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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 19th and early 20th 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]

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:

Subdivision
Number of Publications [58]
Drug Safety
501
Healthcare Safety
486
Occupational Health
270
Medical Devices
182
Food Safety
172

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]

Success
Type
“Requirement that aspirin labels warn of the risk of Reye's Syndrome in children and teenagers”
Drug Safety
“Banning of Oraflex, Tandearil and Suprofen, three nonsteroidal anti-inflammatory (NSAID) drugs and Phenformin, an oral diabetes drug”
Drug Safety
“Urged successful criminal prosecution of Eli Lilly and SmithKline for withholding reports of death and injuries caused by their drugs”
Drug Safety
“Banning of cancer-causing Chloroform in cough medicines and toothpastes”
Drug Safety
“Recall of the Bjork-Shiley heart valve which has killed 1000 people”
Medical Devices
“Withdrawal of the indication of lactation suppression for the drug Parlodel”
Drug Safety
“Forcing OSHA to set safer standards for exposure to cadmium, ethylene oxide and other chemicals”
Occupational Health

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):

Publication Type
Frequency of Occurrence
Letters & Petitions
44
  • (Officially titled as “petitions”
  • (Letters to regulatory agencies
  • (Letters to others, including international organizations, science journals and professional associations
  • 7)
24)
13)
Commentaries
14
Testimonies
9
Press Releases
2
Statements
10
Reports
3
Opinions/Editorials (WA Post)
1
Articles (NEJM)
1
Informal Studies
1
[total
85 publications]

