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The Commercialization of Phase I Trials

The Commercialization of Phase I Trials

Chapter:
(p.100) 4 The Commercialization of Phase I Trials
Source:
Adverse Events
Author(s):
Jill A. Fisher
Publisher:
NYU Press
DOI:10.18574/nyu/9781479877997.003.0005

Abstract and Keywords

Shifting focus from the healthy volunteers to the clinics themselves, Chapter 4 provides a brief history of the Phase I industry to contextualize the opportunistic nature of many of the clinics that are currently operating in the United States. Clinics’ concerns about profitability and/or reputation lead to different investments in their facilities and staffing, which in turn result in a wide variation in experiences for healthy volunteers depending on where they enroll. In short, some clinics are perceived as state-of-the-art facilities that are comfortable and professional spaces, whereas others are rundown and have few amenities, indicating that participants’ needs are clearly not the priority. The material configurations of Phase I clinics communicate to healthy volunteers important messages about their safety and worth.

Keywords:   Phase I industry, United States, clinic space, capitalism, pharmaceutical industry, material investment

Opportunities for healthy volunteers to participate in Phase I clinical trials have proliferated across the United States in the past three decades. New models of outsourcing clinical research restructured how pharmaceutical companies test their investigational drugs from Phase I through Phase IV trials. Beginning in the 1980s, for-profit companies called “contract research organizations” (CROs) were formed to assist pharmaceutical companies with clinical development, especially by providing statistical and project-management services (Mirowski 2011).1 These companies also largely supplanted the central role of academic medical centers in conducting clinical trials (Fisher 2009). By outsourcing many of the routine yet complex tasks associated with testing their investigational drugs, pharmaceutical companies were able to expand the recruitment of research participants and putatively speed up drug development (Fisher 2007; Petryna 2009). In addition, by closing their own Phase I clinics, pharmaceutical companies can outlay resources only when they have clinical trials to conduct as opposed to having constant expenses associated with the operational costs of maintaining and staffing a clinic even when its use is low.2

Spurred on by these patterns of outsourcing and coupled with exponential growth in pharmaceutical R&D and the generic drug market (Borfitz 2013; PhRMA 2016), the commercial clinical trials industry made large-scale capital and infrastructural investments in its Phase I sector in particular. Departing from previous pharmaceutical industry patterns of concentrating growth in the Northeast corridor, commercial companies instead opened Phase I clinics throughout the United States, including in small cities and areas in the Midwest not previously known for medical research. These clinics included independent research companies specializing in Phase I clinical trials and CRO-based facilities. Unlike independent clinics that do not provide (p.101) any other services to pharmaceutical companies beyond conducting Phase I studies, CROs’ decision to invest millions of dollars building trial facilities or acquiring investigative sites is due principally to the companies’ hope that working with pharmaceutical companies from the initial stages of human testing—which is lucrative in itself—will position them to win additional contracts for the entire clinical development process, including ushering investigational drugs to FDA review (Korieth and Zisson 2007).

Not only did the number of new Phase I facilities steadily increase in the 2000s, but also the scale of these facilities changed dramatically. Built to house more participants, newer clinics can accommodate large Phase I trials or conduct multiple studies simultaneously. Most contain no fewer than 50 beds, and several were designed with multiple wards to house hundreds of participants. A far cry from the 12-to 24-bed clinics at most academic medical centers, this is a development that emphasizes the high throughput of clinical trials imagined, if not always realized, by the industry.

While many of these organizational changes are typical contemporary business practices, the Phase I industry has also been plagued by scandal. In the United States, the largest Phase I facility to ever operate was SFBC International in Miami, which was a 675-bed clinic that was housed in a former Holiday Inn and was shut down in 2006 for fire and safety violations and negative press about its enrollment of undocumented immigrants (Evans, Smith, and Willen 2005). In another instance, the massive 544-bed PRACS Institute (Fargo, North Dakota) filed for bankruptcy and abruptly closed, ceasing studies in progress, terminating employees, and failing to compensate hundreds of participants (Redfearn 2013). The FDA has also identified cases of fraudulent data produced by CROs. This has meant that in some instances clinical testing of investigational drugs has had to be recommenced before the FDA would consider pharmaceutical companies’ applications to market the drugs (CenterWatch 2007; Redfearn 2012). However, most of the senior management implicated in these scandals were able to survive them by maintaining the same clinics and infrastructure but operating under a different name.

Hence, there are now more types of organizations involved in clinical research than there were thirty years ago, which, in turn, has (p.102) encouraged at times questionable—if not unethical—business practices. Indeed, the Phase I industry has often been characterized as opportunistic, running clinics in ways that can exploit the social and economic inequalities affecting participants in order to secure significant profits from their contracts with the pharmaceutical industry. Commercial clinics, in particular, are incentivized to reduce the compensation for healthy volunteers and cut corners on operating expenses. As I demonstrate below, they often do so by hiring inexperienced staff, serving low-quality food, and providing few or outdated amenities.3

Notwithstanding these industry trends, not all clinics have prioritized profits at the expense of participants. In other words, the quality of clinic accommodations can be read as an indicator of the safety and worth companies ascribe to healthy volunteers. Indeed, a key feature of healthy volunteers’ experiences at Phase I clinics is the wildly different standards and organizational schemes they have in place. In some instances, the industry’s disregard for healthy volunteers’ comfort also contributes to the continued stigmatization of trial participation. Organizational priorities not only influence both how participants are treated and how studies are conducted; they are also critical to understanding the complex industry in which companies, research staff, and healthy volunteers are enmeshed.

Clinic Configurations

There is no standard template that Phase I clinics follow in terms of their location, amenities, or staffing. As I have already described, Pharma Phase I was a state-of-the-art facility. This might not be surprising given that it was owned and operated by a multinational pharmaceutical company with annual sales totaling tens of billions of dollars. While Pharma Phase I had its own freestanding building located in close proximity to a hospital, the other five clinics on my research itinerary deviated from this model. Examining these spaces provides some insights into the evolution of this industry and healthy volunteers’ Phase I trial experiences (table 4.1).

More than any other, Mega Phase I resembled Pharma Phase I in that it occupied a new building that was designed and constructed as (p.103)

Table 4.1: Clinic Characteristics by Region of the United States

Organization Type

Approximate Capacity

Building Type

East Coast

Academic Phase I

Academic medical center

16

Hospital ward

Pharma Phase I

Pharmaceutical company

50

New, freestanding

Midwest

Cottage Phase I

Independent, commercial clinic

50

Suite in office park

CRO Phase I

Contract research organization

60

Former factory

West Coast

Local Phase I

Independent, commercial clinic

80

Former warehouse

Mega Phase I

Contract research organization

300

New, freestanding

a research clinic, but it differed from Pharma Phase I in two key ways. First, it was located several miles from the nearest hospital that could provide medical support should a serious or life-threatening adverse event occur during a study. Second, Mega Phase I was huge. At full capacity, it could house up to 300 participants. Making its space more flexible to accommodate individual studies or varying volumes of participants, multiple self-contained subclinics, including procedure areas, dormitories, and cafeterias, divided the building. While research staff could travel among the subclinics using interconnected corridors, the participants were locked into their designated space for the length of the study. To maximize the number of research participants housed, Mega Phase I furnished the bedrooms with bunk beds, fitting eight to 12 participants per room. Additionally, one of the clinic areas occupied a vast open space, reminiscent in many ways of a school gymnasium, which contained more than 80 hospital beds. These beds were organized head to head in rows two beds wide and six long. During my initial tour of the building, healthy volunteers occupied these beds, lying on their backs with their arms at their sides; many stared blindly at the ceiling above (p.104) them. Although they were clearly positioned this way for a study procedure, the effect was disconcerting, and I felt relieved to pass through this space and into another. Participants’ recreational spaces were more comfortably designed, with warm colors and wall hangings amplifying the homey effect of the oversized chairs facing large-screen televisions. With different spaces for participants to use in each subclinic, Mega Phase I felt ample despite the large number of participants.

