Congress needs to turn its attention to medical device safety

This article was originally published by STAT (www.statnews.com) on December 21, 2016:

With the landmark 21st Century Cures Act now signed into law, Congress needs to turn its attention to another pressing health issue: the safety — or lack thereof — of medical devices.

Thousands of medical devices are on the market today, with a steady stream of new ones coming along. They include spinal and breast implants, pacemakers, TENS devices for pain, transvaginal mesh slings, tubal occlusion sterilization coils, dental amalgam, prosthetic joints, and more.

The Food and Drug Administration puts medical devices into three categories. Class I devices are simple and have little potential to cause harm, such as bandages. Class II devices are more complicated and present a greater risk or harm. These include motorized wheelchairs and simple implants such as radio frequency identification chips; they are often approved with special guidelines for control. Class III devices help support or sustain life or present a potentially significant risk of injury. Examples include pacemakers, artificial heart valves, and joint replacements.

For all the good that medical devices do, they can also cause harm. I know this because my health was almost irreparably harmed by the mercury-based dental amalgam used over my lifetime to fill cavities — it turns out that genetic susceptibility is a factor. I have friends, relatives, and colleagues who have endured cancers and autoimmune diseases, allergies, rashes, pain, memory loss, and incredible emotional strain from problems caused by various medical devices.

Click here to read the complete article. 
https://www.statnews.com/2016/12/21/medical-devices-safety-congress/

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.

Lyme Disease Continues its Spread

Lyme Disease Continues its Spread, MetroWest Daily News & Milford Daily News

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  By Laura Henze Russell/Guest Columnist

  Posted Aug. 24, 2015 at 1:39 PM 

  Wonder if there is a Lyme epidemic in Massachusetts? The MetroWest had some of the highest incidence rates in Massachusetts in 2013. Middlesex County had a 450 percent growth rate in reported Lyme cases from 1997-2001 to 2007-2011, and the largest number of cases of any county in the commonwealth.

  A CDC map shows Lyme marching on – along with nasty co-infections ticks carry – from its discovery in 1981 in Connecticut and Long Island, New York, throughout the Northeast and MidAtlantic to the Upper Midwest, with beachheads scattered in the Midwest, West and South. The first diagnosed cases came from the Lyme, Connecticut, area.

  Official cases reported to the Centers for Disease Control (CDC) have risen to 30,000. CDC officials say the real number is about 10 times more, 300,000, based on a survey of clinical testing labs (2008) and medical insurance claims (2005-2010). Observers say it is much higher now, as it seems almost every family has someone touched by Lyme – sometimes many times.

  Why is Lyme a big deal? Caught early, a short course of doxycycline is usually sufficient. Some doctors prefer doxycycline monohydrate capsules to the cheaper generic hyclate, and it has been reported to cause less nausea than that tablet form. When Lyme – transmitted by tick bites – is treated early, the parasite is killed before it can establish its reproductive life cycle in the body.

  When it is not caught early, there is potential for longer-term illness and complications as the reproductive cycle is established within the body. There is controversy over whether the parasite is still present, perhaps in cyst form, or hiding in biofilm, spinal fluid, or other hard-to-treat areas, waiting to emerge again, especially in those whose immune systems are now compromised. The CDC disagrees, and calls it "Post-treatment Lyme Disease Syndrome" (PTLDS) as a result of immune changes instead of ongoing infection.

  Some physicians with extensive experience treating Lyme patients, who belong to International Lyme and Associated Diseases Society (ILADS) and are called “Lyme literate” doctors, call it chronic Lyme or persistent Lyme. Lyme disease symptoms vary greatly among people, and also by staging of the disease. Seventy percent got the telltale rash which is not always present and fades with time, 30 percent arthritis, 9 percent facial paralysis (Bell’s palsy), and 6 percent nerve pain, brain swelling (encephalitis) or heart problems.

