Posted by Eugene Volokh:
Sperm Donations and Homosexuals:
http://volokh.com/archives/archive_2005_05_15-2005_05_21.shtml#1116286876
I should stress again that [1]my post this morning about the
Washington Post article was not an attempt to explain who was right
and who was wrong -- rather, it was a criticism of the article's
failure to adequately explain both sides of the debate, and of its
failure to summarize what the conventional scientific wisdom is on the
subject.
For those who are interested in the substantive question, though, you
can [2]find what seem to be the controversial guidelines here (please
let me know if I found the wrong document; I wish the Post online
article had had a link to the right one). The guidelines suggest the
elimination of a wide range of people who seem at risk for HIV (pp.
16-21), including male homosexuals, intravenous drug users,
hemophiliacs, men who have patronized prostitutes (of any gender), and
16 other categories of people.
Interestingly, the guidelines do not include people who have had
promiscuous heterosexual sex; I don't know whether the FDA didn't see
this as a high enough risk factor for HIV transmission, or whether it
had some other reason for this. Perhaps this is a reason to criticize
the guidelines -- but if it is, then again it would have been nice if
the Post article had discussed the issue.
You can also find the FDA's responses to comments -- again, I hope
these are the right ones -- [3]here. Here's what they say about the
exclusion of homosexual donors:
Some comments disagreed with considering homosexual men to be �high
risk donors� and disputed the scientific basis for excluding these
men as donors. Many comments cited the efficacy of the blood test
for HIV, with retesting after a 6-month quarantine, although one
comment noted that HIV antibody testing is imperfect. Many comments
disputed the public health benefits of the rule, although some
applauded the agency for trying to craft safeguards to protect the
public. . . .
In response to the comments suggesting that FDA should allow
establishments to rely on HIV test results alone, or on quarantine
and retesting, without screening for risk factors, FDA rejects that
approach at this time. Although it is reasonable to expect that
more sensitive nucleic acid amplification testing (NAT) will be
available soon for reproductive tissue donors, even that testing
may fail to detect early stage HIV and other infections,
particularly because the level of viremia may be extremely low in
the early stages of infection (Refs. 1, 2, and 3). Moreover, even
the best test may fail to provide an accurate test result due to
human error in running the test or in linking the test result to
the correct donor. Accordingly, FDA believes that, based on the
current state of testing and current knowledge about disease
transmission, it is necessary to screen for risk factors as well as
to test for diseases such as HIV. . . .
After the consultation, it was concluded that there is no new data
that would warrant revising the 1994 guidelines. CDC and others
also concluded that current data are not sufficient to allow the
identification of lower-risk subsets of currently excluded
population groups, and thus, to refine the exclusionary criteria.
At the consultation, representatives of CDC encouraged the
development of new data.
On December 14, 2001, we asked the Center for Biologics Evaluation
and Research's (CBER) BPAC, whether there are existing data that
identify subsets of men who have had sex with other men in which
the incidence and prevalence rates for HIV, HBV, and HCV of the
subsets are similar to the population at large. By a 10 to 0 vote,
the committee advised that these data do not exist.
We have reviewed relevant legal authorities and disagree that these
regulations discriminate or improperly abridge donor or recipient
rights. We further note that, since FDA has tailored the rule's
requirements to take into account an existing relationship between
a donor and recipient (for example, FDA has not required quarantine
and retesting for directed reproductive donors, permits the use of
reproductive tissue from ineligible directed reproductive donors,
and requires no testing for sexually intimate partners), the
comments' remaining objections relate almost exclusively to
anonymous donations of reproductive tissue. We will continue to
examine the data on risk factors and, as new data are developed
that justify changes to our guidance, we will make those changes in
accordance with good guidance practice.
For more details, see the document. Again, I can't speak to whether
the FDA got this right -- but wouldn't it have been good for the
Washington Post article to explain a bit about the FDA's substantive
defense of the guidelines (or, even if the FDA hadn't defended them,
what those who defend the guidelines say)?
References
1. http://volokh.com/archives/archive_2005_05_15-2005_05_21.shtml#1116248831
2. http://www.fda.gov/cber/gdlns/tissdonor.pdf
3. http://www.fda.gov/cber/rules/suitdonor.htm
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