The Politics of the Pharmaceutical Industry

BIG PHARMA AND THE PROBLEM OF

DISEASE INFLATION

Joseph M. Gabriel and Daniel S. Goldberg

Over the course of the past decade, critics have increasingly called attention
to the corrosive influence of the pharmaceutical industry on both bio-
medical research and the practice of medicine. Critics describe the industry’s
use of ghostwriting and other unethical techniques to expand their markets
as evidence that medical science is all-too-frequently subordinated to the
goals of corporate profit. While we do not dispute this perspective, we
argue that it is imperative to also recognize that the goals of medical science
and industry profit are now tightly wed to one another. As a result, medical
science now operates to expand disease definitions, lower diagnostic
thresholds, and otherwise advance the goals of corporate profit through
the redefinition and expansion of what it means to be ill. We suggest that
this process has led to a variety of ethical problems that are not fully captured
by current critiques of ghostwriting and other troubling practices by the
pharmaceutical industry. In our conclusion, we call for physicians, ethicists,
and other concerned observers to embrace a more fundamental critique of
the relationship between biomedical science and corporate profit.

In July 2012 the U.S. Department of Justice (“DOJ”) announced that the pharma-
ceutical giant GlaxoSmithKline had agreed to settle criminal and civil complaints
related to its illegal marketing of the popular antidepressants paroxetine (brand
name Paxil) and bupropion (brand mane Wellbutrin) for $3 billion (1). In addition
to a number of other offenses, the settlement covered allegations that the com-
pany had promoted these drugs for uses not approved by the Food and Drug
Administration (FDA), and that it had failed to report safety data to the FDA for
another one of its products, the popular diabetes drug rosiglitazone (1). Neither
GlaxoSmithKline’s behavior nor the terms of the agreement are particularly

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surprising. In recent years these types of settlements have become increasingly

common; in Table 1 we list the largest of these settlements over the past decade,
but there have been many additional ones at both federal and state levels that
we have not included. The fines levied in these cases might seem large until one
realizes that they are dwarfed by the profits made from the drugs involved. For
example, paroxetine, buproprion, and rosiglitazone earned GlaxoSmithKline at
least $28 billion during the period covered by the settlement described above.
As one industry analyst commented, the price of the settlement “can be rational-
ized as the cost of doing business” (2).
These settlements point to a variety of troubling practices that Big Pharma
uses to promote its goods, include marketing for off-label use, ghostwriting,
seeding trials, and other efforts that, from the perspective of critics, subordinate
the practice of good science to commercial ends.1 These practices pose a sig-
nificant public health problem and have attracted critique from academic physi-
cians, ethicists, social scientists, and other scholars. Reform efforts in the United
States are underway, including the implementation of the Physician Payment
Sunshine Act, which was made law as part of the broader Patient Protection and
Affordable Care Act of 2010 and which mandates the reporting of all financial
interactions between pharmaceutical companies and physicians.
These reform efforts should be applauded. However, the focus on these types
of problems¾while important¾masks deeper issues that merit discussion. In
this article we examine the problem of what we call “disease inflation” and how
the development of new drugs has a tendency to expand diagnostic categories.
We distinguish our concept of “disease inflation” from two superficially similar
concepts, “disease mongering” and “medicalization,” and suggest that both
disease mongering and medicalization should be understood as part of the broader
process of disease inflation. We then discuss a number of potential ethical
problems that attend disease inflation. Finally, we argue that there are concerns
for health and its distribution on human populations that go beyond some of
the ethical and clinical problems that accompany disease inflation. Specifically,
our concern is that the discourse regarding the permissibility of various pharma-
ceutical marketing practices obscures the more important question of the phar-
maceuticalization of health itself. Regardless of the moral status of any particular
marketing practice, we argue that the most significant problem is the extent to

1 We acknowledge, of course, that the pharmaceutical industry is hardly the only for-profit

player involved in biomedicine and public health. Yet while there are similarities between
the interests and strategies of commercial entities engaged in these spheres, there are also
significant differences between the goals and methods of, for example, the health insurance,
pharmaceutical, health insurance, and medical supply industries. We focus our analysis on
the pharmaceutical industry and leave aside the question of whether that analysis is suffi-
ciently representative to apply to other multinational industries involved in biomedicine and
public health.
 Big Pharma and Disease Inflation / 309

