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When the FDA Flip Flops: The Case of Silver Fillings

Posted: 05/27/11 09:19 AM ET

In a recent post on the different types of cavity fillings that are available, I mentioned that I wasn't a huge fan of dental amalgam fillings -- you know, those silver fillings we all got as kids. I don't like them because they contain Mercury.

I also referenced how the Food and Drug Administration had recently changed its stance on amalgam fillings. I'd like to talk a little more in depth about that today, as I feel it's important.

In a nutshell, here's what happened: For years, the FDA said amalgam fillings were just fine and we believed it. Just look in the mirror for proof -- it's a given that most of you still have an amalgam filling in your mouth somewhere.

Then, the FDA reversed its stance and basically said something like "Ok, wait, maybe this isn't so good for pregnant women and young children."

Then, in 2009, they changed their tune again, and said (once again), that there was little to no risk. The roller coaster does not end, however -- there was another "it's bad" reversal in 2010, which is still their position today.

As of right now, the FDA considers amalgam fillings as class II (higher risk), when it used to be class I (low to no risk).

The first thing that I believe should be somewhat troubling to everyone is the trust factor. In essence, we're not all scientists and, until very recently, "regular people" really didn't have much access to scientific data -- and even if we do, who really has the time to peruse it all and make heads or tails of it? So we trust organizations like the FDA to tell us what is harmful and what isn't.

That trust seems to sometimes be somewhat misplaced. Because really, going back and forth on something like this is not comforting. Are amalgam fillings harmful or not?

Now I know some commenters will extol that we've known this for years and shouldn't always trust the FDA blindly. Hey, I happen to agree. But again, unless you are conducting tests yourself, our knowledge of most things scientific is limited to choosing which "report" or "finding" to believe.

The FDA changed its mind essentially due to pressure from four different groups who all said "Wait -- this is harmful -- take another look." So they took another look and did the about-face.

What this says to me is that the FDA is not infallible. Essentially, what I glean from this situation is that an FDA endorsement is temporary, akin to "as far as we know now, it's ok. But in 20 years, if people start growing a third leg, we'll revisit it".

Again, not exactly comfy.

What's the reason for this? Why not have allof the facts and findings before deciding that something is safe? I suppose one valid reason is that then, nothing would get released. If we had to wait 20, 30 or 50 years to see if a substance is harmful for the long-term, well ... let's just say no new drug would ever see the light of day. Since we don't want that, we're left with the imperfect system that we currently have.

Let's look at a few other substances that were deemed "OK" by the FDA, but turned out to be "not so good" (or the other way around).

• The FDA recently reversed its position on a Menaflex Knee Device. It had been given approval, but then, under pressure, the FDA re-evaluated its position. It would appear that the device was given a speedy approval because it was somewhat similar to others. However, it's fair to note that political and industry pressure may possibly influence the FDA -- and decisions such as this one -- to a degree.

• The FDA also reversed itself on Olestra, a fat substitute. Before 2003, the FDA required that Olestra packaging include warning labels about cramping and loose stools. You probably remember that -- potato chips that could allegedly give you diarrhea. But in 2003, the FDA decided that warning labels were unnecessary. I mean, who would buy chips that could cause "loose stools"? When I think about the commercial interests that may have influenced the FDA's decision, it makes me take pause.

• On a different note, the FDA reversed a stance on liquid Morphine, saying that it can stay on the market. Since liquid morphine is essentially a last resort, end of life, hospice drug, this actually makes sense to me. In my opinion, there is a point where "bad for you" might be irrelevant.

Ultimately, I personally believe that you should trust your gut more than anything. The FDA might be useful in providing a guide as to what's safe and what isn't, but as the previously mentioned reversals indicate -- it's not always perfect.

Until next time, keep smiling.

