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THE FLUORIDE ACTION NETWORK

FAN Bulletin 654: A Harvard Whitewash?

Aug 16, 2006

Dear All,

First let me welcome new recipients of the FAN bulletins who come to

us via their support of the Online letter to the EPA on sulfuryl

fluoride. I will try not to overload you and others with too many

bulletins, although at a time when so many developments are taking

place on the fluoride front, it is a little difficult not to do so.

Harvard Releases Statement on s Investigation

Yesterday, Harvard University released the results of its 13-month

investigation into whether one of its Dental Professors (Dr. Chester

s) had suppressed evidence linking fluoride to osteosarcoma

(a form of bone cancer) in children.

While it was widely suspected that Harvard would exonerate s

(a few months ago he was filmed holding a copy of the draft report

claiming that he had been exonerated, see:

http://www.ewg.org/news/video.php?id=5065 ), it came as a disturbing

surprise to see the extreme brevity of Harvard's statement. The full

statement, which is just 4 paragraphs long, says that " s did

not intentionally omit, misrepresent, or suppress research

findings. " However, it provides no explanation to justify the basis

of this conclusion.

Thus, after 13 months and an investigation by two committees,

Harvard has yet to explain why s first concealed, and then

misrepresented, his doctoral student's thesis which found a " robust "

association between fluoridated water and osteosarcoma in young

males. In particular, Harvard has failed to explain why s

misrepresented this data in a submission made - in writing - to a

National Academies of Science committee convened to study the

toxicity of fluoride (see details below).

Based on communications with the Harvard Press Office, it appears

that Harvard will be keeping its Final Report of the

investigation " confidential. " Thus, the only information to which

the public will have access, is the information contained in the

short 4-paragraph statement. While this may be legal, is it truly

the best that Harvard can muster?

Does the public - which funded Chester s' $1.3 million study -

not have a right to know more about whether s has been an

honest steward on this matter? After all, we're not talking about a

trivial academic issue. We're talking about an issue of life and

death, about whether a chemical added to 170 million Americans'

water supply is causing a fatal bone cancer in boys and young men.

Particularly disturbing about this " investigation " is the failure of

Harvard to actually contact the Environmental Working Group (EWG),

which brought the ethics charge, to ask them to provide either their

detailed evidence or their direct testimony on the matter.

Both Harvard's statement, and EWG's response, are printed out below.

The Case Against s

Without knowing how Harvard reached its conclusion, let us look at

some of the facts in the case. (Some of these facts have been

discovered subsequent to Environmental Working Group's issuance of

the ethics complaint in June 2005. Hence, the case against s

has actually become stronger since the original complaint was

issued. However, because the Harvard investigating committees never

contacted EWG or FAN during its 13- month investigation, we have no

way of knowing whether any of this new information was considered by

the Harvard committees.)

A) Conflicts of Interest

Before discussing how s represented, or mis-represented, his

research, it is important - as with all medical research - to

determine whether he has any potential conflicts of interest which

could color his interpretation on the question of whether fluoride

causes osteosarcoma in children.

In addition to being a professor of Dentistry at the Harvard School

of Dental Medicine, s also serves as Editor of

COLGATE's " Oral Care Report. " Colgate is one of the world's largest

manufacturers of fluoride toothpaste. If fluoride were found to

cause osteosarcoma in children, the potential for legal litigation

against Colgate would exist not only in the US, but in many other

countries as well.

Colgate, however, is not s' only conflict of interest.

s, who has been a long-time proponent of water fluoridation,

is the Chairman of the Board of Trustees for Massachusetts' Delta

Dental, an organization that actively promotes, and funds, water

fluoridation programs across the US. In California and Washington

State, Delta Dental has spent hundreds of thousands of dollars

lobbying for, and funding, water fluoridation programs in recent

years. In Massachusetts, Delta Dental has a webpage devoted to its

promotion of " fluoride programs " , including:

* Providing HeadStart Programs with fluoride tablets.

* Funding fluoride mouth-rinse programs to school systems in

towns with non-fluoridated water.

