Thursday, May 28, 2015

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:
    © Copyright 2006-2015 Gatehouse Media, Inc.

ATLANTA WSB-TV2 INVESTIGATES: Are Fillings in Your Mouth Toxic?

Here is a jaw dropper from Atlanta WSB-TV2 on May 18, 2015

Atlanta WSB-TV2 Investigates: Are Fillings in Your Mouth Toxic?

Atlanta WSB-TV2 Investigates: Are Fillings in Your Mouth Toxic?

FDA Stands by its Dental Amalgam Mistake

FDA Stands by its Dental Amalgam Mistake

The agency recently denied three petitions seeking to ban mercury-based dental amalgams, which some studies have linked to kidney damage and neurological disabilities and diseases.
Jim Dickinson
After another of its customary multi-year stalls on politically fraught issues, FDA in January substantially denied three five-year-old petitions seeking to rid American dentistry of mercury-based dental amalgams that have been scientifically linked to kidney damage and neurological disabilities and diseases like multiple sclerosis and Alzheimer’s.
The link is especially strong in children, neonates, and placental transfer to fetuses, and comes primarily from chewing with amalgam-filled teeth and, to a lesser degree, from eating fish.
Throughout patients’ lifetimes, these fillings release mercury vapor that is absorbed through the lungs and oral mucosa, according to studies submitted with the petitions—documentation FDA essentially dismisses as “not new.”
As it did in 2009 when it classified amalgam as Class II (safe and effective), FDA in January again defied the statutory approval standard for medical devices and drugs—production by manufacturers of substantial clinical evidence of safety and effectiveness.
Instead, the agency again stood by its unseen political directors, who in turn harken to the third-biggest-spending health professionals’ lobby, the strongly pro-amalgam American Dental Association. The association, in turn, answers to the estimated 30% of practicing dentists who still use amalgam because it is cheaper and easier than safer substitutes and who reasonably fear liability lawsuits from amalgam’s ill effects.
Turning down the three petitions’ primary objective, the effective removal of amalgam from the market, FDA consolidated its response to the International Academy of Oral Medicine & Toxicology et al and Moms Against Mercury et al, and separatelywrote to Citizens for Health et al.
In both letters, the agency came close to admitting that its denials were based not on science but on a lack of it. There is “very limited to no clinical information available regarding long-term health outcomes in pregnant women and their developing fetuses, and children under the age of six, including infants who are breastfed,” wrote associate commissioner for policy Leslie Kux.
Kux did, however, go on to “partially grant” Citizens for Health’s request to change information on the agency’s dental amalgam Web site. She did not, however, grant its request to remove the term “silver fillings” from the site. The site changes were as follow:
1. Inclusion of the warning that “the developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor” in the potential risks section.
2. Addition of the following sentence after the reference to silver fillings, “Despite the name, ‘silver fillings’ do contain elemental mercury”.
3. Addition of an explanation of the concept of bioaccumulation to the Web site and the addition of links to the other U.S. government agency Web sites to provide further information on bioaccumulation.
4. Changing of the description of the clinical information on “pregnant women and their developing fetuses, and on children under the age of 6, including breastfed infants” from “limited clinical information” to the final rule’s description, which was “very limited to no clinical information”. 
5. Explaining that amalgam’s primary component is mercury on the introductory page of the consumer Web site.

A pivotal but unanswerable question is: How many people with tooth decay consult FDA’s Web site before allowing their dentist to implant mercury-based amalgam fillings?
In evaluating the petitions, FDA cited its convening of a special advisory committee meeting in 2010 to gather input on mercury exposure assessments, reference exposure levels (RELs) for mercury vapor, and the adequacy of clinical studies on dental amalgam. The panel’s composition, conduct, and presentation time limits (three minutes per presenter) were strenuously objected to by the antiamalgam interests, to no avail.
“In general,” the petition denial letters said, “the panel discussed uncertainties with current risk assessments for dental and believed it would be helpful to have RELs that included data from the most recent studies. The panel also discussed that there may be certain populations that are more sensitive to mercury exposure than the general population. In addition, the panel found that a review of the available literature showed there is no causal link between the use of dental amalgam and various clinical diseases in the general population.”
Tulsa, Oklahoma attorney James M. Love (Titus Hillis Reynolds Love Dickman & McCalmon, PC), who filed a lawsuit last year that finally got FDA moving on the petitions, strongly criticized the denials. The agency, he said, “continues to allow the American people to be poisoned by their mercury fillings despite the scientifically demonstrated risks. Despite the shift of many countries away from mercury fillings, it appears that the FDA believes that the human mouth is a safe place to store mercury.”
He added that “the burden of proving safety is on FDA, but FDA ignores this principal and places the burden on us to conclusively prove these fillings are causing diseases. FDA presumes that these fillings are safe—even for fetuses—while admitting that it has no data demonstrating safety.”
In a 2010 study by Mutter et al in the Journal of Alzheimers Disease, the authors compared the amalgam controversy to the “the status of knowledge in the 1970s regarding the relationship between smoking and cancer.”
“The evidence is highly suggestive, but some links are missing,” the authors wrote “While there are clearly knowledge gaps to be filled, we feel that the available data are strongly suggestive of a potential causal link between mercury and Alzheimer’s Disease.”
The authors went on to “suggest removal of mercury from public and ecologic circuits and replacing it wherever possible by less toxic alternatives.”
FDA, in its “infinite wisdom” and politically guided course, has opted for the opposite approach. Because federal courts almost invariably defer to the agency’s presumed expertise, and because all other approaches have failed, Love does not expect to revive his lawsuit.
The next step would appear to be to wait, as former CDRH director Bruce Burlington once suggested in another context (hospital reconditioning of single-use devices), for science to measure a “body count” that can’t be denied.
Jim Dickinson is MD+DI's contributing editor. 

