Medical Writing, Editing & Grantsmanship

Notice is hereby given that ORI and the Assistant Secretary for Health have taken final action in the following case:

Based on the reports of an inquiry and an investigation conducted by the University of Pennsylvania and analysis conducted by the ORI Division of Investigative Oversight, ORI found that Gerardo L. Paez, PhD, former postdoctoral fellow, Section of Medical Genetics, UPenn School of Veterinary Medicine, engaged in research misconduct in research supported by R01EY06855 and R01EY13132.

ORI found that the Respondent engaged in research misconduct by falsifying and fabricating retinal gene profile data that he purportedly obtained from 3-week old normal dogs and dogs with X-linked progressive retinal atrophy in abstracts and poster presentations for the 2006 and 2007 Association for Research in Vision and Ophthalmology meetings and in an unsubmitted manuscript draft. The Respondent also falsely labeled data files in the UPenn bioinformatics core computer and submitted falsely identified files to his research mentors.

Dr. Paez has voluntarily agreed, for a period of 3 years, beginning on June 9, 2010:

(1) To exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant;

(2) that any institution that submits an application for PHS support for a research project on which the Respondent’s participation is proposed or that uses him in any capacity on PHS-supported research, or that submits a report of PHS-funded research in which he is involved, must concurrently submit a plan for supervision of his duties to the funding agency for approval; the supervisory plan must be designed to ensure the scientific integrity of his research contribution. A copy of the supervisory plan also must be submitted to ORI by the institution. Respondent agreed that he will not participate in any PHS-supported research until such a supervisory plan is submitted to ORI.

Update: The Economist covers the entire story (through Sept 2011).

Update: The NYT ran a front-page story on the Potti case … but neglected to comment on Potti’s hucksterish Website.

Update: Another Potti publication, J Clin Oncol 2007;25:4350-7, has been retracted. Details can be found on RetractionWatch.

Update: The IOM now plans to investigate the Potti case and the issue of -omics-based clinical trials more broadly (i.e., whether these biomarkers/predictors are sufficiently robust to support scientifically and ethically sound clinical trials).

Update: On Sunday, Duke and other participating sites (again) halted the 3 clinical trials based on Potti’s earlier results. This morning, Rob commented on the lack of local media coverage of the Hellinga case but the quick reporting of Duke’s rapid action taken against Anil Potti:

Durham’s media has been absolutely silent on the Hellinga debacle. The did, however, take note of another pompous liar in the medical center ranks:

http://www.newsobserver.com/2010/07/17/585434/duke-scientist-placed-on-leave.html

Our friends at GenomeWeb have also alerted the scientific community to detective work by The Cancer Letter (also noted on their blog):

… one of Potti’s biographical sketches says he was a “Rhodes Scholar (Australia)” in 1995 and another says he held a “Research Fellowship at Queensland Research Institute, Australia (Mentor: Gordon McLaren)” at that time. “We don’t have any record that Anil Potti was a Rhodes scholar,” a Rhodes Trust spokesperson told The Cancer Letter. In addition, Rhodes says that its scholarships may only be used to study at the University of Oxford.

Furthermore, McLaren was “‘shocked,’ ‘saddened,’ and ‘flabbergasted’” to learn he was listed as Potti’s mentor in Australia, according to the newsletter. The Cancer Letter goes on to describe other inconsistencies on Potti’s résumé, including the year he graduated from medical school and an assertion that he was a National Merit Scholar.

According to The Cancer Letter, Potti claims to have worked under McLaren at the “Queensland Research Institute” (which does not exist). The Queensland Institute of Medical Research, which does exist, does not have any records of Potti having ever studied or existed there.

GenomeWeb also includes links to Potti’s 2006 Nature Medicine article, Genomic signatures to guide the use of chemotherapeutics, plus 2 corrigenda to correct errors in 2007 and 2008 (MD Anderson biostatisticians found the errors, as reported by Nature Medicine, which also noted Duke’s reluctance be entirely forthright about their outside review of 3 suspended clinical trials that were resumed this January).

According to the Durham News Observer:

“Duke is aware of the allegations raised in the article regarding Dr. Potti and has instituted a formal internal investigation,” Duke spokesman Douglas Stokke said Friday afternoon. “Dr. Potti has been placed on administrative leave pending the outcome of the investigation.”

… On Friday, the American Cancer Society suspended payments to Potti’s grant pending its own investigation.

“We are profoundly concerned to learn that a Duke University researcher made claims about his credentials in applications to the American Cancer Society and others that may not be true,” said Otis W. Brawley, the American Cancer Society’s chief medical officer.

It isn’t clear whether a false biographical claim would put a federal research grant in jeopardy. NIH spokesman Don Ralbovsky would say only that “it is NIH policy to neither confirm nor deny that a review has been initiated or is under way.” [Potti is PI on 5R01CA131049-02 and 1R01CA136530-01A1]

… If he did falsify his biography, Potti may have committed a crime. The federal False Claims Act prohibits, among other things, falsifying applications in order to receive grant funding.

“It is most certainly unethical,” said Peg Vigiolto, UNC-Chapel Hill’s associate vice chancellor for research, speaking generally and not about Potti specifically. “And it would most certainly initiate all sorts of scientific integrity questions.”

Indeed.

As a side note, this issue of The Cancer Letter also covers Harold Varmus’ return to NCI, and his distinct lack of enthusiasm for megascience, giving preference to work done by individual scientists.