Microbiological Associates

Although lawyers appear to have been primarily involved with CTR's special projects, in at least one case they became involved with a project that had been awarded as a contract through CTR. The contract was approved by the Scientific Advisory Board, but CTR had control over the data and publication of the results. The documents describe a contract during the 1970s with Microbiological Associates to conduct studies on the effects of cigarette smoke in mice.

Microbiological Associates was conducting inhalation studies, in which mice were placed in small chambers and breathed smoke-laden air for part of the day. Other studies were short-term biological tests to determine the carcinogenicity of cigarette smoke condensate. Tobacco industry lawyers were unaware that CTR had been funding the biological tests until 1977, when one of the scientists at Microbiological

Associates (a Dr. Gardner) requested additional funding from CTR to study smoke fractions in the biological tests. The ultimate purpose was to identify the compounds within tobacco smoke that are responsible for its carcinogenic effects.

The lawyers were apprehensive about this work because its results might give rise to lawsuits if the tests showed that certain elements in tobacco smoke were carcinogenic and also because the tests might constitute a breach of antitrust laws (discussed in chapter 7). These concerns are described in a memo from Ernest Pepples of B&W to Addison Yeaman, another B&W lawyer, dated March 10, 1977.

I did not understand until I talked with Arthur Stevens [CEO of B&W] that CTR in the last several years has tested cigarette smoke condensate fractions in the following tests: (1) in the Ames microbiological screen for mutagenic activity; (2) for possible tumorigenic activity in a tissue culture assay; and (3) for promoting activity by using subcutaneous injections in mice. The fractions were originally produced by someone at the USDA for CTR under what has been called the "Stedman procedure." Most of the assay work has been carried out at Microbiological Associates.

Let me say parenthetically that years of cherishing Dr. [Robert] Hockett's [of the CTR] oft quoted comment about mice tests—the wrong animal, the wrong tissue, etc.—I confess that I was somewhat jarred by the revelation to me about tests on mice through the CTR [emphasis added]. {1817.02}

Pepples says that he has discussed the tests with several other tobacco industry lawyers, and none of them knew that CTR was engaged in this sort of work.

We all think these tests are so significant that members of your [CTR] Board and people who attend the scientific sessions as I have off and on for the last couple of years should be better informed. Pursuing the thought just a bit further, these tests are so-called red light tests . They have been developed for use by FDA and other agencies in possibly identifying harmful ingredients and substances in products which are available to the consuming public. At best they show only a probability of trouble but they are used as a signal in such things as whether Red Dye No. 7 or cyclamates or hexachlorophene should be yanked off the market. I do not have to tell you what Senator [Edward] Kennedy [D-MA] would do with a finding by a CTR grantee of red lights in one of these tests as it applies to cigarette smoke fractions . We would never be able to explain that we were only replicating or confirming some other person's work. No matter what our explanation happened to be the fact of the red light in our own hands would be a serious burden to the tobacco industry if it came out in legislative hearings or in litigation [emphasis added]. {1817.02}

One of the short-term tests being done at Microbiological Associates was a test to see whether tobacco smoke caused chromosomal abnor-

malities in laboratory animals. Such a study had been done by the Food and Drug Administration in its investigation of cyclamates (see chapter 7). Pepples recommended that the inhalation program at Microbiological Associates should continue until completion, but that the short-term biological tests should not be funded through CTR {1817.03, p. 1}.

The final action taken on the research at Microbiological Associates is described in a memo from Ed Jacob, of the Jacob and Medinger law firm, to Pepples. The memo is dated June 22, 1978, and is titled "Current Status of CTR's Consideration of Microbiological Associates Contract Proposals."

Following the visit by the SAB [Scientific Advisory Board] Task Force and staff to Bethesda regarding status of Microbiological Associates (MA) contract and later discussions between SAB and staff, CTR has now proposed the following action to MA with regard to the MA proposals for the contract year July 1, 1978 through June 30, 1979:

The studies that CTR declined to fund include short-term biological tests. Although the documents do not indicate the reasons for CTR's decision, the decision is consistent with Pebbles's recommendation. Ed Jacob's memorandum on CTR's final action was transmitted to eight industry lawyers (at both tobacco companies and outside firms) in a memo

describing it as "a most interesting report" {1820.02}. The degree of industry lawyer participation and interest in CTR's action on the Microbiological Associates work is particularly noteworthy because the work at Microbiological Associates was funded through CTR's Scientific Advisory Board, not through its special projects division.