A Bloody Shame

by Howard Fienberg
November 4, 2002

The American blood supply is in a stranglehold. The U.S. Food and Drug
Administration (FDA) and Red Cross continue to tighten their rules on who can donate blood. Both aim to ensure blood safety, but seem unable to balance competing risks. Blinded by fears that infection by the human version of mad cow disease, new variant Creutzfeldt Jakob disease (nvCJD), might spread through blood, they have neglected the problem of a shrinking blood supply, which their regulations exacerbate. In their rush to ensure the safety of blood, they risk leaving us no blood at all.


No trace of nvCJD has ever been found in the United States. But travelers to Western Europe just might have consumed beef tainted by mad cow disease, which just might cause nvCJD in humans, which just might be conveyed via their bloodstream into the American blood pool, which just might lead to infection in people who receive transfusions.


Two years ago, the Food and Drug Administration (FDA) banned Americans who have spent more than six months in Britain between 1980 and 1996 from donating blood, eliminating approximately 2.2 percent of eligible donors. This year, the FDA phased in a ban on those who were in Britain for more than three months and those who had spent at least five years in Europe since 1980. The Red Cross went farther, placing their ban on any donors having spent more than six months in Europe. The FDA expects its guidelines to eliminate a further five percent of eligible donors; the Red Cross, eight percent.


Is this sound policy-making? There is still no evidence that nvCJD can spread via blood transfusion. Indeed, a special council of the American Medical Association concluded three years ago that "epidemiological studies show no evidence that transmission can occur through blood." Further, while many researchers agree that mad cow disease is linked to nvCJD, they do not know how. No one knows quite how the disease can get transmitted. Does it take one mad cow-infected hamburger or years of continuous beef-eating? We have no clue. Why did the millions of Britons who ate tainted beef in the eighties only result in more than a hundred cases of nvCJD? We have no idea. And what about the similar lot of American eaters of British beef (before it was banned in 1989), when not one nvCJD case has appeared in the U.S.? Once more, we simply do not know.


Overall, if there is any risk, it is probably low. A little over a hundred people have died from nvCJD. If the disease lives up to its earlier media hype, these victims could just be the tip of the iceberg. But recent projections depict a relatively limited threat to public health - it is possible that the disease could top out at less than a few hundred cases.


If the risk of nvCJD to the blood supply is entirely theoretical, how can we decide whom to bar from donating blood? With the bovine version of mad cow disease all but eliminated from the British landscape, when can we mark a cut-off for the risk there? The most recent FDA and Red Cross proposals were spurred by small outbreaks of mad cow across Europe a year and a half ago, but what happens when mad cow cases hit other countries? Should we then consider a ban on donors who have ever been anywhere outside North America? On top of this conundrum, why do the FDA and Red Cross insist on screening people regardless of their eating habits? If these authorities have convinced themselves that mad cow-tainted beef is the culprit in nvCJD, shouldn't people who don't eat beef be given a free pass? Can't we allow vegetarians and observant Hindus the opportunity to donate blood?


The precautionary principle, invoked to justify destroying a significant part of the nation's blood cache, dictates that it is better to be safe than sorry. But risks must be balanced; swerving to avoid one risk usually sends you careening into several more risks you might not have considered at first.


Jeanne Datiotis, president of America's Blood Centers, explains that the "greatest risk to the blood supply is not having enough," and that continues to be our problem. On the demand side, more surgeries and an ever-graying populace lead to ever-increasing demand. Meanwhile, on the supply side, although some 60 percent of Americans are eligible to donate blood, less than 3 percent do (not counting the temporary surge in donation after 9-11). The increasingly harsh bans on donors seem to target older, well-traveled donors, who are also traditionally the most reliable ones. New donors are hard to find and expensive to attract. But more importantly, they can carry all sorts of diseases, which we know to be transferable (unlike nvCJD). According to estimates from the American Association of Blood Banks, about 25 per 10,000 blood donations test positive for hepatitis C, between 9 and 17 per 10,000 test positive for HIV, and about 6 per 10,000 test positive for hepatitis B.


The impact of the blood bans is already being felt. The greater New York City area, which annually imports 140,000 units of red blood cells from Europe, has had to get creative to make up the shortfall. America's Blood Centers has turned away 30,000 donors (8 percent of all people prevented from donating) since the first phase of the restrictions came into effect on May 31. We can only speculate about how many stayed away of their own accord, having heard of the restrictions beforehand, or how many more donors will be lost now that the remaining facets of the restrictions came into effect October 31.


Wary of repeating past mistakes with the blood safety, like the spread of AIDS, the FDA and Red Cross have become blinded by hyper-cautious instincts. Proper caution should derive from a reasonable assessment of cost and benefit, not the insane fear of poorly-understood risks. While we can't expect good sense from an organization that collected far more blood that it needed in the wake of 9-11 and ended up having to discarding most of the proceeds, we should expect more thoughtfulness from our federal authorities.


If a case of mad cow were one day found in the United States, would all blood donations then be banned? That was the solution in the United Kingdom, which now imports its blood from us. At what point will they draw the line between vague possibilities and concrete probabilities? Both agencies face some tough questions - and temporarily fudging the answers only makes it harder to deal with problems down the road.

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