On the FDA’s “Pathetic Inability to Demonstrate Even C-Grade Regulatory Science”
Posted Aug 07 2009 11:59am
While the mainstream media and skeptic blogs continue to trumpet the “Amalgam Fillings Are Safe Because the FDA Says So” line in the wake of the FDA’s recent reclassification of the material, others continue to question the decision-making process. How is it possible to conclude that a material made of more than 50% mercury – a known neurotoxin and potent environmental toxin – can be safely implanted in people’s teeth, mere inches from their brains?
One analysis we’ve read is particularly eye-opening: that of Jim Dickinson, editor of the watchdog publication FDA Webview. “Rulemaking,” he writes, “is supposed to be an objective process, and all the more so when it is scientific rulemaking. Egregiously, this one was not.”
Reading Dickinson’s analysis, which we received a copy of courtesy of the IAOMT, one is struck by the bad science and shoddy reasoning exhibited by the FDA in its ruling. For instance, we see the “If Mercury Fillings Aren’t Available, People Will Go Without Dental Care” canard that we addressed last month, before the ruling came down. Dickinson writes:
Buried in the depth of the preamble to the rule, on Page 86 of its typescript, under the heading, “Risk,” the intent and the bias of its principal author – thought to be dentist Susan Runner, acting director of CDRH’s Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices – can be discerned: to promote public health through more, not less use of mercury amalgams.
“[A]ny change away from use of dental amalgam,” the preamble baldly says, “is likely to result in negative public health outcomes (delayed dental treatments or increased costs of treatment); while there would be a decrease in mercury exposure, there is no evidence that there would be any reduction in adverse affects associated with mercury. Conversely, any change toward use of dental amalgam is likely to result in positive public health outcomes (fewer delayed dental treatments or decreased costs of treatment).”
This statement is repeated word-for-word on Page 96, under the heading “Potential Public Health Effects of the Final Rule.”
In a particularly obtuse and speculative section, “Alternatives to the Final Rule,” FDA presents no factual reference whatever, but projects an unsubstantiated theoretical cost to the country of $63.9 million in delayed treatments and higher costs if dental amalgam is no longer available and dentists are forced to use more expensive and less durable alternative materials.
More troubling is the appearance of cherry-picking evidence and whitewashing any study limitations acknowledged in the scientific literature they did cite.
The preamble appends 88 references reflecting biased selections of literature that almost invariably reference studies vaguely exonerating dental mercury from human harms, even while repeatedly acknowledging “gaps” in human data and falling back on animal studies and epidemiologic meta-analyses instead. FDA Webview could find no anti-amalgam study conclusions in the one-sided literature that FDA referenced.
However, in a 15-minute Google search, FDA Webview found four such studies that were not included in FDA’s bibliography (but doubtless Runner could find them not in compliance with the regulatory definition of “valid scientific evidence” notwithstanding that many of her own 88 references in the preamble also appear to have that deficiency, including a discredited 2006 FDA White Paper declaring dental amalgams safe and a controversial mercury-exonerating study done for FDA by the Beltway consulting firm LSRO cited favorably in the preamble):
A high proportion (mean 77% SD 17%) of inorganic mercury was found. It is concluded that the cause of the association between amalgam load and accumulation of mercury in tissues is the release of mercury vapor from amalgam fillings. Nylander, M. et al, Swedish Dental Journal (1987)
The results showed that examined subjects with dental amalgams had higher pre-chewing mercury levels in their expired air than those without amalgams. After chewing, these levels were increased an average of 15.6-fold in the former and remained unchanged in the latter group. It was concluded that in situ dental amalgams can increase the level of mercury in expired air. Svare, et al, Journal of Dental Research (1981)
Blood mercury concentrations were positively correlated with the number and surface area of amalgam restorations and were significantly lower in the group without dental amalgams Abraham et al, Journal of Dental Research (1984)
The report points out, supported again by a multitude of studies, that amalgam contributes more mercury to the human organism than all other sources from the environment (food, water, air) combined. Kieler Amalgam Gutachen (2002 German Govt. study)
Among the preamble’s 88 references, however, were two ambiguously described votes from a 2006 joint meeting of FDA’s Dental Products Panel and Peripheral and Central Nervous Drugs Advisory Committee on amalgam. As reported at the time, but not in FDA’s final rule preamble, these declared by 13-7 majorities that FDA’s White Paper did not objectively and clearly present the current state of knowledge about them, and that the White Paper’s conclusions about safety were not reasonable.
In July, before it announced the final rule, which is to publish in the 8/4 Federal Register, FDA updated the White Paper in response to those criticisms, but its updates were largely technical, not substantive. Simultaneously, it updated CDRH’s amalgams Web page to remove advisory language saying: “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.” FDA is about to be sued in federal court over this, according to Consumers for Dental Choice national counsel Charles G. Brown.
Moreover, writes Dickinson, bias can also be seen in the FDA’s response to the approximately 3000 public comments submitted on the issue before the ruling. One point particularly jumped out at us, as it touched upon the crucial issue of informed consent:
FDA also showed its bias in a response to two comments requesting disclosure of mercury in amalgam labeling “citing to a recent poll showing that 76% of Americans do not know that the primary component of amalgam fillings is mercury,” and disclosure of the amount of mercury vapor released. Clearly, the implication of these comments was that patients should be told. Yet in its response, FDA said it agreed that “dental professionals” should be alerted in the device labeling, but said nothing about also alerting patients.
Directly addressing other comments asking for patient informed consent before mercury amalgams are inserted, the preamble said that because dental decision-making is a “complex matter” when selecting restorative materials to use for fillings, “FDA has concluded that it is not necessary to require that dentists provide this information to patients in order to provide reasonable assurance of the safety and effectiveness of the device.” Patient involvement in such decision-making was not addressed here.
What the FDA appears to be saying, then, is that even though most Americans remain unaware that amalgam fillings are made mostly of mercury, they don’t really have a need to know. Just trust the dentist’s judgment. Yet if a dentist has been taught the ADA party line that mercury is safe, how could he or she make any kind of judgment at all, unless care and curiosity compelled him or her to look deeper? In such a case, the dentist’s opinion is just as uninformed as that of his or her patients, and the blind go on leading the blind.
As one apparently knowledgeable FDA employee commented to our report on the rule’s announcement: “Why continue to use and recommend mercury amalgam when there is safer composite alternative? No dentist in our area will use mercury because it is considered a hazardous waste and expensive to deal with. Composite is the only option, but insurance will only cover them for the same amount as mercury, with the patient responsible for the difference. I really question FDA’s motivation here. It seems to be more responsive to industry than human health.”