Excited to be at NHI #PMINetwork Meeting on Participant Engagement and Health Equity and meet all working for health
Medical
and Dental Device Safety Urgent Regulatory Reform
Medscape: Did HHS Cancel Proposed FDA Limits on Mercury Fillings?The 21st Century Cures bill, passed the U.S. House of Representatives on July 10th, would provide $8.75 billion in funding over five years to the National Institutes of Health (NIH), and $550 million in additional funds for the Food and Drug Administration (FDA) to speed discovery and approval of drugs and devices. It needs a little tweaking by the Senate as it takes up its own biomedical innovation bill to accomplish the ultimate objective of curing the most Americans at the least possible cost. This can enable us to begin to pay down the national debt, and finance efforts on more complex health problems.
We would do well to focus attention on the common causes of chronic diseases, and the hidden health epidemics that are endemic to our time. These include Lyme and various tick-borne coinfections, mold that is hidden and off the radar screen, and surprisingly, medical and dental devices that are not pre-tested for biocompatibility in individual patients to ensure the materials are “right for you.”
An increasing number of medical and dental professionals, ill and recovering patients, medical researchers, and public health professionals now consider these hidden health risks as a major driver of chronic diseases that impact Americans across the age spectrum, as transmission of microorganisms, heavy metals and the like can occur through direct exposure, and prenatally and via breast feeding. Device illnesses for people with genetic susceptibilities include such common FDA approved products as artificial joints, cardiac devices, dental amalgam, Essure contraceptive coils, implants, mesh, and stents. I have personal experience with one of these products, and friends with all of them.
With the progress of Precision Medicine in recent years, clinicians are discovering the varied causes behind a range of chronic disease diagnoses. These conditions are legion, and include ADHD, allergies, arthritis and Alzheimer’s; chronic fatigue, diabetes, fibromyalgia, and heart disease; gastrointestinal problems, fungal and yeast infections, skin irritation and rashes; Multiple Sclerosis, Parkinson’s, peripheral neuropathy and tremor; and behavioral, cognitive, memory, mobility, mood and mental status challenges. Surprisingly, good clinicians using the principles of functional medicine are able to properly diagnose and “reverse engineer” some of these diseases, when the specific genetic susceptibilities and toxic inflammatory triggers are revealed by genetic and toxic screening.
It is time for the nation’s health system to catch up. With 21st Century Cures and other bills concerning FDA medical device regulations and taxes in Congress, we have a chance to reboot the system in several ways. There is broad bipartisan and public support from America’s families, who serve as patients, parents, caregivers, relatives and friends to people with a growing number of such health challenges, which tend to multiply as they mature and age.
It is important to do 21st Century Cures and Device legislation right. Here are some Big Ideas.1) Focus attention on common causes of chronic diseases: bad combinations of gene types and toxins outside and within the body, including medical and dental devices. These diseases need remediation and reverse engineering, not lifelong medication. Prompt diagnosis and proper treatment can forestall a future of costly prescriptions for symptom control, joint replacement surgeries, mobility aids, memory care, etc.
2) Rebalance federal health priorities, research, surveillance and spending so it focuses on the biggest, most prevalent, easiest-to-resolve health burdens of chronic inflammatory autoimmune and neurological diseases impacting the body and brain. Focus on common, everyday health risks - especially for those with common genetic variants in their methylation and immune pathways - such as mercury, Lyme and co-infections, and mold. These are endemic, and the hidden epidemics of our time.
3) Medical and Dental Device Safety Urgent Reform (MEDDSURGE) as regulations years out of date and UDIs alone do not go far enough. Patients must get labels, written informed consent for dental fillings, prior biocompatibility screening to determine if a device is "right for you" before installation, entry of all device information into EMRs (not just dental records) seen by one's doctor and big data, and a revised MedWatch Form 3500 with a new section specifically designed for dental device adverse reactions.
4) Redirect Medical Device Tax to a Victims Medical and Dental Device Illness Compensation (MEDDIC) Fund. Many patients wind up with harm after the fact as we still prescribe devices based on averages rather than individual tolerance vs. toxicity pre-testing. Somebody has to pay for remediation, treatment, recovery, lost income, and high uncovered medical, dental and care expenses patients have incurred.
While we are promoting 21st Century Cures, it would be wise to end 19th Century dentistry. Nobody is filing patents to perfect amalgam anymore - not even the ADA - only to mitigate its harm. And stop open season on women and men via reproductive system, heart, joint and other implants that are not well tolerated by those with methylation and immune variations. Test for tolerance or toxicity first.
Call your Representative and thank them for their vote, and Senators Ed Markey and Elizabeth Warren at 202-224-2742 and 202-224-4543, respectively, and ask them to Rebalance Attention to Chronic Diseases and Medical Device Safety, Focus on the Common Causes and Hidden Health Risks for Chronic Diseases, and Reform FDA Regulations for Precision Devices and Safety via MEDDSURGE and the MEDDIC Fund.
Restore, safeguard and protect the health of Americans for the health and well-being of us all.
Laura Henze Russell is the Principal of Precision Research & Communications: Precision Health. She was an invitee at the White House Champions of Change Precision Medicine Event July 8th, and also attended the NIH Precision Medicine Advisory Committee Work Group on Patient Engagement and Health Equity July 1-2, 2015. Her summaries of these events are athttps://storify.com/LauraHRussell/nih-precision-medicine-patient-engagement-health-e andhttps://storify.com/LauraHRussell/white-house-champions-of-change-precision-medicine.
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.
