of SWDocID
Strategies Inuence: How Corporate Power Directs and Constrains the FDA
David Marc Solet Peter Barton Hutt, Advisor Harvard Law School May 1, 2001
Table of Contents
Table of Contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . .
i
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . .
1
The Role of the FDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... . . . . .
4
The Impregnable FDA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . .
4
Shadow-Boxing With the Tobacco Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . .
9
Using the Congress. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11
The Role of Campaign Contributions: Paying the Piper, Calling the Tune . . . . . . . . . . . . ... . .
13
Tobacco Industry Support of Congressional Leadership, 1995-2000. . . . . . . . . . . . . . . . . . .. . . .. 1
16
Tobacco Industry Lobbying: Lend Me Your Ears. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . .
20
Inside Connections, Trustworthy Figures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . .
23
The Shadow FDA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..
25
Flexing Tobaccos Muscles: The Congressional Assault on Kesslers FDA. . . . . . . . . . . . . . .
27
Roll-Call Votes: Winning When it Counts... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..
28
Congressional Committees and the Oversight Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
30
Attacking the FDAs Integrity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...
32
Putting Words in the Mouths of Congress. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
34
High Pressure Letter Writing Campaigns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
35
Friendly Governors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . ...
38
Threatening the FDA Budget. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
41
Aggressive Reform Plans: Eviscerating the FDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
43
The Outside Game: Shaping Public Opinion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
46
Grassroots and Astroturf. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....
47
Buying Legitmacy: A Patron of the Arts. . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . . . . . . . . . . . . . . . . . . . . . . .
51
A Patron of the Sciences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
51
Discarding Evidence, Fabricating Data. . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
53
The Council for Tobacco Research (CTR). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
54
The Tobacco Industrys Scientists: The Whitecoat Project . . . ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
56
The Center for Indoor Air Research (CIAR) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
59
Using Third-Party Front Groups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
66
Attacking Industrys Opponents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
70
Controlling Mass Media. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . .
72
Fox/NewsCorp.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..
75
Forbes: Capitalist Tool. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... . .
77
Tobacco Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . ... . . . . .
79
A Case Study: Procter & Gamble and Olestra. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... . . . . .
80
Olestra: What It Cost Procter & Gamble. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . .
81
Concerns About Olestra. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . . . . . . . ... . . . . . . . . .
83
The FDAs Decision. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . .
85
Behind the Scenes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . . . . . . .
86
Procter & Gambles Scientists. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . . . . . . . . 3
88
Peer-Reviewed Journals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . . . . . . . . . . .... . . . . . . . . . . . . . .
90
Funding the Congress. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... . . . . . . . . . . . . . . .
91
Procter & Gamble Hard Money Contributions, 1997-2000. . . . . . . . . . . . . . . ... . . . . . . . . . . . . . . . . . .
91
Using the Congress to Lobby the FDA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. . . . . . . . . . . . . . .
94
Lobbying for Olestra. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . . . . . . . . . . . . . . . .
96
Eects of Congressional Pressure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...
99
Attacking Olestras Enemies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
101
Using Front Groups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . . . . . . . . . . . . . . .... . . . . .
102
Consumer Alert. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . .... . . . . . . . .
105
Coordination From Above. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... . . . . . . . .
108
Steven Milloy and Junk Science . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .
109
Milloy, Tobacco, and Procter & Gamble. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..
111
Suspicious Endorsements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
114
The American Dietetic Association (ADA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
115
The American Council on Science and Health (ACSH). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
117
The National Consumers League (NCL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
120
The Shadow FDA: Part II. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
122
Conclusion.... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....
125
INTRODUCTION
This paper is about the Food and Drug Administration, and the tactics that regulated and sometimes unregulated industries use to inuence that agencys decision-making process. Many of these tactics are legal; others are illegal, but dicult to recognize and police. In virtually every case, the purpose of these tactics is to undermine the neutral and detached scientic processes to which the FDA aspires, in order to advance the nancial interests of regulated industries. While some of the details recounted herein are gravely disturbing, even outrageous, the purpose of this paper is not to moralize, but to identify these tactics and assess them in a neutral fashion, in order that they may oer some lesson about the systemic structures that created them. Concern about the interaction between the government and regulated industry is not a new development. In 1978, Richard Crout observed, with some disdain, that It appeals to the biases of nearly everyone to view regulatory controversies as basically one-on-one contests between the virtuous and the untrustworthy.1 While this paper will explore in detail the sometimes unsavory methods by which industries regulated by the FDA seek to inuence the regulatory process to their own advantage, it will attempt to heed Crouts warning to avoid simplistic, Manichean analyses of what are, and should be treated as, complex systemic problems. Not every agreement or accommodation between the FDA and its constituent industries should be assumed to represent an abandonment of its statutory obligations; any agency that attempted to litigate
1 Richard
J. Crout, The Nature of Regulatory Choices, 33 Food Drug Cosmetic Law Journal 413 (1978)
5
every potential violation would drown itself in the legal process, and frustrate the accomplishment of its mission. Likewise, it would be unfair to assume that every document request made by a member of Congress is part of a shadowy conspiracy; aggressive oversight by Congress is essential to the proper accountability and functioning of any regulatory agency. What this paper does seek to explore, however, is the range of methods and techniques by which aggressive industry advocates have subtly shifted the balance of power away from the FDA and the consumer and toward regulated industries. The rst part of the paper will deal primarily with the example oered by the tobacco industry, which has waged a protracted and ultimately successful campaign to avoid the regulation of its products by the FDA. I have chosen the tobacco industry (and not, for example, the pharmaceutical industry) for two reasons: rst, because the tobacco industry has been resourceful, determined, and spectacularly creative in its eorts, pioneering many of the techniques that are now widely employed by more benign industries; and second, because the extended civil litigation surrounding the health eects of tobacco smoke has given the public unrivaled access to the internal deliberations and eorts of the industry.
The second part of this paper will focus on a far more benign product, a controversial food additive that has received little serious attention in the mainstream media: Procter & Gambles non-fat fat olestra. Unlike the tobacco industry, the internal machinations of the Procter & Gamble Corporation remain largely shrouded in secrecy. There is enough evidence already available to the public, however, to interpolate and extrapolate from what we know to what we can surmise, and to compare and contrast the techniques employed by this giant of the food products industry to its counterparts in the world of tobacco. What I hope to show is that the techniques that the tobacco industry perfected are not unique to that now
6
notorious industry, but are in fact routinely employed by a range of companies we often think of as harmless.2 Evidence suggests that if we were given access to the inner workings of Procter & Gamble, or indeed of any large American corporation with a signicant nancial stake in a regulatory proceeding before the FDA, we would nd strategies every bit as clever, methods every bit as calculating, as we nd in the records of the tobacco industry giants. Perhaps it should come as no surprise that equivalently situated companies of the same scale, advised by the very same attorneys and guided by the very same public relations experts, will exploit every available opportunity to advance their agenda, and will pursue that agenda every bit as ruthlessly as the corporate leadership of Philip Morris or Brown & Williamson. Nevertheless, I think it would surprise most citizens that this is so and the revelation that the techniques described herein are routine practice would ll them with shock and dismay. The purpose of this paper, however, is not to shock and dismay, but to stimulate thought and debate about structural reforms of the regulatory apparatus and the means by which interested parties seek to inuence them.3
2 If anything, the actions of the tobacco industry are strongly reective of corporate norms. Evidence suggests it is unrealistic to imagine that industry will practice any more self-restraint than prudence demands. See Albert Z. Carr, Is Business Blung Legal? 46 Harv. Business Rev. 143 (1968). In that article, a Midwestern executive (who remains, by request, anonymous) says, So long as a businessman complies with the laws of the land and avoids telling malicious lies, hes ethical. If the law as written gives a man a wide-open chance to make a killing, hed be a fool not to take advantage of it. If he doesnt somebody else will. Theres no obligation on him to stop and consider who is going to get hurt. If the law says he can do it, thats all the justication he needs. Theres nothing unethical about that. Its just plain business sense. While (at the behest of public relations consultants), most businessmen publicly deny that they see their own conduct in such Machiavellian terms, there is ample evidence that this is the dominant understanding in the corporate world. Indeed, adherence to a form of this creed is widely considered mandatory among corporate legal counsel. 3 The primary purpose of this paper is descriptive, rather than prescriptive; it seeks to identify and explore the methods of industry inuence on the FDA, but it is not a comprehensive plan to reform the federal campaign nance system, to regulate the lobbying industry, or to restructure our nations methods of funding scientic research.
7
THE ROLE OF THE FDA
In 1938, Congress enacted the Federal Food, Drug, and Cosmetics Act (FDCA) to protect consumers health and welfare by preventing the introduction or receipt of misbranded or adulterated medicines, foods, or cosmetics.4 To give teeth to this goal, the FDCA conferred on the Secretary of Health, Education and Welfare (now Health and Human Services) the authority to issue regulations;5 the Secretary, in turn, delegated the authority to act under the FDCA to the Commissioner of the Food and Drug Administration (FDA).6 To fulll its mission of protecting consumers, the FDA has been granted the power to approve and regulate drugs, vaccines, over-the-counter remedies, food additives, medical devices, and animal medications; to inspect factories and set standards on food production; to sample marketed foods for impurities; and to regulate advertising for food, drugs, and cosmetics.7 Today the FDA is one of the most inuential regulatory agencies in the nation, with jurisdiction over products that account for twenty-ve cents of every consumer dollar worth more than $1 trillion annually.8
THE IMPREGNABLE FDA With its vast responsibilities, and authority to make decisions with enormous nancial ramications, it should come as little surprise that industry forces have long sought to inuence the FDA in its decision-making processes. What is surprising is the impressive record the FDA has achieved over most of the course of its existence of resisting the overtures of some of the nations most powerful interest groups. Where other arms of the federal bureaucracy have been accused of being captured by the constituencies they are supposed
21 U.S.C. 301-395 (1994 & Supp. 1997); see also United States v. Two Bags, Poppy Seeds, 147 F.2d 123, 126-27 (6th Cir. 1945) (discussing the intent of the FDCA). 5 See 21 U.S.C. 371(a) (1994). 6 See 21 C.F.R. 5.10(a) (1997). 7 Perspectives: GOP Sets Its Sight on Food & Drug Administration, Med. & Health, Feb. 20, 1995 8 Henry I. Miller, The Wrong Choice For The FDA, The Wall Street Journal, June 26, 1998, p. A14.
4 See
8
to regulate (including, for instance, the Departments of Agriculture and Energy), the FDA has achieved a praiseworthy reputation for independence and scientic integrity.
To be sure, the FDAs record is not spotless. In 1987, the Agency suered through one of its darkest hours, in what became known as the Generic Drug scandal. An FDA supervisor named Charles Chang had received expensive gifts (including a fur coat and a videocassette recorder) from drug company lobbyists, in exchange for arranging that their drugs received expedited Agency approval. Chang knew which of his subordinates were quick workers, and which were more methodical; by controlling the assignment of projects, he found he could manipulate the approval schedule. Changs actions were a gross betrayal of the public trust, and a black eye for the Agency. By the end, Chang was in a federal prison, and forty-two other people and ten companies were convicted on charges of fraud and corruption.9 What made the Generic Drug scandal so newsworthy was not merely its tawdriness, but how out of place it was in the history of the Agency. For the most part, those who would exert undue inuence over bureaucratic decision-making appear to have had far less success with the FDA than with other agencies of the federal government. Peter Barton Hutt and Richard Merrill, each a former general counsel to the FDA, oer a number of explanations for FDAs relative impregnability. First, they suggest, the evident scientic basis for most of FDAs positions has helped insulate it from many of the customary forms of political pressure.10 Second, they cite the agencys public prole, which exceeds those of many Cabinet-level agencies: the visibility of FDAs programs has given the agency, and thus the Commissioner, a public standing that frequently blunts pressure from within any incumbent administration.11 Finally, Hutt and Merrill cite the composition of the rank-and-le personnel of the Agency, noting that because few jobs have been
9 David
Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001,
p.8
10 Peter Barton Hutt and Richard A. Merrill, Food and Drug Law: Cases and Materials, University Casebook Series, Foundation Press, Westbury, NY, 1991, p.16 11 Id.
9
subject to political appointment... for most of its existence FDA has operated with considerable decisional independence and enjoyed continuity in the service of employees who hold middle-management positions and sta its several eld oces.12 Certainly some of the factors Hutt and Merrill mention remain clearly present in the contemporary FDA; the esteem in which the public held former Commissioner David Kessler, and the constraints this put on President George H. W. Bush, nicely illustrate the Commissioners potential for blunting pressure from within... the administration. Indeed, in an era where the federal government, and especially the federal bureaucracy, have often been held up to public ridicule, the FDA remains an extremely popular agency, one which commands respect and admiration from citizens across the political spectrum. According to a 1997 nationwide poll of registered voters, the FDA rates among the federal agencies in which they have the greatest condence.13 Eighty-seven percent of voters saw the FDA as necessary, and sixty-one percent described the FDA as very necessary.14 These favorable numbers remained despite the existence, at the time of the poll, of a concerted public relations eort to discredit the FDA. Despite the increasingly partisan nature of debate about the role of the federal government and of economic regulation, and the increasingly partisan battle lines between pro-tobacco Republicans and anti-tobacco Democrats, support for the FDA among the voters remained consistently strong across party lines: eighty-six percent of Republicans, eightyeight percent of independents, and eighty-eight percent of Democrats felt the FDA was necessary.15 A plurality (forty-ve percent) of those surveyed indicated their belief that the FDA does a better job than other government agencies, a gure that included forty-three percent of self-identied Republicans; only thirteen percent described the FDA as doing a worse job than other agencies.16
12 Id. 13 America Supports FDA, Human Rights Campaign, Press Release, April 16, 1997. Analysis based on results from a nationwide telephone survey of 1,000 registered voters by Lake Sosin Snell & Associates and the Tarrance Group, conducted April 8-10, 1997. The margin of error for the sample is +/-3.1 percent. 14 Id. 15 Id. 16 Id.
10
But while FDA still commands the respect of the American public, many of the other factors that Hutt and Merrill cite as providing political insulation have been compromised or eliminated since 1991, the last edition of their text. Increasingly, industry representatives and their surrogates deride Agency scientists as risk-averse and unnecessarily paternalistic, and openly challenge the scientic bases of FDA decisions. Because the general public is largely incapable of choosing between conicting positions on the scientic merits, science no longer serves as a trump for FDA. In addition, while the legacy of David Kessler has left the FDA Commissioner with arguably a greater public prole and moral authority than ever before, turnover among middle management has been greatly accelerated. It has now been nearly twenty-ve years since the FDA launched Operation Hire, an initiative that expanded the agency by hundreds of people. As a result, 70% of all managers will be eligible for retirement between 1999 and 2001.17 Others are leaving because of the treatment FDA ocials have received at the hands of an increasingly hostile Congress. I decided it was no longer worth my time to take the psychological and verbal abuse from members of Congress or their sta, said Curtis Scribner, deputy director of the FDAs blood oce until late 1997. I wasnt having fun any more.18 Ralph Harkins, who spent more than a decade managing a major statistical division at the FDA, said, I just decided I wasnt getting the support I needed. I took my retirement and ran.19 In Harkins division, 12 of 22 statisticians departed between 1998 and 1999. Working conditions were clearly a factor in the mass exodus; most of those who left had been working more than twelve hours a day to try to keep up with more demanding approval deadlines.20 The hostility of the Congress and the budgetary constraints it has imposed risk creating a self-perpetuating cycle: congressional antagonism forces out the stabilizing core of middle managers, and the loss of their stability has left the FDA more vulnerable than ever to undue inuence and bullying.
17 Rochelle 18 Id. 19 Id. 20 Id.
Sharpe, FDA Tries to Find Right Balance on Drug Approvals, The Wall Street Journal, April 20, 1999
11
The state of the FDAs independence remains hotly debated. Consumer advocates like Larry Sasich of Public Citizen argue that Commissioner Jane Henney sold the farm to win conrmation by a Republican Congress, and that the agency has been completely co-opted by industry.21 Others reject the notion that FDAs integrity has been even remotely compromised by its struggles with hostile industries. Former Deputy Commissioner Carol Scheman, for instance, atly rejects the suggestion that FDA ocials would permit industry pressure to compromise their scientic judgement. I dont think its possible, she says. These are among the most rigidly moral people I know.22 If Larry Sasich perhaps overstates his case, Carol Scheman seems to ignore the practical realities of FDAs situation. The prophylactic protections of a rigidly moral sta are vital in avoiding the Watergatestyle corruption that dened the Generic Drug scandal, but they are simply insucient to resist the kind of systemic coercion to which the Agency is now legally subject. Because the methods by which industry players inuence the FDA often go over and around, rather than through, the Food and Drug Administration, the integrity of FDAs ocers has become a necessary, but not sucient characteristic for eective FDA leadership. As the tobacco industry proved, it is possible to subvert the FDA without the Agencys assent.
SHADOW-BOXING WITH THE TOBACCO INDUSTRY Industry actors who nd themselves unable to inuence the FDA directly have come to employ an array of other techniques. These include providing the political campaigns of sympathetic lawmakers with nancial and organizational support, lobbying incumbent lawmakers to pursue an industry-supported agenda, supporting (and sometimes purchasing) scientic research likely to be favorable to industry, and organizing broad-based public relations campaigns, sometimes through third-party actors with independent credibility.
21 Stephen 22 Stephen
Pomper, The New Drug Pushers, Shepherd Express Metro, September 14, 2000 Pomper, Drug Rush: Why the Prescription Drug Market is Unsafe at High Speeds, Washington Monthly, May,
2000
12
In its campaign to avoid FDA regulation, the tobacco industry used all of these techniques to brilliant eect. Since pre-colonial times, tobacco has been one of Americas most protable cash crops. It remains an agricultural staple; according to industry gures, the tobacco industry accounts for more than 680,000 jobs nationwide, and in many regions is the driving force behind the local economy.23 Despite mounting evidence of tobaccos addictive properties and health risks from the 1950s onward, the Food and Drug Administration had never attempted to assert authority over cigarettes. For decades, the FDA acted under the assumption that it would need a specic grant of statutory authority to assert jurisdiction over tobacco products. In 1977, Commissioner Donald Kennedy, challenged by a member of the Senate to explain why the FDA had not regulated tobacco, responded, Senator, Ill be glad to go to work on the cigarette ban as soon as you give me the authority to do so.24 Commissioner David Kessler turned around the FDAs approach to tobacco, aggressively gathering evidence and building his case. On August 28, 1996, the Food and Drug Administration announced its controversial regulation of tobacco products, igniting a restorm of political controversy.25 The tobacco industry called on every weapon at its disposal - chief among them its carefully cultivated allies in the Congress.
USING THE CONGRESS
While in theory most of the FDAs decisions are made on the basis of independent scientic judgements, the
23 Hank Cox, Feds and Smokers Fume Over the Right to Inhale, The Washington Times, Apr. 24, 1995, at 14 (citing to a 1992 Price Waterhouse Study). 24 David Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.27 25 See Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 61 Fed. Reg. 44,396, 44,398 (1996)
13
Agency has always been closely scrutinized by members of Congress, and the degree of support or hostility the Congress demonstrates can have a powerful eect on internal FDA decision-making. Hutt and Merrill note in their seminal casebook:
The [FDA] is controversial. Its decisions are closely watched. Numerous congressional committees critique its performance, very often concluding that it has been reckless in approving new products or insuciently vigorous in acting against old ones. The message conveyed by both the intensity and attitude of congressional oversight has had enormous inuence on both the content of FDAs requirements and the thrust of its enforcement eorts.26
While the statute under which the FDA operates has remained largely unchanged, the Congress controls the FDAs budget on a year-to-year basis, has broad oversight responsibilities, and has demonstrated a willingness to use that authority to control the FDAs regulatory agenda. The willingness of Congress to second-guess the FDA is hardly a new development; legislative micro-management has long been a concern of regulatory experts. Louis Rothschild wrote in 1978, I am not criticizing the right of any segment of the population to take its troubles to Capitol Hill, for hearings to be held, or for members of Congress to express their views. However, I am disturbed by the threat of legislation to cut the ground out from under the FDA if it does not do what isolated Congressmen or a powerful Congressional subcommittee tell it to do, even though it may conict with the Agencys stated policy or mandate.27 This concern remains as vital and relevant in 2001 as when Rothschild voiced it in 1978.
What have changed are the source of congressional dissatisfaction, and the direction of its criticism. In 1974, FDA Commissioner Alex M. Schmidt wrote,
Barton Hutt and Richard A. Merrill, Food and Drug Law: Cases and Materials, University Casebook Series, Foundation Press, Westbury, NY, 1991, p.19 27 Louis Rothschild, The Newest Regulatory Agency in Washington, 33 Food Drug Cosmetic Law Journal 86 (1978), as cited in Peter Barton Hutt and Richard A. Merrill, Food and Drug Law: Cases and Materials, University Casebook Series, Foundation Press, Westbury, NY, 1991, p.1317
26 Peter
14
By far the greatest pressure that the Bureau of Drugs or the Food and Drug Administration receives with respect to the drug approval process is brought to bear through congressional hearings. In all of our history, we are unable to nd one instance where a congressional hearing investigated the failure of FDA to approve a new drug. The occasions on which hearings have been held to criticize approval of a new drug have been so frequent in the past ten years that we have not even attempted to count them.... Until perspective is brought to the legislative oversight function, the pressure from Congress for FDA to disapprove new drugs will continue to be felt, and could be a major factor in health care in this country.28
This sentiment would hardly be recognizable to contemporary observers of the Congress-FDA relationship. Since Schmidts time, FDA-Congressional relations have undergone a profound shift.
Where FDA was once roundly criticized for insucient oversight and an overly solicitous attitude toward the industries it regulates, contemporary Congressional criticism has lambasted FDA for being unnecessarily adversarial in its relations with industry, and for pursuing its regulatory mission with excessive zeal. This paradigm shift in Congressional attitudes reects a number of larger changes: shifts in public attitudes toward government regulation, in the partisan composition of the Congress, in the mounting importance of fundraising to political success, and in events like the HIV/AIDS crisis, which required a more exible and adaptable Food and Drug Administration. This change in congressional attitudes is also reective, in no small degree, to an aggressive, resourceful campaign by the American tobacco industry to deter, or if necessary, prevent the FDA from regulating its products.
of Alex M. Schmidt, M.D., Commissioner of Food and Drugs, Regulation of New Drug R. & D. By the Food And Drug Administration, Joint Hearings Before the Subcomm. On Health of the Senate Comm. On Labor and Public Welfare and the Subcomm. on Administrative Practice and Procedure of the Senate Comm. on the Judiciary, 93d Congress, 2d Session (1974)
28 Statement
15
THE ROLE OF CAMPAIGN CONTRIBUTIONS: PAYING THE PIPER, CALLING THE TUNE
One of the principal means by which an industry can advance its political agenda is by supporting the electoral campaigns of ideologically friendly candidates. Running for elected oce can be enormously expensive candidates for the House of Representatives routinely spend over one million dollars on their campaigns, and candidates for the Senate frequently spend in the tens of millions. As the cost of political campaigns has accelerated, elected ocials have found it necessary to raise ever-increasing amounts of money, and corporate interests have proven to be a reliable source of funding. Though corporations have been prohibited from making direct donations to candidates for federal election since 1907, when Congress passed the Tillman Act,29 corporations still make their inuence felt, through the personal donations of industry-aliated individuals like executives and lobbyists, through industry-aliated Political Action Committees (PACs), and, increasingly, through unregulated soft money contributions, which are ostensibly for party-building purposes and are donated directly to the national or state-level political parties. Louise Overcracker wrote in her 1932 book, Money in Elections, No party which is nancially dependent upon the substantial business interests... would feel free to embark on an economic program which met with their hostility. Even a dog will not bite the hand that feeds it, and a political party will hardly sell out the person whose money it accepts.30 Overcrackers model is of course oversimplied; academics like Herbert Alexander and Frank Sorauf have contended that the popular model of politicians being bought and sold by campaign contributions is unsubstantiated by empirical evidence, and have emphasized the existence of stronger correlation of legislative voting to ideology, party or constituency interests than to contributions.31
29 Election Reform: Basic References United States Senate, Select Committee on Presidential Campaign Activities Pursuant to S. Res. 60, 93rd Congress, 1st session, November, 1973 30 Louise Overcracker, Money in Elections, New York: Macmillan, 1932, pp. 374-375 31 See Herbert Alexander, Brookings Institution Working Group on Campaign Finance Reform, 1996
16
What Alexander and Sorauf ignore, however, is that campaign contributions make the bulk of their impact in the campaigns themselves, by helping to determine who is elected, and consequently the ideology and party aliation that most consistently determine voting behavior. And while elected representatives rarely deviate from their core positions, campaign donations can have a signicant eect at the margins; among uncommitted representatives, on issues that have little salience with the public, nancial support or the threat of its withdrawal can be a deciding factor for a legislator. Because the individual regulatory decisions of the FDA have little salience with the general public, but enormous nancial consequences for interested parties, they are uniquely vulnerable to this kind of legislative inuence.
