Senior U.S. health officials have squelched a proposal that would have curbed dentists’ use of mercury in treating Americans’ decayed teeth.
The proposal, approved by top Food and Drug Administration 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 rejection, after a cost-benefit analysis by officials at the Department of Health and Human Services, 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 citizen 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 flush toxins from the body.
In the Kansas City area, Susan Rustici of Independence tells a similar story. She developed symptoms of aching muscles, anxiety, depression and neurological issues that first surfaced in 1999 and that she eventually attributed to mercury in her teeth.
“I just had extreme fatigue that lasted and lasted and lasted,” said Rustici, now 60.
Married to a chiropractor, she had long been a student of alternative healing methods and had followed the work of a mercury-free dentist.
She had her mercury-and-silver alloy fillings replaced with newer composites and believes her health and energy improved as a result. She recalls being at a movie theater and realizing she could go up and down the stairs without her husband’s help.
“I had tears of joy,” she said. “I knew I was on the other side of this.”
Shuren heard the same sort of story in San Francisco and said he expected the agency to issue a new policy by the end of 2011. 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.
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 insisted on 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 used 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 million Americans, the majority with mercury fillings.
Although 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.
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 in 2009 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.”
The 157,000-member American Dental Association, which has lobbied for years against restrictions on mercury fillings, cites studies it maintains demonstrate they’re safe.
The stakes for active dentists could be high. If it were established that mercury fillings were sickening people, dental product 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.