Monday, August 31, 2015

Got Health Problems from Mercury Fillings or Other Medical Devices? Report them on MedWatcher App

Got health problems from mercury fillings or other medical devices? Report them to FDA on MedWatcher website: www.medwatcher.org or app: www.medwatcher.org/mobileRegister, select medical device, select dental amalgam. It is quick and easy. Be counted!

Health Conditions Related to Mercury Toxicity

The International Academy of Oral Medicine and Toxicology (IAOMT)’s 2013 Position Statement, which includes references to extensive research from hundreds of studies and sources, states: “The mercury in dental mercury amalgam fillings can exacerbate and contribute to all of the conditions stated below, as well as a myriad of other health problems.

o Allergies
o Hearing loss
o Alzheimer’s disease
o Immunodeficiency
o Amyotrophic Lateral Sclerosis
o Kidney disease
o Antibiotic resistance
o Micromercurialism
o Autism Spectrum Disorders
o Multiple sclerosis
o Autoimmune disorders
o Oral lichen planus
o Cardiovascular problems
o Parkinson’s disease
o Chronic Fatigue Syndrome
o Periodontal disease
o Complaints of unclear causation
o Reproductive dysfunction
o Erethism (added by author)
o Chronic mercury poisoning
Source: International Academy of Oral Medicine and Toxicology (IAOMT,) Position Statement against Dental Mercury Amalgam Fillings for Medical and Dental Practitioners, Dental Students, and Patients.



Epidemico's Medwatcher app helps patients report harm from dental and medical devices. It is a tool for quick action. Here is a case study:


"Epidemico and representatives from a patient group, Essure Problems, co-authored a publication describing the use of Facebook outreach and the MedWatcher app to encourage adverse event reporting to the US FDA for Essure, a hysteroscopic sterilization device. Over 1,300 valid reports were received through the app over approximately 19 months... A report took on average 11 minutes to submit, compared to 40 minutes estimated for the traditional FDA MedWatch form."  
Source: Epidemico blog, "Increasing Patient Engagement in Pharmacovigilance," 8/11/15

Background: Before 1993, 900 reports of harm from dental amalgam were filed with FDA under the old DENS system. DENS was replaced with MedWatch in 1993, using Form 3500, a lengthy and cumbersome form that did not mention dental materials, and requested information not available such as model and serial number. Few took the time to report. We have filed a Freedom of Information Act request to get the count for 1993-2004. 

A shorter patient version was developed a few years ago, Form 3500B, but it still did not mention dental materials, and still asked for model and serial number. About 100 Medwatch forms were filed 2004-2015, which can be accessed through the FDA's online MAUDE system. Coding issues make it possible to locate only a dozen using dental amalgam as the product name. FDA staff did a search to locate about 100 total during the past ten years.


Epidemico developed the new MedWatcher portal and app that makes reporting adverse events much quicker and easier. Register online or via mobile, select the category of medical devices, and select the product of dental amalgam.  Fill out the screens that follow, they are simply worded.  If you are not sure, put N/A. Be succinct; give highlights. If you have any questions, email. Thank you!






Thursday, August 27, 2015

Regulatory Timeline for Dental Amalgam





2011-2015: Five Years of Denial and Delay

  • 2011-2014: James S. Woods et. al. publish four retractions of their findings of amalgam safety in children, finding neurobehavioral deficits in boys with four gene types.
  • 2011: At FDA regional public hearings around the country, many dental professionals and patients testified of harm and many diseases caused by mercury in dental amalgam. 
  • 2012: HHS quashed a planned FDA Safety Communication in an election year. The FDA called for reducing the use of amalgam, recognizing the risk of occupational exposure for dental personnel, and avoiding its use in susceptible sub-populations: Pregnant and nursing women; Parents and guardians of infants and children under age 6; People with mercury allergy or sensitivity; People with neurological disease; and People with kidney disease.[1] 
  • 2014: FDA and HHS were sued for failure to respond to multiple petitions for reconsideration.
  • 2015: FDA response to lawsuit is to take no action. McClatchy DC, Medscape and MD+DI Device Talk all report on HHS cover-up. FDA and HHS are sued for third time.

