Abstract
Eric T. Poehlman, Ph.D., was an internationally recognized, tenured professor at the University of Vermont (UVM) in Burlington when, in October 2000, a junior member of Poehlman’s laboratory became convinced that he had altered data from a study on aging volunteers from the Burlington area. This suspicion developed into one of the most significant cases of scientific misconduct in the history of the US Department of Health and Human Services’ (HHS) Office of Research Integrity (ORI), launching a US Department of Justice (DOJ) civil and criminal fraud investigation and, eventually, to a much publicized guilty plea and felony conviction. In the end, Dr. Poehlman admitted to 54 findings of scientific misconduct made by the UVM and ORI, agreed to retract or correct ten of his publications and to exclude himself from federal procurement and nonprocurement transactions for life. The United States Government’s handling of this case was distinguished by a highly cooperative approach that integrated the resources of the US Attorney’s Office for the District of Vermont (USAO) and both ORI and the Office of the Inspector General (OIG) in HHS in the common goal of prosecuting research fraud.
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References
The federal regulation pertinent to this case is 42 C.F.R. Part 50, Subpart A. This PHS rule defines scientific misconduct as “fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.” 42 C.F.R.§50.102
See 42 C.F.R. Part 50, Subpart A—“Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science.”
Poehlman, E.T., Toth, M.J., and Gardner, A.W. “Changes in energy balance and body composition at menopause: a controlled longitudinal study” Annals of Internal Medicine 123: 673–675, 1995: Based on information sent to the editor by UVM, the editor retracted the paper in October 2003 (Ann Intern Med. 2003 Oct 21; 139(8): 702) Dr. Poehlman responded by requesting that the retraction be withdrawn and by threatening to sue for libel but, as part of the settlement with the government, submitted a letter in 2005 that acknowledged the appropriateness of the original retraction (Ann Intern Med. 2005 May 3; 142(9): 798).
Letter from Thomas Mercurio, Senior Associate Counsel, UVM, to Andrew D. Manitsky, Esquire, counsel to Dr. Poehlman (April 10, 2001) (on file with ORI). See 42 C.F.R. § 103(d)(4) (mandating that institutions notify HHS of their decision to commence a scientific misconduct investigation).
Dr. Eric T. Poehlman v. University of Vermont and Joseph Warshaw, No. 2:01-CV-120 (D. Vt. filed April 16, 2001). On December 12, 2005, the court entered an order granting the USAO’s unopposed motion to lift seal.
Id. Motion and Memorandum of Law In Support of Motion for Temporary Restraining Order and Preliminary Injunction at 1–2.
Id. Motion to Seal at 2.
Id. Complaint at ¶12.
See, e.g., Abbs v. Sullivan, 756 F. Supp. 1172, 1182 (W.D. Wisc. 1990) (“Plaintiffs have not shown that [the accused researcher] is suffering or will suffer an alteration in any status secured by state or federal law. His ability to serve on committees, to review journal articles, to participate in peer review, to conduct his research without supervision or special reporting obligations is not a right that is protected by law. Thus, any interference with this ability does not amount to an alteration of a legal status.”), vacated on other grounds, 963 F.2d 918 (7th Cir. 1992).
See Dr. Eric T. Poehlman, supra, Declaration of Dr. Eric T. Poehlman at ¶¶7, 6 and 4.
Letter from Eric T. Poehlman to Dr. Burton Sobel (on file with ORI).
Ann Intern Med. 2003 Oct 21; 139(8): 702. UVM notified the editor of the Annals that its investigation committee had found Dr. Poehlman responsible for scientific misconduct.
The two papers, and the retraction citations are: Poehlman, E., Gardner, A., and Goran, M., “Influence of Endurance training on energy intake, norepinephrine kinetics, and metabolic rate in older individuals,” Metabolism 41 (September): 941–948, 1992, retracted in Metabolism 54(9): 267, 2005, and Poehlman, E.T., Gardner, A.W., Arciero, P.J., Goran, M.I., and Calles-Escandon, J., “Effects of endurance training on total fat oxidation in elderly persons,” J. Appl. Physiol. 76(6): 2281–2287, 1994, retracted in J. Appl. Physiol. 99(2): 779, 2005.
18 U.S.C. § 1001. See, e.g., Ogden v. United States, 303 F.2d 724, 742 (9th Cir., 1962) (Section 1001 is “intended to serve the vital public purpose of protecting governmental functions from frustration and distortion through deceptive practices.”).
See United States v. Eric T. Poehlman, Criminal No.2:05-cc-38-1 (D.Vt. March 21, 2005) (Criminal Information).
United States of America, ex rel. Walter F. DeNino v. Eric T. Poehlman, Ph.D., No.1:04-CV-310 (D.Vt. March 21, 2005). The False Claims Act is codified at 31 U.S.C. §§ 3729–3733 (2000).
Id.
United States of America v. Eric T. Poehlman, No. 2:05-CV-66 (D.Vt. March 21, 2005) (Settlement Agreement and Stipulation for Entry of Judgment).
Id. at ¶ 7.
42 U.S.C. § 1320a-7(b)(1)(B).
45 C.F.R. Part 76. The HHS Department Appeals Board (DAB) has held that scientific misconduct may be a “cause” for debarment of so serious or compelling a nature that it affects a respondent’s present responsibility. See, e.g., Kimon A. Angelides, Ph.D., DAB Decision 1677 (Feb. 5, 1999); 45 C.F.R. § 76.800(d).
Generally speaking, lifetime debarments and exclusions are not rare events. The Food and Drug Administration frequently administers lifetime debarments pursuant to its statutory authority. See, e.g., Harry W. Snyder, Jr., 68 Fed. Reg. 1619 (Food and Drug Administration, December 23, 2002; debarment order).
Poehlman, E.T., Goran, M.L., Gardner, A.W., Ades, P.A., Arciero, P.J., Katzman-Rooks, S.M., Montgomery, S.M., Toth, Ml.J., and Sutherland, P.T, “Determinants of decline in resting metabolic rate in aging females,” American Journal of Physiology, Endocrinology and Metabolism, 264: E450-E455, 1993; the correction was published in Am. J. Physiol. Endochrinol. Metab. 289(2): E357, 2005.
See, e.g., Research Fraud Cases Increasingly Handled Through Courts, U.S. Attorney Sheehan Concludes, Medical Research Law & Policy Report (BNA) Vol. 4 No. 21, at 828 (November 2, 2005).
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The content of this article represents the personal views of the authors and does not express the opinion or policy of DHHS or its components.
A paper on this topic was presented at the 6th International Bioethics Conference on the subject of ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005.
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Dahlberg, J.E., Mahler, C.C. The poehlman case: running away from the truth. SCI ENG ETHICS 12, 157–173 (2006). https://doi.org/10.1007/s11948-006-0016-9
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DOI: https://doi.org/10.1007/s11948-006-0016-9