One of the key elements of the tobacco industrys legislative strategy was to maintain a broad base of political support among the elected leaders of both parties in Congress. For many years, tobacco-producing Southern states like North Carolina, Kentucky and Virginia were rmly in Democratic hands, and the tobacco industry became a generous patron of Southern Democrats. As Southern states gradually gravitated toward the Republican Party, the tobacco industry slowly shifted its political allegiances. That shift was cemented by the 1994 change in party control of Congress, and escalated as David Kesslers FDA with the public support of a Democratic President made regulation of tobacco an Agency priority. Between 1989 and 1994, when Democrats controlled both Houses of Congress, tobacco PACs contributed nearly identical amounts of hard money about $3.3 million each to Republican and Democratic candidates.32 But after the GOP assumed control in 1994, tobacco donations shifted strongly to the new party in power; once Republicans assumed control, the tobacco industry was intent on keeping them there. The alliance was in many ways a natural t: the Republican Party was ascendant in tobacco states like North Carolina and Kentucky, ideologically
32 Buying Inuence, Selling Death: How Big Tobaccos Campaign Contributions Harm Public Health, Common Cause, March 14, 2001
17
opposed to federal regulation and taxation, and strongly in favor of pro-business anti-tort legislation. Today, the tobacco industrys support is rmly behind the Republican Party, and has stayed there, even as the Republican advantage in the Congress has slipped with each successive election cycle. In the 2000 election cycle, the tobacco industry gave $6.3 million, or eighty-three percent of its total contributions, to Republican candidates and committees.33
Part of the tobacco industrys campaign nance strategy was to forge friendly relationships with the leadership of the major parties, those Members who set the legislative agenda in the Congress. The tobacco industry is one of the most generous supporters of the Republican leadership, and while tobacco donations to Democrats have tailed o, particularly in the Senate, Democratic leaders continue to attract disproportionate attention from tobacco PACs.
Tobacco Industry Support of Congressional Leadership, 1995-200034
Senate Republican Majority Leadership President Pro Tempore of Senate Majority Leader Majority Whip
Member
Strom Thurmond (RSC)
Tobacco PAC Donations, 01/01/95-11/27/00 $15,000
Trent Lott (R-MS) Don Nickles (ROK)
$4,500 $15,166
33 Id. 34 Buying Inuence, Selling Death: How Big Tobaccos Campaign Contributions Harm Public Health, Common Cause, March 14, 2001
18
Republican Conference, Chair Republican Policy Committee, Chair Republican Senatorial Committee, Chair
Rick Santorum (R-PA) Larry Craig (RID)
$31,000 $23,000
Bill Frist (R-TN)
$15,500
Senate Democratic Minority Leadership Minority Leader
Member
Minority Whip Democratic Conference, Chair Democratic Policy Committee, Chair Democratic Senatorial Campaign Committee, Chair
Tom Daschle (DSD) Harry Reid (D-NV) Tom Daschle (DSD) Byron Dorgan (D-ND) Patty Murray (DWA)
Tobacco PAC Donations, 01/01/95-11/27/00 0
$6,500 0
0 0
House Republican Majority Leadership
Member
Tobacco PAC Donations, 01/01/95-11/27/00
19
Speaker of the House House Majority Leader House Majority Whip House Republican Conference, Chair House Republican Policy Committee, Chair House Republican Congressional Committee, Chair
Dennis Hastert (RIL) Dick Armey (R-TX) Tom DeLay (RTX) JC Watts (R-OK) Christopher Cox (RCA)
$9,000
$35,500 $56,500
$17,500 $14,500
Tom Davis (R-VA)
$1,000
House Democratic Minority Leadership35 House Minority Leader House Minority Whip House Democratic Caucus, Chair
Member
Richard Gephardt (DMO) David Bonior (D-MI) Martin Frost (DTX)
Tobacco PAC Donations, 01/01/95-11/27/00 $23,000
$8,000 $32,500
35 In the House of Representatives, Democratic leaders Gephardt, Bonior and Lowey have received no tobacco PAC money since January 1, 1997.
20
House Democratic Policy Committee, Chair Democratic Congressional Campaign Committee, Chair
Richard Gephardt (D-MO) Nita Lowey (DNY)
See above
$500
In addition to seducing the leadership of the major parties, the tobacco industrys campaign nance strategy aimed to cement friendly relations with a broad cross-section of the Congress, across regions and across party lines. While the industrys most loyal supporters in Congress hailed from tobacco-producing Southern states, the industry was careful to spread its largesse across the country. Between 1989 to 1994, 73 of the Senates 100 Members accepted campaign contributions from the tobacco industry, as did 287 of the 435 Members in the House.36 While the proportion of Members receiving tobacco contributions has declined in recent years, as the Democratic Party has taken an increasingly anti-tobacco stance, and as accepting tobacco money has become an increasing electoral liability, a considerable proportion of the Congress still receives support from the tobacco industry. Nearly sixty percent of current Members of Congress received contributions from tobacco industry PACs between 1995 and 2000.37
While publicity considerations have led it to assume a low prole in political matters, the tobacco industry
36 Vicki Kemper, The Inhalers: They May Not Smoke Tobacco Products, But Some In Congress Are Addicted to the Industrys Money, Common Cause Magazine, Jan./ Feb./ Mar. 1995. 37 Buying Inuence, Selling Death: How Big Tobaccos Campaign Contributions Harm Public Health, Common Cause, March 14, 2001
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has demonstrated its willingness to target individual Members who have threatened the industrys nancial interests. Rep. Mike Synar (D-OK), who had been one of the tobacco industrys most vociferous critics in the House, faced three opponents in a vicious Democratic primary in 1992, who were heavily funded by tobacco interests. His opponents posted billboards along the highways of his district that depicted his face alongside those of Adolf Hitler, Josef Stalin and Fidel Castro.38 While Synar survived the challenge in 1992, he was weakened, and lost to another tobacco-nanced primary challenger in 1994. This willingness on the part of the industry to lash out at troublemakers not only intimidates or eliminates an individual Member, it sends a message to others that the industry is best kept an ally.
Just as the targeting of specic members has an expressive, as well as a functional purpose, the timing of contributions is sometimes calculated to send a message. On February 24, 1998, the same day tobacco executives were called to Congress to discuss the nationwide antismoking proposal, Philip Morris contributed $100,000 to the Republicans who control the House.39 The donation was the largest the National Republican Congressional Committee took in during the rst three months of 1998, according to documents led with the Federal Election Commission.40
Opponents of campaign nance regulation often argue that full disclosure of contributors should provide a sucient deterrent incentive for politicians to avoid taking money from unsavory sources. But it can be notoriously dicult to track money to its source in industry, a fact that the following memo, a condential inter-oce correspondence, makes clear. At the time the memo was written, Pete Wilson was the Governor
Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.282 39 Tobacco Firms Gave Big to GOP Leaders, Associated Press, April 18, 1998 40 Id.
38 David
22
of California, considered a rising star in the Republican Party and potential presidential timber. During the 1990 election, Wilson publicly declared he would not accept campaign funds from the tobacco industry, but later attended a Philip Morris-sponsored fundraiser that raised $100,000 for the California Republican Party. After the fundraiser prompted an outcry, Wilson claimed he was unaware of the companys involvement. The following memo was circulated inside Philip Morris immediately after Wilsons disavowal.
23
To: Buy From: Jim Subject: Pete Wilson
Date: 4/24/90
Wilson is only sending about 16K of the 100K he collected. This 16K includes checks he received from either a tobacco company or anyone working directly for a tobacco company, i.e. Hamish Maxwell, Mrs. Ehud, Bill Murray.41
Apparently, he has also done with other controversial industries such as lumber, chemical and others. The decision to do this was Wilsons alone, and in the [sic] response to a wave of negative campaigning in California that not only attacks the candidates, but those who give to them as well.
You will be pleased to know that Pete called Hamish to explain that he was doing this to protect Hamish as well as himself. You will also be pleased to know that Pete is still pro-tobacco.
42
In the years that followed, Governor Wilson proved his status as pro-tobacco; he repeatedly tried to divert funds from Californias highly successful anti-smoking campaign.
41 Hamish Maxwell, former CEO of Philip Morris, is the chairman of the executive committee; Mrs. Ehud is the wife of Ehud Houminer, CEO of Philip Morris USA; Bill Murray is the former president of Philip Morris. The remaining $84,000 mentioned in the memo remains unaccounted for. 42 Peter. H. Stone, The Wilson Memo, Mother Jones, May/June, 1996
24
TOBACCO INDUSTRY LOBBYING: LEND ME YOUR EARS
While the tobacco industry is one of the most generous political givers in the country, it is an equally prodigious lobbying inuence. Brown & Williamson spent $25 million dollars in 1998 to lobby Congress successfully to oppose the McCain tobacco legislation; Philip Morris spent $23 million more. No other business, trade association, union or citizens group spent as much as either corporation, though other tobacco industry organizations spent an additional $18 million. In all, the industry spent $66 million lobbying the Congress in 1998.43 The industry is also extremely sophisticated in its employment of lobbying techniques. Because members of Congress are frequently back home in their districts, Philip Morris actually hired friends of the legislators in particular states and congressional districts to deliver the Philip Morris message informally.44 Sometimes lobbying eorts can be as unassuming as throwing a party in a Members honor. At the Republican National Convention in Philadelphia, U.S. Tobacco wined and dined delegates at a tribute to Senator Mitch McConnell (R-KY) and paid for an American Bandstand party honoring Senate Majority Leader Trent Lott (R-MS), complete with appearances by Dick Clark and the Shirelles.45 Philip Morris and Brown & Williamson were among the sponsors of a Mardi Gras Goes Hollywood party honoring Senator John Breaux (D-LA) that was held on a Paramount Studios lot and featured Mardi Gras oats, zydeco bands, gumbo and jambalaya.46 Not all politicians feel comfortable being publicly wooed the way Sens. Lott and Breaux do, particularly by as controversial an industry as the tobacco industry. To protect prospective allies from negative publicity, the tobacco industry has often used front groups to lavish favors on legislators. In 1997, Philip Morris sent
43 The tobacco industry spent another $40 million running television and radio advertisements attacking the McCain bill. Senator Mitch McConnell (R-KY), a staunch supporter of the industry, promised his colleagues the advertisements would continue even after the bill was defeated, in order to provide political cover to those Senators who stood with the industry. See Jerey Taylor, Is the Tobacco Industry Playing Politics With Issue Ads? Wall Street Journal, September 1, 1998 44 Ernest Wittenberg and Elizabeth Wittenberg, How to Win in Washington: Very Practical Advice About Lobbying, the Grassroots, and the Media. 2nd Edition, Blackwell, Cambridge, MA, 1994. p.46 45 Al Cross, Corporate America Gives the Red-Carpet Treatment, The Louisville-Courier Journal 3 August 2000. 46 Bruce Alpert, Despite Ban, Tobacco Filters into Parties, New Orleans Times-Picayune, 16 August 2000
25
twelve state legislators (among them Je Wells, the majority leader of Colorados state Senate, who was then considering a run for state attorney general) on a six-day vacation in Costa Rica, where they stayed at a luxury resort with a casino and pool bar.47 The trip was sponsored by the innocently named New York Society for International Aairs. While that group has a Manhattan telephone number and address, it is actually a front organization funded by Philip Morris. The president of the New York Society, Andrew Whist, is a vice president at Philip Morris; in a rare moment of candor, he bragged to the Wall Street Journal that the New York Societys oce is a chair in my apartment.48 Tax records led by the Society show that Philip Morris was nearly the exclusive donor to the non-prot organization between 1991 and 1995; during that time the tobacco giant was responsible for $620,000, or 98% of the $631,000 in total contributions received by the organization.49 Lobbying is not all attery and vacations. Lobbyists also play an essential role in connecting members of Congress with campaign donors. To raise money for their campaigns, members of Congress often need to woo lobbyists as much as lobbyists need to woo them. In the words of Tommy Boggs, one of Washingtons most famous and powerful lobbyists, The real abuse is the amount of time these guys [members of Congress] have to spend kissing my ass... Its ludicrous how much time these women and fellas have to spend raising money.50 This co-dependence often translates into concrete action by members of Congress: they come to recognize that lobbyists and legislators have a symbiotic relationship, in which each can help the other succeed. Its usually not put in the way of saying, See, we want your vote next week, said Cincinnati attorney and former congressman David Mann, a Democrat who served in the House of Representatives from 1992 to
47 Scott C. Yates, The Marlboro Hombres, Westword.com, August 27, 1997. In 1998 Wells circulated petitions to qualify in the race for attorney general, but did not le them. 48 Tatiana S. Boncompagni and Jill Abramson, Tobacco- Funded Group Gives Legislators Free Trips, The Wall Street Journal, August 4, 1997, p. A20. 49 Thompson Was Among VIPs Who Traveled Through Groups Backed By Firm, Steve Schultze and Daniel Bice, Milwaukee Journal-Sentinel, July 30, 1997 50 The Buying of the Congress: Transcripts, Thomas Hale Boggs, Jr., Interviewed by Chuck Lewis, Center for Public Integrity, August 15, 1997
26
1994. But youre campaigning every two years and youre under pressure to raise and spend money. Your votes are inuenced by that if youre a human being... How you vote on this may aect your ability to raise money, Mann said. Its always on your mind. Anyone who says otherwise is not being truthful.51
INSIDE CONNECTIONS, TRUSTWORTHY FIGURES
Lobbying is expensive because the most persuasive and well-connected lobbyists can command enormous fees. The tobacco industry has spent liberally to land the most credible and trustworthy gures that the Western world had to oer. Former British Prime Minister Margaret Thatcher became a consultant to Philip Morris after she left oce.52 Senator Howard Baker, (R-TN), the former Minority Leader and Majority Leader of the Senate, and Chief of Sta to President Ronald Reagan, also became a paid advocate for Philip Morris.53 Senator Zell Miller (D-GA) actually lobbied for Philip Morris between his service as Governor of Georgia and his ascension to the Senate.54 In addition to the personal relationships they retain from their time in oce, former members of Congress who become lobbyists retain certain advantages in their new incarnation; unlike other lobbyists, they are allowed on the House oor and in private dining rooms reserved for elected ocials.55 While its campaign donations have increasingly shifted toward the Republican Party, the tobacco industrys lobbying eorts retained a heavily bipartisan avor. In February of 1997, the ve largest tobacco companies
Straub, Lobbyists Practice Art of Subtle Pressure, The Cincinnati Post, July 15, 1998 Thatcher would be available to consult with us for an initial three-year period.. [T]he fee we would pay for those services would consist of a $250,000 annual payment to her and a $250,000 annual contribution to the Margaret Thatcher Foundation... we are of like mind. Michael A. Miles, PM memo July 20, 1992, PM ID 2022854068-69, at 68. 53 Senator Bakers attachment to this Company gives us an eective, high-level advocate of our policies...[I]f the Company needs to be publicly identied in a positive way with an issue, he can do it best. Jame Dyer, PM memo to David Greenberg and Buy Linehan, Senator Howard Baker, June 29, 1989, PM ID 2041252693-94). 54 Joshua Micah Marshall, Zellout, The American Prospect, Volume 12, Issue 8, May 1, 2001 55 Lobbyists without access to the House Floor must sometimes rely on other techniques of persuasion. Paula Parkinson, an agricultural lobbyist, claimed to have has sex with eight dierent members of Congress. See Ken Rudin, Congressional Sex Scandals in History, The Washington Post, 1998
52 Ms. 51 Bill
27
Philip Morris, RJR Nabisco, Brown & Williamson, U.S. Tobacco, and Loews Corp. hired Verner, Liipfert, a powerful Washington law rm with strong Democratic ties.56 Among the Democratic luminaries who now lobby their former colleagues for Verner, Liipfert are former Senate Majority Leader George Mitchell (D-ME), former Gov. Ann Richards (D-TX), and former Treasury Secretary and Senator Lloyd Bentsen (D-TX). Both Mitchell and Richards were active in lobbying Democrats on behalf of the tobacco industry.57 On the Republican side, the tobacco group hired Barbour, Grith & Rogers, a lobbying shop that boasts as a name partner Haley Barbour, a former chairman of the Republican National Committee. More than a few Republican members of Congress owe their seats to Barbours fundraising prowess at the RNC.58
THE SHADOW FDA
In addition to former members of Congress, the tobacco industrys lobbyists include many attorneys previously employed in the highest legal positions at the FDA. These individuals have not only substantial knowledge about the internal politics and machinations of the Agency, but the credibility and prestige to publicly second-guess the decisions of the FDA. This Shadow FDA includes Richard Merrill, former chief counsel during the Carter Administration and Peter Barton Hutt, former chief counsel during the Nixon Administration, both of whom are now partners at the Washington law rm of Covington & Burling, which has represented Philip Morris, Lorillard Tobacco and the Tobacco Institute;59 Richard Cooper, a former associate chief counsel in the Carter Administration,
56 Omar 57 Id. 58 Even in his time at the RNC, before he was a tobacco lobbyist, Barbour was accused of whipping votes for the tobacco industry; see p. 30. 59 David Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.337
Beer and Suzanne Herel, Loan Ocer for the Corporate Welfare State, Mother Jones, April 23, 1997
28
now a partner at the Washington law rm of Williams & Connolly, which represents R.J. Reynolds; Thomas Scarlett, former chief counsel during the Reagan Administration; Gene Pfeifer, a former FDA lawyer, now a partner at King & Spalding, which represents Brown & Williamson; Arthur Levine, former deputy general counsel of litigation from 1978-91; and Donald Beers,60 former associate chief counsel for enforcement from 1978-85. Levine and Beers both have represented Philip Morris as members of the law rm of Arnold & Porter.61 It is astonishing. These lawyers are the experts in the eld, and they know where everything is buried at FDA, said one FDA ocial. When they talk to their clients, they say, Ask for this document, and they know about the document because they are the ones who wrote it.62 These lawyers not only have invaluable knowledge, they are often the unchallenged authorities in their eld of expertise; Hutt and Merrill, for instance, literally wrote the book on Food and Drug Law.63 But the impact of these ocials goes beyond their legal acumen. Their past government service gives them unrivaled credibility, a quality which the tobacco industry is willing to pay for dearly. Charlie Edwards, a former commissioner of FDA, became a consultant for Philip Morris in 1994, in part because of the credibility that his stature and years of government service could lend to the industrys message.64 In testimony before the Senate Committee on Labor and Human Resources, Edwards attacked Commissioner David Kessler in starkly personal terms: We have yet to ensure that those who are appointed as Commissioner have the necessary qualications for the job. Far too often, the wrong person is in charge because it is easy but very wrong to assume that a medical degree or a prior post in academia is all that is needed to run this agency.65 Many of Edwards statements matched verbatim the remarks prepared by Philip Morris media
60 See 61 David
Milo Geyelin, Tobacco Industry Gets Help From Ex- FDA Lawyers, The Wall Street Journal, January 16, 1995. Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001,
p.143 62 Robert Dreyfuss, Tobacco Enemy Number One, Mother Jones, 1997 63 See Peter Barton Hutt and Richard A. Merrill, Food and Drug Law: Cases and Materials, University Casebook Series, Foundation Press, Westbury, NY, 1991 64 Charles R. Wall, PM memo to Steve Parrish, Retainer Fee for Dr. Charles Edwards, May 20, 1994, PM ID 2047710586 65 Senate Committee on Labor and Human Resources, testimony of Charles C. Edwards, hearing, The FDA and the Future of American Biomedical and Food Industries, 104th Cong., 1st Sess., April 5 and 6, 1995
29
experts.66 Edwards had been wooed by $125,000 in consulting fees and by Philip Morris proposal to build a scientic research center at Scripps Research Institute in La Jolla, California, where Edwards had served as president.67
FLEXING TOBACCOS MUSCLES: THE CONGRESSIONAL ASSAULT ON KESSLERS FDA
It should come as no surprise that members of Congress who hail from tobacco-producing districts are vigorous supporters of the industry, who are willing, even enthusiastic about standing up for a valued corporate constituent. But supporting tobacco interests is politically risky for many members of Congress whose districts dont depend on tobacco for their vitality. In extreme cases, supporters of the tobacco industry have been called on to armatively cast votes to protect their patrons. This is, however, a last resort, as it exposes both the industry group and their allies in Congress to criticism. More often, recipients of tobacco industry funds earn their keep through simply maintaining the status quo. The activist FDA of Commissioner David Kessler, with its aggressive eort to bring the tobacco industry under FDA jurisdiction, made the status quo approach unsustainable; industry leaders felt forced to call in chits from the entire panoply of political allies in an all-out assault on Kessler and his Agency. The tobacco industrys campaign against the Food and Drug Administration encompassed not only roll-call votes to deny granting the Agency jurisdiction over tobacco, but also casting aspersions on the leadership of the FDA and on the agency itself. Congressional recipients of tobacco industry largesse acted to attack FDAs integrity, its physical plant, its budget, and its statutory mandate.
66 The documents that matched Edwards testimony were PM ID 2044771450-54 and PM ID 2044771477-49. Edwards would admit only that he ran it through executives at Philip Morris. 67 David Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.315
30
ROLL-CALL VOTES: WINNING WHEN IT COUNTS
When necessary, the tobacco industry has been able to muster enough support in the Congress to win rollcall votes, even when the industrys position is disfavored by the general public. National polls show that a substantial majority of registered voters support strong action to address youth smoking; three out of four voters support granting the FDA authority over the manufacture, marketing and sale of tobacco products, and support lawsuits against the industry.68 Support for FDA regulation of tobacco crosses political and demographic lines, as overwhelming majorities of Democrats (eighty-one percent), Republicans (seventytwo percent) and independent voters (seventy-two percent) favored legislation that would grant the FDA authority to regulate tobacco products. Even a lopsided majority of smokers (sixty-seven percent) felt that Congress should pass a bill establishing FDA authority.69 Nevertheless, in July of 1997, the House and Senate defeated eorts to fund enforcement of the Food and Drug Administrations initiative to prevent illegal tobacco sales to minors. On July 23, 52 senators voted against funding; they received, on average, nearly three times the tobacco PAC contributions in the two years before their last election as the 48 senators who supported the funding ($14,884 vs. $5,223). In the corresponding House vote on July 24, 248 Members voting against the funding; they had taken, on average, nearly ve times as much tobacco PAC money in the previous cycle as the 177 Members who voted to fund the compliance checks ($5,636 vs. $1,142).70 In June of 1998, allies of the tobacco industry in the U.S. Senate defeated the comprehensive tobacco legislation sponsored by Senator John McCain (R-AZ). The bill was defeated by libuster on June 17, 1998, when supporters of the bill could muster only 57 of the 60 Senators needed to end debate and bring the bill
68 Market Facts Tele Nation conducted a random national survey of 864 registered voters February 2 through February 4, 2001. The survey has a margin of error of +/- 3.5 percentage points. 69 Id. 70 Buying Inuence, Selling Death: How Big Tobaccos Campaign Contributions Harm Public Health, Common Cause, March 14, 2001
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to a nal vote. The 42 senators who voted to kill the McCain bill received, on average, $17,902 in the two years before their last election; the 57 senators who supported the bill received an average of $4,810.71 In 1999, Congress refused to appropriate the $20 million requested by the Justice Department to fund the lawsuit. The Justice Department then sought funding through a provision of federal law allowing litigation assistance from other aected departments, including the Departments of Defense, Veterans Aairs and Health and Human Services. In June of 2000, the U.S. House of Representatives voted twice on whether to deny that alternative avenue of funding. On the rst vote, on June 19, industry supporters carried the day, 207-197; the 207 industry allies had received, on average, ve times as much tobacco PAC money in the previous two election cycles as the 197 who voted to continue funding ($9,712 vs. $1,750). On a subsequent vote, on June 23, supporters of the suit won a majority, 215-183. Members who voted to cut o funding had taken, on average, nearly seven times as much tobacco PAC money in the previous two cycles as the Members who supported funding for the lawsuit ($10,715 vs. $1,539).72 Eorts to kill the lawsuit also failed in the Senate, where the issue did not come to a oor vote. When hard-money donations are an insucient incentive, the role of soft-money donations to the political parties can also increase pressure on reluctant members of Congress to support party-line votes. In 1996, at the peak of the partisan rancor surrounding the FDAs role in tobacco regulation, the chairman of the Republican National Committee, Haley Barbour, was accused of exerting pressure on Republican members of Congress from Texas and Arizona to support industry-sponsored legislation. Barbour said he made the Arizona calls to check on the legislation but denied exerting pressure. Im not in the business of pressuring anybody, in Congress or anywhere else, he said.73
71 Id. 72 Id. 73 Clinton: RNC Exerted Pro-Tobacco Pressure, Reuters News Service, July 5, 1996. These comments were made before he became a lobbyist for the tobacco industry, at which point his job became, literally, the business of pressuring members of Congress or anybody else.
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CONGRESSIONAL COMMITTEES AND THE OVERSIGHT FUNCTION
Because of the structure of the committee system in Congress, some Congressmen are uniquely positioned to help or hurt a given industry. The Chairman of a Committee or Subcommittee can bottle-up legislation and keep it from reaching the Floor, or he can ensure that it has been neutered by the amendment process. As a result, even an industry that is unpopular with the general public can be eectively protected by a well-placed supporter in Congress. While it has proven its ability to muster a wide base of support in the Congress when necessary, the industry has preferred to make its inuence felt through the discretion of strategically placed allies in the leadership. This low-visibility strategy preserves the industrys political capital for when it is most crucial, and protects allies in the Congress from more criticism than is necessary.
For all these reasons, Rep. Thomas J. Bliley Jr., (R-VA) is the perfect ally for the tobacco industry. Chairman of the House Commerce Committee, which oversees the FDA, Bliley hails from a Richmond district that is home to a major Philip Morris plant; virtually no action he takes on behalf of the tobacco industry could threaten his base of political support in his district. Bliley has received so much tobacco money, and fought on behalf of the industry so vigorously, that he has earned the moniker the congressman from Philip Morris. Philip Morris agreed: in 1986, before Bliley assumed the chairmanship himself, an internal Philip Morris document referred to him as our sentry on the Health and the Environment subcommittee.74 And that feeling was no secret: after Bliley replaced Rep. Henry Waxman (D-CA) as chairman, Philip Morris CEO Georey Bible wrote a letter to shareholders in which he wrote that new faces and new leadership on Capitol Hill [give us] tremendous opportunities to get new and unbiased hearings on the issues that concern
74 Gregory R. Scott, PM memo to Gene A. Knorr, Rebuilding Our Relationship With Tobacco-State Congressmen, August 25, 1986, PM ID 2025854686-89.
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us most.75
In 1996, the RJ Reynolds Tobacco Company sponsored a reception in Blileys honor at the Republican Nominating Convention in San Diego. Asked to explain the attention, Bliley joked, I guess they think Im a great American.76 When he was pressed as to whether RJR was trying to inuence him, Bliley denied that they would have to, replying proudly, Ive been a defender of the tobacco industry since being elected to Congress.77 Bliley used his chairmanship to aggressively pursue FDA Commissioner David Kessler, often making unreasonable, even impossible requests of FDA ocials. One letter demanding documents, dated March 18, 1994, arrived at FDA headquarters March 21; the closing line of the letter read, Please provide this information to my oce no later than March 21, 1994. The letter itself later proved to be a direct product of tobacco industry strategizing; internal Philip Morris documents from the time list a letter to Kessler from Bliley as a top priority.78 Such document requests are often used by hostile Members to tie up the bureaucracy; Rep. Charlie Rose (D-NC) actually submitted document requests drafted by outside counsel to RJ Reynolds.79 Anytime theres an enforcement action or any policy or regulation deemed controversial in the eyes of Republicans, they can slam the FDA with a massive document subpoena and hold hearings on it, an anonymous FDA ocial said. Its an incredible waste of time.80
75 See 76 T. 77 Id.
Ken Silverstein, Washington on $10 Million a Day, Common Courage Press, 1998, p.113 Whitley, Tobacco Plays Host for Bliley Reception, Richmond (Virginia) Times-Dispatch, August 12, 1996
Team, PM notes, March 16, 1994, PM ID 2022838682-83. is what is being sent to Rep. Rose for his review and, hopefully, transmittal to the FDA. Arnold & Porter, fax cover sheet with draft letter attached, June 7, 1994, RJR ID 515786099-107. 80 Richard Blow, 10 Ways the Republicans Will Change Your Life, Mother Jones, 1995
79 This
78 Action
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ATTACKING THE FDAS INTEGRITY
Blileys public attacks on Commissioner Kessler were often scathing. As Kessler sat before the Subcommittee on Health and the Environment, Bliley launched into an ad hominem attack. I was saddened by what took place in this room a couple of weeks ago, Bliley said. I witnessed the Commissioner of the FDA, who is both a trained scientist and a lawyer, take threads of truth and weave them into whole cloth of rumor and innuendo.81 Bliley was sending a message: he would ght tooth and nail to protect the tobacco industry from regulation. A staer for Rep. Charlie Rose (D-NC), a tobacco industry ally, privately warned Kessler that [Blileys] preparing to send investigators all over the Agency looking for dirt... [the t]obacco industrys goal is to dismantle FDA.82 Bliley wasnt the only tobacco ally in the Congress to impugn the integrity of the FDA and its leadership, or even the most prominent. Speaker of the House Newt Gingrich labeled the FDA the number one job-killer in the country, and called David Kessler, a bully and a thug.83 Later Gingrich added, I think the FDA is a bureaucracy that has overreached on a number of fronts. It is weakening American job creations, weakening the introduction of new medications.84 During his campaign for the presidency, Senator Bob Dole (RKS) aggressively criticized Kessler; at a GOP fundraiser in September of 1995, Dole actually promised an audience of pharmaceutical executives that Kessler would be out of a job if he were elected.85 Rep. Joe Barton (R-TX), the Chairman of the Subcommittee on Oversight and Investigations, accused Mitch Zeller, Kesslers Deputy Associate Commissioner for Policy, of committing perjury.86 Where Tom
81 David Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.171 82 Id. at 289 83 Nicholas Regush, Migraine Killer, Mother Jones, 1995 84 See Jeanne Cummings, Preventative Care Gains Support; But Gingrich Rejects Targeting Tobacco, Atlanta J. & Const., Sept. 26, 1996, at 12A 85 Sheila Kaplan, Tobacco Dole, Mother Jones, May/June, 1996 86 David Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.346. A tobacco executive later admitted the strategy behind the accusation to Kessler: If you need to create a diversion because you dont want the agency [FDA] involved, attack the agency. Throw everything at the wall and something will stick.
35
Bliley openly admitted his advocacy for the industry, Barton denied that tobacco played any role in his hostile attitude toward the FDA and its sta. On national television, Barton pulled out a Bible and told ABCs Peter Jennings, This is the Holy Bible. Im a United Methodist. I swear on everything I hold dear to this country, and to my family and to my God, that my concern about FDA reform and my responsibilities and duties have nothing to do whatsoever with tobacco.87 When pressed with the fact that he had received donations from RJR, Brown & Williamson, Philip Morris, U.S. Tobacco, the Tobacco Institute, and Nabisco, Barton declared, Ive never had anybody directly relating a tobacco issue in this oce. Internal Philip Morris reports seem to contradict this statement; they show that tobacco lobbyists secured scheduling of two congressional hearings, one of which was Bartons.88
PUTTING WORDS IN THE MOUTHS OF CONGRESS
Reps. Bliley and Barton were not alone in their willingness to carry out the industrys agenda. At times, the relationship between industry patrons and their friends in Congress is so close that the public relations sta of the corporations can literally put words into the mouths of Congress. At a June 21, 1994 hearing, Rep. Michael Bilirakis (R-FL), among others, peppered Commissioner David Kessler and his sta with elaborate hypotheticals, reading verbatim from a script provided by R.J. Reynolds.89 Philip Morris actually wrote talking points for Reps. Martin Lancaster (D-NC) and James Clyburn (D-SC) to read into the congressional record on its behalf.90 Shortly after Lancasters testimony, Philip Morris sent around an internal e-mail to
News Report with Peter Jennings, June 27, 1996. David Nicoli, Philip Morris memo, Weekly Direct Report, October 20, 1995, PM ID 2047993169-72. This memo includes the notation secured scheduling of two FDA oversight hearings at House O&I [Oversight and Investigations], in November, including one where Kessler will appear. Oversight and Investigations was Rep. Bartons Committee. 89 David Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.249 90 Kathleen Linehan, PM memo to Robert Reese and Gregory Scott, Waxman FDA hearing, March 17, 1994, PM ID 2023029473.
88 See 87 ABC
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its executives, suggesting that they contribute to Lancasters campaign fund: It is suggested that you give $200-250 and that you send a letter with the check indicating that you are an executive of PM.91
HIGH-PRESSURE LETTER-WRITING CAMPAIGNS
Not every elected ocial is as useful an ally as a Chairman Bliley. But even those elected ocials who lack a strategic perch on an inuential committee can still be valuable assets. Internal documents show how important Philip Morris felt it was to have public ocials deliver their message directly to the FDA, to create the impression of massive resistance by political authorities. An internal Philip Morris e-mail dated from October, 1995, described a state-by-state FDA project. The message, from a Philip Morris executive to employees in the eld, suggested, ... the objective is to submit at least 10 quality letters per state primarily from elected ocials... you know your state assignments.
92
Shortly thereafter, three of the four top
Republican leaders in the House of Representatives Majority Whip Tom DeLay (R-TX), Majority Leader Dick Armey (R-TX) and House Republican Conference chairman John Boehner (R-OH) signed a letter in December of 1995 opposing the FDAs proposed regulation of tobacco. So did Senate Majority Leader Bob Dole. The letter was also signed by some prominent Democrats, including Senate Minority Leader Thomas A. Daschle (D-SD) and Sen. Sam Nunn (D-GA).93
The same pattern occurred the next year, when 124 members of the House sent a sharply worded letter to the
91 Ellen 92 Liam
Merlo, PM memo to Fred Laux, et al., Lancaster Contribution, April 19, 1994, PM ID 2041166362. Pleven, How Big Tobacco Courted Senator/Lobbyists Targeted Lack in FDA Fight, Newsday, September 6, 1999 93 Peter H. Stone, Blowing Smoke at its Critics, National Journal, April 20, 1996
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FDA, claiming the agencys tobacco proposal would put 10,000 jobs at risk and trample First Amendment rights to advertise legal products to adults. Two weeks later, 32 senators signed a virtually identical letter.94 Those senators who signed the letter had received an average of $31,368 from tobacco, compared to $11,819 for those senators who did not sign. The House signatories had received an average of $19,446, almost three times the $6,728 that non-signing members had received.95 A similar eort took place at the state level. Though the threat from the FDA was in theory a federal problem, the tobacco industry has taken to heart the adage of former Speaker of the House Tip ONeill that all politics is local. Keenly aware that state-level ocials provide the feeder system for members of Congress, industry representatives have carefully cultivated relationships with governors and state legislators. According to data compiled by the National Institute on Money in State Politics and by the Virginia Public Access Project, tobacco interests have given more than $5.4 million to state candidates and political parties since 1995.96 Tobacco interests are major donors to the American Legislative Exchange Council (ALEC), a group of about 3,000 conservative state legislators committed to ghting excise tax increases; Philip Morris and RJR actually sit on the Councils board of directors. Philip Morris gives the group about $50,000 per year; RJR about $25,000; and UST about $15,000.97 Philip Morris also contributes to the bipartisan National Conference of State Legislatures, a group of more than 7,000 state legislators. In 1995, Philip Morris gave $150,000 for the groups annual meeting, doubling its 1994 contribution.98 This largesse was well rewarded. An Oct. 4, 1995, newsletter cited with approval the view of the Smokeless Tobacco Council that FDA regulation would amount to an agency power grab that outs Congresss steadfast refusal to give FDA jurisdiction over tobacco. The newsletter urged ALEC members to write to the FDA to voice their opposition to proposed
94 Robert 95 Id. 96 See 98 Id. 97 Peter
Dreyfuss, Tobacco Enemy Number One, Mother Jones, 1997
Campaign Finance Information Center, www.campaignnance.org H. Stone, Our Good Friend, the Governor, Mother Jones, May/June, 1996
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regulation.99 Philip Morris wasnt content to rely on the exhortations of ALEC; the company also organized state legislators on its own behalf to rally against the FDAs proposed regulation. One of companys targets was Sen. James Lack (R-East Northport), a New York State legislator who was president of the National Conference of State Legislatures, a nationwide organization.100 Philip Morris courted both Lack and the NCSL, contributing to Lacks campaign, taking Lack and his aides to dinner, and sponsoring NCSL events in Milwaukee and Atlanta. In November of 1995, less than a month after Philip Morriss chief lobbyist in Albany treated Lack, his wife and two sta members to dinner, Lack wrote an impassioned letter to the FDA, drawing heavily on arguments contained in internal Philip Morris documents. Lack signed the letter in his dual capacity as both NCSL president and as a state senator, denouncing the FDA for overreaching its statutory mandate.101 State legislators in North Carolina were even more forceful in their protest. After David Kessler was invited to the University of North Carolina to speak about tobacco control issues, some state legislators actually threatened to cut o funding to the states agship university.102
FRIENDLY GOVERNORS
The tobacco industry has made similar eorts to elect and support friendly governors, and to enlist their aid against the FDA. Both Philip Morris and R.J. Reynolds are members of the elite board of the Republican Governors Association; each contributes approximately $40,000 annually to the group.103 On February 5, 1996, Georey Bible, the CEO of Philip Morris, chaired a dinner for the Republican Governors
99 Peter 100 Liam 101 Id. 102 David Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.355 103 Peter H. Stone, Our Good Friend, the Governor, Mother Jones, May/June, 1996
H. Stone, Blowing Smoke at its Critics, National Journal, April 20, 1996 Pleven, How Big Tobacco Courted Senator/Lobbyists Targeted Lack in FDA Fight, Newsday, September 6, 1999
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Association in Washington that raised a record-breaking $2.6 million.104 Philip Morris underwrote the event with a $100,000 contribution, while Bible delivered a speech extolling the economic benets of the tobacco industry.105 Just eleven days after the dinner, Gov. Kirk Fordice (R-MS), made the unusual move of ling suit against his own states attorney general. Fordices suit alleged that Michael Moore, who in 1994 had been the rst state attorney general in the country to le suit against the industry to recoup Medicaid costs, had exceeded his legal authority.106 In November of 1995, at the annual Republican Governors Association meeting in Nashua, New Hampshire, tobacco lobbyists pressured governors to lobby the FDA on their behalf.107 Tobacco lobbyist Kerry Paulsen reminded one North Dakota ocial that his company, UST (formerly U.S. Tobacco), had long supported Gov. Edward Schafer (R-ND) and that 1996 was an election year. When asked if he was threatening to withhold his companys nancial support, Paulsen said, Id never do that, but added, You know we have PAC money, we like the governor, and we want him to be re-elected.108 Governor Schafer heard the message loud and clear; like many other governors who attended the Nashua meeting, he ultimately signed and sent out under his own name a letter drafted by tobacco industry lawyers. In addition to the North Dakota letter, the FDA received letters opposing tobacco regulation from governors or lieutenant governors in Kentucky, South Carolina, Connecticut, Montana, and Mississippi.109 Many of these letters bear signs of having been adapted from the same source as the North Dakota letter: tobacco industry lawyers and lobbyists. In a letter to the FDA dated November 26, 1995, Lt. Gov. Eddie J. Briggs of Mississippi (R-MS) wrote:
In his August 10 speech, President Clinton stated that he was authorizing federal action against tobacco
104 Id. 105 Peter 106 Id.
H. Stone, Blowing Smoke at its Critics, National Journal, April 20, 1996. Fordices suit was unsuccessful. The lawsuit ultimately failed. 107 Peter H. Stone, Our Good Friend, the Governor, Mother Jones, May/June, 1996 108 Id. 109 Id.
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products to protect the young people of the United States. This insinuates that I and the other members of the Mississippi government cannot look out for the well-being of our children, and that we therefore must rely on the paternal hand of our federal government. I resent the implication that Mississippi is unable to care for its children.
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A letter from Lt. Gov. Dennis Rehberg (R-MT), dated December 25, 1995, said much the same thing:
In authorizing this federal action, President Clinton said he did so to protect young people of the United States. This statement implies that we here in Montana cannot look out for the well-being of our own children, and therefore must rely on assistance from the omnipresent federal government. Quite frankly, I resent this implication, and I rmly reject this unwarranted federal intrusion into our business.110
In another letter, dated January 2, 1996, Gov. David M. Beasley (R-SC) wrote:
First of all, I must be clear on one basic point. I do not recognize FDA authority to regulate tobacco products. The FDA repeatedly has declared that it lacks jurisdiction to regulate tobacco products as traditionally marketed. Now the FDA has reversed course and asserted jurisdiction where it has none.111
This portion bears a striking resemblance to part of the letter from Lt. Gov. Briggs of Mississippi:
Before discussing the proposed regulations, I need to be clear about one basic point. Do not take my participation to mean that I recognize FDA authority to regulate the sale, distribution, marketing and advertising of tobacco products. I do not. For decades, the FDA has declared that it lacks jurisdiction to regulate tobacco products as traditionally marketed. Now, however, the FDA simply has reversed course. I cannot accept this display of federal arrogance. The regulations must be withdrawn.112
While an ocial who serves the governor of North Dakota admits his governors letter was written by a tobacco industry lawyer, the others continue to deny that they were inuenced. Theres no connection between my letter and the tobacco industry, claims Montana Lt. Gov. Dennis R. Rehberg. I stand on the principle of individual responsibility.113 Rehberg has since been elected to the House of Representatives with the aid of $26,500 in contributions from the tobacco industry.114
110 A 111 Id. 112 Id. 113 Id. 114 See The Center for Responsive Politics, Dennis http://www.opensecrets.org/politicians/indus/N00004645.htm
Case of Great Minds Thinking Alike? Mother Jones, May/June, 1996
Rehberg,
Top
Industries,
available
at
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THREATENING THE FDA BUDGET
When veiled threats and angry letters are insucient, members of Congress have other tools with which to protect their industry patrons from the Food and Drug Administration. One of the most powerful of these is Congress control over the purse strings of the federal government. Often the mere existence of this power is sucient to deter cautious bureaucrats from oending the Congress. But as David Kesslers FDA moved forward with its plan to regulate tobacco, industry-friendly members of Congress made that threat a reality, punishing the Commissioner by attacking the FDAs budget.
In particular, tobacco-industry allies in Congress saw an opportunity to send the FDAs leadership a message by attacking a signature spending program. Kessler was intent on moving the FDA to a unied, more modern headquarters; for years it had been spread across forty-eight buildings in twenty dierent locations around Washington, D.C.115 The need for a new headquarters was clear.116 But while there had been a bipartisan consensus in favor of the appropriations in 1992, the FDAs challenge to the tobacco industry had created new opposition. The new headquarters became a symbol, and a rallying point for opposition to the FDA. Rep. John Duncan (R-TN) called the headquarters a Taj Mahal, while others referred to the project as Kesslers Castle.117 Testifying against the new headquarters, C. Boyden Gray, former White House Counsel to President George H. W. Bush and chairman of the conservative (and tobacco-funded) thinktank Citizens for a Sound Economy, actually suggested that the FDA might be best eliminated altogether:
115 David Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.313 116 See Ocials Warn: FDA Infrastructure Could Be Hazardous to Its Work, The Washington Post, June 5, 1991, p.A17 117 FDA Consolidation Plan Hit as a Taj Mahal, The Washington Times, February 1, 1995, p.C6
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The 104th Congress is currently in the process of identifying and eliminating federal agencies that have either outlived their usefulness, or whose mission can be best accomplished at the state level. Breaking ground on a government construction project of this magnitude is shortsighted especially until the future of the FDA can be dened by the new Congress.118
Shortly thereafter, Rep. Duncan proposed an amendment to strike the funds for FDA construction from appropriations legislation; it carried by a vote of 278-146.119 As David Nicoli, a Philip Morris strategist, noted approvingly in an internal email, tobacco was NOT mentioned during the entire debate.120
Some industry allies took their campaign even further. Rep. Jim Bunning (R-KY) actually proposed an amendment to strike all funding for the FDA altogether, crowing that the FDA was a rogue agency and Congress needs to slap it down.121 He was ultimately convinced to withdraw the amendment by embarrassed Republican colleagues. However ridiculous his behavior appeared to his peers, it did not hinder his political career in Kentucky, one of the nations largest tobacco-producing states. Bunning ascended to the Senate in 1998, with more funding from the tobacco industry than all but one other member of the Senate.122
AGGRESSIVE REFORM PLANS: EVISCERATING THE FDA
118 House Appropriations Committee, Treasury, Postal Service, and General Government Subcommittee, testimony of C. Boyden Gray, hearing, March 21, 1995. 119 David Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.316 120 David Nicoli, Philip Morris e-mail to Murray Bring, et al., Round Two on FDA Campus, July 19, 1995, PM ID 2046620272B-73. 121 U.S. Congress, House of Representatives, Congressman Bunning amendment and subsequent debate, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 1996, July 20, 1995. 122 Jim Bunning received $80,366 in tobacco industry PAC funds between January 1, 1995 and November 27, 2000. See Buying Inuence, Selling Death: How Big Tobaccos Campaign Contributions Harm Public Health, Common Cause, March 14, 2001
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An alternate method of protecting the tobacco industry from the FDA is to change the structure of the regulatory process, constraining the powers of the agency under the guise of FDA reform. In the wake of Commissioner Kesslers eort to regulate tobacco, numerous tobacco-supported thinktanks released plans to pare down FDAs responsibilities and to reassign FDA functions to private actors in an eort to eviscerate the Agency. Ever-conscious of public relations ramications, the tobacco industrys front groups were careful to couch the reform plans in terms that emphasized life-saving medicines and devices, and neatly avoided the central role the tobacco industry played in the reform eort.
On February 7, 1996, the Progress & Freedom Foundation (PFF) released a report entitled Advancing Medical Innovation: Health, Safety and the Role of Government in the 21st Century, during a conference attended by Rep. Thomas Bliley (R-VA). Rep. Bliley endorsed the PFF report and promised that his committee would begin holding hearings on reforming FDA beginning in late February.123 The Progress & Freedom Foundations plan would place responsibility for drug development, testing, and review in the hands of government-licensed drug (or device) certifying bodies, or DCBs, private rms hired by the drug companies themselves. According to the proposal, competition between rms would inevitably produce a lower-cost, faster, and higher-quality development and approval process.124 While the FDA would still exist, and would theoretically retain a veto power over new products, the PFF plan would have created a strong presumption that private certication decisions would not be overturned without substantial cause. Further, the FDA would not be authorized to request additional testing or data, and it would have to exercise its veto within a xed time period (e.g., 90 days) after which the drug would automatically receive FDA approval.125 The result would be an almost irresistible pressure on the FDA. The PFFs call for FDA privatization was echoed by Henry Miller, a former director of the FDAs Oce
123 Legislative 124 Nicholas 125 Id.
and Regulatory Overview, McKenna & Cuneo, L.L.P. Client Bulletin, March 1996 Regush, Migraine Killer, Mother Jones, 1995
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of Biotechnology, has been a persistent critic of the agency. Now a Senior Research Fellow at the Hoover Institution, a conservative public policy thinktank that receives funding from the tobacco industry, Miller is aliated with a numerous anti-regulation organizations, including the American Council on Science and Health (ACSH). In To Americas Health: A Proposal to Reform the Food and Drug Administration, Miller argues that The current system of drug regulation is, literally, overkill and works against the public interest, and contends that attempts at regulatory reform have been weak, undermined by the absence of any constituency that demands improvements in our regulatory system.126 In Millers conception, The seminal change would be that day-to-day oversight of drug testing and review of the initial application for marketing approval would be performed by nongovernmental, FDA-certied entities.127 The Heritage Foundation, which has long received substantial tobacco funding, came out with a similarly aggressive privatization approach. Whenever a drug or medical device is kept o the market for extended periods of time, or the cost of a drug or medical device is articially heightened by overregulation, Americans are dying or being forced to suer the unintended consequences of excessive FDA regulation.
128
To the major players in the pharmaceutical industry, however, the FDA is not simply an adversary, but also an important seal of approval, one that reassures consumers and bolsters the publics faith in the safety of its products. They are far less enthusiastic than their tobacco industry colleagues about the prospecting of starving much less eliminating the FDA. Steve Berchem of the Pharmaceutical Research and Manufacturers of America (PhRMA) said that while some drug reviews can be handled by the private sector, it would be a mistake to weaken the FDAs authority over product approvals. We need an FDA
Books from Hoover Fellows: To Americas Health: A Proposal to Reform the Food and Drug Administration, Business Wire, September 14, 2000. The claim that no constituency demands improvements is absurd; numerous and powerful constituencies, including industry, consumer and patient groups, have brought vast resources and millions of dollars to bear on demanding improvements. Whether the FDA remains in need of further reform, and what kind of reform, remain open questions. But the allegation that no constituency demands improvement is absurd. 127 Henry L. Miller, Dont Create a New Entitlement, Reform the FDA, St. Louis Post-Dispatch, July 17, 2000 128 Adam D. Thierer, Balancing Americas Budget: Ending the Era of Big Government, Section 554: Restructure the Food and Drug Administration, The Heritage Foundation, 1997
126 New
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that maintains public condence, Berchem says.129 Said one FDA ocial in 1997, The drug companies are happier than they have been in 10 years.130 Tom Lenard, the Progress & Freedom Foundations director of regulatory studies, admitted as much: The drug companies are not particularly radical. Our proposal is beyond where most of them seem to want to go.131 Nor was the medical device industry calling for drastic structural changes. The device industry doesnt want to see the FDA go away or be weakened, said Jim Benson, senior vice president of the Health Industry Manufacturers Association (HIMA).132 Who, then, was behind radical eorts to restructure the FDA, if not the pharmaceutical and medical device industries those plans claimed to benet? If you look at the people who are pushing for reform of the FDA, says one FDA ocial, behind the scenes you will see the tobacco industry.133
THE OUTSIDE GAME: SHAPING PUBLIC OPINION
All of these eorts aggressive oversight eorts, threats to the budget, reform of the decision-making structure, bullying FDA sta are inside strategies for constraining FDA. But industry strategists are savvy enough to realize that no matter how much lobbying they do, public opinion remains a signicant check on the ability of any interest group to advance its agenda. Accordingly, the tobacco industry has aggressively pursued a campaign to shape public opinion outside the Capitol an outside game to match its inside approach.
Regush, Migraine Killer, Mother Jones, 1995 Dreyfuss, Tobacco Enemy Number One, Mother Jones, 1997. Part of the explanation may be that under Commissioner David Kessler, the FDA made signicant strides in reducing the time required for new drug approval. Changes instituted by Kessler cut approval time by 30 to 40 percent. 131 Id. 132 Id. 133 Robert Dreyfuss, Tobacco Enemy Number One, Mother Jones, 1997
130 Robert
129 Nicholas
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Some members of Congress, like former Rep. Mike Synar (D-OK) or Sen. Dick Durbin (D-IL) oppose the tobacco industry for ideological reasons; the only way to stie their voices is to remove them from oce. Tobacco industry loyalists like Sens. Mitch McConnell (R-KY) and Jesse Helms (R-NC) are equally unshakable in their support for the industry. Between these two polar positions lie the vast majority of the members of Congress. While they may have personal opinions on the subject, their position on tobacco regulation is shaped largely by political realities, by the risks and rewards oered by assuming one position over another. While many political decisions are the product of backroom deals and fundraising considerations, many others are determined in the home districts of the wavering Members, in the hearts and minds of their constituents. Public opinion remains a signicant constraint on legislative action, and the tobacco industry, keenly aware of this fact, has positioned itself to take maximum advantage. The tobacco industry has had two primary goals in pursuing this Outside Game: to create the illusion of scientic uncertainty surrounding the health eects of tobacco use, and to link in the minds of voters FDA regulation of tobacco (which most voters favor) with the expansion of an overbearing bureaucracy and freespending federal government (which most voters oppose). To achieve these ends, the tobacco industry has pursued an unprecedented public relations campaign, using front groups, advertising, promotional schemes, and even direct dissemination of industry disinformation.
