Make America Healthy Again: Congress Must Also Pass a 21st Century Medical Device Safety Act

By Laura Henze Russell, Melanie Goshgarian, and Madris Tomes/Guest Columnists

As women fighting life-changing autoimmune disease, allergies and more - one life threatening, two with illnesses and injuries caused by different FDA-approved medical and dental devices, and one a former FDA employee fighting chronic autoimmune disease of not yet known cause – we call for Congress to do more than pass a 21st Century Cures Act. Congress must also pass a 21st Century Medical Device Safety Act.

The House of Representatives passed the 21st Century Cures Act 392-26. It is on to the Senate for a vote. Its bipartisan leaders smartly loaded it up with some benefits for almost everyone – a total of $4.8 billion in research funding for the Brain Initiative, Precision Medicine Initiative, Cancer Moonshot, and provisions for mental health, opioid abuse, Lyme disease, and more. Representatives from Pharma, Biotech, and Chronic Disease Groups have stormed the halls of Congress to ensure this bipartisan bill is enacted. On the surface, it is a slam dunk. But look beneath the surface, and we have work to do.

Sen. Elizabeth Warren, D-Mass. made a strong speech to stop the bill and fix it, launching a MoveOn petition, “Tell Congress: Don't let Big Pharma hijack the 21st Century Cures Act,” which has gathered over 166,000 signatures in days. Sen. Bernie Sanders, I-Vt, called to rewrite the bill to lower prescription drug costs. A courageous band led by Rep. Mike Fitzpatrick, R-Pa., and Rep. Louise Slaughter, D-NY, have been pressing to address medical device safety, through calls for the passage of Ariel Grace’s Law, the Medical Device Guardians Act, and a reboot of FDA’s device regulations to ensure patient safety first.

Why are we concerned? The Hippocratic Oath - First, do no harm - should apply to all health agencies. The rules governing medical devices at the FDA are focused on cost-benefit. Receiving half of its funding from industry user fees, the FDA’s Center for Devices and Radiological Health (CDRH) has a track record of weighing industry benefits more heavily than patient risks.

FDA’s CDRH uses a dated, mid-20th Century framework to assess device safety. If a new device is tested in a relatively small number of people, with some benefits and without major side effects for a relatively short period of time - as measured and reported by research sponsored by the company - it can be approved as a Class III device. Moreover, the device receives pre-market approval – a get-out-of-liability-free card – so patients have no recourse if harmed.

If a device is “substantially equivalent” to an already approved device, or was “grandfathered,” it can get the go-ahead as a Class II device following a less extensive review process. Facing extraordinary industry pressure for approval, even 19th century devices like mercury-containing dental amalgam are given the benefit of the doubt. There are no patient labels, warnings, or written informed consent for patients or parents, overriding the concerns raised by FDA’s expert Dental Products Panels in 2006 and 2010. Patients also lack recourse. With no medical necessity in dental insurance, insurers deny appeals to replace with biocompatible materials.

Fast forward to today. We know that people vary greatly by gene type, allergies, autoimmune responses, and other metabolic pathways. We know that infants, children, teens, adults and older adults vary greatly over the lifespan. We know that not everyone can eat peanut butter, or wear latex gloves, or get the same blood type transfusion. But we consider a medical or dental device that is safe for the majority, as safe for all. There is no prescreening to determine tolerance vs. toxicity, yet FDA recommends a patch test before using hair color!

What is the scale of harm that results from an outdated framework for FDA device approvals? According to the FDA, for Class III devices:

Device	Deaths	Injuries
Defibrillators	16,206	164,936
Pacemakers	11,869	160,936
Infusion pumps	2,561	92,253
Nerve stimulators	2,883	122,701
Coronary stents	9,600	53,293
Breast implants	92	18,340
Essure	36	12,763
Penile implants	7	10,201

In Class II, 127,000 injuries and illnesses have been reported for various forms of Mesh, both a Class II and Class III medical device. Over 100,000 patients have called patient support groups for information and referral to biologic dentists and physicians to overcome mercury toxicity and illnesses resulting from Class II dental amalgam, as people with certain gene types do not clear mercury well, and it builds up over time. A risk assessment shows 65+ million Americans are at risk. Together, FDA’s MAUDE and old DENS system have 1,230 reports - remarkable given the website and forms do not mention or give examples of dental products being covered. Fortunately, there is a new MedWatcher mobile application patients can use to report harm. Download the app at www.Medwatcher.org, register, click Device tab, and click Device name.

