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Findings of Research Misconduct

07.28.10 by Michelle Kienholz

Notice is hereby given that ORI and the Assistant Secretary for Health have taken final action in the following case:

Based on the reports of an inquiry and an investigation conducted by the University of Pennsylvania and analysis conducted by the ORI Division of Investigative Oversight, ORI found that Gerardo L. Paez, PhD, former postdoctoral fellow, Section of Medical Genetics, UPenn School of Veterinary Medicine, engaged in research misconduct in research supported by R01EY06855 and R01EY13132.

ORI found that the Respondent engaged in research misconduct by falsifying and fabricating retinal gene profile data that he purportedly obtained from 3-week old normal dogs and dogs with X-linked progressive retinal atrophy in abstracts and poster presentations for the 2006 and 2007 Association for Research in Vision and Ophthalmology meetings and in an unsubmitted manuscript draft. The Respondent also falsely labeled data files in the UPenn bioinformatics core computer and submitted falsely identified files to his research mentors.

Dr. Paez has voluntarily agreed, for a period of 3 years, beginning on June 9, 2010:

(1) To exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant;

(2) that any institution that submits an application for PHS support for a research project on which the Respondent’s participation is proposed or that uses him in any capacity on PHS-supported research, or that submits a report of PHS-funded research in which he is involved, must concurrently submit a plan for supervision of his duties to the funding agency for approval; the supervisory plan must be designed to ensure the scientific integrity of his research contribution. A copy of the supervisory plan also must be submitted to ORI by the institution. Respondent agreed that he will not participate in any PHS-supported research until such a supervisory plan is submitted to ORI.


Duke is Capable of Acting Quickly on Misconduct …

07.19.10 by Michelle Kienholz

Update: On Sunday, Duke and other participating sites (again) halted the 3 clinical trials based on Potti’s earlier results. This morning, Rob commented on the lack of local media coverage of the Hellinga case but the quick reporting of Duke’s rapid action taken against Anil Potti:

Durham’s media has been absolutely silent on the Hellinga debacle. The did, however, take note of another pompous liar in the medical center ranks:

http://www.newsobserver.com/2010/07/17/585434/duke-scientist-placed-on-leave.html

Our friends at GenomeWeb have also alerted the scientific community to detective work by The Cancer Letter (also noted on their blog):

… one of Potti’s biographical sketches says he was a “Rhodes Scholar (Australia)” in 1995 and another says he held a “Research Fellowship at Queensland Research Institute, Australia (Mentor: Gordon McLaren)” at that time. “We don’t have any record that Anil Potti was a Rhodes scholar,” a Rhodes Trust spokesperson told The Cancer Letter. In addition, Rhodes says that its scholarships may only be used to study at the University of Oxford.

Furthermore, McLaren was “‘shocked,’ ‘saddened,’ and ‘flabbergasted’” to learn he was listed as Potti’s mentor in Australia, according to the newsletter. The Cancer Letter goes on to describe other inconsistencies on Potti’s résumé, including the year he graduated from medical school and an assertion that he was a National Merit Scholar.

According to The Cancer Letter, Potti claims to have worked under McLaren at the “Queensland Research Institute” (which does not exist). The Queensland Institute of Medical Research, which does exist, does not have any records of Potti having ever studied or existed there.

GenomeWeb also includes links to Potti’s 2006 Nature Medicine article, Genomic signatures to guide the use of chemotherapeutics, plus 2 corrigenda to correct errors in 2007 and 2008 (MD Anderson biostatisticians found the errors, as reported by Nature Medicine, which also noted Duke’s reluctance be entirely forthright about their outside review of 3 suspended clinical trials that were resumed this January).

According to the Durham News Observer:

“Duke is aware of the allegations raised in the article regarding Dr. Potti and has instituted a formal internal investigation,” Duke spokesman Douglas Stokke said Friday afternoon. “Dr. Potti has been placed on administrative leave pending the outcome of the investigation.”

… On Friday, the American Cancer Society suspended payments to Potti’s grant pending its own investigation.

“We are profoundly concerned to learn that a Duke University researcher made claims about his credentials in applications to the American Cancer Society and others that may not be true,” said Otis W. Brawley, the American Cancer Society’s chief medical officer.

