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Cover |
Introduction |
1a |
1b |
1c |
1d |
2a |
2b |
2c |
2d |
3
Errors
and Omissions in Experimental Trials - 2d
ADDITIONAL OBSERVATIONS ON THE
EVANSTON, GRAND RAPIDS AND NEWBURGH TRIALS
1. Gross numerical errors in
statements of the number of children examined.
The Evanston Trial
These comments on the Evanston trial
were published in 1980 in the present author's book
Fluoridation Scientific Criticisms and Fluoride
Dangers. It was stated:
"Additional Errors in the Evanston
Trial Data.
In January, 1967, which was the
twentieth anniversary of the commencement of the
Evanston Trial, an entire special issue of the
Journal of the American Dental Association was
devoted to a report on that study (Blayney and Hill,
1967). In this, the original tables, complete with
their gross numerical errors, were reproduced,
despite the fact that these [errors] had been
pointed out eight years earlier (Sutton, 1959) and
some of them had been acknowledged by the authors
(Sutton, 1960). In addition, several faulty tables
were published for the first time.
The tables [in this issue of the J.
Amer. Dent. Ass.] then showed three different
statements regarding the number of children aged 6-8
years who were examined in Evanston during the 1946
examination:
(i) 1991 children - see Tables 10,
11,30,40 and 47.
(ii) 1985 children - see Tables 7,8,16,18,21 and 32.
(iii) 1754 children - see Tables 24 and 25.
There were also no fewer than six
different statements in that article of the number
of children aged 12-14 years examined in Evanston in
1946:
(i) 1703 children - see Tables 15 and 32.
(ii) 1702 children - see Table 47.
(iii) 1701 children - see Tables 11,30,41,44 and 45.
(iv) 1697 children - see Tables 7,9,12,13,17,19,22
and 31.
(v) 1556 children - see Table 26.
(vi) 1146 children - see Table 46.
Between the sum of the two highest
statements of the number of children examined in
Evanston in 1946, and the sum of the two lowest
statements of children examined in the same year in
the same study in the same city, there is a
difference of 794 children (1991 + 1703 - 1754 -
1146 = 794).
The number of children stated to
have been examined in Evanston is even more
divergent in the original papers than in this
special article. Blayney and Tucker (1948) and Hill
et al. (1950) both gave a figure of 4375
children, compared with the number of 3310 in Hill
et al. (1957b), a difference of 1065
children.
It was these differences which the
medical journalist Anne-Lise Gotzsche, in a letter
to the Lancet in 1975, said that she had showed to
workers in other fields, and that they had "simply
laughed" at the statistics (see Fig. 5, p. 167).
In that book (Sutton, 1980) -
prepared as a submission to the Committee of Inquiry
into the Fluoridation of Victorian Water Supplies
(1980) - it was stated (p. 203):
"These errors were mentioned [by the
present author] 12 years ago to the Tasmanian Royal
Commission on Fluoridation. Since that time I have
not heard of any mention of them or of a criticism
having been made of the numerical data published in
that report."
It appears that, in the manner
common in fluoridation trials, those erroneous
tables have been accepted at their face value,
without investigation.
More than thirty years ago it was
pointed out (Sutton and Amies, 1958b) that:
'This uncritical attitude to these
studies is rife." "Also it has been assumed that
associations and individuals that ... accepted the
responsibility of publicly advocating fluoridation,
have undertaken independent examinations of the
data, and not merely repeated the opinions of
others."
This situation was referred to by
Professor John Polya (1964) in his book Are We Safe?
He wrote:
"It is immaterial that other
evidence in favour of fluoridation is not always
false; the point is that persons, bodies and
arguments that knowingly or in simplicity acquiesce
in one blatant falsehood are unreliable witnesses
before a jury either of scientists or of lay common
sense."
He continued:
"The scandal created by the exposure
of this absurdity resulted in the admission that the
first figure (4,375) was correct. In defence of the
other claims it was explained that "out of range"
children were eventually excluded from the survey,
but then further critical check revealed more
numerical inaccuracies, not to speak of the
magnitude of a correction exceeding 1,000. In better
examples of scientific work the author sticks to his
experimental group; discarding on the scale quoted
strongly suggests that the experiment had to be
altered to fit pre-conceived results. This is one of
the common consequences of working without control
of observer bias."
