America's official health nanny, the Food and Drug Administration, last week announced its intention to ban blood donations from anyone who has spent a cumulative six months or more in the United Kingdom since 1980. Canada immediately followed suit.
The reason for these drastic measures is, ostensibly, concern that blood recipients in America might contract a mysterious and deadly brain infection known as Creutzfeldt-Jakob disease (CJD). Protecting people from brain-eating bacteria seems an appropriate role for the FDA. In this instance, however, a closer look raises serious questions.
The annual incidence of CJD is one in a million. Those odds are pretty comfortable considering that a person's chances of being struck by lightning are almost twice as high. In recent years, a new variant of CJD has sprung up. So far as is known, it exists only in the U.K., with one exception in France. Medical researchers think it is related to Britain's infamous "mad cow disease." Even though the new strain of CJD is even rarer than the previously known one, U.S. and Canadian health officials decided to take precautionary measures.
The problem is that excessive caution in health regulation can have costs that outweigh the risks the regulators are trying to avoid. In this case, by ruling out a selected (albeit small) group of potential blood donors, the FDA will further limit the U.S. supply of whole blood, which is growing tighter by the day. Indeed, In a survey of America's blood banks and hospitals, the National Blood Data Resource Center estimates that demand for blood could outpace supply as early as next year.
According to America's Blood Centers--a nonprofit network that collects about half the nation's blood donations--the FDA's ban on donors who've resided in Britain could cause a 2.2% drop in supply. In its zeal to avoid the risk of a disease that is extremely rare the FDA thus courts another risk: that it ultimately affects substantial numbers of people in need of transfusions.
Since 1995, 42 people have died from the new variant of CJD. But the FDA itself admits "no evidence exists that [new variant CJD] has been transmitted by blood transfusion."
The American Red Cross, which collects the other half of the U.S. blood supply, doesn't seem to see much of a point to the ban. Dr. Richard Davey, chief medical officer, says: "There has never been a case world-wide of this disease or any related disease being transmitted by blood transfusion. The FDA's decision was based on very scanty scientific data."
In addition to the admitted lack of evidence behind the ban, the FDA's decision to exclude only those people who have lived in the U.K. for six months or more appears arbitrary. It seems the FDA arrived at the six-month decision because a more inclusive ban might have created a more immediate blood supply crisis. In other words, there was some attempt to balance the CJD threat against the impact on blood supplies. But given the lack of any evidence, the balance seems to us to have been tilted toward excessive caution and a lack of serious cost-benefit analysis.
It's not hard to figure out why. For regulators are not immune to the kind of hoopla we saw over mad cow disease. High-profile health scares may or may not pose a risk to the public, but they definitely pose a risk for regulators. What if it were learned that CJD had claimed a life in the U.S. and that the FDA had taken no precautions? That is what gives regulators sleepless nights.
But Dr. Davey warns that the FDA ruling "is going to impact our [blood] supply--that itself could be a safety issue." So the lesson is once again repeated. Reactive regulation, as opposed to a careful balancing of risks, often is worse than no regulation at all. Potentially, it could cost lives.
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