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Collection Highlights

Hydrogen and Fuel Cell Technologies and Market

Perspectives 1st Edition Johannes Töpler

Regulating Human Embryonic Stem Cell in China A

Comparative Study on Human Embryonic Stem Cell s
Patentability and Morality in US and EU 1st Edition Li
Jiang (Auth.)

Stem Cell Manufacturing 1st Edition Joaquim M. S. Cabral

Human stem cell toxicology 1st Edition James L Sherley

Stem Cell Research : Hope or Hype? 1st Edition Alt

Stem Cell Derived Models in Toxicology 1st Edition Mike

Clements

Stem Cell Proliferation and Differentiation 1st Edition

Thomas G. Fazzio

Pluripotent Stem Cell Therapy for Diabetes 1st Edition

Lorenzo Piemonti

Stem Cell Oncology : Proceedings of the International Stem

Cell and Oncology Conference (ISCOC, 2017), December 1-2,
2017, Medan, Indonesia First Edition Adella
 Global Perspectives on

Stem Cell
Technologies
EDITED BY
ADITYA BHARADWAJ
 Global Perspectives on Stem Cell Technologies

“Stem cells circulate the globe today in settings where patient desperation con-
fronts regulatory confusion and commercial expectation bumps up against ethi-
cal ambiguity. In Bharadwaj’s fearless editorial hands, the intersection of these
forces, centering on novel Indian therapies, comes alive through voices ranging
from academic and reflective to passionate and deeply personal. The book may
haunt, destabilize or challenge. It will not bore.”
—Sheila Jasnoff, Pforzheimer Professor of Science and Technology Studies at
Harvard University’s John F. Kennedy School of Government
 Aditya Bharadwaj
Editor

Global Perspectives
on Stem Cell
Technologies
Editor
Aditya Bharadwaj
Department of Anthropology and Sociology
Graduate Institute of International and Development Studies
Geneva, Switzerland

ISBN 978-3-319-63786-0    ISBN 978-3-319-63787-7 (eBook)

https://doi.org/10.1007/978-3-319-63787-7

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© The Editor(s) (if applicable) and The Author(s) 2018

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The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
 Foreword: Good Science, Better Patients

In my 2013 book, Good Science: The Ethical Choreography of Stem Cell

Research (MIT Press),1 I characterized the current era as one in which two
kinds of “good science” go together to drive highly capitalized biomedical
innovation: “good science” as in reproducible, reliable, and robust method
and knowledge, and “good science” as in freighted with ethical questions
such as the moral status of embryos or how to compensate egg donors or
find cures. I investigated this intertwining of the moral and technical in
bio-innovation economies through the example of US and California
pluripotent stem cell research during the 15 years from the first successful
derivation of human embryonic stem cell lines until the political and
technical stabilization of induced pluripotent stem cell research. I devel-
oped a mixed ethnographic/archival/participatory method I called “tri-
age” to collect data with the intent of bringing to light processes whereby
some lives come to matter more than others in relation to an emerging
technology. I examined US Democrats’ and Republicans’ competing
framings of stem cell research; stem cell research’s geographies and geo-
politics as seen from California, especially federal and state dynamics in
the USA; putative brain drains to the UK and Singapore; and a short-­
lived rivalry with South Korea over somatic cell nuclear transfer cloning.
I also looked at novel public–private funding and governance structures
that were being erected for dealing with the ever-present risk of market
failure around human cellular technologies at this time, and at how
v
vi Foreword: Good Science, Better Patients

poorly the technical and moral challenges of stem cell research were
addressed by the post-war ethics of what I called the “substitutive research
subject.”
To demonstrate the way that ethical and technical challenges were
articulated together throughout research, and not just before beginning
the research and after the research is let loose upon the social sphere to
have implications or impact, I highlighted California’s “procurial” frame
for human pluripotent stem cell research: pro-cures as the overwhelming
moral mandate and technical challenge; procurement as the simultaneous
ethical roadblock and technical feedstock; and bio-curation as the process
of moving (de)identified characterized tissue and bio-information
between formats and in accounted-for chains of custody. In order to
achieve both epistemologically and morally good science, I argued for
upstream, interactive, and iterative technical, economic, and ethical
innovation, expressed in terms that make sense within the political reper-
toire of a given jurisdiction. I also argued for the iterative, participatory,
and upstream inclusion of distributive justice goals so as to disrupt the
systems-entropy whereby discrimination characteristic of a history, time,
and place is materialized into technologies and their corresponding ethi-
cal instruments. I pushed against the blindness to stratification of the
individualism of much of bioethics, and against the species and mind-­
over-­body exceptionalism of humanism. I also called for a radical updat-
ing of the epistemologically entrenched and globally circulating and
differentiating category of the substitutive research subject. This work has
had concrete outcomes, ranging from invitations to teach animal research
ethics to engagement with human rights lawyers, and the launch with
colleagues of the Science FARE (feminist, anti-racist, equity) initiative to
urge technical infrastructures to embed social justice goals.2
This important edited collection, Global Perspectives on Stem Cell
Technologies, takes up good science in ways that resonate with my own
development of the term, as well as in quite other ways. In close kinship,
this collection focuses on connections forged by cellular technologies
through “the twin processes of extraction and insertion of biogenetic sub-
stance across multiple terrains ranging from geopolitical borders to areas
between biology and machine, governance and ethical dilemmas, every-
day suffering, and religious as well as secularized morality,” (“Introduction:
 Foreword: Good Science, Better Patients
   vii

