May 21, 2004

U.S. FDA: No Gay Parents! (At Least Not Those Men!)

by Chris Geidner

The Bush Administration is not only committed to stopping gay and lesbian couples from marrying. The Washington Times has this headline in this morning's edition: "Gays barred from sperm banks."

Unsurprisingly, that's a bit overstated (hence my attempt at going even further in the headline), but here's the lead:

The Food and Drug Administration yesterday announced a new rule that would prevent men who have engaged in homosexual sex within the past five years from making anonymous donations to sperm banks.

The explanation is as weak as one would expect:

"I do understand their concern, and the desire of everyone to be donors," Dr. [Jesse Goodman, the FDA's director of the Center for Biologics, Evaluation and Research,] said. "With regard to men who have had sex with men, the issue really is the higher incidence of HIV in that population."

One would think all body fluid, tissue, and organ donations should be tested for HIV and other such diseases (as they apparently will be, under the rule) -- making such an exclusionary policy unnecessary. The Administration apparently thinks otherwise. In the Comments section of the Final Rule, it defines the "Donor-Eligibility" rule on page 46 in response to Comment 26:

A donor is "ineligible" if either screening or testing indicates the presence of a communicable disease or risk factor for a communicable disease.

The FDA calls this a "comprehensive, risk-based approach" in its news release about the regulations.

The Final Rule materials briefly discuss this again -- citing a cost savings because those initially screened out as ineligible needn't later have a donation tested -- in the response to Comment 27 on pages 51-52. So, a "higher incidence of HIV" is being used to justify a governmental restriction that, similar to the Texas "Homosexual Conduct" law struck down by the Supreme Court in Lawrence v. Texas, disproportionately restricts gay men’s liberty. (I realize this is not a criminal law at issue, but the criminal element did not seem to figure largely into the analysis of the Lawrence Court so much as the liberty and its restriction-caused infringement.) Interestingly, here it is – using the Lawrence Court’s reasoning – gay men’s reproductive liberty that would be infringed by the government. This is being done even where all those not "screened out" still have their donated sperm tested for HIV.

To put it bluntly, all sexually active homosexuals and bisexuals are shut out of the donor pool while abstinent homosexuals and bisexuals’ blood and all heterosexual donors’ blood will be tested for HIV.

If there is a testing provision, did the Administration provide any proof that enough of the sperm donated from those who would be ineligible through the "homosexual-sex prohibition" screening contains HIV to justify a blanket restriction? Or is this an irrational restriction?

A final note: In response to Comment 12 on page 30, the Final Rule materials make clear that "there are threee categories of reproductive donors, subject to three different sets of requirements listed as follows: (1) The anonymous donor, to whom all the donor-eligibility requirements apply; (2) the directed reproductive donor, whose reproductive cells and tissue may be used even if the donor is determined ineligible; and (3) the sexually intimate partner, for whom testing and screening are not required . . . ."

Since reproduction cannot occur between lesbian or gay couples, No. 3 is obviously out. For some reason, however, No. 2 still requires the screening. If the directed reproductive donor is screened out as a sexually active homosexual, it would seem to me that he would then not be tested for HIV according to the cost-saving response discussed above. So, directed reproductive donors who are sexually active homosexuals won't be tested, but can still donate? This seems to undercut the "public health" reasons cited in the materials to justify the strict screening prohibition in No. 1.

(The Washington Post misses the screening completely, discussing only the testing portion in the second item of today's "Washington in Brief." The NY Times, however, has it: F.D.A. to Limit Sperm Donors.)

May 21, 2004 01:48 AM | TrackBack
Comments

Is there available a questionnaire that is required of the prospective donor? Off hand, it may not be worth the effort.

Posted by: Shag from Brookline at May 21, 2004 07:45 AM

I wonder if the outrage wouldn't be even higher if the FDA decided that African-Americans couldn't donate, since they, as a demographic, have the most highly increasing rate of HIV-infection. Just another anti-gay agenda for the Bush administration.

