This study of the process resulting in the Food and Drug Administration's ban of the diet drug fen-phen following the whistle-blowing of MeritCare, a regional health system in Forgo, North Dakota, expands the concept of whistle-blowing to include external stakeholders who publicly expose problems or errors. The investigation evaluates the conditions surrounding the health system's decision to make public the technician's findings; its whistle-blowing procedures, retaliation fears, perceived need for enhanced credibility, and commitment to an ethic of significant choice are chronicled. The authors conclude that external stakeholders may enact many of the processes found in employee whistle-blowing and that consumer protection appears to be an important value in controversial whistle-blowing decisions. The authors also suggest that traditional notions of whistle-blowing are too narrow.
Keywords: whistle-blowing; ethics; health communication; crisis; credibility
Organizations often face information that exposes problems or wrongdoing or represents dissent. Messages signaling problems or wrongdoing frequently come from internal sources such as employees or from related agencies and organizations aware of problems or wrongdoing. When the organization refuses to take appropriate action in response to these messages, insiders or outsiders may call broader attention to the issue by blowing the whistle. The communicative process of blowing the whistle is critical for organizations and societies seeking to monitor areas of emerging risk that are threatening to an organization's established routines and assumptions (Jensen, 1987; Miceli & Near, 1992; Redding, 1985; Seeger 1997).
The objective of the analysis presented in this article is to examine the public disclosure of serious side effects associated with the combined use of fenfluramine and phentermine, also known as fen-phen, a prescription weight loss drug cocktail produced and actively promoted by Robins Pharmaceuticals and Wyeth-Ayerst, both divisions of American Home Products. In the 1990s, fen-phen was widely prescribed, with as many as 18 million prescriptions written in 1996 alone (Pitts, Crosby, Laufenberg, Meidinger, & Monson, 1998). Although the two drugs had never been approved by the Food and Drug Administration (FDA) for combined use, individual physicians exercising their prerogative to prescribe both drugs in tandem, with the encouragement of American Home Products, made fen-phen one of the pharmaceutical industry's best-selling products (Pitts et al., 1998). These physicians saw fen-phen as an effective prescription for treating obesity. However, in the winter of 1997 an echocardiography technician working for MeritCare Health System (MeritCare) in Fargo, North Dakota, discovered what appeared to be a relationship of fen-phen usage to valvular heart disease. MeritCare staff, expressing serious concern on one hand and serious reservations about the implications of making such an accusation on the other hand, based their decisions on the opinions of several medical, legal, and communication staff members. This group of individuals is noted in this study as the Issues Management Team. Concerned about its ability to draw sufficient attention to the medical risks of taking fen-phen, MeritCare turned for assistance to the world famous Mayo Clinic (Mayo), in Rochester, Minnesota. This collaboration resulted in an article published in the New England Journal of Medicine and a public warning about the dangers of fen-phen usage. In September 1997, the FDA requested that American Home Products withdraw fen-phen from the market (see Table 1).
We focus our analysis on MeritCare's warning about the danger of fen-phen usage as a form of whistle-blowing. Although the whistle-blowers in this case were not employees of the company producing this dangerous product, we argue that this case represents a kind of external or outsider whistle-blowing that reaches beyond the traditional internal form. Complex and highly interdependent networks of organizations push the traditional boundaries of whistle-blowing. As modern organizations depend more and more on networks of relationships with other organizations, this form of whistle-blowing will become more common. In so doing, we describe the functions of such messages and the features associated with their success. Specifically, we address the issue of credibility as a central factor in the effectiveness of whistle-blowing. We also examine the moral foundations of whistle-blowing, using the ethic of significant choice and ethical values involved in patient care.
Finally, we explore how MeritCare's use of an internal team served as a support structure and bolstered MeritCare's ability to call public attention to a national medical problem.
Whistle-blowing involves an individual with some level of unique or inside knowledge using public communication to bring attention to some perceived wrongdoing or problem (Johannesen, 1996; Seeger, 1997; Vinten, 1994). Most definitions of whistle-blowing stress the involvement of an employee or a former employee (Bok, 1980; Johannesen, 1996). Near and Miceli (1985), for example, define whistle-blowing as the "disclosure by organizational members (former or current) of illegal, immoral, or illegitimate practices under the control of their employers to persons or organizations that may be able to effect action" (p. 4). By acknowledging former employees as whistle-blowers, this definition creates room for other kinds of whistle-blower affiliations. We argue that whistle-blowing may also include suppliers, vendors, or members of a professional community who have specialized knowledge and publicly communicate information about perceived problems or wrongdoing. This form of external whistle-blowing, we suggest, has much in common with more traditional internal forms, although the insider sometimes faces greater or more direct risk. Internal whistle-blowers are usually more dependent on the organization accused of wrongdoing. The specific nature of the relationship between the whistle-blower and the organization, as demonstrated in this case, is highly variable.
Organizations increasingly rely on extensive relationships and networks of external groups and agencies. These may take the form of partnerships, cooperative agreements, client-customer relationships, subcontractor and trade relationships, or other kinds of professional associations and relationships. Information about problems or wrongdoings is, therefore, increasingly likely to come from within these networks. Roger Boisjoly and Allan McDonald, for example, were engineers with Morton Thiokol Corporation, a National Aeronautics & Space Administration (NASA) contractor, when they blew the whistle on the design and decisional flaws that led to the Challenger Space Shuttle disaster. Although it may be argued that Morton Thiokol and NASA were so closely connected that Boisjoly was a de facto NASA employee, he clearly fits into a broader conceptualization of whistle-blowing. In a more contemporary example, Houston-based Paine Webber broker Chung Hu was fired for advising his clients to sell Enron holdings (Seeger & Ulmer, 2003). Even though Hu was not affiliated with Enron in any formal sense, he was severely punished for calling attention to serious wrongdoing.
