I should stress again that 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 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 — 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)?
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