Beating the Bluebook Blues: A Response to Judge Posner

Judge Richard A. Posner\u27s recent critique (The Bluebook Blues) of the maddening hypertrophy of The Bluebook is surely a refreshing voice of sanity for the multitudes of law students and legal professionals who have had occasion to consult it. Even at Harvard Law School, the home of its founding institutional sponsor, The Bluebook\u27s labyrinthine rules annually aggravate a fresh crop of otherwise remarkably stoic future lawyers. But while many of Posner\u27s observations regarding The Bluebook are astute, we posit that both form and uniformity are important for citations, and we suggest citation-formatting software as a means of maximizing the utility of legal citations while minimizing the burden of creating them

Explaining the Absence of Surgical Procedure Regulation

Systematic evaluation of both existing and innovative surgical procedures is needed to make important safety and efficacy data available to surgeons, facilitating optimal treatment decisions. High quality risk-benefit data is also essential if the healthcare system is to honor its obligation to inform patients of relevant benefits and risks prior to obtaining their consent to treatment. Yet for a variety of reasons, surgical procedures are not subject to direct regulation. As a result, surgeons consulting the available literature may find it inadequate to answer fundamental questions about optimal treatment choices. This failure of information increases the chance that, for years or even generations, patients will undergo painful or risky surgeries until further study eventually exposes them as either inferior to alternatives, or worse, as causing more harm than good. Unfortunately, history has repeatedly borne witness to such medical embarrassments, from the centuries-old practice of bloodletting to the disconcertingly recent examples of radical mastectomies and autologous bone marrow transplants, among many others. The federal government is well-positioned to support needed surgical research activities at the national level, both through the identification of evidence gaps and the funding of studies to fill those gaps. The government is also well-positioned to coordinate the private surgical research marketplace through activities such as the aggregation of country-level adverse event data and the setting of standards for medical terminology and guidelines for study protocols. In partnership with state governments and private organizations, the federal government can contribute to appropriate regulation that improves evidence development without imposing disproportionate burdens on surgeons or others

Pharmaceutical Efficacy: The Illusory Legal Standard

The very long and expensive process of new drug research and development might suggest to observers that the efficacy standard for drugs is elevated and substantial, but this is not the case. Under the U.S. Federal Food, Drug, and Co smetic Act, new drug approval merely requires that there be “substantial evidence that the drug will have the effect it purports or is represented to have.” While the evidence of effectiveness must therefore be substantial, the efficacy attested to by that evidence need not surpass any particular threshold (other than zero), thus allowing drugs with de minimis efficacy to be approved and sold at market rates. No other concept, principal, or standard applied during the approval process or after changes this result. The “gold standard,” which includes the elements of blinding, randomiza tion, and placebo control, is described in but not required by the drug statute, and in any event addresses various problems related to bias rather than magnitude of efficacy. Similarly, the concept of “statistical significance,” which constitutes an essential element of modern research protocols, addresses the problem of certainty, not degree, of efficacy. The statutory requirement of “clinical significance,” far from ensuring “substantial efficacy,” demands no more than that there be statistical significance in a human study (as opposed to, for example, an animal study). Rather than specifying a fixed level of efficacy or even a flexible standard of efficacy that a drug must possess, the U.S. drug approval framework thus fully delegates to drug companies and to the free market the determination of what level of efficacy is acceptable. The critical implication is that the public (and physicians and insurers) should not rely on the fact of FDA approval as an indication th at medicines, including new and very highly priced ones, possess efficacy that is meaningfully greater than no efficacy at all

Explaining the Absence of Surgical Procedure Regulation

Systematic evaluation of both existing and innovative surgical procedures is needed to make important safety and efficacy data available to surgeons, facilitating optimal treatment decisions. High quality risk-benefit data is also essential if the healthcare system is to honor its obligation to inform patients of relevant benefits and risks prior to obtaining their consent to treatment. Yet for a variety of reasons, surgical procedures are not subject to direct regulation. As a result, surgeons consulting the available literature may find it inadequate to answer fundamental questions about optimal treatment choices. This failure of information increases the chance that, for years or even generations, patients will undergo painful or risky surgeries until further study eventually exposes them as either inferior to alternatives, or worse, as causing more harm than good. Unfortunately, history has repeatedly borne witness to such medical embarrassments, from the centuries-old practice of bloodletting to the disconcertingly recent examples of radical mastectomies and autologous bone marrow transplants, among many others. The federal government is well-positioned to support needed surgical research activities at the national level, both through the identification of evidence gaps and the funding of studies to fill those gaps. The government is also well-positioned to coordinate the private surgical research marketplace through activities such as the aggregation of country-level adverse event data and the setting of standards for medical terminology and guidelines for study protocols. In partnership with state governments and private organizations, the federal government can contribute to appropriate regulation that improves evidence development without imposing disproportionate burdens on surgeons or others

Visualizing second language learning: a microgenetic case study using pantomime comics for adult ESL students

Thesis (M.A.) University of Alaska Fairbanks, 2012Comics are regularly used in language classrooms. Most language teachers and researchers in applied linguistics justify the use of comics through individual characteristics such as motivation, humor, and aiding comprehension. Some studies use comics in social settings, but do not consider the images as a significant factor in language development. This study investigates the effectiveness of instruction using pantomime comics on both language acquisition and language development for adult English as second language (ESL) students. A mixed methods approach is employed to investigate individual acquisition and language development during a collaborative task. Analyses of written tests, transcriptions, and audio/video data using analytical foci, deixis, and transcription conventions following conversation analysis ascertains how comic images affect individual learners and contribute to language development between learners. Results suggest that comics can benefit the language learner individually and act as a powerful, mediational tool for language development and co-construction of knowledge between peers