Stem Cell Intersections: Perspectives and Experiences”) that Aditya

Bharadwaj felicitously refers to as “bio-crossings.” Nayantara Sheron and
Bharadwaj argue in “Bio-crossing Heterotopia: Revisiting Contemporary
Stem Cell Research and Therapy in India” that “science and emerging
political economy of stem cell technologies around the globe are produc-
ing distinct culture-specific responses” (introduction). Sheron and
Bharadwaj compellingly reimagine stem cells in India “as heterotopias:
manifest entities and discursive sites suffused with real and imagined, and
utopic and dystopic alterations made manifest as bio-­crossings gain trac-
tion between the biogenetic, technoscientific, socioeconomic, and geo-
political landscapes of possibilities.”
Sheron and Bharadwaj demonstrate, as I did for the American Medical
Association’s guidelines on medical tourism, how two sets of 2013
Guidelines in India ended up with the consequence of an “automatic
‘good/permissible’ science versus a ‘bad/rogue’ science,” between human
embryonic stem cells (hESC) and somatic autologous cells. In their chap-
ter, “Staging Scientific Selves and Pluripotent Cells in South Korea and
Japan,” Marcie Middlebrooks and Hazuki Shimono show how important
the genre of scientific biography is to establishing good science, which
cannot happen without good scientists. As I did in Good Science, they
reconstruct the portrayal of South Korea’s Hwang Woo-suk before and
after the somatic stem cell cloning scandal. They go further and fruitfully
compare portrayals of Hwang with portrayals of Japan’s Haruko Obokata
during and after the stimulus-triggered acquired pluripotency (STAP)
scandal. When Hwang and Obokata were national heroes, traditional
biographical vignettes were afforded great nationalist significance.
Obokata’s grandmother’s apron in the place of a lab coat, and Hwang’s
cow with whom he shared bucolic roots as a boy, assured their goodness
as moral scientists. Once the scandals broke, however, these same “moral
maternal” tropes began to be treated as evidence of the very flaws that led
to their downfall.
Where I focused on the problems of extending the ethics and episte-
mology of substitutive human and animal models to regenerative medi-
cine, Linda Hogle (“Ethical Ambiguities: Emerging Models of
Donor–Researcher Relations in the Induced Pluripotent Stem Cells”)
draws our attention to a different ethical and epistemological limitation
viii Foreword: Good Science, Better Patients

emerging in stem cell research: the changing nature of trials and how they
advance evidence-based medicine. She draws on her own previous work
to show that “for cell-based products, large-scale trials pose challenges,
blinding is virtually impossible, and endpoints are difficult to establish.”
She convincingly argues that the previous gold standard of good science,
the double-blind randomized controlled trial, is being superseded by
patient activism and computational tools in an emerging assemblage of
evidence-based medicine for the pro-cures era.
Sarah Franklin (“Somewhere Over the Rainbow, Cells Do Fly”) adds a
vital element to the epistemological and geopolitical landscape by zeroing
in on regenerative medicine and its associated industries in the UK. As
she shows, stem cell technologies are increasingly powerful and “disrup-
tive” because they are part of the “technological platform that enabled the
reprogramming of reproductive biology.” “Stage 3 clinical trials in a wide
range of fields,” and “combination products that integrate cells with med-
ical devices, such as patches and scaffolds,” lead to “a far-ranging vision of
induced plasticity delivered through signalling factors extracted from
pluripotent cells and repurposed to trigger in situ cellular reorganisa-
tion.” Franklin points to these technical breakthroughs as well as to
smaller yet higher impactful by-products of changing practice. For exam-
ple, the trend to freeze embryos at a later stage in fertility medicine has
meant that scientists have a diminished source of leftover embryos suit-
able for hESC derivation. Similarly, the development of stem cell product
derived patches that lose many of the cellular properties is making the
delivery of cellular products easier. Franklin challenges readers to con-
sider what contribution the social sciences might play. If there are social
aspects of regenerative medicine throughout the research, development,
and application process, downstream models of social science impact are
likely wrong, too. She argues that we need to develop equally sophisti-
cated models to measure and promote our own research impact.
I want to now turn to another fascinating aspect of this edited collec-
tion. In the title to this Foreword, I have gestured at it with the phrase,
“better patients.” This is a play on the moral and epistemological work
patients and their physicians and advocates do3 which makes the science
better and thus makes their treatment work better, and on the sense of
“being, feeling, or getting better” that we apply to patients who are on the
 Foreword: Good Science, Better Patients
   ix

road to recovery or have reduced symptoms and/or improved quality of

life. The remaining chapters in this collection concern the kinds of good
science captured by this double meaning of “better patients.” Dr. Geeta
Shroff’s chapter, “Establishment and Use of Injectable Human Embryonic
Stem Cells for Clinical Application,” documents her reasons for choosing
a particular population of chronic spinal cord injury (SCI) patients for
hESC-derived transplantations in her Indian embryonic stem cell trans-
plant clinic. She focuses on the needs of those “less likely to suffer oppor-
tunity costs from study participation” for whom there are few treatment
alternatives, and rightly casts this as its own moral imperative. Shroff
displays the methodological virtues of her protocol: its simplicity, the
regenerative nature of the cell line she uses, and the cell culture; freedom
from animal products. The chapter takes time to demonstrate the treat-
ment’s scientific legitimacy in highly recognizable terms, but the empha-
sis is on small clinical improvements that contribute to wellbeing and
more productive life, however manifested, rather than on cures or
increased survival. Petra Hopf-Seidel, in her chapter “Pre-blastomeric
Regeneration: German Patients Encounter hESC in India,” likewise
explains that “each of my patients improved in one way or other, some
visible and measurable, others more invisible with improved stamina,
better moods, or more muscle strength. No one had adverse effects, so I
can say confidently that I was surrounded by happy patients.” Better
treatments are ones that lead to better patients however measured.
Finally, Ripudaman Singh’s chapter, “Active Parents, Parental Activism:
The Adipose Stem Cell In-Vitro Lab Study,” and Lola and Shannon
Davis’ chapter, “Accidental Events: Regenerative Medicine, Quadriplegia
and Life’s Journey,” take us to the heart of the work done by patients and
their parent activists to bring treatments in to being in ways that promote
good science and lead to better patients. Singh, his wife, and son all
worked tirelessly with their fellow families to improve their children’s
conditions of life in a country where “nobody cares,” least of all the Indian
Medical Council, which took the dismissive attitude that “stem cells are
just placebos.” The “parents did most of the research and determined the
protocols, such as how many cells we wanted and the number of infu-
sions,” and, at the very least, knowledgeably and actively bought “time
until something better came along.” In their chapter, Shannon and Lola
x Foreword: Good Science, Better Patients

