The Gender of Genetic Futures:

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The Gender of Genetic Futures:
The Canadian Biotechnology Strategy,
Women and Health






Proceedings of a National Strategic Workshop held at York University,
February 11-12, 2000.






Edited by: Fiona Miller, Lorna Weir, Roxanne Mykitiuk,
Patricia Lee, Susan Sherwin and Sari Tudiver
(The Working Group on Women, Health and the New Genetics, 1999-2000).












NNEWH Working Paper Series
September 2000
York University, Toronto











































The papers in this volume derive from pre-circulated statements, plenary presentations
and respondent commentary prepared for the Workshop.
Most of the Workshop materials are included in this collection, though some participants
elected not to submit their statements for publication.
All papers have been edited for inclusion in this collection, and authors’ biographies and
editors’ introductions have been added.
The authors retain copyright of their material.








































Acknowledgements
We would like to acknowledge the financial support of the following sponsors: the Centres of
Excellence for Women's Health Program, Women's Health Bureau, Health Canada; the Medical,
Ethical, Legal and Social Implications of Genomics / Genetics Research program of the Medical
Research Council of Canada; the National Network of Environments and Women’s Health
(NNEWH), which is financially supported by the Centres of Excellence for Women’s Health
Program, Women’s Health Bureau, Health Canada; the Department of Sociology, Faculty of
Graduate Studies, and Dean of Arts at York University. The views expressed herein do not
necessarily represent the official policy of our sponsors.


Table of Contents

1. Introduction
Placing Values at the Centre of Biotechnology Policy: The Canadian
Biotechnology Strategy and Women’s Health. Opening Remarks
Susan Sherwin 1

2. Opening Plenary
The New Genetic Therapies: The Case of Herceptin for Breast Cancer
Sharon Batt 9

Belling the Cat: Learning to know (but not necessarily trust) the new
genetics
Pat Kaufert 18

3. “Health” Theme

3.1 Ethics and Genetics: The Need for Transparency
Fern Brunger and Sue Cox 27

3.2 Geneticization and the Canadian Biotechnology Strategy: The Marketing
of Women's Health
Abby Lippman 32

3.3 What’s So New about the “New Genetics”?: Genetic Counselling and the
Medical Management of “Genetic” Information
Fiona Miller 41

3.4 The Hazards of Human Developmental Gene Modification
Stuart Newman 50

3.5 Genetic Testing, Citizenship and Subjectivity: Implications for Women and
Health
Jessica Polzer 55

3.6 Risk, biotechnology and political rationality: Lessons from women’s
accounts of breast cancer risks
Ann Robertson 64

4. “Wealth” Theme

4.1 Genetic Engineering in Agriculture and Health: Feminist Dilemmas and/or
Opportunities
Elisabeth Abergel 76

4.2 Engaging the State? Framing Feminist Politics in an Era of State-Led
“Reform”
Pat Armstrong 82

4.3 Biotechnology and Women’s Health: Re-Defining the Questions
i

Madeline Boscoe and Sari Tudiver 86

4.4 Gender and the Gene Giants: Research and action on women and the
new genetics
Julie Delahanty, for RAFI 92

4.5 Environmental Sustainability and the Canadian Biotechnology Strategy
Margrit Eichler 101

4.6 The New Genetics in the Post-Keynesian State
Roxanne Mykitiuk 106

4.7 One Part of an Anti-Racist, Feminist Political Standpoint against Biopiracy
Nandita Sharma 113

4.8 Nurturing Cycles
Penny Van Esterik 120

4.9 Biotechnology, Strategy, and Wealth for Whom: Commentary on the
Theme of Biotechnology and Wealth
Helen Bequaert Holmes, respondent 125

4.10 Preserving Cultural Diversity through the Preservation of Biological
Diversity: Indigenous Peoples, Local Communities, and the Role of Digital
Technologies
Rosemary J Coombe 132

5. “Community” Theme

5.1 Stepping into the Breach: Provincial Funders Replace Federal Regulators
in Defense of Public Priorities and Safety
Ken Bassett 161

5.2 Science Education for a Science Dependent Culture
Ellen Larsen 170

5.3 A Gender Critique of Forensic DNA Evidence: Collection, Storage and
Applications
Patricia Lee 172

5.4 The Human Genome Project and the Issue of Biodiversity
Priscilla Settee 183

5.5 Obscuring Disability: The Pursuit of “Quality” in the CBS
Catherine Frazee, author and respondent 190

5.6 Communities Constituted through the New Genetics: Actions and
Reactions. Commentary on the Theme of Biotechnology and Community
Margaret Lock, respondent 198
ii






Placing Values at the Centre of Biotechnology Policy:
The Canadian Biotechnology Strategy and Women’s Health. Opening Remarks

Susan Sherwin



About the Author
Susan Sherwin is Munro Professor of Philosophy and a Professor of Women's Studies at
Dalhousie University. Her principal area of research is in feminist health care ethics. She
is the author of No Longer Patient: Feminist Ethics and Health Care (Temple University
Press 1992). She also served as Coordinator for the Feminist Health Care Ethics
Research Network which jointly produced The Politics of Women's Health: Exploring
Agency and Autonomy (Temple University Press, 1998). Much of her current work is in
the area of ethics and biotechnology.



About the Article
In these Opening Comments, Sue Sherwin explains the history of the Working Group on
Women, Health and the New Genetics, and the goals of the national Strategic Workshop
held on February 11 and 12, 2000 at York University in Toronto. At issue for concerned
observers of the federal government’s policy agenda for biotechnology, Sherwin
suggests, are “basic questions of values.” It is precisely the imperative of value definition
and judgment which necessitates democratic rather than bureaucratic policy
development in this burgeoning field. Yet the government’s approach to defining values,
Sherwin argues, has been inadequate at best, and incoherent at worst. Drawing on her
own work in the field of feminist health care ethics, Sherwin seeks to “clarify and order
the values underlying the Canadian Biotechnology Strategy” by investigating different
meanings of ‘freedom’ and ‘choice.’ She advocates what she calls “relational autonomy”
as a way to approach these ideals. Finally, Sherwin considers the structures and
processes through which values – other than those advanced by industry – can be
brought to bear in the development and deployment of policies. Despite the difficulty of
such a task, Sherwin commends the importance of engaging citizens in the development
of Canada-specific approaches to the assessment, promotion and restriction of
biotechnology. Only in this way, Sherwin argues, can our policies “reflect and help to
realize the deepest values of Canadians.”

1

Introduction genetics for women’s health and their
sense of research priorities in this realm.
Nearly two years ago, a small group Building on the feedback from that
calling itself the Working Group on Women workshop, the Working Group decided to
and the New Genetics was formed under try to focus the 2000 workshop’s
the auspices of NNEWH (National investigation of the implications of the new
Network on Environments and Women’s technology for women’s health around the
Health). As a group of Canadian three core themes of health, wealth, and
academics and community activists community. We re-framed our initial
sharing a concern with issues related to agenda beyond genetics to the whole
women, health and genetic knowledge, we range of biotechnology in the hope of
structured our investigations around having an impact on the government’s
feminist principles of social justice. current efforts to restructure its approach
Specifically, we were concerned with the to the biotechnology industry. Our hope
absence of concentrated gender-specific was that the national strategic workshop
research investigating the impact of the would provide an opportunity for
new genetics agenda on women. With participants to define and begin to address
some seed money from NNEWH, we a series of fundamental, feminist questions
began a series of teleconferences around about the Canadian Biotechnology
the need for greater research in the realm Strategy (CBS) in relation to women and
of women’s health and the new genetics. health.
The membership of this working group
evolved a bit and soon settled into a core It is our view that that there are basic
1
team. questions of values related to the genetic
modifications of humans and other
The February 2000 workshop was actually organisms that must be identified and
the second in a series of two national addressed. These questions cannot be
strategic workshops. Last February resolved internally through state
(1999), we organized a preliminary bureaucratic processes, since they involve
workshop in Winnipeg to which we invited questions of society’s value commitments.
a small group of community activists Such decisions must be pursued through
concerned with women’s health issues. democratic processes. Indeed, recognition
They were asked to reflect on their of the importance of public debate was a
understanding of the implications of new major factor behind the federal
government’s 1998 efforts to solicit public