It is pertinent to point out that,
in the Foreword to that article in the special
edition of the Journal of the American Dental
Association, in January 1967, Dr F.A. Arnold, Jr.,
the Assistant Surgeon General, Chief Dental Officer,
U.S. Public Health Service (and formerly the chief
experimenter in the study in Grand Rapids) stated:
"Here, in a single report, are data
on the effect of water fluoridation on dental caries
so completely documented that the article is
virtually a text book for use in further research.
It is an important scientific contribution towards
the betterment of the dental health of our nation.
It is a classic in this field."
It is indeed a classic - a
first-class example of the errors, omissions and
misstatements which abound in the reports of these
fluoridation trials.
2. False information in the Abstracts of papers
The abstracts of reports on
fluoridation trials are unusually important, for it
is likely that lay people, and politicians in
particular, will confine their reading of the report
to the Abstract, assuming that it accurately
reflects the findings, and will base their opinions
and actions on its statements.
The Grand Rapids Trial.
The final report of the Grand Rapids study was
published in 1962. Reading the Abstract which
preceded the body of the article it would seem that,
at last, the authors (Arnold et al., 1962)
had come to realize the necessity for comparing the
results from the test city with those from the
control one for they stated that the results had
been "...compared with the caries attack rates in
the control group of children in Muskegon, Mich."
This claim was not made in the body of the article,
which included the statement that: "... fluorides
were introduced to this [Muskegon] water supply in
July, 1951" Therefore at that time Muskegon ceased
to be a control city, some eleven years before this
final report (Arnold et al., 1962) from Grand
Rapids.
How then, in 1962, could the final
result from the test city be compared with data from
a non-existent control one?
The claim of Arnold et al.
(1962) that they compared the Grand Rapids caries
rates with those in the "control group of children
in Muskegon, Mich." is shown to be false by their
statement that: "...in subsequent [after 1954]
analyses of Grand Rapids data, comparison has been
made with the original Grand Rapids findings and
with those for Aurora."
This is confirmed by the statement
in the Abstract that:
"Caries attack rates were lowered by
57 per cent in children 12 to 14 years old in 1959."
This figure of 57 per cent is obtained by averaging
the figures of 57.0, 63.2 and 50.8 per cent for the
ages of 12, 13 and 14 years shown in their Table 2
to be the "per cent reduction in DMF teeth
(19441959)" in Grand Rapids (not between Grand
Rapids and its control city of Muskegon).
The Newburgh Study.
Similar mis-information regarding comparisons being
made between test and control cities was published
in the same year (1962) by Dr David Ast, the senior
author of the Newburgh study. In the Abstract of
that paper (Ast and Fitzgerald, 1962) he wrote:
"Among children 12 to 14 years old
in the four study areas, reductions in the DMF rates
as compared to the rates in control cities ranged
from 48 to 71 per cent."
Table 2 is the only one in that
paper showing DMF rates for children aged 12-14
years (in one case 13-14 years). In the first two
studies listed, Grand Rapids and Evanston, no
reference is made to a control, the "reduction" in
Evanston, shown as 48.4 per cent, is obviously the
48 per cent mentioned in the Abstract. This
"difference" is between the rates in Evanston in
1946 and 1959, not between Evanston and a control,
as stated in the Abstract. The Grand Rapids rates
are also shown between that city in 1944-45 and
1959, no control data being used. Indeed Ast and
Fitzgerald stated in the main text:
"In the Grand Rapids and Evanston
studies the control cities were lost before the
study was completed, so that the current data have
been compared with the base line data."
Not with control cities, as they
stated in their Abstract.
There should not have been any
confusion regarding the use of the term "control",
for the co-author of that paper, Bernadette
Fitzgerald, was described as the "senior
biostatistician, division of special health
services, New York State Department of Health."
Therefore the authors' incorrect statement that they
compared the caries rates "in the four study areas"
with rates in control cities is unlikely to have
been made inadvertently.
3. Continuing publication of
false statements.
It has just been shown that Dr Ast
(the senior author of the Newburgh study) and Dr
Arnold (the senior author of the Grand Rapids study)
continued to disseminate false statements regarding
their studies many years after those ten-year
studies were concluded, Also, the arrogance of Drs
Blayney and Hill (the authors of the Evanston study)
in publishing an article in 1967, which repeated, in
a special issue of the Journal of the American
Dental Association, figures which they had
acknowledged seven years earlier were faulty
(Sutton, 1960), indicates the reckless disdain of
all those authors for the truth, and for the members
of the scientific community (which normally trusts
statements made in established journals by senior
scientists, for it is not used to being misled by
such readily-verified deceptions).
