Freedom of Information Act used to obtain panel information
The day after Helliker's February 8, 2007 story, I e-mailed Dr. Carolyn Clancy, Director of the Agency for Healthcare Research and Quality (AHRQ
) and pursuant to the Freedom of Information Act
(FOIA) requested "the names of all panel members, their bios and their smoking cessation product conflicts disclosures, including how much they have accepted, when, the reason/s for payment, and from which pharmaceutical interests, or point me to Internet links disclosing this extremely critical public information."
On March 21, 2007, I was sent 825 pages of panel member resumes, what academics refer to as "curriculum vitaes" or CVs. Included were CVs of two panel members who, on some unknown date after March 21, 2007, no longer served on the panel.
On September 5, 2007, I was sent 24 signed "Panel Agreement and Financial Disclosure" forms. Nineteen were signed during July 2006, three were signed or dated in August, and the last two, those of 1996, 2000 and 2008 Guideline panel Chairman Michael Fiore
and Michael Goldstein, bore the same date, 9/5/06. Each disclosure form requested "complete" disclosure of all potential financial conflicts for the "past 5 years." I could make out the signatures of all panel members except three, and each of those denied any financial interest.
The May 2008 Guideline discusses the financial disclosure process at PDF page 223. It asserts that, "Prior to the second in-person Panel meeting in June 2007, and before any decisions regarding Panel recommendations were made, Panel members were required to complete a more exhaustive disclosure process for calendar years 2005, 2006, and 2007, based on the United States Department of Health and Human Services, PHS Title 42, Chapter 1, Part 50 guidelines for the conduct of research (ori.hhs.gov/policies/fedreg42cfr50.shtml
The above federal regulation is not simply some "guideline" but the "law of the land" and mandatory. Section 42 CFR 50.604(g)(2) required the reporting of any conflicting interest prior to expenditure of any funds, not a full year into the panel's work.
The above Guideline statement has been modified from the one appearing in the October 2007 draft which asked readers to believe that this had been a planned process. The draft asserts, "This evaluation process entailed a rigorous and transparent two-step procedure for disclosing and handling conflict of interest on the part of panel members."
How transparent is a process when those submitting FOIA disclosure requests are not sent the more "exhaustive" disclosures? I was sent 2006 disclosures in September 2007.
Fiore's website time-line
asserts that the decision to update the Guideline occurred on July 1, 2006 (50 days after the FDA announced
Chantix approval), which explains why nearly all the financial disclosures I received were signed in July 2006, eleven by July 8. But how is it "more exhaustive" to narrow the pre-Panel examination window from the five year disclosures I was provided, to just 18 months prior to selecting panel members?
Did AHRQ use science integrity regulations to prevent transparency?
Did AHRQ administrators intentionally narrowed both the conflicts time window and its scope so as to avoid labeling the Panel's chairman, Fiore, as having a "significant financial interest
"? Guideline page 223 asserts that a financial conflict is deemed significant if "net reportable compensation in excess of $10,000 in any reporting year."
In May 2005, Fiore testified (see PDF page 14) that, "[o]ver the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."
No language in federal disclosure law told AHRQ officials to limit investigation for significant financial interests to 18 months instead of 3 or 5 years.
42 CFR 50.601
tells the AHRQ that these regulations are intended as a flexible common sense tool to promote "objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an Investigator."
What are "we the people" to think when our own government, the Agency for Healthcare Research and Quality, the federal gatekeeper agency charged with guarding research integrity, appears to have used financial conflicts laws as shields to knowingly hide serious investigator financial conflicts from public view?
Fiore also testified in May 2005 as to receiving an annual $50,000 per year unrestricted chair endowment grant from funds given to the University of Wisconsin by GlaxoSmithKline (then Glaxo Wellcome). "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence," Fiore testified. "That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities."
Resolution 7594 in the minutes of the December 5, 1997
meeting of the University of Wisconsin Board of Regents (see PDF page 15) appears to support Fiore's contention that the University not Glaxo Wellcome made the decision to honor Fiore with this professorship chair. "That, upon recommendation of the Chancellor of the University of Wisconsin-Madison and the President of the University of Wisconsin System, Professor Michael C. Fiore, Department of Medicine, be appointed to the Glaxo Wellcome Professorship for Study of Tobacco Dependence, effective immediately."
On May 10, 2008 I e-mailed the University of Wisconsin Foundation asking "whether Glaxo Wellcome or the University of Wisconsin selected Dr. Fiore as the original endowment chair recipient." The Foundation's Vice-President of Legal Affairs responded on May 12 indicating, "I can tell you that the agreement mentions no individual by name. It is intended to support the University's Center for Tobacco Research and Intervention and supports the Director of that Center."
During a follow-up call, it was made clear that Glaxo Wellcome directed that the funds be used to support the Director of the Center for Tobacco Research and Intervention, who was then Dr. Michael Fiore.
If no exemption applies, Glaxo Wellcome's $50,000 per year gift to Fiore is five times greater than necessary to declare a "significant financial interest" under 42 CFR 50.603.
Can federal regulations
intended to protect scientific integrity from financial influence be bypassed by use of university professorship chair endowments? If so, what government produced science relying upon professors effectively placed on the industry's permanent payroll will be worthy of belief?
