The FDA is one of the most highly corrupted and corrupting organizations on the planet. Charged with food, drug and cosmetic safety, what has been protected is the financial safety of corporate profits with the tickle-down effect firmly in place: regulators and panel members get rich quick through lucrative, unethical and often illegal stock deals, stock options, family financial hanky panky and a host of variations on the theme.

Perhaps you remember the advisory panel of experts that put Vioxx back on the market despite at LEAST 55 thousand deaths in the US alone (perhaps as many as 188 thousand, according to some). The members of that panel had a majority of experts on it who owned stock and had other financial interests in Merck and related corporations. They overruled previously presented advice by people who did NOT have financial interests to allow Vioxx back on the market. Shortly thereafter they approved Vioxx for children!

But perhaps things are getting better. Lester Crawford, who served as the acting Commissioner of the FDA for over a year before his confirmation in 2005 suddenly left his post — suddenly, as in during the course of a single day. His reason? Spending time with the family, of course. The real reason? Illegal stock dealings. Could this be the beginning of a house cleaning? Let’s hope so. The Institute of Medicine says that the FDA is broken. It certainly is. What broke it is the corruption of too much money buying too much influence.

The Institute of Medicine released a study on the safety of pharmaceuticals which was a damning condemnation of the FDA.  Coming from the same organization which supports the status quo in a report that says there is no link between autism and mercury (http://www.fda.gov/fdac/features/2004/504_iom.html) this is a stinging criticism, indeed.  The IOM says the FDA cannot be trusted and is, frankly, broken. In placid, cool bureaucratic tones, here is the scathing abstract of that report in the IOM’s words:

In response to growing public concern with health risks posed by approved drugs, U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services announced a series of steps to address drug safety, including asking the IOM to convene a committee to assess the U.S. drug safety system and to make recommendations to improve risk assessment, surveillance, and the safe use of drugs.In its report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, the committee considered the drug safety system as the sum of all activities conducted by FDA and other stakeholders to monitor, evaluate, improve, and ensure drug safety. Although much of the committee’s work was focused around the drug review, safety surveillance, and related activities of the Center for Drug Evaluation and Research (CDER), the committee also reviewed some key aspects of the roles and considered the potential contributions of the pharmaceutical industry, the academic research enterprise, Congress, the health care delivery system, patients and the public. During its research, the committee found that There is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry. Most stakeholders–the agency, the industry, consumer organizations, Congress, professional societies, health care entities–appear to agree on the need for certain improvements in the system. The drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in CDER that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement. FDA and the pharmaceutical industry do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion. Noting that resources and therefore efforts to monitor medications’ risk-benefit profiles taper off after approval, the committee that wrote the report offered a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used. Recommendations include: Labeling requirements and advertising limits for new medications Clarified authority and additional enforcement tools for the agency Clarification of FDA’s role in gathering and communicating additional information on marketed products’ risks and benefits Mandatory registration of clinical trial results to facilitate public access to drug safety information An increased role for FDA’s drug safety staff A large boost in funding and staffing for the agency

Part of that failure, of course, is a failure of leadership.  Lester Crawford is not unique in his corruption.  He is unique in that his corruption (or a small piece of it?) has been publicly exposed.  Here is Pete Yost’s story on Crawford’s corruption:

Ex-FDA Chief to Plead Guilty

By PETE YOST

The Associated Press

Monday, October 16, 2006; 6:44 PM

WASHINGTON — Former FDA chief Lester Crawford has agreed to plead guilty to charges of failing to disclose a financial interest in PepsiCo Inc. and other firms regulated by his agency, his lawyer said Monday.

The Justice Department accused the former head of the Food and Drug Administration in court papers of falsely reporting that he had sold stock in companies when he continued holding shares in the firms governed by FDA rules.

Court papers say Crawford chaired the Food and Drug Administration’s Obesity Working Group while he and his wife owned shares worth at least $62,000 in soft drink and snack food manufacturer Pepsico Inc., based in Purchase, N.Y. In addition, the documents say, he held stock worth at least $78,000 in food product manufacturer Sysco Corp., based in Houston.

While he and his wife owned the stock, the panel Crawford chaired met with representatives from the packaged food industry and gave congressional testimony encouraging manufacturers to relabel serving sizes to give calorie counts greater prominence.

Crawford “is going to plead guilty to two misdemeanors tomorrow afternoon and he is going to admit his financial disclosures had errors and omissions, mostly with his wife’s continued ownership of stocks,” said Crawford’s lawyer, Barbara Van Gelder.