In comparison to Pharma Phase I and Mega Phase I, the three other commercial Phase I clinics were less modern and spacious. All three had adopted space originally intended for another purpose. CRO Phase I acquired a defunct manufacturing facility for its clinic, Local Phase I was located in a former warehouse, and Cottage Phase I was situated in an office park, tucked into a larger building containing a wide array of enterprises. All three were miles away from hospitals, and their appropriated buildings profoundly constrained the design of each clinic. Both CRO Phase I and Local Phase I were nearly windowless, so bunk-bed-lined dormitories, recreational spaces, and procedure areas had no natural light. The furniture at all three was mismatched and worn. Cottage Phase I required participants to stay in the procedure area most of the day, where they sat in rows of assigned recliners—many of them defective—which were positioned uncomfortably close together. This might nonetheless have been an improvement over CRO Phase I, where an insufficient number of tables and chairs forced participants to jockey for space, including taking turns at the tables during meal times. Unlike the other clinics, neither CRO Phase I nor Local Phase I had a kitchen on the premises; all participant meals were instead catered from chain restaurants, such as IHOP and Boston Market, and the food was often at room temperature by the time participants were allowed to eat. Cottage Phase I was more connected to the outside world through its large plate-glass windows. I saw participants periodically talking to family members or friends through the glass, a loophole to clinics’ policies prohibiting visitors. The sum effect of these three clinics’ spaces was rather like that of overcrowded prisons, and those running them seemed quite unselfconscious about the poor accommodations that seemed to have far exceeded their capacities.

In contrast to these clinics, Academic Phase I was located within a large university hospital. The oldest established clinic in my sample, it (p.105) was also by far the smallest, with just over a dozen beds. The clinic had appropriated a traditional nursing ward of the hospital, so participants had the benefit of staying in two-person rooms with private bathrooms. The facility was, however, more outdated and desperately needed some fresh paint. The recreational space was limited, and participants were generally expected to spend most of the study in their hospital bed. To help them pass the time, the recruiter encouraged participants to bring books, games, and electronic devices. Even though the space was smaller, the clinic did not feel as crowded as some of the others because the participants typically remained in their rooms. This could nevertheless be harder on participants who might feel confined not only within the small clinic but within the even smaller space of their beds.

Clinic Views of the Phase I Industry

While these brief descriptions of the clinics provide some sense of place, the organizations responsible for these clinics tell a different story. The material differences in the clinics operated by Pharma Phase I, Academic Phase I, and the four commercial Phase I companies are products of their divergent organizational values and public reputations. Specifically, Pharma Phase I had an interest in protecting its brand. The parent company of Pharma Phase I spent significant resources building its clinic, making it relaxing and comfortable for volunteers. Pharma Phase I easily had the best facility out of the six that I visited. Although Academic Phase I had the oldest clinic and lacked modern amenities, it emphasized its teaching mission, which enhanced the quality of its clinical and research staff. In contrast, the four commercial clinics—CRO Phase I, Mega Phase I, Cottage Phase I, and Local Phase I—had their profit motive much more at the surface of their operations. This manifested in their second-rate staffing and accommodations. Importantly, these commercial clinics needed to concern themselves with their reputation only within the industry (i.e., their standing with pharmaceutical companies), whereas Pharma Phase I and Academic Phase I had reputations to protect beyond Phase I testing. At all six clinics, research staff provided insights into how these facilities operated and how healthy volunteers’ worth to the research enterprise was embedded in the clinics’ larger organizational values.

(p.106) Pharma Phase I

In the case of Pharma Phase I, the reputation of one of the most profitable businesses in the world was on the line for what happened in its clinic. The Pharma Phase I facility was state of the art for a reason. It symbolized the prosperity of the company, and it suggested a deep investment in R&D.4 While other pharmaceutical companies shuttered their Phase I facilities, the parent company of Pharma Phase I chose instead to invest in and expand its clinical research operations. In addition, by maintaining its own research unit, the company could exert more control over the flow of any information about its investigational drugs, especially safety data emerging from early human testing. Like many other businesses, pharmaceutical companies have highly sophisticated public relations teams that engage simultaneously in damage control and “corporate social responsibility” (Banerjee 2008). These teams emphasize the good that companies do while taking the spotlight off the harm their products have created or, more generally, the profits they make from expensive drugs (e.g., Shamir 2005). At Pharma Phase I, these concerns about the parent company’s reputation translated into the organizational values of having a facility that represented the company brand, was beholden to a community mandate, and prioritized a participant-centric approach to research.

Explaining her company’s investment in their new clinic facility, Gail, Pharma Phase I’s operations director, said that “we purposely built a facility like this. You know, it’s clean. This weekend we just replaced the TVs upstairs. … They were six years old and well used, and we want this environment to be comfortable and encouraging.” The perspective on the company from the outside was also important, so before Pharma Phase I opened, the company engaged the local community to explain what the research facility was and why they were locating there. As Gail explained, “We weren’t expecting to draw a great deal [of healthy volunteers] from the neighborhood, although that was gonna be a bonus, but we had to get folks in the neighborhood to understand why we’re here. There was a big fear factor. You know, were we experimenting on animals in the area? Were we gonna come in and just take advantage of the situation and then go away? And [Pharma] is a company that doesn’t do that. … We’re encouraged to become part of the community. (p.107) It’s hugely important to us.” Highlighting the anxiety that communities can have about medical research, Gail also conveyed that the decision to build Pharma Phase I in this particular community was not based on its potential pool of healthy volunteers; on the contrary, participants were expected to travel from all across the country to participate, and since this influx of strangers to the community could be another cause for distrust, it was all the more imperative to show that the company had nothing to hide about Pharma Phase I.

