(Posted by Patrick Sullivan Jr.)
In the past 24 hours, I've had 5 people email this AP story about 2 new studies that show no harm, no foul for kids that were given mercury fillings. Wade Rankin was the latest to send me an email linking to his post on the subject. Here's the comment I left on his blog:
Wade, good comments. While we delve into the thimerosal/autism debate, mercury amalgams are really the Sullivan's major bogey. I first heard about this study several months ago when Consumers for Dental Choice filed a formal ethical complaint (or whatever it's called) with the researchers of this experiment. Using a known toxin on indigent children is good how?
Then, last week, I was CC'ed on what seemed like 25 different emails going back and forth with members of the IAOMT and Consumers for Dental Choice. Since I've mostly been holed up working on another project for the last 9 days, I mostly just skimmed the emails going through. (I still need to go back and read through them more carefully as there are numerous rebuttals proposed.)
What is surprising to me is, all the sudden, mercury amalgam is in the "big" news. I've had 5 different people email this story to me in the last 24 hours. I had no idea how much press this was getting! My goodness, if it's "good" news about mercury amalgams, how is that able to spread so far and wide?
So in the AP article, I guess I'm glad that at the very least, dissenting comments from Charlie Brown of Consumers for Dental Choice and mention of IAOMT made it into the article. Though that is sort of like being thankful for the crumbs that fell from the master's table!
Quite frankly, it's still a positive thing for this to be in the news because we can (re)point people who's interest is peaked to one of the best compilations on the subject, The Scientific Case Against Amalgam from the IAOMT.
And speaking of the IAOMT, they really are in an uproar over the ethical lapse of experimenting with a known toxin on indigent kids without giving any sort of consent. So expect to hear more from them SOON if the press cares to pay any attention to a dissenting opinion from the status quo.
And oh yeah, if mercury amalgams are all fine and dandy, then why the heck did Pat drop $100K into the Jigsaw Health Foundation? Coulda bought a nice boat or something...
PS - My blog parody idea for "New scientific study shows that scientific studies are inconclusive, contradictory, biased, down-right confusing to Joe Public and should NOT be used under ANY circumstances to form an opinion. blah, blah, blah. More funding is needed complete this research." is long overdue.
I'll go through those emails from last week tomorrow if I get the chance and update this post. In the meantime, iIf there are any IAOMT members reading this blog, feel free to post your own comments on the studies.
UPDATE 1: Read Boyd Haley's criticism of these studies.
UPDATE 2: A letter to the editor:
Letters to the Editor:
Elements: Wrong to do, Outrageous misconduct, Designed to fail
Dr. Gupta:
Ever since you featured me as part of the Number One Medical story of the last 25 years I have been a big fan or yours and have enjoyed the many enlightened reports you do for CNN.
Sadly, your network and your viewers were done a major disservice yesterday by publication of a study that was designed to fail.
I urge you to read the attached observations from Dr. Boyd Haley, PhD who explains the flaws in the study far better than I can.
Let me just add this to make my interest in the matter clear. In addition to being a leukemia survivor whose life was saved by participation in a clinical trial for STI-571, now marketed as Gleevec, I had the privilege of working for the Committee on Government Reform and Oversight of the U.S. House of Representatives for three years. Since then I have become a Congressional Relations advisor to several respected organizations in the wellness industry, including the International Academy of Oral Medicine and Toxicology.
During my congressional employment I coordinated several Congressional Hearings on mercury-containing dental amalgam. My clear impressions were that the anti-mercury dentists and scientists who testified at those hearings based their opinions on solid science. The representatives of the pro-mercury groups, including the American Dental Association, the Food and Drug Administration, and the National Institute of Cranial facial and Dental Research of the National Institutes of Health gave notably unpersuasive, unscientific testimony. The pro-mercury groups seemed to work very hard to justify their past and continued use of a potent neurotoxin that has been banned from very other facet of medical treatment, including teething powder, mercurochrome, merthiolate, contact lens solutions, and even horse liniment.
