'83 Transcripts Show Fluoride Disagreements
/ EPA Standards
Articles / Medical Tribune 1989
[See photocopy of article]
April 20, 1989
'83 Transcripts Show Fluoride Disagreements
by Joel Griffiths
- "I realize that we have few facts and many unknowns.
. ." - Stanley Wallach, M.D., Veterans Administration
Medical Center, Albany, N.Y.
- "We could cut it that close. I just don't know where
the truth is. That is what I don't know." - Jay R. Shapiro,
M.D., Clinical Center, National Institutes of Health.
- "If you are talking about potential toxicity, we have
no idea whether it is 18 or puberty. We have no idea."
- Michael Kleerekoper, M.D., Henry Ford Hospital, Detroit.
The question these scientists are struggling to resolve in the
face of such dizzying uncertainties is, of all things: What constitutes
level of fluoride in U.S. drinking water? Moreover, they are
world-class experts working with the best data available. They are
members of an ad-hoc
committee convened by U.S. Surgeon General C. Everett Koop,
M.D., at the request of the Environmental Protection Agency to review
the literature on the health effects of fluoride in drinking water
and to recommend safe levels. The year is 1983, nearly 40 years
after fluoridation of U.S. water supplies began. The quotes are
from a hitherto unpublicized transcript
of the committee's meeting obtained by Martha Bevis of Houston with
the aid of her congressman.
"Let me go ahead on what we don't know. First of all,
any problem with a low latency isn't going to show up by anything
available to us at the present time" - Dr. Wallach.
"I am saying that I accept that we do not have the numbers
from what it is in the literature" - Dr. Shapiro.
Such statements typify the committee's
deliberations, which are being cited by fluoridation opponents
as revealing an astonishing lack of safety data about a chemical
currently being added to more than half of U.S. public water supplies.
Indeed, as the following excerpts show, the degree of uncertainty
on several crucial issues appears near-Heisenbergian.
The proposed permissible levels under discussion were 4 ppm for
adults and 2 ppm for children and adolescents. (By comparison, the
recommended level of fluoride in drinking water for caries prevention
averages 1 ppm, although some proponents have advocated higher levels,
and a 1979 study by the CDC found more than half of water companies
adding either too much or too little.)
The committee apparently felt restrained from setting permissible
levels that would interfere with fluoridation for dental purposes.
Noted Stephen J. Marx, M.D., with the National Institute of Arthritis,
Diabetes, and Digestive and Kidney Diseases: "I think we have
a problem with the lower age range because there we can't say we
want to have the margin of safety, of, say, two-to-fourfold, because
then we get into the range in which you have therapeutic effects
of fluoride for prophylaxis and dental care. If we were just handling
this as an environmental contaminant, we could say we begin to see
fluorosis at 2 ppm. So we want a safety factor of 4. We recommend
that it be kept below half a part per million [0.5 ppm].
"We have to make an allowance there. We can't just talk about
Since 99% of ingested fluoride is assimilated into bone, the major
adverse health effects under review were those summarized by Dr.
Marx: "Just as dental fluorosis is a manifestation of moderately
low levels of fluoride excess, osteosclerosis is the next stage
and crippling fluorosis is a much more severe stage."
Opening the discussion of crippling fluorosis, Dr. Kleerekoper
asked: "Jay [Shapiro], what is the level of fluoride in the
drinking water in those communities that get . . . crippling endemic
bone fluorosis?" Responded Dr. Shapiro, who chaired the committee:
"You don't know what the level is, but certainly you are talking
8-10 ppm and above."
However, Frank A. Smith, Ph.D, interjected: "The problem with
that literature is that they tell you the . . . the waters contain
1.6-15 or 18 or 23 ppm, and you never know what well the guy is
using that shows this."
"Let me quote you a study," continued Dr. Smith, who
was then a toxicologist at the University of Rochester (N.Y.) Medical
Center. "There is only one subject, of course, but he appears
to have been drinking for 43 years water with fluoride concentrations
of from 2.4 to 3.5 ppm. Now he had polydipsia of unknown origin,
but he did have fluorotic radical myelopathy."
Dr. Kleerekoper pointed out that "the reports outside of the
United States, taking everything into consideration, do get clinically
observable adverse effects certainly at 4 ppm or above. There are
plenty of papers." To this Herta Spencer, M.D., Hines (Ill)
VA Hospital, objected: "I don't believe we can compare a report
in India, which is a tropical country where you don't know how much
water you take in, where the nutritional status is very poor . .