The rhetoric around community that Gail and other employees mobilized also inflected their views of healthy volunteers. For Pharma Phase I, the “customer” was the healthy volunteer and not the corporate entity that was feeding the clinic studies. Tanya, an African American woman in her thirties who was one of the recruiters, described Pharma Phase I’s focus on participants: “We have a volunteer survey, and every volunteer is asked to complete one. … And it asks about our professionalism: were we approachable, do they feel they got enough information, do they feel they were treated fairly while they were here? How was the food, did you like it? … I read each and every single comment that is written on the surveys. … And that’s one of the ways [we] keep a pulse on our external customer and if they’re happy with what is going on.” Tanya reported a lot of changes in response to these surveys, including fixing problems in the bathrooms, updating the movie library, and revising the menu. This customer-service attitude applied to Gail as well, even though she was at the top of the organizational chart. She emphasized that everyone at Pharma Phase I was responsible for making the experience a good one for healthy volunteers: “We want people to be comfortable. … Yeah, if you ask me to get [you] a pillow, I’m [personally] gonna go get a pillow. I’m not gonna say, ‘Aaron, go get this.’ It’s a customer service part of it to keep ’em coming back.” The sincerity of these sentiments was quite evident in most of the Pharma Phase I staff. The recruiters in particular took their role as volunteer advocates very seriously. Tanya, for example, spoke at length about the importance of directing people to free clinics to get the care they needed when a screening visit at Pharma Phase I revealed they had diabetes or high blood pressure. She asserted, “It’s not just, ‘Okay, I’m done with them, they don’t qualify [for a clinical trial].’ … It’s an opportunity for us to then educate them about their own health situation and try and … point them in the direction of healthcare (p.108) to be able to do something about it and not to let it linger and go on.” Gail and Tanya illustrate how Pharma Phase I’s commitment to the community permeated how they wanted to be seen by the larger public as well as how they wanted to treat people who screened for their studies.

Reputation, however, is broader than the work done at Pharma Phase I by its research staff. It seemed that in practice Pharma Phase I was not trying to bolster its parent company’s reputation as much as it was struggling against existing negative perceptions of the industry, especially in the healthcare sector if not by the general public. Research staff at Pharma Phase I were keenly aware of these negative views, which became particularly relevant when they needed to make new hires. The medical director of the facility, Paul, a white physician in his fifties, voiced his frustration about this: “I have real objections to the medical schools saying to the kids, ‘Look out for some of the marketing practices of drug companies,’ and stuff like that. … We’re losing really bright and dedicated people on our side [i.e., pharma]. … It’s also difficult to find nurses too, and some of the smearing of pharma, I believe, has produced a certain reluctance of some of our brighter healthcare professionals to have anything to potentially do with pharma research.” This image of pharmaceutical companies was salient to a lot of the research staff when they reflected on their transition to Pharma Phase I. For example, Tanya was explicit about her worries about working for Pharma Phase I: “When I first got hired here, I was the only African American person here. … And I told [Paul] the medical director, … we were talking about recruiting African Americans, [and] I said, ‘If you hired me to be the Tuskegee nurse, I am not the person for you.’ I said, ‘Because if there’s something wrong, I am going to whistle-blow like you never heard a whistle before.’ [Laughs.]”5 Once they were in their positions, dispelling their initial anxieties about the industry might even have made the Pharma Phase I staff all the more committed to embracing the company’s community-oriented values, thereby illustrating that concerns about the company were baseless.

At the same time, another aspect of the pharmaceutical industry’s reputation made some of Pharma Phase I’s employees concerned about perceptions of bias in their research. This was particularly true for the physician-investigators and most clearly articulated by Paul. Commenting on their handling of participants’ adverse events, he said, “I want (p.109) the [FDA] auditor to come in and say, yeah, open-and-shut case. … No conflict of interest in it because Dr. So-and-So from [prestigious academic medical center] who doesn’t work for [Pharma Phase I or its parent company] confirmed it, you know? I’m not gonna make it to the front page of the New York Times with that, you know?” Paul’s concern about outside scrutiny of Pharma Phase I’s conflict of interest in making determinations about the safety of their own drugs is fascinating. On one hand, it underscores the apprehension about maintaining the company’s reputation, but on the other, it raises the possibility that it might lead to more careful research. Regardless, these aspects of Pharma Phase I’s organizational values and reputation indicate that a pharmaceutical company operating its own Phase I clinic might be confronted with different issues than clinics conducting the trials for them.

Academic Phase I

Academic Phase I was in a unique position. It was technically part of an academic medical center, but because nearly all of its clinical trials came from the pharmaceutical industry, it needed to maintain relationships with companies in order to stay afloat, which could be a struggle when competing with CROs and independent clinics. The academic part of its mission also meant that the clinic was responsible for teaching medical fellows enrolled in the clinical pharmacology program. Neil, the clinic director and a white physician in his forties, explained Academic Phase I’s position: “So, for better, for worse, we’re a CRO in terms of contracting, in terms of the job that we do and our deliverables. I mean, where we differ is we have other missions. So, we have a training mission. It’s a great place for our fellows to train, to learn how to do this. Many of whom go on to [work for] the pharmaceutical industry.” Although Academic Phase I was decidedly not a CRO, it is interesting that Neil compared his clinic to the for-profit world and characterized it as a training ground for industry. By this metric, however, he still found his clinic coming up short, adding, “I do feel like lots of times, we’re driving blind, so we—, I have almost no competitive advantage.” From an industry perspective, Neil might be right. Academic clinics have become outmoded, given how much the scale of healthy volunteer trials has changed. At the clinic level, however, he missed a critical part of what his (p.110) organization’s value for training researchers provides: the strong presence in the clinic of physician-investigators. Academic Phase I differed dramatically from the other five I visited in that I frequently observed a physician circulating within the clinic to examine and interact with participants. This was sometimes Neil himself, but more often it was Andrea, a fellow in the training program. In comparison, the other clinics typically relied on nurses and other staff to conduct procedures or check on participants.

From a healthy volunteer’s perspective, the real disadvantage of Academic Phase I’s clinic was its lack of amenities. I mentioned above that the space was quite dated and in need of refurbishing. Patty, a white woman in her thirties and the clinic’s recruiter, flagged the risk the space created for conducting clinical trials: “It’s not a very big place, you know. We don’t have a pool table and video games, so I could see why being here for thirty days straight would get a little antsy. … You know, like I do try to be as upfront—sometimes bluntly so—with our subjects. … ‘Well, you know, we had you here [before], you were here for ten days and you dropped out. … It ruined all the data we had for you.’ … It does reflect badly on our group when that happens.” Patty drew attention to how the clinic space might hurt retention should participants feel unable to remain confined there during long studies. If Academic Phase I failed to deliver the data they were contracted to generate for the sponsoring pharmaceutical company, their ability to secure future clinical trials could be impeded. Patty’s strategy to minimize the chance of volunteers withdrawing from studies centered on being much more lenient about what items participants could bring with them to the clinic. Unlike Pharma Phase I and the other clinics that prohibited camera phones and other items, Academic Phase I encouraged participants to make the space as comfortable as possible for themselves. Additionally, the staff valued their positive interpersonal relationships with participants. Patty explained, “The overall thing that I hear most [from participants] is they don’t want to be treated like cattle or a number. We use their names; you know, we don’t call out, ‘Baseline or Allocation Number Three, come here,’ you know? [Instead, we say,] ‘Joe Smith, you’re up next.’” Although Patty had never visited any other Phase I clinics, she said that from talking with participants, she knew Academic Phase I’s approach and relationships with healthy volunteers was different. She confided, (p.111) “There’s another one … I hear a lot of bad things about. … [Laughs.] No names mentioned! … But they also feel that they’re not treated properly [there]. … So I think it’s that level of trust that they have come to learn with us. You know, Dr. Neil is fantastic; he knows these guys, you know? So he’s willing to go above and beyond what needs to be done sometimes for them. … It is a level of care that he definitely exhibits towards them.”

