[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Notices]
[Pages 19295-19296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10731]



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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) has made final findings of scientific misconduct in the following 
case:

Andrew Friedman, M.D., Harvard Medical School

    Based on a report from Harvard Medical School and Dr. Friedman's 
admission, ORI found that Andrew Friedman, M.D., former Harvard Medical 
School Associate Professor of Obstetrics, Gynecology, and Reproductive 
Biology at the Brigham and Women's Hospital, committed scientific 
misconduct by falsifying and fabricating data in research supported in 
part by a Public Health Service (PHS) grant to the Brigham and Women's 
Hospital General Clinical Research Center.
    Between 1992 and 1995, Dr. Friedman altered and fabricated 
information in permanent patient medical records and notes by changing 
dates, changing and adding text, and fabricating notes for clinical 
visits that did not occur. Dr. Friedman admitted that he had falsified 
and fabricated approximately 80 percent of the data in research reports 
published in Fertility and Sterility (Friedman, A.J. and Thomas, P.P. 
``Gonadotrophin-releasing hormone agonist plus estrogen-progestin `add-
back' therapy for endometriosis-related pelvic pain.'' Fertility and 
Sterility 30:236-41, 1993.), in Obstetrics and Gynecology (Friedman, 
A.J. and Thomas P.P. ``Does low-dose combination oral contraceptive use 
affect uterine size or menstrual flow in premenopausal women with 
leiomyomas?'' Obstetrics and Gynecology, pp. 631-635, 1995.), and in an 
unpublished manuscript.
    Dr. Friedman has entered into a Voluntary Exclusion Agreement with 
ORI 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 C.F.R. Part 76 and 48 C.F.R. Subparts 9.4 and 309.4 (Debarment 
Regulations) for a period of three (3) years beginning April 19, 1996;
    (2) That for a period of two (2) years immediately following the 
three (3) year voluntary exclusion above, any institution that submits 
an application for PHS support for a research project on which Dr. 
Friedman's participation is proposed or that uses him in any capacity 
on PHS supported research must concurrently submit a plan for 
supervision of his duties; the supervisory plan must be designed to 
ensure the scientific integrity of Dr. Friedman's research 
contribution, and the institution must submit a copy of the plan to 
ORI; and
    (3) 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 for 
a period of three (3) years beginning April 19, 1996.
    The voluntary exclusion in (1) above shall not apply to Dr. 
Friedman's future training or practice of clinical medicine whether as 
a medical student, resident, fellow, or licensed practitioner, as the

[[Page 19296]]

case may be, unless that practice involves research or research 
training.
    A statement retracting the article entitled ``Gonadotrophin-
releasing hormone agonist plus estrogen-progestin `add-back' therapy 
for endometriosis-related pelvic pain.'' (Fertility and Sterility 
30:236-41, 1993) has been published in Fertility and Sterility 
(65(1):211, January 1996), and a statement retracting the article 
entitled ``Does low-dose combination oral contraceptive use affect 
uterine size or menstrual flow in premenopausal women with 
leiomyomas?'' (Obstetrics and Gynecology, pp. 631-635, 1995) has been 
published in Obstetrics and Gynecology (85(5):728, November 1995).

FOR FURTHER INFORMATION CONTACT: Director, Division of Research 
Investigations, Office of Research Integrity, 5515 Security Lane, Suite 
700, Rockville, MD 20852.
Chris B. Pascal,
Acting Director, Office of Research Integrity.
[FR Doc. 96-10731 Filed 4-30-96; 8:45 am]
BILLING CODE 4160-17-P