FDA answers questions about new blood donation rules

Posted on 29 Dec 2015 at 1:01pm

bloodFDA spokeswoman Tara Goodin answered questions by email about new blood donation rules coming into effect for gay men. Here are my questions with her answers. If you can’t wade through all this, go down to the bottom paragraph to see where the numbers don’t add up:

1) If there’s a nine-day window for testing to catch HIV, why does a gay man need to be celibate for a year to donate blood? Wouldn’t a month be a safe waiting period?

The FDA’s mission is to help ensure the safety of the blood supply. Although the current generation of HIV testing that is used to screen the blood supply is highly accurate, it is not perfect. With the testing methodology used in the United States, there is a period of about nine days after an individual is infected with HIV during which the virus cannot be detected. During this time, when individuals may have no symptoms, the virus could be passed on to another individual through a blood transfusion. The FDA has examined the possibility of eliminating all deferrals for HIV and simply relying on testing of donated blood; however, scientific evidence has shown this would lead to decreased safety of the blood supply.

Therefore, deferral policies continue to have an important role in ensuring the safety of the blood supply. The recommended deferral period in the final guidance is 12 months because a 12-month deferral has been well studied and found, among other things, to maintain the safety of the blood supply in Australia, a country with HIV epidemiology and blood screening systems similar to the United States. In addition, this change would potentially better harmonize the deferral for MSM with the one-year deferral in place for both men and women who engage in certain other sexual behaviors associated with an increased risk of HIV exposure (e.g., sex with an HIV-positive partner, sex with a commercial sex worker).

Several countries, including the United Kingdom and Australia, currently have 12-month deferrals for men who have sex with men. In fact, Australia, a country with HIV epidemiology similar to the United States, changed its policy over 10 years ago. During the change in Australia from an indefinite blood donor deferral policy for men who have sex with men (MSM) to a 12-month deferral, well-conducted studies evaluating over eight million units of donated blood were performed using a national blood surveillance system. These studies, which have been published, document no change in risk to the blood supply with use of the 12-month deferral. Similar data are not available for shorter deferral intervals.

That being said, the FDA is committed to reevaluating its blood donor deferral policies as new scientific information becomes available.

2) If a same-sex married couple tests negative and has been together and monogamous for years, why wouldn’t we want them to be blood donors? The likelihood is their blood is safer than the gay men lying about being celibate.

3) Although you’re asking all men if they’ve had sex with another man in the past year, why are you believing straight men who say they never cheat on their wives, but not trusting gay men who are in monogamous relationships and test negative?

Answer to #2-3:

The deferral policy is a behavior-based policy, not one based upon sexual orientation. Current epidemiology shows that a history of male-to-male sexual contact was associated with a 62-fold increased risk for being HIV positive, whereas the increase in risk for a history of multiple sexual partners of the opposite sex in the last year was 2.3-fold. According to the Centers for Disease Control and Prevention, about two-thirds of all new HIV infections in the United States occur in men who have sex with men, who make up 2 percent of the total U.S. population. The FDA carefully considered alternative deferral criteria, such as individual risk assessment for individual risk of HIV, as alternatives to a time-based deferral. However, evidence shows that self-reporting presents significant issues in the U.S. for a number of reasons, including lack of sufficient data on the effectiveness of donor educational questionnaires and lack of reliability in self-reports of monogamy by partners in any type of sexual relationship. On the other hand, a 12-month deferral has been well studied and found to maintain the safety of the blood supply in Australia, a country with HIV epidemiology and blood screening systems similar to the United States.

The FDA will closely monitor the effects of moving to a 12-month deferral for MSM over the next few years in order to help ensure that blood safety is maintained. At the same time, the FDA will continue to review its donor deferral policies to ensure they reflect the most up-to-date scientific knowledge. This process must be data-driven, so the timeframe for future changes is not something we can predict.

4) How much does the FDA expect the new rules to increase the donor pool by?

The FDA estimates that under the revised one-year deferral there would be about 4.6 million newly eligible blood donors who are MSM. However, some of these potential donors may be deferred for other reasons, such as travel history, leaving an estimated 2.1 to 3.9 million newly eligible MSM blood donors. In general, approximately 5 percent of eligible individuals actually donate blood each year.


This doesn’t add up. If 2 percent of the population is gay (from her answer to 2-3) and there are 350,000,000 people in the U.S., there would be 7,000,000 gay people. But since half the population is female, there are only 3,500,000 gay men. The FDA is estimating 4.6 million out of a total of 3.5 million gay men are celibate and available to donate blood. In other words, every gay man in the U.S. is celibate plus 1.1 million more men who aren’t gay, but just have sex with other men, or something like that.

Comments (powered by FaceBook)