Whistle-blowing as a form of communication has "illuminated dark corners of our society, saved lives, prevented injuries and disease, and stopped corruption, economic waste, and materials exploitation" (Nader, 1990, p. 156). In blowing the whistle, a person calls public attention to a perceived problematic or unethical situation, such as sexual harassment, job discrimination, illegal activities, price fixing, issues of public and consumer safety, pollution, insider trading, and unsafe products (Miceli & Near, 1992). "Whistle-blowers," Bok (1980) notes, "sound an alarm from within the very organizations in which they work, aiming to spotlight neglect or abuses that threaten the public interest" (p. 10). As a form of public communication, whistle-blowing is characterized by ethical tensions and contradictions positioning the collective needs and values of organizations and groups against larger social needs (Elliston, Keenan, Lockhart, & Von Schaick, 1985; Jensen, 1987).
Whistle-blowing is often presented as a personal act of conscience that contributes to the open dissemination of important information about the well-being of the public (Nader, 1990). It is commonly framed as the ethical act of a hero, a virtuous individual following a personal sense of right and wrong at great personal risk. In other instances, however, whistle-blowers are described as turncoats breaking trust and confidence and lacking in loyalty (Winfield, 1994). Peter Drucker (1982), for example, argued that encouraging whistle-blowing compromises trust and the overall ethical climate of organizations: "Whistle blowing is simply another word for informing" (p. 234).
Whistle-blowing is also rooted in the larger communication values of democratic systems (Seeger, 1997). Free dissemination of information, particularly information that may influence critical decisions, is necessary for the functioning of democratic society (Johannesen, 1996). Thomas Nilsen (1974) described the moral basis of this necessity as the ethic of significant choice. He argued that individuals require free access to information to make reasoned and informed personal choices about significant issues. Therefore, "The good is served by communications that provide adequate information, diversity of views, and knowledge of alternative choices and their possible consequences" (p. 45). Argument, discussion, debate, open and free dissemination of information, knowledge, varying opinions, and diverse perspectives are critical elements of a democratic society. Ulmer and Sellnow (1997) argued that significant choice was the value premise underlying the decades-old struggle to get the tobacco industry to disclose what they knew about the dangers of smoking. Whistle-blowing, then, serves the public good by widely disseminating information about significant issues germane to full discussion and wise decision making. Information set free by whistle-blowers reveals circumstances otherwise unavailable to the public, thereby enhancing the public's ability to make rational, informed decisions and choices (Johannesen, 1996; Seeger, 1997).
The free flow of information is particularly important in questions of health and health care where information may influence life and death decisions. Williams and Sellnow (1998), for example, applied significant choice to the National Cancer Institute's 1992 change in mammography screening policy. They concluded that medical science, in particular, has an obligation to broadly disseminate information and create free debate about medical issues. Failure to disseminate significant information may create a chilling effect, both for the lay public and the medical profession. Similarly, Ulmer and Sellnow (1997) argued that by concealing and withholding evidence about the dangers of smoking, the tobacco industry violated the ethic of significant choice. Consumers were denied access to important information necessary to make informed health-related decisions.
Under democratic systems, the free flow of information occurs with the mass media serving as a watchdog. From the earliest days of the press in colonial America to the muckrakers of the 21st century, the press has worked to expose corporate and governmental wrongdoing by making information available to the public (Seeger, 1997). Recognizing this important function of the fifth estate, whistleblowers use the press and its watchdog function to reach larger audiences (Clark, 1992; Devine & Aplin, 1988). The anonymous whistle-blower Deep Throat broke the Watergate scandal by using the media to spotlight governmental misconduct. Problems at the Hanford Nuclear Weapons facility in Richland, Washington, were brought to light by whistle-blowers in the press (Kippen, 1990). The story of tobacco industry whistle-blower Jeffery Wigand was featured in film. The Government Accountability Project (GAP), a whistle-blower support group, cites a number of examples where government food inspectors were fired after calling attention to unsafe food processing practices (GAP, 2003). In these cases, the fired workers were not employees of the companies on which they reported. These examples illustrate the perceived value of whistle-blowing to society and the personal risk whistle-blowers often take and the diverse range whistle-blowing may take.
THE WHISTLE-BLOWING PROCESS
Murphy (1993) suggested four conditions that influence whistle-blowing behaviors. First, an insider's personal characteristics, including relative high levels of education, professional and social status, and group affiliation within the organization, encourage a whistle-blowing mindset. Second, work responsibilities that expose individuals to problems or wrongdoing are more likely to result in whistle-blowing. Third, certain organizational cultures with strong norms against dissent tend to discourage whistle-blowing. Finally, a supportive organizational climate and decentralized structure may support whistle-blowing (Murphy, 1993, pp. 5254).
Miceli and Near (1992) have identified several situational variables that contribute to the decision to become a whistle-blower: the nature of the wrongdoing, concerns about the seriousness of the offense, and the amount and quality of the evidence. Organizational signals about whistle-blowing indicate the anticipated nature and level of retaliatory response. Finally, other organizational factors, such as culture, climate, and codes of ethics may also influence a decision to blow the whistle (Miceli & Near, 1992).
