US "Smoking And Health" Projects

Selective Filtration: The Fact Cigarette

Selective filtration, the approach first legitimized in 1962 by Lorillard's new filter for its Kent brand, is the focus of several of the documents. B&W developed the Fact brand of cigarette around a filter designed to selectively remove certain volatile compounds, such as acetaldehyde and acrolein, from cigarette smoke (16). Introduced in 1975, Fact was on the market for only a few years.

In November 1977 B&W contracted with Celanese Fibers Company to analyze the vapor phase constituents of Fact in comparison with the following competing brands: L&M Flavor Lights (Liggett), Real Menthol (RJR), Merit (Philip Morris), and Kent Golden Lights (Lorillard). The Celanese report, dated January 1978, includes analyses of fifty-four different vapor phase constituents for the five different brands {1130.01}. The results for acetaldehyde, acrolein, nitrogen oxide, and cyanide are highlighted with handwritten marks in the results table. The Fact brand had lower values than the competition for acetaldehyde and for cyanide, but it ranked second highest for nitrogen oxide. Acrolein was not measured for Fact. The documents do not indicate what use was to be made of these data. Perhaps they were simply an internal check to see whether the competition had introduced filter additives that had effects similar to those found for Fact cigarettes; perhaps they were obtained to justify possible advertising claims of selective filtration.

In 1979 B&W commissioned a survey of physicians to learn whether they would be responsive to claims of reduced gases in cigarette smoke (see chapter 9).

The Tobacco Working Group

The Tobacco Working Group (TWG) was a federally supported project, launched by the National Cancer Institute (NCI), with the purpose of developing a less hazardous cigarette. The documents show that the tobacco companies participated in the meetings of the TWG and attempted to influence the group's work. At first, the tobacco industry attempted to convince the members of the TWG that cigarettes are not dangerous. When this strategy failed, the industry gained unexpected assistance from Dr. Gio Gori, deputy director of the National Cancer Institute's Division of Cancer Cause and Prevention and chairman of the TWG. Gori publicized the idea that less hazardous cigarettes could be created. Gori's proposal ultimately became an embarrassment for the federal government, which was focused on getting smokers to quit, but was a boon for the tobacco industry. The tobacco industry took advantage of Gori's proposal in its marketing of low-tar and extra-low-tar cigarettes.

On February 8, 1973, the Department of Health, Education and Welfare issued a charter for the TWG, which made it a formal and multidisciplinary group consisting of researchers from academia, the government, and the tobacco companies. The group had actually begun meeting informally in 1968 to discuss generally research related to smoking and health, cancer, cardiovascular disease, and respiratory disease {1400.01}. The 1973 charter specified that the purpose of the group was to "identify the criteria and prescribe methods for the development of a less hazardous cigarette, and other methods to decrease the smoking hazard" {1402.02, p. 1}.

The TWG was chaired by Dr. Gori; the other members were "selected on the basis of their personal qualifications in the field of smoking and health, cancer, cardiovascular [disease], and respiratory disease" {1402.02}. In addition to academic and government researchers, the research directors of Liggett & Myers, R. J. Reynolds, Lorillard, and Philip Morris participated in the TWG meetings {1401.02}. The documents clearly show that the main purpose of tobacco companies' participation in the TWG was not to share information but, rather, to keep the tobacco industry informed about government policy and research direction and to attempt to influence such policy.

A B&W file memorandum dated March 15, 1973 {1400.01}, describes a meeting of a subcommittee of the Tobacco Institute's Committee of Counsel and the research directors of the tobacco companies at which they agreed that they would probably not be able to influence Gori's work on the "safe cigarette." Because of this lack of influence, the scientific directors were instructed to distance themselves from the TWG because it could reflect badly on the industry. The file memorandum states:

It was generally felt that there is no chance that the tobacco industry can influence the Government to cut back on the proposal made by Dr. Gori for the Tabacco Working Group . If the industry makes a counter-proposal, it would be but for the record only.

...

After careful consideration of the views of the members of the Tobacco Institute staff with regard to the public relations and political effects of the public withdrawal from TWG [in original document CTR is crossed out and replaced with TWG], it was concluded that the research directors cannot withdraw. We should take steps to give the industry as much protection as is possible and at the same time remain in the Tobacco Working Group [emphasis added]. {1400.01}

To give the tobacco industry as much protection as possible from any TWG statements suggesting that cigarettes are dangerous, the memorandum describes a three-point plan:

Other documents show that the tobacco industry carried out the plan. Throughout the documents related to the TWG, the tobacco companies repeatedly state that they were just observing and were not fully participating in the meetings. A May 31, 1973, letter from I. W. Hughes (research director at B&W) to Gori states:

At the risk of repeating myself, I see my role as making available my knowledge of cigarette design and chemistry of tobacco and smoke, and not participating in approving the many research proposals proposed by the TWG

and outside of my area of expertise. Finally, I would reiterate my view that my participation should not be construed as agreeing with the premise that cigarettes are hazardous or contribute to the development of human disease [emphasis added]. {1400.02}

It is interesting that representatives of the tobacco industry were now making a distinction between the animal studies and human disease.

