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Abstract:
Pharmaceutical regulatory agencies struggle worldwide to maintain public trust these days. Drug safety issues proliferate, the costs of pharmaceuticals take increasingly larger shares of most countries' health service spending, and conflicts of interest afflicting the drug approval and marketing processes capture more and more public attention. The Australian and New Zealand governments are keenly aware of these problems, and have been attempting to forge a regulatory alliance to combine their respective pharmaceutical regulatory agencies, Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe), into the pending Trans Tasman Therapeutic Products Authority (ANZTPA, or TPA). If this effort succeeds, it could serve as a model of cost-effective regulatory cooperation for the rest of a transparency-seeking world to emulate. If it does not, a unique opportunity to merge national pharmaceutical regulatory operations to cope more effectively with 21st century global realities will have been lost.

pharmaceutical regulation, pharmaceutical regulatory agencies, trans-national pharmaceutical regulation, Australia's Therapeutic Goods Administration, TGA, New Zealand's Medicines and Medical Devices Safety Authority, Medsafe, Trans Tasman Therapeutic Products Authority, ANZTPA, TPA

Abstract:
This article examines the troublesome ethical dilemmas arising out of physician conflicts of interest in the context of research on human beings. It focuses on the inevitable conflict between the objectives of clinical investigators and those of their human subjects to illuminate subtle divergences of interest in doctor-patient relationships that patients often do not recognize - or want to believe. Once perceived, however, these potentially corroding conflicts can stun research subjects and their families, and leave them feeling deeply betrayed by their clinicians. The article concludes that a researcher's substantial financial conflicts constitute material information which, absent compelling circumstances, the researcher ought to disclose to human subjects as a matter of course.

Abstract:
The open-ended nature of Medicare and Medicaid funding in the US has made increased governmental oversight of the health sector partly an exercise in fiscal self-preservation. Most EU countries, on the other hand, exert tighter control over total health care spending through budgetary processes, so do not experience as intense fiscal pressures to implement quality improvement measures. On both sides of the Atlantic, however, payor oversight also attempts to improve patient safety and welfare. The regulatory response to medical risks has nonetheless been relatively low-key and cautious everywhere. Apart from a few subject areas - US drug and device regulation, and EU regulation of genetically modified food, for example - the precautionary principle has not found robust expression in regulatory policy focused on health care itself. In both America and the EU the reasons for this range from the difficulty of identifying iatrogenic risk, to the traditional deference accorded to self-regulation in the medical profession, to the paucity of enforcement resources. This chapter compares US & EU approaches to adverse drug reactions, medical accidents and patient safety through the lens of the precautionary principle.

Risk Regulation in the U.S., Risk Regulation in Europe, medical risk, adverse drug reactions, patient safety, medical accidents, iatrogenic risk, precautionary principle

Abstract:
Malcolm Gladwell explored the way ideas and behaviors can proliferate "just like viruses do" once they achieve a critical mass in The Tipping Point, his best-seller about widespread and rapidly-adopted social phenomena he labels epidemics. Gladwell's subtitle, "How Little Things Can Make a Big Difference," indicates that he does not think it has to take much to get one of these social epidemics rolling. He does believe, however, that three factors are essential: getting "people with a particular and rare set of social gifts" involved, packaging the ideas so they are "irresistible" under the circumstances, and making sure that both the right people and the right presentation can be deployed in the perfect context for change. That usually means inheriting or creating a situation where one can "tinker with the smallest details of the immediate environment" to unleash the idea's potential for reaching a tipping point, and thus morphing into an epidemic leading to change.

This Foreword analyzes the six articles in this Symposium on The Politics of Health Law in light of Tipping Point Theory, concluding that only the Schiavo controversy, among articles also dealing with palliative care, organ and tissue donation from children, structural change in the health sector, medical tourism and outsourcing, and The Health Care Choice Act of 2005, seems near to achieving Tipping Point momentum at the present time.

Tipping Point Theory, Malcolm Gladwell, the Schiavo controversy, palliative care, organ and tissue donation from children, structural change in the health sector, The Health Care Choice Act of 2005, Tipping Point, Tipping Point Momentum, epidemic for social change

Abstract:
The recent high-profile financial difficulties of Harvard Pilgrim Health Care, the largest HMO in Massachusetts and consistently rated as one of the top ten HMOs in the nation, shed light on many problems common to health insurers throughout the country. This article explores those difficulties in the context of the short but complicated history of Harvard Pilgrim, and its structural, regulatory and competitive environments. The state legislation which made a receivership proceeding possible for Harvard-Pilgrim offered some protection for subscribers, but failed to provide the means for achieving a long term solution. The statute merely presented a method for staving off immediate collapse by temporarily protecting the plan from dissolution, and forcing the plan's contracting providers to continue delivering care even if owed money by the plan. The article concludes by drawing lessons for understanding and ideally avoiding similar managed care near-fatalities in the future.