More critical articles from FDA journalist Jim Dickinson, www.FDAweb.com:

FDA Classifies Dental Amalgam as Class 2, Suit Threatened
07/28/2009
 
Consumers for Dental Choice national counsel Charles Brown says that a 7/28 FDA decision to reclassify dental amalgam as Class 2 with special controls was a “disappointing move” that broke the agency’s contract and word given in a 2008 court settlement involving warnings that amalgam could hurt children and fetuses. “FDA broke its contract and broke its word that it would put warnings for children and unborn children for neurological damage,” Brown said. “Bowing to the dental products industry, FDA for the first time in history pulled a warning about neurological harm to children. This contemptuous attitude toward children and the unborn will not go unanswered. We will see FDA in court.”

FDA says it classified dental amalgam into Class 2 and issued special controls to provide reasonable assurance of the device’s safety and effectiveness. CDRH Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices acting director Susan Runner told a 7/28 media conference that the special controls cover performance testing, device composition, and labeling statements.

An FDA news release says that FDA is recommending that product labeling include (1) a warning against use of dental amalgam in patients with mercury allergy; (2) a warning that dental professionals use adequate ventilation when handling dental amalgam; and (3) a statement discussing the scientific evidence on the benefits and risks of dental amalgam, including the risks of inhaled mercury vapor, so that dentists and patients can make informed decisions about the use of dental amalgam.

As a “pre-amendment device,” dental amalgam was in use before 5/28/76 when FDA was given broad authority to regulate medical devices. FDA says that over the past six years it has taken several steps to assure that the classification of dental amalgam is supported by strong science. These included a 2002 proposed rule to classify dental amalgam and identify any special controls needed for safe and effective use, a 2006 advisory committee meeting, and a 2008 reopening of the comment period on the 2002 proposed classification to seek the latest information and comment.

Runner told the media briefing that the best available scientific evidence supports the conclusion that patients who receive dental amalgam fillings are not at risk for mercury-related adverse health effects. Asked by reporters why FDA was reclassifying the device if there was no risk, Runner said the agency is aware that the issue of dental amalgam risk has been controversial for many years and that the Class 2 classification allows the use of special controls.

Conspicuously absent from FDA’s presentation was any reference to the litigation brought by Moms Against Mercury and other groups, including Consumers for Dental Choice and the Mercury Policy Project (see earlier story). That suit was settled last year with FDA required to withdraw claims of amalgam safety from its Web site and reclassify it by 7/28.

“After 32 years of delays, FDA finally warned Americans about neurotoxic effects from amalgam to the nervous system of developing children and fetus,” Mercury Policy Project director Michael Bender¸ one of the lawsuit plaintiffs, said in a statement issued before the new rule was released by FDA. “This breakthrough corresponds to the one in 2004 when FDA first warned pregnant women and children to limit consumption of certain tuna.”

In a 5/08 court hearing, federal judge Ellen Huvelle, a 1999 Clinton appointee, said that the “probability of harm is enormous” and asked how FDA could “drag your feet for 32 years.” She said that FDA’s performance on this issue was “government at its worst.”

FDA Webview asked an FDA spokesperson to comment specifically on the 32-year delay cited by Bender and on Judge Huvelle’s characterization of the agency’s performance as “government at its worst.” The spokesperson did not respond specifically to either statement, but instead quoted from the news release passages indicating that FDA had taken time to ensure that it had the best scientific evidence available to use to support the rule.

FDA’s Web site on dental amalgam now contains this statement: “FDA has reviewed the best available scientific evidence to determine whether the low levels of mercury vapor associated with dental amalgam fillings are a cause for concern. Based on this evidence, FDA considers dental amalgam fillings safe for adults and children ages 6 and above. The amount of mercury measured in the bodies of people with dental amalgam fillings is well below levels associated with adverse health effects. Even in adults and children ages 6 and above who have fifteen or more amalgam surfaces, mercury exposure due to dental amalgam fillings has been found to be far below the lowest levels associated with harm. Clinical studies in adults and children ages 6 and above have also found no link between dental amalgam fillings and health problems.

