The FDA versus the Tooth

by on July 15, 2016 at 7:20 am in Economics, Law, Medicine | Permalink

The NYTimes has an incredible story on a simple, paint-on liquid that stops tooth decay and prevents further cavities:

Nobody looks forward to having a cavity drilled and filled by a dentist. Now there’s an alternative: 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.

Ari Armstrong has the right reaction:

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.

The NYTimes continues:

Silver diamine fluoride is already used in hundreds of dental offices. Medicaid patients in Oregon are receiving the treatment, and at least 18 dental schools have started teaching the next generation of pediatric dentists how to use it.

…The main downside is aesthetic: Silver diamine fluoride blackens the brownish decay on a tooth. That may not matter on a back molar or a baby tooth that will fall out, but some patients are likely to be deterred by the prospect of a dark spot on a visible tooth.

…[But] “S.D.F. reduces the incidence of new caries and progression of current caries by about 80 percent,” said Dr. Niederman, who is updating an evidence review of silver diamine fluoride published in 2009.

Fillings, by contrast, do not cure an oral infection.

But as Armstrong writes the craziest part of the story is this:

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

It seems that the future of dental treatment has been here all along but a combination of dentists wanting to be surgeons, lost knowledge, and FDA cost and delay prevented it from being distributed. Incredible.

1 carlolspln July 15, 2016 at 7:23 am

It was the FDA wot did it!

2 mulp July 15, 2016 at 6:28 pm

If the FDA, NIH, and Medicaid were to aggressively push this treatment as part of SCHIP and care for the poor, conservatives would be attacking Democrats for permanently disfiguring the poor and denying them equal opportunity and independence from government welfare. Progressives would be blaming Clinton and Bernie would have named this treatment as Clintons’ selling out to neoliberalism.

The treatment cost has been estimated at 40 cents per year per patient plus supplies, probably a could of bucks, and then labor costs of a hygienist for less than half an hour, probably as little as 15 minutes.

Kids with bad parents, and poor adults, would be clearly visible to all.

3 mulp July 18, 2016 at 10:02 am

Really? You think that? It would likely be Progressives and democrats pushing back on this, because it allows for the poor and middle classes to have access to the same quality and levels of service as the rich.

4 cowboydroid July 15, 2016 at 7:38 am

The FDA hates anything silver. This is old news.

5 rayward July 15, 2016 at 8:15 am

Wikipedia: “Silver diamine fluoride will stain most surfaces black. Skin and soft tissue will discolor within minutes to hours after contact and fade away within a few days. Dentin and enamel with no demineralization present will receive surface (pellicle) stains that can be removed with pumice, while demineralized tooth structure will stain more permanently black. Silver diamine fluoride is corrosive to metal and glass. Contact to metal produces hydrogen gas and hydrogen fluoride while contact with glass will create silicone tetra-fluoride. It is a light sensitive clear liquid with a strong ammonia scent and should be stored in a cool, dark, dry place in a plastic container (LDPE or HDPE).” Tetracycline is an antibiotic that has widespread use, but will stain developing teeth (when taken by a mother during pregnancy) and permanently discolor teeth when taken during childhood. I was given tetracycline when I was a child, before the side effects were (widely) known. Hence, I have permanently discolored teeth, no amount of teeth whitener will correct. Lots of people about my age have the same condition. The only “cure” are veneers (caps) that are permanently affixed to the teeth after the teeth are shaved down (to avoid the appearance of “bulging” teeth). It’s an expensive “cure” for a condition that should never have occurred. I appreciate Tabarrok’s libertarian view, but sometimes his paranoia, about the motives of professionals and regulators, is so off the mark that he needs to get a grip. Cavities are a problem primarily for children, but being the developing creatures they are, medications and treatments can cause unexpected and serious, and often permanent, conditions, the “cure” far worse than the disease. To make the point in a different context, I once represented a pediatric orthopaedist, a highly acclaimed physician in my city. But he was the lowest paid partner in his large orthopaedic group practice. Why? For two reasons: First, all of his his patients were, well, children, and about half were Medicaid eligible (since about half the children in our city, and in most cites, are from poor families and Medicaid eligible); hence, his reimbursement was relatively low as compared to that of his partners. Second, he would only perform surgeries on his patients (i.e., children) in the hospital, and specifically not in the outpatient surgery center owned by the group, because the risk of surgery in children is much higher than in adults. This physician chose to perform his surgeries in the hospital, even though protocols did not dictate it and even though it meant less income for him, because that was right thing to do.

