If you walked into a blood donation center before the HIV crisis, you would have been asked 15 quick questions, then either accepted as a donor or not. Today those questions have burgeoned to almost 50, and the list continues to grow.
The extra caution stems from a colossal error that blood bank officials made two decades ago, when they ignored the early warning signs of HIV and failed to implement appropriate screening and cleaning procedures. As a result, America's blood supply became contaminated and 20,000 people were infected with the deadly virus. It's no surprise that the Food and Drug Administration (FDA) has decided to take no further chances. But its efforts to prevent another HIV fiasco may create a different sort of disaster: a blood supply that is extremely safe but too small to meet the nation's needs.
In response to recent outbreaks of such illnesses as SARS, West Nile virus, and the human form of mad cow disease (Creutzfeldt-Jakob disease), the FDA is forcing blood banks to follow rules that substantially increase the odds that a donor will be rejected. Safety experts consider many of these rules, known as deferrals, nonsensical, and they warn that the restrictions are reducing the donor base so drastically that hospitals would not have enough blood in the event of a large-scale crisis.
One of the most disparaged restrictions on donors is called the European deferral, which is aimed at reducing the risk that Creutzfeldt-Jakob disease will enter the U.S. blood supply. To date, there is no conclusive evidence that the disease can be transmitted via blood, although the FDA argues that studies have shown it is theoretically possible. The mandate bars donors who lived in the U.K. for three months or more between 1980 and 1996 or in Europe for six months or more from 1980 to 1990. Other restrictions exclude people who have had a headache with fever in the previous week; men who have had sexual relations with other men since 1977; women who have had sex with a man who has had sex with another man since 1977; people who have experienced angina in the previous year; and anyone who has received a tattoo in the previous year.
The rules have produced no shortage of critics. One is Arthur Caplan, a University of Pennsylvania medical ethicist who until last year served on the FDA's Blood Supply Advisory Committee. "The blood shortage is the worst challenge the health system faces in terms of doing without a key biological resource," he says. "It grows worse every day as demand continues to rise and supply stays stable."
Caplan argues that the FDA could relax some of the restrictions, thus increasing the number of qualified donors. "What possible reason would we have to defer donors who have not converted to AIDS since 1977?" he asks. "The disease has no such incubation period. Moreover, we can reliably detect anyone exposed to HIV within a year after the exposure." He suggests that instead of disqualifying those people forever, asking them not to donate for three years after engaging in risky behavior would achieve the same level of safety.
Caplan also believes deferring donors from the U.K. or Europe does not square with the evidence about the role played by blood transfusion in transmitting mad cow disease. "If it could be transmitted that way," he asks, "then why did it not appear all over the blood supply in the U.K.?"
Louis M. Katz, medical director of the Mississippi Valley Regional Blood Center in Davenport, Iowa, and president of America's Blood Centers, which supplies half the nation's blood, estimates that blood centers around the country have lost 5 percent to 10 percent of their donors as a result of the new FDA rules. He says the higher estimate applies if you include the people who don't even try to donate because they've heard about the deferrals. He adds that the rules have had an especially noticeable impact in cities such as New York, where a substantial proportion of the blood supply historically came from European donors or from donors with extensive travel to or residence in Europe.
Katz says the blood shortage is bad enough to force cancellations of surgery in some regions. Authorities had to begin making public appeals for blood almost as soon as the deferrals were put into place. In 2002, for instance, as two liver transplants were under way in Jacksonville, Florida, officials put out a press release declaring, "Florida Georgia Blood Alliance desperately needs your help today…to meet the blood needs of local patients."
Lisa Bloch, director of communications for the Blood Centers of the Pacific, says her organization is losing about 100 donors a month due to the European deferral alone. To make up for lost donors, it has to import 20 percent to 25 percent of its blood from outside its region. Asked if she would feel comfortable receiving blood donated without the current deferrals, she says she would. "I'm much more at risk if I don't receive a blood transfusion due to a severe blood shortage," she explains.
The FDA admits the European deferral alone will exclude at least 5 percent of people who habitually give blood, even though studies have shown that those people are least likely to have tainted blood because their motivations stem from a sense of moral obligation and responsibility to the community. But Jay Epstein, director of the FDA's Office of Blood Research and Review, says the deferral is an appropriate, prudent measure. He cites a study of sheep that proved it was theoretically possible for mad cow disease to spread via human blood. What's more, he says, the disease can take years, even decades to appear in its victims. A recent "probable case" of transmission by transfusion in the U.K. is still being investigated.
While the FDA may have reasons to err on the side of caution, the reality remains that Americans need blood and are dangerously short of it. Lisa Bloch believes Americans simply aren't aware of the critical need for blood. "The reality," she says, "is that there is a very small number of people shouldering a huge burden."
So why don't blood banks increase their efforts to recruit new donors? According to Katz, Medicare's reimbursement practices discourage them from doing that. When the FDA makes new demands on blood banks, such as issuing additional deferrals, the responsibility lies with them to make up for the lost donors, and that means an increase in expenses. That would be fine if somewhere along the line the blood banks recouped those expenses. But they don't.
"Where do we cut our expenses?" Katz asks. "In infrastructure, personnel, or investment in donor recruitment?" He says that when Medicare ignores the increased costs of new safety initiatives and doesn't adjust reimbursement to the end users (hospitals), the blood banks are under tremendous pressure to hold the line on their prices. And since most insurance companies use the reimbursement level set by the Centers for Medicine and Medicaid Service (CMS) as a benchmark, its policy "ripples throughout the entire health care system."
If CMS tied its reimbursement schedule to the increased costs of blood safety, Katz says, blood banks could use the extra funds to invest in donor recruitment. "We don't need 'help,'" he says. "We need for the unfunded mandates of the FDA to be funded by CMS. That would not be 'help'; it would be rational."
Another logical step would be to offer blood donors a cash incentive—a proposal that's been met with fierce opposition in the past from those who believe paying for blood would attract people who are so desperate for money that they might not be honest in responding to the screening questionnaire. (Plasma donors, interestingly, have been financially compensated for years.) But according to Richard Epstein, a legal scholar at the University of Chicago and author of Mortal Peril: Our Inalienable Right To Health Care? (2000), quality can be controlled by direct inspection in virtually all cases. (He does agree that some populations should be excluded, such as AIDS patients, intravenous drug users, and alcoholics.)
And the truth is that blood banks already offer donor incentives. Blood Centers of the Pacific gives its donors T-shirts and raffles prizes, for instance, along with the standard post-donation juice and cookies. It's hard to understand why the difference between cash and prizes should stand in the way of a potentially ample blood