Schwetz named acting director of OHRP
Bernard A. Schwetz, DVM, PhD, a longtime Food and Drug Administration (FDA) official with expertise in toxicological research, has been named acting director of the U.S. Department of Health and Human Services Office for Human Research Protections (OHRP).
Schwetz replaces Greg Koski, PhD, MD, who stepped down as OHRP’s first director in November. After two years at the helm of OHRP, Koski resigned to return to Harvard University.
As acting director, Schwetz will seek to "harmonize" the reporting of adverse events, focus on prevention in strengthening human protections, and improve communications with the research community and the public.
"Dr. Schwetz will be a strong voice to ensure human subject protections are always the top consideration in human research decisions," says Secretary of Health and Human Services Tommy G. Thompson. "His proven leadership and extensive experience will help us continue to advance science and medical research for the good of all Americans."
Schwetz has been with FDA since 1993, first as director of its National Center for Toxicological Research in Jefferson, AR. He has served since 1999 as the FDA’s senior advisor for science, and also has been acting deputy commissioner and acting principal commissioner of the department. Prior to his arrival at FDA, he was acting director of the Environmental Toxicology Program at the National Institutes of Health’s National Institute of Environmental Health Sciences. Schwetz also is a distinguished scientist in the College of Life Sciences at the University of Maryland in College Park.
A national search is under way to pick a permanent director for OHRP, says Patricia El-Hinnawy, OHRP public affairs specialist. A timetable for that decision is not available, but she says the process will closely resemble that used to choose Koski.
Books help prepare for FDA inspections
Institutions preparing for Food and Drug Administration (FDA) inspections of clinical trial practices can take advantage of educational materials offered by FDAnews, a company that provides information about FDA regulatory and legislative requirements.
The company’s Clinical Trials Set includes "Navigating Good Clinical Practices: FDA’s Guidelines for Clinical Trials" and "Deciphering Data Monitoring Committees: Guidance for Clinical Trial Sponsors."
"Navigating Good Clinical Practices" provides FDA guidances on issues including interaction with IRBs and data monitoring committees (DMC); treatment of gender, ethnic, and age data; and conflict of interest regulations.
"Deciphering Data Monitoring Committees" is aimed at helping create an effective DMC, including recruitment of members, working with statisticians and organization of data for DMC review. Included are sample meeting agendas, data reports, and other supplemental materials.
Cost of the set is $355, plus $16 shipping and handling. To order, call (888) 838-5578 or (703) 538-7600. The books also are available for purchase via the company’s web site, www.fdanews.com, or by mail at 300 N. Washington St., Suite 200, Falls Church, VA 22046-3431. To order by fax, send to (703) 538-7676.
NEJM retracts study after authors point to forgery
The New England Journal of Medicine announced Feb. 10 that it is issuing a retraction of a study published in its Oct. 24, 2002, issue.1
The decision to retract the study was made at the request of a number of the listed study authors who wrote the journal claiming their signatures had been falsified on documents submitting the article for publication and that they had not had the opportunity to review the original data nor seen any of the manuscripts.
In an editorial comment published on the publication’s web site and to be published in the March 6 print edition, editors Gregory D. Curfman, MD; Stephen Morissey, PhD; and Jeffrey M. Drazen, MD, wrote:
"Of the eight persons named as authors of the article, some claimed that they had never reviewed the original data, and most claimed they had not seen or approved either the original version or one or more of the three revised versions of the manuscript. One author claimed that he had seen neither the original data nor any version of the manuscript. Thus, there was an egregious disregard of the principles of authorship, as specified by the International Committee of Medical Journal Editors."
According to the editors, a co-author falsified signatures of several of the authors without their knowledge during the review process. Falsified signatures appeared on the letters of transmission accompanying the original and revised versions of the manuscript. The journal became aware of the falsifications only after the article was published and several listed co-authors wrote a letter asking that the study be retracted.2
To prevent such occurrences in the future, the journal plans to inform all authors of record via e-mail when a manuscript bearing their name is received.
References
1. Shamim W, Yousufuddin M, Wang D, et al. Nonsurgical reduction of the interventricular septum in patients with hypertrophic cardiomyopathy. N Engl J Med 2002; 347:1,326-1,333.
2. Coats AJS, Henein M, Flather M, et al. Retraction: Shamim et al. Nonsurgical reduction of the interventricular septum in patients with hypertrophic cardiomyopathy. N Engl J Med 2003; 348: in press.
Schwetz named acting director of OHRP; Books help prepare for FDA inspections; NEJM retracts study after authors point to forgery;
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