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National Meeting on Tobacco Funding of Research . . . . . . . . . . . 6 TRDRP Update . . . . . . . . . . . . . . . 8 ( w h at is a tobacco re s e a rch pro gram to do?) by M.F. Bowen The Case for Research Funding by Phillip Gardiner While few are talking about it, the tobacco industry has regained much influence in California, the state with the toughest and most widespread anti-smoking laws and ordinances in the country. California Common Cause Executive Director Jim Knox pointed out that “The failure of the legislature and the governor to enact a cigarette tax increase, and the decision to sell off the proceeds of the historic tobacco litigation set- tlement, were tremendous victories for the tobacco industry that will come at great cost to the public health. These budget actions are a testament to the influence of the tobac- co industry at the state capitol.” (1) To borrow a phrase from the newly released Tobacco Education Research Oversight Committee (TEROC) Master Plan, to think that the tobacco control community has chased the tobacco industry out of Sacramento is “The Myth of Victory.” (2) The article below is drawn mainly from California Common C a u s e * – Tobacco Report, titled:“California: The Campaign Contributions and Lobbying Expenditures of the Tobacco Industry and Its Allies.” (http://www.common cause.org/). *Common Cause is a nonprofit, nonpartisan citizen's lobbying organization promoting open, honest, and accountable government. Supported by the dues and contributions of over 200,000 members and supporters in every state across the nation, Common Cause represents the unified voice of the people against corruption in government, and big money special interests. Absent thee from felicity awhile, And in this harsh world draw thy breath in pain, To tell my story. William Shakespeare [Hamlet,V.ii.360] Lung Cancer – An Overview Lung cancer is the uncontrolled proliferation of non-differentiated, non-functional epithe- lial cells in the airways. There are several dif- ferent types of lung cancer, depending on the type of epithelial cell which succumbs to car- c i n ogenic damage and the histolog i c a l appearance of the transformed cells. Smoking is responsible for 87% of all lung cancers (1) and is strongly associated with all histological classes. (2) The most common out- come for all types of lung cancer is the same: death due to loss of pulmonary function and/or complications due to metastasis to other sites, most commonly bone, live r, lymph nodes or brain. At initial diagnosis cancer patients most often present clinically with cough, blood expectoration, shortness of breath, chest pain and recurring pneumonia or bronchitis. (3) These symptoms are com- monly associated with other, less deadly, con- ditions and by the time a diagnosis of lung cancer is made, it is usually too late: The dis- ease has spread and treatment in such cases is more invasive, more difficult and less effec- tive. If detected early enough, surgery is the treatment of choice. However, because early See “Sacramento” page 2 See “Lung Cancer” page 4 TRDRP Newsletter Volume 6, Number 1, March 2003
Transcript

National Meeting on To b a c c oFunding of Research . . . . . . . . . . . 6T R D R P Update . . . . . . . . . . . . . . . 8

( w h at is a tobacco re s e a rch pro gram to do?)

by M.F. Bowen

The Case forResearch Funding

by Phillip Gardiner

While few are talking about it, the tobacco industry has regained much influence inCalifornia, the state with the toughest and most widespread anti-smoking laws andordinances in the country. California Common Cause Executive Director Jim Knoxpointed out that “The failure of the legislature and the governor to enact a cigarette taxincrease, and the decision to sell off the proceeds of the historic tobacco litigation set-tlement, were tremendous victories for the tobacco industry that will come at great costto the public health. These budget actions are a testament to the influence of the tobac-co industry at the state capitol.”(1) To borrow a phrase from the newly released TobaccoEducation Research Oversight Committee (TEROC) Master Plan, to think that thetobacco control community has chased the tobacco industry out of Sacramento is “TheMyth of Victory.”(2) The article below is drawn mainly from California CommonC a u s e * – Tobacco Report, titled:“California: The Campaign Contributions andLobbying Expenditures of the Tobacco Industry and Its Allies.” (http://www.commoncause.org/).

*Common Cause is a nonprofit, nonpartisan citizen's lobbying organization promoting open, honest,and accountable government. Supported by the dues and contributions of over 200,000 members andsupporters in every state across the nation, Common Cause represents the unified voice of the peopleagainst corruption in government, and big money special interests.

Absent thee from felicity awhile,And in this harsh world draw thybreath in pain, To tell my story.

William Shakespeare [Hamlet, V.ii.360]

Lung Cancer – An OverviewLung cancer is the uncontrolled proliferationof non-differentiated, non-functional epithe-lial cells in the airways. There are several dif-ferent types of lung cancer, depending on thetype of epithelial cell which succumbs to car-c i n ogenic damage and the histolog i c a lappearance of the transformed cells.Smoking is responsible for 87% of all lungcancers (1) and is strongly associated with allhistological classes.(2) The most common out-come for all types of lung cancer is the same:death due to loss of pulmonary functionand/or complications due to metastasis toother sites, most commonly bone, live r,lymph nodes or brain. At initial diagnosiscancer patients most often present clinicallywith cough, blood expectoration, shortness ofbreath, chest pain and recurring pneumoniaor bronchitis.(3) These symptoms are com-monly associated with other, less deadly, con-ditions and by the time a diagnosis of lungcancer is made, it is usually too late: The dis-ease has spread and treatment in such cases ismore invasive, more difficult and less effec-tive. If detected early enough, surgery is thetreatment of choice. However, because early

See “Sacramento” page 2

See “Lung Cancer” page 4

TRDRP Newsletter Volume 6, Number 1, March 2003

Tobacco Industry is Back in the House Since 1997, the tobacco industry hasspent over $9 million lobbying theCalifornia Legislature. Once consid-ered the hard place to give awaymoney, now the California Assemblyand Senate appear to be one of theeasiest places where the industry canbuy influence. Through June 30th ofthe 2002 election cycle, the tobaccoindustry spent over $2 million lobby-ing the Cal iforn ia Leg i s l a t u r e ,$829,306 in 2002 alone. In fact, dur -ing the second quarter of last year, thei n d u s t ry spent $449,755, an 18%increase over the first quarter. This isno small matter since these expendi-tures came right at the time that legis-lature was debating the budget andstruggling with the tough question ofwhat to do with the projected $12.5billion Master Settlement Agreement(MSA) funds.

B e t ween 1997 and 2002, 25C a l i f o rnia State Senators and 55Assemblymembers accepted a total of$2.36 million in contributions fromthe tobacco industry. There are cur-rently many Assemblymembers andState Senators that are receiving tensof thousands of dollars from thetobacco industry, some membersreceiving over $100,000. These fig-ures are just reflective of direct tobac-co industry contributions. It isimportant to keep in mind that duringthis same time period (1997 - 2002),t wo subsidiaries of Philip Morr i s ,Kraft Foods and Miller Brewing, alsocontributed $163, 113 to state officeholders in California. Please go toCommon Cause’s website http://-www.commoncause.org/ for a detail-ed accounting of who is receiv i n gand who is not receiving tobaccoi n d u s t ry support .

The tobacco industry, not beingone to discount the importance ofC a l i f o rn i a ’s diverse populations,

made sure that key racial/ethnicgroups were recipients of their gen-erosity as well. From 1999 to 2002,the Black Leadership Political ActionCommittee (PAC) together with theC a l i f o rnia African American PAC

accepted $72,000 from the tobaccoindustry. S i m i l a r ly, the Californ i aHispanic Chamber of CommercePAC, California Hispanic LeadershipFund and the California LatinoAlliance together received a total of$38,000 between 1997 and 2002.

Selling the FarmThe securitization of the MSA fundshas and will go a long way to under-cut the future of the tobacco controland tobacco research programs in thestate of California. Governor Davisand the Legislature decided duringthe first and second quarter of 2002to securitize $4.5 billion, nearly all ofthe state’s share of the MSA paymentsover the next 22 years. As the Com-mon Cause Report points out: “WereCalifornia to wait and receive the set-tlement payments over time, the statewould have received a total of $12.5billion. The state will now get approx-i m a t e ly 36 cents on the dollar itwould have received in future MSApayments. Critics have likened this totaking out a second mortgage on yourhome to pay for groceries.”

California was once the home tothe largest tobacco prevention pro-gram in the world. However, with thecontinuing cuts to tobacco controlbudget coupled with selling off ofMSA funds, California dropped to

8th place in the Campaign Fo rTobacco Free Kids rankings in 2001,and California’s ranking has plum-meted further to 20th with the contin-uing cuts to the tobacco control budg-et. The California Legislature slashedthe Tobacco Control Program by30%, a total of $46 million in fiscalyear 2002. These cuts have droppedthe California program well belowthe $165 million identified by theCenters for Disease Control andPrevention as the minimum necessaryto make a significant reduction inCalifornia smoking rates.

These cuts are of no minor conse-quence. D r. Wendy Max, tobaccoresearcher at the University ofCalifornia, San Francisco, has point-ed out in her latest report that smok-ing costs California $16 billion annu-ally.(3) This figure includes $8.6 bil-lion for hospital care, ambu l a t o rycare, nursing home expenses, pre-scription drug costs and home healthcare. Another $5.7 billion is due tolost productivity attributable to pre-mature death and $1.5 billion to asso-ciated illnesses. While the number ofsmokers has declined over the pastdecade in California, the costs ofhealth care generally, and caring forsmokers particularly, have sky-rock-eted.

What is a Tobacco ResearchProgram to do?The Tobacco Related DiseaseResearch Program (TRDRP) hasavoided the brunt of the Californiabudget crisis. However, with declin-ing revenues from smokers, our fundsh ave been continually dropping.Ironically, a tax on tobacco productsthat has been so good for the public’shealth, and indeed the font of theTRDRP’s existence, may inadvertent-ly play a role in shortening the life ofTRDRP. It has been well establishedthat a rise in cigarette prices willresult in a decline in tobacco purchas-es. While this is immediately benefi-cial to the health of those smokersand potential smokers who may,

See “Sacramento” page 3

Continued from page 1

indeed, be deterred by the tax, andwhile the mission of the TRDRP isabsolutely that of improving the pub-lic health, one must not overlook thefact that a decline in tobacco purchas-es means a direct loss of revenues forthe TRDRP. The proposed cigarettetax increases, absent new reve n u esources, may prove the undoing ofa rg u a bly one of the top tobaccoresearch programs in the nation.

It is important to note that itwould be short-sighted to think thatas smoking rates drop, there will beless of a need for tobacco-related dis-ease research. On the contrary, even ifevery smoker in California quit today,many people would still develop can-cers and other maladies from pastsmoking habits. Indeed, continuedresearch is imperative to address andhopefully blunt the progression ofsmoking related disease.

The repeated siphoning off ofresearch account revenues to supportthe California Cancer Registry con-tinues to inhibit TRDRP’s ability tofund a broad range of ex c e l l e n t

research. As we haveoften pointed out in thisnewsletter, the nearly $5million a year redirectedto the Cancer Reg i s t rycould fund at least nine,three-year awards at anaverage cost of $170,000per year. We will have towork with the CancerR eg i s t ry and others toremedy this situation.Only the tobacco indus-t ry ’s benefits from lesstobacco research.

However, apart fromsupporting b a c k - f ills t oo ff-set the impac t o fincreased taxation, hag-gling over allocations tothe Cancer Registry, orexposing the tobacco

i n d u s t ry ’s intrigues inSacramento, the TRDRP needs tostrike out in bold new directions. Atrecent meetings of both tobaccoresearchers and tobacco control advo-cates, from around the country andhere in California, it was pointed outthat the TRDRP needs to do a betterjob at publicizing the importance andimpact of the research we fund. Thetobacco control community and thepublic generally need to be madeaware of significant research find-ings, their use in the development ofpublic policy and research’s contribu-tions to prevention and cessationefforts. One participant stated, “Yourprogram has funded critical researchon second-hand smoke, California’sburgeoning racial and ethnic commu-nities, and maternal and child healthto name a few, and these stories aren’tgetting out; no one hears about yoursuccesses.”

It would be programmatically andfiscally naïve to think that in the nearfuture, the California Legislature isgoing to significantly augment tobac-co research funding (let alone replacethe funds taken away from the tobac-co control program over the last fewyears). The tobacco research commu-

nity has to be, indeed needs to be, for-ward thinking and begin to exploreadditional avenues of funding apartfrom the Prop 99 account. Innovativefund raising strategies need to be pur-sued forthwith. Partnering with otherfunding agencies to tackle larg eresearch programs, aggr e s s ive lyseeking funds from founda-t ions, e s t a blishing tobacco-relateddisease support group(s) and hiring afund raising firm, can all lead to aug-mented funding. Greater fundsmeans more research on criticaltobacco use issues facing Californi-ans. The use of fund raising expertsby our sister program, the CaliforniaBreast Cancer Research Progr a m ,which is also reliant on tobacco taxdollars, is proving to be successful.

TRDRP needs to construct a far-sighted plan that incorporates publicrelations, publicity and fund raising,to augment and support our researchmission. While we are exposing thetobacco industry machinations inSacramento, we must be creative ,innovative, proactive and not depends o l e ly on tobacco taxes nor thevagaries of the up-and-down politicalprocess in California to secure ourfuture.

References1. Surrusco M, Knox J, Bycel B, Viggo

C.“California: The Campaign Contri-butions and Lobbying Expenditures of the Tobacco Industry and Its Allies.”California Common Cause – Tobacco Report, October 2002. (http://www.commoncause.org/).

2. Tobacco Education and Research Oversight Committee. “The Myth of Victory: Toward a Tobacco-Free California, 2003 -2005.” California Department of Health Services, Sacramento, California, 2002.

3. Max W, Rice DP, Zhang X, Sung H-Y,Miller L. “The Cost of Smoking in California, 1999.” California Department of Health Services, Sacramento, California, 2002.

Continued from page 2

diagnosis is so problematic, radiationand chemotherapy are usually requir-ed in conjunction with surgery. Thesurvival rate is 49% in those caseswhere the tumor is detected early butonly 15% of lung cancers are detect-ed early enough for patients to quali-fy for this relatively sanguine progno-sis. The 5-year survival rate for allstages of lung cancer progr e s s i o ncombined is only 14%.(4)

Lung cancer is now the leadingcause of cancer mortality in both menand women in the US. An estimated157,400 people died of lung cancer inthe US in 2001, a figure which repre-sents 28% of all cancer deaths thatye a r.( 4 ) Lung cancer annually killsmore women than breast cancer andmore men than prostate cancer. InCalifornia, for example, an estimated13,200 people died of cancer of thelung or bronchus in 2001, 25.8% ofall cancers in California; 2,800 diedof prostate cancer or 5.5% and 3,900of breast cancer or 7.6% of all can-cers.(4)

There are at least two bright spotsin this otherwise gloomy picture. Forone thing, lung cancer rates between1988 and 1997 dropped twice as rap-idly in California as in the rest of thec o u n t ry,( 5 ) due at least in part toCalifornia’s aggressive anti-smokingc a m p a i g n i n i t i a t e d i n 1 9 8 8 .

Secondly, long-term lung cancer sur-vivors have recently been found toh ave a better quality of life thanexpected.(6) Nonetheless, recent inci-dence and mortality statistics remaindismal.

Lung cancer incidence and mor-tality rates display striking and large-ly unexplained racial/ethnic differ-ences.(4) Among men reported lungcancer incidence rates (per 100,000)are highest in African A m e r i c a n s(117), followed by Caucasians (71.9),Asian/Pacific Islanders (51.9), His-panic (38.0) and American Indians(25.1). Mortality rates follow thissame trends. The underlying causesof these discrepancies are likely com-plex but at least part of the reason forthe disparities in mortality may residein the fact that race and ethnicityinfluence access to appropriate andaggressive cancer care and treatmentpost-diagnosis.(7) Biologic differencesmay also play a role as susceptibilityto certain, possibly more deadly, his-tological types of lung cancer arehigher in African Americans as com-pared to Caucasians even after adjust-ment for smoking.(8) Racial/ethnic dif-ferences in the metabolism and detox-ification of tobacco smoke compo-nents, including carcinogens, may beanother factor for the higher inci-dence of lung cancer in A f r i c a nAmerican men . (9, 10, 11) The preferenceof African-American smokers formentholated cigarettes(12) may be yet

another factor in theincreased cancer incidenceseen in this population:Menthol may enhanceexposure to carcinog e n i csmoke components, possi-bly through its action as abronchial dilator.( 1 2 ) L u n gcancer rates among menare 2-3 times higher thanthose in women in all eth-nic categories; howeve r,there is compelling ev i-dence that women aremore susceptible to lungcance r given the same

amount of smoke ex p o-sure.(13) As in the case of ethnic dif-ferences, the reasons for this dispari-ty are largely unexplored and unex-plained.

The Debate That Shouldn’tHave BeenThat lung cancer is caused by smok-ing is a fact so well-known, estab-lished, and incontrovertible that it isdifficult to imagine a time when itwas a subject of debate. Nonethelessit was. The controversy was fueled bythe tobacco industry, which spent ac o n s i d e r a ble amount of time andmoney disputing the facts and cloud-ing the issue.

Before the invention of cigaretteslung cancer was ex t r e m e ly rare.People started smoking in large num-bers during World War I when tobac-co companies distributed free ciga-rettes to members of the armed serv-ices.(14) By the 1930’s the heal theffects of this largesse were evident.Physicians noticed a large number oflung cancer cases in men and lungcancer rates in this group rose rapidlythereafter from approximately 10 (per100,000) in 1940 to approximately 75in the mid-1980’s.(2) Lung cancerincidence in women lagged behindthat in men, but, following a steepincrease beginning in the early1960’s, lung cancer surpassed breastcancer as the leading cause of cancermortality in women in 1987. These

Continued from page 1

See “Lung Cancer” page 5

patterns closely tracked trends in cig-arette smoking. In fact the epidemio-logical association between smokingand lung cancer was so pronounced,so strong, and so consistent and theassociation between lung cancer andsmoking history in patients so com-pelling, that the Royal College ofPhysicians in Britain issued a reportin 1962 on the health hazards ofsmoking(15) which was followed short-ly thereafter by the US Surg e o nGeneral’s report on the same topic in1964.(16) Nonetheless, smoking wasso inculcated into American culturethat the American Medical Associat-ion itself refused to endorse theSurgeon General’s report. In fact,m a ny medical doctors themselve swere addicted to cigarettes. Moreominously, the AMA continued toaccept contributions from the tobaccoindustry.

In such an atmosphere, the tobac-co industry found it advantageous tomount a two-pronged attack on itspublic relations problem. On the onehand, it denied the association bet-ween lung cancer and smoking andon the other it began to market ciga-rettes with implied reduced healthrisks.

In 1954 the tobacco industry setthe tone of the debate by publishing,under the dubious auspices of theTobacco Industry Research Comm-ittee, the now - i n famous “Fr a n kStatement to Cigarette Smoke r s ,”which claimed that there were manypossible causes of lung cancer andthat there was no agreement amongauthorities that cigarette smoking wasone of the causes. Thus began de-cades of refusal by the tobacco indus-try to recognize a cause and effectrelationship between smoking andlung cancer. At the same time thetobacco industry capitalized on thegrowing public awareness that smok-ing was dangerous by promoting firstfilter then low-tar cigarettes startingin the 1950’s and 1960’s. Advertising

“tar wars” ensued between competingtobacco companies (the tar derby),which fueled the consumers’ misper-ception that these products were low-risk.(17) By the 1970s and 1980s thetobacco industry had introducednumerous low tar, “light” ciga r e t t ebrands. Howeve r, subsequent re-search has shown that these productsare anything but safe for human con-sumption and have not appreciablyreduced the risk of lung cancer. Thismay be due to the fact that smokerscompensate for reduced nicotine lev-els by inhaling more deeply andbecause levels of carcinog e n i cnitrosamines in such products haveactually increased over time.(18)

The cause and effect relationshipbetween cigarette smoke and lungcancer has of course, since beena bu n d a n t ly and irr e f u t a bly demon-strated. The first evidence that a

tobacco compound directly interactswith a DNA site known to bei nvo l ved in cancer initiation was produced by a TRDRP-funded re-searcher.(19) As early as 1986 it wasrecognized that environmental tobac-co smoke can cause lung cancer inadult non-smokers (20, 21). It is nos u rprise that in 1993 the U. S .E nvironmental Protection A g e n cydeclared environmental tobaccos m o ke to be a Class A, or know n ,human carcinogen. Moreover, smok-ing has now been linked to manyother types of cancer beside lung can-cer.(22)

Chronic UnderfundingWith lung cancer the leading cause ofcancer mortality in the US, it is sur-prising that it is grossly underfunded

Continued from page 4

Nat King Cole Lon ChaneyCarl Wilson Wayne McLaren Joe DiMaggio (The Marlboro Man)Roger Maris Eddie RabbitJimmy Dorsey Lee RemickSusan Hayward Doug McClureBetty Grable Edward R. MurrowJoe Higgs Larry Linville Gary Cooper Chet HuntleyCal Ripken Sr. Franchot ToneWalt Disney Yul BrynnerGeorge Peppard Sarah VaughanSpencer Tracy Mort Downey, Jr.Harry Reasoner Alan J. LernerMelina Mercouri Desi ArnezAudrey Meadows Chuck ConnorsArt Blakey John WayneEd Sullivan Leonard BernsteinDuke Ellington Bert ParksJack Benny Arthur Godfrey

all died of lung cancer?(from: Smoke-Free Educational Services, Inc.)

See “Lung CancerT” page 12

As part of the ongoing campaign toeducate investigators on the conse-quences of accepting money forresearch from the tobacco industry,the Tobacco-Related DiseaseResearch Program (TRDRP), alongwith the American Lega cy Fo u n -dation, the National CancerInstitute, and the Society for Re-search on Nicotine and Tobacco, haveco-sponsored a national meeting todiscuss the tobacco industry’s recentp u blic ventures into the scientifi carena )e.g., funding external researchprograms). The meeting, “TobaccoI n d u s t ry Funding and Scientif i cResearch: Ethical, Legal and PolicyIssues,” provided a framework to helptobacco researchers, private and pub-lic academic institutions, and fundingorganizations make informed deci-

sions before committing to scientificd i a l ogue or funding arr a n g e m e n t swith the tobacco industry. Over 150scientists, research institutions, ad-ministrators, representatives fromfunding agencies, and tobacco controladvocates were in attendance. Themeeting, which followed the annualconference of the Society of Researchon Nicotine and Tobacco, was held onFebruary 22 and 23, 2003 in NewOrleans.

The two-day meeting provided anopportunity for participants to dia-logue about this emotionally chargedand complex issue. The meetingbegan early Saturday evening withi n t r o d u c t o ry remarks from Chery lHealton, Ph.D., American Lega cyFoundation and a co-keynote addressfrom Mitch Zeller, J. D., PinneyAssociates and Ron Baye r, Ph.D. ,

Columbia University. These speakersthat framed the issue of the tobaccoindustry’s funding of research andprovided a historical background onthe tobacco industry’s use of scienceand the scientific discourse. ScottL e i s c h ow, Ph.D., National CancerInstitute moderated the meeting onSunday over two sessions. The first ofsession, “Ethical and Legal Perspec-tives: Is the tobacco industry differ-ent?” that looked at how the tobaccoindustry is different from other indus-tries that fund research. In addition,the issue of whether academic free-dom is threatened by policies put intoplace by funders and/or academicinstitutions to address tobacco indus-try funding of research was also dis-cussed. The second session, “Re-search Funding Practices: Pro and

A previous attempt to implement a program policy that would make inve s t i gators who have financial ties with thetobacco industry ineligible from receiving an award from TRDRP was unsuccessful due to UC Office of theP r e s i d e n t ’s analysis. The proposed policy was a result the TRDRP Scientific A d v i s o ry Committee’s resolution, passedin June 2001, advising TRDRP to put into place a policy in which any principal inve s t i gator who receives curr e n tfinancial support from the tobacco industry should be ineligible for TRDRP awards. This policy would not have beenr e t r o a c t ive, but instead would have only focused on an inve s t i ga t o r ’s current or future financial ties with tany tobaccoindustries while holding an active TRDRP award. The definition of financial support in the resolution includes gr a n ts u p p o rt from any tobacco industry research program and any consulting fees or direct financial ties to the tobaccoi n d u s t ry or its subsidiaries. In the UC analysis, the TRDRP policy was viewed as being more restrictive than two cur-rent UC policies which protect academic freedom for UC researchers and prevent ex t e rnal funders from controllingresearch outcomes.

A more recent development on this issue has been the vote by the UCSF fa c u l t y, in the fall of 2002, approving aresolution for all faculty members to refuse to accept any funding from the tobacco industry and the foundations its u p p o rts. The results have been communicated to Chancellor Bishop at UCSF. The matter of putting forth a policyis now being considered by the UCSF University Senate. Some suggest that it is open to debate whether the T R D R PS c i e n t i fic A d v i s o ry Committee’s recommended policy is more restrictive or can be considered analogous to the twoUC policies mentioned above. TRDRP will continue to monitor developments at UCSF and at the University ofC a l i f o rnia Office of the President.

As always, TRDRP will keep its stakeholders informed of any progress on this issue. The issue of tobacco indus-t ry funding of research has not and will not disappear in the near future. More than like ly, this issue will continue top l ay an important role in tobacco research and tobacco sciences as more funding agencies and academic depart m e n t s

put in place policy to address the issues of tobacco industry funding or research.

by Francisco O. Buchting

See “MeetingT” page 7

by Joanna Cohen, University of To r o n t o

I. IntroductionToday more than ever, tobacco com-panies have an interest in portraying ap o s i t ive corporate image. Fundingexternal research is one strategy thisindustry has used to counter studiesdemonstrating the negative effects oftobacco use and to deflect criticismsabout its business practices. Althoughsome tobacco industry - f u n d e dresearch has been of high quality,many studies it has sponsored on therisks of active and passive smokinghave been shown not to be. Indeed,the higher quality research hasfocused on substances other thantobacco as a cause of adverse healthoutcomes; this has been called “dis-tracting research” because it con-tributes to the playing down of then ega t ive impacts of tobacco use.Further, it has been documented thatmany grants from tobacco industryresearch councils were controlled byindustry lawyers rather than by scien-tific advisory boards, and they wereawarded specifi c a l ly to promoteresearch “controversies.”

While the tobacco industry contin-ues to set up external funding pro-grams, several U.S. schools of publichealth and organizations that fundtobacco-related science have institut-ed formal policies restricting tobaccoindustry sponsorship of research. InSeptember 2001, the Society forResearch on Nicotine and Tobaccoadopted a position statement toencourage its members not to solicitor accept support from the tobaccoindustry, to continue refusing supportfrom the tobacco industry for Societyactivities, and to “not endorse thesupport of its members’ research ortheir participation in other activitiesfunded by the tobacco industry.”There are legitimate arguments both

for and against accepting tobaccoindustry funding for research. Thepurpose of this backgrounder is toprovide an overview of the issues sur-rounding research sponsorship by thetobacco industry. Seven key issueswill be discussed followed by a briefsummary of what we know about uni-versity, journal and research societypractices in this area. A selected bib-liography can be found at the end ofthis document.

II. The Issues1. Academic FreedomAcademic freedom is a key value inuniversity settings. Some believe thatimposing any boundaries on re-searchers, including prohibiting themfrom accepting funding from certainsources, is an anathema to the idealsof academia. They argue that anysuch restriction could lead to a sti-fling of necessary scientific debatebecause there would be fewer fundingoptions. If it is perceived that debateis curbed in any way researchers andtheir institutions may eventually losesome of their credibility. It is impor-tant to note, however, that a numberof boundaries are already imposed onacademic research. For ex a m p l e ,institutional review boards are feder-ally mandated in the United States,and academic research must adhere tohuman subjects and other ethicalstandards (e.g., scientif ic integr i t y,f inancial confl icts of interest) .Further, funding agencies may placeparticular requirements on the use oftheir funds, and academic institutionsmay also have their own rules andr egulations about the conduct ofresearch and the use of researchfunds. In addition to mandatedrequirements, scientists also have anobligation to society to identify realhealth problems and promote resolu-tions, while institutions have an obli-

An Overview of the Issues

See “Meeting” page 10

con perspectives from scientists abouttaking tobacco industry money ”looked at existing policies and possi-ble future policies at universities andfunding agencies. Additionally, proand con arguments for scientistsaccepting money from the tobaccoi n d u s t ry to conduct research we r edebated. The afternoon began withthe presentation of two case studieson addressing industry funding ofresearch. The first case study, pre-sented by Phillip Gardiner, Dr.P.H.,was based on TRDRP’s experience intrying to put a policy in place. Thesecond study, presented by StantonGlantz, Ph.D., was based on the re-cent UCSF faculty vote on a resolu-tion for all faculty members to refuseto accept any funding from the tobac-co industry, following the case studypresentation, a public “SocraticD i a l og u e ,” moderated by CharlesNesson, J.D., Harvard Law School,pro-vided in-depth discussion amonga panel of ex p e rts in tobacco-related research and tobacco con-trol. Scientists from two tobaccocompanies part icipated in the“Socratic Dialog u e .” After a live lydiscussion, meeting attendees dividedinto small groups to discuss recom-mendations and future action on theissue of tobacco industry funding ofresearch. The meeting closed withbrief reports from the break-outgroups. The meeting’s goal of contin-uing the dialogue on the issue oftobacco industry funding was accom-plished. TRDRP will continue tomonitor this growing and importantissue and will provide updates all ofits all stakeholders.

Fo l l owing is a “briefing” paperwritten by Joanna Cohen, Ph.D. ,University of Toronto that was dis-tributed to all meeting attendees. Thepaper was commissioned by the fun-ders of the meeting. It provides anoverview of the main issues discussedthroughout the meeting.

Continued from page 6

The Tobacco-Related Disease Research Program (TRDRP) is in the processof developing a strategic plan for the next five to seven years, which willguide our response to declining research funds. T R D R P ’s sole source offunds (i.e., the Research Account of the Proposition 99 tobacco surtax fund)has been declining and will continue to decline as tobacco consumptiondecreases in California. It could possibly drop 25% over the next seve r a lyears, from $19.4 million to $14.4 million. Moreove r, for the past three ye a r s ,an increased amount of Proposition 99 Research Account funds has beenappropriated to the California Cancer Reg i s t ry and, as a result, less has beenava i l a ble to T R D R P. If this trend were to continue, in a few years the reg i s t rywould receive 25% of the funds in the Research Account, in contrast to 6%in the years before the allocation was dramatically increased.

TRDRP is committed to supporting excellent science that will contribu t eto improved tobacco control eff o rts in California and to more eff e c t ive pre-vention, detection, diagnosis, and treatment of tobacco-related disease. To bep r ogr a m m a t i c a l ly and fi s c a l ly prudent, it is necessary for us to consider howto modify TRDRP to respond eff e c t ive ly to the aforementioned changes. Onefeature of the plan will be ways to augment funds (e.g., private deve l o p m e n t ) .

To date, we have obtained advice, suggestions, insights, and recommen-dations on the progr a m ’s future directions from scientists within and outsideC a l i f o rnia who are familiar with the program, from attendees at T R D R P ’s2002 Annual Inve s t i gator Meeting, California tobacco control ex p e rts, andother TRDRP stakeholders. Stakeholders were asked the following ques-t i o n s :

1. Curr e n t ly, TRDRP offers the following types of awards: Research Project, Innova t ive Developmental and Exploratory (IDEA), New I nve s t i ga t o r, Postdoctoral Fe l l owship, Dissertation, and Collabor-a t ive. These are ava i l a ble in all research priority areas. Should TRDRP maintain, limit or expand the number and type of mecha-nisms ava i l a ble in different research priority areas?

2. TRDRP funds research across a broad range of scientific disciplines and priority areas. Should the TRDRP prioritize, ex p a n d, limit or maintain funding in all or some areas?

3 . What research would be most useful to your orga n i z a t i o n ?

4. How can TRDRP and the tobacco control community work more c l o s e ly with one another?

We are sincerely grateful to those who responded to our inquiries.Suggestions will be summarized for discussion by T R D R P ’s Scientifi cA d v i s o ry Committee, which will recommend a strategic plan. Changes in thep r ogram will be reflected in the next Call for Applications, which will beissued in the fa l l .

by Charles L. Gruder

T R D R P ’s mission is to mitigate theimpact of tobacco-related illness byfunding research that is relevant toissues surrounding tobacco use anddisease. TRDRP recognizes thevalue to science and society ofincreasing the diversity of inve s t i ga-tors researching tobacco use andtobacco-related disease and inencouraging researchers to addressthe specific needs of under- s e rve ds egments of our society. Diff e r e n c e sin training, backgr o u n d, and ex p e r i-ence will enrich the capacity ofresearchers to eff e c t ive ly tackle theissues surrounding tobacco controlin California. All TRDRP principali nve s t i gators are encouraged to pro-vide training to qualified students,f e l l ows, and community memberswho are underrepresented. In sup-p o rt of these goals, TRDRP off e r sthe Cornelius Hopper Dive r s i t yAward Supplement (CHDAS) andwelcomes participation by all quali-fied individuals, including thosefrom socioeconomic, cultural, eth-nic, racial, linguistic, and geogr a p h i cb a c k grounds who are under- r e p r e-sented in tobacco research.

The CHDAS is named in honorof Cornelius L. Hopper, M.D., wh owas the UC Vice President forHealth A ffairs from 1983 until hisretirement in 2000.

Applications are due April 23, 2003, at 5:00 P.M.

They are available on the TRDRPwebsite: www.trdrp.org.

The gove rn o r ’s 2003-04 budget, introduced on January 10, proposes to appropriate the same amount to TRDRP as inpast two fiscal years, $19,434,000. In the current fiscal climate, no budget cut is good news. The state’s huge bu d g-et problem has been widely reported in the press and readers may reasonably have expected this to result in a reduc-tion in T R D R P ’s resources. It is important to understand a distinction in the sources of state funds. The state bu d g-et short fall is in the general fund, whereas T R D R P ’s revenue derives from a special fund, namely, the ResearchAccount in the Cigarette and Tobacco Products Surtax Fund. This fund, which was created by a constitutional amend-ment (i.e., voter passage of Proposition 99 in 1988) and state statutes, may be spent only on tobacco-related diseaser e s e a r c h .

Although state statutes prohibit the use of tobacco research funds to reduce the budget short fall by allocating themto other state programs, there are still risks to T R D R P ’s 2003-04 budget. The gove rn o r ’s budget proposed to increasethe state tobacco excise tax by $1.10 per pack. As econometric research has demonstrated – some of which was fund-ed by TRDRP – this increase would drive down tobacco sales. Since T R D R P ’s revenue derives from a different tobac-co tax, our budget would fall proport i o n a t e ly. Howeve r, the gove rn o r ’s budget proposes to protect T R D R P, along withthe other programs funded by Prop. 99 tax revenue, by “backfilling” T R D R P ’s potential loss of Prop. 99 revenue withr evenue from the proposed new tobacco tax increase. In other words, if passed, this backfill provision would protectT R D R P ’s budget from a dramatic decline.

As noted above, the gove rn o r ’s budget also included, for the fourth consecutive ye a r, a much larger allocation thanin the past from the Prop. 99 Research Account to the California Cancer Reg i s t ry, $4,738,000. TRDRP will contin-ue to work with Californ i a ’s public health and research communities to identify altern a t ive, stable sources of fundingfor the reg i s t ry.

Although T R D R P ’s budget has remained level for the last two years, it declined over the prior four years and isprojected to continue to decline with decreasing tobacco use in the state. In addition to declining revenue, there areother reasons that TRDRP cannot fund as many of the meritorious grant applications as in the past. Research costsh ave risen. Most grant money is spent on compensation for inve s t i gators and technical staff and this cost hasincreased. Another factor is an increase in the number of grant applications, 9% this ye a r. The percentage of appli-cations funded has dropped, and if this trend continues, it would discourage top inve s t i gators from submitting theirbest projects to T R D R P. These conve rging trends show why the current TRDRP model cannot be eff e c t ive andexplains our motivation to take a systematic look at the progr a m ’s future.

R e c ruitment for the TRDRP director opening continues. We had post-poned recruitment for the opening of a biomedical research administra-tor position. We are ex t r e m e ly fortunate that two current staff membersa greed to accept additional responsibility to cover this opening. T R D R Presearch administrator MF Bowen, PhD, is handling the general bio-medical science grant applications in addition to her other progr a mresponsibilities. A research administrator in the California BreastCancer Research Program, Larry Fi t z g e r a l d, PhD, agreed to manage thecancer grant applications. For those unfamiliar with CBCRP, it is one ofthe other Special Research Programs administered by the University ofC a l i f o rnia for the state (http://www. c b c rp . o rg ) .

TRDRP issued its 2003 Call forApplications in September 2002. The num-ber of applications submitted showed a 9%increase over 2002, from 225 to 245. Peerr ev i ew of the applications for scientifi cmerit will take place this spring, and awardswill be announced in June. It is importantfor all friends of TRDRP to know that fundsfor the grants that will be awarded in 2003do not depend on passage of the 2003-04state budget.

3. Tobacco is “Special”If universities prohibit the acceptanceof tobacco money for research, will,or should, this lead to prohibiting theacceptance of research funds fromtobacco sister companies or fromother industries? Where should aca-demia draw the line? Tobacco is notthe only industry that has demonstrat-ed questionable conduct. Clearly,most industries would have an eco-nomic interest in the outcomes ofresearch they fund, resulting in agreat potential for conflicts of inter-est. Pharmaceutical companies haveshown some suspect practices vis-à-vis its relationships with academicresearch. For example, drug compa-nies have “bought” journal editorials,m a r keting departments rather thanmedical or scientif ic depart m e n t sfund and oversee some studies, andthey have been accused of trying toruin the careers of scientists who havep u blicized research f indings thatwould be detrimental to these compa-nies. Research has shown that havinga financial relationship with a phar-maceutical company is strongly asso-ciated with publishing views that arefavo r a ble to this industry. T h easbestos industry also fundedresearch aimed at quelling fears aboutthe nega t ive health impacts ofasbestos. The asbestos companiessponsored little epidemiolog i c a lresearch or studies that explored therelationship between asbestos andcancer. The companies dictated theresearch strategy of the A s b e s t o s i sResearch Council, vetted publicationsand sometimes censored publications.Despite potential influence from anyc o rporate funder, some argue thattobacco is “special” and that thisindustry should be treated differentlyfrom other private sector sources.Tobacco is a unique product becauseit is addictive, toxic and lethal to halfof its long-term users; further, thenumber of people harmed by tobaccoworldwide is of epidemic magnitude.Moreover, tobacco industry productsare not regulated like other consumer

products; historically they have beenexempt from food and drug legisla-tion, consumer product safety legisla-tion and hazardous product legisla-tion. Given the immense harms oftobacco industry products, and thefact that they are not required for sub-sistence, some argue that the tobaccoindustry cannot be a legitimate part-ner in funding scientific research.

4. Tobacco Products are LegalThose who support the acceptance oftobacco industry funds argue thattobacco companies are legal bu s i-nesses and that their products arelegal, thus, there should be no reasonfor rejecting their money for researchp u rposes. Furt h e rmore, it can beargued that it is preferable to taketobacco money for research (a socie-tal “good”) rather than leave it intobacco company coffers where it canbe used for the marketing and promo-tion of tobacco products. Indeed, uni-versity-industry partnerships contin-ue to be strongly encouraged by bothgovernment and by universities them-selves. However, with revelations thatindustry sometimes has very strongcontrols over the conduct of what issupposed to be independent academicresearch, concerns have been raisedabout whether science is being drivenby a responsibility to contribute to ahealthy, productive and just society,or by the market place and stockprices. Some worry that if universi-ties appear to be responding to theprofit motive, they will lose credibili-ty and subsequently the public trust.In addition, some believe that the sci-entific community has a moral andethical imperative not to collaboratewith an industry that is increasing itspresence and predatory practices indeveloping countries where the regu-latory climate and public attitudestoward the tobacco industry are moresusceptible to abuse by this industry.Although tobacco companies insistthat they are better corporate citizensthan ever before, at least in developedcountries, their actions still do notsupport their words.

Continued from page 7

See “Meeting” page 11

gation to undertake research that ben-efits mankind. Some may contendthat because the tobacco industry hasdeliberately worked to obstruct theseresponsibilities, arguments claimingthe coexistence of academic freedomand tobacco-funded research aremoot. It could also be argued thatthese obligations preclude relation-ships with an industry that knowinglykills its customers and that has sys-tematically suppressed, manipulatedand distorted the scientific record.

2. Respectability by AssociationIt has been argued that recipients oftobacco funding can provide thesecompanies with respectability andlegitimacy by association. By sup-porting research, the tobacco industrycan claim it is acting responsibly andin good faith, while at the same timegenerating good publ i c i t y. Indeed,this industry has pointed to the rep-utable institutions it has funded in anattempt to gain prestige and win thea p p r oval of juries. Recipients oftobacco funding may defend the fun-der’s interests; more subtly, they mayremain silent on issues that impactnegatively on the tobacco industry.These behaviors could help con-tribute to tobacco company objectivesthat undermine public health. Thereare new concerns that the tobaccoindustry is trying to gain respectabili-ty from its associations with universi-ties under the banner of corporatesocial responsibility. In 2000, BritishAmerican Tobacco (BAT) donated£3.8 million for an Intern a t i o n a lCenter for Corporate SocialResponsibility at the University ofNottingham. The following ye a rImperial Tobacco in Canada, which isowned by BAT, made a contributionto a Toronto university’s certificateprogram in corporate social responsi-bility.

5. The Need for FundsAn argument in favor of allowingresearchers to take tobacco funding isthat there are insufficient funds tosupport all potentially useful researchin this area. It is argued that there areno other funders that could (or would)step in to fund the type of researchthat tobacco companies are willing tosupport. Further, some believe thatjust as the pharmaceutical companiesare required to support research toevaluate their products, tobacco com-panies should also be expected tofund research for the evaluation of itsown products. Indeed, many are quickto criticize research about new tobac-co devices when it is conducted bytobacco industry scientists. Suchresearch may be more credible if con-ducted by the academic community.C u rr e n t ly, howeve r, even academicscientists who take tobacco moneyare often suspect. This means thatthere is very little independent verif i-cation of claims being made by thetobacco industry about its productsand there is little ability to test theseproducts before they appear on themarket. Thus, the status quo suggeststhat without a shift in attitudes abouttobacco industry funding forresearch, a truly effective and accept-able harm reduction product devel-oped by the tobacco industry, forexample, could never receive supportfrom most members of the tobaccocontrol community, at least not in atimely manner. Of course if statusquo views about accepting tobaccomoney for research change, parame-ters would have to be set up andenforced to ensure that full scientificindependence is maintained. It maybe that the best scenario for fundingstudies that evaluate novel tobaccoindustry products would be throughan industry-funded neutral third-p a rty organization responsible foradjudicating research proposals and

administering the funds. Still, manyargue that a need for funds is not asufficient reason to accept sponsor-ship from an industry with a historyof funding research aimed at promot-ing “controversies” and distractingattention away from tobacco’s adversehealth effects.

6. Ethical Guidelines andDisclosure PoliciesEthical guidelines exist to protectresearch from undue influence on thepart of the funder. Further, disclosureof funding sources, the peer reviewprocess and some financial conflict-of-interest policies are often thoughtto be sufficient to ensure scientifici m p a rt i a l i t y. Nonetheless, industrysponsors may exert influence over thescientific process at multiple points:withholding “negative” findings re-sulting in publication bias, influenc-ing the study design, limiting investi-gators’access to data and having con-trol over publication. In order toaddress these concerns, the Inter-national Committee of MedicalJournal Editors (ICMJE) updated its“Uniform Requirements for Manu-scripts Submitted to BiomedicalJournals.” However, a recent studyfound that U.S. medical schools failedto include provisions in their agree-ments with industry sponsors ofmulti-center clinical trials thatadhered to the ICMJE guidelines fora c c o u n t a b i l i t y, access to data andcontrol of publication. Even if ethicalguidelines exist and are adopted, theymay not be enforced. A recent studyfound that potential conflicts-of-interest with private industry arerarely reported. Further, it has beenargued that guidelines for industry-sponsored research are not sufficientwhen dealing with the tobacco indus-try because they do not address thetopics of research (i.e., they wouldnot protect against “distractingresearch”), nor do they address otherpossible conflict-of-interest relation-ships between the industry andresearchers or their institutions such

as the acceptance of donations fromthese companies. There are also ethi-cal issues arising from the source oftobacco industry research funds –researchers who are sponsored by thetobacco industry must accept thatthese funds originate directly fromthe sale of cigarettes, including thesale of cigarettes to minors. In addi-tion, some point out that scientistshave a professional obligation to con-sider how their research findings maybe used by others. Scientists whowillingly conduct research they knowwill be beneficial to the objectives ofthe tobacco industry may be taken totask; similarly, some may argue thatignorance or naivety is an unsatisfac-tory defense for those who enter intoresearch relationships with tobaccocompanies. At this time it is likelythat journal submissions and grantproposals that acknowledge currentor past relationships with the tobaccoindustry will be subject to heightenedscrutiny.

7. Funding EligibilityOne development relevant to thisdebate is that taking tobacco moneycould jeopardize eligibility for fund-ing from other sources. Cancer fund-ing agencies, in particular, are begin-ning to take a hard line on tobaccofunding. The National CancerInstitute of Canada, the NationalHeart Foundation of Australia andsome members of the Association ofEuropean Cancer Leagues will notfund researchers who receive supportfrom the tobacco industry. CancerResearch UK will not fund re-searchers if their research institute,university faculty or school receivestobacco funds. This organization iscurrently reviewing its code of prac-tice on Tobacco Industry Funding toUniversities with the aim of taking aneven stronger stand. Cancer councilsin Australia have taken the strongestposition to date: they will not fundindividuals if anyone in their institu-tion receives tobacco support. TheAmerican Lega cy Fo u n d a t i o n

Continued from page 10

See “Meeting” page 14

as compared to other types of cancer.In 2001 approx i m a t e ly $900 perdeath was spent on lung cancerresearch; by (per death) comparison,$9,000 was spent on breast cancerresearch, $3,500 on prostate cancer,and $34,000 on HIV/AIDS.(23) All ofthese diseases richly deserve thefunding support they receive. Butgiven the high incidence and mortali -ty of lung cancer and (because of thedifficulty of early and accurate diag-nosis) the costs of treating it,(24) lungcancer deserves much more fundingthan it presently receives. The factthat lung cancer is not a disease that issexy or that garners much sympathyor empathy from potential donorsdoes not help the situation. Nor doesit help that lung cancer victims, oncediagnosed, do not live long enough tobecome activists for their cause.

TRDRP has tried to rectify thissituation for the California researchcommunity. Of the 962 grants fund-ed by the TRDRP through 2001, 168have involved research either directlyrelated to lung cancer or research onbasic biological phenomena commonto many cancers, including lung can-cer. This issue represents 89% ofTRDRP’s total biomedical portfolio.TRDRP has supported research one t i o l ogical mechanisms, new andimproved diagnostics and innovativetherapies. TRDRP researchers havep r ovided evidence that tobaccosmoke damages the p53 tumor sup-pressor gene,(25) developed sensitivetests for the detection of metastases(26)

and for the early detection of trans-f o rmed cells,( 2 7 ) demonstrated thate nvironmental tobacco smoke in-duces tumor development in an ani-mal model,( 2 8 ) d eveloped an anti-angiogenic DNA vaccine(29) and de-veloped a blood-test for tobacco-spe-c i fic carcinogenic nitrosamines.( 3 0 )

These are only a few examples ofaccomplishments of TRDRP-fundedresearchers that address the inception,p r ogression and devastating con-s equences of lung cancer.

Future DirectionsOngoing work to develop early diag-nostics and to design more effectiveand less damaging treatments forlung cancer needs continued support.We also need to address recently-emerging areas of concern. New andd iverse biomarkers are needed toassess lung cancer risk from the newgeneration of “harm-reduction” to-bacco products. (31) We need to assessthe extent of exposure reduction andthe impact of these products, if any,

on public health.(32) History tells usthat we cannot expect accurate an-swers from the tobacco industry inresponse to questions about their newand “improved” products. Such anassessment must be conducted inde-p e n d e n t ly. The biological mecha-nisms underlying ethnic and individ-ual differences in lung cancer suscep-tibility and mortality need to bedefined; in so doing, new ways toapproach lung cancer diagnosis andtreatment may be revealed. Thisapproach also offers hope that treat-ment can be pharmaco-genomicallydesigned to fit each patient’s specificneeds, thus vastly improving clinicaloutcome.

ConclusionLike AIDS, lung cancer is a stigma-tized disease, with many non-smok-ers of the opinion that smokers “getwhat they asked for.” This ignores

Continued from page 5

several salient and incontrovertiblefacts: That nicotine is one of the mostaddictive substances known; that aslong as it is sold to consumers in theform of cigarettes it is a legal sub-stance; and, perhaps most frighteningof all, that the tobacco companieshave the financial and, by extension,political, power to influence market-ing and legislation to their advantage.Lung cancer will continue to exact ahigh human toll on its victims andtheir families, as well as a financialdrain on our health service systems.Lung cancer surv ival rates havechanged little over the past 10 years.We have an opportunity to changethat. New techniques in molecu-lar biology, biochemistry, syntheticchemistry, and biomedical engineer-ing provide unparalleled opportuni-ties to uncover the mechanismsunderlying lung cancer, develop inno-vative techniques for diagnosis, earlydetection and treatment, and unravelthe mysteries underlying ethnic, sex-based, and individual differences inincidence and survival.

It is not surprising that in most ofthe great mystic and spiritual litera-tures of the world, the terms “breath”and “spirit” are synonymous. Byfinding a cure and by developingtherapies and diagnostics that wouldmitigate the impact of this horrificdisease, we would be doing nothingless than saving the victims of avicious industry - not only in breath,but in spirit.

References1. U.S. Department of Health & Human

Services. Reducing the Health Consequnces of Smoking: 25 Years of Progress. A Report of the Surgeon General. Atlanta, GA. USDHHS, PHS,Centers of Disease Control & Prevention, Center for Chronic DiseasePrevention and Health Promotion, Office on Smoking & Health. 1989.

2.Osann, K.E., Ernster, V. L., and Mustacchi, P. Epidemiology of lung cancer. In “Textbook of RespiratoryMedicine, 3rd edition, vol. II (J.F.Murray, J. Nadel, R.J. Mason, & H.A. Boushey, eds.) 2000. pp. 1395-1414. W.B. Saunders, Philadelphia.

See “Lung Cancer” page 13

3. Prager, D., Cameron, R., Ford, J., Figlin, R.A. Bronchogenic carcinoma.In: Textbook of Respiratory Medicine, 3rd edition, vol. II (J.F. Murray, J.Nadel, R.J. Mason, & H.A. Boushey,eds.) 2000. pp. 1415-1451. W.B.Saunders, Philadelphia.

4. American Cancer Society. Cancer Facts and Figures 2001. American Cancer Society, Atlanta, GA.

5.Centers for Disease Control and Prevention. Declines in Lung Cancer Rate – California, 1988 – 1997. Morbidity and Mortality WeeklyReport. 49: 1066-1069. December, 1, 2000. Centers for Disease Control And Prevention, Atlanta , GA.

6. Sarna, L., Padilla, G., Holmes, C., Tashkin, D., Brecht, M.L. and Evangelista, L. Quality of life of long-term survivors of non-small-cell can-cer. J. Clin. Oncol. 2002. 20: 2920-2029.

7. Shavers, V.L. and Brown, M.L. Racialand ethnic disparities in the receipt of cancer treatment. 2002. J. Nat’l. Cancer Instit. 94: 334-357.

8. Miller, B.A. et al. (eds). Racial/ethnic patterns of cancer in the United States 1988-1992. N.I.H Publication No. 96-4104. 1996. National Cancer Institute, Bethesda, MD.

9. Perez-Stable, E.J., Herrera, B., Jacob, P. and Benowitz, N.L. Nicotine metabolism and intake in black and white smokers. 1998. JAMA 280: 152-156

10. Benowitz, N.L., Perez-Stable, E.J., Fong, I., Modin, G., Herrera, B and Jacob. P. Ethnic differences in N-glucuronidation of nicotine and cotinine. 1999. J. Pharmacol. Exp. Ther. 291: 1196-1203.

11. U.S. Department of Health & Human Services. “Tobacco use among U.S. Racial/ethnic minority groups – African American, American Indians and Alaska Natives, Asian Americans, and Pacific Islanders and Hispanics: Areport of the Surgeon General. 1998. DHHS, Centers for Disease Control & Prevention, National Center for Chronic Disease Prevention and HealthPromotion., Office on Smoking & Health. Pp. 140-141.

12. Gardiner, P. Mentholated cigarettes and African-Americans: An open ques-tion. 2000. Burning Issues 3(2): 6.

The 2nd Annual City of Hope Lung Cancer Symposium

Convened on February 21-22 in Long Beach, California by the City ofHope Cancer Center, Department of General and Oncologic Surgery,Section of Thoracic Surgery, this meeting brought together a group ofn a t i o n a l ly prominent ex p e rts to discuss the latest developments inresearch, prevention, early detection and treatment of lung cancer. TheCity of Hope forum is unique in that it brings researchers, clinicians andresearch funding agencies together with public health and tobacco controlprofessionals, the common goal being the reduction of lung cancer mor-bidity and mortality in the 21st century. Topics discussed included basicbiology, the latest early detection technologies, innovative treatments ofearly, late and advanced lung cancer, prevention, smoking cessation andtobacco control policy. It was a productive, provocative and informativemeeting. Collaborative strategies for the prevention, early detection andtreatment of lung cancer as well as other tobacco-related diseases werediscussed. TRDRP salutes this effort and hopes that it continues into thefuture. For information regarding future symposia, please contact FredericW. Grannis Jr., MD, Head, Section of Thoracic Surgery, City of HopeCancer via email at: [email protected]

Continued from page 12

13. Siegfried, J.M. Women and lung can-cer: Does estrogen play a role? 2001 Lancet Oncol. 2: 506-513.

14.Gardiner, P. Tobacco Use in the Military, Then and Now. 2000. BurningIssues, 3(3): 8

15. Royal College of Physicians. Smoking and Health: A Report of the Royal College of Physicians on Smoking in Relation to Cancer of the Lung and Other Diseases. 1962. Pittman Medical Publishing Co., London

16. U.S. Department of Health, Education and Welfare. U.S. Public Health Service. Smoking and Health: Reportof the Advisory Committee to the Surgeon General of the Public Health Service. 1964. Public Health Service Publication No. 1103. Center for Disease Control. Rockville, MD.

17.Glantz,S. A., Slade, J., Bero, L.A., Hanauer,P., and Barnes, D.E. Smokingand Disease: The Tobacco Industry’sEarliest Responses. 1996. In: The Cigarette Papers.. University of California Press, Berkeley, CA. URL: http://www/library.ucsf.edu/tobacco/cigpapers/

18. Institute of Medicine, Committee to Assess the Science Base for Tobcco Harm Reduction Products, Board on Health Promotion and Disease Prevention. Clearing the smoke: Assessing the science base for tobacco harm reduction. 2001. pp. 66-67. National Academy Press, Washington, D.C.

19. Pfeifer, G.P., Denissenko, M.F., Ollivier, M., Tretakova, NB., Hecht, S.S., and Hainaut, P. Tobacco smokecarcinogens, DNA damage and p53 mutations in smoking-associated cancers. 2002. Oncogene 21: 7435-7451.

20. U.S. Department of Health and Human Services. The health consequences of involuntary smoking. A report of the Surgeon General. USDHHS, Public Health Service, Office of Smoking andHealth DHHS Publication No. 87-8398. Washington D.C.

21. National Research Council. Environmental tobacco smoke: Measuring exposures and assessing health effects. 1986. National Academy Press. Washington D.C.

See “Lung Cancer” page 15

schools reported that 55% hadreceived research funding from thetobacco industry. A recent study ofCanadian universities found that 11%r e c e ived tobacco research fundingfrom 1996-1999, while none had apolicy banning such funding; amongthe faculties of medicine, 25% hadr e c e ived tobacco research funding,and none had a policy to ban accept-ance of these funds.

Journals and scientific societieshave also debated these issues. Themedical section of the A m e r i c a nLung Association, through theAmerican Thoracic Society, has apolicy that its two journals will notreview papers reporting on researchfunded by the tobacco industry. TheJournal of Health Psychology alsowill not accept articles arising fromtobacco industry-sponsored research.The Society for Research on Nicotineand Tobacco does provide member-ship to tobacco industry scientists aslong as they are willing to sign astatement indicating, among otherthings, that they will “encourageresearch on public health efforts forthe prevention and treatment of ciga-rette smoking and tobacco use.” Still,concerns about the presence of tobac-co industry scientists at the Societyconferences and on its listserv contin-ue to be raised. Some members mayfeel that these concerns also extend toacademic researchers who acceptfunding from the tobacco industry.G iven that unive r s i t y, journal, re-search society and funding agencypolicies regarding tobacco industry-sponsored research are on theincrease, it is an opportune time fortobacco control researchers to discusswhether there are any conditionsunder which acceptance of such fundswould be acceptable, and if so, whatthose conditions might be.

IV. Selected BibliographyB a rnes D.E., Bero L. Industry-funded researchand conflict of interest: an analysis of researchsponsored by the tobacco industry through theCenter for Indoor Air Research. Journal of HealthPolitics, Po l i cy, and Law 1996;21:515-42.

B a rnes D.E., Bero L.A. Scientific quality of originalresearch articles on environmental tobacco smoke .Tobacco Control 1997;6:19-26.B a rnes D.E., Bero L.A. W hy rev i ew articles on thehealth effects of passive smoking reach different con-clusions. Journal of the American Medical A s s o c i a t i o n1 9 9 8 ; 2 7 9 : 1 5 6 6 - 7 0 .Bero L., Barnes D.E., Hanauer P., Slade J., GlantzS.A. Law yer control of the tobacco industry ’s ex t e r-nal research program. The Brown and Wi l l i a m s o nDocuments. Journal of the American MedicalAssociation 1995;274:241-247.Bero L.A., Galbraith A., Rennie D. Sponsored sym-posia on environmental tobacco smoke. Journal ofthe American Medical Association 1994;271:612-7.Bloch M. Tobacco industry funding of biomedicalresearch. Tobacco Control 1994;3:297-8.Blum A. Ethics of tobacco-funded research in U.S. medical schools. Tobacco Control 1992;1:244-5.Cancer Research UK. Preventing Lung Cancer:Isolating the Tobacco Industry. Rev i ewing the CancerResearch UK Code of Practice on Tobacco IndustryFunding to Universities. Consultation Document.J u ly 2002.Chapman S., Shatenstein S. The ethics of the cash r egister: taking tobacco research dollars. To b a c c oControl 2001;10:1-2.Cohen Jon. Tobacco money lights up a debate.Science 1996;272:488-94.Cohen J.E. Universities and tobacco money: some u n iversities are accomplices in the tobacco epidemic.British Medical Journal 2001;323:1-2.Cohen J.E, A s h l ey M.J., Goldstein A . O., Fe rrence R.,B r ewster J.M. Institutional addiction to tobacco.Tobacco Control 1999;8:70-4.D yer C. Tobacco company set up network of sympathetic scientists. British Medical Journ a l1 9 9 8 ; 3 1 6 : 1 5 5 5 .Fox B. J., Cohen J.E. Tobacco harm reduction: a callto address the ethical dilemmas. Nicotine & To b a c c oResearch (in press). Gibson B. An introduction to the controversy ove rtobacco. Journal of Social Issues 1997;53:3-11.Glantz S.A., Barnes D.E., Bero L., Hanauer P., SladeJ. Looking through a keyhole at the tobacco industry.The Brown and Williamson documents. Journal ofthe American Medical Association 1995;274:219-24.H i r s c h h o rn N., Bialous S.A., Shatenstein S. PhilipM o rris' new scientific initiative: an analysis. To b a c c oControl 2001;10:247-52.Hurt R.D. Buying credibility. Addiction1997;92:521-2.Schulman K.A., Seils D.M., Timbie J.W.,Sugarman J., Dame L.A., Weinfurt K.P., MarkD.B., Califf R.M. A national survey of provisions in clincial-trial agreements betweenmedical schools and industry sponsors. NewEngland Journal of Medicine 2002;3 4 7 : 1 3 3 5 - 4 1 .Turner C., Spilich G.J. Research into smokingor nicotine and human cognitive performance:does the source of funding make a difference?Addiction 1997;92:1423-6.

Continued from page 11

(Legacy) will not fund applicants thatare “in current receipt of any grantmonies or in-kind contribution fromany tobacco manufacturer, distribu-tor, or other tobacco-related entity, ”and expects that grantees will remainfree from tobacco-related contribu-tions for the duration of the grant. InPe n n s y l vania, institutions receiv i n gtobacco money are ineligible for set-tlement-based state funding forresearch and programming. Just asevidence about the negative healthimpacts of secondhand smoke had aradical effect on the tobacco-controlpolicy debate, the above funding poli-cies also have the potential to quicklylead to changes in university posi-tions about whether individual re-searchers can choose to accept tobac-co industry funds. The academiccommunity will have to address theethical issues that arise when theactions of one researcher limit thechoices of another.

III. Examples of Univers i t y, Jo u r n a land Research Society Po l i c i e sThere have been no systematic stud-ies exploring the behaviors of individ-ual researchers vis-à-vis acceptingresearch funding from tobacco com-panies. However, there have been afew studies in which institutions werethe unit of analysis. An Australiansurvey of institutions of higher learn-ing reported that 30% acceptedresearch funds from the tobaccoindustry in 1991-92, while 2% hadinstitutional policies not to acceptresearch funds from this source. A1997 study of tobacco associations inthe seven New Zealand universitiesfound that five had no formal policiesand one had a general policy to disas-sociate with research that “was not inthe public interest.” Based on ana n a lysis of papers published from1988-94, all UK medical schools butone had accepted tobacco money. Anearly 1990s survey of U.S. medical

See “Meeting” page 13

22. US Department of Health and Human Services. The Health Consequences of Smoking: Cancer. A report of the Surgeon General. Rockville, Maryland:US Department of Health and Human Services, Public Health Service, Officeon Smoking and Health, 1982. DHHS Publication No (PHS) 82-50179.

23. It’s Time to Focus on Lung Cancer Campaign (Sponsors: Cancer Care, Inc., Oncology Nursing Society, The Wellness Community and The CHEST Foundation). URL: http://www.lungcancer.org

24. Desch, C., Hillner, B.E., and Smith T.J.Economic considerations in the care of lung cancer patients. 1996. Curr.Opin. Oncol. 8:126-132.

25. Pfeifer, G.P. Beckman Research Institute, City of Hope Medical Center.“How does cigarette smoke induce cancer?” (TRDRP 6RT-0361).

Continued from page 13

26. Cote, R. University of SouthernCalifornia. “Detection of Lung CancerMicrometastases” (TRDRP 2IT-0037).

27. Shibata, D. USC. “ Direct Analysis ofLung Cancer Development & Progression” (TRDRP 3KT-0127).

28. Witschi, H. UC Davis. “Environmental Tobacco Smoke and Lung Cancer” (TRDRP 3RT-0022).

29. Reisfeld, R. Scripps Research Insititute. “Novel DNA vaccines for the treatment of lung cancer” (TRDRP 9RT-0017)

30. Morton, T. UC Riverside. “Monitoringexposure to tobacco-specific nitrosamines” (TRDRP 8IT-0058)

31. Shield, M. New Tobacco Products: Truth and Consequences. 2002. Burning Issues, 5(1): 7

32. Shields, P.G. Tobacco smoking, harmreduction, and biomarkers. 2002. J.Nat’l. Cancer Instit. 19: 1435-1444.

Tweedale G. Science or public relations?The inside story of the Asbestosis ResearchCouncil, 1957-1990. American Journal ofIndustrial Medicine 2000;38:723-34.Walsh R.A., Sanson-Fisher R.W. What universities do about tobacco industryresearch funding. Tobacco Control1994;3:308-15.Warner K.E. What’s a cigarette company todo? American Journal of Public Health2002;92:897-900.

V. AcknowledgementsThe author would like to thank the members ofthe Tobacco Funding Workshop PlanningCommittee for their helpful comments on earlierdrafts of this backgrounder. The views expressedabove do not necessarily reflect those of thePlanning Committee or of the institutions withwhich the author is affiliated.

Continued from page 13

MARCH 2003 NEWSLETTER

The Tobacco-Related Disease Research Program(TRDRP) supports innovative and creative research

that will reduce the human and economic cost oftobacco-related diseases in California and elsewhere.

TRDRP Newsletter is a publication of the

Tobacco-Related DiseaseResearch Program

Office of Health A f f a i r sUniversity of CaliforniaOffice of the President300 Lakeside, 6th FloorOakland, CA 9 4 6 1 2 - 3 5 5 0Phone: (510) 987-9870

Fax: (510) 835-4740e-mail: [email protected]

visit our new web site at:

w w w. t r d r p . o r g

AApprriill 77––1100,, 22000033Tobacco Control Section Project Directors Meeting

TCS will host the 2003 Project Directors Meeting. TRDRP will once again be on the program with a session on new directions in research on tobacco use.

Newport Beach, CA

AApprriill 2266––2299,, 22000033Community-Campus Partnerships for Health 7th Annual Conference

“Taking Partnerships to a New Level: Achieving Outcomes, Sustaining Change,”The CCPH is a nonprofit organization that promotes health through partnerships

between communities and higher educational institutions. The keynote speaker will be Dr. David Satcher, former US Surgeon General.

San Diego, CA

MMaayy 1166––2211,, 22000033The 99th International Conference of the American Thoracic Society

The conference will offer the latest information in clinical science, basic science and behavioral aspects of respiratory disease. For information visit http://www.thoracic.org/.

Seattle, WA

DDeecceemmbbeerr 33––44,, 22000033TRDRP 8th Annual Investigator Meeting

Please mark the date on your calendars and plan to join us for another enjoyable and intellectually stimulating conference. Details about venue, program, etc. will follow.

San Diego, CA

TRDRP StaffActing Director

Charles L. Gruder, Ph.D.

Research AdministratorsM.F. Bowen, Ph.D.Biomedical Sciences

Francisco Buchting, Ph.D.Epidemiology, Policy and

Economic Sciences

Phillip Gardiner, Dr.P.H.Social and Behavioral Sciences;

Nicotine Dependence

Administrative StaffShana Amenaghawon

Carlin ColbertSharon L. Davis

Teresa E. JohnsonWill Osuna

Jessica RatcliffChristine Tasto

P R E - S O RT E DF I R S T C L A S SU.S. POSTAGE

PAIDUNIVERSITY OF

CALIFORNIA

Tobacco-Related Disease Research ProgramUniversity of California—Office of the President300 Lakeside Drive, 6th FloorOakland, CA 9 4 6 1 2 - 3 5 5 01 6 7 2


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