If you want to see the future of pharma/academe collaboration, then the current edition of Intensive Care Medicine is a must read. The particular issue is the contentious debate over the role of the Eli Lilly & Co. drug, Xigris (drotrecogon alpha/activated – DAA), in severe sepsis. But there are much larger issues at play.
Interesting Sidebar: The first Xigris Advisory Committee meeting was scheduled for September 12, 2001, but was cancelled for obvious reasons – and the Lilly team had to get back to Indy by bus. It seems to have been worth the trip. (The rescheduled meeting was held on October 16, 2001 – and it was a lively one.)
Specifically, Lilly is conducting a placebo controlled study of Xigris in patients with septic shock, and the referenced study (PROWESS-shock) must have been a design nightmare given the past controversy -- in addition to the issues involved in conducting such a study while the drug remains commercially available.
But there are larger issues at play – such as a new model of academia-industry collaboration. As Jordi Mancebo and Massimo Antonelli write in their ICM editorial:
“This month’s issue of the Journal contains a somewhat unusual article and two accompanying editorials. The authors of the article are members of the steering committee of an on-going Eli Lilly trial on activated protein C for persistent septic shock. They describe a number of steps that have been adopted in order to ensure transparency in disclosing financial conflicts, facilitate comprehension and interpretation of results, minimize possible risks, and maximize eventual benefits for patients. This approach constitutes a new model of academia-industry collaboration.”
It’s also important to note that the academic steering committee will oversee not only the conduct of the trial (nothing new there) but will also write the study manuscripts.
Further on Mancebo and Antonelli write:
“The novelty here is the full disclosure of the process by which this study was designed, and a description of how it will be conducted, analyzed and reported.”
In a second ICM editorial, Peter M. Suter and Jukka Takala write about to who benefits from this “new model”:
“The primary objectives of each of the three stakeholders are quite different. The pharmaceutical industry wants to make profit, but is also very much interested in bringing new products to the market (necessary for its sustainable development) and in innovation (which improves its image in the eyes of society). Science is curiosity-driven, with the aim of furthering our understanding of human biology, physiology and mechanisms of disease, also to discover better ways to treat disease. Finally, the objective of medicine is to help patients to get better quickly and to recover a good quality of life.”
Suter and Takala conclude:
“The investigators of the PROWESS-shock trial have made a laudable effort to introduce an improved model of collaboration between science, medicine and industry. This approach could help to get us out of the image of a Bermuda triangle, where benefits of research and resources for health care disappear in a black hole or the wallets of a few.”
(This is the same Peter Suter who once said he wouldn’t give his own brother -- who had septic shock -- Xigris.)
As Mancebo and Antonelli write, “We welcome this unprecedented step forward.”
Amen.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
