Finding What is There: A Medical Ethics Challenge

June 23, 2010

Several prominent blogs have recently covered the story, first reported by Alice Dreger and Ellen K. Feder at  Bioethics Forum, of pediatric urologist Dix Poppas and his research involving clitoral surgery on young girls and young intersex patients to make their genitals less “masculinized” — that is, less large.

The research, conducted at New York Presbyterian Hospital, Weill Medical College of Cornell University, is troublesome for a number of reasons, including lack of indication of an underlying medical problem. In each case, the clitoris was deemed simply  too large, whatever that might have meant to the girls’ parents or the girls’ physicians.

Not only are the surgeries, as well as the accompanying attitudes and ethics, hugely problematic, but there are also issues with the follow-up study, which involved applying a cotton applicator and/or a vibrating device to determine how much nerve sensitivity was retained. Poppas was stimulating the genitalia of young children for the purposes of research, and it’s not clear to readers of the related research papers that those patients had a clear ability to consent or withdraw consent or how the potential for psychological harm was addressed.

The ethics of this research and how it was approved in the first place are quite important. But here’s another issue to consider: The articles in which this research was described were published in The Journal of Urology, a prominent journal, in October 2007 (see “Nerve Sparing Ventral Clitoroplasty: Analysis of Clitoral Sensitivity and Viability,” and “Nerve Sparing Ventral Clitoroplasty Preserves Dorsal Nerves in Congenital Adrenal Hyperplasia“).

They appeared online even earlier, in August 2007. The citations were included in the PubMed database, which is publicly accessible. So the news has been out there, for anybody to find and call attention to, for almost three years. But it didn’t cause alarm or outcry until Bioethics Forum, a project of The Hastings Center, brought the findings to the attention of a wider audience.

Another example of an awareness delay is the cervical cancer experiment in New Zealand, in which women with cervical carcinoma in situ were monitored instead of being fully treated (or informed of the lack of treatment), and many of them went on to develop invasive cervical cancer — most without ever realizing they were part of an experiment in the first place. (Here’s a slideshare presentation I did, explaining the experiment).

Initial “natural history” reports from this experiment were published in the medical literature in 1970, but there was little public attention or outcry until two women’s health activists published an investigation in 1987. In both cases, ethically problematic research was published but didn’t attract public attention or outcry for some years after the fact.

What can we do about this? Of course, many of us don’t have access to expensive journal subscriptions to read the full-text of such researchers’ questionable methodologies. We can, however, set up saved search strategies and alerts in publicly available citation databases (e.g., PubMed), and monitor the results for items that ding our warning bells.

There’s a lot of talk currently about e-patients (loosely defined as internet-savvy health consumers) with regards to researching medical conditions and treatments, but perhaps more activist-minded e-patients, and other online activists, should play a role in monitoring the broader biomedical research landscape. We know there are institutional review boards to monitor research on the front end, but what about research such as Poppas’s work, which is approved and published with little fanfare?

So, readers, what topics would you like to see in a search strategy set up to monitor these type of issues? What procedures or terms are always worth a review for the ethics and inclusion criteria? For example, I’d expect any research on prisoners should get a second look, and the combination of the clitoroplasty terms and the age groups in the Poppas citations might raise a red flag.

More broadly, how can women’s health and other human rights activists most effectively monitor the biomedical literature for ethical lapses and violations? I’m interested in hearing your ideas, and am happy to put my medical librarianship skills to work for better monitoring strategies.

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