[Federal Register Volume 70, Number 56 (Thursday, March 24, 2005)]
[Notices]
[Pages 15092-15095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5876]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Scientific Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the Office of Research Integrity 
(ORI) and the Acting Assistant Secretary for Health have taken final 
action in the following case:
    Eric T. Poehlman, Ph.D., University of Vermont: Based on the report 
of an investigation conducted by the University of Vermont (Report), 
admissions made by the respondent, and additional analysis conducted by 
ORI in its oversight review, the U.S. Public Health Service (PHS) found 
that Eric T. Poehlman, Ph.D., former Professor, Department of Medicine 
at the University of Vermont College of Medicine, engaged in scientific 
misconduct in research. The research was supported by National 
Institutes of Health (NIH) grants from the National Institute of Aging 
(NIA), the National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK), and the National Center for Research Resources 
(NCRR).
    Specifically, PHS found that the respondent is responsible for 
scientific misconduct by engaging in the misleading and deceptive 
practices set forth herein below:

Group 1: Longitudinal Study of Aging; Protocol 678 and Associated Excel 
Spreadsheets

Proposing Research (Report, pp. 22-25)

    1. That Respondent falsified preliminary data purportedly obtained 
in a longitudinal study of aging in NIH grant application 1 R01 
AG17906-01, submitted May 27, 1999; specifically, the claim of 130 
subjects at visit one (T1) and 70 subjects at visit two (T2), mean 
values for total energy expenditure (TEE) obtained with a doubly-
labeled water technique were falsified; additional parameters such as 
physical activity energy expenditure (PAEE), resting metabolic rate 
(RMR), fat-free mass, appendicular skeletal muscle mass, and percent 
body fat were falsified to show significant trends during the aging 
process that were not reflective of the actual data (Abstract and pp. 
19, 21, 22, 23, 27, 29, 34, 41, 42).
    2. That Respondent falsified preliminary data purportedly obtained 
in a longitudinal study of aging in NIH grant application 1 R01 
AG17906-01A1, submitted February 2000, specifically, the claim of 130 
subjects at visit one (T1) and 70 subjects at visit two (T2), mean 
values for total energy expenditure (TEE) obtained with a doubly-
labeled water technique were falsified; additional parameters such as 
physical activity energy expenditure (PAEE), resting metabolic rate 
(RMR), fat-free mass, appendicular skeletal muscle mass, and percent 
body fat were falsified to show significant trends during the aging 
process that were not reflective of the actual data (Abstract and pp. 
32, 34, 38, 39, 45, 46).

