Office of Research Integrity, DAB CR6690 (2025)

RECOMMENDED DECISION GRANTING SUMMARY JUDGMENT

Pursuant to 42 C.F.R. § 93.523(b), I recommend that the Assistant Secretary for Health and Human Services (HHS), grant summary judgment to the Office of Research Integrity (ORI).1  The undisputed facts establish that Respondent, Dr. Ariel Fernandez, engaged in research misconduct by fabricating and/or falsifying research results in published papers, unpublished manuscripts, grant applications, and a presentation.

The extent of misconduct engaged in by Respondent justifies the administrative remedies sought by ORI, which consist of debarring Respondent for a period of fifteen (15) years from participating in “covered transactions” as defined in 2 C.F.R. § 180.200, and procurement transactions covered under the Federal Acquisition Regulation (48 C.F.R. chapter 1).  Further, Respondent’s name will be placed in the “System for Award Management,” which is maintained by the General Services Administration.  ORI additionally seeks that Respondent be prohibited from serving in any advisory capacity to the U.S. Public Health Service (PHS) for a period of fifteen (15) years and ORI proposes to send a notice to the pertinent journals that require retraction and/or correction because of Respondent’s falsified and fabricated research results.

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I.        Background and Procedural History

Respondent is a computational scientist with a master’s degree in chemistry and a Ph.D. in chemical physics.  Respondent worked at Rice University (Rice) from 2006 to 2011 where he served as the Karl F. Hasselmann Chaired Professor of Engineering.  In his position with Rice, Respondent did not conduct experiments or maintain a laboratory (also referred to as a “wet lab”) for others to conduct experiments related to his computational research.  Respondent Exhibit (R. Ex.) 40 at 4.  As a theoretician, Respondent developed hypotheses based on computational research and he collaborated with experimentalists to confirm the theories in their laboratories.  ORI Ex. 9 at 1.

On November 9, 2022, Respondent received a charging letter from ORI, notifying him that ORI found that he engaged in research misconduct under 42 C.F.R. Part 93.  Charging Letter (CL).  The findings were based on the evidence and findings of an investigation by Rice, as well as from additional information that ORI obtained during its oversight review of the investigation and review of additional allegations.  Id. at 6.  ORI determined that Respondent intentionally, knowingly, or recklessly engaged in research misconduct by fabricating and/or falsifying research results in twelve (12) published papers, four (4) unpublished manuscripts, one (1) presentation, and three (3) grant applications for PHS funding.  Specifically, ORI made ten (10) findings of research misconduct that Respondent fabricated and/or falsified the synthesis of six novel chemical compounds:  Entropy Jolt, SUDE (sunitinib-derived editor), Wrapper 1, Wrapper 2, Compound 9, and Compound 10; fabricated and/or falsified the results of spectrophotometric kinetic assays, kinome scans, cell proliferation assays, adsorption/desorption assays, and ATP production assays; and fabricated and/or falsified figures of Western blots and confocal microscopy images by copying, manipulating, and relabeling images.  Id. 

On December 6, 2022, Respondent submitted a hearing request and 30 exhibits (R. Exs. 0-29).  On December 19, 2022, Respondent filed a request to supplement his hearing request with additional arguments and four (4) additional exhibits (R. Exs. 30-33).  ORI did not oppose Respondent’s request to supplement his hearing request, and the presiding judge granted Respondent’s request to supplement.2 

On April 3, 2023, ORI filed a motion for summary judgment, a brief in support (ORI Br.), and a total of 191 exhibits (ORI Exs. 1-191).  Respondent filed no objections to ORI’s proposed exhibits, however, on June 19, 2023, Respondent filed a response brief including a cross motion for summary judgment (R. Resp.) and an additional 29 exhibits (R. Exs. 34-63).  On July 3, 2023, ORI filed objections to Respondent’s exhibits 4-6, 8, 13, 22, 26, 32, 34, 37-43, 46-51, 54-55, and 57-63, as well as objections to each of

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Respondent’s proposed witnesses.  ORI’s Objections to Respondent’s Proposed Exhibits and Witnesses (ORI’s Objections).

1. ORI’s Objections to Respondent’s Exhibits

Respondent Exhibits 4, 5, 26, 39, 6, 57, 34, 62, 63, and 38 are all statements from individuals.  ORI objects to the statement of Dr. Sangtae Kim (Kim) (R. Ex. 4) on the basis that Kim lacks personal knowledge as to whether Eli Lilly Research Laboratories (Lilly) synthesized the compounds in issue and whether Lilly scientists generated and provided to Respondent the experimental data using those and other compounds as asserted by Respondent.  ORI Objections at 2.  Additionally, Respondent does not offer Kim as a witness available for cross-examination.

ORI objects to the statements of Dr. Snidhar Maddipati (Maddipati) (R. Exs. 5, 26, and 39), on the basis that Maddipati lacks personal knowledge about whether Lilly scientists supplied Respondent with the specific experimental data at issue.  Id. at 3.  Additionally, while Maddipati offers an opinion about the Lilly provenance of the experimental data, Respondent has not offered Maddipati as an expert witness within the guidelines of 42 C.F.R. § 93.513(a) or Federal Rules of Civil Procedure 26(a)(2)(B).  ORI Objections at 3-4.

In a notarized statement, Dr. John Feltenberger (Feltenberger) opines that the synthetic pathways and synthetic strategies reported in Respondent’s publications are chemically sound, scientifically correct, and likely to be reproductible to generate the compounds described.  R. Ex. 6.  In an additional statement, Feltenberger opines that there is no plagiarism in Respondent’s publications because the similarities between the reported syntheses and those of the parent compounds are entirely expected.  R. Ex. 57.  ORI asserts that R. Exs. 6 and 57 should be excluded as unreliable expert opinion testimony because Feltenberger’s testimony is not based on sufficient facts or data and is not the product of reliable principles and methods.  ORI Objections at 4-6.  Specifically, ORI maintains that the affidavits provide unfounded conclusions, without reasoning, analysis, or references to the literature in support of the witness’s conclusions.  Id.  Further, ORI objects on the basis that the testimony in question does not meet the requirements for expert witness testimony under 42 C.F.R. § 93.513(a) and Federal Rules of Civil Procedure 26(a)(2)(B).  Id.

ORI also objects to the opinion testimony of Dr. L. Ridgeway Scott (Scott) (R. Exs. 34, 62, 63, and 38) and asserts that Scott’s proffered opinion is not based on sufficient facts or data and is not the product of reliable principles.  Id. 6-7.  ORI points out that Scott holds a degree in mathematics and computer science and is not qualified as an expert in organic chemistry and ORI submits that Scott further admits that he is not a synthetic chemist.  In an additional statement (R. Ex. 38), Scott offers his opinion that Respondent’s student conspired with administrators of Rice to blame Respondent for

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faulty data.  R. Ex. 38.  Scott admits, however, that much of his understanding of what occurred was based on his discussions with undergraduate Sean Sessel (Sessel).  Id.  Scott acknowledges that his main contribution is to offer his strongest support for “whatever Sean Sessel has to say about this affair.”  Id.

ORI further objects to exhibits 8, 13, 22, 32, 37, 40-42, 58, and 59 as these exhibits contain sworn statements from individuals on Respondent’s list of proposed witnesses.  Relying on 701 of the Federal Rules of Evidence (Fed. R. Evid), ORI objects to the extent that such statements constitute improper opinion testimony from a lay witness.  ORI objections at 12.  ORI asserts that such statements are not based on scientific, technical, or other specialized knowledge that is within the scope of expert testimony.  Further, ORI maintains that none of the individuals connected to the statements are offered as expert witnesses and these witnesses are not qualified as expert witnesses within the requirements of 42 C.F.R. § 93.513(a) or Fed R. Evid. 702.  Id. at 12-13.

As discussed above, ORI generally objects to R. Exs. 4-6, 8, 13, 22, 26, 32, 34, 37-42, 57-59, 62, and 63 on the basis that these exhibits contain witness statements or proposed testimony that is improper opinion testimony from a lay witness and/or the witness  lacks personal knowledge and the statements are not based on sufficient facts or data.  For R. Exs. 4, 6, and 57, ORI objects because Respondent does not offer the individual as a witness available for cross examination.

