"We believe that EPA staff and managers should be called to testify, along with members of the 1983 Surgeon Generals panel and officials of the Department of Human Services, to explain how the original recommendations of the Surgeon Generals panel were altered to allow EPA to set otherwise unjustifiable drinking water standards for fluoride."

The following three articles, published in April 1989 by the Medical Tribune and December 1990 by The Progressive, document the altered recommendations of the Surgeon General's panel to which Hirzy refers.

MEDICAL TRIBUNE

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 age.

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 [1982] 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 of fluoride."

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.

MEDICAL TRIBUNE

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 a safe 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 safety."

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 adverse effect."

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."

Skeletal Effects?

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."

Excerpt from:

FLUORIDE'S REVENGE
Has this cure, too, become a disease?

by Daniel Grossman

(See full article)

The EPA issued a regulation to protect the public from dental fluorosis in 1977, under authority of the then newly enacted Safe Drinking Water Act. The rule prohibited public water suppliers from distributing water with more than two ppm of fluoride, though the deadline for compliance extended until 1984. As the deadline neared, however, none of the offending suppliers moved to comply, since defluoridation equipment costs hundreds of thousands of dollars. Instead, EPA came under increasing pressure to reexamine the rule. The regulation was a temporary standard, promulgated hastily with the expectation that the agency would later issue a permanent rule based on further deliberations.

EPA staff scientists were convinced of the need to prevent fluorosis. "This was the only contaminant up to this time that we knew had a human health effect," recalls David Schnare, an EPA drinking water analyst. Other drinking-water contaminants, he explains, were recognized by the results of animal studies only.

Nevertheless, EPA was besieged by petitions from state governors and dental officials to weaken the standard or, better yet, replace the legally binding regulation with a less burdensome, voluntary standard. But voluntary standards are typically ignored.

Dental and other public-health officials opposed the binding rule because they feared EPA would encourage the antifluoridation camp and hinder the ongoing effort to fluoridate the entire country. EPA's plans to regulate fluoride, said John Daniel, a dental official in South Carolina, "served only to stimulate ardent antifluoridationists in their fanatic quest to associate fluoride with every disease and unpleasantness known to mankind."

But many members of the medical community are cautiously beginning to question forty years of doctrinaire advocacy of fluoridation. Even Public Health Service officials are noting today that fluoride may not be as effective as they once claimed. "Perhaps we have been too much the crusaders," says Canadian dental official Alan Gray in calling on his colleagues to reconsider the benefits of fluoridation.

State governments opposed the binding regulation for another reason: because defluoridation is expensive and therefore politically unpalatable. According to EPA estimates, for instance, a typical family in a community that installed defluoridation equipment could expect an increase in its water bill of between $20 and $100 annually.

Though the Public Health Service has long been the chief Federal advocate of fluoridation -- and therefore a less-than-neutral judge -- EPA in 1981 asked Surgeon General C. Everett Koop, a Public Health Service leader, to convene a panel to advise the agency on the relationship between fluoride in drinking water and dental fluorosis. It was an unusual step; according to Joseph Cotruvo, the EPA official directly responsible for drinking-water standards, EPA had never before asked the Surgeon General to conduct such a review of a chemical, nor has it since.

Koop's office assembled a committee of dental researchers in various branches of the Service. Completed in 1982, their report concluded that dental fluorosis, though "cosmetically objectionable," is not a health hazard. Summarizing the report, Koop wrote to EPA: "No sound evidence exists which shows that drinking water...in the U.S. has an adverse effect on dental health."

Public Health Service documents verify that the wording of Koop's letter was intended to hinder EPA plans to set a binding fluoride standard. Unless EPA demonstrates that a contaminant has a "health effect," the agency cannot legally set a binding standard.

"If we send this letter," Koop explained in a memo to Edward Brandt, his superior in the Public Health Service, "it means that [EPA] would not be able to publish [binding] drinking-water regulations." Then he advised, "I think we should go with this letter, in spite of the fact that EPA will not like our response."

Still eager to demonstrate the need to regulate fluoride, the EPA asked the Surgeon General to assemble another panel in 1983, this time to consider the nondental effects of fluoride. A transcript of the panel's two-day meeting shows that, despite its nondental mandate, the panel was especially disturbed by what it learned about dental fluorosis. "You would have to have rocks in your head to allow your child much more than two parts per million," said Stanley Wallach, then medical-service chief of the Veterans Administration Medical Center in Albany, New York.