Wednesday, May 27, 2015

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

Genome, Toxome, Deviceome: Ultimate Selfies for Health

My comment on the CDC Blog Post, The Ultimate Selfie.

The CDC cautions against overreliance on the genome and the dangers of the "narcissome."  Instead, it should accelerate equal attention to the toxome, the exposome, the dentalome, the deviceome.
Among the early adopters of genomics are those whom mainstream top line medicine failed for years, who got sick and tired of living with inexplicable chronic diseases, and doing the best they could with "medication management" and "chronic disease management." They are discovering new learning, medical practitioners, avenues and approaches to explore, and groups to seek out peers and share experiences, initially in person and increasingly online.
We learn that looking at both sides of the equation, genetics and toxicology together, are the keys to chronic diseases, and that one can remediate bad combinations and restore healthy functioning of the body and brain.  We learn that functional medicine physicians can be more helpful than specialists for various conditions because they see they body as a whole, an integrated symphony and set of systems.  We learn that the lack of attention to biocompatibility in the human body is a  gaping whole in medical practice and regulation of installed devices, as is lack of an integrated approach to body, brain, dental and mental health.
We are working to update regulations that are nearly 50 years out of date in which patients get no labels, no written informed consent, no prior biocompatibility screening for the individual before installation of permanent medical and dental devices (while it is recommended for temporary hair color products), no entry and updating of information on our installed devices such as we get for prescription drugs and OTCs at every doctor visit.
There is a Rosetta Stone of sorts, it is to follow basic engineering principles in the body. If genetic glitches impacts one's ability to methylate and clear everyday toxins, we must be vigilant in screening them and clearing them for health. These can be biotoxins like Lyme throughout its lifecycle and coinfections, chemotoxins, metallotoxins like mercury from fillings and fish, mycotoxins like mold, etc.
Health is a powerful motivator, and reward.  As important as genomics is toxicology. As important as Precision Medicine is Precision Devices, to ensure they are right for us. This is where the easy, quick wins and big payoffs for reducing chronic disease rates begins.


1Patient Labeling of All Installed Medical and Dental Devices
2. Funding Recovery Services for Device Related Illnesses
3. Develop Comprehensive Plan for Patient/Worker Protection, Reform
4. Urgent FDA Safety Reform of Installed  Devices, Surgeon General Report
OUTLINE OF COMPREHENSIVE PLAN for Patient Protection and Reform
a)      Patient Protection
i)   Follow the lead of four states and add consumer labels with warnings to the product to discourage its use by those for whom it may be harmful and written consent; the FDA has indicated state consumer laws do not violate preemption.[1]
ii)   Fund and require Medicaid to pay for alternate filling materials, as Pennsylvania does, so people can chose what is best for their children’s and their own health needs.
iii)   Require dental plans to be cost neutral on fillings, and accountable to medical necessity and patient protection laws, and require them to use of biocompatible dental materials.
iv)    Encourage integrated health and dental insurance plans to ensure oral care supports physical and cognitive health, and reduce costly externalities down the road.
v)   Require and expedite inclusion of dental materials and records in electronic medical records for review and analysis by physicians, ACOs, health insurers, HiWay, MA Health Policy Commission.