I am required to admit evidence unless it is clearly irrelevant, immaterial, or unduly repetitious.  42 C.F.R § 93.519(c).  I have broad discretion to admit evidence, and I am not bound by the federal rules.  Id. at § 93.519(a) and (b).  Although expressed opinions may not be well-supported, such testimony may still be admissible in these administrative proceedings.  In order that I may consider the record in its entirety and because I have issued a recommended decision based on ORI’s motion for summary judgement, I admit Respondent Exhibits 5, 8, 13, 22, 26, 32, 34, 37-42, 58, 59, 62, and 63.  I do so despite ORI’s objections so that I may consider those exhibits, along with all other evidence, in the light most favorable to Respondent.  In doing so, however, I find that these witness statements do not meet the criteria to be considered as expert witness testimony and are at best lay opinion testimony lacking foundation.  Furthermore, I agree that there is a lack of personal knowledge and an absence of sufficient data and foundation to explicitly address the specific experimental data in issue in ORI’s findings.

Consistent with the rationale discussed above, Respondent’s Exhibits 4, 6, and 57 would otherwise be inadmissible.  As ORI asserts, ORI would have no opportunity to examine the bases for these witnesses’ opinions and there would be no way to determine these witnesses’ credibility or the validity of their testimony.  Nevertheless, because I am granting ORI’s motion for summary judgment in this recommended decision, I will admit Respondent Exhibits 4, 6, and 57 so that I may consider all evidence in the light most favorable to Respondent.

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ORI additionally objects to R. Exs. 43, 46-51, and 54; containing various charts, graphs, and images.  ORI asserts that Respondent offers no witness to provide foundational testimony identifying and authenticating the information contained in the exhibits.  ORI’s Objections at 7-10.  ORI further asserts that these exhibits are irrelevant to ORI’s findings of research misconduct or administrative actions.  Id.  While Respondent labeled these images when offering them as exhibits, Respondent offers no witness to provide foundational testimony identifying and authenticating the exhibits.  Further, Respondent has not established the relevancy of the exhibits.  I do not accept Respondent Exhibits 43, 46-51, or 54.

ORI additionally objects to R. Exs. 55, 60, and 61.  R. Ex. 55 is a one-page document entitled Summary of ORI Malfeasance.  R. Ex. 60 is entitled Synopsis of Respondent’s Brief-Part I and R. Ex. 61 is a two-page document listing a summary of Respondent’s witnesses, a summary of their testimony, references to other exhibits, references to statutory sections, and is entitled Inadmissibility of ORI evidence.  ORI objects to each exhibit on the basis that the exhibits constitute argument and not evidence.  ORI Objections at 11.  I agree that Respondent Exhibits 55, 60, and 61 are argument and have no probative value as evidence.  Accordingly, I do not accept Respondent’s Exhibits 55, 60, and 61.

2. ORI’s Objections to Respondent Witness’s.  

ORI objects to Respondent witnesses Scott, Maddipati, Sessel, Xi Zhang, Jianping Chen, and Axel Blau. ORI asserts that the testimony of these proposed witnesses should be excluded as their testimony lacks foundation and constitutes improper expert testimony, as well as being unreliable and irrelevant.  ORI Objections at 13-14.  As I discussed above, testimony may be admissible even if it is otherwise based on opinions that are not well-supported.  While I do not find the testimony of these witnesses to defeat ORI’s motion for summary judgement, I have considered the testimony.

3. The record for consideration

As discussed above, Respondent did not object to any of ORI’s exhibits.  Accordingly, I receive ORI exhibits 1-191.  Further, as discussed above, I receive into evidence Respondent exhibits 0-42, 44, 45, 52, 53, 56-59, 62, and 63.

II.    Issues

The issues raised by ORI’s charging document include: 

1. Whether Respondent intentionally, knowingly, or recklessly falsified and/or fabricated research results that were included in twelve (12) published papers, four

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(4) unpublished manuscripts, one (1) presentation, and three (3) grant applications for PHS funding;

2. Whether Respondent committed actions that constitute a significant departure from accepted practices of the relevant research community; and
3. Whether the administrative actions proposed by ORI are reasonable.

III. Discussion

1. Findings of Fact, Conclusions of Law, and Analysis3
   1. Summary disposition is appropriate in a case involving allegations of research misconduct where there are no disputed issues of material fact and where the moving party is entitled to a favorable decision as a matter of law.

Pursuant to 42 C.F.R. § 93.506(b)(15), I may resolve a case, in whole or part, upon motion of a party for summary judgment when there is no disputed issue of material fact.  It is, in fact, appropriate to issue summary disposition when there are no issues of material fact that are in dispute and where the moving party is entitled to a favorable decision as a matter of law.  Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986); Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); see Scott J. Brodie, DAB CR2056 (2010), aff’d Brodie v. U.S. Dep’t. of Health & Human Servs., 796 F. Supp. 2d 145 (D.D.C. 2011) (upholding ALJ finding that HHS was entitled to summary judgment).

A genuine dispute over a material fact occurs when a party opposing a motion supports its version of a material fact with sufficiently admissible evidence so that a reasonable trier of fact could resolve the dispute in favor of the opposing party.  Anderson, 477 U.S. 242 at 247-48.  The opposing party does not meet its burden simply by denying the facts offered by the moving party.  Rather, it must furnish admissible evidence that challenges the material facts alleged by the moving party.

In granting summary judgment, I must distinguish material facts that are supported by evidence that would be admissible at a hearing from unsupported fact allegations.  Unsupported allegations do not establish disputed issues of fact, nor do allegations that are fanciful or that are supported by such minimal evidence as to be beyond any reasonable probability of existence.  Matsushita, 475 U.S. at 587; Scott J. Brodie, DAB CR2056 at 5.

I do not find the facts and arguments offered by Respondent in opposition to ORI’s motion call into legitimate dispute the facts that ORI offers to establish that Respondent engaged in research misconduct.  What Respondent offers in his defense is irrelevant and

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without factual foundation.  In contrast, I find ORI’s allegations to be supported overwhelmingly by the undisputed material facts.  I find that nothing that Respondent asserts either rebuts the undisputed facts of this case or establishes a dispute of material facts.

Accordingly, the issues in this case must be resolved against Respondent as a matter of law, and summary judgment is appropriate such that an oral hearing is unnecessary.

1. Rice’s Investigation and Findings

In September 2008, Abhinav Tiwari (Tiwari) was a graduate student in the Department of Bioengineering at Rice.  ORI Ex. 56.  A part of his studies involved working in the laboratory with biologist Dr. Gabriel Lopez-Berestein at M.D. Anderson Cancer Center (MDACC) with Respondent as his advisor in Rice’s Bioengineering Department.  Id.; ORI Ex. 40.  Tiwari requested that Respondent allow him to change projects, explaining that he had completely lost interest in the work at MDACC and he was much more interested in doing computational research.  ORI Ex. 56.  In May 2009, Tiwari was working with Respondent on revisions to a manuscript for the journal Trends in Pharmacological Science (“TiPSsub09”).  The manuscript reported research involving combining certain anticancer drugs to improve their therapeutic efficacy while lessening side effects.  ORI Exs. 10, 55.

In working on the manuscript, Tiwari did not perform any laboratory experiments for the manuscript.  Instead, his role was to search the literature and to provide suggestions on experiments to test Respondent’s hypotheses.  ORI Ex. 10 at 1; ORI Ex. 43.  Respondent provided Tiwari with the experimental results.  ORI Exs. 58, 49, 62, and 66.

In May 2009, Respondent gave Tiwari a PowerPoint file to insert into the manuscript which contained figures representing experimental results. While revising TiPSsub09, Tiwari noticed that an image in one of the figures had been copied and pasted over an adjacent image.  ORI Ex. 10 at 2.  When Tiwari moved the image, it revealed a different image that did not support the paper’s hypothesis.  Id.  Tiwari contacted Respondent who was out of town and told him about the superimposed image.  ORI Ex. 70.  Tiwari suggested that they resolve the issue before proceeding with the submission.  Id.  When Respondent replied to Tiwari’s email, Respondent assured Tiwari that the issue was resolved, the results were legitimate, and directed that the manuscript submission go forward.  ORI Ex. 10 at 2.  Several times in the email exchange, Respondent referred to an unnamed third party-“they”-as having performed the experiments reported in the figures.  Id.  Tiwari assumed that “they” referred to scientists at the pharmaceutical company Lilly, as Respondent had previously told him that the experiments were performed there.  ORI Ex. 10.

