Cent4dent Blog

The government seems to be speaking out of both sides of its mouth, as the President preaches one thing and the FDA does another. If we are going to have “smarter medicine that really works,” we need to get politics, lobbies and cronyism out of science.

President Obama has proposed covering the costs of his new medical plan with “smarter” medicine, meaning the adoption of procedures that eliminate inefficiencies and stress prevention. At a town hall meeting in New Hampshire on August 11, 2009, he gave the example of a diabetic needing to have a foot amputated, at a cost of $30,000 to $50,000. It would have been smarter to counsel the patient on diet and weight loss and monitor his medications before amputation was required. The insurance company would have saved money and the patient would have saved a foot.
The 2008 Obama/Biden Plan for a Healthy America also stressed preventive approaches to disease, including the reduction of toxins to which the body is exposed; and chief among these toxins was mercury. The Plan stated as a fundamental goal:
Reduce Risks of Mercury Pollution. More than five million women of childbearing age have high levels of toxic mercury in their blood, and approximately 630,000 newborns are born at risk every year. The EPA estimates that every year, more than one in six children could be at risk for developmental disorders because of mercury exposure in the mother’s womb.
As a Senator, Obama was responsible for extensive legislation reducing environmental exposure to mercury, including a ban on the export of elemental mercury, and legislation to phase out the use of mercury in the manufacture of chlorine.
Mercury can get into the blood by various routes, and one that has been lately in the news is the mercury found in the thimerosol in vaccines. Another source that made the news in July is the mercury released from dental fillings by chewing. The World Health Organization has stated that between 3-17 micrograms of mercury are released into the body each day by chewing, compared to only 2-5 micrograms from fish and all other environmental sources combined. In 1990, the New England Journal of Medicine published an editorial calling mercury amalgam fillings “possibly the chief source of exposure [to mercury] of a large segment of the U.S. population”.
Surprise FDA Ruling
When mercury amalgam made the news on July 29, 2009, however, it was not to warn of its hazards. Rather, it was to report the FDA’s surprise ruling that mercury fillings are safe. The ruling came after years of foot dragging by the FDA and a wave of consumer lawsuits. A growing consumer movement had amassed so much evidence for the dangers posed by mercury dental fillings that when a court finally ordered the FDA to come out with a ruling, the plaintiffs announced, “We won!” But instead of the declaration they expected, the FDA imposed no restrictions on the use of mercury amalgam. Dentists were not even required to inform their patients that “silver” fillings are composed mostly of mercury. The FDA conceded that it did not know if amalgam was harmful to children under six, pregnant women, or nursing mothers, but it took no steps to protect them. It even pulled from its website an existing neurological risk advisory that said, “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.”
Consumer advocates were stunned, as the FDA had earlier agreed to strengthen its warnings against mercury amalgam fillings. The evidence against mercury amalgam dental fillings was considered so compelling that Sweden, Norway, Germany, and other countries had already banned their use entirely. Degussa, Germany’s largest producer of amalgam and the world’s largest producer of metals for dentistry, completely shut down its amalgam production after a federal court ruled that dentists who used it faced legal liability. The FDA was expected to follow suit.
Why its unexpected about-face? Charles Brown, of the National Counsel for consumers for Dental Choice, suggests it had to do with a change in personnel. In May 2009, Dr. Margaret Hamburg succeeded to the post of FDA Commissioner. The Wall Street Journal noted that for five years before that, she served on the board of Henry Schein Inc., a $4 billion firm that distributes medical and dental supplies, including vaccines. Brown wrote skeptically:
Washington is famous for the revolving door — those in the party out of power take highly paid corporate positions, then return to government to bail out their benefactors. The new FDA Commissioner, Margaret Hamburg, worked in the Clinton Administration, then went out and became a director at the dental products colossus Henry Schein, earning a quarter million dollars a year for the handful of hours it takes to be a director. Corporations do this because they know the other party will return to power, at which time the corporations will call in their chits.