Posted by: mls at May 21, 2004 01:18 PM

I wonder if the outrage wouldn't be even higher if the FDA decided that African-Americans couldn't donate, since they, as a demographic, have the most highly increasing rate of HIV-infection. Just another anti-gay agenda for the Bush administration.

Posted by: mls at May 21, 2004 01:23 PM

MLS:

Care to justify that statistic?

Why in goodness name would I (or rather, someone who might be worried about sperm donation) care about what demographic has the "the most highly increasing rate of HIV-infection" in any particular donor pool. So long as one is receiving a donation at any particular point in time, the rate of increase simply isn't relevant to risk. All one should care about is the incidence of HIV in any particular segment of the pool.

Of course, what Chris fails to note:
The new rules mirror Centers for Disease Control and Prevention guidelines that have been followed by most of the nation's tissue and sperm banks for more than a decade.
(which is the next sentence of the article) and
Bob Rigney, chief executive officer of the American Association of Tissue Banks, predicted that the effect on the industry would be "minimal."
His organization has adhered for years to CDC guidelines on communicable-disease testing and medical and social history screening, which already includes excluding active homosexuals from anonymous sperm donations.
"We're following the CDC guidelines right now, so this won't have a major impact," he said.
I guess if one really wants to make Bush look bad, that's a good edit, but otherwise how does a CDC rule that either lasted the entire Clinton administration or may even have originated in it make a blind bit of difference?

Tissue donation rules aren't politically correct. I can't donate blood, because I lived in Great Britain during the 1990s. The probability of me transmitting CJD through blood donation--even assuming it can be transmitted in blood plasma, still an unknown--is on a different order of magnitude from the risks involved here. (Although it should be noted that both risks are slight and involve unknowns.) These are the standards by which we make medical decisions.

Note that Chris' discussion never mentions the CDC and treats this as a new decision.

Finally, from Chris:
If the directed reproductive donor is screened out as a sexually active homosexual, it would seem to me that he would then not be tested for HIV according to the cost-saving response discussed above. So, directed reproductive donors who are sexually active homosexuals won't be tested, but can still donate? This seems to undercut the "public health" reasons cited in the materials to justify the strict screening prohibition in No. 1.
A "directed donation" is, by definition on pg 29 of the document Chris links to, "directed donation involved the designation of a specific
potential recipient." So while a public health argument along the lines Chris is making could be made, it borders upon the paranoid. Since the donor and the recipient must both know each other, and the screening itself will make certain that the risk factors are known to the recipient, she could simply decide to take the risk. Further, there's nothing that excludes testing for HIV, either of the donor or his semen, as a matter of policy. Nonetheless, given that the woman involved will be able to accept the donation in any event, there's not much to be gained by mandating testing. Indeed, one rather assumes that in directed donations, most parties involved have been screened anyway.

Finally, Chris discusses the commentary in a completely backwards fashion to get it within the reach of Lawrence:
The Final Rule materials briefly discuss this again -- citing a cost savings because those initially screened out as ineligible needn't later have a donation tested -- in the response to Comment 27 on pages 51-52.
The CDC does not use the saved cost of testing to justify a blanket ineligibility. Rather, it uses a blanket ineligibility to justify not conducting further testing: because the screening means that the donor's tissue cannot be used, why bother mandating testing?

The justification is disease incidence, and whilst a general argument that we are too risk averse with tissue donation could be made (appropos the CJD argument above), unless Chris wants to tell me that the incidence risk of HIV from receiving semen from a gay man is lower than the risk of transmission of CJD from someone who lived in Britain during the 1990s, he's going to have to go peddling a homosexual animus argument elsewhere.

