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.
(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
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.
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