by Paul Connett
Lawyer: “Does NSF require the manufacturer to provide a list of published and unpublished toxicological studies relevant to HFSA [hydrofluorosilicic acid] and the chemical impurities present in HFSA?”
Hazan: “I would say that the HFSA submissions have not come with the tox studies referenced. ”5
The NSF neither provides toxicological studies supporting the safety of the chemicals used in fluoridation nor accepts liability for its standards, as is made clear in this disclaimer in “Drinking Water Treatment Chemicals—Health Effects”:
NSF International (NSF), in performing its functions in accordance with its objectives, does not assume or undertake to discharge any responsibility of the manufacturer or any other party. The opinions and findings of NSF represent its professional judgment. NSF shall not be responsible to anyone for the use of or reliance upon this Standard by anyone. NSF shall not incur any obligation or liability for damages, including consequential damages, arising out of or in connection with the use, interpretation of, or reliance upon this Standard. 6
So while the NSF claims that “NSF Standards provide basic criteria to promote sanitation and protection of the public health, ”7 it accepts no responsibility for damage to those who rely on its standards. Nor, apparently, do any of the agencies whose representatives belong to NSF panels. Another NSF disclaimer states, “Participation in NSF Standards development activities by regulatory agency representatives (federal, local, state) shall not constitute their agency’s endorsement of NSF or any of its Standards. ”8
Thus, we must now add the NSF to the list of agencies that promote or accept water fluoridation but refuse to accept liability for any damage that the program may cause. This is quite a collection of “three-lettered” liability disowners: ADA, CDC, EPA, FDA, and NSF.
Summary
Fluoride is a drug, unapproved and untested by the FDA. It has never been subjected to randomized clinical trials for effectiveness or safety, as required for other drugs. It is added to the drinking water of over 180 million Americans each day (in some cases against intense individual opposition). The virtues of this practice are extolled by the CDC, the ADA, and many other professional bodies that vigorously promote or endorse it. However, no federal agency accepts responsibility for any damages that may accrue. All pass the buck to a self-regulating, private consortium called the NSF, which in turn accepts no liability for the “safe levels” or the “safety of the chemicals” it recommends. Thus to answer the question posed by the title of this chapter (Who is in Charge?) for the American fluoridation program, the answer is no one. We can only assume therefore that whatever liabilities are involved in this practice are taken on by local communities or by state authorities where the practice becomes mandatory via state legislation.
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5 •
An Experimental Program
It may astound our readers to learn that fluoridation of the public water system remains an experimental procedure, even though the practice has been in effect for over sixty years. However, the facts speak for themselves:
1. When the fluoridation trials began in 1945, practically no health studies had been undertaken or published (see chapter 9).
2. When the U. S. Public Health Service (PHS) endorsed fluoridation in 1950, none of the trials had been completed and still no comprehensive health studies had been published (see chapter 9).
3. When a whole series of professional organizations followed the PHS and endorsed fluoridation in 1950, and in subsequent years, those organizations still had no comprehensive health studies to refer to and no trials had been completed (see chapter 10).
4. Since 1950 no rigorous scientific studies have established safety (see chapters 11–19) or effectiveness (see chapters 6–8). Many health questions remain unasked and unanswered.
5. Since 1950 the fluoridation program has not been monitored in a scientific or comprehensive fashion. Many basic health studies have still not been performed, and no effort has been made to monitor exposure in a scientific fashion—that is, there has been no systematic collection of measurements of fluoride levels in the urine, blood, or bones of people living in communities with fluoridated water (see chapter 22).
6. Fluoridating countries have made little or no effort to replicate studies performed elsewhere that have shown associations between fluoride exposure and increased bone fractures in children (chapter 17); arthritic-like symptoms in adults (chapter 17); lowered IQ in children (chapter 15); lowered thyroid function (chapter 16); and the accumulation of fluoride in the human pineal gland, as well as lowered melatonin production and earlier onset of puberty in animals (chapter 16).
7. Fluoridating countries have made little or no attempt to use dental fluorosis, a clearly visible manifestation of early childhood overexposure to fluoride (chapter 11), as a biomarker to investigate health concerns in children that may be related to fluoride exposure.
8. No government that has promoted fluoridation has made any effort to investigate the many anecdotal reports that a subsection of the population is highly sensitive to fluoride’s toxicity and is experiencing a range of common symptoms that, they claim, clear up when the source of fluoride is removed (see chapter 13).
9. Even when independent bodies have recommended key basic research, governments practicing fluoridation have ignored the recommendations. For example, in 1991, the National Health and Medical Research Council of Australia recommended that the government investigate the claims by a number of people that they were particularly sensitive to fluoride. The NHMRC also recommended the collection of data on fluoride levels in bone, so that health agencies would be in a better position to judge whether long-term exposure to fluoride might cause bone damage. 1 Neither federal nor state health authorities in Australia have responded to either recommendation in the nineteen years since the recommendations were made.
