[Federal Register Volume 66, Number 124 (Wednesday, June 27, 2001)]
[Notices]
[Page 34200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16022]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Scientific Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that the Office of Research Integrity 
(ORI) and the Assistant Secretary for Health have taken final action in 
the following case:
    Kuie-Fu (Tom) Lin, D.V.M., Medical University of South Carolina 
(MUSC): Based on the report of an investigation conducted by MUSC and 
additional analysis conducted by ORI in its oversight review, the U.S. 
Public Health Service (PHS) found that Dr. Lin, a former graduate 
student, Department of Biochemistry and Molecular Biology at MUSC, 
engaged in scientific misconduct in research supported by the National 
Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health 
(NIH), grants R01 HL29397, ``Regulation and Function of Renal 
Kallikrein,'' and R01 HL56686, ``Gene Therapy in Experimental 
Hypertension and Renal Diseases.''
    Specifically, PHS finds that Dr. Lin engaged in scientific 
misconduct by:
    A. Falsifying research on the expression and effect of the human 
atrial natriuretic peptide (ANP) gene in rats reported in Hypertension 
26:847-853, 1995. Dr. Lin falsified data in the text on page 850 that 
described RT-PCR results shown in Figure 3 as obtained from multiple 
control and experimental rats, when only one rat was tested for each 
group.
    B. Falsifying research on the expression and effect of the human 
adrenomelullin gene in rats reported in Hypertension Research 20:269-
277, 1997. Dr. Lin falsified data in: (a) Figure 2 on page 272 by 
reusing Figure 2 of the Hypertension paper cited in ``A'' above, and 
falsely relabeling it as being a test of ADM levels in experimental 
rats; (b) Table 1 on page 273 by stating concentrations of human ADM in 
experimental rat tissues without accounting for the high levels of 
endogenous cross-reactive rat ADM; and (c) Table 1 on page 273 by 
claiming that the levels of human ADM seen in rat tissues were obtained 
from four animals when the values were actually obtained from four 
serial dilutions of one sample. The journal published an erratum at 
22(3):229, 1999.
    C. Falsifying research on the expression and effect of the human 
ANP gene in rats reported in Human Gene Therapy 9:1429-1438, 1998. Dr. 
Lin falsified data in: (a) Figure 3 on page 1431 by reusing Figure 2 of 
the Hypertension paper cited in ``A'' above, and falsely relabeling it 
as being based on the use of an adenovirus vector to deliver the ANP 
(gene rather than the use of ``naked DNA'' described in the earlier 
paper); (b) text on page 1433 that stated concentrations of human ANP 
in experimental rat tissues without accounting for the high levels of 
endogenous cross-reactive rat ANP; and (c) Table 2 by making an 
inappropriate calculation for the renal blood flow (RFB) of the 
``AdCMV-LacZ'' group by altering data (from animals that should not 
have been included because their venous flow was greater than their 
arterial flow), to falsely produce an average RBF value that was 
significantly different from the group receiving the ANP vector.
    All three of the questioned papers described gene therapy models in 
which the introduced gene lowered blood pressure in hypertensive or 
salt-sensitive rats. Dr. Lin's falsifications greatly enhanced the 
apparent expression and effects of the introduced ANP and ADM genes in 
the experimental rats.
    Dr. Lin states that he made honest mistakes and deeply regrets his 
unintentional errors in data handling.
    Dr. Lin has entered into a Voluntary Exclusion Agreement 
(Agreement) with PHS in which he has voluntarily agreed:
    (1) To exclude himself from any contracting or subcontracting with 
any agency of the United States Government and from eligibility for, or 
involvement in, nonprocurement transactions (e.g., grants and 
cooperative agreements) of the United States Government as defined in 
45 CFR part 76 (Debarment Regulations) for a period of three (3) years, 
beginning on June 12, 2001;
    (2) 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 for a period of three 
(3) years, beginning on June 12, 2001;
    (3) within 30 days of the effective date of the Agreement to submit 
letters of correction or retraction to:
    (A) Hypertension 26:847-853, 1995: Requesting correction of the 
statement on page 850 to indicate that results on RT-PCR of tissue 
extracts were obtained with only one control and one experimental rat, 
rather than the four animals for each group claimed in the paper;
    (B) Hypertension Research 20:269-277, 1997: Requesting retraction 
of Table 1; the notice to the journal should state that the values for 
human ADM in Table 1 were incorrect because they did not account for 
the high level of endogenous ADM detected in control tissues by the 
RIA, and that only a single rat was tested rather than the four animals 
claimed; and
    (C) Human Gene Therapy 9:1429-1438, 1998: Requesting retraction of 
Figure 2 and correction of Table 2 to indicate that the renal blood 
flow value for the ``Ad.CMV-LacZ (4% NaC1)'' rats was falsified. The 
notice to the journal should state that Figure 2 was falsified because 
it was in large part a duplicate of a previously published figure and 
was falsified both because logit values were deliberately altered and 
because the results were obtained from experimental rats that were 
treated differently from those described in the paper. This statement 
should also note that the first paragraph on page 1433 contained 
misleading concentrations of human ANP in experimental tissues because 
they failed to account for the high level of cross-reactive endogenous 
ANP observed by the RIA used in control tissues.
    These correction and retraction requirements will remain on the 
ALERT System until Dr. Lin sends, and ORI receives, copies of these 
letters that are consistent with the above language.

FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative 
Oversight, Office of Research Integrity, 5515 Security Lane, Suite 700, 
Rockville, MD 20852, (301) 443-5330.

Chris Pascal,
Director, Office of Research Integrity.
[FR Doc. 01-16022 Filed 6-26-01; 8:45 am]
BILLING CODE 4150-31-P