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TC Online First, published on May 12, 2015 as 10.1136/tobaccocontrol-2015-052271 Industry watch
Tobacco documents reveal questionable professional recertification by industry menthol expert Daniel Stevens,1 Stanton Glantz1,2,3,4 1
Center for Tobacco Control Research and Education, University of California San Francisco, San Francisco, California, USA 2 Philip R. Lee Institute for Health Policy Studies, University of California San Francisco, San Francisco, California, USA 3 Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California, USA 4 Department of Medicine, University of California San Francisco, San Francisco, California, USA Correspondence to Professor Stanton Glantz, Center for Tobacco Control Research and Education, Suite 366 Library, 530 Parnassus, University of California San Francisco, San Francisco, CA 94143-1390, USA; [email protected] Received 6 February 2015 Accepted 24 April 2015
To cite: Stevens D, Glantz S. Tob Control Published Online First: [please include Day Month Year] doi:10.1136/ tobaccocontrol-2015052271
Jonathan Daniel Heck, PhD, a board certified toxicologist, career scientist at Lorillard Tobacco, and industry expert on menthol, served as an industry representative on the Food and Drug Administration (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) from 2010 through 2014. In 2011, Heck was the lead author of the “Industry Menthol Report; Menthol Cigarettes: No Disproportionate Impact on Public Health”1 submitted to the FDA. To become certified and maintain his status as a board certified toxicologist, Heck took a certification examination and multiple recertification examinations administered by the American Board of Toxicology. Initial certification required passage of a three-part examination. Recertification occurs through an open-book examination.2 On 11 July 1996, Heck sent a memo to his supervisor at Lorillard describing his plans for completing the American Board of Toxicology recertification examination, saying: “This is a nuisance, but I need to spend some ‘quality time’ on this 300-question, every 5 years, take-home test. It’s due Aug. 9. I’m about halfway done with it. In the good old days I could just ask the Life Sciences staff to cheerfully take on a 25-question block or two.”3 In 2014, Lorillard advanced Heck as an expert witness for its defence in connection with products liability cases in Florida (the ‘Engle progeny’) to testify on tobacco and health, including that “menthol, as used in cigarettes, does not increase the risk of diseases associated with cigarette smoking”.4 In a deposition for one of these cases, Heck confirmed that he gave questions to the staff under his supervision at the time (ref 5, p 272), and acknowledged the impropriety of having someone else answer the questions (“I don’t feel that having another person answer one’s questions is proper” (ref 5, p 304), but denied any wrongdoing, arguing that the examination was open-book and, as such, he was allowed to consult with other colleagues (ref 5, p 277–8). In contrast to what he wrote in 1996, in the deposition Heck, said he merely collected his staffs’ opinions and compared them to his own (ref 5, p 275–6). He also said he was being facetious and joking (ref 5, p 305, 345), and that assigning the staff questions was part of their training and development, to prepare them for their own certification examinations (ref 5, p 304–5). Heck’s counsel offered a 1988 American Board of Toxicology newsletter, which stated that candidates may “[discuss] a question with an expert who can explain the appropriate answer since this activity is a legitimate learning process” (ref 5, p 989), and a statement from Dr A Wallace Hayes, an American Board of Toxicology officer, that
“a recertification candidate may utilise all available resources, including references to books, journals and educational seminars to complete the examination. A recertification candidate may also engage in substantive consultation with experts and colleagues” (ref 5, p 1003–4). At the time, Wallace was Vice President of Biochemical/Behavioral Research and Development at the R.J. Reynolds Tobacco Company.6 7 Whether Heck merely consulted with his staff on the questions or, as he states in the 1996 memo, assigned his staff questions, he took advantage of the open-book nature of the examination. The FDA, other authorities and the scientific community in general, should consider this incident when assessing the reliability of materials Heck produces. Furthermore, FDA should conduct a thorough search of the Legacy Tobacco Documents Library for anyone nominated for an industry position on TPSAC to ensure no ethical issues exist. Funding This work was supported in part by grant CA-87472 from the National Cancer Institute. SG is American Legacy Foundation Distinguished Professor in Tobacco Control. Competing interests None declared. Provenance and peer review Not commissioned; externally peer reviewed. Data sharing statement All data used in this manuscript are publicly available at the Legacy Tobacco Documents Library.