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Because of Respondent’s responses, Tiwari became suspicious, and he re-examined the other figures in the manuscript.  He discovered that many of the images were copied and pasted from published articles by different authors for unrelated experiments.  ORI Ex. 10 at 2-3.  Respondent had also submitted manuscripts with substantially the same content to two other journals in 2009; a Nature Biotechnology submission (“NBTsub09”) (ORI Exs. 51, 52) that was rejected, and a Cancer Research submission (“CRsub09”) (ORI Exs. 53, 54) that was undergoing peer review.  ORI Ex. 10 at 1; ORI Ex. 43 at 2; ORI Ex. 9 at 3.
Tiwari concluded that those manuscripts also contained the fabricated figures.  He then informed Dr. Jennifer West (West), Rice’s Department of Bioengineering Chair, of his findings and provided her the files pertaining to the manuscript and the original research articles from where the figures had been copied.  Id.  West then notified Rice’s Research Integrity Officer (RIO), Dr. James Coleman, Vice Provost for Research and Professor of Ecology and Evolutionary Biology (RIO Coleman), and Rice initiated a research-misconduct proceeding under 42 C.F.R. Part 93.  ORI Ex. 1.

On or about May 19, 2009, RIO Coleman instructed the Rice Information Security Office (ISO) to secure data stored on computers in Respondent’s laboratory and offices on Rice’s campus.  ORI Ex. 1 at 3.  He also instructed the Rice ISO to secure data on Respondent’s laptop computer when Respondent returned from out of the country.  Id.  The external hard drive containing all the mirrored copies of the sequestered hard drives was ultimately provided to ORI in August 2010.  Id. at 4.  From May 2009 through April 2010, the Rice ISO collected all available emails from mirrored drive images, Rice’s servers, and network back-up files involving Respondent and/or other data relevant to the research misconduct proceedings.  ORI Ex. 2 at 5-6.  As a part of Rice’s investigation, RIO Coleman also secured copies of all emails dated September 2007 through the date of collection that were between Respondent and Tiwari, between Respondent and individuals using email accounts from Lilly, and between Respondent and collaborators at MDACC.  ORI Ex. 1 at 3.

On or about June 1, 2009, RIO Coleman sent a letter to Respondent informing him of allegations of research misconduct involving manuscript submissions to the journals Nature Biotechnology, Cancer Research, and Trends in Pharmacological Sciences and requested that Respondent submit original laboratory notebooks and other relevant materials.  Id. at 2; ORI Ex. 8.

After initiating an inquiry into the first allegations, RIO Coleman became aware of additional research misconduct allegations involving a published paper, Molecular Pharmaceutics, (Mol. Pharm) 2008;5:430-437 (“MP08”), authored by Respondent and a former postdoctoral fellow in his laboratory, Dr. Alejandro Crespo (Crespo).  ORI Ex. 1 at 2.  In a letter dated June 22, 2009, RIO Coleman informed Respondent that the research in the paper appeared to be falsified.  ORI Ex. 11 at 2.  RIO Coleman also told Respondent that there may be plagiarism/falsification in the manuscript submitted to Cancer Research.  Id. at 4-6.

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On September 8, 2009, Rice’s Provost, Eugene H. Levy, charged an Investigatory Panel (Panel), under Rice’s policy and procedures on research misconduct, to investigate allegations and evidence of possible fabrication, falsification, and/or plagiarism of research reported in several manuscripts and a publication authored in whole or part by Respondent.  ORI Ex. 48.  The members of the Panel were Seiichi Matsuda, Ph.D. (Chair), The E. Dell Butcher Professor in the Rice Chemistry Department and Professor in the Rice Biochemistry and Cell Biology Department; Michael Stern, Ph.D., Professor in the Rice Biochemistry and Cell Biology Department; and B. Montgomery Pettitt, Ph.D., The Cullen Distinguished Professor in the University of Houston Chemistry Department.  Staff Support was provided to the Panel by RIO Coleman as well as by the Rice Office of the General Counsel.  Id.

Over the course of its investigation, the Panel personally interviewed the following individuals in the presence of a certified court reporter who later transcribed the content of the interviews: (1) Dr. Gabriel Lopez-Berestein, Professor, MDACC; (2) Natalia Pietrosemoli, graduate student; (3) Tiwari; (4) West; (5) Crespo; and (6) Respondent.  Id. at 21.  While Tiwari and Crespo were initially named as respondents in the alleged misconduct investigation, the Panel ultimately determined that only Respondent was responsible for the research misconduct.  Id. at 18.

The Panel’s Final Investigation Report (Rice Report) confirmed that it evaluated the testimony of all witnesses, made comparisons of the statements about related events and actions within and between the different interviews, as well as examined possible confirmation or contradiction with written information that included emails, computer files, papers, and notebooks.  Id. at 21.

In their investigation, the Panel considered the American Chemical Society Publications’ Ethical Guidelines to Publication of Chemical Research.  Id. at 23.  Portions of three of the document’s sections that the Panel considered to be relevant were: 

(1) An author’s central obligation is to present an accurate account of the research performed as well as an objective discussion of its significance. 
(3) A primary research report should contain sufficient detail and reference to public sources of information to permit the author’s peers to repeat the work. 
(11) The coauthors of a paper should be all persons who have made significant scientific contributions to the work reported and who share responsibility and accountability for the results. . . .  The author who submits a manuscript for publication accepts the responsibility of having included as co-authors all persons appropriate and none inappropriate.

Id.

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Additionally, the Panel noted the National Institute of Health (NIH) Guidelines for the Conduct of Research in the Intramural Research Program as another set of standards that reflect the values of the scientific community: 

The scientific community and general public rightly expect adherence to exemplary standards of intellectual honesty in the formation, conduct, reporting and reviewing of scientific research.  Investigators must act with honesty and integrity when editing, analyzing, and presenting data.  Deceptive manipulation of data, be it misrecording of data, inappropriate exclusion of outlying data points, or enhancement of images is research misconduct.

Id. at 24.

The Panel found research misconduct and listed its findings as the following: 

Finding #1:  Dr. Ariel Fernandez falsified Figure 3f (Therapeutic Editor PowerPoint slide #19) in the manuscript entitled “Editors of anticancer kinase inhibitors for side-effect removal” by Abhinav Tiwari, Sean Sessel and Ariel Fernandez, submitted in 2009 to Nature Biotechnology, where the Western blot band at 38h for cytochrome c for sorafenib/SUDE combination treatment was copied and pasted from the band at 32h to show a low expression of cytochrome c, covering an underlying image that showed a much higher level of expression and later to Cancer Research as Figure 5C.

Finding #2:  Dr. Ariel Fernandez falsified Figure 2h (Therapeutic Editor PowerPoint slide #10) and plagiarized photomicrographs of green fluorescent cells from Figure 3 in a publication using different materials by Kerkela et al, Nature Medicine 12:908-916, 2006, with rotation and cropping of those images, for the manuscript entitled “Editors of anticancer kinase inhibitors for side-effect removal” by Abhinav Tiwari, Sean Sessel and Ariel Fernandez, submitted in 2009 to Nature Biotechnology.

Finding #3:  Dr. Ariel Fernandez falsified Figure 2b (Therapeutic Editor PowerPoint Slide #5) and plagiarized the Western blot bands from Figure 3B (Row 3, Columns 3-8) and Figure 3D (Row 3, Columns 3-8) in a publication using

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different materials by Rutkowski et al., PLOS Biology 4:2024-2041, 2006, for the manuscript entitled “Editors of anticancer kinase inhibitors for side-effect removal” by Abhinav Tiwari, Sean Sessel and Ariel Fernandez, submitted in 2009 to Nature Biotechnology and later to Cancer Research as Figure 3B.

Finding #4:  Dr. Ariel Fernandez falsified Figure 2c (Therapeutic Editor PowerPoint slide #6) and plagiarized all the Western blot Figure 2 A (under the label U 87) in a publication using different materials by Liu et al., Molecular Cancer Therapy 6:1357-1367, 2007, for the manuscript entitled “Editors of anticancer kinase inhibitors for side-effect removal” by Abhinav Tiwari, Sean Sessel and Ariel Fernandez, submitted in 2009 to Nature Biotechnology and later to Cancer Research as Figure 3C.

Finding #5:  Dr. Ariel Fernandez falsified Figure 2e (Therapeutic Editor PowerPoint slide #7) and plagiarized the Western blot bands from Figure 2B (“p50” Columns 2-8, “GAPDH Columns 2-7, and “GAPDH” Column 6) in a publication using different materials by Shin et al., EMBO Journal 25:129-138, 2006, for Row 1, Row 2, and the “untreated” column, respectively, for the manuscript entitled “Editors of anticancer kinase inhibitors for side-effect removal” by Abhinav Tiwari,  Sean Sessel and Ariel Fernandez, submitted in 2009 to Nature Biotechnology and later to Cancer Research as Figure 4A and in a manuscript to Trends in Pharmacological Sciences as Figure 4 upper.