Basic Health Questions Unanswered
Few basic health studies have been done in fluoridating countries. In 2006, the U. S. National Research Council (NRC) was forced to make many recommendations for new research to resolve unanswered health questions about the fluoridation of water. 2 The chairman of this important review panel, Dr. John Doull, was interviewed for an article that appeared in Scientific American in January 2008 and was quoted as follows:
What the committee found is that we’ve gone with the status quo regarding fluoride for many years—for too long really—and now we need to take a fresh look. . . In the scientific community people tend to think this is settled. I mean, when the U. S. surgeon general comes out and says this is one of the top 10 greatest achievements of the 20th century, that’s a hard hurdle to get over. But when we looked at the studies that have been done, we found that many of these questions are unsettled and we have much less information than we should, considering how long this [fluoridation] has been going on. 3
In 2001, Professor Trevor Sheldon, chair of the Advisory Group for the York Review4 and founding director of the UK National Health Service’s Centre for Reviews and Dissemination at the University of York, wrote the following about the York Review in an open letter disseminated in the UK:
The review team was surprised that in spite of the large number of studies carried out over several decades there is a dearth of reliable evidence with which to inform policy. Until high quality studies are undertaken providing more definite evidence, there will continue to be legitimate scientific controversy over the likely effects and costs of water fluoridation. 5
Violation of the Nuremberg Code
Those who promote and sanction fluoridation in the United States and other countries lack the answers to very basic health questions, and yet they continue to impose the practice on millions of people. Without suggesting any sinister motivations—we are sure that most of the people who promote fluoridation do so with the very best of intentions—it is clear from what we have said above that fluoridation is an ongoing human experiment and thus violates the Nuremberg Code, which requires informed consent
to human experimentation from each individual being exposed to the treatment involved. 6
Fluoridation is designed to treat people, and millions of people are receiving and drinking fluoridated water without being informed about possible side effects and without being asked to give their consent for such experimentation (see chapter 1). Moreover, those with low income have little choice but to drink the treated water whether they want to or not.
Rejections of Fluoridation
With so many basic health questions unanswered, it is little wonder that many countries have not followed the American example and fluoridated their water. In fact, contrary to the impression given by many fluoridation promoters, the vast majority of countries in the world—including China, India, Japan, and nearly all European countries—do not fluoridate their water. Only about thirty countries in the world have some percentage of their populations drinking fluoridated water, and of those only eight have more than 50 percent of their population doing so: Australia, Colombia, Ireland, Israel, Malaysia, New Zealand, Singapore, and the United States.
The European Experience
The following European countries have never fluoridated their water: Austria, Belgium, Denmark, France, Greece, Iceland, Italy, Luxemburg, and Norway. Countries that started fluoridation in one or more towns but have since stopped include the Czech Republic, Finland, Germany (West and East), the Netherlands, Sweden, and Switzerland. Some of the countries—Austria, France, Germany, and Switzerland—that do not currently fluoridate their water fluoridate their salt, but those, too, are a minority in Europe. Moreover, in those four countries non-fluoridated salt is available, leaving people with freedom of choice in the matter.
Only three countries in Europe have any significant water fluoridation: Ireland, the UK, and Spain. The Republic of Ireland has had mandatory fluoridation since 1963. Currently, over 70 percent of its population drinks fluoridated water. Less than 10 percent of the population in Spain drinks fluoridated water. The UK has had some fluoridation since the 1950s, but the percentage of people drinking fluoridated water has been stable for many years at approximately 10 percent. Since the Water Act was revamped in 2003, the UK government has renewed efforts to increase that figure. The changes made allow for the indemnification of water utilities for any liability involved in the fluoridation of drinking water. 7
Contrary to claims made by promoters of fluoridation, the rejection of fluoridation has not been based on technical difficulties. In most cases countries have rejected fluoridation largely because they considered that a number of health issues had not been resolved and because they did not want to force it on people who didn’t want it. A spokesperson in the Czech Republic, Dr. B. Havlik of the Ministry of Health, gave the following assessment of stopping fluoridation in that country:
Since 1993, drinking water has not been treated with fluoride in public water supplies throughout the Czech Republic. Although fluoridation of drinking water has not actually been proscribed it is not under consideration because this form of supplementation is considered as follows:
(a) uneconomical (only 0. 54 percent of water suitable for drinking is used as such; the remainder is employed for hygiene etc. ). Furthermore, an increasing amount of consumers (particularly children) are using bottled water for drinking (underground water usually with fluor [fluoride])
(b) unecological (environmental load by a foreign substance)
(c) unethical (“forced medication”)
(d) toxicologically and physiologically debatable (fluoridation represents an untargeted form of supplementation which disregards actual individual intake and requirements and may lead to excessive health-threatening intake in certain population groups; [and] complexation of fluor in water into non biological active forms of fluor)8
European countries have not suffered more tooth decay as a result of rejecting fluoridation. In fact, according to World Health Organization (WHO) data available online, 9 rates of tooth decay in twelve-year-olds have been coming down as fast in non-fluoridated countries as in fluoridated ones. A graphical plot of these data can also be accessed online. 10 We show a simplified version of this graph in figure 6. 1 in chapter 6.
