Efter en historisk kupp, där FDA nu övertygats, att ompröva beslutet från 2009 "att bedöma amalgam som säkert", har ingivarna av överklagandet, ledda av en stark trupp från IAOMT, presenterat en expertpanel med omfattande vittnesmål om riskerna med kvicksilver och amalgam. Återigen och som vid FDA:s amalgammöte 2006, understöddes den vetenskapliga och kliniska presentationen av personliga och gripande historier om sjukdom och återhämtning från personer som sanerat bort amalgam fyllningar

Strong Showing for IAOMT at FDA Advisory Panel Meeting

Gaithersburg, MD, December 15, 2010 –

After having scored the historic coup of convincing the Food and Drug Administration to reconsider its 2009 rule that declared mercury amalgam safe, the petitioners, led by a strong contingent from IAOMT, presented an expert panel with extensive testimony about the hazards of dental mercury. As was the case at the 2006 meeting, the scientific and clinical presentations were supported by compelling personal stories of illness and recovery from victims of amalgam toxicity. Of course, there were several representatives of “organized” dentistry, who vigorously expressed confidence in the safety of amalgam, but they presented no new science.

The press coverage was unprecedented. Brian Williams and Katie Couric each broadcast two minute stories, with interviews of Freya Koss, Karen Palmer, and Dr. Mark Breiner. Many print and internet outlets picked it up too, including the New York Times, Wall Street Journal, LA Times, Washington Post, and CNN.com. IAOMT emerges from this meeting as a heavy-weight player in the process. The world is getting to know who we are.

The centerpiece of the discussion was the new two part risk assessment document, organized by IAOMT and written by G. Mark Richardson, et. al. It had a tremendous impact on the panelists and speakers, who spent much of their time grappling with the implication that, counting currently recognized exposure limits, as many as 67 million Americans are getting too much mercury from their amalgam fillings. If the reference dose is lowered, as Richardson recommends, the number of overexposed people could be as many as 122 million.

The panel was composed of dentists, medical doctors, toxicologists, a consumer and an industry representative, and six senior dental school professors, deans and former deans. There was no predetermined question for them to vote on, as there was in 2006. Rather, they were asked to advise the FDA staff present with consensus answers to several questions related to risk assessment – adequacy and relevance of exposure estimates, reference doses, effect levels, etc. The primary conclusion was that the information available from research is still not adequate to conclusively determine risk, and that a more extensive search of recent literature is needed. Apparently much more is known about lead and methyl mercury than elemental mercury exposure.

The dilemma of defining susceptible sub-populations took some debate. Consideration for children under six years old morphed into concern for the pre-pubertal age group. People with genetic predisposition to retention toxicity did not get the attention they deserve due to a lack of immediately relevant scientific literature.

The FDA staff is expected to take as much as six months to propose any changes to the rule. Several panelists suggested that they be more transparent about their deliberative process than last time. We’ll see.

Speaking for the petitioners at the meeting were attorney Jim Love, Drs. Mark Richardson, David Kennedy, Anne Summers, David and Mark Geier, and Boyd Haley. IAOMT members who attended and spoke for themselves were Jack Kall, Mike Jackson, Pentte Nuponnen, Janet Stopka, Michael Margolis, Louis Steinberg, John Rowe, Wayne King, Andrea Brockman, Steve Marcus, Bob Reeves, and Steve Koral. President Matt Young, who could not attend, sent a letter read to the panel by Jack Kall. Charlie Brown and Sylvia Dove spoke for Consumers for Dental Choice.

Impassioned testimony of personal history and outrage was given by Freya Koss, Marie Flowers, Carol Ward, Jessica Kerger, Karen Palmer, Dorice Madronero, Katina Minney, Robert Cartland, and several others. The late president of Consumers for Dental Choice, Sandy Duffy, was honored by her many friends at a memorial dinner.