Davis emphasize the progress made through being a patient of Dr. Shroff
when nothing else had worked. Shannon’s mother describes the range of
incremental improvements in function and quality of life, rather than
total cure, offered by the treatments, and sums it up by noting that “her
life has become as normal as it can be.” Shannon herself underlines the
“rigorous medical attention to treatment protocol,” as a “deciding factor”
in traveling to India for treatment, and also sets the bottom line in terms
of efficacy of the treatment in the absence of alternatives, noting that
“there is no other place in the world to help me.”
Overall, Global Perspectives on Stem Cell Technologies was a pleasure to
read and learn from. It resonated deeply with my own work, while also tak-
ing me much beyond. Good stem cell science and regenerative medicine
has much in common around the world, but also crucially differs according
to local political and ethical and scientific repertoires, economic circum-
stances, governance and regulation or the lack thereof, and the institutional
structure and funding of science. Narratives of moral and epistemological
goodness are produced in and in turn produce scientific and biomedical
innovation. Market failures and a completely new understanding of the
biological are leading to innovation stretching from clinical trials to patient
activism. Cures and care promise, eventually, to be the better for it.

Chancellor’s Professor, UC Berkeley; Charis Thompson

Professor, LSE.
June 2017

Notes
1. Charis Thompson, 2013. Good Science: The Ethical Choreography of Stem
Cell Research. MIT Press.
2. See Nature 538, 371, 2016, Science FARE http://www.nature.com/
nature/journal/v538/n7625/full/538317b.html
3. See, for example, these founding works: Steven Epstein, 1998. Impure
Science: AIDS, Activism, and the Politics of Knowledge. University of
California Press, and Rayna Rapp, 1987. Moral Pioneers: Women, Men
and Fetuses on a Frontier of Reproductive Technology. Women Health
1987;13(1–2):101–116.
 Contents

Stem Cell Intersections: Perspectives and Experiences   1

Aditya Bharadwaj

Part I Regenerating Ethics   25

 omewhere Over the Rainbow, Cells Do Fly  27

S
Sarah Franklin

I ntersections of Technological and Regulatory Zones

in Regenerative Medicine  51
Linda F. Hogle

 taging Scientific Selves and Pluripotent Cells in

S
South Korea and Japan  85
Marcie Middlebrooks and Hazuki Shimono

xi
xii Contents

Part II Therapeutic Horizons 115

 stablishment and Use of Injectable Human Embryonic

E
Stem Cells for Clinical Application 117
Geeta Shroff

 re-blastomeric Regeneration: German Patients Encounter

P
Human Embryonic Stem Cells in India 153
Petra Hopf-Seidel

Part III Patient Positions 171

 ctive Parents, Parental Activism: The Adipose Stem

A
Cell In Vitro Lab Study 173
Ripudaman Singh

 ccidental Events: Regenerative Medicine, Quadriplegia,

A
and Life’s Journey 183
Lola Davis and Shannon Davis

 iocrossing Heterotopia: Revisiting Contemporary

B
Stem Cell Research and Therapy in India 195
Nayantara Sheoran Appleton and Aditya Bharadwaj

Afterword  215
Marcia C. Inhorn

Index 223
 List of Figures

Chapter 5
Fig. 1 Trachtography 125
Fig. 2 Patient 1 after treatment 126
Fig. 3 Tractography images of Patient 2 before and after treatment 128
Fig. 4 Treatment plan for Spinal Cord Injury 132
Fig. 5 Overall change in American Spinal Injury Association
(ASIA) scale at the end of treatment phase 1 and 2 136
Fig. 6 Tractographic images of a SCI patient before and after
hESC therapy using magnetic resonance imaging (MRI) 142
Fig. 7 Risks associated with epidural and caudal route of
administration143

xiii
 List of Tables

Chapter 5
Table 1 Change in American Spinal Injury Association scales
of patients (overall) from admission to discharge at
the end of each treatment period 134
Table 2 Change from baseline to last period in total American
Spinal Injury Association scores by extent and level of injury 135
Table 3 Change in American Spinal Injury Association scales of
patients (gender wise) from admission to discharge at the
end of each treatment period 137
Table 4 Adverse events observed during each treatment period
(safety population) 138

xv
 Stem Cell Intersections: Perspectives
and Experiences
Aditya Bharadwaj

Introduction
Global Perspectives on Stem Cell Technologies is an exploration of social sci-
ence, patient, and biomedical perspectives on stem cell technologies. This
unique engagement takes as its starting point a humble cell lying on an
intersection of ideas as diverse and interlaced as life, knowledge, com-
merce, governance, and ethics. While natural sciences have focused on
the bio-anatomy and unique therapeutic promise of stem cells, social sci-
ence disciplines such as anthropology and sociology in large part endeavor
to reveal the ‘cultural contours of interlocked sociotechnical assemblages
framing stem cell isolation, generation and application’ (Bharadwaj 2012,
p. 304). These are shown to range from scientific production, political
contestations, and economic calculations to ethical variations, religious
objections, and social mobilization around the globe (ibid.). These com-
plex processes and relationships have not only amassed around the scien-

A. Bharadwaj (*)
Department of Anthropology and Sociology, Graduate Institute
of International and Development Studies, Geneva, Switzerland