* Advocating fluoridated water to cities and towns that don't

have it.

See: http://www.deltamass.com/fluoride/

Is it reasonable to believe that these associations with pro-

fluoride organizations could make it more difficult for s to

report a linkage between fluoridation and childhood bone cancer?

Evidence of s' Bias

Over the past year, FAN has identified several documents where

s' bias is evident in his research on fluoride and

osteosarcoma. For example:

In April 1991, following a government-funded animal study reported

increased rates of bone tumors in fluoride-treated rats, s co-

authored a small pilot study on fluoride exposure and osteosarcoma

in humans. The study, published in the Journal of the American

Dental Association, did not find evidence of a fluoride-osteosarcoma

link, but was too small and limited to answer the question.

Nonetheless, s and the co-authors concluded the paper by

urging the promotion of more fluoridation programs. To quote:

" Given present knowledge, every effort should be made to continue

the practice of fluoridating water supplies. "

In 1992, s submitted his proposal to NIH to do a more

comprehensive study of fluoride/osteosarcoma. In his proposal,

s expressed his concern about the negative effects on

fluoridation policy if fluoride were found to cause osteosarcoma. To

quote:

" We will test the primary hypothesis that higher fluoride exposure

is associated with the risk of osteosarcoma. An incorrect inference

implicating systemic fluoride carcinogenicity and its removal from

our water systems under the EPA Delaney clause would have

significant oral health consequences for most Americans,

particularly those who cannot afford to pay for increasingly

expensive restorative dental care. "

By 1997, s had obtained evidence indicating that the odds

ratio for getting osteosarcoma was higher (although not

significantly so) in fluoridated areas. s, who has never

publicly published this information, expressed his concern of

stating that the odds ratios of getting osteosarcoma are higher in

fluoridated areas, even if the odds ratios aren't significant

statistically. To quote:

" Because of the importance of the question at hand, we think the

policy implications of reporting that the relative risk maybe higher

than 1.5 would have consequences for fluoridation health policies. "

Why should it have mattered to s how his findings would

affect fluoridation policy? Isn't his job as a scientist to simply

investigate and report his findings, regardless of the consequences?

C) Misrepresenting the data? A Chronology

NOTE: s' research on fluoride and osteosarcoma comprises two

separate studies. The first study -- a " retrospective study " -- was

initiated in 1992 and completed by 1995, while the second study --

a " prospective study " -- remains ongoing to this day. (s'

graduate student, Elise Bassin, conducted her analysis on s'

first study.) The following discussion focuses on s' first

study.

1995: s had evidence indicating that the Odds Ratio (OR) of

developing osteosarcoma was higher in the fluoridated areas.

This fact can be gleaned from the heavily redacted Final Progress

Report that s submitted to the NIH in 1995. (FAN received

this document in May 2006 after requesting it under the Freedom of

Information Act).

In this 1995 Report, s states:

" The importance of the prospective study is further magnified if one

considers point estimates of OR (Odds Ratio) using the assumption of

[redacted] ppm fluoride in bottled water. All of those analyses have

point estimates of the OR that are greater than [redacted]. However,

all confidence intervals include [redacted]. "

1995-2005: Up until the Environmental Working Group issued its

ethics complaint, s had never publicly disclosed evidence

showing Odds Ratios for osteosarcoma to be higher in fluoridated

areas.

In fact, in 2 of his 3 public presentations between 1995 and 2004,

s summarized his first study as showing a LOWER Odds Ratio

for osteosarcoma in fluoridated areas. (s has yet to actually

publish a full paper on this study - despite having completed it 11

years ago.)

(As noted above, s expressed awareness and concern about the

policy ramifications of reporting that the Odds Ratio for

osteosarcoma may be higher in fluoridated areas - even if the Odds

Ratio isn't statistically significant.)

1998: s acknowledged the importance of specifically

investigating the relationship between fluoridation, osteosarcoma

and growth spurts before dismissing the relationship between

fluoride and osteosarcoma.

