In December 2014, Commissioner Hamburg announced a proposed change in the FDA’s long-standing policy regarding blood donations from gay men – See “FDA Commissioner Margaret A. Hamburg’s statement on FDA’s Blood Donor Deferral Policy for Men Who Have Sex With Men“. The term “men who have sex with men” was coined as a means to be inclusive of those men who have sex with other men who do not identify themselves as being gay – perhaps with good intentions so that the message reach the target audience.
For many years – since 1985, the policy on the subject of blood donation was draconian, deferring donations from any men who have had sex with men since the year 1977 – even if the sexual episode occurred only once – despite the increasing ability over time to screen and detect the presence of a virus. This was a policy opposed by many groups for many reasons – from the medicine and science and from a human rights point of view. The American Medical Association had stated that it supported scientifically based blood donation deferral and opposed the lifetime ban.
This week, FDA issued a draft guidance awaited since the December 2014 statement by Dr. Hamburg “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” which is, let’s face it, about blood donation by gay men, though you might not get that from the title. There was no press release and there was no blog posting on FDA’s Voices blog, but the revised recommendations are a significant departure from the old ones. Under the new recommendation, blood donations will be deferred from a specific list of characteristics that include men who have had sex with men within a period of one year.
The change is well past time. When the AIDS epidemic first emerged, individuals and institutions – both public and private – often took extreme measures in response and these extreme responses were often not based on science, but on unfounded concerns or fears. And too often these extreme responses were formalized into policies – policies that had the opposite impact of what was intended. Rather then act to protect, they harmed. People with HIV were not allowed to travel or immigrate to the United States. Needle exchanges which could save lives were not funded. Correcting these mistakes took decades.
As bad policies go, the lifelong ban on gay blood donation may not be the worst – it was a waste of a potential resource. But it did represent a policy not premised on science but on fear – and further stigmatized gay men. That may seem to some unimportant, but be clear on this – stigma kills. Especially in the dark early days of the epidemic, children thought to have HIV were kicked out of schools, people lost their jobs, patients were denied services. Stigma has a real cost to those who feel the brunt of it.
And in the case of FDA, stigma can backfire. The development of policies based not on fact, but on the weak premise of theoretical conjecture not only wastes valuable resources and contributed to the stigma of a group of people, it erodes the credibility of the policy maker. And for an institution that is charged with protecting the public health – credibility is a commodity that cannot be squandered.