Congress - and the new Trump Administration - your job is not done. The Senate should press for inclusion of Ariel Grace's Law, the Medical Device Guardians Act, for immediate release of the FDA’s draft 2012 Patient Safety Communication on Dental Amalgam, and investigate the history of problems in the dental and gynecological device units.

Begin working on a comprehensive 21st Century Medical Device Safety Act. Make patient health and safety top priority. Reboot FDA’s Device Center. Ensure medical and dental devices are "right for us" before installation. Prevent medical harm, heartache, chronic diseases, disability, and rising health care costs from FDA-approved devices. Make America Healthy Again.

Laura Henze Russell is the Principal of Precision Research and Communications: Precision Health. Melanie Goshgarian is a Patient Navigator and member of Essure Problems and USA Patient Network. Madris Tomes is a former FDA employee, concerned citizen, and founder of Device Events. To join the effort to Make America Healthy Again and prevent medical device harm, please contact us at laurarussell2@comcast.net, melaniegosh27@gmail.com, and madris@deviceevents.com.

Discovering Essure’s problems the hard way

Discovering Essure’s problems the hard way

MetroWest Daily News

By Melanie Goshgarian and Laura Henze Russell
Guest Columnists

September 04. 2015 11:05PM

FDA’s medical device standards outdated, ineffective

Here is a warning for women: do your homework before putting anything in your body. Why? The Food and Drug Administration (FDA) rules governing medical device safety are about 40 years old. They are practically medieval when it comes to patient health and safety.

Can social media and digital apps track illness and help save health? Yes, says a new study by Epidemico, a Boston-based digital health innovator which partnered with the patient illness group, Essure Problems. The study combined social media outreach with the MedWatcher tool to encourage women with medical device illnesses to report problems to the Food and Drug Administration (FDA). Lead author Chi Y Bahk presented it at a major conference in Boston.

This helps to build a more robust database of side effects for an upcoming FDA hearing on the safety problems with Essure, a form of permanent birth control. Essure is made of a nickel titanium alloy and a polyester-like fiber called polyethylene terephthalate (PET). It triggers an inflammatory response, causing scar tissue to form and block the fallopian tubes, preventing pregnancy. The scarring process takes three months. Women must use other contraceptives until testing confirms the tubes are blocked. Most often this test is not covered by insurance.

Over 19,790 have joined the Essure Problems Facebook group, because this contraceptive device that was supposed to be quick, easy and safe permanent birth control, has turned their bodies into a little house of horrors. Through May 2015, nearly 5,100 adverse event reports had been submitted to the FDA. The new study found the most common complaints include: pain, fatigue, abdominal distention, heavy menstrual bleeding, cramps, headache, abnormal weight gain, arthralgia, migraine, painful intercourse and hair loss.

Doctors tell us to rely on their knowledge and look askance at the Internet. However, device manufacturers can get FDA approval based on modest numbers with short term data. In the case of Essure, 400 women were followed for one year, and 200 for two years. There is difficulty in getting device illness reports taken seriously, especially when they are filed by patients, but doctors often do not file reports. There is a lag time for information to be collected, papers published and read, and information shared. Physicians who rely on the highest standards of evidence-based medicine will always be behind the curve.

We have both been injured by very different FDA-approved devices. Our symptoms escalated and cascaded, and our growing series of doctors and specialists could not find out what was wrong with us. At first they did not even consider that a device could be causing these systemic problems. Some were disbelieving as they had not read of reported cases of device illnesses in the literature. In each case, a great doctor helped figure out what went wrong, and we built new excellent medical (and dental) teams to work on addressing multiple and systemic problems.

