by Paul Connett
Swallowing fluoride gels.
C. -J. Spak and his Swedish coworkers, in an investigation of the impacts of swallowing fluoride gels, demonstrated that fluoride could damage the stomach lining. They described their findings as follows: “The histopathological evaluation revealed changes in nine of ten patients, with the surface epithelium as the most affected component of the mucosa. The present study clearly shows that a treatment with a F gel of rather low F concentration may result in injuries to the gastric mucosa. ”35
Treatment of osteoporosis.
As mentioned, sodium fluoride has been used in the treatment of patients suffering with osteoporosis; this is in an effort to increase their bone mineral density and thereby reduce fractures (see chapter 17). The side effects described by those running the clinical trials studying the use of sodium fluoride to treat patients with osteoporosis included gastrointestinal damage. There are many reports; here are two:
Results from several large trials indicate that significant side effects attributable to treatment occur in about one-third to one-half of patients. Symptoms have been of two types—periarticular and gastrointestinal. . . Gastrointestinal symptoms consist of epigastric pain, nausea, vomiting, and occasionally, blood-loss anemia; these presumably result from the irritant effect of fluoride ion on gastric mucosa. . . Diarrhea occurs occasionally. 36
Of 48 patients who began sodium fluoride therapy (dose = 9. 0–27 mg/day F), 25 developed significant side-effects (10 with nausea and dyspepsia, 1 with gastrointestinal hemorrhage). 37
Skeletal fluorosis cases in India.
Gastric problems have also been reported in studies of citizens suffering from skeletal fluorosis in areas of India with high natural levels of fluoride in the water. The following symptoms have been reported among the inhabitants consuming water with high fluoride content: “loss of appetite, nausea, abdominal pain, flatulence, constipation and intermittent diarrhoea. . . When water with negligible amounts of fluoride (safe water) is provided, the complaints disappear within a fortnight. ”38
Dr. A. K. Susheela, executive director of the Fluorosis Research and Rural Development Foundation in Delhi, India, has moved from a general description of these gastric problems to more detailed microscopic observations. In 1996, she and her colleagues reported abnormalities of the gastric mucosa in patients with outright skeletal fluorosis (osteofluorosis). They described their study as follows:
A prospective case-controlled study was performed to evaluate the gastrointestinal symptoms and mucosal abnormalities occurring in patients with osteofluorosis. Ten patients with documented osteofluorosis and ten age- and sex-matched healthy volunteers were included in the study. . . Electron microscopic abnormalities were observed in all 10 patients with osteofluorosis. These included loss of microvilli [small hairlike structures that protrude from the lining of the GI tract and facilitate the uptake of minerals and other nutrients into the blood], cracked-clay appearance, and the presence of surface abrasions on the mucosal cells. None of the control subjects had any clinical symptoms or mucosal abnormalities. It was concluded that gastrointestinal symptoms as well as mucosal abnormalities are common in patients with osteofluorosis. 39
Dismissing Fluoride Sensitivity
In 1971, the PHS, presumably fearing that Waldbott’s reports on sensitivity were threatening the fluoridation program, asked the American Academy of Allergy (AAA) to investigate the matter. Without interviewing Waldbott or any of his patients, the AAA’s eleven-member executive board declared “unequivocally and unanimously” that “there is no evidence of allergy or intolerance to fluorides as used in the fluoridation of the community water supplies. ”40
However, Waldbott pointed out the following:
1. None of the board members had carried out any research into fluoride for themselves.
2. In the references, they cited Waldbott’s A Struggle with Titans, 41 which was intended for a lay audience, and thus these board members ignored most of his published case studies.
3. The request for this statement came from the PHS, which clearly had a vested interest in the outcome.
4. At about the time the statement was released the PHS announced research grants to four of the eleven board members amounting to nearly $800, 000, a huge amount of money in 1971.
5. Most of the other members of the board had previously received funding from the PHS for their work on allergies. 42
Despite the apparent ignorance and bias in the AAA disclosed by Waldbott’s criticisms, and the evidence of Waldbott’s own work, this 1971 statement by the AAA has been cited again and again by fluoridation government agencies and review panels to dismiss the issue, sometimes with little further analysis. The AAA statement has been used in this way by the British Royal College of Physicians, 43 the Inquiry into the Fluoridation of Victorian Water Supplies, 44 the Australian National Health and Medical Research Council, 45, 46 the World Health Organization, 47 the U. S. Department of Health and Human Services, 48 the New Zealand Public Health Commission, 49 and the U. S. National Research Council. 50 Using this statement to negate bona fide research publications without careful scientific analysis is an evasion of responsibility.
