Placing Sidney Wolfe’s Public Citizen Health Research Group

in the Context of the American Consumer Movement

Iris Lan

Harvard Law School, Class of 2002

March 4, 2002

[Submitted in satisfaction of the course requirement

for “Food and Drug Law”

with Professor Peter Barton Hutt]

I. ABSTRACT

This paper summarizes the author’s attempt to understand the role and the activist efforts of the Public Citizen’s Health Research Group under the direction of Sidney Wolfe in the context of the American consumer movement. This understanding is gained (1) by performing some historical analyses and (2) by doing a miniature case study. The historical analyses involved research in the history of the consumer activist movement and then a formulation and threading of some of the major recurrent themes in the consumer movement. The main themes uncovered and discussed were: (1) a general skepticism towards advertisements, (2) the significant role of women in the movement, (3) the ideology that more regulation is better regulation, and (4) the general connection of the movement with contemporary social reform movements. Finally, a case study was done. This involved obtaining, organizing and analyzing approximately 85 primary source documents, which consisted of published letters, petitions, testimonies and various other papers produced by the Health Research Group during the 1997-2002 time period. The methodology for the case study is presented in this paper, as are four interesting trends about risk/benefit analysis, what constitutes “research” and the relationship between authorship and credibility. At the end of the paper, I make some concluding remarks about remaining questions that still need to be answered.

II. INTRODUCTION

The section provides is a brief overview of the structure of the organizational structure of this paper:

In Part III of this paper, I present an account of the history of the consumer movement and then a discussion of some of the recurring themes of the consumer movement. The founders of the consumer movement were determined to protect consumers from the risks of unsafe food, drugs, and other products,[1] and were encouraged by their peers in the consumer rights movements and has developed in tandem with the environmental and patients' rights movements.[2] Understanding the history and recurring themes of consumer movements is crucial for an understanding of the role of the Public Citizen’s Health Research Group.

Having laid out the broad historical context, I then lay out in Part IV a brief history of Public Citizen and its Health Research Group, which includes an analysis of the group’s functions, purposes and priorities. I also discuss relevant details about the Director and Co-Founder of the Health Research Group, Sidney Wolfe.

Part V of this paper presents a miniature case study of the Health Research Group by focusing on its activism efforts regarding drug safety. I lay out my methodology in Part V.A by discussing how I have chosen to analyze my primary sources, which consist primarily of 85 published documents from the Public Citizen’s Health Research Group (amounting to approximately 500 pages of text). These publications include hardcopies of letters, petitions, statements, testimonies, comments and studies co-authored by Sidney Wolfe and other leading members of the Health Research Group. In Part V.B, I present the results of my analytical methods.

Finally, in Part VI, the Concluding Remarks section, I include a few questions (from a list of many) that have yet to be answered. I hope to obtain answers to these questions in a telephone interview, when and if possible.

III. HISTORICAL BACKGROUND

A. History of the Consumer Movement

It is important to consider the Public Citizen’s Health Research Group in the context of the consumer movement in order to understand its distinct role in history. I have chosen to consider the consumer movement in terms of two time periods, pre-1960s and post-1960s. The pre-1960s period contains the following two phases of development, which I emphasize and briefly describe in terms of its relevance to the consumer movement: development through the Progressive Era (the late 19^th and early 20^th centuries) and through the New Deal (the late 1920s and 1930s).[3] Indeed, historians of the American consumer movement in the United States have generally begun with the Progressive Era,[4] which is my main rationale for beginning there as well.

Beginning with the 1960s and also the 1970s, the consumer movement went into a new phase and became tied to larger citizen movements. As Ralph Nader formed the Public Citizen organization in 1971, my description of this phase will be in more detail.

1. The Consumer Movement Before the 1960s

During the beginning of the Progressive Era, consumers were seen as naïve and trusting. However, this would soon change, as it would be during this era that some of the most prominent individual consumer leaders and consumer advocates began to speak out.[5] Women were particularly active in this phase of development in the consumer movement. Some of the most famous female pioneers were Ellen Swallow Richards, who was a prominent chemist; Florence Kelley, who founded the National Consumers League at the beginning of the twentieth century in order to protest the abusive of treatment of laborers[6] ; and, Alice Lakey, who was an active member of the General Federation of Women’s Clubs and who worked with the Chief of the U.S.D.A. Bureau of Chemistry, Harvey Wiley, in order to help prompt Congress to enact new legislation that would protect consumers in the food and drug area.[7]

One main position of early consumer activist organizations, including the National Consumer’s League, continued throughout the consumer movement: skeptical stance towards advertising.[8] There was a distinct moral tone to this stance. Indeed, Florence Kelley stated that advertisements were “distinctly not meant to educate or instruct, but to stimulate, persuade, incite, entice, and induce the indifferent to purchase.”[9] Advertising of the 1920s contained little, if any, real objective information about the actual products. Rather, advertising merely indicated how a product might bring consumers great “health, happiness [and] comfort.”[10] Hence, one of the “point[s] of greatest friction between business and the consumer movement was advertising.”[11]

