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.

NEJM Calls for Revisiting Essure Safety

NEJM published Revisiting Essure - Toward Safe and Effective Sterilization, on the eve of the FDA's Panel Hearing on the Essure permanent contraceptive device. The Essure procedures works by inserting two nickel-titanium coils coated with plastic PET into the fallopian tubes, inducing scarring to prevent passage of the egg to prevent pregnancy. It states:

"The upcoming meeting of the Obstetrics and Gynecology Devices Panel represents a clear opportunity to impose requirements that will more fully elucidate the safety and effectiveness of Essure. A new study focused on patient-centered end points — unintended pregnancy, device migration, tubal perforation, bleeding, pain, and events such as hysterectomy and death — in all enrolled women is needed to provide clear estimates of device performance. Such a study should compare outcomes in women receiving Essure with those in women undergoing laparoscopic sterilization, the standard of care, and should be overseen by an impartial, off-site data and safety monitoring board performing periodic, planned reviews with follow-up for at least 5 years."

"The problems of inadequately rigorous premarketing and postmarketing studies, unregistered clinical trials, and incomplete and delayed dissemination of results are not unique to Essure. Most FDA-required postapproval studies are smaller than the premarketing studies, most follow patients for 1 year or less, and nearly half lack comparator groups.5 The 13-year history of Essure emphasizes the necessity for thorough examination and timely reporting of patient outcomes in well-conducted premarketing clinical trials and dedicated follow-up in postmarketing studies. Only then will we better understand the risks and benefits of various devices. In the case of Essure, these data would allow women to make more informed decisions regarding hysteroscopic sterilization." 

The stories, pictures and experiences women and physicians share at the FDA hearing Thursday are even worse.

Why not call for a moratorium on placement while additional post-market studies are conducted on women already implanted with the device, instead of multiplying the potential for harm, while serious questions of risk have surfaced based on evidence?

Who does the FDA calculation weighing risks and benefits of a device for approval, for warnings, and for removal from the market?  What factors are involved? Whose benefits, and whose risks?  It seems FDA weighs company benefits over patient risks.  Patient benefits are artificially inflated given the existence of safe and effective alternatives, and FDA seeks more to minimize company risks than patient risks.

Update: It was an honor to meet Dr. Ailene M. Gariepy, M.D., M.P.H. of Yale School of Medicine, co-author of this article, at the FDA Panel Hearing on Essure September 24th.

Good Morning America with Melanie Goshgarian on Essure Problems, Sept. 22, 2015

Hear Melanie Goshgarian tell her story on ABC Good Morning America Sept. 22, 2015. Essure women are an amazing force. Join women from across the U.S. at the FDA Panel Meeting on Essure Sept. 24, 2015.

Petition for Medical and Dental Device Safety Urgent Reform (MEDDSURGE)

Please sign this Petition to Congress & Administration: Medical & Dental Device Safety Urgent Reform (MEDDSURGE)

Many friends have been harmed from FDA approved medical and dental devices. 
The regulations are nearly four decades out of date. Fix them now.

Fix FDA regulations for medical devices and dental materials! Unlike for prescription drugs, 

OTCs, personal care and food products, there is NO information required to go to the 
patient or parent about materials they contain. Patients can experience harm from devices 
ranging from dental amalgam fillings to Essure, Mesh, joints, implants, stents and more. 
Reactions vary based on gene types that impact how well we clear materials that are not 
natural to the human body. There is NO pretesting to determine if you will have a reaction in
advance as is recommended for hair color (although a one-time test is available). Peer 
reviewed research links autoimmune, neurological and other illnesses with devices.

For dental fillings, there is NO right of written informed consent. FDA warnings for dental
amalgam (called silver fillings, but 50% mercury) are required only from manufacturer to 
dentist, NOT to patients. There is a flawed MedWatch reporting system for dental device 
reactions, and dental information does not go into patients' Electronic Medical Records so 
it is hard for doctors to connect illnesses. Dental insurance does not cover the higher cost of
replacing amalgam fillings when medically indicated. Patients face high costs and lost income.

Enact Medical and Dental Device Safety Urgent Reform (MEDDSURGE)! 

Refocus CDC and National Institutes of Health (NIH) funding on Chronic Diseases. Provide 

treatment for patients with device illnesses. Ask Surgeon General to take emergency action. 

Put patient safety first.

SIGN THE MEDDSURGE PETITION HERE

MEDDSURGE: Is Your Medical/Dental Device "Right for You?"

