind us. But for older patients, memories of the crisis of the 1980s and early 1990s still linger, and cause great anxiety. Even people unaware of this historical context may consider receiving someone else’s blood disturbing, threatening, or sinful.

As a physician, I have found that patients tend to be more reluctant to get a blood transfusion than they are to take a pill. I asked them to get a detailed medical history of the donor, or they say that they are willing to draw blood only from a close relative. (Normally, none of these requests can be satisfied for reasons of privacy and practicality.) Yet the same patients may accept—without question—medications that carry a risk of serious complications thousands of times greater than the risk of receiving contaminated blood. Even when it comes to blood-borne infections, patients seem to be less concerned about the biggest risk — bacterial contamination — than they are about transmitting viruses like HIV and hepatitis C. But the risk of contracting HIV from a blood transfusion isn’t just low – it’s basically non-existent.

Donor feelings are also important, and the Food and Drug Administration’s policies toward gay and bisexual men who want to donate blood have been unfair for many years. While officials speak the language of danger and supposed safety, their selective spreading of anxiety points to a deeper homophobia. As one scientist put it American Journal of Bioethics More than a decade ago, “the distinction lies not in the risks themselves but in the FDA’s response to the risks.” Many demographic groups are at increased risk of HIV infection, but the agency does not continually improve its exclusion criteria for young people, urban residents, or Blacks and Hispanics. Federal policy banned Haitians from donating blood from 1983 to 1991, but activists lobbied successfully to overturn this ban with a strong slogan ” h in HIV represent humansno Haitian. Almost everyone today would find the idea of ​​refusing blood from one ethnic group morally reprehensible. Under its new proposal, which it claims targets anal sex rather than homosexuality itself, the FDA is effectively continuing to refuse blood from sexual minorities.

The planned update will definitely be an improvement. It comes from years of advocacy by LGBTQ rights organizations, and its details appear to be backed up by recent government research. Peter Marks, director of the FDA’s Biology Evaluation and Research Center, cited an unpublished study showing that a “significant percentage” of men who have sex with men will now be able to donate. But the plan is still likely to exclude a large portion of them — even those who wear condoms or regularly test for STDs. An FDA spokesperson told me via email that “additional data is needed to determine a proportion [men who have sex with men] He will be able to donate under the proposed change.”

Research in France, Canada and the UK, where similar policies have since been adopted over the past two years, shows the risks. A French blood donation study, for example, estimated that 70 percent of men who have sex with men have more than one recent partner. And when Canadian researchers surveyed queer communities in Montreal, Toronto and Vancouver, they found that up to 63 percent would not be eligible to donate because they had recently had anal sex with new or multiple partners. Only 1 percent of previously eligible donors would have been rejected with similar criteria. The UK assumed in its calculations that 35 to 50 percent of men who have sex with men would not be eligible under a policy much like that of the Food and Drug Administration, while only 1.4 percent of ex-donors would be deferred. If the net effect of the new rule is that gay and bisexual men are turned away from blood centers as often as heterosexuals, then what else can we call it? discrimination? US guidelines are supposed to prohibit choosing a lifestyle rather than an identity, but the implication is that a lot of gay men made the wrong choice. An FDA spokesperson told me, “Anal sex with more than one sexual partner is more likely to contract HIV than other sexual exposures, including oral sex or vaginal sex.”

If the FDA wants to get in on my sex life, they must have a good reason to do so. The increasing detail and intimacy of these policies – limiting the number of partners and genders – gives the impression that the stakes are very high: If we do not exclude the most dangerous of donors, blood flow may be impaired. But donor screening questions are a rudimentary tool for picking needles out of a haystack. The only HIV infections recent tests are likely to miss are those picked up within the past week or two. This suggests that, at most, there are a few thousand individuals — both gay and straight — across the country who are at risk of having our experimental defenses bypassed at any time. Of course, very few of them will happen to donate blood at that time. No voluntary questionnaire can completely rule out this possibility, but patients and clinicians already accept that other life-threatening transfusion risks occur at far greater rates than ever could of HIV transmission. When I’m on call to monitor blood transfusion reactions at one hospital, the phone rings several times each night. However, the blood has been distributed tens of millions of times across the country since the last known case of a blood transfusion resulting in an HIV condition.

Early data suggests that the overall risk-benefit calculation of receiving blood is unlikely to change. When eligibility criteria were first relaxed in the United States a few years ago, the already low rate of HIV-positive donations remained minuscule. Actual results from other countries that have recently adopted gender-neutral policies will become available in the coming years. But modeling studies do support the removal of any screening question that explicitly or implicitly targets gay men. A 2022 Canadian analysis suggested that removing all questions about men who have sex with men would not result in significantly higher risks for patients. The researchers concluded that “additional behavioral risk questions may not be necessary.” If restrictions are to be in place, then there must be restrictions narrowly designed to fit the tiny seven- to 10-day window of risk before enough is donated. (The FDA says its proposed policy is “expected to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period.”)

As a gay man, I understand that no one, except for brief periods of crisis during the coronavirus pandemic needs my blood. Only 6.8 percent of men in the United States identify as gay or bisexual, so our potential interest in aggregate viewing is inherently modest. If we go back to lockdown completely, patients won’t be harmed. But reversing that ban, both in letter and in spirit, would send a vital message: Our government and health care system view sexual minorities as more than just vectors of disease. policy used anal sex as an alternative to Men who have sex with men It only serves to stigmatize this population by impugning one of their main sources of sexual pleasure. There is no doubt that non-monogamous gay men have a higher chance of contracting HIV. But a policy that treats everyone equally will accept as little risk as the price of working with human beings.

.

Leave a Reply

Your email address will not be published. Required fields are marked *