Tuesday, April 26, 2016

Open letter to Dr Pamela Byrne CEO Food Safety Authority of Ireland and Dr Leo Varadkar Minister for Health



OPEN LETTER TO
Dr Pamela Byrne, CEO Food Safety Authority of Ireland and Dr Leo Varadkar, Minister for Health

In 2013, I wrote to the CEO of the FSAI and the Minister for Health addressing inaccuracies and scientific irregularities in the total diet survey published by the FSAI in 2010. My concerns specifically addressed how the data on fluoride content in tea products, as well as other beverages such as beers and stouts sold in Ireland where incorrect and significantly under-represented the fluoride concentration, and thus, exposure of consumers to dietary sources of fluoride.

In my previous communications with the FSAI, I forwarded literature specific to risk assessments of fluoride intake from tea undertaken internationally. However, as noted, per capita tea consumption is Ireland is the highest in the world, therefore, the risk of chronic fluoride intoxication is significantly higher in the Republic of Ireland compared to other tea consuming nations. This is particularly the case as drinking water is artificially fluoridated in the RoI, a policy that is not supported in the vast majority of countries internationally. 

Three years ago the FSAI informed me that a second dietary intake study was to be completed in 2013. In undertaking this assessment, the FSAI informed me that they would address my concerns regarding previous methodologies undertaken by the FSAI and in which the fluoride content in tea products, beverages and foods prepared with fluoridated public water supplies would be examined.

As of April 2016, the results of this assessment have yet to be published. In the interim, due primarily to concerns regarding the long term health implications of chronic fluoride intake and lack of available data on fluoride content in Irish tea products, I undertook along with Professor Hardy Limeback, Professor William Potter, and Dr Mike Godfrey, a risk assessment measuring the fluoride content in 54 black tea products for sale in the RoI. This study was published in the International Journal of Environmental Research and Public Health [Int. J. Environ. Res. Public Health 2016, 13(3), 259; doi:10.3390/ijerph13030259].  We have undertaken a similar study for tea products in New Zealand, which is currently being peer reviewed for publication. The findings of this study further support the observations and conclusions of our original study specific to Ireland.

It has recently come to my attention that the FSAI have examined our study on fluoride intake from tea in the RoI and suggested that the intakes of tea examined in our study overestimate the contribution of tea to fluoride intakes in the Irish population. The opinion of the FSAI is based on data on tea consumption from the Irish Universities Nutrition Alliance (IUNA) national dietary surveys. The FSAI noted that the IUNA assessment measured tea consumption in age groups from 1 to 90 years.  The FSAI should be aware, that the IUNA 2001 study did not measure tea consumption in persons 1-90 years of age. It had a statistical number of 1379 persons and only asked people aged 18-64yrs, excluding the highest tea consumers in Ireland who are the elderly. It did also not include pregnant women.

The IUNA study reported that among the age group 18-64yrs, ninety one percent of the sample drank tea with an average daily consumption of 619 ml. However, it should be noted that the IUNA study was undertaken over a 7 day period and did not differentiate whether individuals drank tea from a mug or cup. Moreover, the study did not disclose what season the survey was undertaken. International studies have shown that since the 1980s tea is predominantly consumed in mugs by individuals in western countries. A mug size is substantially larger in volume compared to a cup. In addition, hot beverages such as tea are consumed in greater quantities in the period September to May, when temperatures are colder than the summer months.  From the case studies of habitual tea drinkers I have documented in the RoI, I have personally met numerous individuals who consume up to ten mugs of tea daily. In almost every instance, these individuals reported suffering from multiple morbidity of chronic diseases including chronic pain, diabetes or hypothyroidism.

Moreover, in comparison to the IUNA study, the Australian dietary study of 2008, based on a sample size of over 13,000 subjects reported that the mean consumption of tea for males aged 30-49years was 1004 ml and 1090ml for males aged 50-69years. For females the figures were 984 and 1018 mls respectively. Considering that Ireland has a 3 fold higher per capita consumption of tea than Australia, and the statistically higher quality of the Australian study, this suggests that data on tea consumption in Ireland as noted by the IUNA study is inaccurate. 