Friction between the tobacco industry's researchers and other researchers in the TWG is described in an October 10, 1974, memo from Horace Kornegay of the Tobacco Institute {1907.01}. Kornegay reports an incident in which Dr. Phillippe Shubik, a member of the National Cancer Advisory Board, criticized industry-employed members of NCI's Tobacco Working Group by saying, "you [the industry-employed members] will go down in history denying facts well-known to the scientific community" {1907.01, p. 1}.

The September 10–11, 1974, meeting of the TWG concluded with a discussion by Gio Gori on the scientific foundation of the safe cigarette program:

In the projection of the future [it] is unlikely that Heart and Lung Institute will put much support in TWG in the development of safer cigarettes. On the other hand, the TWG work should not only be limited to reduced nicotine and tar, but at the same time should examine the other phases including CO [carbon monoxide], NOx [oxides of nitrogen], etc., which may cause other health problems. ...

Dr. Gori presented a rough draft of a policy statement which will serve as a guide for the TWG program. He presented a flow chart which indicates three stages of screening for the development of a safer cigarette. The first stage is mouse skin painting; the second stage is inhalation by hamsters or rats; and the third stage is dog (beagle) and/or humans if possible. {1401.02, p. 5}

As the TWG's work on developing a less hazardous cigarette began to be reported in the lay press, the tobacco industry took a proactive role by attempting to prevent publication of comments suggesting that tobacco is dangerous. Both Dr. I. W. Hughes (research director at B&W) and Dr. A. W. Spears (research director at Lorillard) commented on press releases that Gori sent to them in late 1975 regarding research to develop a less hazardous cigarette. The statements in the press releases were made by the directors of the National Institutes of Health's National Cancer Program, the National Cancer Advisory Board, and the National Heart, Lung and Blood Institute. The tobacco industry evidently convinced Gori to cancel at least one press release. The original press releases referred to three upcoming reports from the TWG (to be released

January 1976): (1) a report on the first set of experimental cigarettes; (2) a report on the second set of experimental cigarettes; and (3) a report on an in vitro bioassay of cigarette smoke from experimental filters. The release contained the following statements that disturbed the industry:

Evidence gathered by research efforts throughout the work indicts cigarette smoking in over 300,000 premature deaths each year in the United States alone.

... calling upon the tobacco industry to adopt newly developed techniques to make cigarettes less hazardous ... {1404.08, pp. 1–3}

Because some people are unable or unwilling to quit, the cigarette industry should strive to offer the smoking public cigarettes that minimize the risk to the smoker. {1404.09, p. 1}

Hughes evidently sought advice from Ernest Pepples, general counsel for B&W, about how he should respond to the press releases. Pepples responded to Hughes's request as follows:

It is the classic "pig-in-a-poke" [referring to the fact that the three reports are unpublished].

...

[T]he TWG members from the industry need to dissociate themselves from the releases and any underlying materials which allegedly support the releases.

...

At bottom I think you should come off saying to Gori that such activity as these releases abuses the industry members of the TWG. It is a bad way to treat them. It makes continuing cooperation difficult or impossible. {1404.10, p. 1}

Hughes's letter to Gori (unsigned) states:

I have no choice but to urge you to try and convince the people concerned not to use them [the press releases]. ... from earlier discussions with you regarding the drafts of the publications you considered it important not to draw any firm conclusion from the work done to date. ... The whole attitude of the press releases in contrary to this. ... I certainly would dissociate myself from the releases. ... Lastly, I feel that such releases abuse my membership of the TWG. {1404.03, pp. 1–2}

Horace Kornegay, president of the Tobacco Institute, also commented on Hughes's response to the press releases:

Dr. Hughes' views are sound and, hopefully, they will be persuasive with Gori to be more careful in drafting news releases which purport to report on scientific work. {1404.01}

Spears's comment to Gori (December 18, 1975) states:

I am surprised and disappointed by the dramatic nature of the language, over-interpretation of the data and what I consider to be false statements. ...

The press materials state that newly developed techniques and scientific evidence indicate that 'without question less hazardous cigarettes can be made today.' Less hazardous with respect to what? ...

Another statement asserts that 'people are unable or unwilling to quit.' I am unaware of any information that suggests people are unable to quit smoking [emphasis in original]. {1404.07, pp. 1–2}

Spears also says, "Based upon our recent telephone conversation, I understand that it is unlikely that there will be a press release from NCI along the lines of the material which you previously forwarded" {1404.06}.

After this press release incident, Pepples urged (in a January 19, 1976, memo) Dr. Hughes to keep his distance from the TWG.