Finding # 6:  Dr. Ariel Fernandez falsified Figure 2f (Therapeutic Editor PowerPoint slide #8) and plagiarized the Western blot bands in Figures 2A (“Notch” bands) and 2B (“p65” bands) in a publication on different materials by Shin et al, EMBO Journal 25:129-138, 2006, for Row 1 (“BAX”) and Row 2 (“HSP 60”), respectively, for the manuscript entitled “Editors of anticancer kinase inhibitors for side-effect removal” by Abhinav Tiwari, Sean Sessel and Ariel Fernandez, submitted in 2009 to Nature Biotechnology and later to Cancer Research as Figure 4B.

Finding # 7:  Dr. Ariel Fernandez falsified Figure 2g (Therapeutic Editor PowerPoint slide #9) and plagiarized the

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Western blot bands in Figure 1B, Row 3 (“Actin”) from a publication on different materials by Liu et al., Molecular Cancer Therapy 6:1357-1367, 2007, for Row 2, and also copied Figure 10A, Columns 1-4 (“p38MAPK”) and Figure 10A, Columns 7-9 in a publication on different materials by Fernandez et al., Journal of Clinical Investigation 117:4044-4054, 2007, for Row 1 (“untreat” and “sorafenib + WBZ”) and Row 1 (“sorafenib”), respectively, for the manuscript entitled “Editors of anticancer kinase inhibitors for side-effect removal” by Abhinav Tiwari, Sean Sessel and Ariel Fernandez, submitted in 2009 to Nature Biotechnology and later to Cancer Research as Figure 4C and in a manuscript to Trends in Pharmacological Sciences as Figure 4 lower.

Finding # 8:  Dr. Ariel Fernandez falsified Figure 3d (Therapeutic Editor PowerPoint slide #18) and plagiarized the Western blot bands in Figure 2D (Row 1h on left and Row “P-Perk” and “PDI” on right, and from Row “30” on left and “P-Perk” on right) in a publication on different materials by Rutkowski et al., PLOS Biology 4:2024-2041, 2006, for Rows 2 and 3 and for Row 1, respectively, for the manuscript entitled “Editors of anticancer kinase inhibitors for side-effect removal” by Abhinav Tiwari, Sean Sessel and Ariel Fernandez, submitted in 2009 to Nature Biotechnology and later to Cancer Research as Figure 5B and in a manuscript to Trends in Pharmacological Sciences as Figure 5 upper.

Finding #9:  Dr. Ariel Fernandez falsified Figure 3f (Therapeutic Editor PowerPoint slide #19) and plagiarized the Western blot bands in Figure 1A (Column “ng/ml TM” and Column “nm TG”) in a publication on different materials by Rutkowski et al., PLOS Biology 4:2024-2041, 2006, for Columns 1-6 in both rows and Column 7, respectively, for the manuscript entitled “Editors of anticancer kinase inhibitors for side-effect removal” by Abhinav Tiwari, Sean Sessel and Ariel Fernandez, submitted in 2009 to Nature Biotechnology and later to Cancer Research as Figure 5C and in a manuscript to Trends in Pharmacological Sciences as Figure 5 lower.

Finding #10:  Dr. Ariel Fernandez falsified Supplementary Figure 1 (Therapeutic Editor PowerPoint slide #11) and plagiarized Western Blot Figure 1A (the first seven columns

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in all three rows) in a publication on different materials by Liu et al., Molecular Cancer Therapy 6:1357-1367, 2007, for the manuscript entitled “Editors of anticancer kinase inhibitors for side-effect removal” by Abhinav Tiwari, Sean Sessel and Ariel Fernandez, submitted in 2009 to Nature Biotechnology and later to Cancer Research as Figure 6A.

Finding #11:  Dr. Ariel Fernandez falsified Supplementary Figure 3 (Therapeutic Editor PowerPoint slide #13) and plagiarized Western blot Figure 3B (Rows 1 and 2 under “1d”, Rows 1 and 2 under “5d”, 3 under “4d”, and Row 2 under “4d”) in a publication on different materials Rutkowski et al., PLOS Biology 4:2024-2041, 2006, for columns labeled “Imatinib + editor”, “imatinib”, and “untreated” and “editor”, respectively, for the manuscript entitled “Editors of anticancer kinase inhibitors for side-effect removal” by Abhinav Tiwari, Sean Sessel and Ariel Fernandez, submitted in 2009 to Nature Biotechnology and later to Cancer Research as Figure 6D.

Finding #12:  Dr. Ariel Fernandez fabricated the synthesis and chemical analyses for the “entropy-jolting prototype” (EJ-1) published online in 2008 in the initial and the replacement supplementary material for a paper entitled “Induced Disorder in Protein-Ligand Complexes as a Drug Design Strategy,” Molecular Pharmaceutics 5:430-437, 2008, by Alejandro Crespo and Ariel Fernandez, falsifying and copying material from a publication on a different compound (WBZ_7) that had been synthesized and characterized by organic chemist William Bornmann for the supplementary material for a paper by Fernandez et al., Cancer Research 67:4028-4033, 2007.

Finding #13:  Dr. Ariel Fernandez fabricated the synthesis and chemical analyses for the “sunitinib-derived editor” (SUDE) submitted in 2009 to Cancer Research as supplementary material for a manuscript entitled “Editors of anticancer kinase inhibitors for side-effect removal” by Abhinav Tiwari, Sean Sessel and Ariel Fernandez, falsifying and plagiarizing material on sunitinib in a publication by Wang et al., Bioorganic and Medicinal Chemistry Letters 15:4380-4384, 2005.

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Finding # 14:  Dr. Ariel Fernandez falsified the synthesis and chemical analysis of a β-chloroenone Intermediate #4 published online in 2009 in an Addendum to the Supporting Information for the paper entitled “Induced Disorder in Protein-Ligand Complexes as a Drug Design Strategy,” Molecular Pharmaceutics 5:430-437, 2008, by Alejandro Crespo and Ariel Fernandez.

Finding#15:  Dr. Ariel Fernandez falsified the Western blot in Figure 10 published in 2008 in a paper on the “entropy-jolting prototype” (EJ-1) in Molecular Pharmaceutics 5, 430-437-2008, by Alejandro Crespo and Ariel Fernandez, falsifying and copying bands from Figure 4B from a paper by Fernandez et al., Cancer Research 67:4028-4033, 2007, on a different compound, WBZ_7.

ORI Ex. 48 at 82-85 (internal citation omitted).4

2. Factors Considered by the Panel

There were numerous factors that led to the Panel’s final determination, which were discussed at length in the 92-page Rice Report.  One example dealt with Respondent’s account of the EJ-1 synthesis (as related to Findings 12 and 15) that changed repeatedly.  ORI Ex. 48 at 34.  The Panel noted that Respondent sometimes claimed responsibility for the synthesis and authority over it, but later claimed ignorance.  Id.  Respondent initially told the Panel that he would be able to come up with more synthesis details, but later attributed the synthesis and all experimental work to people at Lilly.  Id. at 35.  Respondent avoided making a concrete claim that a specific individual at Lilly was responsible for the work and the documents.  While Respondent gave the contact information of individuals at Lilly, and stated that the Panel could contact those individuals, he also threatened to sue the RIO and the Panel for defamation if they suggested to those individuals that they were investigating research misconduct allegations involving him.  Id. at 36.  Therefore, the Panel did not contact anyone at Lilly to corroborate Respondent’s assertions.  Id. 

The Panel found that Respondent’s key defense to Allegations 12, 14, and 15 was that materials and information could not be disclosed because of confidentiality concerns with Lilly.  Id. at 37.  Respondent asserted that because of his relationship with people at Lilly, they performed a substantial synthesis as a favor to him.  Id. at 38.  However, he did not disclose their names.  He further asserted that the reason that he did not name anyone at

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Lilly as coauthors was to avoid revealing the company’s interests.  Id. at 39.  The Panel concluded that if Lilly personnel allowed Respondent to publish their work as a favor to him as he claimed, then they should be willing to do him a smaller favor by providing the Panel with evidence of their experimental work.  Id. at 40.  Because the Panel saw no evidence that anyone at Lilly synthesized EJ-1, it concluded that the synthesis was not conducted at Lilly and likely not at all.  Id.  

