Document rpdrDkOXB55vK5D1NKyonRKXV

Clever Deception: Judging Science by Funding Source Instead of Intellectual Content Dennis J. Paustenbach, Ph.D. DRI Toxic Torts and Environmental Law Seminar Phoenix, Arizona March 20, 2009 1 . - .V Overview o Dr. Michaels' claims My take on his claims Five flaws in his beliefs What Michaels avoids The impact of Michaels and his book i 2 Initially... I thought that putting together this presentation would be straightforward - - it w as n o t! I collected Dr. M ichaels' written m aterials and carefully read and reread his book H e identified nearly 100 persons and organizations to be "m anufacturing uncertainty" or "part of the charade" i ? r 3 Deciding the Proper Approach My son, a journalism major, confided that I needed to shed the more polite and academic tone in order to stand up to the ferocity of the claims. ; 4 How Ferocious Are His Claims? `T h e y and the larger, w ealthier industries for which they work go through the motions w e expect of the scientific enterprise, salting the literature with their questionable reports and studies. N evertheless, it is all a charade. T he work has one overriding motivation; advocacy for the sponsor's position in civil court...." - (Michaels, Doubt is Their Product, or, "Michaels' Book," p. 460) 5 ' V . V . . How Aggressive is Dr. Michaels? "[Product defense companies] ...combine science with public relations to help clients avoid regulation and litigation." "Some of the big ones are Exponent, Gradient, C hem R M : and the Weinberg group." When FastCompany asked, "Are there examples of product defense firms rescuing legitimate products?" Michaels responded: "Those examples are rare, if they exist at all." - Interview with FastCompany, Jan. 14,2009 6 Areas Where Dr. Michaels and I Appear to Disagree: The regulated community (including governments and municipalities) is entitled to conduct studies which contribute to the body of scientific knowledge Scientific research should be evaluated on the merits of the study, not the source of the funding 7 Hopeful Areas of Agreement More and better studies are NOT always necessary to resolve many issues of science It is beneficial for journals to insist that scientists have a high level of disclosure 8 .V Other Hopeful Areas of Agreement All scientists should be expected to provide an honest and complete presentation of their results "The best evidence should be used to regulate chemicals." (p. 60, Michaels' Book) 9 H o w e v e r... I strongly disagree with his stream of accusations Intuygrvvfv awfighting g rfm m fi'i Kguktien by fomenting, t m iifie unetw iniv ItVVf.bymv4du.fMci>etian?\]*(.ih- heir Product F ifrmaMWKIM>'Uiw t'~ ^ f ao M iK .Il 6 v m M t r**N K **K vt A . K-* M l4swu UAi^w4, iikv^mooj'*^.ubwi<Ka,)triasVjiwiu.a>MAVnnvi T0V*XrU.Wt.t'lpwCM>riri>wr*A*HJcat*trmmli*MM* iki*xusUduxti^-^'^*il'k^AiWi*v/m)wniiIirni.fali-r f A-* W-TiOitH-. '<nvi fc--Jirat- UmHi >iw.mt khi mIr fiui wmnciuulkkula.!) 10 Allegations of Consultant Alchemy "When product defense specialists cannot get the raw data required for a reanalysis, they have even been known to make them up." Michaels' Book, p. 52 My Six General Views Michaels, Egilman and other pundits are skilled at telling half the story, providing a misleading, if not deceptive version of the facts A dynamic tension in science is to be expected and the struggle is heightened in a courtroom situation 12 JAMA Rothman KJ, JAMA, 1993 ThaJournalcHteAmericanIteefcdJtoxfefaii ah Rtfta Reserved. AppHcafcteFARSDFARSRestrictions Applyto GovernmentUse. ia^agpJfcii^Afc Volume 259(21), 2 .Ton3993, pp2732-2784 Conflict of Interest: The New McCarthyism in Science Rothman,Kenneth J. But... to question scientists based on affiliation echoes McCarthyism and is inconsistent with honest scientific inquiry Weird Science The pundits fail to acknowledge that very bad science and medicine has been put before juries for decades 14 My Six General Views Dr. Michaels and his likeminded colleagues employ fear tactics and are not transparent regarding the real uncertainties Unfortunately, his claims are often inflammatory and abusive, frequently bordering on libel against those who do not share his views Hunter SJhom pson d u lle r c? H e ll's /n g e Is A ScHroge Journey to the H eartof Ih e Am erican D ream JjS ta tc t ?;t v i Sfeo i?-- k - Part of a Coordinated Effort ? These Pundits Claim to Be on the Side of the A ngels... Those who question the scientific basis of proposed regulatory standards are, by definition, "mercenaries" whose views are not to be trusted Dr. Michaels Is Not Just Another Voice - He Is Quickly Becoming the "Go-To" Spokesman for Environmental Health I believe he has the ability to generate a sea change in the regulatory and litigation landscapes 18 Flawed belief #1: Health effects claimed by plaintiffs are invariably due to chemical exposures Claims that every exposure to a single asbestos fiber above background contributes to risk of future disease... excluded! click onthe location ofyourinjury Neurologist claiming plaintiff developed multiple chemical sensitivities after exposures during home remodeling because of "limbic kindling"...excluded! 20 ii Other Courtroom Claims A single exposure to floor wax remover by pregnant woman led to birth defects...excluded! Childhood leukemia caused by exposure to chicken manure...excluded! r i 21 ChemRisk Publications used to Rebut Plaintiff Expert Claims *VFJk , 1CCcUMprtmtttiO'iru<iwS*-VWTr*W*t*"J*t*>trtVt iU>iC7d^7 1` W-JKr F i Occupational Exposure to Airborne Asbestos from Phenolic j Molding Material (Bakeilte) During Sanding, Drilling, and j Related Activities r Wotma MowaV Michael Bono,1 R.J. Le,9Susan Tamburoflo,1 , n'EnipdonDotrtar.tmonotoPPt^tu^k.iaCtooilnwbrHaei h, ..............- -- i 'JFbUi|)^VWweDn, hxnoMnnfl,,. dfcitrtnt nwW,Pw-n5f>aitt i. . SasS^!*tPm3----- t/-WMMiS/mfrd*s4v44te.**i^tVlwWiAE)rrdi*rkim.mm*mtUd/U1%tmHfiyrtftUMUt *TT,tdnrc,ins.*Ed | Occupational exposure to airborne asbestos from coatings, mastics, and adhesives j DENN3S J. PAUSTENBAC H." AM Y SAGE.'' MtCHA CL BONO1" AND 1TONNA MOWAT" ! isjrM u ra il. Ctt&VHb- L i I 'f M . Hal-T Ofa>. VXA [ !I 1DiCo5Ooo2p!8n:y-n71rJi30go9-h1f4Tt0/0oW2o2V$00c100o229l,oT0840ga1yy+0l0o.0u2r0l9&E0m0F7ria1ron4c9oi6ms cnLil Health. Pan A , 65: 1065- 1919?2002 T/Tiahywtofft&h Ficialennd es > AIRBORNE CONCENTRATIONS OF BENZENE AND MINERAL SPIRITS (STODDARD SOLVENT) DURING CLEANING OF A LOCOMOTIVE GENERATOR AND TRACTION MOTOR Flawed belief #2: Corporations should not comment on governmental decision-making Alas, we are a democratic society - - and corporations are entitled to defend themselves against unwarranted claims Michaels and others are attempting an "end-around" to legitimate scientific dialogue by manipulating public sentiment 23 PL* Flawed belief #3: Published studies authored by companies and consulting firms are, by definition, not to be trusted ! have seen no indication that scientific research conducted by consulting firms or corporations has been flawed or less valid than research conducted by universities or the government ehpenlne.org EN V IR O N M EN TAL HEALTH PERSPECTIVES Rethinking the Threats to Scientific Balance in Contexts of Litigation and Regulation William H Freudenburg 24 Flawed belief #4: Studies by Consultants and Professors Supporting Plaintiffs Do Not Require Careful Scrutiny One need only review a few of the studies by many plaintiff experts to know this is not true nJwtA C3eWna5te* s!C8JMl ! ir v i tC *S l& MW #V1AS *-t*r**m . -CVHT ABRADING OF UNION CARBIDE ASBESTOS- CONTAINING BAKELITE FIBER RELEASE STUDY Vyu*ri**w ij William E. Longo AUGUST 2004 25  My Position Since 1 9 8 8 ,1have recommended that the consulting community should publish their research in toxicology journals - A Radical Position? ASSESSMENT OF THE DEVELOPMENTAL RISKS RESULTING FROM OCCUPATIONAL EXPOSURE TO SELECT GLYCOL ETHERS WITHIN THE SEMICONDUCTOR INDUSTRY Dennis J. Paustenbach McLaren-Chemrisk, Rancho Cordova, California This risk assessment evaluates the potential human hazards o f effects posed by exposure to 2-ethoxyethanol (2-EE), 2-ethoxyeth methoxyethanol (2'ME), and 2-methoxyethanol acetate 2-MEA) used in sem iconductor manufacturing. These g lycol ethers are photoresists used in the wafer fabrication process. The available mental toxicology o f these glycol ethers indicates that each cai offspring o f pregnant animals that have been exposed to teladvel tkms. fo r these chemicals, the ratio o f the lowest dose which pregnant animals (A} and the lowest dose which produced de 26 Flawed belief #5: Studies that Question Regulatory Initiatives Are Misdirected o For decades, the merits of a scientific study were judged on their scientific Litigation-Generated Science: Why Should We Care? Leslie f. Bodea a n d D avid Q zonoff DrpirtT m ofEnvironmental HtaMi.Bottcn University ftthool of PubfioHoahh, Boston,Mao content...not the source of funding Would you rather live in a world where the science is not what is debated - - but tiCKE 1 1 I J 4 N h O fru ir derttkns <m t ir cernsod tuferj . U n te ti me 'bsntm em talt, fo t* Jadfe Afcr JCeiintfci ir a t i dm l t dotte ftc tbe pupo ef (stipatoli btcJd bemkjea totetutoput sanArrdiafadaiotftitOtjr duootberestete* iOdWenKcTeWnnEoS*hWrBeEnuaifpBettoAfilejtpfeoMptat iilm i by (O M liaii^lltijtxiwtpHKm Ed ale tot a jabot af 'pdIabsootefttctrrteiiennStgtHifetiCertftiuuoptetocaubJtitprIselnrdlaeittppia<tpKfaafuitctcrltafxainpitf.noatiisyiui'sbMpieEe.txtfirimhraemteoteah*utatUlfrndigiaheale5Dlj3buaoepJsroidofatditoetersaetrenbdtnraaiatrisyadbompupjticucdacst1a-pltiiamrtana:efsatiue!spddcpheiareniiilttsreeupmaeonbAnricssitodobirlaeheansitoncoedir C o ita D fuTta n o tte : riti itotn ito jeese in tu tp x il. Gn trcracji Buy m vnfrgenomi u d spply ta e li orm a tosassejtlnt b ede t and rd de iti eie opmtwoin tKePfr mg.ito' si hfanodknl teStmth, oonflct f i t, Xto tj, ipujoo, peer tmiew. rtgahtafy sciasoe,1sirwienae>e-neod Utjpsiioo. tadeatifirc eridjeUtuew. iwrnmj iB^e7euMTMAtjirp*fOso11m* 117-122 (O . rather, what "team" the debater is on 27 My Position O Bad Science has often found its way into regulations and the courtroom Michaels has confused "creating doubt" with "checking against reality" 28 (A) The "Phantom Epidemic" of Silicosis "A golfer is m ore likely to hit a hole-in-one than an occupational m edicine specialist is to find a single case of both silicosis and asbestosis. [They] parked a van in som e parking lots and found over 4 ,0 0 0 such cases." "Dr. Barry Levy diagnosed approxim ately 1,389 Plaintiffs in this M DL. All told, Dr. Levy perform ed 1,239 diagnostic evaluations in 72 hours." - Less than 4 minutes per evaluation... "T h ese diagnoses w ere driven by neither health nor justice: they w ere m anufactured for m oney." Judge Janis Jack, In Re: Silica Products Liability Litigation, MDL Docket #1553, Order #29 (B) Silicone Breast Implants and Risk of Disease "Substances known to be in breast implants do not provide a basis for health concerns." - Institute of