Conducting Research

    3. That Respondent systematically falsified a number of metabolic 
and physical measures of subjects in the longitudinal study of aging; 
these falsifications of specific types of data in the Protocol 678 
spreadsheet commenced immediately after he assigned responsibility for 
maintenance of the data to a young technician and simultaneously 
arranged to have personal access to the data; his widespread alteration 
of data in specific fields has been detected in a number of different 
versions, often with cumulative effect, and several were transmitted to 
different co-workers for specific reasons, as detailed in the following 
sub issues:
    a. That in the spreadsheet labeled ``678data3.xls,'' produced 
during the late spring/early summer of 2000, Respondent falsified and 
fabricated numerous values in the fields called underwater fat mass 
(UWFM), underwater fat-free mass (UWFFM), leisure time activity (LTA), 
and maximum oxygen consumption (VO2 Max);
    b. That on July 16, 2000, Respondent transmitted a subset of the 
Protocol 678 spreadsheet to Witness 1 entitled ``RevisedTEE--s.xls;'' 
that had 135 values each for T1 and T2 for TEE; many values were 
fabricated and most of the remaining values had been falsified by 
reversing the original T1 and T2 values (Report, pp. 6-8);
    c. That Respondent falsified additional data fields in the version 
of the 678 data set called ``ExcelLongitudinal2.xls,'' on or about 
August 17, 2000; specifically values for total cholesterol, insulin, 
resting metabolic rate (RMR), and glucose values of the subjects with 
names in the second half of the alphabet were falsified (often by 
reversing T1 and T2) or fabricated (Report, p. 10);
    d. That Respondent gave falsified data to Witness 2 in August 2000 
to provide him with data for a presentation to be given in September 
2000 to UVM staff (initially postponed until February 2001); the 
spreadsheet given to Witness 2 contained the falsified and fabricated 
TEE and underwater body composition values of RevisedTEE--s.xls; the 
spreadsheet, when subsequently obtained by ORI, was labeled 
``LongitudinalBodyCompWitness2.xls'';
    e. That Respondent falsified additional data in another version of 
``ExcelLongitudinal2.xls'' that he sent to Witness 3 on or about August 
22, 2000; specifically, this version contained the falsifications 
already described above (Issues 3a through 3c) and, in addition, the 
remainder of the glucose values, and individual lipid components 
(triglycerides, HDL, and LDL) were extensively falsified and 
fabricated; this spreadsheet was transmitted to Witness 3 with the 
expectation that he would write a paper describing the effect of aging 
on lipid metabolism (Report, pp. 8-10);
    f. That Respondent provided a falsified version of the Protocol 678 
spreadsheet to Witness 4 in the fall of 2000 so that Witness 4 could 
write a review article;
    g. That Respondent, in late September/early October 2000, 
extensively falsified body composition data (a number of parameters 
including but not limited to fat mass and fat-free mass) obtained with 
the DEXA method in a spreadsheet transmitted to Witness 5 so that 
Witness 5 could write a paper using the DEXA method to demonstrate body 
composition changes with age (Report, pp. 5 and 39);

[[Page 15093]]

Reporting Research

    h. That Respondent reported falsified data from the longitudinal 
study of aging at the annual North American Association for the Study 
of Obesity (NAASO) meeting in October 2000, and to the Vermont 
community; the falsifications on his slides included falsified values 
for both the number of subjects tested at T1 and T2 for TEE and the 
claim of a significant difference between the means for TEE at T1 
versus T2; values for RMR, PAEE, and body composition (fat mass and 
fat-free mass) were also falsely reported (Report, p. 34);
    i. From the falsified data set that Respondent provided him, 
Witness 4 developed a review article: Rawson, E. and Poehlman, E.T. 
``Resting metabolic rate and aging.'' Recent Research Developments in 
Nutrition 4, 2001, coauthored by Respondent, that included falsified 
yet unpublished results about the decline in RMR upon aging (p. R1792). 
These results, ORI determined, are very similar to the falsified 
results that Respondent presented at NAASO, based on the falsified 
Protocol 678 data set;

Conducting Research

    j. That on October 16, 2000, Respondent provided Witness 6 a 
version of the Protocol 678 data set entitled 
``ExcelLongitudinal4.xls'' that included falsified cholesterol and 
individual lipid component data (as well as falsified parameters such 
as insulin, glucose (all subjects), TEE, RMR, PAEE, and underwater body 
composition data) so that Witness 6 could write a paper on the effect 
of aging on lipid composition (Report, pp. 8-10);

Other

    k. That Respondent falsely testified to the University of Vermont 
Investigation Committee that he had never used data from the 
longitudinal study of aging in grant applications or in public 
presentations (Report, pp. 34 and 36).

Group 2: Muscle Biopsy Results

Proposing Research

    4. That Respondent reported fabricated muscle biopsy data in NIH 
grant application 1 R01 AG17906-01A1 (p. 27), submitted in February 
2000; specifically, he falsely claimed to have successfully tested five 
individuals on two occasions (1994 and 1999) when he had not (Report, 
pp. 25-26).

