Every two seconds someone needs a blood transfusion, according to the American Red Cross, and that amounts to more than 44,000 blood donations every day in the United States. The National Blood Centers Utilization Report found that blood cen­ters collected about 93.8 percent of the nation's total blood sup­ply in 2009 (the last year reported) while hospitals collected the balance (about 6.2 percent). America's Blood Centers, which includes various independent community blood centers throughout the U.S. and Canada, and the American Red Cross contribute more or less equally to the blood center portion of donations. Perhaps surprisingly, a centralized blood donation service does not exist; despite disparity, all donations are regulated by the Food and Drug Administration (FDA) and all blood banks and hospitals are required to follow the FDA's decisions.

Currently, less than 38 percent of the U.S. population is eligible to give blood. Safety for those patients who require blood transfusions — cancer patients undergoing chemotherapy treatment and car accident victims, among them — is the primary reason for this level of admissibility. In order to meet this constant need for blood donations, FDA has begun to examine its policy that prohibits blood donations from gay, bisexual, and other men who have sex with men (MSM).

Standards of Safety

Five layers of protection, as outlined by the FDA, are routinely implemented by the various blood collection groups:

  1. Donor screening
  2. Donor deferral registries to eliminate unsuitable donors from future blood donation
  3. Testing the donated blood for HIV-1 and 2, hepatitis B, hepatitis C, human T-lymphotropic virus types I and II, West Nile virus, Chagas disease, and syphilis
  4. Quarantining donated blood until its safety is established by all required tests and control procedures
  5. Monitoring and investigating problems occurring in blood donation/transfusion to correct deficiencies

In accordance with step two, the FDA has a deferral policy on blood donations from MSM. This ban originated in 1983 in response to the AIDS outbreak, when little was known about the virus. During the early 1980s, the nation's blood supply became contaminated with HIV. Among the many patients who became infected with HIV were more than half of the 17,000 people with hemophilia, a large percentage of whom subsequently died of AIDS.

Yet, a great deal has changed between the early 80s and now, including the science behind testing blood. In December 1999, blood centers began implementing, as part of a study, nucleic acid testing (NAT) for HIV and HCV to narrow the infectious period between the time of viral exposure and the time a virus can be serologically detected. This significantly improved the odds against a patient becoming infected. In fact, the FDA states on its website that, currently, only one in two million blood transfusions (approximately) results in an HIV infection.

And it is for this, among other reasons, that the Department of Health and Human Services Secretary (HHS), which oversees the FDA, created the Advisory Committee on Blood Safety and Availability to discuss the deferral policy on blood donations from MSM on June 11, 2010.

Changes

The committee found the current donor deferral policies to be suboptimal in permitting some potentially high-risk donations while preventing some potentially low-risk donations; nevertheless, its members voted in favor of retaining existing policy. They did, however, identify areas requiring further research and in response to these recommendations, HHS began the process of conducting additional studies to address these among other questions:

  • What is the root cause of the quarantine release errors, the accidental release of blood not cleared for use that occur at blood collection centers and potentially put the blood supply at risk, and what mitigations can be considered?
  • Do potential blood donors correctly understand and properly interpret the current standard questionnaire used to obtain donor history?
  • What motivates men with MSM behavioral history to donate blood and would MSM be likely to comply with modified deferral criteria?
  • Would an alternative screening strategy for MSM (and potentially other high-risk donors) assure blood safety?

Meanwhile, the Red Cross, America's Blood Centers, and AABB, a non-profit organization that represents individuals and institutions involved in the field of transfusion medicine, released a joint statement advocating a change to the policy so that MSM would be able to donate blood as long as a certain amount of time has passed since their last sexual encounter. Louis Katz, the vice president for America's Blood Centers, told ABC news that one option for the FDA is to adopt policies similar to those used abroad.

In Canada, the United Kingdom and Australia, for instance, gay men are allowed to donate blood if they have abstained from sex with a man for a certain period of time. "We understand that it is problematic, but it would be movement from where we've been since the early 80s," said Katz, who stressed this would just be a first step.

On Tuesday, the American Medical Association (AMA) joined the Red Cross and other organizations and voted to oppose the ban prohibiting gay men and other MSM from donating blood. "The lifetime ban on blood donation for men who have sex with men is discriminatory and not based on sound science," said Dr. William Kobler, an AMA board member, in a statement. The AMA recommends that the FDA craft a policy that more accurately represents scientific research and change its deferrals so that gay men are evaluated on an individual level rather than being lumped together in a high-risk category.

Actual Risk

In 2010, MSM accounted for 63 percent of all new HIV infections in the U.S., and overwhelmingly these infections occurred among those aged 25 to 34. Compared to other transmission groups, MSM accounted for the largest numbers of new HIV infections in 2010. At an FDA workshop that convened in 2006, Dr. Jay S. Epstein, M.D., Office of Blood Research and Review, commented on FDA's procedure for assessment of whether a change from permanent deferral to temporary deferral would be fruitful. "First we were going to survey the epidemiological data from public health surveys where we would be looking at the prevalence and incidence of HIV in MSM and other infections that would be prevalent or incident in MSM like hepatitis B, syphilis or recently lymphogranuloma venereum," he said.

For scientists, this policy of prohibiting gay men and other MSM from donating blood may be related not only to known diseases, but also to unforeseen ones. Incalculable fears arose from AIDS, once known as 'the gay plague;' discrimination, wrong and in individual cases wildly inaccurate though it may be part of a complex fear response on the part of policy makers who wish to avoid another such public health catastrophe.

As of today, the HHS and FDA continue to study the issue of whether gay and other MSM should be permitted to join the 9.5 million people, half men, half women, who donated blood (in 2009, as recorded by the American Red Cross). After all, a single donation, which amounts to about a pint of blood, can help save the lives of up to three people. (The average adult has about 10 pints of blood.) Difficult though it may be, the FDA and HHS must decide in the best interests of those who receive blood: in 2009, this number totaled five million.