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

No.
Authors

Publications

Description
1
S. Wolfe
  • (2/14/02) Direct-To-Consumer Advertising--Education or Emotion Promotion? (HRG Publication #1610)
Article in NEJM
(arguing that promotional material is being touted as educational and hence is misleading.)
2
S. Wolfe,
Ben Peck and
Frank Clemente
  • (1/28/02) Comments on: The Prescription Drug User Fee Act (PDUFA) (HRG Publication #1606)
Comment (pointing out disturbing number of drug withdrawals)
3
A. Ardati
(Research Associate) & S. Wolfe.
  • (1/17/02) Letter to American Medical Association urging their support of HRG petition to the FDA to ban dietary supplements containing ephedrine alkaloids (HRG Publication #1604)
Letter to AMA (pointing out adverse effects of the drug)
4
S. Wolfe
  • (11/8/01) Letter to HHS Secretary on Pharmaceutical Research & Manufacturers of America Emergency Preparedness Task Force (HRG Publication #1600)
Letter to HHS (pointing out that HHS meetings with PhRMA are a violation of FACA)
5
B. Wolfman (Attorney),
S. Wolfe,
Peter Lurie (Deputy Director),
A. Ardati.
  • (10/15/01) Letter urging the FDA to reject drug industry's request for liability disclaimer in its withdrawal of products containing phenylpropanolamine (PPA) (HRG Publication #1596)
Letter to FDA (pointing out that the FDA does not have authority to do this, and companies should not be shielded from liability)
6
S. Wolfe
  • § (10/11/01) Statement before the National Academy of Sciences on the Framework for Evaluating the Safety of Dietary Supplements (HRG Publication #1594)
Statement
(pointing out the burden on FDA to demonstrate harm, as opposed to manufacturers)
7
S. Wolfe
  • (8/9/01) Letter to HHS that supports a criminal investigation of Schering-Plough based on the possibility that the company knowingly shipped millions of asthma drug inhalers that may not have contained any active ingredients. (HRG Publication #1586)
Letter to HHS
(pointing out the occurrence of certain deaths, which seem to be associated with the Schering Plough)
8
S. Wolfe
  • (7/27/01) Statement to the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee urging them to not approve the drug teriparatide. (HRG Publication #1585)
Statement to FDA
(pointing out that FDA data and various publications indicate that teriparatide should be not be approved)
9
S. Wolfe
  • (7/26/01) Testimony before the Food and Drug Administration Endocrine and Metabolic Drugs Advisory Committee Meeting on pramlintide (Symlin), recommending that it not be approved and that no addtional clinical trials be done (HRG Publication #1584)
Testimony before FDA
(pointing out benefits and risks of pramlintide)
10
S. Wolfe
  • (7/24/01) Testimony before the Subcommittee on Consumer Affairs Hearing, Senate Commerce Committee on Direct-to-Consumer (DTC) Advertising. (HRG Pubication #1583)
Testimony before Senate
(advocating regulation of content of ads and pointing out decreased FDA enforcement of drug advertising)
11
E. Barbehenn (Research Analyst), S. Wolfe
  • (7/21/01) Letter to the FDA concerning tegaserod (Zelnorm), for constipation-predominant irritable bowel syndrome, and Novartis' reluctance to use ultrasound monitoring for their clinical trial subjects. (HRG Publication #1582)
Letter to FDA
(pointing out that there were ovarian cyst cases in clinical trial recipients)
12
S. Wolfe
  • (6/22/01) Comments to the Food and Drug Administration on the proposed rule to revise the format of prescription drug professional product labeling (HRG Publication #1578)
Comments to FDA
(giving various suggestions for how to revise)
13
E. Barbehenn (Research Analyst),
Peter Lurie
S. Wolfe
  • (6/7/01) Letter to the Food and Drug Administration on a study stating a possible mechanism for the induction of ovarian cysts with the use of tegaserod (Zelmac) (HRG Publication #1577)
Letter to FDA
(note #11)
14
S. Wolfe,
L. Sasich
  • (5/24/01) Testimony before the Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee on a petition to relabel doxazosin (Cardura). (HRG Publication #1575)
Testimony before FDA: labeling
(proposing changes as well)
15
P. Lurie, S. Wolfe
  • (5/2/01) Letter in the Journal of the American Medical Association (JAMA) on problems with the Immune Response Corporation's HIV-1 vaccine study. (HRG Publication #1573)
Letter in JAMA
(pointing out accusations against the IRC for being accused of previous attempts to improperly influence the presentation of scientific data)
16
E. Barbehenn (Research Analyst),
Peter Lurie
S. Wolfe
  • (5/1/01) Letter to the FDA concerning the unresponsiveness of the agency's Freedom of Information Office to our requests (HRG Publication #1572)
Letter to FDA
(includes a chart which points out missing documents)
17
L. Sasich,
S. Wolfe
  • (4/18/01) Comments on the Food and Drug Adminstration's proposed rule concerning the disclosure of safety and effectiveness information about unapproved, investigational products--Human Gene Therapy(HRG Publication #1567)
Comments on FDA
(disclosure rules for gene therapy and xeno-transplantation should also apply to all other unapproved, investigational products
18
E. Barbehenn (Research Analyst),
Peter Lurie
S. Wolfe
  • (4/18/01) Letter-Regulatory by Elizabeth Barbehenn, Ph.D. Peter Lurie, M.D., M.P.H. Sidney Wolfe, M.D. Letter to the Food and Drug Adminstration concerning a memo from their Office of Post-marketing Drug Risk Assessment (OPDRA) that confirms and extends the dangers of the drug Lotronex for irritable bowel syndrome (HRG Publication #1566)
Letter to FDA
(urging FDA not to put Lotronex back on the market because of cases of ischemic colitis and severe constipation)
19
L. Sasich,
S. Wolfe
  • (3/26/01) Comments by Larry Sasich, Pharm. D., M.P.H. Sidney Wolfe, M.D. Comments on the Food and Drug Administration's decision to amend regulations regarding public disclosure of information distributed to advisory committee members for their review and consideration (HRG Publication #1562)
Comments to FDA
(giving reasons for why FDA should not withhold information until 24 prior to meeting)
20
E. Barbehenn (Research Analyst),
Peter Lurie
S. Wolfe
