Douglass Attempts To Downplay Bassin

FAN Bulletin #552

April 5, 2000

Dear All,
 
After I circulated the last bulletin and after FAN had circulated our press release on the Bassin article, we discovered that in the same issue of the journal Cancer Causes and Control, Chester Douglass had submitted a 2-page letter to the Editor attempting to downplay Bassin’s findings. We have printed this in full below.
 
However, Douglass seems to be digging himself a deeper and deeper hole on this. He says that:

 

“We are also finding some positive associations between fluoride and osteosarcoma in the overall (not age specific) analysis of the first set of cases.”

 

Why has he never mentioned this before? Why didn’t he mention this in his 1995 abstract - the only thing he has published himself on this multi-million dollar project? Why didn’t he mention this in his presention to the British Fluoridation Society in 2002? Why didn’t he mention this in his report to his funders at NIEHS in 2003? Why didn’t he mention this in his report to the NRC panel in 2004? In all these he said that he had found NO asscoiation between fluoridation and osteosarcoma?
 
And of course, he is yet to explain why he did not mention Bassin’s thesis to the British Fluoridation Society, to the NIEHS and to the NRC. Was this because he thought her work was not up to par? No. In the Boston Fox TV interview, as EWG has pointed out:
 

“Douglass had nothing but praise for the work. ‘She did a good job. She had a good group of people advising her. And it’s a nice - it’s a nice analysis. There’s nothing wrong with that analysis,’ he said.”

 

As far as the rest of the arguments he presents in his letter, we asked Chris Neurath to do a quick review. Here are his preliminary thoughts:

 

The study or studies which Douglass discusses were originally planned to last for 4 years beginning in 1992. They were in direct response to the NTP rat studies, the Hoover 1991 and Cohn 1992 studies, all of which found an association between fluoride for males, especially young male humans. The funding grants have been extended and renewed until the present date, a length of 15 years, or 10 years beyond the initial planned conclusion date. Douglass has been Principle Investigator for most of that time. To date, he has only published the short 1995 abstract http://www.fluoridealert.org/images/douglass-1995.gif with it’s flawed analysis methods (an analysis which focused only on the average F level of all cases versus controls negates the entire point of conducting a case-control study).

 

No one else associated with this 15 year project has ever published anything until today with Bassin in this issue of Cancer Causes and Control.

 

FAN had to resort to a Freedom of Information Request to try to obtain any interim reports of other progress updates for this 15 year project. Even after almost a year, no reports from this project have been forthcoming under our FOIA request. In fact, FAN would not have known of the existence of Bassin’s work except that Douglass submitted a “Final Report” to the NRC committee reviewing the toxicology of fluoride in late 2004. In that report, Douglass listed Bassin’s thesis as a reference, but in the text of the report claimed that the study had found no evidence of an association between fluoride and osteosarcoma.

 

This misleading information about his government funded study was the basis for a charge of scientific fraud by EWG which is still being investigated by Harvard University. The investigation has gone on for almost 9 months and EWG has not once been contacted by Harvard either to provide any evidence or to update them on the progress of the investigation. Over a month ago a local investigative journalist in Boston interviewed Dr. Douglass and Douglass said he had just come from a meeting with Harvard lawyers where it had been decided to “give them all the reports from the FOIA request”. As FAN was the first party to even learn of the existence of Bassin’s thesis and discover Douglass’s misleading “Final Report” and we submitted our FOIA request soon after that, we must assume he was referring to our FOIA request. His interview was conducted more than a month ago and we have yet to see a single document from Douglass or from his 15 year study, other than a few we received from the very early years.

 

Douglass selectively cites Bassin’s present paper to give the misleading impression that Bassin herself concurs that his second set of data suggest no association between fluoride and osteosarcoma. In fact, Bassin specifically warns that reliance on either bone fluoride or lifetime cumulative exposures is likely to miss finding a risk that exists only in a limited time span. Bone fluoride reflects total lifetime accumulation of fluoride and can not be used to determine exposure rates for specific periods of life such as ages 6-8. The same goes without saying for lifetime cumulative exposure. Douglass says both of these approaches seem to be showing no effect in his 2nd set of data. Bassin warns that this is likely. For Douglass to imply Bassin’s endorsement of his methods distorts her paper.

 

Douglass claims he will also analyze the second set of data using an age-specific analyses, just as Bassin recommends. As almost an afterthought in the final paragraph he says:

 

“A parallel analysis of age-specific exposure to fluoride, especially during growth periods, is also being pursued by our study team in the second set of cases of our study.”

 

This analysis is not dependent on the bone fluoride levels. Douglass states that the second set of data was complete in 2003. It is now 3 years since he had the data that could have been analyzed with an age-specific exposure method, as Bassin recommended in 2001. Douglass has no explanations for this delay in what must be considered a study of serious public health consequence.

 

Osteosarcoma strikes several hundred teenage boys a year, and if Bassin’s findings are borne out, a large portion of those may have been the result of fluoride exposure through fluoridated water. Over 60% of Americans drink water to which fluoride has been added so that it exceeds the level at which Bassin found this strong effect.

 

As far as the claim by Douglass that an unpublished NIEHS report negates the findings in the NTP rat study from 1990, this is a distortion of what the researchers set out to study and what they found. FAN had earlier investigated this study and spoke with the Principal Investigator. We will cover this in more detail in another bulletin.
 