“At the end of the day, he owned these stocks and he will admit he owned them while he was at the FDA and he will take responsibility for that,” said Van Gelder. She said Crawford was not disputing the government’s claims in what she called a plea agreement.

Accused of making a false writing and conflict of interest, Crawford was scheduled to appear before a federal magistrate Tuesday afternoon. Each charge carries a maximum penalty of one year in prison.

The papers say Crawford failed to disclose his income from exercising stock options in Embrex Inc. of Research Triangle Park, N.C., an agriculture biotechnology company that has been regulated by FDA. Crawford had been a member of Embrex’s board of directors, according to federal filings.

Crawford, a veterinarian, abruptly resigned from the FDA in September 2005 but gave no reason for his departure. He had held the top position for just two months but had been acting head of the agency for more than a year.

According to the Justice Department’s court papers:

_A government ethics official inquired about Crawford’s ownership of stock in several companies FDA regulates and Crawford replied in a Dec. 28, 2004, e-mail that “Sysco and Kimberly-Clark have in fact been sold.” Actually, the court papers state, Crawford knew that he or his wife still held shares in both.

_Even though financial reporting requirements for federal officials say all income must be disclosed, Crawford failed to reveal $8,000 in income from the exercise of Embrex stock options in 2003, and failed to report $20,000 from the sale of Embrex stock options in 2004.

Crawford’s ownership of shares in Pepsico, Sysco, Embrex and the other companies was prohibited under federal regulations, since the companies are considered to be “significantly regulated” by the FDA.

___

AP reporter Andrew Bridges contributed to this story.

© 2006 The Associated Press

Of course, the current “leadership” of the FDA, in positions 1 and 2 are industry men, through and through.  Will the outrages, deaths and betrayals of the American people have to get worse before the house is really cleaned by an outraged Congress acting on the outrage of its citizens?  Let’s hope not.   

Fluoride is not OK. When we attended the meeting the US Codex office held prior to the Codex Committee on Nutrition and Foods for Special Dietary Uses 2006 meeting (October 30-November 3, 2006, Chiang Mai, Thailand) we were deeply upset, but not shocked, to learn that the US supported the Codex proposal to put fluoride in infant formula as if it were wholesome and healthy. It is neither. Here are our comments urging the US to change that policy and oppose the addtion of fluoride. You can also read the Press Release on the topic that the Natural Solutions Foundation issued.

Please feel free to share this document widely. Just remember to let people know where you got it: Natural Solutions Foundation at www.HealthFreedomUSA.org.

We are on your side when it comes to your health and your health freedom!

Natural Solutions Foundation
P.O. Box 722
Maryville, MO 64468
U.S.A.

info@healthfreedomusa.org

CODEX COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES, 28th SESSION, U.S. DRAFT POSITIONS As of September 8, 2006

The Natural Solutions Foundation strongly urges the United States to oppose the addition of any level of fluoride to infant formula.

Exposure to dangerous levels of fluoride compounds is already endemic and should not be increased by infant exposure to additional fluoride. Serious negative dental, neurological, orthopedic and biochemical changes occur in infants and young children exposed to fluoride with loss of bone, tooth and intellectual functions.

1. The National Research Council (National Academy of Sciences) recently concluded that the EPA’s Maximum contaminant level for fluoride should be lowered from the current standard of 4mg per day in order to prevent severe enamel fluorosis, reduce risk of bone fracture and skeletal fluorosis. The NRC also concluded that the EPA should update risk assessment of fluoride to include new data on health risks and better estimates of total exposure for individuals.

National Research Council. (2006). Fluoride in Drinking Water: A Scientific Review of EPA’s Standards. National Academies Press.

2. Excessive amounts of fluoride can be ingested from a variety of sources including toothpaste, vegetables and fruits, processed foods and drinks, foods and drinks prepared with fluoridated water, fluoridated water, etc.
3. The U.S. Dept of Health and Human Services estimates that children are exposed to between .9 and 3.6 mg of fluoride compound per day from environmental sources. This figure does not include exposure that occurs from air emissions and dermal uptake in bathing or exposure that may occur from pharmaceuticals. This is already dangerously close to upper safety limit of 4mg per day.
   (Review of Fluorides Benefits and Risks)
4. Xiong X, Liu J, He W, Xia T, He P, Chen X, Yang K, Wang A. (2006). Dose-effect relationship between drinking water fluoride levels and damage to liver and kidney functions in children. Environmental Research Jul 8.

