Anthrax Vaccine Testing in Kids?

It's a post-modern world. Here's the Washington Post's headline on a Friday story: "No testing of anthrax vaccine on children _ for now _ federal advisory board tells regulators." The next day, the San Francisco Chronicle's headline on a story written by a Washington Post reporter reads, "Panel endorses anthrax vaccine test on children." Global Security Newswire's headline? "Panel Urges Ethics Study of Testing Anthrax Vaccine on Minors." And yes, you guessed it, all these articles are about the same report. In fact, the "final draft report" of the National Biodefense Science Board actually recommends the following:

"HHS should develop a plan for and conduct a pre-event study of AVA in children, to include a research IND. HHS should submit the study protocol to one or more IRBs, and comply with the 21 CFR 50.54 / 45 CFR 46.407 federal review process. This recommendation should be revisited if new anthrax vaccines or other therapeutic countermeasures become available."

Translation: do the Anthrax vaccine study in kids after IRB review.

The NBSB report gave considerable attention to the ethics of testing Anthrax vaccine in kids, but it didn't end up "urging an ethics study" or saying "no testing for now." The report takes the position that it's important to understand how the vaccine works in kids before it's used in an emergency--important enough for kids to incur the risks of the trial, given the informed consent of their parents. The recommended trial would begin with older kids and work its way down to lower ages as results come in.

Note that the intended use of the vaccine is not as a routine population-wide prophylactic, since Anthrax isn't infectious. Rather, it would be given to selected people (including children) after they'd been exposed to Anthrax spores, to prevent disease development. Here's the second sentence of the executive summary of the report: "In this emergency scenario, [anthrax vaccine] would be used in conjunction with antibiotics to prevent the development of infection and illness following exposure to anthrax spores, a form of therapy termed “post-exposure prophylaxis." That's why Steven Salzberg's righteous indignation in this Forbes article seems to me to be misplaced; he seems to think that NBSB is contemplating huge and wasteful population-wide vaccination, but it's not.

UPDATE: Here's a nice piece by Art Caplan predicting that the study on kids won't happen. Basically Art is arguing that the likelihood of an anthrax attack is so small, the risks of the vaccine so uncertain, and the likelihood of vaccination being used as a response to an attack so uncertain, that no IRB will ever think the vaccine test has a good enough risk/benefit profile to permit it. Highly recommended!

Human Subjects Protection, Unintended Consequences Edition

The New York Times has a story here (oddly printed in the Arts section) dealing with some unintended consequences of the proposed changes to the Common Rule, which protects human subjects of research. One of the major proposed changes (which I earlier mentioned here) is to implement HIPAA-like privacy and security standards to protect the data gathered in human-subjects research. The idea is to relieve IRBs from having to consider "informational risks" when they evaluate studies (risks related to subjects' having their personal data leaked out into the world). The Times article notes that the actual HIPAA standards prevent data collected for one purpose from being released to researchers for another. This means that studies-about-studies (like the recent work of Susan Reverby, which uncovered unethical US research in Guatemala) could be much more difficult to conduct. Jerry Menikoff of OHRP has said that the government will work on the problem, based on the comments received from historians and social scientists. This is an example of a good feature of our administrative law system: federal regulations are always released in draft form with a comment period, precisely so that problems like this can be pointed out by interested parties and addressed before the rules become final. The rub is that regulators are not as responsive to comments as we'd sometimes like them to be. But in this case, researchers have in Jerry Menikoff a former academic bioethicist with real expertise in this area. He'll take all the comments seriously.

This Year in Bioethics: Common Rule Edition

So, fall is (finally) in the air, and 2011 is winding down. It's not too early (is it?) to start thinking about what this year's top bioethics stories were. I think anybody's list has to start with the massive proposed changes to the Common Rule. Proposed changes include 1) beefing up data security standards in order to relieve IRBs from having to review protocols for informational risks; 2) eliminating continuing IRB review requirements for protocols past their active stages, and for all protocols originally subject only to expedited review; 3) expanding the category of exempt studies and reducing oversight of such studies; 4) permitting blanket prospective written consent for research on biospecimens; 5) expanding the category of studies subject only to expedited review, and streamlining of oversight for such studies; and 6) permitting single-IRB approval of protocols for multi-site studies. For a quick overview, look at this Emanuel/Menikoff article in NEJM. Here's the full text of the advance notice of proposed rulemaking. You can submit your own comments here, until October 26!