FDA rules still block many gay, bisexual men from giving blood

Some say policy for turning away gay, bisexual men overly broad

Last week's shooting spree that killed 49 in a gay nightclub in Orlando, Fla., sparked a surge in blood donation, with hundreds of donors lining up out the door at Florida blood centers.

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But controversial Food and Drug Administration rules meant to keep the blood supply safe also meant many gay and bisexual men, the club's primary patrons, couldn't join them. Here in Arkansas, the rules mean thousands of potential donors and pints of blood are left out of the state's supply, according to Census figures and multiple surveys in the past several years.

At a glance

Reasons blood banks turn donors away

Potential blood donors can be turned away at least temporarily for a variety of reasons, ranging from short-term blood iron levels and medications to longer-term factors like travel to certain countries and diagnosis with some diseases. The Food and Drug Administration recommends donors be deferred, or blocked from giving blood, based on the following reasons.

Donors will be deferred for 12 months:

• After sexual contact with someone who has a history of sex with anyone who has HIV, has had sex for money or drugs or engaged in nonprescription injection drug use.

• After receiving a blood transfusion

• After getting a tattoo or piercing, if it wasn’t done with sterile needles and unused ink or piercing equipment

• After treatment for syphilis or gonorrhea

• Or after a man has sexual contact with another man, or after a woman has sexual contact with a man who has also had contact with another man in the previous 12 months.

Donors are deferred indefinitely:

• After testing positive for HIV

• After exchanging sex for money or drugs

• After engaging in nonprescription injection drug use.

Source: FDA

Until late last year, the FDA banned men who've had sex with men at any point in the past 39 years from donating blood. The policy was put in place during the 1980s AIDS crisis to protect the blood supply when much about the disease was unknown besides it disproportionately affected men who had sex with other men.

As a side effect, the agency barred donations from millions of men who had sex with other men but didn't have human immunodeficiency virus, or HIV, which can lead to AIDS.

To help address the issue, the agency in December softened the ban to require male donors go 12 months without sexual contact with another man, concluding the change wouldn't raise HIV risk. Researchers and health care providers use the term "men who have sex with men" because not all men who do so identify as gay or bisexual.

"We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply," Stephen Ostroff, then FDA acting commissioner, said at the time.

The changed rule allows more donors but still blocks people like Kyle Smith, a healthy, 35-year-old Fayetteville resident who said he donated a gallon of blood in college and would be willing to donate again if he were allowed.

"I suppose a 1-year deferral is infinitely more reasonable than a lifetime deferral, but it's still probably an unnecessary handicap on the system," Smith said last week. "We just quit trying, because why go through the paperwork to be told no?

"I hope that those who are able and allowed to donate will. The blood banks are always in need."

Throughout Arkansas and the country, the potential lost blood multiplies quickly, fueling a continuing debate over the ban.

Local impact

The number of potential donors affected by the FDA rule can be narrowed with a mix of data from the Census and other reports, though the figures should be taken as rough estimates because surveys were taken by different groups at different times.

A report this month in the Archives of Sexual Behavior found about 9.4 percent of men surveyed between 2010 and 2014 throughout the South reported having sexual contact with other men. Based on Census figures, that comes to 106,000 adults in Arkansas.

Roughly half of them had sexual contact with another man in the past 12 months, according to the Centers for Disease Control and Prevention and other reports. About 18.5 percent of those 106,000 had HIV in 2012, according to an analysis of the latest available CDC data released in May by Emory University researchers.

Neither category can donate, but the rest of the men who've had sex with men can because of December's policy change. If HIV status and sexual activity are evenly mixed among the group, that's about 40,000 people who can donate.

Based on typical American donation and eligibility rates, they would likely give more than 3,000 pints each year, based on American Red Cross statistics and a 2010 analysis by researchers at the University of California, Los Angeles. Across the country, the number swells into hundreds of thousands of units.

But since roughly half of the men who have sex with men have done so in the past year, an equal number of potential and safe donations can't come in. With every pint going to up to three hospital patients, the impact of lost donations increases further.

New donations after the policy change are also largely hypothetical at this point in Northwest Arkansas, because the American Red Cross, Arkansas Blood Institute and Community Blood Center of the Ozarks are still in the process of training staff and adjusting computer systems for the 12-month rule, according to their representatives and administrators. They plan to start allowing some gay and bisexual men to donate within the next several months.

