[Federal Register Volume 65, Number 229 (Tuesday, November 28, 2000)]
[Notices]
[Pages 70915-70916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30236]


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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 Assistant Secretary for Health have taken final action in 
the following case:
    Evan B. Dreyer, M.D., Ph.D., Massachusetts Eye and Ear Infirmary 
(MEEI) and Harvard Medical School (HMS): Based on the findings and 
evidence documented in a report by a joint inquiry panel, dated 
November 17, 1997, and additional information obtained by the Office of 
Research Integrity (ORI) during its oversight review, on April 14, 
2000, PHS issued its findings that Dr. Dreyer, former HMS Associate 
Professor of Ophthalmology at MEEI, engaged in scientific misconduct by 
falsifying or fabricating experimental results. These results were 
included in National Institute on Deafness and Other Communication 
Disorders (NIDCD), National Institutes of Health (NIH), grant 
application K08 DC00131-01A1.
    Specifically, Dr. Dreyer falsified or fabricated experimental 
results to support the hypothesis that elevated levels of the amino 
acid glutamate play a role in Meniere's disease and reported these 
falsified or fabricated results in six documents:
    1. An NIH grant application, K08 DC0013 l-0lA1, ``Glutamate 
toxicity in endolymphatic hydrops,'' submitted to NIH for a Mentored 
Clinical Scientist Development Award in July 1996. PHS found that the 
experimental results for 19 amino acids reported in Table 2 and the 
text (pp. 58-59) were falsified or fabricated.
    2. An abstract, Cliff A. Megerian, M.D., Michael J. McKenna, M.D., 
Joseph B. Nadol, Jr., M.D., and Evan B. Dreyer, M.D., Ph.D. ``Elevated 
Perilymphatic Glutamate and Type-1 Spiral Ganglion Cell Loss in the 
Hydropic Ear,'' submitted on August 1, 1996, for the Triological 
Society Eastern Division Meeting scheduled for early February 1997. PHS 
found that the text reports the same falsified or fabricated 
experimental results for the amino acid glutamate that were reported in 
the K08 DC00131-OlA1 grant application to support the conclusion that 
elevated levels of glutamate may play a role in Meniere's disease.
    3. A manuscript, Cliff A. Megerian, M.D., Michael J. McKenna, M.D., 
Joseph B. Nadol, Jr., M.D., Barbara J. Burgess, B.A., David Zurakowski, 
Ph.D., and Evan B. Dreyer, M..D., Ph.D. ``Elevated Perilymphatic 
Glutamate and Type-1 Spiral Ganglion Cell Loss in the Hydropic Ear.'' 
PHS found that Table 1 and the text (pp. 2 and 8) contained the same 
falsified or fabricated experimental results that were reported in the 
K08 DC00131-OlA1 grant application.
    4. A draft NIH grant application, listing Dr. Dreyer as Principal 
Investigator, in which Table 2 and the text of the draft NIH grant 
application contained the same experimental results that the PHS found 
were falsified or fabricated in K08 DC00131-OlA1.
    5. Two computer spreadsheets, which contained the same results that 
the PHS found were falsified or fabricated in the K08 DC00131-OlA1.
    6. Magneto-optical computer disk, which contained files with 21 
fabricated chromatograms of amino acid elution patterns. On January 21, 
1997, Dr. Dreyer provided the computer disk to MEEI officials in 
response to requests for the primary data and laboratory notebooks 
supporting the amino acid results reported in the documents described 
above. On April 7 and May 21, 1997, Dr. Dreyer admitted that he 
fabricated each of the 21 chromatograms.
    On May 10, 2000, Dr. Dreyer appealed the proposed PHS findings and 
administrative actions to the HHS Departmental Appeals Board (``DAB''), 
DAB Docket No. A-2000-72. However, on November 13, 2000, Dr. Dreyer 
entered into a Voluntary Exclusion Agreement (Agreement) with PHS in 
which he agreed to withdraw his appeal of the PHS findings of 
scientific misconduct against him.
    Under the terms of the Agreement, with respect to the items in 
Paragraphs 1-5, Dr. Dreyer did not admit that he falsified or 
fabricated the results at issue, but he recognized that if the DAB case 
proceeded to conclusion, there was sufficient evidence upon which the 
DAB may make a finding of scientific

[[Page 70916]]

misconduct. With respect to the material identified in Paragraph 6, Dr. 
Dreyer admitted that he fabricated the 21 chromatograms contained in 
the magneto-optical computer disk that he provided to institutional 
officials after questions were raised about his research. Dr. Dreyer 
further admitted that the fabrication of the data on the disk amounts 
to scientific misconduct.
    Dr. Dreyer has voluntarily agreed for a period of ten (10) years, 
beginning on November 15, 2000, to exclude himself from:
    (1) Any contracting or subcontracting with any agency of the United 
States Government and from eligibility for, of involvement in, 
nonprocurement transactions (e.g., grants and cooperative agreements of 
the United States Government as defined in 45 CFR Part 76 (Debarment 
Regulations);
    (2) Serving as a mentor to any graduate student, fellow, or other 
individual who applies for or receives Federal funding; and
    (3) Serving in any capacity to PHS, including but not limited to 
service on any PHS advisory committee, board, and/or peer review 
committee, or as a consultant.
    The above voluntary exclusion, however, does not apply to Dr. 
Dreyer's practice of clinical medicine as a licensed practitioner or to 
Federal funds used for purposes of teaching or training medical 
students, residents, or fellows, in clinical medical matters.

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. 00-30236 Filed 11-27-00; 8:45 am]
BILLING CODE 4150-31-P