Students for Fair Screening Measures for Blood and Bone Marrow
As physicians and physicians-in-training, we are the voice of science and facts, and the guardians of policy to make sure it fair and based on what we have learned through evidence-based research.
In the best interest of patients, we believe that guidelines for blood and bone marrow donation should be based on evidence-based measures instead of outdated procedures based on the fears of a previous generation of information.
Current FDA regulations prohibit men who have had sex with men (MSM), even once since 1977, to donate blood or to be listed on the National Bone Marrow registry. This outdated screening method forces us to turn away potential healthy blood and bone marrow donors. The regulation has not been touched since 1992, a time when the mechanisms of HIV were still largely a mystery. A relic of this initial terror remains entrenched in our screening methods for blood and bone marrow donors.
The paramount priority for maintaining a blood supply is first do no harm, which means that blood used for transfusions must be clean of disease. No priority can trump this standard. In order to meet this measure, we must respect the science of the situation and behavior based screening is an insufficient marker for measuring the quality of blood. To clarify in the context of relevance, there is no disease that we fear from men who have sex with men that we do not fear in men who have sex with women. Microbes do not make statements or judgments, they are deaf, blind, and dumb to race, gender, income, and even behavior. Blood collected undergoes thirteen tests, eleven of which analyze evidence of infectious disease including HIV, hepatitis B and hepatitis C. These evidence-based procedures should be and are the golden standard.
Regardless of the behavior that would have transmitted it, disease responds the same way through the rigor of serological testing. There is one risk exclusive to HIV the FDA believes only behavior based interviewing can help filter. After HIV is transmitted, there is a window period of about ten days to perhaps a few weeks, during which those who have been infected will have levels too low for the usual HIV screen to detect. Here is where excluding certain behavioral groups might prove worthwhile. However, more than a few weeks have lapsed since 1977. The date is arbitrary, and this is a disproportionate response to the concern of a window period.
The FDA stands by statistical evidence that MSM still are, as a group, at increased risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion. However, unlike the grouping of IV drug users, MSM is a blanket term that includes everything from high-risk behavior like unprotected sex with multiple partners to long-term monogamous relationships that carry little to no risk. This generalization lumps together disparate categories of behavior and levels of risk, rendering the grouping of MSM meaningless.
Though this is an issue of discrimination because we are making a distinction where one should not exist, far beyond that it is an issue of need. Medical care is deeply dependent on a steady supply of blood donors. We use 43,000 pints of donated blood every day in the United States. One in every seven people entering a hospital needs blood ? one patient every two seconds. The need for a robust bone marrow registry is even more desperate. While thirty percent of patients who need a bone marrow transplant are able to identify a donor within their family, the other seventy percent go to the National Marrow Donor Program. The recruitment effort for bone marrow donors already faces an uphill battle as the procedure for bone marrow donation is out-datedly characterized as a painful procedure. (Bone marrow donation can now be performed with peripheral blood, without the need for surgical procedure.)
It is a heartbreak and a horror to recognize how many healthy, eager donors are turned away every day because of screening measures that can at best be described as lazy. The goal is not to erase the line, but to redraw it based on rational, evidence-based measures rather than outdated fear-based procedures. When crafting fair policy, we must ground it in fact and in need. Here, the FDA fails on both counts.
Current FDA regulations prohibit men who have had sex with men (MSM), even once since 1977, to donate blood or to be listed on the National Bone Marrow registry. This outdated screening method forces us to turn away potential healthy blood and bone marrow donors. The regulation has not been touched since 1992, a time when the mechanisms of HIV were still largely a mystery. A relic of this initial terror remains entrenched in our screening methods for blood and bone marrow donors.
The paramount priority for maintaining a blood supply is first do no harm, which means that blood used for transfusions must be clean of disease. No priority can trump this standard. In order to meet this measure, we must respect the science of the situation and behavior based screening is an insufficient marker for measuring the quality of blood. To clarify in the context of relevance, there is no disease that we fear from men who have sex with men that we do not fear in men who have sex with women. Microbes do not make statements or judgments, they are deaf, blind, and dumb to race, gender, income, and even behavior. Blood collected undergoes thirteen tests, eleven of which analyze evidence of infectious disease including HIV, hepatitis B and hepatitis C. These evidence-based procedures should be and are the golden standard.
Regardless of the behavior that would have transmitted it, disease responds the same way through the rigor of serological testing. There is one risk exclusive to HIV the FDA believes only behavior based interviewing can help filter. After HIV is transmitted, there is a window period of about ten days to perhaps a few weeks, during which those who have been infected will have levels too low for the usual HIV screen to detect. Here is where excluding certain behavioral groups might prove worthwhile. However, more than a few weeks have lapsed since 1977. The date is arbitrary, and this is a disproportionate response to the concern of a window period.
The FDA stands by statistical evidence that MSM still are, as a group, at increased risk for HIV, hepatitis B and certain other infections that can be transmitted by transfusion. However, unlike the grouping of IV drug users, MSM is a blanket term that includes everything from high-risk behavior like unprotected sex with multiple partners to long-term monogamous relationships that carry little to no risk. This generalization lumps together disparate categories of behavior and levels of risk, rendering the grouping of MSM meaningless.
Though this is an issue of discrimination because we are making a distinction where one should not exist, far beyond that it is an issue of need. Medical care is deeply dependent on a steady supply of blood donors. We use 43,000 pints of donated blood every day in the United States. One in every seven people entering a hospital needs blood ? one patient every two seconds. The need for a robust bone marrow registry is even more desperate. While thirty percent of patients who need a bone marrow transplant are able to identify a donor within their family, the other seventy percent go to the National Marrow Donor Program. The recruitment effort for bone marrow donors already faces an uphill battle as the procedure for bone marrow donation is out-datedly characterized as a painful procedure. (Bone marrow donation can now be performed with peripheral blood, without the need for surgical procedure.)
It is a heartbreak and a horror to recognize how many healthy, eager donors are turned away every day because of screening measures that can at best be described as lazy. The goal is not to erase the line, but to redraw it based on rational, evidence-based measures rather than outdated fear-based procedures. When crafting fair policy, we must ground it in fact and in need. Here, the FDA fails on both counts.
View Comments