[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75339-75341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26100]


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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: Findings of research misconduct have been made against Dr. 
David J. Panka (Respondent), former Harvard Medical School (HMS) 
Instructor of Medicine, and former HMS Associate Professor of Medicine 
at Beth Israel Deaconess Medical Center (BIDMC). Dr. Panka engaged in 
research misconduct in research supported by U.S. Public Health Service 
(PHS) funds, specifically National Cancer Institute (NCI), National 
Institutes of Health (NIH), grants P50 CA093683 and P50 CA101942. The 
administrative actions, including supervision for a period of three (3) 
years, were implemented beginning on November 9, 2020, and are detailed 
below.

FOR FURTHER INFORMATION CONTACT: Elisabeth A. Handley, Director, Office 
of Research Integrity, 1101 Wootton Parkway, Suite 240, Rockville, MD 
20852, (240) 453-8200.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the Office of 
Research Integrity (ORI) has taken final action in the following case:
    Dr. David J. Panka, Harvard Medical School and Beth Israel 
Deaconess Medical Center: Based on the report of an inquiry conducted 
by BIDMC and HMS and additional analysis conducted by ORI in its 
oversight review, ORI found that Dr. Panka, former HMS Instructor of 
Medicine, and former HMS Associate Professor of Medicine at BIDMC, 
engaged in research misconduct in research supported by PHS funds, 
specifically NCI, NIH, grants P50 CA093683 and P50 CA101942.
    ORI found that Respondent engaged in research misconduct by 
intentionally, knowingly, and/or recklessly falsifying and/or 
fabricating Western blot images by selectively cutting, flipping, 
reordering, and reusing the same source images or non-correlated images 
to represent different results in the following three (3) published 
papers and one (1) conference presentation:
     The Raf inhibitor BAY 43-9006 (Sorafenib) induces caspase-
independent apoptosis in melanoma cells. Cancer Res. 2006 Feb 1; 
66(3):1611-9 (hereafter referred to as ``Cancer Res. 2006''). 
Retraction in: Cancer Res. 2019 Oct 15;79(20):5459.
     Differential modulatory effects of GSK-3b and HDM2 on 
sorafenib-induced AIF nuclear translocation (programmed necrosis) in 
melanoma. Mol Cancer 2011 Sep 19;10:115 (hereafter referred as to ``Mol 
Cancer 2011'').
     Effects of HDM2 antagonism on sunitinib resistance, p53 
activation, SDF-1 induction, and tumor infiltration by CD11b+/Gr-1+ 
myeloid derived suppressor cells. Mol Cancer 2013 Mar 5;12:17 
(hereafter referred to as ``Mol Cancer 2013'').
     Presentation #5328, ``BAY 43-9006 induces apoptosis in 
melanoma cell lines'', presented during Cellular and Molecular Biology 
session #63 `` (`Apoptosis 4: Chemotherapeutic Agents II')'' on April 
20, 2005, at the 96th Annual American Association for Cancer Research 
(AACR) meeting, held in Anaheim, California (hereafter referred to as 
the ``2005 AACR Presentation'').

[[Page 75340]]

    Specifically, ORI found that Respondent knowingly, intentionally, 
and/or recklessly falsified and/or fabricated:
     Western blot images in twelve (12) figures of three (3) 
published papers and one (1) conference presentation by editing, 
reusing, and relabeling the same source images or the non-correlated 
blots to represent different results from different experiments. 
Specifically:

