Senior U.S. health officials have squelched a Food and Drug Administration proposal that for the first time would have curbed dentists’ use of mercury – one of the planet’s nastiest toxins because it attacks the central nervous system – in treating Americans’ decayed teeth.
The proposal, approved by top FDA officials in late 2011 and kept secret since, would have told dentists they should not use mercury fillings in cavities in pregnant women, nursing moms, children under 6 and people with mercury allergies, kidney diseases or neurological problems.
It also urged dentists to avoid using fillings that contain mercury compounds in any patient, where possible.
The proposal and its secret rejection, after a cost-benefit analysis by officials at the Department of Health and Human Services, have put the Obama administration in the awkward position of concealing for over three years a safety communication potentially affecting millions of Americans.
The FDA has defended the safety of mercury fillings since the agency’s inception in 1930 and especially during an ongoing, 23-year legal battle with consumer groups. Consumer lawyers are pressing the government to ban the compounds, as Denmark, Norway and Sweden have done.
The “safety communication” was drafted in response to citizens petitions and an FDA advisory panel of outside experts, several of whose members expressed concerns in 2010 that the agency had not gone far enough to protect vulnerable groups.
The first public hint that the agency might shift its position came during a town hall meeting in September 2011 in San Francisco, where Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, heard from several dental patients. They described recovering from severe health problems after having their mercury fillings removed and taking chelation agents – supplements that can help the body excrete toxins.
Shuren told them he expected the agency to issue a new policy by year’s end.
Instead, sometime later, the Department of Health and Human Services quietly killed the FDA’s communication.
Jeff Ventura, a spokesman for both the Health and Human Services Department and the FDA, declined to comment because the government’s regulation of mercury in dentistry is a subject of litigation. The citizen groups sued in federal court last year to compel the agency to respond to their petitions.
“FDA will continue to evaluate the safety of dental amalgams and will take any further actions that are warranted,” Ventura said.
Left unexplained are a myriad of questions, including who made the decision, why was it made and whether any special interest group directly influenced the government to curb its warning.
Department officials concluded that the out-of-pocket costs of patients with dental insurance coverage would triple if they had to pay for alternative fillings, imposing an unfair burden on low-income Americans who might then neglect decaying teeth, said an administration official who requested anonymity because disclosure of the information was not authorized.
The price difference for patients to fill a cavity with the most popular and economical alternative, tooth-colored composite resins, can be about $100.
An American Dental Association survey in 2009 indicated 54 percent of U.S. dentists were still using mercury fillings, a durable, easy-to-use remedy for over 160 years. However, the number of dentists abandoning those products has risen steadily over the last 20 years as concerns about the toxin’s effects have mounted and alternatives have improved.
The fillings are still used in taxpayer-funded Medicaid and Medicare programs for the poor and the elderly, in the military, in prisons, on Indian reservations and by doctors serving price-sensitive patients.
The last time the U.S. Public Health Service surveyed Americans about their dental work, from 2001 to 2004, it estimated that dentists had repaired 1.46 billion teeth in 181.1 million Americans, the majority with mercury fillings.
Mercury is often described as insidious. Once in people’s lungs, it moves to the bloodstream and can accumulate in the kidneys, liver and brain, where it damages the central nervous system. It has been linked to an array of health problems, including memory loss, nerve damage, autoimmune diseases, vision problems, kidney failure, depression, autism and foggy thinking. Recent research suggests it may contribute to Alzheimer’s disease. It also can be lethal.
In 2013, the United States was the first of 140 nations to sign a treaty, the Minamata Convention on Mercury, calling on governments to halt emissions and disposal of products containing the toxin. The treaty is named for a disaster in the 1950s, when mercury-laden wastewater from a chemical plant contaminated fish in Japan’s Minamata Bay and then poisoned people who consumed the fish, claiming over 1,700 lives.
140 Nations that signed a treaty to phase out mercury but doesn’t impose deadlines.
Since the FDA’s proposed communication was rejected, the agency has continued to defend the safety of mercury fillings, except in people with mercury allergies.
An expert in medical ethics said he finds the secrecy about the proposed warnings troubling.
While it’s reasonable to conduct cost-benefits analyses, “the government should share what it knows. It should not be hiding, it should not be yielding to lobbying of any sort,” said Art Caplan, director of the Division of Medical Ethics at New York University’s medical school.
If FDA officials “don’t get accurate information out there, then this all shifts to the Internet and the land of the crazy and the thoughts of the goofy,” he said. “People will start to be frightened and get misinformation and distorted information.”
James Love, an Oklahoma lawyer who in 2009 filed one of three citizen petitions contending the agency should have acted more forcefully in a rule issued that year covering mercury fillings, took a harsher view.
“If you inject cost-benefit analysis into the equation,” he said, “then we’re going to justify legally poisoning people.”
During the 2011 town hall meeting in San Francisco, San Diego dentist David Kennedy told FDA officials he has “seen hundreds of people’s lives dramatically improve once these mercury implants were safely removed.”
“I’ve seen infertile women make a whole family, chronic high blood pressure return to normal and multiple sclerosis victims totally recover,” said Kennedy, a past president of the International Academy of Oral Medicine and Toxicology, formed by mercury-free dentists concerned the fillings are harming people.