Table 1

Major federal settlements, 2004–2012

Year of Drug(s)
settlement Company involved Charge Settlement
2013 Johnson & Johnson Risperdal Off-label marketing $2.2 billion

2012 GlaxoSmithKline Paxil, Off-label marketing, $3 billion

Wellbutrin, kickbacks, suppressing
Avandia safety risks
2012 Abbott Depakote Off-label marketing $1.6 billion
2011 Merck Vioxx Off-label marketing, $950 million
suppressing safety
information,
exaggerating benefits
2010 Allergan Botox Off-label marketing $600 million
2010 AstraZeneca Seroquel Off-label marketing $520 million
2010 Novartis Trileptal Off-label marketing, $420 million
kickbacks
2010 Forest Levathroid, Off-label marketing, $313 million
Celexa, suppression of
Lexapro negative study
findings, marketing
without FDA approval
2009 Pfizer Bextra, Geodon, Marketing violations $2.3 billion
Zyvox, Lyrica
2009 Eli Lilly Zyprexa Off-label marketing $1.4 billion

2009 Merck Zocor, Vioxx Marketing violations, $650 million

kickbacks

2008 Cephalon Actiq, Gabitril, Off-label marketing $425 million

Provigil

2007 Purdue Pharma OxyContin Minimizing risk, $634.5 million

misbranding

2007 Bristol-Myers Squibb Abilify Off-label marketing $515 million

2006 Schlering-Plough Temodar, Intron, Off-label marketing, $425 million

Claritin, K-Dur kickbacks, fraud

2005 Serono Serostim Kickbacks, conspiracy $704 million

2004 Pfizer Neurontin Off-label use $430 million

310 / Gabriel and Goldberg

which health itself is conceived as a function of access to pharmaceuticals (or

lack thereof). This is a problem on both descriptive and normative grounds; that is,
it is both false, and it is ethically suboptimal insofar as it facilitates the erosion
of attention and resources to the structures of political economy that the evidence
suggests are the prime determinants of health and its distribution.

PHARMACEUTICAL MARKETING AND THE

CORRUPTION OF SCIENTIFIC NORMS

Pharmaceutical companies operating in the United States face a significant

market incentive to violate both scientific and legal norms. Pursuant to U.S.
federal law, it is illegal for pharmaceutical companies to promote: (a) drugs for
uses that are not approved by the FDA, (b) drugs for the treatment of patients that
are outside of the approved age range, or (c) the use of drugs at higher doses than
that for which they are approved (3). However, it is perfectly legal for U.S.
physicians to prescribe drugs for any condition, to any patient population, and in
any amount that they see fit. The result is that there is a tremendous incentive
for companies to promote their products illegally: doing so expands the use of the
product into the treatment of new conditions, and even if companies are forced
to discontinue their efforts at a later date, the influence of the marketing cam-
paign continues to shape prescription practice for years to come. For example,
GlaxoSmithKline illegally promoted paroxetine from the late 1990s through the
mid-2000s for unapproved use in children. Concerns that paroxetine and other
selective serotonin reuptake inhibitors lead to increased suicidality in children
and adolescents led the FDA to issue public health advisories about the issue
in 2003 and 2004; the result was a significant decline in the use of this class of
drugs to treat pediatric depression (4). Despite this, paroxetine continues to be
prescribed for off-label use in the treatment of pediatric depression to this day.
It is not alone. According to one recent study, antidepressants that are not
approved for pediatric use were associated with nine out of 10 antidepressant
clinical visits among children and adolescents (5).
Pharmaceutical companies use a variety of promotional strategies to increase
the use of their products that strike critics as troubling in nature, including the
use of thought leaders, ghostwriting, and so-called “seeding trials”¾clinical trials
primarily designed to raise interest in the drug among physicians rather than
to produce scientifically useful data. As Sergio Sismondo has argued, these and
other practices are part of an entire “ghost management” process in which the
pharmaceutical industry shapes the production of biomedical knowledge toward
the goal of corporate profit (6). Ghostwriting, for example, is the practice of
drug companies writing scientific articles and then publishing the articles under
the name of reputable physicians, often concealing their own role in the process.
A significant amount of evidence exists for this practice, including case
studies based on internal industry documents typically revealed through mass-tort
 Big Pharma and Disease Inflation / 311

