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Notice

Findings of Scientific Misconduct

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AGENCY:

Office of the Secretary, HHS.

ACTION:

Notice.

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-κB by an IκBα ‘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electronically on November 13, 2000 in the Journal of Biological Chemistry (JBC) as Online Manuscript M008934200 (withdrawn January 16, 2001); and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.

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FOR FURTHER INFORMATION CONTACT:

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

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Chris B. Pascal,

Director, Office of Research Integrity.

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[FR Doc. 02-24952 Filed 10-1-02; 8:45 am]

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