In our study, four scenarios were examined, consumption of 250 mL (about 1 cup) per day, 1 litre per day (4 cups or 3 mugs of tea per day), 1.5 L per day (6 cups or 4 mugs per day) and a reasonable maximum intake of 3.8 L per day (15 cups or 10 mugs per day). Based on the available evidence, for the FSAI to suggest that the intakes examined in our study overestimate the contribution of tea to fluoride intake is not based on any rigorous science based assessment or evaluation and is therefore flawed. 

The principal function of the Food Safety Authority of Ireland is to take all reasonable steps to ensure that food consumed, produced, distributed or marketed in the State meets the highest standards of food safety and to ensure that food complies with legal requirements. As noted in our study, the fluoride content in tea products for sale in Ireland do not comply with the requirements of the General Food law Regulation. Moreover, in preparing tea infusions with fluoridated water the risk of cumulative toxic effects increases for consumers. In addition, as noted in our study, evidence suggests that there is a large subgroup of the population particularly susceptible to the adverse effects of chronic fluoride intake due to low iodine intake, malnutrition, Vitamin D deficiency, calcium deficiency and diabetes prevalence.

In conclusion, the FSAI are responsible for putting consumer interests first and foremost. Thus, there is an urgent need for the FSAI to protect public health and consumer interests using the latest and best scientific advice available. Failure to act raises a significant danger to public health. In the current context, the delays in completion of the studies which were to be completed in 2013 are inexcusable and the consequences of this inaction is contributing to the high prevalence of chronic disease in our population. 


Yours sincerely
Declan Waugh
EnviroManagement Services

Thursday, March 10, 2016

Scientists highlight fluoride health risks in the Republic of Ireland.






A new scientific study on fluoride exposure is the first to establish excessive fluoride levels in tea products for sale in Ireland and provides the strongest evidence to date that the total dietary fluoride intake in the general population can readily exceed the levels known to cause chronic fluoride intoxication. That’s the main finding of the paper published this month in the International Journal of Environmental Research and Public Health. 

The study is authored by an international team of researchers lead by Irish scientist Declan Waugh of Enviro Management Services. The study, the first of its kind to be undertaken in Ireland, assessed human exposure to fluoride from the consumption of tea by measuring the fluoride content in tea infusions from 54 different black tea products sold in Ireland. The fluoride content in tea infusions was found to range from 1.6 to 6.1 mg/L. The study found that all of the black teas had fluoride concentrations exceeding the maximum enforceable level in drinking water while also exceeding the maximum permitted level requiring labelling and safety precautions for bottled mineral water under European regulations.
 
“These findings are important because the European Food Safety Authority previously reported that drinking  just 2 cups of tea per day prepared with fluoridated water, in addition to other dietary sources of fluoride can provide almost twice the recommended intake for adults.” said lead author Declan Waugh. “Drinking water has been artificially fluoridated in Ireland since the 1960s on the premise that the population had inadequate intake of fluoride in their diet for the prevention of dental caries “ he added, “what we’ve shown is that the Republic of Ireland has one of the highest fluoride intakes in the world due to our high consumption of tea, which is six times the global average”.  

The study highlights that when Health Authorities implemented water fluoridation in Ireland no risk assessment was undertaken to establish the populations dietary fluoride intake from food sources, including tea. “Public health policy should not be based on assumptions” said Mr. Waugh “the results of our study demonstrate that the decision to fluoridate public water supplies in Ireland was a misguided political decision based on poor reasoning and a lack of scientific knowledge.”

