| Table of Contents - July/August 2003 | |||||||||||||||
| Past PFA President Martin Naimark | 2003 Calendar | ||||||||||||||
| Desk of the Executive Director | |||||||||||||||
| FDA Dental Amalgam Review | Foundation Section News | ||||||||||||||
| PFA Dental Museum |
Section News- International |
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| The Legacy Continues
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Section News- United States |
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| PFA Adds Another Book |
Beverage of Choice for Teens | ||||||||||||||
| Minority Dentists Honored |
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Dental World
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| July/August 2003 |
Page 3
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ADA Response to FDA Dental Amalgam Review |
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| In recent months, concern over the use of the traditional silver-mercury amalgam has been raised again by certain Congressmen in the United States interested in banning its use. On 9 May 2003, the U.S. Food and Drug Administration announced in the Federal Register that they will be establishing a panel to review the dental literature on the use of amalgam. The National Institute of Dental and Craniofacial Research, along with the Center for Disease Control and Prevention, will cosponsor the review. The stated purpose is to determine whether any published studies in peer-reviewed scientific literature provide any evidence related to the health effects in using dental amalgam in patients. The review will search literature from 1 January 1996 up to 1 June 2003. Comments have been made that the time frame is too confining and that significant studies may predate 1996 and should be considered as well. While the FDA has stated that an independent group will conduct the review, questions have come up about who will be doing the review, their qualifications, how they are selected, and the methodology that will be used. These questions have been asked in order that the scientific community may have an opportunity to comment. While selecting reviewers with no potential bias or conflict of interest is worthy, it also excludes knowledgeable individuals who have previously been involved in such studies and reports, thus denying the expertise the agency would need to make an accurate evaluation. ADA Executive Director James B. Bramson has announced that the ADA has issued comment that the Review Board should contain qualified dental experts that are familiar with the material and its clinical use. It is possible that anti-amalgam groups could use this opportunity to place inappropriate restrictions on the use of amalgam. |
n Dr. Bramsons reply to the FDA, the ADA has submitted a bibliography of peer-reviewed journal articles published from 1996 to mid 2003 concerning the effects of dental amalgam on humans. That data supplied was a cross search from the MEDLINE and the Toxnet databases. More than 400 articles were produced on the physical and biological properties of dental amalgam. But the ADA noted that prior studies to the 1996 date exist and have stood the test of time. These should be included as well. These articles were the subject of the prior 1993 federal agency reviews, and those in 1997. These were included in the 1994 Swedish review, the 1995 Canadian review, the 1996 World Health Organization review, and the combined 1997 Canadian and WHO review. Dr. Bramson noted that significant studies should not be excluded just because they fall before the 1996 time limit. The ADA supplied the bibliography but with the understanding that it did not endorse them. In fact, the ADA is on record as challenging a number of the studies on scientific grounds. But in the spirit of neutrality, the ADA supplied the entire list without screening out the ones they objected to. That is why the ADA questions the level of integrity of the planned FDA review to include appropriate screening criteria. The ADA requested the FDA to publish the scientific methodology or protocol, which the ADA would expect to include such factors as background, objectivity, inclusion criteria, search strategy, quality assessment criteria, data extraction, and analysis. Anyone wishing to provide comments to the FDA should send such to: Dockets Managements Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland, 20852 Or contact them at: http://www.FDA.gov/dockets/ecomments |
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| Table of Contents - July/August 2003 | |||||||||||||||
| Past PFA President Martin Naimark | 2003 Calendar | ||||||||||||||
| Desk of the Executive Director | |||||||||||||||
| FDA Dental Amalgam Review | Foundation Section News | ||||||||||||||
| PFA Dental Museum |
Section News- International |
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| The Legacy Continues
|
Section News- United States |
||||||||||||||
| PFA Adds Another Book |
Beverage of Choice for Teens | ||||||||||||||
| Minority Dentists Honored |
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Dental World
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