Blood, Sex, and the FDA

Long before his name became synonymous with AIDS, Ryan White, a hemophiliac from the central Indiana city of Kokomo, spent precious hours of his young life regularly receiving blood transfusions -- one of which would forever alter the course of his life.

Around the same time -- but not soon enough for White or the 10,000 affected hemophiliacs -- doctors in New York, Los Angeles, and San Francisco struggled to understand a baffling wave of opportunistic infections chiefly affecting gay men, many of whom were in otherwise good health. The illness had yet to be named, nor was it yet known that it could be passed through the nation's blood supply.

In 1983, a year before White was diagnosed with AIDS and subsequently pushed into the national spotlight, the Food and Drug Administration, a subagency of the Department of Health and Human Services that regulates the nation's collection of blood and blood products, barred from donating blood any man who'd had sexual contact with another man (or "MSM," in FDA parlance) since 1977. In the panicked, early days of the pandemic, the ban was born out of utter necessity. Twenty-six years later the medical and scientific landscape has changed, but the policy remains.

Today, three years after the American Red Cross, the American Association of Blood Banks, and America's Blood Centers blasted the policy as "scientifically and medically unwarranted," congressional representatives have ramped up pressure on the FDA to reconsider the ban. They're not alone. Several colleges and universities throughout the nation have scrapped on-campus blood drives, claiming that the policy runs counter to collegiate antidiscrimination rules. Abroad, Italy and Spain have adopted blood donation policies based on the risks of sexual practices, regardless of sexual orientation, while several other countries now allow gay men to donate if they have abstained from sexual contact for one year.

President Barack Obama, who announced just weeks into his administration that the nation "will make scientific decisions based on facts, not ideology," tapped Margaret Hamburg, MD, a former New York City health commissioner who spent much of the 1990s intimately involved with HIV/AIDS issues, to head the FDA. In August the president nominated Helene Gayle, MD, a 25-year veteran of HIV research who has worked for the Bill and Melinda Gates Foundation and the Centers for Disease Control and Prevention, to replace Oklahoma U.S. senator Tom Coburn, a medical doctor who has railed against the efficacy of condoms in preventing sexually transmitted diseases, as chair of the Presidential Advisory Council on HIV/AIDS.

So the groundwork has been laid for examining if and how gay men can donate blood safely in the United States. But whether this will lead to a scientifically sound change in blood donation policy remains unclear.

The safety of the nation's blood supply is ultimately the responsibility of the FDA, and while the work of collecting and distributing blood is performed by individual blood banks and organizations like the American Red Cross, all must adhere to the agency's rules. The FDA rejects potential donors for a wide variety of reasons -- primarily if they're not "feeling healthy and well" or if they're taking certain medications. International travel or living abroad can be a concern because of possible exposure to diseases like malaria. So is a new tattoo or a piercing, due to the risk of hepatitis B and C.

With HIV, current screening technology can find evidence of the virus in most people within 10 to 21 days. The combination of independent nucleic acid (viral load) testing and serologic (antibody) testing performed on all donated blood has created an incredibly safe blood supply. But if a person donates too recently after being infected, HIV-positive blood could still mistakenly yield negative results. To ensure a person won't accidentally donate tainted blood during that window, the FDA uses a questionnaire that screens potential donors by asking them questions about high-risk behavior.

"One of the most powerful things we do is turning [potential donors] away," says Richard J. Benjamin, MD, the chief medical officer for the American Red Cross, which collects more than 40% of the nation's blood supply. "We turn away one in eight." And it works. By Benjamin's estimate, the HIV rate among the general U.S. population is approximately one case per 300 to 500 people, yet in blood donors who have passed the questionnaire screening the rate is only one in 10,000.

Though it acknowledges the merits of the FDA questionnaire, the American Red Cross takes issue with question number 34: "From 1977 to the present, have you had sexual contact with another male, even once?" When the major blood collection groups called the lifetime MSM ban unwarranted, they did so because officials believe the risk involved justifies not a lifetime ban but rather a "deferral" -- a period of time when a donor cannot give blood. "When we look at MSM, there is inequity there," Benjamin says. "For comparable behaviors we have 12-month deferrals."

FDA officials don't view the issue as a matter of inequity; they assert that their conclusions are simply data-driven. "We understand that there are debates, and we're respectful of them," says Jay Epstein, MD, director of the Office of Blood Research and Review for the FDA's Center for Biologics Evaluation and Research. "But when we reexamine the issue scientifically, we haven't seen data showing that [altering] the current [ban] could be accomplished without some degree of increased risk." Epstein particularly warns of the threat that screened, HIV-positive units could accidentally enter the blood supply through human error.

There's no denying that the HIV rate among MSM population is disproportionately high (the FDA claims it is as much as 60 times that of the general population and 800 times that of first-time blood donors). But Steven Kleinman, MD, senior scientific adviser to the American Association of Blood Banks, says there is a historical flaw in the way the FDA looks at the data. "Much of the [MSM] data comes from STD clinics, so they come from people who have the most promiscuous MSM behavior," he says.

This poses an essential question: Why can't a gay man in a monogamous relationship donate blood, when a heterosexual with multiple sex partners often can?