 

Follow Thomas P. Connelly, D.D.S. on Twitter: www.twitter.com/dr_connelly

In a recent post on the different types of cavity fillings that are available, I mentioned that I wasn't a huge fan of dental amalgam fillings -- you know, those silver fillings we all got as kids. I ...
In a recent post on the different types of cavity fillings that are available, I mentioned that I wasn't a huge fan of dental amalgam fillings -- you know, those silver fillings we all got as kids. I ...
 
 
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11:13 AM on 06/02/2011
I don't glean any actual helpful information regarding amalgam fillings. What is the writer's point here?
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Runey
anti-religionists, converge and amass
03:34 PM on 05/31/2011
wait.. until next time keep smiling??! what's coming next?! :(
04:54 AM on 05/31/2011
I can't believe this debate is going on. I graduated from Dental School (DDS) and went on to a 6-year Residency Program in Oro-Maxillo-Facial Surgery (OMFS). The residency program granted an M.D. and included those courses and rotations in Medical School that weren't taken during Dental School. I went on to 2 year Fellowship in my specialty. I'll never forget those Dental Materials courses. The amalgam debate in the late 1980's hasn't changed. Our info was based on solid empirical research. I haven't restored a tooth since Dental School, but there was no solid empirical data to back-up claims from the anti-amalgamists. We learned about the different metals and ratios of metals that comprised an amalgam filling and the reactions of those metals when mixed. There were variations of amalgam, but the bottom line was that there was no evidence that "mercury bleeding" took place.The amount of mercury was miniscule and it reacted with the other metals, changing it's state. I still receive the JADA, and I haven't noticed any amalgam research that's significantly changed from that learned in the 1980's. Most of the guys I graduated with from Dental School use composite fillings for cosmetic reasons. Many still use amalgam for crown build-ups. My advice when researching anything or taking advice from anyone is to determine the independence of the researcher, who's funding the research, and what the practitioner or company stands to gain from making various claims.
06:50 PM on 06/03/2011
I never heard of a 6yr MD DDS program , probably because there is no such thing .
The JADA is clearly not unbiased . Even dentists admit that hg is released from filling and that the bonds in amalgam do not prevent hg release. There have been many tests done measuring the mercury vapor in people who have many amalgams and they have found high vapor levels that translate into exposures of more than 50 micrograms hg /day in many .Anything over 0ne microgram a day is a toxic level. the exposure is greatest in the hour after eating but is too high at other times.It is absurd to conclude that no hg "bleeding" occurs . Did you ever study chemistry ? Tell me the concentration in micrograms/ cm3 in mouths people with several amalgams.I have studied chemistry extensively so perhaps you can tell me what happens to hg that prevents its release once in amalgam .Can you tell me why it is illegal to toss amalgam into the trash ?
There is no data to back up the safety claims of amalgam dentists. Hg is hg regardless of whether it comes from paint, fillings , fish coal burning etc and it is extremely toxic . Where did the expression mad hatter come from ? It came from the fact that hat makers used to be exposed to hg vapor and hg is a neurotoxin that causes anxiety , depression and other psychiatric symptoms.
04:58 AM on 06/04/2011
You need to brush up on your comprehensive reading skills. It's not a 6-yr. DDS-MD program. It's 4 years of Dental School (DDS or DMD). Then, one may apply to an Oro-Maxillo-Facial Residency Program. Some residency programs offer the option to receive an MD ( 6-year Residency). Look up the OMFS programs offered at the University of Texas Health Science Center. Better yet, google the OMFS residencies that offer the option of an M.D.

The science courses required at Medical and Dental Schools: 2 Semesters of General Chemistry, 2 Semesters of Organic Chemistry, one semester of Biochemistry, 2 Semesters of Physics (Trig-based), 4 Semesters of Biology and one semester of College Calculus. Very few applicants with overall GPA's of less than 3.5 are accepted. I scored in the top 5% of the DAT. I graduated Magna Cum Laude (hook 'em horns). I graduated 2nd in a Dental class of 90 students. I scored in the top 2% on the MCAT. Was I supposed to be impressed with your microgram and Hg references?

