Petition for Medical and Dental Device Safety Urgent Reform (MEDDSURGE)

Please sign this Petition to Congress & Administration: Medical & Dental Device Safety Urgent Reform (MEDDSURGE)

Many friends have been harmed from FDA approved medical and dental devices. 
The regulations are nearly four decades out of date. Fix them now.

Fix FDA regulations for medical devices and dental materials! Unlike for prescription drugs, 

OTCs, personal care and food products, there is NO information required to go to the 
patient or parent about materials they contain. Patients can experience harm from devices 
ranging from dental amalgam fillings to Essure, Mesh, joints, implants, stents and more. 
Reactions vary based on gene types that impact how well we clear materials that are not 
natural to the human body. There is NO pretesting to determine if you will have a reaction in
advance as is recommended for hair color (although a one-time test is available). Peer 
reviewed research links autoimmune, neurological and other illnesses with devices.

For dental fillings, there is NO right of written informed consent. FDA warnings for dental
amalgam (called silver fillings, but 50% mercury) are required only from manufacturer to 
dentist, NOT to patients. There is a flawed MedWatch reporting system for dental device 
reactions, and dental information does not go into patients' Electronic Medical Records so 
it is hard for doctors to connect illnesses. Dental insurance does not cover the higher cost of
replacing amalgam fillings when medically indicated. Patients face high costs and lost income.

Enact Medical and Dental Device Safety Urgent Reform (MEDDSURGE)! 

Refocus CDC and National Institutes of Health (NIH) funding on Chronic Diseases. Provide 

treatment for patients with device illnesses. Ask Surgeon General to take emergency action. 

Put patient safety first.

SIGN THE MEDDSURGE PETITION HERE

Call for Surgeon General Report on Dental Amalgam and Mercury Health Risks - A Rachel Carson/Deborah Sampson/Norma Rockwell Moment

Deborah Sampson vs. Goliath: Will Sharon Make History as First Town to Call for Surgeon General Report on Mercury Health Risks?

Article 24 is expected to come up on the second night, Tuesday May 6th, at Town Meeting at the Sharon High School Auditorium. Non-residents must request permission in advance to attend Town Meeting.

Watch Russell's Presentation to Sharon Finance Committee on Article 24: Why We Need a Surgeon General Report  

Sharon resident Laura Henze Russell filed Article 24 to raise awareness, and begin to change official government policy on dental amalgam, which is still in unrestricted use in the United States. Four Scandinavian nations and Japan ban amalgam. Canada and much of Europe have warnings and consent.

Russell is acting in the spirit of Deborah Sampson, a patriot who fought against all odds for her beliefs and for the rights of others. She is acting in the tradition of promoting an environment free of toxins for health and wellness, and lessening the burden and impact of chronic diseases. She is acting as a witness to her personal experience of illness and recovery, that of others she has met with similar experiences, and her belief, faith and knowledge from two years of in-depth research.

Russell was an ocean lifeguard in her youth. In her late 30s Russell developed fibromyalgia that restricted her physical activities. In her 40s she was treated for breast cancer and developed osteopenia that contributed to fractures of her foot, wrist and elbow. In her late 50s she developed escalating problems that specialists at leading Boston hospitals were unable to diagnose, and had to stop working.

Finally diagnosed and treated for mercury toxicity, she learned she has some common genetic glitches that increase susceptibility to heavy metals and toxins, and impact immunity. Large amalgams were drilled out with only a dental dam (inadequate protect from inhaled vapor) after she stopped breastfeeding, right before she developed fibromyalgia. Russell has experienced a remarkable recovery, and resolved to help others avoid her fate.  

James S Woods et al have published three peer reviewed studies retracting their prior findings of amalgam safety in the Children’s Amalgam Trial, finding neurobehavioral deficits in boys with certain gene types. Many studies show associations between amalgam and chronic diseases. Three dental associations – International Academy of Oral Medicine and Toxicology, International Association of Biologic Dentistry and Medicine, and Holistic Dental - are opposed to its use as mercury vapor off-gasses with heath and abrasion, harming genetically susceptible patients, dentists and staff.  They provide training in safer removal.

The FDA has a logjam on amalgam. We do not get labels, we do not get information, we do not have the basic human and medical right of informed written consent for a medical device that has a potent neurotoxin. Unlike the AMA, the ADA is also a commercial and trade association, with 83 patents in the 38 years in which the US Patent Office has fully digitized records. The ADA’s last patents on dental amalgam were filed in the mid 1970s and expired in the mid 1990s. 