© The Author(s) 2018 1

A. Bharadwaj (ed.), Global Perspectives on Stem Cell Technologies,
https://doi.org/10.1007/978-3-319-63787-7_1
2 A. Bharadwaj

tific possibility of purging the cellular form of therapeutic promise but

also increased levels of promissory hope and indorsed hype in the cellular
form.
This book is an engagement with an emerging but vital area of science
spanning geopolitical, socio-economic, and techno-scientific as well as
bioethical dimensions. The endeavor is to deepen our understanding of
stem cell entities and the concerns, hopes, and aspirations that shape
them and make them imaginable as viable therapeutic entities. ‘Several
key intersections between individual, group, and institutional relation-
ships have become central to locating and debating the production of
stem cells’ (Bharadwaj 2012, p. 306). Gradually, stem cells are emerging
as biogenetic objects bestriding intersections as diverse as ethical/unethi-
cal, science/commerce, religious morality/secular governance, somatic/
embryonic through to utopian hope and dystopian despair. There is,
however, a paradox at the core of stem cell intersectionality: stem cells can
be imagined and materially deciphered across a variety of sites. That is,
the culturally ascribed identity of stem cells acquires value precisely
because stem cells can be imagined as ‘both like and not like human
beings’ (Squier 2004, p. 4). It is on the precise intersection of shifting
individual, group, and institutional relationships that stem cells continu-
ally renew to mean different things and embody different moral, ethical,
economic, and therapeutic values.
The millennial turn saw the rise of the biotechnology of stem cells in
nations of the ‘South’ such as India and beyond. The rapid globalization
of stem cell research and clinical application is producing an uneven
landscape of opportunity to research, regulate, promote, and debate the
cellular form. These moves are also rapidly problematizing long-­
established oppositions of global North/South, First/Third worlds, devel-
oped/developing economies, and Western/Eastern cultures (Bharadwaj
2009; Bharadwaj and Glasner 2009). What is to count as local and global
is rapidly dislocating. In large part, this also means that the twentieth-­
century-­development discourse that privileged the unidirectional flow of
knowledge from the ‘global’ North/developed to the ‘local’ South/devel-
oping is disintegrating. As long argued, this geopolitical worldview is
now both an untenable orthodoxy and an unsustainable project (ibid.). It
is in this world order in which twentieth-century geopolitical stability is
 Stem Cell Intersections: Perspectives and Experiences 3

rapidly shifting and intersecting in ways previously unimaginable that

stem cells have begun to proliferate and mutate to body forth culture-­
specific responses to certain core and contested arenas.
The book addresses three overarching arenas of concern: (1) regenerat-
ing the very notion of regulation and ethics, (2) emerging therapeutic
horizons, and (3) patient positions. In large part, these concerns have
framed the research focus and lived experience of the authors in this
book. These concerns are continually ‘co-produced’, to use Sheila
Jasanoff’s apt phrasing, to mean different things in different global con-
texts. For example, as the accounts in this volume show, while there is
emerging evidence of growing social and regulatory concerns around
stem cell research and clinical interventions from the United States, the
United Kingdom, and Japan, stem cell therapies have become firmly
embedded as therapeutic practice in global locales like India. Similarly, in
some parts of the world, regulatory and ethical concerns are focused pre-
dominantly on the clinical manipulation of the embryonic form and
sourcing of reproductive gametes for research (Sperling 2013). In some
other global locales, the impact of invasive extraction practices to procure
such biogenetic tissues and exploitation of vulnerable populations is
being framed as a major area of concern (Waldby and Cooper 2010). The
global political economy of such biotechnological developments along
with the commercial exploitation of future therapeutic possibilities is also
causing alarm and mobilization. While the origins and ethical objections
to using embryos for stem cell research can be traced back to the religious
domain in specific Euro-American formations (Bharadwaj 2009), the
global variability notwithstanding, creation of human embryos for fertil-
ity treatments and stem cell research alike have become core bioethical
subjects as ethical concerns and, to borrow from Sarah Franklin’s insight-
ful analysis, are ‘built into’ new life forms (2003, 2013). The question of
ethics covers a spectrum of issues ranging from scandals involving unethi-
cal stem cell research (chapter ‘Staging Scientific Selves and Pluripotent
Cells in South Korea and Japan’) to what Clare Williams and her col-
leagues have shown to be ‘ethical boundary work’ (Wainwright et al.
2006) within stem cell laboratories and clinical application of stem cells
in specific global locales to the ethics of gamete and embryo sourcing for
research through stem cells.
4 A. Bharadwaj

The emerging treatment modalities in a globalized research and thera-

peutic landscape are similarly mired and caught up in the crude but read-
ily available intersection between good and bad science (Bharadwaj
2015). The conversation this book seeks to instigate significantly involves
one notable example of an emerging embryonic stem cell treatment
modality in India (see chapters ‘Establishment and Use of Injectable
Human Embryonic Stem Cells for Clinical Application’, ‘Pre-blastomeric
regeneration: German patients encounter human embryonic stem cells in
India’, and ‘Accidental Events: Regenerative Medicine, Quadriplegia and
Life’s Journey’). In large part, the intent is to let the voices of those most
intimately involved in this breakthrough—from the clinician scientist
and author of this unique breakthrough to international interlocutors
ranging from physicians to patients embodying the cellular therapy—put
forward their perspectives. For too long, these voices have been marginal-
ized in bioscience and social science literature as fringe, guileful, or gull-
ible (cf. Bharadwaj 2013a, b, c, 2015). However, as decade-long
anthropological analysis has shown that to the purveyors and surveyors of
normative ‘good science’, clinical breakthroughs in India may seem prob-
lematic because they perceive human embryonic stem cells (hESCs) to be
digressing from what is often seen as adjudicated and consensible science
(Bharadwaj 2013a). Nonetheless, hESC interpolations achieved in the
Indian clinic amply illustrate ways in which the slow-paced but high-­
stakes, capital-saturated, Euro-American forays into stem cell research
produce structural conditions that allow the tropic notion of ‘bad name
science’ to solidify on the intersection of states, capital, and science (see
Bharadwaj 2015). However, we must remain alert and not lapse into a
just as radially available and tempting essentialism that could recast the
critique of hESC in India, for example, as mere evidence of a ‘West versus
the rest’ mindset. Rather, it seems the politics of life and science (in that
order) paint a more complicated portraiture that takes as their rhetoric of
persuasion the notion ‘first in the West then elsewhere’ (see Chakrabarty
2000, p. 6). Let us also be clear that the emerging global intersection of
state, science, and capital is bringing together a collation of strange bed-
fellows. For instance, the emerging regulatory guidelines in India have
more in common with the standardized regulatory norms long fantasti-
cally fantasized in the Euro-American landscape as establishing a global
 Stem Cell Intersections: Perspectives and Experiences 5