Because Academic Phase I was a small research unit, it facilitated the kind of relationships that Patty described between the research team and healthy volunteers. With no more than a dozen participants in the clinic at any one time, it was much easier for the doctors and nurses to remember everyone’s name and provide individual care. Whereas some of the commercial clinics might have actually treated participants poorly, as Patty suggested, many of these larger Phase I clinics might have simply had a volume problem. With 50 or more participants present at a time, it could become an impossible task for research staff to remember everyone’s names. Regardless, the size of Academic Phase I coupled with its training mission created the conditions for the staff to cultivate a handson atmosphere prioritizing participants’ welfare.

Commercial CRO and Independent Clinics

In comparison to both Pharma Phase I and Academic Phase I, the profit motive was much more front and center in the CRO-based and independent clinics. This does not mean that these companies were purely profit driven, but unlike a pharmaceutical company or academic medical center, they did not have other competing organizational missions. Because their businesses depended on winning contracts for clinical trials from pharmaceutical companies, they had to be attentive to their reputations within the industry. As such, they needed to enhance the value of their services to pharmaceutical companies, which, in turn, directly shaped their short-term and long-term business objectives.

At the same time, attention to the bottom line affected their practices because there was more incentive to operate on the smallest budget possible as a way of increasing their profits. Cottage Phase I provided a striking example of this in its staffing decisions. Rather than hiring separate staff to manage the day-to-day operations, senior management instead required personnel to fulfill multiple roles. For example, other (p.112) clinics had nurses or phlebotomists to conduct procedures, lab technicians to process blood and other research samples, and kitchen staff to prepare food. At Cottage Phase I, however, the nurses and phlebotomists did all three of these jobs. On the first day of my visit to the clinic, I was truly astonished to see Kristen, a white woman in her thirties and the lead phlebotomist at the clinic, making dinner for the participants. She had a break from her responsibilities while the participants were eating, which prompted me to ask her to make time for a formal interview. About halfway through the interview, I asked how it happened that her job included cooking. Kristen defensively asserted, “This is actually one of the things that keeps me happy at this job.” As I explained my surprise, she relaxed and provided a fuller explanation: “Because this company, I think, only has 25 people full time on the books, everybody has to do everything or it just wouldn’t work. … There’s only so much income that the company is gonna bring in—I mean, as a final number. … And it was kind of presented to me like, ‘Look, if you learn everything, you’ll make more [money] ’cause then we have to hire less people.’ … I love cooking, and I like working in the lab.” Although Kristen personally enjoyed performing these duties, she acknowledged the turnover in nurses at the clinic who had not appreciated such an expanded job description, remarking, “This job isn’t for everybody.”

Even though Kristen expressed enthusiasm for her position at Cottage Phase I, she recognized that balancing multiple roles did not necessarily place the clinic or herself in the best possible light for the healthy volunteers. She wondered, for instance, how they perceived that the person who took their bodily fluids also prepared their meals. Because this would make her uncomfortable if she were volunteering for a study, she adapted her behavior to reduce any concerns they might have: “I try to be very open about my hand-washing procedures, so that they [the participants] see me. Sometimes perception is everything, ’cause they know I’m in the lab. They watch me walk away with their pee. And then they watch me walk in here and make sandwiches. … I make sure they see me put the fresh gloves on when making a sandwich. And some of my co-workers think that’s a little ridiculous, but I make these emphasized movements.” Kristen’s awareness of how the participants might perceive the situation indicates that she had not completely normalized the multiple roles she was asked to fill in her job. Yet, she did not openly (p.113) question the management decision to maximize profits by intensifying the labor of the clinical staff. The intentionality of the clinic’s strategy was highlighted when the director of operations, an African American man in his fifties named Samuel, boasted, “I’m a Six Sigma black belt, so … I knew of some places that we could cut some of the fat off … and make things run a lot smoother.”6

Another aspect of how clinics can run more profitably involves the degree to which they choose to invest in amenities for participants. As noted above, Cottage Phase I had multiple broken recliners that participants were nonetheless expected to use. At CRO Phase I, insufficient and mismatching furniture was packed into a cramped, windowless space, indicating the company’s priority was on function not form. Other than televisions, the commercial clinics tended to lack activities for participants. Most had neither the games, movies, and books that Pharma Phase I supplied nor the comforts of a semi-private room that Academic Phase I had. When describing the space at Mega Phase I where he worked, Spencer, a white physician-investigator in his forties, declared, “I think the subject comfort level [at our clinic], just being a newer structure with more modern amenities, is probably greater [than other facilities]. However, interestingly, the average Phase I participant isn’t really expecting probably as high level of accommodations as perhaps the general traveling public [is]. So even though, you know, the employees may feel that a newer and nicer facility is better ’cause it’s more comfortable and it’s fancier for the subjects, they themselves maybe not appreciate it as much as we think that they should [laughs] because they don’t really need such fancy conditions.” Mega Phase I was spacious and well designed, but with its bunk beds for participants, it would hardly have been considered “fancy” by most people’s standards. Still, Spencer’s comment about the space not really being for the participants was likely not too far off from the corporate decision to design such a facility. Rather than designing the clinic for the participants, the company appears to have invested in its infrastructure to impress clients—pharmaceutical companies whose business Mega Phase I was trying to lure. On the surface, everything was modern, clean, and comfortable, but in actuality there was not much for participants to do during long confinements other than watch television.

(p.114) There are limits to the extent to which many clinics would be comfortable cutting corners to earn more profits. Many would be concerned about their reputations if they did so. Unlike Pharma Phase I, which was concerned with its reputation with the general public, the commercial Phase I clinics prioritized how potential pharmaceutical company clients might view them. For example, Melanie, a white woman in her thirties who was the operations director at CRO Phase I, reflected on the parent company’s relative obscurity: “I don’t know that many people would recognize [CRO]. I’m from this area, and I’ve worked for [CRO] for 15 years. … Even people in the industry haven’t heard of [CRO], you know, so I don’t know if it’s any kind of name recognition, other than people very local like within the [city neighborhood] where they’ve seen our building.” CRO Phase I was part of a relatively small but growing contract research organization, which was not only unfamiliar to the general public, but also unknown to many pharmaceutical companies. The parent company had opted to start a Phase I clinic in order to build its reputation in the industry and, as noted earlier, to try to capture contracts for drug development that could span from Phase I studies conducted in the clinic to later-phase studies managed by the larger company. The haphazardness of the clinic space might have reflected the priorities of the parent company, which focused on expanding its broader business portfolio rather than conducting Phase I trials, and it leveraged its resources accordingly. Of course, the clinic had to be adequately equipped to convince pharmaceutical companies that CRO Phase I was prepared to test their investigational drugs, but the comfort of research participants was not part of the calculus.

