Among the intimate questions asked of Mr. McMoore by the Red Cross, and posed to all prospective donors by all blood banks in the land, were these: Had he been diagnosed or treated for a sexually transmitted disease in the last year? Had he had an organ transplant in the last five years? Had he visited a prostitute in the last year? And then the one question that struck him like a brick: Had he ever had sex with another man, even once, since 1977?
As an openly gay man in a committed relationship, Mr. McMoore answered yes. As a result, he was denied permission to donate blood. Since Mr. McMoore is not infected with HIV, and had no other reason for being denied permission to donate, he filed a sexual orientation discrimination complaint against the Red Cross with the District of Columbia Human Rights Commission. The complaint against the Red Cross by Mr. McMoore was eventually settled privately. Although his pursuit of legal redress is unusual, his experience is familiar to any gay man who has tried to participate in a volunteer blood drive.
Is the policy a discriminatory relic of an earlier era? Is the policy based on the nasty ideas that gay blood is "dirty" or that all gay men have HIV? Since the nation faces a severe shortage of blood, why are otherwise healthy gay men prohibited from blood donation? What is the basis of this policy, and what, if anything, is the FDA willing to do about it?
The answers to these questions require taking a look back at the early years of the epidemic, understanding current patterns of HIV transmission, estimating the numbers of gay men in the United States, and examining how the nation's blood supply is collected and regulated.
In this information vacuum, blood safety officials at the FDA decided to exclude from blood donation those emerging as the first "risk groups" for the new illness: gay men and Haitians foremost among them. Because of a high rate of Hepatitis B virus (HBV) infection among gay men, blood safety officials started screening donated blood for antibodies to HBV, using it as a surrogate to identify individuals who might have the new illness. After HIV was identified as the cause of AIDS in 1983 and an HIV test developed over the next year, blood safety officials at the FDA finally mandated HIV screening for the blood supply in 1985.
During this early period, the nation's blood supply's safety systems were revealed to be inadequate and overly influenced by the commercial interests of major blood products companies. Tens of thousands of blood transfusion recipients and persons with hemophilia became infected with HIV during this period, many unnecessarily so -- because of corporate and institutional inertia, indecision, and perhaps darker reasons. Several years, many lawsuits, research studies and millions of dollars later, the FDA eventually developed a redundant safety process to protect the integrity of the blood supply.
Today, blood safety is assured by a three-stage safety system. The system has redundancy built in because the FDA assumes that mistakes may be, and indeed are, made at any step of the process. The first step is "donor deferral" -- that is, a policy of restricting those who are most likely to introduce HIV or other infectious agents into the blood supply. Donor deferral is meant to minimize the chance that an HIV-infected unit of blood is ever drawn in the first place. The policy is most evident in the intimate questions asked of all who donate blood. It is the most visible step in the blood safety process, and the point when gay men confront the fact that their blood is unwanted.
Donor deferral is a complex process. Each question asked can lead to different restrictions. A person who recently received a tattoo cannot donate blood for twelve months after being inked, nor can a person who's visited a prostitute. Pregnant women cannot donate until six weeks after delivery. A person who has had tuberculosis must wait two years after successful curative therapy to give blood. The list of restrictions is long and complex and not all seem obviously justified. (See box: The Top 52 Reasons for Not Being Able to Donate Blood.)
What rankles gay men the most is that any homosexual activity since 1977 results in, what is essentially, a lifetime ban on blood donation. Homosexuality is placed in the same class as prostitution and intravenous drug use, practices that also result in a permanent ban on giving. For a well-adjusted, HIV-negative, upper middle-class, homosexual college student, this seems like a smear and smells discriminatory. The only other permanent restrictions are for people with medical conditions like cancer and heart disease. The contradiction for gay men becomes apparent when one considers that a heterosexual man can have unprotected anal sex with female prostitutes for years, stop, and then donate blood twelve months later, while a gay man in a monogamous relationship who practices safe sex is forever barred from donation.