I stand by my claim. You merely stated the symptoms of pure Mercury poisoning, making the leap to amalgam. Like almost everyting else, after being mixed in the "amalgamator", it was medical waste and was disposed of accordingly. You're obviously not a Dentist or a Physician (Dental Assistant?). You would've known about the OMFS residency options. After 20 years, still no solid evidence that precludes the use of amalgam.
10:35 PM on 05/30/2011
If amalgam fillings were deadly, I'd have been toes up years ago. I'm almost 60, and had a mouth full of them, since in my long-ago childhood that's all that was available, at least for children. (Gold and porcelain weren't options in my family.) A lot of them have been replaced, but only because they finally broke down in one way or another, not because I was paranoid about them.

Nowadays, if parents take their children to the dentist starting when they're small, and they can be given the anti-cavity sealants and be taught proper brushing and flossing methods, they may well grow to adulthood without ever needing a filling, whether amalgam or composite or whatever. A young adult in my family went about 8 years during college and onwards without ever going to the dentist for even a cleaning -- stupid, but it's not like he could be kidnapped and forced to go -- and when he finally got it together and went in for an evaluation, the only cavity that was found was on one of his unremoved wisdom teeth.

Maybe there are better solutions now, but amalgam is cheaper and more durable than some others. Avoid it? OK, but make it a crime? Nonsense.
06:55 PM on 06/03/2011
Many people smoke for decades too without getting cancer or heart disease.
As far as your relative who didn't go to a dentist for years and then found just one cavity , that may be because dentists are filling healthy teeth . When I was younger and more trusting , i had several fillings on teeth that were not bothering me at all.
Gold fillings are much more durable.
OverseasVet
Stationed not deployed
12:36 AM on 05/30/2011
This article is very misleading. The PDF suggesting the FDA "basically said something like "Ok, wait, maybe this isn't so good for pregnant women and young children." " is not an FDA document but a simple letter by one dentist submitted to the FDA. The FDA concluded no such danger exists.
01:09 PM on 06/02/2011
The FDA never concluded any such thing. In the 2009 amalgam rule, FDA did admitted that amalgam could be harmful for children and pregnant women: "The developing neurological systems in fetuses and young children may be more sensitive to the neurotoxic effects of mercury vapor. Very limited to no clinical information is available regarding long-term health outcomes in pregnant women and their developing fetuses, and children under the age of six, including infants who are breastfed." http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073311.htm
08:07 PM on 05/29/2011
Amalgam has been one of the most commonly used materials in this field.It has other properties too such as micro-leakage and delayed expansion, if they are improperly manipulated.Proper manipulation of the material minimizes the adverse effects. Other compounds like composites and GIC are available and seems to work out satisfactorily in selective cases, although materials requirements differs as per the case . Like every medicines has side -effects, but still we are bound to use many of them, as there are no other alternatives
06:57 PM on 06/03/2011
Gold is an alternative.
06:57 PM on 06/03/2011
When they expand they crack teeth
06:09 AM on 06/04/2011
Proper manipulation is needed and yes gold can be a option but is expensive for the masses .
05:59 PM on 05/29/2011
Most people with many alalgam fillings have abnormally low body temperatures an indication that mercury has affected their thyroid and this is reason enough to ban amalgam .
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onionboy
Blessed are the Cheese Makers
04:00 PM on 06/01/2011
"Most people with many alalgam fillings have abnormally low body temperatur­es"