  • (3/22/01) Letter/Comments-Regulatory by Elizabeth Barbehenn, Ph.D. Peter Lurie, M.D., M.P.H. Sidney Wolfe, M.D. Letter to the Food and Drug Administration urging that it not approve tegaserod (Zelmac) because of its highly questionable efficacy and its potential to cause ovarian cysts (HRG Publication #1561)
Letter to FDA: drug approval
(citing various papers and also criteria for safety and efficacy)
21
S. Wolfe
  • (3/20/01) Testimony-Congressional by Sidney Wolfe, M.D. Testimony before the House of Representatives Committee on Government Reform Hearing on Dietary Supplements.
Testimony to Congress
(pointing out adverse reactions to dietary supplements)
22
L. Sasich,
S. Wolfe
  • (3/1/01) Letter by Larry Sasich, Pharm. D., M.P.H. Sidney Wolfe, M.D. Request to Deparatment of Health and Human Services to investigate charges against Schering-Plough for possibly knowingly shipping millions of asthma drug inhalers that may not have contained any active ingredient
Letter to HHS
(see also #7; pointing out defective drug inhalers)
23
P. Lurie, S. Wolfe
  • (2/22/01) Request by Peter Lurie, M.D., M.P.H Sidney Wolfe, M.D. Request to the Department of Health and Human Services to halt plans for unethical placebo-controlled study of drug for respiratory distress syndrome in Latin America unless it is redesigned to treat all patients
Letter to HHS
(pointing out alternatives to placebo and unethical nature of placebo trial for infants)
24
S. Wolfe, L. Sasich
  • (1/7/01) Testimony-Regulatory by Sidney Wolfe, M.D. Larry Sasich, Pharm.D., M.P.H. Testimony before the FDA Arthritis Drugs Advisory Committee on the Nonsteroidal Anti-Inflammatory Drugs Celecoxib and Rofecoxib
Testimony to FDA
(pointing out risks and benefits of these drugs)
25
E. Barbehenn (Research Analyst),
Peter Lurie
S. Wolfe
  • (12/9/00) Letters-Science by Elizabeth Barbehenn, Ph.D. Peter Lurie, M.D., M.P.H. Sidney Wolfe, M.D. Letter in Lancet on Alosetron for irritable bowel syndrome showing data manipulation in a company-sponsored clinical trial.
Letter in Lancet
(pointing out possible data manipulation; see also #11 and 18)
26
L. Sasich, S. Wolfe
  • (11/22/00) Letter by Larry Sasich, Pharm. D., M.P.H. Sidney Wolfe, M.D. Letter to the National Institute for Clinical Excellence urging it to reconsider recommendations concerning Relenza use among people in the United Kingdom.
Letter to NICE
(pointing out adverse effects of Relenza)
27
S. Wolfe,
E. Barbehenn,
L. Sasich
  • (10/30/00) Letter-Regulatory by Sidney Wolfe, M.D. Elizabeth Barbehenn, Ph.D. Larry Sasich, Pharm.D., M.P.H. Letter to the Food and Drug Administration updating the number of cases of ischemic coliitis reported in our 8/31/00 petition.
Letter to FDA
(pointing out more cases of colitis; see also #11,18, 25)
28
S. Wolfe
  • (10/19/00) Petition by Sidney Wolfe, M.D. Petition to the Food and Drug Administration requesting an immediate ban of all uses of Phenylpropanolamine (PPA) in over-the-counter products.
Petition to FDA
(pointing out adverse effects of PPA; see also #5)
29
S. Wolfe
  • (10/19/00) Testimony-Regulatory by Sidney Wolfe, M.D. Testimony before the Food and Drug Administration NonPrescription Drugs Advisory Committee Meeting on Safety Issues of Phenylpropanolamine/PPA.
Testimony before FDA
(pointing out adverse effects of PPA; see also #5, 28)
30
L. Sasich
  • (9/15/00) Comments-Regulatory by Larry Sasich, Pharm. D., M.P.H. Comments before the Food and Drug Administration's Public Meeting on the Prescription Drug User Fee Act (PDUFA).
Comments to FDA at meeting
(pointing out problems with PDUFA; see also #2)
31
E. Barbehenn,
P. Lurie,
L. Sasich,
S. Wolfe
  • (8/31/00) Petition by Elizabeth Barbehenn, Ph.D. Peter Lurie, M.D., M.P.H. Larry Sasich, Pharm.D., M.P.H. Petition to the Food and Drug Administration to remove Lotronex from the market.
Petition to FDA
(discussing safety, efficacy, See also #11, 18, 25)
32
E. Barbehenn,
P. Lurie,
L. Sasich,
S. Wolfe
  • (7/15/00) Letters-Science by Sidney Wolfe, M.D. Peter Lurie, M.D., M.P.H. Larry Sasich, Pharm.D., M.P.H. Letter sent to the Lancet on availability of information on thiazolidinediones.
Letter to Lancet (pointing out that a review of the safety of a drug is flawed, because it relied primarily on studied done by drug companies instead of public sources, which are less biased)
33
S. Wolfe
  • § (7/13/00) Testimony-Regulatory by Sidney Wolfe, M.D. Testimony before the Food and Drug Administration's Endocrinologic/Metabolic and Non-Prescription Advisory Committee on prescription to over-the-counter switch.
Testimony to FDA
(discussing risk assessment and risk/benefit analysis for cholesterol test)
34
S. Wolfe
  • (6/28/00) Comments-Regulatory by Sidney Wolfe, M.D. Comments at a Food and Drug Administration hearing on switching drugs from prescription to over-the- counter.
Comment at FDA hearing
(presenting seven principles which should be considered in switching, including a risk/benefit ratio; specific concerns about cholesterol drugs; see also #33)
35
E. Barbehenn,
S. Wolfe
  • (6/5/00) Letters/Comments:Regulatory by Sidney Wolfe, M.D. Elizabeth Barbehenn, Ph.D. Letter to Center for Drug Evaluation and Research urging the Food and Drug Administration (FDA) to reject the approval of Uprima.
Letter to FDA
(pointing out adverse effects to drug and problems with trials)
36
S. Wolfe
  • (4/24/00) Comments-Regulatory by Sidney Wolfe, M.D. Comments on the Department of Health and Human Services' Inspector General’s Study of Adverse Event Reporting for Dietary Supplements.
Comments to HHS
(pointing out concerns with FDA’s adverse reaction reporting system for dietary supplements, pointing out ephedrine/PPA concern; see also #3)
37
P. Lurie,
L. Sasich,
S. Wolfe
  • (4/13/00) Report by Larry Sasich, Pharm. D., M.P.H. Peter Lurie, M.D., M.P.H. Sidney Wolfe, M.D. Study of the drug industry's performance in finishing required postmarketing research (Phase IV) studies.
Report to FDA
(reporting on a “meta-study” that the authors did, based on data from FDA, showing that drug companies are failing to fulfill Phase 4 trial commitments)
38
E. Barbehenn,
P. Lurie,
L. Sasich,
S. Wolfe
  • (4/11/00) Letters/Comments:Regulatory by Sidney Wolfe, M.D. Elizabeth Barbehenn, Ph.D. Larry Sasich, Pharm.D., M.P.H. Letter to the Food and Drug Administration/FDA asking for the immediate withdrawal of Propulsid from the market.
Letter to FDA
