At the urging of Congress, the National Toxicology Program (NTP) studied fluoride/cancer effects in rodents. Some rodents developed cancer. But the 1990 report downgraded those and other effects, officially calling the certain cancer findings "equivocal"(uncertain), some said to protect the US fluoridation program and the government agencies promoting it. An EPA Senior Science Adviser blew the whistle on this discrepancy, was fired for doing so, then re-hired with back pay under the whistle blower's act. But the NTP never corrected its misrepresentation. Below is Dr. Marcus' May 1, 1990 Memo on the falsification of the NTP fluoride/cancer results which got him fired. Here is a 1995 transcript of his experience.
Bioassay on Fluoride
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
OFFICE OF WATER
MEMORANDUM
DATE: May 1, 1990
SUBJECT: Fluoride Conference to Review the NTP Draft Fluoride
Report
FROM: Wm L. Marcus, Ph.D., Senior Science Advisor, Criteria &
Standards Division, ODW (WH-550D)
TO: Alan B. Hais, Acting Director, Criteria & Standards Division,
ODW (WH-550D)
The conference was held in RTP at the NIEHS headquarters on April
26, 1990. The subject of the conference was a peer review of the NTP
draft report on the toxicology and carcinogenesis studies of Sodium
Fluoride in F344/N Rats and B6C3F Mice (Drinking Water Studies)
NTP Report Number 393. Dr. Robert Scala was to chair this meeting
but was unable to attend because of ill health. Dr. Michael Gallo
appointed acting Chairperson. One of the attenders seated with the
panel members was David Rall, Ph.D., M.D., Director of NIEHS. Dr.
Rall took an extremely active interest in the proceedings and remained
seated for the entire proceedings with only two minor interruptions.
The most disturbing part of the report was the continual reference to
the historical controls as having the same or higher cancers as the test
groups. On pages 89 - 90 of the report starting with the last paragraph
the authors state the following:
An important consideration which limits the usefulness of the historical
control data base in the current studies is that the diet used in all other
NTP studies had not been closely monitored for fluoride content.
Fluoride concentrations in typical batches of NHI-07 diet range
between 28 and 47 ppm (.7 and 1.2 mg/kg/day)(Rao and Knapka (1),
1987). Assuming a minimum bioavailability of 60% (Tests show 66%
absorption page I-18), the historical database animals actually
constitute a group receiving sufficient fluoride to place them between
the low- and mid-concentration group in the current (the studies
reviewed at RTP at the conference). The fact that this fluoride is
available for absorption from the standard diet is supported by the
levels of fluoride found in the bones of animals maintained on this diet
in the six months studies (Appendix I). (The levels in the bones of the
rats on the standard NHI chow was ten [10] times the levels of those
fed the semisynthetic diet and deionized water, 0.922 vs 0.0901). If the
fluoride [is] in fact influencing the "spontaneous " or background
incidence of osteosarcoma in male rats, comparisons with those in the
historical database maybe misleading. This forces an even greater
reliance on the within-study comparisons, ie., the incidences of the
dosed groups compared with the concurrent control, in the
interpretation of the results of the sodium fluoride studies. [italics in
memo]
When I plotted a bar graph of osteosarcoma in male rats and placed the
historical controls on the graph 0.6% is just where expected. This helps
demonstrate a relationship between osteosarcoma and fluoride. The
purpose of such graphs is to predict occurrence. Since the historical
controls comprise some 6,000 animals, this data point is extremely
significant compared to the other three. Osteosarcoma is an extremely
rare animal tumor and may be the result of the variable high fluoride
content in the feed. In order to demonstrate this, all that need be done is
require that the fluoride content of animal chow be lowered
dramatically and that fluoride be removed from the water given to the
animals under study.
The dose of fluoride to which the concurrent controls were exposed is
0.2 mg/kg/day. A 70 kg man who drinks 2 liters daily is exposed to
0.03 mg/kg/day. The "control" animals were exposed to an amount of
fluoride six to seven (6-7 X) greater. Lois Gold, Ph.D. of the review
panel concluded that, "this group of animals therefore, can hardly be termed a control group. It can best be described as a lowest dosed
group." This is an important consideration because as the document
reports on page 9, the levels of fluoride in bone are linearly dependent
upon dose and length of exposure ("depends upon total intake") in
people. The level of fluoride in ashed samples of bone of 20-30 year
old people is 200 - 800 mg/kg compared to 70 to 80 year old people of
1,000 - 2.500 mg/kg. In the document, the authors cited Zipkin (2) who
reported on bone fluoride concentrations in four groups of individuals
with average ages of 56 to 76 who lived in areas with fluoride
concentrations in drinking water of 0. 1, 1, 2.6, or 4 ppm The
relationship to bone fluoride concentrations and water fluoride content
was linear; bone fluoride ranged from about 800 to 7,000 ppm ash with
increasing water fluoride."
In the animal studies the levels of fluoride (Appendix I) found in the
bones of the animals were the same as or lower than those found in
people. The highest dosed level of rats had lower levels of fluoride in
their bones (5,470 ppm) compared to people (7,000 ppm) at the MCL
of 4 ppm. This can be interpreted as people who ingest drinking water
at the MCL have 1.3 times more fluoride in their bones than male rats
who get osteosarcoma This is the first time in my memory that animals
have lower concentrations of the carcinogen at the sight of adverse
effect than do humans. An important toxicologic consideration is that a
toxic substance stores at the same place it exerts it toxic activity. This is
true of benzene and now for fluoride. Fluoride however, is at twice the
concentration in human bones compared to benzene which is 10 to 100
[times] greater in animal marrow. This portends a very serious
problem. One would expect to be able to discern a carcinogenic effect
in the exposed population when compared to the unexposed population
especially if data exist on the populations before fluoridation.
