With better HIV tests, should FDA end its ban on gay men donating blood?


April 16, 2012

Raymond Robbins was ready to roll up his sleeve and give blood for the first time when a question asked of potential donors stopped him cold:

“From 1977 to the present, have you had sexual contact with another male, even once?”

“I answered yes, but I was caught off guard by the question,” said Robbins, 28, of Washington.

His answer got him turned away, stopped by a longstanding Food and Drug Administration policy that bans sexually active gay men from ever donating blood. The federal ban, now three decades old, has come under increasing scrutiny in recent years as HIV detection tests and procedures for screening donated blood have improved greatly and blood shortages have become common.

“It makes me feel like I’m placed in a negative category, like they are labeling me as diseased and decrepit,” said Robbins, who because of the ban has never tried to give blood since being rejected 10 years ago during high school. “The policy is very backward.”

But the FDA defends the ban, saying men who have sex with men are at a much higher-than-average risk of HIV and other infections that can be transmitted through transfusions. Although the FDA wouldn’t make officials available for an interview, the agency said in a statement that it’s trying to protect the public and is basing its policy on science, not “any judgment concerning the donor’s sexual orientation.”

The FDA said studies are underway that could lead it to reevaluate the ban, which was most recently upheld after a 2010 review by the Department of Health and Human Services Advisory Committee on Blood Safety and Availability. Meanwhile, a similar ban was lifted last year in England, Scotland and Wales, which now allow men to give blood if they haven’t had sex with another man for at least a year, more than enough time for HIV to be detected in their blood.

Time for a change?

Some medical experts say it’s about time the United States also lifts its ban, or at least adopts a less restrictive policy.

Richard Benjamin, chief medical officer of the American Red Cross, said his organization, along with America’s Blood Centers (a network of community blood centers) and the tranfusion and cellular therapy organization AABB, is calling for the ban to be shortened to a year.

That’s the same waiting period imposed on men who have had sex with a prostitute or with a woman known to be infected with HIV. There’s no waiting period for heterosexuals who don’t fit into those categories even if they have had numerous sexual partners.

“The way we look at it, our first obligation is to every patient, to provide you with the safest possible blood,” Benjamin said. “Our second obligation is to treat donors fairly and equitably.”

Benjamin said that HIV was a much bigger threat to the U.S. blood supply decades ago but that scientific advances have allowed much earlier and better detection of the virus that causes AIDS.

Benjamin said everyone who wants to donate blood through the American Red Cross is screened for HIV. The highly sensitive nucleic acid test, which U.S. blood banks introduced in 1999, will pick up HIV infections that occurred as recently as 12 days before the test, he said. A person who was infected within 12 days of donating blood might test negative, although Benjamin said that on average infected people will test positive nine to 11 days after exposure. That means there’s a slim chance a donor could have the virus and not have it detected through screening.

For an extra measure of safety, Benjamin said, five tubes of blood are collected during blood donation and sent to a lab that same evening to test for HIV and other viruses. If an initial test is “reactive,” or seems to be positive, scientists retest the blood the next day, but they discard all the blood from that donor even if the second test is negative. That donor’s blood is never given to another person; further testing is done to provide more conclusive information to the donor.

Benjamin said such precautions are an effective way to reduce the transmission of HIV, even if donors don’t tell the truth about their medical or sexual history.

“Everything is tested. That’s why this policy makes no sense,” said Darlene Nipper, deputy executive director of the National Gay and Lesbian Task Force.

Kali Lindsey, public affairs director of the nonprofit National Minority AIDS Council, said he does not even like the idea of a year-long waiting period for men who have sex with men. Given the effectiveness of testing, “it’s hard for me to support a policy stigmatizing a particular community,” Lindsey said.

Some activists said federal policies should be based on behavior, not the risk profile of certain populations. More than 40 organizations signed a letter to the HHS committee in 2010 saying the current policy makes no effort to distinguish between men at high risk or low risk for HIV. Activists said it’s not fair that the lifetime ban applies to gay men in monogamous, long-term relationships but not to heterosexual men who, for example, have had sex with a prostitute.

“I know many straight people who live a more risky lifestyle with multiple partners and unsafe sex,” said Jon Rohner, a 29-year-old gay man from Louisville.

Rohner, who said he gets tested regularly for HIV and has never tested positive, said he learned of the FDA’s blood donation policy when he was turned away from a blood drive last year. “I was shocked in this day and age, with all the advances in science, that something as simple as wanting to donate blood was even an issue,” he said. “It makes you feel like less than an equal person.”

Fewer than one in a million

Yet even scientists who oppose the ban acknowledge that the threat to the blood supply from HIV has not been eliminated.

Benjamin, other scientists and the FDA agree that today’s tests fail to detect fewer than one in a million HIV-infected donors. That’s a very low failure rate, but Benjamin and others said it can still pose a danger because there are more than 20 million transfusions in the United States each year.

Since new testing methods went into effect in 1999, according to Benjamin, there have been only four known HIV transmissions through blood transfusions.

The FDA says detection of HIV infection is particularly difficult when there are very low levels of the virus in a donor’s blood, such as during the first 12 days after a person becomes infected.

So they look at another indicator: the level of HIV in various groups in the population.

According to the FDA, HIV prevalence — a measure of the total number of cases in a population at a specific point — is 60 times higher among men who have sex with men (post-1977, which the FDA calls the beginning of the AIDs epidemic in the United States) than in the general public.

In 2008, an estimated 1.18 million people in the United States were living with HIV infections, including 580,000 who got the virus through men having sex with men, according to the Centers for Disease Control and Prevention.

“Even taking into account that 75 percent of HIV-infected men who have sex with men already know they are HIV-positive and would be unlikely to donate blood, the HIV prevalence in potential donors with history of male sex with males is 200 times higher than first-time blood donors and 2,000 times higher than repeat blood donors,” the FDA says in a question-and-answer document on its policy, which it terms a “lifetime deferral” and not a ban.

The agency also points out that gay men aren’t the only ones subject to this policy. Among the other groups are anyone who has received money, drugs or other payment for sex since 1977; and anyone who has injected drugs for a nonmedical reason.

James Small, director of anatomic pathology at Porter Adventist Hospital in Denver, said the FDA’s policy is a way to help keep HIV-tainted blood out of the blood supply, given that HIV testing is still not perfect. “The demand from the general public for completely safe blood products is insatiable,” Small said. “It’s not a pro- or anti-gay issue.”

If it were, he said, women who have sex with women would also be prohibited from giving blood — and they’re not. That’s because, as a group, they have a lower prevalence of HIV than do men who have sex with men, he said.

“There are certain populations that are at risk for certain infections,” he said. “It’s not like this is a moral issue or a discrimination issue.”

Yet to Robbins, who now works as an intern at the DC Center for the LGBT Community, the lifetime ban certainly feels like discrimination that reflects a “hatred and fear of gay people.”

He is a healthy man in a monogomous, long-term relationship who regularly tests for HIV and has always been negative. “They are totally missing out by not allowing people like me to donate,” he said. “There are so many healthy individuals who would be willing to go out and do that. And blood is something we want more of.”

Ungar is the medical writer at the Courier-Journal in Louisville.

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