input on these matters through a round of
1
The Working Group for 1999-2000 consists
policy consultations. Many of us
of: Patricia Lee, Fiona Miller, Roxanne
participated in some of those sessions and
Mykitiuk, Yvonne Peters, Sari Tudiver, myself,
were confirmed in our sense that the level
and our reluctant but fearless and much
of critical cultural knowledge and public
overworked leader, Lorna Weir, Department of
understanding of biotechnology is weak.
Sociology, York University, Toronto. Though
The development of socially accountable
Ann Rochon Ford has had to give up active
membership in the group, she was a very
strategic frameworks for state
important early member who helped to get us
biotechnology policy suffers from this
going. The activities of the Working Group
dilemma. We are particularly troubled by
have been facilitated by continuing support
the lack of attention directed at the
from NNEWH. That support, supplemented
question of what these policies mean for
with grants from MRC, the Department of
women. A distinctly feminist perspective
Sociology at York, and the Dean of Arts at
must be brought to bear on the
York, allowed us to hold this workshop. We are
very grateful to all our sponsors.
2

identification and investigation of the many vague suggestions found within the
values underlying biotech policy. government documents about the values
that should be guiding Canada’s
We use the term 'women and health' quite biotechnology strategy. We can begin by
expansively to refer to three processes: documenting the incoherence in the
the impact of policy and technology on values expressed in the government’s own
women's health; women's relationship to statements of the values that form the
medicine and health systems; and basis for policy directions. For example,
women's 'interests' in health – health as the expressed commitment to advancing
women's business – personally, culturally, the health and well-being of Canadians is
socially. We asked Workshop participants often incompatible with the strongly
to focus on the following: What are the key endorsed value of supporting industry.
questions to ask so that we might best Just making clear the competing and
understand the impact the CBS will have incommensurate value frameworks that
on women and health? What kinds of are being proposed allows us to insist that
research and action need to be government be explicit about the priorities
undertaken to answer these questions? it attaches to the various value systems at
work. Toward this end, it is particularly
In deciding on participants for the important that we ask the familiar feminist
workshop, we sought out individuals questions as to who is likely to benefit
engaged in developing new knowledge or from the various types of biotechnology
in carrying out advocacy work. We tried to and who is likely to suffer from them. Let
structure the workshop to facilitate the me try to be a bit more specific.
exchange of existing knowledge, and also
to produce new questions and to incite the It is essential that Canadians understand
development of new knowledge and the different forms of freedom and choice
advocacy. We intended the workshop to that are proposed as a central value for
be a forum for the design of future emerging policy. The terminology of
research projects and activities, where freedom and choice is often used to
resources could be identified and networks represent quite different value systems.
formed of individuals and groups Not surprisingly, industry is particularly
committed to taking the issues further. The enthusiastic about market models in which
aim of the workshop was not to produce freedom is reduced to the ideal of
consensus. We meant to stimulate and unrestricted consumer choice. In this
facilitate rather than conclude. We hoped conception, government is assigned a role
to leave with a clearer sense of what of regulating trade to ensure accuracy of
questions should be asked, what research information and adequate opportunities to
undertaken and what advocacy pursued to acquire the information necessary to make
deal with the Canadian Biotechnology a rational choice. This is especially tricky
Strategy from the perspectives of women terrain for feminists for we often hear our
and health. The collection of papers in this own slogans about the importance of
Proceedings suggests that we “choice” and personal control over
accomplished our goals. decisions regarding our bodies invoked to
support industry’s right to market any
I have the privilege of leading things off. “health” or “reproduction” related product
Let me do that by situating my own or service directly to consumers.
research interests in the context of our
agenda. I work in the field of ethics, more We must, therefore, be very clear about
specifically feminist health care ethics. It is the type of personal freedom we
very clear that there is need for sustained understand to be central to feminist
feminist research directed at clarifying the values. Specifically, feminists need to
3

insist that the personal control we demand fully formed and self-transparent; but
is not a matter of being granted selves are never fully formed, coherent,
unrestricted access to problematic consistent, and clear. When individuals
technologies. Rather, we seek access to are faced with difficult personal decisions
opportunities that can support women’s they often surprise themselves with the
overall autonomy, and not increase their decisions they make. Real autonomy
oppression. We cannot decide whether comes not from entering such
any particular consumer option meets this circumstances with our values settled,
criterion by examining it in isolation and such that all we need is respect for our
seeing if it meets some particular person’s well-articulated preferences, but from
current desires or needs. To determine a having the opportunity to discover what
technology’s impact on personal autonomy our values really are and how they apply
we need to investigate it in the context of to the situation at hand. We need to
what opportunities are created or lost by wrestle with the implications of serious
its introduction. options to know what we stand for and
how we want to be treated. Thus, to
Elsewhere, I have proposed that we try to respect autonomy for individuals it is not
understand the ideal in question through a sufficient to leave them free to exercise
concept I call “relational autonomy” their preferences; rather we must provide
(Sherwin, 1998) The idea of relational them with the resources necessary for
autonomy is that we must critically discovering what they truly value and what
examine not only the decision-making sort of person they wish to be. It is our
capacity of the agent to make rational reflective, considered values that demand
choices free of direct coercion, but also respect, not our current inclinations. Self-
the nature of the set of options from which discovery and self-definition are relational
she must choose. Emphasis on the activities that are essential pre-conditions
relational dimension of autonomy (which of genuine self-direction.
literally means self-government) is meant
to counter the familiar over-simplification Therefore, a consumer model of choice
by which autonomy is equated with the with respect to various sorts of
exercise of preferences without biotechnologies cannot be equated with
interference. Relational autonomy the moral ideal of autonomy. The fact that
demands moral evaluation of the context people are willing, perhaps even eager, to
in which the person is being asked to purchase some form of biotechnology is
choose. In particular, agents should be not evidence that this technology should
free of the “double binds” of oppression be brought to market. Individuals are often
that tend to reduce an individual’s options in no position to resist technologies on
to a set of harmful choices where the best their own. If some form of technology is
she can do is to select that option most normalized, the option of refusing it may
likely to minimize the resulting damage. disappear. For instance, it is already
difficult for many women to resist prenatal
Relational autonomy is also distinguished testing of their fetuses even if they are
from consumer freedom in its appreciation committed to carrying the pregnancy to
of the processes that are essential term and the information available from
elements of becoming autonomous. It prenatal testing will be of no benefit to
rejects the common assumption that being them. Similarly, if the crops produced by
autonomous is achieved merely by virtue genetically modified seeds prove invasive
of reaching adulthood and being free of to other crops, or if they allow production
explicit coercion. Under the consumer at vastly reduced rates for a few years,
choice model of freedom the self is independent farmers may be unable to
expected to approach important decisions continue to plant traditional seeds in an
4

economically viable way. The fact that one drug trials from 60 days to two days
women choose prenatal testing under the because it hoped such a move would
mistaken belief that it will improve the attract more pharmaceutical research to
health of their fetus or that farmers choose Canada.
to buy seeds from the major distributors is
not evidence that the individuals Moreover, it is not only the producers who
concerned are acting autonomously. Only may resist national restrictions. In an era
if their decisions reflect their deepest where free trade has become a mantra of
values can we consider their actions fully politicians and economists, it is difficult for
autonomous. nations to develop policies that effectively
protect their citizens from the potential
We need to do more than clarify and order hazards of products originating elsewhere.
the values underlying the Canadian While consumers may welcome
Biotechnology Strategy, of course. We government’s role in setting minimal safety
also need to explore structures that can standards and promoting truth in
ensure that the values selected will be advertising, they tend to be rather
reflected in the policies our government intolerant of government restrictions on the
adopts. This project is especially availability of goods they personally
challenging, since it is difficult to see how desire. In fact, many Canadians have
Canadians might actually go about limiting become quite adept at “cross border
the development of any potentially shopping.” This means that if our
profitable biotechnology industry. While government ever does manage to finally
government is well positioned to foster the introduce its long-promised legislation to
development of favoured industries, it is regulate reproductive technologies, we
not as well equipped to restrict the can anticipate that some Canadians will
undesirable ones. Biotechnology side-step restrictions on reproductive
industries are particularly resistant to services (e.g., sex selection) through
government restrictions, for the companies travel to U.S. clinics. Similar action will be
involved are typically engaged in a global, taken for access to home-testing kits for
not a national, marketplace. In fact, many genetic traits, anti-aging potions, and even
belong to that most postmodern of organs for transplant if such products are
phenomena: multi-national corporations restricted in Canada but available for
that are situated both everywhere and purchase in other jurisdictions.
nowhere. Producers effectively resist
national regulations on the grounds that Nonetheless, I believe that Canada must
local restrictions would put them at an develop a national policy on
unfair economic disadvantage in a biotechnology. We need to do this in order
competitive global marketplace. Typically, to protect and promote the personal
they are able to make credible threats that autonomy of our citizens, because
they will move production to a different individuals cannot control the social and
jurisdiction if their interests are ignored. material conditions that structure the
Governments are understandably reluctant options they face; many of the
to introduce policies that inhibit the growth preconditions for relational autonomy can
of industries when the jobs in question can only be achieved through political action.
be easily moved off-shore. Indeed, In order to make certain that the options
governments are far more inclined to facing Canadians in the realm of
support than to restrict these new biotechnology will promote and not limit
industrial initiatives. For example, Health personal relational autonomy, it is
Canada was very explicit in its recent necessary for the government to develop
announcement that it would shorten the policies that reflect our national autonomy.
waiting time needed before initiating phase That is, they must be policies that reflect
5