litigation, investigative journalism, the testimony of former ghostwriters, and the

revelations of practitioners who have been approached by industry with offers
to place their names on articles that have already been written (7–9).
Critics argue that ghostwriting and other such practices are simultaneously
unethical, corrosive to the scientific process, and injurious to the public’s health.
“Ghost writing initiated by industry is a big concern,” notes Robert Fletcher,
professor emeritus at Harvard Medical School and chair of the editorial policy
board of the World Association of Medical Editors. “When it is undetected,
it distorts the scientific record, substituting marketing and persuasion for the
balanced exchange of views and the search for sound answers that characterize
the contents of medical journals at their best” (15). According to critics such as
Fletcher, these techniques subordinate the norms of science to the pursuit of profit.
There is now a substantial literature addressing these types of concerns, and
critique of the pharmaceutical industry and its promotional efforts is quickly
becoming a mainstream position among academic physicians, bioethicists, and
members of the public (11–15).
We agree with these critiques. Ghostwriting, seeding trials, and other promo-
tional strategies that subordinate scientific practice to commercial ends threaten
the health of the public in a variety of important ways, including by exposing
patients to significant risk of harm, distorting the evidence base and diluting
its quality, and by undermining trust in medical science. However, there is an
important way in which these types of criticisms against the industry miss a
deeper issue. Let us assume the unlikely event that all the research that goes
into ghostwritten articles is conducted in a scientifically rigorous manner; let
us also imagine that the authorship of all such articles is revealed. Indeed,
let us imagine that all scientific research is conducted in a rigorous manner
according to the best norms of the day. Would the problem of commercial bias
really then be eliminated? Would medical science be free from the corrosive
effects of the drive for corporate profit?
We do not think so. As we argue below, ethical concerns about the relationship
between the drug industry and medical practice are not limited solely to the
problem of how drug companies subvert the norms of science. Rather, significant
ethical concerns are raised by the fact that the scientific process itself¾even
when conducted in a rigorous and ethical manner¾contributes to the expanding
definition of what it means to be ill.

THE PROBLEM OF DISEASE INFLATION

Since the end of World War II, the biomedical enterprise has been radically
transformed as growing aspects of life are understood through the framework
of disease and rendered suitable for therapeutic intervention. Biomedicine has
expanded its domain from the treatment of acute conditions to the daily manage-
ment of chronic disease; from the treatment of visible symptoms to the reduction
312 / Gabriel and Goldberg

of risk; from problems of the body and mind to social and behavioral difficulties.
It has occupied and transformed a vast number of realms previously outside its
reach, including the control of reproduction, the management of deviant behavior,
and the optimization of our future selves. Increasingly, we understand ourselves
and the world in which we live through the lens of the biomedical sciences,
through the language of genes and brain mechanisms, through the identity of
the patient or the victim of a disease, through our efforts to understand, extend, or
resist the expansion of medicine and its allied sciences. Of course, a tremendously
important part of this process has been the impact of the pharmaceutical industry
on both the practice of medicine and on the creation of biomedical knowledge.
Increasingly, pharmaceutical science and corporate power combine in complex
ways to define the nature of health and illness and to render a growing number of
conditions suitable to pharmacological intervention (16–19, 27, 49, 50).
What are we to make of this process? Since the 1970s critics have pointed
out that medical science has increasingly rendered what were once social or
personal troubles into medical problems through the “medicalization of life”
(20). Although there is some debate about the utility of the medicalization frame-
work among sociologists (50), and medicalization is, ideally, a value-neutral term,
running through much of this type of analysis is the assumption that medical-
ization has taken place primarily for commercial reasons and should be resisted.
Critics argue that the industry promotes the medicalization of hyperactivity,
depression, anxiety, sexual dysfunction, and other ailments that are not, in their
view, true diseases; still others describe how the industry works to lower the
threshold of diagnostic criteria, define risk factors as diseases requiring medical
intervention, and otherwise work to create, maintain, and expand markets for
pharmaceuticals by expanding the definition of what it means to be ill (21, 25–28).
Critics also attack the industry for “disease mongering” more broadly, suggesting
that drug companies and their allies in the medical and insurance industries
promote the overuse of pharmaceuticals, sell products to patients that they do not
need, and otherwise prioritize corporate profits over patient health by “selling
sickness” (21–24, 27, 28, 49, 50). Critics see all this as deeply troubling and
seek to expose, as Moynihan and Cassels put it, “how the world’s biggest phar-
maceutical companies are turning us all into patients” (28).
These are important critiques, and those who make them raise legitimate and
significant ethical concerns about the industry’s role in expanding what it means
to be ill. Yet it is also important to recognize that the transformation of non-
medical problems into medical ones, the lowering of diagnostic thresholds, and
other processes that critics frequently decry are often pursued for both scien-
tifically valid and humane reasons. The fact that these efforts also advance the
financial goals of the industry and the professional goals of those involved in
pursuing them does not change this fact, nor does it mean that the results of their
efforts are by definition illegitimate. Take hypertension: few would argue that
people diagnosed with “hypertensive emergency” should not promptly receive
 Big Pharma and Disease Inflation / 313

