Yesterday, Harvard University released the results of its 13-month investigation into whether one of its Dental Professors (Dr. Chester Douglass) had suppressed evidence linking fluoride to osteosarcoma (a form of bone cancer) in children.

While it was widely suspected that Harvard would exonerate Douglas (a few months ago he was filmed holding a copy of the draft report claiming that he had been exonerated), 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 "Douglass 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 Douglass 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 Douglass 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 that the public will have access to, 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 Douglass' $1.3 million study – not have a right to know more about whether Douglass 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 young children.

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.

The Case Against Douglass

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 Douglass 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 Douglass 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, Douglass 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 Douglass’ only conflict of interest. Douglass, who has been a long-time proponent of water fluoridation, is the Chairman of the Board of Trustees for the Delta Dental Foundation of Massachusetts, an organization that -- along with its other state affiliates -- 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.

Is it reasonable to believe these associations with pro-fluoride organizations could make it more difficult for Douglass to report a linkage between fluoridation and childhood bone cancer?

As noted by Douglass:

“Linkage of fluoride ingestion and cancer initiation could result in a large-scale defluoridation of municipal water systems under the Delaney clause. (One aspect of this clause prevents the addition of carcinogenic agents to the nation’s water supply.)”

B) Evidence of Douglass’ Bias

Over the past year, FAN has identified several documents where Douglass’ 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, Douglass 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, Douglass 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, Douglass submitted his proposal to NIH to do a more comprehensive study of fluoride/osteosarcoma. In his proposal, Douglass 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, Douglass had obtained evidence indicating that the odds ratio for getting osteosarcoma was higher (although not significantly so) in fluoridated areas. Douglass, 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 Douglass 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: Douglass’ 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. (Douglass' graduate student, Elise Bassin, conducted her analysis on Douglass' first study.) The following discussion focuses on Douglass' first study.

1995: Douglass 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 Douglass 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, Douglass 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, Douglass 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 since 1995 (in March 1998 & November 2002), Douglass summarized his first study as showing a LOWER Odds Ratio for osteosarcoma in fluoridated areas. (Douglass has yet to actually publish a full paper on this study - despite having completed it 11 years ago.)

As noted above, Douglass 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: Douglass 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 Douglass 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, Douglass' 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. Douglass reviewed and approved Bassin's analysis, and in 2001 the University awarded her a PhD for her work.

2002: Just one year after approving Bassin's thesis, Douglass summarized the results of the first study as showing a LOWER odds ratio for osteosarcoma in fluoridated areas. He did not mention Bassin's findings or his 1995 analysis which found higher Odds Ratios in the fluoridated areas.

Douglass gave this presentation before the British Fluoridation Society (BFS). According to a BFS report, Douglas presented findings which "showed no association between fluoridation and osteosarcoma" in both his first and second studies.

January 2004: In a submission to the National Research Council, Douglass 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, Douglass made no mention of Bassin's findings and that they contradicted his assertions.

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, Douglass failed to present all the facts.

March 2004: In his Final Report to the NIH, Douglass again summarized the results of his first study as showing no significant association between fluoridation and osteosarcoma. As with his report to NRC, Douglass 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 such an important issue as a possible connection between water fluoridation and osteosarcoma?

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 ?

2) Why did Douglass 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?

3) Why was the NIH willing to tolerate a situation where Chester Douglass 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 Douglass 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 Douglass’ 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, or to the public that ultimately funded this work. It isn’t even fair to Douglass 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 Douglass 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 we can get the report of the Douglass investigation made public, please contact us at: paul@fluoridealert.org

-- Paul & Michael Connett, FAN

On the Web:

- Harvard Statement
- Environmental Working Group's Response to Harvard Statement
- FOX News: Is Harvard Professor Hiding a Link?