and help to realize the deepest values of development of a biotechnology strategy
2
Canadians. which would “enhance the quality of life of
Canadians in terms of health, safety, the
In order to develop such policies, we must environment and social and economic
conduct exercises in collective self- development by positioning Canada as a
discovery and self-definition about the responsible world leader in biotechnology.”
sorts of activities well informed citizens (CBS, 1998). Ethical analysis was
wish to permit and the sorts of threats they understood to be a central element of
wish government to protect them from. It is these deliberations. But as several papers
only through a complex exercise of noted, the motivation for discussion was
communication and debate that we can couched in language aimed at facilitating
decide what might constitute “Canadian the development and promotion of
values” in the diverse, multi-cultural, biotechnology industries and did not really
heterogeneous society we inhabit. In fact, leave room for alternative strategies to
the federal government has recognized emerge. It is, therefore, essential that we
that potential transformations of make clear the inherent contradiction
fundamental values and understandings between a commitment to explore
are inherent in many forms of Canadian values regarding biotechnology
biotechnology. It has undertaken efforts to and an assumption that the outcome of
promote the conversations Canadians such analysis will be a shared commitment
must undertake in pursuing the activities of to support most biotechnology industries.
self-discovery and self-definition that are
essential for genuine autonomy. For Last fall, the federal government took the
example, more than ten years ago it next step in its biotechnology strategy
established the Royal Commission on process and appointed a 20 member
New Reproductive Technologies to advise Biotechnology Advisory Committee
on policies in the realm of reproduction. (CBAC). According to the Minister of
The Royal Commission conducted Industry “CBAC is an expert, arm's-length
extensive consultations with Canadians committee created under the renewed
and determined that we are united in not Canadian Biotechnology Strategy (CBS) to
wanting to be a society that treats children advise Ministers, raise public awareness
or women’s reproductive capacities as and engage Canadians in an open and
commodities to be bought and sold. By transparent dialogue on biotechnology
exploring the meaning of this commitment, matters. . . . CBAC will advise government
the Commission learned that Canadians on broad policy issues associated with the
did not think it appropriate to treat ethical, social, regulatory, economic,
reproductive activities, including the scientific, environmental and health
contribution of embryos, eggs, and sperm aspects of biotechnology.” (CBAC, 1999).
as commodities to be auctioned off to the Its express purpose is to facilitate
highest bidder. continued dialogue of self-direction and
self-definition in the pursuit of national
In 1998, the federal government initiated autonomy in the realm of biotechnology.
conversations central to self-discovery and There is, however, plenty of reason to
self-definition in the sphere of worry about its effectiveness in achieving
biotechnology broadly defined. It held a this task. It is arguable that the advisory
series of public consultations regarding panel of distinguished Canadians is not
representative of all concerned citizens;

certainly, there are many groups that fear
2
I do not believe that oppression of minorities
their views will not be represented nor
reflects national autonomy at all, but rather the
their voices heard. Health activists seem
co-optation of ethical language in the service
to have been deliberately excluded and I
of immoral abuses of local power.
6

know of only one member who is explicitly processes that have been put in place
committed to a woman’s health agenda. make it difficult for the government to hear,
CBAC will need to find ways to promote let alone adopt, values other than those of
trust in its ability to fully engage Canadians industry. We need to identify strategic
in self-discovery and self-definition and to ways to demand more accountability from
report accurately the outcomes of these government in:

conversations if its advice is to carry the
necessary authority. One thing we can do, 1. identifying the appropriate values to
here and in the future, is to begin to guide biotech policy; and
2. ensuring that the values agreed upon
formulate a substantive list of questions
regarding the impact on women’s health do in fact structure both national and
that CBAC should attend to in its international policies.
deliberations. We might also propose
procedural ways that can facilitate Protecting and promoting women’s health
meaningful input from citizens who are must surely be fundamental to that
concerned with, and knowledgeable about, agenda. Our hope for the workshop was
women’s health. that it would help to provide direction to
the research and political activities that are
Of course, self-discovery and self- essential elements of translating this
definition are not the only elements of commitment into practice. Clearly, there is
autonomy. Self-direction is also required. much work for feminists to do in promoting
So far, the Canadian government has biotechnology policies that truly support
been unwilling or unable to engage in the women’s health. The following papers
final step of exercising national autonomy provide some guidance for how to
in the realm of biotechnology. Despite the proceed.
thoroughness of its public consultations
and of its research and analysis, none of
the 293 recommendations of the Royal
Commission on New Reproductive
Technologies has yet been implemented.
It is still too early to determine whether
CBAC will be able to contribute effectively
to self-direction on biotechnology policy. It
is clear, however, that there are likely to
be structural impediments to its capacity to
influence policy, that is, to see its moral
analysis translated into national self-
direction. The panel reports to an inter-
governmental agency in which the
Department of Industry plays a leading
role; the principal responsibility of this
ministry is to promote industrial
development. Such an arrangement does
not seem to be particularly conducive to
generating policy that may require
imposing restrictions or prohibitions on
certain industries.

So far, then, the biotechnology strategy
espouses interest in identifying and
reflecting the values of Canadians but the
7


References

Sherwin, S. 1998. “A Relational Approach to Autonomy in Health Care” in The Politics of
Women’s Health: Exploring Agency and Autonomy by the Feminist Health Care Ethics
Research Network, Susan Sherwin Coordinator. Philadelphia: Temple University Press.

CBS (Canadian Biotechnology Strategy Task Force), 1998. Renewal of the Canadian
Biotechnology Strategy: Roundtable Discussion Document. Available on-line,
http://strategis.ic.gc.ca/cbs.

CBAC (Canadian Biotechnology Advisory Committee). 1999. announcement of
membership and terms of reference, September. On-line, http://cbac.gc.ca.
8








The New Genetic Therapies:
The Case of Herceptin for Breast Cancer

Sharon Batt





About the Author
Journalist and community activist Sharon Batt has written extensively about breast
cancer issues. She is the author of Patient No More: the Politics of Breast Cancer
(Gynergy Books, 1994) and co-founder of Breast Cancer Action Montreal. In July 1999
she began a two-year term as Nancy’s Chair in Women’s Studies at Mount Saint Vincent
University in Halifax.


About the Article
For many women’s health advocates, the challenge of genetics in relation to breast
cancer is the challenge posed by a new breed of genetic tests. In this piece, Sharon Batt
suggests that there are other challenges to consider. Batt introduces readers to a new
treatment protocol for breast cancer, involving a genetically engineered antibody which
targets a malfunction that is genetically associated − Herceptin (or Trastuzumab). As
Batt discusses it, the new drug Herceptin poses both new and familiar challenges. On
the familiar side of the ledger, and despite the hype to the contrary, this new genetic
therapy is no miracle cure; moreover, like the better known therapeutic protocol of
chemotherapy, Herceptin has dangerous adverse effects. On the less familiar side of the
ledger, this drug is exorbitantly expensive, and herein lies the new challenge. While this
drug and others like it that are coming down the pipe may provide new tools for fighting
cancer, they may also prove unaffordable. Batt argues that if the new era of biotech
medicine provides some medical assistance for the few, while contributing to the demise
of a public health care system for the many, women in general are unlikely to be the
winners.
9

