Tobacco documents reveal questionable professional recertification by industry menthol expert

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 wrong-doing, 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.