[Federal Register Volume 71, Number 110 (Thursday, June 8, 2006)]
[Notices]
[Pages 33308-33309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-5204]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Scientific Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the Office of Research Integrity 
(ORJ) and the Assistant Secretary for Health have taken final action in 
the following case:
    Steven Anthony Leadon, Ph.D., University of North Carolina: Based 
on the report of an investigation conducted by the University of North 
Carolina (UNC) at Chapel Hill and additional analysis conducted by ORI 
in its oversight review, the U.S. Public Health Service (PHS) found 
that Steven Anthony Leadon, Ph.D., former Professor of Radiation 
Oncology, Department of Radiology, School of Medicine, UNC, engaged in 
scientific misconduct while supported by National Cancer Institute 
(NCI),

[[Page 33309]]

National Institutes of Health (NIH), grant R01 CA40453-09 to 15.
    Specifically, PHS found that Dr. Landon engaged in scientific 
misconduct by falsifying DNA samples and constructing falsified figures 
for experiments done in his laboratory to support claimed findings of 
defects in a DNA repair process that involved rapid repair of DNA 
damage in the transcribed strand of active genes, included in four 
grant applications and in eight publications and one published 
manuscript, which were included as an Appendix to the Voluntary 
Exclusion Agreement entered into by Dr. Leadon and are as follows:
    Figures 1, 2, and 3 in the article by Gowen, L.C., Avrutskaya, 
A.V., Latour, A.M., Koller, B.H., & Leadon, S.A. ``BRCAI Required for 
Transcription-Coupled Repair of Oxidation DNA Damage.'' Science 
281:109-1012, 1988. In grant application 2 R01 CA40453-14 (p. 9), this 
article was used as justification for proposed research on BRCA1 and 
related proteins that may be required for transcription-coupled DNA 
repair of oxidative DNA damage. Data from the research reported in this 
paper was also used as preliminary data (Figure 2, p. 16) to support 
proposed experiments on BRCA1.
     Figures 1A, 2A, and 3 in the article by Leadon, S.A. & 
Avrutskaya, A. ``Differential Involvement of the Human Mismatch Repair 
Proteins, hMLH1 and hMSH2 in Transcription-coupled Repair.'' Cancer 
Research 57:3784-3791, 1997.
     Figures 1 and 3 in the article by Leadon, S.A. & 
Avrutskaya, A.V. ``Requirement for DNA Mismatch Repair Proteins in the 
Transcription Coupled Repair of Thymine Glycols in Saccharomyces 
cerevisiae.'' Mutation Research 407:177-187, 1998.
     Figures 7B and 7C in the article by Cressman, V.L., 
Backlund, D.C., Avrutskaya, A.V., Leadon, S.A., & Koller, B.H. ``Growth 
retardation, DNA repair defects, and lack of spermatogenesis in BRCA1-
deficient mice.'' Molecular and Cellular Biology 19:7061-7075, 1999.
     Figures 1 A-D, 3A, 3C, ajd 3D and graphs in the 
unpublished manuscript by Rauscher, F. J. III, Jensen, D.E., Patel, G., 
Fredericks, W.J., Schultz, D.C., Proctor, M., Sekido, Y., Minna, J., 
Chernova, T.A., Wilkinson, K.D., Avrutskaya, A.V., & Leadon, S.A. 
``BRCA1-associated ubiquitin hydrolase required for transcription-
coupled repair of oxidative DNA damage.'' Submitted to Science on May 
16, 2001. In figure 4 in grant application 2 R01 CA40453-14 (pp. 17-
18), data from this unpublished manuscript was used regarding BAP1 
defects in TCR.
     Figure 1A and 3A in the article by Cooper, P.K., 
Nouspikel, T., Clarkson, S.g., and Leadon, S.A., ``Defective 
transcription-coupled repair of oxidative base damage in Cockayne 
syndrome patients from XP group G,'' Science 275: 9907ndash993, 1997. 
In NIH grant application R01 CA40453-10A1, some of the same data for 
XPG or XP-G/CS cells from this Science article were included by Dr. 
Leadon as graphs (Figures 4 and 5, pp. 25-27) before the Science paper 
was published.
     Figure 1C, 2A and 2B in the article by LePage, F., Kwoh, 
E.E., Avrutskaya, A., Gentil, A., Leadon, S.A., Sarasin, A., & Cooper, 
P.K. ``Transcription-coupled repair of 8-oxoguanine: requirement for 
XPG, TFIIH, and CSB and implications for Cockayne Syndrome.'' Cell 
101:159-171, 2000. Figure 7 in grant application 1 R01 CA092390-01.
     Figures 1 and 2 and Table 1 in the article by Leadon, 
S.A., Barbee, S.L., & Dunn, A.B. ``The yeast RAD2, but not RAD1, gene 
is involved in the transcription-coupled repair of thymine glycols.'' 
Mutation Research 337:169-178, 1995.
     Figure 6 in the article Nouspikel, T., Lalle, P., Leadon, 
S.A., Cooper, P.K., & Clarkson, S.g. ``A common mutational pattern in 
Cockayne syndrome patients from xeroderma pigmentosum group G: 
Implications for a second XPG function,'' Proc. Nat. Acad. Sci. USA 94, 
3116-3121, 1997.
    Dr. Leadon's position is that he did not engage in scientific 
misconduct. His position is that a systematic error was introduced into 
the experiments in question and he recognizes that it could have 
influenced or accounted for the results. Dr. Leadon states that he has 
entered into a Voluntary Exclusion Agreement (Agreement) because he 
cannot sustain the significant financial burden of a legal proceeding 
to resolve the disagreements between his position and that of HHS. By 
entering into this Agreement, Dr. Leadon has voluntarily agreed:
    (1) To exclude himself from knowingly contracting or subcontracting 
with any agency of the United States Government and from eligibility or 
knowing involvement in nonprocurement programs of the United States 
Government referred to as ``covered transactions'' as defined in the 
debarment regulations at 45 CFR Part 76 for a period of five (5) years, 
beginning on May 10, 2006;
    (2) 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 consultant for a period of 
five (5) years, beginning on May 10, 2006; and
    (3) To submit letters of retraction to the editors of the journals 
listed below within ten (10) business days from the effective date of 
this Agreement, stating as follows:

    (A) ``I have recently had the opportunity to review some of the 
raw data used for this paper in the above-referenced publication, 
and it is clear that the data as reported in this paper cannot be 
relied upon. Therefore, I request that you retract this paper.'' A 
letter using only the aforementioned language in this subsection 
will be sent to Mutation Research to retract the following paper: 
Leadon, S.A., Barbee, S.L., & Dunn, A.B. ``The yeast RAD2, but not 
RAD1, gene is involved in the transcription-coupled repair of 
thymine glycols.'' Mutation Research 337:169-178, 1995.
    (B) ``I have recently had the opportunity to review some of the 
raw data used for Figure 6 in this paper in the above-referenced 
publication, and it is clear that the data as reported in this 
figure cannot be relied upon. Therefore, I request that you retract 
Figure 6 of this paper.'' A letter using only the aforementioned 
language in this subsection will be sent to Proceedings of National 
Academy of Sciences concerning the following article: Nouspikel, T., 
Lalle, P., Leadon, S.A., Cooper, P.K., & Clarkson, S.G. ``A common 
mutational pattern in Cockayne syndrome patients from xeroderma 
pigmentosum group G: Implications for a second XPG function.'' 
Proceedings of the National Academy of Sciences 94:3116-3121, 1997.
    (C) ``I have recently had the opportunity to review some of the 
raw data used for Figures 7B and 7C in this paper in the above-
referenced publication, and it is clear that the data as reported in 
these figures cannot be relied upon. Therefore, I request that you 
retract Figure 7B and 7C of this paper.'' A letter using only the 
aforementioned language in this subsection will be sent to Molecular 
and Cellular Biology concerning the following article: Cressman, 
V.L., Backlund, D.C., Avrutskaya, A.V., Leadon, S.A., & Koller, B.H. 
``Growth retardation, DNA repair defects, and lack of spermatogensis 
in BRCA1-deficient mice.'' Molecular and Cellular Biology 19:7061-
7075, 1999.

FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative 
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 
750, Rockville, MD 20852, (240) 453-8800.


Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. 06-5204 Filed 6-7-06; 8:45 am]
BILLING CODE 4150-31-M