A number of studies have concluded that those who speak out face the threat of retaliation (Miceli & Near, 1992; Near & Miceli, 1986; Parmerlee, Near, & Jensen, 1982). Whistle-blowers often lose professional credibility or their jobs. They may be blacklisted and shunned by friends and coworkers. They are sometimes falsely accused of wrongdoing, alcoholism, drug use, psychological problems, or incompetence in an effort to destroy their credibility and justify their termination. Research shows that for public-sector employees, who generally enjoy greater protection than private-sector employees, several factors are related to retaliation (Parmerlee, Near & Jensen, 1982). First, the level of managerial and supervisory support for the whistle-blower plays a part, with higher levels of support tending to shield whistle-blowers. Second, the severity of the wrongdoing in terms of its implications for the organization seems related to retaliation. Accusations resulting in legal action, for example, have a greater chance of prompting retaliation. Parmerlee et al. (1982) found that organizations are more likely to retaliate against highly valued employees who speak out and against those whose charges lack external support.
Retaliation is also associated with the choice of external channels. When a whistleblower chooses to make accusations public rather than agitate for change within the organization, the probability of serious retaliation rises. Whistle-blowers, therefore, often seek internal resolution before externally communicating issues. Whistle-blowers may also collect evidence to bolster the credibility of their charges and recruit other employees for support before communicating externally (Clark, 1992; Devine & Aplin, 1988). The government accountability project recommends that, when possible, whistle-blowers work in groups for enhanced support and credibility (GAP, 2003).
Perceptions of whistle-blower credibility and motivation are fundamental to answering ethical questions and provide the basis for larger arguments and strategies for both attacking and defending whistle-blowers (Seeger, 1997). Because the whistle-blower seeks to use the mass media to shed light on wrongdoing, perceptions of high credibility are essential in obtaining widespread public awareness. If a person calling attention to a perceived problem or wrongdoing is viewed as an ethical hero and moral champion, the message has more credibility and is more likely to be taken seriously. In contrast, if a whistle-blower is labeled as a self-serving, disloyal squealer or stool pigeon, then credibility is questioned and the message has less impact. Moreover, whistle-blowers often use media attention as a form of protection from retaliation. A whistle-blower who is not perceived as credible is more likely to face retaliation (Elliston et al., 1985; Jensen, 1987). Credibility, therefore, appears to be an essential component of successful whistle-blowing.
Traditional notions of whistle-blowing are based on the assumptions that workers have access to particular kinds of information signaling wrongdoing and that these workers risk their personal and professional well-being by disclosing that information. They do so, however, to serve the public good. As illustrated by the MeritCare case described below, these characteristics are also relevant to at least some instances of external whistle-blowing, where members of one organization call attention to wrongdoing within an affiliated organization.
METHOD AND PROCEDURES
The present investigation provides a case study that illustrates the role of external stakeholders in the whistle-blowing process. The case study is based on a series of extended interviews with MeritCare staff members who were directly involved with either the discovery of an apparent link between fen-phen and valvular heart disease or the decision to make this information public. Specifically, extended interviews were conducted with seven MeritCare staff members who worked closely with the fen-phen issue. Members who dealt with the medical information included the echocardiography technician who first suspected a link between the use of fen-phen and valvular heart disease, the interventional cardiologist who coauthored the New England Journal of Medicine article, and an internal medicine physician who was the medical director of the quality management department. Staff members of the group addressing media requests included the executive partner of strategic support services, the health system attorney, the public relations coordinator, and a public relations specialist. Certain individuals of this group, along with staff from the Quality Management Department, were ultimately responsible for MeritCare's decision to join with Mayo and make public their findings about fen-phen.
Individual interviews lasting between 30 and 60 minutes were conducted. Sessions were tape-recorded and later transcribed. Narratives were then interpreted based on four themes derived from the whistle-blowing literature: (a) the whistle-blowing process within the organization, (b) perceived threats of retaliation, (c) need for credibility, and (d) ethics and significant choice. In so doing, we seek to illustrate the reasoning of the MeritCare staff as they embarked on a form of external whistle-blowing. In the text, all references to personal communication are based on the interviews described above.
MeritCare and the Case of Fen-Phen
In December 1994, two echocardiography technicians at MeritCare Health System in Fargo, North Dakota, identified strange valvular abnormalities in two middle-age women that they suspected might be related to fen-phen use. (1) This was the first step toward a discovery that "would touch off a firestorm and eventually prompt the withdrawal from the market of two wildly popular diet drugs taken by hundreds of thousands of people" (Hellmich, 1997, p. D3). For a timeline of events in the case, see Table 1. The two drugs, fenfluramine and phentermine (fen-phen), were administered in tandem to significantly overweight patients. Separately approved by the FDA, the combination of the two drugs had not undergone FDA scrutiny, despite its widespread popularity and usage (Gorman, 1998).
For the next 2 years, technicians tracked the suspected relationship between fen-phen and heart valve abnormalities. When interviewed, one of the technicians reflected, "We were seeing maybe one a month.... It's not like that was a landslide. But the common thing that tied all these women together were [sic] the diet drugs" (Hellmich, 1997, p. D3). In casual conversations during 1996, the technician and the interventional cardiologist explored the possibility of a connection between fen-phen and valvular heart disease. About the same time, MeritCare formed a weight loss management protocol design team. In early 1997, the interventional cardiologist called Mayo to discuss and share MeritCare's concerns about 20 cases of apparent fen-phen usage and valvular heart damage. Mayo indicated it had 2 similar cases. At that time, MeritCare had no formal relationship with Mayo other than the occasional referral of patients. These discussions resulted in a Mayo cardiologist and one of MeritCare's interventional cardiologists collaborating on an article for the New England Journal of Medicine. The article, submitted in February 1997, was initially rejected because the journal viewed the data as anecdotal since it only included 5 cases (Hellmich, 1997). Four months later, a revised version was accepted.
