[Federal Register Volume 67, Number 191 (Wednesday, October 2, 2002)]
[Notices]
[Page 61889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24952]


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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 
(ORI) and the Assistant Secretary for Health have taken final action in 
the following case:
    Heather J. Muenchen, Ph.D., University of Michigan: Based on the 
report of an investigation conducted by the University of Michigan 
(UM), Dr. Muenchen's admissions, and additional analysis conducted by 
ORI in its oversight review, the U.S. Public Health Service (PHS) found 
that Dr. Muenchen, former postdoctoral fellow at UM, engaged in 
scientific misconduct in research funded by National Institutes of 
Health (NIH) Urology Research Training Grant T32 DK07758 and SPORE 
grant PSO CA69568. Dr. Muenchen falsified and fabricated research data 
by computer manipulation of 12 Western blot analyses in three 
publications and two draft manuscripts.
    Specifically, PHS found that Dr. Muenchen:
    (1) Falsified Western blot data in Figures 3, 4A, and 4B in the 
following paper: Muenchen, H.J., Lin, D-L., Walsh, M.A., Keller, E.T., 
and Pienta, K.J. ``Tumor necrosis factor-alpha-induced apoptosis in 
prostate cancer cells through inhibition of nuclear factor-[kappa]B by 
an I[kappa]B[alpha] `super-repressor.' '' Clinical Cancer Research 
6(5):1969-1977, 2000;
    (2) Falsified Western blot data in Figures 2 and 3 in the following 
paper: Muenchen, H.J., Poncza, P.J., and Pienta, K.J. ``Different 
docetaxel-induced apoptotic pathways are present in prostate cancer 
cell lines LNCaP and PC-3.'' Urology 57(2):366-370, 2001;
    (3) Falsified Western blots and associated claims for Figures 1, 
5A, 5B, and 8 in the following paper: Muenchen, H.J., Lin, D-L., 
Poncza, P.J., McLean, L.L, Dirette, M.L., Keller, E.T., and Pienta, 
K.J. ``Re-expression of functional androgen receptor in androgen-
independent prostate cancer cells.'' Published electronically on 
November 13, 2000 in the Journal of Biological Chemistry (JBC) as 
Online Manuscript M008934200 (withdrawn January 16, 2001); and
    (4) Falsified Western blot analyses in Figures 4A, 4B, and 7 of the 
original draft submitted for publication on September 29, 2000, (and 
the corresponding Figures 5A, 5B, and 8 in the second draft submitted 
October 20, 2000) of the JBC manuscript.
    Dr. Muenchen was the first and corresponding author on the above 
publications, which were supported in part by Urology Research Training 
Grant T32 DK07758 and SPORE grant P50 CA69568. These falsifications are 
significant because they misrepresent the expression of the androgen 
receptor, the necessary control data, the evidence for ``super-
repressor'' binding and its effect, and the control data for assaying 
apoptosis. These misrepresentations occurred through a series of 
separate and specific deceptions in an attempt to obviate the 
legitimate criticisms of publication reviewers. These falsifications 
were designed to be misleading about the experiments' true results and 
to wrongfully induce publication of the experiments. Dr. Muenchen's 
work could have provided tools for understanding metastasis in prostate 
cancer and ultimately impact on treatment of this disease.
    Dr. Muenchen has entered into a Voluntary Exclusion Agreement in 
which she has voluntarily agreed:
    (1) To exclude herself from any contracting or subcontracting with 
any agency of the United States Government and from eligibility for, or 
involvement in, nonprocurement transactions (e.g., grants and 
cooperative agreements) of the United States Government as defined in 
45 CFR part 76 (Debarment Regulations) for a period of five (5) years, 
beginning on September 5, 2002;
    (2) To exclude herself 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 a period of 
five (5) years, beginning on September 5, 2002; and
    (3) Within 30 days of the effective date of this Agreement, to 
submit letters of retraction to the editor of Urology retracting the 
paper published at 57(2):366-370, 2001, and to the editor of Clinical 
Cancer Research, published at 6(5):1969-1977, 2000, identifying and 
retracting the falsified or fabricated data in Figure 3 and Figures 4A 
and 4B. The retraction requirements will remain on the ALERT System 
until Dr. Muenchen sends, and ORI receives, copies of the retraction 
letters consistent with the above language.

FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative 
Oversight, Office of Research Integrity, 5515 Security Lane, Suite 700, 
Rockville, MD 20852, (301) 443-5330.

Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. 02-24952 Filed 10-1-02; 8:45 am]
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