I first heard of the Children's studies during one of those hearings, and I wondered at the time whether they would be based on solid science, or on the need to justify past practices. Now the answer is clear. Science lost out.
Do these reports represent a deliberate cover-up or were they the result of ignorance? Before you brush aside the notion that highly trained professionals might be accused of ignorance, one must consider the specifics of their training. Dentists and dental materials specialists have little no training in toxicology, neurology, biochemistry, or any other discipline that would help them understand the connection between mercury poisoning and various neurological problems.
Consider this. Painters did not identify and solve the lead-based paint problem. Tobacco companies did not raise the red flag about diseases connected to smoking. Asbestos manufacturers did not alert their workers and the public to the health hazards of asbestos.
Similarly, the dental industry cannot be expected to solve the mercury toxicity problem. They just don't have the knowledge.
In my opinion, the startling increase in cases of ADD, ADHD, Fibromyalgia, lupus, Autism, and Alzheimer's disease constitute iatrogenic epidemics that can and should be stopped. That will happen only when the emphasis is placed on true science and not on protecting past practices.
I sincerely thank you for your interest, and I urge you to study Dr. Haley's document.
John Rowe
Baltimore,
UPDATE 3: Were these studies ethical? According legal precedent, no. Sandra Duffy from Consumers for Dental Choice wrote in an email:
The Grimes case focused in on the legal requirement that there must be the possibility of some benefit for the subject .... and in the Grimes case the kids got dosed with lead but no treatment protocol ... so it failed the test according to the court.
...Grimes IS analogous despite the dentists' claim that dental care is a treatment benefit of the trial. No it is not. The mercury fillings have been an informal experiment for 170 years. Making it a formal experiment for 7 years doesn't transform a negligent standard of care into a beneficial standard of care. As I noted in my Op Ed piece to the Oregonian, when the U of W investigators were applying for the grant they said THEY ACTUALLY WROTE THAT they used children because they were more sensitive to neurological damage and would show more harm. Good grief!
Consumer for Dental Choice's full critique of these two studies can be read here.
UPDATE 4: Criticism from Dr. David Kennedy, past-president of IAOMT.
Grossly inadequate informed consents both in the US and Portugal and in Portugal did not tell the guardian parent they were implanting mercury silver dental fillings.
The very questionable ethics of experimenting on indigent and orphaned children with a very
toxic heavy metal looking for neurological impairment. Mercury poisoning in childhood is not necessarily reversible even with medical intervention.
The information is not new and these experiments make no meaningful contribution to the body of knowledge
Poorly designed and did not even try to identify vulnerable subsets
Used spot urine which has never been an adequate measure of chronic mercury toxicity (CMT)
Cost was enormous. So far the NIH has funded over 500 studies and only a handful have been published and they have all confirmed exposure to mercury
Lack of disclosure in the published article such as membership on the trade associations that advocate amalgam use
Did not disclose a 10 year child abuse scandal at the Casa Pia school for orphans in Portugal (would obviously skew the data on neurological impairment)
Did not disclose the ethical complaints being investigated by NIH
Used toxic composite that contained carcinogens instead of ones rated Zero by ANSI
High drop rate and meaningless tests for mercury
UPDATE 5: Read Dr. Needleman's editorial that appeared in the same issue of JAMA as these two studies.
"It is predictable that some outside interests will expand the modest conclusions of these studies to assert that use of mercury amalgam in dentistry is risk free. This conclusion would be unfortunate and unscientific."
More updates to follow? If this isn't enough, then heck yeah.
UPDATE 6: More from Dr. David Kennedy. Looking for a non-Klingon sounding critique? Then read this!
From all the knowledge that we have about mercury exposure and its consequences this study did not address even one of those known short term effects. Those investigators who have examined urine have unanimously concluded that there is little correlation between urine mercury and exposure, body burden and any physiological or psychological effects. This study inaccurately relied upon urine and blood mercury as its only measurement of exposure. Statistical significance is irrelevant if the investigators are comparing the wrong things.
Moreover, a more careful examination of the minimal data displayed in this report does however raise serious concerns about the impact of mercury on these children.