Two important facts about this article should be noted. First, the authors described the study of "24 cases of valvular heart disease in patients who had been taking fen-phen" (Kassirer & Angell, 1997, p. 1762) as "small" and "uncontrolled" (Kassirer & Angell, 1997, p. 1763). Second, in an unusual move, the journal's editorial staff decided to waive the Ingelfinger Rule. This rule stipulates that authors may not release their data prior to the date that the journal is published. The decision to waive the rule was made because of the health implications and the need to quickly disseminate the information. In July 1997, the FDA, Mayo Clinic, and MeritCare announced their findings at a nationwide press conference held at Mayo. Eight weeks later, the full article was published. One month later, American Home Products withdrew fenfluramine and dexfenfluramine from the market (Pitts et al., 1998).
The Whistle-Blowing Process at MeritCare
When the echocardiography technician suspected a link between fen-phen and a valvular disorder, she initially found only modest interest from MeritCare's interventional cardiologists. The technician's frustration intensified as the problem became increasingly apparent:
I think knowing that these women, for the most part, were taking a medication that was harming them and not being able to tell them what I suspected.... I truly struggled with that. Every time I would get a new patient who had been taking fen-phen and they had a problem with their valve, it was very upsetting to me, especially after I truly knew that there was something going on and I felt helpless, I really felt helpless, but ethically I couldn't step out and say that because I'm not a physician. (personal communication, January 29, 2001)
The technician's concern for the welfare of her patients strengthened her resolve to develop support among her supervisory physicians:
I had to be persistent. I had to be, literally, a real ... pain. A real burr under the saddle and keep at it, and keep at it, and keep at it because it's not like we had an onslaught of patients. Twenty-one patients over a couple of years is not an onslaught, but it's enough that it needed to be attended to, and I was determined that somebody was going to attend to it. (personal communication, January 29, 2001)
The public relations specialist empathized with the technician's frustration and noted that credibility in such situations is often suspect. He commented
Who's going to believe me? I'm sure she [the echocardiography technician] was thinking, "Who am I to say this is a problem?" and then ... there were challenges in getting her peers to believe her and then problems with peers in getting other people to believe them and it just, up the ladder it went. (personal communication, February 1,2001)
The technician explained that eventually the "[interventional cardiologist] and I sat down and talked about it, and he said, 'You know, we are really on to something ... now what are we going to do about it?'" (personal communication, January 29, 2001). At this point, MeritCare had no formal procedures governing a discovery of this magnitude. The technician said, "I felt like I was flying by the seat of my pants" (personal communication, January 29, 2001). MeritCare's attorney similarly observed, "There were certainly no rules written anywhere" (personal communication, January 23, 2001).
However, MeritCare applied general ethical standards and guidelines. The director of quality management stated the rules he followed were "just the rules that go along with being doctors. Do what's best for the patient" (personal communication, January 26, 2001). The interventional cardiologist referred to the Hippocratic Oath as an ethical framework, saying, "I felt that that was the important rule ... something needed to happen in a hurry. That was the only rule I was following. I didn't check with anybody here.... I didn't go around and say 'Is this okay?' or 'Is that okay?'" (personal communication, January 23,2001).
The public relations specialist expressed a similar dependence on his profession's code of ethics: "The one [rule] that came into play the most was ... patient confidentiality and their rights" (personal communication, March 5, 2001). The executive partner of strategic support services described a similar set of ethical principles. "We were guided by legal principles ... that wasn't the primary issue, but it was certainly something that frames a lot of our PR decisions, as far as maintaining our position ethically and legally" (personal communication, March 5, 2001). The realization of a potentially serious health risk for people taking fen-phen and the staff's desire to act were, however, accompanied by a developing awareness of the political and personal consequences of blowing the whistle. As we discuss in the next section, some staff members reported a fear that publicly sharing their evidence and conclusions was personally threatening to them as well as to the health system.
Risk to the Organization
Much of the assumed risk by the health system staff stemmed not from questions related to the echocardiography technician's data but from a lack of experience and an assumed risk of legal retaliation. As the PR specialist explained, "A small health system, an unknown cardiologist, and a weird set of circumstances, all created a pretty suspicious environment" (personal communication, February 1, 2001).
