James L Charles (SCDoc 1982)

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The state of knowledge in 1982

Comments by James L Charles ('Jim') the Director of Research at Philip Morris USA on Future Strategies for the Changing Cigarette. [2] This statement appears to have been requested with the intention it could be used to counter claims likely to arise from the National Conference on Smoking Or Health. They would have been disappointed.

A document prepared by James Charles before this event gives a good outline of the range of problems they needed to handle in the laboratory when collecting smoke in various ways for laboratory studies. [This is fairly technical and 93 pages] They are having problem with their test of mouse-skin painting (and the 'assay' attempts to produce lymphoma) because of an "inability to obtain a negative response". [3] This was a legitimate research problem since base-lines are needed for all genuine research (which this appears to refer to). It also includes reports from other scientists.

They appear to be concentrating on two main research methods: (1) mouse-skin painting using condensate 'fractions' from the different types of tobacco smoke (to see if they produce cancerous skin changes in the short life-span of a mouse), and (2) on the quick and cheap Ames test method which uses bacterial strains to look for potential mutagenicity (DNA changes) in the condensate fractions (separate chemicals).

Similar work was carried on in the FTR division of Philip Morris in Switzerland (mainly under 'Ted' Sanders), and for work that needed total secrecy they had purchased an 'independent' laboratory called INBIFO in Germany which was run by Ulrich Hackenberg. [4]
[Note that they want "Oral annual reports" from Hackenberg, not written ones.]

The document

1982 Feb 22 At Philip Morris USA Tom Osdene has directed Charles to review the subject documents used in the 1982 Surgeon General Koop's report and provide comments. He had obviously attended a briefing, and he replied the next day in a five-page (perhaps more) handwritten note which has been extensively used in subsequent court cases.

[Note: If a search is conducted at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/ on its original Bates Number 1003171563 this document turns up mentioned in 51 different court documents.]

Jim Charles had a 20 year association with PM's R&D division, and for ten of those years he was involved in smoking and health issues. In 1982 he headed the main USA company research laboratory involving both R&D of cigarette manufacturing (such problems as additives and flavours), and research trying to identify the cause of their health problems with the hope of making a safe cigarette. They also wanted to understand why nicotine made cigarettes so addictive (although the term was banned).

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He wrote:

"You may shred this document, have it typed as is, incorporate the suggestions in a position paper for management, or use the document in any way you see fit.

This company is in trouble. The cigarette industry is in trouble. If we are to survive as a viable commercial enterprise we must act now to develop responses to smoking and health allegations from both the private and the government sectors.

The anti-smoking forces are out to bury us, and the techniques used to attack us do not always invoke good science. Their goal is to destroy the industry and their means to do that end is justified (in their opinion).

The Surgeon-General's press conference was disturbing. for the first time associations between concerns other than lung and cigarette smoking are being made in an emphatic manner.
[Until this time lung-cancer among smokers had been the focus of anti-smoking activists. Now evidence was emerging of health consequences of 'second-hand' passive smoking among non-smokers. This raised totally different ethical and legislative questions. These 'smokers' didn't chose to smoke.

Associating cigarette smoke with 30% of all cancer deaths should make someone sit up and take notice. The issue of side-stream smoke and the potential influence on the non-smoker was also discussed and, even though the scientific basis for the statements was not sound, nevertheless the damage is done.
The really important fact is that in a period of decreased governmental involvement and an economic recession, the pressure is not decreasing. The problem will just not go away.

The Future Strategies document is even more disturbing than the Surgeon-General's comment. Terms such as -- "standards setting", "government or voluntary agency guidelines", "qualitative analysis of tar" ... emphasis on brands with very low (tar) yields ... disclosure of additives ... regulations of future additives ... are all worthy of concern. Again this reflects a continuing pressure on the industry and requires a strategic response.

Let's face the facts:

• Cigarette smoke is biologically active. [The industry often denied this.]

A. "Nicotine" is a potent pharmacological agent. Every toxicologist, physiologist, medical doctor and most chemists know that. It's not a secret.
[The industry always claimed that nicotine wasn't addictive, and that cigarettes were only 'habit forming'. They needed to reject the addiction claim because it conflicted with their human-rights arguments that "smokers choose to smoke".

B. Cigarette smoke condensate applied to the backs of mice cause tumors.
[This had been known since 1956 following the Wynder/Graham experiments -- but the industry maintained that "mice aren't men" and "skin isn't lungs" and therefore the evidence wasn't applicable to smoking and lung cancer.]

C. Hydrogen cyanide is a potent inhibitor of cytochromosome oxidance - a crucial enzyme in the energy metabolism of all cells

D. Oxides of nitrogen are important in nitrosamine formation. Nitrosamines, as a class, are potent carcinogens.

E. Tobacco-specific non-volitile nitrosamines are present in significant amounts in cigarette smoke

F. Acrolein is a potent eye irritant and is very toxic to cells, Acrolein is in cigarette smoke.

G. Polonium-210 is present in cigarette smoke. {Note: A low level radioactive material.

H. We know very little about the biological activities of sidestream smoke.
[They had three different forms of smoke to worry about: (1) Directly inhaled smoke in smokers. (2) Passive smoking by both smokers and non-smokers. This consisted of (a) exhaled smoke ("second-hand smoke") and (b) side-stream smoke from cigarettes left burning in ash-trays and between puffs. Each type of smoke had different chemical characteristics.]

I. We do not know enough about the biological activities of additives which have been in use for a number of years.
Tobacco is laced with additives, both to keep the cigarettes burning, preservatives residual on the leaf, and flavourings added to the tobacco to change taste.]

[5]

it is obvious that further pages were excised from this memo before it began circulating in the court cases. There are no further major dot-points, and there is no sign-off or summary. All existing copies are the same.

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Withdrawal of Cited Abstracts

A short time later (April 6 1982) Charles is advising Philip Morris's senior scientific executives that, on legal advice, he has decided to withdraw two scientific study papers "from consideration for publication due to a unfavorable environment for PM in the areas where these abstracts would be pertinent." [6]
[Note: This is pretty close to an admission that, in the critical climate created by the Surgeon-General's report, these paper (both on mouse skin painting techniques of research) might not stand up to independent analysis.]