Introduction Herceptin is the first therapy of its kind

ever approved for the treatment of breast
Breast cancer is the number one killer of cancer. Unlike cytotoxic chemos which
mid-life women and has been for decades. simply aim to kill the misfunctioning cell,
Treatments are harsh and have limited Herceptin aims to re-balance the process
benefits. An effective new treatment would
that is misfunctioning. In this case, the
be welcome indeed, and one that worked therapy is designed to correct an over-
and had few or no adverse side effects production of the protein produced by a
would transform the experience of breast
certain oncogene (i.e., cancer gene),
cancer beyond recognition. Enter the which the defective gene uses to make the
1
Human Genome Project, promoted as cell cancerous. This gene has been
precisely the Aladdin’s lamp we’ve been
named “HER-2 neu,” a clever moniker for
waiting for. Research mapping genes to a drug designed for women. HER-2 refers
diseases will lead us into a world of just to the protein, “Human Epidermal-growth-
such therapies, miraculously effective factor Receptor-2,” and neu is the name a
because they are based on a true different scientist, who discovered the
understanding of how genes work. At least gene first, decided to call it. Geneticists
that’s the hype. Women’s health refer to the production of excess protein as
advocates need to weigh these claims, "overexpression". Herceptin is intended to
balancing our scepticism of this project correct the overexpression of the Her-2
2
against the desperate need of sick women protein.
for more enlightened therapeutic
approaches to cancer.
Because the Her-2/neu gene produces an
excess of the Her- 2/neu protein,
Feminist discourse about breast cancer researchers developed what is called a
and genetics has concentrated on the
"monoclonal antibody" to attack the protein
issues related to genetic testing for breast and shut it down. (The body produces
cancer susceptibility, especially the BRCA
millions of different antibodies − which
1 and 2 genes, and on the reductionist
themselves are proteins −to attack
emphasis on genetics − to the exclusion of
invading viruses and infections. A
environmental triggers – as the basis of
"monoclonal" antibody is laboratory
cancer. While these are critical issues, we
manufactured, using genetic engineering.)
can’t neglect the questions arising from

genetic treatments that are now coming
Researchers working on this problem in
onstream. Health Canada approved
the late 1980s were amazed and delighted
Herceptin, the first novel gene therapy for
when they added the monoclonal antibody
breast cancer, in August, 1999.
to a petri dish containing breast cancer

cells that overexpressed Her-2/neu: the
In the rest of this paper, I look at what we
cancerous cells stopped growing and
know so far about what Herceptin does for
dividing. When they injected the antibody
women with breast cancer, its side-effects,
into mice into which breast cancer cells
its cost, how advocates are responding to
had been implanted, the tumours shrank.
this new therapy, and the dilemmas the

drug presents for those of us concerned
1
NB. This genetic change is part of the cancer
about Canada’s biotechnology strategy.
process; it is not inherited.

2
Again, the language reverberates for

feminists: women have long been chastised as
What is Herceptin?
overexpressing our emotions; now we have a

“women’s gene” that overexpresses and gives
us cancer.
10

Over the next decade, the antibody was 20.3 months from the beginning of
adapted for use in humans and then treatment; those who had chemo plus
tested in clinical trials using women who Herceptin lived a median time of 25.4
had breast cancer tumours that tested months from the beginning of treatment.
positive for Her-2/neu. (Bazell, 1998:42-3) (Slamon et al 1998). After two years of the

trial, researchers were announcing that the
This modus operandi is very different from
addition of Herceptin to chemotherapy
traditional cancer chemotherapies, which increased patient survival by 22% (Zoler,
are systemic, and which are designed to 1999).
kill cancer cells. In theory, herceptin is a

huge therapeutic advance. As everyone In the world of breast cancer treatments,
knows, conventional chemotherapy drugs this was considered remarkable. Very few
have horrible side-effects, because they
chemotherapy trials have ever shown a
kill any rapidly dividing cell, healthy or survival difference between two
cancerous. What's more, they have not treatments. On the other hand, this is far
been very successful in treating breast from the miracle women with breast
cancer, especially in patients with cancer hope for.
advanced disease − in fact, they often kill
The drug has been disappointing on a
the patient before the disease does. While
number of other counts. First of all, it
Herceptin was in development, the drug
was touted as a treatment that would work benefits only a subset of women with
advanced disease. To see if she qualifies
better than cell-kill chemo and which
for Herceptin, a woman is given a test to
would have no side-effects at all. A
patient’s dream drug. see if she is one of the cancer patients
who are Her-2 positive; that is, one of the

25-30% of women with advanced breast
Does Herceptin Work? cancer who overexpresses the Her-2
protein.
Does Herceptin Work? The answer is
sometimes and sort of. But even a positive Her2 test result is no
guarantee that Herceptin will benefit
Like most new cancer therapies, Herceptin women who take it. In the clinical trials
data, 32 percent who were treated with
is being tested in patients with advanced
cancer, that is, in women whose condition chemotherapy alone showed tumour
is very likely to be fatal. Twenty-five to shrinkage compared to 49 per cent of
Her2 positive women under the Herceptin
thirty percent of women whose cancer has
reached this stage have been found to + chemotherapy regimen. Even with the
combined treatment, 51 per cent of Her2
overexpress HER-2 − and they are women
positive women did not respond to
whose disease is typically unusually
Herceptin.
aggressive, or fast-spreading.


Other trials have suggested that
Clinical trial data for Herceptin have been
Herceptin-alone may be a useful treatment
coming out since 1998. The original study,
for metastatic breast cancer. Because it
which convinced regulators to approve the
was considered unethical to deny
drug, comprised 469 women with
chemotherapy to women with cancer,
metastatic breast cancer. Women treated
with a Herceptin-chemotherapy these trials have involved women who
have already had a course or more of
combination lived longer than women
chemo, but whose cancer has returned. In
treated only with chemotherapy by a
median time of 5 months. Those who had the largest trial of this kind, involving 222
women, the results were considered
standard chemo lived a median time of
11

significant. Herceptin produced a 15% experienced what’s known as “cardiac
“response rate” (in other words, 15% of dysfunction.”
these women had at least a 50% reduction
in the size of their tumours), for a median In May 2000, Genentech, the
time of 9.1 months. (Cobleigh et al,1999) biotechnology company that developed
the drug, sent out an alert to providers,
warning them to pay special attention to
Adverse Effects heart function when prescribing this drug.

Genentech reported 62 serious adverse
Though potentially a useful addition to the
events related to the use of Herceptin; 15
treatment protocol for metastatic breast of these women died. The company noted
cancer, Herceptin has not lived up to its that while some of these events had been
advance billing. As one American activist
observed in the clinical trials of the drug,
summed it up, "While Herceptin may some were more severe, or new:
represent an important new direction for specifically, “adult respiratory distress
cancer therapy, the oncology community's syndrome, anaphylaxis and death within
excitement about a 5.1 month median 24 hours of a HERCEPTIN infusion.”
survival benefit also shows how little has (Genentech, 2000)
been achieved since the war on cancer
began in 1971." (Schiff, 2000:23) Such extreme and fatal outcomes
prompted heart specialists to speak out
But more surprising for its proponents than about the drug. They note that “heart
its limited efficacy, has been the extent to failure, like many cancers, is a progressive
which this drug is associated with adverse
disease, “and they argue that physicians
effects. On the one hand, Herceptin is should take care that “patients do not
generally given in combination with trade one lethal disease for another.”
chemotherapy drugs. The researchers'
(Feldman et al, 2000:272). Fear of cancer,
thinking was that the antibody would hold and particularly fear of breast cancer, is
the cancer in check, while chemotherapy clouding clinical judgement, in the view of
attacked it (Bazell, 1998:137). If a selling
cardiovascular specialist Arthur Feldman
point for genetic treatments is that they are of the University of Pittsburgh Medical
more targeted and less toxic than cell-kill Centre. “…if someone were to go to the
chemotherapy, this advantage is FDA with a new drug for heart failure or
somewhat academic if the drug is given in cholesterol or high blood pressure – all of
combination with a cell-kill regimen. which are leading killers of people – and
Another problem is that Herceptin can't that drug was associated with even a 1%
cross the blood/ brain barrier. Some incidence of cancer, it would never be
women whose metastases disappeared in approved by the FDA,” said Dr. Feldman.
their liver, lung or bones eventually died of “No manufacturer would take the drug to
brain metastases. (Bazell, 1998:170) the FDA. Yet here is an anticancer drug

that is associated with a 28% incidence of
But most important is the apparent toxicity heart failure and it is approved.” (Gottleib,
of Herceptin for heart tissue. The cell-kill 2000) BMJ 2000; 321:259 (29 July)]
chemotherapy regimen which is used is

Given these results, the future of
already quite toxic − especially to heart
tissue. To everyone's surprise, Herceptin Herceptin is not certain. What is certain,
actually increased the heart toxicity by however, is that other genetically
engineered drugs are on the way, and
25%. This was the case even for those
women who had Herceptin-alone; in the some of the issues that Herceptin raised
trial of 222 women noted above, 4.7% are bound to recur.

12

women actually take advantage of this
The Price of Herceptin possibility.


No one involved in Herceptin’s Hoffman-La Roche, which took over
development ever expected the world’s Genentech in 1990 (Bazell, 1998:54-55),
first designer breast cancer drug to be made it clear the company intended to cut
cheap. A book about HER-2’s
no deals to increase women’s access to
development, by TV journalist Robert the drug in Canada. In a June 1999 letter
Bazell, culminates at an oncology to a woman seeking access to the then-
conference in Los Angeles at which the
unapproved drug, Medical Director Dr Len
results of the clinical trials are presented to Walt wrote:
an audience of 18 thousand delegates.
That evening, Genentech held a party for
It is important to note that the
its researchers, for the clinical trial responsibility of providing new
investigators, and for activists who had therapies to patients is a shared one.
helped promote the trial. "Everyone at the There are three critical sectors, each
party could celebrate an enormous with definitive accountabilities,
success,” Bazell (1998) writes. “Women's responsible for bringing new therapies
lives would be saved and a huge fortune to Canadian patients.
would be made.”(186)

•the pharmaceutical industry develops
Drug pricing hasn't been an issue in breast
and manufactures new products;
cancer until recently. The pricing of two
•Health Canada reviews the scientific
earlier drugs, tamoxifen and taxol made
evidence in support of new products
some waves, but the cost of Herceptin is a
and gives the manufacturer the
big issue. To give away the punch line, if
authority to distribute new products in
this drug were made available to all the
Canada;
women with breast cancer who test HER-2
•provincial and other funding
positive it, and the imitators sure to follow,
agencies ensure that adequate funds
could bankrupt our health care system.
are set aside to cover the costs of

new products introduced into the
In the US, the FDA approved Herceptin in
health care system.
October 1998; health Canada approved

the drug in August 1999. In the US,
Each of these sectors should be held
Herceptin costs about US$2,000 a month;
accountable for delivering on their
the Canadian price is about $Can $16,000
responsibilities. The pharmaceutical
for a 6-month course (Sibbald, 1999). This
industry cannot make up for the
is unprecedented for a breast cancer drug.
deficiencies in Health Canada or the

provincial funding agencies (Personal
Insurance-wise, US patients fall into 3
Communication 1999).
categories:

• those covered by a private medical

plan, usually via their employers;
In Canada, each of the provinces have
• those who qualify for MedicAid;
had to decide how to deal with the drug.
• and the "working poor, the 40 million When it looked like Herceptin was a
who have no medical coverage. benign cure, Ontario and BC decided to

cover the drug under medicare; it is not
Genentech has agreed to provide
clear what some other jurisdictions will do,
American women in this latter category especially in light of information about
with HER-2 free of charge, although I adverse effects.
know of no figures showing how many

13

Our Patented Medicine Prices Review treatments, Herceptin sets a positive
Board sets the price of drugs like precedent for gene therapies to come.
Herceptin by comparing the prices in From the standpoint of provincial
seven other countries: the US, the UK, treasuries, however, the high cost of
Germany, France, Italy, Switzerland and Herceptin is clearly a problem.
Sweden. The Canadian price can't be
higher than the median international price.
When Canada approved Herceptin, the Advocacy

only other country the drug was available
From an advocacy standpoint, Herceptin is
in was the US, so the price was set
an interesting test case of the two
relative to the US price − and the US is the
competing philosophies described in
only country in the world that has no
several of the papers included in this
system of price controls on drugs.
3
volume.


Herceptin is being heralded as the
One can look at Herceptin as a possible
harbinger of a new era. In her introduction
breakthrough that provides sick women
to Bazell's book on Her2, geneticist Mary
with a new choice, and stimulates the
Claire King, harkened back to Churchill's
economy at the same time. Or one can
declaration at the battle of El Alamein, in
look at Herceptin as the latest chapter in
1942: "Now this is not the end. It is not
an old story, the focus on downstream
even the beginning of the end. But it is,
solutions to cancer, while the upstream,
perhaps, the end of the beginning."(Bazell,
causal factors are ignored. One can
1998:xi)
question the ethics of a system designed

to spin enormous private profits from the
Herceptin is expected to be the first in a
genetic information provided by dying
long line of such treatment options. And to
women praying for a few extra months of
a dying woman, the chance of being one
life.
of the few patients for whom a drug like

this means a long-term remission, is
Already, the cancer drug pricing issue has
invaluable − especially when the
fostered some strategic alliances. In
alternative is a median life expectancy of
October, McGill medical ethicist Margaret
20 months. But Genentech never intended
Somerville (1999) published a paper called
that this drug be reserved for dying
"The Ethics and law of Access to New
women. Cancer drugs are always tested
Treatments for Cancer." The paper was
first on the terminally ill. Genentech hoped
financed by an educational grant from
to move Her-2 quickly to the status of a
Bristol-Myers Squibb, the maker of taxol,
front-line treatment, that is, a drug that is
another expensive cancer treatment with
prescribed immediately after breast
modest benefits for patients. Somerville
surgery (Bazell, 1998:175). Because of
argues that physicians have a primary
cardiac toxicity, this is unlikely to happen
obligation of personal care to patients, and
with Herceptin, but that will certainly be the
that provinces must provide medically
goal for other such drugs. And such a
necessary treatments as a condition of
strategy, while increasing the market for
receiving federal transfer payments. She
manufacturers, poses additional
challenges for those who pay for health

care.
3
Herceptin brought other advocacy issues to

the fore, including the questions of
If the main goal of the Canadian
compassionate access, advocates’
Biotechnology Strategy is to generate jobs
involvement in clinical trial recruitment, and
and goose the economy by encouraging
fast-tracking of drug approval. These issues
the manufacture and sale of profitable new
are outside the scope of the present paper.
14


suggests that cancer patients would be on
firm ground in suing a provincial Even though Herceptin is beginning to
government that denied potentially life- seem like a false start for the new era of
saving care. Acknowledging the difficulty genetic therapies, we cannot expect this to
this presents for a universal system, she always be the case. If the high cost of
suggests that a parallel, private system in treatments like Herceptin have the
potential to split our universal system into
Canada may emerge. “This would change
the locus of, but certainly not eliminate, the two tiers, it's fair to assume women will be
difficult ethical and legal issues raised by over-represented in the bottom tier. It
would be ironic indeed if the very women
decisions on access to new or emerging
treatments for cancer,” she concludes. who come out in such numbers to “run for
the cure” and who volunteered for clinical
trials, were unable to access not only new
Somerville also refers to a group of
"patients and advocates", "concerned genetic therapies, but the hospital beds,
about timely access to new cancer nursing care and other health services we
treatments in Canada" who conducted a take for granted.
survey of provincial governments to find
out how decisions about access to drugs As an activist, I see Herceptin as a test
are made in each province. This group has case for advocacy in biotech therapy. I am
issued press statements under a number concerned when I see women with breast
of names, including ACT (Access to cancer, funded by industry and describing
Cancer Treatments) and the Cancer themselves as advocates, promoting
Advocacy Coalition of Canada, and its access to new therapies as a right, in
isolation from its likely consequences. The
activities are funded by major
pharmaceutical companies, including environmental movement calls industry-
Bristol Myers Squibb. In November, 1999, funded groups that present themselves as
green lobby groups as “Astro-turf groups”.
the group convened a meeting of cancer
patients, oncologists, and representatives What should we call their counterparts in
from cancer agencies, to discuss the health field? I suggest we call them
questions raised in Dr Somerville's report “placebo health groups” − for sugar-coated
and by their inquiry.
advocacy.

Interestingly, neither Dr. Somerville's
We need to be clear about the issue,
paper nor the advocacy group raise the
values and vested interests behind various
issue of drug pricing although the cost of lobbies. Despite the novel language of
drugs is clearly the nub of the access
biotechnology, the central political
problem. Nor are the larger contexts of
questions raised by the herceptin story are
overall medical care and the familiar to feminists. Drugs have been
environmental and social determinants of
over-promoted to women before; the
health part of their discussions.
issues of rising drug prices and corporate
influence on health policy are among the
Yet surely an ethical analysis must take up
galvanising issues of our age.
the cause of access for all needy patients,

not only the privileged. And in considering
the ethics of drug access, we also need to
What can we do?
address the broader implications of

skyrocketing drug costs for overall health The anti-consumerist organisation
care.
Adbusters has developed strategies to

disrupt the consumer culture, a process its
founders call "culture jamming". An
Conclusion
example is Buy Nothing Day, their day of
15

“consumer fasting”. Canada’s We could boycott Runs for the Cure,
biotechnology strategy has been honed to unless sponsoring agencies agree that the
serve a consumerist economy, with no money raised be used to finance
public discussion of the consequences: treatments that would be reasonably
biotechnology activists need strategies for priced, and unless the funds are
“genome-jamming”. distributed equally to “upstream” disease
prevention work.