Science or Politics? The Liability Question
Beyond that potential conflict of interest, there was likely to have been heavy pressure from the American Dental Association, the professional union of dentists. If mercury amalgam were officially declared to be toxic, an estimated two billion mercury amalgam fillings might have to be replaced at practitioners’ or insurers’ expense, not to mention the flood of lawsuits for medical injuries that would follow.
Dentists could hardly defend by pleading ignorance of mercury’s harmful effects, since its health risks have long been known. Lewis Carroll alluded to the toxic effects of mercury in his nineteenth century character the Mad Hatter. Felt hat workers exposed to mercuric nitrate were observed to exhibit emotional symptoms including sudden anger, depression, loss of memory, timidity, insomnia, irritability, hallucinations, delusions and mania, a condition referred to as “mad hatter syndrome.” The manufacturer of the product Dispersalloy, consisting of capsules of metal powder mixed with liquid mercury and placed in the patient’s mouth, has a warning on its website stating:
Inhalation of mercury vapor over a long period may cause mercurialism which is characterized by fine tremors and erethism… Erethism may be manifested by abnormal shyness, blushing, self-consciousness, depression or despondency, resentment of criticism, irritability or excitability, headache, fatigue and insomnia. In severe cases, hallucinations, loss of memory and mental deterioration may occur.
Among other disturbing studies prompting consumer concerns was one reported in August 1990 by Drs. Lorscheider and Vimy of the University of Calgary in Alberta, in which twelve radioactive mercury amalgam fillings (a typical number for a human adult) were placed in the mouths of sheep. A control group received fillings made of an inert material. Within thirty days, the sheep that got the amalgam had lost half their kidney function. The study showed that mercury in amalgam fillings is not locked in the teeth but spreads through the body to the organs. Similar data have been reported for monkeys. The isotope labeled mercury showed poisoning of the internal organs and the brain of both sheep and monkeys.

Studies in humans include one conducted at the University of Kentucky, showing significant elevations of mercury in the brains of 180 Kentucky residents who were autopsied after dying of Alzheimer’s disease. When the concentrations of trace elements were analyzed, the most important imbalance found was an elevation of mercury. In studies of the cadavers of accident victims, those with a mere five amalgams had three times the amount of mercury in their brain tissues as cadavers without amalgams.
Other studies have linked mercury fillings to multiple sclerosis. In one reported by Colorado State University researcher Robert Siblerud, MS patients having amalgams were compared to MS patients whose amalgams had been removed. The former group was found to have significantly lower levels of red blood cells, hemoglobin, hematocrit, T-Lymphocytes and T-8 suppressor cells (indicating lowered immunity). They also had 33 percent more flare-ups of their symptoms during the previous year. In another study, mercury levels in the cerebrospinal fluid of MS patients were shown to be eight times higher than in controls. Siblerud observed that MS was first described by a French doctor in the mid-1830s, less than a decade after silver/mercury fillings were first promoted in Paris.

All of which suggests that the FDA’s July 31 ruling was based more on politics than science. The effects of mercury amalgam fillings on the patients themselves apparently carried less weight than its effects on the balance sheets of medical professionals and insurance companies.
If we are going to have “smarter medicine” that really keeps people well, we need to get politics out of medicine. We need a government agency that explores and funds solid research into what keeps people healthy and what makes them sick, an agency that makes its determinations independently of lobbies, drug detail men, funding from industries standing to benefit from the results, or revolving doors into and out of those industries.
Written in consultation with Richard Hansen, D.M.D., co-author of The Key to Ultimate Health: Non-Toxic Dentistry.

By Ellen Brown, in The Huffington Post, August 28th 2009http://www.huffingtonpost.com/ellen-brown/the-mercury-mischief-as-o_b_271520.html

For more information, search this blog: http://cent4dent.com/blog/?cat=3
and the mercury links page of my site: http://www.cent4dent.com/html/mercury_issues/limits_mercury_fillings.html

FDA Webview, 08/26/2009

Unprecedented consumer-level pressure is attacking FDA’s 8/4 final rule on mercury-based dental amalgams, and its chief critic is claiming he sees “signals” from the agency that it is looking for a way out. The rule, which essentially declares the neurotoxic heavy element safe as currently used, becomes effective 11/2 — unless FDA finds a way to defer or withdraw it. Press officer Mary Long, however, tells us that there is “no truth to observations that the FDA is trying to get out of implementing” it.