That's a pretty strong statement. Got some data to back that up? Maybe even a definition of "many"? I would imagine there are at least 100,000,000 people in this country who have had at least one amalgam filling.
11:12 AM on 06/02/2011
Fair question. I have over 25 amalgam fillings from childhood, and I have a thyroid problem and I have a normal body temperature of 96.8, even with thyroid medications. I was also given huge quantities of flouride pills to chew as a child to "prevent" cavities, to add insult to injury. The pills didn't work and the flouride probably damaged my thyroid further.
I wouldn't trust the FDA to my own children if I had no choice.
I don't know why that point was so important to you to make a request for documentation, though. Do you think the FDA is infallible?
06:35 PM on 06/03/2011
The people who are most affected are those with the most fillings , not one filling , those that also have gold in their mouths under crowns and elsewhere because it increases hg release and those that grind their teeth which increases hg release.
05:58 PM on 05/29/2011
It is indisputable that mercury is a toxin so the only issue is how great is our exposure from fillings . We can determine this level by measuring the mercury vapor in the mouths of people with amalgam and then determine the exposure in micrograms per day with some accuracy . When people with alalgam have their mercury vapor measured , they are found to have far more than the maximum exposure considered safe .Proponents of amalgam claim that the hg2 vapor is less toxic than methyl mercury but this is not true.
OverseasVet
Stationed not deployed
01:27 PM on 05/28/2011
These amalgums have been used without adverse reactions for generations. To suggest otherwise is nothing more than an attempt to scare the money out of our pockets.
05:48 PM on 05/29/2011
Who would ever form a causal connection between a symptom and their amalgam fillings? The answer is almost no one. If you have kidney or thyroid problems or depression or a host of other symptoms , you don'tassociate these with your fillings.
OverseasVet
Stationed not deployed
12:24 AM on 05/30/2011
And without any hint of association why is this scare article attempting to make such an argument? $$$$? The FDA has studied the potential harm and found none exists even for infants and pregnant mothers. Is there science based studies which show otherwise or is this simply a scare to generate ad sells and drive people to those unscrupulous enough to take advantage of the fear?
07:27 PM on 05/27/2011
Science changes its mind. That's one of the things that separates it from religion. Expecting the FDA to be right the first time, every time, is ridiculous. When new evidence comes in, they change their recommendations - exactly as they should.
11:36 PM on 05/27/2011
So when your friendly government comes to take your children away because you will not follow the law and subject your babies to injections that science has oh so clearly and currently deemed to be "SAFE," just smile and tell yourself that all is- exactly as it should be! When new evidence comes in and "whoops, we were wrong, LOL!!" maybe then you can get your babies back.
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John Rathe
11:51 PM on 05/27/2011
Straw man. Why not address their point? Science should be self correcting given new evidence. Or are you suggesting an unwavering approach where information is never corrected yet nevertheless distributed as fact to an unsuspecting public? Or worse, withholding any findings whatsoever because of the future possibility of new evidence being uncovered?
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onionboy
Blessed are the Cheese Makers
04:02 PM on 06/01/2011
Can you cite a case where someone's children have been taken away because they would not let them get an injection?
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onionboy
Blessed are the Cheese Makers
04:04 PM on 06/01/2011
Exactly. Science is about questions. It's always looking to correct itself.

If all people want are unwavering answers, they should stick to their holy books.
05:12 PM on 05/27/2011
DO SILVER FILLINGS CONTAIN SILVER OR IS IT CALLED SILVER BECAUSE THE 50% OF IT WHICH IS MERCURY LOOKS LIKE SILVER ?

APPERENTLY GREEN DOCTORS [ HOLISTIC DENTISTRY ] DONT USE MERCURY AMALGAM

SOEM SAY THE MERCURY IS MORE DANGER TO THE DENTIST THAN THE PATIENT

ONE CONCERN IS THAT THE PRESSURE OF CHEWING CAUSES THE MERCURY TO PRODUCE TOXIC VAPOUR
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RMankovitz
Researcher, inventor, entrepreneur, author
01:40 PM on 05/27/2011
Great article, which begs the question of what to do, if anything, if you already have a mouth full of mercury.

Getting mercury safely out of your teeth and body is quite tricky. The process of amalgam removal should be performed by biological dentists trained in procedures that minimize inhalation and ingestion of mercury during the procedure.

The next trick is to choose a replacement material that, itself, is not toxic. Many plastic composites contain BPA, and other replacement metals may cause toxic reactions. Compatibility testing, including the Melisa test, should be performed. My favorite replacement material is zirconia. Care also should be taken in choosing a compatible bonding agent.