According to a 1998 presentation s gave before the American

and European Musculoskeletal Tumor Society:

" specific analysis of Fluoride ingestion during the childhood growth

spurt periods will further test the consistency of reported

findings. "

In the late 1990s, s' graduate student, Elise Bassin,

conducted an analysis on the relationship between fluoridation,

growth spurts, and osteosarcoma. In so doing, Bassin found

a " remarkably robust " association between fluoridation and

osteosarcoma in boys. s reviewed and approved Bassin's

analysis, and in 2001 she was awarded a PhD for this work.

2002: Just one year after approving Bassin's thesis, s

summarized the results of the first study as showing a LOWER odds

ratio for osteosarcoma in fluoridatd areas. He did not mention

Bassin's findings or his (unpublished) 1995 analysis which found

higher Odds Ratios in the fluoridated areas.

s gave this presentation before the British Fluoridation

Society (BFS). According to a BFS report, presented findings

which " showed no association between fluoridation and osteosarcoma "

in both his first and second studies.

January 2004: In a submission to a panel of the National Research

Council (NRC), s summarized his first study as showing no

significant association between fluoridation and osteosarcoma.

Although he cited Bassin's study as one of the 2 supporting

references for his summary, s made no mention of her findings

and that they contradicted the assertions he was making to the NRC.

This omission was particularly serious as the NRC committee was in

the final stages of its report on the toxicity of fluoride. At this

pivotal moment, s failed to present all the facts.

s' submission to the NRC was a draft copy of his Final Report

to NIH. s submitted a slightly revised Final Report to NIH

two months later, in March 2004.

March 2004: In his Final Report to his funders at the NIH, s

again summarized the results of his first study as showing no

significant association between fluoridation and osteosarcoma. As

with his report to NRC, s referenced Bassin's thesis without

mentioning the fact that her findings contradicted his summary.

Was the NIH a willing accomplice?

1) Why was a researcher at a dental school put in charge of

government funded research on a such an important issue as a

possible connection between water fluoridation and osteosarcoma?

2) Bearing in mind the avid support dental schools give to

fluoridation, was not the NIH naively ignoring a potential conflict

of interest, since if a relationship between fluoridation and

osteosarcoma was found it would end water fluoridation overnight?

3) Why did s feel comfortable expressing his concern to NIH

(in January 1997) about the adverse political implications to

fluoridation of reporting higher rates of osteosarcoma in

fluoridated areas?

4) Why was the NIH willing to tolerate a situation where Chester

s received over $1 million in funding for this research, but

in 13 years only produced a single abstract? This abstract, which

claimed no relationship between fluoridation and osteosarcoma, was

published in 1995, and has not yielded a published paper after

another 11 years of government funding!

Did Harvard do an Honest Job?

As noted above, without having access to Harvard's final report,

there is no way of knowing how they reached the conclusion that

s did not misrepresent his research on fluoride and

osteosarcoma.

A few things, however, make us wonder about the integrity of the

Harvard review.

First, the investigating panel didn't even contact EWG - who brought

the complaint - to provide all the evidence they had on this matter.

If this were a court case, this would be akin to disallowing one

side from ever taking the witness stand!

Second, while it may be legal for Harvard to keep their report

confidential, why not release to the public their explanation for

s' behavior? Surely there would be nothing to lose in issuing

a sound, water-tight explanation to the public?

Harvard's failure to release even a basic explanation is neither

fair to Bassin, nor to the public that ultimately funded this work.

It isn't even fair to s himself. For, without a cogent

explanation, the assumption will be made by many that this has been

a Harvard " whitewash. "

How you can help

We are not giving up on this until we have heard a credible

explanation as to why s concealed Bassin's thesis from his

peers and his funders, even while he was claiming the very opposite

to what she had found. Thus, we would like to hear from any one who

is, or knows someone who is, a graduate of one of Harvard's schools,

or is, or knows someone who is, a big financial donor to the

University.

If you can help or have any ideas about how to get a cogent

explanation out of Harvard on this matter, please contact us at

.