Among the consequences: unable to work, impacts on our families, and high uncovered costs. Device illness patients face lives changing from a series of adventures, enjoyments and accomplishments to a series of medical appointments, medications and procedures.

According to the original Essure brochure given to women, the device should not be used in women who, “Have a known hypersensitivity or allergy to nickel as confirmed by skin test.” The brochure also stated (emphasis added): “There are very little data on the safety of or the chance of pregnancy with Essure beyond this time frame. Once longer-term data are available, the information on the safety of and chance of getting pregnant while using Essure may be different than the data based on 1 or 2 years of use.” By 2014, Bayer's updated brochure included additional warnings of pelvic pain, device migration, ectopic pregnancy, and allergy warnings.

Why does the FDA alert you to do a patch test for hair color 24 hours in advance, yet not require or recommend pretesting for biocompatibility (allergy and immune reactivity tests) before permanent devices are installed in non-emergency situations? Medical devices are not subject to the same type of premarket safety testing as prescription drugs. They have always been the poor stepchild of the FDA, and women, children and men who are unlucky enough to not be “average” pay a tragically high price. Metals allergies – and genetic variations in methylation – are not uncommon - but are rarely tested in advance.

Patients like us learn that our installed medical and dental devices were not “biocompatible” with our bodies, genes and cells after the fact, when it is too late. Historically, reporting of medical device health impacts – called adverse events by the FDA – has been done sporadically by doctors and rarely by patients. There is little incentive for research on post-market health problems – that arise after devices have been approved and are in widespread use. Nobody makes money on limiting uses of devices, vs. expanding their use.

Epidemico’s Medwatcher app empowers patients to report their health problems directly to the FDA quickly and easily, adding a new, direct experience database to document health impacts, and improvements from remediation that include operations to remove the device. Some patients have undergone multiple operations in efforts to contain and reverse the damage.

Many women will be going to an FDA Expert Panel Meeting on Essure September 24, 2015 – the day Pope Francis will be in town to address Congress. They will ask FDA to remove Essure from the market until further testing is done, or at a minimum issue a black box warning. Basically get this product off the market and find a remedy for those who have been harmed. Patients with other device illnesses – there are many – are submitting statements of support.

If you have any health problems whatsoever, look into whether a medical or dental device might be a factor in causing it. Do not be afraid to speak up when they think something is wrong. Only you know your body and nobody can tell you how you feel. Without your information, doctors and the FDA will be missing key impacts. If you have problems, report them on MedWatcher, so your experience can help support others’ health. Learn more, and tell FDA, the Administration and Congress to put patient safety and health first. Act now.

Melanie Goshgarian is a 911 Emergency Dispatcher with over 17 years of experience in police, fire, and medical emergencies. She volunteers as a patient advocate to Women harmed by Essure and collaborated with Epidemico on this MedWatcher study. Laura Henze Russell is Principal of Precision Research & Communications and Hidden River Health Challenge. She is launching a call for Medical and Dental Device Safety Urgent Reform: MEDDSURGE.

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

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.

 Follow

Laura H Russell @LauraHRussell

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

11:01 AM - 1 Jul 2015

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From MetroWest Daily News July 14, 2015

• Russell: Congress can do more to fight ‘hidden health risks'

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   By Laura Henze Russell
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  Guest Columnist

  Posted Jul. 14, 2015 at 3:52 PM 
  
  
  

  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.

  
  

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 

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  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.
  

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.

OLD HARD AND NEW FAST WAYS OF LEARNING ABOUT THE GENOME, THE TOXOME, AND HOME

I learned the old hard way (20+ years of chronic disease), then the new fast way about gene types and toxins: two years discovering biocompatibility issues in dentistry and medical devices, and immersion in the sciences and arts of investigative and scientific research. An economist and ethicist by training, with a new vocation and skill set by life's necessities and the fundamental urge to be well.

