Findings of Scientific Misconduct, 5161-5162 [E9-1933]
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Federal Register / Vol. 74, No. 18 / Thursday, January 29, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
rmajette on PRODPC74 with NOTICES
ACTION:
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:
Nima Afshar, PhD., University of
California, San Francisco: Based on a
University of California, San Francisco
(UCSF) report and Respondent’s own
admission, the U.S. Public Health
Service (PHS) found that Dr. Nima
Afshar, former postdoctoral fellow at
UCSF engaged in research misconduct
in research supported by National
Cancer Institute (NCI), National
Institutes of Health (NIH), grant T32
CA108462 and National Institute of
General Medical Sciences (NIGMS),
NIH, grant R01 GM59704.
PHS found that Respondent engaged
in research misconduct in the
performance of research on yeast to test
whether disruption of the tight controls,
to prevent re-replication, on the
initiation of DNA replication could
produce gene amplifications with a
copy number greater than two (2).
Specifically, Respondent falsified files
containing raw scanned microarray
images from another researcher’s
experiments to demonstrate that in
experiments that she claimed to have
conducted, she successfully observed
gene amplifications with a copy number
greater than two (2); there were 36 such
instances of falsifying data files.
Dr. Afshar has entered into a
Voluntary Settlement Agreement in
which she has voluntarily agreed, for a
period of three (3) years, beginning on
December 22, 2008:
(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;
and
(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 the Respondent in any
capacity on PHS supported research, or
that submits a report of PHS-funded
research in which the Respondent is
involved, must concurrently submit a
plan for supervision of the Respondent’s
duties to the funding agency for
approval. The supervisory plan must be
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15:25 Jan 28, 2009
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designed to ensure the scientific
integrity of the Respondent’s research
contribution. Respondent agrees to
ensure that a copy of the supervisory
plan also is submitted to ORI by the
institution for ORI approval.
Respondent agrees that she will not
participate in any PHS-supported
research until such a supervisory plan is
submitted to ORI.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
John E. Dahlberg,
Acting Director, Office of Research Integrity.
[FR Doc. E9–1819 Filed 1–28–09; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Scientific Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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:
M. Nguyen, M.D., University of
California, Los Angeles: Based on a
University of California, Los Angeles
(UCLA) report and Respondent’s own
admission, the U.S. Public Health
Service (PHS) found that Dr. M. Nguyen,
former Associate Professor at UCLA,
engaged in scientific misconduct in
research supported by National Cancer
Institute (NCI), National Institutes of
Health (NIH), grant 1 R01 CA69433,
National Center for Complementary and
Alternative Medicine (NCCAM), NIH,
grant 1 P50 AT00I51–01, and National
Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), NIH, grant
T32 DK03688.
Specifically, PHS found that
Respondent engaged in scientific
misconduct by:
1. Dr. Nguyen’s laboratory conducted
a single experiment on the effect of
Livistona extract on the growth of 106
mouse fibrosarcoma (FSA) cells injected
into C3H mice. The drug was
administered in the drinking water of
the treated mice and tumor sizes were
measured twice weekly with calipers.
Dr. Nguyen falsified and fabricated the
results of this experiment in Figure 3 of
Oncology Reports 8:1355–1357, 2001:
A. The data reported for the control
group were from an experiment in nude
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5161
mice implanted with human breast
tumor implants, rather than with mouse
fibrosarcoma cell implants, as Dr.
Nguyen reported in the paper. The
control data for FSA implanted C3H
mice could not be located in the
laboratory records.
2. Dr. Nguyen’s laboratory conducted
a single experiment on the effect of
Livistona extract on the growth of 108
MDA–MD–231 cells injected into nude
mice. The drug was administered in the
drinking water of the treated mice and
tumor sizes measured twice weekly
with calipers. Dr. Nguyen falsified and
fabricated the results of this experiment
in Figure 9 of NIH grant application P50
AT00151–01, dated May 19, 1999, by:
A. Falsely stating in the associated
text that there were ten mice per group
and that the experiments were repeated
once, while in fact, there were only five
mice per group with no repetition of
this experiment
B. Omitting data on the control curve
for two of the measurement times (at 2
and 3.5 weeks) and falsely reporting the
times at which three other
measurements were taken.
3. Dr. Nguyen’s laboratory conducted
a single experiment (1998–99) testing
the anti-angiogenic effects of Livistona
chinensis extract on human umbilical
vein endothelial cells (HUVEC). HUVEC
cells were counted from duplicate wells
when exposed to extract and controls
were counted from single wells:
A. Figure 8 of NIH grant application
P50 AT00I51–01, dated 5/19/99, plots
the data as a bar graph. However, the
same data were reported in Figure 1 of
Oncology Reports 8:1355–1357, 2001, by
falsely expressing them as the rate of
growth obtained by measuring the
uptake of radioactive thymidine into
cellular DNA and plotting the data as
normalized to control values. UCLA
concluded that Figure 1 was falsified by
claiming the data were obtained by a
state-of-the-art technique not actually
employed by the Respondent to obtain
the data for that figure (Admission).