some sort of pharmacological intervention in order to reduce the risk of stroke

and other serious problems, and the advent of antihypertensives in the 1950s
has been an important factor in reducing the mortality rate associated with
hypertension (29). Yet as Jeremy Greene has shown, the very idea that elevated
blood pressure represents a medical problem requiring treatment¾rather than
simply a measurement that otherwise has little meaning¾was itself partially the
result of efforts by the pharmaceutical industry to create new markets for its
products (19). People who would have once been considered asymptomatic
were thus transformed into patients with urgent medical conditions requiring
prompt treatment. This seems unquestionably to have been an important thera-
peutic advance. Few critics would argue, after all, that people with extremely
high blood pressure should not receive prompt treatment.
What we see here is the expansion and proliferation of biomedical science
for reasons that are simultaneously humane (or, at least, strive to be), scientifically
valid, and profitable to the corporate interests involved. At the same time, we
increasingly see the construction of what it means to be healthy and ill in ways
most consistent with the process of capital accumulation, and in particular the
fortunes of Big Pharma¾what Williams, Gabe, and Davis have called the
“pharmaceuticalization” of health (27). This means that the distinction between
“science” and “commerce” that is at the heart of the critique of current practices by
Big Pharma is, in some ways, an artificial one. Even if all science practiced
by pharmaceutical firms was conducted in a scientifically rigorous manner, all
data were publicly available, all conflicts of interest revealed, all drug advertising
tightly regulated, all free lunches banned¾even then, diagnostic categories would
continue to grow and markets for new drug technologies would continue to
expand. This is not just a question of the drive for corporate profit, though it is
that; it is not just a question of medical expertise being corrupted by commercial
motives, though it is that. The medicalization of social and personal problems,
the lowering of diagnostic thresholds, the discovery and rendering of risk into
problems suitable for pharmacological intervention¾these and other processes
grow out of the fundamental fact that during the post-World War II era medical
science became tightly wedded to the corporate pursuit of profit, and that both
biomedical science and the accumulation of profit have, in many ways, become
indistinguishable from the act of healing.
The result is a type of inflationary pressure that constantly expands what it
means to be sick and the possibilities for therapeutic intervention, even as indi-
vidual diseases and treatments may fall out of fashion or recede from use. This
broad process¾which we call disease inflation¾is both more general and more
ethically complex than the specific processes referred to by the terms “disease
mongering” and “medicalization,” in part because it is not limited to activities
that are obviously morally dubious. The pharmaceuticalization of health is just
one part of this broader process of disease inflation; other industries and tech-
nologies play crucially important roles as well, although for the purposes of this
314 / Gabriel and Goldberg