Obviously many men lie when questioned on these touchy topics. The questionnaire is carefully worded, of course. It does not inquire if a man identifies himself as gay, but rather asks the more general question if he "has had sex with another man." Who is more likely to answer this honestly -- an openly gay man, a closeted but married man, or a bonafide heterosexual who had sex a few times in 1983 with his college roommate? Blood safety officials assume some fraction of prospective donors will fib on this question, which leads to the next stage of the process.
The second stage of the blood safety system involves testing all donated blood for infectious agents, including hepatitis viruses, HIV, HTLV (a cancer-causing virus), and syphilis. Many people erroneously believe this is the full extent of the blood safety process. The tests for HIV and other infectious agents are very good, and every day, units of infected blood are identified and discarded at this stage. However, testing all blood for HIV is not, by itself, an adequate safety measure.
Most may be familiar with the concept of a "window period" with new HIV infections -- that is, a time of weeks to months when a recent HIV infection may not be detected by standard HIV tests. Because the tests spot antibodies to the virus, and antibodies take time to develop in a newly infected person, there is a period when one can test "HIV negative" yet still transmit the virus to others. This "infectious window" remains open due to the current limitations of testing technology. When HIV testing first became available, the tests were not very refined -- they often left open as much as a six-month window for HIV to slip through. Improvements in testing technology have narrowed the window period to no more than a few weeks. But the testing technologies in place cannot close the window entirely because of the way HIV establishes an infection in a new host.
We have to assume that some people who have recently been infected with HIV donate blood and that a few of these infected units get into the blood supply despite HIV testing. The present risk of acquiring HIV from an infected blood transfusion is about one in every million units of blood, with almost every infected unit having slipped through during the window period.
To help close the window, the U.S. government has invested in a variety of technologies to detect fragments of HIV itself, rather than the delayed antibody response. p24 testing is used by blood banks to detect HIV antigens that appear in blood before antibodies develop. The FDA estimates that HIV p24 antigen testing can detect HIV-infected blood donations, on average, five days before antibodies are detectable by standard screening tests.
To improve this performance further, the FDA and others have invested in a new HIV testing technology called Nucleic Acid Testing (NAT). NAT testing is in advanced stages of evaluation for use in blood screening. It has the potential to shave a few extra days off the window period, and could, in practical effect, close the window almost completely. However, the FDA has not yet licensed this test for blood screening purposes, and more research remains ahead.
"HIV RNA viral load" testing -- familiar to anyone who is HIV infected and receiving health care in the United States -- is a technology that not only quantifies the amount of HIV in a person's blood but also has the potential to detect HIV infection sooner than any other technology available. "It wins hands down," said FDA blood expert Michael Busch at a recent public hearing. But cost and technological complexity have raised objections from the blood industry and others. In any event, the window remains slightly open, and although a technological fix is possible, it is expensive and not quite ready for general use.
The third stage of blood safety in the United States is the regulation and quality control of the blood banks themselves. The collection, processing, and distribution of blood is a big business in the United States. The FDA ensures that blood banks operate according to good manufacturing practices. These include having automated systems and making sure HIV-infected units of blood are properly labeled and separated from the usable blood when they are identified. This is perhaps the messiest part of the blood safety system.
Recently the FDA filed a lawsuit against the American Red Cross, which collects about half the blood in the United States. The FDA filings maintained the Red Cross has "a long-standing and ongoing failure to comply with good manufacturing practice standards in collecting, processing and distributing blood used in medical procedures." The Red Cross "has not been in compliance since at least 1985," the FDA maintains, and increasingly tough action by the government has failed to correct these problems. Over the past decade, the FDA has taken similar steps against other blood banks, including the New York Blood Center, the major source of blood for the New York region.
In summary, the blood safety system in the United States has three parts:
Of course safe sex works, and many gay men are in monogamous relationships. But HIV prevention is not perfect. Gay men continue to become infected with HIV in substantial numbers, despite the best prevention efforts. Researchers put the annual infection rate for urban gay men in their teens or twenties as 1 to 3 percent annually. This number sounds small, but it is cumulative. In some major cities, like New York, around 15 to 20 percent of gay men are now infected with HIV -- and the prevalence is higher in some regions and ethnic groups. Furthermore, gay men in monogamous relationships still become infected. People cheat on their lovers, whether gay or straight, but the risks of such cheating, especially if unsafe sex is involved, are increased for gay men because of the high prevalence of HIV in the pool of potential sex partners.
