[Federal Register Volume 80, Number 216 (Monday, November 9, 2015)]
[Pages 69230-69231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28437]



Office of the Secretary

Findings of Research Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.


SUMMARY: Notice is hereby given that the Office of Research Integrity 
(ORI) has taken final action in the following case:
    Anil Potti, M.D., Duke University School of Medicine: Based on the 
reports of investigations conducted by Duke University School of 
Medicine (Duke) and additional analysis conducted by ORI in its 
oversight review, ORI found that Dr. Anil Potti, former Associate 
Professor of Medicine, Duke, engaged in research misconduct in research 
supported by National Heart, Lung, and Blood Institute (NHLBI), 
National Institutes of Health (NIH), grant R01 HL072208 and National 
Cancer Institute (NCI), NIH, grants R01 CA136530, R01 CA131049, K12 
CA100639, R01 CA106520, and U54 CA112952.
    ORI found that Respondent engaged in research misconduct by 
including false research data in the following published papers, 
submitted manuscript, grant application, and the research record as 
specified in 1-3 below. Specifically, ORI found that:
    1. Respondent stated in grant application 1 R01 CA136530-01A1 that 
6 out of 33 patients responded positively to dasatinib when only 4 
patients were enrolled and none responded and that the 4 CT scans 
presented in Figure 14 were from the lung cancer study when they were 
    2. Respondent altered data sets to improve the accuracy of 
predictors for response to treatments in a submitted paper and in the 
research record by:
     Reversing the responder status of 24 out of 133 subjects 
for the adriamycin predictor in a manuscript submitted to Clinical 
Cancer Research
     switching the cancer recurrence phenotype for 46 out of 89 
samples to validate the LMS predictor in a file provided to a colleague 
in 2008
     changing IC-50 and R-code values for the cisplatin 
predictor in a data set provided to NCI in 2010
    3. Respondent reported predictors and/or their validation by 
disregarding accepted scientific methodology so that false data were 
reported in the following:
     Blood 107:1391-1396, 2006: Describing a predictor for 
thrombotic phenotypes
     New England Journal of Medicine 355:570-580, 2006: 
Describing a predictor of lung cancer relapse
     Nature Medicine 12:1294-1300, 2006: Describing a predictor 
for the response to the chemotherapeutic drugs topectan and docetaxol
     Journal of Clinical Oncology 25:4350-4357, 2007: 
Describing a predictor for the response to the chemotherapeutic drug 
     Lancet Oncology 8:1071-1078, 2007: Describing a predictor 
for the response to the combination of the chemotherapeutic drugs 
flurouracil, epirubicin, and cyclophosphamide or docetaxol, epirubicin, 
and docetaxol
     Journal of the American Medical Association 299:1574-1587, 
2008: Describing a predictor for breast cancer relapse
     Public Library Science One 3:e1908, 2008: Describing a 
predictor for the response to the chemotherapeutic drugs paclitaxel, 5-
fluouracil, adriamycin, and cyclophosphamide
     Proceedings of the National Academy of Sciences 105:19432-
19437, 2008: Describing a predictor of colon cancer recurrence
     Clinical Cancer Research 15:7553-7561, 2009: Describing a 
predictor for the response to the chemotherapeutic drug cisplatin
    As a result of Duke's investigation, the published papers listed 
above were retracted.
    Respondent has entered into a Voluntary Settlement Agreement with 
ORI. Respondent neither admits nor denies ORI's findings of research 
misconduct; the settlement is not an admission of liability on the part 
of the Respondent. The parties entered into the Agreement to conclude 
this matter without further expenditure of time, finances, or other 
resources. Respondent has not applied for or engaged in U.S. Public 
Health Service (PHS)-supported research since 2010. Respondent stated 
that he has no intention of applying for or engaging in PHS-supported 
research or otherwise working with PHS. However, the Respondent 
voluntarily agreed:
    (1) That if the respondent obtains employment in a research 
position in which he receives or applies for PHS support within five 
years of the effective date of the Agreement (September 23, 2015), he 
shall have his research supervised for a period of five years;

[[Page 69231]]

    (2) that prior to the submission of an application for PHS support 
for a research project on which the Respondent's participation is 
proposed and prior to Respondent's participation in any capacity on 
PHS-supported research, Respondent shall ensure that a plan for 
supervision of Respondent's duties is submitted to ORI for approval; 
the supervision plan must be designed to ensure the scientific 
integrity of Respondent's research contribution; Respondent agreed that 
he shall not participate in any PHS-supported research until such a 
supervision plan is submitted to and approved by ORI; Respondent agreed 
to maintain responsibility for compliance with the agreed upon 
supervision plan;
    (3) that any institution employing him shall submit, in conjunction 
with each application for PHS funds, or report, manuscript, or abstract 
involving PHS-supported research in which Respondent is involved, a 
certification to ORI that the data provided by Respondent are based on 
actual experiments or are otherwise legitimately derived and that the 
data, procedures, and methodology are accurately reported in the 
application, report, manuscript, or abstract; and
    (4) to exclude himself voluntarily 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 for period of five years beginning on September 23, 2015.

FOR FURTHER INFORMATION CONTACT: Acting Director, Division of 
Investigative Oversight, Office of Research Integrity, 1101 Wootton 
Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.

Donald Wright,
Acting Director, Office of Research Integrity.
[FR Doc. 2015-28437 Filed 11-6-15; 8:45 am]