Dr. William Potter, one of the four authors of the study and Professor of Chemistry and Biochemistry explained the results by pointing our that, “in countries with large water fluoridation programmes, such as the Republic of Ireland, fluoridated water is used in food processing and in making beverages such as tea, thus, raising the fluoride content of the foods above that of products consumed in countries without water fluoridation. This is particularly important in Ireland due to the culture of tea drinking, yet the significance of this has largely been ignored to date.  Our study found that based on normal tea consumption intakes alone, that there is a high risk of chronic fluoride intoxication among the population in Ireland.”

Previous studies have already highlighted that in countries where tea drinking is common that water fluoridation is both unnecessary and possibly harmful. You cannot control the dose of fluoride exposure on an individual level when you artificially fluoridate the public drinking water supply due to the wide range of other dietary sources available, particularly tea, fish and fluoridated medications” said co-author Dr. Hardy Limeback, Professor Emeritus and former head of preventive dentistry at the University of Toronto. “Our research demonstrates that when you include the contribution of tea to daily fluoride intake it is evident that excessive fluoride exposure is commonplace in Ireland. More importantly, the effect of fluoridation of drinking water is that it has resulted in compounding safety factors associated with uncontrolled exposure and contributed to excessive accumulation of fluoride in the general population.”

The researchers highlighted that the consequences of excessive fluoride intake will vary from one individual to another. "For me, as a medical physician, one needs to know the nutritional and health status of individuals when considering fluoride exposure. The dose by which fluoride can affect individuals is dependent on many factors” said co author Dr. Mike Godfrey MD. “For example, individuals with diabetes with reduced kidney function, as well as individuals with iodine, calcium or vitamin D deficiency have a much lower tolerance to fluoride. In Ireland, almost 10% of the general  population are estimated to have diabetes and deficiencies in iodine, calcium and Vit D are commonplace, which places the Irish population at particularly high risk to the toxic effects of fluoride.”
 
The study also looked at potential health risks associated with excessive fluoride intake and reported that excess intake has been found to contribute to neurotoxicity, endocrine dysfunction, musculoskeletal disease, chronic pain, kidney and liver toxicity, cardiovascular disease and abnormal heart rhythms called arrhythmias. Cardiac arrhythmias can be serious and lead to sudden unexpected death. The study found that the burden of many of these diseases is high in Ireland and that excess fluoride intake may play a large part in contributing to the burden of these diseases among the population.

Authors: Waugh DT, Potter W, Limeback H and Godfrey M.
Source: Int. J. Environ. Res. Public Health. 2016, 13(3), 259; doi:10.3390/ijerph13030259

Tuesday, June 23, 2015

Medical Malpractice and Water Fluoridation in the Republic of Ireland






The Irish Health Research Board (HRB) in their recent review say that they found no definite evidence that community water fluoridation has negative health effects. Yet remarkably, and extraordinarly, the review did not in any way access the exposure of the Irish population to fluoride; including the contribution of water fluoridation, food or beverage consumption, medicines or occupational exposures to fluoride from major industries that are known to be significant sources of fluoride such as computer manufacturing, aluminium processing, coal fired electricity generation, chemicals industry, cement, brick, glass or fertilizer manufacturing all of which have large workforces in Ireland. From a risk management perspective there is only one accurate way to access exposure and therefore risk, and that  is to use established biomarkers of fluoride exposure by measuring the fluoride content in human blood, urine or bone, as well as measuring the fluoride content in commonly consumed beverages, foods as prepared with fluoridated water and to determine the exposure of the population to fluoride releasing medications that are commonly prescribed in Ireland. For engineers and scientists the concept of cumulative exposure is  well understood, as it is applied in environmental, flood and pollution risk management and impact assessment. However, when its comes to the consumption of a known and established bio-accumulative toxin that is deliberately added to the water supply, it appears that the rigours of scientific assessment do not apply. In the case of the HRB review not one of these most basic tasks were undertaken.

