20 Hard Questions to FDA Science Forum on Storify

20 Hard Questions to FDA Science Forum 2015 (Click here) 

Will FDA throw medical device illness patients a lifesaver, or continue to see, hear and speak no evil of dental and medical devices that - due to genetic variability in methylation, immunity, and detoxification pathways - are not "Right for Us?" We need #RightToKnow and #WrittenInformedConsent for everything installed in our bodies. We need all installed device #UDIs in #EMRs - not just in dental records, not seen by our doctors or #BigData. 

It is time to recognize and respect #GeneticRights, and put patients' health first through #PrecisionDevices. We do not control our DNA, so we need strict controls and prior biocompatibility screening for all dental and medical device materials before they are installed. This is basic science and safety to protect children and adults as genetically unique snowflakes. 

Silent Spring 2015 - FDA: Lifesaver, or See/Hear/Speak No Evil. Q: Is Your Device "Right for You?"

Silent Spring 2015 - FDA Must Recognize Dental Amalgam Dangers
MetroWest Daily News 
By Laura Henze Russell, Guest Columnist Posted May. 28, 2015 at 8:39 PM 

• 
  
  

  Will FDA throw medical device illness patients a lifesaver, or continue to see, hear and speak no evil of dental and medical devices that - due to genetic variability in methylation, immunity, and detoxification pathways - are not "Right for Us?"

  We need Right To Know and Written Informed Consent for everything installed in our bodies. We need new Universal Device Indicators (UDIs), now being rolled out by FDA, in our electronic medical records - not just in dental records, which are not seen by our doctors, or by BigData, and considered as a factor in disease and health.

  It is time to recognize and respect Genetic Rights, and put patients' health first through Precision Devices. We do not control our DNA, so we need strict controls and prior biocompatibility screening for all dental and medical device materials before they are installed. This is basic science and safety to protect children and adults as genetically unique snowflakes.

  It is impressive that Makers and the Makers movement can make anything these days. That brings great promise, especially as we do not take care to preserve our bodies by being careful about what we eat and what we install in them. The FDA needs to come down squarely on the side of patients and the Maker - who makes our bodies and brains as living, pulsing cells, neurons, organs and systems - that do not take kindly to foreign materials, especially if they have common genetic methylation variants.

  FDA tells us to do a patch test for hair color products 24 hours in advance. It is time to require a one-time advance biocompatibility test for all installed dental and medical materials, before they are permanently installed, with an exception for emergency procedures, in which case post-testing can be done.

  Rachel Carson was a marine biologist who helped protect birds from extinction by noting the impact of DDT on their ability to reproduce. Today, humans are the endangered species, and the endangering one. Mercury is human DDT, wreaking havoc on cells, health and lives. It is time to get it out of U.S. dentistry for all time.

  We must make Precision Devices the top priority for President Obama, the FDA, CDC, NIH, PHS, IHS, HHS and the Surgeon General of the United States, so we stop chronic toxic poisoning of those for whom dental and medical devices are not a good fit, based on their genetic profile. This will significantly lower rates of autoimmune, behavioral, cardiovascular, cognitive, dermatological, kidney, neurological, and psychiatric diseases, as well as memory, mobility, movement, mood and mental status changes, as these are triggered or exacerbated by systemic chronic inflammation.

  The administration, Congress and the courts must take swift action now to reboot the FDA's practically medieval medical device regulations. The bill to regulate devices was proposed by President John F. Kennedy in 1962. It passed 14 years later, in 1976. There is now action to add UDIs to devices under recent legislation that is being rolled out for comment starting this month. However, patients still get no information sheets on composition and health risks, no right of written informed consent for installation of dental fillings or information on who to contact if problems arise as MedWatch Form 3500B Adverse Event Reports make no mention of dental devices, patients do not know the manufacturer or model and serial number as it was never provided, and hundreds of reports filed over the years have been lost or misplaced by the FDA and never entered into MAUDE.

  The FDA repeatedly overrules its own expert product panels on dental amalgam, repeatedly ignores petitions for reconsideration of its flawed risk assessment, repeatedly ignores expert dentist and ill and injured patient testimony. The FDA repeatedly ignores new scientific evidence of immediate neurobehavioral harm and kidney changes to children with certain gene types, and mounting evidence of harm to dentists, dental workers, and patients compared to matched controls, with harm linked to certain gene types that do not methylate well.

