In Need of New Blood

When it comes to donor discrimination, blame the feds

by by Robert Moor

Staring up into the dusty rafters of Brown's Sayles Hall, I lie on my back and feel the blood drain out of me. It coils down into a plastic bag, which gets refrigerated, spun, separated, tested for pathogens and then doled out to patients in need of a transfusion. It is an act of beautiful simplicity: we open our veins and give of ourselves so that others may live.

As businesses that deal primarily in the currency of human altruism, blood centers worldwide must take precautions to keep from turning off potential donors.

Unfortunately, this is precisely what happens every week in towns across America as potential donors encounter the crudely worded "donor eligibility survey," which screens out donors who are demographically at higher risk for certain blood-born diseases, particularly malaria, hepatitis C, and HIV/AIDS. Among those patients "deferred indefinitely" by the survey are certain West African citizens, British residents, people who have spent more than 3 days in jail and any man who has had sex with another man, "even once, since 1977." Since all donated blood is tested for all blood-born diseases anyway, many believe that this screening process is redundant and in need of revamping. More damningly, some allege that the process unfairly discriminates against gay and bisexual males.

However valid, these arguments tend to overlook a subtler point: broad demographic-based statistics are misleading when applied to donor groups, because the donor population is not the same as the general public. For example, while male homosexuals are 60 times more likely to test positive for HIV/AIDS than the average citizen, they are also more likely to have already been tested in the past. The likelihood of a gay male donor having HIV is thus lower than that of an average gay man; the donor pool is to a large extent self-screening.

The net result of the FDA's policy is that it ends up blindly screening out a huge quantity of healthy, clean blood--blood that could be saving lives. Moreover, since the test relies upon what is essentially the honor system, if a donor from Nigeria wants to donate blood, there is no reason he can't simply lie and say he's from Kenya, or even from Iceland. That the survey has no safeguard against such deception indicates that the ban on West Africans is not a matter of absolute necessity. In truth, the donor screening procedure is a relic of the FDA's panicked response to the AIDS scare of the early 1980's-- a time before the invention of blood testing--and has persisted more out of fear than prudence ever since. It is high time for the entire practice to be rethought.

"Blood is a drug"
One of the first things Jeanne Egan tries to impress upon me is that, according to the FDA, blood is considered a drug to be used for medical purposes. The second thing she makes clear is that the FDA is very, very stringent about regulating drugs. Jeanne is the Quality Assurance Manager for Donor Services at the Rhode Island Blood Center (RIBC), which coordinates all the state's blood drives. Unlike other states, whose blood donation services are handled by the Red Cross, Rhode Island's blood drives are managed by a relatively small, community-run blood center. When I sat down with Jeanne to discuss the screening criteria, I was struck by the sharp distinction between the roles of RIBC and the FDA. While RIBC alone is in charge of every level of the blood drawing process from vein-to-vein, the FDA writes the safety protocol. Each month the FDA issues a pamphlet of "guidances," densely worded instructions detailing exactly how blood should be drawn, stored, tested and transported. It is from these FDA guidances that the donor eligibility survey is culled.

Kathleen Connolly, who has been with RIBC since its inception in 1979, has watched the number of questions swell from somewhere around 20 in the early 1980s to its current 42 questions and sub-questions. She remarked that the FDA frequently adds questions, but very rarely removes them. There are some notable exceptions, however. During the 1980s, no person with a tattoo of any kind could give blood. This regulation changed when the state of Rhode Island (at the behest of RIBC) filed for a variance with the FDA, reasoning that people who visited state-inspected, state-approved tattoo parlors should be at very low risk for blood-born diseases. The FDA listened and repealed the restriction, much as it did with regards to donors over the age of 66 and to people with unusually high red blood cell counts, both of whom were also prohibited from donating in the past.

Unfortunately, Kathleen explained, these repeals took years of badgering and countless man-hours. Workers at RIBC seem wearied by the prospect of lobbying for a repeal on an issue as contentious as man-to-man sex, and thus unlikely ever to do so in the future.

Around the RIBC office, the prototypical FDA worker is envisioned as a bespectacled 90 year-old sifting drowsily through an endless pile of paperwork. The image is apt; both the myopia and the logistical morass speak volumes about the FDA's current approach to risk management. The FDA is a colossal bureaucracy, with a budget of over $2.4 billion and employing over 80,000 workers, which only slows the already glacial pace of change.

This backward-glancing, bureaucratic style of decision-making puts the FDA at a higher risk of being caught unawares by unforeseen pandemics. When the FDA first assumed the oversight of blood donation in the late 1970's, the earliest inspectors were ex-meat inspectors, many of whom admitted that they had never been trained for this task. Meat has blood in it, after all. It is thus unsurprising that the FDA was unprepared for the AIDS crisis that began in 1981, when an uncounted number of people received transfusions of contaminated blood. Among these victims were high numbers of hemophiliacs, who, in a poignant twist, are now banned from giving blood by the donor eligibility survey, precisely for their higher rate of (transfusion-contracted) HIV and AIDS.

Closing the window
Following the AIDS crisis, the FDA began implementing a number of preventative measures to cut down on the number of 'high-risk' individuals donating blood, specifically homosexuals, intravenous drug users and prostitutes. When the first HIV test was invented in 1985, the 'window period' (the time span between the contraction of the disease and its detection) was on average 22 days, and sometimes as many as six months. While the invention of the nucleic acid-based test has cut the window period down to between 4-12 days, Jeanne Egan argues that it is still enough time for HIV-infected blood to "slip through the cracks." Given this legitimate concern, it seems unlikely to Jeanne and many others that the FDA will ever lift their ban on high-risk groups of donors until the window period comes down to zero.

In light of this crucial impediment, gay rights activists concerned with altering the donor eligibility survey should urge Congress to increase funding for research initiatives working to design zero-window HIV tests. By quickening the rate of HIV diagnosis, such a test would expedite the reform process.

Looks like somebody's in need of a paradigm shift
Apart from supporting research initiatives, activists need to address the FDA directly if they are ever going to change the screening policy. Attacking community blood centers and the Red Cross is futile since safety protocol decisions are ultimately out of their hands. Instigating a boycott of blood drives--which some activists have proposed--is worse than futile: it would cost lives.

Perhaps the most cogent solution has been proposed by Dr. Joel Ginsberg, director of the Gay and Lesbian Medical Foundation, who argues that the FDA needs to shift from a paradigm of demographic risk to one of behavioral risk. He rightly points out that what puts people, regardless of their sexual orientation, at higher risk for contracting STDs are certain well-studied unsafe actions, many of which the donor eligibility survey already addresses. A behavioral model would also remedy the unreasonable 'permanent deferral' for West African immigrants who have repeatedly tested clean for blood-born pathogens. Updating the paradigm of risk management and setting up avenues for previously high risk donors who are verifiably disease-free to donate would be effective and deeply needed steps for the FDA to take.

In the past, activist groups have been offered to meet with the FDA in Washington, Kathleen Connolly says, and yet she recalls that "no one showed up." If the screening criteria are ever going to be changed, concerned activists are going to have to show up. And when they do, they will need to lay out a case for why screening based on demographic risk is wrong not just for one particular group, but is wrong, both philosophically and practically, for every person involved in the business of giving and receiving blood.

ROBERT MOOR B'08 listens only to Slayer when writing articles about blood.