Tuesday, September 29, 2015

Steven Brill's Brilliant Expose, America's Most Admired Lawbreaker: Pharma

Steven Brill's America's Most Admired Lawbreaker reveals the inside story of Johnson & Johnson's pharmaceutical marketing gone bad. His accounts of aggressive off-label marketing of its anti-psychotic drug Risperdal to children and elders, paying for steering and revising medical research and journal articles, and building partnerships to market off-label uses are electrifying.  
Here are the chapters of Brill's 15-day serialized series in Huffington Post.

Chapter 1. The Credo Company - J&J's evolution from its founder's credo of putting patients first to today, putting its management and shareholders first. 
Chapter 2. Blowing Past the Label - Marketing plan and SWAT team go off label.
Chapter 3. Sales Over Science - Risperdal legos. 46% of sales children, elders.
Chapter 4. Massaging the Data, Spreading the Word - Buying research.
Chapter 5. Three Card MonteHow to get away with data manipulation.
Chapter 6. Trouble - The Yo Yo Ma Brochure, and a Whistleblower emerges.
Chapter 7. A Multi-Front War - Cooking research findings for FDA, hiding weight gain and male breast development.
Chapter 8. Firing Blanks, Hunting for Smoking Guns - Gods, Doctors who would be Gods, Conflicts of Interest.
Chapter 9. Under Siege, Ducking and Weaving - Too Big to Nail, so the Game Plays On.
Chapter 10. Chess, at $1,000 an Hour - Playing Wizard's Chess with children's and elders' health at stake.
Chapter 11. Pleasing Wall Street - A plea to settle on illegal marketing to elders, in exchange for a skate on illegal marketing to children.
Chapter 12. Showdown, Almost - Unconscionable. How will candidates for President address this?
Chapter 13. Hardball - Thank goodness for David Kessler. Throw the book at pharma, devices and research crimes against humanity.
Chapter 14. The Good Soldier, The Good Mother, The Faded Star - Time to throw the moneychangers out of the temples of our bodies.
Chapter 15. The Verdict... And Moving On - Pulitzer Prize please. The best since Watergate. 

Thank you, Steven Brill, for an excellent narrative, cross, and summation. The honor system has become a dishonor system, and the sky's the limit. The FDA and U.S. Justice Dept. fiddle while American lives and health go up in flames. 

Reading this series is captivating, electrifying, and nauseating. What I find most troubling is that the US attorneys investigating would spend years and years developing evidence, rather than alerting FDA and taking swift action to protect the public. Think about that each time you consider taking a new drug, or installing a new medical device, that the time for the system to catch up with harm inflicted can take years or even decades.

The FDA drug approval system, which Steven Brill describes as an "honor system," clearly broke down and became a dishonor system. This is the system that Congress now wan
ts to fast track through the 21st Century Cures bill, which the House passed in July. Call your Senators and tell them to put patient safety first. 

We need a Precision Medicine and Precision Devices framework to ensure something is "right for you" before use. Patients vary and are not all average. Here is a petition for Medical and Dental Device Safety Urgent Reform: MEDDSURGE.

Wednesday, September 23, 2015

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.

Tuesday, September 22, 2015

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.

Saturday, September 5, 2015

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.

Monday, August 31, 2015

Got Health Problems from Mercury Fillings or Other Medical Devices? Report them on MedWatcher App

Got health problems from mercury fillings or other medical devices? Report them to FDA on MedWatcher website: www.medwatcher.org or app: www.medwatcher.org/mobileRegister, select medical device, select dental amalgam. It is quick and easy. Be counted!

Health Conditions Related to Mercury Toxicity

The International Academy of Oral Medicine and Toxicology (IAOMT)’s 2013 Position Statement, which includes references to extensive research from hundreds of studies and sources, states: “The mercury in dental mercury amalgam fillings can exacerbate and contribute to all of the conditions stated below, as well as a myriad of other health problems.

o Allergies
o Hearing loss
o Alzheimer’s disease
o Immunodeficiency
o Amyotrophic Lateral Sclerosis
o Kidney disease
o Antibiotic resistance
o Micromercurialism
o Autism Spectrum Disorders
o Multiple sclerosis
o Autoimmune disorders
o Oral lichen planus
o Cardiovascular problems
o Parkinson’s disease
o Chronic Fatigue Syndrome
o Periodontal disease
o Complaints of unclear causation
o Reproductive dysfunction
o Erethism (added by author)
o Chronic mercury poisoning
Source: International Academy of Oral Medicine and Toxicology (IAOMT,) Position Statement against Dental Mercury Amalgam Fillings for Medical and Dental Practitioners, Dental Students, and Patients.

Epidemico's Medwatcher app helps patients report harm from dental and medical devices. It is a tool for quick action. Here is a case study:

"Epidemico and representatives from a patient group, Essure Problems, co-authored a publication describing the use of Facebook outreach and the MedWatcher app to encourage adverse event reporting to the US FDA for Essure, a hysteroscopic sterilization device. Over 1,300 valid reports were received through the app over approximately 19 months... A report took on average 11 minutes to submit, compared to 40 minutes estimated for the traditional FDA MedWatch form."  
Source: Epidemico blog, "Increasing Patient Engagement in Pharmacovigilance," 8/11/15

Background: Before 1993, 900 reports of harm from dental amalgam were filed with FDA under the old DENS system. DENS was replaced with MedWatch in 1993, using Form 3500, a lengthy and cumbersome form that did not mention dental materials, and requested information not available such as model and serial number. Few took the time to report. We have filed a Freedom of Information Act request to get the count for 1993-2004. 