I recommend you decline the proffered appointment [to formally join the TWG] and ask to continue in your present capacity—auditing, but not voting, present but not participating. {1405.01}

In October 1976 the TWG's safe cigarette project did make the press. An October 29 article in the Louisville Courier-Journal reported on a speech made by Gio Gori at the National Academy of Sciences in which he talked about safe cigarettes and the numbers of cigarettes that could be smoked without causing cancer (i.e., safe smoking standards) {1408.02}. A letter from Pepples to H. A. Morini of BAT comments on the Courier-Journal article and expresses the tobacco industry's concern about the safe cigarette project:

It must be kept in mind, however, that Gori is a man who claims to be building a better mousetrap with Government funds. Accordingly, he must continue pointing out that the mice are a hazard. ... The issue would seem now to be whether "safer" smokes should be legislative or the free market system should be permitted to operate. {1408.01, pp. 1–2}

An attached written statement made by Gori, entitled "Etiology and Prevention of Smoking Related Disease," outlines the rationale for his safe cigarette program:

It is unrealistic to expect a society of nonsmokers in a short time period. ... Tobacco use cannot be abolished easily; therefore, alternative solutions for disease prevention are necessary. Two such solutions are the selective removal of toxic elements from smoke and the reduction of total smoke

intake. ... The technology required to reduce hazardous components in cigarette smoke has been established, ... the tobacco industry is beginning to utilize these procedures. Consumer acceptability of low hazard cigarettes can lead to intake limits that could make the resulting risk of disease virtually undetectable. These limits are defined as the smoke intake dose that would result in approximately the same disease risk for a smoker as for a nonsmoker. {1408.05, p. 1}

Gori later sent a paper entitled "Less Hazardous Cigarettes[:] Current Manufacturing Advances, 1977," written by Gori and Cornelius Lynch of Enviro Control, Inc., to the tobacco industry for comment {1408.08}. (Enviro Control was the main contractor with NCI for the safe cigarette project {1403.01}.) The paper describes how cigarettes have been made less hazardous, compares them by brand name, and recommends brand switching to achieve "critical values" of smoking, below which smoking is safe:

These critical values may serve as intermediate goals for a smoker who is intent on reducing his smoking habit through progressively less hazardous smoking stages.

...

The incorporation of these and other state-of-the-art advances, coupled with flavor acceptability characteristics, has resulted in commercially available cigarettes that can properly be termed less hazardous. {1408.08, p. 6}

In other words, Gori was recommending that smokers switch to low-tar brands in lieu of recommending that they quit.

On August 22, 1977, in a letter to Gori, I. W. Hughes commented on this paper.

The purpose, then, of your supplying the draft to me and of my commenting on it is not to rehash our differences in the smoking and health area, but merely to see whether, given these differences, a paper of the kind you propose would serve to advance the scientific debate.

For the reasons listed below, I feel that it would not:

It is ironic that a tobacco industry employee was worried about encouraging smoking. The main thrust of Hughes's letter, however, indicates that he was worried about the tobacco companies' using Gori's data to get into marketing wars for low-tar cigarettes.

The TWG was officially terminated on August 12, 1977 {1411.01}. However, The TWG continued to meet "unofficially" {1411.03}. The tobacco companies may now have been eager to continue their participation in the TWG so that they could remain informed about the development of less hazardous cigarettes. Such information would help the companies gain a competitive edge in the low-tar cigarette market.

In mid-1978 Lisher and Company, a marketing management consultant, submitted a draft proposal for a "low delivery project" to B&W {1203.01}, in line with emerging recommendations from the NCI under Gori. This proposal illustrates that the tobacco industry viewed Gori's work as useful for marketing purposes but was concerned about calling cigarettes "safe." The editing of this draft with regard to nicotine was discussed in chapter 3. The draft's statements on smoking and health issues were also edited. The following sentence was in the original draft:

The parameters of a "safe" cigarette have been defined by Dr. Gori of the Federal Government, although his definition of "safe" is believed to be as yet largely unrecognized by the medical community at large. {1203.01, p. 1}

The edited version reads:

Within the past several years, Dr. Gogio Gori of the National Institute[s] of Health has discussed guidelines for the potential reduction of selective cigarette smoke components. {1203.02, insert card}

The word "safe" was systematically excised at three other places {1203.01, pp. 2, 3, 4}:

The phrase "Dr. Gori's (and other Government Agencies') parameters of safety" is edited to delete the last two words.

The phrase "low tar/safe" is changed to "low tar."

The phrase "a safe and satisfying cigarette" is changed to "a Goritype, satisfying cigarette."

Gori's support for the concept of a "safe" cigarette and a "safe" level of smoking became increasingly controversial. Gori left NCI in 1980 and became director of the Franklin Institute's Health Policy Center {1415.01}. Since 1980 Gori has been a paid consultant to the tobacco industry and testifies on the industry's behalf on issues related to smoking and health (17).