This isn't politics, it's epidemiology. To discuss it--or even challenge it in a forthright and reasonable manner--would take the introduction of data, and an accounting for statistics. (Incidentally, Chris makes no mention of the accuracy of the tests in comparison to the incidence in risk pools, which is of course a key cost-benefit consideration: so much so that the classic example to illustrate the heuristic bias in this regards is called the "AIDS Test Problem.") At the very least, these 'fast and effective' AIDS tests would need to be specified as to how accurate they are, particularly in relationship to the risk incidence: otherwise any statement of cost benefit is, at best, a guess.

Of course, if you just want to say the Administration's in the wrong--never mind the fact that this is essentially a crystalization of a Clinton administration policy--then who needs the data?

Posted by: A. Rickey at May 22, 2004 02:04 PM

Anthony:

http://www.aidshotline.org/crm/asp/refer/statistics/stats_race.asp

"According to the CDC, from 1996 through 2001, AIDS incidence declined sharply and then slowed among whites; declined more slowly and then slightly increased among African Americans, Latinos and Asian/Pacific Islanders; and increased among American Indian/Alaska natives."

There's also a nice little graph at the bottom of the page.

I guess my short-and-sweet post didn't convey precisely what I meant. Of course, the particular point in time is relevant. What I was trying to highlight is that the FDA guideline is arbitrary. As of 2001 there were 313,180 African-Americans in the United States diagnosed with AIDS, out of 816,149 cases. That's 38%. The FDA could refuse to allow any African-American males to donate and save themselves significant amounts of money. It's no more arbitrary than saying all gay males can't donate, but you can bet there would be a hell of a lot more uproar about it.

Posted by: mls at May 25, 2004 08:46 PM

MLS:

Seriously, mate, I like your writing, but you really need a course in statistics.

Whether African-Americans make up 38% of AIDS cases is completely irrelevant, as was your first statistic, unless for some heretofore unexplained reason African-Americans who are HIV positive are far more likely to donate semen than African-Americans as a whole.

The only statistic that is relevant for prevalence in the context of the FDA's decision is the percentage of a given group that is HIV+ with respect to that group as a whole. In other words, what percentage of African-Americans are HIV+, not what percentage of HIV+ people are African-American. Only the former gives any indication of the risk that a given semen sample from a randomly-chosen African American male will be HIV+, which is the risk the FDA is evaluating.

You have to be very careful when playing with percentages, simply because they're so sensitive to size. The number of African-Americans dwarfs the number of homosexuals in the United States. Similarly, 'fastest growing' racial group can be very misleading. For a while, women were the fastest-growing HIV+ segment. (I think they still are.) But this was simply that because they were starting from a low baseline, it was easy for the number of HIV+ women to increase in a percentage fashion.

So, having just highlighted your abuse of statistics, I'd get to:
The FDA could refuse to allow any African-American males to donate and save themselves significant amounts of money. It's no more arbitrary than saying all gay males can't donate, but you can bet there would be a hell of a lot more uproar about it.
First, there's no evidence that anyone would be "saved a significant amount of money" through the policy you propose. To the extent that--and this may or may not be true, and I don't have the data--African Americans are more likely than whites to have HIV, there may be a marginal cost savings. Nonetheless, the scale of the cost savings would be markedly lower than the homosexual ban.

So, at least we agree upon this: there would be a hell of a lot more uproar about it. But that would be because the policy is distinctly unlike the homosexual donation ban, in that the incidence statistics used to support it would be almost arbitrary.

Man, I'm getting flashbacks to my Reg State course here...

Posted by: A. Rickey at May 26, 2004 10:52 AM

Heh... actually, I should be more careful with my own statistics:
The number of African-Americans dwarfs the number of homosexuals in the United States.
This is not necessarily true, for certain values of 'dwarfs.' The stat should be "the percentage of AA with HIV is dwarfed by the percentage of homosexuals with HIV in the U.S." and Tony should not try to do mental math in the morning.

Posted by: A. Rickey at May 26, 2004 11:01 AM
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