Yesterday, in the hours following the largest mass shooting the US has ever seen, a number of news outlets, including The Verge, initially reported that the main blood bank network in Orlando, OneBlood, was taking donations from all gay and bisexual men. Had these reports been accurate, it would have meant that America’s third-largest network of blood banks was violating the FDA’s most recent guidelines for blood donation — guidelines which have stated since December, that men who have sex with men can only donate if they’ve abstained from gay sex for more than a year. But in a statement, OneBlood denied the story. It also told The Washington Post that it had yet to update its systems to "allow" gay men who met the new criteria to donate.
It was a stunning reversal of initial reports: not only was OneBlood not taking blood from all gay men, it wasn’t taking blood from any. It’s not just OneBlood, either. According to people who worked to get the new guidelines approved by the FDA, the lag at OneBlood reflects national delays involving the questionnaire that’s given to donors, donor records, and international partners that continue to refuse blood donated by gay men.
Both the Red Cross and Blood Systems — providers of blood components to close to 3,200 hospitals and transfusion centers across the country — have experienced the same delays. Because of this, gay men in the US who meet the FDA’s current guidelines continue to face the same barriers to blood donation that they’ve faced for more than 30 years.
Most blood collection organizations "have had to delay the implementation."
"Most blood collection organizations in the US, including the American Red Cross and Blood Systems, have had to delay the implementation," says Michael Busch, director of the Blood Systems Research Institute, which led the studies to revise the policy. Busch confirmed that blood banks owned by Blood Systems, his parent company, had yet to accept donations from gay men, "for the same reasons as OneBlood." The Red Cross also confirmed that it had not made the change. The Verge emailed OneBlood for comment on two occasions; it did not get back to us before the publication of this story.
The first obstacle that blood banks have had to face is the pre-donation questionnaire. Most blood banks use the questionnaire designed by the FDA; the updated version wasn’t approved by the federal agency until May 27th. "So while the policy has been changed for some time, the donor history questionnaire — as well as the donor education material — had to be edited and approved," says Jay Franzone, director of communications at the National Gay Blood Drive, an organization that aims to end the ban on blood donations by gay and bisexual men.
The donor history questionnaire was approved in late May
Getting the questionnaire approved "was necessary" to implement the change, says Kara Lusk Dudley, public affairs manager at the American Red Cross. Busch agrees. Technically, blood banks could have written their own questionnaire and asked for FDA approval, but then they would likely have to modify it once more when the FDA released its own, more rigorous version — so most blood banks decided to wait, he says.
The fact that the FDA took months to approve a questionnaire is "inexcusable," says Arthur Caplan, a bioethicist at New York University who once chaired the Advisory Committee to the Department of Health and Human Services on Blood Safety and Availability. A delay such as this one means that patients who need blood might be missing out on blood that the FDA says is safe. "When there is a surge in demand and willing donors, failure to update could cost lives," he says. This is only made worse by the fact that the FDA had years to prepare. "Way back in 2000, we were trying to get this changed; it should be ready." The Verge contacted the FDA and asked why the approval hadn’t happened earlier; the FDA did answer this question.
But the questionnaire is only the first step. Blood banks have to revise their software with the new questionnaire, and that takes time. "While these changes will take longer than we would like to implement, we want to ensure we make changes in a careful manner so as not to compromise recipient safety," the Red Cross’ Lusk Dudley says. "We continue to work diligently to determine a process for the reinstatement of eligible donors who were deferred under the previous policy." As for Blood Systems, Busch is hopeful that the company will make necessary changes to its software before the end of the year.
"Failure to update could cost lives."
Blood banks also have to make changes to their donor records. "Donors who were previously indefinitely deferred will need to have records updated," said FDA spokesperson Tara Goodin. Unlicensed establishments can change their system for keeping records without notifying the FDA, but licensed establishments — places like OneBlood — need to notify the agency. "The FDA has been working with firms to review quickly," she said. "It’s our understanding that about 90 percent of the large establishments have made changes."
Computer updates might not even be the biggest problems faced by blood banks in the US. According to Busch, the largest obstacle to implementing the guidelines is the fact there’s still no international standard for determining the eligibility of blood donors. That’s because blood banks in the US send a lot of blood to companies that manufacture plasma derivatives. And because other countries haven’t modified their policies regarding gay men, these companies haven’t changed the blood that they’ll accept, Busch says.
Because of this, blood banks that accept blood from eligible gay men won’t be able to send it to be processed; their blood will only be used for transfusions. "This adds a level of complexity. We have to have an international consensus and it’s moving that direction, but it’s going to take time," Busch says. The FDA, for its part, said that collectors that ship plasma to countries that haven’t changed their donor deferral policies will probably keep rejecting all blood donations by gay men. We called and emailed the International Plasma Fractionation Association and The Plasma Protein Therapeutics Association for comment; we will update this story when we hear back.
Blood banks don't have to follow the FDA's lead
Given how long this change has been coming, the FDA could have been better prepared. But the fact that the Red Cross, One Blood, and Blood Systems all intend to implement the new guidelines is actually encouraging. The FDA actually doesn’t have much power to enforce its guidelines, so companies could just stick to the old guidelines without facing any repercussions. "Establishments may voluntarily elect more stringent donor deferral criteria than those required or recommended by the FDA," the FDA’s Goodin told The Verge.
It’s impossible to discuss this delay without mentioning the many people who think that the 12-month waiting period to donate blood is overkill — and discriminatory. And in the wake of the Orlando shooting, telling gay men who want to save lives that even that standard hasn’t been met is especially hurtful. But this is bigger than Orlando. In February, the Red Cross said it was facing an emergency need for blood and platelet donors. It’s not clear if having a questionnaire ready in December, when the change was announced, would have changed that. Perhaps it would have made no difference — or maybe this would have saved a life. There’s no way to know. That’s why the main point to remember is this: in February, there were people in the US with demonstrably safe blood — and despite having a newfound right to donate, bureaucratic delays made that impossible.