What might genome-jammers do? “Choice” is an illusion if genetic treatments
are the only options on the menu; that is, if
We could oppose private ownership of prevention is excluded from serious
genetic material for therapies; these discourse; if lower-cost interventions are
therapies are developed from specimens not even tested; if treatment prices bear
no relationship to the true benefit of the
donated by − or taken from − patients who
intervention for patients.
hope to see treatments developed for the

benefit of other cancer suffering
Treatment choice is also a moot
individuals, if not themselves.
advantage if we fail to provide adequately

for the needs of the dying, if our society
We could boycott clinical trials by
remains intolerant of people living with
companies that won't agree to price
disease and its consequences, and if our
controls, and which maintain secrecy
worldview rejects the inevitability of death.
about their true R & D costs.

16


References

Bazell, Robert. 1998. Her-2: the making of Herceptin, a revolutionary treatment for
breast cancer. NY: Random House.

Cobleigh, Melody et al. 1999. Multinational Study of the Efficacy and Safety of
Humanized Anti-HER2 Monclonal Antibody in Women Who Have HER2-Overexpressing
Metastatic Breast Cancer That Has Progressed After Chemotherapy for Metastatic
Disease. Journal of Clinical Oncology. 17:9, 2639-48.

Feldman, Arthur et al. 2000. Trastuzumab in the Treatment of Metastatic Breast Cancer:
Anticancer Therapy Versus Cardiotoxicity. Editorial. Circulation. 102, 272-4.

Genentech, 2000. Important Drug Warning. May 3. Posted on FDA site:
http://www.fda.gov/medwatch/safety/2000/hercep.htm (accessed Sept 5, 2000).

Gottlieb, Scott. Cancer drug may cause heart failure. British Medical Journal. 321:259
(29 July)

Personal Communication. 1999. Letter from Dr Len Walt, Medical Director, Hoffman-La
Roche Ltd. (Canada) to a Canadian seeking pre-approval access to Herceptin. (June).

Schiff, Helen. 2000. Herceptin's Track Record: What does it mean for us?, Mamm
magazine, January.

Sibbald, 1999. Making a case for a $2700-a-month drug. Canadian Medical Association
Journal. 161:9, 1173.

Slamon D et al. 1998. Addition of Herceptin (humanized anti-HER2 antibody) to the first
line Chemotherapy for HER22 Overexpressing Metastatic Breast Cancer (HER2 +
/MBC) Markedly Increases Anticancer Activity: A Randomized Multinational Controlled
Phase III Trial. Proceedings of the American Society of Clinical Oncology 17:98a (abstr
377).

Somerville, Margaret. 1999. The Ethics and Law of Access to New Treatments for
Cancer. Current Oncology. 6:3.

Zoler, Mitchel. 1999. Two-year Follow-Up Shows Herceptin Ups Survival. Family
Practice News. V29 (June 15).
17







Belling the Cat:
Learning to know (but not necessarily trust) the new genetics

Patricia Kaufert




About the Author
Patricia Kaufert is a British trained social scientist who did her Ph.D. at the Centre of
West African Studies, University of Birmingham. After coming to Canada in 1977, she
was retro-fitted as a health researcher, courtesy of a post doctoral fellowship and
National Health Research Scholar Award from Health Canada. Her areas of specialty in
women’s health include menopause, midwifery and mammography. Her most recent
interest is in health policy, women and the new genetics. She is a Professor in the
Department of Community Health Sciences at the University of Manitoba.



About the Article
To talk about the new genetics, Patricia Kaufert argues, we need not only a new
language, but a new way of doing research. This new research approach must respect
the fact that our subject manifests itself in a multiplicity of forms, institutions and
meanings, and obliges consideration at different levels of analysis. Our research
methods must be more than multi-disciplinary, Kaufert writes; “If we are to capture some
element of this rapidly changing, chaotic world we … need an approach more akin to
collage, allowing for the constant addition of new pieces of information, new actors, new
technologies.” Kaufert’s paper teaches by example. Pursuing an initial review of breast
cancer genetics, Kaufert raises questions, and provides insight into women’s complex
decisions, uncertain medical options, health policy challenges and the connections
between research and trans-national profiteering.
18

Introduction about genetics, but we also need a new
form of research. Although there are
While preparing what to say at this important exceptions, the primary focus of
workshop, I read the papers that the the social science literature on the new
conference organisers had loaded into my genetics has been on the meaning of
e-mail. A diverse, marvelously exciting genetic testing for the individual tested.
collection – a series of bright lights shone Some part of this choice may be dictated
into the ‘black box’ of biotechnology. They by access to research funding, but it also
forced me into constantly scrapping what I reflects a deep commitment to grounding
had written and starting over because a research on biotechnology in the
paper, or a combination of papers, had experience of the individual, particularly
sparked a new idea, suggested a new the individual woman (Franklin and
theme. What I finally wrote was not so Ragone 1998). While essential that this
much a paper as a series of reflections. type of focused, in depth work continue,
there are also many questions about the
The background papers for the workshop new genetics, relevant to women, that this
covered the spectrum from micro to type of research cannot answer.
macro, from the individual to the
community, from society writ large through Rayna Rapp recently wrote about the
to microscopy of the individual cell, from need for research at the place “where the
biotechnology in medicine to cutting edges of genetic research
biotechnology in agriculture. Reading them converge with social policy.” The problem
as a package, one switches from the micro is that this “place” is one of relative chaos,
level (the women reflecting on the risk of packed with a very disparate array of
breast cancer in Anne Robertson’s paper) actors, each with a particular perspective
to the meso (Ken Basset’s discussion of on the new genetics. As a rough list, they
the policy issues faced by provincial include the federal and provincial
governments) and then forward to the governments, researchers, family
macro level (the role of the multi-nationals practitioners, geneticists and genetic
in the agricultural and pharmaceutical counselors, research funding agencies,
industries as discussed by Margaret family practitioners, priests and ethicists,
Eichler and Pat Armstrong). families and multinational companies,
lawyers and providers of venture capital,
Trained in different disciplines, the people Myriad Genetics of Utah, Inc., and public
who wrote these papers brought insights health departments. If we are to capture
from ethics, history, anthropology, law, the some element of this rapidly changing,
biological sciences, sociology and chaotic world we also need an approach
medicine into their discussion of the new more akin to collage, allowing for the
genetics. The challenge for the workshop constant addition of new pieces of
was to find the connections between these information, new actors, new technologies.
different voices and themes. Yet, the
critical importance of the workshop lay In putting this paper together, I used the
also in its representation of so many background papers, but also drew on a
different perspectives on the new genetics study with Margaret Lock in which we are
and so many different ways of collecting looking at the process by which a genetic
and collating information and doing test moves out of the laboratory and into
research. the clinic. In addition, I made use of the
bric-a-brac of news and information picked
I agree very much with Abby Lippman that up from the media or the internet, as well
we need a new language in which to talk as small pieces of academic gossip, books
19

read, conferences and meetings attended buy/not-buy genetically modified foods, or
and conversations held. I also drew on my to be screened/not screened, or to have
own background and experience in their fetus screened/not screened. To
different areas of research on women’s make decisions about the new genetics
health, although the result is best within the terms of their own lives, women
described as idiosyncratic rather than self- need information and they need
reflexive. This is a collage rather than a information of many different sorts in many
structured academic paper. It provides different forms.
very little by way of answers, but raises a
lot of questions. In the sense of being put together from
bits and pieces, patched together into a
whole fabric, we need research by
Cassandra(s) and the Information Age
bricolage. As a brief illustration of what this
might mean, I have taken a single topic
The first of these questions is the product and pursued it across different disciplines
of a sleepless night, the result of talking and up and down different levels of
with Madeline Boscoe and then going analysis from micro to meso to macro and
back to re-read what Abby Lippman had back again. There was time and space
written. At four o’clock in the morning, I only to raise questions rather than find
asked myself: “Can we stop it?” “It” being answers, but finding answers is not the
roughly everything that sits under the label purpose of the exercise. It is rather to
‘biotechnology’; “we” being the doubters, show how the questions change with
the luddites, those sceptical of the every boundary crossed, but also how a
promises of the new genetics, the critics single question may have multiple
and questioners. Reluctantly, my answer answers at many different levels.
had to be “No”. Less optimistic of the
possibility of revolution than Abby
(particularly at four o’clock in the morning), Micro: the woman and the prophylactic
I see the momentum as too advanced, the oophorectomy
forces as too strong; the motivators –
particularly fear and money – as too My starting point is a prophylactic
powerful. Where does this leave us? oophorectomy. Attending a meeting of
Possibly in the role of Cassandra; a set of oncologists, geneticists and genetic
truth tellers, crying doom, but condemned counselors last year, I heard some one
never to be believed. discuss the advisability of a woman, tested
positive for BRCA1, having a prophylactic
Yet, while pessimistic, I do not think that oophorectomy. Looking back, I am not
things are altogether dark. There is sure why this shocked me as much as it
evidence, admittedly scattered, that some did, for I was already familiar with the
people in some places are making some literature on the increased risk of ovarian
choices. Companies have ‘chosen’ not to cancer among women testing positive for
use genetically modified foods. A number BRCA1 and BRCA2. Possibly it was
of European countries chose to oppose because discussion was about a real
Canada and the US over the importation body, a real person, rather than part of an
of ‘Franken’ foods. Offered the academic debate.
opportunity, some individuals have
‘chosen’ not to be screened for genetic Yet, my reaction was partly a product of
diseases. Women are very key to this my work on menopause and my
process as the implementation of many of knowledge of that clinical literature. The
the new technologies depends on their bilateral oophorectomy, included in that
compliance, whether a willingness to literature as a surgical form of menopause,
20