Epstein recognizes the "argument that's been made that we can identify which donors have controlled their risk through mutual monogamy and low numbers of [sexual] partners. But there are no scientific studies that indicate questioning in the donor room can accurately identify [high-risk] donors." Yet the same questioning is relied upon in the donor room to prescreen the risks of heterosexuals.

"The [American Association of Blood Banks] and I personally believe it's a valid question to ask men if they've had sex with other men," Kleinman says. But, he adds, the act should be dealt with as an individual incident of risk based on recent activity. "I don't see the rationale for keeping the current policy in place."

A small but forceful congressional contingent agrees. In April, California representative Diane Watson sent a letter, signed by six House colleagues, to FDA officials urging them to reconsider the lifetime gay ban and to replace it with a one-year deferral policy. Watson cited research pointing out that Argentina, Austria, Hungary, and Japan have adopted one-year deferrals with no increase in HIV in their blood supplies. She also noted that cases of HIV infection via transfusion in Spain decreased from 24 during the last year of its gay ban to just four annual cases five years after restructuring its protocols. "[The policy] relies on generalizations to justify a double standard for MSM compared to heterosexual donors who engage in high-risk sexual activities," Watson wrote.

The FDA's written response to Watson's letter ignored the international evidence. One portion of the response was particularly troublesome: "FDA is also concerned about the transmission of other transfusion-transmissible infections, both known and potentially unknown.... It is important to recall that by the time AIDS was recognized, long before HIV was discovered as its cause and a test for its detection developed, the virus had spread into and through the blood supply, infecting thousands of individuals."

The argument seems to imply that, because HIV is spread in the United States largely through unprotected gay sex, gay men shouldn't be trusted as donors -- ever. After all, who knows what they might be stricken with next? "The concept that disease enters the population before we realize it, it's not wrong, but it's not specific to the gay community," Benjamin says. AIDS has spread through heterosexual populations across Africa. Severe acute respiratory syndrome (SARS), H1N1 ("swine flu"), and West Nile virus are all infectious diseases that spread in America without sexual contact as the vehicle for transmission.

Gayle says she will approach this debate with an open mind -- though it's not yet clear what her stance on the FDA policy is. Obama's pick for the Presidential Advisory Council on HIV/AIDS says she would like to see the policy reexamined, but she acknowledges both the complexity of the issues and the damaging discord between the FDA and blood collection organizations: "All the parties and the public have to understand why there is a policy, and then we can say, 'This is why the policy is staying in place or not staying in place.' "

The public might not be so keen to change, however. "We live in a nation with a zero tolerance of risk," Gayle says. "There has been a lot of work making the blood system as safe as possible, and there are many people who say, 'I'm not an intolerant person, but why argue with what is working?' "

Critics of the ban, however, point to practices that carry a greater risk of HIV infection than ending the lifetime MSM ban would create. The June issue of the journal Transfusion contains a study of one such example: Platelets, small cells that aid in blood clotting, are a vital blood product for many Americans, including cancer patients undergoing certain types of treatments that cause platelet loss. Because platelets are only one element of blood, it's difficult to obtain enough platelets equal in volume to a unit of whole blood. To do so, the FDA allows platelets to be culled from multiple donors. In the United States, 87.5% of blood-platelet units are collected from single donors, while 12.5% are pooled from four to six donors. Each pooled unit is therefore four to six times more likely to be contaminated than one from a single donor. Using pooled platelets means an additional HIV-infected unit could erroneously enter the supply on average every 2.13 years. But reducing the lifetime MSM ban to a one-year deferral would mean an additional HIV-infected unit could enter the system on average every 5.55 years, while a five-year deferral would mean one unit every 33.3 years.

Writing in a separate, peer-reviewed editorial in Transfusion, Eleftherios C. Vamvakas, MD, of Cedars-Sinai Medical Center in Los Angeles makes this conclusion about the study: "Concerning the HIV risk alone...the MSM deferral should be harmonized with the current deferral for similar-risk activities through heterosexual contacts." He writes, "Even if [the use of pooled platelets] were banned, however, other examples would demonstrate that the currently tolerated transfusion risk is often higher than" the risk of lifting the lifetime ban on blood donation by gay men.

If you ask experts whether the FDA policy barring gay male donors is governed by science or politics, the answers won't be uniform. Epstein defends his agency as having "an open mind" on this issue and adamantly denies that the policy is subject to political influence. Even those who disagree, however, are heartened that the FDA is now under the direction of Hamburg, who has spent her career fighting HIV and other infectious diseases. Likewise, the Presidential Advisory Council on HIV/AIDS may spur more progressive policy under the leadership of an in-the-trenches HIV veteran like Gayle than it did under Senator Coburn.

Changing the blood policy may not currently be a high priority for the FDA, an agency overwhelmed with emerging food safety threats and a new mandate to monitor the tobacco industry, but with the president pledging to make "scientific decisions based on facts, not ideology," the FDA may soon be unable to ignore the mounting evidence against the ban. As Vamvakas recognizes, the need to "provide a scientific justification for indefinitely deferring all MSM from donating blood cannot be ignored."