Mario Negri Institute: A public health model for developing new drugs

Medical care has been deeply compromised by the ways in which prescription drugs are developed, tested, reviewed, and promoted to clinicians and their patients. Drugs are the 4^th leading cause of death, tied with stroke. Yet expert review teams have judged that 90 percent of newly approved drugs over the past 30 years offer few or no clinical advantages to offset their 1 in 5 chances of receiving a serious warning for adverse events. How can we get to a better place, a place of untainted medical care based on ethical research?

Based on research done at the E.J. Safra Center for Ethics at Harvard, this paper will describe a place of ethical research and health promotion – the Mario Negri Institute for Pharmacological Research in Milan, Italy. The audience will the historic ways in which Institute staff learned to do research with major companies, as well as public and private funders, under ethical requirements that all data, negative, and positive results be publicly available. Institute staff, not the funders, controls the research design. They pioneered trials run by organizing networks of specialists throughout the national health care service to co-design and co-author with them. Almost never do they use surrogate measures, or placebos, but design trials for clinical superiority. They trained clinicians how to use research methods and measures to assess the quality of their practices. 

The Institute has a long history of educating clinicians and patients about how to stay healthy and treat clinical problems. It runs call-in centers and websites to address clinical and patient questions. Its leaders have campaigned tirelessly against quack medicine and ineffective drugs. The Institute developed early evidence-based formularies, which led to the Essential Medicines list. It was given sweeping powers to de-list ineffective and harmful drugs for the nation. At a European and international level, Institute leaders have long promoted policies for transparency, ethical trials, non-commercialized clinical care, and publicly funded regulators. For the promotion of research integrity and science-based medicine, the Mario Negri Institute and Italy are the place to be.

            A forthcoming book describes the Mario Negri Institute as a model for other nations.