General Information

Project Description:
  The Life Sciences Research Office (LSRO) as a subcontractor to BETAH Associates, Inc. is conducting an independent, third party review of the peer-reviewed, scientific literature published since 1996 on potential adverse human health effects caused by dental amalgam. This review is being funded in whole or in part with Federal funds from the National Institutes of Dental and Craniofacial Research, National Institutes of Health and the Centers for Devices and Radiological Health, US Food and Drug Administration (Sponsors).

Project Goal:
  The principal goal of this review is to evaluate the potential adverse human health effects of dental amalgam. It will be based on scientific literature published since the Department of Health and Human Services review of this subject in 1997. All parties undertaking this study agree that it will be conducted openly, inclusively, independently, and objectively. In particular:
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    		• The review will be conducted so as to allow public comment and to provide public access to the final report.
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    		• The review will be structured as an independent, third party review. The LSRO will select the expert panel, perform the literature search, develop the review standards, criteria, and procedures, and conduct the review in a manner that is neither restricted nor influenced by the Sponsors.
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    		• The review will not make recommendations for action, assess government policy, or address the effects of any individual manufactured product.

    Study Design:
      The LSRO will identify and recruit an ad hoc Expert Panel of eight (8) or more members with expertise in such areas as toxicology, neurology, nephrology, pathology, allergy/immunology, pediatrics, psychology/psychiatry, developmental and/or reproductive toxicology, chemistry, materials science, occupational health, methodology and design, public health, and other necessary disciplines. The panel will be composed of experts internationally recognized for their scholarship, understanding of the subject matter, scientific acumen, and credibility. The Chair will be a leader in the field of toxicology and of such stature as the editor of a major toxicology journal, society past-president, department chair, etc. The LSRO will ensure that the panel is free from conflict of interest and will act to minimize bias. A prior public position on the toxicity of dental amalgam will be considered to indicate bias and result in the exclusion of a potential candidate from the Panel. We plan to complete the review in the early part of 2004.

    The Panel will meet on at least two occasions. The first meeting will be scheduled between September and November 2003. A second meeting is planned for early 2004. Although portions of the Expert Panel meetings are public, most deliberations are conducted privately. The first meeting may include presentations from the Sponsors to delineate their reasons for sponsoring the review, as well as to express their needs and requirements, and from interest groups desiring to present their point of view. At the conclusion of these presentations, the meeting will be closed to the public. The Panel will then deliberate about survey methodology, evaluation methodology, standards of evidence, and a general plan of action (i.e., whether additional members need to be included in the Panel, whether the volume of literature will require division of the Panel into subcommittees for evaluation, etc.). The minutes of this meeting and content of the public presentations will be published on the LSRO web site.

    Subsequent meeting(s) will review the literature and assign significance levels to each article. Depending on the volume of literature, these meeting(s) will be comprised of either the Expert Panel as a whole or of subcommittees. During the final meeting, the Expert Panel will deliberate the overall conclusions pertaining to human health effects and the details of the final report.


    The Relationship between LSRO, BETAH, and the Sponsors:
      The Sponsor, through its contract with BETAH Associates, Inc. is expected to provide funding, background information about previous reviews, a public request for information, the documents submitted as a result of that public request, and other resources as necessary to the successful conduct of the review. LSRO, as the organization conducting the review, is responsible for assembling the Expert Panel, supporting the Panel with staff and facilities, identifying the literature, conducting an independent review of the literature, and publishing the final report. BETAH will provide overall management of the project, conduct literature searches, compile, index and maintain literature files, create and maintain a database of the literature, provide graphic and publication support and provide logistical support for the Expert Panel.

    The Sponsors have no role in the design, conduct, deliberations, or conclusions of the panels. This is done to ensure third party independence of the review. The Sponsors retain fiduciary oversight; will supply information on request; and have the option to review the final reports for conformance to the contractual scope of work.