BioCentury
Edition: January 2, 2017 (pp. 22-24)
Turning
and turning in the widening gyre
The falcon cannot hear the falconer;
Things fall apart; the centre cannot hold;
Mere anarchy is loosed upon the world,
The blood-dimmed tide is loosed, and everywhere
The ceremony of innocence is drowned;
The best lack all conviction, while the worst
Are full of passionate intensity.
The falcon cannot hear the falconer;
Things fall apart; the centre cannot hold;
Mere anarchy is loosed upon the world,
The blood-dimmed tide is loosed, and everywhere
The ceremony of innocence is drowned;
The best lack all conviction, while the worst
Are full of passionate intensity.
--The Second Coming, W.B. Yeats
Be not deceived…for whatsoever a man soweth,
that shall he also reap.
--Epistle to the Galatians, 6:7, Paul
--Epistle to the Galatians, 6:7, Paul
In
the presidential election, a significant proportion of American voters, feeling
unspoken for and left behind by establishment politicians and policies,
expressed their displeasure and desire for change. The campaign also gave voice
to disturbing currents of thought -- a disregard for science, a lack of respect
for defined social groups and a view that the modern corporation’s sole
responsibility is maximizing the profit of its owners.
The
leadership of the biotechnology industry has deep reasons, based in the
founding tenets of our industry, to raise our voices in opposition to these
troubling ways of thinking. As the Trump administration takes over this month,
I want to suggest the biotech industry’s leadership has not yet risen to the
occasion.
Our Enlightenment roots
The
biotechnology industry was born of the recombinant DNA revolution. In the
ensuing 40 years, while the revolution in the life sciences has transformed
modern drug discovery, contemporaneous transformations have occurred in our
understanding and expectations of modern corporate and organizational behavior
and responsibility.
Modern
scientific inquiry and discourse embody grounding principles that are far older
-- they come down to us from the Enlightenment. Among these are the belief that
the quality of data, not the economic, political or physical power of an
interlocutor, should determine its authority.
Also
handed down to us from the Enlightenment, and intrinsically bound up in that
conception of rational, scientific discourse, are the ideals of equality of
opportunity and justice. As citizens, we all have an obligation to contribute
to the conditions that enable all persons to participate and thrive in a
community embodying those ideals. We understand that open discourse involving
everyone with something to contribute -- regardless of skin color, ethnicity,
religious belief, gender, sexual orientation, etc. -- is essential to the quest
for truth.
Once
it becomes recognized that a person or group once branded as “The Other” also
has something to contribute to the dialogue, excluding that voice is repugnant
to the rationality that undergirds the scientific endeavor. It is the moral
equivalent of excluding data that potentially contravene conventional belief.
These
principles and values, and the putting of them into practice, are not
incidental to the quest to sustainably transform scientific advances into
medicines -- they are its foundation.
. . . a world in which science flourishes but justice is absent is
condemned to the same fate as Sodom.
--
Murderous Science, Benno Mueller-Hill
The intrinsic connections
The
birth and definition of modern scientific inquiry and discourse in the
Enlightenment, coming down to us from Bacon and Newton, are therefore
intrinsically related (not merely accidentally related) to the Enlightenment
socio-politico-ethical philosophies of human rights and social/political
discourse that come down to us from Locke, Hume, Rousseau, Jefferson and Kant.
These
scientific and societal threads both are essential to, and are woven into, the
modern biotechnology enterprise. This has, or should have, profound
implications for how we organize and empower our employees and colleagues and
how we work in the broader society to ensure the accessibility of medicines.
For example: the objectification of women in the workplace is the first
(intellectual and social) moment in their exclusion from participation as
equals in the discourse.
Pull
out one thread and the glorious tapestry begins to unravel.
Just
as Enlightenment science and political/ethical values are ineluctably
intertwined, anti-science views expressed during the presidential campaign, on
vaccination and climate change, to name only two, are equally bound up with
expressions of misogyny, racism and other shameful bigotries.
Anti-science
rests on the authority of the powerful and the economically self-interested,
not open scientific discourse in which the data, not the position of power of
their authors, carry the day. Bigotry is about the exclusion of The Other, and
rationally held competing views and interests, from the discourse.
This,
too, is a tapestry of intertwined threads. Do not think it is possible to
approve, or even quietly disapprove but countenance, one without thereby
endorsing the other.
Ours
is an industry with noble origins not just in cutting-edge science but also in
the advancement and establishment of the social preconditions for our mission
to make and deliver important new medicines to all who need them. It is the
bedrock that must needs direct our behavior.
The parable of Medicare Part D
In the
beginning was the act.
--Faust, Sc.6, 1224-1237, Goethe
--Faust, Sc.6, 1224-1237, Goethe
The
impetus for the creation of the Medicare Part D Prescription Drug benefit in
December 2003 was as simple as it was powerful. Senior citizens living
month-to-month on their Social Security checks were having to choose between
buying food or their life-saving prescription medications. In a bountiful
American society, this was shameful and deeply abhorrent.
