Location, location, location: ethical considerations in where to run a clinical trial.

A day later than promised, let’s kick off our discussion of “Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site” (PDF). The case study concerns a clinical trial of whether tenofovir, an antiretroviral drug, could prevent HIV infection. Before it was halted in the face of concerns raised by activists and the media, the particular clinical trial discussed in this case was conducted in Cameroon. Indeed, one of the big questions the activists raised about the trial was whether it was ethical to site it in Cameroon.
From the case study:

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Coming Monday: our discussion the case of a halted international clinical trial in Cameroon.

Almost a month ago, I told you about a pair of new case studies released by The Global Campaign for Microbicides which examine why a pair of pre-exposure prophylaxis (PrEP) clinical trials looking at the effectiveness of antiretrovirals in preventing HIV infection were halted. In that post, I also proposed that we read and discuss these case studies as a sort of ethics book club.
Next Monday, June 15, we’ll be kicking off our discussion of the first case study, “Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site” (PDF).

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Vaccine refuseniks are free-riders.

In a post a couple weeks ago, I commented on the ethical dimension of opting out of vaccination against serious contagious diseases:

Of course, parents are accountable to the kids they are raising. They have a duty to do what is best for them, as well as they can determine what that is. They probably also have a duty to put some effort into making a sensible determination of what’s best for their kids (which may involve seeking out expert advice, and evaluating who has the expertise to be offering trustworthy advice).
But parents and kids are also part of a community, and arguably they are accountable to other members of that community. I’d argue that members of a community may have an obligation to share relevant information with each other — and, to avoid spreading misinformation, not to represent themselves as experts when they are not. Moreover, when parents make choices with the potential to impact not only themselves and their kids but also other members of the community, they have a duty to do what is necessary to minimize bad impacts on others. Among other things, this might mean keeping your unvaccinated-by-choice kids isolated from kids who haven’t been vaccinated because of their age, because of compromised immune function, or because they are allergic to a vaccine ingredient. If you’re not willing to do your part for herd immunity, you need to take responsibility for staying out of the herd.
Otherwise, you are a free-rider on the sacrifices of the other members of the community, and you are breaking trust with them.

(Bold emphasis added.)
In the comments on that post, Jennifer takes issue with the free-rider characterization:

My kids are not vaccinated, and I am not a free-rider. So far my kids have had chickenpox, pertussis, and measles. I expect my kids to get many of the diseases for which there are vaccines. By the way, the measles was from a child who had recently gotten the MMR, and was shedding the live virus.
Please stop the scaremongering. My kids got through those illnesses just fine, and are extremely healthy. I’ve chosen the possibility of occasional acute disease over the very real possibility of chronic disease. For example, 1 in 10 kids now has asthma! 1 in 67 now has autism.

I thought, therefore, that it would be worthwhile to examine at more length my claim that vaccination refuseniks are free-riders.

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Familiar themes in a new instance of scientific misconduct: the Kuklo case.

The New York Times has an article about a physician-scientist caught in scientific misconduct. The particular physician-scientist, Dr. Timothy R. Kuklo, was an Army surgeon working at Walter Reed Army Medical Center. He is now (for the time being anyway) a professor of medicine at Washington University in St. Louis. Since the wrongdoing of which Kuklo was accused happened while he was at Walter Reed, the Army investigated.
That investigation “substantiated all the accusations against the physician.”
The Kuklo case has lots of ethical issues we’ve seen before. The New York Times article goes through them for the Nth time. That we’ve seen these same issues in misconduct and “misbehavior” cases on many, many, occasions might make one wonder how scientists, journal editors, and corporate sponsors of research failed to internalize any of the lessons they might have learned from the (N-1) times that came before this one.
After all, they’re supposed to be good at spotting trends in the data.
Among the familiar themes in this case, I notice:

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Ethics and the ‘Oprah effect’.

There’s an interesting piece in the Chicago Tribune on the “Oprah effect”. The upshot is that products or people who Oprah deigns to grace with airtime tend to find enormous public acceptance.
While this is well and good if the product is a novel or the person is a television chef, it’s less clear that the Oprah effect is benign in the case of people without medical expertise offering medical advice.
From the article:

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Trust and accountability in the vaccine-autism wars.

There’s a new feature article by Liza Gross [1] up at PLoS Biology. Titled “A Broken Trust: Lessons from the Vaccine-Autism Wars,” the article does a nice job illuminating how the themes of trust and accountability play out in interactions between researchers, physicians, patients, parents, journalists, and others in the public discourse about autism and vaccines. Ultimately, the events Gross examines — and the ways the various participants react to those events — underline the questions: Who can we trust for good information? and To whom are we accountable for our actions and our decisions? In many ways, it strikes me that the latter question needs more consideration than people typically give it.
The question of trust, on the other hand, is one with which people seem more ready to grapple. The challenge, however, is that such grappling seems more often than not to result in mistrust.

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‘Chronic’ Lyme disease article in Journal of Medical Ethics called unethical.

You may recall my examination earlier this month of a paper by Johnson and Stricker published in the Journal of Medical Ethics. In my view, it was not a terribly well-argued or coherent example of a paper on medical ethics. Now, judging from an eLetter to the journal from Anne Gershon, the president of the Infectious Diseases Society of America (IDSA), there is reason to question the factual accuracy of that paper, too. The Johnson and Stricker paper promised an exploration of ethical issues around an antitrust investigation launched by the Connecticut Attorney General examining the IDSA’s process for developing guidelines for Lyme disease. In particular, Johnson and Stricker suggested that conflicts of interest led the IDSA panel to improperly exclude “chronic” Lyme disease from their disease definition and treatment guidelines.
It’s true that IDSA has a horse in this race. However, as I noted in my earlier post, so do Johnson and Stricker. And unlike Johnson and Stricker, IDSA president Gershon seems to have a good handle on how to frame coherent and persuasive arguments.
From Gershon’s eLetter:

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Proposed guidelines for embryonic stem cells: applying new ethical rules to old research.

You may have heard that the Obama administration has proposed new rules for federal funding of embryonic stem cell (ESC) research. (The proposed rules are available in draft form through the end of the public comment period; the NIH expects to finalize the rules in July).
While researchers are enthusiastic at the prospect under this administration of more funding for ESC research, not everyone is happy about the details of the proposed rules. Indeed, in a recent article in Cell Stem Cell [1], Patrick L. Taylor argues that there is something fundamentally misguided about the way the new rules would be applied to old research:

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