The Pure Food and Drugs Act of 1906[12] was in large part fueled by the patent medicine and meat scandals publicized by these periodicals and advocates.[13] A pattern developed during this time period for what one might call a chronological life-span of a consumer protest: (1) an occurrence food or drug disaster, (2) focused research analyzing the disaster, (3) public protest of the causes behind the disaster, (4) responsive government regulation or legislation.[14] Indeed, the pattern seems to have lasted to this day, as a number of examples indicate.[15]

During the era of the New Deal, consumers were viewed as targets of the dangers of available goods and drugs, and there was major reform with more organized action than in previous times. Much of this was the result of the institution of the Consumer Advisory Board,[16] which encouraged the formation of various grassroots organizations and various publications whose main aim was to test consumer products.[17] The first edition of the Consumer Research Bulletin was published during this time.[18] This marked the first time that a publication seemed to seek true objectively in testing products, as the Bulletin accepted no advertisements. Additionally, Consumer Reports, published by the Consumers Union, also attempted to provide consumers with information about objective product testing.[19]

The 1920 and 1930s brought about a need for objective scientific testing to support product approval and marketing decisions. By the end of the 1930s, various expose-type articles and reports on adulterated foods and drug controversies,[20] combined with the infamous sulfanilamide tragedy,[21] helped to set the scene to force some major change in food and drug regulation. Accordingly, the Pure Food and Drugs Act of 1906 was revised to create the Food, Drug and Cosmetic Act of 1938.[22] Perhaps the most important aspect of this law was that it forbade the sale of any drug unless the FDA found it to be safe.[23] Whatever the most important impact or aspect of the new law was, the Food, Drug and Cosmetic Act of 1938 definitely provided the FDA with greater authority over drug safety and allowed the burden of safety to shift to manufacturers.

2. The Consumer Movement After the 1960s

The consumer movement in the 1960s and 1970s is generally remembered for the incorporation of consumer affairs into the national government and an immense distrust in corporations and industry generally.[24] The consumer movement also became responsive to racial minority and the economically disadvantaged generally.[25] For the first time in American history, consumer reform became an established ideology, as opposed to a mere pattern of protest. Ralph Nader has become seen as one of the leaders of this movement, beginning with the gathering of “Nader’s Raiders,” which was a network of activists who held great skepticism for corporate America.[26] Many other new consumer organizations were also formed,[27] reflecting the widespread idea that not only enactment, but also strict enforcement, of legislation was needed in order to reduce risk to dangers to consumers.

Like the earlier eras of the consumer movement, activists complained about manipulative advertising and the existence of unsafe products,[28] and the occurrence of a drug scandal helped to force legislative change.[29] Ultimately, however, historians say that the consumer movement in the 1960s and 1970s is remembered for the efforts and activism of Ralph Nader.[30] Nader was initially known for his tirade against General Motors. He argued that the company, along with other American car manufacturers, had misled the public by convincing the public that automobile safety was an issue associated with the behavior of drivers and the design of highways, as opposed to the design of the automobile itself.[31] Nader published his ideas in 1965 in the form of a 365-page book, describing in detail numerous safety problems with the Chevrolet Corvair that stemmed from the car’s design defects.[32] This book has since become known as “an indictment of the entire automobile industry, and by extension other giant corporations, for ignoring the consumer's desire for [safety].”[33] Moreover, it seems to have had the landmark effect of mobilizing consumers into a formidable political and social force.[34]

After 1965, in addition to private manufacturers, Nader and his gathering of followers (the “Nader Raiders”) also began to point its fingers at federal regulatory agencies for not protecting consumers. The FDA was one of the many agencies targeted. Nader asserted that these agencies were not properly carrying out and enforcing statutes.[35] In particular, the most popular allegations against federal agencies were that they were (1) inactive and (2) improperly influenced by the businesses that they were supposed to be regulating.[36] The latter allegation is central to understanding one of the main philosophies behind Nader’s leadership in the consumer movement. In particular, Nader views the federal government and its regulations as crucial for counteracting the evils of the large corporations in America who wield considerable power because of their market and economic status.[37] In sum, however, Nader played a central role in creating a social and political atmosphere that would foster the creation of a variety of consumer protection legislation.[38] Indeed, the creation of the Consumer Product Safety Commission can be seen as a culmination of Nader’s efforts and one of the high points of the 1970s for the consumer movement.[39]

There is some current debate about the current influence of Nader and his followers. A number of commentators consider Nader and his cause to have entered a dormant phase since the 1980s, with the election of Ronald Reagan.[40] Their main rationale is that the prevailing ideology fostered since the Reagan era regarding the federal regulatory agencies seems to have been that the regulations produced in the 1960s and 1970s placed needless controls and unwarranted burdens on American businesses that hindered economic growth and development.[41] However, one might still argue that, despite this situation, Nader is probably far from being shut out of governmental and political influence entirely. This should not be a difficult task, given Nader’s effect on the recent 2000 presidential campaign.[42]

B. Themes in the History of the Consumer Movement

The brief history of the consumer movement that I have provided in the above section gives an indication that there are indeed a number of recurring themes in the area of consumer activism. I present four of these here, which shall be useful to keep in mind with respect to their relationship to the role of the Public Citizen’s Health Research Group.

