The University of California and The University of California and Tobacco Funding: An UpdateTobacco Funding: An Update

Michael OngMichael Ong

October 24, 2007October 24, 2007

Academia & Research FundingAcademia & Research Funding

Promotion CriteriaPromotion Criteria

teaching teaching

research and creative research and creative workwork

professional professional competence and competence and activity activity

University and public University and public service service

Trends in Federal Research Trends in Federal Research SpendingSpending

From AAAS, 2008

Academia & Industry FundingAcademia & Industry Funding

Relationship Between Industry Relationship Between Industry Funding and Outcomes of StudiesFunding and Outcomes of Studies

Close financial ties between industry sponsors and Close financial ties between industry sponsors and clinical investigators may influence the quality and clinical investigators may influence the quality and outcome of clinical studies (Boyd et al, 2003)outcome of clinical studies (Boyd et al, 2003)– Small amounts of funds have been shown to influence health Small amounts of funds have been shown to influence health

professionalsprofessionals– Discovery of these influences also undermine public trust of Discovery of these influences also undermine public trust of

clinical researchclinical research

The tobacco industry (TI) uses funding to suppress, The tobacco industry (TI) uses funding to suppress, manipulate, and distort scientific researchmanipulate, and distort scientific research– To support industry positions and counters scientific work To support industry positions and counters scientific work

(Barnes & Bero, 1996)(Barnes & Bero, 1996)– To cultivate credibility and generate positive public image To cultivate credibility and generate positive public image

(Malone & Bero, 2003)(Malone & Bero, 2003)

Tobacco Industry (TI) FundingTobacco Industry (TI) Funding

Center for Indoor Air Research (CIAR)Center for Indoor Air Research (CIAR)– Central element of 2006 federal court ruling that TI Central element of 2006 federal court ruling that TI

violated Racketeer Influenced Corrupt Organizations violated Racketeer Influenced Corrupt Organizations (RICO) Act(RICO) Act

– "special reviewed" projects by lawyers outside of their "special reviewed" projects by lawyers outside of their "peer" review system"peer" review system

Philip Morris External Research Program is a Philip Morris External Research Program is a continuation of CIAR activity continuation of CIAR activity – Funded scientists are often same as those funded Funded scientists are often same as those funded

through CIAR (Hirschhorn, et al, 2001 & 2006)through CIAR (Hirschhorn, et al, 2001 & 2006)

Example: TI-Funding of Studies Using Example: TI-Funding of Studies Using ACS Cancer Prevention Studies DataACS Cancer Prevention Studies Data

LeVois & Layard, 1995LeVois & Layard, 1995concluded no cardiac risk concluded no cardiac risk from passive smokingfrom passive smokingDid not separate current Did not separate current smoking spouse from smoking spouse from former smoking spouse, former smoking spouse, when comparing to never when comparing to never smoking spousesmoking spouseExclusion of older CPS Exclusion of older CPS data and former smoking data and former smoking spouse shows 20% spouse shows 20% increase in cardiac risk increase in cardiac risk from passive smoking from passive smoking (Steenland, et al, 1996)(Steenland, et al, 1996)

Enstrom & Kabat, 2003Enstrom & Kabat, 2003Long-term follow up on Long-term follow up on LeVois & Layard dataLeVois & Layard datarepeats same exposure repeats same exposure misclassification errormisclassification errorreports same conclusion reports same conclusion of no cardiac risk from of no cardiac risk from passive smokingpassive smokingWarned specifically by Warned specifically by ACS that older CPS data ACS that older CPS data used is inappropriate for used is inappropriate for passive smoking studies passive smoking studies

From Tong & Glantz, 2007

TI-Funding Bans: IssuesTI-Funding Bans: Issues

Academic IntegrityAcademic IntegrityThe tobacco industry has a history of, and The tobacco industry has a history of, and continues to restrict and undermine academic continues to restrict and undermine academic freedomfreedomstringent and rigorous thresholds must be met stringent and rigorous thresholds must be met before undertaking any restrictionbefore undertaking any restriction lower levels of safeguards are unlikely to result lower levels of safeguards are unlikely to result in adequate protection from manipulation by the in adequate protection from manipulation by the tobacco industrytobacco industry