6 cowboydroid July 15, 2016 at 8:27 am

Tooth discoloration is “far worse” than tooth decay? I disagree with your subjective valuation.

7 msgkings July 15, 2016 at 12:07 pm

Permanent tooth discoloration is far worse than temporary, correctable childhood tooth decay, yes. Because one of those is curable.

8 secretivek July 15, 2016 at 1:59 pm

And because of that, the FDA needs to ban it?

9 secretivek July 15, 2016 at 2:00 pm

And tetracycline should have been banned because it would discolor children’s teeth?

10 Axa July 15, 2016 at 8:26 am

Is the FDA or the irrational fear for “fluoridation”? This is great, a dentist that uses the product had to say this: “This is not communist plot”. http://www.bendbulletin.com/news/1284843-151/fighting-cavities-with-silver

Also the dentists answer to the NYT article: “Although FDA-cleared for use in the management of hypersensitivity, SDF received coverage in the Times for its use in treating cavities in children, although this might be more accurately described as caries control and management……….SDF is not a complete solution to caries risk. Single application has been reported to be insufficient for sustained benefit.” http://www.ada.org/en/science-research/science-in-the-news/silver-diamine-fluoride-in-caries-management

In conclusion, silver and fluoride are delicate topics in popular culture. It’s strange to assign responsibility on the FDA for public misinformation.

11 Thiago Ribeiro July 15, 2016 at 8:51 am

“This is not communist plot”. Says he.

12 Urso July 15, 2016 at 11:51 am

Best to stick to rain water and grain alcohol.

13 MOFO. July 15, 2016 at 8:50 am

5 posts and no one has mindlessly shouted Thalidomide yet? Thalidomide! Thalidomide! Foreigners want to turn us all into Thalidomide flipper babies.

14 dearieme July 15, 2016 at 9:02 am

“Incredible.” Au bleedin’ contraire, matey.

15 DCBob July 15, 2016 at 9:02 am

You can’t handle the tooth!

16 Lord Action July 15, 2016 at 10:54 am

No no no. The correct pop culture reference is “Remember the tooth!”

17 JWatts July 15, 2016 at 3:28 pm

What difference at this point does it make?

18 PD Shaw July 15, 2016 at 9:40 am

IIRC dentists are drilling far fewer cavities because of widespread use of sealants. Is the choice here really btw/ drilling and painting cavities?

“Silver diamine fluoride is more effective as a primary preventative than any other available material, with the exception of dental sealants which are >10 times more expensive and need to be monitored.”

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4778976/

Not clear about pricing. Sealants are generally applied on all teeth with fissures or features that pose risks of cavities. The Silver diamine fluoride appears to be painted only on teeth with cavities. And note that the paint needs to be monitored, perhaps indefinitely as well: “Clinical evidence supports continued application 1-2 times per year until the tooth is restored or exfoliates, and otherwise perhaps indefinitely. Some treated lesions keep growing, particularly those in the inner third of dentin. It is unclear what will happen if treatment is stopped after 2-3 years and research is needed.”

19 Cliff July 15, 2016 at 10:12 am

Do they have a lot of cavities?

20 dearieme July 15, 2016 at 10:46 am

Perhaps the Japanese don’t subscribe to the view that everyone’s mouth should sport an identical array of uniform tombstones.

21 Pshrnk July 15, 2016 at 10:55 am

What you call terrible teeth may simply be fashion in a land where people value bagel head and snaggle tooth looks.

22 Taeyoung July 15, 2016 at 4:09 pm

Bagelhead is not exactly a real thing (if it exists at all, it’s a tiny, tiny subculture). Cute little fangs (yaeba) is not what people are talking about when they talk about Japanese having horrible teeth. Or, well, maybe it’s part of it. But mostly, it’s just that many Japanese have noticeably crooked and discoloured teeth.

23 Andrew M July 15, 2016 at 11:04 am

Japan and the USA aren’t the only two countries in the world. Is nobody using this in Australia, Brazil, China, Denmark, etc.? Do *all* those countries also have lethargic state bureaucracies like the FDA?