Despite all these weaknesses, we can rest assurred that the ADA will spin this Douglass “rebuttal” into a huge cloak of distraction.
 
Paul Connett
—————————–
LETTER TO THE EDITOR
Caution needed in fluoride and osteosarcoma study
Chester W. Douglass & Kaumudi Joshipura
Received: 3 January 2006 / Accepted: 12 January 2006
 Springer 2006

 

This issue of Cancer Causes and Controls includes a paper
with results from an analysis of a subset of participants in
our ongoing study of fluoride and osteosarcoma. The paper,
‘’Age-specific fluoride exposure in drinking water and
osteosarcoma'’, presents a partial view of this ongoing
study. We would like to advise the readers to be especially
cautious when interpreting the findings of this paper for
several reasons. The authors themselves have already
raised a flag of caution in their final paragraph with the note
that they are aware of additional findings from other incident
cases that appear not to replicate the findings from the
cases presented in their paper.

 

The Harvard School of Dental Medicine study of fluoride
and osteosarcoma has been a 15-year collaboration
among NIEHS, NCI, NIDCR, and Harvard. Two sets of
cases have been collected each with their own control
groups. The study started in 1992. The first set of cases was
recruited from existing cases between 1989 and 1992, and
the second set of cases was recruited from new incident
cases between 1993 and 2000. The Bassin et al paper
reports age-specific results among only the cases from 1989

 

to 1992. We are also finding some positive associations
between fluoride and osteosarcoma in the overall (not age specific)
analysis of the first set of cases. However, our
preliminary findings from the overall analysis of the second
set of cases (1993-2000) do not appear to replicate the
overall findings from the first part of the study. Our findings
currently being prepared for publication, do not suggest
an overall association between fluoride and
osteosarcoma. This seems particularly important since the
cases had been accrued essentially from the same hospitals
within the same orthopedic departments with the same
providers, and the same pathology departments making the
diagnosis of the osteosarcoma and also using similar
methods of fluoride exposure.

 

In addition to fluoride intake history, many of the cases
and controls that were accrued in the 1993-2000 time
period agreed to provide bone specimens. The cases provided
bone that was obtained proximal to the osteosarcoma
lesion as well as from their contra lateral hip. The control
group of non-osteosarcoma cancer patients provided bone
specimens. Our preliminary analysis of the fluoride content
of the bone specimens suggests that the fluoride level
within the bone is not associated with excess risk of osteosarcoma.
 

We are grateful to Dr. Bassin and her coauthors
for mentioning at the end of their paper that we are not
finding a positive association from the bone specimens in
the second set of cases.

 

Obtaining and analyzing sufficient numbers of bone
specimens has been a laborious and a time consuming
effort by many people throughout the hospitals and
research teams. The analysis of these specimens has
included quality control procedures on laboratory techniques,
pilot studies to test reliability, many runs of small
batches of specimens, the double checking of specimen
transport procedures, and the preparation of data sets for
analysis.

 

We are now in the possession of the complete analytic
data sets and are pursuing previously planned analysis and
comparisons with the earlier set of collected cases. We
have delayed publication of all the major findings until we
found replication or lack of replication of the earlier positive
findings. Our role model in this process has been Sir
Richard Doll, whose first publication associating smoking
with illness was rejected for publication until it could be
replicated (New York Times, July 26, 2005). It was too
important and too unexpected to be published on its own.

 

Professor Doll did replicate his initial findings; we apparently
have not and the bone specimens seem to corroborate
the lack of an association between the fluoride content in
drinking water and osteosarcoma in the new cases. Interestingly,
the NIEHS replication of their own earlier study
that found excess osteosarcoma in male rats was recently
presented on the NIEHS web site [1]. The findings of their
second study do not replicate their original widely quoted
National Toxicology Program study [2]. Drinking water
with very high fluoride content was not found to be associated
with osteosarcoma in either male or female rats.

 

A parallel analysis of age-specific exposure to fluoride,
especially during growth periods, is also being pursued by
our study team in the second set of cases of our study.
Accordingly, readers are cautioned not to generalize and
over-interpret the results of the Bassin et al. paper and to
await the publications from the full study, before making
conclusions, and especially before influencing any related
policy decisions.

 

References

 

1. The National Toxicology Program (NTP). Supplemental 2-year
study of sodium fluoride in male F344 rats (CAS No. 7681-49-4)
 
2. National Toxicology Program (1990) Toxicology and carcinogenesis
of sodium fluoride in F344 TN rats and B 6C3FL mice.
Technical Report Services 393, NIH Publication No. 90-2848
482 Cancer Causes Control (2006) 17:481-482
 
 
C. W. Douglass (&) Æ K. Joshipura
Harvard School of Dental Medicine, Boston, MA, USA;
Harvard School of Public Health, Boston, MA, USA
e-mail: chester_douglass@hsdm.harvard.edu
Tel.: +1-617-432-1456
Fax: +1-617-432-0047
K. Joshipura
University of Puerto Rico, Medical Sciences Campus, San Juan,
Puerto Rico
Cancer Causes Control (2006) 17:481-482
DOI 10.1007/s10552-006-0008-8