The Ethics of Bioethics: Mapping the Moral Landscape

15 Ties without Tethers: Bioethics Corporate Relations in the AbioCor Artificial Heart Trial

c h a p t e r f i f t e e n Ties without Tethers Bioethics Corporate Relations in the AbioCor Artificial Heart Trial e . h a a v i m o r r e i m , p h.d. My objective in this essay is not to argue the broader question whether bioethicists should become involved with corporations or, if so, under what conditions. Rather, I describe one arrangement in which a corporation-bioethics relationship seemed to work well, with minimal opportunities for the kinds of potential corruption about which many bioethicists have expressed concern. background The AbioCor artificial heart is a totally implantable biventricular replacement device. Eligibility for the initial trial of fifteen patients1 was limited to people in biventricular failure who were on maximal medical support, ineligible for cardiac transplantation, and very close to death. The AbioCor’s goal is to promote quality as well as duration of life (ABIOMED 2006). Prior to the first human implants in 2001, executives at ABIOMED, the small Massachusetts corporation that created the device and sponsored the trial, initiated an advisory group to serve two purposes: assisting patients and families both during the informed consent process and following implantation, and advising the corporation concerning ethical issues of the trial. The company deemed it imperative that such a group be independent. This was reflected in the structure of the IPAC (independent patient advocacy council), of which I became chair. independence The IPAC needed independence not only from the company but also from the hospitals and clinical staffs at the six cities across the country at which the initial implants would take place. Several elements were important. Financial Structure Funding for the IPAC was in the form of a lump-sum, irrevocable trust fund. By contract with the fund’s trustee (a Boston area bank), once the money went into the trust, it could never revert to the company. If the trial somehow ended early, any residual funds would go to a charity. The trustee was instructed to pay any bill it received from IPAC members within ten business days, no questions asked. No substantive criteria delineating what would be legitimate bills were provided , leaving the IPAC itself to determine how best to use the money. Only two specific constraints were placed on the trust. One, a written agreement between IPAC members and ABIOMED, stated that the funds were to be used to provide advocacy services to patients in the AbioCor trial. However, none of the formative documents defined “patient advocacy services,” thereby permitting the IPAC to define this pivotal concept. Neither the company nor the trustee could deny payment on the grounds that IPAC activities did not fit some preconceived definition of patient advocacy. The other specification was that IPAC members would receive a modest annual honorarium, plus per diem payment designed to replace any monies forgone because the member was providing services during the trial. To fit more closely the nature of our activities, the IPAC transformed the per-diem sum into a per-hour remuneration. To avoid financial conflicts of interest, IPAC members were required to sign an agreement promising that we and our families would not own shares of ABIOMED stock for the duration of the trial. The same agreement was also signed by the trial’s surgeons and other people in positions of key clinical decision making. By implication of this structure, ABIOMED had no financial leverage to influence IPAC activities. It could not withdraw or reduce our funding if displeased, nor reciprocally would IPAC spending decisions affect the company or its finances in any way. Once transferred to the trust fund, the money was permanently out of the company’s hands. Quite literally, the company would have had no recourse had the group decided to spend the majority of the funds on meetings at exotic resorts, discussing the nuances of patient advocacy. A few months 182 c o n t r i b u t i o n s a n d c o n f l i c t s : c o n s u l t a t i o n after the first implant, the IPAC evaluated its spending patterns and developed in-house criteria to govern what sorts of expenditures would be covered, so that we could live within our means and achieve reasonable consistency across the members’ expenditures. Several months thereafter, these criteria were tightened further to ensure...