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
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.”