Pharma Ethics Roundtable

Dec 01, 2004
By Pharmaceutical Executive


Genzyme's Roger Louis notes that defined processes help create ethical behavior.
What does it mean for a pharma company to behave ethically? What sorts of in-house policies and procedures can keep companies and employees on track? What are pharma's obligations to patients? These questions and others like them are being debated today not just within companies but in the media and the halls of government. Too often, especially in public forums, the answers heard are simplistic, politicized, and ill-informed about the industry. To dig deeper into these important issues, Pharmaceutical Executive, in partnership with the law firm of Beirne Maynard & Parsons, hosted a roundtable discussion. The conversation was moderated by Joseph Cohen, a partner at the law firm. The participants were Raul Perea-Henze, MD, senior director/team leader, science and medical advocacy, for Pfizer; Roger Louis, chief compliance officer for Genzyme; Nicholas Capaldi, PhD, Legendre-Soule chair in business ethics at Loyola University New Orleans; Kevin Soden, MD, worldwide medical director for Texas Instruments and Celanese, and medical reporter for NBC and MSNBC; and Patrick Clinton, editor-in-chief of Pharm Exec. The following is an edited transcript of the session. For the complete version, visit http://www.pharmexec.com/.

COHEN: The pharmaceutical industry deals in products with a profound connection to life and health. Must ethics be assigned a formal role in corporate decision making?

LOUIS: At Genzyme, I'm the chief compliance officer. There's a tension in that role between legality and ethics. Doing what's legal and what's ethical can mean very different things at different times. Ethics is about process. It's hardly ever about right and wrong. It's about choosing between two rights and having processes to help with that.

PEREA-HENZE: At Pfizer we make a separation between bioethics and business ethics. When the question involves how you treat people and investigate your subjects, that funnels through the bioethics path. And then you have business ethics, which really involves issues that come up on marketing or other business processes.


Capaldi, says the path to full disclosure lies in a competitive market situation.
CAPALDI: Now that you're dealing with finite resources, there's no way you can separate ethics from business issues. Bioethics is inevitably going to involve business ethics.

PEREA-HENZE: In our case, maybe given the size or complexity of our business, there's always been a traditional separation between the marketing arm and the R&D side. There are two cultures, and you don't want the marketing side to unduly influence the R&D side. We actually have an in-house bioethicist who deals with issues as they come up. And on the other side, we have the lawyers and all the people who deal with that dichotomy between legality and business ethics.

CAPALDI: I wasn't questioning whether there were different sorts of issues, but whether under some circumstances bringing them together might be useful. I understand your concern in not allowing marketing to influence R&D, but one could make a case that R&D ought to influence marketing. If there were communication between those two, marketing could actually do its job better.