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Suppression by medical journals of a warning about overdosing formula-fed infants with Fluoride
Abstract
In January 1990, a short letter was sent to the editor of the international medical journal, Pediatrics, to alert its readers that the standard, highly quoted paper by Singer and Ophaug on fluoride intake by infants, published in 1979 in the same journal, required revision/correction in order to protect one group of infants from receiving substantial overdoses of fluoride. This group comprises infants who are fed almost entirely on powdered formula which is reconstituted with fluoridated water.The letter was based on the well‐established pediatric guidelines of water intake by infants and the fundamental toxicological principle of protecting groups at highest risk. It did not question the fluoridation of public water supplies. Nevertheless, the letter, together with a response to it by Ophaug, was rejected by the editor of Pediatrics, “due to a large backlog of articles.”; Following a protest, the letter was reviewed by three referees, two of whom conceded its main point, but was still not published.In the present paper, the original, previously unpublished letter on fluoride intake by infants is first reproduced verbatim, and then the comments of the referees and editors are reported and examined. It is concluded that the most plausible explanation for the rejection of the letter is that it might assist the anti‐fluoridation movement. Another possible contributing explanation is that publication of the letter might reduce the status of the scholars who had defended the previous position and might be perceived to diminish the status of the journal.
Supplementary resource (1)
... In contrast to advocates, opponents tend not to be academics or scientific experts (although see Dissendorf and Dissendorf, 1997;Peckham, 2012), but consist of a loosely associated network of small groups and individuals. Their common aim is clear, however: to prevent the adoption of water fluoridation; with Local Fluoride Action Networks (Hampshire Against Fluoridation, Fluoride Free Bedford, for example) generally representing the extent of their formal organisation. ...
Background
Tooth extractions are the most common cause of hospital admissions for children in England. Water fluoridation has the potential to reduce this number by 60%, is backed by the scientific and public health communities, and yet is currently consumed by only 10% of the population.
Aims and objectives
This ‘evidence-policy gap’ is explored through Kingdon’s ‘multi-streams approach’ which provides insights into the circumstances under which water fluoridation has made it onto the political agenda, the rationale underpinning opponent and advocate policy positions, and the role of the political arena in fostering or hindering policy action.
Methods
Over 100 primary documents were reviewed to develop an understanding of the scientific and ethical arguments for and against water fluoridation, as well as to identify how they have all historically sought to mobilise their policy preferences. Eleven consultations were also conducted with stakeholders as part of the knowledge exchange process.
Findings
The key finding of this research is that evidence is only likely to trigger policy change if it emerges into a receptive sociopolitical context. In substantiating this claim we identify evidence not of an ‘evidence-policy gap’ but of a more complex and multidimensional ‘evidence-policy-politics gap’.
Discussion and conclusions
The findings contribute to a range of debates in relation to: (1) the apparent irreconcilability of background ideas about what ought to form the basis of public health policymaking; (2) the presence of differing evidential standards that create an uneven playing field; and (3) the central underpinning role of politics in public health policymaking.
... Most studies of fluoride exposure from infant formula consumption have focused on risk for later development of dental enamel fluorosis (Brothwell and Limeback, 2003;Hong et al., 2006;Berg et al., 2011). Beyond fluorosis, the safety of fluoride exposure from infant formula has not been rigorously tested, despite warnings of overexposure (Diesendorf and Diesendorf, 1979). A recent study showed that up to 59% of infants younger than four months exceed the upper limit (0.1 mg/kg/day) (Institutes of Medicine, 1997) when optimally fluoridated water is used to reconstitute infant formula (Harriehausen et al., 2019); 33% and 14.3% of six-and nine-month old infants exceeded the upper limit threshold, respectively. ...
Background:
Infant consumption of formula reconstituted with fluoridated water can lead to excessive fluoride intake. We examined the association between fluoride exposure in infancy and intellectual ability in children who lived in fluoridated or non-fluoridated cities in Canada.