  According to specialists like Dr. Richard I. Horowitz, author of “Why Can't I Get Better?” Solving the Mystery of Lyme and Chronic Disease,” Lyme is a “great imitator” of many chronic diseases, including chronic fatigue syndrome, fibromyalgia, autoimmune conditions like M.S., psychiatric conditions like depression and anxiety, and it also causes significant memory and concentration problems, mimicking early dementia. He writes that co-infections are a significant and growing factor in tick-borne diseases. They require different tests and different treatments.

  Diagnosis, testing and treatment are all the subject of controversy, but there has been movement to recognize the validity of both ILADS and Infectious Diseases Society of America (IDSA) guidelines, to get insurance to cover more forms of treatment, and to stop disciplining doctors who use the ILADS guidelines. The Massachusetts legislature passed a law to that effect, and efforts are underway in Congress.
  

  What does all this mean for us?

  First, do your best to avoid ticks like the plague, spray your yard and clothes, wear tick protective clothing, and do thorough daily tick checks of children, pets and you. If you find one embedded, use special tweezers and techniques or have it removed or it may break off and flood you with a full exposure to Lyme immediately, as happened to me last year, so I caught it again.

  Second, if you see or suspect you have a tick bite, have a bull’s-eye rash or have fever, pain or Lyme-like symptoms, get to a doctor right away. Early antibiotic treatment now can forestall months, years or a lifetime of costly, debilitating, and harder to treat health problems.

  Third, if you are sick and tired with fibromyalgia, chronic fatigue syndrome, arthritis and other migrating pains, brain fog, memory loss, neurological or other mystery symptoms, don’t just chalk it up to aging. Even if you have been treated for Lyme disease in the past, it may not have been the right protocol to rid Lyme and co-infections from your system, or you may have been reinfected by another bite. Find an ILADS doctor and get another opinion.

  Fourth, it is time for broader action. Dr. Horowitz outlines a plan for Centers for Excellence in treating Lyme and Chronic Diseases. Congress is starting to pay attention. Massachusetts needs to do more. It is high time to march on Lyme.

  For diseases like HIV/AIDS, there are public education and screening programs, and aggressive coverage of lifetime therapies to forestall progression of disease. For diseases like malaria, there is prophylactic treatment routinely prescribed for the duration of travel and living in areas where it is endemic. Is such an approach needed for Lyme? Do we need prophylaxis in season? Do we need routine tests and screening? Can we develop safe and effective vaccines against “tick spit?”

  For Eastern equine encephalitis and West Nile, we have county mosquito control programs. It is harder for Lyme as tick habitat is everywhere, not just stagnant water. Would deer control help? Driving to Dr. Richard Horowitz’s excellent “Living Well with Lyme” weekend workshop at the Omega Institute in New York’s Hudson Valley, I nearly hit a deer as it sped across six lanes of the Mass Pike a few hundred yards ahead. Not long after, a dead deer lay on the median. Do we put up deer warning signs on the Pike like the Hudson Valley highways, and take steps to control the booming population?

  
  

  Hearing stories of misdiagnosis, pain and denial faced by many at the workshop, one got the sense that the U.S. has stronger laws to protect deer than patients with complex chronic diseases. Can we recognize Lyme strain variations when it comes to lab tests, where we are behind Europe which tests for three Lyme strains instead of one? Add tests for common co-infections? Have insurance companies cover expanded treatments when needed for health instead of deny them? It is important to treat Lyme and co-infections in their different lifecycle phases, to cover complementary and supportive therapies that boost the immune system, and to recognize that not all patients respond equally well to standard treatments once infections have been established.

  In addition to learning what it takes to heal ourselves and treat others as patients or physicians, we need to reboot health systems, agencies, insurers and providers to work for us - for our health, instead of against us, lagging far behind – especially on the hidden health challenges of our time.

  Laura Henze Russell is the principal of Precision Research and Communications, and Hidden River Health Challenge. Email her at laurarussell2@comcast.net. 

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.

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.