    2006-2010: Five Years of Wrong Action


    •       2006: FDA issued a White Paper concluding dental amalgam was safe. However, the FDA’s Dental Products Panel rejected the FDA’s position 13-7. The FDA did not act.
    •       2008: a number of organizations and plaintiffs sued the FDA for its failure to classify amalgam. The FDA settled the lawsuit, published a website warning, and agreed to issue a final rule within a year. FDA Commissioner Hamburg came in after a six year board seat on dental products distributor Henry Schein; the website warning was removed. 


    • 2009: FDA classified dental amalgam as Class II, with warning labels only to dentists.
    • 2010: After strong objections, FDA reconvened a Dental Products Panel. FDA did not take a vote. Dentists, patients and an expert risk assessment testified of risk and harm.

    1976-2005: Thirty Years of Inaction

    • 1976: Congress passed legislation to add medical, dental and radiological devices to the Food and Drug Administration (FDA).  Certain materials were ‘grandfathered’ as generally recognized as safe (GRAS) initially, including cigarettes, asbestos, and dental amalgam, but were to be reviewed and classified. The FDA declined to classify dental amalgam for decades. The FDA also declined to exempt it from classification.
    • 1987: FDA developed a new definition for the element mercury, “dental mercury.” The FDA ruled “dental mercury” to be Class I – generally recognized as safe.
    • 2002: FDA announced a proposal to reclassify dental amalgam as Class II with special controls related to dentists. Then it was put on the back burner again.


