Chemosol: An Additive To Reduce Cancer

In the late 1960s the American cigarette companies briefly joined forces to sponsor the study of a cigarette additive, Chemosol, which promised to greatly reduce the risk of smoking-induced cancer. The willingness of these companies to come together for such an extraordinary activity speaks eloquently to the seriousness with which the whole industry

privately regarded the cancer risks of cigarettes. In addition, the Chemosol story illustrates the extent to which lawyers controlled critical pathways of scientific endeavor about sensitive subjects within the industry.

Chemosol, described in the documents as a "fuel additive," had been developed under the name "flowebin" by a physician named Max Bindig from Munich, Germany {1807.06}. When used as an additive in cigarettes, it was supposed to promote more complete combustion, which would reduce the levels of the carcinogen benzo(a)pyrene (or benzpyrene) in mainstream smoke. When the rights to flowebin were acquired by a US company, the Chemical Research and Development Corporation, the additive was renamed Chemosol and the company was renamed the American Chemosol Corporation.

During 1966 Dr. Perry Hudson, a biologist affiliated with Columbia University, who ran a research laboratory called the High Tor Foundation, conducted a mouse skin—painting experiment in which cigarettes treated with Chemosol were compared with cigarettes that had not been treated {1807.02}. In this experiment mice exposed to standard tobacco smoke condensate developed a high percentage of malignant tumors, whereas animals exposed to Chemosol-treated tobacco smoke condensate did not develop tumors. This result suggested that Chemosol reduced the carcinogenicity of tobacco smoke condensate.

In the spring of 1967, Joachim Schumacher, vice president of McDonnell & Company, agents for the owners of Chemosol, wrote Ed Finch, president of B&W, about the additive {1807.06}. The letter was a follow-up to a meeting between Schumacher and B&W general counsel, Addison Yeaman. While Schumacher was offering B&W an opportunity to obtain an exclusive license for Chemosol, B&W seems to have been committed from the beginning to bringing this potential additive to the attention of the industry as a whole {1807.07}. The file copy of a letter to the executive director of the Council for Tobacco Research, dated December 12, 1967, states:

Some time ago Ed Finch was approached by representatives of Chemical Research and Development Corporation with an offer to negotiate with Brown & Williamson for an exclusive license to an undefined additive to tobacco called CHEMOSOL . It was claimed that CHEMOSOL I ) very significantly reduced the benzo-a-pyrene content of the mainstream smoke, and 2) that smoke condensate from tobacco treated with CHEMOSOL was virtually free of biologic activity. Finch replied that under no circumstance would Brown & Williamson consider such a proposal, but was willing to act as the conduit of information from the promoters of CHEMOSOL to the United States cigarette industry. {1807.07}

Dr. Griffith reviewed the data on Chemosol that Dr. Hudson had prepared and shared his thoughts in a July 19, 1967, memorandum to Addison Yeaman {1807.01}. Although he was impressed with the quality of the technical report and the soundness of the mouse skin—painting protocol that Dr. Hudson had used, he expressed considerable skepticism about Chemosol. He strongly recommended an attempt at replication of Dr. Hudson's study in another laboratory.

Plans for such a replication apparently were already under way when Dr. Griffith wrote this memo. By August 1, 1967, the Hazleton Laboratory in Falls Church, Virginia (a private laboratory), had submitted a draft protocol for testing Chemosol {1807.08}. Finch's initial decision to involve the entire industry in any development of Chemosol was maintained: nine companies (including B&W, Lorillard, R. J. Reynolds, Philip Morris, and American Tobacco) were sponsors of the 1967 protocol that Hazleton had developed (7). However, the experiment had still not been done by the time the matter was brought to the attention of a congressional committee in April 1969.

During the House hearings on cigarette package labeling in 1969, Dr. Hudson testified about his work on Chemosol. He said that it was capable of reducing the benzo(a)pyrene level in cigarette smoke by 34 percent. He described a mouse skin—painting experiment in which only 5 percent of the mice receiving the condensate from Chemosol-treated cigarettes, compared with 25 percent of those whose skin had been painted with the conventional condensate, developed cancer (7). Dr. Hudson also indicated that scientists in academic medicine and from the National Cancer Institute had reviewed the work done on Chemosol and had found it promising. His striking testimony was covered in the New York Times the following day (8), and by the end of August the tobacco industry was publicizing its agreement with Hazleton to proceed with the experiment (9). It appears that the glare of publicity got this project moving again.

On September 10, 1969, representatives of Hazleton met with the research directors of the major tobacco companies to discuss the protocol. Five days later, another meeting was held with representatives of Hazleton, three tobacco company representatives, and two lawyers from Covington and Burling (counsel for the Tobacco Institute) to discuss the fine points of the proposed protocol. The meeting is documented by a detailed set of notes written the following day by Allan J. Topol, one of the two lawyers present {1807.08}. Topol wrote these notes in the form of a memo to the other lawyer who was there, H. Thomas Austern. Austern

was a prominent expert in food and drug law at the time. He had represented the Tobacco Institute before the Federal Trade Commission a few years earlier (10). The lawyers (purportedly on behalf of the research directors) sought to add defensive language to the protocol. According to Topol's memo,

AJT [Topol] stated that the research directors had decided that the objective [statement in the protocol] should include a sentence stating that the relationship of skin painting to smoking and health had not been established. {1807.08, p. 1}

This embellishment was proposed despite the fact that mouse skin painting was being used to guide product development of less toxic cigarettes within the industry (see chapter 4). The Hazleton spokesman, a Mr. Gargus, disagreed with this change on the grounds that such a disclaimer belonged in the final report, not the protocol.