Group 3: Protocol 467, Including the ``Longitudinal Menopause Study'' 
and Other Falsifications/Fabrications

Reporting Research

    5. That Respondent published falsified thyroid hormone results for 
women entered in a cross-sectional study (Protocol 467) (Figures 3A and 
3B and related text and the portion of Table 2 related to T3 and free 
T3) in the following paper: Poehlman, E.T. Goran, M.I. Gardner, A.W., 
Ades, P.A., Arciero, P.J., Katzman-Rooks, S.M., Montgomery, S.M., Toth, 
M.J., and Sutherland, P.T. ``Determinants of decline in resting 
metabolic rate in aging females.'' American Journal of Physiology 264 
(Endrocrinol Metab. 27):E450-E455, March 1993 (Correction required);
    6. That Respondent published in November 1995 falsified and 
fabricated data from a longitudinal study of menopause in women in the 
following paper: 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(9):673-675, November 1, 1995; Respondent has admitted that this 
longitudinal study was never conducted (the number of women seen at T1 
was falsified, and there were at most 3, rather than 35, women seen at 
T2) (Report, pp. 27-32) (Retracted by editor; letter from Respondent 
required);

Proposing Research

    7. That Respondent repeatedly reported this non-existent 
longitudinal menopause study and cited the 1995 Annals of Internal 
Medicine paper in NIH grant applications as proof that Respondent could 
conduct such longitudinal studies, and the falsified and fabricated 
data supported his proposed hypotheses:
    a. Respondent provided for the annual report for the University of 
Vermont General Clinical Research Center (GCRC) grant (M01 RR00109) for 
the period 12/1/94-11/30/95, information about the falsified 
longitudinal menopause study, and the Annals of Internal Medicine paper 
was cited as having utilized the University of Vermont GCRC facilities;
    b. In application 5 K04 AG00564-05, submitted July 18, 1995, 
Respondent reported the results of a seven (7) year \1\ followup study 
of pre- and post-menopausal women, noting an article was in press in 
the Annals of Internal Medicine 1995 (unnumbered page 3);
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    \1\ All other reports of the ``longitudinal menopause study'' 
claimed an average of six (6) years of follow-up.
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    c. In application R01 AG13978-01, submitted in September 1995, 
Respondent reported falsified and fabricated data on menopause related 
changes in metabolism, body composition, and other variables in 
Preliminary Data (pp. 35, 41, and 42), and cited the published Annals 
of Internal Medicine 1995 paper;
    d. In application R01 AG13978-01A1, submitted in July 1996, 
Respondent reported falsified and fabricated data on menopause related 
changes in metabolism, body composition, and other variables in 
Preliminary Data (p. 33) and cited the published 1995 paper in the 
Annals of Internal Medicine and a submitted manuscript on the same 
topic (pp. 25, 29, 33, 40, 44, 49);
    e. In Project 1 of application P01 AG16782-01, submitted in June 
1998, Respondent reported (p. 233) fabricated data showing that 
menopause led to significant changes in body composition (pp. 229, 230, 
231, 232, 233, 246, 256) (Report, p. 32);
    f. In application 1 R01 AG 18238-01, submitted in April 1999, 
Respondent reported falsified and fabricated data from his longitudinal 
menopause study (RMR, leisure time physical activity, fat-free mass, 
fat mass, waist to hip ratio, and insulin (pp. 9, 18, 19, 20, 22, 23, 
33, 37, 44);
    g. In application 1 R01 AG17906-01, submitted in May 1999, 
Respondent reported falsified and fabricated data in the description of 
his longitudinal menopause study (RMR, leisure time physical activity, 
and fat-free mass, p. 25);
    h. in Project 1 of application P01 AG16782-01A1, submitted in 
January 2000, Respondent reported the falsified and fabricated 
longitudinal menopause study (pp. 214, 220, 221, 228, 250) (Report, p. 
32);
    i. In application 1 R01 AG17906-01A1, submitted in February 2000, 
Respondent reported the falsified and fabricated longitudinal menopause 
study (pp. 31 and 59);
    j. In application 1R01 AG19800-01, submitted in September 2000, 
Respondent reported the falsified and fabricated longitudinal menopause 
study (pp. 18 and 43).