Any criticisms of Waldbott’s methodologies could have been easily resolved scientifically if the governments promoting fluoridation had been prepared to put some resources into the matter. However, they chose to resolve the issue politically, by using the authority of an expert body in the same way that they had used endorsements in the promotion of the program. The result is that health agencies in fluoridated countries have never attempted to perform systematic studies, even when it has been recommended that they do so by several independent observers. 51, 52
Michael Prival, PhD, writing on behalf of the Center for Science in the Public Interest, made the following suggestion in 1972:
It is important to realize that Waldbott’s work constitutes a central medical core of the American anti-fluoridation movement. . . Rather than simply denying the validity of his reports, it would be to the advantage of all concerned to have them thoroughly analyzed. This could best be done if a small number of unbiased, qualified physicians, agreed upon by both “sides, ” would independently examine and diagnose several of the patients who are reportedly allergic to fluoride. Only when this is done will there be any possibility of resolving the long-standing controversy surrounding this issue. 53
In 1979 Donald Taves stated, “Most of the above counter arguments [to Waldbott’s findings] are based on passive observations; so while it seems unlikely to most scientists that fluoride is causing adverse effects at 1 ppm F, active study is desirable. ” Taves went on to recommend a study design that would take into account the criticisms leveled at Waldbott and others. 54 No such government-sponsored study has been attempted in the years since Taves’s suggestions were made.
In 1991, the National Health and Medical Research Council (NHMRC), the Australian government’s own research body, also recommended that the matter be put to rest with well-designed studies. The authors wrote:
It is desirable to explore in a rigorous fashion whether the vague constellation of symptoms which are claimed to result from ingestion of fluoridated water can be shown to be reproducibly developed in these “susceptible” individuals. These claims are being made with sufficient frequency to justify well-designed studies which can properly control for subject and observer bias. 55
Not one health agency in Australia, in the nineteen years (as of 2010) since this recommendation was made, has attempted any formal study on the matter. This, despite the fact that citizens have offered to be tested in this way. 56
Fluoride Allergy
A very small number of people appear to be exquisitely sensitive to fluoride and have an apparent allergic reaction to it, which in some cases can be acute, even life-threatening. 57 Although a true allergy to fluoride, in the sense of an action of the immune system, initially postulated by Waldbott in some of his early cases, has generally been considered imp
robable, there is some experimental evidence that a response to fluoride might mimic a true allergy. In association with calcium, fluoride can trigger the release of histamine, a major effector substance in many allergic reactions, from mast cells in vitro. 58, 59 However, the concentrations of fluoride used in these experiments were higher than would normally be found in human plasma.
Summary
A small minority of people, perhaps 1 percent, appear to be acutely sensitive to exposure to fluoride at the concentrations present in fluoridated water. The wide range of signs and symptoms resemble those seen in poisoning with larger amounts of fluoride. These findings date from the 1950s. However, far from leading to more extensive studies, they were ridiculed when introduced and have since been largely ignored. Also, an “authoritative” statement by the board of the American Academy of Allergy has been used repeatedly for almost forty years to dismiss the issue. It is long past time that governments that promote fluoridation investigated this matter in a rigorous scientific manner, as recommended by a number of independent observers.
•
14 •
The 2006 National
Research Council Report
Many of the reviews of fluoride’s toxicity and the risks of water fluoridation sponsored by pro-fluoridation governments have amounted to little more than self-fulfilling support for water fluoridation (see chapter 24). This support has usually been accomplished by the selection of a panel of known fluoridation promoters and/or government employees. The review by the NRC in 2006 was refreshingly different. 1
In 2002, the Office of Drinking Water of the U. S. Environmental Protection Agency (EPA) commissioned the NRC to review the safe drinking water standards for fluoride. It did this for two reasons: (1) Such reviews are required every ten years, and (2) new scientific evidence suggested that fluoride could cause more damage than the single end point of crippling skeletal fluorosis that the EPA had used to determine the MCLG (maximum contaminant level goal) for fluoride in 1986. 2
The last NRC review had been undertaken in 1993. 3 In that review, a largely pro-fluoridation panel of authors confirmed the safety of the 4 ppm MCLG but recommended that new studies should be undertaken.
In 2003, the NRC appointed a panel to undertake the review requested by the EPA. The twelve-member scientific panel was the most balanced ever appointed in the United States to do any kind of review on fluoride. It included some scientists opposed to fluoridation, others who actively promoted the practice, and still others who had never taken a position on the matter. However, the brief to the panel was to examine not the benefits of fluoridation, but the toxicology of fluoride. In fact, the name of the NRC study from its inception was Toxicologic Risk of Fluoride in Drinking Water (BEST-K-02–05-A) until it was published in March 2006, at which time it was changed to Fluoride in Drinking Water: A Scientific Review of EPA’s Standards.