In addition, the review while examining the literature on fluoride and neurological disease somehow managed to exclude the recently published study in the Journal Environmental Health, titled “Exposure to fluoridated water and attention deficit hyperactivity disorder prevalence among children and adolescents in the United States: an ecological association”. After controlling for socioeconomic status this study empirically demonstrated an direct association between more widespread exposure to fluoridated water and increased ADHD prevalence in U.S. children and adolescents [1]. This large scale ecological study, the first of its kind to investigate this association was published the same week as the study by Peckham and associates who also found a significant association between water fluoridation and hypothyroidism disorders in the UK [2]. The latter study was included in the HRB review but the former was not? Why not?

As for the prevalence of thyroid disorders in Ireland, we must assume that the HRB are aware that the third most popular prescribed drug in Ireland is for the treatment of hypothyroid disorders [3]. From the sheer number of prescriptions and the normal prescription patterns for this drug, the data suggests that almost 10% of the Irish population suffer from hypothyroid disorders. This would indicate that Ireland has the highest prevalence of thyroid disorders in the developed world and would agree with the findings of Peckham and associates that water fluoridation was associated with a 60% increase in thyroid disorders among the population.

Overall, their desk based review entirely excluded the published literature which has found that many common medications can cause fluoride intoxication. This is a matter of significant public health concern, as the European Food Safety Authority noted that medications can contribute over 75% of the daily fluoride intake for infants alone [4].  So did the HRB review access fluoride intake from medications? No they did not.
Neither did the HRB review determine the fluoride intake and exposure from tea in Ireland, which is by far the most significant dietary intake source of fluoride for the Irish population. Over 60 published studies have been published internationally which have found excessive concentrations of fluoride in tea, yet remarkable not a single study has every been published in Ireland documenting the fluoride exposure from tea. As the worlds largest consumer of tea and with mandatory water fluoridation this omission is simply extraordinary. So did the Health Research board measure the fluoride content in tea products sold in Ireland? No they did not.

In fact, tea as a source of fluoride was only noted in their report as it was previously documented by myself in correspondence almost two years ago to the Chief Medical Officer, Minister for Health, Minister for Food and Agriculture among others, where I warned about public safety from excessive fluoride exposure and to which I have received neither a reply nor acknowledgement. Despite this, the HRB review could only conclude without actually testing tea products for fluoride content that “tea leaves contain proportionally higher levels of fluoride than CWF water that is used to make it”. This statement reflects a gross misrepresentation of the facts. Tea contains substantially higher concentrations of fluoride than CWF.

In 2006, the National Research Council of the United States (NRC) stated that in the UK consumers can ingest 9mg per day of fluoride from tea drinking alone and that making tea with fluoridated water contributes to excess fluoride intake and the risk of chronic disease. Furthermore, the NRC (2006) reported that consumption of just half a cup of brewed tea with an average fluoride concentration of 3.3 mg/L would equal the total background intake of fluoride from all food sources [5]. Moreover, in 2008, the Department of Public Health in Taiwan conducted a risk assessment on fluoride exposure from tea drinking measuring the fluoride content in over fifty specimens of tea using de-ionized water. The concentration of fluoride in the majority of tea samples was found to exceed 4 mg/L [6]. The authors found that elderly persons, who generally consume greater quantities of tea, would exceed the Acceptable Daily Intake (ADI) for fluoride from tea drinking and concluded that caution should be undertaken in considering fluoridation of water in Taiwan in order to avoid side effects. Drinking water is not fluoridated in Taiwan, but more importantly, per capita consumption of tea in Ireland is significantly higher than Taiwan.

The HRB must clearly be aware, that Ireland has the highest per capita consumption of tea in the world, 17% higher than the UK, 14 fold higher than the United States and over 40 fold higher than countries such as Spain, Belgium or Portugal [7]. Tea is consumed by 91% of adults in Ireland [8], with the average person consuming four cups of tea every day [8]. The European Food Safety Authority (EFSA) have established that the upper tolerable intake for fluoride to prevent chronic disease for a healthy adult is 7 mg/day [9]. Furthermore, the EFSA estimated that drinking just 2 cups of tea per day, combined with an average consumption of fluoridated drinking water and use of fluoridated tap water in the preparation of food, but excluding all other sources (including solid foods, toothpaste and dental products), would provide a daily dietary intake of 6 mg per day [4].  So what does this say about fluoride intake among the Irish population? It clearly suggests that chronic fluoride intoxication is a major public health problem in Ireland and that the authorities are turning a blind eye in order to protect a public policy of mandatory fluoridation.