Fluoride exposure at levels currently deemed safe by the US Environmental Protection Agency (EPA) can damage both kidney and liver function in children.

5. Additional exposures may occur from other ready to consume food products such as juice being marketed for infants. Analysis of fluoride content in commercially available juices found that 42% of samples contained fluoride at more than 1ppm.

Stannards, JG Journal of Clinical Pediatric Dentristry .16:38-40, 1991 et al, Fluoride concentrations in infant food range from .01 to 8.38 parts per million.

Heilman, JR et al Journal of the American Dental Association found 128:857-63, 1997.

6. Acute fluoride poisonings have occurred at doses as low as 0.1 to 0.8 mgF/kg of body weight.

Akiniwa, K. (1997). Re-examination of acute toxicity of fluoride. Fluoride 30: 89-104.

7. Dental fluorosis, a form of chronic fluoride toxicity, is increasing among American children. The survey found an overall dental fluorosis rate of 32% among U.S. school children aged 6 to 19 years old. This compares to an incidence of 22.8% reported in the last national survey of fluorosis, conducted by the National Institute of Dental Research (NIDR) in 1986-87.

Center for Disease Control, the National Health and Nutrition Examination Survey’ (NHANES). 1999-2002

Cognitive Defects Related to Fluoride Exposure

8. “…it is apparent that fluorides have the ability to interfere with the functions of the brain.”

National Research Council, (2006), Fluoride in Drinking Water: A Scientific Review of EPA’s Standards, National Academies Press.

9. Population exposed to 4.12 ppm fluoride in drinking water has drastically higher levels of dental and skeletal fluorosis than population exposed .91 ppm in fluoride drinking water.

Pre-natal and early postnatal exposure to fluoride sufficient to cause mild dental fluorosis in the mother may result in significant reductions in mean IQ and IQ range of children.

Zhao, LB, GH Liang, DN Zhang, and XR Wu, Effect of a high fluoride water supple on Children’s Intelligence, Fluoride 29(4):190-192 (1996)

10. Persons chronically exposed to environmental or industrial fluoride reported symptoms related to impaired central nervous system functioning including impaired cognition and memory, difficulties with concentration, general malaise and fatigue.

Possible mechanisms whereby fluoride could affect brain function include influencing calcium currents, altering enzyme configuration by forming strong hydrogen bonds with amide groups, inhibiting cortical adenylyl cyclase activity and increasing phosphoinositide hydrolysis.

Spittle, B., Psychopharmacolgy of Fluoride: a review, Inter Nat Clin. Pychopharmacol, 9:79-82, (1994)

11. Fluoride accumulates in the hippocampus of animals exposed to fluoride. The pattern of elevation of fluoride concentrations in the brain is the same as the pattern of changes in behavioral repertoire, responses to novelty, and the temporal or sequential organization of spontaneous behavior.

This methodology has been used to study alterations in Central Nervous System function, behavioral alterations and cognitive deficits due to chemotherapy, amphetamine induced hyperactivity, and triethyltin induced hypoactivity.

Mullenix, P.J., PK Denbesten, A Schunior and WJ Kern an, Neurotoxicity of Sodium Fluoride in Rats. Neurotoxicol and Teratol, 117(2):169?177. 1995.

Mullenix, PJ, WJ Kernan, MS Tassinari, A. Schunior, DP Waber, A Howes and NJ Tar bell. An Animal Model to study toxicity of central nervous system therapy for childhood acute Iymphoblastic leukemia: Effects on Behavior. Cancer Res. 50:6461?6465. 1990.

12. Adult volunteers exposed to one drop of sodium fluoride in water (0.1,1,10, or 100 ppm) exhibit increased in error rate (missed responses) and latency (response time) on secondary tasks.

Rotton, J. RS Tikofsky, HT Feldman, Behavioral Effects of Chemicals in Drinking Water, J. Appl. Psycho. 67(2):230?238. 1982

Effects on Bone Fracture Rates

13. Bone formed in response to high and/or prolonged doses of fluoride exhibits reduced strength and increased fragility.

Riggs, BL, et al., Effect of fluoride treatment on the fracture rate in post-menopausal women with osteoporosis., N. Engl. J. Med., 322:802-809 (1990)

Kleerekoper, M and Balena R, Fluorides and osteoporosis, Ann. Rev. Nutr. 11:309-324, (1991)

Riggs, BL, et al., Drug therapy: the prevention and treatment of osteoporosis, N. Engl. J. Med., 327:620-627, (1992)

14. Sodium fluoride therapy fails to decrease the propensity toward hip fractures, increases the incidence of stress fractures in the extremities, and is accompanied by so many medical complications and side effects that it is hardly worth exploring in depth as a therapeutic mode for postmenopausal osteoporosis.