During the last 12 years, the only new patents granted on dental amalgam are to help mitigate its impacts on the environment, through better wastewater separators, and for encapsulation in corpses prior to cremation to minimize release of toxic mercury vapor from crematoria, which are exempt from strict pollution controls.

Russell has provided extensive information the Massachusetts Department of Public Health, Executive Office of Human Services, and the Division of Insurance which regulates dental insurance, but they can take no action as long as the FDA says it is safe. The IAOMT sued FDA March 5th for failing to respond to a petition to reconsider its Class II ruling with numerous errors in its risk assessment. States are permitted to require labels and give information for patients, as in CA, CT, ME and NH.

Rep. Kafka and Sen. Joyce filed bills on amalgam; they were sent to study. Russell shared extensive information with Rep. Kennedy, Sen. Warren and Sen. Markey. Rep. Kennedy and Sen. Markey are not on the right committees to lead. Sen. Warren's staff said they will need to see a large coalition before taking action. This is a step to raise awareness and help build momentum.

Russell founded Hidden River Health Challenge: A Social Innovation Enterprise, to help people learn about genes and toxins, and the importance of our own health information, share what we learn, and take action to help ourselves and others. Hidden River is forming a Coalition for Good Health, co-sponsored by the International Academy of Oral Medicine and Toxicology.  For information, contact Laura Henze Russell, laurarussell2@comcast.net.  

Filed by Laura Henze Russell, here is Article 24: "To see if the Town will request that the Sharon Board of Selectmen write to President Obama asking him to instruct the Surgeon General of the United States to prepare a report on Dental Amalgam and Health Risks; or take any other action relative thereto." 

The Board of Selectmen voted 2-0-0 against approval. THE FINANCE COMMITTEE VOTED 8-0-1 AGAINST APPROVAL."

Add More Protection to the Protect Bill! - March 12, 2014

My Comment on Venture Beat's blog, March 12, 2014: We Need to Return to Delivering Health Information, Anne Wojcicki

"The Protect Bill also needs... respect for biocompatibility and impact of toxins like mercury off-gassing from dental amalgam.  

Dental amalgam is scientifically and clinically proven to harm genetically susceptible children and adults who have gene types that do not clear mercury well. At least a half dozen gene glitches have been identified impair methylation (important to nerves) and detoxification (important to toxins) pathways. 

There are impacts for many of us as we age with these glitches, as our protective hormones and immune systems weaken.  The largest of these affects 20%+ of the population, 63M people.  In addition, 67M people have enough amalgams to exceed the FDA's "safe" reference dose, which doesn't take into account gene type. 

There are impacts for boys with CPOX4 from amalgam immediately - changes in kidney markers and neurobehavioral deficits.  James S. Woods, lead researcher of the initial CAT study of dental amalgam in children, retracted his findings of amalgam safety from the Children's Amalgam Trial in Portugal twice, in 2012 and 2013. Google to find the articles which the media ignored.

Animal studies show immediate distribution of mercury from installation of dental amalgam to the brains, kidneys and livers of sheep and monkeys.

The Net, Google, social media, courageous doctors, biologic dentists, scientists, Health IT, new tests, engaged people and parents and patients, and 23andMe helped save my health, my life, my family, my finances and my future after 20 years of chronic disease, and a year of serious, escalating health problems.

The FDA protects dated, dangerous products and industries over people and health. Protectionism is bad in the economy.  It is even worse in health, where the consequences are deadly, and incredibly costly to families, employers, health plans, and governments.   

The IAOMT sued the FDA March 5th for not responding to a petition for reconsideration of its flawed 2009 Class II ruling for amalgam after 54 months.  The Administration has not yet agreed to a request for a Surgeon General Report on Dental Amalgam and Mercury Health Risks.  Congress has not yet shown interest or leadership on this issue since its shining lights retired.

23andMe'ers, this is our time. Promote use and understanding of genetic information, and end genetic discrimination in medical and dental care.  Many of us require labels and protection from synergistic toxins like dental mercury which are ubiquitous and federally sanctioned, not labeled nor disclosed to us as patients or parents, and for which we do not get the basic human and medical right of written informed consent."

Sound an Alarm on Dental Amalgam: House Call for the Surgeon General

Sound an alarm on dental amalgam

2014 January 10

by Rick Holmes
A guest post from Laura Henze Russell:

Fifty years after the U.S. Surgeon General’s Report on Smoking, it is high time for President Obama to ask the U.S. Surgeon General to prepare a Report on Dental Amalgam.

The great United States of America, through the U.S. Food and Drug Administration, lags behind other advanced, emerging and developing nations in recognizing and protecting its citizens from dental amalgam’s scientifically proven health risks to genetically susceptible children and adults.

