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Research supported by the Food and Drug Administration “will potentially help end” a blanket ban on blood donations from sexually active gay men, the agency said Wednesday. This initiative will significantly change an initiative to prevent the spread of HIV. Experts and workers Is Criticized at length As overly broad and misleading.
Current federal laws prohibit blood banks from collecting donations from men who have sex with men. Within the last three months. An alternative approach to FDA-funded research Advanced study Experimented with relying on questionnaires from screen donors instead of extensive “time-based deferrals”.
“Although we do not have a specific timeline for when our analysis will be complete, the agency believes that preliminary data from this study, along with other data available from blood monitoring in the United States and other countries taken in perspective, would likely support this. Policy transition to individual risk-based donor screening questions to reduce the risk of HIV transmission,” said Carly Kempler of the FDA. said in a statement.
Kempler said the FDA has not yet determined when and how the study results will be published. The agency is working on draft guidance to be released “in the coming months” that will include findings from the study and other “international developments in donor deferment policies.”
Several countries have already moved away from extended waiting periods for gay men to limited screening methods, including Canada. Earlier this year.
“We have the most relevant information to imagine what an individualized risk-based approach would look like,” said Brian Custer of Vitality Research, the study’s principal investigator. told The Wall Street Journal, which first reported news of the impending change.
Although donated blood can be tested for HIV, it can be difficult for most blood banks to detect the virus during the initial “window period” after infection.
Study volunteers answered questions designed to assess their personal risk of contracting HIV, and then donated blood samples that were sent to research laboratories to look for signs of the virus. Coins and pre-exposure prophylaxis drugs, which are taken in laboratories. Reduce risk Contracting the virus that causes AIDS.
It is unclear what exact questions will be used in the FDA’s required screening. Nick Gehrig, a spokesman for the Vitality Research Institute, which helped lead the study, declined to provide details about what questions were tested.
Gehrig said the advance study is examining whether different questions can be added to donor history questionnaires that are based on individual risk of HIV infection, and whether these questions are similar to time-based deferrals. will be effective.
An end to a rule since the 1980s
The ban on blood donations from men who have sex with men was first introduced in the 1980s, in the early days of the HIV/AIDS epidemic, when little was known about the virus and treatments were scarce. Options were not available yet. The FDA moved first. In 2014 to lift the ban for life, and one year later Converted to a one-year “grace period”. Because they last had sex, before they can donate.
As the COVID-19 pandemic unfolded in 2020, the FDA shortened the deferral period Up to 3 months. The agency said Hopefully it will subside “Sudden and immediate” loss of blood.
But the regulator has faced persistent calls to scrap the ban altogether, prompted by what the American Red Cross has declared a “first blood crisis”. Earlier this year. Federal officials even before the pandemic was found That the demand and supply of blood was decreasing. In 2019, a years-long slowdown in blood supply utilization appeared to be ending, while blood collections continued to decline.
“America’s Blood Centers strongly supports a safe and accessible blood supply that treats all potential donors fairly, equitably and respectfully,” said Kate Frye, CEO of America’s Blood Centers, in a statement. Is.”
The group is one of several that have recently renewed their call for a policy change from the FDA, including Happinessthe American Medical Associationand many more State health authorities.
“ABC strongly supports this effort as a way to establish donor screening based on individual risk behaviors, not on sex or gender identity. The use of a rational, science-based deferral period for all blood donations.” should be fairly and consistently between the doers.” Bhuvan said.
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Source by [CBS News]
