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June 18 , 2010

FDA panel retains ban on gay men’s blood donations

But one member says the rule will eventually be dropped

Washington, D.C.--An Ohio heart surgeon says the 33-year-old ban on blood donations by men who have sex with men will disappear eventually, and that advocates for change “need to keep chipping away at it.”

Dr. John Arnold of Columbus was one of six votes on the Health and Human Services Department’s Advisory Committee on Blood Safety and Availability in favor of a recommendation that the Food and Drug Administration lift the ban now.

Nine members voted against the resolution.

“The resistance to change now was due to gaps in knowledge,” not opposition to collecting blood from men who have sex with men,” said Arnold, who spoke as an individual, not for the committee.

Arnold also believes the issue will not be going away.

The ban was established in 1983 and covers all men who have had sex with a man, even once, since 1977. The purpose was to keep HIV out of the blood supply prior to reliable detection tests. What is now known as HIV was discovered in the U.S. in 1981. At that time, it appeared primarily in gay men and intravenous drug users.

Since, other high risk groups, including African-American women, have emerged, though there is no categorical ban on their donating blood. At the same time, regulations have been put in place ensuring that all blood is screened for HIV, and the tests have evolved to detect the virus within a few days of infection.

The committee met June 10-11 to hear testimony and consider the evidence, largely at the request of Democratic senators who sent a letter to Food and Drug Administration commissioner Margaret Hamburg in March urging a change in the regulation.

The letter was spearheaded by Senator John Kerry of Massachusetts. Ohio Senator Sherrod Brown joined the effort.

Arnold said Kerry’s office provided most of the educational material used to brief the committee prior to the meeting.

Arnold was appointed to the committee by Bush administration Health and Human Services Secretary Michael Leavitt, and serves there until 2013.

Arnold says he was asked to serve because he treats lots of patients who are “high-end users” of blood and blood products, which he described as “highly organized, most vocal and visible” opponents of lifting the ban.

These users include people with hemophilia and other chronic conditions that require large amounts of blood over a lifetime.

Arnold, who describes himself as coming from no political agenda, said he was unaware that the ban existed before he prepared for the meeting.

Arnold said the advocates for high-end blood users oppose any changes to regulations “that are not clean-cut beneficial” or that might add risk, no matter how small.

“They oppose anything gray, anything with any controversy, anything not guaranteed to reduce the risk,” Arnold said.

“The risk of changing this policy is not zero,” said Arnold, “but the policy doesn’t make a lot of sense, especially given other things we tolerate in the blood pool.”

The blood industry has favored lifting the ban since the largest supplier, the Red Cross, officially reversed its position in 2006.

The committee heard from experts and members of the public representing aspects of the issue ranging from medical ethics, blood consumers, HIV experts, and public health policy experts.

Arnold said he was especially impressed with the presentation by Nathan Schaefer and Sean Cahill of the Gay Men’s Health Crisis.

The committee also heard about the condition of the blood supply in European countries, some of which have deferrals for gay men based on behavior, but no bans.

Most observers believe the United States will move closer to that system eventually.

There has been some pontification, largely in the blogosphere, that the committee members may have been confused about what a vote for the recommendation would really mean.

This is probably because there were a number of modifications to the language of it during discussion, and because the committee later voted 14-0 that the ban is “suboptimal in permitting some high risk donations while preventing some low risk donations.”

Since that seems to be agreement with the position of those who want the ban lifted, some see the earlier vote as inconsistent.

Arnold disagrees, saying that in his opinion, Dr. Jerry Holmberg, who chaired the meeting, was very careful to make sure that all members understood what they were voting for.

Arnold believes that the difference is that the failed recommendation called for the regulation to change immediately, and that some members who agree with the change also want more evidence to be examined.

“The sense of the committee is that the regulation should change,” Arnold said, adding that the lack of consensus is around the steps to getting there.

Arnold said the meeting’s biggest success was that the steps toward the fix were defined, and the questions got asked.

The entire proceeding is on the web at www.hhs.gov.

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