Methods:
We examined 398 mother-child dyads in the Maternal-Infant Research on Environmental Chemicals cohort who reported drinking tap water. We estimated water fluoride concentration using municipal water reports. We used linear regression to analyze the association between fluoride exposure and IQ scores, measured by the Wechsler Primary and Preschool Scale of Intelligence-III at 3-4 years. We examined whether feeding status (breast-fed versus formula-fed) modified the impact of water fluoride and if fluoride exposure during fetal development attenuated this effect. A second model estimated the association between fluoride intake from formula and child IQ.
Results:
Thirty-eight percent of mother-child dyads lived in fluoridated communities. An increase of 0.5 mg/L in water fluoride concentration (approximately equaling the difference between fluoridated and non-fluoridated regions) corresponded to a 9.3- and 6.2-point decrement in Performance IQ among formula-fed (95% CI: -13.77, -4.76) and breast-fed children (95% CI: -10.45, -1.94). The association between water fluoride concentration and Performance IQ remained significant after controlling for fetal fluoride exposure among formula-fed (B = -7.93, 95% CI: -12.84, -3.01) and breastfed children (B = -6.30, 95% CI: -10.92, -1.68). A 0.5 mg increase in fluoride intake from infant formula corresponded to an 8.8-point decrement in Performance IQ (95% CI: -14.18, -3.34) and this association remained significant after controlling for fetal fluoride exposure (B = -7.62, 95% CI: -13.64, -1.60).
Conclusions:
Exposure to increasing levels of fluoride in tap water was associated with diminished non-verbal intellectual abilities; the effect was more pronounced among formula-fed children.
... Since its inception, this pattern of bias has been de rigeur in the handful of the primarily English speaking countries that practice fluoridation. Emphasis on poor quality science is part of this pattern, a pattern that is continuing in the 21st century [1,10,46,[49][50][51][52]. ...
Municipal fluoridation was a mid-twentieth century innovation based on the medical hypothesis that consuming low doses of fluoride when young provided protection against cavities with only a small risk of mild dental fluorosis, a cosmetic effect. In the 21st century, more than half of American teens are afflicted by dental fluorosis with approximately one in five having moderate to severe dental fluorosis in at least two teeth. Scientific literature since the 1990s has found that even low doses of fluoride adversely affect cognitive-behavioral development and that deficits are correlated with the severity of dental fluorosis in afflicted individuals. Evidence of neurotoxic impact from low dose systemic exposure to fluoride prompted an investigation by a branch of the governmental agency that has promoted fluoridation policy since its 1940′s inception. This review identifies ten significant flaws in the design of an animal experiment conducted by the U.S. National Toxicology Program as part of that investigation into the neurotoxic impact of systemic prenatal and postnatal fluoride exposure. The authors hypothesize that organizational bias can and does compromise the integrity of fluoride research.
... Incidentally, these infants receive 100 times the daily fluoride dose of breast-fed babies and at least 4-6 times that recommended by medical authorities for fluoride supplementation in unfluoridated areas. 5 In practice, the top fluoride consumers in places with 1 ppm of fluoride in drinking water ingest about the same amount of fluoride daily as the average fluoride consumers in places with 4 ppm. ...
Fluoridation was first introduced as a public health measure in the USA in the 1950s, after cross-sectional studies of naturally fluoridated regions of that country suggested that levels of tooth decay declined as the fluoride concentration in drinking water increased. An intense lobbying campaign was organised by a group of dentists and dental officials. Several 'controlled fluoridation trials' were conducted in the USA and Canada and, even before they were complete, the US Public Health Service reversed its previous cautious stance and endorsed fluoridation. Then, in Australia, the National Health & Medical Research Council, Australian Dental Association and Australian Medical Association all endorsed fluoridation in the 1950s, despite considerable opposition from doctors in the letters columns of the Medical Journal of Australia. At that time there was almost no knowledge of the mechanisms of action of fluoride in the human body. The promoters of fluoridation, rewriting existing scientific knowledge, claimed that there were no adverse effects, apart from a slight increase in the prevalence of dental fluorosis (fluoride-induced mottling of teeth). In 1960, a book published by Dr Philip R.N. Sutton, a dental researcher at the University of Melbourne, showed that the early North American fluoridation trials were riddled with fundamental errors of experimental design and were therefore unreliable. More recently, Dr John Colquhoun, former head of the New Zealand Fluoridation Promotion Committee, called into question the early research of naturally fluoridated communities of the USA, by showing that the key published paper derived its results by selecting a few communities from hundreds actually studied. However, by then fluoridation had become institutionalized in several countries, including Australia and New Zealand.