“There is limited clinical information about the potential effects of dental amalgam fillings on pregnant women and their developing fetuses, and on children under the age of 6, including breastfed infants. However, the estimated amount of mercury in breast milk attributable to dental amalgam is low and falls well below general levels for oral intake that the Environmental Protection Agency (EPA) considers safe. FDA concludes that the existing data support a finding that infants are not at risk for adverse health effects from the breast milk of women exposed to mercury vapor from dental amalgam. The estimated daily dose of mercury vapor in children under age 6 with dental amalgams is also expected to be at or below levels that the EPA and the Centers for Disease Control and Prevention (CDC) consider safe. Pregnant or nursing mothers and parents with young children should talk with their dentists if they have concerns about dental amalgam.”

Bender’s statement says that manufacturers advise dentists against placing amalgam in pregnant women, nursing mothers, children under age six, and anyone with kidney disease. But, he says, most Americans are not aware of such warnings.

“FDA remains alone in the world in failing to protect children and pregnant women from mercury fillings,” Brown said. “Since 1996, Canadian dentists have been told not to put mercury amalgam in children or pregnant women. Since 1988, British dentists have been told the same for pregnant women. Norway and Sweden have banned amalgam altogether. Regrettably, this rule should have meant the end of two-tiered dentistry: mercury for the poor and choice for the rest. Instead, FDA has failed to carry out its mission of protecting the public health.”

Earlier this month, FDA commissioner Margaret Hamburg recused herself from the reclassification decision (see story). An official response to FDA Webview indicated that her action was based on the requirements of federal ethics laws and standards of ethical conduct. However, Brown said it could have been because Hamburg had been a board member at Henry Schein, the leading distributor of dental products including mercury amalgams, before coming to FDA.

Experts Fault FDA’s Dental Amalgam Rulemaking
08/03/2009
 
In separate statements to FDA Webview 8/3, two experts on mercury in dental amalgams criticized the literature-review and procedural bases of FDA’s final rule classifying these amalgams as Class II medical devices. The classification upholds prior controversial agency assertions over 32 years that continued use of mercury in amalgams is safe, except for allergic patients, despite a sustained retreat from them by dentists in favor of safer, less durable and more expensive alternatives.
 
International Academy of Oral Medicine and Toxicology past president David Kennedy, a San Diego-based preventive dentist and international lecturer on toxicology and restorative dentistry, told us he had read the complete document and had “found numerous errors in their assumptions.”
 
In particular, he said, the preamble to the rule minimized the impact of mercury amalgams on children between the ages of two years and seven years as measured clinically in urine. He said the preamble discounted the importance of clinical studies showing progressively less mercury leakage into the urine of children, particularly boys, year-to-year. “If less and less is leaking into urine, it’s obviously accumulating in the body,” Kennedy told us.
 
Kennedy also faulted FDA for adhering to what he called “the fundamental pillar of all this” — the agency’s 2006 White Paper declaring mercury amalgams safe — even after it was soundly rejected by a joint meeting of its Dental Products Panel and Central Nervous System Drugs Advisory Committee. The drugs committee was added, Kennedy said, because the dentists lacked toxicology expertise: “There isn’t a dental school in the country that has a toxicologist — that’s why dentistry and medicine went their separate way over 100 years ago.”
 
Asked to say whether the White Paper “objectively and clearly present[s] the current state of knowledge about the exposure and health effects related to [mercury from] dental amalgam,” the joint meeting voted 13-7 (9 out of 10 Neurology Drugs panelists) that it did not, with many members questioning the scope of the literature the White Paper had reviewed.
 
Also, asked whether, given the amount and quantity of the information available for the draft FDA White Paper, its conclusions were reasonable, the meeting again voted 13-7 that they were not.
 
Kennedy scorned FDA’s compilation of an “Addendum,” completed only last month, to resolve these negative votes. “You’d have to be embarrassed,” he told us, “if you didn’t go back to the panel with your addendum to see if it did, indeed, resolve their concerns. But some of the people who wrote the White Paper also wrote the rule. They didn’t go back.”
 
FDA’s preamble said the White Paper and its Addendum “considered” more than 200 scientific articles, including 33 case studies. “The conclusions of the Addendum,” it said, “generally confirmed the conclusions of the White Paper and previous assessments by other organizations and agencies regarding the potential health risks presented by the presence of mercury in dental amalgam. More specifically, the articles and case studies reviewed in the Addendum to the White Paper were consistent with the conclusion in earlier government safety assessments that exposures to mercury vapor from dental amalgam are not associated with adverse health effects in the population age six and older.”
 
That appears to concede possible adverse effects on those below age six, yet the agency lost no time in removing from its amalgams Web page advisory language that “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.”
 
