ANALYSIS OF THE CCEHRP (USPHS 1993) REPORT
"SEE-SURP" REPORT CONFLICT! by: Michael F. Ziff D.D.S. and Sam Ziff
from BIOPROBE Volume 9 Issue 2 March 1993
At what point does factual misrepresentation influence the public health to a degree that demands corrective action?
The misinterpretation of conclusions from the January 1993 CCEHRP ("See-Surp") report is so blatant that nothing less than formal investigation by the United States Congress is warranted!
The closing paragraph of the Preface to the Final Report sums up the veracity of the entire effort: "This report is not intended to serve as the authoritative source on dental amalgam safety, but rather as a planning tool to assist policy-makers in deciding on appropriate risk management actions."
THE CCEHRP DOCUMENT
The Final Report is entitled:
"DENTAL AMALGAM: A SCIENTIFIC REVIEW AND RECOMMENDED PUBLIC HEALTH SERVICE STRATEGY FOR RESEARCH EDUCATION AND REGULATION."
The study represents 25 months of effort by subcommittees from eight Public Health Service (PHS) agencies, including; the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDCP), the Food and Drug Administration (FDA), the Health Resources and Services Administration, and the Indian Health Service. The Environmental Protection Agency (EPA) and non-government "peer reviewers" also participated.
The conclusion on the safety of dental amalgam, stated on page 3 of the document under the section entitled "Amalgam Risks," is:
"In the absence of adequate human studies, the Subcommittee on Risk Assessment could not conclude with certainty whether or not the mercury in amalgam might pose a public health risk."
The conclusions of the Subcommittee on Risk Assessment, stated on page 29 of Appendix III, are:
"Available data are not sufficient to indicate that health hazards can be identified in non-occupationally exposed persons. Health hazards, however, cannot be dismissed."
"Because there are no scientifically acceptable studies with sensitive standardised measurements for physiological and behavioural changes in non-occupationally exposed populations, we cannot, at present, determine whether such changes observed in persons with low-level occupational exposure to mercury also occur as a result of exposure to mercury from dental amalgams."
"The margin of safety may, however. be lower because body burdens of mercury are already high as a result of exposure to other sources; some persons may perhaps respond adversely to the incremental exposure to mercury derived from dental amalgams."
"At the mercury doses produced by amalgam fillings the evidence is not persuasive that the wide variety of non-specific symptoms attributed to fillings and "improvement" after their removal are attributable to mercury derived from the fillings. Conversely, the evidence is not persuasive that the potential for toxicity at the levels attributable to dental amalgams should be totally disregarded."
"The potential for effects at levels of exposure produced by dental amalgam restorations has not been adequately studied."
Further information is derived from the conclusions of the Research Work Group (RWG) Report, found on page 8 of Appendix IV:
"The available research evidence is not specific enough or strong enough to make sound pronouncements about human health risks from dental amalgam."
"Given the potential that end effects from low level mercury exposure may well be subtle and non-specific and that the relative importance of various forms and sources of mercury are not clearly established, much work remains." "Based on comprehensive scientific reviews of the risks and benefits of dental amalgam, the RWG has identified an extensive list of research opportunities and needs relative to the safety and utility of dental amalgam and alternative dental restorative materials." Finally, even Assistant Secretary for Health and head of the Public Health Service Dr. James O. Mason stated in his introductory letter, dated 15 January 1993: "Because the possibility of adverse health effects resulting from the use of dental amalgam cannot be fully discounted based on available scientific evidence, I am requesting the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration to undertake an expanded and targeted program of research, professional and consumer education and product regulation."
From the above statements, the following facts are clear and obvious:
- Humans with amalgam dental fillings are chronically exposed to mercury from the fillings.
- There is insufficient documented human evidence to clearly determine whether or not this chronic exposure to mercury causes specific adverse health effects.
- The potential for adverse health effects to mercury exposure from amalgam dental fillings is a definite possibility, as well as a cause for concern and a definitive re- search need.
- Public announcements that the CCEHRP Committee concluded that mercury exposure from amalgam dental fillings has no adverse health effect in humans or that mercury/silver amalgam dental fillings are "safe" or "harmless" are clearly contradictory to the Committee findings, are misrepresentative, and are potentially harmful to the public health.