  The FDA is repeatedly sued and ordered to act by a federal judge, but still allows dental amalgam to be in Class II unrestricted use with no warnings to patients and no written informed consent. It still allows dental amalgam to be called silver fillings, even though they are 50 percent mercury fillings. It is still studying the safety of dental amalgam, six years after its flawed classification. Labels and warnings to dentists only protect the manufacturers from liability, they do not help patients. Dentists are silent because of gag orders on the health risks of amalgam in the ADA Code of Ethics.

  The ADA is a patent-holding organization that mixes professional and commercial/trade functions. Nobody knows, acts or cares about this fundamental conflict of interest. Except the legions of prematurely aged, cognitively challenged, unsteady on their feet, chronically diseased, disabled, hearts failing, kidneys failing, unemployed and suffering mercury poisoned patients and their families.

  The same thing happens in other devices. Some 4,500 reports have been filed and five women have died from complications from the Essure contraceptive coil. Many women have been harmed by vaginal mesh. Men and women alike have been harmed by various implants in the teeth, jaw, and throughout the body. While modern engineering marvels and the Makers Movement can make anything these days, we must first pay attention to the original Maker - how our bodies as cells and electrical charges operate, and what they can tolerate that is foreign to the human body, which varies as each individual is as genetically unique as a snowflake.

  Laura Henze Russell is the Principal of Precision Research and Communications: Precision Health. She planned to attend the FDA Science Forum May 27-28 in Washington, DC, but is home recovering from pneumonia. Participating through the Webcast, on Day 1 four of her 14 questions have been posed to panelists. You can see them in the Tweet stream here: https://twitter.com/hashtag/FDAScienceForum. 

  © Copyright 2006-2015 Gatehouse Media, Inc.
  

20+ QUESTIONS ON DENTAL AMALGAM AND MERCURY HEALTH RISKS: DID YOU KNOW?

These questions are posted as a guide to increase consumer, patient and parent awareness about a toxic substance - mercury - that is mixed with amalgam and installed in our teeth without any labels, warnings, or the basic human and medical right of informed written consent in the United States.

20+ QUESTIONS ON DENTAL AMALGAM AND MERCURY HEALTH RISKS: DID YOU KNOW?

THE AMERICAN DENTAL ASSOCIATION (ADA)

1.  The ADA was founded in 1859 (155 years ago) as a pro-amalgam trade association?

2.  A 1990 60 Minutes special, Is There Poison in Your Mouth? the highest-watched 60 Minutes show at the time, was pulled and never again shown or referred to on network TV? 

3.  The ADA put a gag order clause in its Code of Ethics saying that dentists who promote removal of amalgam for health reasons will be expelled, and expelled dentists until the courts put a stop to it? 

4.  Center for Responsive Politics calls ADA a ‘heavy hitter’ for campaign contributions, legal expenses?

5.  The ADA is also a commercial organization, with 83 patents in 38 years, while the AMA has none? 

DENTISTS AND DENTAL PLANS

6.  There are serious health warnings on mercury amalgam that dentists receive from manufacturers?

7.  About half of dentists don’t use amalgam any more, out of concerns for safety or environment?

8.  Dentists who want to teach at US dental schools keep quiet any concerns or reservations about the health impacts of amalgam?

9.  Dental plans are not cost neutral, the vast majority only pay the amount it would cost to put more amalgam back in the back of your mouth, and deny appeals despite medical proof of toxicity?

10. Removal of amalgam by regular dentists without special techniques and equipment beyond a dental dam increases exposure to mercury vapor, while biologic dentists use special training and equipment?

DIAGNOSTIC TESTS AND REPORTING

11. Blood, urine and hair tests for mercury levels are not that reliable with false negatives, as how your metabolism processes mercury determines if it shows up in tests, or stays in body, cells and brain?

12. More reliable tests for mercury damage may include urinary porphyrin levels, and glutathione levels?

13. A biocompatibility blood test can determine, among the vast quantity of dental metals and materials, which are most reactive, somewhat reactive and least reactive to your individual immune system?

14. Simple genetic tests can find at-risk gene types impacting methylation and detoxification pathways?

15. Reporting amalgam reactions is not mandatory, nor billable, and is confusing, so rarely happens?

16. The FDA considers sensitivity or reactivity reactions rare, because they are rarely reported?

17. You can and should report adverse events to the FDA, and report unsafe medical devices?

18. You can and should also report adverse events to the State Dental Board, and Poison Control Hotline?

THE FOOD AND DRUG ADMINISTRATION (FDA)

19. Mercury amalgam is considered a medical device, a prosthetic device, not a substance, by the FDA?

20. The FDA long grandfathered it “generally recognized at safe,” never rigorously tested or proven safe?

21. As a result of a lawsuit, the FDA only ruled it Class II, with a guidance document for manufacturers to dentists in 2009 stating that mixed metals should not be used in the same or abutting teeth, because it creates galvanic micro-electrical currents that can degrade mercury in amalgam?