(requesting withdrawal of drug from market based on reported deaths)
39
S. Wolfe
  • (3/30/00) Testimony-Regulatory by Sidney Wolfe, M.D. Testimony regarding the Food and Drug Administration categorization of "morning sickness" and "leg edema" during pregnancy as conditions not diseases which allows dietary supplement manufacturers to promote for these symptoms
Testimony regarding FDA
(pointing out that pregnancy discomfort are not “diseases”, and should not be advertised as such)
40
S. Wolfe
  • (3/22/00) Letters/Comments-Regulatory by Sidney Wolfe, M.D. Letter to the Department of Health and Human Services urging that they implement and enforce the Code of Ethics for Government Service with regards to Food and Drug Administration scientists.
Letter to HHS
(urging enforcement of the code in part because of the “repressive atmosphere” at FDA)
41
S. Wolfe
  • (3/14/00) Letters/Comments:Regulatory by Sidney Wolfe, M.D. Letter to the Food and Drug Administration requesting a criminal investigation of Warner Lambert/Parke Davis for what appears to be illegally delaying the submission of data known to the company before troglitazone was marketed. (HRG Publication #1515)
Letter to FDA
(pointing out delay of liver toxicity data under after the drug had been marketed)
42
S. Wolfe,
P. Lurie
E. Barbehenn
  • (3/7/00) Petition by Sidney Wolfe, M.D. Peter Lurie, M.D., M.P.H. Elizabeth Barbehenn, Ph.D. Petition to the Food and Drug Administration requesting that it immediately require labeling for the diabetes drugs troglitazone (Rezulin), rosiglitazone (Avandia)
Petition to FDA
(pointing out the dangerous effects of Rezulin, presenting their data review, efficacy concerns, toxicity, etc.)
43
S. Wolfe
L. Sasich
  • (3/2/00) Letters/Comments:Regulatory by Sidney Wolfe, M.D. Larry Sasich, Pharm.D., M.P.H. Letter to the Food and Drug Administration concerning the United Kingdom's Committee on Safety of Medicine's recent warning about potentially serious drug interactions between St. John's Wort and a large number of other drugs.
Letter to FDA
(pointing out the British studies and urging that the FDA not only change labeling, but require that they send out warnings to physicians)
44
L. Sasich,
S. Wolfe
  • (2/29/00) Letters/Comments-Regulatory by Larry Sasich, Pharm. D., M.P.H. Sidney Wolfe, M.D. Comments on a Food and Drug Administration survey on the status of useful written prescription drug information for patients, requesting that it be redesigned.
Comments on FDA
(pointing out shortcomings of FDA survey design and presenting the results of their own informal survey)
45
S. Wolfe,
G. Oakley (Visiting Professor of Epidemiology)
  • (2/3/00) Letters/Comments:Regulatory by Sidney Wolfe, M.D. Letter to the Food and Drug Administration regarding their final regulations on dietary supplements and their definition of adverse effects of pregnancy.
Letter to FDA
(urging FDA not to allow dietary supplement manufacturers to categorize pregnancy discomforts as “diseases”; see also #39)
46
P. Lurie,
S. Wolfe
  • (8/9/99) Editorial-Lay Press by Sidney Wolfe, M.D. Opinion appearing in USA Today concerning the promotion of off-label uses of drugs.
Letter to Medical Journal of Australia
(arguing that placebo-controlled trials for Zidovudine in Asia and Africa were not “quicker” and did not same more lives than active controlled trials)
47
J. Sharfstein (Fellow in General Pediatrics, Boston Medical Center),
S. Wolfe
  • (8/3/99) Letters/Comments:Regulatory by Joshua Sharfstein, M.D. Sidney Wolfe, M.D. Letter to the Department of Heath and Human Services concerning Pfizer's campaign to counter the Centers for Disease Control recommendations for treatment of ear infections.
Letter to HHS
(asserting that Pfizer has launched a campaign to convince doctors to ignore CDC’s recommendations
48
S. Wolfe,
L. Sasich
E. Barbehenn
  • (6/3/99) Letters/Comments:Regulatory by Sidney Wolfe, M.D. Larry Sasich, Pharm.D., M.P.H. Elizabeth Barbehenn, Ph.D. Letter to the Food and Drug Administration to immediately ban the antibiotic trovafloxacin (Trovan).
Letter to FDA
(arguing that Trovan is a drug with “no unique benefits and unquestionably unique life-threatening risks”)
49
L. Sasich,
S. Wolfe
  • (6/1/99) Letters-Lay by Larry Sasich, Pharm. D., M.P.H. Sidney Wolfe, M.D. Letter to the Editor in the Washington Post concerning dangerous drug information found on their web site entitled InteliHealth which is associated with Johns Hopkins University.
Letter (Lay) to Washington Post
(pointing out errors on their website regarding various drugs)
50
S. Wolfe
  • (5/11/99) Statement by Sidney Wolfe, M.D. Statement about a Food and Drug Adminstration article in the Journal of the American Medical Association regarding recently withdrawn drugs and the safety of newly approved drugs.
Statement about FDA
(pointing out that FDA article failed to point out various dangers/risks of drugs mentioned in the article, which were approved by the FDA)
51
E. Barbehenn,
L. Sasich,
C. Pearson,
S. Wolfe
  • (4/4/99) Petition by Elizabeth Barbehenn, Ph.D. Larry Sasich, Pharm.D., M.P.H. Sidney Wolfe, M.D. Citizen's petition with the National Women's Health Network to the Food and Drug Administration to change the labeling on tamoxifen (Nolvadex).
Petition to FDA
(pointing out that tamoxifen is a carcinogen and hence the label should reflect this; indicate risk/benefit)
52
P. Lurie,
S. Wolfe
  • (3/29/99) Letters/Comments-Other by Peter Lurie, M.D., MPH Sidney Wolfe, M.D. Letter to the World Medical Association expressing alarm at athe current Draft Revised Version of the Declaration of Helsinki.
Letter to World Medical Association
(arguing that revisions to the Declaration are intended to accommodate HIV transmission trial researchers who are unwilling to be ethical)
53
S. Wolfe
  • (3/26/99) Letters/Comments-Regulatory by Sidney Wolfe, M.D. Statement before the Food and Drug Administration Endocrine and Metabolic Drugs Advisory Committee meeting advising them to withdraw troglitazone from the U.S. Market.
Statement before the FDA
(urging withdrawal of diabetes drug, because of adcerse (toxic) effects; see also #41)
54
L. Sasich,
S. Wolfe
  • (3/23/99) Letters/Comments-Regulatory by Larry Sasich, Pharm. D., M.P.H. Sidney Wolfe, M.D. Comments to the Food and Drug Administration on their List of bulk drug substances that may be used in pharmacy compounding.
