Influencing Government Policy

The documents reveal at least one instance where a CTR contract monitored by industry lawyers funded work that attempted to directly influence future publication of government documents on public policy related to tobacco and health. In 1967, the US Public Health Service published a study on the health effects of tobacco entitled Cigarette Smoking and Health Characteristics . The documents contain corre-spondence among industry lawyers in which the CTR contract is described as calling "for recommendations concerning the feasibility of a review and public analysis of the PHS report [emphasis added]" {2001.02, p. 1} that would criticize the methods used to collect the data for the PHS report. According to the documents, Theodor Sterling, then at Washington University, convened an "Advisory Panel" to for-mulate such recommendations, funded by a CTR contact to Washington University.

A December 26, 1968, letter from David R. Hardy of Shook, Hardy, and Bacon to the counsels for the tobacco companies describes a letter from Sterling and enclosures. (Neither the letter from Sterling nor the enclosures are among the documents.) Referring to the advisory panel, Hardy states: "I believe that this is perhaps the best work that Professor Sterling has done and it appears that we now have several other distinguished scientists who were members of the panel and who concur in our long held position that the Government's work in these various surveys is not reliable" {2001.01}.

One of the enclosures with Sterling's letter described by Hardy is a summary of the advisory panel's analysis of the PHS study. Sterling states:

It is worth quoting the concluding paragraph in [the summary of the advisory panel's analysis]:

There can be no doubt, however, that the claims made by Cigarette Smoking and Health Characteristics cannot be justified. Neither are the

data of adequate validity and reliability, nor is the analysis of these data properly designed and executed. The problems raised by these unjustified claims ought to be reviewed with the authority of a public body, properly constituted to do so, behind it.

Final recommendations of the [e]valuation group were delayed because of an apparent loss in the mail of comments from one member. These have just been received by me and are enclosed. ... It contains (a) the actual recommendations of the "Advisory Panel", (b) the principal justifications for such recommendations (Cigarette Smoking and Health Characteristicsand PHS claims based on it are examples used to demonstrate why a review procedure is needed ) and (c) minutes of the group's discussions ("not to be distributed outside the sponsoring agency") which bear on many problems in the health area.

The group which Dr. Sterling convened saw little use in going forward with a "definitive evaluation" of the morbidity study, preferring, in the words of the "Status Report" enclosed, to recommend that "a permanent commission needs to be formed for the purpose of establishing a consensus on the results of various studies and what they mean ."

This is an extremely ambitious undertaking and is not dissimilar to other recommendations made in the past. Dr. Sterling feels, however, that simply attacking the morbidity study alone would not cause the Government to withdraw the report nor make any headlines. Sterling believes that a top level advisory group (perhaps working with the [US] President's Science Advisory Committee or under its auspices, for example) would have the necessary prestige to prevent the future publication of documents such asCigarette Smoking and Health Characteristics [italic emphasis added]. {2001.02, pp. 1–3}

Hardy's description makes it clear that the CTR contract was not funded simply to critique the PHS morbidity study; it was intended to stimulate a "public analysis" of the PHS study—an analysis with a government imprimatur. Judged against this goal, Hardy's assessment of Sterling's success is understandable—Sterling's panel went beyond recommending a public analysis of the PHS report, and instead (apparently justifying the recommendation on the basis of alleged flaws in the PHS study) recommended the creation of a high-level government agency (perhaps in the White House) that would divert scientific efforts in an attempt to establish a "consensus on the results of various studies and what they mean" {2001.02, p. 2}. It was Sterling's judgment that such an agency would prevent the publication of future studies on tobacco and disease like the PHS study.

Although Hardy was enthusiastic about the boldness of the advisory panel's recommendation, he was also concerned that creation of a high-level agency could have adverse repercussions for the industry. He stated:

Obviously, there are problems involved in setting up any advisory group where conclusions might be binding on industry. There would certainly be implications involving the present industry-government dialogue. In any event, the very recommendations by Sterling's panel appear to be a condemnation of publication quality control at PHS. {2001.02, p. 3}

The advisory panel's recommendation that the process by which the report was generated be criticized, as well as the data in the report, is similar to a strategy that the tobacco industry has used to criticize the EPA's risk assessment of ETS (15). Seven tobacco industry-affiliated individuals who reviewed the risk assessment criticized the government procedure used to assess risk. In contrast, the independent EPA Science Advisory Board concluded that the risk assessment of ETS was "fully consistent with the risk assessments that [the EPA has] done for many other carcinogens" (1).