In a dramatic turn of events the Environmental Working Group has discovered that Harvard has violated federal rules in the 'investigation" which led it to exonerate Professor Douglass of any academic wrong doing in his misrepresentation of Bassin's PhD findings that water fluoridation is associated with an increase in osteosarcoma in young men.
EWG's letter to President Bok is printed below.
To borrow a phrase from the Harvard Crimson, "the plot thickens" still further "like toothpaste!"
Paul Connett
October 11, 2006
Derek Bok, J.D.
President
Harvard
University
Massachusetts
Hall
Cambridge, MA
02138 USA
Dear President
Bok:
I am writing to
inform you of an
apparent
violation of
federal rules by
Harvard
University
during its
investigation
into charges
that Dr. Chester
Douglass, of the
Harvard Medical
School faculty,
misrepresented
or suppressed
the findings of
federally funded
research into
whether fluoride
in tap water is
associated with
bone cancer in
adolescent boys.
The review also
addressed
whether Dr.
Douglass's
employment as a
paid consultant
for the
toothpaste
giant, Colgate,
which has a
clear
pro-fluoride
stance, was a
conflict of
interest.
In August of
this year, after
a year-long
investigation,
the university
issued a four
paragraph
statement
concluding that
Dr. Douglass did
not
"intentionally"
misrepresent or
suppress
research
findings when
reporting his
results to the
National
Institutes of
Health. The
committee also
cleared him of
conflict of
interest charges
despite his cozy
relationship
with Colgate.
A review of
federal rules
for ethics
inquiries and
investigations
indicates that
in the conduct
of this review,
Harvard has
clearly violated
federal
procedures.
These rules
describe a
two-stage
process that
begins with an
ethics inquiry,
and if justified
can then lead to
a full ethics or
research
misconduct
investigation.
According to the
Department of
Health and Human
Services final
rule on Public
Health Service
Policies on
Research
Misconduct,
dated March 17,
2005, an inquiry
shall not make a
determination as
to whether the
ethics breach in
question was
intentional:
"The determination of whether the alleged misconduct is intentional, knowing, or reckless, including consideration of evidence of honest error or difference of opinion, should be made at the investigation stage, following a complete review of the evidence" (Fed Reg vol 70, no 94, May 17, 2005, pg. 28378, section H)."
An investigation, on the other hand, may reach such a conclusion, but must contact and seek testimony from the organization that brought the charges under review, which, as you know, was not done. According to 42 CFR, part 50, Subpart C, section 93.310, institutions conducting research investigations must:
"(g) Interviews. Interview each respondent, complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation"
Environmental
Working Group (EWG),
which brought
the charges
against
Douglass, was
never contacted
during the
course of your
review, nor was
anyone else that
we know of ever
contacted for
testimony or
interviewed by
any member of
the ethics
review panel.
The final report
of the review
panel has
similarly been
kept hidden from
the public.
Given the
clandestine
nature of the
proceedings, it
is not clear to
us whether
Harvard
conducted an
inquiry or an
investigation,
but either way,
federal
regulations were
not followed. If
Harvard claims
that the
Douglass
proceeding was
merely an
inquiry, then it
may not pass
judgment on
whether the
alleged ethics
breach was
intentional,
which it clearly
did in its
August
statement. If,
on the other
hand, Harvard
conducted a
full-blown
investigation,
then it clearly
violated federal
rules by failing
to contact the
complainant,
Environmental
Working Group,
during the
course of the
review.
On top of all of
this, it has
recently come to
light that
Douglass donated
one million
dollars to the
University's
Dental School in
2001. Although
giving one's
employer a
million dollars
is a perfectly
noble gesture,
it heightens
concern about
the integrity
and propriety of
this entire
proceeding.
If you as
President stand
behind your
ethics
investigation or
inquiry, there
is no reason not
to release it to
the public and
let it stand in
the light of
public scrutiny.
We call on you
to immediately
release:
-
the full text of the final report and the minutes of all the meetings of the ethics panel that produced it, and;
-
the identities of all the panel members along with all information that you have on their potential conflicts of interest including but not limited to disclosure documents required for participation on the ethics review panel.
We look forward
to your prompt
release of the
information.
Sincerely,
Richard Wiles
Sr. Vice
President
Cc:
Mr. Chris B.
Pascal,
Director
Office of
Research
Integrity
Department of
Health and Human
Services
Mr. John E.
Dahlberg,
Director
Division of
Investigative
Oversight
Office of
Research
Integrity
Department of
Health and Human
Services
Mr. Christian C.
Mahler
Research
Integrity Team
Leader
Office of the
General Counsel
Office of
Research
Integrity
Department of Health and Human Services
