Government RX--Back to the Future in Science Funding? The Next Era in Drug Development

The roles of government, industry, and academia in science research have been recast repeatedly since the U.S. began infusing tremendous funding during WWII. Recently, the National Institutes of Health (NIH) proposed a billion-dollar center to intervene in commercial drug development with the objective of lifting it out of a frightening fifteen-year slump in productivity. This article questions the role of the U.S. government in pharmaceutical development after completion of a map of the human genome (the touchstone of the Human Genome Project, HGP), a research undertaking spearheaded by the U.S. Government that spanned more than a decade. Specifically, the article proposes that the U.S. return to its WWII-era science past and draw from the contemporary human genome mapping experience to advance human clinical research and improve drug development—to lift it out of its depressing state of disappointment. The article concludes that substantial, direct government involvement in clinical research is essential at this time to raise the science standard. Other crucially needed benefits include increasing research transparency in an era of aggressive science commercialization and intellectual property protection, ensuring the integrity of resulting data in an age of academia-industry integration that spans from the research bench (basic research) to pharmacy shelves, improving drug effectiveness, and thereby rising to the occasion of meeting dire human health needs. The proposed government intervention in clinical research, arguably essential to overcome the dismal state of drug development and skepticism about its foreseeable future in spite of unprecedented investment, would launch a new era in U.S. science research funding

Throwing Dirt on Doctor Frankenstein’s Grave: Access to Experimental Treatments at the End of Life

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and development increasingly commingles clinical research and clinical care—as patients and physicians routinely reach into the drug development pipeline for treatment options. Given the vulnerabilities of those who confront end-of-life decision making, should the regulatory standard be raised to more effectively protect the terminally ill from additional suffering and the loss of quality time with family and friends, and to increase recognition of the opportunity to die with priority placed on comfort care and dignity? Alternatively, where death is the only existing option under standard of care, should the regulations be relaxed to promote access to experimental treatment alternatives? What importance should be placed on the overall advancement of biopharmaceutical research and development (R&D) in addressing these human health issues? This article proposes modifying the Common Rule to enhance human subject protection of the terminally ill, which the U.S. standard of care generally recognizes as a diagnosis of life expectancy of six months or less