At the same time, research staff were aware of negative press about other Phase I clinics and CROs more generally. In order to maintain or enhance their reputations, the clinics certainly had to avoid anything in their pursuit of profits that could tarnish their organizations. Kyle, a white man in his fifties who was an executive at Cottage Phase I, took pains to map out the industry for me. When talking about the recent closures of several Phase I clinics, he remarked,

I have my theories, or hypothesis—whatever the correct word is—as to why those sites closed. I know a couple of ’em are quality issues, significant quality issues. I also know a lot of ’em are financial issues, meaning (p.115) the profit margin wasn’t what the investment community thought they would be. … These things need to be continually examined to prevent fraud and abuse. I just don’t have the seeds to cut corners because I know if I ever get caught, that’s the end of my business. And I think most research institutions are like that. … The risk isn’t worth it, ’cause it’ll catch up to you. … SFBC, … that’s the greatest example.7

Kyle’s reference to the Phase I clinic that had been run out of a former Holiday Inn before being shut down is an interesting representation of the risks of cutting corners. Even more fascinating, however, is the fact that he nonetheless seemed to prize taking chances to increase revenue in a way that almost conflated profitability with fraud and abuse. Within this frame, the only reason not to commit fraud was the risk of getting caught and ruining his company’s reputation. While this was not literally what he meant, Kyle truly was concerned with making his business profitable. This might be one of the reasons why Cottage Phase I continued to have broken chairs for participants to use.

Although the Phase I industry is relatively small, there are clear differences among clinics based on their organization type. As a general rule, companies that have the most to lose from a scandal are more likely to be cautious about how they manage their Phase I clinics. Pharma Phase I had a global, and very public, reputation to protect as well as an image to project with its clinic. Like other university hospitals, Academic Phase I was also concerned about its reputation, especially as research tragedies could have wide-ranging consequences for its entire research portfolio and federal funding (e.g., Kolata 2001b). As for Mega Phase I, CRO Phase I, Cottage Phase I, and Local Phase I, these commercial clinics likely believed they had much less to lose by cutting some corners in the clinic, but these choices affected, to varying degrees, participants enrolled in their studies. These clinic differences raise the question of how these trends are reflected in the experiences and perspectives of healthy volunteers.

Healthy Volunteers’ Views of the Phase I Industry

Serial participants were also aware of the shifts in the Phase I industry even if they were not privy to the big picture. They witnessed the closure (p.116) of clinics and tracked the different names emblazoned on the buildings. Many helped to spread the word about new clinics, the changing availability of studies, and trends in compensation. While they might not have been familiar with the term “contract research organization” or its acronym, they knew that Phase I clinics were run by pharmaceutical companies, private research companies, and universities. Healthy volunteers, regardless of their region of the country and experience in trials, also took note when research staff were professional and cared about participants or when clinics seemingly focused solely on maximizing their profits.

Changes to the Northeast Circuit

As we have seen, not all serial participants are equally plugged into information about Phase I studies. These differences can largely be attributed to the density of clinics and patterns of openings and closures in each region of the country. Historically, healthy volunteers in the Northeast had the readiest access to multiple Phase I clinics. Referred to as “the circuit” by participants, this area included the hub of clinics that were owned and operated by pharmaceutical companies as well as being home to the National Institutes of Health and myriad academic medical centers. Additionally, participants in the Northeast have witnessed more of the closures of pharmaceutical company clinics and experienced a greater decline in study compensation than any other region. For example, Wesley, an African American in his early thirties who had been participating in Phase I trials for ten years, guessed that he had joined about 30 studies based on his pattern of enrolling in three each year. He said, “I’ve been with GlaxoSmithKline, but they closed down. I’ve been to Wyeth. They closed down. … And Bristol-Myers, I used to go because that’s closer to [where I live]. But they closed down.” That each place Wesley mentioned was a pharmaceutical company clinic indicated how much the Phase I landscape had changed in the Northeast.

With fewer Northeast clinics available to them, serial participants have not only become more apt to travel within the entire circuit from New Haven to Baltimore, but some have also felt compelled to venture to other parts of the country. In discussing the clinic closures, Eddie, an African American in his early forties with more than 50 studies under (p.117) his belt, asserted that it had become much harder to earn the same amount of money from studies as he did ten years ago when he began participating. He took this as a sign that he needed to travel even farther to do studies: “They force us to travel. I’ll travel from here to Texas, and I’ll go from Texas to Chicago, and we’ll go to California, and we’ll go for where the money is … whoever’s paying us the most. … We’ll travel now. So, it’s getting kinda crazy.” From the perspective of healthy volunteers, traveling for studies could give them a sense of control over their participation because it increased their options for where to screen. Indeed, for participants around the country, Texas, with its cluster of clinics in the Austin area, had become a virtual Phase I mecca, a place everyone should visit at least once because it was believed to offer better studies and worth the travel. Despite this view, traveling for Phase I trials is also risky. Taking trains, planes, and long-distance buses clearly increases people’s financial precarity because they spend the little money they might have in the hopes of making significantly more.

Changes in the Caliber of Clinics

Regardless of whether healthy volunteers travel or participate locally, the clinic conditions have also changed, and generally for the worse. Many long-term healthy volunteers spoke nostalgically about the pharmaceutical company clinics that had closed and praised Pharma Phase I.8 Recognizing that pharmaceutical companies have a different type of investment in the clinical trial process, healthy volunteers viewed these clinics as a benchmark against which to hold other facilities. While decreased study compensation was a key concern, they also stressed that compared with many of the remaining commercial clinics, those pharmaceutical company clinics had been better places to participate in studies. For example, Fred, an African American in his forties who had started participating three years before and had done six studies, fondly recalled his time at one of the pharmaceutical company clinics: “They had like a pool table. They had the TV and the video game [console], but they … [also] had a karaoke machine. And they offered like, ‘Well, which one of y’all think y’all can sing? Whoever can sing the best, they’ll get a hundred dollars.’ And they really did it. … They had incentives that would pass time by and kept you occupied.” (p.118) That a clinic structured participants’ time through friendly competition for a monetary prize is particularly clever because it helped make studies there more fun and positioned the company as generous with their resources. Likewise, Pharma Phase I was held up as an exemplar for how clinic spaces should be designed. Don, an African American in his late forties, asserted,

The reason I like about it is that whoever designed it designed it [so] it’s perfect for—, it’s like a lot of earthy colors, … like the paint is like purple and brown. … It doesn’t look like some units you go to like it’s all white walls, [and] you feel like you’re in a mental cell. … [At Pharma Phase I] they’ve got some nice pictures of the outdoors, and you can get on the computer. And one thing I really like [is] they have a quiet room that I like, ’cause I like to get away from people sometimes.

Comparing Pharma Phase I to other places, Don even likened his experience there to a vacation. Moreover, Trent, an African American in his late thirties, indicated that differences among clinics could influence where he would enroll in a long-confinement study: “[Pharma Phase I] got a great facility. … If you want to do a long study, that’s probably where you want to do it ’cause it’s very comfortable. A lot of places they don’t have as much money as [Pharma], so it’s not as comfortable.” For Trent, the difference in clinic comfort came down to the wealth of the company and meant that a place like Pharma Phase I should be better than academic or commercial clinics.

Thus, the industry trend was toward closure of the clinics healthy volunteers preferred only to be replaced by ones about which they had many complaints. Because of the vast Phase I trial experience he gained by traveling throughout the United States, Eddie had strong criticisms of the direction the industry had taken:

Different clinics are different. I understand you have like the major pharmaceutical companies, and you have the middle men actually test [the drugs for them]. … It’s kinda getting a little crazy now because, like, … these different [commercial] places, it’s like, you know, it’s like a manufacturing plant now [in how they treat healthy volunteers], … processing ’em in and processing ’em out. … I mean, it’s getting a little (p.119) out of hand, and there needs to be more regulation in this industry. … All the veterans [healthy volunteers] have said, “That’s it, they need to regulate this; it’s getting out of hand now.”

