Making Ethics Fit

ﾩ PAUL VASARHELYI

Six years ago, Rosalynn Gill-Garrison and her colleagues sought to launch Sciona, a small biotech company now based in Boulder, Colo. Because they planned to sell genetic-based health and nutritional information to consumers, they knew that ethical concerns would be crucial. "There wasn't a model for giving this type of information to the public. We knew we had to run the business in the most responsible and ethical manner as we could," says Gill-Garrison, chief science officer.

Sciona, perhaps needing to be more sensitive to these issues than most biotech start-ups, ended up hiring an outside ethics consultant and made the ethics of handling genetic information a core element of its business plan. "Every venture capitalist we pitched to questioned our response to ethical issues," Gill-?Garrison says. "It was critical in their minds and invaluable to us as part of our identity."

Today, Sciona is one of hundreds of biotech, pharmaceutical, and other life science companies prodded to paying closer attention to ethics. Following the Vioxx debacle, problems with a TGN1412 biologic trial in Britain, and other missteps at least partially being blamed on pharma, industry executives are increasingly concerned that the life sciences will come under increased political scrutiny and oversight. But while companies often pay lip service to addressing ethical concerns, the question remains what companies are actually doing and what impact it may have. Two recent studies attempt to address these issues.

Peter Singer, director of the University of Toronto's Joint Center for Bioethics, and his colleagues published a study in May aimed at measuring the motivation and focus of bioscience companies that had already chosen to address bioethics. The study, appearing in PLoS Medicine, ¹ was based on more than 100 interviews with managers and executives at 13 bioscience companies of all sizes around the world and known to have implemented "interesting and varied" bioethics decision-making programs.

In addition to bringing in outside bioethics consultants, the companies reported that they had established advisory boards, reinforced ethics through hiring practices and employee performance evaluations, and encouraged their suppliers and partners to share standards and practices. Danish biopharmaceutical giant Novo Nordisk, for example, requires suppliers to complete a survey to see if they follow the same social and environmental norms to which Novo Nordisk ascribes. If not, Novo Nordisk will work with them to improve their standards. Millennium Pharmaceuticals, Genzyme, and Merck installed an "ethics hotline" that employees can call anonymously for guidance on ethical issues. This study, says Singer, is a starting point for a more rigorous exploration of the potential impact of addressing, and by default not addressing, ethics.

The American Association for the Advancement of Science (AAAS), also addressing companies' approach to bioethics, found in their March report ² that the primary motivation for companies that employ ethics consultants was for advice on data collection and confidentiality as well as to improve relationships with the media, customers, and government (see Addressing Bioethics). This result initially surprised Mark Frankel, director of the Scientific Freedom, Responsibility & Law Program at AAAS and one of the survey directors. Frankel had expected high-pitched debates over such things as cloning and stem-cell research to take center stage. But, he points out, the top issues motivating companies do parallel lower-charged but long-standing public concerns related to privacy, identity theft, and data mining.

Ultimately bioscience executives hope that ethical decision-making will enhance profitability, share price, and reputation, but thus far no solid research links enhanced ethics with improved financial performance. The field is in its infancy and few companies have mechanisms in place to measure the economic impact of ethics. "It's too soon to say what the effects are, because [the emphasis on ethics] is not a widespread practice," says Mildred Cho, associate director of the Stanford University Center for Biomedical Ethics.

But Millennium Pharmaceuticals, a company in the Toronto study, believes the impact of its bioethics programs can be seen by its enhanced industry reputation, which aids in recruiting and retaining top talent, says Joel Goldberg, the company's chief compliance officer and associate general counsel. While not quantifiable, he believes ethics has also enhanced the bottom line, aiding in inking partnerships and licensing deals. "I have no doubt we would not be as successful as we are if we were not viewed by large pharma and large biotechs as having a reputation as an ethical company," Goldberg says.

"For those that do it well, ethics will help them develop their reputation and brand," says Carlos Novas, a postdoctoral fellow at the London School of Economics and author of an article about biobusiness ethics ³ accompanying the study in PLoS Medicine. For smaller biotechs such as Sciona, paying attention to ethical issues can help attract startup capital, and increasingly is being viewed as a necessary part of a business plan. "Early-stage investors are always interested in mitigating every risk," notes Jeffrey Sohl, director of the Center for Venture Research at the University of New Hampshire. "It's an easy box to check off if you get it right," he says.