MeritCare does not emphasize medical research as its primary mission. Prior to the fen-phen finding, the health system had never been credited with a major medical discovery and had rarely been the focus of national media attention. MeritCare enjoyed considerable respect in the region's medical community, but the staff was concerned that it lacked the national stature necessary to command adequate media attention in getting the word out about fen-phen. Had the health system failed to manage the situation effectively, it risked embarrassment and a loss of credibility. MeritCare's public relations specialist described the staff's perception:
When you think about it, I mean, God, it was something that nobody else was thinking about. How in the world could these folks here, in Fargo, North Dakota, be seeing this and no one else be seeing it? It had to be pretty intimidating for [the medical staff]. (personal communication, February 1,2001)
Regarding potential retaliation, MeritCare's attorney explained that where possible product failure is involved in a case and "there's a claim that arises out of it, you always have to, as a healthcare facility, deal with the potential that the manufacturer will attempt to shift part of the blame onto the healthcare provider" (personal communication, January 23,2001). The PR specialist also recognized the risk to MeritCare by going public:
The decision to go forward with it [communicating the discovery] was a huge deal because we were sticking our necks out.... As an organization, we were taking a lot of risks, putting ourselves in the limelight, and who knows how that whole thing could have ended up.... You're really talking about some huge shoes to fill when you're trying to get something that's that popular nationwide, worldwide, pulled off the shelves ... and so we took a major chance. (personal communication, February 1,2001)
Although the issues management team acknowledged the perceived risks to MeritCare, the interventional cardiologist reported feeling personally threatened. He spoke vividly about the pressures plaguing him as he contemplated making the technician's findings public:
Have you seen the movie The Insider? He was clearly threatened by the tobacco industry, and this [fen-phen] is a billion dollar project; this is a billion dollar cost, and I didn't anticipate that at first, but I've wondered about whether I've been investigated or not. I've been told that I might have been by the drug companies, I don't know if that's true ... I wondered, though, if I had tried to do this on my own [communicate the discovery], and not gone through Mayo, where Mayo took all the credit, or a lot of the credit ... if I had been ... the point person, if that might not have been a bigger issue. (personal communication, January 23, 2001)
Clearly, these perceived risks, organizational and individual in nature, influenced MeritCare's decision to seek outside support before going public with their findings.
Issues of Credibility
Mayo Clinic's acceptance of MeritCare's data assured MeritCare that its data were credible and validated its decision to disseminate the information. The issues management team saw Mayo as a source of reassurance, fortification, and credibility. Contacting Mayo was, however, no small decision. As the executive partner of strategic support services explained, "That was a huge, a major decision and certainly one that wouldn't necessarily have been in our best PR interests ... so [the decision was based on] putting the community, the people first, versus putting MeritCare first" (personal communication, January 25, 2001). Team members reported they were willing to surrender credit for their discovery to Mayo because disseminating the information to the public was far more important to them than consideration of who received credit. The echocardiography technician explained, "We discussed it and decided that the most important thing was to get the information out and it would mean a lot more coming from Mayo than it would from MeritCare" (personal communication, January 29, 2001). The medical director of quality management reflected the group's general consensus that Mayo was a key source of credibility, saying, "Mayo was critical in assuring that the word got out and that it was credible" (personal communication, January 26, 2001).
The director of quality management commented that, in retrospect, he believed that without Mayo, MeritCare might not have been successful in communicating its findings:
I think if [the interventional cardiologist] ... hadn't made the decision to go to Mayo we wouldn't have had the wherewithal to get it out like it got out. We didn't have the connections, and we didn't have the national name, so that was critical. (personal communication, January 26, 2001)
By partnering with Mayo, MeritCare reduced its perceived risk. Mayo had the credibility and experience that MeritCare lacked. As a research institution, Mayo had the necessary resources to generate the article in the New England Journal of Medicine, get it published, host a press conference with national media, and defend the health systems' findings.
The only trade-off MeritCare witnessed was a lack of recognition as the findings were announced to the public. Initially, the echocardiography technician said that she "sort of felt a little bit like Cinderella whose wicked stepsisters had gone to the ball without her" (personal communication, January 29, 2001). She explained that she was
surprised that it took the media so long to find out where it came from, to find out, to dig past that first layer of initial coverage in July and after the FDA banned it, to come back and dig a little deeper and find out that it really wasn't the Mayo Clinic that did it, in fact, it wasn't even any doctors, it was just me. (personal communication, January 29, 2001)
The interventional cardiologist was equally direct in his description of Mayo:
I was surprised at how Mayo ... tried really hard to have this recognized, in my opinion, as being a Mayo issue and a Mayo discovery.... One thing I've learned is that when you're dealing with big ... they want the credit. That's very important to them. (personal communication, January 23, 2001)
Despite the disappointment, the executive partner said her staff took the "high road" because getting the information out about fen-phen "was a bigger issue that was more important than the recognition that we got" (personal communication, January 25,2001). These concerns with a lack of attention faded quickly, however, as the media coverage of the fen-phen story intensified.
Significant Choice and Media Attention
The interviews revealed that the most compelling value driving the issues management team decisions was the welfare of the patients--the same value championed from the beginning by the echocardiography technician. All the interviewees expressed an overwhelming desire simply to get the word out to inform the public. Because of this, an ethic of significant choice dominated the team's decision making. In some cases, the health risks related to obesity are potentially as severe as those related to fen-phen usage. However, from the perspective of significant choice, the apparent link between fen-phen and valvular heart disease was an essential factor for the FDA and the general public to consider when making an informed choice about fen-phen. The interventional cardiologist emphasized this view: "I think the ethical issue that I felt was that I needed to do something. I felt that it would have been unethical not to say anything ... MeritCare, first and foremost, and myself had patient's interests in mind" (personal communication, January 23, 2001). The quality management director reinforced this position:
There was no conflict because nobody thought about it; everyone agreed. Once people [the weight loss management protocol design team] were satisfied, it didn't take heaps and heaps of proof and re-proof once everyone was convinced that there was a serious possibility, a real possibility. They weren't going to wait. (personal communication, January 26, 2001)
Similarly, the public relations specialist also appeared to be operating from the ethic of significant choice:
I think certainly the decision to do everything we could to get the word out was an ethical decision in many ways. We felt an obligation, an ethical obligation ... to people's safety, to get the word out about this, and we took a big risk in doing that, but that was an ethical decision that had to be made. (personal communication, February 1, 2001)
This form of risk was clearly secondary to the need to share the information with the public.