Reporting Research

    8. That Respondent continued to publish papers on the fictitious 
longitudinal menopause study, referring to the same cohort of 35 women, 
18 of whom purportedly went through the menopause transition during the 
six year followup period; all or parts of the

[[Page 15094]]

following additional papers \2\ reported this non-existent study and 
require correction or retraction:
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    \2\ The first paper describing the longitudinal menopause study, 
the 1995 Annals of Internal Medicine paper, was the subject of PHS 
Issue 6.
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    a. Poehlman, E.T., Toth, M.J., Ades, P.A., and Rosen, C.J. 
``Menopause-associated changes in plasma lipids, insulin-like growth 
factor I and blood pressure: A longitudinal study.'' European Journal 
of Clinical Investigation 27(4):322-326, April 1997 (Report, p. 30) 
(Retraction required);
    b. Tchernof, A., and Poehlman, E.T. ``Effects of the menopause 
transition on body fatness and body fat distribution.'' Obesity 
Research 6(3):246-254, May 1998 (pp. 249-251) (Correction required);
    c. Tchernof, A., Poehlman, E.T., and Despres, J.P. ``Body fat 
distribution, the menopause transition, and hormone replacement 
therapy.'' Diabetes and Metabolism 26(1):12-20, February 2000 (Report, 
p. 31) (p. 17 Correction required);
    d. Rawson, E. and Poehlman, E.T. ``Resting metabolic rate and 
aging.'' Recent Research Developments in Nutrition 4, 2001 (Correction 
required);
    e. Poehlman, E.T. ``Menopause, energy expenditure, and body 
composition.'' Acta Obstet. Gynecol. Scand. 81(7):603-611, July 2002 
(Retraction required).
    f. Poehlman, E.T. and Tchernof, A. ``Traversing the menopause: 
Changes in energy expenditure and body composition.'' Coronary Artery 
Disease 9(12):799-803, 1998 (Correction/retraction required).
    9. That Respondent reported falsified and fabricated longitudinal 
menopause data in a talk presented in October 2000 at the annual NAASO 
meeting and to the Vermont community; specifically he reported to the 
NAASO falsified RMR and fat mass data on 40 women followed over six 
years (17 pre-menopausal, 18 post-menopausal, and 5-peri-menopausal) 
and RMR, FM, F-FM, PAEE, WHR, and insulin (Vermont Community) (Report, 
pp. 33-34).

Other

    10. That Respondent falsely wrote to the University of Vermont 
Investigation Committee that the subjects in the longitudinal menopause 
study had not stayed overnight in the GCRC for the second visit. In 
fact, no women were seen a second time at the GCRC on an in-patient or 
outpatient basis (Report, p. 29).

Group 4: Protocol 646--Hormone Replacement Therapy and Visceral Fat and 
Weight Loss; the Genetics of an Obesity Gene