Alvioli, L, quoted in Hileman, B, Fluoridation of Water, Chem. & Eng. News, 66:34, (1988)

Dental and Skeletal Fluorosis

15. Fluoride ingestion has a definite relationship with the prevalence and severity of dental fluorosis, decrease of stature, and decrease of thyroid hormone secretion.

Ayoob S, Gupta AK. (2006). Fluoride in Drinking Water: A Review on the Status and Stress Effects, Critical Reviews in Environmental Science and Technology 36:433–487

16. Populations exposed to 2-4 times the “optimal” fluoridation level [1ppm] have exhibited dental fluoridosis in nearly 70% of the teeth studied.

Ad Hoc Committee on Fluoride of the Committee to coordinate Environmental Health and Related Programs, Review of Fluoride Benefits and Risks. U.S. Dept. of Health and Human Services, Public Health Service, Feb 1990, p. 20.

17. “Optimally” fluorinated populations exhibit dental fluorosis at a much higher level than low fluoride communities.

Colquhoun, J., Disfiguring, White and Strong, Fluoride, 23 (3):104-111, (1990)

Effects on Pineal Function

18. “…any agent that affects pineal function could affect human health in a variety of ways, including effects on sexual maturation, calcium metabolism, parathyroid function, postmenopausal osteoporosis, cancer, and psychiatric disease.”

National Research Council, (2006), Fluoride in Drinking Water: A Scientific Review of EPA’s Standards, National Academies Press, Washington D.C. p221-22.

19. The pineal gland is a major target for fluoride accumulation in humans. Animals treated with fluoride had lower levels of circulating melatonin, accompanied by an earlier onset of puberty in the fluoride-treated female animals.

Luke J. (1997), The Effect of Fluoride on the Physiology of the Pineal Gland. Ph.D. Thesis. University of Surrey, Guildford.

Effects on Fertility

20. Laboratory studies of rodents exposed to fluoride in food or drinking water show reduced fertility. Heifers exposed to 5 ppm fluoride in water during four breeding seasons calve at 30% of the normal rate. At higher fluoride doses, the effect was earlier and more severe.

Freni, S.C., 1994. Exposure to high fluoride concentrations in drinking water is associated with decreased birth rates. J. Toxicol. and Environ. Health 42:109-121.

21. Laboratory studies of rats exposed to sodium fluoride in food show adverse reproductive effects including reduced sperm motility and lower sperm count. Withdrawal of sodium fluoride reversed most, but not all of the observed alterations.

Narayana, M.V., and Chinoy, N.J., 1994, Reversible effects of sodium fluoride ingestion on spermatozoa of the rat. Int. J. Fertile. Menopausal Stud. 39(6):337-346.

Carcinogenicity

22. “Taken together as a whole, the evidence – laboratory, animal, and human – suggests that fluoride could either directly initiate, or contribute to, the development of osteosarcoma in boys under the age of 20.

As acknowledged by the U.S. National Toxicology Program there is a “biological plausibility” of a link between fluoride exposure and osteosarcoma. The biological plausibility centers around three facts: 1) Bone is the principal site of fluoride accumulation, particularly during the growth spurts of childhood; 2) Fluoride is a mutagen when present at sufficient concentrations, and 3) Fluoride can artificially stimulate the proliferation of bone cells (osteoblasts).

In addition to its biological plausibility, there is now a substantive body of evidence indicating that fluoride can in fact induce osteosarcomas in both animals and humans.

Most notably, a recent national case control study conducted by scientists at Harvard University found a significant relationship between fluoride exposure and osteosarcoma among boys, particularly if exposed to fluoridated water between the ages of 6 and 8 (the mid-childhood growth spurt).

The Harvard study’s findings are consistent with the U.S. National Toxicology Program’s congressionally-mandated fluoride/cancer study in rats; the National Cancer Institute’s 1990 analysis of osteosarcoma rates among young males in fluoridated versus unfluoridated areas in the U.S., and the New Jersey Department of Health’s 1992 analysis of osteosarcoma rates among young males in fluoridated versus unfluoridated areas of Central New Jersey.