THE PRESS RELEASE, AND BEYOND
None of the above statements are contrived; they are all direct quotes from the CCEHRP document itself. However, the press release issued by the Public Health Service on 21 January 1993 is certainly puzzling, if not downright misrepresentative. (HHS NEWS. U.S. Department of Health and Human Services. Public Health Service. Bill Grigg. (202) 690-6867.)
The release stated: "The U.S. Public Health Service today released an evaluation of mercury-containing dental amalgam - silver fillings - that says that amalgam has continuing value in maintaining oral health. According to the report:
- There is no solid evidence of any harm for millions of Americans who have these fillings, and
- No persuasive reason to believe that avoiding amalgams or having them removed will have a beneficial effect on health."
The release further stated:
"James Mason, M.D., who ordered the study as HHS assistant secretary for health and head of the Public Health Service, said, "This report makes clear that, except for a very few people who may be allergic to substances in the amalgam, there is no scientific justification for refusing to have amalgam fillings or for having them removed."
These statements clearly do not portray the content of the CCEHRP document or the conclusions of the Committee. In point of fact, they convey to the United States public a message contradictory to the findings and conclusions of the Committee and its Document, thereby encouraging the public to accept chronic exposure to mercury from amalgam dental fillings without concern.
Indeed, media articles and reports, as well as an extensive presentation in the ADA News by the American Dental Association closely followed the PHS press release. They all proclaimed that the CCEHRP Committee had determined that amalgam dental fillings are "safe" and "harmless" to humans.
WHY THE CONFLICTING VIEWS? The direct quotes from the CCEHRP document vividly demonstrate a contradiction with the portrayal of dental amalgam in the PHS press release and subsequent media and ADA presentations. There is an obvious difference of opinion between the CCEHRP scientists and those individuals responsible for the public information. There are even conflicting statements issued by Dr. James O. Mason; his quoted statement in the PHS press release being notably divergent from his statement in the introductory letter in the CCEHRP document.
The extreme disparity of the positions, along with the potential for their effect on the public health, raise profound questions of motivation.
Is it POLITICAL? If so, to who's benefit? The conclusions of the CCEHRP scientists, shown above, clearly demonstrate that public announcements that mercury exposure from amalgam dental fillings is harmless to patients are not to the benefit of the public health!
Is it ECONOMIC? If so, to who's benefit? The study by the Insurance Bureau of the government of Sweden demonstrating a 30% reduction in health care costs two years after removal of amalgam fillings (BPNL July 1992) clearly demonstrates that public announcements that mercury exposure from amalgam dental fillings has no adverse health effect is not an economic benefit to patients, or to the United States taxpayer.
The answer to these questions may well be found in the CCEHRP document itself.
EDUCATION WORK GROUP REPORT
The following revealing statements are found in Appendix V. page 4:
"The public's concern over the risk of dental amalgams was heightened following the "60 Minutes" television broadcast on December 16, 1990. The report, based on anecdotal information and victim-oriented stories heightened the perception of risk in many viewers."
"Consumer anxiety and concern were further demonstrated in a 1991 survey of 1,083 adults (543 men, 540 women) sponsored by the American Dental Association. Forty-eight percent of those surveyed responded that they had heard about people possibly developing problems caused by amalgam restorations. Forty-eight percent also believed that people should have concerns about health problems that might develop from amalgam restorations."
"Finally, 16 percent had considered having their restorations removed while four percent reported having their restorations removed." Further, on page V-6;
"Public education could lead to increased demands on the dentist by the patient. In the litigious nature of our society, these demands may generate increased concerns over liability for existing amalgam restorations and lead to unnecessary removals." Finally, on page V-7:
"In addition, given the number of intergovernmental groups that have been evaluating dental amalgam restoration materials, many groups (consumer and professional) are expecting action on this issue. Credibility will be enhanced by a proactive program, but diminished over the long-term by a failure to respond now."
It would appear that "credibility" may be the key word. In the face of ever increasing scientific and clinical evidence that dental amalgam is not harmless to patients, the only remaining weapon for the defense of dental amalgam is utilization of governmental "opinion" committees, at taxpayer expense!
REGULATORY WORK GROUP REPORT
Perhaps the most damning section of the CCEHRP document is this report by the Regulatory Work Group, consisting of five employees of the Food and Drug Administration (FDA). The wide perception of the dental community has been that the use of dental amalgam carries with it the full backing and authority of the FDA. Indeed, health-conscious dentists have been punished, some severely, for removal of dental amalgam fillings - a dental device that HAS NOT been evaluated and approved by the FDA.
