Letter to the Editor: As medical science advances, so should the FDA
AT A GLANCE
More information about the petition to the U.S. Food and Drug Administration
According to the American Red Cross (ARC), "[s]ummer is one of the most difficult times of the year for the Red Cross to recruit enough blood donors to meet the needs of patients." Dr. Richard Benjamin, chief medical officer for the ARC, said this shortage of blood occurs because "schools are not in session, businesses are on holiday schedules and people are on vacation."
However, a current petition presents a solution. It proposes that gay men who have slept with men are an untapped source of willing blood donors.
In 1983, the U.S. Food and Drug Administration changed its policy to ban men who have had sex with men from giving blood. Because of the AIDS scare of the '80s, the FDA feared the inclusion of this population of men would increase the risk of HIV-positive blood entering the donor blood pool.
However, in the past few years, many countries have enacted policies that address the same concern as the FDA’s but don't go so far as to issue an all-out ban. Argentina, Australia, Japan, Hungary, the United Kingdom and Sweden instituted a one-year ban. South Africa instituted a five-year ban, and New Zealand instituted a 10-year ban on donors who qualify as men who have had sex with men.
Recently, several U.S. organizations have called for the FDA to lift the all-out ban and enact a one-year ban instead. The HIV Medicine Association petitioned first in 2004 and was followed by the American Red Cross, the America's Blood Centers and the American Association of Blood Banks in 2006. All of these organizations lobbied the FDA to change its policy, but the FDA has still refused to change its 30-year policy.
The FDA is denying itself a large population of potential new blood donors. Banning only men who have had sex with men in the last five years from donating blood would create an estimated 85,000 potential new donors. However, banning only men who have had sex with men in the last one year would yield an estimated 3,300,000 new donors. If approximately 16 percent are willing to donate, blood banks would see an increase of 71,400 donors for a five-year deferral and 139,000 donors for a one-year deferral.
The FDA is right to be concerned about HIV entering the supplies of donor blood. However, its precautions are far too extreme. Changing its policy to only a one-year deferral would be still be four times the amount of time necessary for HIV to reach detectable levels after infection. This renders the FDA’s concern of the “detection of HIV infection [being] particularly challenging when very low levels of virus are present in the blood” a moot point, given that all donor blood is subjected to an extensive battery of tests, including a test for the presence of the HIV virus, before it is ever used.
The FDA’s concern about HIV is a valid one that any sane person would share. However, its reaction to the concern is not. Blanket bans may be appropriate in situations when there is a complete lack of understanding and an almost total absence of empirical, scientific knowledge — and this was almost certainly the case during the late '70s and '80s, when AIDS was a sure-fire death sentence and was still called GRID.
However, our understanding of HIV has come immeasurably far since that time, and hysterics and paranoia are no longer appropriate reactions. Medical science has advanced far enough that HIV is no longer a part of the looming unknown, and one would hope that, of all organizations, the FDA would be capable of comprehending and reacting appropriately to advances in medical science.
Please join us in letting the FDA know it is no longer time to react to HIV as if the last 20 years of advances in medical science haven’t happened. Sign and let your voice be heard.
Michael Kevin Hernandez, research associate for the Center for Analysis and Prediction of Storms