Sunday, June 19, 2016

Is the FDA's "Ban" on Gay Men Donating their Blood Discriminatory?

In the wake of the horrific Orlando shootings, there has been renewed attention given to the US Food and Drug Administration's (FDA) so-called ban on blood donations from Gay men.  A congressman called the ban discriminatory, and demanded it's repeal- a call joined by the American Medical Student Association and many others.

I can understand how many gay men feel.  I often donated blood at various American Red Cross locations.  Either they loved my blood or have way too many volunteers, because I was seemingly besieged with calls every 8 weeks (the minimum waiting time between blood donations).  Then in February of this year I was diagnosed with DLBCL- a form of lymphoma.  During my treatment, the Red Cross called, and I told them I couldn't donate this time because I was undergoing chemotherapy for lymphoma, and to call me back in a few months.  The worker apologized, and told me he would put me on the permanent deferral list.  It was then I realized- my diagnosis of a blood borne cancer meant I couldn't donate for life.  Despite a lack of definitive scientific evidence, the unknowns were judged to be too great.  After all, what if lymphoma is found to be caused by a virus, like many liver failures were later found to be caused by Hepatitis C?  Being on the deferred list wasn't easy to bear- I feel like I am permanently marked, damaged goods.  But nevertheless, despite my empathy for what many Gay men may feel about the policy, the FDA's "ban" on them donating blood is not discriminatory.

To start with, it should be noted that no one, gay men and me included, are or were banned from donating blood.  Rather, individuals are "deferred"- either for a period of time or indefinitely.  Furthermore, the FDA has never said anything about sexual orientation- the term they used described only the behavior- men who have sex with men (MSM).  These distinctions are important: the verbiage simply meant that at that time, blood from those individuals was not accepted, but may be in the future.  And people of a certain sexual orientation were never targeted- only people who engaged in a behavior that was considered high risk.

Until a few years ago, MSMs were deferred indefinitely.  In 2015, that policy was re-evaluated by the FDA, and changed to a deferment for 1 year after the last episode of intercourse.  This new policy matches several other deferments: Women who have sex with a man who they know or believe has had sex with other men are deferred for one year.  Tattoo recipients are deferred for one year- but are not deferred at all if they received their tattoo at a registered tattoo parlor.  And even individuals with known gonorrhea and syphilis infections are also deferred only for one year- clearly demonstrating that the deferments were for medical reasons, not social judgments.

Why is it that women who have sex with MSMs are deferred for one year, while MSMs themselves were previously life-time banned?  Because of the biology of HIV.  The virus is inherently more transmissible by anal sex than by vaginal sex- by a factor of 10.  In other words, a man having receptive anal intercourse with an HIV+ man is 10 times as likely to be infected as a women who has vaginal intercourse with an HIV+ man.  In fact, the act of receptive anal sex is approximately twice as likely to infect the recipient as sharing a needle for IV drug use!  This is why HIV is still overwhelmingly a disease of gay men.  MSMs make up only ~2% of the population- but account for 68% of the approximately 50,000 new cases of HIV every year.

One common response is to point to blood testing: the FDA mandates that all blood in the United States be subject to an extensive series of tests for blood borne disease including HIV.  Won't this catch the disease?  But the reality is that no test is perfect.  A certain percentage of individuals who are HIV positive will be missed by every test.  Right now, despite all the testing, the risk of HIV being transmitted through the blood is estimated to be 1 in 1 million to 1 in 1.5 million.  This seems to not be a big deal, until one considers that 21 million blood products are transfused every year.  Of note, this is an estimated risk- the true rate is impossible to know, since the US doesn't routinely test all recipients of blood products for HIV 6 months after the event.  Some believe the rate is much lower- the last documented case of transmission of HIV through blood in the US was in 2008.

The scientific reason for this rate of transmission is the HIV window period- the time a person who was just infected with the disease is still capable of transmitting it, but will not show up on any tests.  This period could be months long in the 1980s- the tests that were being used were that insensitive.  The modern tests that are now in place are capable of picking up HIV only 11 days after infection- hence why the policy of deferring MSMs was relaxed in 2015.  Why is the deferral for a year when the window period is 11 days?  The innate conservatism of medicine- no one wants to take an action that will hurt patients, and if 2 weeks is the safe margin, a year is safer still.

So, faced with this latent period where individuals can donate blood which is tainted, what is the only way to reduce the risk of transmission?  It is to reduce the probability that anyone who does donate has HIV- which means the deferral list.

One might object: what about Gay men in stable relationships who have both tested negative in the past?  What about Gay men who always use condoms?  Sadly, condoms can fail.  18% of couples who use only condoms for contraception will have a pregnancy- hence why most Ob/Gyns and public health specialists recommend IUDs.  And spouses can cheat.  While the individual donating blood may know himself to be perfectly monogamous, ultimately, how sure can he be that his partner is?

These may seem to be objections to heterosexual individuals donating as well.  But, remember- the risk of contracting the disease is 10 times higher for individuals who engage in receptive anal sex, and that doesn't take into account the far greater prevalence of HIV in the gay community.  And there are other considerations- per the FiveThirtyEight article above, when the Canadians looked at better stratifying heterosexual donations based on behaviors and risk, they found that the drop in blood donations would simply be far too great.

Ultimately, I do not believe the US FDA is made up of a bunch of villainous bigots bent on denying Gay men permission to donate blood for no reason other than to be evil.  The FDA's doctors and scientists are the heirs to the proud legacy of Dr. Francis Oldham Kelsey, who single-handedly saved thousands of American children from horrific birth defects by facing down a pharmaceutical giant and preventing the sale of thalidomide.  They make the decisions they make to keep patients safe- and indeed in many ways they are more liberal than some other western societies- Canada has a deferral policy for MSMs of 5 years from the last episode of intercourse.  Great Britain, France, and Australia all match the US policy of a 1 year deferment.

The FDA's research recently concluded that an additional 68 people would be exposed to HIV if the current behavior-based deferrals were dropped.  Without significant evidence establishing the number of people who will die from lack of blood if any, and that this lack of blood can be significantly alleviated by the addition of at most approximately 2% of the population to the potential donor pool, I don't think it's appropriate to call the FDA's deferral policy discriminatory.  While I understand more than most how it feels to be told that your donations will not be accepted, pending further research I fully support the FDA's position.