No. This is much more simple. Just like when your mechanic tells you that your car needs new brake shoes, your dentist tells you that you need a filling. You don’t know any better – after all, that’s why you took your car (teeth) to the mechanic (dentist). The dentist can charge more for a filling than for a cheap bottle of liquid.

This problem is widespread in all fields of medicine.

24 No More Snake Oil July 15, 2016 at 11:08 am

If it works, then they could do an experiment showing that it works! And if not, well then I am tired of you selling snake oil.

25 dearieme July 15, 2016 at 11:48 am

Besides “good” teeth are overrated. It’s a notionnstarted by the Americans who had the dreadful habit of consuming hard or undercooked food. You can soften your Digestives in tea or eat watercress sandwichs on soft white bread and make sure your vegetables are thoroughly cooked. We are not rabbits we don’t need teeth able to gnaw through raw carrots.

26 IVV July 15, 2016 at 12:04 pm

We’ve already established the real dearieme takes tea with Garibaldis, not digestives.

But in any case, dental experiences are definitely one of the greatest differences between my wife and myself. She came to this country with a considerable array of dental problems, and we poured a couple thousand dollars each year for a few years into her mouth to correct infections, misalignments, decay, etc. My teeth, on the other hand, are not prone to decay (and I’ve had dentists look in my mouth and remark despondently, “Oh. You’re one of those people.”).

Yes, I’ll eat crudité without flinching or worry, while even now, with all the decay gone and her teeth in much better shape, my wife cannot eat it. She can’t bite through it. I have to render vegetables into a near mush so that she can enjoy her cauliflower and carrots. I’ll grab an apple and eat it out of hand in a quarter of the time it takes her to carefully slice it into manageable pieces.

And no, this is not the result of sealants or fillings or treatments. Teeth and jaws are naturally designed to deal with these. I’m not sure why someone would fear their own masseter.

27 Jon July 15, 2016 at 12:35 pm

Alex: Can you show us the details of how the FDA is at fault here? Perhaps nobody wanted to market the treatment in the US and never applied for approval? The FDA does not test medical products; private companies do.

28 secretivek July 15, 2016 at 2:06 pm

The point is, nobody could use it without someone going through that process. The mere fact that things a forbidden by default, instead of allowed by default, is the problem with the FDA.

29 cowboydroid July 15, 2016 at 4:36 pm

The point is that the cost of testing and approval for low cost treatments is often prohibitively expensive. As a result, consumers are denied an effective, low cost treatment option, and their living standards are proportionally lower.

30 Moo cow July 15, 2016 at 1:56 pm

Lulz…have you seen how this looks? Do an image search.

31 Urso July 15, 2016 at 3:07 pm

Yes, it appears to look much worse than the article suggests – not just “a dark spot”.

32 cowboydroid July 15, 2016 at 4:39 pm

Is it the FDA’s responsibility to save us from effective treatments with minor cosmetic side effects?

Who should be making that cost/benefit analysis?

33 Thanatos Savehn July 15, 2016 at 2:36 pm

Looks to be a paradigm change a la breast/prostate/colon cancer screening. Yet another little boy examined the emperor’s premises and the available evidence and cried “Uncle Sam’s naked again!” At what point do we get mad at the guildsmen who weave him such clothes?

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4736084/

http://www.ncbi.nlm.nih.gov/pubmed/27044232/?

34 Kevin Outterson July 15, 2016 at 10:11 pm

Why are you blaming the FDA? A company could present those decades of Japanese data and get approval on label.

35 Abelard Lindsey July 15, 2016 at 10:39 pm

The FDA is a parasite bureaucracy that should be abolished immediately.

36 PaulB July 19, 2016 at 8:12 am

The stuff does work and the esthetic result is an issue. Use on primary teeth, that will exfoliate, is a no brainer. The other potential use is the elderly. Working on a pt with dementia or multiple medical issues can be a real problem. They can be every bit as obstinate as a small child, but much stronger. Placing this compound on easily accessible lesions would be extremely helpful in the nursing home population. One quibble with the article…The compound doesn’t really cure the disease, it arrests it locally (just as excavating the decay and placing a restoration does). The only way to “cure” dental caries is to remove all the teeth. The condition is kept in check by routine exams, diet control, and excellent home care.

Comments on this entry are closed.

Previous post:

Next post: