The University of California and Tobacco Funding: An Update Michael Ong October 24, 2007

Academia & Research Funding Promotion Criteria teaching research and creative work professional competence and activity University and public service

Trends in Federal Research Spending From AAAS, 2008

Academia & Industry Funding

Relationship Between Industry Funding and Outcomes of Studies Close financial ties between industry sponsors and clinical investigators may influence the quality and outcome of clinical studies (Boyd et al, 2003) –Small amounts of funds have been shown to influence health professionals –Discovery of these influences also undermine public trust of clinical research The tobacco industry (TI) uses funding to suppress, manipulate, and distort scientific research –To support industry positions and counters scientific work (Barnes & Bero, 1996) –To cultivate credibility and generate positive public image (Malone & Bero, 2003)

Tobacco Industry (TI) Funding Center for Indoor Air Research (CIAR) –Central element of 2006 federal court ruling that TI violated Racketeer Influenced Corrupt Organizations (RICO) Act –"special reviewed" projects by lawyers outside of their "peer" review system Philip Morris External Research Program is a continuation of CIAR activity –Funded scientists are often same as those funded through CIAR (Hirschhorn, et al, 2001 & 2006)

Example: TI-Funding of Studies Using ACS Cancer Prevention Studies Data LeVois & Layard, 1995 concluded no cardiac risk from passive smoking Did not separate current smoking spouse from former smoking spouse, when comparing to never smoking spouse Exclusion of older CPS data and former smoking spouse shows 20% increase in cardiac risk from passive smoking (Steenland, et al, 1996) Enstrom & Kabat, 2003 Long-term follow up on LeVois & Layard data repeats same exposure misclassification error reports same conclusion of no cardiac risk from passive smoking Warned specifically by ACS that older CPS data used is inappropriate for passive smoking studies From Tong & Glantz, 2007

TI-Funding Bans: Issues Academic Integrity The tobacco industry has a history of, and continues to restrict and undermine academic freedom stringent and rigorous thresholds must be met before undertaking any restriction lower levels of safeguards are unlikely to result in adequate protection from manipulation by the tobacco industry

TI-Funding Bans at U.S. Academic Institutions Schools of Public Health Columbia University Harvard University John Hopkins University Loma Linda University Louisiana State University Ohio State University University of Arizona University of Iowa University of Medicine and Dentistry of New Jersey University of North Carolina University of Puerto Rico University of South Carolina Schools of Medicine Emory University Harvard University John Hopkins University Institutions & Hospitals Brigham and Women’s Hospital MD Anderson Cancer Center in Houston, Texas Massachusetts General Hospital Roswell Park Cancer Institute in Buffalo, New York From

UC and TI-Funding 23 current TI funded projects at UC campuses –All funded by Philip Morris USA –Total $: 16,647,661 in funding –Total UC research funding in FY 2006: $4 billion –$39 million in total funding from 113 total TI funded projects among the UC campuses since gifts from TI to UC campuses –Total $: 485,000 between 1/2005 – 6/2007 –Total UC gifts in FY 2006: $1.29 billion From UCOP, 2007

TI-Funded UC Projects From UCOP, 2007

TI-Funding Debate at UC Individual UC units implement tobacco industry funding bans Individual UC units implement tobacco industry funding bans –UC Berkeley: School of Public Health (2004) –UC Los Angeles: School of Nursing (2004) –UC San Diego: Cancer Center (2004) –UC San Diego: Department of Family and Preventative Medicine (2003) –UC San Francisco: Cancer Center (2003) –UC San Francisco: Institute for Health Policy Studies (2005) 2005: UC Academic Assembly overturn individual UC unit policies. States only the UC Regents can adopt policies to decline funding based on source 1/2007: Regents ban on tobacco industry funding proposed (RE-89) 4/2007: 8 of 10 UC campus Academic Senates vote to oppose RE-89 (UCSF approves, UC Merced abstains) 9/2007: UC Regents adopt a compromise version of RE-89 From UCOP, 2007

TI-Funding Bans: Issues Academic Freedom “slippery slope”: Although the tobacco industry is bad, other funding sources may be singled out solely based on political winds accepting funding from a corporate sponsor is not an endorsement of the corporate sponsor’s products or actions individual investigators and the peer review system can ensure the integrity of research regardless of the source of its funding

Can we count on individual disclosure or peer review? Conflict-of-interest disclosures often are inadequate to describe relationships –Many researchers are not familiar with their own institution’s policies (Boyd et al, 2003) –Scientific journal financial disclosure statement requirements are too general to identify actual funding arrangements (Bero et al, 2005) –Example: Enstrom & Kabat, 2003

Bero et al. Tob Control 2005 Disclosure published in BMJ that met BMJ’s standards Findings 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 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 Policy Scientific review and Chancellor approval of research proposals prior to submission to TI for funding –reviewed by a Chancellor-designated scientific review committee drawn from the community of scholars –committee advises the Chancellor whether the proposed study uses sounds methodology and appears designed to allow the researcher to reach objective and scientifically valid conclusions –approved by the Chancellor, who will use the committee recommendations as part of the decision-making process Annual report to UC Regents on proposals –number submitted to the scientific review committees –number approved by the Chancellors –number funded by the tobacco industry –description or abstract of each proposal From UCOP, 2007

UC Regent Policy: Little Impact Policy focuses only on the initial proposal –will only detect initially flawed research that could be manipulated by the tobacco industry –does not review ongoing work or identify any manipulation of the findings afterward TI-funded research may actually increase –scientists may feel projects are “sanctioned” by the new process –public reporting to UC Regents may uncover effects