11

Epidemiologic Techniques: How to Epidemiologic Techniques: How to Hide a Benzene Cancer Relationship:Hide a Benzene Cancer Relationship:You can’t regulate if the Companies LieYou can’t regulate if the Companies Lie

A case study of Shell’s A case study of Shell’s Benzene Historical Exposure Benzene Historical Exposure

Study (BHES)Study (BHES)

Based on documents produced in toxic tort discovery

The view expressed here are those of the authors; the documents are available for review at: http://egilman.com/browse.php?display=list&dir=benzene_apha/

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1948

Science deniedScience denied

Early 1900s

Benzene first reported as toxic

American Petroleum Institute says “Only safe concentration is zero.”

1977 Infante et al. published first cohort study assessing benzene/leukemia

1978 OSHA attempts to lower Benzene PEL from 10 ppm to 1 ppm 1978-80 Challenge by allied petroleum industry stays then overturns new PEL

1983 OSHA announces plans for new PEL by 1984, accepting evidence 1983 Shell Oil quickly conducts Benzene Historical Exposure Study (BHES)1984 Shell Oil presents findings to OSHA

1985 Shell Oil BHES publication #1

1986 Shell Oil BHES publication #2

1987 OSHA collects enough evidence to reinstate 1 ppm PEL

1987 on – Shell continues to publish data follow-ups of faulty BHES study.

1987 through 2006 – liability cases for occupational benzene exposure in courts.

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Means more workers die Means more workers die 1978-80 Challenge by allied petroleum industry stays

overturns lower PEL

1987 OSHA collects enough evidence to reinstate 1 ppm PEL

Estimated 30-490 extra deaths from this regulatory delay.

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Benzene & Shell refineriesBenzene & Shell refineries

Used in gasoline refinery processesUsed in gasoline refinery processes

Frequent addition to chemical Frequent addition to chemical blendsblends

Used as cleaning solvent, esp. Used as cleaning solvent, esp. during 1940s-50s. during 1940s-50s.

Benzene is understood to be a Benzene is understood to be a causal agent for Acute causal agent for Acute Myelogenous Leukemia (AML)Myelogenous Leukemia (AML)

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Shell refineries with excess deathsShell refineries with excess deaths

Wood River Manufacturing Complex Wood River Manufacturing Complex (WRMC) & Deer Park Manufacturing (WRMC) & Deer Park Manufacturing Complex (DPMC) Complex (DPMC)

Elevated leukemia rates noted in Elevated leukemia rates noted in mid-1970s as a result of a contractor mid-1970s as a result of a contractor worker lawsuit for compensation.worker lawsuit for compensation.

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MethodsMethods

1.1. Never admit a fault or wrong; Never admit a fault or wrong;

2.2. Never leave room for alternatives; Never leave room for alternatives;

3.3. Never accept blame; Never accept blame;

4.4. People will believe a big lie sooner People will believe a big lie sooner than a little one; and than a little one; and

5.5. If you repeat it frequently enough If you repeat it frequently enough people will sooner or later believe it.people will sooner or later believe it.

--LudeckeLudecke “I Knew Hitler”

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How to Hide…How to Hide…Step 1Step 1

Never admit a fault or Never admit a fault or wrongwrong

Reassure everyone that Reassure everyone that there’s no evidencethere’s no evidence

88

The Lie – AP Wire Press Release The Lie – AP Wire Press Release 19831983

Shell has found no link between benzene and the relatively high incidence of deaths from a certain type of leukemia in Texas & Illinois plants that handle the chemical

99

The Truth The Truth

1010

How to Hide…How to Hide…Step 2Step 2

Repeat the LieRepeat the Lie

Report new (and flawed) evidence Report new (and flawed) evidence that shows “no relationship” that shows “no relationship” between benzene and cancerbetween benzene and cancer

1111

1984 to OSHA/NIOSH1984 to OSHA/NIOSH

1212

1984 Lie to OSHA/NIOSH1984 Lie to OSHA/NIOSH

Our analysis has nevertheless failed to establish a causal relationship between benzene exposure and AML.

1313

1984 letter to OSHA/NIOSH1984 letter to OSHA/NIOSH

Basis of “no causal relationship” was Basis of “no causal relationship” was the report that 9 of 23 leukemia the report that 9 of 23 leukemia cases had “nil” exposure to benzene cases had “nil” exposure to benzene at the plants.at the plants.

Plus cases didn’t cluster in highest Plus cases didn’t cluster in highest exposure jobs.exposure jobs.

Exposure estimates were based on Exposure estimates were based on reconstructed histories of work reconstructed histories of work locations + peer interviews.locations + peer interviews.

1414

From a related study -You can fool From a related study -You can fool some of the people…1983some of the people…1983

“It must be recognized that this study’s negative result will generally be perceived as not highly persuasive” because.. Benzene, being highly volatile, may permeate nearly the entire facility and affect just “susceptible” individuals.”

1515

Methods: Never leave room for Methods: Never leave room for alternatives alternatives

Exposure assessments based on smellExposure assessments based on smell

“I fear we will be seriously underestimating the exposure”

Omitted from papers

1616

Methods: Never leave room for Methods: Never leave room for alternativesalternatives

The suggestion has been made previously that existing and available

extensive leak rate data on petroleum refineries be

combined with air pollution dispersion modeling

techniques…The notable lack of enthusiasm among your experts concerns me.

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Worker Exposures “disappeared”Worker Exposures “disappeared” There was little evidence on exact There was little evidence on exact

worksites of people assigned to refinery-worksites of people assigned to refinery-wide jobs such as laborer or carpenter. wide jobs such as laborer or carpenter.

This meant there was no basis to establish This meant there was no basis to establish ‘nil’ exposures‘nil’ exposures

Nil = nothing; naught; zero, having no value Nil = nothing; naught; zero, having no value or existenceor existence

1818

The Truth - Worker Exposures The Truth - Worker Exposures “disappeared”“disappeared”

The 7 “nil” exposure cases The 7 “nil” exposure cases (refinery-wide workers) (refinery-wide workers) were either probably or were either probably or definitely exposed definitely exposed

1919

““None determinable” becomes “Nil” None determinable” becomes “Nil”

BUT:BUT: “I do not know” “I do not know” ≠ ≠ “Zero”“Zero”

Case No. Reported exposure category Raw data shows…

I"none determinable to very slight" later “nil” Worked refinery-wide (1956-73)

III "none determinable" later “nil”Worked refinery-wide (intermittent, duration approx 1 yr)

V "none determinable" later “nil” Worked refinery-wide (1937-54)

VI "very slight" later “nil” Worked refinery-wide (1947-8 & 1962-3)

XI "360-950 ppm days" Worked refinery-wide (1941-74)

XIV "none determinable" later “nil” Worked refinery-wide (13 wks)

XV "none determinable" later “nil” Worked refinery-wide (1943-70)

2020

The Truth - Worker Exposures The Truth - Worker Exposures “disappeared”“disappeared”

Wood River leukemia cases had a combined total of 164 Wood River leukemia cases had a combined total of 164 years assigned to “refinery-wide” positions.years assigned to “refinery-wide” positions.

You cannot say “subjects did not work You cannot say “subjects did not work in jobs identified as having the in jobs identified as having the highest benzene exposures” if you highest benzene exposures” if you don’t know where they worked!don’t know where they worked!

2121

Worker Exposures “disappeared”Worker Exposures “disappeared”

In a minimum of 4 cases, Shell ignored In a minimum of 4 cases, Shell ignored evidence of benzene use as a evidence of benzene use as a cleaning agent. cleaning agent.

Case No. Reported exposure Benzene as cleaner?

Was this included in total exposure estimate?

II "1,300-10,400 ppm days" very likely in laboratory No

IV "25-70 ppm days" reported by interviewees No

VII "230-480 ppm days" reported by interviewees No

XI "360-950 ppm days" reported by interviewees No

2222

Worker Exposures “disappeared” Worker Exposures “disappeared”

Accounting for direct use of benzene Accounting for direct use of benzene as a cleaning agent (highest as a cleaning agent (highest exposure level) would have exposure level) would have shattered the claim that people with shattered the claim that people with AML didn’t work in the highest AML didn’t work in the highest exposure jobs. exposure jobs.

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Published LIEPublished LIE “ONLY ONE“ONLY ONE ≠ NONE≠ NONE

Cole P, McCraw D, Joyner R. Brief Communication: Cole P, McCraw D, Joyner R. Brief Communication: Excess Leukemia in a Refinery Population. Excess Leukemia in a Refinery Population. JOM JOM 1985/3/1;27(3):220-222.1985/3/1;27(3):220-222.

“This investigation has shown that the subjects did not work in jobs identified as having the highest benzene exposure”

“Five [of the leukemia cases] spent most of their years as maintenance [Laborer] workers, but it is not known if they were ever assigned to benzene units.”