Known in the trade as amalgam, the dental compounds consist of about half mercury blended with metal alloys that include silver and often have been presented to patients as “silver fillings.” While the mercury is described as encapsulated, the fillings still release very low levels of mercury vapor that patients inhale on a continual basis – the more fillings, the more vapor. Chewing or vigorous brushing can increase the vapor release.
340 Metric tons of mercury implanted in teeth every year worldwide, according to a 2013 report of United Nations Environment Program.
For decades, the FDA has agreed with dental products manufacturers and the American Dental Association that those exposure levels are not a cause for concern, citing the lack of clinical studies showing harm. Hence, the agency has never advised dentists that they should inform patients of potential health risks before placing mercury fillings in their teeth. James Turner, who is among consumer lawyers battling the agency, said the “core argument is that the public should be told about the risks.”
Besides the critical 2010 panel of experts, an FDA advisory panel in 2006 voted 13-6 to state that an agency white paper failed to properly represent research about the potential dangers of mercury fillings.
Consumer lawyers and some scientists believe the toll from the pervasive effects of mercury in dentistry already may be impairing millions of people who have yet to connect serious health problems to their dental work.
“What the FDA says in that document is the beginning of the discussion about what a problem mercury fillings are,” Turner said. “It’s the tip of the iceberg. It’s cracking the door open, and they’re trying to keep that door shut.”
Freya Koss, 73, of Wynnewood, Pa., accuses the government of “an enormous coverup.”
She accepted an undisclosed sum last year to settle her 15-year-old suit alleging she suffered “acute mercury poisoning” when a New York dentist improperly used an outdated formula of liquid mercury to fill a cavity in 1998. In a phone interview, she said she developed double vision, an autoimmune disease and other problems. But after a dozen of her fillings were removed, she said, her health improved and a decade-long bout with depression came to an end.
If she hadn’t made the connection to her mercury fillings, Koss said, “I could be in a wheelchair or dead.”
I will not leave this Earth until mercury fillings leave this Earth.
Freya Koss, patient and anti-mercury activist
Chris Scarano, 44, of Miami, said a dentist drilled out a mercury filling from a problem tooth in his mouth in 2009 without taking special precautions to shield him from mercury vapor or loose particles. Within a day or two, he began experiencing flu-like symptoms and later, “concentration problems, stuttering . . . twitches, eyesight problems.” A mercury filling in a second tooth caused a relapse in 2011 that nearly cost him his business, he said.
Some dentists or their assistants were exposed to much higher doses of mercury.
Blanche Grube, the Scranton, Pa., dentist who drilled out Koss’ fillings, said she underwent a blood test while taking a class about the dangers of mercury fillings in the early 1990s in Colorado Springs, Colo., and was told she had the early stages of leukemia, a type of blood cancer.
After removal of her 18 amalgam fillings, as well as five teeth where root canals likely caused infections, her blood tests showed no signs of cancer, Grube said. Since converting to a mercury-free dental practice, she said, she has drilled out and replaced mercury fillings for about 2,000 patients from as far away as Japan and Australia. To do so, she wears a gas mask and protects patients by isolating each tooth with a rubber dam while drilling, she said.
Grube said that, depending on the number of fillings, the work can cost from $1,000 to $20,000. Few dental insurance policies provide coverage for replacements, unless the affected tooth or filling is damaged.
A Lafayette, Colo., firm, Quicksilver Scientific LLC, has conducted cutting-edge laboratory tests on the blood, urine and hair of at least 10,000 people using a new method for identifying those who might have been harmed by mercury fillings.
Chris Shade, the firm’s founder and CEO, said he believes 5 percent to 10 percent of people with mercury fillings – theoretically as many as 18 million people – may be sick and many don’t realize why. In a phone interview, Shade also estimated that mercury is weakening the immune systems of about 20 percent of people with the fillings.
5% to 10% People with mercury fillings who could face serious health problems, says Colorado scientist Chris Shade.
On the other side of such projections is the 157,000-member American Dental Association, which has lobbied for years against restrictions on mercury fillings, citing studies it maintains demonstrate they’re safe. The association’s political action committee donated nearly $2.5 million to candidates for Congress in the two-year cycle ending Dec. 31, 2014.
The stakes for active dentists could be high. If it were established that mercury fillings were sickening people, dental products manufacturers and ten of thousands of dentists could face heightened legal exposure.
The dental association has taken a hard line on the issue, adopting a provision in its code of conduct advising dentists that it would be “unethical” to tell patients their health would improve if their fillings were removed.
The FDA continues to leave the decision about dental treatment right where it needs to be – between the dentist and the patient.
Maxine Feinberg, president, American Dental Association
Last Jan. 27, the FDA finally responded to the citizen petitions, hours before a federal judge’s deadline to do so. The agency denied the petitions and stuck by the 2009 rule that classified mercury fillings as a Class II medical device, rather than among the riskiest devices, in Class III, as consumer lawyers wanted.
A Class III designation would have forced manufacturers to provide scientific evidence of their products’ safety before marketing them.
In letters to the petitioners, Associate FDA Commissioner Leslie Kux presented a position decidedly different from the ominous warnings drafted in 2011 by the very same agency. The evidence to date indicates, she wrote, that “exposures to mercury vapor from dental amalgam are not associated with adverse health effects.”
CORRECTION: An earlier version contained a pullout figure that misstated a United Nations estimate of how much mercury dentists use each year. The correct figure is 340 metric tons. An earlier version of this story dropped the full description of the unnamed administration official in the 13th paragraph.