FDA Deserves Some Blame for Unnecessary Teeth Drilling

Recently my wife had to pay $1,500 out of pocket to crown a molar. This was necessary because, years ago, a dentist over-drilled a cavity in the tooth and then packed it badly, resulting in the tooth eventually cracking.

It turns out that the drilling probably wasn’t even necessary. A dentist could have simply brushed a treatment on the cavity, and that would have been that—except that the treatment, used widely elsewhere, was illegal in the United States, thanks to the onerous medical approval processes Congress imposed via the Food and Drug Administration.

The New York Times reports:

Now there’s an alternative [to dilling and filling]: an antimicrobial liquid that can be brushed on cavities to stop tooth decay—painlessly.

The liquid is called silver diamine fluoride, or S.D.F. It’s been used for decades in Japan, but it’s been available in the United States, under the brand name Advantage Arrest, for just about a year.

The Food and Drug Administration cleared silver diamine fluoride for use as a tooth desensitizer for adults 21 and older. But studies show it can halt the progression of cavities and prevent them, and dentists are increasingly using it off-label for those purposes.

So the Japanese have been using this drill-free treatment for “decades,” yet we in the United States have had to wait until last year to get it. And the only reason we can get it now to treat cavities is that it happens to be allowed as on “off-label” use for what the FDA officially approved it for.

There is a downside to the treatment: It turns the infected part of the tooth black, the Times reports. But in cases of molars, children’s teeth, and the teeth of the physically frail (among others), it can be a great alternative.

One dental site carried a news release last year about Advantage Arrest:

Elevate Oral Care LLC and Advantage Silver Dental Arrest LLC recently introduced Advantage Arrest Silver Diamine Fluoride 38%, the only silver diamine fluoride cleared for use in the United States by the FDA.

After more than eight years of research to assess safety and efficacy, Advantage Arrest recently received clearance from the Food and Drug Administration to be marketed, said Dr. Peter Milgrom, scientific director for Advantage Silver in the US. . . . In a 2010 two-site clinical study, Advantage Arrest was found to significantly reduce dental hypersensitivity.

So, despite being used for “decades” in Japan, despite proving its worth for one purpose in 2010, we’ve had to needlessly get our teeth drilled until just last year. Unbelievable.

But the story gets even crazier: American dentists first started using similar silver-based treatments in the early 1900s. The FDA is literally over a century behind the times.

Dentist John Frachella relates:

Dr. G. V. Black, the “Father of Modern Dentistry,” described how to arrest cavities in children using a precise silver nitrate protocol in 1908. Silver nitrate was used successfully to treat tooth decay in troops being deployed to the front lines in World War I. Dr. Percy Howe, president of the ADA from 1928 to 1929, the first research director of the Forsyth Institute, and a professor at Harvard Dental School) used silver nitrate to stop the growth of decay so routinely between 1917 and 1950 that it became known as “Howe’s solution.” Dentists used to buy it from a catalogue of dental materials published by the ADA.

Here’s how Frachella learned first-hand the value of silver-based treatments:

I first learned about the magic of silver solutions not from a professor in dental school, but from my family dentist, my dad. In 1962, he applied silver nitrate to a small cavity between my permanent lower front teeth. I was 12 years old. The decay never grew, the teeth were never drilled or filled, and now more than 50 years later, there’s a small, unnoticeable black dot there.

Frachella says that trends in dentistry made silver-based treatments unpopular:

Most dentists stopped using silver nitrate more than 50 years ago. Today, confusion, controversy, and misinformation dominate debates among dentists for and against silver’s use. That’s because silver doesn’t fit very neatly into the modern, popular standard of dental care. Dentists are trained in school to be surgeons who cut out decayed tooth structure and replace it with synthetic materials.

However, undoubtedly the FDA’s blockage of the use of various treatments also hindered dentists’ use of them. Dentists cannot use something that is illegal for drug suppliers to sell to them.

V. Kim Kutsch is another dentist who has long used other silver-based treatments and has now switched to silver diamine fluoride:

I have personal experience with using silver nitrate in a technique modified by Dr. Steve Duffin. He immediately covered the lesion with fluoride varnish following the silver nitrate solution. I have used this technique for years with excellent outcomes. . . .

Silver diamine fluoride has been used extensively for years in other countries with similar outcomes to silver nitrate. . . . I am now also using silver diamine fluoride for the same types of patients that I have used silver nitrate with in the past. . . . For the right patient, this offers another option to their care.

At least the FDA’s long delay of silver diamine fluoride hasn’t killed anyone—it has “merely” caused countless collective hours of needless suffering at great expense. Horribly, people with more serious sorts of medical problems often fare much worse.

As economists Daniel B. Klein and Alexander Tabarrok review:

The delay and large reduction in the total number of new drugs has had terrible consequences. It is difficult to estimate how many lives the post-1962 FDA controls have cost, but the number is likely to be substantial; [Dale H.] Gieringer (1985) estimates the loss of life from delay alone to be in the hundreds of thousands (not to mention millions of patients who endured unnecessary morbidity).

Last year at Marginal Revolution Tabarrock also discussed a paper and an article about the FDA.

Of course, government properly intervenes to protect people’s rights, as by outlawing fraud and criminal negligence and by adjudicating tort claims. But the current medical approval process—more accurately called a medical delay process—does not protect people’s rights; it violates the rights of doctors and patients to seek drugs and medical devices that they judge best in their circumstances. Dr. Black never would have been able to get modern dentistry off the ground under today’s regulatory burdens.

It is impossible to accurately estimate how many dentists would have used—and how many patients would have asked for—silver diamine fluoride over drilling had it been legally available. I think a safe guess is that the government-caused delay has resulted in at least hundreds of thousands, if not millions, of unnecessary tooth drillings.

Getting your teeth drilled is certainly not the end of the world. But, as my wife and I try to adjust to the expenses of a new baby and of ever-higher health insurance (our older, far less expensive policy got cancelled thanks to ObamaCare), that $1,500 resulting from a bad drill is a pretty painful loss. Chances are good that, but for legal hurdles, my wife could have avoided the pain and expense not only of the original drilling but of the capping as well.

Fifteen-hundred bucks will buy a lot of toothpaste, not to mention diapers and baby food.

Note: The author is not a medical professional and nothing in this article is intended as medical advice.

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