The second expert criticism of FDA’s rule came from University of Washington Department of Environmental and Occupational Science research profession James S. Woods, who told us in an email response that the rule’s preamble had erroneously used three out of nine citations to his publications on the effects of mercury amalgams in humans.
 
“The descriptions of the findings in reference to citations #59 and 60,” Wood said, “ ignore (fail to mention) the very important central findings of these publications — that genetic polymorphisms of brain-derived neurotrophic factor (BDNF) and coproporphyrinogen oxidase (CPOX) lower the threshold for the neurotoxic effects of dental amalgam mercury in humans. Thus, persons carrying these polymorphisms may be adversely affected by exposure to mercury at concentrations which may not adversely affect persons without these genetic changes. These polymorphisms are prevalent from 2 to 30% of the population and so may be of substantial public health significance in terms of mercury toxicity.”
 
A third reference, #68, Woods said, “describes the genetic characteristics of the CPOX polymorphism and is misquoted (on page 48) in reference to clinical studies of dental amalgam in children.” Those clinical studies were attributed, along with six other citations in the preamble to findings of “no neurological deficits in children who first received dental amalgam restorations at ages six to ten and were followed for five or seven years.”

FDA Defends Dental Mercury Amalgam Rule
08/04/2009
 
“The FDA does not agree with the characterizations of its rulemaking,” said agency spokesperson Mary Long in a brief response 8/4 to FDA Webview requests for comment on criticisms of the final rule on classifying mercury dental amalgams in Class II (“moderate risk”). The rule and its preamble have been criticized for not being stronger, being biased in favor of mercury, selective in literature citations, procedurally flawed and disregarding or minimizing anti-mercury science.
 
“The agency’s findings and conclusions,” Long defended, “are based on an extensive review and analysis of the scientific data pertaining to potential adverse health effects from exposure to mercury vapor from dental amalgams in the general population and in sensitive subpopulations. The FDA believes its rulemaking is in compliance with the Administrative Procedures Act.”
 
Long indicated her statement may only be preliminary, as the agency continues to review the criticisms, which come primarily from experts associated with the International Academy of Oral and Medical Toxicology (IAOMT), who were joined 8/1 by the nine-member, Rome, Italy-based Association for Environmental and Chronic Toxic Injury (AMICA) with a three-page criticism.

FDA Blinks, Modifies Mercury Amalgam Web Site
08/11/2009
 
In its long stand-off with dental mercury amalgam activists, FDA blinked 8/11 and modified its Web site to accommodate one of their lesser concerns. In an email to Consumers for Dental Choice national counsel Charles G. Brown, the agency’s Office of Chief Counsel advised that “although we have declined to repost the old Web site as you requested, the agency has modified the language in the current website regarding the potential risks of dental amalgam.
 
“The first full paragraph under the heading ‘Potential Risks’ now states: ‘Dental amalgam contains elemental mercury. It releases low levels of mercury vapor that can be inhaled. High levels of mercury vapor exposure are associated with adverse effects in the brain and the kidneys.’”
 
Until it did this, FDA had repeatedly maintained that the risk to dental patients from these vapors is so minimal as to be almost irrelevant, except for persons who are “allergic” to mercury, and in its 8/4 final rule it still declines to require that patients be asked by dentists to give their informed consent prior to being implanted with mercury amalgam fillings.
 
Brown told us FDA’s Web site modification is, while a “small step,” a sign that the agency is listening to its critics. His organization’s legal review is continuing with a view to suing the agency for not requiring warnings about risks to young children and fetuses from the mercury in dental amalgams.
 
In an overnight email to his network, Brown wrote:
 
“FDA realizes that its Web site, like its rule, is a cover-up of the existence and risk of mercury, so its lawyers are trying to ease FDA into a more defensible position….
 
“But it is still ‘the Henry Schein Amalgam rule.’  It still allows the nation’s #1 distributor of mercury amalgam, Henry Schein Inc. untrammeled rights to market amalgam for everyone, even pregnant women, without even disclosing the mercury to patients. (As you will recall, Schein paid Margaret Hamburg about a million bucks to be its director during her revolving-door time outside of government.)
 