b)      Research
i)        Set up a surveillance system and reporting system as there is none functioning at the federal or state level, and include as a priority for the Health Prevention Trust Fund.
ii)       Hold hearings and survey the public as to prevalence of people who had health impacts, survey biologic dental practices and functional medicine practices to quantify numbers served with dental mercury toxicity and assess training and capacity building needs, and conduct a learning tour to get their input on steps to expand training and capacity.
iii)     Include dental insurance data in the all-claims database and analyze connections between oral health, dental materials, chronic diseases, and health and long-term care costs.
iv)     Require organ donor programs operating in Massachusetts, and all autopsies performed with state funds, to measure bioburden of mercury in the brain, heart, kidneys and liver of its donors and report to state and federal authorities, along with proximate cause of death.

c)       Systems Reform and Building Capacity
i)        Update dental and medical practice and insurance standards to confidentially screen people for genetic glitches, and for toxic burden; and/or require biocompatibility tests for dental materials.
ii)       Tax dental amalgam to equalize the costs with alternative filling materials, and neutralize the bias of dental insurance plans that base what they will pay on amalgam fillings cost.
iii)     Reboot community hospitals that have overcapacity for acute care needs as centers for the training and practice of biologic dentistry, train all dentists in mercury safe removal protocols and special safety equipment. Explore launch of a state university Biologic Dental School.
iv)     Design a new a Mass Save Health program, similar to Mass Save, helping screen people for toxins in their bodies and homes, and fund treatment and remediation, as win-win.

d)      Occupational and Environmental Risks
i)        Require dentists and staff who work chairside be tested periodically for mercury exposure. Because standard blood and urine tests only measure circulating mercury, more sensitive tests are required to rule out false negatives for non-excretors.
ii)       Require dentists and staff get special training and equipment to protect patients, staff and dentists from mercury vapor during installation, polishing and amalgam removal.
iii)     Test mercury levels in all dental offices and dental schools, and inspect all dental offices and dental schools for proper use and functioning of amalgam separators.
iv)     Require removal of amalgam from all bodies before cremation, and require installation of adequate scrubbers on crematoria, to protect people from exposure via air, water and fish.

4Ask Delegation for Urgent FDA Safety Reform of Installed Dental and Medical Devices
5. Petition for Surgeon General Report on Dental Amalgam and Mercury Health Risks

European Committee Recommends Amalgam Alternatives for Certain Patients

From DrBicuspid, European Committee Recommends Amalgam Alternatives for Certain Patients.  Sanity prevails in Europe. Madness continues in the United States... FDA Fiddles while Rome heals...

May 26, 2015 -- "In a final opinion on dental amalgam, a European Commission scientific committee concluded that alternative materials to dental amalgam should be the first choice for certain restorations, such as those in pregnant patients and primary teeth.

The updated opinion by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) updates the committee's previous one published in 2008. It assessed the safety and effectiveness of dental amalgam and possible alternatives, such as resin-based composites, glass ionomer cements, ceramics, and gold alloys, by evaluating the scientific evidence on the potential association of amalgam and its alternatives with allergies, neurological disorders, or other adverse health effects.
This opinion contrasts with the January 2015 U.S. Food and Drug Administration (FDA) update of its consumer advisory on dental amalgam, which did not change the agency's position on amalgam fillings and concluded that such fillings are safe for adults and children ages 6 and older.
Individual patient characteristics
The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) of the European Commission wrote that, while "current evidence does not preclude the use of either amalgam or alternative materials in restorative treatment," individual patient characteristics should determine the material used in treatment.
The following patient characteristics should be considered:
  • Primary or permanent teeth
  • Pregnancy
  • The presence of allergies to mercury or other components of restorative materials
  • The presence of impaired renal clearance
“Alternative materials have now been in clinical use for well over thirty years. ... Existing clinical experience has revealed little evidence of clinically significant adverse events.”
— Scientific Committee on Emerging and Newly Identified Health Risks, European Commission
"Alternative materials have now been in clinical use for well over thirty years, initially in anterior teeth and more recently also for restorations in posterior teeth," the committee wrote. "Existing clinical experience has revealed little evidence of clinically significant adverse events." It noted that the composition of available materials has changed substantially in recent years because of "improved polymerization processes and particular improvement in the adhesive systems and the filler parts." Among the benefits, the committee wrote, is that there is "no evidence that infants or children are at risk of adverse effects arising from the use of alternatives to dental amalgam."
There is a trend toward minimal interventional, adhesive techniques in dentistry, which are "based on adhesion to tooth structure by chemical interaction, and/or micromechanical retention," according to the opinion. At the same time, the committee noted, the quality and durability of alternative materials have improved.
As a general principle, the committee recommended that the relative risks and benefits of any dental treatment should be explained to patients to help them make informed decisions. Also, manufacturers should provide better information concerning the relative risks of dental restorative materials, it added.
An effective material
Dental amalgam is "an effective restorative material for the general population" and has "long been considered the material of choice," the committee noted in its executive summary noted. However, the drawbacks of dental amalgam are well-known, including the exposure to mercury and that it is neither tooth-colored nor can it adhere to remaining tooth tissues. The use of amalgam has been decreasing in recent years, and the alternative tooth-colored filling materials are increasingly used in Europe.
The committee, however, concluded that already-in-place dental amalgam is not considered a health risk for the general population and should not be removed as a preventive measure.
Future research
In the opinion, the committee wrote further research is needed relating to the "evaluation of the potential neurotoxicity of mercury from dental amalgam and the effect of genetic polymorphisms on mercury toxicity." It also recommended that more research be conducted in the development of new alternative materials with a "high degree of biocompatibility" and to expand knowledge of the toxicity profile of alternative dental restorative materials.
More publicly available research data are also needed, and it would be "beneficial for the community in general to be better informed of the recognized benefits and risks," the committee noted.
The opinion corresponds with the intentions of the 2013 Minamata Convention on Mercury to reduce mercury and the general aim to reduce mercury use in the European Union, according to a press release by the European Commission."