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Data: “Data: “ONLY ONEONLY ONE ≠ NONE≠ NONE

“Of potential significance is that the highest exposure jobs are not reflected in the work records of the diagnosed leukemia case. For example only one [a maintenance worker] of the Wood River cases worked in the highest exposure jobs related to the Cumene Plant”

2525

How to Hide…How to Hide…Step 3Step 3

Populate the peer literature with Populate the peer literature with articles repeating the pointarticles repeating the point

Repeat the lie as often as possibleRepeat the lie as often as possible

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Repeat the Lie - 1986Repeat the Lie - 1986Austin H, Cole P, McCraw D. A Case-Control Study of Austin H, Cole P, McCraw D. A Case-Control Study of

Leukemia at an Oil Refinery. Leukemia at an Oil Refinery. Journal of Journal of Occupational Medicine. Occupational Medicine. 1986/11/1;28(11):1169-1986/11/1;28(11):1169-1173.1173.• Incorporated same design flaws as earlier SMR studyIncorporated same design flaws as earlier SMR study• Incorporated personnel misclassification errors, biasing Incorporated personnel misclassification errors, biasing

outcome to the nulloutcome to the null• Key personnel were not blinded – invalidating studyKey personnel were not blinded – invalidating study

““Thus the reason for the Thus the reason for the excess leukemia at this excess leukemia at this refinery was not identified.”refinery was not identified.”

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Repeat the Lie - 1989Repeat the Lie - 1989Wongsrichanalai C, Delzell E, Cole P. Mortality from leukemia and other diseases among workers at a petroleum refinery. Wongsrichanalai C, Delzell E, Cole P. Mortality from leukemia and other diseases among workers at a petroleum refinery.

J.Occup.Med. J.Occup.Med. 1989/2;31(2):106-111.1989/2;31(2):106-111.• Mortality study on WRMC populationMortality study on WRMC population• They admit a statistically significant elevated risk for leukemia at plantThey admit a statistically significant elevated risk for leukemia at plant• But argue against a benzene relationshipBut argue against a benzene relationship

Why? Key reason is Shell’s earlier two studies showed noneWhy? Key reason is Shell’s earlier two studies showed none

““Several observations argue to some extent against the hypothesis that the excess Several observations argue to some extent against the hypothesis that the excess [leukemia] is due to refinery [benzene] exposures.”[leukemia] is due to refinery [benzene] exposures.”

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Eliminate the - 1995Eliminate the - 1995Honda Y, Delzell E, Cole P. An updated study of mortality among workers at a petroleum manufacturing Honda Y, Delzell E, Cole P. An updated study of mortality among workers at a petroleum manufacturing

plant. plant. J.Occup.Environ.Med. J.Occup.Environ.Med. 1995/2;37(2):194-200.1995/2;37(2):194-200.• Update of 1989 mortality study, checking to see if excess leukemia is now disappearing.Update of 1989 mortality study, checking to see if excess leukemia is now disappearing.• Study incorporated systemic misclassification errors.Study incorporated systemic misclassification errors.• Published study excluded relevant negative findings from the internal version. Published study excluded relevant negative findings from the internal version.

““These results indicate that any occupational leukemogenic exposures at the plant have These results indicate that any occupational leukemogenic exposures at the plant have been reduced to the point where they are insufficient to cause leukemia.” been reduced to the point where they are insufficient to cause leukemia.”

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How to Hide a Benzene Cancer How to Hide a Benzene Cancer RelationshipRelationship

1.1. Reassure everyone that there’s no Reassure everyone that there’s no evidenceevidence

2.2. Report new (flawed) evidence that Report new (flawed) evidence that shows “no relationship” shows “no relationship”

3.3. Populate the peer literature with Populate the peer literature with articles repeating the pointarticles repeating the point

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Disclosures and contactDisclosures and contact Financial disclosure statementFinancial disclosure statement

• D. Egilman consults at the request of D. Egilman consults at the request of lawyers representing patients with AML lawyers representing patients with AML who have had benzene exposure. who have had benzene exposure.

Correspondence to:Correspondence to:David Egilman, MD, MPHDavid Egilman, MD, MPH

8 North Main Street8 North Main StreetSuite 404Suite 404Attleboro, MA 02703Attleboro, MA 02703508-226-5091508-226-5091

Authors: D. Egilman, Scout, L. Kol, S. BohmeAuthors: D. Egilman, Scout, L. Kol, S. Bohme