22. The FDA Commissioner recused herself because she sat on the board of an amalgam distributor for six years before taking this position?

23. The FDA ignored recommendations of its own Scientific Advisory Panels in 2010 to restrict its use and post warnings for use in children, pregnant women and people with a known allergy to mercury?

24. Thomas Duplinsky of Yale SOM published a 2012 study finding dentists have higher prescription usage for neurological, psychiatric, cardiovascular and respiratory diseases than matched controls?

GENES AND IMMUNE SYSTEM

25. People with ApoE4, CPOX4, or with a number of other common genetic mutations (SNPs) affecting methylation and detoxification do not clear mercury well, so have higher rates of toxicity?

26. People with these gene types have higher rates of Alzheimers, autoimmune and movement disorders?

27. Genetic screening diagnostic tests for the above, and for immune pathways are covered by insurance?

28. Mercury can cause allergies and skin reactions to yeasts, sugars, wheat, gluten, corn and soy?

29. Monkeys and sheep with amalgam placed in their teeth immediately start redistributing it throughout their bodies and brains? And get very ill pretty quickly when amalgam is put in their teeth?

HEALTH AND HEALTH IMPACTS

30. Mothers pass mercury on to our children via the placenta and breast milk?

31. There are changes in children’s urinary porphyrins evident soon after amalgam is installed?

32. Loss of teeth does not protect one from mercury poisoning, as the body and brain burden persists if one does not clear mercury well, or follow an effective, medically supervised detox protocol?

33. Populations with high amalgam exposures include midlifers, boomers and older adults, Native Americans, the Military, Medicaid patients, and all who don’t know or can’t afford alternatives?

34. Crematoria are exempt from adequate pollution controls, and have no provisions to remove mercury amalgam dental fillings prior to cremation? 

35. Health disparities and chronic health problems have proven correlations with amalgam exposure, but this is not considered sufficient proof to act to ban or restrict its use?

36. James S Woods, an author of the Children’s Amalgam Trial in Portugal, reanalyzed data by gender and gene type, publishing new studies that amalgam led to kidney and behavioral problems in some boys?

OTHER NATIONS

37. Amalgam was banned in Norway and Denmark in 2008, Sweden 2009, and other nations restrict it?

38. The third largest Israeli dental plan will not pay for amalgams in children?

39. Parker Hannifin, a major engineering company that self-insures, pays for amalgam removal to protect the health of its employees, and only pays for fillings using safer, biocompatible alternatives?

40. The World Health Organization has called for its end in dentistry, and under a new International Treaty signed in 2013, many nations are working to phase out its use in dentistry worldwide?

41. The EEC is laying the groundwork to follow the Scandinavian countries and stop using it?

WHAT STATES CAN DO (AND CANNOT DO)

42. Courts have ruled that states cannot ban amalgam because of the Interstate Commerce Clause, as long as the FDA maintains in is safe, despite the recommendations of the FDA Scientific Advisory Panel?

43. That there are no informed consents required or health warnings shared with patients, except in the four informed consent states of Maine, California, Connecticut and Vermont, and Philadelphia, PA?

44. Consumers do not get a label or the most basic right of informed written consent for use of amalgam?

45. The FDA was sued by the International Academy of Oral Medicine & Toxicology et al in March 2014 for violating the federal APA law by not responding to petitions for reconsideration for years?

46. What can we do?  What ideas do you have?  What can you do?  What can we all do together?

 This work is licensed under a Creative Commons Attribution 3.0 Unported License. 

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."

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

Additional Volunteers Welcomed to Help Improve This Blog!

The Poison in Our Teeth - On Massachusetts' Limitations as a Medical Mecca - May 29, 2012

• Russell: The poison in our teeth

Posted May. 29, 2012 @ 12:01 am

• Updated May 29, 2012 at 1:01 AM 

  
  

  By Laura Henze Russell/GUEST COLUMNIST
  

  I learned the hard way over the past year that while Boston is a great place if you need a face transplant, if you have a vexing medical condition — even one widely known in past centuries — not so much.