    Wednesday, August 26, 2015

    Lyme Disease Continues its Spread

    Lyme Disease Continues its Spread, MetroWest Daily News & Milford Daily News



    • By Laura Henze Russell/Guest Columnist
      Posted Aug. 24, 2015 at 1:39 PM 
      Wonder if there is a Lyme epidemic in Massachusetts? The MetroWest had some of the highest incidence rates in Massachusetts in 2013. Middlesex County had a 450 percent growth rate in reported Lyme cases from 1997-2001 to 2007-2011, and the largest number of cases of any county in the commonwealth.
      A CDC map shows Lyme marching on – along with nasty co-infections ticks carry – from its discovery in 1981 in Connecticut and Long Island, New York, throughout the Northeast and MidAtlantic to the Upper Midwest, with beachheads scattered in the Midwest, West and South. The first diagnosed cases came from the Lyme, Connecticut, area.
      Official cases reported to the Centers for Disease Control (CDC) have risen to 30,000. CDC officials say the real number is about 10 times more, 300,000, based on a survey of clinical testing labs (2008) and medical insurance claims (2005-2010). Observers say it is much higher now, as it seems almost every family has someone touched by Lyme – sometimes many times.
      Why is Lyme a big deal? Caught early, a short course of doxycycline is usually sufficient. Some doctors prefer doxycycline monohydrate capsules to the cheaper generic hyclate, and it has been reported to cause less nausea than that tablet form. When Lyme – transmitted by tick bites – is treated early, the parasite is killed before it can establish its reproductive life cycle in the body.
      When it is not caught early, there is potential for longer-term illness and complications as the reproductive cycle is established within the body. There is controversy over whether the parasite is still present, perhaps in cyst form, or hiding in biofilm, spinal fluid, or other hard-to-treat areas, waiting to emerge again, especially in those whose immune systems are now compromised. The CDC disagrees, and calls it "Post-treatment Lyme Disease Syndrome" (PTLDS) as a result of immune changes instead of ongoing infection.
      Some physicians with extensive experience treating Lyme patients, who belong to International Lyme and Associated Diseases Society (ILADS) and are called “Lyme literate” doctors, call it chronic Lyme or persistent Lyme. Lyme disease symptoms vary greatly among people, and also by staging of the disease. Seventy percent got the telltale rash which is not always present and fades with time, 30 percent arthritis, 9 percent facial paralysis (Bell’s palsy), and 6 percent nerve pain, brain swelling (encephalitis) or heart problems.
      According to specialists like Dr. Richard I. Horowitz, author of “Why Can't I Get Better?” Solving the Mystery of Lyme and Chronic Disease,” Lyme is a “great imitator” of many chronic diseases, including chronic fatigue syndrome, fibromyalgia, autoimmune conditions like M.S., psychiatric conditions like depression and anxiety, and it also causes significant memory and concentration problems, mimicking early dementia. He writes that co-infections are a significant and growing factor in tick-borne diseases. They require different tests and different treatments.
      Diagnosis, testing and treatment are all the subject of controversy, but there has been movement to recognize the validity of both ILADS and Infectious Diseases Society of America (IDSA) guidelines, to get insurance to cover more forms of treatment, and to stop disciplining doctors who use the ILADS guidelines. The Massachusetts legislature passed a law to that effect, and efforts are underway in Congress.
      What does all this mean for us?
      First, do your best to avoid ticks like the plague, spray your yard and clothes, wear tick protective clothing, and do thorough daily tick checks of children, pets and you. If you find one embedded, use special tweezers and techniques or have it removed or it may break off and flood you with a full exposure to Lyme immediately, as happened to me last year, so I caught it again.
      Second, if you see or suspect you have a tick bite, have a bull’s-eye rash or have fever, pain or Lyme-like symptoms, get to a doctor right away. Early antibiotic treatment now can forestall months, years or a lifetime of costly, debilitating, and harder to treat health problems.
      Third, if you are sick and tired with fibromyalgia, chronic fatigue syndrome, arthritis and other migrating pains, brain fog, memory loss, neurological or other mystery symptoms, don’t just chalk it up to aging. Even if you have been treated for Lyme disease in the past, it may not have been the right protocol to rid Lyme and co-infections from your system, or you may have been reinfected by another bite. Find an ILADS doctor and get another opinion.
      Fourth, it is time for broader action. Dr. Horowitz outlines a plan for Centers for Excellence in treating Lyme and Chronic Diseases. Congress is starting to pay attention. Massachusetts needs to do more. It is high time to march on Lyme.
      For diseases like HIV/AIDS, there are public education and screening programs, and aggressive coverage of lifetime therapies to forestall progression of disease. For diseases like malaria, there is prophylactic treatment routinely prescribed for the duration of travel and living in areas where it is endemic. Is such an approach needed for Lyme? Do we need prophylaxis in season? Do we need routine tests and screening? Can we develop safe and effective vaccines against “tick spit?”
      For Eastern equine encephalitis and West Nile, we have county mosquito control programs. It is harder for Lyme as tick habitat is everywhere, not just stagnant water. Would deer control help? Driving to Dr. Richard Horowitz’s excellent “Living Well with Lyme” weekend workshop at the Omega Institute in New York’s Hudson Valley, I nearly hit a deer as it sped across six lanes of the Mass Pike a few hundred yards ahead. Not long after, a dead deer lay on the median. Do we put up deer warning signs on the Pike like the Hudson Valley highways, and take steps to control the booming population?

      Hearing stories of misdiagnosis, pain and denial faced by many at the workshop, one got the sense that the U.S. has stronger laws to protect deer than patients with complex chronic diseases. Can we recognize Lyme strain variations when it comes to lab tests, where we are behind Europe which tests for three Lyme strains instead of one? Add tests for common co-infections? Have insurance companies cover expanded treatments when needed for health instead of deny them? It is important to treat Lyme and co-infections in their different lifecycle phases, to cover complementary and supportive therapies that boost the immune system, and to recognize that not all patients respond equally well to standard treatments once infections have been established.
      In addition to learning what it takes to heal ourselves and treat others as patients or physicians, we need to reboot health systems, agencies, insurers and providers to work for us - for our health, instead of against us, lagging far behind – especially on the hidden health challenges of our time.
      Laura Henze Russell is the principal of Precision Research and Communications, and Hidden River Health Challenge. Email her at laurarussell2@comcast.net. 