It isn’t clear whether a false biographical claim would put a federal research grant in jeopardy. NIH spokesman Don Ralbovsky would say only that “it is NIH policy to neither confirm nor deny that a review has been initiated or is under way.” [Potti is PI on 5R01CA131049-02 and 1R01CA136530-01A1]

… If he did falsify his biography, Potti may have committed a crime. The federal False Claims Act prohibits, among other things, falsifying applications in order to receive grant funding.

“It is most certainly unethical,” said Peg Vigiolto, UNC-Chapel Hill’s associate vice chancellor for research, speaking generally and not about Potti specifically. “And it would most certainly initiate all sorts of scientific integrity questions.”

Indeed.

As a side note, this issue of The Cancer Letter also covers Harold Varmus’ return to NCI, and his distinct lack of enthusiasm for megascience, giving preference to work done by individual scientists.


More Retractions, More Misconduct

05.19.10 by Michelle Kienholz

Nothing to say here except thanks to DrugMonkey for the heads-up on spotting another case of misconduct causing extensive havoc in the scientific community – this time, Suresh Radhakrishnan, PhD, formerly at the Mayo Clinic Dept of Immunology. No word on whatever formal misconduct investigation may be in progress, but quite a list of affected articles, and some brief insight via the authors’ note to PLoS ONE:

An investigation by the Mayo Clinic has determined that one of the researchers in Professor Pease’s laboratory at the Mayo Clinic, Dr. Suresh Radhakrishnan, tampered with another investigator’s experiment with the intent to mislead toward the conclusion that the B7-DCXAb reagent has cell activating properties. Using blinded protocols, experiments were done to see if the results based on this reagent could be replicated. Specifically, the repeat experiments examined the activation of dendritic cells, activation of cytotoxic T cells, induction of tumor immunity, modulation of allergic responses, breaking tolerance in the RIP-OVA diabetes model, and the reprogramming of Th2 and T regulatory cells. In no case did these repeat studies reveal any evidence that the B7-DCXAb reagent had the previously reported activity. The authors of this paper therefore wish to retract this paper because of the inability to reproduce key aspects of the studies and hence the results in them cannot be considered reliable.

The note in PNAS gives the scope: “In the course of this re-examination, we were able to study all the antibodies used in the various phases of our work spanning the last 10 years. None of these antibodies appears to be active in any of our repeat assays. We do not believe something has happened recently to the reagent changing its potency.”

Retraction: Suresh Radhakrishnan, Esteban Celis, and Larry R. Pease, Proc Natl Acad Sci USA 2005;102:11438–11443

Retraction: Radhakrishnan S, Cabrera R, et al. (2009) PLoS ONE 4(4): e5373

Retraction: Suresh Radhakrishnan, Loc T. Nguyen, Bogoljub Ciric, et al., The Journal of Immunology, 2003, 170: 1830–1838

Retraction: Suresh Radhakrishnan, Koji Iijima, Takao Kobayashi, et al., The Journal of Immunology, 2004, 173: 1360–1365.

Retraction: Suresh Radhakrishnan, Loc T. Nguyen, Bogoljub Ciric, et al., The Journal of Immunology, 2007, 178: 1426–1432.

Retraction: Suresh Radhakrishnan, Karla R. Wiehagen, Vesna Pulko, et al., The Journal of Immunology, 2007, 178: 3583–3592.

Retraction: Suresh Radhakrishnan, Rosalyn Cabrera, Erin L. Schenk, et al., The Journal of Immunology, 2008, 181: 3137–3147.

Retraction: Suresh Radhakrishnan, Laura N. Arneson, Jadee L. Upshaw, et al., The Journal of Immunology, 2008, 181: 7863–7872.

He has other publications and patents that may have some issues as well. Stay tuned.


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Press Reports on Another UW Misconduct Case

05.17.10 by Michelle Kienholz

Update: A King County Superior Court Judge rejected Aprikyan’s request for a temporary injunction to stop the university from firing him. A trial on the case has been set for November.

Hot on the heels of one sensational misconduct case at U Wash, details have been made public about another since the research assistant professor (and UW table tennis coach) at the heart of the investigation, Andrew Aprikyan, has sued in court to save his job.

The Seattle Times reports on “some eye-opening revelations in the court documents — including Aprikyan’s own account that a technician working with him at one point wrote research notes on ‘approximately 30 paper towels,’ and the notes were never transcribed.” Clearly someone missed the seminar on maintaining a good lab notebook.

The case has dragged on 7 years, during which time Aprikyan has continued to publish, secure grant funding, and present his results. This year, UW President Mark Emmert intervened to say Aprikyan should be fired for academic misconduct.