Comments to FDA
(describing the efficacy and side effects of 29 nominated bulk drug substances, many of which have not been tested for safety, and urging that consumer be told that the drugs that they are receiving have not been tested for safety)
55
S. Wolfe
  • (2/10/99) Letters/Comments:Regulatory by Sidney Wolfe, M.D. Letter and documents sent to the Food and Drug Administration urging them to immediately recall all lots of Abbokinase because of possible contamination with infectious agents.
Letter to FDA
(reporting that his interviews with FDA officials show that the precursor to a clot-busting drug has been possibly contaminated, derived from kidneys of aborted fetuses)
56
S. Wolfe
  • (1/28/99) Letters/Comments-Regulatory by Sidney Wolfe, M.D. Larry Sasich, Pharm.D., M.PH Statement before the Food and Drug Administration's Cardiovascular and Renal Drugs advisory committee urging that they not approve dofetilide (Tikosyn) to prevent recurrent arrythmias
Statement before FDA
(pointing out that they have been denied access to information about the safety and efficacy of dofetilide and that published literature reflect doubt of both)
57
P. Lurie,
S. Wolfe
  • (1/15/99) Letters/Comments-Other by Peter Lurie, M.D., MPH Sidney Wolfe, M.D. Letter to United Nations Program on HIV/AIDS commenting on their Guidance Document on ethical considerations in international trials of HIV vaccines.
Letter to UN Program on HIV/AIDS
(arguing that the Guidance document needs more in terms of increased human subjects protection; discusses historical context; see also #52)
58
L. Sasich,
S. Wolfe
  • (1/6/99) Letters/Comments:Regulatory by Larry Sasich, Pharm. D., M.P.H. Sidney Wolfe, M.D. Letter to the Food and Drug Administration regarding an ad for troglitazone (Rezulin) in a Hispanic publication, El Tiempo Latino, where the benefits are in Spanish and the warnings and risks in English
Letter to FDA
(pointing out the seriousness of the risks associated with Rezulin and the unacceptability of not having these risks in Spanish)
59
S. Wolfe,
L. Sasich,
E. Barbehenn
  • (12/30/98) Letters/Comments:Regulatory by Sidney Wolfe, M.D. Larry Sasich, Pharm.D., MPH Elizabeth Barbehenn, Ph.D. Letter to the Food and Drug Administration concerning a study in the New England Journal of Medicine amplifying our concerns about the safety of cilostazol
Letter to FDA
(pointing out a NEJM study which reports an increased death rate associated with a drug HRG had urged the FDA to pull)
60
P. Lurie,
S. Wolfe
  • (12/30/98) Editorial by Peter Lurie, M.D., M.P.H. Sidney Wolfe, M.D. OPED in the Washington Post entitled Troubling Climate at the FDA which discusses medical officer's opinions of the drug approval process.
Opinion in the Washington Post
(reports the results of HRG informal survey of 53 medical officers who were dissatisfied with the drug approval process)
61
S. Wolfe
  • (12/9/98) Letters/Comments-Regulatory by Sidney Wolfe, M.D. Statement before the Food and Drug Administration before the Food and Drug Administration's Science Forum on Biotechnology regarding threats to safe and effective regulation of products.
Statement before FDA
(emphasizes the importance of research to make safe and effective regulations)
62
S. Wolfe,
L Sasich
  • (12/1/98) Letters/Comments-Regulatory by Sidney Wolfe, M.D. Larry Sasich, Pharm.D., M.P.H. Statement before the Food and Drug Administration's Arthritis Drugs advisory committee on the nonsteroidal anti-inflammatory drug celexocib.
Statement before FDA
(points out that the drug at hand is as effective as other existing drugs, but has a gastrointestinal safety profile similar to placebo; also discusses drug companies misrepresentative portrayal)
63
P. Lurie
S. Wolfe
  • (11/1/98) FDA Medical Officers Survey: Medical Officers Report Lower Standards Permit Dangerous Drug Approvals.
Report
(informal survey that was used in the letter from #60 to point out that lower standards are being permitted for drug approval)
64
S. Wolfe,
L. Sasich,
E. Barbehenn
  • (10/29/98) Press Release by Sidney Wolfe, M.D. Larry Sasich, Pharm.D., MPH Elizabeth Barbehenn, Ph.D. Press Release Concerning FDA’s Approval of Tamoxifen to Reduce incidence of breast cancer in healthy women puts women at risk.
Press release
(pointing out likelihood of increase of risk to disease due to taking tamoxifen; see also #51)
65
L. Sasich,
S. Wolfe
  • (9/16/98) Letters/Comments-Regulatory by Larry Sasich, Pharm. D., M.P.H. Sidney Wolfe, M.D. HRG Comments on Section 406(B) of the FDA MODERNIZATION ACT OF 1997.
Comments
(arguing that the new act goes against protecting consumers and that what needs to be done is to fix the defective drug approval process and the postmarketing safety system)
66
S. Wolfe,
L. Sasich
  • (8/27/98) Letters/Comments-Other by Sidney Wolfe, M.D. Larry Sasich, Pharm.D., M.P.H. Letter to the Medicines Control Agency, United Kingdom, urging them to require important warnings on labeling of sildenafil/Viagra.
Letter to the Medicines Control Agency in UK
(urging UK to include warnings about adverse effects of Viagra, which have been omitted on American labels)
67
S. Wolfe,
L. Sasich,
J. Lexchin
  • (8/25/98) Letters/Comments: Regulatory by Sidney Wolfe, M.D. Letter to the Food and Drug Administration supporting Dr. Robert Misbin concerning a letter he had written to the Washington Post criticizing FDA policies.
Letter to FDA
(supporting an FDA medical officer’s criticism of FDA’s inappropriate use of placebos; see also #60, 63)
68
S. Wolfe,
L. Sasich,
J. Lexchin (The Toronto Hospital)
  • (8/24/98) Letters/Comments-Other by Sidney Wolfe, M.D. Larry Sasich, Pharm.D., M.P.H. Letter to the Therapeutic Products Program in Canada urging them to require important warnings on the labeling of sildenafil/Viagra.
Letter to Canada
(urging Canada to include warnings about adverse effects of Viagra, which have been omitted on American labels ; see also #66)
69
S. Wolfe,
L. Sasich,
E. Barnehenn
  • (8/20/98) Letters/Comments-Regulatory by Sidney Wolfe, M.D. Larry Sasich, Pharm.D., M.P.H. Elizabeth Barbehenn, Ph.D. Letter to the Food and Drug Administration urging them to immediately convene an advisory committee to review various serious problems related to the use of sildenafil (Viagra).