is recognized in this literature as having a Familial Breast Cancer Collaborative
more severe impact on the body and as Groups came to a very similar conclusion.
producing more severe symptoms than While conceding that the data were
natural menopause. The orthodox clinical insufficient, they also advised that the
response is to put a woman on immediate prophylactic oophorectomy was “a
and long term hormone therapy to control reasonable option in high risk women”. A
her symptoms, protect her heart and the third review of essentially the same
density of her bones. As a quasi- literature concluded that prophylactic
epidemiologist, the key question for me oophorectomy resulted in, at most, small
was whether or not the routine prescription gains in life expectancy (Schrag et
of estrogen therapy would be advisable for al.1997).
a young woman with a genetic pre-
disposition to breast cancer. Yet even as Why would the members of these different
the question was framed in my mind, I study groups and consortia – largely
knew that not only is no information geneticists and oncologists – recommend
immediately available, but that it is unlikely something for which the epidemiological
to be in the future. For given the current evidence was weak by their own
inability to closely monitor the ovaries for admission. Broadening the initial
the first signs of cancer, it would be MEDLINE search by dropping ‘genetics’
unethical to set up a controlled trial in as a key word produced several papers on
which healthy women with the same the use of prophylactic oophorectomy in
genetic test results and the same surgery healthy women with healthy, but
are randomized to take or not take postmenopausal, ovaries. Two of the
estrogen. Unfortunately, this is only one of studies in the search reported on reviews
the many questions within the new of the medical records of women with
genetics for which there is no absolute ovarian cancer to determine if there had
answer. been an earlier, but missed, surgical
‘opportunity’ to save them. (The
Still thinking as a quasi-epidemiologist. I opportunity being the body opened, the
wondered also what was the quality of the uterus removed, the ovaries left in place,
evidence being used to advise a test- but subsequently becoming cancerous.)
positive woman to have a bilateral Another paper, a survey of Irish surgeons,
oophorectomy? A MEDLINE search reported that 88% of the participants
produced a small but very recent collection would remove the post-menopausal ovary.
of papers including one on the costs of A third paper based on a 1996 survey of
screening Ashkanazi Jewish women for gynecological surgeons in Alaska, found
BRCA1 and BRCA2. Its authors claimed that 98% said that their usual practice was
an economic benefit, but only if women to remove apparently normal ovaries in
who tested positive underwent postmenopausal women; 86% said they
prophylactic surgery. Reviewing their would perform a prophylactic
evidence, this conclusion represented an hysterectomy in women with a strong
enormous leap of faith even for a health family history of ovarian cancer regardless
economist. More cautiously, the Cancer of age; 71% would be influenced by a
Genetics Study Consortium advised that family history of breast cancer.
there was “insufficient evidence to
recommend for or against prophylactic My naïve assumption that prophylactic
oophorectomy as a measure for reducing oophorectomy had gone out of style was
ovarian cancer risk”, but added that: misplaced; it was clearly normative for the
“Women with BRCA1 mutations should be majority of the surgeons in the two
counseled that this is an option open to surveys. Even more interestingly from my
them (Burke et al. 1997). The European perspective, the design of the two medical
21

record reviews implied that failure to In population terms, ovarian cancer is
remove was blameworthy. In all of these relatively rare, but for the geneticist or
studies, the underlying model is that the oncologist working in the heredity cancer
ovaries, seen as likely to go bad, are best clinic, or for a woman from a family with a
removed before they can damage or history of heredity cancer, it is a common
destroy the whole body. These few papers and known risk. They have experiential
were also a reminder that the “new” knowledge, based on actual women with
genetics comes into being in the context of ovarian cancer, patients or family
“old” medical practice, which includes members. Relative to this knowledge,
existing beliefs about heredity and danger, statistical knowledge questioning the
but also this very particular fear of the quality of the epidemiological evidence in
cancer-prone ovary. The very new support of a prophylactic oophorectomy
contribution of the new genetics lies in will probably seem a relatively
being able to test closely related women meaningless component in the decision
and determine which ones are vulnerable making process. Yet, if one moves up a
and which not. The problem is, however, level, from the micro to the meso, to the
that this information is somewhat in level of provincial governments and
advance of the technological capacity to provincial cancer agencies, then this
determine when a predisposition turns into information takes on a new relevance as
an actual cancer, leaving the prophylactic necessary evidence in health policy
oophorectomy as still the primary decision making. Social scientists, but also
response. bioethicists although in a more abstract
sense, have tended to focus at the micro
Another part of my reaction, however, was level, the level of the woman and those
as an anthropologist rather than an who meet with her in the clinical
epidemiologist and owed something to encounter, namely the geneticist, the
Terri Kapasalis’ (1997) account of the oncologist, the genetic counselor. In the
history of the bilateral oophorectomy. next section, I want to shift to the meso
Once known as “Battey’s operation”, level, focusing initially on just one of these
practiced on slaves in the American South, figures, the genetic counselor.
it became fashionable in the late
nineteenth century as treatment for
insanity in women. Although losing favor The Clinic, the Government and the
among psychiatrists, the use of Breast Cancer Gene
oophorectomy was revived in the 1930s
and 1940s by gynecological surgeons, Seen through the eyes of a woman waiting
who saw all ovaries as potentially for her test results, a counselor should be
diseased and took pride in removing them empathic, supportive and able to provide
whenever possible. The temptation was to her with the information she needs in
write off the incorporation of this surgery language she can understand. Most
into the genetics discourse as another Canadian women testing positive for
example of the medicalisation of the BRCA1 or BRCA2 within Canada will have
female body. My problem with this seen a genetic counselor, as their need for
interpretation was that it both cuts off counseling is still one of the most taken-
further discussion and turns women into for-granted assumptions of the Canadian
passive victims rather than active figures programs. Some Canadian women have
in the increasingly complex dance that traveled to the United States for testing;
decision making has become in heredity their number is unknown and so also is the
cancer clinics across North America. quality of their counseling care. Women go
to the United States usually because they
do not meet the strict criteria for testing set
22

by Canadian centres, or they do not want undergraduate training in genetics and
to wait. When this paper was written systematic postgraduate training in
(February, 2000), the waiting period to see genetics is even more rare (Harris and
a genetic counselor in my own province of Harris 1999). Should the problem of
Manitoba was approximately one year. access to counseling be met by ‘retro-
fitting’ other health professionals, not only
The implications of waiting can be studied the family practitioners, obstetricians and
at the micro-level by talking to the women oncologists, but also nurses and social
waiting and their families as was done by workers? Who should pay for further
Lodder et al. (1999). Alternatively, the training for these groups? Is one-on-one
analysis can be moved to the meso level counseling the best or only way? Would
and questions formulated at the level of an interactive video serve as a substitute,
the clinic, the research agency, the or supplement to a live counselor as
provincial ministry of health, and a local Pershkin and Lerman suggest (1999)?
cancer foundation or breast cancer
support groups. At this level, many of the The issues and the questions are also
key questions are framed in terms of political. Access to genetic testing and
traditional health policy issues, such as genetic counseling has rarely been evenly
training, funding, access, cost distributed across geographical or social
effectiveness and evidence based space, favoring the white, the urban and
decision-making. Other questions, the middle class. As discussed in Ken
however, have to do with the politics (but Bassett’s paper, so long as the scale has
also the ethics) of health care delivery. been small and largely invisible outside
the amniocentesis or genetics clinics,
There is, for example, an international there has been little concern or protest. Is
shortage of clinical geneticists and genetic this likely to change with the expansion of
counselors, a reflection of the gap genetic testing into high profile diseases
between the rapid expansion in genetic such as breast and ovarian cancer?
testing and the time needed to train those Already there are rumors of pressures on
capable of doing the diagnostic work-up ministers of health to increase the number
and the counseling. Around the time that of counselors and to expand the number
testing for BRCA1 was just getting started of clinics testing for hereditary cancers.
in 1995, there were only two medical
geneticists per million population in the UK The list of questions is long, although by
and only about a 1000 board-certified no means exhaustive. They are left
genetic counselors in the United States without answers, as their purpose is to
(Reilly 1995). Many of these counselors suggest that the questions about the
and geneticists will have trained when the genetic counselor to be asked at the
expectation was that they would work health policy level have a quite different
within a prenatal screening clinic with very resonance than if asked within the clinic of
different clients to those seen at a the woman waiting. Yet, the length of her
hereditary cancer clinic, a different set of wait is determined by how these questions
diseases, and very different data on risk are answered. Possibly part of our
and probabilities. How should training obligation as latter day Cassandra’s is to
change given a rapidly changing keep women informed on how health
knowledge base? How should the policy in this area is made and
numbers in training be increased? Who implemented.
should pay for this expansion? Counseling
has increasingly become the responsibility An equally long, if different set of
of obstetricians and family practitioners; questions could be generated about the
most of whom had very little test itself and looking towards the future.
23

