Wednesday's announcement from the Food and Drug Administration that it will retain a ban on blood donations from homosexual men, is coming under fire from advocacy groups and some physicians as scientifically unsound and discriminatory.
As perfectly healthy gay men face a lifetime ban from voluntarily donating blood, many have been re-examining the scientific validity of this FDA policy.
Yet doctors who work at blood banks, including Dr. Robertson Davenport, associate professor of pathology at the University of Michigan Hospital, believe the move is justified.
"The data are clear that men who engage in sexual contact with other men, as a whole, have a significantly higher risk of HIV," says Davenport. "Given our testing is not perfect, we will increase the risk to patients."
The chance of getting HIV from a blood transfusion is about one per each 2 million units of blood transfused, according to the FDA's Web site. Yet despite this statistic and the increased accuracy of HIV testing options, the FDA declines to re-evaluate the 15-year-old ban on gay men donating blood.
"This policy reflects public health thinking in 1989, before the availability of excellent laboratory tests for major infectious diseases," says Dr. Neil Blumberg, director of transfusion medicine and the blood bank at the University of Rochester in New York.
The FDA Web site goes on to say that the risk of getting HIV from a blood transfusion has been nearly eliminated in the United States. However, the agency cites a laundry list of reasons that support the ban, including the risk of false negative HIV tests and human error.
Indeed, statistics from the Centers for Disease Control and Prevention show that men who have sex with other men account for the largest number of people newly infected with HIV.
But still, a gay man in a healthy, HIV-negative, monogamous relationship gets no special consideration. The FDA maintains that this man, and any other man like him, is still at an increased risk for contracting HIV and other transfusion-transmissible infections.
This is "scientifically unsound," says Blumberg, adding, "Men who have sex with men are at no greater risk to transfusion recipients than heterosexuals with many partners."
These sentiments are echoed by others, including Joel Ginsberg, executive director of the Gay and Lesbian Medical Association who calls the FDA's actions "disappointing."
"If a man has sex with a high-risk woman, he's allowed back into the donation pool after 12 months," says Ginsberg. "If he has safe sex with another man, he's banned for life."
All potential blood donors undergo a routine screening that outlines any potential risks the donors may face. The screening procedure also includes a questionnaire intended to determine the safety of the donor's blood.
Donors who lived in European countries with reported cases of bovine spongiform encephalopathy, more commonly known as mad cow disease, are automatically disqualified from donating. Additionally, anyone found to have a history of intravenous drug use is banned from giving blood.
"Blood bankers have an ethical duty to patients to provide safe and effective therapy," says Davenport.
"Patients are more vulnerable than the donors, because they are being transfused out of necessity, not choice," he says. And a transfusion-transmitted HIV infection would be a significant harm the patient would otherwise not have been exposed to.
The FDA's screening program has been largely successful. According to its Web site, it has helped eliminate nearly 90 percent of unsuitable donors.
Yet much of the screening relies on the honesty of those answering the questions. There remains a risk that donors will lie about their medical history, misunderstand the questions posed to them, or not remember using intravenous drugs.
The possibility that these donors may be carrying the HIV virus could be compared with the possibility that a gay man is carrying the virus.
"They are part of a similar higher-risk demographic group," says Blumberg, who adds that taking a donor history is of little to no protective value to transfusion recipients.
Donor histories are "notoriously unreliable and now much less useful in screening blood donors than we would like to think," he says.
No one denies that the FDA has made great strides in providing patients with adequate supplies of healthy blood.
Critics only hope that its policy of banning an entire demographic comes from sound evidence.
"We're just trying to make sure that these decisions are based on science," says Ginsberg, "and not preconceptions about gay and bisexual men."