Stuart, a white man in his fifties who also traveled the country for studies, was explicit in comparing Pharma Phase I to the other places he had been: “There are sort of differences, you know. I mean this, because it’s owned by [Pharma] itself is really nice, and then a lot of places are—, you know, the different drug companies … farm it out to ’em or whatever, and they’ll just, as far as the physical environment … may be a little more cut-rate. [Laughs.]” Both Eddie and Stuart presented these industry changes as dire ones, with Eddie even suggesting that the government should step in to manage the declining conditions.

There was a strong sense among healthy volunteers that certain clinics made for a much worse study experience than did others. Several commercial clinics were mentioned as the worst offenders, with one in New Jersey repeatedly named as a place to avoid. Participants regularly described this particular New Jersey clinic as “ghetto,” meaning that it felt rundown and unsafe. Additionally, Alexandra, a white transwoman in her forties, depicted that clinic as stressful, saying, “It’s kind of like the cattle mart. It’s so—, everyone is just bunched up together. … And also they can have like 120 volunteers at one time, and it’s a smaller facility than here [Pharma Phase I], and it seems they just bunch everyone in [the New Jersey clinic] like sardines.” Likewise, Tia, an African American participant in her early thirties, made several negative observations of different commercial clinics, but her experience of that same New Jersey clinic was particularly memorable: “We had dogs—bedbug sniffing dogs—come in because there were bedbugs in the facility. In the main area [for procedures] where they have all the chairs, they had to pull several of them out and dismantle them. The dogs literally were sniffing us and our baggage and everything. They had to pull beds out. This is the middle of the summer. Air conditioners were broken. The beds would stink. … It was horrible. Horrible. [Laughs.]” For Tia, these conditions confirmed in her mind that this clinic was “almost like jail.”

Many participants astutely observed that these commercial clinics were uncomfortable because they were more profitable that way. Speaking about the same New Jersey clinic, Terrell, an African American in (p.120) his late thirties who had enrolled in an estimated 54 studies, asserted, “When I think of a corporation, like the epitome of the—I’m not gonna say ‘evil’—the money-hungry corporation, that’s [this New Jersey clinic]. Any way they can cut corners to save a little bit, that’s them. And when you’re going through this [experience there], … you realize that you’re going through this so somebody [at the company] can have a bigger boat.” Without exception, participants viewed poor clinic conditions not as signs of struggling businesses but instead as intentional cost-cutting measures to increase company profits. Aidan, a white man in his thirties, made a similar complaint about the food at Mega Phase I on the West Coast. Commenting on the clinic’s recent change in management, he griped, “The food still sucks, it will always suck, which is terrible. I mean, I can’t even imagine the [large amount of] money that flows through one of these studies. … I understand it’s expensive to do these, but there’s no reason the food has to be as bad as it is. Like, I had a turkey sandwich today, maybe ate half of it. How can a turkey sandwich taste bad? But it does. That’s pretty sad.” Also remarking on Mega Phase I, Frank, a white man in his forties who had participated in about ten studies, thought that the pharmaceutical companies paying for the Phase I trials just had no idea that their funds were not being invested into the clinic:

The pharmaceutical people that are spending the money … doesn’t know. … Has the client [i.e., the pharmaceutical company] actually ate their food here? … The client only sees it printed on a paper. … They see the menu, but what you’re getting and you’re eating is a totally different thing. … You got guys that are … giving your food with tattoos on their head: “Yo, what’s up? Whatcha want to drink, homey?” … So the client really doesn’t know. The client should actually come in here … be like a little secret shopper.

Frank in no way believed that the pharmaceutical companies might be complicit in the poor conditions he experienced in studies; instead, he assumed that they had been duped by a profit-seeking commercial clinic.

Most clinics include detailed information in their consent documents about the specific menu participants are required to consume during a (p.121) study. This is largely to ensure that participants do not have any dietary restrictions that would preclude them from participating (e.g., pork, gluten, or nuts). Marshall, an African American in his thirties, related an experience at an East Coast clinic that also had terrible food: “So they would tell you—and they actually put that in the informed consent—that the food didn’t taste good, ’cause everybody complained about it ’cause it was so nasty.” This is particularly condemning because it suggests callousness on the part of clinic management. Instead of actually changing the quality of the food, they simply made people consent to eat bad food—no additional expenditure required.

Not only were the less desirable commercial clinics cutting corners on amenities and food, but some healthy volunteers reported that they also engaged in unscrupulous practices regarding study payment. For example, Brian, a white man in his late fifties who traveled all over the country for studies, accused some clinics of nickel-and-diming participants out of the promised compensation. He fumed, “They’re looking to get 10 percent of the money they pay you, they’re gonna get it back from you in fines. So they will fine you for every little thing that they can. It’s ridiculous.” He provided the example of a participant forgetting that he had a blood draw and showing up late to the phlebotomy station. The clinic “fined” that participant $50—meaning that the fine was deducted from the eventual study payment. Participants also argued that clinics took financial advantage of them by making them agree to additional procedures after a study was underway. While not actually reducing their compensation, these participants strongly felt they should be paid more for any extra blood draws required by a study. Ross, an African American in his forties who had been participating in Phase I studies for 12 years, became so angry when this occurred at a Northeast clinic that he withdrew from the study entirely: “I checked in in the morning, I wanna say around 7:00 something. That evening they did an orientation, and during orientation, they casually mentioned, ‘Oh, well, there are 10 additional blood draws.’ And people grumbled but rolled over and took it. And on that 8th day [of the study], … they said it involved two more, which wasn’t in the informed consent. … I complained about it. They said, ‘You can leave if you want.’ I said, ‘I know I can,’ and I left. You know, but they were just tacky in their approach.” If it was not sufficiently clear that Ross disliked that particular clinic, he added, “I think (p.122) really the only thing lower than going there is doing that study out of the back of a van.”

Healthy volunteers experienced a final type of unfairness surrounding compensation: luring people to screen for a study with the false promise of high stipends. For instance, John, a white serial participant in his early thirties, had received a text message from a commercial clinic advertising a study that offered “up to” $5,700 in compensation, but when he called, the recruiter told him the stipend was only $4,500. In John’s view, “They inflated the price to get you to call, and then they just dropped the price. They’re playing games with you. … That made me not trust them. … If they’re gonna play games like this, I don’t think it’s worth it for me to gamble in that way.” As a result, John did not enroll in the study, and he told other healthy volunteers about the experience to alert them to the possibility that this clinic might not pay participants as promised.