One must assume that the HRB and Food Safety Authority would also be aware that the Regulatory Authorities in China recently banned the importation of tea from Kenya, due to toxic levels of fluoride that were found in tea produced in Kenya [10]. Obviously, the HRB and Food Safety Authority are aware that 90% of tea leaves consumed in the Irish market are sourced from Kenya. If they are not aware of this, or indeed the fluoride content in tea products consumed in Ireland, than this further demonstrates that they are not protecting public health.

So what does this say about the HRB review? Clearly, it is plainly obvious that the HRB review found no definite evidence that water fluoridation was causing harm, because, as with every other review on fluoridation undertaken in this country, they failed abjectly in their duty to protect Irish consumers, by actually measuring the fluoride exposure of the population. On the basis of a large body of published studies and risk assessments of fluoride intake from tea and certain medications, there is absolutely no doubt that the Irish population are chronically exposed to fluoride and that water fluoridation is further contributing to this overexposure. The MRB, Department of Health  and Food Safety Authority of Ireland have a legal responsibility to determine the actual exposure to fluoride among the Irish population from food, beverages and medications. Only when they have undertaken this can they determine if the risk of water fluoridation is acceptable. In the absence of such robust studies and the abject failure of regulatory health authorities in Ireland to understand that it is total fluoride intake and exposure that is important when assessing the risk of water fluoridation, any claim that water fluoridation is safe is  unscientific and unreliable. To allow this farce to continue may indeed breech medical and public law.

References.
[1] Malin AJ and Till C. Exposure to fluoridated water and attention deficit hyperactivity disorder prevalence among children and adolescents in the United States: an ecological association Environmental Health 2015, 14:17  doi:10.1186/s12940-015-0003-1
[2] Peckham S, Lowery D, Spencer S. Are fluoride levels in drinking water associated with hypothyroidism prevalence in England? A large observational study of GP practice data and fluoride levels in drinking water. J Epidemiol Community Health. 2015;Jul;69(7):619-624. doi: 10.1136/jech-2014-204971.
[3] Barry M. Economies in Drug Usage in the Irish Healthcare Setting, National Centre for Pharmacoeconomics, St. James’s Hospital, RoI. http://www.lenus.ie/hse/bitstream/10147/66358/1/economies_drug_usage.pdf  [Accessed 12 June 2015]
[4] Scientific Opinion on Dietary Reference Values for fluoride, EFSA Panel on Dietetic Products, Nutrition, and Allergies: EFSA Journal. 2013;11(8):3332.
[5] National Research Council, Review of Fluoride in Drinking Water, U.S. National Research Council 2006.
[6]  Lung SC, Cheng W, Fu CB. Potential exposure and risk of fluoride intakes from tea drinks produced in Taiwan. J Exposure Sci and Environ Epidem. 2008;18:158–166.
[7] Beresniak A, Duru G, Berger G, Dominique Bremond-Gignac. Relationships between black tea consumption and key health indicators in the world: an ecological study. BMJ Open. 2012;2:e000648. doi:10.1136/bmjopen-2011-000648.
[8] North/South Ireland Food Consumption Survey, Irish Universities Nutrition Alliance; 2001.
[9] Kavanagh D, Renehan J. Fluoride in Tea - Its Dental Significance. J Ir Dent Assoc. 1998;44(4):100-105.
[10] China rejects tea from Kenya over high fluoride levels. Business Daily, Kenya. 16th April 2015 Web: http://asokoinsight.com/news/china-rejects-tea-from-kenya-over-high-fluoride-levels/  [Accessed 12 June 2015].