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 investigationÉ
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