The report of the FDA Regulatory Work Group verifies that dental amalgam has never been approved and classified. It states, on page VI- 1, that dental mercury has been accepted as a safe and effective Class I dental device and amalgam alloy as a safe and effective Class II dental device. [This is also stated on page 19 of the CCEHRP summary.]
Further, the following statements are taken directly from page 2, Appendix VI:
"A Class III device is one for which insufficient information exists to assure that general and special controls provide reasonable assurance of safety and effectiveness."
"While it is clear that mercury vapor is continually released from dental amalgam, it is not clear that this exposure leads to toxicity. However, the potential for toxic effects due to low levels of exposure to mercury vapor from dental amalgam restorations must not be disregarded." [ED Note: Thereby determining, by FDA Rule, that Dental Amalgam must be considered a Class III device!]
"The Regulatory Work Group recommends that the Food and Drug Administration view dental amalgam as a kit, in that both mercury and alloy must be used together to create dental amalgam restorative material. FDA considers the class of the kit to be that of the component of the kit assigned the highest classification. In this case the kit would be viewed as a Class II device because that is the classification of amalgam alloy."
"The Regulatory Work Group feels that reclassification of dental amalgam to Class III should not be readdressed until a body of substantial scientific evidence establishes that dental amalgam restorations are a health hazard."
[ED Note: Contradicting the FDA Rule that devices of unknown risk must be placed in Class III.] Considering these admissions on pages VI-1 and VI-2, the following formally published statements by the FDA Regulatory Work Group on page VI-4 are both reprehensible and indefensible:
"Information dissemination on "mercury-free" dental practices, which advocate removal of dental amalgams and replacement with alternative restorative materials, may be through newsletters published by one of several anti-amalgam organizations, or by word-of-mouth "
"Advertising is considered to be labelling. "
[ED Note: Who made that determination? The FDA is clearly usurping, by self-proclaimed edict, the authority of the Federal Trade Commission!] If individual dentists were participating in false advertising such as claiming that dental amalgams are toxic to humans or causative agents for diseases, and if literature purporting these claims were on the premises of the dentist's office, FDA would have the authority to take legal action against that dentist. However, this situation is unusual in comparison to the more common case of illegal use of a device. In view of this, the Regulatory Work Group feels that it would be more appropriate for this issue to be handled by state licensing and regulating bodies, or by the state professional association, i.e., state dental association. [This is also stated on page 20 of the CCEHRP summary.] "ILLEGAL USE OF A DEVICE!" The FDA has admitted that it has never evaluated and classified dental amalgam! Therefore, by its own admission PLACEMENT of amalgam, not its REMOVAL is illegal! Furthermore, the FDA has now established, by formal published government document, that the previous punishments of dentists for the removal of dental amalgam fillings was done illegally!
In addition, the FIDA statements urging punishment for use of written materials or "word-of-mouth" communication raises serious questions of infringement of Constitutional Rights of Freedom of Speech!
Finally, if claims that dental amalgam mercury exposure presents a potential health risk to patients is a punishable offense (through the FDA, the state licensing boards, or the professional organisations) then, obviously, claims that the CCEHRP Committee determined that the mercury exposure is harmless to patients must be considered equally punishable offenses.
It is clear from the documented statements of the CCEHRP Committee, its Risk Assessment Subcommittee, its Research Work Group, its (FDA) Regulatory Work Group, and Dr. James 0. Mason, himself, that there is insufficient human evidence to publicly proclaim mercury exposure from dental amalgam fillings to be harmless. Public pronouncements, by government representatives or anyone else, that the CCEHRP Committee concluded that dental amalgam fillings are safe or harmless to humans constitute misrepresentation and could have a detrimental effect on the public health. It is now formally documented and established that dental amalgam has never been evaluated and classified as dental device, a clear dereliction of the mandate issued to the Food and Drug Administration by the President and Congress in 1976. The openly inflammatory and inciting statements formally published by the FDA Regulatory Work Group and the CCEHRP Committee might be flagrant violations of law, as well as the constitutional rights of citizens of the United States. The actions and statements of employees of the United States government involved in this issue clearly call for executive and/or congressional investigation.