The biggest complaint voiced by participants about the commercial clinics concerned the lack of qualified phlebotomists on staff. This was in contrast to the academic medical centers and pharmaceutical company clinics, where participants found the staff “professional” and skilled. Tia made the comparison between clinic types explicit: “I love [Pharma Phase I] because it’s professional. … The staff is very well trained. Most of the people who will draw your blood are actually nurses, and that’s not the case with most other facilities. … It’s kinda, I don’t know, I call these the ‘hood study spots. [Laughs.] They’re like any street corner you can go on, you know? Everything is just so lax.” Whereas a lot of participants bemoaned the multiple attempts it took less qualified staff to draw blood successfully, Tia had a terrifying experience at a commercial clinic. In her last study at one, the blood collection was so frequent that the clinic decided to use catheters to facilitate the process. This did not go smoothly for Tia:

They broke a catheter in my arm! … And it took somebody who it was their first day [on the job] to actually get the needle out of my arm. No one else could get this needle out of my arm. I had blood spraying everywhere. Thankfully, the point was still sticking out of my skin, so she was able to get some forceps and grab it. And it was excruciating. … I said, “Please don’t tell me sorry one more time in here. Y’all better get this thing out of my arm. Get it out of my arm!” [Laughs.]

(p.123) While Tia’s catheter experience was anomalous, stories about staff struggling with blood draws abounded. Even though he was in his first study, Eric, a multiracial man in his twenties, observed that half of the staff drawing blood at CRO Phase I were not skilled phlebotomists. Becoming distrustful by the midway point in the study, he stated, “If you’re, like, somebody new and you try to draw my blood, get me somebody else. … If you don’t know what you’re doing, you don’t need to be sticking nobody in their arm.” Interestingly, when describing these situations, many participants claimed to stand up for themselves and request someone with more experience to step in. In Eric’s case, it is difficult to know if he was narrating his inner monologue as he encountered new staff or if he really had asked the clinic for someone else to draw his blood. Reportedly, these requests have led to altercations between staff and participants, as Robert, an African American in his twenties, indicated in his criticism of untrained staff: “You’re supposed to know where the vein is. … I’ve seen people get mad at the staff. They’re ready to fight.”

Healthy volunteers’ perceptions about the professionalism and expertise of the staff also carried over to their experiences of study adverse events. First, participants assumed that academic clinics and pharmaceutical companies were better equipped in the short term to handle medical problems. Even though he participated at all types of clinics, Marcus, an African American long-time participant in his forties, reflected on enrolling in studies at Academic Phase I: “This is a little bit more safer actually [to do studies] in this environment because you have the hospital here. If something happens, they take care of you right away.” Second, participants doubted commercial clinics’ commitment to providing medical care should health issues emerge during clinical trials. Indeed, the stories participants told about struggling to get medical attention following a study always involved a commercial clinic. Unfortunately for Javier, a Latino in his forties, he had developed a rash that turned into a “bubble” during an Alzheimer’s study at an independent clinic. When the rash went away and what might have been a cyst remained, the clinic recommended he consult an outside physician to have it evaluated. Javier recounted the details of what happened by contrasting his experience with his expectations for how Pharma Phase I would have handled it:

(p.124) [Pharma Phase I], when there’s something wrong with you, they will check you. … They will make sure that you’re all right. … People gettin’ reactions and they always take care of you. And not all the places is like that. … You know how long it took me to get this [cyst] operated on? But this is a little company called [independent clinic]. They gave me the runaround for about four months because they didn’t want to pay for it. … And they didn’t want to pay for it because they are not like [Pharma Phase I]. [Pharma Phase I] tests their own medicine. They [this other clinic] do testing for other companies. So, they don’t wanna dig into their profits. And I try to stay away from those little places like that because … do you know what they told me? “If something goes wrong, I’m not there for you.” [Laughs.] That’s what they told me.

Although the clinic staff did not literally tell Javier that they did not care about his safety, it is nonetheless important that this was his interpretation of their inaction around his adverse event. Moreover, the motif that they were maximizing their profits at Javier’s expense echoes all the other critiques of these commercial companies as “cheaper” versions of the best clinics.

In the previous section, Spencer, a physician at Mega Phase I, suggested that the clinic facilities do not need to be high quality because healthy volunteers do not expect or require it. This might be true in the literal sense that healthy volunteers still enroll even when they perceive the accommodations to be uncomfortable and the staff inadequately trained. Russell, an African American in his mid-forties, was irritated by people who complained about the clinics when they knew exactly what they had agreed to. He pointed out, “I know why I’m here, so I signed the consent form and act accordingly. It’s that simple. [Laughs.] … You wasn’t complaining when you wanted to get in there, so just fall back and get paid. I don’t care if they have no windows. I don’t care, as long as you give me my little three squares [meals].” Russell’s focus on the transactional aspect of clinical trials—consent, submit, get paid—supports Spencer’s point. Healthy volunteers do participate even when clinic conditions are subpar.

Yet, healthy volunteers’ willingness to participate at subpar clinics does not account for how they experience these conditions. Many, such as Javier and Tia, articulated a strong feeling of being mistreated and (p.125) devalued. Additionally, Marcus commented on how this was a change in the industry: “Not too many people used to do this [participate in Phase I trials], [so] they needed you. Now it’s like, ‘Oh well, we got a million people now,’ [and] they started to—, they talk trash to you. … They treat you like you’re actually in jail. … That’s why … over the years I just haven’t gone to certain places. You know, my blood is good anywhere, … but yeah, it’s like you got certain places that they just treat you real, real bad.” Narratives like Marcus’s about study clinics being like jail also communicate that some participants have felt dehumanized by their experiences at certain clinics. This was particularly salient in Eddie’s reflections on the state of the Phase I industry. He lamented,

We wish it would change for the better, [but] we see it changing for the worse. And we just want it to, you know, “Hey, stabilize it. Don’t let it get any worse than what it is, ’cause we’re human and, you know, you gotta treat us that way.” … It’s getting to the point where they are, from my point of view, that you are starting to treat me like a guinea pig now. And no, I mean, I’m a human. You know what I’m saying? If you want a guinea pig, just test it on an animal, and that’ll be it. They [nonhuman animals] don’t talk, they can’t say nothing, all you see is their labs: “Okay, his organs failed. Okay.” But I can tell you, “Hey, I’m not feeling well. I need some—, I need you to do a blood draw and run that lab, [because] something’s wrong.”

Eddie’s literal comparison between healthy volunteers and guinea pigs is an interesting response to the decline in clinic conditions that he has experienced. It draws attention to the difference that might exist between calling oneself a human “guinea pig” or “lab rat” and being treated like a laboratory animal. In arguing that humans have value beyond that of lab animals because they can verbalize any adverse effects they experience, Eddie was protesting the material changes in the treatment of healthy volunteers. His perspective also serves as a reminder of what the Phase I industry is meant to support.

Reflections on Industry Changes

We have examined the Phase I industry and its relationship to the clinics engaged in healthy volunteer research. Many of the companies that (p.126) offer clinical research services to the pharmaceutical industry do so opportunistically, seeing the chance to profit from larger trends in corporate outsourcing. There have been numerous documented scandals that have drawn attention to the shady business practices deployed by some Phase I companies, such as SFBC’s appropriation of a Holiday Inn with troubling fire and safety violations that forced the company to shut down operations. These same issues were mirrored on a lesser scale in healthy volunteers’ experiences of other commercial clinics that seemingly prioritized company profits over participants’ welfare.