Allegations 1-11 deal with falsified and/or plagiarized figures that were submitted for publication to Nature Biotech, Trends in Pharm. Science, and Cancer Research.  Id. at 49.  These allegations of research misconduct involve mainly several Western blot images in each manuscript, which appear to have been generated by copying blots or images previously published by several other groups of authors on different materials, manipulating these images with Photoshop or a related program, and adding new lettering to falsely represent the research.  Id.  In addition, the fluorescent images of cultured cells appear to have been generated by copying, cropping, and rotating an image of other materials, previously published by other authors.  Id.  Respondent responded to the Rice investigation by asserting that Tiwari provided him with the falsified data and that he has no responsibility for any of the work that Tiwari produced.  Id. at 50.  The Panel concluded that by shifting responsibility to Tiwari, Respondent was confessing to misconduct, although of a different nature than the research misconduct of which he is accused.  Id. at 53.  They reasoned that as Principal Investigator of a grant from NIH, as well as his responsibility as a dissertation advisor to Tiwari, it was Respondent’s ultimate responsibility for the performance of his group and for the data published from the lab.  Id. at 53-54.

The Panel reported that the findings are not only based on the preponderance of the evidence standard in the Rice policy and ORI regulations, but the evidence would support such findings even with a considerably higher standard.  Id. at 85.  The Panel found that Respondent acted intentionally, under all findings, to fabricate, falsify and/or plagiarize research that he submitted for publication.  Id.  The Panel found no evidence of lesser negligence, error, nor differences in opinion or judgment underlying his actions.  Id.  The Panel found only repeated, deliberate acts of research misconduct that were intended to deceive the reviewers and other readers of these manuscripts and publications.  Id.

The Panel determined that as corresponding author, Respondent would bear significant responsibility even if the scenario were that other authors had committed the fabrication and/or falsification, and he had simply overlooked the problems.  Id.  However, the Panel never found any evidence that any of the other authors committed misconduct.  Id.  For each of the 15 allegations, the Panel reviewed multiple pieces of documentation that proved to them, by the preponderance of the evidence, that it was Respondent himself who conceived of and carried out these acts of misconduct, without the knowledge or cooperation of his co-authors.  Id.

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The Panel observed that Respondent gave inconsistent explanations of who did the experiments.  Id.  The Panel also observed that Respondent contradicted himself so frequently that his credibility was seriously compromised.  Id.  In contrast, the Panel found that the accounts given by all the other individuals connected with the case were remarkably consistent and credible.  Id.  Further, the Panel explicitly stated that enough reliable documentation was available that the Panel was able to reach most of its conclusions using hard evidence, rather than the recollections of any specific individuals.  Id.  The Panel found the interviews primarily useful for better connecting the details of what happened and understanding the possible motivations.  Id.

3. ORI’s Investigation and Findings

ORI received the Rice Report in a letter dated June 30, 2010.  ORI then conducted an independent oversight review of the evidence and findings in the Rice Report, including review of the relevant research records, consideration of Respondent’s assertions about the reported data at issue, analysis of the questioned data, review of computer files, and review of information from individuals who would have knowledge of the facts.  ORI Charge Letter (CL) at  16-17.

Ultimately, ORI made ten findings that Respondent intentionally, knowingly, or recklessly engaged in research misconduct by fabricating and/or falsifying research results in twelve (12) published papers, four (4) unpublished manuscripts, one (1) presentation, and three (3) grant applications.  CL at 1.  Specifically, ORI found: 

1. Respondent intentionally, knowingly, or recklessly fabricated and/or falsified the syntheses of six (6) novel chemical compounds reported in:  MP08, MP08 Original Supporting Information, MP08 Revised Supporting Information, MP08 Addendum to Supporting Information (“Entropy Jolt”); NBTsub09, NBTsub09 Supporting Materials, CRsub09, CRsub09 Supporting Materials, TiPSsub09, Trends in Pharm Sci 2009; 30:403-10 (“TiPS09”) (“SUDE”); Structure 2005; 13:1829-36 (“Struct05”), Structure 2006; 14:947 (“Struct05 Addendum”), Proc Natl Acad Sci 2006; 103:323-8 (“PNAS06”), J Mol Bio submission 2006 Supporting Materials (“JMBsub06”) (“Wrapper 1”); JMBsub06, JMBsub06 Supporting Materials, PNAS06 (“Wrapper2”); J Med Chem 2006; 49:3092-100 (“JMC06”), JMBsub06, JMBsub06 Supporting Materials, Front Biosci 2007; 12:3617-27 (“FBS07”), J Med Chem 2008; 51:4890-8 (“JMC08”), JMC08 Supporting Information (“Compound 9”); and JMC08, JMC08 Supporting Information (Compound 10”).  Id. at 7-9.
2. Respondent intentionally, knowingly, or recklessly fabricated and/or falsified figures of Western blots by copying previously published images and altering and/or relabeling those images in twenty-four (24) figures reported in three (3)

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manuscripts submitted by Respondent and two (2) figures reported in one (1) PowerPoint presentation by Respondent.

3. Respondent intentionally, knowingly, or recklessly fabricated and/or falsified the results of spectrophotometric kinetic assays reported in BioE06, FBS07, JMC06, MP08, PNAS06, Struct05, JMBsub06, and NIH grant application X02 RR023858-01.
4. Respondent intentionally, knowingly, or recklessly fabricated and/or falsified the results of high-throughput kinase screening reported in MP08, JMC08, DDT09, CRsub09, CRsub09 Supporting Materials, and two NIH granted applications (R01 CA138431-01 and R01 LM010163-01).  
5. Respondent intentionally, knowingly, or recklessly fabricated and/or falsified results of cell proliferation and other experiments involving SUDE and WBZ_4 reported in TiPS09.  
6. Respondent knowingly, intentionally, or recklessly fabricated and/or falsified Figure 3b of ACS Nano 2008;2:61-8 (“NANO08”), Figure 2h of NBTsub09, and Supplemental Figure S3 of CRsub09 by copying and manipulating confocal microscopy images from other papers and relabeling them to report falsely different experiments.  
7. Respondent intentionally, knowingly, or recklessly fabricated and/or falsified the results of adsorption/desorption assays reported in Figure 2b of NANO08 and Figure 3 of J Chem Phys 2007;126:061102 (“JPCB07”).  
8. Respondent intentionally, knowingly, or recklessly fabricated and/or falsified the results of cell proliferation assays involving the compound SUDE reported in Figure 5a of CRsub09, Figure 3e of NBTsub09, and Figure 3 of TiPSsub09.  
9. Respondent intentionally, knowingly, or recklessly fabricated and/or falsified the results of ATP production assays involving the compound SUDE reported in Figure 5d of CRsub09 and Figure 3g of NBTsub09.
10. Respondent intentionally, knowingly, or recklessly fabricated and/or falsified images of Western blots in figure 10 of MP08 and Figure 4B of CR07.  

Id. at 17, 54, 93, 103, 115, 121, 128, 133, 134, 135.

In its 137-page charging letter, ORI set out in detail the bases for these findings.  Rather than restating all the rationale and foundation for such findings, I include the more

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significant factors in their analysis.  Respondent’s asserted defenses to the ORI’s additional investigation primarily centered around these arguments: (1) the data that he used came from Lilly; (2) any fabrications or fraudulent data were provided by his graduate assistant Tiwari; (3) Rice and its investigative officers tampered with or deleted critical evidence that would exonerate him; and (4) ORI did not have jurisdiction over the research in issue.

1. Respondent’s alleged reliance on Lilly for producing the experiments in issue

ORI found no basis for Respondent’s assertions that collaborators at Lilly provided him with the synthesis data for the six compounds as part of their collaboration on an NIH grant.  Id. at22.  Specifically, ORI found that while it appears that Lilly initially intended to work with Respondent on research related to his NIH grant, this collaboration never transpired.  Id. at 22-23.  ORI determined that there was simply no evidence that the syntheses of the six compounds occurred as reported in these 11 papers.  Id. at 25.  ORI determined that Respondent fabricated the syntheses of the compounds Entropy Jolt, SUDE, Wrapper 1, Wrapper 2, Compound 9, and Compound 10.  Id.  As part of the fabrication, Respondent published purported synthesis information of the six compounds by copying information for similar compounds from the scientific literature, manipulating it, and misrepresenting it as documentation of the syntheses of the six compounds.  Id. at 17, 50, and 54.