Medicine, Safety of Silicone Breast Implants, 1999 Before these studies were released, however, several plaintiffs had won multimillion dollar verdicts, leading to a $4.25 Billion class action settlement; the largest in history up to that time 30 Coincidentally... SKAPP, headed up by David Michaels and others, is generously funded by the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability Litigation Interestingly, the junk science that led to the collapse of several prominent companies lives on to support SKAPP ...who now advocate repeal of Daubert and Frye 31 (C) Misleading Testimony Can Influence Judges and Juries Some plaintiff experts use "tyndall lighting" to provide an impression of "real" exposures to asbestos But, this lighting can not differentiate asbestos from house dust or illuminate respirable particles (as they are too small) 33 (D) " Popcorn lung" is clearly linked to diacetyl exposure and every claim warrants a m ultim illion dollar verdict tmAicti(tecvpEavtnxi Ukatfc dot UU(ttfrtUU>*(30ti-QJ?1st Popcorn lung and bronchiolitis obliterans: a critical appraisal Ik.via fil.lhndlh *!) rid Udfl Many alternative disease processes are often in play in worker populations... - Occupational asthma, hypersensitivity pneumonitis, smoking... Michaels does not seem to believe there is any remaining uncertainty... However, NIOSH and OSHA agree that the agent and mechanism of disease is still unclear 33 Examples Where Regulatory Agencies or Other Authorities Initially Got it Wrong Saccharin increases the risk of several cancers (1969) Bendectin and birth defects (1970s) - origin of Daubert Coffee increases the risk of pancreatic cancer - Prof. MacMahon, Harvard 1981 34 Was "Uncertainty" Warranted? Risks of dioxins in breast milk outweigh the benefits of breast feeding (Schecter, 1986) Mercury in vaccines increases the risk of autism (2006-2009) Mercury in fish outweighs the overall benefits of seafood to human health (2008-2009) 35 O Although Dr. Michaels' book, his articles in the Washington Post, his blog and his lectures focus on " environmental and occupational health," it seems that the real target is the courtroom... S K hBB ;M iQ r- :..r~ iBKSkSk.i 'WSffiKi 36 Egilman " Papers" and Testimony M ich a e ls' Book Chapters 37 Consultants Corrupting Science (2005) Maximizing Profit and Endangering Health; O Corporate Strategies to Avoid Litigation and Regulation SUSANNA RANKIN BOHME, AM. JOHN ZORABEDIAN. DAVID S EGIIMAN, MD, MPH [Hi J OCCUR ENVIRON WEALTH 2006,1 f;638-646 15 The BushAdministrations Political Science DAVID MICHAELS DOUBT IS THEJR PRODUCT (2008) 38 Brake Dust Abus o f Epidemiology: v tAouAtosmbeosbtoilse LMiaabniluityfacturers Manufacture a Defense DAVID S. EG ILM AN, M D , M PH, M A R IO N A BILLINGS, M SC INI J OCCUR ENVIRON HEALTH 2006s 11:160-371 I Workplace Cancer before OSHA W AITING FOR THE BODY COUNT DAVID M ICHAELS DOUBT IS TH EIR PRODUCT (2008) Popcorn Lung Popcorn-worker Lung Caused by (2007) Corporate and Regulatory Negligence: O An Avoidabl Tragedy DAVID EGILMAN, MD, MPH, CAROLINE MAILLOUX, CLAIRE VALENTIN INT J O CCU P ENVIRON HEALTH 2007; 13:85-98 10 Popcorn Lung DAVO SIDH AMGIIVCEHS AUPELS DUJ6T IS THEIR PRODUCT (2 0 0 8 ) 40 Beryllium (2002) Anything But Beryllium: The Beryllium Industry's Corruption of Safety Information DAVID EGILMAN, MD, MPH AMERICAN JOURNAL O f INDUSTRIAL MEDICINE 42:270- 2 7 ) <2002) Defendingthe TaxicabStandard DAVID MICHAELS DOTJBT IS THEIR PRODUCT Chromium (2006) Corporate Corruption of Science-- The Case of Chromium(VI) DAVID E6ILMAN, MD, MPH, SCOUT, PHD INT J OCCUP ENVIRON HEALTH 2004,12:149-176 9 Chrome-Plated M ischief DAVID MICHAELS DOUBT IS THBIR PRODUCT (2008) 42 Benzene Manipulated Data in Shell's (2007) Benzene Historical Exposure Study Egilman David; Scout; Kol Lerin; Hegg Lea Anne; Bohme Susanna Rankin International Journal of Occupational and Environmental Health, Vol 13, No (2007) 6 Tricks o f the Trade HOW MERCENARY SCIENTISTS MISLEAD YOU DAVID M ICHAELS DOUBT IS THEIR PRODUCT (2008) Is it any coincidence that these chemicals have represented the lion's share of most toxics cases? 44 Have the W ritings And Speaking Engagements of Dr. Michaels Altered The Regulatory and Legal Landscape? 45 Intimidating Corporations... Over the past three years, there has been a precipitous drop in the participation of the regulated community in offering comments or providing scientific input to the rulemaking process Might they fear becoming the "new" focus for Dr. Michaels or like-minded NGOs ? i 46 What Is the End Game? To intimidate experts and keep them from participating in the regulatory arena and in litigation? To "stonewall" legitimate research by corporations and consultants from being published? To reverse Daubert and Frye? 47 Chapter 13 of his book, entitled "Daubert: The most influential supreme court ruling you've never heard o f '... Michaels notes...after having his credibility challenged for testifying in a Daubert challenge... "These Daubert hurdles were unnecessary." [p. 175, Michaels' Book] 48 Intimidating Corporations From Participating in Rulemaking For example, during the recent EPA Asbestos Science Advisory Board (SAB) m eetin g ... ...guess who submitted letters of outrage regarding the proposed appointment of experts to the asbestos SAB? ir 49 Letters Asking EPA to Disqualify Nominated Experts Name Roger Worthington, Esq. Mr. Jeffrey Simon Ms. Maggie Van Norman Ms. Caroline K Shining Mr. Christian Hartley Mr. James Nevin Dr. Jennifer Sass Mr. Richard Wiles Mr. Robert Paul Mr. Tom Lent R o le Plaintiff lawyer in asbestos Plaintiff lawyer in asbestos Plaintiff lawyer in asbestos Plaintiff lawyer in asbestos Plaintiff lawyer in asbestos Plaintiff lawyer in asbestos NRDC, coauthor with Egilman Environmental Working Group Plaintiff lawyer in asbestos Health Building Network Mr. Victor Schwartz Defense attorney, also a Professor 51 1 rtsi. Guess who appeared to deliver oral testimony before the Asbestos SAB? H int...it wasn't academic professors, NGOs, or consultants fo r industry. 51 Speakers at Convening of EPA SAB The majority were attorneys for plaintiffs in asbestos cases or their experts 52 Presented Oral Comments to Asbestos EPA SAB (July 2008) Name o Dr. David Egilman Mr. Jon Ruckdeschel Mr. Rick Nem eroff Dr. Richard Lernen Mr. Scott Frost Ms. Linda Reinstein Mr. Terry Lynch Ms. Randy Rabinowitz Dr. Michael Silverstein Dr. Laura Welch Dr. Franklin Mirer Dr. William Cleveland Dr. Barry Castleman Mr. James Morris Ms. Pat Girtin R o le Adj Professor and Plaintiff Expert Plaintiff Lawyer in Asbestos Plaintiff Lawyer in Asbestos Professor, Plaintiff Expert in Asbestos Plaintiff Lawyer in Asbestos Scientist from Labor Union Representative of Labor Union American Association of Justice MD, contributor to the SKAPP blog Plaintiff Expert in Asbestos Professor, Scientist from Labor Union Physician and apparent plaintiff expert Plaintiff Expert in Asbestos Husband of asbestos plaintiff W ife of asbestos plaintiff Dr. Suresh Moolgavkar Professor and Defense Expert in Asbestos o Have the Writings And Speaking Engagements of Dr. Michaels Altered The Regulatory and Legal Landscape? Absolutely!! 54 Recognizing that Dr. Michaels has often cited statements from the late Senator Moynihan...! w ill cite one of my favorites: "Everyone is entitled to his own opinion, but not to his own facts."