Having decided to go public and with the Mayo partnership in place, MeritCare assumed the onslaught of media attention needed to inform the public about fen-phen would focus on Mayo. However, the amount of media attention directed at MeritCare both surprised and exceeded the expectations of the issues management team. The executive partner of strategic support services said she understood that "managing the media calls was not an eight-to-five job, but that public relations and planning staff worked on managing the requests day and night for several weeks" (personal communication, January 25, 2001). In great demand by the media, the echocardiography technician offered the following description of her experience:
The media onslaught was tremendous. I managed to avoid the first part of that in July, but when the FDA banned the drug [in September, 1997] then I got caught up in that and it was ... a nightmare. It was very frightening for me to be put in that position and getting phone calls at home from CNN or Good Morning America.... It was like nothing I'd ever experienced before. (personal communication, January 29, 2001)
The public relations specialist also described an unrelenting pressure to accommodate seemingly endless media requests: "We didn't perceive this thing getting as big as it did and ... every week, I think we thought, 'Oh, things will get back to normal,' and they just never ever did" (personal communication, February 1, 2001).
An additional challenge for the public relations staff was distinguishing between legitimate media sources and more sensational programs and publications. The executive partner explained that to maintain the health system's dignity, staff "didn't respond to certain kinds of things" (personal communication, January 25, 2001). She was, however, emphatic that MeritCare was highly responsive in its media relations:
I think we maintained ethics in our relationships with the media and were caretakers of that. We were honest. We were always honest. We didn't lie. We didn't always say everything maybe, but we didn't ever lie ... we didn't mislead. We were always driven by that as well. (personal communication, May 5, 2001)
The intense media pressure also forced MeritCare's legal counsel to be more accommodating than usual. MeritCare's attorney explained that numerous requests for information and interviews and the pressure to meet media deadlines forced him to abandon his typical procedures:
Normally, when you get a [media] request ... I think that's the challenge that the law department has in a healthcare facility ... that the deadlines that the media have are really not our deadlines.... On the other hand, if you've got the rest of the department and the PR department saying to you, "We really need to say something; otherwise, they're going to go on air with this story with no comment from MeritCare." ... I realize that that's not positive either.... You have to function in the real world. (personal communication, January 23, 2001)
In short, MeritCare staff worked hard to accommodate the historically unprecedented levels of media requests, thereby enabling staff to achieve its ultimate goal of disseminating its message about fen-phen to the widest possible audience. This dissemination of information enabled MeritCare to function within the boundaries of significant choice.
CONCLUSIONS AND IMPLICATIONS
Three broad conclusions can be drawn from the fen-phen MeritCare case. First, the whistle-blowing experiences of an external affiliated organization are largely consistent with those of internal whistle-blowers found in more traditional settings. Second, the MeritCare case calls for reconsideration of traditional notion of whistle-blowing that limit the phenomenon to internal employees. Finally, established value systems and the ethic of significant choice guided and supported individual and organizational decisions to identify and call attention to the medical risks associated with fen-phen usage.
MeritCare staff experiences paralleled the constraints typical of internal whistleblowers. For example, some staff members expressed serious apprehension about possible retaliation, including one physician who worried about retaliation from the manufacturer, American Home Products. Although no known retaliation materialized, this perception of vulnerability was so strong for some members of the issues management group that MeritCare felt compelled to partner with a larger, better known institution in revealing its findings. Mayo's involvement served to both legitimize MeritCare's findings and shield it from unwanted risk and media attention.
The MeritCare whistle-blowers, as outsiders, were also empowered by characteristics and processes typically identified in internal employee whistle-blowing cases. The health system's issues management team, for example, included individuals with high levels of education and positions of organizational influence. The group appeared to serve as a support structure accommodating a variety of perspectives and encouraging consensus to emerge. Although no organizational or cultural injunctions existed inhibiting whistle-blowing, there were no organizational policies or procedures to guide the group, either. However, MeritCare clearly fostered cultural norms respecting an individual employee's compulsion to share concerns. In short, MeritCare's issues management team possessed the same characteristics typical of individual whistle-blowers. By using a group, the health system overcame its perceived apprehensions as it considered the evidence and decided to go public.
As with internal employee whistle-blowing, several MeritCare employees viewed blowing the whistle on a multibillion dollar drug as professionally risky for the staff involved and for the MeritCare organization. The specter of major lawsuits and professional ridicule was present throughout the fen-phen episode. The staff expressed uneasiness about the risk MeritCare faced, suggesting that the risk of serious consequences represented a significant impediment to disseminating their fen-phen warning.
One feature most consistent with traditional employee whistle-blowing involves the role of credibility. The need for credibility was MeritCare's primary reason for approaching the more prestigious Mayo Clinic. This alliance brought credibility to the message and helped ensure the message was widely publicized. Interestingly, there was some concern at MeritCare that its staff did not receive as much credit, at least initially, as it should have. This case suggests that external whistle-blower partnerships, such as that between MeritCare and Mayo, have relational tensions that are not typically seen with internal stakeholders.
A second conclusion drawn from the MeritCare case is that traditional notions of whistle-blowing as only including insiders are too narrow. Although research literature typically defines whistle-blowing as an exploit of internal employees, this case offers support for the notion that external stakeholders can and do initiate the whistle-blowing process. Whistle-blowers have some specialized or proprietary knowledge about a wrongdoing and choose to call public attention to that wrongdoing. In so doing they face a serious risk to career, livelihood, psychological well-being, reputation, or, in extreme cases, physical safety. Whistle-blowers are more appropriately characterized by the nature of the risk they face by calling public attention to wrongdoing than by the strict parameters of an employee-employer relationship. This extended notion of whistle-blowing is particularly important as the kinds of relationships between individuals and organizations become more complex and less direct. These kinds of relationships, constituted through complex networks of affiliation, partnerships, professional relationships, and cooperative agreements are increasingly common.