1. Skepticism Towards Advertising

A major theme in consumer movements seems to be the heavy skepticism held towards advertising. The main gripe of activists over advertising is closely linked to the with the consumer activists’ protests against big corporations, as advertising demonstrates how a large business may choose to engage in deceptive business practices. In essence, activists have felt that advertising has been misleading (either because of false statements or failure to disclose certain information) and therefore improperly influences a consumer’s choice preferences so that they purchase a product that is useless, or even harmful, to them. Hence, it seems that activists would prefer that advertising be completely truthful and that there be less of it.

2. Association with Women

It is also interesting to note that the consumer movement has been associated primarily with women. President Johnson chose Esther Peterson to be his first presidential advisor for consumer affairs, and every president since then has chosen a women to sit in that position.[43] This trend may have originated under the influential leadership of Florence Kelley, whose activism was extremely successful in the fight for female workers. In any case, while one can really only speculate regarding what really has kept women involved in the movement, what matters is that the woman’s voice in the consumer activism was and remains influential.

3. More Regulation is Better Regulation

Another trend in the history of consumer activism seems to be the consumer movement’s desire always to regulate more. In other words, it seems that the remedy for counteracting big business is to have “bigger” (or, rather, more) regulations. There has never been any kind of push towards de-regulation, and it does not seem like any consumer activist group would currently make such a move.

4. Connection with Contemporary Social Reform Movements

Finally, it seems that the most memorable and influential events in consumer activism have been associated with or at least coinciding with larger periods of social reform. For example, the first two “phases” of significant activism in American history seemed to have occurred during the Progressive Era and then the New Deal. The changes in the 1960s and 1970s also seemed to ride the spirit of the social movement during that time as well, which challenged the status quo and held skepticism about businesses and corporate America.

It is also interesting to note that the American consumer movement has been in large part a reaction, or, rather, defiance against large businesses and corporations. In particular, consumer activist leaders, such as Kelley and Nader, sought to unify people in order to create a larger collective group that would be able to battle against the economic power and political influence of large businesses. Protests against large corporations and petitions to the federal regulatory agencies centered on the theory that businesses were producing unsafe products and engaging in deceptive business practices that could not be eliminated only by market forces. Hence, given that market forces were insufficient protection, federal regulatory agencies needed to create better laws, provide more effective enforcement and educate consumers. It became the job of the activists to remind the regulatory agency of this fact.

IV. UNDERSTANDING THE GOALS OF PUBLIC CITIZEN, THE HEALTH RESEARCH GROUP AND STANLEY WOLFE

A. The Formation of Public Citizen and Its Current Leadership

Public Citizen was founded in 1971 as a national, nonprofit consumer advocacy organization,[44] in order to “fight for openness and democratic accountability in government...and for safe, effective and affordable prescription drugs and health care.”[45] Public Citizen houses six national divisions[46] : Auto Safety,[47] Congress Watch,[48] Critical Mass Energy and Environmental Program,[49] Global Trade Watch,[50] Health Research Group[51] and Litigation Group.[52] While Ralph Nader is the founder of the organization, he is no longer a member of the group, having resigned from Public Citizen in 1980 in order to turn his attention to fight against big insurance companies and various international trade treaties. The current President of Public Citizen is Joan Claybrook, who was a founding member of the group and had worked with Nader since 1966.

1. The Purpose and Scope of the Health Research Group: Research-Based Advocacy and Education

The Public Citizen’s Health Research Group is the “health arm” of Public Citizen. It has one main goal: to “use[] research and public education to promote system-wide changes in health care policy . . . [by] engag[ing] in oversight of the government concerning drugs, medical devices, doctors, hospitals, and occupational health.”[53] More specifically, the members of the Health Research Group aim “to ban or relabel unsafe or ineffective drugs and medical devices and to improve safety standards at work sites”[54] by petitioning and testifying before Congress and federal agencies. The Health Research Group, like the other divisions of Public Citizen, aims to take preventative measures. Since the Reagan era, it has even more strongly defended the following position:

Preventive regulation is cheaper than after-the-fact fixes; good regulation avoids expensive litigation and counterproductive blame-laying when products fail; smart regulation results in the development of better and more efficient products; and above else reasonable regulatory measures save lives and our environment.[55]

The Health Research Group is concerned with the following public-health-related matters:[56]

• drug safety
• healthcare delivery
• medical devices
• food safety
• occupational health

These five matters are not treated equally. It would be difficult to rank exactly the priority of their treatment, even by counting the number of petitions and letters filed by the Health Research Group currently on record. This is in part due to the fact that the Health Research Group’s current records for all non-drug concerns seem to have incorrect time gaps, even up to a length of years. For example, between June of 1992 and April 2001, there seemed to be no letters or petitions on file regarding the issue of food safety.[57] However, having provided that caveat, I provide the following chart:

From this informal compilation, it does seem that drug safety seems to garner the most attention for the Health Research Group.