The official thinking for why gay men should not be allowed to donate, therefore, goes something like this: If the blood donor pool is opened to healthy gay men, not many more potential donors are included given the small numbers of gay men overall. Assume 5 percent of the 130 million American males are gay, which gives a rough estimate of 6.5 million gay men in the United States. Assume at least 85 percent of these men are healthy, HIV-uninfected, with no other exclusions and that they would donate blood at roughly the same rate as the rest of the population (less than 5 percent). This results in an expansion of the donor pool by only about 250,000 people. At the same time the donor pool is opened up to a much larger number of potentially HIV-infected people. The risk of allowing gay men to donate is therefore disproportionate to the benefit of a relatively small increase in the donor pool.
This cold calculation gives a sense of the underlying argument for a level of caution when considering the issue but does not answer why all gay men, or at least any man who has had sex with a man since 1977, should be permanently barred from blood donation. Why not expand the donor pool by 250,000 when the nation faces a blood shortage? Is there some other way to formulate a policy based on science that recognizes epidemiological reality but also feels less discriminatory and stigmatizing to healthy gay men?
A recent meeting of the Blood Products Advisory Committee of the FDA addressed this question. At the start of the meeting, the committee agreed that the permanent ban on gay men seemed discriminatory, lacked a firm foundation in science, and should be changed. A majority of committee members indicated they would vote to change the policy. Public statements from the Gay and Lesbian Medical Association, the Human Rights Campaign, various hemophilia groups, and the American Association of Blood Banks all urged a change in the policy. Only the American Red Cross urged no change be made. But, what should the policy be changed to?
The FDA proposed changing the lifetime ban to five years, bringing the gay ban in line with the length of time organ or tissue transplant recipients are barred from blood donation. In other words, any man who has had sex with another man during the last five years would be barred from donating. The blood bank association urged a one-year ban, putting the gay ban in line with that for visiting a prostitute, and the gay doctors made a similar proposal. Any of these approaches are unlikely to feel less discriminatory, and are unlikely to have much practical effect for the majority of gay-identified men. The only men who may be included in the donor pool as a result of such a change would be those who had their last homosexual experience five or more years ago.
The committee seemed poised to recommend a change in the gay donation policy, but then the slides on herpes virus 8 were presented. Human herpes virus 8 (HHV-8) is a newly discovered virus thought to be the cause of Kaposi's sarcoma (KS). HHV-8 is also widespread among gay men, which helps explain the early, baffling concentration of KS among gay AIDS patients but not heterosexual ones. Although KS in gay men is almost always the result of infection with both HIV and HHV-8, there have been a few isolated cases of KS in gay men with HHV-8 alone. Data emerging on HHV-8 show that it shares a similar epidemiological profile with HIV. Gay men begin acquiring HHV-8 during late adolescence when sexual activity begins, and its incidence accelerates through early adulthood. By age 40, about one-third of gay men seem to be infected with HHV-8. The virus appears rarely in the U.S. heterosexual population.
HHV-8 is most likely transmitted orally, but no blood test is routinely available to detect those who have it. In Africa, where HHV-8 is endemic, the virus seems to be acquired in childhood. HHV-8 has also been transmitted through kidney transplants and dialysis procedures. Can HHV-8 be transmitted through a blood transfusion? No one knows. Faced with this uncertainty, the committee changed its mood, and declined to recommend a specific revision of the gay blood donation policy.
After deciding not to alter the policy, the committee outlined a series of research questions for the FDA that may help the agency revisit the issue at a later date:
All of these are fascinating and important questions, and answers to each could have a broader use in fighting the epidemic. However, given the paucity of epidemiological data generated about gay men after 15 years of research, these questions are unlikely to be answered soon, if ever. So what can gay men do now?