The FDA refuses to follow the recommendations of its own Scientific Advisory Panels on amalgam in 2006 and 2010 which called for clear health warnings, patient restrictions, and specific prior informed written consent before its use. Instead, the FDA requires clear health warnings and contraindications to be provided to dentists, but not patients.

Why? The American Dental Association and FDA fight tooth and nail to preserve its use as a “safe, effective restorative material.”  The ADA was founded as a pro-amalgam trade association, has filed patents on it.  Whistleblowers at the FDA went to Congress, but nothing happened.  There was a 36-year delay in classifying amalgam as a medical device, then in 2010 the FDA shocked everyone by only making it Class II, with special controls for dentists and none for patients, instead of Class III, which requires proof of safety. The International Academy of Oral Medicine & Toxicology (IAOMT) and injured patients petitioned for reconsideration, nothing happened.

They have not convinced the IAOMT, IABDM, Holistic Dental Association, or a growing number of doctors treating the growing number of patients recovering from the raft of chronic autoimmune, neurological and other diseases that plague us as we age.

They have not convinced the over 100,000 people who finally figured out why they were ill, and contacted the volunteer patient counseling, information and referral, and support group Dental Amalgam Mercury Solutions (DAMS), which is run by a volunteer executive director, board members, and volunteer coordinators in all 50 states, many of whom are on disability due to mercury poisoning from amalgam.

They have not convinced the American Public Health Association, a majority of whose members declined in 2013 to ratify a policy somewhat hastily pushed through by ADA allies in late 2012, so APHA no longer endorses dental amalgam as safe and effective for use.

The U.S. signed the Minamata Treaty in Japan this year to phase out use of mercury worldwide, in all products, to reduce the burden of this potent neurotoxin on human health.  But when it comes to dental amalgam mercury, the U.S. takes baby steps, backward steps, bumbling steps.

Industrial and medicinal mercury gave us Mad Hatter’s Disease, Pink’s Disease for toddlers and children, Minamata Disease in Japan, and took down a number of venerated nurses and healers, including Clara Barton and Florence Nightingale.

We need a house call, and a wake up call, from the Surgeon General. May he come soon to save us from ourselves and our dentists, so we can all get and stay healthier and make the need for health care fall for the first time in the U.S.

Laura Henze Russell is the Founder of Hidden River Health Challenge: A Social Innovation Enterprise Promoting Health.

Audio: Rob Moir's Environmental Dialogues with Laura Henze Russell

Audio: Moir's Environmental Dialogues

Listen to Dr. Rob Moir and Laura Henze Russell discuss mercury poisoning and safer alternatives in dentistry.

March 20,2014 Episode  - Dental Assistant Karen Palmer of Bethlehem, PA talks about her occupational mercury poisoning.

March 6, 2014 Episode - Laura Henze Russell talks about the Campaign for Good Health, Call for a Surgeon General's Report, and IAOMT Lawsuit Against the FDA and HHS.

November 29, 2012 Episode - Laura Henze Russell talks about the upcoming Sharon, MA Town Warrant Articles.

Hidden River Health Challenge on YouTube - Watch Us!

Hidden River Health Challenge on YouTube - Watch Us!

March 2014 Resolution for Surgeon General Report to Sharon Finance Committee for May Town Meeting, and IAOMT Lawsuit vs. FDA in a Nutshell (14 min)


December 2012 Articles at Sharon Town Meeting to Learn About, Share and Act on Health Risks of Mercury Dental Amalgam for Genetically Susceptible Children and Adults (14 min)

November 2012 Cable TV Show FYI with Colleen Tuck

October 2012 Presentation to Board of Selectmen on Articles for Town Meeting Dec 2012

Oct. 2012 Presentation to Sharon Finance Committee on Articles for Town Meeting Dec. 2012

July 2012 Presentation to Sharon Board of Health on Health Risks for Dental Mercury Amalgam for Genetically Susceptible Children and Adults

Resources for Patients and Policy Makers: Lawsuit v FDA, Call for Surgeon General Report, FDA Guidance Document, State Dental Code, IAOMT Questions for Dentist

Lawsuit Against FDA For Failure on Health Risks of Mercury Dental Amalgam

Good Health Coalition Calls for Surgeon General Report on Dental Mercury

20+ Questions on Amalgam: Did You Know?

Save Health Health Care Costs and Protect Our Health Across Generations

FDA Guidance Document on Amalgam and MA State Dental Code Flyer

IAOMT Questions for Your Dentist, and How to Find a Dentist

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