--Respondent reused and relabeled the same source bands to falsely 
represent different protein expression in the following two figures in 
Cancer Res. 2006 and to represent more than one lane within a single 
row:
    [ssquf] Figure 1A, bottom row, in Cancer Res. 2006, representing 
MEK expression in A375, A2058, and SK MEL 5 cells treated by different 
doses of Bay 43-9006
    [ssquf] Figure 2C, bottom row, in Cancer Res. 2006, representing 
the expression of Vinculin in the same three cell types without or with 
Bay 43-9006 treatment at different time points
--Respondent reused and relabeled the same source bands to falsely 
represent different protein expression in two figures as follows and to 
represent more than one lane within a single row:
    [ssquf] Figure 5, bottom row, in the 2005 AACR Presentation, 
representing the expression of Total Bad in A375 cells with different 
treatments
    [ssquf] Figure 2C, second row, in Cancer Res. 2006, representing 
the expression of Bax in three different cell types
--Respondent reused and relabeled the bands that were used for Figure 
4, bottom row, in Cancer Res. 2006, representing ERK expression in 
A2058 cell type with different treatments at different time points, to 
falsely represent the expression of ERK in three different cell types 
in Figure 1A, second row, in Cancer Res. 2006.
--Respondent reused and relabeled the same source bands to falsely 
represent unrelated experimental results in two rows of Figure 3A in 
Cancer Res. 2006 as follows:
    [ssquf] Figure 3A, fourth row, in Cancer Res. 2006, representing 
the expression of pBad ser 75 in A2058 cell type with different 
treatments at different time points
    [ssquf] Figure 3A, seventh row, in Cancer Res. 2006, representing 
pBad ser 75 expression in A375 cell type with the same treatments and 
at the same time points as the representation of the fourth row
--Respondent reused and relabeled the source bands to falsely represent 
unrelated experimental results in two rows of Figure 3A in Cancer Res. 
2006 as follows:
    [ssquf] Figure 3A, first row, in Cancer Res. 2006, representing the 
expression of pBad ser 75 in SK MEL 5 cell type with different 
treatments at different time points
    [ssquf] Figure 3A, eighth row, in Cancer Res. 2006, representing 
pBad ser 99 expression in A375 cell type with the same treatments and 
at the same time points as the representation of the first row
--Respondent fabricated the bands that were used for Figure 3A, second 
row, in Cancer Res. 2006, representing the expression of pBad ser 99 in 
SK MEL 5 cell type with different treatments at different time points 
by using an unrelated image.
--Respondent reused and relabeled the bands to falsely represent AIF 
expression in mitochondria of the three cell types with different 
treatments in Figure 6A, the bottom row, in Cancer Res. 2006, by:
    [ssquf] Duplicating the bands in the second to fourth lanes to 
represent mitochondria expression in A375 cell type with Bay 43-9006 
(second lane), PD 98059 (third lane), and U0126 (fourth lane) 
treatments
    [ssquf] duplicating the band for both the fifth and seventh lanes 
to represent AIF expression in mitochondria of A2058 cell type with no 
treatment control (fifth lane) and PD 98059 treatment (seventh lane)
--Respondent reused and relabeled the same source bands to falsely 
represent different experimental results in Figure 3A in Mol Cancer 
2011 as follows:
    [ssquf] Figure 3A, first four lanes in the middle row of the left 
panel, in Mol Cancer 2011, representing c-myc expression in nucleus of 
A375 cell type
    [ssquf] Figure 3A, first four lanes in the middle row of the right 
panel, in Mol Cancer 2011, representing c-myc expression in nucleus of 
SK MEL 5 cell type
--Respondent reused and relabeled the same source bands to falsely 
represent different experimental results in Figure 5 in Mol Cancer 2011 
as follows:
    [ssquf] Figure 5, sixth to eighth lanes of the middle row, in Mol 
Cancer 2011, representing BCL-XL expression in A375-GSK cells with DOX
    [ssquf] Figure 5, last three lanes of the middle row, in Mol Cancer 
2011, representing BCL-XL expression in SK MEL 5 S9A
--Respondent reused and relabeled the unrelated source bands to falsely 
represent different experimental results in Figure 5 of Mol Cancer 2011 
as follows:
    [ssquf] Figure 5, thirteenth to fifteenth lanes of the top row, in 
Mol Cancer 2011, representing BCL2 expression in SK MEL 5 S9A
    [ssquf] Figure 5, thirteenth to fifteenth lanes of the bottom row, 
in Mol Cancer 2011, representing VINCULIN expression in SK MEL 5 S9A
--Respondent reused and relabeled the same source bands to falsely 
represent different experimental results in Figure 1 in Mol Cancer 
2013; specifically respondent:
    [ssquf] Reused the bands that were used for Figure 1, fourth to 
fifth lanes of the second row, in Mol Cancer 2013, representing noxa 
expression in the control group of A498 cell type, to falsely represent 
noxa expression in the sunitinib resistant group of A498 cells in the 
same figure, eleventh to twelfth lanes of the second row
    [ssquf] reused the band that was used for Figure 1, eighth lane of 
the second row, in Mol Cancer 2013, representing noxa expression in the 
third sample of the sunitinib responding group, to falsely represent 
noxa expression in the fifth sample of the sunitinib responding group 
in the same figure, tenth lane of the second row
--Respondent reused and relabeled the same source bands to falsely 
represent different experimental results in Figure 6B in Mol Cancer 
2013 as follows:
    [ssquf] Figure 6B, first two lanes of the bottom row, in Mol Cancer 
2013, representing vinculin expression in control group
    [ssquf] Figure 6B, eleventh and twelfth lanes of the bottom row, in 
Mol Cancer 2013, representing vinculin expression in dox + sunitinib 
group
--Respondent reused and relabeled the same source bands to falsely 
represent different experimental results in the following three 
figures:
    [ssquf] Figure 10, second rows of both upper and lower panels, in 
the 2005 AACR Presentation, representing pSRC-Y416 expression in A2058 
(upper) and A375 (lower) cell types
    [ssquf] Figure 4 in Cancer Res. 2006 and Figure 6 in the 2005 AACR 
Presentation, second rows of middle and lower panels, representing Bcl-
XL expression in

