Friday, March 5, 2010

Senators ask FDA to lift gay blood donor ban

Friday, March 5, 2010

Cheryl Wetzstein

The push to eliminate the lifetime ban on blood donations from gay and bisexual men received a boost yesterday, when 18 senators signaled their support for such a change.
"[H]ealthy blood donors are turned away every day due to an antiquated policy," Sen. John Kerry, Massachusetts Democrat, said in a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg.
"We live in a very different country than we did in 1983," when gay and bisexual men were permanently "deferred" from giving blood, due to the HIV/AIDS crisis, the letter said.
Now that more is known about HIV transmission and dramatic technological advances have been made to detect HIV in blood, "we agree with the American Red Cross, America's Blood Centers, AABB, and others that the time has come for the FDA to modify" its donor rules, said senators, including 17 Democrats and Sen. Bernard Sanders, Vermont independent.
They asked the FDA to consider using the same deferral policies with men who have sex with men (MSM) that apply to heterosexuals who engage in high-risk behavior - usually a 12-month deferral. This would mean that a gay or bisexual man could donate blood if he had not had sex with a man in the past 12 months.
The senators' letter to the FDA comes a week after the Gay Men's Health Crisis (GMHC) released a report on why the lifetime ban on MSM blood donations is punitive, unfair and unnecessary.
"We don't want to increase the risk to the nation's blood supply," said Joseph Wardenski, lead author of the GMHC report and a former associate at Davis Polk & Wardwell law firm.
"We would like to reduce discrimination, and we would like a blood-donor pool that's large enough to ensure that there's a safe and sufficient blood supply, particularly in times of emergency," he said.
U.S. blood bank organizations have been amenable to change since 2006. The AABB, America's Blood Centers and American Red Cross support a one-year deferral for MSM because that would be "consistent with the deferral period for other potentially high-risk sexual exposures," the organizations said in a joint statement.
But an association for people with blood-clotting disorders supports the FDA's very cautious approach.
When it comes to pathogens transmitted in the blood supply, "100 percent of the risk is borne by the recipient" and none is borne by the donor, said Mark Skinner, president of the World Federation of Hemophilia.
Blood-donor rules are discriminatory by design, Mr. Skinner said. But the rules are grounded in science and intended to protect the end users, not target a group, he said, noting that hemophiliacs like himself can never give blood. "It really isn't even a gay issue because lesbians are not excluded unless they fall into other risk categories," Mr. Skinner said.
"We can't look narrowly at HIV; we have to look at the whole system," he added. The hemophilia community "serves as the canaries in the mine for the nation ... we're on the front line, and we require constant vigilance."
The lifetime ban on MSM donations was established because in the early stages of the AIDS epidemic a major share of cases involved transmission via blood transfusion. Now such cases are extremely rare - less than 1 percent of all new HIV infections, the Centers for Disease Control and Prevention says.
However, transmissions with HIV-infected blood still occur, and the number of "bad units" would increase if the MSM deferral was changed, Dr. Andrew I. Dayton told an FDA workshop in March 2006.
His computer models found that if MSM were deferred for five years, about 1,430 HIV-infected units would enter the blood supply in the first year of the new policy; with a one-year deferral, the number of infected units would "about double," to 2,780, Dr. Dayton said.
This "small but definite increased risk" is part of the reason the FDA has upheld the MSM ban several times, most recently in 2006. MSM have an HIV prevalence "60 times higher than the general population, 800 times higher than first-time blood donors, and 8,000 times higher than repeat blood donors," the agency added.
Other countries that currently ban MSM from blood donations are Canada, Denmark, Finland, France, Germany, Iceland and the Netherlands. Hong Kong also bans them.
Still, gay rights groups have long been fighting to change blood-donor rules, and several countries have relaxed their policies. On March 1, Sweden began allowing MSM to give blood if they have not had sex with a man in the past 12 months.
Argentina, Australia, Hungary and Japan already have such "one-year deferrals," and South Africa has a six-month deferral policy. In 2008, New Zealand changed its 10-year deferral for MSM to five years.

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