[Lula-chat] Fwd: [FAN Bulletins] #654: A Harvard Whitewash?
Chuck Kerschner
OLFarCnArt at dslextreme.com
Wed Aug 16 17:55:40 EDT 2006
Fellow Geeks:
(I was told I was a geek too, since I'm getting started with Linux,
so I feel comfortable addressing the List so...)
This subject generated a good deal of discussion and a degree of
contention generally. Watching the discussion was a valuable
experience for me -- I learned much.
It is obviously of vital interest to me, but I will not bombard the
list with more like this. Those for whom it generates interest may
look into it further to establish for themselves whether it reinforces
or negates preconceived notions.
Yours,
Chuck
[Quote:]
-------- Original Message --------
Subject: [FAN Bulletins] #654: A Harvard Whitewash?
Date: Wed, 16 Aug 2006 15:43:45 -0400
From: Paul Connett <paul at fluoridealert.org>
To: <fan_bulletins at lists.fluoridealert.org>
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 Douglass Investigation
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 Douglass (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 "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 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 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 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 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 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 Douglass to report a
linkage between fluoridation and childhood bone cancer?
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 between 1995 and 2004,
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 she was awarded a
PhD for this 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 fluoridatd areas. He did not mention Bassin's
findings or his (unpublished) 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 a panel of the National Research
Council (NRC), 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 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,
Douglass failed to present all the facts.
Douglass' submission to the NRC was a draft copy of his Final Report to
NIH. Douglass 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, 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 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 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?
4) 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, nor 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 to get a cogent explanation
out of Harvard on this matter, please contact us at
<paul at fluoridealert.org>.
Paul & Michael Connett
-----------------------------------------------------------------------
<http://web.med.harvard.edu/sites/RELEASES/html/8_15Douglass.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 Douglass, DMD, PhD, professor of oral
health policy and epidemiology at HSDM, has concluded that Douglass 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 Douglass 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 Douglass 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 Douglass's editorship of the newsletter did not
constitute a conflict of interest under school and federal guidelines.
-----------------------------------------------------------------------
<http://www.ewg.org/issues/fluoride/20060816/index.php>
EWG Response (August 16, 2006)
For Immediate Release: August 16, 2006
Contact: Lauren Sucher, EWG, (202) 667-6982
Michael Connett, FAN, (802) 355-0999
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 Douglass "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 Douglass 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
Douglass'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. Douglass
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 Richard Wiles, Senior Vice President of EWG.
"Whether or not Dr. Douglass 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 Douglass 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. Douglass 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>.
[UNquote]
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Footnotes - my soapbox:
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GIVE "W" Bush, Donald Rumsfeld, Dick Cheney, Karl Rove, Richard Perle,
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and some sun-tan lotion and SEND THEM to Iraq to replace the troops.
URGE the British Parliament to do the same with their Prime Minister.
Info: <http://www.whatreallyhappened.com/>
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