The task of the NRC panel was described in its report as follows:
The committee was charged to review toxicologic, epidemiologic, and clinical data on fluoride—particularly data published since the NRC’s previous (1993) report—and exposure data on orally ingested fluoride from drinking water and other sources. On the basis of its review, the committee was asked to evaluate independently the scientific basis of EPA’s MCLG of 4 mg/L and SMCL (secondary maximum contaminant level—a concentration intended to avoid cosmetic damage) of 2 mg/L in drinking water, and the adequacy of those guidelines to protect children and others from adverse health effects. The committee was asked to consider the relative contribution of various fluoride sources (e. g. , drinking water, food, dental-hygiene products) to total exposure. The committee was also asked to identify data gaps and to make recommendations for future research relevant to setting the MCLG and SMCL for fluoride. Addressing questions of artificial fluoridation, economics, risk-benefit assessment, and water-treatment technology was not part of the committee’s charge [emphasis added]. 4
Promoters of fluoridation have claimed that the panelists looked only at studies involving exposure to fluoride at 2–4 ppm. 5–8 However, it is important to stress that no restrictions were placed on what levels of fluoride were used in the studies reviewed by the panel. In fact, the panel examined several studies that found adverse effects at levels less than 2 ppm. 9–14
On August 12, 2003, Paul Connett was invited to give a forty-five-minute presentation to the panel. He was the only scientist known to be opposed to fluoridation who was given this formal opportunity to present his views and evidence in person. 15 The panel heard from Dr. Connett immediately after hearing from Dr. William Maas, who, at the time, was the director of the Oral Health Division at the CDC. We are happy to say that most of the concerns Dr. Connett expressed were eventually addressed in the NRC’s review.
The review, which occupied the panel intensively for more than two years, was finally published in March 2006; it ran to 507 pages, including over 1, 100 references.
Unlike those of the York Review16 and the NHMRC, 17 the NRC panel members did not restrict themselves to epidemiological studies but availed themselves of all the science that might throw some light on fluoride’s toxic potential. That included biochemical studies, animal studies, modeling calculations, clinical trials, and human epidemiological studies. That allowed a “weight-of-evidence” approach to assess potential harm.
The panel’s exposure analysis in chapter 2 of its report indicated that certain subsets of the population consuming water fluoridated at 1 ppm were already exceeding the EPA’s reference dose of 0. 06 mg/kg/day (listed in the EPA’s Integrated Risk Information System18 ). These population subsets included bottle-fed infants (receiving formula reconstituted with fluoridated water); those with borderline iodine deficiency; those with impaired kidney function; and those who drank excessive amounts of water, including outdoor laborers, athletes, military personnel, and diabetics. The panel concluded that the 4 ppm standard for fluoride was not protective of health and recommended that the EPA’s Office of Drinking Water perform a new health risk assessment to determine a new MCLG.
While not discounting any of the other health concerns revealed in the eleven chapters of the report, the authors singled out three clinical conditions that they believed triggered the need for a new health risk assessment:
1. Clinical stage II skeletal fluorosis: “The committee judges that stage II is also an adverse health effect, as it is associated with chronic joint pain, arthritic symptoms, slight calcification of ligaments, and osteosclerosis of cancellous [porous] bones. ”19
2. Bone fractures: “The majority of the committee concluded that the MCLG is not likely to be protective against bone fractures. ”20
3. Severe dental fluorosis: “After reviewing the collective evidence, including studies conducted since the early 1990s, the committee concluded unanimously that the present MCLG of 4 mg/L for fluoride should be lowered. Exposure at the MCLG clearly puts children at risk of developing severe enamel fluorosis. ”21
The Difference between the MCLG and MCL
The MCLG (maximum contaminant level goal) is the level of fluoride deemed safe by the U. S. EPA, based on the best science available and the application of appropriate safety factors, to protect all members of society, including vulnerable subgroups, from known, and reasonably anticipated, bad health effects. The MCLG is not an enforceable standard but a goal.
The MCL (maximum contaminant level) for drinking water is an enforceable federal standard. This is set by the EPA as close to the MCLG as economic considerations will allow. For example, as mentioned previously, the MCLG for arsenic is set at zero, because it is a known human carcinogen, but the MCL for arsenic is set at 10 ppb (parts per billion) because of the costs of removal of naturally occurring arsenic. Currently, both the MCLG and the MCL for fluoride are set at 4 ppm.
As of July 2010, it had been four years since the NRC recommended that the EPA produce a new MCLG, but the EPA’s Office of Drinking Water has yet to produce a new health risk assessmen
t, hence no new MCLG or MCL. Meanwhile, a former risk assessment expert at the EPA has reviewed the NRC report and concluded that if normal regulatory and toxicological procedures were followed, a new MCLG would have to be set at 0 ppm. 22 If that were to be the conclusion of the EPA, it would force an end to water fluoridation.
ADA and CDC Responses
If the EPA’s response has been tardy, the response of both the American Dental Association (ADA) and the Oral Health Division at the CDC was very rapid. On the day the NRC report was released, the ADA declared that it was irrelevant to water fluoridation, erroneously claiming that the NRC panel concerned itself only with water containing 4 ppm, which the ADA said was “much higher” than the levels used in fluoridation programs (0. 7–1. 2 ppm). 23
It took the CDC six days to announce the same conclusion. On March 28, 2006, the Oral Health Division of the CDC declared on its Web page, “The findings of the NRC report are consistent with CDC’s assessment that water is safe and healthy at the levels used for water fluoridation (0. 7–1. 2 mg/L). ”24 As of July 2010 this statement still appeared on the CDC Web page.
The CDC produced no comprehensive analysis to support its claim. It is hard to believe that in six days Oral Health Division personnel could have read and digested the report, let alone its over 1, 100 references. They certainly did not have time to perform a health risk assessment to determine a new MCLG to see how it would compare with the level at which communities now fluoridate their water.