During a blood drive, coworkers and fellow students are rounded up and exhorted to donate. But, as we've seen, some people shouldn't give blood. When asked, "Why didn't you donate?" awkward, embarrassing moments can ensue if people feel compelled to discuss sensitive behaviors or personal medical conditions in an insecure social setting. What male employee at an auto plant, for example, wants to say to a fellow mechanic, "I can't give blood 'cause I fool around with guys?"
Members of other risk groups blacklisted by donor deferral may feel the insult and anxiety experienced by gay men when pressured to donate even more acutely. While a gay man who knows his HIV-negative status may fib and donate without causing harm, individuals with HIV do not have that option. People with HIV or hepatitis C virus (HCV), to name only two, face a difficult choice of either revealing their status (and certain presumed behaviors) or appearing selfish and unwilling to volunteer for a good cause. Either way they face stigma. These problems are compounded when there is a risk that a person can be fired or even meet physical violence if they are discovered to be gay or HIV positive.
A search of the medical literature, and interviews with blood supply experts, yielded virtually no insights into better blood collection strategies. Given the shortage of blood nationwide, this seems like a major oversight. Clearly new blood collection initiatives are needed, and hopefully methods can be found that will not place people in uncomfortable situations.
A review of "blood drive organizing kits" illustrates the problem. The packets, available from any local blood bank, help a civic-minded person organize a blood drive in his or her school or work place. The packets advise organizers to "be persistent!" "Ask every employee personally, and confirm their participation." "Involve management and give managers updates on who is participating!" Of twenty-three blood drive packets reviewed, only one from the New York Blood Center advised organizers to respect the privacy of employees who decline to donate. One easy and immediate improvement would be to train blood drive organizers -- obviously well intentioned people -- to understand that some people cannot donate blood, and that their privacy must be protected. Another tactic to preserve one's privacy might be to become familiar with the myriad reasons why people can't donate, then toss out a plausible excuse when the blood drive organizer pounces. Or, if you must, simply call in sick when the blood mobile pulls up.
-- Daar ES, et al. Diagnosis of Primary HIV-1 Infection. Ann Intern Med. 2001;134:25-9.
|The Top 52 Reasons for Not Being Able to Donate Blood|
|Condition||Length of time (before you can give blood)|
|Not feeling well for any reason||Until symptoms are over|
|Difficulty breathing, shortness of breath, asthma||No difficulty breathing on day of donation|
|Ears, nose, or skin pierced, acupuncture||One year after procedure unless done under sterile conditions|
|Blood transfusion||One year after receiving blood|
|Abortion or miscarriage||Six weeks if after the first trimester (12 weeks)|
|Dental work||Seventy-two hours after root canal or after tooth is pulled|
|Have had sex with a male or female prostitute within the past 12 months, even once||Twelve months after last incident|
|Measles, mumps, chicken pox||Three weeks from day of exposure (can give blood if vaccinated or had disease in past) and no signs or symptoms|
|Tuberculosis (T.B.)||Two years after completion of treatment|
|Have been an inmate of a correctional institution for more than 72 consecutive hours||One year from date of release|
|Sniffed cocaine within last 12 months or had sex with someone who sniffed cocaine in last 12 months||Twelve months after last incident|
|Cold, sore throat, respiratory infection, flu||Until symptoms are over|
|Antibiotics (except antibiotics for acne)||Two days after treatment is over if taken for infection|
|Tattoos||Twelve months after procedure|
|Full-term pregnancy||Six weeks after delivery|
|Surgery, serious injury||When healing is completed|
|Sexually transmitted disease: venereal disease, chlamydia, genital herpes, syphilis, gonorrhea||Twelve months following diagnosis and treatment|
|Open-heart surgery (except coronary artery bypass)||Three years after surgery|
|Lyme disease||Six months after date of last signs or symptoms/48 hours|
|Accutane||One month after taking last dose|
|Aspirin||If donating platelets by apheresis, three days after last dose|
|Have had sex with anyone listed in the first five categories in the Permanent Restrictions listed below||Twelve months after last incident|
|Permanent Restrictions (Please do not give blood if you:)|
|Source: New York Blood Center|