... For infants of typical mass 8.1 kg at age 6 months, this gives total fluoride intakes of 1.0-1.5 mg/day, which are adult doses. 61 Li et al. 134 suggested a no-observed-adverse-effect level (NOAEL) of 0.15 mg fluoride/kg/day and a lowest observed-adverse-effect level (LOAEL) of 0.25 mg fluoride/kg/day of fluoride in human, 8 though these levels are currently subject to scientific debate. ...
‘Water is life,’ so central to human life, yet over one billion people across the world have no access to safe drinking water. Of late, there has been increasing global attention focused on resolving water quality problems especially in developing countries, as the lack of access to clean water denies the most essential of all rights, the right to life. The latest estimates suggest that around 200 million people, from among 25 nations the world over, are under the dreadful fate of fluorosis. India and China, the two most populous countries of the world, are the worst affected. India is plagued with numerous water quality problems due to prolific contaminants mainly of geogenic origin and fluoride stands first among them. The weathering of primary rocks and leaching of fluoride-containing minerals in soils yield fluoride rich groundwater in India which is generally associated with low calcium content and high bicarbonate ions. The unfettered ground water tapping exacerbates the failure of drinking water sources and accelerates the entry of fluoride into groundwater. Most of the scientific literature substantiates the benefits of low fluoride concentrations in preventing dental decay. However, as a surprising paradox, incidence of dental, skeletal and crippling skeletal fluorosis was reported in India with average fluoride concentrations as low as 0.5, 0.7 and 2.8 ppm respectively. Fluorosis, turns out to be the most widespread geochemical disease in India, affecting more than 66 million people including 6 million children under 14 years age. Though fluoride has spread its tentacles in 36,988 habitations and the number of people falling prey to fluoride poisoning have been steadily increasing, an exact exposure-health relationship is yet to be properly elucidated. There is an essential relation between poverty and fluorosis as malnutrition is found to play an aggressive role in its severity.
... Dissemination of data can be blocked by hostile editors or referees. Many rejections can be justified on the grounds of quality control, of course, but some rejections may be forms of censorship, for example when profluoridationists reject articles they perceive as threatening to fluoridation (see Diesendorf and Diesendorf, 1997) or when Luis Garcia, recipient of awards for his pioneering work on pseudoconditioning, was blocked from core psychology journals for nearly two decades (Lubek and Apfelbaum, 1987;Revusky, 1977). More generally, there is considerable evidence that many editors and referees are hostile to papers that challenge prevailing beliefs (Armstrong, 1996(Armstrong, , 1997Campanario, 1995;Epstein, 1990;Horrobin, 1990;Lang, 1998;Mahoney, 1976Mahoney, ,1979Thompson, 1999). ...
Research data can be suppressed in various ways, including organizational secrecy, defamation law and refusal to reply to queries. In a broader sense, methods of suppression include pressures not to do research in the first place and attacks on scientists who produce unwelcome data. The context of this sort of suppression includes individual self‐interest, vested interests, and paradigms. Suppressing research data can be either compatible with or contrary to accountability, depending on the constituencies involved. Ways to challenge suppression of research data include individual requests, exposés, refusal to suppress, publicity, creating new data, and social movements.
Fluoride contamination has created a drinking water crisis globally.
Fluorine is widely dispersed in nature and is estimated to be the 13th most abundant element on our planet (Mason and Moore 1982). It is the most electronegative of all chemical elements, and as a result, it never exists in elemental form, but rather combines with other elements; fluoride compounds represent about 0.06-0.09% of the content of the earth's crust (Wedephol 1974). Fluoride is distributed universally throughout soils, plants, and animals, and is assumed to be an essential element in animals, including humans. Fluoride has an important role in bone mineralization and formation of dental enamels. Fluoride, when consumed in inadequate quantities (less than 0.5 ppm), causes health problems such as dental caries, lack of formation of dental enamel, and reduced bone mineralization, especially among children (WHO 1996). In contrast, when fluoride is consumed in excess (more than 1 ppm), health problems may result, which equally affect the young and old (WHO 1996). At higher fluoride concentrations, metabolic processes are affected in humans, and overexposed individuals may suffer from skeletal or dental fluorosis, non-skeletal manifestations, or combinations of these maladies (Susheela et al. 1993). The incidence and severity of fluorosis depends upon the fluoride concentration in air, soil or water, and the degree of exposure to these levels.