This falsification did not bear upon the
findings of the paper.
4. Dr. Nguyen’s laboratory tested
whether the levels of bFGF (basic
fibroblast growth factor) and VEGF
(vascular endothelial growth factor) in
nipple fluid aspirates were significantly
elevated in breast cancer patients in
comparison to values from normal
lactating and non-lactating breasts. Dr.
Nguyen falsified the number of subjects
who were lactating in The Lancet
356:567–569, 2000, by claiming that
bFGF data were obtained from four
separate subjects while in fact the data
were from both breasts of two subjects.
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5162
Federal Register / Vol. 74, No. 18 / Thursday, January 29, 2009 / Notices
Dr. Nyugen has entered into a
Voluntary Settlement Agreement with
ORI. As part of that Agreement, Dr.
Nyugen admits to UCLA’s findings of
fact but denies ORI’s findings that the
actions rise to the level of scientific
misconduct. The settlement is not an
admission of liability on the part of the
Respondent. Dr. Nyugen voluntarily
agreed, for a period of three (3) years,
beginning on December 29, 2008:
(1) Not to serve 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; and
(2) That although Respondent is not
currently engaged in PHS–supported
research, any institution that submits an
application for PHS support for a
research project on which the
Respondent’s participation is proposed
or that uses the Respondent in any
capacity on PHS supported research, or
that submits a report of PHS-funded
research in which the Respondent is
involved, must concurrently submit a
plan for supervision of the Respondent(s
duties to the funding agency for
approval. The supervisory plan must be
designed to ensure the scientific
integrity of the Respondent(s research
contribution. Respondent agreed to
ensure that a copy of the supervisory
plan also is submitted to ORI by the
institution for ORI approval.
Respondent agreed to not participate in
any PHS-supported research until such
a supervisory plan is submitted to ORI.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. E9–1933 Filed 1–28–09; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
rmajette on PRODPC74 with NOTICES
Notice of Meeting: Secretary’s
Advisory Committee on Genetics,
Health, and Society
Pursuant to Public Law 92–463,
notice is hereby given of the eighteenth
meeting of the Secretary’s Advisory
Committee on Genetics, Health, and
Society (SACGHS), U.S. Public Health
Service. The meeting will be held from
10 a.m. to approximately 5:30 p.m. on
Thursday, March 12, 2009, and 8:30
a.m. to approximately 3 p.m. on Friday,
March 13, 2009, at the Hubert H.
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Humphrey Building, 200 Independence
Avenue, SW., Washington, DC 20201.
The meeting will be open to the public
with attendance limited to space
available. The meeting also will be Web
cast.
At this meeting, the Committee will
begin to explore issues related to
genetics and the future of the health
care system with the first in a series of
roundtables focusing on perspectives of
stakeholders in the payer community.
Other agenda items include a session on
developments related to informed
consent for genomic data sharing,
discussion of the Committee’s next steps
to address concerns related to
consumer-initiated genomic services,
and updates on Department of Health
and Human Services and agency
priorities.
As always, the Committee welcomes
hearing from anyone wishing to provide
public comment on any issue related to
genetics, health and society. Individuals
who would like to provide public
comment should notify the SACGHS
Executive Secretary, Ms. Sarah Carr, by
telephone at 301–496–9838 or e-mail at
carrs@od.nih.gov. The SACGHS office is
located at 6705 Rockledge Drive, Suite
750, Bethesda, MD 20892. Anyone
planning to attend the meeting, who is
in need of special assistance, such as
sign language interpretation or other
reasonable accommodations, is also
asked to contact the Executive
Secretary.
Under authority of 42 U.S.C. 217a,
Section 222 of the Public Health Service
Act, as amended, the Department of
Health and Human Services established
SACGHS to serve as a public forum for
deliberations on the broad range of
human health and societal issues raised
by the development and use of genetic
and genomic technologies and, as
warranted, to provide advice on these
issues. The draft meeting agenda and
other information about SACGHS,
including information about access to
the Web cast, will be available at the
following Web site: https://
oba.od.nih.gov/SACGHS/
sacghs_home.html.
Dated: January 22, 2009.
Jennifer Spaeth,
Director, NIH Office of Federal Advisory
Committee Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Assessing Organizational Responses to
AHRQ’s Health Literacy Pharmacy
Tools.’’ In accordance with the
Paperwork Reduction Act of 1995, 44
U.S.C. 3506(c)(2)(A), AHRQ invitesthe
public to comment on this proposed
information collection.
DATES: Comments on this notice must be
received by March 30, 2009.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports clearance Officer, AHRQ, by email at doris.lefkowitz@ahrq.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at doris.leflowitz@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project: Assessing
Organizational Responses to AHRQ’s
Health Literacy Pharmacy Tools
According to the 2003 National
Assessment of Adult Literacy, only 12
percent of adults have proficient health
literacy-the capacity to obtain, process,
and understand basic health
information and services needed to
make appropriate health decisions.
Limited health literacy often leads to
medication errors. For example, one
study found that a majority of adults
with low health literacy did not
understand instructions to ‘‘take
medication on an empty stomach.’’