A look at a list of what the Health Research Group considered as its achievements also indicate that drug-related activism is likely to be its central focus. The following list is taken from a recent publication from the Health Research Group, in which it described itself as a “major participant” towards success in these matters:[59]

Indeed, only two of the seven in the above “successes list” relate to non-drug matters; the large majority of the list pertains to drug safety.

Education, to the consumer population, another success touted by the Health Research Group, is done mainly through publications, such as books and newsletters. The goal of these publications is to help consumers make informed decisions. At least three books, all on pharmaceutical, published by the Health Research Group have become bestsellers.[60] Additionally, two monthly newsletters, entitled “Health Letter” and “Worst Pills, Best Pills News”, give consumers information about drug safety.

Another means of education is through a web site that is maintained by the Health Research Group. The resources from Health Research Group page on the Public Citizen web site are impressive. It makes available to the public, the full text of a healthy number of their publications, such as petitions,[61] request letters,[62] commentaries,[63] and press releases.[64] Access to the documents on the web are free, although there are a significant number of documents not available through the web and must be ordered by calling Public Citizen and paying a fee.

C. Sidney Wolfe, Director of the Public Citizen Health Research Group

The Public Citizen Health Research Group is headed by Sidney Wolfe, a physician who co-founded the group with Nader in 1971 and has been with the group since then. Wolfe received his college education in Chemistry from Cornell University and received his medical education at Case Western Reserve University School of Medicine.[65] After an internship and residency in internal medicine, completed in 1966, Wolfe worked at the National Institutions of Health (NIH), where he focused his research on blood clotting and alcoholism. While he was at NIH, Wolfe attended a meeting of the American Patients Association, which is where he met Nader. Soon thereafter, Wolfe began advising Nader on health issues and recruiting students to work for Nader. When Nader founded Public Citizen in 1971, he asked Wolfe to set up the Health Research Group. Wolfe has since then been a full-time employee of the Health Research Group as its Director and received a MacArthur Fellowship in 1990 in recognition of his work there.[66]

Wolfe currently sees four main problems and issues with drug safety today: [67]

1. There has been insufficient criticism of the FDA in the media (particularly on television) by both the current commissioner Jane Henney and her predecessor Michael Friedman.
2. Ninety-two drugs were approved in 1996 and 1997, which is the largest number of drugs ever approved in a 2-year period by the FDA. Wolfe sees this as clearly the result of an inappropriate lowering the standards of drug approval.
3. The general enactment of the 1997 Food and Drug Modernization Act, which, Wolfe asserts, favors drug companies, who helped to craft it.
4. The new, more relaxed requirements for prescription drug television advertising, which, Wolfe claims, creates a windfall for manufacturers, many of whom can now increase sales using misleading advertising.

In essence, all of these relate to the government being too soft on the FDA

Finally, Wolfe has continued to advocate the following approach for consumer activism:[68]

The first method involves petitioning...the government -- especially the Food and Drug Administration (FDA) ...-- to enforce the health protection laws they are charged with upholding. In the case of the FDA, this means gathering enough scientific data to force the FDA to put a warning label on a drug or medical device, or, if necessary, to ban the product or other regulated FDA-regulated substances such as food additives. . . . The second means of concern involves providing information to the public so that even before the government takes the actions, we are requesting the public be informed about the problem, so that they may use that information to protect themselves and their families.

This has been the approach of the Public Citizen Health Research Group for the past thirty years.

1. A MINI-CASE STUDY IN THE CONTEMPORARY HISTORY OF THE CONSUMER MOVEMENT: DRUG SAFETY AND SIDNEY WOLFE’S PUBLIC CITIZEN’S HEALTH RESEARCH GROUP (1997-2002)

1. Methodology

1. Archival Materials: Primary Sources

I have employed eighty-five written publications (amounting to roughly 500 page) from the Public Citizen’s Health Research Group as my main primary archival sources for this study. All the publications are taken from the time period from April of 1997 to February of 2002, which spans approximately five years, and all publications refer to drug safety. I have chosen to study these five years (1997-2000) for two main reasons: (1) I wanted to have a real sense of the contemporary history of the Health Research Group with regards to drug safety as well as a sense of the recent history of the consumer movement generally; (2) I wanted to have a broad enough data sample in order to get a sense of patterns and trends, if any exist.

There are four main types of publications: letters/petitions, commentaries, statement and testimonies. The following chart lists all of the main types of publications (in addition to other less numerous types) as well as the frequency of their occurrence (i.e., the number of times, out of the total 85, that this publication has appeared during this time period):

I have created a more detailed chart in APPENDIX A, which lists all eighty-five publications in chronological order, beginning with the most recent publication from February 14, 2002. For each publication, the chart gives the names of the authors (ordered in the manner listed in the publication, when applicable), the full title of the publication (as it appears on the publication) and a brief description of each document (under the last column “Type of Publication”).

