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/

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FDA’s medical device standards outdated, ineffective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. 

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.

The Aha! Moment: Why Houston (Boston, Washington, Congress) We Have a Huge Problem...

Medical and Dental Associations: Professional, Commercial and Trade, or Both?

 Ethical and Legal Questions

1. Is it appropriate for professional medical and dental associations to hold patents on products?

2. Should the licensing, teaching and practice of medicine and dentistry be separate from their trade and commercial interests?

3. What is the appropriate regulatory stance? What happens when conflicts of interest arise?

AMA

The American Medical Association (AMA) is concerned with the licensing, teaching, and practice of medicine. It does not hold patents on specific products.

ADA

The American Dental Association (ADA) is concerned with the licensing, teaching and practice of dentistry, and also with the trade and commercial aspects of dentistry. It was founded in 1859 to promote the use of an inexpensive restorative material at the time, dental amalgam, first introduced in the United States in the early 1830s. There have been improvements in its formulation over the years.

The ADA has been assigned 83 patents during the period of online records at the US Patent Office, 1976 to the present. Patents from 1790 through 1975 are searchable only by Issue Date, Patent Number, and Current US Classification.

The ADA’s most recent patent on dental amalgam, “Method for eliminating gamma.sub.2 phase from dental amalgam and improved dental amalgam composition” was granted in 1977, amended in 1978, and expired in the mid-1990s.  The ADA’s latest patent, granted February 25, 2014, is, “A method and apparatus for measuring the polishability of a solid material such as a dental restorative material.”

Trends in Patents on Dental Amalgam

There have been 42 patents filed with dental amalgam in the title during the period of online records at the US Patent Office, 1976 to the present. Patents from 1790 through 1975 are searchable only by Issue Date, Patent Number, and Current US Classification. Recent patents note a record of an early one filed, “Improvement in Dental Amalgams,” in 1874 by Stephen Southworth of Niagara Falls, NY.

In addition to the ADA 1977 and 1978 patents noted above, there have been additional ones granted. Of note, Japanese researchers were granted a patent in 1987, “Dental amalgam alloys containing selenium,” to counteract, “the cytotoxicity resulting from mercury eluting from the amalgam filler.”

Since 2003, the only patents that have been granted have been related to the mitigation of harm from dental amalgam to water, air, crops, fish, etc.: “Dental amalgam separator,” “Low-cost magnetically aided apparatus for separating dental amalgam from waste water,” and “System and method for reducing environmental crematorial release of mercury from mercury-containing dental amalgam, in which teeth are encapsulated to reduce mercury vapor as crematoria have weak emissions controls.

 This work by Laura Henze Russell is licensed under a Creative Commons Attribution 4.0 International License.