In addition, two later independent analyses of NCI’s national cancer data also found a relationship between fluoridation and osteosarcoma among young males (Yiamouyiannis 1993; Takahashi 2001).”

http://www.fluoridealert.org/health/cancer/osteosarcoma.html#bassin

23. Rats with fluoride in their bones equivalent to the fluoride content of the bones of humans drinking water with fluoride concentrations above 2 ppm show marginal differences between control animals and dosed animals with respect osteosarcoma, cancer of the oral mucosa, thyroid gland and uterus of rats and the hematopoietic system and liver in mice. Two tumor types, hepatoblastoma and hepatocholan-giocarcinoma, were highly unusual.

Bucher, JR., MR Hejtmancik, JD Toft II, Persing, RL, Eustis, SL and Haseman, JK, Results and conclusions of the NTP’s rodent carcinogenicity studies with sodium fluoride. Int. J. Cancer 48:733-737, (1991).

Wm. Marcus, US EPA, Memo to Alan Hais, Acting Director, Criteria and Standards Division, Office of Drinking Water, US EPA on Fluoride Conference to Review the NTP Draft Fluoride Report. May 1, 1990. [Reference provided by Shirley Brown].

24. Fluoride is shown to be genotoxic in numerous test systems, a property associated with carcinogens.

Stamm, JW, on behalf of the ADA, NTP Public Hearing on the NTP Technical Report on the toxicology and carcinogenesis studies of sodium fluoride. April 26, 1990.

25. Fluoride is a plausible carcinogen:

“The “biological plausibility” of a fluoride-osteosarcoma link is acknowledged in the scientific literature. The 3 key, acknowledged mechanisms supporting the plausibility of a fluoride/osteosarcoma connection are:

1) The preponderance of laboratory evidence indicates that fluoride can be mutagenic when present at sufficient concentrations. Most mutagens are also carcinogens.

2) The bone is the principal site for fluoride accumulation within the body, and the rate of accumulation is increased during periods of bone development. Thus, the cells in the bone, particularly during the growth spurts, may be exposed to some of the highest fluoride concentrations in the body.

3) Fluoride is a ‘mitogen’ – meaning it can stimulate the proliferation of bone-forming cells (osteoblasts). Osteosarcoma is a cancer caused by an abnormal proliferation of the osteoblasts.

Hence, fluoride’s ability to induce mutagenic damage in fluoride-rich environments coupled with its ability to stimulate proliferation of osteoblasts provides a compelling biological basis by which fluoride could cause, or contribute to, osteosarcoma.

http://www.fluoridealert.org/health/cancer/osteosarcoma.html#bassin

26. “We observed that for males diagnosed before the age of 20 years, fluoride level in drinking water during growth was associated with an increased risk of osteosarcoma, demonstrating a peak in the odds ratios from 6 to 8 years of age. All of our models were remarkably robust in showing this effect, which coincides with the mid-childhood growth spurt. For females, no clear association between fluoride in drinking water during growth and osteosarcoma emerged.”

Bassin EB, Wypij D, Davis RB, Mittleman MA. (2006), Age-specific Fluoride Exposure in Drinking Water and Osteosarcoma (United States), Cancer Causes and Control 17: 421-8.

27. “Significant increases in the frequencies of chromosome aberrations were induced in a dose- and treatment time-dependent fashion when NaF was administered to [rat vertebral bone] cells at 0.5 and 1.0 mM for 24 and 48 h. The results indicate that NaF is genotoxic to rat vertebrae, providing a possible mechanism for the vertebrae, as a target organ of NaF carcinogenesis.”

Mihashi M, Tsutsui T. (1996), Clastogenic activity of sodium fluoride to rat vertebral body-derived cells in culture, Mutation Research 368:7-13.

28. “Age-specific and age-standardized rates (ASR) of registered cancers for nine communities in the U.S.A. (21.8 million inhabitants, mainly white) were obtained from IARC data (1978-82, 1983-87, 1988-92)… The incidence rate of bone cancer as the mean of three five-years ASRs was significantly correlated with FD (fluoridated water) only in males, with CIR-100 of 1.22, whereas in 1978-82 it showed a high CIR-100 of 2.53

Takahashi K., Akiniwa K., Narita K. (2001), Regression analysis of cancer incidence rates and water fluoride in the U.S.A. based on IACR/IARC (WHO) data (1978-1992), International Agency for Research on Cancer. Journal of Epidemiology 11:170-9.

