From the Wall Street Journal, 15 December 2010. (Story by Amy Dockser Marcus)
An advisory committee to the federal Food and Drug Administration is recommending that people with chronic fatigue syndrome be barred from donating blood, amid concerns a retrovirus may be linked to the disease.
The panel voted Tuesday 9 to 4 that the FDA should require a screening question to ask potential donors if they have a medical history of chronic fatigue syndrome and, if so, exclude them from donating.
The recommendation by the panel must now be reviewed by the FDA, which typically follows the advice of such panels but is not required to do so. An FDA spokeswoman said there was no timetable yet on a final decision.
The panel’s recommendation is a significant milestone for patients, who have often felt maligned by the medical community. The syndrome, which affects over one million people in the U.S., is diagnosed based on symptoms that include severe pain, debilitating fatigue and cognitive difficulties. There isn’t a known cause, however, and many patients say doctors often don’t believe they are sick.
There has been intense interest about whether sufferers of the syndrome should be barred from donating blood since last year, when the journal Science published a paper linking a retrovirus called XMRV to the disease. The science on whether XMRV is associated with chronic fatigue syndrome or other diseases, causes disease, or can be transmitted through the blood is still hotly debated.
The AABB, an umbrella group comprising centers and groups that collect most of the nation’s blood supply, recommended in August that until the scientific questions are worked out, people with chronic fatigue syndrome should be discouraged from donating blood. The American Red Cross, which collects about 50% of the nation’s blood supply, has been asking potential blood donors since October to say whether they have the condition and bars such patients from giving.
The panel’s recommendation, if adopted by the FDA, goes a step further because it would include a question about diagnosis as part of the screening questionnaire that donors must answer before giving blood. The FDA regulates the nation’s blood supply and so its decision would cover all blood centers.
The decision isn’t expected to have a big impact on the volume of the blood supply. Susan Stramer, executive scientific officer of the American Red Cross, presented data to the panel based on the experience of the Red Cross in the two-month period since they told their centers to stop taking donations from patients with the syndrome.
Dr. Stramer said that of one million blood donors in this period only 34 came forward and identified themselves as being diagnosed with it. She said this represented only .003% of the donors.
Judy Mikovits, who led the team of researchers that published the study in Science linking XMRV to chronic fatigue syndrome, said Tuesday’s decision is a victory for patients because “for the first time ever, they are being seen as sick with an infectious disease.”
John Coffin, a retrovirologist who was a member of the advisory panel and voted to support a screening question, said that he still didn’t know for certain whether or not XMRV is associated with chronic fatigue syndrome. But he said there was enough scientific evidence to support the notion that at least some cases of the condition are caused by an infectious agent.
“Even if it turns out that XMRV is not the cause, there might be something else and prudence dictates a deferral of blood donations,” Dr. Coffin said.
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