What am I learning? Health and chronic disease has a lot to do with methylation, and other basic biochemical and bioelectrical pathways essential for human life, animal life, probably plant life. We are the biome, the toxome, the home. Much as we like to think we are a higher being or species, our higher creative and economic capabilities come back to bite us when we ignore the fundamental economic, social, medical, environmental externalities at the scale of patient, profession, and  local, national and global levels.

It's all about luck in the gene pool, and in the toxins pool.Those with great genes can swill toxins and expel them with ease, and dance and compose magna opi in their 90s. Those with bad luck in methylation, detoxification, and immunological pathways can still be healthy - but only if they avoid toxins like the plague. Because they are ubiquitous, and stick with us given our genetic glitches, we begin the long slow decline, the long sunset, and the long goodbyes much too early, before our time.

But there is hope! We can now learn our gene types and our toxins, separate the bad from the bad, and strengthen the good.The body, brain and psyche has an astonishing capacity to heal itself when, like a computer or a car, we clean out bugs, reboot/reset electrical pathways and get things humming in the right direction again.

After being 25 years clinically older, I am now 25 years clinically younger. At 60, I may live to 101 like my grandmother relatively intact, instead of mid 80s with a horrible last few years like my mom. When my time comes I'd vote for a massive heart attack in my sleep or the ice floe or ocean to reenter the great sea and circle of life from which it began.

There are clinical trials underway in Sweden of a compound that boosts glutathione to help with metals toxicity because the FDA wouldn't grant orphan drug status. People travel even overseas for biologic dentistry because dental plans have no patient protection nor medical necessity rules, they are strictly commercial contracts that write their own rules. Health insurers would be so wise to cover biologic dentistry like any specialty, make referrals, and incorporate all things dental into EHRs.

Dental is the root of much inflammation and oxidative stress throughout the body and brain. Teeth are god's plan for mortality. Dental infections, and toxins - conveniently denied by the ADA and the FDA - cheat us of years of health, vitality, cognition and mobility. Dental mercury poisoning is acknowledged in many advanced countries, not in the USA. Toxins - bad for humans - are synergistic.

Biologic dentistry, functional medicine, integrative and holistic approaches are growing by leaps and bounds not just because they make people feel better, but because they work.

I am interested in partners for fascinating ventures. New interests include health innovation, apps and IT, wellness, chronic diseases, etiology, epidemiology, QR codes, old and new medicine, genomics, toxicology, pharmacology, cellular bio-chem-electrics, medical devices, FDA, Form 3500s, govt regulation of dentistry and medicine, self regulation of the professions, patents held by professional associations, conflicts between professional and commercial roles, civil rights, genetic rights (none where it counts in dentistry and not enough in medicine), constitutional law, health law, conflicts of interest among top regulators and industry, lobbying and campaign spending reports, media, censorship and journalism. 

From Ocean Lifeguard to Health Lifeguard

Hidden River Health Challenge: A Social Innovation Enterprise

April 23, 2012

From Ocean Lifeguard to Health Lifeguard

I was an ocean lifeguard and have the lifeguard's mission to protect everyone in and out of the water. 

If there is a rip tide, I'd swim out and help guide people in safely to minimize risk. I'd help them understand what to do next time to stay safe. I'd give anyone who needed it first aid. I also loved to teach Red Cross swimming lessons - how to enjoy the ocean, bay and lake while enjoying nature, exercise, and breaking waves' ozone and endorphins. 

After being chronically ill, and finally figuring it out, and working to regain and restore my health and vitality, I have a new calling: as a sort of Health Lifeguard.

Hallelujah, I am Healthy Again!

After 20 years of chronic disease and a year of escalating health problems, I'm healthy again! 

The keys to understanding chronic diseases are unfortunate combinations of gene types and toxins, which trigger inflammation.

Inflammation, causes a raft of awful, no good, very bad, cognitive, immune, neurological and psychiatric diseases, as well as damage to cells, nerves, organs, senses and skin.  

I am healthier! I lost years of health, lost years of income, and still have years of higher dental and medical costs.  

I don't want others to have to go through what I went through, physically or financially.

Join us at Hidden River, to help ourselves and others too.