Consumer-level pressure to do that got a big boost this week when widely published osteopathic physician Joseph Mercola, who operates what he calls “The World’s Most Popular Natural Health Newsletter” posted a three-part video interview with amalgam opponent Charles G. Brown, national counsel for Consumers for Dental Choice. According to the Web site, by 8/26 the interview had attracted more than 68,000 views. In it, Brown urges viewers to call and email principal deputy commissioner Joshua Sharfstein with their opinions about the mercury amalgam controversy: “Ask FDA’s Sharfstein why he covers up the mercury in amalgam.” No final rule in FDA’s modern history, or perhaps ever, has attracted this kind of organized opposition.

As of 8/25, FDA said Sharfstein’s office had received 58 responses, “all of which were answered individually via email with a standard response letter.”

The Brown videos are headlined “FDA’s Mercury Ruling Defies ALL Scientific Reasoning” and appear with a separate newsletter article that has attracted more than 11,500 views and 38 comments, under the headline “The FDA has the Audacity to Claim Mercury is Completely Harmless” and a sub-headline: “Outrageous conflict of interest uncovered in recent FDA ruling on mercury and what you can do to correct it.” This is a reference to conflict-of-interest allegations, denied by FDA, that Brown has made and repeats in the videos against commissioner Margaret Hamburg.

In the videos, Brown says FDA “is giving a lot of signals that they want to change what they’ve done” in the final rule. Asked by FDA Webview what those signals are, Brown said they include a post-publication change to FDA’s amalgam Web site to say: “Dental amalgam contains elemental mercury. It releases low levels of mercury vapor that can be inhaled. High levels of mercury vapor exposure are associated with adverse effects in the brain and the kidneys.” In addition he, said there have been informal verbal comments by senior FDAers indicating concern about public reaction to the rule, and a media statement earlier this month by FDA press officer Long that indicated her statement “may only be preliminary, as the agency continues to review the criticisms, which come primarily from experts associated with the International Academy of Oral and Medical Toxicology.”

FDA’s seeming discomfort with its position on mercury coincidentally drew additional attention on another Web site 8/25 — an interview on Green Option.com’s Echo Childs Play site with former CFSAN scientist Renee Dufault, who recently retired early because, she says, supervisors discouraged her continuing research. The article says she discovered the presence of mercury in the widely used “natural” sweetener high fructose corn syrup.

“The FDA as an agency had mixed feelings about my results,” Dufault says in the interview. “Some individuals were not happy with my findings. I think they were afraid. Some individuals at FDA supported my work and applauded my efforts. There may have been some things going on behind the scenes to put an end to my work but I do not know this for sure. I did not have to retire early but I was discouraged from doing the field work that I liked doing and in fact told not to continue some of the research that I was doing. I found myself with lots of time on my hands. I do not twiddle my thumbs well. I need to be intellectually challenged and I need to feel like I am making a difference. I was no longer able to meet these basic needs doing my FDA job.”

Dufault said the U.S. should “follow Sweden’s lead and ban the use of mercury in manufacturing processes and products. Congress needs to provide FDA with substantial funding to conduct its own sorely needed research into product safety.”

—Jim Dickinson, Editor
FDA Webview & FDA Review (www.fdaweb.com)

Charles G. Brown, National Counsel
Consumers for Dental Choice
316 F St., N.E., Suite 210, Washington, DC 20002
Ph. 202.544-6333; fax 202.544-6331
charlie@toxicteeth.org,
www.toxicteeth.org
Working for Mercury-Free Dentistry
www.SmileSouthJersey.com
www.cent4dent.com

FDA’s amalgam rule is a moral travesty: no contraindications, no warnings to any consumer, not even disclosure of the mercury. FDA knows any of these steps would lead to the end of amalgam, but has chosen a rule to protect sales of this primitive 19th-century health, environmental, and workplace hazard. Aiding and abetting those who want to deceive American consumers, FDA even blesses the marketing of amalgam under the deceptive term “silver fillings.” In bad faith, FDA removed from its consumer website the advisory they promised, in writing, to post: Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.”