But getting back to that long investigation (Duke watchers take note):

In 2003, when the journal “Blood” posted an Aprikyan paper on its website, another researcher noticed that something looked wrong: An image of a cell in one panel appeared to have been rotated 90 degrees and relabeled in another panel.

Aprikyan later withdrew the paper, which other researchers contributed to, noting that “errors in some of the digital images in the manuscript are under investigation.”

“We … extend our deepest apologies to the scientific community,” Aprikyan wrote on the “Blood” website.

In court papers, Aprikyan said it was a rival faculty member who turned him in after “I had refused to work with him on a research project.”

The UW appointed a committee, composed of three scientists, to investigate Aprikyan’s work. Under UW rules, such investigations are supposed to take 90 days. But the committee got at least 16 extensions as the investigation dragged on. It worked for three years, eventually issuing a report of more than 450 pages.

It took another year for Paul Ramsey, dean of the UW School of Medicine, to review the reports and issue his own findings. Ramsey concluded that Aprikyan had falsified seven figures and tables in two research papers, and that his actions amounted to academic misconduct.

Then things took a turn. Ramsey and Provost Phyllis Wise asked a faculty panel — which included professors of English, Scandinavian studies and several other disciplines — to decide whether Aprikyan should be fired. Aprikyan, in turn, asked the panel to reconsider the entire case against him.

Over the objections of UW administrators, a law professor decided the faculty panel could reconsider the case. Two years later, the panel concluded, in a 70-page report, that while there was plenty of evidence of sloppy methods and erroneous results, there was no evidence Aprikyan had deliberately falsified his work.

Earlier this year, Emmert made his own ruling: The second panel had no authority to review the first committee’s findings. Emmert wrote that he, therefore, accepted those initial findings — that Aprikyan had committed scientific misconduct — and concluded the researcher should be fired.

Whoa … 3 scientists devoted 3 years to preparing a 450-p report about 7 falsified figures & tables in 2 papers?

Wonder what will be left for ORI to say when they finally issue their report.


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Findings of Misconduct in Science

05.10.10 by Michelle Kienholz

And then some …

“Specifically, ORI made 15 findings of misconduct in science based on evidence that Dr. Brodie knowingly and intentionally fabricated and falsified data reported in 9 PHS grant applications and progress reports and several published papers, manuscripts, and PowerPoint presentations.”

Oof. Note the multiple mechanisms (3 P01s, 4 R01s, 1 U01, and 1 R01 converted to a U01) and funding institutes (NICHD, NIAID, NIDCR, NHLBHI). And Dr. Brodie, a research assistant professor (i.e., non-tenure track) fought them every step of the way it seems. Without further ado …

Notice is hereby given that on March 18, 2010, the DHHS Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the misconduct in science findings of the ORI in the following case:

Based on the findings in an investigation report by the University of Washington and additional analysis conducted by ORI in its oversight review, ORI found that Scott J. Brodie, DVM, PhD, former Research Assistant Professor, Department of Laboratory Medicine, and Director of the UW Retrovirology Pathogenesis Laboratory, committed misconduct in science (scientific misconduct) in research supported by or reported in the following US PHS grant applications:

1 P01HD40540
5 P01HD40540
1 P01AI057005
1 R01DE014149
2 U01AI41535
1 R01HL072631
1 R01(U01)AI054334
1 R01DE014827
1 R01 AI051954

The 15 findings [of misconduct in science] are as follows:

1. Respondent knowingly and intentionally falsified a figure that was presented in manuscripts submitted to the Journal of Experimental Medicine and the Journal of Virology and in several PowerPoint presentations that purported to represent rectal mucosal leukocytes in some instances and lymph nodes in other instances.

2. Respondent knowingly and intentionally falsified portions of a three-paneled figure included in several manuscript submissions, PowerPoint presentations, and grant applications.

3. Respondent knowingly and intentionally falsified a figure included as Figure 1N in American Journal of Pathology 54:1453-1464, 1999, three NIH grant applications, and several PowerPoint presentations.

4. Respondent knowingly and intentionally falsified a figure that was published as an insert within Figure 1K in American Journal of Pathology 54:1453, 1999 and included the figure in a number of NIH grant applications.

5. Respondent knowingly and intentionally falsified a figure representing a panel of four green fluorescent cells and included it as a figure in several grant applications claiming that each cell had been subjected to different treatments when three of the cells came from a single image.