The final set of conclusions drawn from this case study concerns the role of value systems. MeritCare's actions in the fen-phen case display a firm commitment to patient well-being and unfettered public access to important health risk information. Lacking formal rules and regulations governing whistle-blowing, the staff turned to other well-established value systems, namely general values of patient care, the Hippocratic Oath, and standards for the ethical practice of public relations. Patients' rights and related values of the greater social good were dominant guides for the issues management team. These values functioned consistently throughout the case, from the first inklings of a problem noticed by the echocardiography technician and her seeking the attention of the intervention cardiologist in 1994 to the joint announcement with Mayo in July 1997.
In particular, the ethic of significant choice functioned in this case through the media. The involvement of the well-known and prestigious Mayo Clinic facilitated widespread media coverage of the warning. Despite initial feelings of being upstaged by Mayo, the MeritCare staff devoted a considerable amount of time to the media. They did so with the recognition that media attention was necessary to achieve their larger goal of "getting the word out."
This case suggests additional avenues of inquiry. First, additional inquiry should be conducted to further explore this form of outsider or external whistle-blowing. External whistle-blowers clearly have a different kind of relationship with the organization than do internal employees. In this case, as with many others, external whistle-blowers still faced significant risks. Despite sharing much in common with traditional whistle-blowers, it is likely MeritCare staff felt less fear than they may have perceived had they been whistle-blowers within the American Home Products system.
Second, the role played in the whistle-blowing process by a credible partner should be investigated. Clearly, Mayo was instrumental in facilitating MeritCare's decision to blow the whistle and in drawing widespread media attention. Similar cases have occurred where whistle-blowers have received the support of regulatory agencies, law enforcement, or private support groups.
Finally, the role of values requires further investigation. MeritCare employees were able to identify long-standing, traditional medical ethics to guide their actions and bolster their resolve. These ethical systems are connected to the ethic of significant choice in supporting the decision to go public. Employees in other industries may not have well-developed value systems and traditions to draw on. In these cases, the employees may refrain from whistle-blowing by turning to other justifications for their decisions.
Many organizations behave ethically without the impetus that the tear of internal and external whistle-blowers may provide. However, for some organizations, whistle-blowing is a critical social process in maintaining ethical integrity. Clearly, many individuals were saved from potentially serious health problems because of MeritCare's devotion to the ethic of patient care that permeates the organization. Ironically, even American Home Products ultimately benefited from MeritCare's discovery and announcement. The company's litigation and loss would have increased dramatically if fen-phen had not been withdrawn as quickly as it was. Announcement of MeritCare's findings resulted in the rapid withdrawal of a potentially dangerous product.
As organizations increasingly rely on extended networks of suppliers, contractors, and partnerships, information will become more fragmented. The knowledge of wrongdoing, accidents, and oversights will increasingly fall to individuals and groups who are technically outsiders. Although on one hand this outsider status may help facilitate blowing the whistle, these individuals may not be afforded the protections associated with traditional internal whistle-blowing. It may actually be easier for corporations to punish external whistle-blowers by terminating contracts and initiating lawsuits. An expanded understanding of what constitutes whistle-blowing may be helpful in understanding the complexity of messages that address organizational wrong-doings.
Table 1. Sequence of Events in the Fen-Phen Case Beginning With Food and Drug Administration (FDA) Approval of Phentermine and Ending With the Settlement of the Class Action Suit March 1959 Phentermine first receives approval from the FDA as an appetite suppressant for the short-term treatment of obesity and its use is restricted to 3 months in duration. June 1973 A.H. Robins's fenfluramine receives FDA approval for the short-term treatment of obesity. Together, phentermine and fenfluramine produced a powerful diet drug cocktail. The FDA never approved the fen-phen combination, but once the FDA has approved a drug, doctors may prescribe it at will. Their use, together, was considered "off-label." Early 1980s First use of fen-phen combination occurs. 1981 Michael Weintraub, a former pharmacologist for the University of Rochester, publishes a study of the effects of taking both of the drugs at one time. The research was funded by a grant from A. H. Robins. June 1984 A second Weintraub study funded by A. H. Robins is published. This study concluded that fen-phen users experienced more weight loss than patients using just one or the other drug. 1989 A. H. Robins is forced into bankruptcy because of the Dalkon Shield class-action lawsuit and American Home Products (AHP) purchases A. H. Robins. May 1992 Weintraub publishes a series of articles that led to the popularity and widespread use of fen-phen. Wyeth-Ayerst, a subsidiary of American Home Health Products, used the Weintraub studies and articles to promote to physicians the use of fenphen for obese patients. December 1994 An echocardiography technician at MeritCare Medical Center first suspects a link between fen-phen and valvular heart disease and begins to collect data. February 1995 Evidence from Weintraub's study is published in Allure magazine and a condensed version of the article later appears in Reader's Digest. May 1996 MeritCare forms a group of internal experts to develop practice guidelines for weight-loss drug usage. February 1997 MeritCare contacts the Mayo Clinic to discuss the data collected by the echocardiography technician. Mayo agrees to coauthor an article based primarily on MeritCare's data for the New England Journal of Medicine. June 1997 The New England Journal of Medicine accepts the article from Mayo Clinic and MeritCare. July 1997 Mayo hosts a news conference announcing the results of their New England Journal of Medicine article. September 1997 At the request of the FDA, American Home Products withdraws fenfluramine from the market. September 2002 American Home Products wins final court approval for a $3.75 billion settlement of a class action lawsuit. January 2004 Today, phentermine is the most commonly prescribed prescription appetite suppressant.