GRASSROOTS AND ASTROTURF
Professional lobbyists like George Mitchell and Haley Barbour may be personally persuasive, but to convince wavering members of Congress that a given position is politically viable, an industry must convince Members
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that the voters in their district support or at least will not oppose the industrys position. To do this, industry lobbyists have employed what they euphemistically call grassroots organizing, and what skeptics refer to as Astroturf the eort to make a narrow corporate agenda appear to have broadbased support among voters. Using specially tailored mailing lists, eld ocers, telephone banks and the latest in information technology, public relations rms are able to generate hundreds of telephone calls and thousands of pieces of mail to elected ocials, creating the impression of wide public support for their clients position. In 1995, Bob Beckel, once the manager of Walter Mondales 1984 presidential campaign and now a Washington lobbyist, organized a grassroots lobbying campaign on behalf of large long-distance telephone companies that generated more than 500,000 telegrams to members of Congress. Ultimately as many as half proved to be faked; some had been sent on behalf of people who were dead.134 Campaign and Elections magazine reported in mid-1995 that some $790 million dollars had been spent on grassroots telemarketing campaigns over the previous two years a jump of seventy percent.135
One expert in creating grassroots support for corporations is John Davies, whose print advertisements features a picture of an old lady carrying a sign bearing the legend Not in my backyard. The caption below reads:
Dont leave your future in her hands. Traditional lobbying is no longer enough. Today numbers count. To win in the hearing room, you must reach out to create grassroots support. To outnumber your opponents, call the leading grassroots public aairs communications specialists.136
At a 1994 conference of public relations professionals entitled Shaping Public Opinion: If You Dont Do It, Someone Else Will, Davies explained how his operation produced authentic-looking letters for grassroots
134 See 135 Id. 136 John Stauber and Sheldon Rampton, Deforming Consent: The Public Relations Industrys Secret War on activists, CovertAction Quarterly 55, 1995/96, p. 18
Ken Silverstein, Washington on $10 Million a Day, Common Courage Press, 1998, p.88
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campaigns:
We want to assist them with letter writing. We get them on the phone, and while were on we say Will you write a letter? Sure. Do you have the time to write it? Not really. Could we write the letter for you? I could put you on the phone right now with someone who could help you write a letter. Just hold, we have a writer standing by. We hand-write it on little kitty cat stationary if its an old lady. If its a business we take it over to be photocopied on someones letterhead. [We] use dierent stamps, dierent envelopes.. Getting a pile of personalized letters that have a dierent look to them is what you want to strive for.137
In this way, Davies proudly relates, he is able to create the impression of a spontaneous explosion of community support for needy corporations.138
The tobacco has industry used this method to great eect. As early as 1986, Philip Morris had assembled a database of almost three million customers that it used to generate phone calls and letters to elected ocials.139 Philip Morris launched the National Smokers Alliance (NSA) in 1993 with an estimated $4 million in seed money, and contributed a total of $42 million to the NSA between 1993 and 1996.140 Publicly, the NSA claimed it sought to empower smokers. In private, industry strategists expressed concern that empowerment not go too far:
The issue of empowerment of smokers was viewed as somewhat dangerous. We dont want to empower them to the point that theyll quit.141
The tobacco industrys letter-writing campaign was highly eective: between the FDAs August 1995 decision to regulate tobacco as a drug and January 1996, when the ocial period for public comment on the plan
Ken Silverstein, Washington on $10 Million a Day, Common Courage Press, 1998, p.91 Stauber and Sheldon Rampton. Deforming Consent: The Public Relations Industrys Secret War on activists, CovertAction Quarterly 55, 1995/96, p. 18 139 Allison Mitchell, The Inuence Industry: A New Form of Lobbying Puts Public Face on Private Interest, New York Times, September 30, 1998. 140 Andrew Tobias, Those Lovable Tobacco Execs, February 16, 2000, http://www.andrewtobias.com/bkoldcolumns/000216.html See also Myron Levin, Smoker Groups Thick Wallet Raises Questions,, The Los Angeles Times, March 29, 1998 141 Document available at http://www.prwatch.org/prwissues/2000Q3/empower.gif
138 John 137 See
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ended, the Agency received nearly 700,000 pieces of mail, most of them strongly condemning the FDAs action.142 The tobacco companies think it will have some psychological eect on the FDA, on the courts, and on Congress, said Alan Morrison, an attorney with the consumer advocacy group Public Citizen. These guys are used to sparing no expense. This is war.143 In March of 1994, a hidden camera belonging to an ABC crew captured Elizabeth Gallagher, an RJR employee who organized smokers rights groups around the country, explaining the industry strategy. A politician will not listen to you if they think all you are is a mouthpiece for the tobacco companies. Your only prayer is being independent, appearing independent, and for that reason, we dont get directly involved with organizing you guys.144 RJR actually obtained the itineraries of various members of Congress who supported or were considering supporting proposed tax increases - particularly a cigarette excise tax so that industry-funded protesters could pursue them carrying placards with anti-tax slogans. The protests appeared to be spontaneous, but in at least one instance the placards for a choreographed demonstration were literally shipped by Federal Express directly from RJR headquarters in Winston-Salem, North Carolina.145
BUYING LEGITIMACY: A PATRON OF THE ARTS
One of the challenges facing the tobacco industry was to create a positive corporate image. As in all their pursuits, the tobacco industry spared no expense. In New York, for instance, the tobacco industry became a major patron of the arts. In other parts of the country tobacco companies sponsored NASCAR events (the Winston Cup, for instance) and the Virginia Slims womens tennis tournaments. By its own estimate, Philip
142 Robert 143 Id. 144 Tobacco Under Fire, Mother Jones, 1996. ABC Executive Vice President Paul Friedman called Tobacco Under Fire a boring rehash; the program never aired. 145 Ted Gup, Fakin It, Mother Jones, 1996
Dreyfuss, Tobacco Enemy Number One, Mother Jones, 1997
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Morris spends over $150 million a year on public relations eorts, including millions in charitable giving.146 These investments dont create as readily recognizable nancial returns as donations as to elected ocials, or magazine advertising, but their purpose is every bit as calculated. Philip Morris actually spends more on promoting public awareness of its charitable giving than it does on charitable giving itself.147
A PATRON OF THE SCIENCES
In the scientic eld, the tobacco industry has had two primary goals: to forge friendly relationships with important institutions, and to produce plausible scientic studies which, if they could not demonstrate the truth of the industrys positions, could at least muddy the waters of scientic certainty and create doubt in the minds of jurors and the voting public. To achieve the rst goal, the tobacco industry followed the same strategy it did in politics and in civil society: it gave away enormous amounts of money. It made grants to prestigious institutions like Johns Hopkins Medical School and Harvard Medical School (one industry insider noted that the importance of the Harvard grant continues to be viewed by some as relating wholly to the name of Harvard,148 ). While the industry was largely unable to purchase endorsements of the industrys scientic positions from these institutions, it often succeeded in purchasing passivity and inaction. Just as generous campaign donations could persuade members of Congress not to make trouble, donations to scientic and medical institutions could at least purchase neutrality. In recounting donations made to UCLA Medical School, an internal industry document noted The industry also funded a project at UCLA
146 Dan 147 Id. 148 Janet C. Brown, memo to Arnold Henson, Industry Research Review Study Group, November 4, 1978, p.17, B&W ID 0012684784,
Harris, Corporate Goodwill or Tainted Money, ABC World News Tonight, February 8, 2001.
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Medical School, but only after the Medical School reassured the industry that nothing damaging to the industry would be discovered.149
Perhaps the most cynical eorts by the industry were to associate itself with cancer research institutions. Philip Morris, R.J. Reynolds, the American Tobacco Company, Liggett & Myers, Lorillard, and Rothmans all contributed money to the Sloan-Kettering Institute for Cancer Research; Philip Morris alone contributed over $200,000 before 1970.150 Amazingly, the tobacco companies reaped more than merely positive publicity, winning the complicity of some of the nations most respected doctors. One Philip Morris memo noted with pleasure that Frank Horsfal, the director of Sloan-Kettering, had publicly expressed his doubt that smoking is implicated in carcinoma causation. Dr. Horsfals opinion (coupled with his demonstrated liking for our Marlboro cigarettes) has been benecial. As head of the nations principal cancer research organization, he has tremendous inuence.151 The contributions apparently helped to silence Ernst Wynder, a researcher at the Institute. According to an internal industry document, Horsfal and other Sloan-Kettering ocials, conscious of the interests of their patrons, began subjecting Wynder to more rigorous screening procedures before letting him speak in the name of the Institute. This has had a proper and pleasing eect... The [tax-] deductible contribution to Sloan-Kettering is probably the most eective of all health research contributions.152 The irony of this statement is truly chilling; the contribution was eective because it prevented the truth from coming to light. Even the American Medical Association was wooed by the tobacco industrys largesse. In 1964 the six largest tobacco companies oered the AMA $10 million dollars to fund research on smoking and health; two weeks
149 Jones, 150 David
Day, Reavis & Pogue, draft report, Corporate Activity Project, B&W ID 681879254-715. Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001,
p.207 151 C.H. Kibbee and J.C. Bowling, PM memo to Joseph F. Cullman III, Sloan-Kettering Institute for Cancer Research, 18 February 1970, PM ID 2024774530. 152 J.C. Bowling, PM memo to C.H. Kibbee, Sloan-Kettering Contributions, November 23, 1964, PM ID 1005038364.
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after the AMA accepted the oer, Francis Blasingame, the AMAs executive vice-president, penned a letter to the Federal Trade Commission in which he opined that with respect to cigarettes, cautionary labeling cannot be anticipated to serve the public interest with any degree of success.153 Ultimately, the companies contributed $15.005 million between 1964 and 1972.154
DISCARDING EVIDENCE, FABRICATING DATA
To the general public, the tobacco industry presented itself as interested in scientic research, regardless of where it might lead. In a full page advertisement which ran in 448 leading newspapers, beneath the headline A Frank Statement to Cigarette Smokers, one tobacco ad read: We accept an interest in peoples health as a basic responsibility, paramount to every other consideration in our business. We always have and always will cooperate closely with those whose task it is to safeguard the public health.155 The advertisement announced an initiative to fund research into tobacco use and its health implications an eort that culminated in the creation of the Council for Tobacco Research. The research eort, however, proved to be anything but altruistic.
153 David Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.207 154 Shook, Hardy & Bacon, Brown & Williamson American Medical Association Issues Notebook, January 1990, B&W 682623623-788. 155 David Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.200
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THE COUNCIL FOR TOBACCO RESEARCH
The Tobacco Industry Research Committee, later renamed the Council for Tobacco Research (CTR), was headed by a man of impeccable credentials. Clarence Cook Little was a Harvard-educated cancer researcher and former university president who had been active at both the National Cancer Institute and the American Cancer Society. His stature in the scientic community provided the essential element of credibility the industry needed. Though CTR was a grant-making organization that claimed to be dedicated to the cause of scientic health research, applications for grants from the CTRs Special Projects division were vetted by tobacco industry lawyers rather than scientists. Their explicit purpose was to develop scientic data that could be used to defend the tobacco companies in court.156 One internal memorandum from Philip Morris noted, [I]f CTR [the Center for Tobacco Research] is to be useful, ways must be found to bolster its reputation so it can be useful to launder industry money.157 Another internal document was even more frank:
[CTR] was set up as an industry shield.... CTR has helped our legal counsel by giving advice and technical information, which was needed in court trials. CTR has provided spokesmen for the industry at Congressional hearings... On these projects, CTR has acted as a front.158
At a 1979 meeting of American Tobacco ocials, tobacco industry ocials agreed that CTR Special Projects should continue under CTR to give investigators an aura of independence.159 That aura was a deception. Wrote a Lorillard ocial, CTR is NOT independent because of what we have asked them not to do.160
156 Environmental Tobacco Smoke: The Brown and Williamson Documents, Journal of the American Medical Association, Special Communication, July 19, 1995, available at http://www.ama-assn.org/scipubs/journals/archive/jama/vol 274/no 3/sc5045.htm 157 Philip Morris notes, New York meeting, November 15, 1978. 158 See Haines v. Liggett Group, 140 F.R.D. 681 (E.D.N.J. 1992) 159 American Tobacco meeting notes, May 7, 1979. AT ID MNATPRIV00034812-13. 160 James Bowling, PM notes, quoting Alexander Spears at meeting of Industry Research Study Committee, April 19, 1979, cited in William L. Alinder (Shook, Hardy & Bacon), letter to K.F. Bixenstein (Jones, Day), October 22, 1992, PM ID 2048925020.
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Tobacco companies did more than tailor the direction of their research; they were so dominated by the threat of litigation that they willfully avoided recognizing data that contradicted the industrys litigation positions. In one memo, an ocial of Brown & Williamson suggested that certain kinds of information from British American Tobacco (BAT), Brown & Williamsons parent company, were better left uncommunicated: [I]f the reports include discussions of pharmacological eects of nicotine, the information will not be interesting and would be helpful to the plainti. The company ultimately decided to receive the reports, but remained ready to inform BAT to cease sending the data to B&W if the science is not interesting.161 Interesting in this context is an industry euphemism meaning favorable for our litigation defense strategy.
When such uninteresting research was produced, the industry was more than willing to destroy or suppress it. Another memo, from RJR, makes this willingness explicit:
We do not foresee any diculty in the event a decision is reached to remove certain reports from Research les. Once it becomes clear that such action is necessary for the successful defense of our present and future suits, we will promptly remove all such reports from our les. As a rule, we invalidate about 15 reports each year for various reasons... [W]e can cite misinterpretation of data as reason for invalidation.... As an alternative to invalidation, we can have the authors rewrite those sections of the reports which appear objectionable.162
What is clear from these documents is that the tobacco industry was intent not merely on averting its eyes from potentially harmful discoveries, but on making scientic claims it knew to be untrue.
Wells III, B&W memo to E. Pepples, BAT Science, February 17, 1986, B&W ID 682419469-70 Senkus, RJR memo to Max Crohn, Invalidation of Some Reports in the Research Dept., December 18, 1969, RJR ID 500284499.
162 M.
161 J.K.
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THE TOBACCO INDUSTRYS SCIENTISTS: THE WHITECOAT PROJECT
While they knew that giving to recognized institutions like Harvard and Sloan-Kettering would win the industry praise (and perhaps even some breathing room), tobacco industry lawyers recognized that they would need scientic evidence to support the industrys positions. To protect themselves from regulation and litigation, the tobacco companies needed scientists who were willing to go on the record. In 1967, Rosser Reeves, a public relations expert employed by the tobacco industry, proposed to enlist janissaries to challenge the conventional wisdom on smoking and health, with the knowledge that those people would come to depend on it for their livelihood and whose zeal, consequently, often runs well ahead of their facts.163 In short, Reeves sought to create a class of advocates who could be expected to play fast and loose with science, while maintaining plausible deniability for the industry. The eort was code-named The Whitecoat Project, after the white lab coats worn by scientists. The project had four primary goals:
-
-
163 Rosser Reeves, Tiderock Corp. memo to Anne Heteld et al., The Study of a Propaganda Phenomenon, July 18, 1967, PM ID 1003059283-85.
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-
Records of correspondences between industry ocials and Whitecoat Project scientists sometimes resemble negotiations between businessmen, explicit in their recognition of a quid pro quo: A 1965 RJR memorandum describes such an exchange:
Dr. Sprunt wants something more than the hope they will approve his grant application before he takes further public position on our behalf... Dr. Sprunts present attitude is that he is prepared to testify in Washington (including an adequate statement by accepting our help in preparing the nal form...) but feels that before he does so, we should adopt a more positive attitude towards his situation.165
While it is written in euphemisms, the meaning of the conversation is clear: Dr. Sprunt is willing to testify to industry-friendly conclusions (adequate statement), even sign his name to a document drafted by industry lawyers (accepting our help in preparing the nal form) but only in exchange for more money that he has previously been oered (a more positive attitude toward his situation).
The American Medical Association and the American Public Health Association have had policies for years urging researchers not to accept tobacco industry money, but nearly all universities have continued to allow professors to accept such support, citing the importance of academic freedom.166 The tobacco industry had its own reasons for funding research, which had little to do with academic freedom. In 1993, after the Environmental Protection Agency ruled that environmental tobacco smoke (ETS) was a Class A carcinogen
165 Edwin Jacob (of Cabell, Medinger, Forsyth & Decker), letter to H.H. Ramm (of R.J. Reynolds), January 25, 1965, RJR ID 500887112-13. 166 Scott Shane, Tobacco Deal Would Disband Controversial Research Center, Baltimore Sun, November 14, 1998
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and a health hazard, the tobacco industry paid thousands of dollars to scientists to voice their objection to the nding in letters to medical and scientic journals.167 Dr. Gio Gori was one of thirteen scientists who accepted large sums of money from the Tobacco Institute to write letters to the editor attacking the EPAs report. Records show that Gori was paid $20,137 for two letters to the Wall Street Journal, one letter to the British medical publication The Lancet, one letter to the NCI Journal, and one opinion piece for the Wall Street Journal. Dr. Gori, a former scientist at the National Cancer Institute, is now a consultant to the tobacco industry.168 Said Clive Bates, director of the antismoking organization Action on Smoking and Health, No matter how strict you are about conicts of interest, there is not much you can do if scientists conceal who they are paid by.169
THE CENTER FOR INDOOR AIR RESEARCH
Concealing the existence of nancial relationships between scientists and industry gures became a critical component of the tobacco industrys research strategy. As late as the 1980s, some industry groups were maintaining their campaign through openly tobacco-aliated groups. While the results invariably favored the industrys position, the subterfuge involved was so transparent that the studies lacked credibility. A 1987 Tobacco Institute memo lamented:
Yesterday morning, the Texas Association of Wholesale Distributors and the Tobacco Institute held a news conference in Dallas to release the results of an environmental smoke study...The highly favorable results of the study were reviewed at our meeting last week....Questioning at the conference was skeptical but not
167 David Hanners, Scientists Were Paid to Write Letters Tobacco Industry Sought to Discredit EPA Report, Pioneer Planet/St.Paul Press, August 4, 1998. See also Philip Morris Report, IAQ Goals, January 25, 1993, Philip Morris ID 2023206195/6198. 168 David Hanners, Scientists Paid to Write on Tobacco: Letters Aimed to Discredit Report on Secondhand Smokes Eects, Saint Paul Pioneer Press, August 14, 1998 169 Clare Dyer, Tobacco Company Set Up Network of Sympathetic Scientists, British Medical Journal, May 23, 1998
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hostile. The Institutes open sponsorship of the study aected the credibility of the results...170
Because industry allies lacked credibility, and most independent scientists (particularly in medicine) were unwilling to associate themselves with such a disreputable industry, cigarette companies created a front group called the Center for Indoor Air Research (CIAR). Formed in late 1987, and funded by a coalition that included Lorillard, Philip Morris and R.J. Reynolds, the purpose and origins of the organization had to be carefully concealed if it was to fulll its mission of legitimizing industry propaganda.171 As a result, many of the documents about hiring sta and recruiting scientists for it were stamped condential, and much of the work to form CIAR was labeled Attorney Work Product by Covington & Burling, the Tobacco Institutes legal counsel. The minutes of a secret meeting in London makes the purpose of funding CIAR clear:
Philip Morris presented to the UK industry their global strategy on environmental tobacco smoke [ETS]. In every major international area (USA, Europe, Australia, Far East, South America, Central America and Spain) they are proposing, in key countries, to set up a team of scientists organized by one national coordinating scientist and American lawyers, to review scientic literature or carry out work on ETS to keep the controversy alive.172
While tobacco industry executives were conscious of the deceptive nature of their enterprise, their chief concern was how this might hinder their ability to recruit scientists:
The excessive involvement of external lawyers at this very basic scientic level is questionable and, in Europe at least, is likely to frighten o a number of scientists who might otherwise be prepared to talk to the industry.
173
available at http://www.pmdocs.com/getallimg.asp?DOCID=2025855771/5772 Tobacco Institutes Center for Indoor Air Research (CIAR), http://www.tobaccofreedom.org/issues/documents/ets/cia center/ See http://www.tobaccoinstitute.com/getallimg.asp?DOCID=TIMN0014390/4393 for minutes and participants of that December 10, 1987 meeting. 172 Note On a Special Meeting of the U.K. Industry on Environmental Tobacco Smoke, London, February 17th, 1988, document available at http://www.tobaccofreedom.org/issues/documents/landman/conspiracy/401247331a.pdf 173 Id.
171 The
170 Document
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This concern was well-founded; the industrys sometimes manic eort to recruit scientists had already created a number of embarrassing, awkward situations, as the Philip Morris memorandum below indicates.
MEMO174 To: J.P. Rupp, Attorney [A partner at Covington & Burling] From: Helmut Gaisch [Philip Morris, Europe] Date: November 16, 1987 Dear John, I had a surprise phone call earlier today from Dr. Bieva in Brussels. He was rather amazed that a certain Dr. Weimberg in Washington should call, asking him exactly the questions that we had already asked him and also oering him a contract. It made him uneasy that so much attention was suddenly focussed upon him from America (we had already introduced him to Shook Hardy).175 We really should not be seen falling over each other when contacting independent scientists. When I gave you the other day in condence our list of whitecoats, it was precisely with the purpose in mind of avoiding double approaches....May I suggest that we agree as quickly as possible amongst ourselves on who contacts whom.... Kind regards,
Helmut
According to a memo from industry law rm Covington & Burling, which emerged during the discovery phase of litigation in Minnesota, the companys consultants included an editor of the Lancet, an adviser to a select committee of the British House of Commons, and members of working groups of the International Agency for Research in Cancer.176
One of our consultants is an editor of this very inuential British medical journal, and is continuing to publish numerous reviews, editorials, and comments on environmental tobacco smoke and other issues.177
174 Document 175 Shook,
available at http://www.tobaccofreedom.org/issues/documents/landman/whitecoats/p1.gif Hardy & Bacon is a national law rm that represented both Philip Morris and R.J. Reynolds. 176 Clare Dyer, Tobacco Company Set Up Network of Sympathetic Scientists, British Medical Journal, May 23, 1998 177 Id. The Philip Morris memo can be found at http://www.bmj.com/misc/philipmemo.shtml
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These scientists were asked to cover all substantial scientic conferences where they can usefully inuence scientic and public opinion, and were not paid unless and until they actually perform work, according to the Covington and Burling memo.178
Because deniability was a cornerstone of the industry eort, the CIARs scientic recruits were carefully picked to avoid any detectable evidence of bias:
The consultants should, ideally, according to Philip Morris, be European scientists who have had no previous connection with tobacco companies and who have no previous record on the primary issue which might, according to Remes,179 lead to problems of attribution.180
The memorandum, however, leaves little doubt that biased research was the explicit goal of the project:
Philip Morris then expect [sic] the group of scientists to operate within the connes of decisions taken by PM scientists to determine the general direction of research, which apparently would then be ltered by lawyers to eliminate areas of sensitivity.181
CIAR acknowledged no connection with the tobacco industry.182 Its annual budget of about $5 million, however, came almost exclusively from the four largest U.S. tobacco companies.183 Though they worked assiduously to the create perception of independence, the nancial powers behind CIAR were not shy about ensuring that the research the Center produced was favorable. The authors of a 1996 study on CIAR-funded
178 Id. 179 David 181 Id. 182 According to a CIAR grant advertisement, The Center for Indoor Air Research was established in 1988, as an independent, non-prot corporation. Its primary purpose is to sponsor scientic and technical research on the sources, transformation, and fate of constituents aecting indoor air quality; on factors governing human exposure to and retention of those constituents; on the eects of those constituents on health, including exposure-response relationships; and on methods of preventing or abating indoor air contaminant concentrations. The research program is supplemented by periodic conference workshops and commissioned monographs. This description is available on the web page of the Pacic Northwest Pollution Prevention Resource Center, which itself appears to be an industry front, at http://www.pprc.org/pprc/rfp/archives/indoora.html 183 Scott Shane, Tobacco Deal Would Disband Controversial Research Center, Baltimore Sun, November 14, 1998 180 Note
Remes was and is a partner at Covington & Burling. On a Special Meeting of the U.K. Industry on Environmental Tobacco Smoke, London, February 17th, 1988, document ava
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projects found that . . . one recipient of an applied project, Roger A. Jenkins (1995), of Oak Ridge National Laboratory, testied at length regarding the funding process for his project. He stated that CIAR had approached him with a proposal for his project, and that he and his colleagues had developed the study methodology with input from CIAR, R.J. Reynolds, and Bellomy Research (a marketing research rm). CIAR tax records show that the Oak Ridge lab received $797,892 in 1993 for Jenkins to conduct a study titled Determination of Human Exposure to Environmental Tobacco Smoke.184 Another project related to ETS was conducted by ACVA Atlantic, a small rm that was paid $13,800 in 1985 to conduct a study of air quality in homes.185 Although the president of ACVA Atlantic, Gray Robertson,186 has since characterized his organization as an independent consulting rm specializing in solving indoor air problems such as sick building syndrome, his research proposal stated before even preliminary tests were conducted - that the results of his study could demonstrate that ETS has a relatively insignicant eect on indoor air quality.187 In addition, the methodology for the study stated the following:
Twelve homes will be selected in three discrete areas of the country giving a total of 36 homes, the selection will be by the Tobacco Institute who will provide the names, addresses, phone numbers and contact at each of the homes chosen to [sic] ACVA.188
As the Journal of the American Medical Association later noted, It is highly unusual for an independent company to allow an organization such as the Tobacco Institute, which clearly has a strong interest in the outcome of a study, to select the sites for the study.
184 D.E.
189
Barnes and L.A. Bero, Industry-funded research and conict of interest: an analysis of research sponsored by the tobacco industry through the Center for Indoor Air Research, Journal of Health Politics, Fall 1996, pp. 515-542, 515-542, 185 ACVA Atlantic Inc and Robertson G. Residential InspectionIndoor Air Pollution. Quotation, May 2, 1985. 186 Robertson G, Healthy Buildings International Inc. Testimony before the House Subcommittee on Health and the Environment, Committee on Energy and Commerce, US House of Representatives; March 17, 1994. Washington, DC: US Government Printing Oce serial No. 103-127. 187 ACVA Atlantic Inc and G. Robertson. Residential InspectionIndoor Air Pollution. Proposal, May 2, 1985. 188 Id. 189 Environmental Tobacco Smoke: The Brown and Williamson Documents, Journal of the American Medical Association, Special Communication, July 19, 1995, available at http://www.ama-assn.org/scipubs/journals/archive/jama/vol 274/no 3/sc5045.htm
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Perhaps to avoid association with it previous work for the tobacco industry, ACVA Atlantic later changed its name to Healthy Buildings International (HBI). In practice, however, it remained the same organization, faithfully carrying out the same industry-supported agenda. A 1994 sta report prepared by the House Subcommittee on Health and the Environment suggested that a study conducted by HBI to measure levels of ETS in typical oce environments contained fabricated and falsied data.190 The HBI study, like the ACVA Atlantic study before it, had been funded as a special project by the Center for Indoor Air Research, and concluded that with good ventilation, acceptable air quality can be maintained with moderate amounts of smoking.191 HBI employees stated that their eld notes had been routinely altered so that the levels of ETS reported were lower than those that had actually been measured.192 Alfred H. Lowrey, a research chemist at the Naval Research Laboratory who reviewed the HBI data, concluded that the data is so marred by unsubstantiated data entries, discrepancies, and misclassications that it raises serious questions of scientic fraud.193 Though the revelation of the falsied data brought HBIs usefulness to an end, the organization had already served its purpose well. Between August, 1985, and September, 1994, employees of HBI/ACVA Atlantic testied on at least 129 occasions before federal, state, or local government agencies concerning ETS. HBIs standard statement was that, according to their analyses, moderate levels of smoking could be tolerated indoors with adequate ventilation. In many cases, they did not acknowledge tobacco industry funding.194 One of the main goals of CIAR was to mainstream industry-friendly research, to create the (false) im190 House Subcommittee on Health and the Environment. Oversight Hearing on Tobacco Product Regulation. Washington, DC: Committee on Energy and Commerce, US House of Representatives; 1994. House Subcommittee on Health and the Environment. Environmental Tobacco Smoke Investigation: Exhibits. Washington, DC: Subcommittee on Health and the Environment, Committee on Energy and Commerce, US House of Representatives; 1994. 191 Turner S, Cyr L, Gross A. The Measurement of Environmental Tobacco Smoke in 585 Oce Environments, Environ Int. 1992;18:19-28. 192 House Subcommittee on Health and the Environment, Oversight Hearing on Tobacco Product Regulation. Washington, DC: Committee on Energy and Commerce, US House of Representatives; 1994. House Subcommittee on Health and the Environment. Environmental Tobacco Smoke Investigation: Exhibits. Washington, DC: Subcommittee on Health and the Environment, Committee on Energy and Commerce, US House of Representatives; 1994. 193 Id. 194 See M. Levin, Whos Behind the Building Doctor? The Nation, August 9, 1993; D. Levy, Smoking Data Tampered With, Researchers Say, USA Today, November 2, 1994
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pression that scientic opinion was divided on issues surrounding Environmental Tobacco Smoke. In this, they were largely successful. Publications of the Center for Indoor Air Research are to this day included alongside legitimate scientic publications, in the University of Washington library, for instance, and at many other sites.195 As late as 1998, the CIAR was still oering fellowships through the website of The American Thoracic Society - the medical section of the American Lung Association.196
USING THIRD-PARTY FRONT GROUPS Just as the tobacco industry learned in the 1970s to conceal the source of its scientic claims, it also learned to mask its eorts in the political and commercial realms. Because tobacco money has attracted negative attention from the press, tobacco interests often use front groups with benign-sounding names, a tactic that enables corporations to take part in public debates and government hearings behind a cover of community concern or scientic independence.197 Merrill Rose, executive vice president of the public relations rm Porter/Novelli, advises her clients: Put your words in someone elses mouth... There will be times when the position you advocate, no matter how well framed and supported, will not be accepted by the public simply because you are who you are. Any institution with a vested commercial interest in the outcome of an issue has a natural credibility barrier to overcome with the public, and often, with the media.198 The tobacco industry has taken Roses words to heart. Said a Philip Morris ocial at a 1984 workshop on cultivating relationships with third-party organizations,
The whole question of getting third-party assistance and enlisting this whole third-party concept in our defense structure is to give us clout, to give us power, to give us credibility, to give us leverage, to give us access where we dont ordinarily have access ourselves. Those are the kinds of things we are looking for.
example, the University of Washingtons library shows CIAR publications alongside legitimate scientic works. See http://sta.washington.edu/ehlib/outlinks/bibls/iaqbibl.html 196 A copy of the fellowship oer is available at http://www.thoracic.org/news/atsnews/news0998/story19.html 197 This has become a common, although still highly eective practice for supporters of unpopular causes. The Seniors Coalition and United Seniors, for instance, are actually anti-Medicare groups. 198 Merrill Rose, Activism in the 90s: Changing Roles for Public Relations, Public Relations Quarterly, Vol. 36, No. 3 (1991)
195 For
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And to make them useful, we have to cultivate them, we have to build them, we have to stay with them... what were doing is nothing new because the company has been doing this all along. Every time we have an issue, we always reach out to third parties wherever we can.199
In 1994, as part of the coordinated campaign against the FDA, Philip Morris strategists proposed to their board of directors a series of Allied attacks, where friendly third parties are engaged on our side but without direct or obvious connection to the industry.200 In one report, Philip Morris identied twenty-ve third-party ally organizations:
Action Institute for the Study of Religion and Liberty Alexis DeToqueville Institution Americans for Tax Reform Cato Institute Center for the Study of American Business Citizens for a Sound Economy Citizens for Tax Justice/Institute on Taxation and Economic Policy Claremont Institute for the Study of Statesmanship and Political Philosophy Consumer Alert Grocery Manufacturers of America Heartland Institute Heritage Foundation Hoover Institution on War, Revolution and Peace Institute for Research on the Economics of Taxation Mackinac Center for Public Policy Manhattan Institute National Association of Manufacturers National Center for Policy Analysis National Empowerment Television National Journalism Center National Policy Forum Pacic Research Institute for Public Policy Tax Foundation Texas Republic Washington Legal Foundation201
Dealing with the Issues Indirectly: Constituencies, Philip Morris 1984 Corporate Aairs World Conference, September 13, 1984, Philip Morris ID 2025421934/2000 200 Steven Parrish, PM draft presentation to the PM board of directors, Sea Island, Georgia, April 11, 1994, PM ID 2048310347. 201 Philip Morris strategy report, Tobacco Strategy, March 1994, PM ID 2045741542-48.
199 Workshop:
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Some of the above organizations are simply ideological peers of the tobacco industry, dedicated to unregulated markets, but otherwise generally independent. In many other cases, however, these third-party groups took their marching orders directly from the tobacco industry. One internal Philip Morris memo suggested of the Washington Legal Foundation, have them publish an article.[emphasis added]202 When a Philip Morris executive learned that Roll Call, the Capitol Hill newspaper, was running a special issue on the Food and Drug Administration, he dashed o an e-mail that ordered Contact CSE [Citizens for a Sound Economy] about running an ad.203
The tobacco industry was a major contributor to most, if not all, of the listed groups, including the American Enterprise Institute, the Cato Institute, the Competitive Enterprise Institute, Citizens for a Sound Economy, the Heritage Foundation, and the Washington Legal Foundation.204 These thinktanks and public policy organizations serve multiple purposes for the industries that support them. They provide an illusion of independence and scholarship, and they provide a resource for cultivating industry-friendly experts.205 They also serve as a clearinghouse for data; in the words of lobbyist Tommy Boggs, information... became something that special interests learned they could develop quicker, better, faster, and more accurately than the government could.206
L. Fuller, PM memo to Michael A. Miles, February Monthly Report, March 17, 1994, PM ID 2023439346-51. Nicoli, Philip Morris e-mailto Ellen Merlo et al. Roll Call/FDA-October 9, September 26, 1995, PM ID 2037027442B. 204 A Million For Your Thoughts: The Industry-Funded Campaign Against the FDA by Conservative Think Tanks, Public Citizen, July 24, 1996 205 For instance, Alan Slobodin, a lawyer at the Washington Legal Foundation before the Republican takeover in 1994, became counsel to the Commerce Committees Subcommittee on Oversight and Investigations, which has jurisdiction over the FDA. In his new post, Slobodin continued an aggressively campaign against the agency, draining resources with constant hearings and demands for documents. Slobodin is constantly saying, Give us all your documents on this or that, said one attorney close to the FDA. And then all of a sudden these papers show up in the hands of the Washington Legal Foundation. See Robert Dreyfuss, Tobacco Enemy Number One, Mother Jones, 1997 206 The Buying of the Congress: Transcripts, Thomas Hale Boggs, Jr., Interviewed by Chuck Lewis, Center for Public Integrity, August 15, 1997
203 David 202 Craig
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The relationship between the tobacco industry and the Cato Institute is typical. The Cato Institute, one of the most frequently quoted policy institutions in Washington, has received hundreds of thousands of dollars of support from Philip Morris and R.J. Reynolds. In return, Cato has produced industry friendly reports, conferences, and articles. One policy forum was entitled, The New Prohibition? Freedom & Tobacco Under Siege by the FDA.207 Cato published an article in Regulation, its quarterly journal, entitled Lies, Damned Lies, & 400,000 Smoking-Related Deaths, which challenged the validity of data from the Centers for Disease Control and Prevention (CDC). If the same study had been written by the Tobacco Institute, it would have been immediately dismissed by serious journalists (particularly if it had borne the same title). But because Catos status as a legitimate conservative thinktank is secure, its contentions were not viewed with the same skepticism. As a result, the article provoked positive commentary that appeared in newspapers around the country, including in The Boston Globe.208
ATTACKING INDUSTRYS OPPONENTS
Most industry players remain unwilling to attack the FDA in public, either for fear of retaliation or, more likely, for fear that openly attacking an agency charged with protecting health and safety could create a political backlash. As a result, one of the most important roles of the tobacco industrys third-party front groups was to engage in the hand-to-hand combat of the public relations business a role that large companies are constrained from playing themselves. The public relations rm Hill & Knowlton outlined a strategy for dealing with the tobacco industrys scientic critics:
207 Public Citizen Congress Watch, A Million for Your Thoughts: The Industry-funded Campaign Against the FDA by Conservative Think Tanks, pp. 29-32 Washington, D.C., 1996 208 See e.g. Je Jacoby, Big Lies About Tobacco, The Boston Globe, May 10, 1999
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-
-
-
-
Examples of smearing and belittling by third-party groups abound. The Washington Legal Foundation, which received generous support from the tobacco industry, and appeared in Philip Morris list of third party allies (see pp.67-68), produced advertisements that showed two gravestones accompanied by the headline If a Murderer Kills You, Its Homicide. If a Drunk Driver Kills You, Its Manslaughter. If the FDA Kills You, Its Just Being Cautious.210 These advertisements ran in The New York Times, USA Today, The Wall Street Journal, The National Journal, and Roll Call.211 Citizens for a Sound Economy (which also appears on Philip Morris list of allies) sponsored ads that claimed, A better quality of lifeeven life itselfis being denied to too many Americans because of the FDAs misplaced priorities.212 The group received about $250,000 a year in the early 1990s from Philip Morris to help launch its state aliates in New Jersey, New York and four other states.213 CSE spent some $2 million on anti-F.D.A. advertising, organizing and lobbying between 1995 and 1996.214
Dreyfuss, Tobacco Enemy Number One, Mother Jones, 1997 Castagnoli, What is the WLF and Why is it Challenging the FDA? Med. Marketing & Media, April, 1995 212 Robert Dreyfuss, Tobacco Enemy Number One, Mother Jones, 1997 213 Peter H. Stone, Blowing Smoke at its Critics, National Journal, April 20, 1996 214 A Million For Your Thoughts: The Industry-Funded Campaign Against the FDA by Conservative Think Tanks, Public Citizen, July 24, 1996
211 William 210 Robert
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Like industry allies in Congress, third-party allies of the tobacco industry showed a willingness to engage the FDAs leadership on a personal level. The National Legal and Policy Center, for instance, made more than 850 FOIA requests in an attempt to nd damaging information about David Kessler. It found $850 worth of taxi cab receipts over a six-year period, which industry allies in Congress seized upon in an eort to impugn Kesslers integrity and divert attention from the tobacco debate.215
CONTROLLING MASS MEDIA
One of the most important components of the tobacco industrys outside game has been attention to the mass media. Just as the industry has leveraged its nancial resources to forge relationships with political leaders, scientists and social organizations, so it has used its vast resources to win inuence in the mass media. Sometimes this inuence is used to quell a specic crisis. In order to defuse potential criticism over the marketing of tobacco products to minority neighborhoods, the tobacco industry provided direct nancial support to the National Association of Hispanic Publishers, the National Newspaper Publishers Association, California Hispanic Publishers, West Coast Black Publishers, and the National Federation of Hispanic-Owned Newspapers.216 In 1993, the West Coast Black Publishers Association actually passed a resolution endorsing the right of the tobacco industry to market to the black community, and penned a letter to Senator Ted Kennedy (D-MA) explaining their support for the industry.217 The increasing consolidation of media corporations has helped to facilitate the forging of alliances between industry and media. In an internal memo from 1985, former Philip Morris chief executive Hamish Maxwell outlined a strategy to shape public opinion in the companys favor by directly inuencing the content of the
Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.344. See also Kessler Travel Investigation Called A Smear, USA Today, February 21, 1996, p.1D 216 Id. at 206 217 Id. at 211
215 David
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television and print media:
The sixth point I want to make is that we are not using our considerable clout with the media. A number of media proprietors that I have spoken to are sympathetic to our position Rupert Murdoch and Malcom Forbes are two good examples. The media likes the money they make from our advertisements and they are an ally that we can and should exploit.218
An appendix to the memo, written by another Philip Morris employee, notes approvingly
As regards the media, we plan to build similar relationships to those we now have with Murdochs News Limited with other newspaper proprietors. Murdochs papers rarely publish anti-smoking articles these days.219
This concern with directly inuencing media was still alive and well in 1990, by which point the project had been dubbed Operation Rainmaker. As the memo below makes clear, Philip Morris had become convinced that merely inuencing the media would be insucient for its purposes, and had concluded that purchasing major media conglomerates oered the potential for reliably disseminating industry propaganda.
TOP SECRET: Philip Morris Operation Rainmaker
TOP SECRET Internal Report Date: March 20, 1990
What are we trying to accomplish? Prevent further deterioration of overall social, legislative and regulatory climate, and ultimately, actually improve the climate for the marketing and use of tobacco products.220
Perspective of PM International on Smoking and Health Issues: Text of the discussion document used at the meeting of top management, Internal Memorandum, Philip Morris, 1985, available at http://www.media-awareness.ca/eng/news/news/two/rupsmoke.htm 219 Internal Memorandum, Philip Morris, 1985, available at http://www.media-awareness.ca/eng/news/news/two/rupsmoke.htm 220 Operation Rainmaker, Internal Memorandum, Philip Morris, March 20, 1990, http://www.tobaccofreedom.org/issues/documents/landman/rainmaker/p1.gif
218 The
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ACTION ... ACQUISITION - if we are to truly inuence the public policy agenda and the information ow to the populace we must be the media, we must be part of it. The only way to do this is to own a major media outlet. If we are not willing to take this step, then we are not serious about really wanting to change the atmosphere.
Organizations that should be very seriously considered include:
- Knight Ridder - Zuckermans group - the Copley News Service - United Press International - or a major city daily that has access to and from all of the major wire services.221
The signicance of the last portion of the memo that has access to and from all of the major wire services should not be overlooked. A media organization with access to the major wire services could arrange that its stories be picked up by the thousands of smaller local papers around the country, a unique vantage point from which to legitimize and disseminate the industrys point of view. Philip Morris seriously considered proposals to buy UPI,222 but ultimately declined; the extent to which the plans outlined in the Operation Rainmaker memorandum were ever put into eect is unclear. But it is apparent that the tobacco industry has made signicant inroads into major media organizations, among them those of Rupert
221 Id. 222 David Kessler, A Question of Intent: A Great American Battle With A Deadly Industry, PublicAairs, New York, 2001, p.211. UPI was purchased in May, 2000 by New World Communications, Inc., the publisher of The Washington Times, the arch-conservative newspaper aliated with the Rev. Sun Myung Moons Unication Church. The transfer of ownership sparked the resignation of veteran White House correspondent Helen Thomas and International editor Lee Michael Katz. See The New York Times, May 16, 2000.
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Murdoch and Malcom Forbes, mentioned in Hamish Maxwells 1985 memorandum.
FOX/NEWS CORP.
Some of the most obvious connections between Rupert Murdochs media conglomerate and the tobacco industry are at the very top of the corporate structure. Philip Morris CEO Georey Bible joined News Corp.s Board of Directors on June 23, 1998; News Corp. owns the Fox Network. Bible eectively replaced Hamish Maxwell, the former chief executive of Philip Morris, who served on the News Corp. Board of Directors until early in 1998. Rupert Murdoch, CEO of News Corp., has sat on Philip Morris corporate board since 1989. As a result, each is intimately familiar with the business of the other, and the two have oered one another public support. Murdoch himself has defended the tobacco industry in public; he told 240 executives attending the Forbes CEO Forum that Philip Morris and the tobacco industry in general were victims of a classic media feeding frenzy.223 The Fox News Channel shows a pronounced conservative bias in its stang (anchorman Tony Snow is a former aide to Vice President Dan Quayle), and is also known for being particularly heavy-handed in its topdown control of content. Ive been at editorial meetings, said one Fox News Channel employee. Certain stories y and certain stories dont. Im not blind and neither are my colleagues. Everyone is aware that something is at work. Theres a reason that theres a perception that Fox leans to the right.224 One of those reasons is Roger Ailes, the Chairman and Chief Executive Ocer of the Fox News Channel.225 Ailes is the former executive producer of the right-wing Rush Limbaugh Show.226 Ailes also has tobacco connections of his own. An internal R.J. Reynolds memo from 1988 details how Ailes was the media director
Klein, Where Theres Smoke, Mother Jones, September/October, 1998 Eviatar, Murdochs Fox News, The Nation, March 12, 2001 225 See http://www.newscorp.com/management/foxnews.html 226 Limbaugh, a proud cigar smoker, is also an outspoken defender of tobacco products. It has not been proven that nicotine is addictive, the same with cigarettes causing emphysema [and other diseases]. See The Rush Limbaugh Show, April 24, 1994, as cited by EXTRA!, http://www.fair.org/press-releases/limbaugh-debates-reality.html#nicotine-addictiveness
224 Daphne 223 Jerey
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for the California Tax Initiative Campaign, an eort by tobacco companies organized and directed to deal with Proposition 99.227 The memo notes that Roger Ailes, a nationally recognized candidate and issue media professional, has replaced Hal Larsen as media director, and notes condently that in addition to working with the tobacco industry, Ailes is director of Bush for President media operations.
228
Ailes Fox News exhibits more than a generalized conservative bent; it is sometimes stridently anti-regulatory. The Fox News website, www.foxnews.com, is lled with attacks on the EPA229 and FDA,230 many written by Steven Milloy, a Cato Institute scholar with ties to the tobacco industrys public relations arm (see pp. 109-114). Milloy refers to FDA warnings as yet another example of a government agency terrorizing the public... for political gain. Fox News applies a similar skepticism to anti-smoking activism: the channel recently declined to air an anti-smoking advertisement produced by the American Legacy Foundation. The advertisement, Body Bag, depicts corpses wrapped in body bags being pulled from a truck in front of Philip Morris headquarters. Fox ocials said the decision not to air the ad was based on content, not board relationships.231 But from the network which popularized such programs as When Animals Attack and Worlds Greatest Police Chases, the explanation seems incomplete.
FORBES: CAPITALIST TOOL
In 1994, Philip Morris began a nationwide counterattack on second-hand smoke, purchasing full-page advertisements in forty newspapers, including the New York Times, Washington Post, Los Angeles Times,
99 was an antismoking ballot initiative passed in 1988 by the voters of California. from Roger Mozingo to Dolph W. von Arx, W.G. Champion Mitchell, and Gene Ainsworth dated July 7, 1988, re California Tobacco Initiative meeting July 6, 1988, Tobacco Institute Board Room, Washington, D.C. Copy available at http://www.library.ucsf.edu/tobacco/calminnesota/html/3425/001/ 229 Adjusting Science to Fit Policy, available at http://foxnews.com/views/junkscience/030201.sml 230 FDAs Mercurial Fish Story, available at http://foxnews.com/views/junkscience/010119.sml 231 Wendy Melillo, Fox, CBS Nix Morbid Anti-smoking Ads, Ad Week, February 14, 2000
228 Memorandum 227 Proposition
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Chicago Tribune, Miami Herald, Boston Globe, and Baltimore Sun. The ads consisted of an article reprinted from Forbes MediaCritic that questioned the notion that second-hand smoke causes cancer in non-smokers, and appeared under the headline, If We Said It, You Might Not Believe It.232 You probably shouldnt believe it anyway. The Forbes article was written by Jacob Sullum, then managing editor of Reason magazine, who called the Environmental Protection Agencys 1993 report on second-hand smoke one-sided, credulous and supercial, and argued that journalists missed an important story about the corruption of science by the political crusade against smoking.233 What neither the original article nor the advertisements mentioned was that Sullum himself received tobacco industry funding, that Reason magazine received tobacco funding, or that Sullums key sources for the article, Gary Huber of the University of Texas Health Science Center234 and Alvin Feinstein, described as an epidemiologist at Yale University,235 also received tobacco industry support. Sullum wasnt the only voice at Forbes to come to the defense of the tobacco industry. Forbes editor Peter Brimelow, a former staer of Senator Orrin Hatch (R-UT), actually wrote an article citing the supposed health benets of smoking. In another, Brimelow attacked David Kessler in starkly personal terms, calling him the quintessential D.C. chameleon... with an intense desire to control,236 describing his career path as one that would be snied at by doctors concerned with professional standards,237 and characterizing his willingness to stay on under President Clinton as a stunning act of treachery.238 The cover of that issue
232 Sheldon Rampton and John Stauber, Tobaccos Second-hand Science of Smoke-Filled Rooms, PR Watch, Volume 7, No. 3, Third Quarter, 2000 233 Jim Naureckas, Smoke Screens, Extra!, September/October 1994 234 Hubers research on secondhand smoke at Harvard was funded in part by a grant from the major tobacco cigarette manufacturers in the United States. He left the University of Kentuckys Tobacco and Health Research Institute after evidence surfaced of further payments from R.J. Reynolds, Brown and Williamson, and the Tobacco Institute. Over the years, Huber received more than $7 million in tobacco industry research funding. For Hubers own perspective, see Frontline, Inside the Tobacco Deal: Interviews, Gary Huber, 1998, available at http://www.pbs.org/wgbh/pages/frontline/shows/settlement/interviews/huber.html. 235 Between 1985 and 1990, according to condential documents that leaked from Brown and Williamson, Feinstein received at least $700,000 for basic epidemiological research from the special projects fund of the industrys Center for Tobacco Research. See Jim Naureckas, Smoke Screens, Extra!, September/October 1994 236 Peter Brimelow and Leslie Spencer, Just Call Me Doc, Forbes, November 22, 1993, pp. 108-110 237 Id. 238 Id.
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of Forbes caricatured Kessler dressed as Napoleon Bonaparte.239 Speaking at a conference sponsored by the Pacic Research Institute for Public Policy, a pro-business 501(c)(3) organization dedicated to principles of individual freedom and personal responsibility (which also appears on Philip Morris secret list of allied third-party organizations, see p.68), Brimelow spoke in terms more betting a political consultant than a journalist: What we need in science policy is countervailing stereotypes to hand to the troops so they know which way to re. Said Brimelow, The FDA is slowing arrival of new drugs on the market and people are dying. Its a simple stereotype now being accepted, largely because of the AIDS crisis... The question of cost is another stereotype. You can express a stereotype in one sentence. Its commission or omission. They are not letting the drugs through.240
TOBACCO CONCLUSION
It is dicult to read a recounting of the misdeeds of the tobacco industry the deception, the manipulation, the perversion of science and of the democratic process without experiencing frustration, even anger. And it is surely a natural response to seek individuals to hold accountable; indeed, many have condemned the industry itself. While this is an understandable response, it is woefully, even dangerously incomplete. In fact, it may well be the conclusion that many of the performers in the tobacco industry drama would prefer, because such a conclusion has a clinical neatness to it, and compartmentalizes the infection to the tobacco industry alone. To conclude that the individuals who led the tobacco industry are simply depraved is to risk obscuring the institutional structures that enabled, and perhaps even determined the tobacco industrys
Forbes, November 22, 1993 Science: A Hazard to Your Health, Conference of the Pacic Research Institute for Public Policy, June 25-28, 1998. Summary available at http://www.pacicresearch.org/events/jscience.html
240 Junk 239 See
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actions. As the following section of this paper aims to demonstrate, the tobacco industrys behavior is not primarily the fault of any exceptional failure of corporate morality, because the tobacco industrys moral compass is not exceptional. When confronted with a similar situation, working with similar constraints and similar choices - Procter & Gamble followed the tobacco industrys battle-tested game plan precisely. While a similar demonstration could be made with virtually any other industry that faces FDA regulation, for purposes of simplicity the following section focuses on the FDAs consideration of the food additive olestra.
A CASE STUDY: PROCTER & GAMBLE AND OLESTRA Not every industry player is as destructive as the tobacco industry; the tobacco industry is relatively rare among legal industries in that its products are both addictive and lethal. But the strategies that the tobacco industry pioneered have an enduring usefulness beyond the campaign to evade tobacco regulation; the range of techniques employed by the tobacco industry and their legal and public relations arms can be neatly adapted to other campaigns to manipulate the regulatory process. Procter & Gambles campaign to promote the approval and sale of olestra, its controversial non-fat fat, serves to illustrate this larger point.
What emerges from a thorough comparison of the campaign to oppose the FDAs tobacco rules and the campaign to secure the FDAs approval of olestra is that the proper locus of debate is not one which anthropomorphizes the corporate form, and which denes misbehavior as a sign of personal deviancy, but one which assesses systemic pressures and seeks systemic remedies. Whatever one thinks of the tobacco industry, there is little reason to believe that Procter & Gamble is a rogue corporation; in fact, there is every reason to believe it is not (for example, P&G has been hailed as a good corporate citizen in its home state of Ohio, where it has stood behind politically risky tax hikes to support education).241 Yet Procter &
241 See,
e.g., Randy Ludlow, Voinovich, P&G Lead School Tax Fight, The Cincinnati Post, February 17, 1998
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Gambles tactics are startlingly reminiscent of the tobacco industrys.
Just as it is beyond the scope of this paper to opine upon the legal and scientic legitimacy of the FDAs claim of authority over tobacco, it is beyond the scope of this paper to debate the scientic merits of the FDAs approval of olestra; limitations of space and technical expertise demand this concession. The goal of this section is not to show that the approval of olestra was a mistake, but to show that the approval did not occur in a vacuum that the activities of olestras sponsor had the clear potential to inuence the FDAs decision in ways that threaten the integrity of the process. Regardless of whether olestra is actually dangerous, one can fairly conclude that factors irrelevant to the scientic merits play a signicant role in the approval process, and in matters of health and safety, and this is cause for concern.
OLESTRA: WHAT IT COST PROCTER & GAMBLE
Procter & Gamble, a multinational company with some $35 billion in annual sales, spent nearly 25 years and more than $200 million developing olestra, a chemical which tastes and cooks like fat but passes through the body undigested.242 In addition to the research and testing, Procter & Gamble made signicant capital investments; P&G constructed, with the help of equity partner Frito Lay, a $200 million olestra-making plant in Cincinnati.243 In addition to the sunk nancial costs, by the mid-1990s olestra had become a kind of test of corporate will. As P&G nally began marketing the product, P&G Chairman and Chief Executive Ocer John Pepper said proudly, This is one of a handful of events... that they will look back to and help dene what this company is at its best. Its been torturous and at moments a source of some anxiety, but
242 Art 243 Je
Levine, Food Fight in Indianapolis, U.S. News, May 5, 1997 Harrington, Olestra Snacks Ready for Market, The Cincinnati Enquirer, February 10, 1998
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our people have stayed with it.244 It was also the dening event of Peppers tenure as CEO. For all of these reasons, Procter & Gamble was deeply committed to securing olestras approval. Procter & Gamble had an enormous nancial incentive to secure and retain - FDA approval for their product. The market for a non-fat fat is potentially enormous; Americans spend close to $2.4 billion on diet-related foods each year, and $15 billion annually on snack foods.245 Given the rising rates of obesity among Americans, and the increased emphasis on diet, olestra has the potential to be a dynamic revenue generator. Financial analysts at Drexel Burnham Lambert predicted that olestra could generate $1.5 billion annually in sales which would make it the most protable product in Procter & Gambles impressive corporate history.246 In June of 1995, a House subcommittee held hearings that focused on the FDAs long delays in completing its reviews of food-additive petitions. Many of the industry witnesses who appeared before the subcommittee used olestra as an example of a benecial food additive that was languishing on the desks of FDA reviewers. Members of Congress voiced their agreement. Under attack from all sides, FDA got the message.
CONCERNS ABOUT OLESTRA
In October of 1995, an FDA advisory committee of 22 scientists met to review the application and determine their recommendation. Two issues dominated their discussion: the risk of so-called fecal urgency, and the danger that olestra would wash out benecial nutrients from a consumers body. In 1995 FDA medical ocer Karl Klontz reviewed a P&G study entitled Measurement of Selected Fecal Parameters in Subjects Consuming Increasing Levels of Olestra.247 For seven days, fteen volunteers who
244 Id. 245 Art 246 Ken
Levine, Food Fight in Indianapolis, U.S. News, May 5, 1997 Silverstein, Procter & Gambles Academic White Hats, Multinational Monitor, November, 1997, Volume 18, Num-
ber 11 247 Michael Jacobson and Leila Corcoran, Snack Attack: Olestra, The Center for Science in the Public Interest, March, 1998
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had previously reacted to the fake fat were fed meals with zero, ten, or twenty grams a day of hidden olestra. There was a steady increase in the number of subjects who reported diarrhea with increasing dose of olestra consumed, Klontz reported. The same was true of severe diarrhea as well as loose stools. The study showed that severe diarrhea only showed up when the volunteers ate olestra.248 In another P&G study from 1993 - the most complete available on olestra and gastrointestinal symptoms fully one-third of the volunteers reported suering diarrhea at least once when they ate twenty grams of olestra a day. Only one out of seventeen people who ate no olestra reported diarrhea.249 Except in extreme cases for seriously ill people or young children diarrhea is not a serious health risk. But it could be commercially lethal for a consumer product. Procter & Gamble was terried that negative publicity about this side eect could threaten its investment. The more serious medical concern was the risk of washing out nutrients particularly carotenoids like lycopene.250 In two 1993 P&G studies, thirty-nine people who ate eight grams a day of olestra (the equivalent of sixteen chips about one serving size) with meals for eight weeks had a fty percent drop in their total blood carotenoids.251 Much of the debate within the Advisory Committee centered on the questions surrounding carotenoids themselves. Some argued that carotenoids play a crucial health role. There are dozens of studies indicating that carotenoids protect against cancer, heart disease, and macular degeneration,
248 Final Report: Assessment of the Dose-Response Eect of Olestra on the Status of Fat-Soluble Vitamins and Other Marker Nutrients in Humans, submitted by P&G to the FDA on January 29, 1993. See also An Eight-Week Vitamin Restoration Study in Humans Consuming Olestra, submitted by P&G to the FDA on June 2, 1993. 249 Michael Jacobson and Leila Corcoran, Snack Attack: Olestra, The Center for Science in the Public Interest, March, 1998 250 In human beings, carotenoids can serve several important functions. The most widely studied and well-understood nutritional role for carotenoids is their provitamin A activity. Deciency of vitamin A is a major cause of premature death in developing nations, particularly among children. Vitamin A, which has many vital systemic functions in humans, can be produced within the body from certain carotenoids, notably beta-carotene. Carotenoids also play an important potential role in human health by acting as biological antioxidants, protecting cells and tissues from the damaging eects of free radicals and singlet oxygen. Lycopene, the hydrocarbon carotenoid that gives tomatoes their red color, is particularly eective at quenching the destructive potential of singlet oxygen. See Britton, G. (1995). Structure and properties of carotenoids in relation to function. FASEB J., 9:1551-1558; Di Mascio, P., Kaiser, S., and Sies, H. (1989) Lycopene as the most ecient biological carotenoid singlet oxygen quencher. Arch. Biochem. Biophys., 274:532-538. 251 Final Report: Assessment of the Dose-Response Eect of Olestra on the Status of Fat-Soluble Vitamins and Other Marker Nutrients in Humans, submitted by P&G to the FDA on January 29, 1993. See also An Eight-Week Vitamin Restoration Study in Humans Consuming Olestra, submitted by P&G to the FDA on June 2, 1993.
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the most common form of blindness that strikes the elderly, said Walter Willett, head of the nutrition department at the Harvard School of Public Health.252 The United States own Dietary Guidelines for Americans cite carotenoids potentially benecial role in reducing the risk for cancer and certain other chronic diseases.253 Others, including Procter & Gamble, contended that evidence was inconclusive.
THE FDAS DECISION
Despite a heated debate, the FDAs Food Advisory Committee recommended approval after just four days of meetings in November 1995. Ultimately, seventeen members of the committee endorsed olestra for approval and ve opposed it.
The panel didnt include a single expert on carotenoids. The Center for Science in the Public Interest, a watchdog group, contended that At least nine of the seventeen yea votes came from food industry consultants, and concluded that the panel had been stacked in favor of P&G.254 This may give P&G too much credit; there is no publicly available evidence that Procter & Gamble inuenced the composition of the Advisory Committee. Given the relationship between scientic experts and industry, it may no longer be possible to assemble a group of academic nutrition experts that are both qualied to assess the scientic merits of a product like olestra and have never consulted for the food industry. Even if P&G played no role in their selection, however, the dual role clearly implicates conict of interest concerns. Despite criticism of the panels composition, the FDA said it would try to issue a decision within two months.
Attack: Olestra, Michael Jacobson and Leila Corcoran, The Center for Science in the Public Interest, March, 1998 USDA-NCC Carotenoid Database for U.S. Foods 1998, U.S. Department of Agriculture, Nutrient Data Laboratory, 1998. Document available at http://www.nal.usda.gov/fnic/foodcomp/Data/car98/car98.html 254 Michael Jacobson and Leila Corcoran, Snack Attack: Olestra, The Center for Science in the Public Interest, March, 1998
253 See 252 Snack
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In the intervening period, a number of distinguished scientists lobbied the FDA to deny olestras petition for approval. One week before the FDA made its determination, Walter Willett, head of the department of nutrition at the Harvard School of Public Health, and Harvard colleague Meir Stampfer wrote a letter to then-FDA commissioner David Kessler cautioning him that olestras widespread use in snack foods could cause hundreds of cases of blindness and thousands of deaths each year from heart disease and prostate and lung cancer. Avoid submitting the U.S. population, including children and pregnant women, to a massive uncontrolled experiment with potentially disastrous consequences, they asked.255 Despite the outcry from many scientists, in January 24, 1996, the FDA approved olestra for use in savory snacks such as chips, crackers, and tortilla chips. There were conditions: though olestra had been determined to be safe, all snacks containing olestra would have to carry a label that stated:
This Product Contains Olestra. Olestra may cause abdominal cramping and loose stools. Olestra inhibits the absorption of some vitamins and other nutrients. Vitamins A, D, E, and K have been added.
A second condition of FDA approval was a requirement that Procter & Gamble, which makes the fat, and Frito-Lay, which manufacturers and sells the chips, report on any adverse health eects.256
BEHIND THE SCENES The FDAs decision to approve olestra did not end the debate. Shortly after its approval, Henry Blackburn of the University of Minnesota School of Public Health, one of the ve FDA panel members who voted against olestras approval, wrote a scathing criticism of the approval process in the prestigious New England Journal of Medicine. The FDA did not conduct a disinterested peer review, he charged. The FDA sta worked closely with P&G and acted as proponents of the companys petition.257 At another point he wrote,
255 Id. 256 Paul 257 Ken
Recer, Advisers Consider Label Change for Chips Made With Phony Fat, Associated Press, June 17, 1998 Silverstein, How the Chips Fell, Mother Jones, May/June 1997
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The olestra meetings carried the sense of a fait accompli, or at least a juggernaut moving inevitably toward FDA approval, he wrote.258 Blackburn concluded that by the time of the meeting, FDA sta members had already concluded that olestra was safe and were acting as proponents of the petition for approval.259 He complained bitterly about both the lack of available scientic research, noting that there is almost no relevant scientic literature on [olestras] potential health eects, except for studies by Procter & Gamble.260
Blackburn also echoed CSPIs concern that the panel was disproportionately composed of industry-friendly scientists. Blackburn alleged that the committee that reviewed olestra was weighed heavily with entrepreneurs, animal scientists, clinical scientists, and there was little representation of people with public health and consumer interest.261 Of the seventeen FDA panelists voted to approve olestra, nine had links to companies that could benet from its approval, including Bruce Chassy of the University of Illinois, whose departments research has been funded by Nestl and Dean Foods; John Doull of the University of Kansas e Medical Center, who has worked for Pillsbury and Best Foods; and David Lineback, a consultant whose client list has included P&G.262 Blackburn and Willett were not alone in their concern. Dr. John Bertram of the Cancer Research Center of Hawaii called olestra a public health time bomb, while Dr. Herbert Needleman of the University of Pittsburgh Medical School said it would be clear folly to introduce this product into the diet of children.263 Olestra has the potential to do signicant harm, said Ernst Schaefer of the Jean Mayer U.S. Department of Agriculture Human Nutrition Research Center on Aging at Tufts University in Boston.264 I dont think the adverse health eects of olestra were given a reasonable public hearing, said Ian Greaves of the University
258 Henry 259 FDA 260 Id. 261 Id. 262 Ken 263 See
Blackburn, M.D., N Engl J Med 1996;334:984-986 Panel Member Voice [sic] Olestra Concerns, USA Today, April 11, 1996
Silverstein, How the Chips Fell, Mother Jones, May/June 1997 Ken Silverstein, Washington on $10 Million a Day, Common Courage Press, 1998, p.58 264 Michael Jacobson and Leila Corcoran, Snack Attack: Olestra, The Center for Science in the Public Interest, March, 1998
83
of Minnesota School of Public Health. It was a triumph of marketing over health concerns. The marketing people out-shouted the health people.265 FDA spokesman Jim OHara defended the FDAs review process, describing them as a very open and public debate about olestra. He also attempted to defuse criticism of the panels composition. The advisory committees recommendations are just that: they are advisory. It is the agency that made its decision.266 OHaras comments left unanswered a larger, more important question: even if it was the Agency that made the decision, was the decision made for the right reasons? The FDAs decision did not occur in a vacuum. Procter & Gamble conducted an intensive political and public relations campaign to shape the debate and inuence the decision-making process.
PROCTER & GAMBLES SCIENTISTS
Just as the tobacco industry paid scientists to write to the EPA,267 Procter & Gamble engineered a massive eort to recruit scientists as advocates for their product. In the brief period between the committees adjournment on November 19 and the December 1 deadline for public comments, the FDA received nearly 800 letters concerning olestra. Most were from health professionals recommending that the product not be approved. But many others were the product of a Procter & Gamble-sponsored letter-writing drive. To ensure that it conveyed the appearance of at least some support from the scientic and medical communities,
265 Id.
Panel Member Voice [sic] Olestra Concerns, USA Today, April 11, 1996 Hanners, Scientists Were Paid to Write Letters Tobacco Industry Sought to Discredit EPA Report, Pioneer Planet/St.Paul Press, August 4, 1998. See also Philip Morris Report, IAQ Goals, January 25, 1993, Philip Morris ID 2023206195/6198.
267 D.
266 FDA
84
P&G wrote to dozens of scientists, asking that they write letters to the FDA on its behalf during an extended period for public comments. Many of the 26 scientists who complied had been paid consultants to P&G. Procter & Gamble denies that its nancial generosity toward scientists and academics is any cause for concern. These are known academics and health researchers who have built reputations for sound science over their careers, said P&G spokeswoman Jacqui dEon. They are not going to be bought.268 If they are not going to be bought, however, that doesnt seem to have prevented Procter & Gamble from trying. Certainly the example of the tobacco industry should serve as a note of caution of the dangers of scientic conict of interest. And not all observers feel P&Gs scientist selection process is neutral. John Stauber, editor of PR Watch, a newsletter which covers the public relations industry, says that P&G hires people who appear to have some distance from the company, but they are carefully selected and can be counted on to promote the ocial line. Theres nothing objective or independent about them.269
Marion Nestle of New York Universitys nutrition department was one of the many scientists who turned down Procter & Gambles overtures. She declined an oer of $1,000 from P&G, for which she was to y to New Orleans, give a short speech and eat products made with olestra to demonstrate her condence in its safety. Dozens of other academics accepted P&Gs money and went to New Orleans, a favorite tourist destination. Its too crude or imprecise to say people are bought o, Nestle told a reporter from the Boston Phoenix. But I just know if somebody is giving my department money, then I would think twice before saying something mean about that particular industry.270
268 Ken 269 Ken
Silverstein, How the Chips Fell, Mother Jones, May/June 1997 Silverstein, Procter & Gambles Academic White Hats, Multinational Monitor, November, 1997, Volume 18, Num-
ber 11 270 Id.
85
PEER-REVIEWED JOURNALS
Like the tobacco industry, Procter & Gamble has made a concerted eort to place industry-friendly research in peer-reviewed scientic journals. Procter & Gambles nancial clout has clearly facilitated this goal. For instance, in October of 1996 the International Life Sciences Institute (ILSI) held a conference on fat and sugar substitutes held in Arlington, Virginia. Panelists at the conference included P&G scientist John Peters, and P&G consultants Penny Kris-Etherton of Penn State and John Foreyt of the Baylor College of Medicine, as well as representatives from food industry giants like Kraft Foods and Nabisco, both of which stood to reap nancial benets from olestras approval. The attendance of P&G scientists at this particular conference was not coincidental; P&G sits on the Institutes Board of Directors, is a major nancial supporter of the ILSI, and helped to underwrite for the conference.271 The proceedings of the conference were later published as a bound volume in the Annals of the New York Academy of Science, which are distributed to more than 700 libraries and, according to the Academy, are among the oldest and most frequently cited sources of scientic research.272 As a result, studies on P&G products which were produced by paid P&G consultants and received by a P&G-funded organization at a P&G-funded conference have now been entered, mostly anonymously, into the ranks of peer-reviewed scientic literature.
FUNDING THE CONGRESS
Though less visible than the tobacco industry, Procter & Gamble is a prodigious political force in Washington, with a full-time lobbying sta and a governmental relations arm which vigilantly guards its interests on Capitol Hill. P&Gs political action committee contributes hundreds of thousands of dollars to candidates
271 George 272 Ken
Hardy, ILSIs executive director, would not reveal the amount of P&Gs contribution. Silverstein, Procter & Gambles Academic White Hats, Multinational Monitor, November, 1997, Volume 18, Num-
ber 11
86
each election cycle, and its executives, lawyers and lobbyists contribute thousands more. During the 19971998 election cycle, P&G gave $25,000 in soft money donations,273 part of the $161,700 it gave overall.274
Like the tobacco industry, P&G focused its contributions on the leadership of the two parties.
PROCTER & GAMBLE HARD MONEY DONATIONS, 1997-2000275
Senate Republican Majority Leadership President Pro Tempore of Senate Majority Leader Majority Whip
Member Strom Thurmond (RSC)
P&G Donations 0
Republican Conference, Chair Republican Policy Committee, Chair Republican Senatorial Committee, Chair
273 Federal 274 The
Trent Lott (R-MS) Don Nickles (ROK) Rick Santorum (R-PA) Larry Craig (RID)
$2,000 $2,000
$1,000 0
Bill Frist (R-TN)
$5,000
Election Commission data, see www.tray.com/fecinfo/98lbst/oh $$.htm Center for Responsive Politics, see http://www.opensecrets.org/states/contribs98/OH.asp 275 The Center for Responsive Politics, see http://www.opensecrets.org/pacs/pacgot/1998/00257329.htm
87
Senate Democratic Minority Leadership Minority Leader
Member Tom Daschle (DSD) Harry Reid (D-NV) Tom Daschle (DSD) Byron Dorgan (D-ND) Patty Murray (DWA)
P&G Donations $2,000
Minority Whip Democratic Conference, Chair Democratic Policy Committee, Chair Democratic Senatorial Campaign Committee, Chair
0 $2,000
0 0
House Republican Majority Leadership Speaker of the House House Majority Leader House Majority Whip House Republican Conference, Chair
Member Dennis Hastert (RIL) Dick Armey (R-TX) Tom DeLay (RTX) JC Watts (R-OK)
P&G Donations $3,000
$1,000 $1,000
0
88
House Republican Policy Committee, Chair House Republican Congressional Committee, Chair
Christopher Cox (RCA)
$500
Tom Davis (R-VA)
0
House Democratic Minority Leadership House Minority Leader House Minority Whip House Democratic Caucus, Chair House Democratic Policy Committee, Chair Democratic Congressional Campaign Committee, Chair
Member Richard Gephardt (DMO) David Bonior (D-MI) Martin Frost (DTX)
P&G Donations $3000
0 0
Richard Gephardt (D-MO) Nita Lowey (DNY)
$3,000
$500
89
Procter & Gambles pattern of corporate giving is more opportunistic than it is ideological. Because it was unclear to political oddsmakers which party would control the Congress after the 2000 elections, Procter & Gamble gave generously to the potential Speakers of the House (Reps. Gephardt and Hastert) from both parties. Likewise, in the 2000 cycle alone, P&Gs PAC gave $5000, the legal maximum, to Rep. Charles Rangel (D-NY), a liberal African-American from Harlem. Rangel is stood to be Chairman of the powerful Ways and Means Committee if the Democrats reclaimed the House.
Like its counterparts in the tobacco industry, P&G made a dramatic shift in its giving patterns when the Congress changed hands in 1994. Where before the company had expressed a mild preference for Republican candidates (explained perhaps in part by P&Gs home state in Republican-leaning Ohio), after the Republican sweep of 1994, P&Gs giving became heavily weighted toward the GOP. Procter & Gamble Federal Campaign Contributions by Election Cycle:
Year 1992 1994 1996 1998 2000
P&G Contributions $124,850 $187,075 $221,384 $199,750 $272,140
% Given to Republicans 54% 54% 81% 84% 79%
Procter & Gamble is also a major contributor to state-level politicians and political organizations, giving both under its own name and through other groups. For instance, Procter & Gamble is a major supporter (along with DuPont, Dow, Eastman Kodak, General Electric Plastics, and Exxon) of the American Chemistry Council (ACC), a trade association that provides additional nancial support to a number of groups P&G 90
supports on its own including Consumer Alert and the American Legislative Exchange Council.276
USING THE CONGRESS TO LOBBY THE FDA
Just as the tobacco industrys most loyal supporters, like Mitch McConnell (R-KY) and Jim Bunning (R-KY) hail from tobacco-producing states, Cincinnati-based Procter & Gamble has received some of its strongest support from Ohios congressional delegation. Like the tobacco industry, Procter & Gamble has cemented that relationship by generously supporting the ocials of its home state.
Procter & Gamble Campaign Contributions to the Ohio Congressional Delegation:
Member Boehner, John A (ROH) Chabot, Steve (R-OH) DeWine, Mike (ROH) Gillmor, Paul E (R-OH) Hall, Tony P (DOH) Hobson, David L (R-OH)
276 American
P&G Donations, 1997-2000 $4,500
$10,000 $6,000
$2,000 $1,500
$3,500
Chemistry Council, The Environmental Working Group, Washington D.C., January 10, 2001
91
Hollister, Nancy (R-OH) Kasich, John R (R-OH) LaTourette, Steven C (R-OH) Ney, Bob (R-OH) Oxley, Michael G (R-OH) Pryce, Deborah (R-OH) Sawyer, Tom (D-OH) Tiberi, Pat (R-OH) Voinovich, George V (R-OH)
$5,000 $2,500 $1,000 $500 $2,000 $4,000 $2,500 $1,500 $11,000
Like the tobacco industry, Procter & Gamble beneted from the spirited advocacy of its favored legislators especially in its dealings with the FDA. In February of 1995, Sens. John Glenn (D-OH) and Michael DeWine (R-OH), and Reps. John Boehner (R-OH)
277
, Steve Chabot (R-OH) (all of whom received money from
P&Gs political action committee), and Rob Portman (R-OH) (who doesnt accept PAC money but took contributions from P&G executives) wrote a joint letter to Health and Human Services Secretary Donna Shalala.278 In it they argued that olestra was safe and that the FDA approval should be expedited. The Ohio delegations letter made the obligatory concession that the public health was more important than prots, but noted that olestras approval would mean $17.8 billion to Ohio over the next thirteen years.279 Observers might think it natural, even desirable, that Ohio legislators would act as advocates for one of the largest employers in their state. But evidence strongly suggests that Procter & Gamble expects a quid pro quo for its campaign contributions. When home-state legislators refuse to carry water for Procter & Gamble, the company has proved its willingness to strong-arm members of Congress. In 1998, Rep. Bob Ney (R-OH) reported that R. Scott Miller, who heads Procter & Gambles political action arm, had threatened to cut o campaign contributions in retaliation for Neys votes on international trade. In a letter to Procter &
277 Rep. John Boehner (R-OH) is another of the repeat players in the tobacco and olestra stories. Boehner actually distributed checks from tobacco giant Brown & Williamson to Members on the oor of the House of Representatives, a violation of House rules for which he was disciplined. See Boehners Blunder: Handing Out PAC Money Makes a Poor Floor Show, Leader Learns, Cincinnati Enquirer, May 23, 1996, p. A18 278 Ken Silverstein, How the Chips Fell, Mother Jones, May/June 1997 279 See Ken Silverstein, Washington on $10 Million a Day, Common Courage Press, 1998, p.59
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Gamble CEO John Pepper, Rep. Ney wrote that Miller told a member of my sta, in no uncertain terms, that contributions to my campaign were directly reduced because of my stance against Fast Track [trade legislation] and future contributions have been completely put in jeopardy due to my decision to vote against Most Favored Nation status for China.280
Bill Dobson, Procter & Gambles vice president of international public aairs, said there was absolutely no intent to suggest nancial contributions were tied to how Ney voted on specic legislation, and attributed the exchange to a simple misunderstanding.281 Ney bristled at that suggestion. This is the most blatant correlation of campaign contributions and votes, he said. If [Miller] said we wont support you, thats ne. This was a denite statement: You should notice your contributions have dwindled, future contributions are in jeopardy.282
There is little public evidence to suggest that P&G employed such heavy-handed tactics in 1995, when olestra was facing its FDA review. In fact, Frank Cremeans, (R-OH), one of the only members of Congress to publicly comment on being subjected to P&Gs olestra lobbying campaigns, was eusive in his praise. I knew very little about it, Im not a chemist, he said. They came in and explained it to me, how it worked and it was very helpful.283 Cremeans, however, seems to have been an easy sale for P&G. Perhaps the rest of Ohios delegation was as easy to convince. For more reluctant members, the process may have borne more resemblance to Rep. Neys experience with P&G than to Rep. Cremeans.
Complains of Extortion By Contributor, Associated http://www.publicampaign.org/news/news7 13 98.html 281 Bill Straub, Lobbyists Practice Art of Subtle Pressure, The Cincinnati Post, 282 Congressman Complains of Extortion By Contributor, Associated http://www.publicampaign.org/news/news7 13 98.html 283 Bill Straub, Lobbyists Practice Art of Subtle Pressure, The Cincinnati Post,
280 Congressman
Press,
July
13,
1998,
available
at
July 15, 1998 Press, July July 15, 1998
13,
1998,
available
at
93
LOBBYING FOR OLESTRA
Procter & Gamble spent enormous sums on lobbying on average more than $3,000,000 each year between 1997 and 1999.284 While P&G maintains a full-time lobbying sta in Washington (among them R. Scott Miller), it recognized that lobbying for olestra would be especially delicate. To carry its olestra campaign to Capitol Hill, P&G retained Carol Tucker Foreman, a former Assistant Secretary of Agriculture in the Carter administration and the founder of the Safe Food Coalition.285 Carol Tucker Foremans Democratic Party credentials were impeccable, particularly in the Clinton era; her brother, Jim Guy Tucker, was Lieutenant Governor of Arkansas under Clinton, and moved to the governors mansion after Clinton won the presidency. Her status as founder of the Safe Food Coalition only enhanced her credibility in endorsing olestras safety. Foremans Safe Food Coalition is not a front group; it has actually been a strong voice for consumers, speaking out on salmonella poisoning, for instance.286 But like many in the Washington lobbying community, Foreman wears more than one mask. In 1994, it emerged that Foreman had been discreetly lobbying on behalf of Monsanto and its controversial recombinant bovine growth hormone.287 Foreman also lobbied for Philip Morris.288 As a lobbyist for olestra, she seemed a perfect t: she had personal connections with the Democratic Party and the White House, and credibility on food safety with the media, but was not so moralistic in her approach toward clients that she couldnt be trusted. Because Procter & Gamble had already secured a hearing before the FDA, there was no need for P&G to rally all of the companys supporters in Congress. Foremans task was more focused: she had merely to convince those members of Congress who had concerns about the product that the FDA was capable of making
284 Addicting 285 Procter
Congress: Drug Companies Campaign Cash & Lobbying Expenses, Public Citizen, July 2000, Appendix B & Gambles Academic White Hats, Ken Silverstein, Multinational Monitor, November, 1997, Volume 18, Num-
ber 11 286 Safe Food Coalition Charges USDA Proposal to Allow Retained Water in Poultry is an Attempt to Cover Economic Adulteration in a Cloak of Faux Food Safety, Safe Food Coalition, Press Release, January 14, 1999. Available at http://www.consumersunion.org/food/0114sfcdc399.htm 287 See The 1995 Lobbying Hall of Shame, Multinational Monitor, January/February 1996 288 Will CFA Save GM Foods? PR Watch, Volume 7, No. 2, Second Quarter, 2000
94
all the proper determinations. Of particular concern for Procter & Gamble was rst-term Congresswoman Julia Carson (D-IN), who P&G targeted for intensive lobbying. Carsons Indiana district includes much of Indianapolis, one of olestras original test markets. After receiving numerous complaints about olestra from her constituents, many of whom experienced intense gastrointestinal problems, Rep. Carson threatened to introduce legislation strengthening the warning label.289 We need to do a new, complete and independent review of olestra and its side eects, she declared.290 Carson also called for more prominent warning labels on products made with olestra; a more conscious eort by the snack industry to take care in the marketing of olestra-based snacks, especially with children; and a public awareness campaign warned potential consumers of snacks made with olestra to the potential side eects of the product.291 It is apparent to me and other residents of Indianapolis that olestra can do serious harm. My duty to my constituents is to assure that their public health is not at risk, Carson said in a prepared statement to the press. The implications for using olestra on a nationwide basis is [sic] also at stake. The eects of olestra on the citizens of Indianapolis need to be examined thoroughly before expanding the use of this product to other communities across America.292 The potential for negative publicity even Congressional hearings posed a tremendous threat to the olestras protability. P&G sent lobbyists to her oce to get her to stop and even hired former Secretary of Health and Human Services Louis Sullivan to call her. Sullivan called an old friend, Rep. Carsons personal physician in Indianapolis, to help arrange a meeting. Though Carsons doctor convinced her to meet with Sullivan and listen to his arguments on olestra, Sullivan had little success. Instead, Carson attacked P&G in public for trying to mue her. Its irresponsible for P&G to try to impede my investigation, said Carson, and my support of constituents who have had stomach cramps.293 P&G, of course, denied trying to impede her investigation. Rep. Carson failed to convince any other Members to join her call for hearings,
289 Rep. 290 Id. 291 Id. 292 Id. 293 George
Carson Calls For Action on Olestra, Press Release, Congresswoman Julia Carson, July 15, 1997
Srait, Fight Over a Fat Substitute, ABCNEWS.com, June 10, 1998
95
and her ght died a quiet death.294
EFFECTS OF CONGRESSIONAL PRESSURE
The letter from the Ohio delegation and the intensive lobbying on Capitol Hill had the desired eect: pressure from the Congress and from the Department of Health and Human Services was felt acutely by the FDA panelists that reviewed olestras application. They were under intense pressure from Congress to get o the backs of industry, said Dr. Walter Willett, head of the department of nutrition at the Harvard School of Public Health.295 In recent years this pressure has come not only from Procter & Gamble, but from regulated industries generally. In an anonymous September 1998 survey conducted by Public Citizen, FDA Medical Ocers were asked how they would compare the current standards of FDA review for safety and ecacy to those in existence prior to 1995. Seventeen Medical Ocers described the current standards as lower or much lower, while thirteen described them as about the same and six described them as higher. None described the standards as much higher.296 Nineteen Medical Ocers stated that the pressure on them to approve a greater proportion of new drugs was somewhat greater or much greater compared to the
period prior to 1995.297 One Medical Ocer reported, In the last 2 years, I recommended that two drugs not be approved. They were both approved without consulting me. This never happened before. In one
Carson did face a bruising battle for reelection, in which she was attacked with vicious negative advertisements. Republican Gary Hofmeister ran a series of attack ads against Carson, including a 30-second ad that featured the face of Representative Carson (who is black) morphing into images of prison doors and hypodermic needles. It is unclear, however, if Carsons role as an olestra antagonist was responsible for her well-funded opponents. See Joshua Micah Marshall, The Firewall Next Time, The American Prospect, January 31, 2000 295 George Srait, Fight Over a Fat Substitute, ABCNEWS.com, June 10, 1998 296 Statement by Sidney M. Wolfe, M.D., Director, Public Citizens Health Research Group, FDA Science Forum on Biotechnology, December 9, 1998 297 Id.
294 Rep.
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case, the drug did not meet the standards set up by the division, so they nullied the standards.298
With the implicit support of a hostile Republican Congress, direct industry lobbying of FDA ocials has increased: nine Medical Ocers reported a total of 23 inappropriate phone calls regarding a drug they were reviewing, usually from the sponsor.299 And senior ocials in the FDA have contributed to the pressure on their subordinates. Eight Medical Ocers reported instances in which they had been instructed, usually by the Oce Director, not to present their own opinion or data to an FDA Advisory Committee when to do so might have reduced the likelihood that a drug would be approved.300 One Medical Ocer stated: My feeling after more than 20 years at FDA is that unless drugs can be shown to kill patients outright then they will be approved with revised labeling and box warning.301 Evidence suggests that this attitude played at least some role in the decision to approve olestra and the way in which that approval was granted.
ATTACKING OLESTRAS ENEMIES
The most prominent critic of olestra and the process by which it was approved was the Center for Science in the Public Interest (CSPI). Under its director, Michael Jacobson, CSPI had earned an impressive reputation as a public health watchdog, making headlines for its exposes on fast food restaurants and junk food. While Procter & Gamble sought to reassure a wary public, Jacobson and his organization opened up telephone hotlines for suerers of olestra-related anal leakage and fecal urgency, and held press conferences where they voiced their concerns.
298 Id. 299 Id. 300 Id. 301 Id.
97
Despite the FDAs approval of olestra, high-ranking Agency ocials made little eort to hide their sympathy for CSPIs battle against olestra. FDA deputy commissioner William Schultz said that CSPI sta were the only ones there raising the right questions.302 CSPIs scientic credibility was further underscored in 1996 when FDA Commissioner David Kessler honored Michael Jacobson with the agencys highest award, the Commissioners Special Citation. The citation read, For helping government, industry, and the public understand the relationship between diet and health, and, in doing so, accomplishing one of the great public health advances of the century.303 Procter & Gamble was keenly aware of the danger that an outspoken campaign against olestra particularly one which focused on its embarrassing side eects - could pose. Even after initial FDA approval was secured, CSPI posed a serious threat to the protability of olestra. In a worst-case scenario, if sucient public outcry were raised, the FDA might even reconsider its approval, or add further conditions.
Like the tobacco industry, Procter & Gambles rst impulse was to move against CSPI on their own. Greg Allgood, a senior P&G scientist, called the statements of CSPI President Michael Jacobson ridiculous. Its not supported by any scientic facts, Allgood told United Press International. What hes saying is false. He has a passion to limit food options for people. Thats his track record. He goes after all kinds of foods. I would think people are getting tired of hearing about Michael Jacobsons press conferences.304 P&G spokesman Don Tassone distilled the message into an even simpler formula: CSPI is obviously interested in sound bites, not sound science.305
for Science in the Public Interest, Letter to the Editor of The New Republic, http://www.cspinet.org/new/newrepb.html 303 Id. 304 United Press International, October 23, 1996 305 Congresswoman Wants Olestra Review, Cincinnati Enquirer, July 16, 1997
302 Center
January 8,
1997,
98
These comments telegraphed Procter & Gambles public relations strategy: rather than argue the scientic merits of the debate, they would attempt to discredit CSPI, depicting the organization as ideologically driven and extreme. To manage their perception problem, Procter & Gamble called on Hill & Knowlton, the same Washington D.C. public relations rm that created the smearing and belittling plan for the tobacco industry (see p.71).306 Shortly thereafter a coordinated strategy emerged.
USING FRONT GROUPS
At a conference of public relations experts in November of 1996, Je Prince, formerly of the National Restaurant Association, identied the Center for Science in the Public Interest as a threat to the protability of the food industry. Prince urged CSPIs foes to put out the money needed for a campaign that would undermine the Centers credibility.307 Just as Philip Morris had coordinated a campaign of allied attacks, where friendly third parties are engaged on our side but without direct or obvious connection to the industry,308 Prince urged an oensive that employed industry front groups: The companies and industries that wish to undermine [CSPIs] credibility can best do so working together to make a case that is partially removed from their own immediate interests, said Prince.
309
Princes reasoning followed Philip Morris to a tee:
If it is the National Restaurant Association and Proctor & Gamble out there making the case, nobody is going to believe them. Their ox has been gored.
310
And just as Philip Morris CEO Hamish Maxwell stressed cooperation with major media outlets (The sixth point I want to make is that we are not using our considerable clout with the media. A number of media
306 Art
Levine, Food Fight in Indianapolis, U.S. News, May 5, 1997 Bleifuss, Food Flacks Say: Skip the Science, PR Watch, Volume 3, No.4, Third Quarter, 1996 308 Steven Parrish, PM draft presentation to the PM board of directors, Sea Island, Georgia, April 11, 1994, PM ID 2048310347. 309 Joel Bleifuss, Food Flacks Say: Skip the Science, PR Watch, Volume 3, No.4, Third Quarter, 1996 310 Id.
307 Joel
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proprietors that I have spoken to are sympathetic to our position,311 ), Prince suggested that media would be receptive to attacks on consumer advocates: The whole project would... require considerable skill in media management and almost innite tact, but through a concerted eort I think it could be done, because the press no longer wants to believe CSPI. They would like to nd an excuse not to carry those stories, but we havent given it to them yet. It may well be a job for some currently underfunded organization, or perhaps for some new organization, but it seems to me the food industry ought to get together and get this job done soon.312 The food industry and particularly Proctor & Gamble was listening. Almost immediately after Princes lecture, a well-organized and well-funded coalition against CSPI coalesced. P&G had a ready supply of potential allies; it had long been a supporter of numerous industry front groups,313 and a range of surrogates moved to take up the defense of olestra and a series of withering attacks on olestras critics. The Hoover Institutions Henry Miller, who had proposed the eective dismantling of the FDA during its battle with the tobacco industry, leapt to the defense of olestra. Miller wrote a blistering op-ed attack on CSPI that ran in The Wall Street Journal, and was subsequently republished by the Washington Times 314 and The Cincinnati Inquirer. Miller lauded the FDA for approving olestra and called the fat substitute perhaps the most tested food in history.315 Another pu piece was entitled Yes, There is Free Lunch
311 The Perspective of PM International on Smoking and Health Issues: Text of the discussion document used at the meeting of top management, Internal Memorandum, Philip Morris, 1985, available at http://www.media-awareness.ca/eng/news/news/two/rupsmoke.htm 312 Joel Bleifuss, Food Flacks Say: Skip the Science, PR Watch, Volume 3, No.4, Third Quarter, 1996 313 Mark Megalli and Andy Friedman, Masks of Deception: Corporate Front Groups in America: Essential Information, 1991) , p. 4; Richard Stapleton, Green vs. green, National Parks (November/December 1992), pp.184-185. Other Procter & Gamble front groups include The Keep America Beautiful Campaign, an organization that focuses on anti-litter campaigns and downplays the potential of recycling legislation and changes to packaging. The Keep America Beautiful Campaign receives approximately $2 million per year from some 200 companies that manufacture and distribute the aluminum cans, paper products, glass bottles and plastics that account for about a third of the material in US landlls. In addition to Procter & Gamble, the Campaigns board of directors include representatives of Philip Morris, Mobil Chemical and Procter and Gamble and PR giant Burson-Marsteller. See Michael Parenti, Inventing Reality: The Politics of the Mass Media, (New York: St Martins Press, 1986) , p. 73l. 314 Henry Miller, The Washington Times, July 25, 1996 315 Miller didnt mention that P&Gs tests of olestra were conducted almost exclusively on healthy people between the ages of 18 and 44, hardly a representative sample, or that the longest consecutive testing period for children was one week, with children consuming less than the equivalent of one ounce of potato chips per day.
100
Fat Free.316 Miller ran another similar article in the Washington Times in 1998, writing, As a solution to Americans constantly-expanding waistlines and fat consumption, olestra is the closest thing to a free lunch.317 In none of the articles did Miller note that Procter & Gamble was a generous nancial supporter of the Hoover Institution. Norman Ornstein joined the attack on CSPI with a column that appeared in USA Today.318 Ornstein belittled concerns about olestra, noting that while the fat substitute can cause diarrhea, beans can cause gas and... hot peppers and Tabasco sauce can give me heartburn.319 Once again, P&Gs surrogate followed a consistent message, which ignored the health debate and instead focused on the eorts of a self-appointed elite to constrain consumer choice. Ornstein asserted that CSPI had attempted to intimidate the FDA into blocking olestra, and accused the Center of trying to be a national nanny.320 Ornsteins byline revealed that he is a Fellow at the American Enterprise Institute (AEI), but failed to note that AEI receives about $125,000 annually from P&Gs foundation,321 or that P&Gs Chief Executive Ocer, John Pepper, sits on AEIs Board of Directors.322
CONSUMER ALERT
Another eager combatant in the campaign against CSPI was Consumer Alert. Consumer Alerts name and
316 Henry 317 Henry
Miller, Yes, There Is a Free LunchFat-Free, San Jose Mercury News, Nov. 15, 1995 I. Miller, The Cutting Edge of Cutting Calories, The Washington Times, April 16, 1998 318 Norman Ornstein, USA Today, August 1, 1996 319 Id. 320 Id. 321 From Leather Boots to Velvet Gloves, Corporate Watch, Issue 11, Summer 2000 322 Ken Silverstein, Corporate Enemies, Corporate Friends, EXTRA! May, 1997
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self-description (it calls itself a free market consumer group, that has members in all 50 states,323 ) are benign enough that it is frequently quoted by unsuspecting journalists as an independent voice on consumer health. On its website, www.consumeralert.org, the ubiquitous Dr. Henry Miller of the Hoover Institution boldly proclaims that Consumer Alert is everything that most other self-styled consumerist organizations are not: scholarly, scientic, honest, and motivated not by self-interest, but by the public interest.324
The endorsement Henry Miller may provide some indication about the true loyalties of Consumer Alert. In fact, Consumer Alert is funded by some decidedly self-interested parties including Pzer Pharmaceuticals, Philip Morris, American Cyanamid, Eli Lilly, Monsanto, Upjohn, the Chemical Manufacturers Association, and Ciba-Geigy.325 It serves as an industry counterweight to genuine consumer groups like Consumers Union. Consumer Alert (a noted friend of the tobacco industry; see pp. 67-68) eagerly joined the attack on CSPI, blast-faxing press releases and writing op-ed pieces. One press release was entitled (appropriately enough) CSPI Throws Consumer Choice Down the Toilet.326 In another variation on the CSPI-as-paternalist theme, Consumer Alerts John Berlau wrote, In a free society, consumers should have the right to decide if olestra is right for them, and the self-appointed Food Police should not be allowed to throw consumer choice down the toilet.327 In December of 1996, Consumer Alerts Sarah Durkin and James Plummer wrote an article in the Detroit News that again referred to CSPI as the food police, and argued that CSPI aggressively ignores the
http://www.consumeralert.org/ http://www.consumeralert.org/ 325 John Stauber, Trust Us, Were Experts! How Industry Manipulates Science and Gambles With Your Future, Tracher/Putnam, 2001. 326 CSPI Throws Consumer Choice Down the Toilet, Consumer Alert press release, Washington, D.C.: Consumer Alert, July 1, 1996 327 John Berlau, Cursing the Cure for Fatty Food, Consumer Alert, available at http://www.consumeralert.org/issues/food/berestra.htm. This follows almost exactly the game plan set our by Je Prince, the public relations consultant. The second thing the restaurants have pushed, of course, is the food police line, and they push that as far as possible, Prince said. The idea is simply that people... dont need a third party interfering and making those choices for them especially when this third party seems inhuman, inexible, puritanical, rigid. See Joel Bleifuss, Food Flacks Say: Skip the Science, PR Watch, Volume 3, No.4, Third Quarter, 1996
324 See 323 See
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ability of consumers to weigh the pros and cons of eating various foods without the uninvited opinion of nutrition activists.328 At one point they went so far as to declare It is clear that the center has a nutrition mission that lacks any eort to educate the public about what a truly healthy diet is. Rather than oer examples of how much fat is necessary to maintain good health, and how to make food choices to avoid eating too much fat, the center chooses to push an aggressive agenda designed to scare the public into a predominantly vegetarian and granola diet.329 The Detroit News piece was little more than an ad hominem attack; CSPI has never endorsed a granola diet. The clear purpose of the article was to paint CSPI as a radical group, without addressing the scientic merits of the issues they raised. Consumer Alerts website echoed the same core message, counseling consumers to Decide for yourself if they taste as good as the real thing. But dont let Luddite busybodies decide for you.330 The goal is clear: to shift the focus of the debate from Procter & Gambles product to the motivations of its critics, by enlisting a kind of crude populism. Durkin and Plummer identied themselves as policy analyst[s] at Consumer Alert, a Washington-based consumer group, and admitted no aliation with Procter & Gamble. Indeed, there is as yet no hard evidence (leaked internal memoranda, for instance) that Consumer Alerts campaign was conducted at the behest of Procter & Gamble. Their timing, however, was suspiciously well-coordinated, and their argument, was strikingly similar to Je Princes advice that industry, through third parties, assert that people... dont need a third party interfering and making those choices for them.331
328 Ken
Silverstein, Corporate Enemies, Corporate Friends, EXTRA! May, 1997 Durkin and James Plummer, Guess Whos Not Coming to Dinner? The Detroit News, December 1, 1996 330 Who are the Food Police? See http://detnews.com/1996/menu/stories/77247.htm 331 Ken Silverstein, Corporate Enemies, Corporate Friends, EXTRA! May, 1997
329 Sarah
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COORDINATION FROM ABOVE
There is other evidence to suggest that Procter & Gambles surrogates did not hit on the same themes and develop the same strategy by coincidence. Like the letters to the FDA that were penned by tobacco lobbyists and signed by Republican governors (see pp. 40-41), the texts produced by Procter & Gambles allies show suspicious signs of having been coordinated from above by a single source. Henry Millers Wall Street Journal op-ed, the Consumer Alert piece in the Detroit News, and an article by Stephen Glass in The New Republic all contain virtually identical phrases and diction.332 Either media attention to CSPI has been marked by rampant plagiarism, or the pieces seem to have been written from the same set of talking points.333
direct comparisons of the language, see http://www.cspinet.org/new/reeks.html the case of Stephen Glass, plagiarism seems to have been at least part of the story. His career was destroyed amid the revelation that he had plagiarized and fabricated numerous stories in the course of his work as a freelance writer. For more on his plagiarism, see http://www.interlog.com/rmcginn/Glassindex.htm
333 In
332 For
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Henry Miller, The Wall Street Journal , July 11, 1996 [CSPIs] budget is funded mostly by $24-a-year subscriptions to its Nutrition Action Healthletter, a newsletter that has seen its circulation triple since 1991 to 800,000. Keeping that circulation up requires a lot of hype.
Mr. Jacobson was quoted in a Los Angeles Times Magazine article last year as telling one of his newsletter writers to be more direct by removing weasel words qualiers such as suggests and maybe.
Stephen Glass, Hazardous to Your Mental Health, The New Republic, December 30, 1996 In a drive to boost the newsletter subscriptions that are its primary source of revenue, the center has increasingly tended to abandon the scientic method in favor of media hype... Since 1991, the newsletters circulation has tripled. At $24 per year... Now about three-quarters of CSPIs funding comes from the publication. According to a report, Jacobson instructed CSPIs nutrition director to be more direct by removing weasel words qualiers such as suggests and maybe from the newsletter.
The Detroit News, December 1, 1996, by Consumer Alert
Stephen Glass, Hazardous to Your Mental Health, The New Republic, December 30, 1996
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The Centers Nutrition Action Healthletter uses Quarter Pounders and Big Macs as yardsticks of death to measure other foods by.
Given the puritanical nature of the centers fat denunciations...
Instead of measuring fat content of food items in grams, it [Nutrition Action Healthletter] began using the Big Mac or the Quarter Pounder as a yardstick. Less respect for good science also allows CSPI to push more easily a puritanical agenda..
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... one would have thought it would welcome the potential of Procter & Gambles new noncaloric fat substitute, olestra, to the American diet. Certainly an occasional splurge is no cause for self-loathing or even fear of clogged arteries.
Knowing how much CSPI hates fat, Procter & Gamble might have expected the group to embrace olestra, their new fake fat, which has no calories..
... what they regularly eat rather than the occasional splurge is far more important.
STEVEN MILLOY AND JUNK SCIENCE
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Not all the attacks from industry front groups were directed at CSPI. Procter & Gambles public relations campaign also directed its eorts at Dr. Henry Blackburn, one of the most vehement dissenters on the FDA review committee, and a man whose scientic reputation and outspokenness about olestra made him a potential threat to long-term protability and far more dicult to ridicule and belittle than Michael Jacobson and CSPI. Steven Milloy, however, was up to the task. The operator of junkscience.com, a website dedicated to exposing practitioners of junk science and debunking their claims, Milloy attacked both Blackburns science and his integrity. Addressing the olestra controversy and Dr. Blackburns New England Journal of Medicine article, Milloy wrote:
Apparently, one of Blackburns public health concerns is that Olestra [sic] may leach certain vitamins from the body, including vitamins A, D, E, and K. At least some of the concern with this leaching is that these antioxidant vitamins are thought to play a role in preventing cancer. News ash to Blackburn....Beta Carotene and Vitamin A Cause Lung Cancer in Major Study! [J Natl Cancer Inst 1996;88:145- 6]. I think its fairly safe to conclude that no one really knows the true association (one way or the other) between vitamin intake and cancer.334
No serious scientists would endorse the positions that Milloy takes in the above paragraph; these are specious and irresponsible claims. But Milloy is not acting in any ocial capacity as a P&G spokesman, and any scientic errors or misrepresentations he makes are his alone. This is not an accident. Like Rosser Reeves suggested to the tobacco companies in 1967, Procter & Gamble has assembled a roster of janissaries Milloy among them who can make materially false scientic claims for the companys benet without any risk of P&G being held responsible.