Once amalgam replacement is complete, the next step is to remove at least some of the mercury that has been stored in your body over a lifetime. There is much conflicting information as to the proper methods of removal, including using true chelating agents such as DMSA, DMPS, and alpha lipoic acid. Used incorrectly, chelators can redistribute mercury throughout the body, increasing toxicity. In addition to chelation, there are various compounds that can adsorb and/or displace mercury from tissues.

A discussion and references concerning mercury detoxification, including some new approaches based on how nature removes heavy metals from the environment, can be found in "The Wellness Project."

Roy Mankovitz, Director
http://www.MontecitoWellness.com
A research organization
05:51 PM on 05/29/2011
Compatibility tests only test for allergic ractions and they are inaccurate anyway.
05:52 PM on 05/29/2011
Gold fillings are the least toxic.
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RMankovitz
Researcher, inventor, entrepreneur, author
06:43 PM on 05/29/2011
Thanks for sharing your personal opinions.

Regarding “gold” as a filling material, its toxicity strongly depends on the other major alloy material. Much of the gold alloy dental filling material being used today contains large quantities of palladium, which is quite toxic. Thus, it is important to be sure the “gold” put in your mouth is a platinum alloy, free of palladium, tin, nickel, copper, and chromium.

Here is an example of data on Melisa testing of dental filling materials and CFS:

http://www.melisa.org/chronic-fatigue.php

What gold alloy is in your mouth?

What is your experience with the accuracy of Melisa testing?

Zirconia is a crown material.
01:38 PM on 05/27/2011
There is something that is true, that you left our of your article, and it's a serious omission. It's this:
SCIENCE is not infallible, our knowledge of biology, human or otherwise, is miniscule, "risk" is a very fuzzy, hazy term opening to signficant argument by highly intelligent, well intentioned people, and no one is in the omnipotent/omniscient position to give guarantees.

In other words, the FDA is composed of people doing their best in the face of an impossible mission and their vacillation should be seen as the consequence of conscientious people doing their best in the face of an impossible mission.

Your advice to "trust your gut" is just horrible. Trusting your gut is what led to the Salem witch trials: it is a resort to superstition. The better advice is this: go with the latest conclusions, refuse to worry about it, and go with the next set of conclusions when they come out, and refuse to worry about that. Or, do your own research.
11:01 AM on 05/27/2011
In light of the dearth of safety evidence for children and every indication that mercury exposure is harmful to them, I agree with The Mouth Physician columnist who writes for the dental newsletter Dr. Bicuspid: "it is a crime to place an amalgam in a child's or teenager's tooth." [3] It is time that the FDA, the trade groups, and the "pro-mercury" dentists be held accountable for subjecting children -- especially low-income children -- to the unnecessary neurological risks associated with amalgam.
[3]http://www.drbicuspid.com/index.aspx?sec=wom
11:00 AM on 05/27/2011
Then the FDA assembled an advisory panel on amalgam in December 2010. Here are some of the comments from panelists: Dr. Kotagal of the Mayo Clinic says there is “no place for mercury in children.” Dr. Ismail says “children less than 6 years of age, I would restrict it significantly.” Dr. Thompson says “definitely not in pregnant women and definitely not in those below 6 years of age.” Dr. Fleming says we need contraindications for pregnant women. Dr. Burbacher says, “why put amalgams in children if we know they're going to live with that for the rest of their lives? And we don't know what that's going to do.” Dr. Zelikoff says FDA staff members “need to really consider the sensitive subpopulations that I would define as pregnant women and the fetus, as well as elderly and anyone with pre-existing disease. I don't see where this is being taken into account.” Dr. White says “What's not said is it's not safe for use by everyone. We'd all agree with that, it's not safe for use by everyone.” Ms. Rue says “the safety issue from everything we’ve heard in the last 2 days still is in question.” [2] FDA has said nothing in the wake of the 2010 advisory panel's conclusions -- as a result amalgam is still endangering children.
[2]http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/DentalProductsPanel/UCM242363.pdf