article we have left an examination of additional processes aside. At the same

time, disease inflation raises significant ethical questions that, in our opinion, are
not being adequately addressed in the medical, public health, and ethics literature.
For example, there is the question of what it would mean to eschew the use of
scientific knowledge about disease. In some cases, a plausible case can be made
that the “de-medicalization” of certain problems would be an ethical course: a
strong case can be made, for example, that in some cases what is diagnosed as
“depressive disorder” might be better understood as sadness, with the question
then following of whether or not pharmacological treatment is an appropriate
response (31). Yet in other cases it would seem ethically troubling to try to ratchet
back scientific knowledge about what are now considered diseases or to suggest
that known treatments should not be used. Would we wish to go back to a world
in which people died due to highly elevated blood pressure at rates much higher
than they do today? Would we wish to go back to a world in which juvenile
diabetes killed virtually everyone it touched, despite the fact that the develop-
ment of insulin in the early 20th century gave rise both to immense profits for
its manufacturer and to the need for a new population of adult diabetics to
constantly monitor and manage their own health and, in doing so, to tie them-
selves closely to the accumulation of industry profit? In some cases, then, the
pharmaceuticalization of health might be ethically resisted; in others, however,
it seems that it might be ethically acceptable. The question of how to draw the
line between the two needs to be more fully explored.
There is also the question of iatrogenic harm, and whether or not the “cures”
we use to address the problems we face should be considered such. Relevant
here are important questions about whether or not the harms that result from
the adoption of treatments are actually justified by the problems that they are
intended to address. Adverse drug events, side effects, and other harms must be
balanced against the benefits gained from taking medication. Yet the relentless
demand on the part of the industry to promote its products directly impacts the
way in which risks and benefits are evaluated. For example, Brody and Light
(32) have developed a variation of Hart’s inverse care law that they term the
“inverse benefit law.” New drug approvals most easily demonstrate efficacy in
high-risk groups, which makes sense because members of such groups are likely
to be sicker. Moreover, if administered to high-risk groups, the all-important
“number needed to treat” will be lower than if the drug were administered to a
lower-risk group; and, at the same time, there will be fewer adverse drug events
(because fewer people are taking the drug). The problem from the drug company’s
perspective is that the sickest members comprise a very small percentage of
the overall population. Thus, Brody and Light demonstrate that pharmaceutical
companies “shift the drug-recommendation threshold” lower down the disease
severity axis, which can result in “major increases in company revenues” (32,
p. 400). This process tends to benefit at least some individual patients, who are
able to benefit from the increased use of the drug with only a small risk of adverse
 Big Pharma and Disease Inflation / 315

event. However, from a public health standpoint it is troubling because adminis-

tering the drug to those who are less sick increases¾sometimes by an order of
magnitude¾the number of such adverse events, and worsens the benefit-to-harm
ratio (32). The drive to industry profit thus gives rise to the difficult question
of how to balance potential individual benefit against the increase of harm at the
level of the population.
These are just two examples of the many ethical questions raised by disease
inflation and the pharmaceuticalization of health. Although we consider the
critiques leveled against the industry through the framework of both medical-
ization and disease mongering to be extremely important, we also believe that
critics need to think more seriously about the many difficult issues raised by
pharmaceuticalization that cannot be captured by these frameworks. The con-
version of suffering into illness is not a neutral act, as critics of medicalization
have widely argued; yet neither is the association of behaviors and adverse events
through the calculation of risk, the discovery of new physiological and biological
mechanisms that underlie human suffering, the bifurcation of one disease into
two based on response to a treatment, and other mechanisms through which
pharmaceuticals increasingly define, transform, and expand disease categories.
The pharmaceuticalization of health raises complex ethical questions about how
we define health, the goals of medicine and the limits of medical expertise, and
other deeply important issues. In our view, we need to begin discussing these
issues in ways that move beyond the important yet limited critiques of ghost
writing, seeding trials, and other nefarious practices that the industry uses to
expand the use of its products. Indeed, we need to consider the ethical implications
of disease inflation in ways that move us beyond the valuable yet limited critiques
of medicalization and disease mongering.

DISEASE INFLATION AND PUBLIC

HEALTH ETHICS

Finally, in our view it is necessary to contextualize disease inflation and the

pharmaceuticalization of health within a critical public health framework. The
pressing ethical problem here flows from the overwhelming evidence that health
and its distribution in human populations are generally not a function of phar-
maceuticals. This is not to suggest that such products are irrelevant to health or
even necessarily harmful—although they sometimes are—but simply that, as a
2006 editorial in PLoS Medicine put it, “the stark fact is that most disease on
the planet is a product of the social conditions in which people live and work”
(33, p. 1). If we wish to improve overall population health and compress health
inequities—and we say without hesitation these ought to be the primary goals
of public health practice and policy in a just social order (34, 35)¾the best means
to do so, far and away, is to alter the social and economic conditions in which
people live. Giving more people more access to pharmaceuticals may or may not
316 / Gabriel and Goldberg

