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Keeping A Finger On The PULSE Of Blood Donation Policy After Orlando

Keeping A Finger On The PULSE Of Blood Donation Policy After Orlando

On June 12, 2016, a gunman murdered 49 people at PULSE, a Florida LGBT nightclub, in the most lethal mass shooting in U.S. history. Many more were critically injured, requiring blood transfusions and exacerbating the need for blood donors in the Orlando area.

Yet gay, bisexual, and other men who have sex with men (MSM) who wanted to donate blood were turned away. Garrett Jurss, for example, is a gay man who showed up to donate after the urgent call for blood, but was turned away because of the MSM blood policy. “I want to be able to help my brothers and sisters that are out there, that are suffering right now,” Jurss said. “But I can’t, and I feel helpless.”

In the face of such a crisis, why were blood donation agencies turning away people trying to donate? The answer is the “gay blood ban,” an antiquated U.S. Food and Drug Administration (FDA) policy that prohibits nearly all MSM from donating blood. This policy persists in spite of scientific evidence from the U.S. and other countries showing that no harm is done to the blood supply by allowing MSM to donate blood.

Perhaps in response to the Orlando tragedy, the FDA recently requested public comment on its current blood donation policies, including its policy for MSM. The FDA has a significant opportunity to modernize its policies by adopting an evidence-based approach that allows individuals to donate blood based on their individual risk profile, rather than their status as MSM. This would help reduce blood shortages and end a discriminatory relic of the early days of the HIV epidemic, while also ensuring the continued integrity of our nation’s blood supply.

A Brief History of the ‘Gay Blood Ban’

Flash back to the 1980s in the heat of the HIV/AIDS crisis. The first five cases of AIDS reported in 1981 were all gay men, and the disease quickly became known as “gay cancer” and “gay-related immune disease (GRID).” This led to an association in the minds of public health officials—and the general public—between gay and bisexual men, “risky” sex, and disease. It wasn’t until heterosexual people, including intravenous drug users, hemophiliacs, and women who had sex with men, began presenting with HIV/AIDS in 1982 and 1983 that scientists and physicians acknowledged that HIV was not a gay-specific disease.

But the damage was already done. In 1983, the FDA implemented a lifetime blood donation ban for any man who had sex with another man since 1977. This policy was described as an emergency measure to keep “high risk” donors from infecting blood transfusion recipients: given the unreliable testing technology for HIV at the time, HIV infections from transfusions were a significant risk.

Current FDA Policy: From Lifetime Ban to 12-Month Deferral

Since then, however, this risk has been dramatically reduced thanks to highly advanced HIV screening methods. Whereas screening methods in the 1980s used to have a “window period”—the period during which an infected person’s blood may test negative for the HIV virus—of up to several months, current FDA screening methods have a window period that is as short as several days, reducing the risk that HIV-positive donated blood erroneously tests as HIV-negative (i.e., false negative) to almost nothing.

Despite these advances, the lifetime ban remained in place for more than 30 years, until new 2015 guidelines replaced it with a 12-month deferral policy. As a result, MSM can now donate blood, but only if they have not had sex with another man in the previous 12 months.

Although this is a positive change from the lifetime ban, critics argue that the 12-month deferral policy is not based on scientific evidence and continues to unfairly stigmatize MSM. Under the current policy, for example, an HIV-negative man who has sex with his monogamous, HIV-negative male partner of 20 years is unable to donate blood, but a man who has had unprotected sex with 20 women whose HIV statuses are unknown is able to donate without a deferral.

This new policy came under attack after the Orlando shootings in June 2016. Congressman Mike Honda (D-CA) introduced the Deliver for Our Nation at Times of Emergency Act, or DONATE Act, that would require the U.S. Department of Health and Human Services to amend its blood donor screening standards during times of national or local need. Senator Tammy Baldwin (D-WI), Senator Elizabeth Warren (D-MA), and Congressman Mike Quigley (D-IL), among others, also criticized the FDA’s policy and spearheaded letters from bipartisan groups of 24 U.S. Senators and over 100 U.S. Representatives calling for a new policy that is rooted in scientific evidence and urging the FDA to adopt an approach to donor eligibility based on individual risk.

In response, the FDA has released a request for public comments on its current deferral policy. In particular, the FDA has requested scientific evidence regarding blood donor deferral policy options, including individual risk assessments, and research studies to “evaluate the feasibility and effectiveness of such alternative deferral options.” This request for public comment suggests that the FDA may be considering a shift away from its categorical, one-size-fits-all deferral policy for all MSM.

The Path Forward: Towards an Individual Risk Assessment

Now is the time for the FDA to modernize its blood donation policy. In particular, the FDA should adopt an individual-based risk assessment (IRA) that applies to all potential donors. Under an IRA policy, screeners assess the risk factors for each potential donor based on set criteria, such as number of sexual partners, use of HIV-prevention methods such as condoms and pre-exposure prophylaxis (PrEP), and intravenous drug use. These risk factors are then evaluated to determine whether that individual can safely donate blood.

Research from other countries, such as Italy, suggests that an IRA model does not endanger the blood supply. Although Italy had previously banned blood donation by MSM, officials replaced this ban with an IRA in 2001. In studying the impact of this change, researchers found that Italy’s IRA did not endanger the blood supply. Several other countries have similarly rescinded categorical restrictions on MSM blood donors, and there has been no evidence to suggest that these policies have increased HIV transmission through transfusion. Still other countries may move towards IRAs in the future: the United States, the United Kingdom, and Canada are in the process of reviewing their current deferral policies in favor of more equitable, evidence-based policies. In particular, Canadian officials have already funded research that aims to develop and implement nondiscriminatory practices in blood donation screening.

In addition to being a more evidence-based policy, an IRA would help ameliorate local and national blood shortages by encouraging MSM—many of whom want to donate blood but do not satisfy the abstinence criteria of the 12-month deferral policy—to serve as donors when appropriate based on their individual risk factors. Before the FDA changed its policy in December 2015, for instance, the Williams Institute at the UCLA School of Law estimated that an additional 360,600 men would donate blood if the FDA fully lifted its ban, increasing the domestic blood supply by as much as 4 percent.

An IRA policy would also end a policy that has long perpetuated stigma and discrimination against MSM. While MSM continue to bear a disproportionate burden of the HIV epidemic, this does not mean that all MSM are engaging in “risky” sexual behavior, nor are all MSM HIV-positive, as the current policy suggests. The current FDA policy, like the previous lifetime ban on blood donation, reinforces the inaccurate notion that MSM are, as a group, risky, dirty, and unsafe. These damaging stereotypes underpin the animus that gave rise to other—now discredited—anti-LGBT policies, from sodomy laws to the HIV entry ban for immigrants to the military’s discarded “Don’t Ask, Don’t Tell” policy.

In light of the advances in blood safety and our nation’s need for a robust supply of blood donors, the FDA should adopt an evidence-based, nondiscriminatory individual risk assessment policy that maintains the integrity of the blood supply while also maximizing number of potential healthy donors. Gay, bisexual, and other men who have sex with men were moved by the human need to help in the aftermath of the horrific attack in Orlando. Current policy prohibited them from doing so. Now is the time for the FDA to modernize its blood donation policies by adopting an approach based on the common humanity of MSM rather than outdated and discriminatory stereotypes.

Posted by: Dr.Health

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