“The Web site still does not re-instate the language FDA agreed in writing in 2008 to maintain on its Web site: ‘Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.’ In particular the Web site still fails to inform consumers that young children and unborn children are especially susceptible to the effects of mercury. FDA does not want parents to know about this danger to children even though it admits that this information is true (buried deep in the labeling intended for dentists in the new rule’s special controls, the agency writes that ‘The developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor’).
 
“Now that you had an impact writing deputy commissioner Sharfstein, our next step will be to write your representative in Congress. My next e-mail will suggest talking points and the route to e-mail and to phone him or her.”
 
FDA is covering up the mercury risks, but doing so a little bit less than yesterday. We move forward; they retreat. In the words of our first naval hero John Paul Jones, “We have not yet begun to fight.”

Mercury Amalgam Protest Spreads to Congress
08/14/2009
 
Members of Congress may soon be hearing from constituents who are concerned about FDA’s decision on mercury amalgam dental restorations and the role that FDA commissioner Margaret Hamburg did or did not play in that decision. That’s because anti-amalgam lawyer Charles Brown, who is national counsel for the Consumers for Dental Choice advocacy group, has called on his group’s members to contact representatives and senators to request that they obtain answers from Hamburg on her “stock deal with amalgam distributor Henry Schein, Inc.” Brown says that what he considers Hamburg’s conflict of interest and participation in the mercury amalgam rule means that she is continuing a “culture of corruption at FDA.”

In e-mailed talking points to his constituency, Brown suggested that one or more of these points be made to members of Congress:
1.  Hamburg served on the Schein board of directors between 2003 and 2009 and owned $250,000 to $500,000 of company stock at the time she became commissioner, according to media accounts.
2.  FDA’s new rule does not contain contraindications for children and pregnant women and not even a warning for those populations. “This is in spite of the fact that children and the unborn are more susceptible to mercury’s neurotoxic effects and that no study indicates that mercury amalgam does not pose these known neurological risks to this subpopulation,” Brown writes.
3.  Most consumers and parents don’t realize that amalgam is mainly mercury, due to the fact that it is marketed as “silver fillings.” Brown says that FDA wants to keep the mercury unknown and has justified marketing amalgam as silver fillings due to its color. FDA under Hamburg removed from its Web site a warning that had been posted by former commissioner Andrew von Eschenbach that “dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.”
4.  Brown asserts that agency secrecy benefits the amalgam industry and that Hamburg’s ownership of Schein stock created a conflict of interest. She was given 90 days to dispose of the stock but the amalgam rule had to be completed within 75 days. Instead of recusing herself due to the conflict of interest, Brown says, “she indicated her intention to work with staff on the rule in response to Sen. Enzi’s question about amalgam during the confirmation process.”
5.  Consumers for Dental Choice contacted Hamburg asking that she recuse herself from the dental amalgam decision. Brown says that their first letter was ignored and that eventually they heard from the FDA chief counsel that Hamburg’s participation was not personal and substantial. “FDA’s culture of corruption is maintained by such loopholes — participating in rule-making to protect your stock value is OK if you participate just a little,” Brown says.
6.  Brown says that Hamburg’s failure to remove herself from the start is particularly reprehensible in light of what he terms the “well-publicized corruption at the Center for Devices and Radiological Health,” which had responsibility for the amalgam rulemaking. [Editor's note: FDA says Hamburg never worked on the rule.]
7.  Hamburg’s defense that she “took no action” while overseeing the rule is meaningless, Brown says, claiming that she waited until CDRH director Daniel Schultz “had prepared the pro-industry, anti-disclosure amalgam rule before moving Schultz out. So when Hamburg says she took ‘no action,’ she had arranged the cards in the deck so she did not need to.”
8.  “This rule is so pro-Henry Schein and anti-patient that in the fine print it even expresses FDA’s concern about a possible decline in mercury exposure if it did not act to protect amalgam,” the e-mail says. It quotes FDA that “the daily potential exposure to mercury vapor originating from dental amalgam is expected to decrease gradually in the absence of the final rule,” and says that projection may come as a surprise to President Obama, who wrote the law banning mercury exports and is negotiating a treaty to ban all anthropogenic mercury.
9.  The Schein company’s stock rose after the amalgam rule was announced and the company thanked Hamburg at a meeting pitching its stock the morning after the rule was published.

Brown’s e-mail also contains questions to be asked of members of Congress, including the date on which Hamburg recused herself, the date on which Hamburg sold her Schein stock, and the reasons why FDA believes that patients need not be told of the mercury in amalgam.