The version here differs from the published version in a number of details of expression, a different format, different page numbering (151 instead of 274 pages) and omission of the index.
REPEATED HEMODIALYSIS in patients with chronic uremia is being undertaken on an experimental basis at several medical centers. In addition to prolonging the patients' lives, these procedures are providing a better understanding of chronic renal disease. The case reported here is of interest for these reasons: (1) Dialysis was performed when uremic symptoms became pronounced, not on a fixed schedule to maintain BUN at normal levels. (2) The Kolff twin coil kidney, a high flow apparatus now available in many hospitals, was used, rather than one of the slow flow machines more commonly used for dialysis of chronic uremia at some research centers.Report of a Case
A 43-year-old nurse in terminal uremia due to chronic glomerulonephritis survived 8 months with the aid of 14 dialyses. A permanent indwelling teflon shunt, which had to be replaced after 20 weeks, was used to provide access to an artery and vein.
Two patients had a combination of renal insufficiency and systemic fluorosis. One had bilateral vesicoureteral reflux and recurrent pyelonephritis, with resulting renal atrophy; the other had probable renal dysgenesis of indeterminate origin. Both patients had polydipsia, polyuria, and markedly reduced renal function. Both also had clinical and roentgenographic evidence of systemic fluorosis. It is postulated that the renal insufficiency which resulted in the large intake of fluoride-containing water and reduced excretion of fluoride combined to produce systemic fluorosis.
Objective: To determine the cause of an outbreak of acute illness and death in a long-term hemodialysis unit. Design: A retrospective cohort and case-control study of patients receiving hemodialysis and a laboratory study of a model deionization system to purify water for hemodialysis. Setting: An outpatient hemodialysis unit of a university hospital. Patients: 12 patients who became severely ill after hemodialysis treatment and 20 patients who did not become ill after receiving hemodialysis treatment in the same unit. Measurements: Medical and dialysis unit records were reviewed to identify and characterize cases. Fluids for dialysis were tested for toxic substances, and fluoride was measured in patients'serum
THE FLUORIDE concentration in fluoridated water (1 ppm) is normally about six times that in serum. Therefore, when such water is used in the dialysate bath of an artificial kidney, fluoride ions would be expected to move into the patient's blood. How much of the fluoride is absorbed from the dialysate has not been reported, but the volume of the dialysate would generally be at least 200 liters, representing 200 mg of fluoride. The amount absorbed would depend at least in part on the average concentrations of fluoride in the serum during dialysis. This is a report of the absorption of fluoride by a patient with chronic renal insufficiency who underwent dialysis repeatedly with fluoridated water in the dialysate bath.
Report of Case
The patient was a 41-year-old nurse who had had proteinuria for over 20 years, hypertension for 11 years subsequent to a pregnancy, and periodic urinary tract
To the Editor.
— In a recent article in The Journal
FRACTURE of the hip is a major cause of morbidity and mortality in persons 65 years of age and older. Incidence rates for hip fracture are known to vary by both sex and race.1-4 There is also marked variability in hip fracture incidence by geographic region, with the highest rates found in Scandinavia, followed by the United States, Western Europe, Asia, and Africa.5,6
Within the United States, relatively little is known about the geographic pattern of hip fracture. Most studies have described the incidence of hip fracture for the country as a whole,2,3 for limited geographic regions,4,7,8 or by broadly defined Census divisions.9 This study examines the geographic distribution of hip fracture incidence in the United States at the county level. To this end, data are obtained from the Health Care Financing Administration (HCFA) and the Department of Veterans Affairs (VA) that identify all hospital