The area agencies said they follow FDA rules and generally didn't have a stance on the donor policy, but more donors would always be helpful. Summer can be a particular challenge because of family vacations and because high school and college students, some of the most reliable donors, are for the most part out of school and away from blood drives.

"The need for blood never takes a vacation," said Chris Pilgrim, spokesman for the Community Blood Center of the Ozarks, which accepts donations in Springdale and supplies the Mercy, Northwest Health and Washington Regional systems.

He said the center Thursday had less than two days' worth of Type-O blood despite a slight bump after the Orlando attack. The ideal supply is three days.

"Someone needs blood every two seconds regardless of the busy summer months," Laurie Nehring, spokeswoman for the American Red Cross, wrote in an email. "We're asking the community to schedule an appointment to donate and help save lives."

Donation centers and hospitals need a constant and consistent flow of donated blood in case of emergencies ranging from those like in Orlando to traffic accidents and more common events, said Terry Ridenour, vice president of eastern division operations for the Arkansas Blood Institute.

"The blood is needed on the shelf right then, not necessarily two days later," he said. "The need is daily."

The community blood center plans to adopt the 12-month deferral for men who have sex with men next month, Pilgrim said. The Red Cross and Arkansas Blood Institute officials didn't have specific dates but said it would happen before the end of the year.

"We want to ensure we make changes in a careful manner so as not to compromise recipient safety," Nehring wrote.

While Kyle Smith can't donate, his sister, Gina Smith, donated last week. She said the ban takes away one of the most direct ways gay and bisexual men could help out with Orlando, and while she would have donated either way, she felt as if she were donating in her brother's place.

"Donating money, donating blood -- those seem to be all we can do," she said. "It really shows that those of us who can, we have to do this."

Debate continues

Criticism of the donor policy as prejudiced and overly broad has largely continued despite December's switch, especially following the Orlando attack. Every pint of blood is screened for HIV and other diseases, and while gay and bisexual men are disproportionately likely to have the virus, most don't.

Critics of the policy have suggested targeting specific high-risk behaviors that could apply to anyone regardless of sexuality, such as having a high number of partners or unprotected sex.

"They (heterosexual people) could have a very large number of partners, and we don't ask," Brian Custer, associate director of the Blood Systems Research Institute, told the online news outlet FiveThirtyEight in an article published Thursday.

The FDA hasn't announced any further changes to its rules, noting sex between men is about 30 times as likely to cause HIV exposure as having multiple heterosexual partners. Half of the people living with HIV in the U.S. are men who have sex with men, according to the U.S. Department of Health and Human Services.

Other high-risk behaviors, such as injection drug use or sex for money or drugs, also require donation centers to turn a donor away.

"The deferral policy is a behavior-based policy, not one based upon sexual orientation," Tara Goodin, an FDA spokeswoman, wrote in an email Friday.

"The FDA carefully considered alternative deferral criteria, such as individual risk assessment for individual risk of HIV, as alternatives to a time-based deferral," but the technique hasn't been shown to be as effective as a general deferral, Goodin said.

In December the FDA said it would continue to look at research into blood safety to see if more changes are needed, and Goodin said that was still the case.

"We empathize with those who might wish to donate but reiterate that at this time no one who needs blood is doing without it," she added.

HIV transmission through a blood transfusion remains possible, but rare. Out of tens of millions of transfusions in the past decade, only one has transmitted the virus, a case in 2008 in which a man married to a woman wasn't truthful in his donor questionnaire about sexual contact with several men and women, according to the CDC.

The tests to detect HIV's presence in blood are "damn good," said John West, a research associate professor with the Nebraska Center for Virology at the University of Nebraska-Lincoln. Today's technology provides a "very, very small margin of false negatives."

"But it's not zero," West said. "The FDA I think is weighing a lot of things, and I don't think they're trying to be discriminatory, but I think they're so risk-averse they may be appearing to be discriminatory.

"It's something that needs to be discussed. There's no clear resolution."

At the Ozarks blood center, donors are at least temporarily deferred for some reason 5 to 10 percent of the time, Pilgrim said. The Arkansas Blood Institute, which takes donations in Fort Smith and Little Rock, defers about 18 percent, Ridenour said. Nehring didn't know the number for the Red Cross.

"Sometimes it's their iron levels are too low, sometimes it's questions of where they've traveled to," Pilgrim said. Most take the news well, he added. "Some are naturally disappointed, but I think by and large they realize that the rules and regulations are in place for a reason."

NW News on 06/19/2016

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