UPDATE 7: Need a refresher?
UPDATE 8: Via email from Amy Carson of Moms Against Mercury:
For Immediate Release
April 25, 2006
Contact: Bert Hammond (202) 225-7084, Lois Hill Hale (323) 965-1422
Press Advisory -- Reps. Watson and Burton Criticize NIH Studies on Mercury Dental Fillings Schedule Press Conference for Thursday, April 27, at HHS
Washington, DC — Representatives Diane E. Watson (CA) and Dan Burton (IN) will hold a press conference on Thursday, April 27, 2006, in front of the Department of Health and Human Services, 200 Independence Ave., SW., at 11:00 AM.
Reps. Watson and Burton will discuss their serious concerns about two studies commissioned by the National Institute of Health (NIH) and published last week in JAMA on the safety of mercury dental amalgams. The government-funded studies found no evidence that dental fillings containing mercury are a health risk for children. The studies, however, did not look at the health effects of mercury amalgam on two groups that may be more susceptible to unhealthy concentrations of mercury in the body: older adults and pregnant women and their infants.
The studies also did not assert that use of mercury amalgam in dentistry is risk-free. In fact, an editorial printed in the same edition of JAMA by Herbert L. Needleman, MD, a recognized authority on lead toxicity, cautioned against using the two NIH funded studies to conclude that the use of dental amalgams in children poses no significant health risks.
One study commissioned by NIH tracked minority children in inner-city Boston and low-income children in Maine. The other traced children at an orphanage in Portugal. Both studies failed to disclose the risks of mercury exposure to the children, parents, or guardians – a fact that has led the HHS’s Office of Human Research Protections to open a comprehensive investigation about the medical ethics of the studies.
Immediately following the press conference, Reps. Watson and Burton will deliver a letter outlining their concerns about the studies to HHS Secretary Leavitt.
Reps. Watson and Burton are cosponsors of H.R. 4011, The Mercury in Dental Fillings Disclosure and Prevention Act, which prohibits after 2008 the use of mercury in dental fillings.
Additional speakers at the press conference are
- Charlie Brown, Consumers for Dental Choice;
- Amy Carson, Moms Against Mercury;
- Dr. Richard Fisher, International Academy of Oral Medicine and Toxicology (IAOMT).
Five nonprofit groups, led by the group Moms Against Mercury, will be filing a lawsuit against the FDA that addresses the agency’s failure to classify mercury dental amalgam or to ever approve its safety. The suit petitions the court to halt the use and sale of mercury dental amalgam immediately.
Find out more at the Congresswoman's official website: http://www.house.gov/watson/
I guess nothing rallies the troops like bad news.
UPDATE 9: Bernie Windham weighs in, heavily.
Preliminary Comments on Neurobehavioral Effects of Dental Amalgam in Children, T. A. De Rouen, et al, JAMA, April 19, 2006
In justifying the study design the authors state on page 1 that there is little or no evidence concerning health effects of low level mercury exposure from amalgam, especially in children. In fact, there are over 3,000 peer-reviewed studies in the medical literature(3) that were submitted by parties in the FDA amalgam docket to the FDA (4), that document the mechanisms by which mercury(from amalgam) commonly causes over 30 chronic health conditions. And there are hundreds are peer-reviewed studies and clinical studies that document that many thousands of patients with these conditions have improved after amalgam replacement(2). While it is clear that hundreds of thousands (or millions) of children have had their health adversely affected by mercury, since there are multiple exposure mechanisms its not clear the extent to which dental amalgam is responsible(7).
But the main problem with the study design appears to be the choice of what conditions were tested for and the kinds of tests that were used. In describing why the chosen conditions were tested for and in what manner, the authors stated on page 2 of the study that the target organs for elemental mercury exposure from amalgam were identified to be the renal system and neurological functions(memory, attention/concentration, and motor/visuomotor). Actually, while there is documentation in the medical literature of many other types of health effects, there is little evidence in the literature on common renal effects.(1,2,3). And there are
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