Cent4dent Blog

US Department of Labor files complaint against Niles Family Dentistry,
owner in Niles, Ohio, for violating OSHA’s Whistleblower Protection Act

CLEVELAND – The U.S. Department of Labor’s Occupational Safety and Health
Administration has filed a complaint in federal court against Niles Family
Dentistry and owner Dr. A. Scott Santucci for allegedly violating OSHA’s
Whistleblower Protection Act by creating a hostile work environment for two
employees and forcing them to resign. Santucci harassed the two employees
because he suspected them of reporting mercury spills at the dental
practice to OSHA on June 6, 2010. The spills occurred on June 2 and 4.

“Failing to protect workers from known hazardous substances such as mercury
is inexcusable,” said Michael Connors, OSHA’s regional administrator in
Chicago. “Taking retaliatory action against employees for reporting safety
concerns is a clear violation of the law.”

Santucci is alleged to have reduced working hours and created a hostile
work environment by repeatedly cursing and threatening a dental auxiliary
employee who had refused to work until the mercury spills were adequately
cleaned by qualified personnel. The employee worked at the dental practice
from August 2007 until she resigned on June 24, 2010, citing a hostile work
environment.

Santucci also is alleged to have reduced working hours and created a
hostile work environment by repeatedly cursing and threatening a second
worker after she refused to clean the spilled mercury. The second worker
was employed by the dental practice from April 2005 until she resigned on
June 21, 2010, also citing a hostile work environment.

The Labor Department is seeking reinstatement of both employees to their
positions; payment of lost wages and benefits, including interest and
punitive damages; and expunction of any mention of their protected activity
from their employment records. OSHA also is seeking to require the dental
office to post a notice to employees stating they it will not discriminate
against employees for engaging in protected activities such as OSHA
notification. The suit further seeks to enjoin Niles Family Dentistry and
Santucci from violating the Occupational and Safety Health Act in the
future.

OSHA enforces the whistleblower provisions of 21 statutes protecting
employees who report violations of various airline, commercial motor
carrier, consumer product, environmental, financial reform, food safety,
health care reform, nuclear, pipeline, public transportation agency,
railroad, maritime and securities laws. Under these laws enacted by
Congress, employers are prohibited from retaliating against employees who
raise various protected concerns or provide protected information to the
employer or to the government. Employees who believe that they have been
retaliated against for engaging in protected conduct may file a complaint
with the secretary of labor for an investigation by OSHA’s Whistleblower
Protection Program. Detailed information on employee whistleblower rights,
including fact sheets, is available online at http://www.whistleblowers.gov.

Under the Occupational Safety and Health Act of 1970, employers are
responsible for providing safe and healthful workplaces for their
employees. OSHA’s role is to ensure these conditions for America’s working
men and women by setting and enforcing standards, and providing training,
education and assistance. For more information, visit http://www.osha.gov.

U.S. government calls for the phase-out of amalgam!

In an extraordinary development that will change the global debate about amalgam, the United States government has announced that it supports a “phase down, with the goal of eventual phase out by all Parties, of mercury amalgam.” This statement – a radical reversal of its former position that “any change toward the use of dental amalgam is likely to result in positive public health outcomes” – is part of the U.S. government’s submission for the upcoming third round of negotiations for the world mercury treaty.*

While couched in diplomatic hedging – remember it is still early in the negotiations – this new U.S. position makes three significant breakthroughs for the mercury-free dentistry movement:
The U.S. calls for the phase-out of amalgam ultimately and recommends actions to “phase down” its use immediately. Incredibly, the government adopted three actions that the World Alliance for Mercury-Free Dentistry and Consumers for Dental Choice proposed at the negotiating session in Chiba, Japan. Our key ally, The Mercury Policy Project, laid the groundwork for this success at a World Health Organization meeting in 2009!

The U.S. speaks up for protecting children and the unborn from amalgam, recommending that the nations “educat[e] patients and parents in order to protect children and fetuses.”