Overall, it is estimated that low health
literacy costs the U.S. health care
system $50 billion to $73 billion per
year. Pharmacies can serve as an
important source of medication
information for people with limited
health literacy, but relatively few
pharmacies have implemented health
literacy practices (Praska et al., 2005).
E:\FR\FM\29JAN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 18 (Thursday, January 29, 2009)]
[Notices]
[Pages 5161-5162]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-1933]
-----------------------------------------------------------------------
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:
M. Nguyen, M.D., University of California, Los Angeles: Based on a
University of California, Los Angeles (UCLA) report and Respondent's
own admission, the U.S. Public Health Service (PHS) found that Dr. M.
Nguyen, former Associate Professor at UCLA, engaged in scientific
misconduct in research supported by National Cancer Institute (NCI),
National Institutes of Health (NIH), grant 1 R01 CA69433, National
Center for Complementary and Alternative Medicine (NCCAM), NIH, grant 1
P50 AT00I51-01, and National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), NIH, grant T32 DK03688.
Specifically, PHS found that Respondent engaged in scientific
misconduct by:
1. Dr. Nguyen's laboratory conducted a single experiment on the
effect of Livistona extract on the growth of 10\6\ mouse fibrosarcoma
(FSA) cells injected into C3H mice. The drug was administered in the
drinking water of the treated mice and tumor sizes were measured twice
weekly with calipers. Dr. Nguyen falsified and fabricated the results
of this experiment in Figure 3 of Oncology Reports 8:1355-1357, 2001:
A. The data reported for the control group were from an experiment
in nude mice implanted with human breast tumor implants, rather than
with mouse fibrosarcoma cell implants, as Dr. Nguyen reported in the
paper. The control data for FSA implanted C3H mice could not be located
in the laboratory records.
2. Dr. Nguyen's laboratory conducted a single experiment on the
effect of Livistona extract on the growth of 10\8\ MDA-MD-231 cells
injected into nude mice. The drug was administered in the drinking
water of the treated mice and tumor sizes measured twice weekly with
calipers. Dr. Nguyen falsified and fabricated the results of this
experiment in Figure 9 of NIH grant application P50 AT00151-01, dated
May 19, 1999, by:
A. Falsely stating in the associated text that there were ten mice
per group and that the experiments were repeated once, while in fact,
there were only five mice per group with no repetition of this
experiment
B. Omitting data on the control curve for two of the measurement
times (at 2 and 3.5 weeks) and falsely reporting the times at which
three other measurements were taken.
3. Dr. Nguyen's laboratory conducted a single experiment (1998-99)
testing the anti-angiogenic effects of Livistona chinensis extract on
human umbilical vein endothelial cells (HUVEC). HUVEC cells were
counted from duplicate wells when exposed to extract and controls were
counted from single wells:
A. Figure 8 of NIH grant application P50 AT00I51-01, dated 5/19/99,
plots the data as a bar graph. However, the same data were reported in
Figure 1 of Oncology Reports 8:1355-1357, 2001, by falsely expressing
them as the rate of growth obtained by measuring the uptake of
radioactive thymidine into cellular DNA and plotting the data as
normalized to control values. UCLA concluded that Figure 1 was
falsified by claiming the data were obtained by a state-of-the-art
technique not actually employed by the Respondent to obtain the data
for that figure (Admission). This falsification did not bear upon the
findings of the paper.
4. Dr. Nguyen's laboratory tested whether the levels of bFGF (basic
fibroblast growth factor) and VEGF (vascular endothelial growth factor)
in nipple fluid aspirates were significantly elevated in breast cancer
patients in comparison to values from normal lactating and non-
lactating breasts. Dr. Nguyen falsified the number of subjects who were
lactating in The Lancet 356:567-569, 2000, by claiming that bFGF data
were obtained from four separate subjects while in fact the data were
from both breasts of two subjects.
[[Page 5162]]
Dr. Nyugen has entered into a Voluntary Settlement Agreement with
ORI. As part of that Agreement, Dr. Nyugen admits to UCLA's findings of
fact but denies ORI's findings that the actions rise to the level of
scientific misconduct. The settlement is not an admission of liability
on the part of the Respondent. Dr. Nyugen voluntarily agreed, for a
period of three (3) years, beginning on December 29, 2008:
(1) Not to serve 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; and
(2) That although Respondent is not currently engaged in PHS-
supported research, any institution that submits an application for PHS
support for a research project on which the Respondent's participation
is proposed or that uses the Respondent in any capacity on PHS
supported research, or that submits a report of PHS-funded research in
which the Respondent is involved, must concurrently submit a plan for
supervision of the Respondent(s duties to the funding agency for
approval. The supervisory plan must be designed to ensure the
scientific integrity of the Respondent(s research contribution.
Respondent agreed to ensure that a copy of the supervisory plan also is
submitted to ORI by the institution for ORI approval. Respondent agreed
to not participate in any PHS-supported research until such a
supervisory plan is submitted to ORI.
FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852, (240) 453-8800.
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. E9-1933 Filed 1-28-09; 8:45 am]
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