Although Austern was present as counsel for the consortium of tobacco companies sponsoring the research, he made a number of substantive scientific suggestions about the conduct and organization of the project. He asked whether a sufficient number of cigarettes would be available for the entire project, a question that led to agreement to raise the number to be made from 500,000 to 1 million. He offered the services of the Tobacco Institute Testing Laboratory to conduct preliminary quality control testing of the experimental cigarettes, and he suggested that organoleptic tests (human panel tests of subjective smoking qualities) be added to the protocol. He also suggested that the protocol specify the type of cigarette paper to be used in the manufacture of the experimental cigarettes.

Hazleton had planned to assay the smoke of experimental cigarettes for benzo(a)pyrene levels, but Austern objected

in view of the claims made by Chemosol for benzo(a)pyrene reduction, and in view of the decision of the research directors at the meeting of September 10, 1969, that no decision would now be made as to the test for benzo(a)pyrene content, and that such a decision would be made at the termination of the biological tests. {1807.08, p. 3}

The tobacco company sponsors apparently did not want to consider collecting data that might validate Chemosol's claim for reducing benzo(a)pyrene levels unless the additive was first proven to protect mice from developing cancers. The report indicated that Hazleton's proposed assay of the condensate for benzo(a)pyrene would have been for routine quality control. It is interesting, then, to speculate as to why the attor-

ney chose to object to the use of such a routine procedure. Our hypothesis is that if the experiment showed no protection, but benzo(a)pyrene levels were, in fact, lower, this result would suggest that other carcinogens in the smoke were responsible for cigarettes' carcinogenicity.

Austern also objected to the use of benzo(a)pyrene as the carcinogen to be employed for a positive control in the experiment. It was routine practice to include a positive control in these studies, and benzo(a)pyrene was the one that Hazleton had used in the past. (In fact, BAT later used benzo(a)pyrene—which it described as a "pure carcinogen"—as a positive control in precisely this way in its Janus mouse skin—painting experiments {1138.02, p. 4}; see chapter 4.)

Mr. Gargus explained that benzo(a)pyrene had been employed because it was the best known carcinogenic agent and the one generally used in experiments of this type ... HTA [Austern] suggested that Hazleton employ some control other than benzo(a)pyrene in view of the repeated assertions made by Chemosol for benzo(a)pyrene reduction, and in view of the psychological implications of "benzo(a)pyrene" in the cigarette controversy . Mr. Gargus rejected these suggestions, and Mr. Jessup [of Hazleton] stated that unless Mr. Gargus was satisfied on the scientific grounds, Hazleton would not enter into the contract [emphasis added]. {1807.08, p. 4}

Hazleton retained its preferred positive control, but Austern's attempt to get it changed is an example of how an attorney placed public relations concerns—not the lawyer's traditional concern with liability—ahead of scientific judgments.

Topol's account also describes a substantive discussion about the publication of the results of the experiment. Austern sought to establish control of the results by the tobacco companies (see chapter 8):

With regard to publication of the results, Mr. Gargus suggested that Hazleton be authorized to publish the results of its study in a scientific journal even prior to submission of a report by Hazleton to the sponsors, and prior to Hazleton's submission of its final results to the sponsors. In this way, Mr. Gargus stated, Hazleton could secure its scientific reputation by making sure that Hazleton published its test results. Under this approach no-one would see the Hazleton results until they were published. HTA [Austern] disagreed with this suggestion, stating that the sponsors were paying for the work and should certainly see the results before they were published. In addition, publication is generally a matter of the sponsors' discretion. {1807.08, p. 5}

Austern prevailed. After discussion, Gargus agreed to submit a copy of the report to the nine sponsoring tobacco companies for review prior to publication. However, he insisted that there be an explicit clause in the

contract relating to publication rights. This matter was to be decided later, after Austern had had an opportunity to discuss it fully with his clients.

The following suggestion was also made at this meeting:

HTA [Austern] further suggested that AJT [Topol] should be present at any future technical discussions between Hazleton and industry representatives. {1807.08, p. 6}

In other words, a Convington and Burling lawyer was to participate in all scientific discussions about this experiment between Hazleton and the sponsors.

An interesting facet of the Chemosol story is Ed Finch's insistence that the additive be tested and developed as an industry-wide joint project. Finch may have felt this way for two reasons. In the United Kingdom BAT was part of an industry-wide consortium, the Tobacco Manufacturers' Standing Committee (TMSC), which was committed to the joint development of safe cigarette technology through its Harrogate research lab. Moreover, B&W may still have harbored memories of the reaction felt within the company when Lorillard had gone out on its own in 1962 and developed a filter that selectively removed phenols (see chapter 4). Eight other cigarette manufacturers agreed with B&W's position that Chemosol should be examined jointly, despite the fact that the joint development of a commercially important additive might have invited examination of this activity from an antitrust perspective (see chapter 7).

The documents provide no information on whether the Hazleton protocol was ever implemented or, if it was, what the results may have been. We are not aware that there was any further press coverage, either. There is no indication that Chemosol was ever used commercially.

What is certain is that nine cigarette manufacturers were willing to sponsor research on an additive that promised to reduce the risk of cancer from cigarette smoking; and this venture was coordinated by a lawyer who had worked for the Tobacco Institute. The record of the 1969 negotiation session about the protocol indicates that lawyers played a remarkably large role in discussions about the procedures for carrying out the scientific work. Moreover, there were plans for continued involvement by lawyers in the Chemosol studies at every significant step.