Why the Red Cross is pressuring the FDA to make it easier for gay men to donate blood – Yahoo Lifestyle

The American Red Cross, which supplies 40 percent of the nation’s blood, has issued a revised, eased-up position on its policy regarding blood donations from gay men — putting public pressure on the Food and Drug Administration (FDA), which oversees the American Red Cross, to do the same.

“The American Red Cross seeks to build an inclusive environment that embraces diversity for all those who engage with our lifesaving mission,” reads the statement, released on Thursday. “As such the Red Cross believes blood donation eligibility should not be determined by methods that are based upon sexual orientation.  We are committed to working toward achieving this goal.”

If you’re wondering what the so-called “gay ban” is all about and why different rules apply to different people when it comes to donating lifesaving pints of blood, here’s a quick primer.

Blood donation and the AIDS crisis

Up until 2015, the FDA had enforced a lifetime ban on blood donations from men who had sex with men (MSM), regardless of sexual orientation — a policy originating from an emergency safety measure instituted during the height of the AIDS and HIV epidemic, in 1983, to prevent HIV from getting into blood supplies. That ban fully prevented gay and bisexual men from donating blood — a restriction that, according to the Williams Institute, decreased the total annual blood supply in the U.S. by up to 4 percent, translating into a possible million-plus lives lost.

The lifetime ban, harshly criticized by both LGBTQ and public-health organizations for being “stigma-based,” was changed in 2015, however, to a partial ban, with a rule stating that any man wishing to donate blood would have to wait for a full year from any male-to-male sexual contact — essentially a 12-month enforced abstinence, as explored in a New York Times opinion piece.

“It shouldn’t be a big deal that I gave blood this week, but it is,” wrote Jay Franzone in 2017 New York Times piece. “To do it, I had to give up all forms of sex for a year. The reason: I’m gay. With what we know today about the disease, it’s a stupid reason.”

Since its inception, the one-year deferral rule — though praised as a step in the right direction — has also been largely derided, being called “discriminatory,” stigma- rather than science-based, and going against the forward trends of other countries.

Still, an FDA statement provided to Yahoo Lifestyle explains, “Among other studies reviewed at the time, epidemiologic studies in blood donors showed that a history of male-to-male sexual contact was associated with a 62-fold increased risk for being HIV positive, whereas the increase in risk for a history of multiple sexual partners of the opposite sex in the last year was 2.3-fold. While acknowledging at the time that the change to a 12-month deferral was less than hoped for by some, the FDA considered this to be a first step in the process of evaluating and progressing its blood donor deferral policies for all donors.”

So what’s changed now?

The FDA policy remains the same. But now the American Red Cross, after years of grappling with the issue, has released its latest position — suggesting the FDA change its 12-month deferral rule to a 3-month one.

“As a scientifically-based interim step, the Red Cross encourages the Food and Drug Administration (FDA) to consider reducing its deferral time for men who have sex with men from 12 to three months while further options are evaluated for the United States,” noted its new position statement. “This is consistent with policy changes made by several other countries including Canada and Great Britain. We also strongly support the expanded use of new technologies to work toward elimination of donor eligibility questions that would no longer be necessary.”

As for what prompted the revised position, the Red Cross provided Yahoo Lifestyle the following statement:

“Over the past several years, the Red Cross, along with other U.S. blood providers, has been actively collecting and evaluating infectious disease markers and other data through federally supported studies to help determine the safety of the current MSM policy. The Red Cross has revised its position regarding MSM to better align with current scientific data regarding infectious disease window periods.”

The statement continued: “We are committed to working to achieve an inclusive and equitable blood donation process that treats all potential donors with equality and respect, and ensures a safe, sufficient blood supply is readily available for patients in need.”

The Red Cross was unable to provide Yahoo Lifestyle with an expert to discuss the specific scientific reasoning for the three- vs. 12-month deferral. But an expert in the field, Brian Custer, PhD, vice president of research and scientific programs and director of epidemiology and health policy science at University of California San Francisco, tells Yahoo Lifestyle that the three-month deferral idea is a good compromise.

“The move to three months is much more consistent with the available science of HIV infection and disease progression,” Custer tells Yahoo Lifestyle. “Not removing the deferral altogether is also based on the known epidemiology of HIV infection and additional factors related to testing for HIV infection in donated blood.”

He adds, “At this time we do not have sufficient ways to differentiate higher risk from lower risk gay/bisexual men, who may wish to donate. Out of caution, the deferral for three months would move the policy closer to equity. This would strike a balance for the various stakeholder groups, who have different perspectives on this issue.”

What does the FDA say in response?

“The FDA’s deferral policy regarding men who have had sex with men (MSM) is a behavior-based policy, not one based upon sexual orientation,” the FDA notes, in part, in a lengthy statement provided to Yahoo Lifestyle.

“Developing the scientific information that is needed to further change blood donor policies does take time and effort. The FDA has made forward progress in this regard. A blood safety surveillance system to look at more than half of the blood collected in the U.S. is fully operational and providing data that will help inform further changes in policy,” adding that it has also sought public input and is involved in an “ongoing dialogue” on the matter. 

“Additionally,” the FDA statement notes, in March, an advisory committee met in an open session “to discuss blood donation policies regarding MSM,” and to hear presentations on the current epidemiology of HIV and global developments in blood donor policies. 

How effective is the deferral rule?

“It makes absolutely no sense to require 12 months of abstinence,” Paul Volberding, MD, director of the AIDS Research Institute at University of California San Francisco, told the San Francisco Chronicle in 2016. “The tests we have are amazingly accurate and fast. They can detect people [donors] in as little as three days who have been exposed to the virus.”

As GLAAD pointed out on World AIDS Day last year, “The FDA screens every unit of blood donated for infectious diseases prior to entering the donation pool. Current tests for HIV are able to detect the presence of the virus with high precision within 11 days after infection. Based on this science, a 12-month deferral for MSM does not make any sense; furthermore, the test is able to detect HIV with such a high precision ­that only 1 in 3.1 million units of blood infected with HIV will make it past the screen.”

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