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Should FDA lift ban on gay men donating blood?

Blood is collected during a blood drive at

Blood is collected during a blood drive at Saint Vincent Health Center in Erie, Pa. The Food and Drug Administration on Tuesday, Dec. 23, 2014 recommended an end to the nation’s lifetime ban on blood donations from gay and bisexual men, a 31-year-old policy that many medical groups and gay activists say is no longer justified. Photo Credit: AP

A controversial lifetime ban on blood donations by men who have had sex with other men could be headed for a change.

The Food and Drug Administration has recently proposed changing the long-standing policy to only prohibit blood donations from men who have had homosexual activity within the past year. The original policy banned all male blood donors who say they’ve had sex with another man anytime since 1977.

The topic has generated a lot of heated discussion — including a recent Newsday editorial — with some even saying the newly proposed change doesn't go far enough.

And while everyone seems to have an opinion, not everyone seems to have the facts.

In the early 1980s, AIDS swept through the country, killing thousands. The cause initially was unknown but being gay was a significant risk factor. Receiving a blood transfusion was another risk factor. To help protect the blood supply, anyone who had engaged in homosexual activity as far back as 1977 was prohibited from being a blood donor.

We now know AIDS is caused by the human immunodeficiency virus. The CDC estimates there are more than 1.2 million people living with HIV in the United States. About 50,000 people get infected with HIV annually, with 4,175 new cases diagnosed in New York in 2012, the center reports. Even today,  men who have had sex with other men are the most severely affected by the virus in the United States.

But despite the fact that HIV has persisted, the blood supply has also become much safer. Potential blood donors are initially screened with a questionnaire, and are not allowed to donate if their answers indicate they are at high risk for having HIV.

Blood that is donated is also screened for HIV, in addition to other diseases. Note the blood is checked for HIV, not for AIDS. Acquired Immunodeficiency Syndrome is the clinical problem that develops years, or decades, after becoming infected with HIV; a patient's immune system becomes so weakened that they become very vulnerable to many different infections (the terms are not interchangeable).

So doesn’t being able to check for HIV guarantee the blood is safe?

No.

The problem is it takes time for an infected person to have enough of the virus in their blood for the test to be able to detect it. This time period is known as the “window.” Even with the most sophisticated — and expensive — test available, there is still a window of about 10 days. In other words, if someone becomes infected with HIV today and donates blood anytime in the next 10 days or so, their blood will test negative for HIV and can be used for transfusions, most likely infecting the recipient.

This is extremely rare but it does happen; the best estimate is that HIV is transmitted once in every one or two million transfusions.

Many men who have sex with men object to a policy that limits their ability to donate blood. Their arguments include: it is discriminatory to ban them as a group; a man in a monogamous relationship with an HIV negative man is not at increased risk; and the questionnaire does not ask females if they are engaging in unprotected heterosexual intercourse, which is the number one HIV risk factor for females.

The proposed change tries to address these arguments by easing the restriction, but it essentially continues to ban all men who actively have sex with other men from being donors.

Organizations such as the American Medical Association  agree the current policy is outdated, calling it “discriminatory and not based on sound science.”

FDA officials say that while advances in science allow for easing the restriction, “we simply don’t have the evidence” needed to lift the restrictions entirely.

The FDA argues that having sex with another man still remains, by far, the number one risk factor for HIV. And more importantly, these men are much more likely to transmit HIV than those in other high risk categories. They also note that there are indeed other entire groups excluded from donating blood, such as people who have traveled to or lived in certain areas outside the country.

If a change to the ban is enacted, the United States will be following in the footsteps of other countries, such as Australia, Japan and Sweden, that have a one-year deferral period. Italy and Spain have an even less restrictive approach. In these countries, potential donors are screened for high-risk sexual practices and deferred on a case-by-case basis. A 2013 study that looked at the change in Italy found no evidence that the new policy impacted the HIV epidemic in that country.

Is the FDA still being unfair to men who have sex with other men? Are they taking a risk by easing the restriction? In 2015, the FDA will post a draft of proposed changes to the blood donor deferral policy for men who have sex with men that will include a period for public comment. And while there are legitimate grounds for disagreement on this issue, the debate should be based on facts, not emotions.

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