Letter to FDA
(urging a meeting on Viagra of its cardiovascular advisory committee, because of possible cardio side effects; see also #66, 68)
70
P. Lurie,
S. Wolfe,
Ben Bagdikian (Former Assisting Managing Editor for National News)
  • (7/29/98) Letter by Peter Lurie, M.D., M.P.H. Sidney Wolfe, M.D. Letter to USA Today, demanding action against all USA Today employees responsible for the Glaxo Wellcome Special Editionof the paper distributed at an AIDS conference and promoting Glaxo Wellcome.
Letter to USA Today
(pointing out that, at a conference, 7000 people received a “special edition” of USA Today, which looked like a regular issue, but it was actually an ad)
71
S. Wolfe,
L. Sasich
  • (7/27/98) Petition by Sidney Wolfe, M.D. Larry Sasich, Pharm.D., M.P.H. Petition to the Food and Drug Administration to ban troglitazone/Rezulin due to its causing several cases of liver failure.
Petition to FDA
(pointing out adverse effects of Rezulin; see also #42, 58)
72
L. Sasich,
S. Wolfe
  • (7/23/98) Letters/Comments-Regulatory by Larry Sasich, Pharm. D., M.P.H. Sidney Wolfe, M.D. Comments on Food and Drug Administration proposed regulation on dissemination of information on unapproved/new uses for marketed drugs, biologics and devices.
Comment on FDA
(pointing out possible public access issues and arguing that off-label prescribing has devastating consequences)
73
L. Sasich,
E. Fuller Torrey,
S. Wolfe
  • (7/15/98) Report by Larry Sasich, Pharm. D., M.P.H. E. Fuller Torrey, MD Sidney Wolfe, M.D. Report on the International Comparison of Prices of Antidepressant and Antipsychotic Drugs.
Report
(finding that acquisition cost of drugs in the US was higher than in any other country in N. America or Europe)
74
S. Wolfe,
L Sasich
  • (7/1/98) Petition by Sidney Wolfe, M.D. Larry Sasich, Pharm.D., MPH Elizabeth Barbehenn, Ph.D. Petition to the Food and Drug Administration to change the labeling and other sources of information on sildenafil/Viagra to reflect problems with the drug.
Petition to FDA
(pointing out that men with diseases which would have excluded them from pre-approval experiments but who are not excluded from Viagra use now; see also #66, 68, 69)
75
L. Sasich,
S. Wolfe,
A. Zieve (attorney, Litigation Group of Public Citizen),
P. & B. Christen (parents of a child who died from drug-induced arrhythmia)
  • (6/9/98) Petition by Sidney Wolfe, M.D. Larry Sasich, Pharm.D., M.P.H. Allison Zieve, J.D. Petition to the Food and Drug Administration to immediately stop the distribution of dangerous, misleading prescription drug information to the public.
Petition to FDA
(pointing out that, as a reulst of unregulated, misleading, commercially produced written patient drug information, a child and many others have died; petition to recall or seize unregulated information that is being distributed with prescription drugs that is not consistent with drug’s FDA approval)
76
L. Sasich,
S. Wolfe
  • (6/8/98) Statement by Larry Sasich, Pharm. D., MPH Sidney Wolfe, M.D. Statement on the withdrawal of mibefradil/Posicor from the market.
Statement
(pointing out that the drug has no special benefit, but has problems which pose an unreasonable risk to consumers)
77
S. Wolfe
  • (5/28/98) Statement by Sidney Wolfe, M.D. Statement concerning a report by the Center for Science in the Public Interest on threats to antibiotic effectiveness.
Statement
(arguing that misleading advertising is resulting in dangerous prescribing of antibiotics, which could lead to resistance
78
S. Wolfe
  • (11/13/97) Statement by Sidney Wolfe, M.D. Response to the Institute of Medicine's Report on Halcion.
Statement on IOM
(arguing that Halcion is more dangerous than the IOM study impies and pointing out that the UK banned the drug)
79
L. Sasich,
S. Wolfe
  • (10/14/97) Letters/Comments-Regulatory by Larry Sasich, Pharm. D., M.P.H. Sidney Wolfe, M.D. Comments on Food and Drug Administration's Draft Guidance for Industry on direct to consumer advertising.
Comments on FDA
(arguing that the current regulations on direct to consumer advertising do not protect consumers sufficiently and are misleading)
80
L. Sasich,
S. Wolfe
  • (8/21/97) Statement by Larry Sasich, Pharm. D., M.P.H. Sidney Wolfe, M.D. Statement on misleading direct-to-consumer advertising by Schering for loratadine (Claritin).
Comments
(pointing out that a drug company violated DTC TV advertising regulations only 11 days after they were passed)
81
S. Wolfe
  • (8/13/97) Press Release by Sidney Wolfe, M.D. Press release challenging the Clinton Administration for announcing new testing requirements for children's medications but allowing off-label prescribing to children.
Press Release
(pointing out that requiring safety and efficacy for children does not protect children from off-label use problems)
82
L. Sasich,
S. Wolfe
  • (8/11/97) Letters/Comments-Regulatory by Larry Sasich, Pharm. D., M.P.H. Sidney Wolfe, M.D. Comments supporting the Drug Enforcement Administration's proposed placement of butorphanol (Stadol and Stadol Nasal Spray) into Schedule IV.
Comments
(pointing out that this new classification will allow consumers to consider its potential addicting properties as a controlled substance, although this comes too late for those already addicted)
83
R. Nader,
S. Wolfe
  • (7/28/97) Letters/Comments: Congressional by Ralph Nader Sidney Wolfe, M.D. Letter to Senators urging them not to vote for S.830 since it would roll back Food and Drug Administration protections.
Letter to senators
(makes assertions for what would happen if S.830 was signed into law)
84
S. Wolfe
  • (7/17/97) Letters/Comments: Congressional by Sidney Wolfe, M.D. Letter to Senators urging then to vote agains an amendment to S.830 which would make it legal for companies to promote drugs and medical devices for unapproved uses.
Letter to senators
(makes assertions for what would happen if S.830 was signed into law; see also #83)
85
S. Wolfe
  • (4/11/97) Testimony-Congressional by Sidney Wolfe, M.D. Testimony before the Senate Labor and Human Resources Committee on the Food and Drug Administration performance, efficiency and use of resources.
Testimony before Senate
(answers questions on PDUFA, FDA resources and regulatory power)