Moreover, there is no evidence that where fluoridation has been started and stopped in Europe there has been a rise in tooth decay. Indeed, two studies published in 2000, from Finland and the former East Germany, show that tooth decay continued to decline after fluoridation was halted. 11, 12 There have been similar reports from Cuba 13 and Canada’s British Columbia. 14 The ADA15 claims that in cases where fluoridation has been halted and no increase in tooth decay observed, other steps have been taken to fight tooth decay. Whether or not that is the explanation, European countries have clearly demonstrated that there are other ways of reducing tooth decay without forcing everyone to take a medicine in their drinking water.
Summary
When the fluoridation of drinking water began, there was little evidence for its long-term safety, and since then little attempt has been made to monitor its health effects systematically. Because there are so many unanswered health questions, fluoridation of water must be considered an ongoing experimental procedure, and as such it is a violation of the Nuremberg Code, which forbids experimentation on humans without their informed consent. Only a minority of countries practice fluoridation. In Europe, nearly all countries either have never fluoridated their water or have ceased doing so. Yet the incidence of caries has declined just as much in those countries as in countries that practice fluoridation.
PART TWO
The Evidence That
Fluoridation Is Ineffective
One of the big surprises awaiting someone who decides to review the literature on water fluoridation is that, despite the impression conveyed by its promoters for over sixty years, the evidence that swallowing fluoride actually reduces tooth decay is weak. In chapter 6, we review the many lines of evidence that fluoridation is ineffective at reducing tooth decay. In chapter 7, we examine the evidence that the famous 1942 study by Dean, Arnold, and Elvove and the early trials in the United States, Canada, and New Zealand were either seriously flawed or fraudulent.
In chapter 8, we review many of the studies published since 1980 that indicate little or no benefit from fluoridation. We also discuss two other lines of evidence that cast doubt on the effectiveness of fluoridation: (1) the impact on tooth decay when fluoridation is halted, and (2) the dental crises being reported in American cities that have been fluoridated for over thirty years.
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6 •
Fluoridation and Tooth Decay
Incredibly, in the sixty years that public water systems have been fluoridated, there has never been a study of the results of fluoridation of the quality required by the Food and Drug Administration when approving new drugs for efficacy—that is, a study involving randomized clinical trials. Such trials require random selection and double-blind testing. “Double-blind” means that neither the people being tested nor the people determining the outcome know which subjects have received the drug and which have received a placebo.
The York Report, a systematic review carried out by a team from York University at the request of the UK government, adopted the following criteria for awarding Grade A status to a fluoridation study:
• The study started within one year of either initiation or discontinuation of water fluoridation and had a follow-up of at least two years for positive effects and at least five years for negative effects.
• The study either was randomized or addressed at least three possible confounding factors and adjusted for these in the analysis where appropriate.
• The fluoridation status of participants was unknown to those assessing outcomes. 1
Even using these criteria, an exhaustive review of the literature identified no Grade A studies. Eventually, the York Review team was able to find only six longitudinal studies that met its Grades B and C classifications. Those six studies were published over a period of years from 1961 to 199
0. That does not speak well of the general quality of the studies that have addressed fluoridation. The absence of Grade A studies is extremely unfortunate because there are so many aspects of tooth decay that might have been revealed if the issue were examined using stringent scientific methods.
Instead of randomized clinical trials, proponents of fluoridation have relied heavily on the famous two-part, twenty-one-city study by Dean, Arnold, and Elvove;2, 3 trials conducted in North America between 1945 and 1955; and an early trial in New Zealand. The methodologies and legitimacy of both the Dean study and these early trials have been challenged by fluoridation critics for many years (see chapter 7).
Proponents of fluoridation like the CDC have claimed that the incidence of tooth decay is coming down in fluoridated communities because of the introduction of water or salt fluoridation; however, we saw in chapter 5 that most industrialized countries, including most European countries, fluoridate neither their water nor their salt, yet according to World Health Organization (WHO) data available online, tooth decay in twelve-year-olds has come down as fast in non-fluoridated countries as in fluoridated countries. 4 As mentioned in chapter 5, a graphical plot of these data can also be accessed online, 5 and a similar graph is presented in an article by Cheng, Chalmers, and Sheldon in the British Medical Journal. 6 Because it is difficult to distinguish which country is which in the plot, especially when the image is converted into black and white, we have selected just four of the non-fluoridated countries to compare with four fluoridated countries in figure 6. 1. The four non-fluoridated countries fluoridate neither their water nor their salt, yet there is little obvious difference in the rate of decline in tooth decay in these eight countries.