6. Respondent knowingly and intentionally falsified an image included as Figure 5A in a paper published in the Journal of Clinical Investigations 105:1407, 2000 and submitted to various journals and included in different grant applications.

7. Respondent knowingly and intentionally falsified a figure appearing as Figure 3.III.A, inset, in a manuscript submitted to Science entitled “A persistent reservoir of HIV-1 in pulmonary macrophages’ and as figures in various grant applications and PowerPoint presentations.

8. Respondent knowingly and intentionally falsified multiple versions of a figure depicting green and red fluorescent cells used as Figures 3.III.H and I in a manuscript submitted to Science, as Figures 6C and 6D of grant application 1 R01 DE14827-01, as Figures C.2.1 1H and C.2.11I of grant application 1 R01 HL072631-01, and in PowerPoint presentations.

9. Respondent knowingly and intentionally falsified a figure, labeled as Figure 9E in grant application 1 R01 DE014827-01 and in various other grant applications and PowerPoint presentations.

10. Respondent knowingly and intentionally falsified the bottom half of Figure C.2.5 of grant application 1 R01 HL072631-01 by using the same image twice, labeling it once as being treated for 2 hours with lipopolysaccharide (LPS) and the second as being treated for 12 hours with LPS. Respondent also used a second image twice, labeling it once as “no LPS’ and the second time as “24 hours with LPS.’

11. Respondent knowingly and intentionally falsified a figure that purports to represent viral decay in rectal mucosa and included the figure as a slide in two PowerPoint presentations and three NIH grant applications.

12. Respondent knowingly and intentionally falsified: (a) A histopathology figure that was described in a paper published in the Journal of Infectious Diseases 83:1466, 2001, as inguinal lymph nodes from an untreated AIDS patient using in situ PCR to show the presence of HIV-1 cells when it was actually from a tissue expressing the neomycin marker; (b) the gel images resembling Figures 2A and C, which Respondent claimed to be based on lymph node cells, although he reported the gel images elsewhere to represent results from rectal tissue; and (c) various versions of these blots that Respondent reported elsewhere and labeled differently with respect to the copy numbers detected and as detecting DNA in some instance and RNA in others.

13. Respondent knowingly and intentionally falsified Figures 2DI and 2DII included in a paper published in the Journal of Leukocyte Biology 68:351-359, 2000.

14. Respondent knowingly and intentionally falsified Figure 4, Panels A and B, in grant application 1 R01 DE014827-01 by manipulating the source images.

15. Respondent knowingly and intentionally falsified a number of figures and made false statements in the text of grant application 1 R01 AI051954-01 submitted jointly with a colleague by relabeling figures based on research carried out with HIV-1 or HIV-2 and identifying the figures and text as research conducted with ovine lentivirus (OvLV).

ORI issued a charge letter enumerating the above findings of misconduct in science and proposing HHS administrative actions. Dr. Brodie subsequently requested a hearing before an Administrative Law Judge (ALJ) of the Departmental Appeals Board to dispute these findings. In January 2009, the ALJ issued a ruling holding that there were no triable issues challenging ORI’s findings that there were materially false statements, images, and other data in the relevant publications, presentations, and grant applications. However, the ALJ held that Dr. Brodie raised triable issues about his intent to commit scientific misconduct and the reasonableness of the proposed debarment of 7 years.

On January 12, 2010, the ALJ issued a recommended decision to the HHS Assistant Secretary for Health granting summary disposition to ORI. The ALJ also stated that Dr. Brodie committed scientific misconduct on multiple occasions and that its extent amply justified debarment for a period of 7 years.

On February 1, 2010, Dr. Brodie submitted a letter to the HHS Debarring Official with attachments to request that the ALJ’s recommended decision be rejected as a whole. On February 26, 2010, Dr. Brodie submitted a letter requesting the opportunity to meet with the HHS Debarring Official to orally present the reasons supporting his request that the ALJ’s recommended decision be rejected. However, the HHS Debarring Official determined that Dr. Brodie had been afforded an opportunity to contest ORI’s findings of scientific misconduct … Given the findings of facts in this case, the HHS Debarring Official determined that the issues in his presentation in opposition to the ALJ’s recommended decision did not raise a genuine dispute over facts material to the recommended debarment.

Accordingly, the HHS Debarring Official also denied Dr. Brodie’s request to make an oral presentation and issued a notice of debarment to begin on March 18, 2010, and end on March 17, 2017.

