Finally Posting Where this Blog Started

BioCentury

Edition: January 2, 2017 (pp. 22-24)

Leadership and responsibility

By Steven Holtzman, President and CEO, Decibel Therapeutics Inc.

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 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

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

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”)

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.