1. Studies Along Different Axes

Because the sample of data that I have been able to obtain is sufficiently large, I have chosen to study all 85 sources along different axes. By “axes,” I mean to refer to different factors. For example, it was possible to read all of the primary sources in order to investigate whether the Health Research Group has changed any of its major interests (which I found it has not). I was also able to try to find patterns according to authorship by asking the question of whether certain authors have been associated with certain topics or kinds of publications. I present what I have found to be the more interesting factors and findings in the next section.

My process for analysis is best summarized as follows: I made an additional hard copy of all the documents that I had ordered, so that I would be able to set aside one set of publications in chronological order while being able to re-group the other set in terms of subject matter or some other criteria. Next, I took one copy of all of the documents and first skimmed through all of it in one sitting. When I read through the documents a second time, I took notes with the purpose of filling in summary information about each document into a chart (APPENDIX A ) in order to begin looking for trends. During the third time I read through the documents, I pulled out “hot documents” that seemed to belong together either because they belonged together topically (e.g., they were a series of publications dealing with exactly the same subject matter) or because they were expressing similar themes (e.g., how to perform risk/benefit analysis). I left aside the documents that were not pulled for later reference and then performed textual analysis of the different groups of publications that I had produced. Additionally, I would move documents from one grouping to another or copy certain publications into another group, if and when necessary.

I would like to note that all articles that I have chosen to analyze for this paper were authored or co-authored by Sidney Wolfe. My main rationale for this was that these would be the publications that were likely to be most important to the Health Research Group. Even if another member of the group had done most of the work, say, for a letter, it would still be logical for Wolfe to co-sign the document as the Director of the Health Research Group, if the letter was to grab the attention of the reader of the letter. For the sake of completion, however, I was personally compelled to order all publications and documents from the Health Research Group that related to drug safety, regardless of whether they were authored or co-authored by Sidney Wolfe. I found that only ten documents or so lacked Wolfe’s co-signature and that this group of documents consisted only of statements, commentaries or press releases. Significantly, none of the documents were letters or petitions, as Wolfe had co-signed all letters, even if he was not the first-author.

1. Results of Analysis: Some Interesting Trends

1. The Definition of “Research”: What Counts

The name “Health Research Group” and the repeated statement that the group was aiming towards “research -based advocacy” encouraged me to investigate and analyze exactly what the group meant by “research”:

1. Collecting and Analyzing FDA Data: Most publications were not thoroughly “researched” in the traditional scientific sense of the term. The group had not conducted any experiments or full-blown meta-analyses. A representative publication demonstrating typical “research” by the Health Research Group was a letter to the FDA concerning the need to use ultrasound to monitor clinical trial subjects for a particular drug.[69] Not every single experimental or medical claim was backed up with a citation to an article or paper. Like most of its other publications, it seemed that the letter primarily discussed a few statistical or scientific reviews that had been produced by the FDA itself and that indicated that the drug being discussed had adverse effects. The only citation that was to an independent research paper was not by any means central to the letter.
2. Reports on Other’s Experimental Research: There were a number of publications that took the form of a letter to the FDA informing it of one new publication from some refereed scientific journal that indicated a mechanism or further proof for some adverse effect of a drug.[70] Hence, there was research in the sense that it took effort to find and inform an agency about a study.
3. Informal Studies: The Health Research Group has itself conducted research in the form of informal surveys. One particular survey of note was a relatively extensive interview study done on the lowering of drug approval standards, based on the questioning of 53 medical officers.[71] This survey was then cited by the Health Research Group in an Opinion/Editorial in the Washington Post entitled “Troubling Climate at the FDA.”[72] In another publication, the Health Research Group also cited to information its own newsletter “Best Pills, Worst Pills” as mounting evidence regarding the adverse effects of dietary supplements.[73]
4. Newsletters: Of course, an obvious research aspect of the Health Research Group is seen through its best-selling books and the newsletters on pharmaceuticals, as mentioned in Part III.
5. Explanations as “Research”: A chart depicting the related structures of phenylpropanolamine (PPA), amphetamine, and ephedrine was used at least four times in order to show the similarities between PPA and ephredine, which is a toxic chemical.[74] The purpose of the chart was to show that one small part of a compound, if changed, would transform PPA into the dangerous ephedrine. This is a basic chemical concept, which did not seem to be scientific proof or “research,” in the spirit of what one would generally think of as scientific research. However, this seemed to be presented as such and seems representative of a general trend found amongst various Health Research Group letters, petitions and statements: explanations of concepts seemed to be touted as research.
6. What Counts as “Risk-Benefit Analysis”

The Health Research Group advocates taking into account “the risks as well as the benefits”[75] of a drug. In letters to or other statements before the Food and Drug Administration, the Health Research Group has employed a risk-benefit analysis to argue that a drug not be approved or be withdrawn. For example, it has asserted a number of times that, for whatever reason (either because of a drug manufacturer’s or the FDA’s statements or failure to disclose), benefits were exaggerated, and risks were not disclosed or were downplayed inappropriately. The following is typical of the kind of language employed:

The benefits of COX-2 inhibitors as far as reducing GI toxicity appear to have been grossly exaggerated and oversold. Years after the research on these benefits was done, a rapid accumulation of evidence on risks is occurring.