2. Respondent’s failure to produce the underlying data to support his defense

Additionally, ORI noted that both the Rice Panel and ORI requested that Respondent provide original data related to the synthesis of the six compounds either from his own records or through his collaborators.  Id. at 25.  Respondent failed to provide such data and claimed that he was unable to do so because he was prohibited by the terms of confidentiality agreements with Lilly.  Id.  RIO Coleman confirmed however, that the confidentiality agreement, which went into effect in November 2008, was between Lilly and Rice, not Respondent, and therefore permits disclosure of confidential information in Respondent’s permission to Rice’s representatives and officials.  Id.  ORI was also unpersuaded by Respondent’s assertions that he could not disclose the source of the data as it was proprietary and that Lilly employees performed chemical syntheses for him as a favor and yet he was unable to remember the names of those employees.  ORI Ex. 15 at 17-18, 22, and 26; CL at 26.

3. Respondent’s assertion that Rice conspired against him

Respondent also alleged that any raw data from Lilly that he had in his possession was removed from his computers by Rice as a part of a cover-up scheme to frame him.  Rice, however, found no evidence to support his allegations that anyone from Rice tampered with his computer or email account.  CL at 26.

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4. Respondent’s assertion that Tiwari engaged in the research misconduct

As a part of his defense, Respondent accused his graduate assistant Tiwari of fabricating all the information related to the synthesis of the compound SUDE.  ORI Ex. 15 at 56, 60, and 67-68. ORI found however, that Respondent’s email correspondence with Tiwari, as well as other evidence, contradicts Respondent’s assertions regarding Tiwari’s role in the SUDE synthesis.  ORI determined that the email correspondence demonstrates that Respondent provided Tiwari with data from the alleged SUDE synthesis.  CL at 36.

5. Respondent’s authorship of the publications in issue

ORI noted that Respondent is the only author of publication Struct05 and no other individual is acknowledged as having any role in the research presented in this paper.  Id. at 50.  Additionally, Respondent is a coauthor of the ten remaining papers and there are no other coauthors or other collaborators common to all eleven papers.  Id.  Further, Respondent is also corresponding author of all eleven papers and the responsibilities of the corresponding author typically include preserving original data and ensuring that the data presented in the manuscript reflect the original data.  Id.

ORI determined that the fabrication of the syntheses of the six compounds was bolstered by manipulating data and text pertinent to the syntheses of similar compounds and presenting it as data regarding the syntheses of the six compounds.  Id.  ORI considered the fact that as Respondent is the only individual involved in all the papers at issue, it is far more likely that he repeatedly employed the same method to cover up these fabrications rather than multiple of his collaborators, without his knowledge, having independently fabricated different syntheses and used the same method as each other to mask these fabrications.  Id.  Simply stated, ORI found it beyond belief that each of the other coauthors were independently fabricating the data using the same method and process.  Id.  It was not lost on ORI that not only did Respondent’s manuscripts reflect a repeated pattern of attempts to conceal the fabrication of the six compounds, but the manuscripts also show recurring errors in the cover up attempts.  Id. at 46.  Accordingly, ORI found that the repeated errors made throughout the manuscripts where Respondent is the only common author further indicate Respondent committed the fabrication of each of the six compounds.  Id.

However, Respondent’s role as corresponding author, his being the only common author of all the manuscripts describing the alleged syntheses of the six compounds, the pattern of falsifying data to mask these fabrications, and their recurring errors made during these falsifications is not the only evidence indicating his responsibility for the research misconduct.  ORI also discovered that for several of the compounds, computer files from Respondent’s hard drive and emails he sent to his collaborators further demonstrate he provided the falsified date in support of the reported syntheses of the six compounds.  Id. at 51.  Furthermore, ORI concluded that the preponderance of the evidence does not

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support that any of Respondent’s collaborators conducted the syntheses or provided Respondent with experimental data related to the syntheses of the six compounds.  Id. at 52.

ORI noted that collectively, there were seven individuals listed as Respondent’s coauthors in the eleven manuscripts containing the false synthesis information for the six compounds and none of these coauthors were synthetic organic chemists at the time the manuscripts were authored.  Id.  ORI further noted that Respondent did not present, and ORI did not otherwise identify any documentation that demonstrates that any of these coauthors provided the original data related to the syntheses of the six compounds.  Id.

2. Respondent has not submitted sufficient evidence to overcome ORI’s motion for summary judgement or to establish that there is a genuine issue of material facts.

Respondent contends that he has established the following facts in his brief:  (a) ORI’s findings are scientifically baseless; (b) the Rice investigation is fatally flawed because Tiwari lied to the Rice authorities and falsified dates; (c) the evidence introduced by ORI had been tampered with as Tiwari colluded with Rice authorities to frame Respondent; (d) the experimental data in his published papers is valid and of genuine provenance; (e) Rice appointed a “kangaroo court” admitting no defense; (f) ORI deceitfully misrepresented his certifications on the provenance and validity of his data introduced in the record eleven years before; and (g) ORI has no jurisdiction over his experimental data generated at a private company with no PHS support.  R, Resp. at 1-2.  

While Respondent asserts several defenses, the focus of his response to the allegations includes his argument that the misconduct was attributed to Tiwari and his assertions that the scientific data was obtained from individuals at Lilly.  His secondary arguments include his assertion that ORI did not have jurisdiction over some of the experiments and research upon which ORI relied to find misconduct, as well as his assertion that Rice colluded with Tiwari to construct the allegations of misconduct.  He supports the various arguments with conjecture, indignation, and the solicited opinion of others.  I also note that some of those individuals with opinion evidence also have a vested interest in maintaining the integrity of the research.5  Overall, Respondent simply denies the allegations without providing specific evidence that rebuts the allegations that were first determined by Rice and then further confirmed by ORI in their investigation.

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1. Respondent’s claim that Tiwari fabricated the experimental figures questioned by ORI

Respondent asserts that Tiwari not only fabricated the research results, but he also conspired with Rice authorities to accuse Respondent of misconduct.  Further, Respondent asserts that Rice authorities “covered up for Tiwari and framed [him] with 41 violations to the C.F.R.”  R. Resp. at 5.  Respondent submitted no sworn testimony or other exhibits with proof that Tiwari fabricated the research results or that Tiwari conspired with Rice authorities to frame him.  Respondent relies on his own conjecture and that of others to argue that Tiwari fabricated the results and conspired with Rice to frame him.  In his arguments, Respondent relies heavily on the testimony of graduate student Sessel, who testified before the Rice Panel.  Sessel told the Panel that Tiwari was responsible for generating almost all the data for the reported experiments.  R. Ex. 32 at 3-6.  When questioned by the Panel to give specific evidence in support of his assertion, Sessel reframed his assertions to acknowledge that he was “under the very clear perception” that Tiwari was responsible for the data based on the emails and conversation with both Tiwari and Respondent.  Id. at 6.  However, Sessel acknowledged that he no longer had any of the emails from which he had drawn that conclusion.  Id. at 7.  He recalled that Tiwari didn’t speak very much.  Id. at 6.  Sessel also confirmed that while he saw Tiwari only two or three times in passing and he attended one meeting where Tiwari was presenting Respondent with data from MDACC, he did not speak with Tiwari.  Id. at 9.

Although Sessel told the Panel that he had not spoken with Tiwari, he later asserted that he “knew” that Tiwari was responsible for the fraudulent data because the information came from Respondent and Tiwari.  Id. at 31.  Sessel also admitted to the Panel that he didn’t have any hard proof or any eyewitness account of Tiwari presenting fraudulent data.  Id. at 34.  He explained that he was “under the impression” that Tiwari was “in charge of such things” and this was based on his communication with Respondent.  Id.  He further explained that he was “led to believe” that Tiwari was primarily responsible for experimental data, however, he admitted that he had never claimed to have conclusive proof that Tiwari was responsible for the experimental data.  Id. at 64.

In a statement dated February 24, 2023, Dr. Xi Zhang (Zhang) asserts that Tiwari “was in charge of doing the experimental work” in the project “Therapeutic Editor” because Respondent assigned the project to Tiwari.  R. Ex. 40 at 3.  However, Zhang’s statement does not refute ORI’s finding that Respondent gave the fabricated data to Tiwari to use for the project.  The statement does not establish that it was Tiwari and not Respondent who engaged in research misconduct as Respondent asserts.

Jianping Chen (Chen) received his doctorate in Physics from Rice.  Chen asserted that Tiwari “was in charge of doing the experimental work” in the project called “Therapeutic Editor” and presented his experimental results in group meetings in 2008 and 2009 as a

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part of his doctoral thesis.  R. Ex. 41.  While Chen opined that Tiwari’s work was performed at MDACC in the lab of Respondent’s collaborators at MDACC, he provided no evidence in support of his assertion.  His opinion did not establish that there were facts in issue.