The
biotechnology and pharmaceutical industries regularly claim their raison d’
être is the provision of medicines to patients in need. While we are organized
as for-profit entities with financial investors and shareholders, we claim our
mission to be broader than simply a financial return.
But
when the legislation to create Medicare Part D was introduced before Congress,
PhRMA immediately opposed it. The notion of a powerful buyer in the form of
Medicare entering the marketplace, potentially creating price pressure and,
thereby, decreased profits, trumped basic human decency, principles of social
justice, the industry’s claimed reason for being -- the dedication to the
well-being of patients.
BIO,
representing the biotechnology industry, immediately supported the creation of
the Medicare Part D benefit.
Pulling
through the lesson of this parable to 2016: When persons with “pro-industry”
views are nominated to lead federal agencies involved in the regulation and
pricing of pharmaceuticals, it is incumbent on our industry leadership to
consider their public policy positions holistically.
Can
we say this is happening now? Have we responded appropriately when we are faced
with Rep. Tom Price (R-Ga.) as the nominee to head HHS, a physician who has
espoused views or backed legislation that would declare that personhood and the
right to life begin at the moment of fertilization or cloning; prohibit
federally funded abortion; remove federal funding for Planned Parenthood and
other providers of women’s health services that offer abortion; remove
Affordable Care Act requirements to cover contraception; oppose the use of
human embryos in stem cell research; and allow insurers to exclude pre-existing
conditions when insurance coverage has been interrupted?
Our
industry leadership should tread lightly before conferring approbation on such
a nominee, or others like him.
Realizing our purpose (τέλος)
For
what shall it profit a man,
if he
shall gain the whole world,
and
lose his own soul?
-- Mark, 8:36
Our
leadership should also look deeply within. Do we mean what we claim for our
industry motives? What actions must we take and what policies must we support
to fully mean what we claim: that our mission transcends the market’s demand
for maximum financial return?
During
the life span of our industry, we have experienced corporate America
transforming from the post-World War II ideal of command and control (by
middle-aged white men) to a less hierarchical and egalitarian model that
provides the environment necessary for creative ideas and their creators to
flourish.
We
have also experienced the dawning recognition that corporations such as ours
have stakeholders -- patients, their families, their caregivers, our employees,
our local communities, our society at large -- in addition to our investors. We
understand that our challenge and responsibility as stewards of our companies
is to deliver value to all our stakeholders,
simultaneously.
Moreover,
we understand that the output of our labor is a basic human good/right, not (or
not merely) a market or consumer product. That is the purpose, the telos, of our labor.
Can
we realize that telos without fighting for
universal accessibility to the medicines we create? If we as leaders of the
biotechnology industry presume to benefit personally from our efforts, along
with our shareholders, must we not, inter
alia, assume responsibility for universal access?
This
includes support for value-based pricing; support for reasonable periods of
monopoly for inventions to encourage innovation; condemnation of unjustified,
unrelenting price increases in the absence of improved benefit; and
condemnation of pay-for-delay tactics that impede the low-cost distribution of
our innovations at the end of an appropriate period of exclusivity.
The
moral imperative for our leadership does not end here. We also must advocate
for government programs and insurance regulation to ensure the affordability
and accessibility of our medicines, and healthcare in general, to all.
Taking a stand
You are the light of the world. A city located
on a hill cannot be hidden.
-- Matthew, 5:14 (“Sermon on the Mount”)
-- Matthew, 5:14 (“Sermon on the Mount”)
We
claim to make transformative medicines, not mere incremental improvements. We
claim to care about accessibility. We claim that even our most expensive
medicines, because of the transformative benefits they provide, decrease
overall healthcare costs while improving the quality of life. Let us fully mean
what we claim, let us act so as to reclaim our authenticity, for, in so doing,
we will realize our purpose, our telos.
Idealism
alone will never result in business success, and business success is the necessary
condition of our ability to transform the revolution in biology into a
revolution in medicine. Idealism must be leavened with pragmatism.
But,
equally, in the name of pragmatism and business success, we can never
compromise our most deeply held founding values. We do so at the risk of
sacrificing whatever moral authority we may have: to speak for science; to
speak for our patients; to speak for our employees; to speak for the creation
of a better and more just world.
May
we all embrace this sacred trust.
Note
on the Author
Steven
Holtzman, president and CEO of hearing disorder company Decibel Therapeutics
Inc., was appointed by President Bill Clinton to the National Bioethics
Commission, where he served from 1996 to 2001. He also was founder and chairman
of BIO’s Bioethics Committee from 1995 to 2001. In addition to serving on BIO’s
board, Holtzman has founded or served as senior executive at five biotechnology
companies since 1986. He earned a B.Phil. in philosophy as a Rhodes Scholar at
Oxford University.
Editor’s
note: This article can be found on Decibel
Therapeutics’ website, where you can add your comments.
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