TI-Funding Bans at U.S. TI-Funding Bans at U.S. Academic InstitutionsAcademic Institutions

Schools of Public HealthSchools of Public HealthColumbia UniversityColumbia UniversityHarvard UniversityHarvard UniversityJohn Hopkins UniversityJohn Hopkins UniversityLoma Linda UniversityLoma Linda UniversityLouisiana State UniversityLouisiana State UniversityOhio State UniversityOhio State UniversityUniversity of ArizonaUniversity of ArizonaUniversity of IowaUniversity of IowaUniversity of Medicine and University of Medicine and Dentistry of New JerseyDentistry of New JerseyUniversity of North CarolinaUniversity of North CarolinaUniversity of Puerto RicoUniversity of Puerto RicoUniversity of South CarolinaUniversity of South Carolina

Schools of MedicineSchools of Medicine

Emory UniversityEmory University

Harvard UniversityHarvard University

John Hopkins UniversityJohn Hopkins University

Institutions & HospitalsInstitutions & Hospitals

Brigham and Women’s HospitalBrigham and Women’s Hospital

MD Anderson Cancer Center in MD Anderson Cancer Center in Houston, TexasHouston, Texas

Massachusetts General HospitalMassachusetts General Hospital

Roswell Park Cancer Institute in Roswell Park Cancer Institute in Buffalo, New York Buffalo, New York

From http://www.academic-integrity.com

UC and TI-FundingUC and TI-Funding

23 current TI funded projects at UC campuses23 current TI funded projects at UC campuses– All funded by Philip Morris USAAll funded by Philip Morris USA– Total $: 16,647,661 in fundingTotal $: 16,647,661 in funding– Total UC research funding in FY 2006: $4 billionTotal UC research funding in FY 2006: $4 billion– $39 million in total funding from 113 total TI funded $39 million in total funding from 113 total TI funded

projects among the UC campuses since 1995projects among the UC campuses since 1995

11 gifts from TI to UC campuses11 gifts from TI to UC campuses– Total $: 485,000 between 1/2005 – 6/2007Total $: 485,000 between 1/2005 – 6/2007– Total UC gifts in FY 2006: $1.29 billionTotal UC gifts in FY 2006: $1.29 billion

From UCOP, 2007

TI-Funded UC ProjectsTI-Funded UC ProjectsAward Title Campus Amount* Role Of SnoN Oncoprotein In Lung Carcinogenesis Berkeley $985,805* Chemical-Genetics And Proteomics Of Mitotic Kinases And Their Targets Berkeley $842,139* SnoN as a Negative Regulator of Smad Activity in T Cells: Role in Leukemogenesis Berkeley $43,200* The Biology of Chromosonal Amplification at 8q24 in Cancer Berkeley $195,723* Pulmonary Dispersion And Deposition Of Ultrafine Particles Davis $384,426* Tobacco Oxidants Prolong EGF Receptor Signaling In The Lung Davis $684,292* Genomic Responses Of The Lungs To Tobacco Smoke: Roles Of Inducible Nitric Oxide Synthase And A-Tocopherol Transfer Protein Genes Davis $654,276* Mechanisms And Treatment Of Tobacco Smoke-Induced Pulmonary Inflammation And Epithelial Damage In Rats Davis $773,230* Regulation Of Mucin Gene Expression By Smoke Davis $497,214* Mechanisms Of Release And Role Of T Cell Exosomes In Intercellular Communication Davis $650,036* Development of an Optical spectroscopy Technique for In Vivo Monitoring of the Efficiency of Therapy in Atherosclerotic Cardiovascular Davis $154,000* Characterization of Emulsion Stability Davis $13,726* A Novel Non-Selenocystenic Phospholipid Glutathione Peroxidase Mediating Oxidative Stress Serves as a Prognostic Biomarker for Breast Cancer Irvine $582,228* UCLA Adolescent Smoking Cessation Center Los Angeles $6,000,000* Salivary Biomarkers For Early Oral Cancer Detection Los Angeles $250,000* Patient-Based Genomic Predictors Of Oral Premalignancy Progression In Heavy Smokers Los Angeles $1,031,110* An Aerosol Lab-On-A-Chip For In-Situ Quantification Of Soluble Airborne Toxics Los Angeles $393,494* Nicotinic Signaling Using Nicotinic Acetycholine Receptors (nACHRS) And Their Contribution To Higher Order Brain Functions San Diego $43,200* Nicotinic Receptors On Hippocampal Neurons San Diego $810,727* Tobacco Smoke and Chronic Inflammation – The Role of NOD2 Protein and its Ability to Activate IL-1B Production San Diego $43,200* A Structure-Activity Model For Eye Irritation Potency F San Diego $640,686* Smoking-Altered Gap Junction Hemichannel Structure and Activity Modulate Cell Physiology and Viability Santa Barbara $647,815* MCP-1 Functions in Cigarette Smoke-Induced Atherogenesis Riverside $327,134