At present, most testing for BRCA1 and evidence of benefit from prophylactic
BRCA2 in Canada is done in major oophorectomy is too weak to justify the
research laboratories. Who will own the use of public monies. While some health
laboratory in which the test is done, pay activists might question what place genetic
for its staff and its equipment, as testing testing for ovarian cancer should occupy
becomes a routine clinical service? Will it on a priority list of women’s health needs
be the government or the private sector? If given that current thinking suggests that
genetic testing becomes part of routine only 5% of ovarian cancers are genetic in
clinical service, will it have to be shifted to origin?
laboratories licensed by a foreign patent
holder? Will government still retain the
right to regulate all laboratories in the Macro: Global Companies and Global
Politics
province, or will the patent holder set
standards? Who will set the price of the
test and who will pay? Does genetic Moving from meso to macro, the questions
testing, as some health bureaucrats in shift from cost to money and profits. This
some provincial ministries might argue, fall level is occupied by a vast array of
outside the scope of the Canada Health speculators, venture capitalists,
Act? Would making the woman pay fall multinational pharmaceutical companies,
inside or outside her entitlements under universities, biotechnology companies,
that act? Should we urge women that this and different levels of government, all
is an occasion for political protest and hoping to grow rich or at least financially
lobbying the politicians for equitable benefit. Even we benefit, doing research,
access to testing? attending workshop such as this.

Genetic testing up until mid-1990s has The sums involved are quite large; for
been a cottage industry, a small item on example, a quick scan of the Breast
the overall medicare budget line, often part Cancer Bulletin (Summer, 2000) published
of block grants to departments of by the Canadian Breast Cancer Initiative
pediatrics. Suddenly all this is changing suggests that well over half the award
and very rapidly. The ‘old’ system is still in made out of a total of $14.4 million was
place for the very rare genetic diseases spent on some form of genetic research.
and for prenatal testing, but the money
used in genetic testing for BRCA1 or Research The connections between
BRCA2 is more likely to have come out of the different institutions are also quite
a research budget, or a line item in the tight. Myriad Genetics, the company
budget of a cancer foundation. This holding the patent for the BRCA1 and
situation clearly cannot last, but how BRCA2 breast and ovarian cancer
important is it that women understand their susceptibility genes, recently made a
options? deal with the National Cancer Institute
in the US to do full BRCA testing at a
What are these options? Answers, self- cost of $1,200 per person, “less than
obvious at the micro-level of the woman half the commercial costs”, but only for
being tested, are less clear at the level of researchers funded by NIH. Myriad’s
government or advocates for women’s own Web site notes that the company
health? Will the demand for access to has formed strategic alliances with a
genetic testing and counseling for breast remarkable list of multinational
and ovarian cancer not only increase, but pharmaceutical companies, including
become a woman’s health issue or at least Bayer, Eli Lilly, Hitachi, Pharmacia,
an issue for the breast cancer movement? Novartis, Roche, Schering AG and
Yet, health bureaucrats might say that the Schering-Plough.
24


Research A small item of news late
last year noted that Myriad was trying Conclusion
to move forward its patent claims in the
European market. British scientists As the latter-day daughters of Cassandra,
were furious over Myriad claims to our task may be less one of crying doom,
exclusive patent rights to what they saw but rather one of collecting, sorting,
see as their own, British discovered, analyzing, critiquing and disseminating
genetic property, the BRCA2 gene. information to women. To do this
Myriad countered by questioning the effectively will require a degree of
quality of British testing. openness to different types of knowledge,
a willingness to collaborate across
An awareness of the history of our health disciplinary boundaries, and the capacity
care has perhaps made women more to seek out information from many
skeptical than men of the bright promises different sources. It will also require being
of science. They also have somewhat able to say when a question cannot be
greater awareness than men that their answered, because there is no information
sicknesses may be profitable to others, but or the information is inaccessible. The
mainly in the form of physician incomes consequences of informing women as
being increased by a little extra surgery, a health consumers may be as unexpected
few more visits. The money to be made in and radical as learning to read the bible
the new genetics is of a quite different proved to be for the making of the English
order and the mechanics of its making working class.
very different to understand.

References

Franklin S. and Ragone H., (Des) (1998) Reproducing Reproduction, University of
Pennsylvania Press, Philadelphia

Rayna, R., “Extra chromosomes and blue tulips; medico-familial interpretation”. In, Living
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and A. Cambrosio (eds) Cambridge University of Press, Cambridge, 184-208.

Grann V., Whang W., Jacobson J. Antman K. Neugut A. (1999) “Benefits and Costs of
screening Ashkanenazi women for BRCA1 and BRCA2”. Journal of Clinical Oncology
Vol 17, No 2, 494-500

Burke W., Daly M. Garber J., Botkin J. for the Cancer Genetics Studies Consortium
(1997) “Recommendations for follow-up care of individuals with an inherited
predisposition to cancer: BRCA1 and BRCA2”. Journal of the American Medical
Association, Vol 277, No 12, 997-1003

Vasen H. and the European Familial Breast Cancer Collaborative Group (1998) “Current
policies for surveillance and management in women at risk of breast and ovarian
cancer”. European Journal of Cancer, vol 34, no 12, 1922-1926 )

Schrag D., Kuntz K., Garber J., and Weeks, J. (2000) “Life expectancy gains from
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mutations”. Journal of the American Medical Association. Vol 283, No 5, 617-624

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Rozario D., Brown I., Fung Kee Fung,M., Temple, L. (1997) “Is Incidental prophylactic
oophorectomy an acceptable means to reduce the incidence of ovarian cancer”. The
American Journal of Surgery, vol 173, 495-498)

Greary M. Geoghegan A. and Foley M. (1997) “Prevention of ovarian cancer: a survey
of the practice of prophylactic oophorectomy by consultant gynecologists in Ireland” Irish
Medical Journal Vol 90, No 5, 186-187

Conklin B., McGuire, P., Weiler P., Webb D. (1996) “A survey of the practice of
prophylactic oophorectomy by gynecologists in the State of Alaska”. Alaska Medicine
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Terri Kapasalis (1997) Public Privates: performing gynecology from both ends of the
speculum. Duke Universiry Press, Durham and London

Reilly, P. R. (1997) The Gene Letter Vol 1, Issue 4

Lodder, L. Frets P., Trijsburg R., Meijers-Heijboer, E., Tibben A., (1999)
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weeks”. Journal of Medical Genetics Vol 36, No 12, 906-13

Harris, R., LaneB., Williamson P., Dodge J, Modell B. and Alberman, E. (1999) National
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http://www.myriad.com/crp.html
26









Ethics and Genetics:
The Need for Transparency.

Fern Brunger and Susan M. Cox,



About the Authors
Fern Brunger is a post-doctoral fellow at the Centre for Applied Ethics and the Centre for
Health Services and Policy Research. Fern uses the framework of cultural anthropology
to understand genomic research, examining the cultural, economic and political contexts
in which genomic knowledge is produced and applied. She is primarily interested in how
culture and genomic research are mutually defining and transforming. Her current
research focuses on the values, interests and practices that shape population-specific
genomic research; and how this “culture” of genomic research shapes, and is shaped
by, the values, interests and practices of researched communities.

Sue Cox is a post-doctoral fellow at the Centre for Applied Ethics, UBC. Sue has a long-
standing interest in the social and ethical dimensions of the new genetics; other research
interests include gender and interpersonal communication, and the role of narrative in
sociological investigation and ethical analysis. Her work focuses on the moral issues and
experiences most salient to individuals and families at risk for adult onset hereditary
illness. She emphasizes the value of adopting an interpretive approach to studying
hereditary risk within the context of everyday life.



About the Article
Fern Brunger and Sue Cox remind researchers to be aware of the social location of their
own criticisms. “Political, economic and cultural contexts not only shape the production