Proposing Research

    11. That Respondent included Protocol 646 in grant application 2 
M01 RR00109-33 (funding for the University of Vermont, GCRC), submitted 
in February-March 1996, in which he provided falsified and fabricated 
data on 40 women with and without the variant gene Trp64Arg; falsified 
parameters included body weight, body mass index, and percent body fat 
that were falsely claimed to be significantly different between the two 
groups.
    12. That Respondent reported falsified and fabricated preliminary 
data and results in application 1 R01 AG18238 on HRT and its 
preferential effect on abdominal fat content:
    a. That Respondent, in grant application 1 R01 AG18238-01 (p. 24), 
submitted in April 1999, presented falsified data in Table 1, on a 
study of women who had reported to be on, or not on, hormone 
replacement therapy (HRT); specifically, he claimed that women on HRT 
had significantly lower intra-abdominal fat than non-users and that 
there was a significant difference in PAEE between the two groups;
    b. Respondent also falsely claimed to have evaluated the effect of 
HRT on intra-abdominal fat loss in a double blind placebo controlled 
study of 27 weeks duration (Figure 4); the actual study was not 
unblinded until 2002;
    c. Respondent also falsely claimed (pp. 36-37) to have completed a 
six month pilot study on the effect of exercise weight loss on 
postmenopausal women administered HRT, compared to women not on HRT.
    13. That Respondent, in grant application 1 P01 AG16782-01A1, 
submitted in January 2000, presented (p. 230) falsified data:
    a. On a study of women reported to be on, or not on, HRT; 
specifically the number of subjects in Table 4 was 25 for HRT users and 
23 for non-users, while seven of eight values for PAEE and intra-
abdominal fat (3 means and 4 standard deviations) were unchanged from 
Table 1 of Application 1 R01 AG18328-01, where the number of subjects 
was 13 for each group;
    b. Respondent repeated the false claim in the April 1999 
application to have evaluated the effect of HRT on intra-abdominal fat 
in a double blind placebo controlled study of 27 weeks duration; the 
actual study was not unblinded until 2002; Respondent admitted to 
falsifying the figure in this application relative to the version in 
the 1 R01 AG18328-01 application;
    c. Respondent falsely claimed (p. 231) to have studied 8 post-
menopausal women on HRT and 7 women not on HRT in a six month weight 
loss program, when the average ages, standard deviations and certain 
mean values were unchanged from the smaller and purportedly different, 
groups described in the April 1999 application (see PHS Issue 12c 
above).
    14. That Respondent, in grant application 2 R01 DK052752-05, 
submitted in June 2000:
    a. Falsified the number of subjects carrying or not carrying the 
Trp64Arg genotype in Tables 4, 5, and 6 (pp. 30-31); specifically in 
the application, he falsely claimed to have tested 40 in each group; 
Respondent admitted that the actual number tested varied from 8-13, 
depending on the group and parameter being measured;
    b. Respondent also falsely claimed that the number of women 
recruited to his funded grant on the menopause transition was 85 (p. 
49).
    15. That Respondent, in grant application 1 R01 AG19800-01, 
submitted in September 2000:
    a.-c. Made the same three false claims with respect to HRT as in 
application 1 P01 AG16782-01A1 (Findings 13 a-c); in addition, 
Respondent falsely claimed in Table 5 that the number of subjects with 
and without HRT participating in the six-month weight loss program (see 
PHS Issue 13 c. above) was now 10 in each group rather than the group 
sizes of 8 and 7 claimed in Table 5 of the 1 P01 AG16782-01A1 
application; many of the means and standard deviations in these two 
tables match the values obtained in a 6 month weight loss pilot study 
described on pp. 36-37 of application 1 R01 AG18238-01, where the two 
groups were comprised of 3 and 4 individuals; (pp. 13, 15, 17, 20, 21 
and Tables 4 and 5 and Figure 6);
    d. Falsely claimed (Table 3, p. 19) to have weight-reduced 70 obese 
women in the genetic study.

Reporting Research

    16. That in public presentations or material prepared for these 
fora, Respondent falsified or fabricated data and results of the 
effects of HRT and of the effects of the Trp64Arg genotype:
    a. That Respondent, at talks given at the annual NAASO meeting in 
October 2000, and to the Vermont Community (October 17, 2000), 
presented false information on the effects of HRT on visceral fat loss 
and glucose disposal when the HRT users and non-users were on a six-
month weight loss program;

[[Page 15095]]

    b. That Respondent, in both the NAASO and Vermont Community talks, 
falsely claimed that Trp64Arg carriers have significantly lower rates 
of glucose disposal than non-carriers.

