Michael J. Malinowski

Race and ancestry in biomedical research: exploring the challenges.

The use of race in biomedical research has, for decades, been a source of social controversy. However, recent events, such as the adoption of racially targeted pharmaceuticals, have raised the profile of the race issue. In addition, we are entering an era in which genomic research is increasingly focused on the nature and extent of human genetic variation, often examined by population, which leads to heightened potential for misunderstandings or misuse of terms concerning genetic variation and race. Here, we draw together the perspectives of participants in a recent interdisciplinary workshop on ancestry and health in medicine in order to explore the use of race in research issue from the vantage point of a variety of disciplines. We review the nature of the race controversy in the context of biomedical research and highlight several challenges to policy action, including restrictions resulting from commercial or regulatory considerations, the difficulty in presenting precise terminology in the media, and drifting or ambiguous definitions of key terms.

Technology Transfer in BioBanking: Credits, Debits, and Population Health Futures

Michael J. Malinowski ioinformatics, the integration of information technology and biotechnology, is the primary B means to make medical sense out of the map of the human genome,’ and bioinformatics capabilities continue to expand exponentially.2 Consequently, the demand for access to human biological samples and medical information has never been greater.3 This demand is giving rise to ambitious biobanking initiatives meaning the organized collection of samples and medical information from human population^.^ This article will apply an intellectual property (IP) approach to biobanking that encompasses university models for biotech research and development (R&D) with emphasis on the objectives of protection of human subjects and the advancement of ongoing biomedical research and improvement of human health. Consideration will be given to potential use of the United States’ university technology transfer law-policy and biotech R&D experience5 to empower populations presently left out of the genomics revolution, and to lessen the widening life sciences gap between economically developed and developing communities.6 Part I will provide an overview of the US. technology transfer experience over the last ten to fifteen years, during which time the U.S. integrated academia and industry notably in the field of biotechnology.7 Part I1 will place biobanking in the context of contemporary biomedical R&D. This section will emphasize that responsible biobanking is desirable as a means to make actually, a prerequisite for making medical sense out of the map of the human genome. Part I11 will summarize the law, policy, and R&D challenges posed by biobanking and, with sensitivity to these issues, propose a law-policy approach premised upon utilization of technology transfer and commercial incentives to promote responsible biobanking.

Biotechnology in the USA: responsive regulation in the life science industry.

Biotechnology has evolved from a research platform into nearly 100 pharmaceutical drug products and myriad other commercial applications, ranging from predictive genetic tests to industrial processes and agricultural products. The evolution of biotechnology has taken place during an era of advancement of information technology that has introduced an unprecedented level of international communication and promoted globalisation. Biotechnologys extraordinary evolution in the USA is largely attributable to supportive federal policy and the resulting infrastructure. However, the US now faces some significant challenges that threaten to set its biotechnology establishment back significantly, or at least significantly impede the pace of future progress. Pressing regulatory and policy challenges to the continued advancement of biotechnology along the R&D continuum are of unprecedented complexity. The USA, as the primary developer and exporter of this technology, faces global policy and regulatory challenges to economic expansion and continued commercial success. The pace of accomplishment is contingent on US ability to continue to demonstrate regulatory responsiveness in the face of increased complexity and challenges of a global economy.

Biting the Hands that Feed “the Alligators”: A Case Study in Morbid Obesity Extremes, End-of-Life Care, and Prohibitions on Harming and Accelerating the End of Life

Obesity, recognized as a disease in the U.S. and at times as a terminal illness due to associated medical complications, is an American epidemic according to the Centers for Disease Control and Prevention (“CDC”), American Heart Association (“AHA”), and other authorities. More than one third of Americans (39.8% of adults and 18.5% of children) are medically obese. This article focuses on cases of “extreme morbid obesity” (“EMO”)—situations in which death is imminent without aggressive medical interventions, and bariatric surgery is the only treatment option with a realistic possibility of success. Bariatric surgeries themselves are very high risk for EMO patients. Individuals in this state have impeded mobility and are partially, if not entirely, bedridden, highly vulnerable, and dependent upon caregivers who often are enablers feeding their food addictions. The article draws from existing Centers for Medicare and Medicaid Services (“CMS”) and Social Security Administration (“SSA”) policies and procedures for severe obesity treatment and disability benefits. The discussion also encompasses myriad areas in which the law imposes a duty to report on professionals to protect vulnerable individuals from harm from others, and constraints and prohibitions on accelerating the end of life. The article proposes, among other law and policy measures, to introduce an obligation on medical professionals to investigate and report instances of enablement when food addiction has put the lives of individuals at risk of imminent death. The objectives of the proposals are to give providers more leverage to prevent food addiction enablers from impeding treatment and to enable EMO patients to comply with treatment protocols, to save lives and, ironically, to empower enablers to stand firm against the demands of individuals whose lives have been consumed by their food addictions.