& Connett

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http://web.med.harvard.edu/sites/RELEASES/html/8_15s.html

HARVARD STATEMENT (August 15, 2006)

STATEMENT CONCERNING THE OUTCOME OF THE REVIEW INTO ALLEGATIONS OF

RESEARCH MISCONDUCT

INVOLVING FLUORIDE RESEARCH

BOSTON-August 15, 2006-The Harvard Medical School and School of

Dental Medicine (HSDM) review of Chester s, DMD, PhD,

professor of oral health policy and epidemiology at HSDM, has

concluded that s did not intentionally omit, misrepresent, or

suppress research findings of a graduate student surrounding federal

grant work looking at potential links between fluoride in drinking

water and osteosarcoma, a form of bone cancer.

An Inquiry Panel and the Standing Committee on Faculty Conduct, both

comprised of senior faculty from a range of fields, each conducted

reviews and found that s did not commit research misconduct.

The committees did not examine and took no position on the question

of whether or not there is a correlation between fluoride in

drinking water and ostesarcoma.

The U.S. Department of Health and Human Service's Office for

Research Integrity (ORI) has oversight authority for misconduct

reviews and processes that govern the handling of inquiries. The ORI

has reviewed the record from the Harvard inquiry and has determined

that further investigation is not warranted.

The review also looked at whether or not s violated school

and federal conflict of interest guidelines by serving as editor of

the quarterly newsletter The Colgate Oral Care Report. The two

review groups found that s's editorship of the newsletter did

not constitute a conflict of interest under school and federal

guidelines.

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http://www.ewg.org/issues/fluoride/20060816/index.php

EWG Response (August 16, 2006)

For Immediate Release: August 16, 2006

Contact: Sucher, EWG,

Connett, FAN,

Harvard: Prof Did Not " Intentionally " Suppress Fluoride-Cancer Study

Data in Question Show Strong Link Between Fluoride and Bone Cancer

in Boys

(WASHINGTON, Aug. 16) - A closed-door Harvard University panel said

yesterday that professor Chester s " did not intentionally

omit, misrepresent or suppress research results " of a fluoride bone

cancer study. But Environmental Working Group (EWG), whose questions

triggered the investigation, said the panel's brief statement

sidestepped the question of whether s did in fact omit,

misrepresent, or suppress critical data that show a strong link

between bone cancer in adolescent boys and fluoride in tap water.

The panel's announcement came in the form of a four-paragraph

statement. The panel's report, like the proceeding that produced it,

is secret and not available to the public.

The data in question, which have since been published in a peer-

reviewed journal by four Harvard professors and PhDs, strongly rebut

s's position and reveal a highly significant relationship

between bone cancer in boys and fluoride in tap water.

" This excuse is so tortured, you can see why it took a bunch of

Harvard professors a year to concoct it. Are we to believe that Dr.

s somehow forgot about the results of research that he signed-

off on, that completely contradicted what he'd told taxpayers and

public officials about bone cancer in boys and drinking fluoridated

water? " said Wiles, Senior Vice President of EWG.

" Whether or not Dr. s intentionally suppressed and

misrepresented these data is irrelevant, " said Wiles. " He deceived

the public and health officials about critical research findings for

years, and hundreds of boys suffered the consequences. "

The Harvard panel also brushed aside a clear conflict on interest

stemming from the fact that s is a paid consultant for the

toothpaste industry, a major user of fluoride. " It is a sad day for

Harvard when such a blatant financial conflict of interest is

acceptable, particularly when the health of children is at stake, "

said Wiles.

Environmental Working Group, which brought the issue to light, was

never contacted by the Harvard panel.

###

The Environmental Working Group is a nonprofit research group based

in Washington, DC that uses the power of information to protect

public health and the environment. The Group's research on fluoride

is available online at

http://www.ewg.org/issues/siteindex/issues.php?issueid=5031 . A

Boston Fox-TV story showing Harvard's Dr. s waving a draft

copy of the University's report on his conduct is viewable online at

http://www.ewg.org/news/video.php?id=5065.

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