The U.S. stands up for the human right of every patient and parent to make educated decisions about amalgam.
What does this mean? Our position – advocating the phase-out of amalgam – is now the mainstream because the U.S. government supports it. Who is the outlier now? It’s the pro-mercury faction, represented by the World Dental Federation and the American Dental Association. With the U.S. continuing its leadership role in this treaty, we will broadcast the U.S. position to other governments around the world, encouraging them to support amalgam “phase downs” leading to phase-outs not only globally, but within each of their countries.

We applaud the U.S. government. But tough work lies ahead. For example, we must demonstrate to the world that the available alternatives – such as composites and the adhesive materials used in atraumatic restorative treatment (“ART”) – can cost less than amalgam and will increase access to dental care particularly in developing countries.

For now though, let’s mark this watershed in the mercury-free dentistry movement: the debate has shifted from “whether to end amalgam” to “how to end amalgam.”

– Charlie

Charles G. Brown
National Counsel, Consumers for Dental Choice
President, World Alliance for Mercury-Free Dentistry
5 April 2011

* The full text of the U.S. submission is available at http://www.unep.org/hazardoussubstances/Portals/9/Mercury/Documents/INC3/United%20States.pdf Here is the excerpt on amalgam:

“We are aware that several delegations at INC-2 suggested mercury amalgam should not be included in Annex C, noting a number of difficulties and complexities related to this issue. The United States supports further consideration of dental amalgam by the INC such that the agreement is able to achieve the phase down, with the goal of eventual phase out by all Parties, of mercury amalgam upon the development and availability of affordable, viable alternatives. To the extent that Annex C is not structured to accomplish such a goal, the United States believes that a number of obligations could be considered within an appropriate operative paragraph of the agreement itself. Such a paragraph could commit Parties to phase down the use of mercury amalgam or address mercury releases through conducting and promoting further research on alternatives, mandating the use of separators in dental offices, promoting and incentivizing prevention strategies, educating patients and parents in order to protect children and fetuses, and training of dental professionals on the environmental impacts of mercury in dental amalgams, and to report on their progress in doing so to inform the Conference of the Parties on the progress being made to phase down amalgam use.”

The U.S. Food & Drug Administration convened a Town Meeting in a Dallas suburb on March 10. Several dentists, a dental hygienist, and a number of victims of mercury toxicity turned out. Although the Town Meeting was open to any subject, amalgam dominated. There was huge press coverage – the major Dallas TV stations and the Fort Worth Star-Telegram – was exclusively about mercury fillings!*

Presiding was the very man in charge of reconsidering FDA’s abysmal amalgam rule: Center for Devices Director Jeff Shuren. Dr. Shuren told the Texas press:
“Now, the [FDA scientific] panel did …point out that there may be certain populations who are more sensitive to dental amalgam, like young children and pregnant women.”
and
“We may decide to change our current regulation and that could include changing the status of dental amalgam, which means it comes off the market or has other controls on it or we may decide to leave things as they are.”

My reply to Mr. Shuren:

Dear Mr. Shuren:

I read the story below with great interest. Beyond the question of WHEN is this going to finally happen, I’d like to understand your take on the fact that there are other succeptible populations. What about those who have a tremendous number of large mercury fillings in their mouths? What about those who are APOE4 dominant and who can’t transport the mercury out of their bodies? What about the fact that women don’t find out they’re pregnant the day of conception, and have a 2-3 month window sometimes to have mercury fillings placed while they don’t know they’re pregnant? Shouldn’t the regulation therefor be women between their first menses and their final one? Does that sound sexually discriminatory to you? Why children under a certain age? In most states, other than Arkansas and West Virginia teeth (filled or not) usually last a lifetime. How do you use age as a determinant for who is most sensitive? Most of the patients whose problems I’ve reversed have been adults.

What sinisiter forces could there possibly be influencing FDA decisions to place the most toxic substance on the planet in the mouths of US citizens?

Read more about my testimony (twice) before the FDA on my website.