The article will then proceed to describe which benefits were exaggerated and which risks were downplayed or undisclosed.

In one testimony, to show that a drug, Symlin, should not be approved, Sidney Wolfe’s entire presentation rested on his own version of a risk benefit analysis.[76] Wolfe structured his entire talk in the following manner: “Benefits: ... Risks: ...”. He asserted that the lowering of a certain chemical by a drug, which would have been a benefit, was in fact quite small in amount compared to the placebo study. Then, he presented various nervous and gastrointestinal problems, which, according to Wolfe, should have been considered risky enough to outweigh the minimal benefit.

It is important to note that Wolfe has a specific notion of what constitutes benefit beyond general efficacy. In a number of publications, he states explicitly that the benefits must be “unique.” For example, in a letter to the FDA petitioning for the immediate ban on the antibiotic Trovan, there was the following statement:

TROVAN is another example of a drug with no unique benefits and unquestionably unique , life-threatening risks .[77]

Wolfe never spells out this argument in this letter or any other letter or statement.[78] However, it seems as though, while it may not be necessary for risks to be unique or life threatening for a drug to be banned, it is required that the benefit be unique, given the kinds of risks involve. It seems that certain level risks may be accepted for one situation in which a benefit is unique, but not for another situation in which a drug does not have a unique benefit.

In a Statement before the FDA advising the withdrawal of troglitazone, Wolfe made an argument that was a kind of semi-combination of both the “exaggerated benefits” argument in addition to the “uniqueness” argument: “The drug was...said to have unique advantages ... [but instead] it had a unique type of toxicity...” In other words, consumers had been misled into thinking that there were unique benefits, when instead there were unique risks.

1. Authorship and Credibility

There did not seem to be definite patterns in how co-authors were chosen for publication. However, Wolfe has been more likely co-author than sole author, except in the case where he was presenting a testimony. In most cases, Wolfe has been joined by Deputy Director Peter Lurie or pharmacology expert Larry Sasich in letters of all kinds. Additionally, when there has been a petition to the FDA, it almost always co-signed by the following three authors: Elizabeth Barbehenn, Larry Sasich and Sidney Wolfe. One possible theory behind this is that each of the three authors covers an area of expertise; Barbehenn possess a research degree (Ph.D.), Sasich possesses a pharmacology degree (Pharm.D.), and Wolfe is the “physician anchor” (M.D.). In other words, use of all three people as co-signatories is in a sense pulling out all the stops and showing the FDA the gravity of the situation. Finally, there is a trend regarding non-Health Research Group co-signatories: they are employed on an as-necessary basis, depending on the audience of the publication. For example, a letter to foreign officials included the signature of a doctor from that country,[79] and a letter to senators included the signature of a politician (i.e., Ralph Nader).[80]

1. Letters to Organizations in Foreign Countries

Finally, I wanted to note that the letters to foreign countries from the Health Research Group have gone only to two places: United Kingdom[81] and Canada.[82] Three letters have gone to the first, and one has gone to the second. There does not seem to be any particular reason for the Health Research Group to choose these two countries, except that both countries are English-speaking. Two of the four total letters, one to the United Kingdom and the other to Canada, were almost identical in content and urged both countries to require warnings on labels for the drug Viagra.[83] Both letters referred to adverse effects caused by Viagra and the current petition to the FDA by the Health Research Group to change the labeling.[84] There have been no other letters of request to any foreign countries filed since the year 2000.

1. Concluding Remarks: Continued Curiosity

In late January of 2002, and then in February of 2002, I email and telephoned Public Citizen to request to have some telephone interview time with Sidney Wolfe or any other consumer activist working in Public Citizen’s Health Research Group. To date, I have had no response. Perhaps it is because I do not have an authentic consumer complaint or am not a journalist looking for a good story! In any case, I will try contacting the Group again in the near future to see whether it might be possible set up some time to speak with someone in order to ask some questions that are still on my mind, including the following questions (in no particular order):

1. When and how does the Health Research Group decide to write a petition or produce any other publication? (E.g., Is it based on consumer-contact, consumer surveys, journalist reports, studies, or word of mouth?
2. When the Health Research Group has decided to produce a publication, such as a petition, who actually writes it?
3. What does Sidney Wolfe spend his time doing? Is he looking for He co-signs many of the letters, but is he the author?
4. How has Sidney Wolfe viewed himself as a consumer activist in the post-Reagan era?
5. How does the Health Research Group keep in touch with its consumer base? (E.g., does it place advertisements at all? Does it send people out people regularly to do informal field surveys? And if so, are they kept private?)
6. Has Ralph Nader been involved with Public Citizen or any of its divisions since his departure from the group in 1980? If so, in what way?
7. What does the Health Research Group see as its main focus currently? Is it drug safety? Is food safety going to be occupying more time in the near future?
8. How large is the Health Research Group? Who are the members in charge of running the group on a day-today basis?
9. Does the Health Research Group employ any consultants, such as specialists in risk assessment or risk analysis?