be a good idea in any given case, but from a whole population perspective it is
decidedly suboptimal. Indeed, such interventions may not only fail to improve
absolute population health, they may actually serve to expand health inequities
insofar as whatever benefit they do bestow depends on the resources and capital
the individual user possesses and can use to capture that benefit (34–36).
Accordingly, disease inflation is troubling in a way that reaches beyond the
very real problems of ghostwriting and other such practices, disease mongering,
and the conversion of previously normal states into pathological conditions requir-
ing medical intervention. Increasingly, the pharmaceuticalization of health means
that health, illness, pathology, “normalcy,” and other fundamental categories are
understood as a function of the products the pharmaceutical industry provides.
Of course, this is one of the features of a Weltanschauung¾the organizing
framework melts into the background and becomes invisible to participants in
the relevant social matrix even while it sets the stage and frames the ensuing
social action. It even frames the terms of some of the most heated disputes
within that matrix.
For example, one of the top priorities among stakeholders advocating a
health and human rights approach in the global public health movement has
been the facilitation of greater access to essential medicines. The World Health
Organization has an entire department devoted to the subject, the United Nations
Millennium Project commissioned a lengthy report on such access, and countless
books, scholarly and grassroots articles, and presentations addressing the extent
to which such access is a key component of health and human rights are easily
available. We do not deny that “essential medicines” are in some important
sense essential. Yet the question from a critical public health perspective must
be one of effect size: of all the various determinants of health and its distribution in
human populations, the evidence suggests that some are of greater significance
than others. And however necessary essential medicines are to health in both
the global North and the global South, the evidence is overwhelming that the
overall contribution to health made by such medicines pales in comparison to that
made by social and economic conditions and material deprivation (37, 38).
Therefore, even the debate over how best to extend access to essential medicines
reflects, at least in part, the extent to which pharmaceuticals have come to define
the very idea of health. The same can be said for the question of how to implement
public health strategies more broadly. Fairchild and colleagues, for example,
describe the transformation of American public health during the 20th century,
charting what they term an “exodus” away from attention to social and economic
conditions in favor of services, programs, and priorities that, in many cases,
depend on providing access to pharmaceuticals (39).
A similar critique can be made of the complex debates about clinical trials
in the developing world. Over the past several decades, drug companies have
increasingly conducted clinical trials in developing countries (40). Partially as
a result, ethicists, clinicians, and others have begun to debate whether the same
 Big Pharma and Disease Inflation / 317

ethical framework should be maintained for the conduct of clinical tests in

developed and developing regions. Some argue, for example, that since the
standard of care is significantly lower in developing countries, and the disease
burden high, this justifies placebo-controlled testing when already known
effective treatments are available¾a position that would be unacceptable for
clinical trials run in the United States. Others decry this line of argument as
unethical at best. Following the AIDS Clinical Trials Group Study in 1995,
which demonstrated the effectiveness of zidovudine in HIV+ pregnant women,
there were at least 18 trials in different parts of the world in which control
groups did not receive treatment; these trials involved a total of more than 17,000
women, with a significant number of deaths that, presumably, could have
been avoided if the control groups had received zidovudine (41). The experi-
ments prompted a significant amount of controversy, leading some to accuse the
researchers involved of engaging in unethical and even racist science equivalent
to the notorious Tuskegee syphilis experiment (42).
The point here is that the very terms of debate are structured according to a
logic in which increased access to pharmaceuticals is assumed to be equivalent
to the promotion of health. Generally left unasked are questions such as whether
there are better ways to reduce the burden of AIDS in developing countries,
or perhaps even more fundamentally, what structures of international political
economies produce staggering global inequities in HIV prevalence, treatment,
and mortality (43). Vicente Navarro, for example, criticizes this framework when
he notes that even generally successful efforts to categorically eradicate single
diseases¾which typically emphasize the role of essential medicines¾may have
actually undermined health in the global South inasmuch as such efforts encourage
the pursuit of “technical silver-bullet-type solutions that degrade rather than
improve countries’ public health situations” (44, p. 207). Similarly, public health
ethicist Jacquineau Azetsop criticizes the relentless focus within African bioethics
on research and clinical medicine, with attention to the social determinants of
health, political economies, and histories of colonialism, oppression, and struc-
tural violence relegated to the background (45).
Finally, it is important to point out that there are still significant coercive aspects
to the public health enterprise that many find ethically troubling. Despite the
increasing orientation of biomedicine toward individual betterment and flexibility
of choice, the critique of “coercive healthism” is still an important one, even as
it is increasingly linked to a neoliberal framework in which individuals increas-
ingly bear the financial and moral responsibilities for remaining healthy (46–48).
Yet these debates are also increasingly framed by and through debates about
access to pharmaceuticals: who should get them, who should pay for them,
whether their use should be mandatory, and what are the consequences and
possibilities¾ethical, legal, scientific, and otherwise¾of refusal. Recent debates
about mandating Gardasil vaccination as a prophylactic against human papillo-
mavirus point to the way in which the pharmaceuticalization of health, and the
318 / Gabriel and Goldberg