Undue influence took over this rule. It’s time to determine whether this outrage is connected to Commissioner Margaret Hamburg’s intertwining relationship with top amalgam seller Henry Schein Inc., or to ex-Director Daniel Schultz of the Center for Devices and his reputation for approving unsafe devices.

We have filed a complaint with the U.S. Inspector General, asking for an investigation — You may view it at http://www.toxicteeth.org/I_G_complaint_(F).pdf It is a public document and may be circulated , re-published, or sent to your Member of Congress. Please consider . . .

1) Writing the Inspector-General, HHSTips@oig.hhs.gov . . with your views about the need for such an investigation.

2) Writing your Representative . . . ask that he or she request an investigation of FDA and the amalgam rule, https://writerep.house.gov/writerep/welcome.shtml

3) Telephoning your Representative: the House of Representatives switchboard is 202.224-3121 or 202.225-3121.

The first crack in FDA’s armor has appeared, folks. This morning, FDA changed its website, adding this sentence: “High levels of mercury vapor exposure are associated with adverse effects in the brain and the kidneys.” (Go to http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/ucm171094.htm and scroll down to “Potential Risks”). Prior to this, the website did not explain to consumers the damage caused by mercury at all.

Congratulations to all of us in the mercury-free dentistry movement. FDA realizes that its website, like its rule, is a cover-up of the existence and risk of mercury, so its lawyers are trying to ease FDA into a more defensible position (see e-mail below).

But it is still “the Henry Schein Amalgam rule.” It still allows the nation’s #1 distributor of mercury amalgam, Henry Schein Inc. untrammeled rights to market amalgam for everyone, even pregnant women, without even disclosing the mercury to patients. (As you will recall, Schein paid Margaret Hamburg about a million bucks to be its director during her revolving-door time outside of government.)

The website still does not re-instate the language FDA agreed in writing in 2008 to maintain on its website: “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.” In particular the website still fails to inform consumers that young children and unborn children are especially susceptible to the effects of mercury. FDA does not want parents to know about this danger to children even though it admits that this information is true (buried deep in the labeling intended for dentists in the new rule’s special controls, the agency writes that “The developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor”).

Now that you had an impact writing Deputy Commissioner Sharfstein. our next step will be to write your Representative in Congress. My next e-mail will suggest talking points and the route to e-mail and to phone him or her.

FDA is covering up the mercury risks, but doing so a little bit less than yesterday. We move forward; they retreat. In the words of our first naval hero John Paul Jones, “We have not yet begun to fight.”

Charlie

11 August 2009

PS—Breaking news: The Director of FDA’s Center for Devices, an accomplice to FDA’s years of covering up mercury resigned today under pressure. Dr. Dan Schultz had repeatedly rebuffed my efforts to get the Center for Devices to change course on amalgam. His exit on the same day that FDA alters its website is more evidence that FDA is being rocked by this egregious mistake over amalgam. FDA minus Schultz means more momentum for our movement.

Charles G. Brown, National Counsel

Consumers for Dental Choice, ,www.toxicteeth.org

Working for Mercury-Free Dentistry

————————————————

From: xxx.xxxxx@fda.hhs.gov
Sent: Tuesday, August 11, 2009 8:57 AM
To: Charlie Brown
Subject: FDA website

Mr. Brown, although we have declined to repost the old website as you requested, the agency has modified the language in the current website regarding the potential risks of dental amalgam. You can read the modified language at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/ucm171094.htm

The first full paragraph under the heading “Potential Risks” now states:
“Dental amalgam contains elemental mercury. It releases low levels of mercury vapor that can be inhaled. High levels of mercury vapor exposure are associated with adverse effects in the brain and the kidneys.”

(A lawyer in FDA’s Office of the Chief Counsel)

for further information visit the mercury links page of my website.