[[Page 75341]]

A2058 (middle) and SK MEL 5 (lower) cell types
--Respondent reused and relabeled the same source band to falsely 
represent two different experimental results in Figure 5 in the 2005 
AACR Presentation as follows:
    [ssquf] Figure 5, lane 1 of the seventh row, in the 2005 AACR 
Presentation, representing pBad ser 75 expression at 0 hour in control 
group
    [ssquf] Figure 5, lane 2 of the seventh row, in the 2005 AACR 
Presentation, representing pBad ser 75 expression at 1 hour in control 
group
    Dr. Panka entered into a Voluntary Settlement Agreement and agreed 
to the following:
    (1) Respondent agreed to have his research supervised for a period 
of three (3) years beginning on November 9, 2020. Respondent agrees 
that prior to the submission of an application for PHS support for a 
research project on which 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 contribution. 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) The requirements for Respondent's supervision plan are as 
follows:
    i. A committee of 2-3 senior faculty members at the institution who 
are familiar with Respondent's field of research, but not including 
Respondent's supervisor or collaborators, will provide oversight and 
guidance for a period of three (3) years from the effective date of the 
Agreement. The committee will review primary data from Respondent's 
laboratory on a quarterly basis and submit a report to ORI at six (6) 
month intervals, setting forth the committee meeting dates and 
Respondent's compliance with appropriate research standards and 
confirming the integrity of Respondent's research.
    ii. The committee will conduct an advance review of any PHS grant 
applications (including supplements, resubmissions, etc.), manuscripts 
reporting PHS-funded research submitted for publication, and abstracts. 
The review will include a discussion with Respondent of the primary 
data represented in those documents and will include a certification to 
ORI that the data presented in the proposed application/publication are 
supported by the research record.
    (3) Respondent agreed that for a period of three (3) years 
beginning on November 9, 2020, any institution employing him shall 
submit, in conjunction with each application of 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.
    (4) If no supervisory plan is provided to ORI, Respondent agreed to 
provide certification to ORI at the conclusion of the supervision 
period that he has not engaged in, applied for, or had his name 
included on any application, proposal, or other request for PHS funds 
without prior notification to ORI.
    (5) Respondent agreed 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 a period of three (3) years, beginning on November 
9, 2020.
    (6) As a condition of the Agreement, Respondent will request that 
the following papers and conference abstract be corrected or retracted 
in accordance with 42 CFR 93.407(a)(1) and Sec.  93.411(b):

 Mol Cancer 2011 Sep 19;10:115
 Mol Cancer 2013 Mar 5;12:17
 2005 AACR Presentation

Respondent will copy ORI and the Research Integrity Officer at HMS and 
BIDMC on the correspondence.

    Dated: November 20, 2020.
Elisabeth A. Handley,
Director, Office of Research Integrity, Office of the Assistant 
Secretary for Health.
[FR Doc. 2020-26100 Filed 11-24-20; 8:45 am]
BILLING CODE 4150-31-P