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

No.
Publication
1
  • (7/19/01) Report submitted to the Department of Agriculture which discusses the lack of systematic sampling of cow brains for Mad Cow Diseae in the U.S. (HRG Publication #1581)
  • 2
  • § (4/4/01) Testimony before the Consumer Affairs, Foreign Commerce and Tourism Subcommittee concerning Bovine Spongiform Encephalopathy (BSE), otherwise known as "Mad Cow Disease" (HRG Publication #1563)
  • 3
  • § (7/6/92) Letter - HRG Letter to Linda Carey, U.S. Department of Agriculture, opposing DOCKET NUMBER 90-011P, allowing radiation of poultry products.
  • 4
  • § (11/15/90) Statement – Statement before the National Academy of Sciences Commettee on evaluation of USDA streamlined inspection system for cattle.
  • 5
  • § (1/30/90) Statement – Statement by Public Citizen concerning the proposed ban on RED DYE #3. affects only provisionally listed uses of the dye.
  • 6
  • § (8/19/87) Transcript/Speech – Transcript of the MACNEIL LEHRER NEWS HOUR which focused on health hype labeling on supermarket food products.
  • 7
  • § (3/30/87) Comments – On FDA’s proposed rule regarding labeling of cholesterol and fatty acids in food..
  • 8
  • § (2/28/86) Comments – Object to FDA’s proposal to formalize a new interpretation of the DES PROVISO that would allo the presence of carcinogenic residues in food.
  • 9
  • § (2/1/86) Report – The other side of the irradiation story.
  • 10
  • § (1/21/86) Comments – On USDA’s notice of intent to initiate proposed rulemaking regarding requirements for DEFATTE SCRAP TISSUE used in processed meat products.
  • 11
  • § (8/15/85) Comments – On HHS REPORT of color additive scientific review panel on carcinogens in food, drug and cosmetic dyes.
  • 12
  • § (7/12/85) Transcript/Speech – The Macneil/Lehrer New Hour: HOUR: PRESSURING PRETORIA COMDEN AND GREEN: MUSIC MAKERS DANGEROUS DYES
  • 13
  • § (2/22/85) Lawsuit/Legal Dcmts – Lawsuit against HHS seeking an order which would ban ten widely-used color additives.


[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 .

[58] “Publication” refers to the following materials: (1) petitions to all federal government agencies, (2) request letters to various federal government agencies, foreign government organizations, and other organizations, (3) letters to various scientific journals, (4) letters to various newspapers, (5) testimonies before various federal government agencies (primarily the FDA) as well as Congress, (6) commentaries before various federal agencies, independent commentaries, (7) studies done by the Health Research Group, and (8) general press releases.

[59] See e-Letter on Drugs for Serious Psychiatric Illnesses, at (last visited February 13, 2002) http://www.citizen.org/eletter/aboutus.htm.

[60] See, e.g., SIDNEY M. WOLFE, CHRISTOPHER M. COLEY, AND THE HEALTH RESEARCH GROUP , PILLS THAT DON’T WORK: A CONSUMERS' AND DOCTORS' GUIDE TO OVER 600 PRESCRIPTION DRUGS THAT LACK EVIDENCE OF EFFECTIVENESS (New York: Farrar, Straus & Giroux, 1981); JOEL KAUFMAN, LINDA RABINOWITZ-DAGI, JOAN LEVIN, PHYLLIS MCCARTHY, SIDNEY WOLFE, EVE BARGMANN, AND THE PUBLIC CITIZEN HEALTH RESEARCH GROUP, OVER-THE-COUNTER PILLS THAT DON’T WORK ( New York: Pantheon Books, 1983). SIDNEY WOLFE, LARRY SASICH, ROSE-ELLEN HOPE, AND THE PUBLIC CITIZEN HEALTH RESEARCH GROUP, WORST PILLS, BEST PILLS: A CONSUMER’S GUIDE TO AVOIDING DRUG-INDUCED DEATH OR ILLNESS (New York: Pocket Books, 1999). See Sidney Wolfe, Medical Monitors: Public Health Advocacy Exposes Threats, Educates Consumers, 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/publichealth.pdf.

[61] See, e.g., Sidney Wolfe, Petition to the Food and Drug Administration requesting an immediate ban of all uses of Phenylpropanolamine (PPA) in over-the-counter products. (10/19/00, Health Research Group Publication # 1542).

[62] See, e.g., Sidney Wolfe & Larry Sasich, Letter to the Medicines Control Agency, United Kingdom, urging them to require important warnings on labeling of sildenafil/Viagra. (08/27/98, Health Research Group Publication # 1454).

[63] See, e.g., Larry Sasich & Sidney Wolfe, Comments on a Food and Drug Administration survey on the status of useful written prescription drug information for patients, requesting that it be redesigned. (02/29/00, Health Research Group Publication # 1512).

[64] See, e.g., Sidney Wolfe,Press release challenging the Clinton Administration for announcing new testing requirements for children's medications but allowing off-label prescribing to children. (08/13/97, Health Research Group #1423).

[65] Since 1995, Wolfe has served as an Adjunct Professor of Internal Medicine at the Case Western Reserve University School of Medicine.

