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  1. 1. Epidemiologic Techniques: How to Hide a Benzene Cancer Relationship: You can’t regulate if the Companies Lie A case study of Shell’s Benzene Historical Exposure 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 /
  2. 2. Science denied 1948 American Petroleum Institute says “Only safe concentration is zero.” 1987 on – Shell continues to publish data follow-ups of faulty BHES study. 1987 through 2006 – liability cases for occupational benzene exposure in courts. Early 1900s Benzene first reported as toxic 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
  3. 3. Means more workers die Estimated 30-490 extra deaths from this regulatory delay. 1978-80 Challenge by allied petroleum industry stays overturns lower PEL 1987 OSHA collects enough evidence to reinstate 1 ppm PEL
  4. 4. Benzene & Shell refineries <ul><li>Used in gasoline refinery processes </li></ul><ul><li>Frequent addition to chemical blends </li></ul><ul><li>Used as cleaning solvent, esp. during 1940s-50s. </li></ul><ul><li>Benzene is understood to be a causal agent for Acute Myelogenous Leukemia (AML) </li></ul>
  5. 5. Shell refineries with excess deaths <ul><li>Wood River Manufacturing Complex (WRMC) & Deer Park Manufacturing Complex (DPMC) </li></ul><ul><li>Elevated leukemia rates noted in mid-1970s as a result of a contractor worker lawsuit for compensation. </li></ul>
  6. 6. Methods <ul><ul><li>Never admit a fault or wrong; </li></ul></ul><ul><ul><li>Never leave room for alternatives; </li></ul></ul><ul><ul><li>Never accept blame; </li></ul></ul><ul><ul><li>People will believe a big lie sooner than a little one; and </li></ul></ul><ul><ul><li>If you repeat it frequently enough people will sooner or later believe it. </li></ul></ul>- Ludecke “I Knew Hitler”
  7. 7. How to Hide… Step 1 Never admit a fault or wrong Reassure everyone that there’s no evidence
  8. 8. The Lie – AP Wire Press Release 1983 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
  9. 9. The Truth
  10. 10. How to Hide… Step 2 Repeat the Lie Report new (and flawed) evidence that shows “no relationship” between benzene and cancer
  11. 11. 1984 to OSHA/NIOSH
  12. 12. 1984 Lie to OSHA/NIOSH Our analysis has nevertheless failed to establish a causal relationship between benzene exposure and AML.
  13. 13. 1984 letter to OSHA/NIOSH <ul><li>Basis of “no causal relationship” was the report that 9 of 23 leukemia cases had “nil” exposure to benzene at the plants. </li></ul><ul><li>Plus cases didn’t cluster in highest exposure jobs. </li></ul><ul><li>Exposure estimates were based on reconstructed histories of work locations + peer interviews. </li></ul>
  14. 14. From a related study -You can fool some of the people…1983 <ul><li>“ 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.” </li></ul>
  15. 15. Methods: Never leave room for alternatives <ul><li>Exposure assessments based on smell </li></ul>“ I fear we will be seriously underestimating the exposure ” Omitted from papers
  16. 16. Methods: Never leave room for alternatives 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. Rejected
  17. 17. Worker Exposures “disappeared” <ul><li>There was little evidence on exact worksites of people assigned to refinery-wide jobs such as laborer or carpenter. </li></ul><ul><li>This meant there was no basis to establish ‘nil’ exposures </li></ul><ul><li>Nil = nothing; naught; zero, having no value or existence </li></ul>
  18. 18. The Truth - Worker Exposures “disappeared” <ul><li>The 7 “nil” exposure cases (refinery-wide workers) were either probably or definitely exposed </li></ul>
  19. 19. “ None determinable” becomes “Nil” <ul><li>BUT: “I do not know” ≠ “Zero” </li></ul>Worked refinery-wide (1943-70) &quot;none determinable&quot; later “nil” XV Worked refinery-wide (13 wks) &quot;none determinable&quot; later “nil” XIV Worked refinery-wide (1941-74) &quot;360-950 ppm days&quot; XI Worked refinery-wide (1947-8 & 1962-3) &quot;very slight&quot; later “nil” VI Worked refinery-wide (1937-54) &quot;none determinable&quot; later “nil” V Worked refinery-wide (intermittent, duration approx 1 yr) &quot;none determinable&quot; later “nil” III Worked refinery-wide (1956-73) &quot;none determinable to very slight&quot; later “nil” I Raw data shows… Reported exposure category Case No.
  20. 20. The Truth - Worker Exposures “disappeared” <ul><li>Wood River leukemia cases had a combined total of 164 years assigned to “refinery-wide” positions. </li></ul><ul><li>You cannot say “subjects did not work in jobs identified as having the highest benzene exposures” if you don’t know where they worked! </li></ul>
  21. 21. Worker Exposures “disappeared” <ul><li>In a minimum of 4 cases, Shell ignored evidence of benzene use as a cleaning agent. </li></ul>No reported by interviewees &quot;360-950 ppm days&quot; XI No reported by interviewees &quot;230-480 ppm days&quot; VII No reported by interviewees &quot;25-70 ppm days&quot; IV No very likely in laboratory &quot;1,300-10,400 ppm days&quot; II Was this included in total exposure estimate? Benzene as cleaner? Reported exposure Case No.
  22. 22. Worker Exposures “disappeared” <ul><li>Accounting for direct use of benzene as a cleaning agent (highest exposure level) would have shattered the claim that people with AML didn’t work in the highest exposure jobs. </li></ul>
  23. 23. Published LIE “ONLY ONE ≠ NONE <ul><li>Cole P, McCraw D, Joyner R. Brief Communication: Excess Leukemia in a Refinery Population. JOM 1985/3/1;27(3):220-222. </li></ul>“ 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.”
  24. 24. Data: “ ONLY ONE ≠ 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”
  25. 25. How to Hide… Step 3 Populate the peer literature with articles repeating the point Repeat the lie as often as possible
  26. 26. Repeat the Lie - 1986 <ul><li>Austin H, Cole P, McCraw D. A Case-Control Study of Leukemia at an Oil Refinery. Journal of Occupational Medicine. 1986/11/1;28(11):1169-1173. </li></ul><ul><ul><li>Incorporated same design flaws as earlier SMR study </li></ul></ul><ul><ul><li>Incorporated personnel misclassification errors, biasing outcome to the null </li></ul></ul><ul><ul><li>Key personnel were not blinded – invalidating study </li></ul></ul><ul><ul><li>“ Thus the reason for the excess leukemia at this refinery was not identified.” </li></ul></ul>
  27. 27. Repeat the Lie - 1989 <ul><li>Wongsrichanalai C, Delzell E, Cole P. Mortality from leukemia and other diseases among workers at a petroleum refinery. J.Occup.Med. 1989/2;31(2):106-111. </li></ul><ul><ul><li>Mortality study on WRMC population </li></ul></ul><ul><ul><li>They admit a statistically significant elevated risk for leukemia at plant </li></ul></ul><ul><ul><li>But argue against a benzene relationship </li></ul></ul><ul><ul><ul><li>Why? Key reason is Shell’s earlier two studies showed none </li></ul></ul></ul><ul><ul><li>“ Several observations argue to some extent against the hypothesis that the excess [leukemia] is due to refinery [benzene] exposures.” </li></ul></ul>
  28. 28. Eliminate the - 1995 <ul><li>Honda Y, Delzell E, Cole P. An updated study of mortality among workers at a petroleum manufacturing plant. J.Occup.Environ.Med. 1995/2;37(2):194-200. </li></ul><ul><ul><li>Update of 1989 mortality study, checking to see if excess leukemia is now disappearing. </li></ul></ul><ul><ul><li>Study incorporated systemic misclassification errors. </li></ul></ul><ul><ul><li>Published study excluded relevant negative findings from the internal version. </li></ul></ul><ul><ul><li>“ These results indicate that any occupational leukemogenic exposures at the plant have been reduced to the point where they are insufficient to cause leukemia.” </li></ul></ul>
  29. 29. How to Hide a Benzene Cancer Relationship <ul><li>Reassure everyone that there’s no evidence </li></ul><ul><li>Report new (flawed) evidence that shows “no relationship” </li></ul><ul><li>Populate the peer literature with articles repeating the point </li></ul>
  30. 30. Disclosures and contact <ul><li>Financial disclosure statement </li></ul><ul><ul><li>D. Egilman consults at the request of lawyers representing patients with AML who have had benzene exposure. </li></ul></ul><ul><li>Correspondence to: </li></ul><ul><ul><ul><li>David Egilman, MD, MPH </li></ul></ul></ul><ul><li>8 North Main Street </li></ul><ul><li>Suite 404 </li></ul><ul><li>Attleboro, MA 02703 </li></ul><ul><li>508-226-5091 </li></ul><ul><li>Authors: D. Egilman, Scout, L. Kol, S. Bohme </li></ul>