From UCOP, 2007

TI-Funding Debate at UCTI-Funding Debate at UC

Individual UC units implement Individual UC units implement tobacco industry funding banstobacco industry funding bans

– UC Berkeley: School of Public UC Berkeley: School of Public Health (2004)Health (2004)

– UC Los Angeles: School of UC Los Angeles: School of Nursing (2004)Nursing (2004)

– UC San Diego: Cancer Center UC San Diego: Cancer Center (2004)(2004)

– UC San Diego: Department of UC San Diego: Department of Family and Preventative Medicine Family and Preventative Medicine (2003)(2003)

– UC San Francisco: Cancer Center UC San Francisco: Cancer Center (2003)(2003)

– UC San Francisco: Institute for UC San Francisco: Institute for Health Policy Studies (2005)Health Policy Studies (2005)

2005: UC Academic Assembly 2005: UC Academic Assembly overturn individual UC unit overturn individual UC unit policies. States only the UC policies. States only the UC Regents can adopt policies to Regents can adopt policies to decline funding based on decline funding based on sourcesource1/2007: Regents ban on 1/2007: Regents ban on tobacco industry funding tobacco industry funding proposed (RE-89)proposed (RE-89)4/2007: 8 of 10 UC campus 4/2007: 8 of 10 UC campus Academic Senates vote to Academic Senates vote to oppose RE-89 (UCSF oppose RE-89 (UCSF approves, UC Merced approves, UC Merced abstains)abstains)9/2007: UC Regents adopt a 9/2007: UC Regents adopt a compromise version of RE-89compromise version of RE-89

From UCOP, 2007

TI-Funding Bans: IssuesTI-Funding Bans: Issues

Academic FreedomAcademic Freedom““slippery slope”: Although the tobacco industry is slippery slope”: Although the tobacco industry is bad, other funding sources may be singled out bad, other funding sources may be singled out solely based on political windssolely based on political windsaccepting funding from a corporate sponsor is accepting funding from a corporate sponsor is not an endorsement of the corporate sponsor’s not an endorsement of the corporate sponsor’s products or actionsproducts or actionsindividual investigators and the peer review individual investigators and the peer review system can ensure the integrity of research system can ensure the integrity of research regardless of the source of its fundingregardless of the source of its funding

Can we count on individual Can we count on individual disclosure or peer review?disclosure or peer review?