Steve Markus
The Centre for Dentistry at Haddon
209 White Horse Pike
Haddon Heights, NJ 08035
www.SmileSouthJersey.com856 SMILE S J

Another article about the end of the use of mercury fillings, if the FDA does its due diligence. If you want to learn more, visit the mercury links pages of our website.

DON’T MISS MAESTRO BEN ZANDERS ACCOUNT OF RECOVERING FROM MENIERE’S DISEASE AFTER REMOVAL OF 15 AMALGAM FILLINGS.

Ben Zander’s testimony as filmed by Scott and Patricia of DDV Productions: www.ddvideoproductions@gmail.com

Stephen J.Markus, DMD FACE
www.Cent4Dent.com

After serving less than two years as the Deputy Commissioner of the U.S. Food and Drug Administration (FDA), Joshua Sharfstein recently announced that he is resigning from his position at the agency to become head of Maryland’s Department of Health and Mental Hygiene. During his time at the FDA, Sharfstein took some aggressive steps to crack down on unsafe medical devices that were on the market, which some say may have played a role in his ultimately stepping down.
Learn more:

Freya Koss, Leader of Consumers for Dental Choice Comments:
My intuition regarding Sharfstein’s resignation is that he wasn’t willing to continue to kowtow to the bureaucrats at FDA. I believe his efforts were thwarted by Shuren, Hamburg and the politics behind the scenes at FDA. He was handed the original amalgam classification by Hamburg and was ordered to sign it………..that’s my opinion.

I spoke with Josh Sharfstein for 45 minutes during the transparency meetings. He welcomed my comments and suggestions relative to informed consent and the proposed classification, but it became apparent when thhe mucky mucks upstairs became aware of our conversation and his offer to work cooperatively with us, he was forced to back down. His resignation resonates of the dirty deals that take place behind closed doors at FDA.

A few years ago Boyd Haley and members of the IAOMT scientific advisory committee while meeting with FDA officials, Norris Alderson said: FDA couldn’t make a move on the amalgam issue without ADA’s approval. It’s became clear who has been running FDa’s Dental Device Div. under Susan Runner’s tutelage the ADA.

To my way of thinking, we cannot trust Shuren, Hamburg or any of the other FDA honchos involved with this issue to protect the American public.

However, we are garnering great media coverage and continue to do so. If you haven’t seen the videos of the public comments and professional testimony at the FDA hearing. thanks to Dorice and Scott and Trish of DDV Productions, they are available on YouTube:

NEXT WEEK, BEN ZANDER AND ROBERT EVANS ON BOSTON 5 TV

http://www.thebostonchannel.com/index.html

Ben Zander and Dr. Robert Evans will be interviewed by Rondella Richardson on Boston’s ABC TV 5 station, currently scheduled to be aired in Boston on Weds 11:00 NEWS pm ET and Thurs 5:30 – 6:30 news.

The program will also be available on http://www.thebostonchannel.com/index.html should you wish to alert others who aren’t in the Boston area..

At the end of the two-day hearing to evaluate the safety of amalgam, FDA’s own scientific panel – including neurologists, toxicologists, epidemiologists, and environmental health specialists – told the agency to stop amalgam use in children, pregnant women, and hypersensitive populations.
After reviewing the available scientific studies and the presentations of researchers, experts, dentists, and injured consumers, the scientists concluded that – contrary to the claims of FDA’s in-house dentist Susan Runner – amalgam is not safe for everybody. According to the panel, FDA’s amalgam risk assessments were not adequate to protect hypersensitive adults, children, and unborn babies. Repeatedly, panel members expressed their concern about amalgam use in children. Pediatric neurologist Dr. Suresh Kotagal of the Mayo Clinic summed it up for the entire panel: “There is really no place for mercury in children.” Other panelists went on to explain that dental mercury is like lead. The panel urged FDA to quickly contraindicate amalgam for these vulnerable populations and insisted that FDA provide consumers with labeling containing clear warnings.
The press heard the scientists loud and clear. According to the well-respected trade publication FDA Webview, the panelists “suggested the agency should ban the device’s use in children and pregnant women.” * Reuters announced that “Use of fillings in kids, pregnant women biggest concern…Enough uncertainty surrounds silver-colored metal dental fillings with mercury that U.S. regulators should add more cautions for dentists and patients, a U.S. advisory panel said.” **