Yiamouyiannis and Burk published epidemiology studies that have
since been revised twice (3), by Burk (former head of the
Cytochemistry section at NIH). In these extensively peer reviewed
papers, the authors found that about 10,000 deaths a year are
attributable to fluoride water treatment. The U.S. Public Health Service
(U.S.PHS) criticized the original studies by erroneously asserting that
the results reported by the authors were a result of changes in the age,
race and sex composition of the sample. The U.S.PHS made
mathematical errors and did not include 90% of the data. U.S.PHS
method of analysis when applied to the database, confirmed that 10,000
excess cancer deaths yearly were linked to fluoridation of watersupplies. This evidence has been tested most recently in the
Pennsylvania Courts and found scientifically sound after careful
scrutiny.
There were three different short term in vitro tests performed on
fluoride and all these tests proved fluoride to be mutagenic. An Ames
test was performed and reported to be negative. Bruce Ames, in a letter
to Arthur Upton introduced in the Congressional Record, stated that his
test system was inappropriate for fluoride testing based on a number of
technical considerations. EPA's own guidelines require that in vitro
tests be taken into consideration when found positive. In this case, the
mutagenicity of fluoride supports the conclusion that fluoride is a
probable human carcinogen.
Melvin Reuber, M.D, a board certified pathologist and former
consultant to EPA and part time EPA employee, reviewed some of
pathology slides and the Battelle report. Dr. Reuber has had his
pathologic diagnoses questioned several times in the past. When an
independent board together with Dr. Reuber went over the Slides his
opinion was always upheld. He first published the work that identified
hepatocholangiocarcinoma as a pathologic entity. The report changed
Battelle's board certified veterinary pathologists diagnoses from
hepatocholangiocarcinoma to hepatoblastoma and finally to
hepatocarcinoma. Dr. Reuber reviewed the pathology slides [in the NTP fluoride/cancer rodent study]and stated
that these lesions are indeed hepatocholangiocarcinoma. Because Dr.
Reuber first identified and published his findings on this tumor, I trust
his opinion in this matter. These tumors are extremely rare. Dr.
Reuber's diagnoses would make the liver cancers significant because of
their rarity. This changes the equivocal finding of the board to at least
some evidence or clear evidence of carcinogenicity. In addition, the
oral changes in the report were down-graded from dysplasia and
metaplasia to degeneration. Dr. Reuber said that this. change should
also be reviewed. The report also down-graded adrenal
pheochromocytomas and tumors to hyperplasia. This needs to be
reviewed by an independent board. The other liver carcinomas were
down-graded to foci by artificially defining a need for 75%
compression in the tumor before it was no longer a foci. Using this
changed definition carcinomas were down-graded to adenomas and
adenomas downgraded to eosinophilic foci. In almost all instances, the
Battelle board certified pathologists' findings were down-graded. It is
my suggestion that a board independent of NIEHS should be assembled
by ODW consisting of human pathologists (for their experience in an diagnosing osteosarcoma), the Battelle pathologist (to defend his
original diagnoses), Dr. Melvin Reuber, Dr. Thomas Squires and two
other well known independent board-certified animal pathologists. The
charge to this board is to meet as a body, review the slides, agree on a
pathologic diagnoses and prepare a report to be submitted to ODW for
incorporation in our docket for the fluoride regulation.
The report talks about the efficacy of fluoride and tooth decay. Since
the studies were performed to determine the carcinogenicity of fluoride
this should not have been addressed. There appear to be at least four
different publications from the U.S., Canada, and New Zealand that
have reported similar or lower tooth decay rates in nonfluoridated areas
as compared to fluoridated areas (4,5,6,7). Therefore, the entire
question of the efficacy of fluoridation based on extensive and multiple
studies has been called into question. Our job is to set safe levels for
fluoride in drinking water based on the scientific evidence.
The problem with this meeting was the inability of independent
reviewers to get to see the slides prior to the meeting. We must perform
our own scientific review of the slides and write our conclusions for
use in the development of the revised fluoride regulation.
(1) Roa, G.N., and Knappa, J.J. 1987. Contaminant and nutrient
concentrations of natural ingredient rat and mouse diet used in
chemical toxicology studies. Fundam. Appl. Toxicol.
9, 329-338.
(2) Zipkin, L., McClure, F.J., Leone, H.C., and Lee, W.A. 1958.
Fluoride deposition in human bones after prolonged ingestion of
fluoride in drinking water. Public Health Rep. 73,
732-740.
(3) Graham, J.R., Burk, O., and Morin, P. 1987. A current restatement
and continuing reappraisal concerning demographic variables in
American time-trend studies an water
fluoridation and human cancer. Proc Pennsylvania Academy of Sci.
61:138-146.
(4) Colquhoun, J. 1987. Comm. Health Studies. 11:85.
(5) Gray, a. 1987. J. Canadian Dental Assoc. 53:763.
(6) Hildebolt, C.F. et al. 1989. Amer J, Physiol. Anthropol. 78:79-92.
(7) Diesendorf, M. 1986. Nature. 321:125.
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1995 Radio Interview with Dr. Marcus on NTP fluoride/cancer study is here:
http://fluoridealert.org/content/marcus-interview/
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Because EPA management allegedly uses politics and not science to protect fluoridation, EPA scientists and other professionals under the safety umbrella of their union demanded an end to fluoridation http://www.fluoridation.com/epa2.htm
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FluorideGate, The Movie reveals more from Dr. Marcus and his lawyer
Dr. Marcus starts at about 12 minutes into this film
https://www.youtube.com/watch?v=T_vlwJPcYW8
About 13 minutes, hear from Dr. Marcus lawyer from the National Whistleblowers Association
Fluoridation Fails America, New Report Proves
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