(1.) Although several echocardiography technicians were initially involved in compiling data, one technician maintained primary interest. Thus, for the remainder of the article, we refer to her as the technician.
Bok, S. (1980). Whistle blowing and professional responsibility. New York University Education Quarterly, 10, 2-10.
Clark, L. (1992, Spring). The Governmental Accountability Project: The 1992 program. Bridging the Gap, 1-2.
Devine, T. M., & Aplin, D. G. (1988). Whistleblower protection: The gap between the law and reality. Howard Law Journal, 31, 223-239.
Drucker, P. (1982). The changing world of the executive. New York: Times Books.
Elliston, F., Keenan, J., Lockhart, P., & Von Schaick, J. (1985). Whistleblowing: Managing dissent in the workplace. New York: Praeger.
Gorman, C. (1998, September 21). Diet pill Redux. Time, p. 152. Retrieved October 28, 1998, from http://cgi.pathfinder.com/time/magazine
Government Accountability Project. (2003). Retrieved August 14, 2002. from http://www. whistleblower.org/
Hellmich, N. (1997, September 18). Behind the demise of fen-phen: Early signs of heart-valve problems surfaced in N.D. laboratory. USA Today, p. D3.
Jensen, V. (1987). Ethical tension points in whistleblowing. Journal of Business Ethics, 6, 321-328.
Johannesen, R. (1996). Ethics in human communication (45th ed.). Prospect Heights, Ill: Waveland.
Kaissirer, J. P., & Angell, M. (1997, December 11). Prepublication release of journal articles. New England Journal of Medicine, 337, 1762-1763.
Kippen, A. (1990, February). GAPs in your defense. Washington Monthly, 29-36.
Miceli, M. P., & Near, J. P. (1992). Blowing the whistle: Organizational and legal implications for companies and employees. New York: Lexington Books.
Murphy, K. R. (1993). Honesty in the workplace. Pacific Grove, CA: Books/Cole.
Nader, R. (1990). The anatomy of whistleblowing. In M. P. Madsen & J. H. Shafritz (Eds.), Essentials of business ethics (pp. 152-160). New York: Meridian.
Near, J. P., & Miceli P. M. (1985). Organizational dissidence the case of whistleblowing. Journal of Business Ethics, 4, 1-16.
Near, J. P., & Miceli P. M. (1986). Retaliation against whistleblowing: Predictors and effects. Journal of Applied Psychology, 1, 137-145.
Nilsen, T. R. (1974). Ethics of speech communication (2nd ed.). Indianapolis, IN: Bobbs-Merril.
Parmerlee, M. A., Near, J. P., & Jensen, T. C. (1982). Correlates to whistleblowers' perception of organizational retaliation. Administrative Science Quarterly, 27, 17-34.
Pitts, B. G., Crosby, R., Laufenberg, S., Meidinger, G., & Monson, N. (1998). The use of clinical practice guideline to manage and verify weight loss outcomes of patients treated with fen-phen in primary care settings. Nutrition in Clinical Practice, 13, 241-250.
Redding, W. C. (1985). Rocking boats, blowing whistles, and teaching speech communication. Communication Education, 34, 245-258.
Seeger, M. W. (1997). Ethics and organizational communication. Cresskill, NJ: Hampton Press.
Seeger, M. W., & Ulmer, R. R. (2003). Explaining Enron: Communication and responsible leadership. Management Communication Quarterly, 17, 58-84..
Ulmer, R. R., & Sellnow, T. L. (1997). Strategic ambiguity and the ethic of significant choice in organizational crisis communication. Communication Studies, 48, 215-233.
Vinten, G. (1994). Whistleblowing: Subversion or corporate citizenship. New York: St. Martin's.
Williams, S. L., & Sellnow, T. L. (1998). Chilling effect and significant choice: A case study of the National Cancer Institute and the screening mammography guideline controversy. In M. Seeger (Ed.), Free speech yearbook, 36 (pp. 118-133). Washington, D.C.: National Communication Association.
Winfield, M. (1994). Whistleblowing as corporate safety net. In G. Vinten (Ed.), Whistleblowing: Subversion or corporate citizenship (pp. 21-32). New York: St. Martin's.
Carrie E. Johnson (M.A., North Dakota State University, 2000), is a media relations specialist at MeritCare, Fargo. ND. Timothy L. Sellnow (Ph.D., Wayne State University, 1987) is a professor in the Department of Communication at North Dakota State University. Matthew W. Seeger (Ph.D., Indiana University, 1982) is a professor in the Department of Communication Studies at Wayne State University, Detroit, MI. Kathryn C. Hasbargen (B.A., Concordia College, 1995) and M. Scott Barrett (MBA, Fort Hays State University, 1993) are doctoral students in the Department of Communication at North Dakota State University. A portion of this study is based on Carrie E. Johnson's master's thesis, "Group Decision Making and Public Communication in Times of Crisis: The Fen-Phen Story." Some segments of the interviews reported in this analysis also appear in other projects that are in progress. Correspondence regarding this article should be addressed to Timothy L. Sellnow, firstname.lastname@example.org.…