Other

    17. That Respondent falsely testified to the University of Vermont 
Investigation Committee that the slide shown at NAASO regarding the 
loss of visceral fat in women on or not on HRT during a six-month 
weight loss program (Issue 16a) had been labeled ``hypothesized.'' 
Respondent falsely labeled the NAASO slide ``hypothesized'' and 
submitted it to the University of Vermont Investigation Committee with 
the intention of misleading the committee (Report, pp. 34, 37).

Group 5: Alzheimer's Disease

    18. That Respondent, in applications 2 R01 AG07857-06 and 7 R01 
AG07857-07, submitted June 26, 1992, and March 28, 1994, respectively, 
falsified certain preliminary data (average ages, height, and fat-free 
weight values) to show that the Alzheimer's and control patients were 
more closely matched for age than shown in the original data;
    19. That Respondent, in application 5 R01 AG07857-09, submitted May 
18, 1995, falsified preliminary data; specifically, compared to data in 
the preceding 5 R01 AG07857-08 application, where the number of 
Alzheimer's and control subjects was 7 and 13 respectively, the number 
of Alzheimer's and control subjects was doubled to 14 and 26 
respectively, while many of the data values and standard deviations 
remained unchanged; in the latter application however, Respondent 
claimed that Alzheimer's patients had significantly lower fat-free mass 
and significantly higher fat mass than control patients, while no claim 
of significant differences had been made in the earlier application.

Group 6: Effect of Endurance Training on Metabolism

    20. Respondent admitted to falsifying norepinephrine data (a 
measure of sympathetic nervous system activity) in two papers published 
in 1992 and 1994 and agreed to retraction of the papers.\3\ 
Specifically:
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    \3\ Both the 1992 and 1994 papers were designed to reproduce, 
under more controlled conditions, an earlier result, published in 
Poehlman, E. and Danforth, E. ``Endurance training increases 
metabolic rate and norepinephrine appearance rate in older 
individuals.'' Am. J. Physiol. 261:E233-E239, 1991. These papers 
claimed that plasma levels of norepinephrine increased significantly 
in older individuals following endurance training. Because the 
norepinephrine results in the two carefully controlled studies 
conducted to verify this finding were falsified, it is apparent that 
this original report cannot be relied upon.
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    a. Respondent falsified norepinephrine data in Table 2 and Figure 4 
of Poehlman, E.T., Gardner, A.W., and Goran, M.I. ``Influence of 
endurance training on energy intake, norepinephrine kinetics, and 
metabolic rate in older individuals.'' Metabolism 41(9):941-948, 
September 1992, in order to strengthen the relationship between 
endurance training and increased norepinephrine levels and rate of 
appearance (paper to be retracted);
    b. Respondent falsified norepinephrine data in Table 2 and 
associated text of 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, 
June 1994, in order to make the claims that norepinephrine 
concentration and norepinephrine appearance were significantly enhanced 
following endurance training (paper to be retracted).
    Dr. Poehlman has entered into a Voluntary Exclusion Agreement 
(Agreement ) in which he has voluntarily agreed, beginning on March 9, 
2005:
    (1) To exclude himself permanently 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) To exclude himself permanently from any contracting or 
subcontracting with any agency of the United States Government and from 
eligibility or involvement in nonprocurement programs of the United 
States Government referred to as ``covered transactions'' as defined in 
the debarment regulations at 45 CFR part 76; the respondent agrees that 
he will not petition HHS to reverse or reduce the scope of the 
permanent voluntary exclusion or administrative actions that are the 
subject of this Agreement; and
    (3) To execute and deliver letters requesting retraction or 
correction to the editors of the journals that published the ten papers 
named in the Agreement and cited above, and to sign the letters 
requesting the retraction or correction prepared for his signature by 
ORI without alteration or modification in any way.

FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative 
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 
750, Rockville, MD 20852, (301) 443-5330.

Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. 05-5876 Filed 3-23-05; 8:45 am]
BILLING CODE 4150-31-P