29. “Osteosarcoma presents the greatest a priori plausibility as a potential cancer target site because of fluoride’s deposition in bone, the NTP animal study findings of borderline increased osteosarcomas in male rats, and the known mitogenic effect of fluoride on bone cells in culture. Principles of cell biology indicate that stimuli for rapid cell division increase the risks for some of the dividing cells to become malignant, either by inducing random transforming events or by unmasking malignant cells that previously were in nondividing states.”

National Research Council, (2006), Fluoride in Drinking Water: A Scientific Review of EPA’s Standards, National Academies Press, Washington D.C. p 275.

30. “It is biologically plausible that fluoride affects the incidence rate of osteosarcoma, and that this effect would be strongest during periods of growth, particularly in males. First, approximately 99% of fluoride in the human body is contained in the skeleton with about 50% of the daily ingested fluoride being deposited directly into calcified tissue (bone or dentition). Second, fluoride acts as a mitogen, increasing the proliferation of osteoblasts and its uptake in bone increases during periods of rapid skeletal growth. In the young, the hydroxyapatite structure of bone mineral exists as many extremely small crystals each surrounded by an ion-rich hydration shell, providing a greater surface area for fluoride exchange to occur.”

Bassin EB, Wypij D, Davis RB, Mittleman MA. (2006), Age-specific Fluoride Exposure in Drinking Water and Osteosarcoma (United States). Cancer Causes and Control 17: 421-8.

31. “…if fluoride were to exert a neoplastic effect, it is reasonable to expect that this might be expressed in a tissue that accumulates fluoride. This would include bone, and, therefore, there is biological plausibility for an association between sodium fluoride administration and the development of bone osteosarcomas.”

National Toxicology Program [NTP] (1990). Toxicology and Carcinogenesis Studies of Sodium Fluoride in F344/N Rats and B6C3f1 Mice. Technical report Series No. 393. NIH Publ. No 91-2848. National Institute of Environmental Health Sciences, Research Triangle Park, N.C.

32. “…it would appear that sodium fluoride is genotoxic in a number of genetic toxicity assays, through as yet undetermined mechanisms. So, a neoplastic effect in a tissue that accumulates fluoride would appear possible.”

Bucher J. (1990). Peer Review of Draft Technical Report of Long-Term Toxicology and Carcinogenesis Studies and Toxicity Study, Sodium Fluoride; Research Triangle Park, North Carolina, Thursday, April 26, 1990. p. 30-31.

33. “[T]he carcinogenicity of fluoride is consistent with growth stimulation of osteoblasts, unscheduled DNA synthesis by human fibroblasts, and transformation of embryonal hamster fibroblasts into transplantable sarcoma cells. Osteoblasts are differentiated fibroblasts, and fluoride is accumulated in the skeleton. Therefore, osteosarcoma would be the natural target effect to look for in a cancer bioassay of fluoride, and an excess of osteosarcoma in rats exposed to fluoride in drinking water clearly confirms an a priori hypothesis.”

Freni S.C., Gaylor, D.W. (1992), International trends in the incidence of bone cancer are not related to drinking water fluoridation, Cancer 70: 611-8.

34. “When fluoride exposure increases, the following bone responses generally occur:

1) An increase in the number of osteoblasts

2) An increase in the rate of bone formation

3) An increase in the serum activity of alkaline phosphatase

4) An inhibition of osteoblastic acid phosphatase… The increase in osteoblast proliferation and activity may increase the probability that these cells will undergo malignant transformation.”

Gelberg KH. (1994), Case-control study of osteosarcoma, Doctoral Thesis, Yale University. p.13.

35. “Because the origin of osteosarcoma is considered to be osteoblastic/osteogenic cells, the ability of sodium fluoride to induce chromosome aberrations in these cells provides a mechanistic basis for the occurrence of osteosarcomas observed in sodium fluoride treated animals in the NTP study. Ingested fluoride is accumulated in bone, suggesting that osteoblastic/osteogenic cells in the bone microenvironment can be exposed to high levels of fluoride during bone formation. Our data and the NTP findings provide evidence that bone can be an organ for NaF carcinogenesis.”

Mihashi M, Tsutsui T. (1996), Clastogenic activity of sodium fluoride to rat vertebral body-derived cells in culture, Mutation Research 368:7-13.