On March 23, 2010, Dr. Brodie submitted a letter requesting a postponement of the effective date of the debarment. This request was denied by the Debarring Official on April 6, 2010.

Thus, the misconduct in science findings set forth above became effective, and the following administrative actions have been implemented for a period of 7 years, beginning on March 18, 2010.

I wonder if ORI began to think 7 years wasn’t enough …


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Findings of Research Misconduct

04.16.10 by Michelle Kienholz

Notice is hereby given that ORI and the Assistant Secretary for Health have taken final action in the following case:

Based on the report of an investigation conducted by Wyeth Pharmaceuticals and additional analysis conducted by ORI in its oversight review, ORI found that Boris Cheskis, PhD, former senior scientist, Discovery Research, Women’s Health, Wyeth Pharmaceuticals, engaged in misconduct in science by intentionally falsifying Figures 5 and 6 in R01DK072026-01 (submitted to NIH on September 28, 2004) and Figures 6 and 9 in R01DK072026-01A2 (submitted to NIH on November 9, 2005).

Dr. Cheskis’ research was in an area of research (estrogen receptors and modulation of nongenomic phosphorylation cascades) that is of importance to women’s health. Dr. Cheskis’ team identified an adapter protein, MNAR, that coordinates interactions between certain nuclear receptors, Src and PI3K and may play important roles in regulation of cell proliferation and survival.

Both Dr. Cheskis and the US PHS were desirous of concluding this matter without further expense of time and other resources. Dr. Cheskis neither admits nor denies that ORI’s findings represent findings of research misconduct. The settlement is not an admission of liability on the part of the Respondent.

Dr. Cheskis has entered into a Voluntary Settlement Agreement. Dr. Cheskis has voluntarily agreed, for a period of 2 years, beginning on March 22, 2010:

(1) To exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant;

(2) That any institution that submits an application for PHS support for a research project on which the Respondent’s participation is proposed or that uses him in any capacity on PHS-supported research, or that submits a report of PHS-funded research in which he is involved, must concurrently submit a plan for supervision of his duties to the funding agency for approval; the supervisory plan must be designed to ensure the scientific integrity of his research contribution; respondent agreed that he will not participate in any PHS-supported research until such a supervisory plan is submitted to ORI.

This next one is also covered in The Scientist [h/t Federale] …

Notice is hereby given that ORI and the Assistant Secretary for Health have taken final action in the following case:

Based on the Respondent’s own admissions in sworn testimony and as set forth below, Indiana University (IU) and the US PHS found that Ms. Emily M. Horvath, former graduate student, IU, engaged in research misconduct in research supported by R01AT001846, F31AT003977, and R01DK082773 by falsifying the original research data when entering values into computer programs for statistical analysis with the goal of reducing the magnitude of errors within groups, thereby gaining greater statistical power.

Respondent admitted to falsifying Figures 6B, 18, 22, 23B, and 24 in grant application R01AT001846-06 (application was withdrawn in May 2009).

Respondent admitted to falsifying Figures 6B, 8, 9D, 16D, and 21 in R01DK082773-01.

Respondent admitted to falsifying Figures 2C, 5, 6D, and 11 in the publication: Horvath et al. Molecular Endocrinology 22:937-950, 2008.

Respondent admitted to falsifying Figure 2C in the publication: Bhonagiri et al. Endocrinology 150(4):1636-1645, 2009.

Respondent also admitted to falsifying Figures 2C, 5, 6D, 11, 13C, 15A, 16A, 17A, 18, 19C, and 20A, which are included in her thesis, “Cholesterol-dependent mechanism(s) of insulin-sensitizing therapeutics.’ The PhD was awarded on December 31, 2008. Respondent was supported by F31AT003977 (9/30/06-9/29/09).