Though the premise behind the Junkscience.com website is the debunking of fraudulent and overblown
334 See
http://www.junkscience.com/news/olestra.html
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scientic claims, Milloys essays contain little in the way of serious scientic argument, and are instead geared toward attacking Blackburn personally. Just as Consumer Alert did in its attacks on CSPI, Milloy seeks to ridicule and lampoon Blackburn as a radical. At one point Milloy writes, It appears that Blackburns standard of proof is so high that it could never be met. Blackburn would prevent virtually any new product from ever coming on the market.335 Later, Milloy asks rhetorically, Is Blackburn really concerned about public health? Or, is his protestation against olestra a facade covering anti-technology sentiment? Could it be that he has taken a page from the Unabombers manifesto and applied it to public health?336 Ridicule has long been a weapon of Milloys; after yet another researcher published a study linking secondhand smoke to cancer, Milloy wrote in 1997 that she must have pictures of journal editors in compromising positions with farm animals. How else can you explain her studies seeing the light of day?337
MILLOY, TOBACCO, AND PROCTER & GAMBLE Steven Milloy is not merely an independent operator; he is a professional, and a gure whose role in both the tobacco industry eort and P&Gs olestra campaign helps to explain the similarities between the two. Milloy was previously employed by a number of professional public relations and lobbying companies, including Multinational Business Services, which was Phillip Morriss primary lobbyist on the environmental tobacco smoke issue in late 1992, when Milloy worked there. In addition to being an adjunct fellow at the Cato Institute (which has a history of advocacy on behalf of the tobacco industry; see pp.68-70), and apparently the only member of an organization called Citizens For The Integrity of Science (its registered address is that of Milloys home in Potomac, Maryland),338 Milloy is also the Executive Director of The Advancement
335 Id. 336 Id. 337 Sheldon Rampton and John Stauber, How Big Tobacco Helped Create the Junkman, PR Watch, Volume 7, No.3, Third Quarter 2000 338 Stewart Fist, Milloy and the Art of Spin-Doctoring, available at http://www.electricwords.com/junk/milloy/milloy2.html
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of Sound Science Coalition (TASSC).339
TASSC began as a front group for the tobacco industry, much like Healthy Building International (HBI) or the Center for Indoor Air Research (CIAR), built on the recognition that explicit connections to the industry or a single-minded focus on smoking issues would ruin the credibility of the organization and its usefulness as a front group.340 TASSC was originally created and controlled by APCO Associates, an international public relations and lobbying company. APCO had been founded in 1984 by Arnold & Porter (the AP in the APCO name) which was then the primary legal counsel to Philip Morris.341 If the connections seem tenuous and hard to follow, there is a reason: they were designed to be. TASSC aimed to redene the rules of proof and standards of epidemiology and toxicology, to a level that would frustrate eorts by government agencies like the EPA, FDA and OSHA to ever regulate tobacco smoke in a way that was based on the precautionary principle.342 To this end, TASSCs web site oered examples of junk science, alongside a host of entries defending bovine growth hormone, genetically engineered foodstus, dioxin, electromagnetic elds and endocrine disrupting chemicals. Milloy joined TASSC in 1997 as its Executive Director, when responsibility for administering TASSC shifted from APCO to the EOP Group, where Milloy had worked as a lobbyist. The shift had been necessitated by a minor scandal; in much the same way that Andrew Whist let slip to the Wall Street Journal that the New York Society for International Aairs was a chair in my apartment,343 Neal Cohen, an APCO lobbyist, had bragged about TASSCs status as an industry front group at a meeting of public relations
was originally dubbed the Restoring Integrity to Science Coalition; but was renamed to resemble the venerable American Association for the Advancement of Science, a legitimate scientic organization. 340 Stanton Glantz and Elisa Ong, Tobacco Industry Eorts Subverting International Agency for Research on Cancers SecondHand Smoke Study, The Lancet, April 8, 2000 341 Stewart Fist, Milloy and the Art of Spin-Doctoring, available at http://www.electricwords.com/junk/milloy/milloy2.html 342 Id. 343 Tatiana S. Boncompagni and Jill Abramson, Tobacco- Funded Group Gives Legislators Free Trips, The Wall Street Journal, August 4, 1997, p. A20.
339 TASSC
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experts, and was quoted in the New York Times.344 Since its inception, TASSC has expanded beyond simply defending the tobacco industry it also defends other industries whose products are of dubious safety. It was no coincidence, then, that Milloy came to the defense of olestra - Procter & Gamble is a major nancial supporter of TASSC.345 Through years of trial and error, the public relations industry has learned that credibility is best achieved by creating a mixture of truth and falsehood, with legitimate information blended carefully with industry propaganda. The greatest testimony to the success of Milloys junk science subterfuge is the acclaim it has received in the mainstream press. The Denver Post has called TASSC an organization that provides a much needed balance to the public debate that often surrounds disputed areas of science,346 while Milloys work on the Junk Science Home Page has garnered numerous awards, including being named One of the 50 Best Web Sites of 1998 by Popular Science; and designation as a Hot Pick by Science. The site has also been recommended by the New York Times, Los Angeles Times, Times of London, Financial Times, Forbes and MSNBC.347 Outlets that publish Milloys work have made little eort to probe his background, or the source of his contrarian scientic positions. Beneath one of his op-ed pieces, the Chicago Sun-Times described Milloy simply as a Washington-based business writer specializing in science who holds advanced degrees in health sciences from Johns Hopkins University and a law degree from Georgetown University.348
344 Sheldon Rampton and John Stauber, How Big Tobacco Helped Create the Junkman, PR Watch, Volume 7, No.3, Third Quarter 2000 345 Stewart Fist, Milloy and the Art of Spin-Doctoring, available at http://www.electric-words.com/junk/milloy/milloy2.html TASSCs other supporters include Amoco, Chevron, Dow Chemical, Exxon, General Motors, Lorillard Tobacco, Louisiana Chemical Association, National Pest Control Association, Occidental Petroleum, Philip Morris Companies, Santa Fe Pacic Gold, and W.R. Grace. 346 See Ken Silverstein, Washington on $10 Million a Day, Common Courage Press, 1998, p.103 347 While the New York Times, for example, was almost certainly duped when it made its recommendation, Forbes has shown tobacco sympathies before. See pp.77-78. 348 Milloys advanced degrees in health sciences actually consist of a bachelors degree in natural sciences and a masters degree in biostatistics.
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SUSPICIOUS ENDORSEMENTS
One measure of the scope of Procter & Gambles olestra campaign is the range of organizations and individuals whose testimony they oer. Virtually every party to publicly endorse olestra can be traced to P&Gs campaign and P&Gs nancial support. Like the tobacco industry, Procter & Gamble has found that its easy to make friends if you have money to spread around. Take, for instance, the organizations and personalities whose endorsements grace the wowchips.com website a promotional tool for Wow! Chips, a brand of snack chips that contain olestra. Organizational links on the site include the American Council on Science and Health (ACSH), the American Dietetic Association (ADA), and the Journal of the American Medical Association (JAMA).349 Providing endorsements on the site are former Secretary of HHS Louis Sullivan and the National Consumers League. The Journal of the American Medical Association has never endorsed olestra; its presence on the wowchips.com website is simply an act of corporate name-dropping, one that suggests the JAMAs approval without going so far as to be actionable.350 The other links tell a more interesting story.
http://www.wowchips.com/wowcrowd/links/indexmap.html formula is a favorite public relations tactic. Henry Miller writes, Widespread use of olestra could enable more Americans to adhere to the American Heart Associations recommendation to consume less than 30 percent of total calories from fat. This formulation implies that the American Heart Association supports olestras use, when, in fact, it has taken no such position. See Henry I. Miller, The Cutting Edge of Cutting Calories, The Washington Times, April 16, 1998. Procter & Gamble also employ this technique at their olean.com website: Leading health organizationsincluding the American Heart Association, the American Dietetic Association and the American Cancer Societyurge people to cut excess fat and calories as a key step toward good health. See One Tool for a Healthier Lifestyle, Procter & Gamble, 1998, at http://www.olean.com/media/media3.html
350 This
349 See
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THE AMERICAN DIETETIC ASSOCIATION
On the wowchips.com website, the American Dietetic Association oers a glowing review of olestra: Fat replacers make it possible for Americans to eat a wide variety of foods without increasing their fat intake, which may already be too high. These products can help consumers achieve a lower-fat diet while still enjoying their favorite foods.351 The enthusiastic tone (favorite foods) and the willingness of a nutrition organization to endorse a nutritionally suspect product seem out of place. This may be because the remarks were prepared not by an ocer of the ADA, but by Procter & Gambles own public relations sta. As part of its olestra marketing campaign, P&G distributed a pro-olestra fact sheet from the American Dietetic Association352 that was virtually identical to P&Gs own handouts a fact which should come as little surprise, since P&G (which provides signicant annual funding to the ADA) also underwrote the fact sheet in its entirety.353 In addition to its use at P&G promotional events, the fact sheet was mailed to each of the 70,000 nutritionists and dietitians who make up the ADA membership presumably to encourage them to recommend olestra to their clients. Both P&G and the American Dietetic Association defend the funding concept. Its done fairly frequently, P&Gs Jacqui dEon says, as a way to get information to professionals about research that has been done, so they can answer questions theyre getting from their clients.354 Nancy Schwartz, director of the ADAs National Center for Nutrition and Dietetics, explains, We have a couple such fact sheets a month, and its something weve been doing for several years. Companies, even companies with ties to the product, always fund them. Its how we nance things.355 Schwartz insists that P&Gs involvement in no way inuenced the positive tone of the fact sheet: Absolutely not. If it were bad news, or
351 See
http://www.wowchips.com/what/expert/text.html#ADA American Dietetic Association. Nutrition Fact Sheet: What is olestra? 1998. 353 Ken Silverstein, How the Chips Fell, Mother Jones, May/June 1997 354 Jim Knippenberg, P&G-funded brochure chews fat on olestra, The Cincinnati Enquirer, November 17, 1996 355 Id.
352 The
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if there were negative issues involved, yes, certainly wed communicate it no matter who was funding it.356 Apparently, in the opinion of the ADA, there was simply no bad news about olestra.
THE AMERICAN COUNCIL ON SCIENCE AND HEALTH
Another group which oers its endorsement on the Wow! Chips website is the American Council on Science and Health (ACSH). While its name suggests a public interest organization, the ACSH is in fact funded almost exclusively by chemical and food industry interests, and serves primarily as a front group for disseminating industry public relations material. Dr. Elizabeth Whelan, the ACSHs executive director, has claimed that the US government spends far too much on unproven health risks such as dioxin and pesticides because of the publics unfounded fears of man-made chemicals and their perception of these chemicals as carcinogens.357 She has made such outlandish statements as There is no such thing as junk food, and There is insucient evidence of a relationship between diet and any disease.358 Dr. Whelan is not incompetent; she is simply available for rent. The ACSH receives funding from chemical, oil and pharmaceutical companies like Monsanto, Dow USA, Exxon, and Union Carbide, as well as from food and beverage interest like Burger King, Coca-Cola, PepsiCo, NutraSweet, Nestle USA and Procter & Gamble.359 Any doubt that might have existed that the ACSH sees its role as that of industry advocate, rather than merely an honest broker of sound science, was erased with the revelation of an internal 1992 memo. In that document, Dr. Whelen bemoaned the loss of funding from the Shell Oil Company Foundation: When
356 Id. 357 Joel Bleifuss, Science in the Private Interest: Hiring Flacks to Attack the Facts, PR Watch, Vol. 2, No. 1, 1995 , p. 11; Public Interest Pretenders, Consumer Reports, Vol. 59, No. 5, 1994 , p. 319; Misguided Health Priorities Could Aect Economy, International Insurance Monitor, Vol. 41, No. 6, 1987; Dr. Blasts US Health care Priorities, Cash Flow, Vol. 91, No. 47, 1987 358 PR Watch, Volume 5, Number 4, available at http://www.prwatch.org/prwv5n4.pdf 359 Id.
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one of the largest international petrochemical companies will not support ACSH, the great defender of petrochemical companies, one wonders who will.360 In 1991, when the the great defender of the petrochemical companies last made its sources of funding available to the public, some forty percent of its $1.5 million annual budget was supplied directly by industry, including a long list of food, drug and chemical companies.361 Since 1991, the ACSH has refused to disclose the sources or amounts of its funding. In a 1997 interview, Whelan explained that since she was already being called a paid liar for industry, she had decided to abandon restraints on corporate funding altogether.362
A survey of the Councils board of directors provides some additional perspective on its mission. The board includes scientists with an avowedly anti-regulatory bent, such as chairman A. Alan Moghissi, a former EPA ocial who in 1990 served on a panel to challenge the EPAs policy requiring asbestos removal from schools and other public buildings;363 Henry Miller, a former FDA ocial now at the Hoover Institution (who participated in the pro-olestra campaign on his own behalf as well as through ACSH); corporate public relations professionals Albert Nickel of the rm Lyons Lavey Nickel Swift (their motto: We change perceptions), and Lorraine Thelian, a senior partner at Ketchum Communications, which handles environmental PR work for Dow Chemical, the Aspirin Foundation of America, Bristol Myers Squibb, and the National Pharmaceutical Council.364 Procter & Gamble got its moneys worth from Dr. Whelan and the ACSH. Dr. Whelan took her spirited brand of advocacy to the newspapers, and made little eort at balanced
Wolf, DRKOOP.CON? Americas Family Doctor and His Conicts of Interest: The Doctor in Need of Doctoring, TomPaine.com, 2001 361 Sheldon Rampton and John Stauber, In Industrys Hip Pocket? The American Council on Science and Health (ACSH), TomPaine.com, 2001 362 Id. 363 Id. 364 Id.
360 Sidney
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analysis. In an article that appeared in the Washington Times, Dr. Whelan wrote, Within months we will be able to buy a variety of delectable zero-fat snacks a real-life case of getting something for (almost) nothing.365 At another point, Dr. Whelan hailed olestras approval by the FDA, writing Dr. Kesslers decision represents a triumph of sound science and common sense over scaremongering with the American consumer the clear winner.366 Whelan parroted Procter &Gambles line on CSPI almost word for word, implying that Jacobson and his cohort were untrustworthy and unscientic: Since everyone these days seems to be anti-fat, one might be forgiven for assuming that olestra would be welcomed by everyone. But this has not been the case: The usual suspects who routinely condemn products of food technology declared war on olestra and so did a few respected scientists.367 Nowhere in the article did Whelan mention that her group receives funding from P&G at least $12,500 in 1995 and $10,000 in 1996.368 When questioned, Whelan would say only that P&Gs support represents less than one percent of her groups total budget, and refused to comment further.369
The ACSH also acted as a stand-in for P&G on television. Dr. Whelan appeared on both NBCs Today show and CNNs CNN Live to debate CSPIs Dr. Michael Jacobson, as well as on CNBCs Business Insiders to debate CSPIs Mira Karstadt. According to the ACSHs newsletter, ACSH was called upon to oer a mainstream scientic perspective.370 The letter does not make clear who exactly called on the ACSH. But the money and Dr. Whelans words leave little doubt. According to the same newsletter, On all three programs, Dr. Whelan emphasized how fat-free foods containing olestra will oer weight-conscious Americans more alternatives in their diet and refuted the fallacious and exaggerated claims of those who
365 Elizabeth 366 Id. 367 Id. 368 Ken 369 Ken
Whelan, The New Skinny on Snack Foods, The Washington Times, January 28, 1996
Silverstein, Washington on $10 Million a Day, Common Courage Press, 1998, p.63 Silverstein, How the Chips Fell, Mother Jones, May/June 1997 370 ACSH Newsletter, available at http://www.acsh.org/publications/newsletter/
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have attempted to describe olestra as nutritionally harmful.371
THE NATIONAL CONSUMERS LEAGUE
The same website that bears the enthusiastic endorsement of the ACSH also bears the cautious pseudoendorsement of the National Consumers League: The National Consumers League (NCL) is fully condent in the thorough review of this product by the FDA.372 That the NCL feels the need to endorse the FDAs process, rather than the product itself, is suspicious; it scarcely seems like the endorsement of a front group. There is a good reason for this: unlike the ACSH, the NCL was at least at one time a legitimate watchdog group. Founded by labor and consumer activists at the turn of the century, the NCL calls itself Americas oldest consumer organization.373 Today, the original consumer focus of the NCL has been heavily diluted; while it continues some activism in the eld of child labor, the National Consumers League has come to rely on corporate interests for a signicant portion of its budget. Though they refuse to give specic numbers detailing how much money each particular corporation or industry association has contributed, League ocials admit that thirty-nine percent of the groups 1997 budget of $1.3 million came from corporations and industry associations.374 Asked why a consumer group would take any money at all from corporations that invest so heavily in opposing consumer interests, NCL spokesperson Cleo Manuel says mournfully, I wish we didnt have to.375 Its easy to understand why Manuel feels that way; the inux of corporate funding appears to have had a dramatic eect on the substantive content of the NCLs work. A survey of the publications produced by the
371 Id. 372 See 373 See
http://www.wowchips.com/what/expert/text.html#NCL http://www.natlconsumersleague.org/ 374 Russell Mokhiber, Corporate Consumer Group, The Multinational Monitor, April, 1998, Volume 18, Number 4 375 Id.
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National Consumers League and who paid for them - is illustrative:
NCLs Consumer Guide to Choosing Your Telephone Service was paid for by Ameritech. NCLs Consumer Credit Series of reports was paid for by Fleet Finance Inc, a subsidiary of Fleet Financial Group. A brochure entitled Making Sense of Your New Communications Choices was paid for by GTE. A pamphlet bearing the legend Take Care with Over the Counter Asthma Medicine was paid for by Syntex, a pharmaceutical company. A newsletter, Community Credit Link, was paid for by Visa USA.376 Of course, all manner of valuable products are produced by corporations for the benet of their customers. What is far less likely is that any of the above publications contain information that threatens the nancial interests of the sponsoring industries. In abandoning that function, one of the most important roles of the National Consumers League has been quietly subverted.
The NCL has one other, more attenuated relationship to P&Gs olestra campaign. In 1996, at the annual NCL Trumpeter Award Reception and Dinner, which brings in about forty percent of the Leagues annual budget, the NCL honored Carol Tucker Foreman, a noted food safety advocate - who was also Procter & Gambles primary lobbyist on the olestra issue.377 Foremans Safe Food Coalition is a legitimate organization; but given NCLs increasing advocacy for corporate causes, and its support for the FDAs olestra approval, it appears at least possible that Procter & Gamble convinced the National Consumers League to enhance the pro-consumer reputation of P&Gs corporate lobbyist.
376 Id. 377 Id. See also, NCL Honors Carol Tucker Foreman With Trumpeter Award, National Consumers League, Press Release, October 8, 1997. Available at http://www.natlconsumersleague.org/trmpctf.htm
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THE SHADOW FDA PART II
When the tobacco industry came under attack from FDA Commissioner David Kessler, the tobacco industry called on its roster of lawyers and consultants who served the FDA in the past what I have called the Shadow FDA. The tobacco industry used former Commissioner Charlie Edwards not so much for what he had to say, but for what it meant for him to say it. Those who leave public service carry with them a credibility and reputation that would be unattainable in the private sector, and where food safety is at stake, and protability depends on gaining the trust of wary consumers, credibility is paramount. Conscious of the questions that surrounded olestra, and aware that they needed credible gure to stand behind their product, Procter & Gamble called on two former Secretaries of Health and Human Services: Louis Sullivan and Otis Bowen.
Louis Sullivan, a Secretary of HHS during the administration of George H. W. Bush, not only lobbied members of Congress like Julia Carson; he also played a major role in Procter & Gambles promotional campaign, addressing press conferences and writing letters to newspaper editors on behalf of olestra. Only rarely did these papers note that Sullivan was a paid P&G consultant. In one letter to the New York Times, Sullivan - identied only as the president of the Morehouse School of Medicine wrote unequivocally, Americans can feel condent in the safety of snacks made with olestra.378 Sullivan also promoted olestra in a 10-minute video P&G sent to local groups, such as Parent-Teacher Associations, as part of its marketing eort in Columbus, Ohio.379 Many press outlets uncritically accepted the representations of Sullivan and Bowen as unbiased, and repro378 Ken 379 Id.
Silverstein, How the Chips Fell, Mother Jones, May/June 1997
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duced them verbatim. A story by the Associated Press was typical. Written under the headline, Experts Say Fake Fat Helps In Weight Control, the story read like a Procter & Gamble press release:
Former HHS Secretary Dr. Otis Bowen said he surveyed emergency rooms and physicians in Indiana and found no evidence of olestra causing medical problems. The product causes no signicant health risks, said Bowen. I eat the chips and so do my grandchildren. Dr. Louis Sullivan, another former HHS secretary, said too many Americans are obese and olestra gives them another tool to improve their lifestyle and overall health.380
Though it emphasized their status as former Cabinet members, the article makes no mention of the fact that both were employed at the time by Procter & Gamble.
At another point, Bowen, a medical doctor, former two-time Indiana governor, and Secretary of Health and Human Services under President Reagan, reassured journalists at a press availability that the concern over olestras gastrointestinal side eects was unnecessary. On average, Bowen told members of the press, all people have gastrointestinal upsets every three months or so; the number of cases that have been called in is probably an incidental thing.381 Like the tobacco industrys Shadow FDA, that used its credibility to attack the FDA of David Kessler, Louis Sullivan explicitly underlines his former government post when doing promotional work for Procter & Gamble. On the wowchips.com website, Sullivan says
All Americans can feel condent in the safety of snacks made with olestra. As a former Secretary of Health and Human Services, I am aware of the intense scrutiny new food ingredients like olestra are subject to before they are approved by the FDA. The FDA with input from the many respected experts including the National Cancer Institute carefully reviewed more than 25 years of research supporting olestras safety. Louis Sullivan, M.D. President, Morehouse School of Medicine382
380 Paul 381 Art
Recer, Experts Say Fake Fat Helps In Weight Control, Associated Press, 1998 Levine, Food Fight in Indianapolis, U.S. News, May 5, 1997 382 See http://www.wowchips.com/what/expert/text.html#Sullivan
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Like the Associated Press story, the Sullivan quote mentions nothing of his conict of interest. It also implies incorrectly that the National Cancer Institute has lent its name to olestras approval. It has not.
CONCLUSION
What I hope this paper has shown is that the sins of the tobacco industry are not unique or personal to that industry, but a natural and predictable outgrowth of the adversarial process that puts the Food and Drug Administration between regulated industry and enormous prot. Because of the scope and nature of the tobacco industrys long campaign of deception, it is tempting to see tobacco as a mad dog among industries, the corporate equivalent of a rogue state that agrantly dees behavioral norms. This paper has sought to expose that reasoning as na and unrealistic, and to suggest that, far from being unique, the actions of ve the tobacco industry in fact adhere quite closely to corporate norms. As this paper has tracked the tobacco industrys campaign against the FDA, and Procter & Gambles campaign to secure olestras approval and market share, consistent parallels have emerged: Each industry gave generously to members of Congress, concentrating on the leadership of the two major parties and the chairmen of important committees, each shifting their support with the changing of political tides. Each relied on the loyalty of their home-state delegations to pressure the FDA with letters and with hostile hearings. Each enlisted well-connected lobbyists to smooth over dissenters, and employed Astroturf campaigns to generate pressure on reluctant legislators.
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Each poured resources into scientic research and scientists, in order to produce a steady stream of favorable data and friendly witnesses. Each proved willing to pick and choose among studies to nd those that t the industrys agenda. Each was ruthless in attacking potential threats, lampooning and slandering opponents, often through unaccountable third parties. Each used their vast corporate resources to purchase the support of credible organizations. Each employed a cast of former public servants especially veterans of the FDA and HHS to provide a public counterweight to government.
There is a dierence between the actions of Philip Morris and the actions of Procter & Gamble, and it is an important one there is no reason to believe that olestra is addictive, that it has been marketed to children, or that it will kill millions. But when it comes to their approach to the regulatory process, that dierence is only one of degree. I cannot say whether the FDAs approval of olestra was a mistake - I am unqualied to judge the arguments on their scientic merits. But I hope this paper has demonstrated that the process that preceded olestras approval was dangerously tainted that institutional concerns unrelated to the public health appear to have played a signicant role in securing its safe passage through the regulatory process. The continuing danger to the American public is not so much in olestra itself as in the increasing porosity of the regulatory structure. This paper could equally have focused its attention on pharmaceuticals, on blood products, or on medical devices, and demonstrated the same consistent industry strategies and the same systemic failures of our political and regulatory process. Eventually, such lax procedures will cause unnecessary harm to the American public, a public that barely questions the safety of the products it consumes because it believes in the FDA.
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The relationship between the FDA and its regulated industries is by necessity adversarial, and will be so long as there is prot to be made in the sale of food and medicine. For practical, if not for moral purposes, we must come to grips with that fact. But this recognition need not lead to resignation. If the tobacco industry blazed a trail that other industries learned to follow as I believe it did it also left a blueprint for reform. What follows is merely a thumbnail sketch of prophylactic steps that could re-empower the FDA to protect the public health: The federal campaign nance structure has warped the loyalties of the Congress. The cost of campaigning continues to climb with each election cycle, but because only a fraction of one percent of the voting public donates money to elected ocials, legislators face a double constituency problem: they must answer not only to the voters, but to their nancial supporters. Too often, the nancial supporters carry the day. So long as Members are beholden to wealthy individuals and corporations to win reelection, special interests will be able to use the Congress as a weapon against the FDA. While banning unregulated soft money is a good rst step, it is insucient; it would be a simple enough matter to redirect soft money into hard money donations, particularly if the Congress raises the hard money cap (as it is currently considering). Attempting to contain private expenditures is not only unfeasible, but potentially unconstitutional. Instead, the Congress should adopt a strong system of voluntary public nancing for federal elections a solution which eliminates the dependence of candidates on private wealth, but respects constitutional guarantees. The lobbying system has a clear public value: it enables legislators and regulators to hear persuasive arguments and gain access to valuable information. Lobbying is not a problem in itself. It becomes a problem, however, when lobbying is bound up with campaign donations, and where it perpetuates a revolving door between public service and the private sector. The revolving door process not only introduces personal relationships to what should be neutral policy determinations, it also oers a dangerous incentive for public 123
servants to satisfy private masters, in the hope of future employment. President Clinton instituted waiting periods between the time someone left his administration and the time they could return to lobby it, but repealed them when his own administration left oce just in time for his loyalists to capitalize. Those prophylactic measures should be restored and enforced. Legislators should also be required to keep and make publicly available a record of the time they spend with registered lobbyists another simple step toward achieving a transparent process. One of the most odious acts of the tobacco industry was its submission of fraudulent scientic testimony to government agencies. While there is no public evidence of Procter & Gamble engaging in such conduct, the FDAs approval of olestra was based almost entirely on industry-sponsored research a situation that leaves open the possibility of fraud. There must be severe penalties for organizations that knowingly submit false or incomplete information to the FDA, including signicant nes for corporations and criminal sanctions for executive ocers. Unlike most criminal sanctions, there is reason to believe that such penalties if vigorously enforced could have a signicant deterrent eect. The corporate context is one of the few scenarios in which the rational calculations inherent in deterrent theory actually take place. Other measures must address the dangers of tainted scientic research, increase awareness of front groups like HBI and the ACSH, and protect the public market for information from the emerging monopoly structure of the mass media. These are but a few suggestions, a jumping-o point for what must be a comprehensive series of systemic reforms.
The American public cannot aord to assure itself that the corporate malfeasance of the tobacco industry is unique to that industry and that product. It is not. The problems described in this paper are systemic problems, endemic within the adversarial structure that denes the FDA-industry relationship, and if they are to be successfully addressed they must be met with systemic solutions. 124
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