These are just some of the questions that I have yet to answer, but have already tried to answer somewhat, based upon the documents I was able to obtain. However, if given a chance, I would be thrilled to ask them directly to Sidney Wolfe one day.

APPENDIX A: LIST AND DESCRIPTION OF HEALTH RESEARCH GROUP DRUG PUBLICATIONS EMPLOYED IN THIS STUDY

I. APPENDIX B: LIST OF HEALTH RESEARCH GROUP PUBLICATIONS AND DOCUMENTS RELATED TO FOOD SAFETY

[1] See Patricia M. Kuntze, Communicating with the FDA: The Office of Consumer Affairs , 48 Food & Drug L.J. 15 (1993).

[2] See id. at 15-16.

[3] However, historian Robert Mayer has chosen to identify three distinct periods of consumer activism, not two: (1) the 1880s to World War I; (2) the late 1920s to World War II; and (3) the late 1950s to the early 1970s. The main rational for this seems to be that he has chosen to organize around three particular causes. See generally ROBERT N. MAYER, THE CONSUMER MOVEMENT: GUARDIANS OF THE MARKETPLACE (Boston: Twayne Publishers, 1989).

[4] For example, the three most well known books on the consumer movement in American history begin with the Progressive Era. See, e.g., ROBERT N. MAYER, supra note 3; LORINE S. GOODWIN, THE PURE FOOD, DRINK, AND DRUG CRUSADERS, 1879-1914 ( Jefferson, N.C.: McFarland, 1999). NORMAN I. SILBER, TEST AND PROTEST: THE INFLUENCE OF CONSUMERS UNION (New York: Holmes & Meier, 1983).

[5] Periodicals also started to warn consumers about the risks of adverse effects to various drugs and the risks of adulterated foods. See Kuntze, supra note 3, at 16.

[6] For example, one of the earlier causes of the National Consumers League was to improve the conduction of women and children who worked for textile manufacturers. See KATHRYN K. SKLAR , Two Political Cultures in the Progressive Era: The National Consumers' League and the American Association for Labor Legislation , in U.S. WOMEN'S HISTORY: NEW FEMINIST ESSAYS (Linda Kerber et al., Eds., 1995), 41. [hereinafter Kathryn K. Sklar, Two Political Cultures ]

[7] See Kathryn K. Sklar, Florence Kelley and the Nation's Work: The Rise of Women's Political Culture , 1830-1900, 143 (1995). See also Patricia M. Kuntze, Communicating with the FDA: The Office of Consumer Affairs , 48 Food & Drug L.J. 15, 16 (1993).

[8] See Kathryn K. Sklar, Two Political Cultures, supra note 6, at 44.

[9] See Florence Kelley, Aims and Principles of the Consumers’ League , 5 Am. J. Soc. 289, 294 (1899).

[10] See Stephen Fox, The Mirror Makers: A History of American Advertising and Its Creators (Urbana: University of Illinois Press, 1997), 95.

[11] See THE CONSUMER MOVEMENT: LECTURES BY COLSTON E. WARNE (Richard L.D. Morse ed., 1993), 91.

[12] Pub.L. No. 59-384, 34 Stat. 768 (1906).

[13] See Kuntze, supra note 1, at 16.

[14] See id.

[15] For example, tampon labeling and tamper-resistant packaging laws seem to arise from such a matter. See id.

[16] This was instituted by the National Recovery Administration. See id.

[17] See id.

[18] See id. at 16-17.

[19] See id. at 17.

[20] See, e.g., Ruth D. Lamb, American Chamber of Horrors: The Truth About Food and Drugs (New York: Farrar & Rinehart, incorporated, 1936).

[21] The tragedy is most often referred to as the Elixir of Sulfanilamide Tragedy of 1937, which killed 107 people, most of whom were infants. A drug company in Tennessee had marketed an antibacterial drug called Sulfanilamide against strep-throat infections for children as syrup using diethylene glycol (antifreeze) as solvent. Unfortunately, the drug was never tested for safety, because it had not been required by the FDA to do so. Therefore, it was not discovered that the solvent was lethal until after the drug was sold. For a detailed account of the tragedy and its aftermath, see James H. Young, Three Southern Food and Drug Cases , The Journal of Southern History, Vol. 49, No. 1. (Feb., 1983), 3-36. See also Henry A. Wallace, Report of the Secretary of Agriculture, on Deaths Due to Elixir-Sulfanilamide -Massengill (Senate Documents, 75 Cong., 2 Sess., No. 124, Serial 10247, Washington, 1937), 2-3; George M. Burditt, Overview of the Last 50 Years: The History of Food Law , 50 Food & Drug L.J. 197 (1995).

[22] Pub.L. No. 75-717, 52 Stat. 1040 (1938), as amended 21 U.S.C. § § 301 et seq. (1988).

[23] See id.

[24] See Kuntze, supra note 1, at 17.

[25] This was likely due to the influence of the civil rights movement during this time. See id.

[26] See id .

[27] These included the American Council on Consumer Interests, the Consumer Federation of America, and the Alliance for Consumer Protection. See id.