Ms. Horvath has entered into a Voluntary Settlement Agreement in which she has voluntarily agreed, for a period of 3 years, beginning on March 22, 2010:

(1) To exclude herself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant;

(2) That any institution that submits an application for PHS support for a research project on which the Respondent’s participation is proposed or that uses her in any capacity on PHS-supported research, or that submits a report of PHS-funded research in which she is involved, must concurrently submit a plan for supervision of her duties to the funding agency for approval; the supervisory plan must be designed to ensure the scientific integrity of her research contribution; respondent agreed that she will not participate in any PHS-supported research until such a supervisory plan is submitted to ORI;

(3) That any institution employing her submits, in conjunction with each application for PHS funds or report, manuscript, or abstract of PHS-funded research in which the Respondent is involved, a certification that the data provided by the Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, analyses, and methodology are accurately reported in the application, report, manuscript, or abstract; the Respondent must ensure that the institution sends a copy of the certification to ORI; and

(4) That she will write letters, approved by ORI, to relevant journal editors of the published papers cited above to state what she falsified/fabricated and to provide corrections if she has not already done so. These letters should state that her falsifications/fabrications were the underlying reason for the retraction/corrections.


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One that Won’t Make it to ORI

03.4.10 by Michelle Kienholz

A colleague from a prior institution alerted me to this unusual case of a scientist behaving badly.

In September 2004, Dr. William Fals-Stewart (University at Buffalo and Research Institute on Addictions) was accused of fabricating data in NIDA-funded studies; there were discrepancies between the number of subjects reported on progress reports and the actual number of consent forms signed. In December,
a University at Buffalo Inquiry Panel found the data fabrication charges to be warranted and recommended a formal investigation be undertaken.

At that point, this could almost have just been an accounting error that needed to be clarified, but probably a bit more as Fals-Stewart was apparently pressured to leave the University in 2005. And clearly there was serious fabrication of one at least one according to a news release from NY Attorney General Andrew Cuomo:

… during a subsequent formal investigation launched by the University, three witnesses testified by telephone because Fals-Stewart claimed they were out of town. In reality, they were actors who thought they were taking part in a mock-trial. Fals-Stewart paid the actors to testify. He also provided them with scripts to use during the proceedings that were riddled with inaccuracies regarding his research. Fals-Stewart told the three actors, who he had hired before for legitimate training videos, that they would be performing in a mock trial training exercise. They were not aware that they were testifying at a real administrative hearing, nor did they know they were impersonating real people. Because of these false testimonies, Fals-Stewart was exonerated at the administrative hearing.

Claiming that the misconduct allegations tarnished his reputation, Fals-Stewart sued the University, seeking $4 million from the state in damages. The Office of the Attorney General, in its role of defending the University and the state in the court action, conducted a thorough investigation of the claims against the University. It was during this investigation that Cuomo’s office discovered the alleged fraud, forced Fals-Stewart to withdraw his lawsuit and initiated a criminal investigation.

Fals-Stewart was arrested February 16th on multiple felony charges (attempted grand larceny, perjury, identity theft, offering a false instrument and falsifying business records) … and was found dead at his home on February 23rd. Cause of death, after autopsy but probably not all toxicology results, remains unknown (or unreported). The Buffalo News suggests he may have been ill in recent years.

But wait, there’s more. Between 2005 and 2010, Fals-Stewart was not idle. According to the University of Rochester Campus Times:

After leaving UB, Fals-Stewart worked at Research Park Triangle in North Carolina before coming to UR, where he was hired as a professor at the School of Nursing in 2007.

He resigned in November 2009, and in January he filed against UR in the State Supreme Court, claiming that he should have been granting tenure at the University.

I assume the Campus Times means he thinks he should have been granted tenure versus doing the granting … fortunately, his response to denial of tenure did not inflict tragedy on others.


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One that Won’t Make it to ORI

03.4.10 by Michelle Kienholz

A colleague from a prior institution alerted me to this unusual case of a scientist behaving badly.

In September 2004, Dr. William Fals-Stewart (University at Buffalo and Research Institute on Addictions) was accused of fabricating data in NIDA-funded studies; there were discrepancies between the number of subjects reported on progress reports and the actual number of consent forms signed. In December,
a University at Buffalo Inquiry Panel found the data fabrication charges to be warranted and recommended a formal investigation be undertaken.

At that point, this could almost have just been an accounting error that needed to be clarified, but probably a bit more as Fals-Stewart was apparently pressured to leave the University in 2005. And clearly there was serious fabrication of one at least one according to a news release from NY Attorney General Andrew Cuomo:

… during a subsequent formal investigation launched by the University, three witnesses testified by telephone because Fals-Stewart claimed they were out of town. In reality, they were actors who thought they were taking part in a mock-trial. Fals-Stewart paid the actors to testify. He also provided them with scripts to use during the proceedings that were riddled with inaccuracies regarding his research. Fals-Stewart told the three actors, who he had hired before for legitimate training videos, that they would be performing in a mock trial training exercise. They were not aware that they were testifying at a real administrative hearing, nor did they know they were impersonating real people. Because of these false testimonies, Fals-Stewart was exonerated at the administrative hearing.