2. Respondent’s argument that he received the experimental data from Lilly

Other than his arguing that Tiwari was responsible for falsifications of data in 2009, Respondent asserts Lilly data was used in all publications questioned in ORI findings.  R. Resp. at 29.  In support of his argument that Lilly supplied the data in question, Respondent submitted statements from several individuals to support his claims.  However, none of these individuals provided specific proof to substantiate his claims.

As noted above, ORI objects to the admission of Kim’s notarized email statement as Respondent did not present Kim as a witness whose testimony could be tested by cross-examination.  Because I grant ORI’s motion for summary judgment, and in order to fully consider the record before me, I have admitted Kim’s statement.  I note, however, that even if Respondent presented Kim as a witness who could be cross examined, his statement provides no proof that the experimental data was provided by Lilly or negates Rice and ORI’s determination that the data was plagiarized or fabricated from other scientific data.  While I do not find Kim’s statement sufficient to overcome ORI’s motion, I note that Kim’s statement is referenced in the testimony of Maddipati.  In his statement, Kim states that during an earlier period from 2002 to 2003, he had championed and facilitated the interactions with Respondent and various research groups at Lilly and that Lilly granted unrestricted funds for Respondent to pursue his collaborative endeavors with Lilly scientists.  While he asserted that the collaborations were expected to corroborate and support Respondent’s work, Kim provided no evidence that Lilly produced the experimental data at issue.  R. Ex. 4 at 1.

In a statement dated September 1, 2013, Maddipati confirmed that he and Respondent were only involved in the theoretical and computational parts of the research reported in three of the papers that were a part of ORI’s investigation.  R. Ex. 5 at 1.  While he maintained that the experimental data were obtained through the collaboration with Lilly, Maddipati provided no evidence as to the identity of the Lilly scientist who provided the data or how it was provided.  Referencing the email provided by Kim, he maintained that he was “absolutely certain about the provenance of the experimental data” because his Ph.D. thesis advisor Kim had been the Vice President at Lilly and began the collaboration between Lilly and Respondent.  Id.  However, Maddipati did not authenticate the data or provide any proof as to who at Lilly provided the data or when or how it was provided.

Similarly, Dr. Axel Blau (Blau) testified that Respondent collaborated with Lilly for a part of the research data in issue.  R. Ex. 42 at 1.  However, as with other individuals presented by Respondent, Blau vouched for the provenance of the experimental data in

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issue by relying on the “unrestricted grant from Eli Lilly.”  Blau asserted that because Respondent did not have a wet lab, he had to rely on collaboration with Lilly for experimental validation.  Id.  While Blau offers his opinion and speculation, he does nothing to refute ORI’s findings or to establish facts in dispute.

Respondent submitted an affidavit from Feltenberger, a synthetic organic chemist with the University of Wisconsin-Madison.  As discussed above, ORI objected to this affidavit as Respondent did not present Feltenberger as a witness who could be cross examined.  As discussed above, because I grant ORI’s motion for summary judgment, I admit Feltenberger’s statement in order that I may consider the submitted evidence in the light most favorable to Respondent.  I note however, that even if Respondent presented Feltenberger as a witness who could be cross examined, his statement provides no proof to support that the experimental data was provided by Lilly or to negate Rice and ORI’s determination that the data was plagiarized or fabricated from other scientific data.  In his affidavit, Feltenberger stated that he surveyed the supporting information for the research data included in three of the publications in issue.  He opined “the synthetic pathways and synthetic strategies reported in the publications indicated are chemically sound, scientifically correct and likely to be reproductible as means to generate the compounds described.”  R. Ex. 6.  As with other witnesses offered by Respondent, his opinion of the merits of the research does not disprove that Respondent fabricated or plagiarized the results.

Respondent also submitted the testimony of Crespo when he was telephonically interviewed by Rice’s investigative panel on November 6, 2009.  R. Ex. 33.  Crespo began an association with Rice and with Respondent in 2006 and provided calculations for cancer research papers in 2007.  Id. at 3.  Crespo testified that individuals from Lilly were never named authors in any of Respondent’s papers.  Id. at 5.  Crespo recalled that Respondent told him that it would have been a conflict of interest for the Lilly scientist to be named as authors for the research.  Id.  Crespo stated that Respondent sent him data and told him that the experiments were done by Lilly.  Id. at 19.  Crespo had no contact with the alleged Lilly scientists.  Id. at 29.

Respondent also offered the testimony of Scott, a Professor of Computer Science and of Mathematics as an expert witness.  In Scott’s April 2023 statement, he listed each of ORI’s findings and offered his opinion as to the validity of each finding.  R. Ex. 34.  In essence, he opined that the ORI findings were in error and/or insufficient.  Id.  With respect to a finding concerning Compound 9, he opined that the finding “is embarrassing in a serious scientific discussion.”  Id.at 2.  In assessing the finding concerning the compound Entropy Jolt, he opined that ORI’s finding was bogus.  Id.  Scott also included that ORI’s statements indicate “a lack of understanding of the synthesis processes and intricacies of structural biology.”  Id. at 3.  He added that he is not a synthetic chemist and cannot add to what experts have already testified.  Id.  He further added  “it seems

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that ORI is beating a dead horse with a broken whip.  They should be strongly criticized for raising these false issues.”  Id.  He concluded his statement by asserting:  

It is personally disturbing to me to see such a poor quality of analysis emerging from ORI.  ORI has access to everyone in the field to provide expert opinion.  But they seem to have found a very weak group of scientists in this case.  This reminds me of my teaching days.  I saw behavior like. this, but not from the good students.  I cannot give ORI a passing grade in this case.

Id.  While Scott extensively discussed his opinion regarding what he felt to be ORI’s erroneous findings, he provided no proof to support Respondent’s assertions that the experiments or research data in issue were produced by Lilly.

Respondent also submitted the notarized statements from Zhang, a graduate student who coauthored the paper that is identified as CR07, published in Cancer Research, and identified by ORI as a part of Respondent’s research misconduct.  CL at 3, R. Ex. 40 at 3.  Zhang was also paid by the NIH grant, along with Respondent.  R. Ex. 40 at 3.  Respondent submits that Zhang’s statements defend the validity and integrity of the papers he coauthored and asserts the genuine Lilly provenance and validity of the experimental data reported in the papers and refuting ORI’s findings.  However, Zhang merely asserts that the provenance of the experimental diagram in issue is “beyond dispute” and comes from Lilly.  Id.  In support of this assertion, Zhang simply refers to an “unrestricted grant from Eli Lilly” and argues that coauthors from MDACC produced similar results and those results have never been questioned.  Id.  Zhang states he examined and confirmed the validity of the data from Lilly as the manuscript was being prepared for submission.  Id.  However, despite his assertions, Zhang presented no evidence of how, when, and by whom this data was provided at Lilly.  I also note that as coauthor, Zhang has a vested interest in supporting the authenticity of the research data and in arguing Lilly’s participation in providing the research data.  Zhang maintains that Respondent did not have a wet lab at Rice and that Respondent relied on his collaborations with MDACC or Lilly to obtain experimental validation for his work.  R. Ex. 13.  While Zhang relies on the grant from Lilly to authorize the research initiatives, Zhang provides no specific information to describe or to confirm Lilly’s involvement in Respondent’s purported research that is alleged by ORI to be fraudulent and/or plagiarized.

In their statements Maddipati, Blau, and Zhang refer to “unrestricted funds” or an “unrestricted grant” from Lilly as a basis for believing that Lilly provided the research data for Respondent’s publications.  I note, however, that Respondent did not submit or identify any document that provided for unrestricted funding that would support this conclusion.  The NIH grant application submitted by Respondent on October 19, 2004,

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proposed a budget of $2,086,404 for a proposed period of July 1, 2005 through June 30, 2010.  R. Ex. 1 at 1.  Although Respondent applied as the Principal Investigator/Program Director, funding was to be allocated among Respondent and four other collaborators, as well as ancillary research costs.  The budget allocation for Respondent for a nine-month period was $76,879.  R. Ex. 1 at 4.  Most noteworthy is the fact that Lilly was named as only one of three performance sites for the research.  R. Ex. 1 at 2.

