[Federal Register Volume 79, Number 181 (Thursday, September 18, 2014)]
[Notices]
[Pages 56076-56077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22192]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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:
    Makoto Suzuki, M.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. 
Makoto Suzuki, currently a Professor in the Department of Thoracic 
Surgery, Kumamoto University Hospital, Kumamoto, 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), grants P50 CA070907 and U01 CA084971.
    ORI found that Respondent knowingly, intentionally, and recklessly 
falsified data reported in six (6) publications:

 Suzuki, M., Hao, C., Takahashi, T., Shigematsu, H., 
Shivapurkar, N., Sathyanarayana, U.G., Iizasa, T., Fujisawa, T., 
Hiroshima, K., & Gazdar, A.F. ``Aberrant methylation of SPARC in human 
lung cancers.'' Br J Cancer 92(5):942-8, 2005 Mar 14 (hereafter 
referred to as ``BJC 2005-1''); Retraction in: Br J Cancer 108(3):744, 
2013 Feb 19
 Suzuki, M., Shigematsu, H., Shames, D.S., Sunaga, N., 
Takahashi, T., Shivapurkar, N., Iizasa, T., Frankel, E.P., Minna, J.D., 
Fujisawa, T., & Gazdar, A.F. ``DNA methylation associated inactivation 
of TGFbeta-related genes DRM/Gremlin, RUNX3, and HPP1 in human 
cancers.'' Br J Cancer 93(9):1029-37, 2005 Oct 31 (hereafter referred 
to as ``BJC 2005-2''); Retraction in: Br J Cancer 109(12)3132, 2013 Dec 
10
 Suzuki, M., Shigematsu, H., Takahashi, T., Shivapurkar, N., 
Sathyanarayana, U.G., Iizasa, T., Fujisawa, T., & Gazdar, A.F. 
``Aberrant methylation of Reprimo in lung cancer.'' Lung Cancer 
47(3):309-14; 2005 Mar (hereafter referred to as ``LC 2005''); 
Retraction in: Lung Cancer 85(2):337, 2014 August
 Suzuki, M., Toyooka, S., Shivapurkar, N., Shigematsu, H., 
Miyajima, K., Takahashi, T., Stastny, V., Zern, A.L., Fujisawa, T., 
Pass, H.I., Carbone, M., & Gazdar, A.F. ``Aberrant methylation profile 
of human malignant mesotheliomas and its relationship to SV40 
infection.'' Oncogene 24(7):1302-8, 2005 Feb 10 (hereafter referred to 
as ``ONC 2005''); Retraction in: Oncogene 33(21):2814, 2014 May 22
 Suzuki, M., Shigematsu, H., Shivapurkar, N., Reddy, J., 
Miyajima, K., Takahashi, T., Gazdar, A.F., & Frenkel, E.P. 
``Methylation of apoptosis related genes in the pathogenesis and 
prognosis of prostate cancer.'' Cancer Lett. 242(2):222-30, 2006 Oct 28 
(hereafter referred to as ``CL 2006'')
 Suzuki, M., Shigematsu, H., Shames, D.S., Sunaga, N., 
Takahashi, T., Shivapurkar, N., Iizasa, T., Minna, J.D., Fujisawa, T., 
& Gazdar, A.F. ``Methylation and gene silencing of

[[Page 56077]]

the Ras-related GTPase gene in lung and breast cancers.'' Ann Surg 
Oncol. 14(4):1397-404, 2007 Apr (hereafter referred to as ``ASO 
2007'').

    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 in BJC 2005-01, Figure 1A, lanes 4-12, and 
Figure 1C, lanes 4-12
    (b) GAPDH RT-PCR panels in BJC 2005-2, Figures 1A and 1B, and ASO 
2007, Figures 1A and 1B
    (c) unmethylated form of p16 (p16U) RT-PCR panel in CL 2006, Figure 
1, lanes 3-10, positive (P) and negative (N) controls, and the p16 U 
RT-PCR panel in ONC 2005, Figure 2A.
    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:
    (a) GAPDH RT-PCR panels in LC 2005, Figures 1A and 1B
    (b) methylated form of Decoy receptor 2 (DcR2 M) methylation-
specific PCR (MSP) panel in CL 2006, Figure 1
    (c) methylated form of small Ras-related GTPase (RRAD M) MSP panel 
in ASO 2007, Figure 3B.
    Dr. Suzuki 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. 2014-22192 Filed 9-17-14; 8:45 am]
BILLING CODE 4150-28-P