In the final draft of its report, panel chair Jay Shapiro concluded, "There was a consensus that... dental fluorosis per se constitutes an adverse health effect that should be prevented." Shapiro wrote a memo warning that "because the report deals with sensitive political issues which may or may not be acceptable to the PHS, it runs the risk of being modified at a higher level or returned for modification." He attached the memo to his draft and sent them on to John Small, a Public Health Service official. Small, in turn, forwarded the draft to Koop.

The final report, which Koop sent the EPA a month later, included none of the Shapiro draft's conclusions about dental fluorosis. Instead, it concluded that it was "inadvisable" for children to drink water containing high levels of fluoride to prevent the "uncosmetic effect" of dental fluorosis. Koop had again foiled EPA by repeating his conclusion that dental fluorosis is not an "adverse health effect."

When contacted recently, members of the panel assembled by the Public Health Service expressed surprise at their report's conclusions; they never received copies of the final--altered--version. EPA scientist Edward Ohanian, who observed the panel's deliberations, recalled being "baffled" when the agency received its report. But, he added, "it's what they give us in writing that counts."

But William Ruckelshaus, then the administrator of EPA, wanted to set a binding standard to prevent dental fluorosis, so EPA tried one more time. In 1984, Ruckelshaus asked the National Institute of Mental Health to assemble a panel to examine the psychological effects of dental fluorosis. This time the request was submitted directly to NIMH rather than through the office of the Surgeon General.

Although there was no body of research on the psychological effects of dental fluorosis per se, the panel was guided by numerous studies of facial attractiveness and the behavioral impacts of other dental impairments, such as cleft lip and palate. Panel members were also impressed by photographs they were shown of the teeth of people suffering from severe dental fluorosis. They concluded that people with moderate or severe cases risked "psychological and behavioral problems or difficulties."

EPA staff members were pleased with the results of this study. "The staff response was: Here is our silver bullet," says Paul Price, then an analyst working on the standard. He recalls that the staff was vacillating between recommending a standard of one ppm or two PPM, to prevent the psychological effects of dental fluorosis.

Ruckelshaus was shown a set of pictures of dental fluorosis at a high-level meeting in July 1984, recalls drinking-water analyst Schnare. Ruckelshaus's comment: "That's an adverse health effect." But he stepped down as EPA administrator in January 1985 and was replaced by Lee Thomas, a man less sympathetic to staff concerns about dental fluorosis.

Recent interviews confirm that the staff was preparing at the time to recommend that Thomas issue a one-PPM standard. "It is legally and scientifically indefensible to set the [standard] at a level other than optimum (e.g., 1 PPM)," reads the draft of a memo prepared for Thomas's approval.

A handwritten note scribbled on this draft, however, says a higher-level office, controlled not by staff scientists but by political appointees, preferred a binding standard of four PPM, justified by the threat of skeletal fluorosis, another effect of fluoride, but a much less common one. The note added, "And they have the final say!"

The final draft, completed a few weeks later, concluded that dental fluorosis is merely a "cosmetic effect" and recommends a binding standard of four PPM, and a voluntary one of two PPM When issued six months later, the standard followed this recommendation.

One drinking-water official believes Thomas succumbed to pressure. A native of South Carolina, a state abundantly endowed with fluoride-rich water, Thomas listened not to his staff but to Republican Senator Strom Thurmond, a relentless opponent of the fluoride standard. Edward Groth of the Consumers Union, who wrote a doctoral dissertation on the fluoridation controversy, surmises that Thomas took "the path of least resistance" in following the lead of the Surgeon General.

The technical staff was "devastated" at the decision to go with a standard of four PPM instead of one, according to Paul Price, who managed the writing of the standard and its official justification issued by the EPA. But, he says, once the decision was made, "there were arguments that could be made to justify it."

Price calls the struggle over fluoride regulation "a clash of two different cultures." The Public Health Service, he says, was guided by a 1950s-era attitude that health problems are solved with medication and that doctors know best; anyone questioning this is a crackpot. The Environmental Protection Agency, in contrast, works on the principle -- and is staffed with scientists who believe -- that nothing should be allowed in drinking water unless its safety can be proven. This conviction dictates stringent regulations justified by conservative analyses with ample margins of safety. In the case of fluoride, these two philosophies collide.