Harvard Prof Isn't Recruiting Neanderthal Moms

Oh, good. This story isn't true. There isn't actually a Harvard professor who wants to recruit a woman to bear a Neanderthal child from an embryo constructed, using stem-cell and cloning technology, from Neanderthal bone DNA. Turns out there was some translation error in the account of his interview with a German magazine. And the professor is upset. He's not actually proposing to clone a Neanderthal baby; he only thinks the issue should be up for discussion. For several years.
Oh, good.

Drug Research on Non-Representative Populations

A while back I had my eyes opened by this review by Alex John London of Adriana Petryna's wonderful book, When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. One of Petryna's important points is that when drug-trials are conducted in the developing world, the populations on whom drugs are tested are not very similar to the populations to whom the drug companies expect, eventually, to sell most of their drugs. Not only that, but the drug companies know this, and can work to choose populations with particular characteristics favorable to good trial results. Of course, they can do that at home, too, using inclusion and exclusion criteria for drug trials. A letter in last week's JAMA drives the point home: hardly any drug studies in high-impact journals include patients with multiple chronic conditions--this, in spite of the fact that 28% of Americans, and 2 of 3 three seniors, have multiple chronic conditions; and treatment of multiple chronic conditions accounts for 66% of overall US healthcare expenditure, and 95% of Medicare expenditure. The letter's sobering conclusion: "Given the possible drug-to-drug, drug-to-disease, and disease-to-disease interactions that remain unexamined, most of the evidence gathered to date by [clinical trials] is of limited value to guide decisions about medication use by patients with multiple chronic diseases."

Presidential Commission Report on Protection of Human Subjects

The Presidential Commission for the Study of Bioethical Issues has released its report on protection of human subjects. This is the follow-up to September's report on the unethical studies done by the US Public Health Service in Guatemala in the 1940s. Major recommendations in the new report seem to be for better data collection and transparency by funding agencies, and for provisions guaranteeing that subjects injured in research are compensated for their research-related medical care.

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!

Bioethics Hall of Fame, Henry K. Beecher Edition

My second nomination to the notional Bioethics Hall of Fame is Henry K. Beecher. Beecher, an distinguished anaesthesiologist, wrote a highly influential 1955 paper on the placebo effect; wrote a then-controversial 1966 paper which served as the single most important goad to regulation of research on human subjects; was one of the cast of all-star contributors to the American Academy of Arts and Sciences influential 1969 book, "Experimentation with Human Subjects" (Paul Freund, ed.); and chaired the Harvard Medical School ad hoc committee whose report supplied the first generally accepted criteria for brain death. Less well-known is Beecher's post-war work on LSD and mind-control, some of which was done on unconsenting subjects. Indeed, it may have been this military and CIA-sponsored work which led him, shortly thereafter, to embrace the necessity of informed consent.