Friday, December 5, 2014

The FDA's Lifetime Ban on Gay Men Donating Blood Makes My Blood Boil

AIDS has been a frightening virus since its discovery in 1983. Since men who have sex with other men, also known as MSM, were the predominant carriers of AIDS, the Food and Drug Administration (FDA) decided to ban these men from donating blood. In some countries, deferrals allow for MSM to donate after a certain period of time. In the United States, however, no such deferral is allowed. This ban has been FDA policy for over thirty years, but the FDA has decided to revisit the topic and possibly change the law where MSM would have a deferral one year after their latest male-to-male sexual encounter. Part of the change of heart is because we have realized that AIDS is not a "gay disease." Part of it is because we have developed technology to better screen for HIV, the virus that causes AIDS. Has the ban outlived its usefulness, or should it still be in force?

According to the FDA, the purpose of this ban to use "multiple layers of safeguards in its approach to ensuring blood safety....A history of male-to-male sex is associated with an increased risk for exposure to and transmission of certain infectious diseases, including HIV, the virus that causes AIDS. Men who have had sex with other men represent approximately 2% of the US population, yet are the population most severely affected by HIV." Essentially, the FDA's concern is with safety and making sure that donated blood is not contaminated with HIV. Let's see how valid the FDA's concern really is.

According to CDC statistics, the most common transmission category of HIV (CDC, 2012, Table 1a) is male-to-male sexual contact. This accounted for 64 percent of overall diagnoses of HIV, which totaled at 30,695 estimated diagnoses in 2012. As for number of individuals who carry the virus, MSM account for 52 percent of the subpopulation, totaling at 451,656 men (Table 14a). Undiagnosed individuals have a comparable result (CDC, 2011, Table 9a): 596,600 MSM out of 1,144,500 persons living with HIV, i.e., 52 percent.

So 596,600 MSM with HIV make up 0.18 percent of the 316 million American populace. Even if you want to filter out the 23.3 percent of Americans who are under 18, these individuals are only 0.25 percent of the American population. Assuming that gay men make up six percent of the overall male population, that makes for 7.27 million gay men over 18. Even if one makes the highly tenuous assumptions that a) only gay men are MSM, and b) all gay men are MSM, then that would still mean that only eight percent of gay men have HIV. Even if we were to take this unreasonably high estimation at face value, is the ban justifiably based on science? In short, no.

Not only has our understanding of how it is transmitted changed, but treatment and detection have also developed since 1983. Nucleic acid tests can diagnose HIV within two weeks of infection (FDA, p. 3), but the window period lasts from three to six months. Additionally, federal laws require that the blood be tested for diseases, including HIV. The odds of HIV infection through a blood transfusion, 1 in 2,000,000, is so small that it is almost non-existent. This is why many countries have changed their policies from a lifetime ban to relatively short deferral periods. Australia found no increased rates of transmission of HIV when it switched from a five-year deferral to a one-year deferral (Seed et al., 2010). Many countries, including the UK, Sweden, and Japan have switched to one-year deferral periods. Although a one-year deferral is an improvement over a lifetime ban, it is still arbitrary and discriminatory.

Even if switched to a one-year deferral, it still makes the mistake of identifying high-risk groups instead of high-risk behaviors. Go back to the CDC statistics (Table 1a) and you'll see that 48 percent of those newly diagnosed with HIV are African-American. Does anyone hear clamoring for African-Americans to be barred from donating blood? No, because that would be discriminatory, and it wouldn't target the issue at hand. After all, why should a high-risk heterosexual male who has unprotected sex with multiple partners get a free pass while a homosexual male in a committed relationship and doesn't have anal intercourse get punished? Looking at a potential donor's behaviors is more accurate of a proxy than targeting homosexual males. Italy went from a lifetime ban to an individualized risk assessment, which had no adverse impact on the incident rate of HIV (Suligoi et al., 2013).

The American Red CrossAmerican Osteopathic Assocation and the American Medical Association, have all realized that the science does not support such prohibitions. I know the FDA is trying to be risk-averse as humanly possible, but there's a fine line between justifiable, precautionary measures and counterproductive measures with nothing to show for it except blood banks experiencing a shortage of donated blood. If the ban were lifted, it would mean 615,300 additional pints of blood. A one-year deferral would still mean an extra 317,000 pints of donated blood (Miyashita and Gates, 2014). Whatever minimal risks that exist are considerably outweighed by the clear benefit of helping close the shortage of donated blood so people can receive the medical services they need and deserve. I hope the FDA realizes that its policies are causing more harm than good, and that they use science-based evidence to overturn this ban that can only be described as bloody idiotic.

2 comments:

  1. Are you crazy dude? Some people are just plain evil in this world and will donate blood even if they are infected with aids for the money. The amount of tax dollars (the ones that also pay for about 50% aids treatment) to test all the blood for sexual diseases would be ridiculous. I'd rather dodge the bullet and lack blood in a blood bank than have more than enough, but raise taxes or risk infection.

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    1. Normally, I don't allow for such ad hominem attacks on my blog, but this amused me enough where I decided to post it. I have to ask "Did you even bother reading or did you go straight for the comments section?" I actually have a better question for you: "Do you have anything to back up your claim, or is simply fear-mongering?" You say they would have to pay tax dollars to test the blood, as if they don't already. Spoiler alert: they already test the blood for HIV and a number of other diseases, which I already brought up. There's also the matter of the statistical improbability that an HIV infection would take place, and given modern technology, even if that one in 2,000,000 probability happened, I'm pretty sure that the cost could be contained to a minimum. Since additional taxes are not an issue, and the probability for infection is very low, I hope you can come back with some hard evidence if you choose to respond.

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