Law Commons^™

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, Michael J. Malinowski

Michael J. Malinowski

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. …

The U.S. Science And Technology “Triple Threat”: A Regulatory Treatment Plan For The Nation’S Addiction To Prescription Opioids, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Foreword: Academic-Industry Collaborations In The Clinic, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

A False Start? The Impact Of Federal Policy On The Genotechnology Industry, Michael J. Malinowski, Maureen A. O'Rourke

Michael J. Malinowski

No abstract provided.

The Impact Of Current Policy And Regulation On Future Stem Cell Human Health Applications, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Globalization Of Biotechnology And The Public Health Challenges Accompanying It, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Institutional Conflicts And Responsibilities In An Age Of Academic-Industry Alliances, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Coming Into Being: Law, Ethics, And The Practice Of Prenatal Genetic Screening, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Federal Enclaves And Local Law: Carving Out A Domestic Violence Exception To Exclusive Legislative Jurisdiction, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Commercialization Of Genetic Testing Services: The Fda, Market Forces, And Biological Tarot Cards, Michael J. Malinowski, Robin J.R. Blatt

Michael J. Malinowski

No abstract provided.

Could Biobanking Be A Means To Include "Health Care Have-Nots" In The Genomics Revolution?, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

A Law-Policy Proposal To Know Where Babies Come From During The Reproductive Revolution, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Ethics In A Global Biopharmaceutical Environment, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Ethics In Global Biopharmaceutical Environment, Michael Malinowski

Michael J. Malinowski

No abstract provided.

All That Is Gold Does Not Glitter In Human Clinical Research: A Law– Policy Proposal To Brighten The Global “Gold Standard” For Drug Research And Development, Michael J. Malinowski, Grant G. Gautreaux

Michael J. Malinowski

This Article challenges the global science standard for putting new drugs on pharmacy shelves. The primary premise is that the “gold standard” of group experimental design is an antiquated extension of drug development’s crude-science past, and is inconsistent with the precision of contemporary genetics— the science that increasingly dominates the drug development pipeline. The Article identifies law– policy options that would raise the standard for human clinical research under the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Doctors, Patients, And Pills--A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski

Michael J. Malinowski

This article challenges the scope of physician discretion to engage in off-label use of prescription drugs. The discretion to prescribe dimensions beyond the clinical research that puts new drugs on pharmacy shelves has been shaped by two historic influences: a legacy of physician paternalism, solidarity, autonomy, and self-determination that predates the contemporary commercialization of medicine by more than half a century, and regulatory necessity due to the limits of science and innate crudeness of pharmaceuticals prior to the genomics revolution (drug development and delivery based upon genetic expression). Although both factors have changed immensely, the standard for drug approval has …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

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 …

Drug Development--Stuck In A State Of Puberty?: Regulatory Reform Of Human Clinical Research To Raise Responsiveness To The Reality Of Human Variability, Michael J. Malinowski

Michael J. Malinowski

Scathing critiques of the Food and Drug Administration's (“FDA”) performance by the Government Accountability Office and Institutes of Medicine, a plummet in innovative new drug approvals in spite of significant annual investment increases in biopharmaceutical research and development (“R&D”), and market controversies such as the painkiller Vioxx and the diabetes drug Avandia (both associated with significantly escalated risks of heart attacks and strokes) have raised doubts about the sufficiency of FDA *364 regulation. This Article questions how prescription medicines reach the market and proposes law-policy reforms to enhance the FDA's science standard for human clinical trials and new drug approvals. …

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

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 …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

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 …

Choosing The Genetic Makeup Of Children: Our Eugenics Past-Present, And Future?, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Law, Policy, And Market Implications Of Genetic Profiling In Drug Development, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Patents For Chemicals, Pharmaceuticals And Biotechnology: Fundamentals Of Global Law, Practice And Strategy By Philip W. Grubb, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Introduction, Michael J. Malinowski, Bartha Maria Knoppers, Claude Bouchard

Michael J. Malinowski

No abstract provided.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Michael J. Malinowski

This Commentary is part of a colloquy on race-based genetics research.

Taking Genomics To The Bio Bank: Access To Human Biological Samples And Medical Information, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Dealing With The Realities Of Race And Ethnicity: A Bioethics-Centered Argument In Favor Of Race-Based Genetics Research, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski

Michael J. Malinowski

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

Government Rx--Back To The Future In Science Funding? The Next Era In Drug Development, Michael J. Malinowski

Michael J. Malinowski

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 …