Copyright © 2015

Tuesday, May 26, 2015


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.



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? 


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?


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?


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?


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?


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?


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?


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?

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

Thursday, May 7, 2015

More Should Be Done to Fight Lyme Disease

From the Sharon Advocate

    • Column: More should be done to fight Lyme disease

      • emailprint

      • By Laura Henze Russell/
        Guest Columnist
      Posted May. 7, 2015 at 8:17 AM 
      Lyme disease is one of the biggest health scourges of our time. The numbers of patients affected keeps rising skyward with official CDC estimates now at 300,000, or 10 cases for every one officially reported.
      Patients and observers believe many more cases exist than are ever diagnosed, as the walking wounded and mysteriously ill wander among us.
      May Day is being organized as a national day of action for Lyme awareness and proper treatment, with advocates in Washington, DC until May 1 to lobby Congress and meet with the CDC to call for better diagnostic and treatment guidelines.
      Our public health system lags badly on all the biggest scourges impacting health. As with other governmental institutions, change is lumpy, episodic and slow. While that is unfortunate in other fields, in health where new threats emerge but their seriousness is not recognized and acted upon, it is dangerous.
      Our public health system is quick to act on exotic, foreign, rare threats, but not on the garden variety, everyday things in our yards, homes and bodies that are making us ill.
      Growing up on Long Island and living in eastern Massachusetts, Lyme is among the three challenges that took down my health and vitality for more than 20 years.
      For others and me with persistent Lyme - a short course of generic doxycycline hyclate and even a longer course, didn't fully work (it did make me nauseous).
      Perhaps Lyme spirochetes have developed resistance, or it only works on some strains and times of the life cycle, or people with different gene glitches need different Rx - all of these questions urgently need research. A short course of doxycycline monohydrate did work.
      Different treatments are needed for different stages of the disease. Why is this knowledge not spreading in the medical community and to the CDC, leaving patients to fight to update their guidelines?
      Regarding tests, it is important to remember this: "In order to cycle between two very different hosts, B. burgdorferi varies its gene expression, leading to different protein components and enabling physiological adaptation to these environments [49–53]. A number of studies have begun to delineate those changes." ( Therefore, "gold standard" PCR tests with narrow interpretations regarding the bands may be correct in identifying a particular stage of a particular strain of Borrelia burgdorferi (Lyme spirochete), but miss related strains of the disease, miss other life cycle stages (e.g. spores), and also miss co-infections, for which too few doctors test.
      The CDC must keep up with new science, diagnostics and effective treatments in this era of precision medicine. The FDA has far to go in protecting people from all kinds of toxics which it lets slip through the regulatory approval process, especially for installed medical and dental devices for which people have varying genetic tolerance and toxicity levels.
      Informed observers - from physicians to researchers to patients - believe Lyme reached truly epidemic proportions. It is worth exploring whether prophylaxis is in order for those at greatest risk, just as one takes prophylactic Rx for malaria when traveling to parts of Africa, Asia, and Central and South America.  
      There is a renewed drive to crack down on anything that deviates from medical orthodoxy. True innovation and advancement comes from disruption, whether in medicine or other fields. These agencies need a reboot on materials safety, and to take a broader view of tests and treatments that are helping hard-to-diagnose but very ill patients recover and get back with their lives, back to their work and paying taxes, and fully back to their families. They need to put patients and health first.
      Laura Henze Russell is the principal of Precision Research, Writing and Communications in         Sharon.