Claiming that the misconduct allegations tarnished his reputation, Fals-Stewart sued the University, seeking $4 million from the state in damages. The Office of the Attorney General, in its role of defending the University and the state in the court action, conducted a thorough investigation of the claims against the University. It was during this investigation that Cuomo’s office discovered the alleged fraud, forced Fals-Stewart to withdraw his lawsuit and initiated a criminal investigation.

Fals-Stewart was arrested February 16th on multiple felony charges (attempted grand larceny, perjury, identity theft, offering a false instrument and falsifying business records) … and was found dead at his home on February 23rd. Cause of death, after autopsy but probably not all toxicology results, remains unknown (or unreported). The Buffalo News suggests he may have been ill in recent years.

But wait, there’s more. Between 2005 and 2010, Fals-Stewart was not idle. According to the University of Rochester Campus Times:

After leaving UB, Fals-Stewart worked at Research Park Triangle in North Carolina before coming to UR, where he was hired as a professor at the School of Nursing in 2007.

He resigned in November 2009, and in January he filed against UR in the State Supreme Court, claiming that he should have been granting tenure at the University.

I assume the Campus Times means he thinks he should have been granted tenure versus doing the granting … fortunately, his response to denial of tenure did not inflict tragedy on others.


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PLoS Tobacco Ban

02.24.10 by Michelle Kienholz

PLoS Medicine has joined PLoS Biology and PLoS ONE in not accepting “papers where support, in whole or in part, for the study or the researchers comes from a tobacco company.”

Long-time readers of the blog will know that I say, Bravo! I particularly appreciate their rationale:

First, tobacco is indisputably bad for health. … Tobacco interests in research cannot have a health aim—if they did, tobacco companies would be better off shutting down business—and therefore health research sponsored by tobacco companies is essentially advertising.

Second, we remain concerned about the industry’s long-standing attempts to distort the science of and deflect attention away from the harmful effects of smoking. … we do not wish to provide a forum for companies’ attempts to manipulate the science on tobacco’s harms.

They acknowledge this policy will have minimal impact on submissions as PLoS Medicine has not received any manuscripts involving tobacco support and PLoS ONE only two. However, they note that

the business model used to support our open access publishing (the research funder covers publication costs, unless the author requests a waiver) means we would essentially be accepting money from the tobacco industry by publishing their papers. This is unacceptable to the editorial team of PLoS Medicine.

Again, I applaud PLoS for another commendable contribution to the scientific community.


Findings of Misconduct in Science

02.2.10 by Michelle Kienholz

Notice is hereby given that on January 7, 2010, the DHHS Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the misconduct in science findings of ORI in the following case:

James Gary Linn, PhD, former Professor, School of Nursing, Tennessee State University (TSU) committed misconduct in science and research misconduct in research supported by S06GM008092 and G12RR03033. Specifically, ORI found:

  • The Respondent knowingly and intentionally falsified and/ or fabricated the data and results of a study in which he purportedly tested the effects of an intervention to reduce sexual risk behaviors in high risk, impaired populations of homeless men with mental illness by reporting false values for variables in Tables 2-5 of Cellular and Molecular Biology 49(7):1167-1175, 2003. In that published article, he falsified the values in Tables 2-5 by altering the values that he had obtained from another author’s manuscript.
  • The Respondent provided a CD ROM disc to TSU’s Institutional Research Investigation Committee (RIC) that he claimed contained files supporting his analyses for the article in question but that contained fabricated and/or falsified data.
  • The Respondent submitted falsified summary data to the TSU RIC during the TSU investigation and to ORI.

ORI issued a charge letter enumerating the above findings of misconduct in science and proposing HHS administrative actions. Dr. Linn subsequently requested a hearing before an Administrative Law Judge of the Departmental Appeals Board to dispute these findings. However, on November 30, 2009, Dr. Linn withdrew his request for a hearing. On December 18, 2009, the Judge accepted Dr. Linn’s withdrawal and dismissed his request for a hearing.

For 3 years, beginning January 7, 2010, Dr. Linn is debarred from any contracting or subcontracting with any agency of the US Government and from eligibility or involvement in nonprocurement programs and from serving in any advisory capacity to PHS.


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