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06/22/2015

At Long Last: FDA Changes the Law for Hemochromatosis

by Arthur Caplan, Ph.D.

Summer in the U.S. is known for many things—time at the beach, picnics, baseball, thunderstorms, vacations and ice cream. Sadly, it is also known by hospitals as the season when blood is in short supply. Schools and businesses close making blood drives harder. Frequent donors go away leaving blood and blood products in their communities in short supply. That is why a recent hard-fought breakthrough as to who can donate blood deserves much more attention and recognition than it has received which, if Google is to be believed, to date has been exactly nothing.

Hemochromatosis is a genetic disease that causes the human body to absorb too much iron from food. The excess iron can damage vital organs like the heart and the liver. The disease is more common in Caucasians and in men. The solution to these problems—get rid of excess iron by frequent bleeding. Hemochromatosis is the one disease that justifies all the horrific blood letting engaged in by medicine over the centuries. Giving blood gets rid of the iron.

So you might think if some people need blood and some people have to frequently get rid of a lot of iron-rich blood frequently then why don’t they use blood from those with hemochromatosis? Very good question. Why has it taken so long? Partly because hemochromatosis is a disease and that led to confusion about the safety of blood from affected people. There is no safety issue. The FDA has, after 8 years of fighting, asking, hoping and lobbying, issued a rule that recognizes exactly that. People who must give blood due to the disorder can now do so and the blood doesn’t have to be labeled as diseased or dangerous since there is nothing wrong with it!

I got the good news from my friends at the Iron Disorders Institute who I have had the honor to work with for many years on this and other issues. Finally those with hemochromatosis who have no other health issues will no longer see their blood discarded while hospitals frantically search for donors to maintain their supplies.

The FDA rule has been greeted with silence by the media. That is typical when the issue is blood. It is so familiar to us and so ordinary that it tends to be taken for granted and the risk of shortages viewed with a yawn. That should not be. And when a dent can be made in the risk of shortage by linking those with ‘too much’ iron rich blood with the rest of us who need it that is surely a win-win and very good news.

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