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Posted by on Jan 6, 2011 in Ethics, Genetics

Duke’s Exculpating Review of Potti’s Work Used Mislabeled Data

Duke’s Exculpating Review of Potti’s Work Used Mislabeled Data

anil_potti.jpgThe continued castigation of Andrew Wakefield and now that of The Lancet editors, who published and then retracted Wakefield’s dubious MMR-autism study, overshadow allegations of scientific fraud elsewhere.

Namely the staff at Nature and the journal’s The Great Beyond blog continue to investigate Anil Potti, the former Duke University researcher whose genetics work on personalized chemotherapy has been called into serious question. Potti’s dubious work informed the design of several clinical trials that were haltingly reviewed and then ultimately closed by university administrators. (For important background on this story, go here and here.)

The latest development: Nature has obtained, under the US FOIA, a year-old university report on Potti’s work. This report, in a more heavily redacted form, had been previously obtained by an investigative reporter from The Cancer Letter, who originally outed Potti’s false claim to have been a Rhodes Scholar (or finalist) and who described the claims of M. D. Anderson biostatisticians. The biostatisticians discovered “a series of errors,” including mislabeling errors, in a seminal article by Potti and others.

The upshot of the Duke panel’s December 2009 report: The members could validate Potti’s work, but they seriously erred in not correcting Potti’s mislabeling errors. Moreover one of the M. D. Anderson biostatisticians, Keith Baggerly, had contacted Duke’s VP for Research and VP for Medical Affairs a month before the report was completed, alerting them to the mislabeling errors; however, Baggerly’s alert was not forwarded to the panel members. In a tepid apology, the Duke VPs offered their excuses for failing to ensure that these crucial corrections be provided to the panel.

[I]t was determined that it would be best to let the data, publications, etc., speak for themselves and not bias the independent investigation for or against any party. In retrospect, we did not realize that the data provided by our investigators were flawed (as the public record now shows), rendering an outside review addressing the methodology flawed as well. In hindsight, we would have ensured that the IRB provided all communication with Dr. Baggerly, recognizing the risk of bias. We’ve learned considerably from this process and are introducing key changes in the way we deal with research that will be translated to the clinical arena as a result.

According to The Great Beyond blog, a second university investigation is ongoing, and a report will be submitted to the Office of Research Integrity at the DHHS.*

DHHS = Department of Health and Human Services; FOIA = Freedom of Information Act.

* Some of Potti’s work was funded through NIH grants.

Photo of Anil Potti, formerly from the ISGP web site.

bmartin (1127 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.