Dx Launch Risks
This case study shows how a risk management strategy for possible recalls could prevent disruption, not only to a biomarker's market progress, but to ...
Peter Keeling, CEO of Diaceutics, comments on the Plavix lawsuits and the impact on personalized medicine.
As recently reported in the US financial press [i] , the first real personalized medicine influenced litigation has arrived. Specifically, attorneys general in five US states—California, Hawaii, Louisiana, Mississippi and West Virginia—have sued Plavix co-developers Bristol-Myers Squibb (BMS) and Sanofi, accusing the companies of lying to authorities about the blockbuster blood thinner’s ability to treat specific subpopulations. Both companies vigorously defend their positions.
As we published in the Personalized Medicine Journal as far back as 2007,[ii]such litigation was only a matter of when, not if. It remains our view that several layers of potential risk lie hidden in ‘subpopulation therapy design’.
Such litigation will be complex, with science versus science alongside ‘who knew what and when’ arguments which no doubt will rage on in the courts for years to come. Since personalized medicine development is characterized every day by matrixed decisions to co-develop a test strategy or not, based on early clinical trial read outs and, as our data indicates, there are approximately 400- plus biomarker targeted therapy assets currently working their way through Phase 2 and 3 trials, such litigation has the potential to spread quickly.
At its core, this litigation poses a central and fundamental cultural issue for Pharma C suites, namely does the well-publicized commercial uncertainty about personalized medicine and untrained decision-making to market a therapy without a test, create long-term legal exposure for pharma?
Our view postulated some seven years back remains unchanged: “It is very likely that the pharmaceutical industry treating physicians will eventually face legal liability arising from the use of PGx in drug development…this liability will arise in the form of standard product liability litigation, medical malpractice and novel defect theories. If sufficient time passes, liability might even arise from failing to utilize PGx strategies in drug development as the state of art shifts.”
We have gone on record to say that the personalized medicine tipping point will need sticks and carrots. Specifically, we have postulated that alongside the carrot, well-designed personalized medicine commercial strategies can deliver equivalent or greater ROI to pharma shareholders will likely be the stick of litigation. The carrot has been evident in niche blockbuster oncology therapies for a few years now. The stick just appeared!