00-30236. 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:

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 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, [phone].

Chris Pascal,

Director, Office of Research Integrity.