Fiore's May 2005 testimony also suggested that the University of Wisconsin Center for Tobacco Research and Intervention (UW CTRI) receives in the neighborhood of $1 million per year to conduct research for pharmaceutical companies. In that the May 2008 Guideline declares AHRQ to have developed the Guideline in "partnership" with both the UW CTRI and Robert Wood Johnson Foundation (RWJF), and federal disclosure regulations require disclosure by public or private "Institutions" as well as "Investigators," where are the UW CTRI's and RWJF's conflicts disclosure?
After Helliker's story, did AHRQ look back to see if the integrity of the 1996 and 2000 Guidelines were compromised by significant conflicts of interest? On December 12, 1996
Fiore declared at an FDA advisory committee meeting that I "am speaking today as a consultant to Glaxo Wellcome." He states, "I served ... as Chair for the Clinical Practice Guideline on Smoking Cessation," released in April 1996.
Fiore research funded by Glaxo Wellcome was published in March 2000
, the same period during which he chaired the June 2000 Guideline. A 2002
study financial disclosure asserts, "Dr. Fiore has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, Pharmacia, and Glaxo Wellcome."
Why were Robert Wood Johnson Foundation relationships ignored?
The Robert Woods Johnson Foundation's (RWJF) hands are all over the U.S. Guidelines. Its hands are also all over Guideline panel members. Not only did RWJF partner in funding both the June 2000 and May 2008 Guidelines, it approved and awarded Guideline panel members research project funding while in service as panel members.
Robert Wood Johnson II built the original 1886 three brother family business of Johnson & Johnson (J&J) into the world's largest health products company. Today the Johnson & Johnson "Family of Companies
," subsidiaries with interlocking management
, number 250. They include the ALZA Corporation
which created the NicoDerm® CQ® and Clear NicoDerm® CQ® nicotine patches, McNeil Consumer Healthcare
which manufactures the Nicotrol nicotine patch (that on July 3, 1996 became the first FDA approved
patch approved for over-the-counter sales), licenses sales of Nicoderm nicotine patches and Nicorette® nicotine gum, and markets
the Nicotrol inhaler
, and McNeil Pharmaceuticals which the FDA
authorized to market Nicotrol nasal spray on July 3, 1996.
When Robert Wood Johnson II died in 1968 his will devised his 10,204,377 shares of Johnson & Johnson common stock to establishment of a foundation, the foundation that today bears his name, The Robert Wood Johnson Foundation (RWJF). As of 2006, RWJF owned 55,983,308 shares of J&J common stock valued at $33.4 billion dollars.
(Click link to see RWJF Financial Statement of J&J stock ownership)
In June 2006, J&J announced
it was buying Pfizer's Consumer Healthcare business for $16.6 billion dollars. The purchase was concluded on December 20, 2006
with J&J announcing that with "the acquisition, the Johnson & Johnson Consumer Group portfolio will now feature products such as ... the NICORETTE line of smoking cessation treatments."
Since its creation, the RWJF Board of Trustees charged with governing the foundation has included many J&J executives and one namesake. Today RWJF's website reports that Trustee Robert E. Campbell
is a retired vice chairman of the board of directors of J&J, Trustee Edward J. Hartnett
is a retired company group chairman of Johnson & Johnson, grandson and heir Robert Wood Johnson IV is a Trustee, Trustee George S. Frazza
"previously served Johnson & Johnson for more than 30 years in the roles of corporate secretary, vice president and general counsel, and was a member of the executive committee," and Trustee Ralph S. Larsen
is a former chairman of the board and CEO of Johnson & Johnson.
According to RWJF, it contributed $102,016 to the University of Wisconsin School of Medicine with Michael Fiore as overseer, toward creation of the June 2000 Guideline. "On September 14-15, 1999, panel members met in Madison, Wis., where they evaluated their findings and prepared a draft of the new Guideline," asserts the RWJF. "The final version was sent to RWJF, and submitted to the USPHS for approval."
On December 20, 2007
, the RWJF disclosed it had awarded the University of Wisconsin School of Medicine and Public Health $100,000 for "updating, testing and disseminating the 2008 tobacco treatment guideline," with Fiore listed as one of two project directors
. The RWJF's primary asset is J&J stock. Its primary income is by earnings from, and sales of, J&J common stock. RWJF's financial well being is tied directly to J&J's stock values. Would the RWJF foundation dare make decisions harmful to its own economic interests? Has the RWJF ever once reached out to the 80-90% of smokers annually voting to attempt quitting without medications, and attempted to help save their lives by creating access to high quality non-pharmacology counseling and support programs that it knows would dramatically increase their odds of success?
Is it realistic to expect the RWJF to ever fund research that might tend to prove that Johnson & Johnson quit smoking product efficacy findings are grounded in sham clinical trials that were never blind as claimed? Does the RWJF Board of Trustees truly believe that researchers discovered some magic means to hide from nicotine addicts volunteering to participate in "medicine" clinical trials, the fact that they had instead been randomly assigned to receive a placebo device, and were, contrary to their expectations, now experiencing the onset of full-blown nicotine withdrawal? Is RWJF's focus on the integrity and quality of medical science or, in this case, its use to bolster sales and stock values?
If current federal financial disclosure regulations exempt nearly "anything of monetary value" flowing to an "Investigator" from non-profit entities ( 42 CFR 50.601
), should they? Should a paid employee of the RWJF have been allowed to sit on a panel authoring U.S. cessation policy? Would all pharmaceutical companies be wise to establish their own foundation, allowing them not only to shield and hide researcher financial ties but to participate in writing government policy favorable to their founding corporation's economic interests?