MedWorm: Medical Law Research

End of gene patents isn't the end of innovation in biotech

bizjournals.com Health Care:Physician Practices headlines — Fri, 14 Jun 2013 20:16:38 +0100

Thursday's U.S. Supreme Court decision barring gene patents isn't a disaster for Seattle's biotechnology industry. The ruling still allows companies to patent synthetic DNA, which is most important for commercialization. “I certainly don't think it's an innovation squasher,” said Andrew Serafini, an intellectual property lawyer specializing in life sciences. “I think the Supreme Court could have rendered a far more severe decision that really would have impacted the biotechnology industry… (Source: bizjournals.com Health Care:Physician Practices headlines)

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BASF Stops Potato Research; Moves Research Unit to U.S.

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:41 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 147-147. (Source: Biotechnology Law Report)

New Patents

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:38 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 149-149. (Source: Biotechnology Law Report)

DuPont, Pioneer Hi-Bred Turn Attention to Wheat

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:37 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 147-147. (Source: Biotechnology Law Report)

Huge Increase in African Cotton Crop with Introduction of Genetically Modified Strains

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:35 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 147-147. (Source: Biotechnology Law Report)

India Contemplating Compulsory License for Trastuzumab

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:34 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 148-148. (Source: Biotechnology Law Report)

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Illumina Ordered to Pay $96 Million to Syntrix in Patent–Trade Secret Suit

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:32 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 152-152. (Source: Biotechnology Law Report)

Another Suit Against Thompson et al. on Use of Cancer Therapy Data

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:31 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 148-149. (Source: Biotechnology Law Report)

Australian Court Finds Isolated Genes Patentable

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:30 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 148-148. (Source: Biotechnology Law Report)

Amicus Curiae Brief of the Washington Legal Foundation in Support of Respondents in Vernon Hugh Bowman v. Monsanto Company, et al. (Supreme Court of the United States)

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:28 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 196-203. (Source: Biotechnology Law Report)

Trials of Sensipar Halted

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:27 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 144-144. (Source: Biotechnology Law Report)

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Brief of the Washington Legal Foundation in Support of Respondents in Federal Trade Commission v. Actavis, Inc., et al. (Supreme Court of the United States)

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:27 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 204-215. (Source: Biotechnology Law Report)

Questions About Utility of REMS

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:26 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 144-144. (Source: Biotechnology Law Report)

Amicus Curiae Brief of the Washington Legal Foundation in Support of Respondents in In re Jeffrey Hubbell, Jason Schense, Andreas Zisch, and Heike Hall (U.S. Court of Appeals for the Federal Circuit)

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:24 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 216-224. (Source: Biotechnology Law Report)

Washington Legal Foundation Supports Abbott Laboratories on Biosimilars

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:22 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 143-144. (Source: Biotechnology Law Report)

Insurance Companies, Not FDA, Are Now Biotechnology Industry's Biggest Problem

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:22 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 144-144. (Source: Biotechnology Law Report)

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FDA Guidance on Assessing Immunogenicity of Protein Drugs

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:16 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 143-143. (Source: Biotechnology Law Report)

FDA Issues Guidance on Financial Disclosure

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:15 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 143-143. (Source: Biotechnology Law Report)

Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators [excerpts]

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:14 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 155-171. (Source: Biotechnology Law Report)

Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products [excerpts]

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:12 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 172-185. (Source: Biotechnology Law Report)

New Rules for Clinical Trials in India

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:11 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 146-146. (Source: Biotechnology Law Report)

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Comments of the Washington Legal Foundation to the Food and Drug Administration Concerning Citizen Petition by Abbott Laboratories Regarding Biosimilar Applications That Cite Biological Products for Which the BLA Was Submitted to FDA Before March 23, 2010

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:10 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 186-195. (Source: Biotechnology Law Report)

Amgen, UCB Stop Most Development of Bone-Building Antibody

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:09 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 146-146. (Source: Biotechnology Law Report)

Omontys Recalled After Several Cases of Anaphylactic Shock

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:08 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 144-145. (Source: Biotechnology Law Report)

PhRMA, BIO Critical of New Clinical Trial Rules

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:07 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 145-145. (Source: Biotechnology Law Report)

WLF Files Amicus Brief in Patent Exhaustion Case

Biotechnology Law Report — Thu, 13 Jun 2013 13:46:06 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 150-150. (Source: Biotechnology Law Report)

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Coming Events

Biotechnology Law Report — Thu, 13 Jun 2013 13:45:24 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 225-228. (Source: Biotechnology Law Report)

Former InterMune CEO Harkonen's Conviction for Wire Fraud Stands

Biotechnology Law Report — Thu, 13 Jun 2013 13:45:09 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 153-153. (Source: Biotechnology Law Report)

On the Move

Biotechnology Law Report — Thu, 13 Jun 2013 13:45:07 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 154-154. (Source: Biotechnology Law Report)