Respondent justifies his failure to disclose to Rice or ORI the identity of the Lilly scientists who provided the research data to him or the circumstances in which it was provided by referring to an unknown confidentiality agreement with Lilly.  R. Resp. at 38.  Although Respondent acknowledged a November 7, 2008 agreement with his signature, the agreement was signed by representatives of Rice University and Lilly and was clearly between these two entities.  Respondent’s assertion that he could not provide the requested information concerning Lilly’s alleged responsibility for the research data is disingenuous.

In his defense to ORI’s allegations, Respondent presented a total of 63 exhibits, including multiple witness statements and portions of witness testimony before the Rice Investigative Panel.  As noted, some of these witnesses were coauthors with Respondent on some of the publications at issue and as such, they had a vested interest establishing the validity of Respondent’s research.  Other witnesses presented their opinions that the research data must have come from Lilly because of Respondent’s working relationship with Lilly.  Witnesses also provided speculation and conjecture that Tiwari fabricated the research data.  None of the witnesses presented by Respondent had personal knowledge of Tiwari’s alleged fabrication of the data or had knowledge of the identity of the alleged Lilly scientists providing the data for Respondent’s research in issue or any specific information about how and when Lilly provided such data.  Although Respondent was not under a duty to testify personally, he did not do so.  While he vehemently asserts that Tiwari was responsible for fabricated research and that his other research at issue was based on data provided by Lilly, he provided no specific evidence to support his argument.  In summary, his bare assertions and other witnesses’ speculation are insufficient to overcome ORI’s motion.

3. Respondent’s Argument that ORI lacks jurisdiction

As an additional argument, Respondent asserts that ORI has no jurisdiction over the Lilly experimental data mentioned in ORI’s findings 1-7, 10.  R. Resp. at 31.  He maintains that Lilly is a private company and did not receive any PHS support to generate the experimental work he used in his publications questioned in ORI findings 1-7, 10.  Id. at 2, 15.  He asserts “In all papers that contained Lilly primary data and were attacked by ORI, I acknowledge the Lilly unrestricted funds that supported the experimental research reported [].  The experimental research in these papers helped validate my theoretical work performed with PHS support but was not itself supported by the PHS.  Hence, the

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data of Lilly provenance is outside ORI jurisdiction, since ORI findings of research misconduct must involve research conducted or supported by the PHS [].”  Id. at 31 (emphasis in original).  

Respondent also asserts that neither Rice nor ORI created a data transfer agreement that would enable surveillance or jurisdiction over the participation of Lilly in his research project.  Id. at 31-32.  He also argues that the published papers NANO08 and JPCB07 in ORI findings 6 and 7 lie outside ORI jurisdiction because they are thematically unrelated to his project and thus do not contribute to the NIH project.  Id. at 32.

As ORI correctly points out, ORI has the authority to make research-misconduct findings in this case because it involves research supported by the National Institute of General Medical Sciences, NIH, grant R01 GM072614, as acknowledged in Respondent’s papers, and research referenced in three NIH grant applications submitted by Respondent: X02 RR023858-01 to the National Center for Research Resources, R01 CA138431-01 to the National Cancer Institute, and R01 LM010169-01 to the National Library of Medicine.  ORI Exs. 85-88.  Citing ORI v. Philippe Bois, Ph.D., DAB CR2366, at 1 (2011), rev’d on other grounds, Bois v. U.S. Dep’t of Health & Human Servs., No. 11-1563, 2012 U.S. Dist. LEXIS 27396 (D.D.C. Mar. 2, 2012).  ORI maintains that it has jurisdiction over the misconduct because NIH funded the research project.  ORI Br. at 20.  I agree that whether Lilly itself received NIH support is irrelevant.  Further, Respondent cannot argue that ORI lacks jurisdiction because Lilly did not receive the NIH support and at the same time rely on his NIH grant proposal to support his contention that Lilly performed the experiments that are the subject of ORI’s findings.  Further, while Respondent challenges jurisdiction for his papers NANO08 and JPCB07, the papers as originally published acknowledged NIH support.  ORI Ex. 171 at 7, ORI Ex. 170 at 5.

Accordingly, Respondent’s arguments that ORI lacks jurisdiction do not establish that there are material facts in dispute and do not overcome ORI’s motion for summary judgment.

3. Summary Judgment is warranted because the undisputed material facts establish by a preponderance of the evidence, that Respondent intentionally, knowingly, or recklessly engaged in research misconduct by falsifying and/or fabricating research results, and in doing so, Respondent significantly departed from accepted practices of the relevant research community.

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.  42 C.F.R. § 93.103.  Fabrication is making up data or results and recording or reporting them.  42 C.F.R. § 93.103(a).  Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.  42 C.F.R. § 93.103(b).  Plagiarism is the appropriation of another

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person’s ideas, processes, results, or words without giving appropriate credit.  42 C.F.R. § 93.103(c).  Research misconduct does not include honest error or differences of opinion.  42 C.F.R. § 93.103(d).

Regardless of the reason why Respondent’s publications and grant applications contained fabricated and falsified research results, Respondent repeatedly reported the flawed data without confirming its accuracy.  ORI has demonstrated, without valid rebuttal by Respondent, that Respondent departed from the accepted practices of the relevant research community by reporting false and fabricated research results.

Research misconduct is shown by a preponderance of the evidence.  See 42 C.F.R. § 93.106(a).  Even if I accept Respondent’s claims that Tiwari is responsible for the fabrication and falsification or that unknown individuals with Lilly conducted the research, at face value and for purposes of summary judgment, Respondent nevertheless acted “intentionally, knowingly, or recklessly” in committing research misconduct.  Repeatedly, Respondent submitted publications and grant applications that contained false and fabricated data.  Respondent has simply not disputed the overwhelming evidence that he repeatedly submitted false images and data; rather, he blames others and argues various conspiracy theories for the allegations brought against him.  Even if, assuming for summary judgment, Respondent did not create the falsified and fabricated images, Respondent was reckless in repeatedly adopting those flawed images as his own and reporting them in grant applications and journal articles.

4. The undisputed material facts support that the proposed HHS administrative actions are reasonable.

Pursuant to 42 C.F.R. § 93.408, ORI considered aggravating and mitigating factors in determining appropriate HHS administrative actions and their terms.  The HHS Debarring Official also considered factors in 2 C.F.R. § 180.860 in determining to debar Respondent and the length of Respondent’s debarment period.  ORI determined that Respondent’s actions were knowing and intentional.  42 C.F.R. § 93.408(a) and that Respondent solely planned, initiated, and carried out the wrongdoing.  2 C.F.R. § 180.860 (f).

The undisputed facts of this case resoundingly support ORI’s proposed remedies, and I sustain them for that reason.  The remedies sought by ORI are:  a 15-year debarment from participating in “covered transactions” as defined in 2 C.F.R. § 180.200 and procurement transactions covered under the Federal Acquisition Regulation ( 48 C.F.R. chapter 1); a 15-year prohibition from serving in any advisory capacity to PHS, including but not limited to service on any PHC advisory committee, board, and/or peer review committee, or as a consultant; and ORI proposed that it will send a notice of ORI’s findings and of the need for retraction and/correction to the pertinent journals of the eleven (11) papers that require retraction and/or correction.

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The material facts establish the presence of multiple aggravating factors that amply justify the length of the debarment and prohibition.  Respondent’s research misconduct was not an isolated event, but rather part of a continuing and prior pattern of dishonest conduct over several years, with fabrication and/or falsification in twelve (12) PHS-supported papers, four (4) PHS-supported submitted, unpublished manuscripts, one (1) PHS-supported presentation, and three (3) PHS grant applications.  42 C.F.R. § 93.408(b).  Thus, ORI has established that Respondent frequently fabricated and falsified research records over a long duration. 2 C.F.R. § 180.860(b).

The facts clearly establish that Respondent engaged in intentional misconduct or misconduct committed in reckless disregard of the truth.

As initially determined by Rice, Respondent’s research misconduct squandered Rice and NIH funds, the time and resources of scientists and engineers who have tried to follow up on his work, and the time and energy of his departmental personnel and other people connected with this case.

Respondent shows no remorse for nor understanding of the seriousness of his misconduct.  He continues to assert that he committed no misconduct in the face of voluminous undisputed facts that prove otherwise.  I can only infer from Respondent’s continued defiance that his defense is untrustworthy and that his untrustworthiness justifies a lengthy debarment and prohibition.

I therefore recommend that the proposed administrative actions be upheld.

IV.    Conclusion

I recommend that the Assistant Secretary for Health and Human Services uphold the administrative actions proposed by ORI based on the scientific misconduct committed by Respondent.