    Friday, August 14, 2015

    FDA Safety Communication: Reducing Exposure to Mercury Vapor Released From Dental Amalgam (Draft Jan 2012)


    FDA Amalgam Safety Proposal


    In January 2012, the FDA prepared a “Safety Communication” that recommended reducing the use of mercury amalgam in the general population, and avoiding it in susceptible subpopulations:
    • pregnant and nursing women
    • children under six years of age
    • people with allergy to mercury or other components
    • people with neurological disease
    • people with renal disease
    It also recognized the risk of occupational exposure for dental personnel.
    The recommendations were never made public, and in January 2015, the FDA issued another statement saying that amalgam was unequivocally safe for everyone. Somehow, somewhere in the reaches of government and the Health and Human Services Administration, this amendment to the FDA rule was killed.

    Here is the full text of the original, 2012 proposed rule:

    FDA Safety Communication: Reducing Exposure to Mercury Vapor Released From Dental Amalgam (“Silver Fillings”)

    HHS has not allowed FDA to release this safety warning. The most vulnerable continue to be harmed by a hidden river of mercury poisoning installed without our knowledge or consent.

    Please sign the Petition for Medical and Dental Device Safety Urgent Reform (MEDDSURGE).

    Thursday, August 6, 2015

    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

    Monday, August 3, 2015

    MD+DI DeviceTalk: Lawsuit Tells How Politics Trump FDA's 'Gold Standard' on Mercury Fillings


    FDA tarnishes its reputation as the regulatory "gold standard" with its stance on mercury-based dental amalgam.
    ..."Copiously documented with legal, regulatory, and scientific exhibits, the 28-page Washington complaint supplements a 16-month-old lawsuit that FDA has been trying to ignore from the International Academy of Oral and Medical Toxicology and other mercury-opposed plaintiffs who, on other fronts, are winning as the archaic amalgam market in U.S. dentistry dwindles in favor of non-mercury composite resin alternatives.
    The darkest tarnish on FDA’s illusory gold glitter could be the new complaint’s discovery that after the agency in 2012 dutifully sent to its political bosses at HHS a scientifically-based final decision restricting mercury amalgam’s use in dentistry, FDA mysteriously reversed course.
    That final decision remained a secret, internal document until by a process unexplained in the complaint, it came into the hands of the plaintiffs’ lawyers, enabling them to compare what FDA had decided to tell the world about amalgam and what it was diverted from above to say instead. It did this last January in deceptive responses to three petitions from plaintiffs for a ban on amalgam."...

    Sunday, August 2, 2015

    Storify: White House Champions of Change for Precision Medicine July 8, 2015

    Click here for highlights, comments, questions and tweets from White House Champions of Change for Precision Medicine July 8, 2015. Also attended Pre-Meeting on Regulations with FDA. 

    Key points: 
    Reboot FDA device regulations for patient safety 
    Recognize genetic variation in tolerance vs. toxicity
    Patient labels, Informed consent, Precision Devices 
    Pretest "right for you" before they are installed
    Include in medical (not just dental) record
    Add dental section to MedWatch Report Forms 
    Integrate dental into healthcare, insurance, records


    Embedded image permalink

    NIH Precision Medicine Patient Engagement & Health Equity Work Group, July 1-2, 2015



    Storify: NIH Precision Medicine Advisory Committee Work Group on Patient Engagement & Health Equity July 1-2, 2015

    Click here for highlights from the Meeting, comments, questions and tweets.




    View image on Twitter

    Excited to be at NHI Meeting on Participant Engagement and Health Equity and meet all working for health