Dental Marketing and Practice Management

When Scandal Strikes, Some Bury Their Heads in the Sand

Dentists and dental labs have been in the spotlight recently due to the news of lead-tainted dental products like crowns and bridges. Right now, we don’t know if it’s a widespread problem, whose fault it might be, or whose job it is to resolve this whole mess.

Though the story broke a few months ago, there’s been precious little actual information released on the subject. So what’s going on behind the scenes? Let’s examine the paper trail… You have to read between the lines a little, but it’s frightening how no agency seems willing to take responsibility for this public health hazard.

The correspondence starts on March 6, when the American Dental Association (ADA) sent nearly identical letters to both the Food and Drug Administration (FDA) and Centers for Disease Control (CDC). Does this circle of ineptitude remind you of anything?

Here’s what the ADA had to say to the CDC: (PDF)

“Staff members from the ADA… have been in contact with the CDC’s Oral Health Division. We are undertaking our own efforts to study the problem, including random, objective testing of prosthetics from both overseas and domestic labs and will be happy to share that information with the CDC. Of course, any such testing by the ADA is no substitute for the CDC and other government agencies performing their mandated functions to protect the health and safety of the public.

“Although we are not aware of any risk to health based on the small amount of information available, we and our patients are looking to CDC to affirm that this is true or, if it is not, take the appropriate steps to protect the public. Accordingly, we request that the CDC keep the ADA informed of its efforts to identify the extent of the potential contamination and the health effects of lead in dental prosthetics as well as any CDC plans for action.”

The ADA wrote the same thing to the FDA. (PDF)

“Staff members from the ADA divisions of Science and Government and Public Affairs already have been in contact with the FDA’s Center for Devices and Radiological Health Dental Devices Branch…. Of course, any testing by the ADA is no substitute for the FDA and other government agencies performing their mandated functions to protect the health and safety of the public.”

Let me translate: “”The ADA is doing our own research, but it’s really the FDA’s or CDC’s job to determine if this is a problem and what we should do next.”" The ADA’s point is legitimate; a professional organization should not be expected to provide the same public health services as the government.

On March 18, the ADA again wrote to virtually identical letters to both the FDA (PDF) and CDC (PDF).

“Media reports on ‘contaminated’ dental materials produced in foreign dental laboratories have become more frequent. The reports have an increasingly alarming tone and a sense of urgency since we first wrote to you on March 6. As a result, dentists are fielding more inquiries from concerned patients and there are disquieting reports of patients declining recommended treatment because of unsubstantiated fears.

“We are eager to understand the extent of any problems with dental materials, whether they are produced in foreign or domestic dental laboratories. In particular, we ask that you provide some context for claims of possible health impacts of lead in dental prosthesis in the amounts reported in the media. While recognizing that much remains to be learned about this issue, some general information from the CDC/FDA about the likelihood of harm would be of great interest to both dentists and patients and should come from the federal agency whose mission is to protect the public’s health.

“We also look to your agency to reassure patients that recommended dental treatment should not be ignored. The ADA is asking both the CDC and the FDA to consider providing a media update that will reassure the public that government agencies are taking appropriate steps to protect dental patients and that oral health care should not be postponed.”

Let’s translate that again: “Hey, guys, this goes beyond the scope of the ADA’s job… Can the government please offer some guidance?”

On April 14, the FDA responded to the ADA.

“The FDA is taking this report very seriously. FDA’s Center for Devices and Radiological Health (CDRH) is also working to obtain information on the presence of lead in dental prosthetics.

“At this time, FDA will not be issuing a consumer update; however, the agency will consider further actions after careful examination of the scientific evidence.”

Translation: “Sorry ADA, the FDA has nothing to say on the topic. Ask us again later.”

On April 17, the CDC replied to the ADA’s letters.

“Thank you for your correspondence regarding media reports about the lead content in a dental prosthesis made in a dental laboratory in China. The CDC became aware of this issue through conversations with staff at the ADA’s Divisions of Science and Government and Public Affairs and through media interest in this story.

“As you indicated, the FDA has regulatory authority over dental products, including dental prosthetic materials, and for the registration of foreign laboratories that import dental products into the United States. It is our understanding that the FDA is already acting on this information, At this time, CDC has had no formal request for any type of engagement from a state of local health authority.

“Although CDC has no specific information regarding the case to which you refer, we can provide you with some general information on lead exposure. Many consumer products contain lead in trace amounts, and federal regulations limit the amount of lead in consumer products… Certainly, CDC recommends against the unnecessary use of lead in consumer products, including dental crowns.

“The recent media reports of lead in dental porcelain/metal crowns suggest a level of approximately 200 parts per million. Such small amounts of lead as reported, however, are extremely unlikely to cause adverse health effects in adults because the dental products wear out slowly, so the lead would be released in tiny amounts over time. Even at an increased rate, it is highly unlikely that this amount would be a health risk to an adult.

“It is our understanding that testing for potential leaching of lead from these products is being conducted in ADA laboratories. CDC would be happy to assist ADA in interpreting the health impact of the testing of dental porcelains/meals that is currently underway. CDC will also provide any support if requested from the FDA, as that agency conducts further testing of these products.”

Translation: “It’s the FDA’s job, not the CDC’s. Maybe it’s the ADA’s job, but definitely not the CDC’s. And the amount of lead in dental prostheses is probably safe.”

Are you as amazed by what you’re reading as me?!? Here are a few of the most bothersome points:

• “It is our understanding that testing for potential leaching of lead from these products is being conducted in ADA laboratories,” writes the CDC, suggesting that it is the ADA’s responsibility to monitor the safety of dental products. The ADA is a private, voluntary professional organization funded by dues from member dentists. Testing and regulation is the government’s job, not the ADA’s.

  The ADA points this out in their initial letter, saying that “testing by the ADA is no substitute for the FDA, CDC and other government agencies performing their mandated functions to protect the health and safety of the public.”

• “The CDC became aware of this issue through conversations with staff at the ADA and through media interest in this story,” wrote the CDC.

  Really?!? Why was the ADA the one to bring this issue to the CDC’s attention? Does the CDC only investigate health threats that receive media attention?

• “At this time, FDA will not be issuing a consumer update; however, the agency will consider further actions after careful examination of the scientific evidence,” says the FDA.

  The FDA took over a month to respond to the ADA. The organization in charge of regulating dental materials (you know, making sure they’re safe and lead-free) hasn’t offered the public any guidance on this threat.

The CDC’s passing the buck to the FDA, and the FDA doesn’t appear to be doing much of anything. But dentists are worried, patients are panicking, and public is desperate to know more. As the public face of dentistry in the US, the ADA is now forced to stand in for do-nothing government agencies. Doctors, it’s time to put on your hip-high waders… it is going to get really deep before anyone in the government takes action or gives definitive guidance.

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