[66] Wolfe received his MacArthur Fellowship in recognition of his work in the field of public health. Since the inception of the MacArthur Fellows Program in 1978, there have been, in addition to Wolfe, a total of nine other recipients of the fellowship who were recognized for their contributions to the field of public health: Byllye Avery, Mark Harrington, Eva Harris, Donald Hopkins, Michael Lerner, Aaron Shirley, Ellen Kovner Silbergeld, Wilma Subra and David Werner. Most recipients engaged in some kind of health care activism work, whether it is local (e.g., chairman of a local health services center), national (head of an AIDS activist organization) or international (physician/activist organizing a project in Guinea). See Complete List of MacArthur Fellows, at (last visited January 15, 2002) http://www.macfound.org/ programs/fel/complete_list_5.htm.

[67] See Sidney Wolfe, Medical Monitors: Public Health Advocacy Exposes Threats, Educates Consumers, 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/publichealth.pdf.

[68] See id .

[69] See E. Barbehenn & Sidney Wolfe, Letter to the FDA concerning tegaserod (Zelnorm), for constipation-predominant irritable bowel syndrome, and Novartis' reluctance to use ultrasound monitoring for their clinical trial subjects. (7/21/01, Health Research Group Publication #1582).

[70] See Elizabeth Barbehenn, Peter Lurie & Sidney Wolfe, Letter to the Food and Drug Administration on a study stating a possible mechanism for the induction of ovarian cysts with the use of tegaserod (Zelmac) ((6/7/01, Health Research Group Publication #1577).

[71] See Peter Lurie and Sidney Wolfe, FDA Medical Officers’ Survey: FDA Medical Offers Report Lower Standards Permit Dangerous Drug Approvals (11/01/98). See also Larry Sasich and Sidney Wolfe, Comments on a Food and Drug Administration survey on the status of useful written prescription drug information for patients, requesting that it be redesigned (2/29/00, Health Research Group Publication # 1512) (referring to its informal survey on patient information leaflets being distributed for ibuprofen, which found that various information was not being included in the leaflets).

[72] See Peter Lurie and Sidney Wolfe, OPED in the Washington Post entitled Troubling Climate at the FDA which discusses medical officers’ opinions of the drug approval process (12/30/98, Health Research Group Publication # 1469).

[73] See Sidney Wolfe, Testimony before the House of Representatives Committee on Government Reform Hearing on Dietary Supplements (03/20/01, Health Research Group Publication # 1560) (including a five-page appendix from “Best Pills, Worst Pills,” which describes cases of adverse reactions to various dietary supplements).

[74] See, e.g., Sidney Wolfe, Ben Peck & Frank Clemente Comments on the Prescription Drug User Fee Act (PDUFA) (01/28/02, Health Research Group Publication #1606).

[75] See Sidney Wolfe & Larry Sasich,, Testimony before the FDA Arthritis Drugs Advisory Committee on the Nonsteroidal Anti-Inflammatory Drugs Celecoxib and Rofecoxib (02/08/02, Health Research Group Publication # 1555).

[76] See Sidney Wolfe, Testimony before the Food and Drug Administration Endocrine and Metabolic Drugs Advisory Committee Meeting on pramlintide (Symlin), recommending that it not be approved and that no additional clinical trials be done (07/26/01, Health Research Group Publication #1584).

[77] Sidney Wolfe, Larry Sasich, and Elizabeth Barbehenn, Letter to the Food and Drug Administration to immediately ban the antibiotic trovafloxacin (Trovan). (06/03/99, Health Research Group #1485) (emphasis added).

[78] See also Larry Sasich & Sidney Wolfe, Statement on the withdrawal of mibefradil/Posicor from the market. (06/08/98, Health Research Group Publication #1441) (arguing that Posicor should be withdrawn from the market, because it has not been shown to offer “special benefit” and has been shown to present an “unreasonable risk.”).

[79] See, e.g., Sidney Wolfe.& Larry Sasich, Letter to the Therapeutic Products Program in Canada urging them to require important warnings on the labeling of sildenafil/Viagra , supra note 75.

[80] See, e.g., (7/28/97) Ralph Nader and Sidney Wolfe, Letter to Senators urging them not to vote for S.830 since it would roll back Food and Drug Administration protections (07/28/97, Health Research Group Publication # 1421).

[81] See Sidney Wolfe & Larry Sasich, Letter to the Medicines Control Agency, United Kingdom, urging them to require important warnings on labeling of sildenafil/Viagra. (8/27/98, Health Research Group Publication #1454); Larry Sasich & Sidney Wolfe, Letter to the National Institute for Clinical Excellence urging it to reconsider recommendations concerning Relenza use among people in the United Kingdom .(11/22/00, Health Research Group Publication # 1547); Letter to the Food and Drug Administration concerning the United Kingdom's Committee on Safety of Medicine's recent warning about potentially serious drug interactions between St. John's Wort and a large number of other drugs. (03/02/00; Health Research Group Publication # 1513).

[82] See Sidney Wolfe.& Larry Sasich,. Letter to the Therapeutic Products Program in Canada urging them to require important warnings on the labeling of sildenafil/Viagra (8/24/98, Health Research Group # 1452).

[83] See Sidney Wolfe & Larry Sasich, Letter to the Medicines Control Agency, United Kingdom, supra note 74. See also Sidney Wolfe.& Larry Sasich, Letter to the Therapeutic Products Program in Canada, supra note 75.

[84] See Sidney Wolfe, Larry Sasich & Elizabeth Barbehenn, Letter to the Food and Drug Administration urging them to immediately convene an advisory committee to review various serious problems related to the use of sildenafil (Viagra) (8/20/98, Health Research Group Publication # #1451).