Showing posts with label regulations. Show all posts
Showing posts with label regulations. Show all posts

Sunday, April 27, 2014

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.


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

Wednesday, April 16, 2014

Sound an Alarm on Dental Amalgam: House Call for the Surgeon General

Sound an alarm on dental amalgam

2014 January 10
by Rick Holmes
A guest post from Laura Henze Russell:
Fifty years after the U.S. Surgeon General’s Report on Smoking, it is high time for President Obama to ask the U.S. Surgeon General to prepare a Report on Dental Amalgam.
The great United States of America, through the U.S. Food and Drug Administration, lags behind other advanced, emerging and developing nations in recognizing and protecting its citizens from dental amalgam’s scientifically proven health risks to genetically susceptible children and adults.
The FDA refuses to follow the recommendations of its own Scientific Advisory Panels on amalgam in 2006 and 2010 which called for clear health warnings, patient restrictions, and specific prior informed written consent before its use. Instead, the FDA requires clear health warnings and contraindications to be provided to dentists, but not patients.
Why? The American Dental Association and FDA fight tooth and nail to preserve its use as a “safe, effective restorative material.”  The ADA was founded as a pro-amalgam trade association, has filed patents on it.  Whistleblowers at the FDA went to Congress, but nothing happened.  There was a 36-year delay in classifying amalgam as a medical device, then in 2010 the FDA shocked everyone by only making it Class II, with special controls for dentists and none for patients, instead of Class III, which requires proof of safety. The International Academy of Oral Medicine & Toxicology (IAOMT) and injured patients petitioned for reconsideration, nothing happened.
They have not convinced the IAOMT, IABDM, Holistic Dental Association, or a growing number of doctors treating the growing number of patients recovering from the raft of chronic autoimmune, neurological and other diseases that plague us as we age.
They have not convinced the over 100,000 people who finally figured out why they were ill, and contacted the volunteer patient counseling, information and referral, and support group Dental Amalgam Mercury Solutions (DAMS), which is run by a volunteer executive director, board members, and volunteer coordinators in all 50 states, many of whom are on disability due to mercury poisoning from amalgam.
They have not convinced the American Public Health Association, a majority of whose members declined in 2013 to ratify a policy somewhat hastily pushed through by ADA allies in late 2012, so APHA no longer endorses dental amalgam as safe and effective for use.
The U.S. signed the Minamata Treaty in Japan this year to phase out use of mercury worldwide, in all products, to reduce the burden of this potent neurotoxin on human health.  But when it comes to dental amalgam mercury, the U.S. takes baby steps, backward steps, bumbling steps.
Industrial and medicinal mercury gave us Mad Hatter’s Disease, Pink’s Disease for toddlers and children, Minamata Disease in Japan, and took down a number of venerated nurses and healers, including Clara Barton and Florence Nightingale.
We need a house call, and a wake up call, from the Surgeon General. May he come soon to save us from ourselves and our dentists, so we can all get and stay healthier and make the need for health care fall for the first time in the U.S.
Laura Henze Russell is the Founder of Hidden River Health Challenge: A Social Innovation Enterprise Promoting Health.