At the end of the hearing, presiding FDA official Anthony Watson, Director of the Division of Dental Devices, announced that FDA would act quickly in response to concerns raised by the panel. But already FDA is ignoring the scientists. FDA’s official summary of the hearings reads like the American Dental Association press release that was issued the day before, simply noting that more research is needed.*** The summary does not even mention the scientists’ vocal cry for contraindications and restrictions to protect vulnerable populations. And even though panelists insisted that FDA has a responsibility to provide clear labeling for consumers, the summary twists their comments to absolve FDA of all responsibility – it claims that the panel only suggested the need for informed consent within the dentist-patient relationship.
We cannot let FDA get away with rewriting history and ignoring the scientists as it has done so many times before. Please write Anthony Watson at anthony.watson@fda.hhs.gov
Tell Mr. Watson of FDA:
• Since FDA’s own panel of scientists advise that amalgam should “definitely not” be implanted in children, pregnant women, and hypersensitive people, how soon will you take action to protect these vulnerable populations from this toxin?

• Since FDA has a duty to tell consumers that amalgam contains mercury that can damage the neurological systems of unborn babies, children, and hypersensitive populations, when does FDA intend to clearly state this warning on its consumer website and in consumer labeling?

• Since Commissioner Hamburg claims FDA is committed to transparency, how does FDA plan to keep the public updated on its progress with regard to the amalgam issue?
Thank you to all who came out to testify at the hearings, participated in the demonstration, and submitted comments to FDA! We’ve gotten this far, let’s keep it up.

– Charlie
Charles G. Brown
National Counsel, Consumers for Dental Choice
President, World Alliance for Mercury-Free Dentistry
316 F St., Suite 210, Washington DC 20002

MY RESPONSE TO MR. WATSON:
To: Watson, Anthony
Subject: FDA Hearings
As one of the presenters before the ADA Hand-picked panel, led by the former editor in chief of the ADA Journal, I am writing to let you know that simply banning fillings in the mouths of pregnant women and childrend does not go far enough. I had already written the ADA (I mean FDA – but it seems on the mercury issue they’re one and the same) in 2008, about this after they questioned me about their plans. The answer I wrote them is attached.

Until there is a way to determine who is “sensitive” to mercury from fillings everyone must be treated as such. Similarly, in 1988 there was a paradigm shift in dentistry where we had to treat all patients as if they had AIDS (universal precautions). We need another paradigm shift now.

When I watched you oversee the hearings, I felt there was promise for change. The murmurings I’m hearing from others who haven’t been able to believe the level of influence-peddling that is downright sinister, is that once again, the FDA will succumb to the ADA lobby. What power do they hold over your institution to be able to make your government agency look so corrupt?

Steve Markus
The Centre for Dentistry at Haddon
209 White Horse Pike
Haddon Heights, NJ 08035
www.SmileSouthJersey.com
856 SMILE S J

HIS RESPONSE TO ME:
Dear Dr. Markus,

All I can say is don’t lose hope. It has only been three weeks. We are still making sense of the panel and what to do within our authority. I have received numerous e-mails regarding the panel and it seems like many people have already come to the conclusion that we have completed our work and nothing else will be done. The truth is, we are not done. Mr. Markus, I am an optimist by nature so I believe we will take some affirmative action. I am also certain that someone will not be happy with our decision. It always seems that there is an unhappy constituent. The e-mails I have been getting all reflect a wide range of possible actions that people believe we ought to take. This begs the complexity of the issue and the need for deliberate approaches to decision-making. Thank you again for your e-mail and have a great day.

