Strong Showing for IAOMT at
FDA Advisory Panel Meeting...
Guest Article by
Steve Koral
DMD,
International Academy of Oral Medicine & Toxiclogy (IAOMT)
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.
Stephen M. Koral DMD
2006 Broadway