. to the high-fluoride areas in this country." Dr. Smith: "I
think you are going to find some populations of that sort in this
country, too." Dr. Spencer: "Then we should see more pathological
indications of myelopathy and fluorosis in this country. Why don't
we see it in the areas of 4 ppm?"
"I think that you have to conclude that we haven't looked
for it and we really don't know," summarized Dr. Shapiro. It
is estimated that 184,000 Americans are drinking water that contains
more than 4 ppm fluoride.
Moving on to osteosclerosis and its pathologic significance, Dr.
Kleerekoper announced: "I don't know whether there is a component
of the crippling fluorosis that is related to osteosclerosis."
Dr. Wallach: "If you don't know, that makes it potential."
Dr. Shapiro: "That is the point. You don't really know what
is happening. I think it is reasonable to leave it as a potential
At another point, however, David W. Rowe, M.D., then a pediatrician
at the University of Connecticut Health Center, Farmington, remarked:
"If it were my daughter, I would be concerned. We can say all
of those things, but when you see a change occurring in the bones
that we don't know what its implications are, but it is clearly
recognized as two standard deviations from the norm . . . "
Suggested Dr. Shapiro: "Let's just say, because we really
don't have the information to come off of this, that osteosclerosis
occurs and we really don't know whether it is potentially adverse
or not. We don't have the data."
Dr. Marx: "But we can still vote on it. That is what we are
here for." By restricting the definition of osteosclerosis
to a radio-dense skeleton, the committee was able to agree that
osteosclerosis was not an adverse health effect.
The members were, however, concerned about the possible effects
of osteosclerosis on skeletal development in children and young
adults. Important, then, was the question: At what levels of fluoride
in drinking water did osteosclerosis begin to occur? Referring to
levels of 2-3 ppm, Dr. Kleerekoper, a bone specialist, acknowledged:
"There is just no information as to what the bone looks like
at that point."
Moderate dental fluorosis, however, has been observed to occur
in a small percentage of individuals drinking water with 2-3 ppm
fluoride. Was the presence of dental fluorosis therefore an indicator
that bone changes were present? The discussion was summarized by
Robert Marcus, M.D., then with the Palo Alto (Calif.) VA Medical
Center: "I think it is fairly close to unanimous that we all
agree that dental fluorosis, in fact, has medical ramifications.
Almost everybody agreed on that. Not knowing where bone disease
begins at any age, what you are saying is that if there is something
going on in the teeth, then the likelihood is that there is something
going on in the bones. You don't know that it is there; you don't
know that it is not there." The fluoride levels of
possible health significance, then, were quite low. At one point
Dr. Shapiro asked, "You have some data on a town in Texas where
there were some children with rather severe fluorosis with a level
of something like 1.2 in the drinking water. Is that true?"
Dr. Smith: "I think that is correct."
'Rocks in Your Head'
The panel therefore debated whether the permissible level for children
should be lower than the one it had already set for adults - 4 ppm.
A proposed level of 2 ppm would be indicated, moderated Dr. Shapiro,
"if one seriously believes going above that and allowing children
to take in 4 ppm would be compromising their health. Unfortunately,
we don't have the answer one way or another." Dr. Kleerekoper
was able to magnify the uncertainty: "From all the available
data, we can't state that there is no apparent adverse health effect
on a water fluoride level of 2 ppm or below." Finally, Dr.
Wallach clarified the committee's thinking with this observation:
"You would have to have rocks in your head, in my opinion,
to allow your child much more than 2 ppm." Dr. Rowe: "I
think we all agree on that."
The committee thereupon plunged back into the unknown with a debate
over what the cutoff age for the 2-ppm limit should be. Dr. Kleerekoper
strove to delimit the magnitude of the mystery: "If you are
talking about potential toxicity, we have no idea whether it is
18 or puberty. We had no idea." Dr. Marcus offered: "My
own feeling would be that I would go to nine, since this is the
best information you have, at least as far as teeth are concerned,
but I would make it very, very clear that we know nothing about
this issue and maybe it should be 14, maybe it should be 18."
Later, Dr. Kleerekoper attempted to forge a consensus: "I think
everybody is in agreement, including the dental aspects, that, after
age nine, 4 ppm is without harm, both observed or even potential."
But Bess Dawson Hughes, M.D., USDA Human Nutrition Research Center,
Boston, countered: "No, I am not in agreement with that. I
am not sure a 10-year-old is going to have no harm from 4 ppm. I
am not sure what it is going to do to their bone turnover rate and
to the concerns that have been expressed here."