ever-expanding nature of our understanding of disease and risk, increasingly

shape our understanding of public health and both its limits and possibilities.
In the current environment, there seems to be little possibility of formulating
a public health approach toward the endemic nature of human papillomavirus
that is not grounded on the expansion of vaccination and concomitant increase
in profits for Merck & Company, the maker of Gardasil.
The pharmaceuticalization of health (49, 50) is therefore mirrored by a con-
comitant pharmaceuticalization of public health policy (51). This is ethically
problematic because prioritizing pharmaceutical management of population
health problems may be ineffective and may even expand existing health
inequities. There are concrete alternatives to pharmaceuticalizing health
policy, most of which revolve around centering the significance of the social
determinants of health and material deprivation in health policy. Rose’s whole
population approach (52) presents one such example, as does the growing
movement toward Health in All Policies (53). As a point of departure, each
of these begins with the notion that attention to the structural factors that
are the prime determinants of health and its distribution are paramount, and
that a narrow focus on the delivery of medical treatment is both inadequate and
ethically problematic. Understanding and articulating the relationship between
disease inflation, the pharmaceuticalization of health, and the pharmaceutical-
ization of public health policy helps bring the importance of these efforts
into sharper focus.

CONCLUSION

In recent years, academic physicians, bioethicists, and other concerned observers

have increasingly raised alarm bells about ghostwriting, seeding trials, and
other disturbing efforts by the pharmaceutical industry to expand the use of its
products. These critiques are frequently leveled through a framework that assumes
that these efforts are corrosive to both biomedical science and to the practice
of good medicine. We do not dispute these arguments. However, we also believe
that the problem of disease inflation forces us to ask more fundamental questions
than simply how to protect science from the dangers of corruption. In asserting
this, we do not mean to downplay the dangers of ghostwriting and other rela-
tively crude efforts to harness the creation and distribution of biomedical knowl-
edge to commercial ends. These are dubious practices that should be significantly
curtailed if not entirely eliminated. Drug companies should obviously not be
pushing their products for the treatment of conditions for which they are not
approved; nor should they be secretly generating marketing material and pre-
senting it as if it was produced according to the norms of the scientific community.
This much seems obvious.
And yet what to do beyond this is significantly less clear. The fact that
medical science, even when practiced in scientifically rigorous and humane
 Big Pharma and Disease Inflation / 319

ways, is now closely aligned with the goals of advancing corporate profit raises
difficult and yet exceedingly important ethical issues that, we believe, are not
being adequately addressed in much of the scientific and bioethics literatures.
Focusing on the corrosive impact of admittedly disturbing industry practices is
not enough to help us think through these issues and guide us to engaged action.
Of course, there is ample reason to embrace the cliché that resistance is futile,
that is, that disease inflation and the pharmaceuticalization of health are now
so deeply embedded in both biomedical science and the broader institutional
structures of medicine that acting and thinking outside, or against, such a
framework is nigh impossible. However, caution is warranted, for the naturalistic
fallacy¾permitting what is to define what ought to be¾hovers over such assess-
ments. Skepticism about the practical possibilities of resisting disease inflation
and the pharmaceuticalization of health is not equivalent to accepting that such
frameworks act as standards for morality. So while we admit to no small amount
of cynicism regarding the possibility of subversion, we are also unprepared
simply to accept that there are no alternatives to living in a world in which
capital accumulation and the very idea of health are so deeply intertwined.
We leave for future work the task of formulating strategies for how the two
might be disentangled.

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Direct reprint requests to:

Joseph M. Gabriel
Department of Medical Humanities and Social Sciences
Florida State University, College of Medicine
1115 West Call Street
Tallahassee, FL 32306-4300

joseph.gabriel@med.fsu.edu