Anthony D. Watson, BS, MS, MBA
Director
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Phone: (301) 796-6296

Hello Dr. Markus,

I spoke to you briefly about the kidney problems my son has had as, I believe, a result of my amalgam fillings. I believe they are the cause of the problems because I consider myself a very cautious mother and I never ingested anything while I was pregnant that may have had the potential to be harmful – no caffeine, no alcohol at all, not even Tylenol! I scoured all of my cosmetics and personal care items and removed everything that contained chemicals like phthalates, parabens, and bpa. I never cook with teflon pans, I avoid fire retardants as much as I can, and I’ve never used chemicals on my lawn. I even had a reverse osmosis water filtration system installed in my kitchen. My son eats mostly organic foods and I use only glass or metal for food preparation and storage. Despite everything I researched, and despite all of my efforts, I never came across anything that warned against mercury in tooth fillings. No one ever told me that my fillings could easily harm my baby. I never had cavities until I reached my 20’s, but in the last 5-6 years, I’ve had a lot of amalgam fillings that were all put in. If I had any idea that there was even a small chance that my son could suffer as a result of my fillings, I would never have agreed to have them put in.

My son was diagnosed with hydronephrosis of the left kidney when I was approximately 6 months pregnant. By the time he was born, his left kidney was a grade 2. His condition continually worsened as he got older and eventually his right kidney developed hydronephrosis as well. He underwent various tests to determine the cause – VCUGs, MAG 3 Renal Scans, renal ultrasounds – but no cause for the hydronephrosis was ever found. There was no obstruction that could be seen on these tests and there was no reflux. Yet, his kidneys continued to worsen.

I nursed my son until he was almost 10 months old. Just before I stopped nursing him, his “half time” was 26 minutes. His left kidney was a grade 4 and his right kidney was a grade 2. At this time, the urologist decided to schedule my son for surgery for shortly after his 1st birthday. The doctor wanted to get one last round of tests done a few days before my son’s surgery was scheduled, and I’m so glad he did. In just those 2-3 months since I stopped nursing him, his kidneys had improved significantly. The tests showed that my son’s right kidney cleared up completely and his left kidney was back down to a grade 2. His half-time was now down to 16 minutes. His kidneys even showed that they had become “thicker” and more healthy looking. From the moment he was conceived until the time I stopped nursing him, his kidneys grew worse and worse. I stopped nursing him and he dramatically improved within a short period – I don’t think there’s any coincidence there. He continues to improve to this day, although, he’s never had the significant improvement that he had after I initially stopped nursing him.

Please feel free to share my story with your patients and warn them against problems like this that could arise from their fillings – especially the women who may consider having children in the near future.

Thanks,
Ellen Brooks

Mercury Fillings May Pose Health Risks, FDA Panel Says

Mercury Fillings may cause medical problems for some CNN reports

FDA Panel Calls for Safety Review of Mercury in Dental Fillings

For further information, visit the mercury links page at www.cent4dent.com

A pregnant woman’s number of amalgam filling is associated with risk of
autism.

Results of two studies:

1. “The mothers in the autistic group had significantly higher
levels of mercury exposure through Rho D immunoglobulin injections and
amalgam fillings than control mothers.”

Reduced levels of mercury in first baby haircuts of autistic children.
Holmes AS, Blaxill MF, Haley BE.
Int J Toxicol. 2003 Jul-Aug;22(4):277-85. Link to Article

2. “Subjects [ie, autistic children of mothers] with 6 or more mercury amalgam fillings were 3.2-times
more likely to be diagnosed with autism (severe) in comparison to ASD
(mild) than subjects with 5 or less amalgams.”
A prospective study of prenatal mercury exposure from maternal dental
amalgams and autism severity.
Geier DA, Kern JK, Geier MR.
Acta Neurobiol Exp (Wars). 2009;69(2):189-97.
Link to Article

For further information, visit the mercury links page at www.cent4dent.com