REFERENCES 1
2 3
4
5
6
7
Heck J, Hamm L Jr, Lauterbach J. The Industry Menthol Report, Menthol Cigarettes: No Disproportionate Impact on Public Health. 23 March 2011. http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/TobaccoProductsScientificAdvisory Committee/UCM249320.pdf (accessed 15 Jan 2015). Candidates Section. American Board of Toxicology. http://www. abtox.org/candidates.aspx (accessed 3 Feb 2015). Heck J. Memo Outlining Recent Activities. 11 July 1996. Lorillard. http://industrydocuments.library.ucsf.edu/tobacco/docs/xtnk0076 (accessed 15 Jan 2015). Greenberg Traurig, PA. (Attorneys For Defendant Lorillard Tobacco Company) Defendant Lorillard Tobacco Company’s Expert Witness Disclosure in the Circuit Court of 17th Judicial Circuit in and for Broward County, Florida Complex Litigation Unit Case No. 08-80000 (27) Judge John J. Murphy, Iii. In Re: Engle Progeny Cases. Tobacco Litigation Pertains to: Heather Irimi, as Personal Representative of the Estate of Dale Moyer Case No.: 08-026337. 14 April 2014. http://industrydocuments.library.ucsf.edu/tobacco/ docs/zgwv0222 (accessed 22 Apr 2015). Deposition of Jonathan Daniel Heck. Complex Litigation Case No. 08-80000(19). Circuit Court of the Seventeenth Judicial Circuit, Broward County, Florida. On behalf of plaintiffs Scott P. Schlesinger, Jonathan R. Gdanski. 15 May 2014. http://industrydocuments.library. ucsf.edu/tobacco/docs/pjvv0220 (accessed 4 Feb 2015). Wallace Hayes A. RJR. Statement of A. Wallace Hayes on Behalf of RJ Reynolds Tobacco Company 04 April 1989. http://beta. industrydocuments.library.ucsf.edu/tobacco/docs/xsmj0086 (accessed 27 Mar 2015). Hayes W. Affidavit of Wallace Hayes. In the Circuit Court of the Seventeenth Judicial Circuit in and For Broward County, Florida. Complex Litigation Case No. 08-80000 (19). In Re: Engle Progeny Cases Tobacco Litigation. 26 June 2014. http://industrydocuments. library.ucsf.edu/tobacco/docs/tgwv0222
Stevens D, et al. Tob Control 2015;0:1. doi:10.1136/tobaccocontrol-2015-052271
Copyright Article author (or their employer) 2015. Produced by BMJ Publishing Group Ltd under licence.
1
Downloaded from http://tobaccocontrol.bmj.com/ on November 15, 2015 - Published by group.bmj.com
Tobacco documents reveal questionable professional recertification by industry menthol expert Daniel Stevens and Stanton Glantz Tob Control published online May 12, 2015
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TC Online First, published on May 12, 2015 as 10.1136/tobaccocontrol-2015-052271 Industry watch
Tobacco documents reveal questionable professional recertification by industry menthol expert Daniel Stevens,1 Stanton Glantz1,2,3,4 1
Center for Tobacco Control Research and Education, University of California San Francisco, San Francisco, California, USA 2 Philip R. Lee Institute for Health Policy Studies, University of California San Francisco, San Francisco, California, USA 3 Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California, USA 4 Department of Medicine, University of California San Francisco, San Francisco, California, USA Correspondence to Professor Stanton Glantz, Center for Tobacco Control Research and Education, Suite 366 Library, 530 Parnassus, University of California San Francisco, San Francisco, CA 94143-1390, USA; [email protected] Received 6 February 2015 Accepted 24 April 2015
To cite: Stevens D, Glantz S. Tob Control Published Online First: [please include Day Month Year] doi:10.1136/ tobaccocontrol-2015052271
Jonathan Daniel Heck, PhD, a board certified toxicologist, career scientist at Lorillard Tobacco, and industry expert on menthol, served as an industry representative on the Food and Drug Administration (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) from 2010 through 2014. In 2011, Heck was the lead author of the “Industry Menthol Report; Menthol Cigarettes: No Disproportionate Impact on Public Health”1 submitted to the FDA. To become certified and maintain his status as a board certified toxicologist, Heck took a certification examination and multiple recertification examinations administered by the American Board of Toxicology. Initial certification required passage of a three-part examination. Recertification occurs through an open-book examination.2 On 11 July 1996, Heck sent a memo to his supervisor at Lorillard describing his plans for completing the American Board of Toxicology recertification examination, saying: “This is a nuisance, but I need to spend some ‘quality time’ on this 300-question, every 5 years, take-home test. It’s due Aug. 9. I’m about halfway done with it. In the good old days I could just ask the Life Sciences staff to cheerfully take on a 25-question block or two.”3 In 2014, Lorillard advanced Heck as an expert witness for its defence in connection with products liability cases in Florida (the ‘Engle progeny’) to testify on tobacco and health, including that “menthol, as used in cigarettes, does not increase the risk of diseases associated with cigarette smoking”.4 In a deposition for one of these cases, Heck confirmed that he gave questions to the staff