gold standard in which biogenetic tissue could become normalized as

intellectual property, commercial transaction, standardized therapeutic
protocol, and normative bioethical compliance. Put another way, these
imagined ‘tracks’ are fast becoming essential for the smooth shuttling of
capital-fueled biotechnological locomotion. The emerging binary
between the hESCs and somatic cells in Indian regulatory thinking is a
fine reflection of this purportedly globally standardized view on human
embryonic source of stem cell as inherently unethical, dangerous (cancer-
ous), and difficult to regulate (chapter ‘Biocrossing Heterotopia:
Revisiting Contemporary Stem Cell Research and Therapy in India’). It
seems the very notion of regulation is in a double bind: how to regulate
embryonic stem cell proliferation in petri dishes and across the globe and
how to regulate (and not proliferate) ethical, moral, and political issues.
Yet, hESCs are proliferating in India and attracting patients from around
the globe (see chapters ‘Pre-blastomeric regeneration: German patients
encounter human embryonic stem cells in India’ and ‘Accidental Events:
Regenerative Medicine, Quadriplegia and Life’s Journey’). The so-called
regulatory vacuum, as some argue (Sleeboom-Faulkner and Patra 2008),
is purportedly allowing this proliferation to go unchecked. The reason
this collection includes the Indian hESC breakthrough prominently is
because the Indian case is quite possibly the only contemporary example
in the world where hESCs are being used clinically with accumulating
patient data and testimonies that render problematic the spectral fears
of dangerous proliferating potential of embryonic cellular form
(Widschwendter et al. 2006).
Against this backdrop, the growing movement of people from around
the world in search of stem cell therapies becomes yet another emerging
arena of concern. Stem cell tourism, as global therapeutic travel is fre-
quently euphemized, has expanded to include India as a major hub. The
so-called stem cell tourists are part of the conversation this book seeks to
set in motion, and only their voices can best complicate the problematic
nature of the ‘tourism’ euphemism. It would be erroneous to view this as
a mere experimental moment in charting the rise of an innovative bio-
technology. Instead, this book’s main orientation is a belief that no matter
how noble our intentions as social science researchers, we cannot truly
give voices to people we ‘study’ be they scientists, clinicians, or patients.
6 A. Bharadwaj

Instead we can merely create conditions for voices to emerge. Taken

together, these developments turn stem cells into a ‘spectacle ripe for …
analysis’ (Hogle 2005).

Stem Cell Theory Machine

Stem cell intersections offer a unique opportunity to revisit Galison
(2003) and Helmreich’s (2011) notion of the ‘theory machine’ (also see
Bharadwaj 2012), that is, ‘an object in the world that stimulates a theo-
retical formulation’ (Helmreich 2011, p. 132). Helmreich explains that
for Galison, ‘networks of electrocoordinated clocks in turn-of-the-­
twentieth-century European railway stations aided Einstein’s thinking
about simultaneity’. Similarly, ‘animal husbandry provided a theory
machine for Darwin’ (ibid.). Retooling Galison, Helmreich focuses on
theory as neither fixed above the empirical nor deriving from it in any
straightforward sense but rather as crossing the empirical transversely
(also see Helmreich 2009, p. 23–25). Thus argued, theory becomes at
once an abstraction and an object in the world. In Helmreich’s formula-
tion, ‘theories constantly cut across and complicate our paths as we navi-
gate forward in the “real world”’ (Helmreich 2011, p. 135).
Manifestly a humble stem cell is a theory machine par excellence. As a
quintessential ‘emergent form of life’ (Fischer 2003), a stem cell is at once
constricted in the specific context of its cultural medium and dispersed as
a ‘global biological’ entity (Franklin 2005). The theory machine potential
of a stem cell is thoroughly realized in its cultural capacity to manifest as
the progenitor idea that transforms the notion of ‘life’ as not only emer-
gent but also simultaneously regenerating. It is the regenerating potential
of stem cells, both therapeutically and the social, economic, political
regeneration such therapeutic promise sets in motion that further com-
plicates the symbiotic and semiotic emergence of a vital concept: life.
As an abstraction and a real object, a stem cell is rapidly becoming vital
to the vitality of the emerging notion of life as regenerative and its evolv-
ing institutional and structural framing in the new century. One can
argue that the stem cell theory machine crosses sharply athwart the
empirical terrain of life. This produces complications. In other words,
 Stem Cell Intersections: Perspectives and Experiences 7