Their false statements do not
engender confidence in the reliability of the data
published and the statements made by those senior
scientists in their original reports of what are
still regarded by fluoridation advocates as three of
the four main fluoridation studies on which the case
for fluoridation mainly relies - those in Newburgh,
Grand Rapids and Evanston in U.S.A.
Commenting on the Grand Rapids
study, Ziegelbecker (1983) pointed out that the
experimenters had examined "all" children from 79
schools in Grand Rapids at the commencement of the
trial, but that:
"After 5 years in 1949 they selected
children at only 25 schools in Grand Rapids for
their investigation and observed children at the
same time at all schools in Muskegon (the control
city)."
For instance, the number of children
aged 12 to 16 years who were examined in Grand
Rapids at the commencement of the trial was 7,661,
but only 1,031 were examined in 1959 (Arnold et
al., 1962).
In 1988, Colquhoun stated:
"In the control city of Muskegon all
children were examined throughout the period. From
the year-by-year figures for six-year-olds which
were published three years later in 1953, it is
revealed that an impossible 70.75% reduction was
recorded in the first year of the trial (Arnold
et aL,1953) and that there was then an increase
and no overall reduction in the following years.
Examination of similar data for other age groups
shows that the sample of 25 schools could not have
been representative of the population being
studied."
He pointed out that:
"The reported DMF of several of the
age groups in this sample, approximately one year
after the initial examinations, was lower than that
of the same children when they were a year younger."
He concluded:
"Fluoridated water cannot turn
decayed, missing or filled teeth into sound ones. It
follows that the caries experience of the children
had not been reduced as claimed. The large recorded
reductions, which were mostly in the first year
only, were a result of selection of data."
4. Fictional results?
In 1954 De Stefano reported the
findings of professional statisticians regarding the
Grand Rapids study. They raised the question whether
"... the reported results are merely the fiction of
a biased sample."
Ziegelbecker (1983) also, studied
this situation. He stated:
"We must conclude from this result
that the sample in Grand Rapids was not
representative for all children and with respect to
the basic examination. In the following years from
1946 to 1949 (and later to 1954) the 25 schools in
the sample were the same each year and we see that
the caries experience in the sample was not reduced
by fluoride in 1946-1949.
If we accept that the sample was
representative for the children, aged 6, in the 25
schools in those years then we must conclude that
fluoride in the drinking water had not reduced the
dental caries experience of children, aged 6, in
Grand Rapids in the years before the US Public
Health Service released the policy statement
[endorsing fluoridation] to the American Dental
Association."
He concluded:
"We must conclude from these results
that a fluoride content of 1 ppm in the public water
supply does not reduce dental caries experience."
Colquhoun stated in 1988:
"In their final study in Grand
Rapids, published in 1962 after 15 years of
fluoridation, American health officials [including
the director of the U.S. National Institute of
Dental Research, Dr F.A. Arnold, Jr.] wrote: "... no
such dramatic and persistent inhibition of caries in
large population groups had ever been demonstrated
by any other means than fluoridation of a domestic
water supply."
Colquhoun commented:
'That statement, which could be
described as the dogma of fluoridation, is now
considered by an increasing number of critics to be
unscientific and untrue."
In view of the disclosure of the
types of error which have just been mentioned, such
a grandiose claim, although it was widely accepted
at the time, can no longer be considered to be true.
More than thirty years ago Sutton
and Amies (1958a) commented on this sudden initial
decrease in caries reported from Grand Rapids (and
from other studies considered). It was stated that
the results reported were not those which would be
expected if the hypothesis was correct that fluoride
"strengthens" developing teeth and makes them more
resistant to attack by caries. Despite the fact that
the results published from fluoridation studies do
not support this hypothesis, it is still mentioned.
For instance, the ten members of the task group
which in 1984 wrote the latest WHO book on this
subject: Environmental Health Criteria 36. Fluorine
and Fluorides, referred to the importance of
"lifelong consumption" of fluoridated water.
Cover |
Introduction |
1a |
1b |
1c |
1d |
2a |
2b |
2c |
2d |
3 |
