Shuren Takes No Definitive action at FDA Town Meeting on May 5, 2011
When FDA's Center for Devices showed up in Orlando for the public Town Hall Meeting on May 5th, an impressive group of professionals and consumers confronted Director, Dr. Jeffrey Shuren, the apologist for the abysmal Amalgam Rule. Floridians turned out en masse outraged over FDA's failure to protect even children from dental mercury. Sixteen of the twenty-four who spoke delivered indisputable testimony setting the stage for the end of amalgam. The event was not only front- page news in the Orlando Sentinel – it reached press outlets clear across the country including dental, legal, and investigative websites . Major newspapers, L.A. Times and Chicago Tribune headlines read: "Mercury in dental fillings comes under fire at FDA meeting in Orlando"!
Floridian witnesses included IAOMT members Dr. Jim Hardy, who's book Mercury Free has educated thousands, Doctors Claire Stagg and Kirk Youngman set the record straight from the dental prospective, and Carol Roberts, M.D. of Brandon, FL, an alternative practitioner spoke of the medical repercussions of mercury fillings. Dr. Stuart Scheckner delivered a heartfelt account of his occupational mercury exposure and the ensuing years of disability: "I'm living proof that mercury exposure from any source is a critical health hazard."
The venerable Sam Queen, long-time guiding hand of the mercury-free dentistry movement addressed health and environmental dangers of mercury, particularly for children: "The failure of the FDA to reclassify mercury as recommended by many authorities means that indigent children throughout America are having their health and learning further compromised."
Rounding out the convincing appeal to FDA for immediate policy change was Bernie Windham, president of Dental Amalgam Mercury Solutions (DAMS) who presented his prodigious research on amalgam, Dr. Hardy's dental hygienist, a nurse and injured consumers. A poignant saga was related by forty-one year old Michael Miller who faltered as he spoke of his years of schizophrenia, mental institutions and an incarceration due to having sixteen amalgam fillings placed during his teen years. He confined in me that telling his story in public was the hardest thing he had ever done in his life.
Kym Smith, IAOMT director relayed Darlene D'Angelo 's story of having developed 25 chronic symptoms days after having an old amalgam improperly drilled out. Maria Bolton, a Sierra club activist demanded in no uncertain terms that FDA apologize to the American public for lying to them. So convincing was the testimony , that various industry employees admitted that they knew nothing of the dental mercury issue, and asked for the names of dentists who don't use amalgam and remove the fillings safely.
Compelled to answer for FDA's inaction on amalgam – something FDA officials are able to duck when they sit behind their desks, Dr. Shuren told the Orlando Sentinel that "If I had my druthers, I would like to say something this year," noting that the agency would have to reconsider the scientific and legal issues surrounding the amalgam issue. Charlie Brown, Director of Consumers for Dental Choice, believes "It's hardly a timetable, but it's more than FDA has been willing to say in Washington. Despite the fact that Dr. Shuren offered what appeared to be sympathy for those injured, he said he empathized with all the people who have experienced medical problems irrespective of the cause: "We take it seriously, which is why we've reconvened our scientific advisory panel.". I believe we must continue to put pressure on FDA to ban amalgams for children and the unborn and to issues warnings for all.
Serving as organizer, liaison with FDA and press spokesperson I questioned Shuren about FDA's failed amalgam policy and the reasoning behind not classifying amalgam as Class III and questioned the outcome of the future ruling based on the fact that the Office for Management and Budget (OMB) has the leverage to change anything FDA decides. Shuren reaffirmed that FDA has no control over OMB. In response to my relentless questioning: Shuren amusingly responded: "Freya, I see you more than I see some members of my family."
Our message was carried throughout Florida on public radio stations. Reporter Euna Hee's program "FDA Weighs Safety of Mercury in Dental Fillings" was aired on public radio and can be read at: http://healthystate.org/archives/10442, which also contains a link to a spot interview with me.
The meeting was videotaped by producer Monica Esteban and Carolyn Nardiello, a freelance N.Y. film producer.
In closing I want to thank David Kennedy for his support and generosity in purchasing my ticket to fly to the meeting, and for hiring Monica to videotape the event. it was essential that I be on site considering the press coverage and organization of those who presented.
Should you have any questions please feel free to contact me.