Conflict-of-interest disclosures often are Conflict-of-interest disclosures often are inadequate to describe relationshipsinadequate to describe relationships– Many researchers are not familiar with their own Many researchers are not familiar with their own

institution’s policies (Boyd et al, 2003)institution’s policies (Boyd et al, 2003)– Scientific journal financial disclosure statement Scientific journal financial disclosure statement

requirements are too general to identify actual funding requirements are too general to identify actual funding arrangements (Bero et al, 2005)arrangements (Bero et al, 2005)

– Example: Enstrom & Kabat, 2003Example: Enstrom & Kabat, 2003

Bero et al. Tob Control 2005Bero et al. Tob Control 2005

Disclosure published in BMJ that met BMJ’s standardsFindings from tobacco industry documents and other sources that go beyond what was required by BMJ

"The American Cancer Society (ACS) initiated CPS-I in 1959, conducted follow up until 1972, and has maintained the original database"

ACS epidemiologists repeatedly cautioned Enstrom before he began the study that the CPS-I dataset was not appropriate to investigate the effects of environmental tobacco smoke (ETS)21

"Extended follow up until 1997 was conducted at the University of California at Los Angeles with initial support from the Tobacco-Related Disease Research Program, a University of California research organisation funded by the Proposition 99 cigarette surtax. After continuing support from the Tobacco-Related Disease Research program was denied,

Dr Enstrom’s application for continued funding from the California Tobacco-Related Disease Research Program was not funded because it had inadequate scientific merit in a year when the program’s budget was drastically reduced.22

follow up through 1999 and data analysis were conducted at University of California at Los Angeles with support from the Center for Indoor Air Research, a 1988–99 research organisation that receive funding primarily from US tobacco companies"

The Center for Indoor Air Research funded grants that were peer reviewed by scientists and "special projects" that were reviewed by tobacco industry lawyers and executives.38 The CPS-I analysis was funded through the same mechanism as the special projects

"In recent years JEE has received funds originating from the tobacco industry for his tobacco related epidemiological research because it has been impossible for him to obtain equivalent funds from other sources"

JEE sought research funding from the tobacco industry beginning in 1975 and received his first funding in 1992. He has also received funding for serving as an expert witness, reviewing dissertation and grant proposals

"GCK never received funds originating from the tobacco industry until last year, when he conducted an epidemiological review for a law firm which has several tobacco companies as clients. He has served as a consultant to the University of California at Los Angeles for this paper"

GCK has had an ongoing indirect relationship with the tobacco industry since at least 1981 though his collaborations with Ernst Wynder whose American Health Foundation was funded by Philip Morris.

"JEE and GCK have no other competing interests. They are both lifelong non-smokers whose primary interest is an accurate determination of the health effects of tobacco."

The analysis of the CPS-I dataset was also funded by Philip Morris tobacco company and this was not disclosed

UC Regents PolicyUC Regents Policy

Scientific review and Chancellor approval of research Scientific review and Chancellor approval of research proposals prior to submission to TI for fundingproposals prior to submission to TI for funding– reviewed by a Chancellor-designated scientific review committee drawn reviewed by a Chancellor-designated scientific review committee drawn

from the community of scholars from the community of scholars – committee advises the Chancellor whether the proposed study uses committee advises the Chancellor whether the proposed study uses

sounds methodology and appears designed to allow the researcher to sounds methodology and appears designed to allow the researcher to reach objective and scientifically valid conclusionsreach objective and scientifically valid conclusions

– approved by the Chancellor, who will use the committee approved by the Chancellor, who will use the committee recommendations as part of the decision-making process recommendations as part of the decision-making process

Annual report to UC Regents on proposalsAnnual report to UC Regents on proposals– number submitted to the scientific review committeesnumber submitted to the scientific review committees– number approved by the Chancellorsnumber approved by the Chancellors– number funded by the tobacco industrynumber funded by the tobacco industry– description or abstract of each proposaldescription or abstract of each proposal

From UCOP, 2007

UC Regent Policy: Little ImpactUC Regent Policy: Little Impact

Policy focuses only on the initial proposal Policy focuses only on the initial proposal – will only detect initially flawed research that could be will only detect initially flawed research that could be

manipulated by the tobacco industrymanipulated by the tobacco industry– does not review ongoing work or identify any does not review ongoing work or identify any

manipulation of the findings afterwardmanipulation of the findings afterward

TI-funded research may actually increaseTI-funded research may actually increase– scientists may feel projects are “sanctioned” by the scientists may feel projects are “sanctioned” by the

new processnew process– public reporting to UC Regents may uncover effectspublic reporting to UC Regents may uncover effects