Showing posts with label big data. Show all posts
Showing posts with label big data. Show all posts

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

Thursday, May 28, 2015

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 


  • 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.

Wednesday, May 21, 2014

PRESS RELEASE: FOR GOOD HEALTH, INTEGRATED CARE AND MAKING CHRONIC DISEASES HISTORY

For release: May 22, 2014                
         

Contact: Laura Henze Russell, Principal, Hidden River Health Challenge, 339-364-0701 laurarussell2@comcast.net
Elizabeth Brody, Chief of Staff, Sen James Timilty, 617-722-1222, elizabeth.brody@masenate.gov

                                 

Sen. Timilty Working for EHS 692: For Good Health, Analyze Dental and Health Records

Sen. James Timilty (D-Walpole) filed Senate Budget Amendment EHS 692 to ask the MA Center for Health Information and Analysis to include dental insurance records in their health insurance database analyses, which are used by the MA Health Policy Commission to look at trends in chronic diseases and health care costs. Biocompatibility problems with dental materials, and dental infections are major drivers of inflammation, the common cause of many chronic diseases.

Rep. Louis Kafka and Sen. Brian A. Joyce each filed a bill related to dental amalgam in 2013. They were sent to study by the Public Health Committee, but its co-chairs welcomed a related budget amendment. Three other New England states and CA provide some consumer information, and the FDA says state consumer labeling does not violate preemption. The label could include a bar code and a QR code so people can look up more product information on their cell phones. The bills will be refiled next year.

Many legislators thought dentists stopped using amalgam years ago, and are surprised it is still in use. Everyone has an interest in keeping people healthy. Dental plans should be cost neutral and subject to patient protection laws and medical necessity. MassHealth should cover alternatives to amalgam, as Pennsylvania has for years. Paying a little more upfront for biocompatible filling materials can forestall years of higher health care costs for genetically susceptible children and adults. There are a half dozen common gene types that do not clear mercury well, raising the risk of immune and neurological damage. There are numerous studies on higher rates of chronic diseases with amalgam, and occupational risks.

Hidden River Health Challenge is also releasing a new Issue Brief today to make the case for action, subtitled, How We Can Get Better & Lower Health Care Costs by Blending Old & New Knowledge, Ending Conflicts & Rebooting the Health Sector. “It is time to catch up with the rest of the world, put patients instead of industry protectionism first, and end ‘conflict regulation’ and ‘conflict dentistry’ in the United States, says Laura Henze Russell, founder of Hidden River Health Challenge. 

Russell recovered from two decades of fibromyalgia and a year of escalating medical misery which turned out to be due to a genetic glitch in clearing mercury, which off-gases from dental amalgam. She delved into the subject in order to recover her health, and help protect others from her fate. “It is astounding to me that we get no labels, and have no right of written informed consent, for installation of a dangerous neurotoxin that is considered a medical device by the FDA,” says Russell.

Unlike the AMA which holds no patents so has no commercial and trade interests, the ADA was assigned 83 patents in the 38 years - 1976 to the present - in which the US patent office records are fully digitized, including two related to dental amalgam that expired in the mid-1990s. Patents granted to all sources on dental amalgam since 2002 are all related to mitigating its harm to the environment.

Russell sent in-depth letters with information on new peer reviewed journal articles on clinical trials showing harm from dental amalgam to boys with certain gene types to the Massachusetts Department of Public Health, EOHHS, Division of Insurance, Attorney General, and the Sharon Board of Health. The Issue Brief is being shared with  the MA Legislature, Health Policy Commission, and stakeholders. The findings of amalgam safety from the Children’s Amalgam Trials have been retracted. The American Public Health Association declined in 2013 to ratify its interim policy that amalgam is safe and effective. Nigeria is the latest nation to end the use of dental mercury, announced May 21, 2014.

The International Academy of Oral Medicine and Toxicology (IAOMT) filed a lawsuit against the FDA March 5th for failing to respond to a petition to reconsider the flawed 2009 Class II dental amalgam ruling based on numerous errors in the FDA’s risk assessment after 54 months. The Administrative Procedures Act requires a response within one year.  IAOMT is one of three dental associations opposed to the continued use of dental amalgam. It supports science and trains dentists on safe removal techniques when indicated and special equipment needed beyond a dental dam to minimize patient and staff exposure to mercury vapor.

Mercury vapor from dental amalgam, mercury from fatty fish such as tuna and swordfish, from skin lightening creams, and from old medications such as mercurochrome and merthiolate are different forms of a potent neurotoxin and human exposure from all sources should be minimized.

It took Congress 14 years to pass President John F. Kennedy’s bill to add medical devices to the FDA. Unfortunately, Congress never instructed the FDA to require medical devices contain the kinds of patient labels, composition information, health risks, side effects, and a number to call to report adverse events that patients get for every prescription drug, and for chemicals. We get labels on our Cheerios, and labels and health warnings on toothpaste not to swallow it, but nothing on medical devices permanently installed in our teeth. It took the FDA 33 years to classify dental amalgam, and the risk classification is flawed, outdated, and out of step with much of Europe and Canada, which have warnings and consent. Four Scandinavian countries and Japan have banned its use.

There is a growing movement for funding, running and analyzing clinical trials data by gender, led by Dr. Paula Johnson of Brigham and Women’s Hospital, Senator Elizabeth Warren, and other speakers at the Women’s Health Summit in Boston in March. FDA Commissioner Margaret Hamburg, who sat on Henry Schein’s board for six years, disagreed, saying it would be too expensive to reanalyze old studies, and we need to move forward. Biotech and medical researchers confirm the need to add gene type and gender.

Russell is a social innovation entrepreneur, economist and ethicist concerned with health and family wellbeing, an injured patient, a mother, wife and daughter with a family tree with its share of chronic diseases. After two decades of fibromyalgia, and a year of medical hell, Laura regained her health and ability to work. She faces large dental costs and lost her appeals to a “great” dental plan due to the FDA ruling that amalgam is still Class II, standard of care for everyone. A former ocean lifeguard, she renewed American Red Cross Water Safety Instructor, Lifeguard, and Lifeguard Trainer certifications.

Russell founded Hidden River Health Challenge: A Social Innovation Enterprise to help people learn about the impact of genes and toxins, importance of our own health information, share and take action. Hidden River is reaching out to people, stakeholders, and candidates running for office to build support for good health, integrated whole body care, and helping make chronic diseases history.
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