A shorter patient version was developed a few years ago, Form 3500B, but it still did not mention dental materials, and still asked for model and serial number. About 100 Medwatch forms were filed 2004-2015, which can be accessed through the FDA's online MAUDE system. Coding issues make it possible to locate only a dozen using dental amalgam as the product name. FDA staff did a search to locate about 100 total during the past ten years.

Epidemico developed the new MedWatcher portal and app that makes reporting adverse events much quicker and easier. Register online or via mobile, select the category of medical devices, and select the product of dental amalgam.  Fill out the screens that follow, they are simply worded.  If you are not sure, put N/A. Be succinct; give highlights. If you have any questions, email. Thank you!

Thursday, August 27, 2015

Regulatory Timeline for Dental Amalgam

2011-2015: Five Years of Denial and Delay

  • 2011-2014: James S. Woods et. al. publish four retractions of their findings of amalgam safety in children, finding neurobehavioral deficits in boys with four gene types.
  • 2011: At FDA regional public hearings around the country, many dental professionals and patients testified of harm and many diseases caused by mercury in dental amalgam. 
  • 2012: HHS quashed a planned FDA Safety Communication in an election year. The FDA called for reducing the use of amalgam, recognizing the risk of occupational exposure for dental personnel, and avoiding its use in susceptible sub-populations: Pregnant and nursing women; Parents and guardians of infants and children under age 6; People with mercury allergy or sensitivity; People with neurological disease; and People with kidney disease.[1] 
  • 2014: FDA and HHS were sued for failure to respond to multiple petitions for reconsideration.
  • 2015: FDA response to lawsuit is to take no action. McClatchy DC, Medscape and MD+DI Device Talk all report on HHS cover-up. FDA and HHS are sued for third time.

    2006-2010: Five Years of Wrong Action

    •       2006: FDA issued a White Paper concluding dental amalgam was safe. However, the FDA’s Dental Products Panel rejected the FDA’s position 13-7. The FDA did not act.
    •       2008: a number of organizations and plaintiffs sued the FDA for its failure to classify amalgam. The FDA settled the lawsuit, published a website warning, and agreed to issue a final rule within a year. FDA Commissioner Hamburg came in after a six year board seat on dental products distributor Henry Schein; the website warning was removed. 

    • 2009: FDA classified dental amalgam as Class II, with warning labels only to dentists.
    • 2010: After strong objections, FDA reconvened a Dental Products Panel. FDA did not take a vote. Dentists, patients and an expert risk assessment testified of risk and harm.

    1976-2005: Thirty Years of Inaction

    • 1976: Congress passed legislation to add medical, dental and radiological devices to the Food and Drug Administration (FDA).  Certain materials were ‘grandfathered’ as generally recognized as safe (GRAS) initially, including cigarettes, asbestos, and dental amalgam, but were to be reviewed and classified. The FDA declined to classify dental amalgam for decades. The FDA also declined to exempt it from classification.
    • 1987: FDA developed a new definition for the element mercury, “dental mercury.” The FDA ruled “dental mercury” to be Class I – generally recognized as safe.
    • 2002: FDA announced a proposal to reclassify dental amalgam as Class II with special controls related to dentists. Then it was put on the back burner again.

    Wednesday, August 26, 2015

    Lyme Disease Continues its Spread

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

    • 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. 

    Friday, August 14, 2015

    FDA Safety Communication: Reducing Exposure to Mercury Vapor Released From Dental Amalgam (Draft Jan 2012)

    FDA Amalgam Safety Proposal

    In January 2012, the FDA prepared a “Safety Communication” that recommended reducing the use of mercury amalgam in the general population, and avoiding it in susceptible subpopulations:
    • pregnant and nursing women
    • children under six years of age
    • people with allergy to mercury or other components
    • people with neurological disease
    • people with renal disease
    It also recognized the risk of occupational exposure for dental personnel.
    The recommendations were never made public, and in January 2015, the FDA issued another statement saying that amalgam was unequivocally safe for everyone. Somehow, somewhere in the reaches of government and the Health and Human Services Administration, this amendment to the FDA rule was killed.

    Here is the full text of the original, 2012 proposed rule:

    FDA Safety Communication: Reducing Exposure to Mercury Vapor Released From Dental Amalgam (“Silver Fillings”)

    HHS has not allowed FDA to release this safety warning. The most vulnerable continue to be harmed by a hidden river of mercury poisoning installed without our knowledge or consent.

    Please sign the Petition for Medical and Dental Device Safety Urgent Reform (MEDDSURGE).

    Thursday, August 6, 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.


    Monday, August 3, 2015

    MD+DI DeviceTalk: Lawsuit Tells How Politics Trump FDA's 'Gold Standard' on Mercury Fillings

    FDA tarnishes its reputation as the regulatory "gold standard" with its stance on mercury-based dental amalgam.
    ..."Copiously documented with legal, regulatory, and scientific exhibits, the 28-page Washington complaint supplements a 16-month-old lawsuit that FDA has been trying to ignore from the International Academy of Oral and Medical Toxicology and other mercury-opposed plaintiffs who, on other fronts, are winning as the archaic amalgam market in U.S. dentistry dwindles in favor of non-mercury composite resin alternatives.
    The darkest tarnish on FDA’s illusory gold glitter could be the new complaint’s discovery that after the agency in 2012 dutifully sent to its political bosses at HHS a scientifically-based final decision restricting mercury amalgam’s use in dentistry, FDA mysteriously reversed course.
    That final decision remained a secret, internal document until by a process unexplained in the complaint, it came into the hands of the plaintiffs’ lawyers, enabling them to compare what FDA had decided to tell the world about amalgam and what it was diverted from above to say instead. It did this last January in deceptive responses to three petitions from plaintiffs for a ban on amalgam."...

    Sunday, August 2, 2015

    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

    Embedded image permalink

    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.

    View image on Twitter

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