Blood, Sex, and the FDA: Despite Recent Policy Changes in Other Countries and Technological Advances in Screening for HIV in Donated Blood, the FDA Stands Firm: Gay Men Pose Far Too Great a Risk to Give Blood. Will We Ever Be Allowed to Donate Again?

Article excerpt

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.

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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. …