under his supervision at the time (ref 5, p 272), and acknowledged the impropriety of having someone else answer the questions (“I don’t feel that having another person answer one’s questions is proper” (ref 5, p 304), but denied any wrongdoing, arguing that the examination was open-book and, as such, he was allowed to consult with other colleagues (ref 5, p 277–8). In contrast to what he wrote in 1996, in the deposition Heck, said he merely collected his staffs’ opinions and compared them to his own (ref 5, p 275–6). He also said he was being facetious and joking (ref 5, p 305, 345), and that assigning the staff questions was part of their training and development, to prepare them for their own certification examinations (ref 5, p 304–5). Heck’s counsel offered a 1988 American Board of Toxicology newsletter, which stated that candidates may “[discuss] a question with an expert who can explain the appropriate answer since this activity is a legitimate learning process” (ref 5, p 989), and a statement from Dr A Wallace Hayes, an American Board of Toxicology officer, that
“a recertification candidate may utilise all available resources, including references to books, journals and educational seminars to complete the examination. A recertification candidate may also engage in substantive consultation with experts and colleagues” (ref 5, p 1003–4). At the time, Wallace was Vice President of Biochemical/Behavioral Research and Development at the R.J. Reynolds Tobacco Company.6 7 Whether Heck merely consulted with his staff on the questions or, as he states in the 1996 memo, assigned his staff questions, he took advantage of the open-book nature of the examination. The FDA, other authorities and the scientific community in general, should consider this incident when assessing the reliability of materials Heck produces. Furthermore, FDA should conduct a thorough search of the Legacy Tobacco Documents Library for anyone nominated for an industry position on TPSAC to ensure no ethical issues exist. Funding This work was supported in part by grant CA-87472 from the National Cancer Institute. SG is American Legacy Foundation Distinguished Professor in Tobacco Control. Competing interests None declared. Provenance and peer review Not commissioned; externally peer reviewed. Data sharing statement All data used in this manuscript are publicly available at the Legacy Tobacco Documents Library.
REFERENCES 1
2 3
4
5
6
7
Heck J, Hamm L Jr, Lauterbach J. The Industry Menthol Report, Menthol Cigarettes: No Disproportionate Impact on Public Health. 23 March 2011. http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/TobaccoProductsScientificAdvisory Committee/UCM249320.pdf (accessed 15 Jan 2015). Candidates Section. American Board of Toxicology. http://www. abtox.org/candidates.aspx (accessed 3 Feb 2015). Heck J. Memo Outlining Recent Activities. 11 July 1996. Lorillard. http://industrydocuments.library.ucsf.edu/tobacco/docs/xtnk0076 (accessed 15 Jan 2015). Greenberg Traurig, PA. (Attorneys For Defendant Lorillard Tobacco Company) Defendant Lorillard Tobacco Company’s Expert Witness Disclosure in the Circuit Court of 17th Judicial Circuit in and for Broward County, Florida Complex Litigation Unit Case No. 08-80000 (27) Judge John J. Murphy, Iii. In Re: Engle Progeny Cases. Tobacco Litigation Pertains to: Heather Irimi, as Personal Representative of the Estate of Dale Moyer Case No.: 08-026337. 14 April 2014. http://industrydocuments.library.ucsf.edu/tobacco/ docs/zgwv0222 (accessed 22 Apr 2015). Deposition of Jonathan Daniel Heck. Complex Litigation Case No. 08-80000(19). Circuit Court of the Seventeenth Judicial Circuit, Broward County, Florida. On behalf of plaintiffs Scott P. Schlesinger, Jonathan R. Gdanski. 15 May 2014. http://industrydocuments.library. ucsf.edu/tobacco/docs/pjvv0220 (accessed 4 Feb 2015). Wallace Hayes A. RJR. Statement of A. Wallace Hayes on Behalf of RJ Reynolds Tobacco Company 04 April 1989. http://beta. industrydocuments.library.ucsf.edu/tobacco/docs/xsmj0086 (accessed 27 Mar 2015). Hayes W. Affidavit of Wallace Hayes. In the Circuit Court of the Seventeenth Judicial Circuit in and For Broward County, Florida. Complex Litigation Case No. 08-80000 (19). In Re: Engle Progeny Cases Tobacco Litigation. 26 June 2014. http://industrydocuments. library.ucsf.edu/tobacco/docs/tgwv0222
Stevens D, et al. Tob Control 2015;0:1. doi:10.1136/tobaccocontrol-2015-052271
Copyright Article author (or their employer) 2015. Produced by BMJ Publishing Group Ltd under licence.
1
Downloaded from http://tobaccocontrol.bmj.com/ on November 15, 2015 - Published by group.bmj.com
Tobacco documents reveal questionable professional recertification by industry menthol expert Daniel Stevens and Stanton Glantz Tob Control published online May 12, 2015
Updated information and services can be found at: http://tobaccocontrol.bmj.com/content/early/2015/05/12/tobaccocont rol-2015-052271
These include:
Email alerting service
Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article.
Notes
To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