36. “Recent studies showing substantial increases in the incidence of bone cancer and osteosarcoma in males (but not females) exposed to fluoride gave us the unique opportunity of using females as a control group to determine whether there is a link between fluoridation and bone cancer in males. Using three different data bases, we found that 1) the bone cancer incidence rate was as much as 0.95 cases a year per 100,000 population higher in males under age 20 living in fluoridated areas; 2) the osteosarcoma incidence rate was 0.85 new cases a year per 100,000 population higher in males under age 20 living in fluoridated areas; and 3) for males of all ages, the bone cancer death rate and bone cancer incidence rate was as much as 0.23 and 0.44 cases higher per 100,000 population, respectively, in fluoridated areas. These findings indicate that fluoridation is linked to an increase in bone cancer and deaths from bone cancer in human populations among males under age 20 and that this increase in bone cancer is probably all due to an increase in osteosarcoma caused by fluoride.”

Yiamouyiannis JA. (1993), Fluoridation and cancer: The biology and epidemiology of bone and oral cancer related to fluoridation. Fluoride 26:83-96

37. “Recently, a national study of drinking water fluoridation at the country level found a significant association with osteosarcoma incidence among males under 20 years of age (Hoover et al., 1991). However, the meaning of the association was questioned by the authors because of the absence of a linear trend of association with the duration of time for which the water supplies were fluoridated… As a follow-up to the study by Hoover et al., a small study of similar design was initiated by the New Jersey Department of Health to compare drinking water fluoridation at the municipal level with the municipal residence of osteosarcoma cases at the time of diagnosis… The study observed an association between fluoridation of water and osteosarcomas among males under 20 years of age in seven Central New Jersey counties.”

Cohn PD. (1992), A Brief Report on the Association of Drinking Water Fluoridation and the Incidence of Osteosarcoma among Young Males. New Jersey Department of Health: Environmental Health Service: 1- 17.

Elevated Blood Lead Levels, Reduced Bio-availability, Enzymatic and Other Disruption

38. There is a consistent and significant correlation between exposures to water treated with Sodium fluorosilicate or fluorosilic acid and elevated blood lead levels.

R.D. Masters, M.J. Copla, B.T. Hone, J.E. Dykes. Neurotoxicology 21(6) 1091-1100, 2000

39. Fluoride ingestion is related to the prevalence and severity of dental fluorosis, decrease of stature, and decrease of thyroid and hormone secretion.

Ruiz-Payan A, Duarte-Gardea M, Ortiz M, Hurtado R (2005), Chronic effects of fluoride on growth, blood chemistry, and thyroid hormones in adolescents residing in northern Mexico. Paper presented at the XXVIth Conference of the International Society for Fluoride Research. September 26-29. Fluoride 38: 46.

40. Fluoride can affect the bioavailability magnesium, manganese, and calcium or otherwise interact with any enzyme system that requires one of these metals as a co-factor.

Villee, C, Birth Defects & Glycolysis, N. E. J. Med., 310: 254 (1981)

Chlubek, D, Some aspects of prenatal fluoride metabolism in human studies performed during the perinatal period, Ann. Acad. Med. Stein., 31: 1-99, (1996)

41. Fluoride interferes with metabolic processes involving calcium. When calcium is supplemented in osteoporotic patients, a large number of those who have also been treated with fluoride still show evidence of calcium deficiency.

Dure-Smith, BA, et al., Calcium deficiency in fluoride-treated osteoporotic patients despite calcium supplementation, J. Clin. Endocrinol. Metab., 81:269-275, (1996)

42. Fluoride ion may completely disrupt the Thymine-Adenine linkage in DNA.

Emsley, J, et al., The Uracil-Fluoride interaction, J.A.C.S., 104:476 (1982)

43. Fluoride inhibits metalloproteins, necessary for metabolizing and excreting heavy metals.

Bunick, FJ, and Kashket, S, Enolases from Fluoride Sensitive…Streptococci., Infect. Immun. 34:856 (1981), cited in “Should Natick Fluoridate?, Natick Fluoridation Study Committee, 1997

44. Fluoride inhibits DNA polymerase.

Lehman, IR, DNA Synthesis, in Methods in Enzym., VI, Academic Press (1963).