  During the past year, I had a vexing medical problem. It led to a series of co-infections, also confounding and not properly diagnosed.

  I went on to develop a systemic fungal infection, skin crawling and nerve firing sensations that were especially bad at night, allergic skin reactions and sensitivity to yeasts, gluten, corn and soy, falling immune markers, anxiety and mood swings, balance issues, dulling of hearing and smell, fatigue, finger tremors, memory issues, mental fog and neuropathy in my legs. Nearly a dozen specialists concluded I was imagining things, and it was all in my head.

  Turns out, they were half right. The problem was all in my head — amalgam fillings over the years, which are 50 percent mercury. How we continue to let this poison enter and remain in people’s mouths is beyond me. We have stringent lead testing and lead paint remediation laws, a Surgeon General’s warnings on cigarettes, and instead of leading the charge to ban mercury, the ADA persecutes dentists who remove it — using strict safety protocols — from sick, suffering patients’ mouths. First, do harm?

  How did I get enough mercury in me to be toxic? Let me count the ways. All eight of my molars once had amalgam fillings. They had given way to three root canals and five crowns, which involved drilling amalgam without protections and spitting out what I didn’t swallow. Many if not all still have some amalgam under them. Additionally I had two amalgam fillings in the past 10 years in upper bicuspids. A biologic dentist said my bite was heavy on my bicuspids, and I was grinding my teeth at night, which explains the worse symptoms at night. To add to cumulative exposure, when I grew up chemistry sets had mercury — it was kind of fun. I also had a mercury thermometer break when young. Then there is fish, to top off the tank. I now carry a fish mercury level wallet card, no more swordfish and tuna.

  How did I get a diagnosis? I had to work the problem. It took a year, going way beyond the confines of my health plan, and the third opinion consults from numerous of the specialty disciplines in Boston’s Medical Mecca. It included an integrative doctor, a parasitologist from Arizona, a biologic dentist and my PCP’s support for not giving up hope. It was additionally confirmed by a blood test by a neurologist I saw at a teaching hospital after I developed finger tremors. Two months into a detox protocol, my blood mercury level is 40 percent above the top of normal range.

  The root cause was predominantly dental material toxicity — mercury poisoning. There are only a half-dozen biologic dental practices in Massachusetts who practice safe removal for people with mercury toxicity. I began a protocol of homeopathic detox, which was markedly effective within the first two weeks in reducing nerve and skin sensations. It also includes herbs, nutritional support, lymphatic massage and diet. The biologic dentist discovered an infection deep in a facial muscle over an old root canal, and prescribed a highly effective antibiotic and two more antibiotics for another hidden infection.

  • Now, I am on the mend. Amazingly, some chronic health challenges are cured, my body is strong and energetic, my memory is better, I am brimming with health, and I feel like the clock has been turned back 20 years.

    The AMA, ADA, Boston area doctors, dentists, medical and dental schools, teaching hospitals, and computer-aided diagnostic programs evidently consider mercury poisoning a quaint artifact of the past, as the score of doctors and specialists I saw were clueless about this as a potential cause. I ran into a woman at my church whose father, grandfather and great grandfather were physicians — she was immediately familiar with it. Because I lost much of the last year to this fiasco, I am resolved to prevent it for others.

    What if I hadn’t discovered people who have gotten to the root of the problem and its causes, learned of and followed unusual treatment protocols, and paid for much of this out of pocket? The costs of treating accelerating medical, neurological, physiological, psychological, and problems in every other dimension of my body, mind, psyche and spirit are off the charts. Mercury wreaks havoc on the neurological system and the immune system, opening the door to all sorts of costly and debilitating conditions and disease from movement disorders to neurological degeneration. Multiply this by the number of boomers and older adults with aging mouths, silver smiles, and grinding teeth.

    I was a very costly date in the health care system last year, both to my health plan, and to me and my family. There is no excuse for this. If we want to bring down health care costs, stop putting a poisonous element permanently in people’s mouths. It’s that simple.

    The FDA convened a scientific advisory panel twice in recent years, 2006 and 2010. Both concluded that dental amalgam should not be used in children, pregnant women and hypersensitive adults. I am a poster child for the fact that mercury can cause hypersensitivity, so nobody is safe from it. We all age. The FDA has not acted and there is no timetable for action. Whatever happened to, “First, do no harm?”

    It is high time to follow in the footsteps of other nations and strike up the BAND — Ban Amalgam Now in Dentistry. Pass Legislation, issue an executive order, launch a ballot initiative — whatever it takes.