[28] See ROBERT N. MAYER, supra note 3, at 26-27.

[29] In the 1960s, a drug called thalidomide was marketed to pregnant women in Great Britain and West Germany, which resulted in numerous birth defects. This resulted in stricter drug regulations in the United States. See id., at 26-27.

[30] See id., at 26-30.

[31] See LUCY B. CREIGHTON, PRETENDERS TO THE THRONE: THE CONSUMER MOVEMENT IN THE UNITED STATES (Lexington, MA: Lexington Books, 1976), 28.

[32] RALPH NADER, UNSAFE AT ANY SPEED: THE DESIGNED-IN DANGERS OF THE AMERICAN AUTOMOBILE (New York, Grossman, 1965).

[33] See ROBERT N. MAYER, supra note 3, at 28.

[34] See id. In the end, it also had the immediate and tangible effect of helping to support Nader’s organization from a monetary standpoint. Dismayed with Nader’s book, General Motors tried to undermine Nader’s credibility in various ways. Nader turned around and sued General Motors for invasion of privacy and won a half-million dollar settlement, which he then used to support his organization. See LUCY B. CREIGHTON , supra note 31, at 52. General Motors’ attempt to discredit Nader was unsuccessful, as his reputation remained intact. Indeed, it would have been hard to find any conflicts of interest, at least financially, because of Nader’s choice to live a “poor man’s” lifestyle. He did not own any automobile, resided in a low-rent district, and had no real social life. See Mayer, supra note 3, at 29.

[35] See ROBERT N. MAYER, supra note 3, at 28-29.

[36] See id .

[37] See LUCY B. CREIGHTON , supra note 30, at 54.

[38] See ROBERT N. MAYER, supra note 3, at 29.

[39] See id., at 29-30.

[40] See id.

[41] See id.

[42] See Barry Burden, Did Ralph Nader Elect George Bush? An Analysis of the Minor Parties in the 2000 Election [Paper prepared for presentation at the 2001 meeting of the American Political Science Association], at (last visited February 08, 2002) http://www.people.fas.harvard.edu/~burden/minor.pdf.

[43] See ROBERT N. MAYER , supra note 3, at 28. Peterson was replaced by Betty Furness. Then, Nixon appointed Virginia Knauer, who continued in this position during the Ford and Reagan administrations. When Carter came to office, he chose Peterson to resume her old post. Then, Bonnie G. Hill served during the Bush Administration. See United States Government Manual 1990-1991 287 (1990). Leslie L. Byrne served during the Clinton administration. See United States Government Manual 1997-1998 263 (1997).

[44] Public Citizen does not take any money from the government or from private businesses. See Public Citizen, Protecting Health, Safety and Democracy, at (last visited February 01, 2002) http://www.citizen.org/about/.

[45] See id .

[46] Public Citizen also has offices in Texas and California. The Oakland California Office focuses upon energy regulation, while the Texas office has had a wider variety of concerns covering all of the interests of the national divisions. See id.

[47] The goal of the Auto Safety division is to ensure “stronger standards for vehicle safety and more sensible regulation of the trucking industry.” See id.

[48] The goal of Congress Watch is to serve generally as a “government watchdog” and to advocate consumer interests before Congress. See id .

[49] The Critical Mass Energy and Environment Program works to “protect citizens and the environment from the dangers posed by nuclear power and seeks policies that will lead to safe, affordable and environmentally sustainable energy.” See id.

[50] The Global Watch works mainly as an educational body in Public Citizen. It aims to inform Americans about the impact of economic globalization. See id.

[51] Instead of giving a footnote description, as with the other divisions listed here, I discuss more thoroughly the goals and purposes of the Health Research Group in the next section.

[52] The Litigation Group is a public interest law firm that litigates cases at all levels of the federal state courts. They aim to specialize in “federal health and safety regulation, consumer litigation, open government, union democracy, separation of powers and the First Amendment.” See Public Citizen, Protecting Health, Safety and Democracy, supra note 44.

[53] See Public Citizen Health Research Group Citizen, at (last visited February 01, 2002) http://www.citizen.org/hrg/.

[54] See id .

[55] See David Vladeck, Under-Regulated? Big Business Fights Health, Safety Standards That Save Lives, Money , in Public Citizen: Special Anniversary Issue, 30 Years Protecting Health, Safety & Democracy Since 1971, at (last visited February 02, 2002) http://www.citizen.org/documents/ healthsafety.pdf.

[56] The web site for the Health Research Group seems to list these categories as informal sub-divisions. See Public Citizen Health Research Group Citizen, at (last visited February 01, 2002) http://www.citizen.org/hrg/.

[57] This was based on a thorough library and Internet search, in addition to a phone call to Public Citizen at their Washington, D.C. office location. While the discussion in this paper focuses upon drug safety, I have also compiled a list of all documents related to food safety for future research and for reader’s interest. See APPENDIX B: LIST OF HEALTH RESEARCH GROUP PUBLICATIONS AND DOCUMENTS RELATED TO FOOD SAFETY .