New England Journal of Medicine on MSM: "Rethink the Ban"

Wed, February 08, 2017 1:34 PM | Steve Bolton

After the June 12, 2016 massacre at the Pulse nightclub it became clear people throughout Orlando, and around the nation, wanted to help in any way they could. Thousands volunteered to give blood. Local restaurants offered free food and water to those waiting long hours in the Florida heat. Yet after the attack that specifically targeted the LGBTQ community, that group was notably absent from those donation lines.

The New England Journal of Medicine’s January 12, 2017 article on MSM (men who have sex with men) took this issue head on in the article, Rethinking the Ban — The U.S. Blood Supply and Men Who Have Sex with Men:

“The ban on donation from men who have sex with men was instituted at a time of public health panic and vast uncertainty, but 31 years later, scientific advances in testing and in understanding of disease transmission offer new tools and better ways than a sweeping ban to minimize the risk of transmission-related HIV.”

Additionally, HBO recently aired a VICE News piece reporting on the FDA's MSM deferral.  VICE News, a short-form documentary-style news program promotes itself on its coverage of “under-reported stories.” It covered the story of Jay Franzone and his year-long abstinence in order to donate blood. Franzone, who is the communications director for the National Gay Blood Drive, advocates for an individual risk assessment policy for potential donors that concentrates on behavior rather than sexual identity.

The NEJM article seemed to agree, “Though we believe that the current population-based ban on donation by men who have sex with men should be replaced with an individual risk-based assessment, it is also undeniable that the ban’s initial institution early in the AIDS epidemic was critical in the creation of a safer blood supply.”

In 2015, the FDA revised its policy recommending that blood banks ban donations only from men who have had sex with a man in the previous year, rather than at any time since 1977. The NEJM article said of this, “Still, the 1-year deferral is misaligned with the current science of HIV test characteristics and viral transmission.”

In response to the VICE News story, AABB, America’s Blood Centers and the American Red Cross issued the following joint statement regarding the U.S. Food and Drug Administration’s guidance “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” which outlines the deferral criteria for men who have had sex with men (MSM):

“All blood collectors in the U.S. are required to follow the rules and regulations issued by the U.S. Food and Drug Administration, including blood donation eligibility. AABB, America’s Blood Centers and the American Red Cross support the FDA’s revised MSM blood donation policy of a 12-month deferral. Our top priority is the safety of our volunteer blood donors and the patients in need of lifesaving blood products.

Based on several years of research, the FDA’s decision to change the MSM blood donation policy from a lifetime deferral to a 12-month deferral is consistent with selection criteria for other activities that are used to safeguard the blood supply from equivalent risks of transfusion-transmissible infections. At present, there are insufficient scientific data available to determine whether it is safe to rely only on individual behavioral risk factors when determining donation eligibility. 

While testing has greatly improved, it is not 100 percent effective at detecting infectious diseases in donors with very early infection. The FDA selected the 12-month deferral to provide adequate time for the detection of infected individuals. 

Donors who were previously deferred under the prior MSM policy may be evaluated by the blood collection organization for reinstatement. It is important to understand that the donor reinstatement process involves potentially thousands of donors, and it will take time. We advise previously deferred donors to review information about the reinstatement process at their blood collection organization before presenting to donate: 

America’s Blood Centers: 

American Red Cross: 

AABB, America’s Blood Centers and the American Red Cross continue to work with the FDA to gather additional scientific risk data to assist the FDA in determining whether further changes are warranted in the future.

Individuals can also visit the FDA website for detailed information about its decision and the scientific data that it relied upon to make it.”

Excerpts from Rethinking the Ban — The U.S. Blood Supply and Men Who Have Sex with Men, Chana A. Sacks, M.D., et al, January 12, 2017

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