[Federal Register Volume 79, Number 181 (Thursday, September 18, 2014)]
[Notices]
[Pages 56075-56076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22191]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research Misconduct

AGENCY:  Office of the Secretary, HHS.

ACTION:  Notice.

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SUMMARY:  Notice is hereby given that the Office of Research Integrity 
(ORI) has taken final action in the following case:
    Takao Takahashi, M.D., Ph.D., University of Texas Southwestern 
Medical Center: Based on the report of an investigation conducted by 
the University of Texas Southwestern Medical Center (UT Southwestern) 
and analysis conducted by ORI in its oversight review, ORI found that 
Dr. Takao Takahashi, currently a faculty member in the Department of 
Surgical Oncology, Gifu University, Graduate School of Medicine, Gifu, 
Japan, and formerly a Visiting Scientist in the Hamon Center for 
Therapeutic Oncology Research, UT Southwestern, engaged in research 
misconduct in research supported by National Cancer Institute (NCI), 
National Institutes of Health (NIH), grant U01 CA084971.
    ORI found that Respondent knowingly, intentionally, and recklessly 
falsified data reported in four (4) publications:

 Takahashi, T., Shivapurkar, N., Reddy, J., Shigematsu, H., 
Miyajima, K., Suzuki, M., Toyooka, S., Z[ouml]chbauer-M[uuml]eller, S., 
Drach, J., Parikh, G., Zheng, Y., Feng, Z., Kroft, S.H., Timmons, C., 
McKenna, R.W., & Gazdar, A.F. ``DNA methylation profiles of lymphoid 
and hematopoietic malignancies.'' Clin Cancer Res. 10(9):2928-35, 2004 
May 1 (hereafter referred to as ``CCR 2004''); Retraction in: Clin 
Cancer Res. 19(1):307, 2013 Jan 1
 Takahashi, T., Suzuki, M., Shigematsu, H., Shivapurkar, N., 
Echebiri, C., Nomura, M., Stastny, V., Augustus, M., Wu, C.W., Wistuba, 
I.I., Meltzer, S.J., & Gazdar, A.F. ``Aberrant methylation of Reprimo n 
human malignancies.'' Int J Cancer 115(4):503-10, 2005 Jul 1 (hereafter 
referred to as ``IJC 2005''); Retraction in: Int J. Cancer 132(2):498, 
2013, Jan 15
 Takahashi, T., Shigematsu, H., Shivapurkar, N., Reddy, J., 
Zheng, Y., Feng, Z., Suzuki, M., Noomura, M., Augustus, M., Yin, J., 
Meltzer, S.J., & Gazdar, A.F. ``Aberrant promoter methylation of 
multiple genes during multistep pathogenesis of colorectal cancers.'' 
Int J Cancer 118(4):924-31, 2006 Feb 15 (hereafter referred to as ``IJC 
2006''); Retraction in: Int J Cancer 132(2):499, 2013 Jan 15
 Tokuyama, Y., Takahashi, T., Okumura, N., Nonaka, K., 
Kawaguchi, Y., Yamaguchi, K., Osada, S., Gazdar, A., & Yoshida, K., 
``Aberrant methylation of heparan sulfate

[[Page 56076]]

glucosamine 3-O-sulfotransferase 2 genes as a biomarker in colorectal 
cancer.'' Anticancer Res. 30(12):4811-8, 2010 Dec (hereafter referred 
to as ``AR 2010''); Retraction in: Anticancer Res. 32(11):5138, 2012 
Nov.

    Respondent falsified data representing glyceraldehyde 3-phosphate 
dehydrogenase (GAPDH) loading controls and methylated/unmethylated 
polymerase chain reaction (PCR) in reverse transcription-PCR (RT-PCR) 
gel panels.
    Specifically, ORI found by a preponderance of the evidence that 
Respondent engaged in research misconduct by knowingly, intentionally, 
and recklessly falsely reporting the results of RT-PCR experiments by:
    1. Reusing and relabeling an image and claiming it represents 
different experiments of human tumor cell lines subjected to different 
treatments; specifically, an identical image was used to represent the:
    (a) GAPDH RT-PCR panels of several lymphoma, leukemia, multiple 
myeloma, and colorectal cancer cell lines in CCR 2004, Figures 1A and 
1B, IJC 2005, Figure 1A, IJC 2006, Figures 1A and 2A, and AR 2010, 
Figure 1A
    (b) GAPDH RT-PCR panels of the lymphoma cell lines BC-1 and Raji in 
CCR 2004, Figure 1B, lanes 1-3, and the colorectal cancer cell lines 
HCT116 and COLO201 in AR 2010, Figure 1C, lanes 4-6
    (c) unmethylated form of p16 (p16UM) controls in the methylation-
specific PCR (MSP) panels for the leukemia (Le) and multiple myeloma 
(MM) samples in CCR 2004, Figure 2
    (d) p16UM MSP panels for the lymphoma (Ly) and Le samples in CCR 
2004, Figure 2, and the unmethylated (UM) bands MSP panel for the 
colorectal cancer (CRC) cell line in IJC 2005, Figure 5.
    2. Manipulating an image and claiming it represents a gel with 
contiguous lanes; specifically, the RT-PCR products in the lanes of 
gels were cropped, spliced, and pasted together to form a single image 
for the MSP panels in IJC 2006, Figure 3.
    Dr. Takahashi has entered into a Voluntary Settlement Agreement 
(Agreement) and has voluntarily agreed for a period of three (3) years, 
beginning on August 26, 2014:
    (1) To have his research supervised; Respondent agrees that prior 
to the submission of an application for U.S. Public Health Service 
(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; Respondent agrees that 
he shall not participate in any PHS-supported research until such a 
supervision plan is submitted to and approved by ORI; Respondent agrees 
to maintain responsibility for compliance with the agreed upon 
supervision plan;
    (2) 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
    (3) 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 FURTHER INFORMATION CONTACT: Acting Director, 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. 2014-22191 Filed 9-17-14; 8:45 am]
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