45. Fluoride induces chromosome aberrations.

Tsutsui, T, et al., Cytotoxicity, Chromosome aberrations…Fluoride, Mutation Res., 139:193 (1984) cited in “Should Natick Fluoridate?, Natick Fluoridation Study Committee, 1997

46. Fluoride effects the aylase cyclase system

Sternweis, PC and Gilman, AG, Aluminum: A Requirement….by Fluoride, Proc. Natl. Acad. Sci. (USA), 79:4888 (1982) cited in “Should Natick Fluoridate?, Natick Fluoridation Study Committee, 1997

47. Fluoride inhibits yeast enolase.

Fluoride Inhibition of Yeast Enolase, Biochemistry, 20:6894 (1981)

48. Fluoride inhibits protein synthesis enzymes.

Song, XD, et al., The Effect of Sodium Fluoride…..Study, Fluoride, 21:149 (1988)

49. Fluoride inhibits gycolytic enzymes. cited in “Should Natick Fluoridate?, Natick Fluoridation Study Committee, 1997

Bartholmes, P, et al., Inhibition of Gylcolytic Enzymes by Fluoride Ions, Dtsc. Zahnarztl. Z., 42:916 (1987)

50. Fluoride inhibits cell growth enzymes.

Holland, RI, Fluoride Inhibition of Protein Synthesis, Cell. Biol. Int. Rep. 3:701 (1979)

51. Fluoride inhibits testosterone synthesis.

Kanwar, KC, et al., In Vitro inhibition of testosterone synthesis in the presence of fluoride ions, I. R. C. S. Med. Sci., 11:813-814, (1983).

Kidneys and Thyroid Toxicity

52. “Human kidneys… concentrate fluoride as much as 50-fold from plasma to urine. Portions of the renal system may therefore be at higher risk of fluoride toxicity than most soft tissues.”

National Research Council, (2006), Fluoride in Drinking Water: A Scientific Review of EPA’s Standards, National Academies Press.

53. “Persons with renal failure can have a four fold increase in skeletal fluoride content, are at more risk of spontaneous bone fractures, and akin to skeletal fluorosis even at 1.0 ppm fluoride in drinking water.”

Ayoob S, Gupta AK, (2006), Fluoride in Drinking Water, A Review on the Status and Stress Effects. Critical Reviews in Environmental Science and Technology, 36:433-487.

Manocha SL, et al. (1975), Cytochemical response of kidney, liver and nervous system to fluoride ions in drinking water, Histochemical Journal 7: 343-355.

54. Fluoride-related kidney damage is exhibited is animals at exposure levels as low as 1 ppm in rats, and 5 ppm in monkeys.

Varner JA, et al., (1998), Chronic administration of aluminum-fluoride and sodium-fluoride to rats in drinking water: Alterations in neuronal and cerebrovascular integrity, Brain Research 784: 284-298.

Sullivan WD, (1969), The in vitro and in vivo effects of fluoride on succinic dehydrogenase activity, Fluoride 2:168-175.

Ramseyer WF, et al., (1957), Effect of sodium fluoride administration on body changes in old rats, Journal of Gerontology 12: 14-19.

55. Fluoride inhibits the secretion of insulin in rats.

Menoyo I et al, (2005), Effect of fluoride on the secretion of insulin in the rat. Arzneimittelforschung 55:455-60.

The Natural Solutions Foundation strongly recommends that because of the infant-specific, organ-specific and function-specific dangers, alerts and cautions raised by fluoride levels even will within the so-called “safe” exposure levels, and because infant metabolism of fluoride is not well understood, that the United States oppose the inclusion of fluoride at any level in infant formula or any other food for special dietary uses. Infant nervous systems are especially vulnerable to the impact of heavy metals and fluoride accelerates the accumulation of lead and compromises the availability of magnesium and other vital metabolites.

The impact of fluoride on the developing nervous system, apart from any impact due to the potentiation of lead’s impact, is negative, lowering IQ and other essential higher functions. Fluoride is a suspected or likely carcinogen and interferes with crucial enzyme functions and DNA base coupling. Young males appear to be particularly susceptible to osteogenic sarcoma, a deadly disease, when exposed to fluoride. Since it is not clear what the impact of adding fluoride to infant formulas and weaning foods, it would be highly prudent to avoid any levels of this dangerous metal to infant and childhood foods.

Fluoride concentrates in and impairs pineal function with unknown, but possible, long-term increases in pediatric cancers. Fluoride has a strongly negative impact on renal and endocrine function and should be avoided for that reason as well.

Despite the wide-spread belief that fluoride supports and maintains healthy ossification and bone mineralization, the data do not support that conclusion. In fact, mineralization is impaired and fractures are increased with fluoride exposure at levels well within the supposed “safe” levels.

Because of the wide spread negative effects of fluoride on vulnerable, rapidly growing infants and children, and because so many infant-specific questions remain, the Natural Solutions Foundation urges the United States to strongly oppose any level of fluoride in these foods.

Thank you for considering the comments of the Natural Solutions Foundation on fluoridation of infant formula.