stem cells are abstractions with real-life consequences. The athwart move-
ment of cells through everyday lived complexities that imbricate science
and suffering, as well as regulatory necessities and ethical contingencies,
can be seen tropically instantiating a ‘biocrossing’ (Bharadwaj 2008). As
a conceptual trope, the notion of biocrossing alerts us to ‘crossings’
achieved through the twin processes of extraction and insertion of bioge-
netic substance across multiple terrains ranging from geopolitical borders
to areas between biology and machine, governance and ethical dilemmas,
everyday suffering, and religious as well as secularized morality (ibid.). A
crucially important way to examine these complexities is to become
attentive to ways in which biocrossings traverse the heterotopic spaces in
which utopian promise and dystopian angst are reflected and refracted
(see Foucault 1986; chapter ‘Biocrossing Heterotopia: Revisiting
Contemporary Stem Cell Research and Therapy in India’, this volume).
These reflected sites produce counter-sites within cultures that allow life
to assert its vitality within a set of circumstances and material conditions
that run counter to individual or shared ideas about life. The theory
machine of stem cells is uniquely placed to operate in and as heterotopias:
manifest entities and discursive sites suffused with real and imagined,
utopic, and dystopic alterations made evident as ‘biocrossing gain trac-
tion between the biogenetic, technoscientific, socioeconomic, and geo-
political landscapes of possibilities’ (ibid.). To be clear, heterotopias are
not negative spaces per se but rather multiple concrete and discursive
counter-spaces that can be experienced. While Foucault neglected to
unpack the notion of heterotopia in any meaningful detail, a close read-
ing of his limited musings on the topic suggests that the notion of hetero-
topia allows life to unfold and accumulate temporally and spatially even
in the face of structural conditions seemingly not conducive to nor suf-
ficient for life. For example, in Foucault’s formulation, both prison and
museum would typify a heterotopia. While the latter would accumulate
time and space indefinitely, the former could become transitory surveyed
time and panoptic space. In a similar vein, the temporal and spatial vital-
ity inhered in the cellular form and the vital force of human life itself
become equally heterotopic. As counter-spaces, heterotopias contain the
potential to operationalize life and enable life to willfully accumulate or
dissipate by ‘juxtaposing in a single real place several spaces, several sites
8 A. Bharadwaj

that are in themselves incompatible’ (Foucault 1986, p. 25). These spaces

can range from the human corporeal form, stem cells ensconced in a petri
dish, hospitals, and laboratories to conference halls, classrooms, and
national parliaments promoting or neglecting panoptic ethicality through
to international stock markets and pharmaceutical corporate entities.
These sites, incompatible in scale, temporality, and power, are impor-
tantly reflected and rendered vibrant as they interact and counteract over
time and space to produce dynamic shifting social arrangements that
ironically sustain and curtail stem cells. Foucault reminds us that ‘the
heterotopic site is not freely accessible like a public place’ (1986, p. 26).
The entry into a heterotopia is either compulsorily overseen (e.g., bar-
racks or a prison) or via rites and purifications. This unique heterotopic
character isolates as well as renders accessible a counter-site. The purifica-
tion of stem cells as ethical objects and shards of hermetically isolated and
panoptically surveyed biogenetic tissue (imprisoned in a laboratory) fur-
ther behooves us to inspect the open and closed character of stem cell
heterotopia.
The ethical space framing stem cells has a discursive presence. However,
the theory machine of stem cells concertizes the discursive and specializes
it to hone and ‘home in’ on competing social orderings that not only
harden to become canonical practices and pronouncements but also end
up subordinating ethical practices that materialize in response to mun-
dane encounters with life and living. The ordering of good and bad sci-
ence, however, makes the moral binary factitious. In Thompson’s
brilliantly insightful account of ethical choreography surrounding stem
cell science, she shows that a truly good science with ethics would do
more than conceive best scientific and ethical practices as mere instru-
ments for overcoming ethical barriers to research (or for that matter clini-
cal application). Instead Thompson eloquently argues that:

… dissent and assent and other interests in relation to fields of science

should be solicited, not shut down by scientists and ethicists and adminis-
trators; that criticism of science should open up, rather than shutting down
avenues of research; that the process and procedures of ethical inquiry
should be honored; and that multiple forums for ethical deliberation
should be developed, recognized, and made integral to robust science.
(2013, p. 64–65)
 Stem Cell Intersections: Perspectives and Experiences 9

Perhaps it is time to embrace and advocate the open-ended nature of

ethical deliberations, broadly participatory and somewhat democratic, as
emerging cellular potential gets realized and theorized around the globe.
The alternative and slightly closed and inward-looking bioethical farming
merely bureaucratizes ethics to mean something altogether specific. The
true answer is perhaps to be (re)searched on the intersection of these
competing ethicalities. The theory machine potential of stem cell and its
ethical pluripotency is uniquely placed to achieve and propagate this
integration.

Regulating Pluripotency
The global stem cell landscape can be imagined as inherently pluripotent.
This inherent pluripotency gives rise to much more than vibrant cellular
forms—that is, the science and emerging political economy of stem cell
technologies around the globe are producing distinct culture-specific
responses. It is as if by virtue of differentiating in divergent cross-cultural
mediums, stem cell science has become an arena in need of robust stan-
dardized regulation. Yet, the notion of regulation remains a slippery con-
cept in much of the social science scholarship and state response to stem
cells these accounts focus on as their empirical base. There is an unwitting
assumption that greater regulation would somehow rein in the euphemis-
tic pluripotency from assuming dangerous proportions (Salter 2008;
Patra and Sleeboom-Faulkner 2009).
Sheila Jasanoff shows that ‘biotechnology politics and policy are situ-
ated at the intersection of two profoundly destabilizing changes in the
way we view the world: one cognitive, the other political’ (2005, p. 13).
Science has historically maintained its legitimacy by cultivating a careful
distance from the politics (Jasanoff 2005, p. 6). She argues that as state-­
science relations become more openly instrumental, we can reasonably
wonder whether science will lose its ability to serve either state or society
as a source of impartial critical authority (p. 6). In other words, Jasanoff
(1990, 2004, 2005) equips us to ask how inventions, both scientific and
social, relate to public and private actors in (predominantly democratic)
nations and assist in the production of new phenomena through their
10 A. Bharadwaj