Medical and Dental Device Safety Urgent Regulatory Reform

MEDDSURGE: Top Priority for FDA Reform

Is Your Medical/Dental Device “Right for You”? Keep Pace with Science, Reduce Harm, Lower Costs

 For All Medical and Dental Devices, Congress should require:

·         Written information for patients on what materials devices contain, like for Rx & OTC.

·         One-time pretest to determine which devices are “right for you” in advance.

·         Immediate full implementation of the new system of Universal Device Indicators (UDIs).
·         Redirect device tax to Medical & Dental Device Illness Compensation (MEDDIC) Fund, and end federal preemption so ill and injured patients can seek redress in the courts.

Additionally for Dental Materials:

·         Written informed consent for dental fillings.

·         Medical records to include dental devices, fillings and materials information to allow physicians, epidemiologists and Big Data to assess the potential for health impacts.

·         FDA MedWatch Form 3500B to include a section tailored for dental fillings and devices.

·         Order HHS to release FDA January 2012 Safety Communication on Dental Amalgam.

Thousands of Patients Are Harmed by Medical and Dental Devices:

·         According to MedWatch & DENS, over 1,000 complaints have been filed on dental amalgam. Over 100,000 people have sought volunteer counseling from DAMS to find dentists qualified and able to work with patients ill from dental mercury toxicity.

·         FDA’s MAUDE shows thousands of women have filed complaints for medical devices such as Essure contraceptive coils, vaginal mesh, morcellators, and breast implants.

·         FDA’s MAUDE shows thousands of men and women have filed complaints for cardiac devices, implants, joints, stents, etc. If they are “right for you” is learned after the fact.

We Need Precision Medical and Dental Devices
MEDDSURGE Can Improve Health, Reduce Diseases and Lower Healthcare Costs By:

·         People react differently to foods, prescription drugs, and medical devices and materials.

·         Medical and dental devices provide 24/7/365 exposure to sources of inflammation.

·         Inflammation is at the root of many chronic diseases, from autoimmune to neurological.

·         Ensuring devices are ‘right for us’ will lower chronic disease rates and health care costs.

·         Tailoring medical devices selected for treatment to the characteristics of patients.

·         Conducting clinical trials run as “basket studies” by major genetic variants to determine which device materials are safer for which patients, and which should not be used.

·         Making sure any device used is “right for you” before it is installed.

·         Enabling patients to be reimbursed for uncovered medical, dental and supportive treatments by a Medical & Dental Device Illness Compensation (MEDDIC) Fund, and for patients to recover lost income and care expenses when needed.

Sign MEDDSURGE Petition here.

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.
  

FDA Stands by its Dental Amalgam Mistake

Posted in Regulatory and Compliance by MDDI Staff on February 13, 2015

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. 

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.

RACHEL LOUISE CARSON: Google lets fly a Doodle true to ‘Silent Spring’ writer’s nature - May 27, 2014

My Comment on Today's 
Washington Post Article on Rachel Carson's Google Doodle: 

We have many scourges we have unleashed upon ourselves. We need to pick up the mantle and continue fighting not just the silent spring from pesticides, but the rising tide of chronic cognitive, immune, neurological and psychiatric diseases caused by the hidden river of toxins within us. 

The greatest scourges of our time, stealthily ravaging our bodies and minds, are mercury, mold and Lyme. They are not significantly recognized, they are not sufficiently considered and screened and tested for, and when found, they are not properly treated by the vast majority of physicians. 

Please read and share the Issue Paper: For Good Health, Integrated Care, and Making Chronic Diseases History, posted on www.hiddenriverhealthchallenge.blogspot.com. It addresses the first scourge.  

Rachel Carson was, and is my inspiration, and my muse. I organized a 1970 Earth Day cleanup in my high school, founded a local environmental organization, set up a school-based recycling center, and collected pictures for the first Dirty Dozen Campaign while a college intern at Environmental Action. 

Now we need to organize a People Day. Hidden River Health Challenge is gearing up to launch a Fishing Expedition to land the worst offenders, and celebrate the champions, of ending the scourge of dental mercury installed without our knowledge or informed written consent. Think about that. No labels No informed written consent. For a medical device. Containing a known neurotoxin. That off-gases mercury vapor with heat and abrasion, in teeth made to chew. Genetically susceptible children and adults experience great harm. It is not on our radar screen. 

The media is silent. The FDA was sued March 5th by the International Academy of Oral Medicine and Toxicology and others, and no mainstream media covered the release. Congress is silent. The Obama Administration is silent. Apparently the media and politicians are even more sensitive to toxins - the ones called money, lobbying, and spin.