Vote time was announced by Dr. Shapiro: "All right. How many
people feel that 18 - picking that one out of the air - is a more
appropriate age to run the [2 ppm] up to than nine?" The first
vote was Dr. Wallach's: "I know I mentioned every age under
the sun. I guess I will settle with a recommendation for 18."
Split down the middle, the committee voted 5-4 for age nine.
Following the meeting, the committee apparently became uncertain
even about its own uncertainty: it eviscerated its recommendations
and conclusions and vouched unequivocally for the safety of fluoride
levels of 4 ppm.
Voluntary Regulation Urged
On April 27, 1985, Douglas H. Ginsburg, then Office of Management
and Budget administrator for the Office of Information and Regulatory
Affairs, sent an internal memo to EPA administrator Lee Thomas.
The memo (MT, Aug 7, 1985) not only supported increasing the standard
but also urged EPA to consider a voluntary, rather than mandatory,
regulation. The memo cited estimates that a mandatory regulation
could cost the federal government $5 million a year to administer,
yet would affect a minority of the populace. The memo questioned
why EPA would "impose burdens or costs on everyone in order
to deal with a few."
[See photocopy of article]
April 27, 1989
Fluoride Report Softened
by Joel Griffiths
In his opening remarks to the U.S. Surgeon General's ad-hoc committee
on the health effects of fluoride, Robert Mecklenburgh, D.D.S.,
then Chief Dental Officer, U.S. Public Health Service, stated: "There
isn't any group in the U.S. better qualified to come up with a recommendation
than the group that is around this table today. It would be hard
to refute or overwhelm what this committee in its judgement decides."
Indeed, it did require a group with equally high qualifications
to refute and overwhelm the committee's decisions - namely, the
committee itself. Between the draft report that was circulated among
members for review and the final report that was presented to the
Surgeon General C. Everett Koop, M.D., the committee's most significant
conclusions and recommendations were eviscerated.
For example, the draft
report stated: "The committee concluded that the fluoride
content of drinking water should be [emphasis added] no
greater than . . . 1.4-2.4 ppm for children up to and including
age 9 ... because of a lack of information regarding fluoride effect
on the skeleton in children (to age 9) over 3 ppm, and potential
cardiotoxic effects at that level." (Ingested fluoride forms
calcified deposits in the aorta, the report noted.) As for dental
fluorosis, "There was a consensus that mottling or pitting
of teeth could represent as yet unknown skeletal effects in children
and that severe dental fluorosis per se constitutes an adverse health
effect that should be prevented." Additionally, the draft noted
that "there was some sentiment (especially among the pediatricians)
in the committee that the age limit for children ... should be as
high as 18 years because of continued rapid bone development between
ages 8 and 18."
This draft version accurately reflects the votes and conclusions
of the committee, as documented in the transcript
of its meeting. But in the final
report that was sent to the Surgeon General, the recommendation
has been changed to read: "It is inadvisable [emphasis
added] for the fluoride content of drinking water to be greater
than ... 1.4-2.4 ppm for children up to age 9." This phrasing
made the recommendation optional.
Moreover, the only reason given in the final report for even suggesting
a lower level for children was "in order to avoid the uncosmetic
[emphasis added] effects of dental fluorosis." Vanished
from the conclusions were the committee's concerns about skeletal
and cardiotoxic effects over 3 ppm, its consensus that dental fluorosis
was an adverse health effect, and the sentiment for a higher cutoff
In their place was this statement: "There exists no directly
applicable scientific documentation of adverse medical effects at
levels of fluoride below 8 mg/l (ppm). Therefore, it can be concluded
that four times optimum in U.S. drinking water supplies [2.4-4.8
ppm] is a level that would provide 'no known or anticipated adverse
effect with a margin of safety.'"
The committee chairman, Jay R. Shapiro, M.D., declined to comment
on these disparities.
In a January 1984 letter to the Environmental Protection Agency
(EPA, which had requested the review). Surgeon General Koop set
forth his summary conclusions based on the committee's final report:
"My  recommendations about the advisability of limiting
fluoride concentrations to twice the optimum [1.4-2.4 ppm] in order
to avoid unsightly dental fluorosis still pertain. At the same time,
based on current scientific evidence, there is essentially no likelihood
of even non-adverse medical effects where drinking water supplies
contain up to four times the optimum [2.4-4.8 ppm] concentration
These two sentences constituted the sole residual force of the
committee's original recommendations and conclusions. Subsequently,
EPA raised the permissible level of fluoride in drinking water to
4 ppm for all members of the population, according to Joseph Cotruvo,
Ph.D., director of the Criteria and Standards Division, Office of
Drinking Water, EPA.