support for biotechnology and how they reassure themselves and others
about the safety of the resulting changes—or fail to do so (2005, p. 6).
Broadly speaking, the notion of ‘pluripotent stem cell’ encapsulates this
troublesome complexity. The issue of unregulated invention and science
with its normative inversion—compliant and adjudicated science—cir-
cumscribed by state-science consensus in public and private realms pro-
duces a shared sense of belonging to an epistemological and regulatory
technology. The technoscientific act of honing cells co-produces (Jasanoff
2004) the equally complex task of honing the technoscientific procedure
itself. Similarly, the act of reassuring selves and others becomes a mani-
festly political act of forging a consensual polity of instrumental and ethi-
cal action. Moves to standardize and universalize ethical and
epistemological procedures are intimately connected to such impulses
interested in honing the pluripotent potential of stem cells.
Regulating the social and scientific pluripotency in a globalized
research and therapeutic system is a complex task. In the late twentieth
and early twenty-first centuries, these moves have birthed the triumvirate
of state-science-capital. Increasingly, this troika works to contain, curtail,
and cultivate zones of consensible epistemology, shared ethicality, and
commercial viability (see Bharadwaj 2013a)—as if anything proliferating
outside this consensible vision of a globalized stem cell terrain becomes,
like stem cells themselves, peripherally dangerous. The failure to coax
cells, science, and society into an orderly development becomes a failure
to foresee and prevent a malignant disruption. However, it would be
erroneous to assume that some monopolistic state-science machine of
global domination is circumscribing stem cells from proliferating ‘unreg-
ulated’ in nation-states and petri dishes. On the contrary, it is becoming
increasingly difficult and complex to determine how democratic nations
function and respond in the context of the emerging global politics of
science and technology around stem cells. For example, Sperling’s rich
ethnography on the bioethics debate in Germany offers a peek into the
established presence of a pronounced sense of ‘German’ and ‘un-German’
modes of doing stem cell research (Sperling 2013). The boundaries
around German research at best remain ambiguous even as bioethicality
posits research inside and outside Germany by German scientists or
research on stem cell lines imported rather than indigenously developed
 Stem Cell Intersections: Perspectives and Experiences 11

as the threshold for precarious border [bio]crossing of the ethical terrain.

The Euro-American terrain is internally diverse and distinct. The national
cultures of stem cell research and regulation do depart on occasion sig-
nificantly. However, regulatory protocols and bioethical thinking in the
Euro-American formations, differences, and digressions notwithstanding
share a distinct philosophical and ideological provenance. While these
manifest differently in different nation-states, for example, at the level of
the European Union as opposed to individual member states, they do
pose problems, as they travel globally. In India alone one finds that while
stem cell scientists effortlessly incorporate Western biomedical training
and biotechnological developments into their indigenous stem cell tool
kits, they do struggle to make sense of normative injunctions around eth-
ics and new regulatory concerns around human embryonic forms. The
resounding pushback observed for over a decade can simply be para-
phrased to read that the human embryonic form is neither a religious nor
a moral nor ethical ‘hot potato’ in India. Yet, the moves by the Indian
state to problematize the destruction of an embryo as an ethical concern,
the creation of hESC lines as inherently perilous, and the regulation of
such embryonic entities as exceedingly complex reflect the consensus in
the Euro-American formations on the subject. More important, the
emerging regulatory concern of the Indian state is seeking to transform
the stem cell terrain in India by stemming the therapeutic viability of the
pluripotent embryonic cell while proactively coaxing the proliferation of
autologous cellular research and therapies (see chapter ‘biocrossing
Heterotopia: Revisiting Contemporary Stem Cell Research and Therapy
in India’). Manifestly, it is no surprise that the emerging stem cell nations
like India are seeking to create global reach and access by co-opting and
building into the stem cell entities ethical, moral, and regulatory thresh-
olds of their probable lay and professional consumers and future markets
(see Bharadwaj 2009). The triumvirate of state-science-capital necessi-
tates that political regulation, scientific consensus, and economic calcula-
tion seamlessly align if nascent entities like stem cells are to become viable
as ethical, therapeutic, and commercial objects. To read these emerging
socio-political complexities as mere standardized regulatory and bioethi-
cal practices or in some unique sense hallmark good science would be
hugely one dimensional.
12 A. Bharadwaj

Policy and regulatory thinking that assumes simplistic divisions such

as good/bad and ethical/unethical often miss the nuanced complexities
routinely imploding such binaries. If we subject prefixes such as ‘good’
and ‘bad’, usually appended to an idea of science, to critical scrutiny, we
soon discover that these prefixes curiously circulate and mutate as they
converse with their immediate and distant ‘environments’ and in so doing
attach and detach from the very idea of ‘science’. Take, for example, the
controversy surrounding Proposition 71 of 2004 (or the California Stem
Cell Research and Cures Act), a law enacted by California voters to sup-
port stem cell research, most notably embryonic stem cell research, in the
state. The California Institute for Regenerative Medicine (CIRM) became
the state agency brought into existence by the passage of Proposition 71.
Funded by state bond funds and backed by taxpayers to the tune of three
billion over ten years, the CIRM became a unique holding space for
hype/hope, promise/despair, risk/reward, and intractable diseases/prom-
issory cures (Bharadwaj 2015, p. 4). However, the promissory value of
the CIRM was somewhat tarnished when local media began highlighting
its ‘insular’ and ‘insider-like’ way of doing business (Los Angeles Times
2014). The main bone of contention was the CIRM’s former president’s
unethical practices and the subsequent CIRM-sponsored cover-up. From
its very inception, the CIRM was to be the crucible of good science, and
its remit was to find cures for humankind’s worst afflictions. This ‘procu-
rial’ remit, to use Charis Thompson’s felicitous framing, was the defining
feature of the CIRM’s rapid and unprecedented rise. However, the ‘pro-
cure’ rhetoric of ‘good science’ that enabled the CIRM to come into exis-
tence in the first place paradoxically bore fruit in distant India. The fact
of stem cell therapies in India can achieve and deliver results that elude
good science elsewhere remains an enduring irony. This is because the
critique often encountered in the Indian stem cell terrain has in large part
focused on imagined violations of an epistemic kind: no animal models
or clinical trials and/or no standardized ethical choreography prefiguring
good scientific performativity. In this respect, following Shroff’s work
(chapter ‘Establishment and Use of Injectable Human Embryonic Stem
Cells for Clinical Application’) is illuminating in one crucial respect: it
lays bare the pursuit of ‘local good’ circumscribed by contingent ethics
produced in relation to sensibilities populating the everyday engagement
 Stem Cell Intersections: Perspectives and Experiences 13

with life (see Das 2015). For instance, in all my interactions with Geeta
Shroff, I have found her to see placebo-controlled trials as unethical since
stem cells at her clinic are used to treat only terminal and incurable
conditions:

We never opted for a clinical trail because we are against giving placebos.
The patient is the control because there is chronicity, and it is not fair to
treat a patient with placebos especially if a motor-neuron-disease patient is
coming to you who is going down every day. The institutional ethics com-
mittee took this decision a very long time ago that there will be no placebo,
as it is against our ethics; we can’t stand back and watch a motor-neuron-­
disease patient rapidly worsen and die. It is against our ethics. (Bharadwaj
2015, p. 13)

How do we then accommodate this call for localized ethical contin-

gency in the grand narrative of bioethics? In the register of everyday
ethics that Veena Das (2015) has brilliantly illuminated through her
work, the contingency and frailty of the human condition and its
unpredictable social trajectory render untenable a scientific and bio-
ethical commitment to standardized epistemic choreography. However,
procedures and processes are changing. As Hogle shows within the pur-
view of the Twenty-First-­Century Cures Act in the United States, the
law is instructing the FDA in no uncertain terms to use observational
data in the evaluation of drugs, biologics, and devices. This data, Hogle
explains, could come, in addition to other sources, from case histories
and patient narratives about their own experience (chapter ‘Ethical
Ambiguities: Emerging Models of Donor–Researcher Relations in the
Induced Pluripotent Stem Cells’). While these moves stop far short of a
watershed moment in eliciting evidence, newer and older notions of
appropriate evidence are likely to become more hybrid (ibid.).
Nevertheless, these developments can only give hope. For now, it seems,
the mode of building and doing ‘good science’ as envisioned by
Thompson seems a step closer to realization.
On the question of regulation, certain expedient logics appear to
underscore the rise of science policy and governance around the globe
today. This expediency, I think, is an unwitting corollary (and on rare
14 A. Bharadwaj

occasions a willful manifestation) of processes that both operate and are

operationalized as the global circulation of intellectual and monetary
capital gain traction. We need to pay particular attention to such an
emergence within the policy landscape, national and regional differences
notwithstanding. We should also remain somewhat ambivalent in the
face of two popular and explicit suggestions embedded in the existing
social science literature on stem cells that see robust governance of stem
cells predicated on common acceptable principles and mechanisms as
facilitating good scientific practice and international collaborations and
the standardization and globalization of ethical concerns. In my view one
of these aims, international collaborations encouraging good scientific
practice, is often unattainable given the woeful lack of a level global play-
ing field; the other, the standardization of ethical concerns, is undesir-
able. This is because in order to understand science policy and regulation,
we also need to understand how power structures set definite limits to
individual and collective negotiating capacities. The resulting negotiating
choreography produces seemingly new norms, but these reassert the
hegemonic view that either seeks to co-opt the emerging new in its own
image or reject it altogether, a sense of ‘our way or the highway’.
The foregoing policy, scientific, ethical, and regulatory concerns often
eclipse one important stakeholder in the global stem cell landscape:
patients suffering from chronic and degenerative medical conditions.
Ironically, the manifesto of ‘good science’ that Thompson troubles and
expands to include a diverse pool of concerns and ethicalities takes as its
point of departure a strong ‘pro-cure’ stance as the main justification for
intensified research, enhanced funding, and procuring access to biogene-
tic tissue. The affect saturated call for this intensification takes human
suffering and progressive and degenerative afflictions as the only humane
justification for developing and delivering therapy-grade stem cell tech-
nologies. The suffering patient thus co-opted in the triumvirate circuit of
state-science-capital paradoxically serves to obfuscate the troika at the
cost of her own obfuscation. The suffering patient and her suffering is
deferred, disappeared, and dispersed into a promissory therapeutic future.
The certainty of her suffering and eventual end in the present assumes a
totemic quality: a sacrifice that guarantees promised future returns on the
investment elicited in her name from state, science, and capital.
 Stem Cell Intersections: Perspectives and Experiences 15

I have had the rare privilege of documenting and following biogra-

phies of stem cell treatment seekers for nearly a decade. I am delighted
that rather than represent them, some of these inspirational pioneers will
represent themselves and their experiences in the pages of this book. As
noted previously, it is my firm belief that no matter how noble our inten-
tion as researchers we cannot truly give voices to people. Instead we can
merely create conditions for voices to be heard.
Through the course of my research, I have encountered numerous
patients reporting reversals in their rapidly worsening conditions post-­
stem cell interpolations and voicing deep frustrations on being seen as
either psychosomatic or responding to mere placebos (Bharadwaj 2013b).
For example, many patients had to contend with well-meaning but
unsupportive biomedical opinions advising against stem cell treatments
in India. Patients were continually asked to wait for therapeutic alterna-
tives to emerge within their home countries in Europe or the United
States. The well-meaning tropic construct of desperate gullible dupe in
need of protection from a guileful maverick often silenced the enduring
frustration patients articulated. To these intrepid treatment seekers, the
ethical stance of principled good science seemed callous and inhuman. As
one treatment seeker told me, ‘They [purveyors of bioethically settled
stem cell science] appear to be saying we rather you die than try’. In a
similar vein, a young man told Thompson (2013) he would travel abroad
for stem cell treatments if he could. He couldn’t understand why there
were concerted efforts to demonize countries offering treatments even if
those interventions were largely experimental. To the young man, the
demonized experimental nature of stem cell treatment modality abroad
was more desirable than dying waiting for the FDA in the United States
(Thompson 2013, p. 16).
It appears the figure of an independent, autonomous, free, rational,
and calculating subject—routinely resurrected in ethically adjudicated
consent procedures—is rendered problematic, as a decision to seek stem
cell treatments around the globe cannot be captured under the sign of a
clinical trial or some form of normative treatment seeking. It appears
outside the state-science-capital circuit; autonomy, consent, and choice
add up to mean something rather specific—gullibility and desperation.
Alternatives to what I am calling the triumvirate-sponsored biomedical
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