Ban on Gay Men Donating Corneas May No Longer Be Supported by Evidence – AJMC.com Managed Markets Network

“At the time of the policy’s introduction, HIV screening tests were unreliable up to 6 months after viral exposure, so it was argued that a categorical exclusion policy for sexually active MSM donors was necessary to protect corneal transplant recipients,” researchers wrote.

However, in the years since, HIV testing has become more reliable within 4 to 8 days of viral exposure, while modern virologic testing and a better understanding of the risk of HIV transmission through corneal transplants may mean the 5-year deferral policy is no longer supported by evidence.

Currently, an estimated 12.7 million individuals around the world are in need of a corneal transplant while for every 70 corneal transplants needed, only 1 is available. “Because the United States exports thousands of corneas annually, any policy that restricts the supply of donated corneas in the United States may reduce the availability of vision-restoring surgery worldwide,” authors said.

To investigate the number of potential cornea donations prevented each year as a result of the policies, researchers contacted every eye bank in the United States and Canada. Neither the FDA nor the Eye Bank Association of American requires facilities to track the number of referrals inhibited by the policy.

Non-validated telephone surveys were conducted between May 2019 and February 2020 at all 65 eye banks in the United States (n = 57) and Canada (n = 8). A total of 54 eye banks provided responses to the survey which included the following metrics:

• If they document when a referral is disqualified for corneal donation specifically because of MSM contact
• How many referrals they rejected in the 2018 calendar year owing to MSM status
• How many corneas were recovered altogether at their eye bank in 2018

Thirty eye banks contacted said they do not keep specific records of MSM referrals. Among the eye banks that did keep track:

• 24 eye banks reported disqualifying 360 referrals in 2018 because of MSM status, equating to 720 corneas
• The 24 eye banks accounted for 46.2% of corneal donations in the United States and Canada in 2018, yielding an estimate of approximately 1558 corneas rejected that year because of MSM status
• A separate estimate using published MSM demographic data indicates that up to 3217 potential corneal donations may have been disqualified in 2018 because of federal policies

Findings may also be an underestimate, as family members may not be aware of sexual practices of the deceased individual or may inaccurately answer questions due to associated stigma. However, implications for donor supply may be smaller because donor corneas may not be transplantable due to outstanding factors like quality.

According to previous research, there have been at least 10 reported cases of corneal transplants using tissue from donors found to be HIV-positive after surgery. None of the corneal donation recipients contracted HIV while all 12 recipients of solid organs from the same donors did contract the virus.

“Even in patients with a high enough HIV viral load for HIV to be transmissible via solid-organ transplant, the risk of HIV transmission via corneal transplant is low,” authors wrote, while, to their knowledge, no case of HIV transmission from a corneal transplant has been reported anywhere in the world.

Currently, the FDA mandates MSM must wait 3 months after last contact to donate blood, a loosening of the previous policy banning donation for 1 year.

Furthermore, according to FDA policy, “a heterosexual person who has been in a sexual relationship with someone known to be infected with HIV should be deferred for only 1 year after the last sexual contact with the infected individual, whereas a hypothetical monogamous MSM donor who has never been exposed to HIV would remain ineligible to donate his corneas for 5 years after his last sexual contact,” researchers noted.

In an accompanying editorial², authors Alan Sugar, MD, and Woodford S. Van Meter, MD, argued the exclusion period of 5 years for MSM is clearly excessive if the window period for testing is very short and the sensitivity of testing for the HIV virus is very high.

“If any exclusion for corneal donation by MSM is maintained, it should be based on data and science, not on a lingering fear based on past conditions and long discredited biases,” they wrote. “Such a change would also help add fairness and restore dignity to an unjustly stigmatized population.”

Discussions on updating the FDA’s guidelines on the subject are underway.

Reference:

1. Puente MA, Patnaik JL, Lynch AM, et al. Asociation of federal regulations in the United States and Canada with potential corneal donation by men who have sex with men. JAMA Ophthalmol. Published online September 24, 2020. doi:10.1001/jamaophthalmol.2020.3630
2. Sugar A and Van Meter WS. Using data to rethink the ban on cornea donation from men who have sex with men. JAMA Ophthalmol. Published online. September 24, 2020. doi:10.1001/jamaophthalmol.2020.3629

Favorite