In examining these industry changes from the perspective of the clinic staff, it becomes clear how reputation and organizational values influence how Phase I facilities are run. Reputation operates in uneven ways in the Phase I industry because the different players have different audiences. Pharmaceutical companies and academic medical centers are generally more concerned about their public reputation than are commercial Phase I clinics because the former are prone to broader and more direct impacts should problems arise during clinical trials. In contrast, commercial clinics are generally more concerned with their reputations vis-à-vis the pharmaceutical industry because this is the source of their business—about which the general public has little knowledge in any case.

The various clinics also had different values that dictated their operations. In the case of Pharma Phase I, the clinic espoused a strong commitment to upholding or enhancing its larger corporate brand, being a good community member, and responding to the needs of research participants. Notably, the customer or client for Pharma Phase I was identified as the healthy volunteer; whereas for all the other clinics, the customer was the pharmaceutical company sponsoring the trial. For Academic Phase I, much of its clinic practices were influenced by its training mission. With its emphasis on teaching physicians to be clinical researchers, Academic Phase I provided better clinical care for and more attention to research participants than any other clinic. In contrast, the commercial clinics were much more obviously business-oriented, looking for ways to increase their contracts with the pharmaceutical industry while lowering their costs in the clinic. Cottage Phase I notably took the approach of combining traditionally disparate job descriptions by requiring research staff to work with participants, in the laboratory, and (p.127) in food preparation. At CRO Phase I, Mega Phase I, and Local Phase I, there were numerous examples of clinic conditions being less than ideal, either in terms of the space and amenities or the quality of the food. Even though these decisions can negatively affect healthy volunteers, the clinics had a financial incentive to cut corners provided these decisions would not cost them a contract with a pharmaceutical company.

The changes in the industry can be appreciated more directly through the stories and experiences of healthy volunteers. Long-term participants, especially those on the East Coast, have witnessed the shift in the industry with the closure of pharmaceutical company clinics and the proliferation of commercial clinics. Some have responded to this new landscape by traveling for studies, trying to find the best-paying trials in their region or throughout the country. Overall, healthy volunteers have been confronted with less than ideal choices about where to enroll in studies. While their reports of the clinic conditions are concerning, their experiences of unprofessional and untrained staff are much more alarming because they suggest that the commercialization of Phase I trials has led to a decline in the protection of human subjects.

Another effect of these industry changes is to reinforce the stigma of participating in clinical trials. If healthy volunteers believe there is some shame in enrolling in Phase I trials, subpar facilities, in which they are made to feel as though they were in jail or less than human, might just confirm this belief. Additionally, some interpreted their own or others’ willingness to participate in studies at clinics with poor accommodations and untrained staff as a sign of financial desperation; to return to those places meant that someone was truly out of better options, which made enrollment all the more shameful. At the same time, the commercial clinics could also be seen as exploiting the extent to which participants are already marked by imbricated stigma. As long as there are healthy people who, because of broader social inequalities, enroll in their trials, what incentive do the clinics have to improve their facilities or to invest more in study stipends?

Moreover, the capitalistic orientation of the Phase I industry precipitates the formation of the healthy volunteer as a type of model organism. In the business model advanced for clinical research, healthy volunteers are constructed in a way that mirrors that of nonhuman animals. Generally speaking, they are present as research material to get the job done (p.128) and generate profits for the industry; they are not the client whose needs must be met. While the treatment of healthy volunteers might vary from clinic to clinic, their trial enrollment is nonetheless always a part of the broader engine of profit propelling drug development. The next chapter examines what the job of the model organism is in Phase I research.

Notes:

(1) In addition to reflecting broader trends in outsourcing, neoliberal legislation in the 1980s contributed to the formation and success of the clinical trials industry. Specifically, the 1980 Patent and Trademark Law Amendments Act—or the Bayh-Dole Act, the combined names of the bill’s co-sponsors—aimed to spur innovation by allowing individuals and universities to hold patents and profit from inventions that resulted from federally funded contracts and grants (Goozner 2005). Additionally, Congress passed the 1984 Drug Price Competition and Patent Term Restoration Act, more commonly referred to as “Hatch-Waxman.” The goal of this latter legislation was, in part, to modernize the FDA review of generic drugs. In brief, the law stipulated that to have generic drugs approved for the market, manufacturers needed simply to demonstrate that in healthy volunteers their products were “bioequivalent” to the original brand-name drug (Carpenter and Tobbell 2011; Greene 2014).

(2) The early history of Phase I trials also included the widespread use of prisoners as healthy participants (Harkness 1996). Pharmaceutical companies found that many prisons were eager to partner with them, cooperating to the point of offering prisoners reduced prison sentences, better food, more comfortable living conditions, and modest compensation (Hornblum 1998). For their part, pharmaceutical companies received large populations of motivated research participants in a highly controlled environment, helping to establish Phase I trials as “confinement” studies. By 1976, 85 percent of all Phase I trials occurred in (p.273) prisons (Bonham and Moreno 2008). However, fallout from the US Public Health Service’s 40-year Syphilis Study in Tuskegee, Alabama, drew national attention to unethical human subjects research (Jones 1981; Reverby 2009), and prisoners’ participation in nontherapeutic research also became the subject of congressional scrutiny (Mitford 1973). Prisoners came to be identified as a vulnerable population (National Commission 1976, 1979), and subsequent federal regulations restricted the use of prisoners in research, requiring that the research would benefit the prisoners themselves or provide important information about crime, corrections, and recidivism that could benefit society. With these regulations in place, Phase I trials were effectively banned from prisons. More recently, there has been concern that the federal regulations have been too restrictive and should be relaxed to allow more research to occur in prisons and with prisoners (Institute of Medicine 2007).

(3) In her research on the clinical trials industry, Adriana Petryna (2009) refers to these research clinics as “floater sites” that underbid on contracts from the pharmaceutical industry and have subpar operations compared to more legitimate contract research organizations.

(4) Investing in this way in its testing facility could have been particularly important to Pharma Phase I given that the largest pharmaceutical companies have been criticized for not being the source of innovation in the industry (e.g., Angell 2004; Goozner 2002). The most profitable companies often wait for smaller companies to develop promising products, which they then acquire and test in Phase III clinical trials (Fisher, Cottingham, and Kalbaugh 2015).

(5) In my earlier research on clinical trials, some of the research coordinators also vilified Eunice Rivers for her role as an African American woman who helped to recruit and retain African American men in the Public Health Service Tuskegee Syphilis Study (Fisher 2009: 92–93).

(6) Six Sigma is a method for creating more efficiency in organizations and is generally directed at increasing companies’ profits (https://www.6sigma.us, last accessed June 18, 2018). The training and certification process has levels that borrow from martial arts, with colored belts indicating someone’s proficiency in the method. To earn certification, individuals must pay for and enroll in online or in-person seminars. The cost of these seminars increases dramatically to earn higher-level “belts.”

(7) Kyle’s use of the word “seeds” in this quotation is likely slang for testicles, with the more common idiom being “to have the balls” to do something risky.

(8) It is unclear whether healthy volunteers would have criticized these same pharmaceutical company clinics had I interviewed them five or ten years earlier. It is quite possible that participants remembered them better than they had been or that they looked good only compared to worse clinics in operation. An important component of nostalgia is that individuals are often missing a past that was never as happy as the memories convey. Regardless, nostalgia importantly reveals how people wish things to be now.

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