More Counterfeit Avastin Found

Biotechnology Law Report — Thu, 13 Jun 2013 13:45:00 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 153-153. (Source: Biotechnology Law Report)

Double-Patenting Ruling by PTO in Tissue Engineering Course Upheld by Federal Circuit

Biotechnology Law Report — Thu, 13 Jun 2013 13:44:55 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 151-152. (Source: Biotechnology Law Report)

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WLF Files Amicus Brief in Favor of Some Pay-to-Delay Arrangements

Biotechnology Law Report — Thu, 13 Jun 2013 13:44:53 +0100

Biotechnology Law Report Jun 2013, Vol. 32, No. 3: 150-151. (Source: Biotechnology Law Report)

Australian Court Agrees That Isolated DNA Is Patent-Eligible Subject Matter

Biotechnology Law Report — Sat, 08 Jun 2013 03:01:35 +0100

Biotechnology Law Report , Vol. 0, No. 0. (Source: Biotechnology Law Report)

Can Access to a Medical-Legal Partnership Benefit Patients with Asthma who Live in an Urban Community?

Journal of Health Care for the Poor and Underserved — Wed, 05 Jun 2013 01:46:16 +0100

Authors: Pettignano R, Bliss LR, Caley SB, McLaren S Abstract Approximately one in 10 children in the U.S. has a diagnosis of asthma. African American and low-income children are more likely to be diagnosed with asthma. They are more likely to suffer the worse outcomes because of low socioeconomic status and environmental exposures. A medical-legal partnership is an interdisciplinary collaboration between a medical entity such as a hospital or clinic and a legal entity such as a lawyer, law school, or legal aid society created to address barriers to health care access and limitations to well-being. Addressing the legal concerns of these patients can improve access to medical services, reduce family stress, and address legal concerns that contribute to poor health. The Health Law Pa...

Delinquency Best Treatments: How to Divert Youths from Violence While Saving Lives and Detention Costs

Behavioral Sciences and the Law — Tue, 04 Jun 2013 04:00:00 +0100

Youth development and violence prevention are two sides of the same public policy. The focus of much theoretical and empirical effort is identifying delinquency risks and intervening. Given the great costs of homicide and the historically high nationwide prison population, new policies must address increasing violence and rising expenses. Treatments of prenatal care, home visitation, bullying prevention, alcohol‐substance abuse education, alternative thinking promotion, mentoring, life skills training, rewards for graduation and employment, functional family and multi‐systemic therapy, and multi‐dimensional foster care are effective, because they ameliorate age‐specific risks for delinquency. At present, these interventions only yield a 10–40% diversion from crime however. Return...

Explaining psychological distress in the legal profession: The role of overcommitment.

International Journal of Stress Management — Mon, 03 Jun 2013 04:00:00 +0100

The purpose of this study was to explain previously reported high levels of psychological distress in lawyers. General demands (i.e., time pressure and emotional demands) and lawyer demands (i.e., emphasis on profits and competitiveness), as well as three resources (i.e., control, pay, and praise) were examined, along with the moderating role of overcommitment. Participants included 448 Australian lawyers who completed an online questionnaire distributed to them by their state or territory law society. Results revealed significant direct relationships between the demands, resources, and overcommitment on depression and anxiety. Significant two-way interactions indicated that the positive relationship of general demands on depression and anxiety were more marked for high overcommitted lawye...

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Review of Law, standards, and ethics in the practice of psychology (3rd edition).

Canadian Psychology — Mon, 03 Jun 2013 04:00:00 +0100

Reviews the book, Law, Standards, and Ethics in the Practice of Psychology (3rd Edition) by David R. Evans (2011). Although Evans is the central author, with overall responsibility for the book’s conceptualisation, organisation and selection of topics, the third edition again benefits from the specific expertise of other psychologists as well as lawyers. They capture both subject matter knowledge as well as an appreciation of “how it works” in particular jurisdictions. The book is organized in 15 chapters, each with its own references and some with appendixes. The latter typically provide useful tools. As a whole, the book does a fine job of balancing the ethical, regulatory standards and legal elements that must be understood together to practise competently. It belongs not only in ...

Brain Scans and the Law (Watch the Full World Science Festival Event)

Scientific American - Official RSS Feed — Sat, 01 Jun 2013 13:24:00 +0100

The question of whether brain scanning can detect the intentions of a criminal defendant fascinates cops, lawyers and John and Jane Doe. It's probably still a theoretical question and may remain so for a long time to come.Even so, Alan Alda moderated a panel of experts whose members spend a lot of time on the issue of scanners and criminal intent. Watch this session from the World Science Festival that took place on the afternoon of June 1. [More] (Source: Scientific American - Official RSS Feed)

[World Report] Rights abuses linked to Irish surgical college in Bahrain

LANCET — Sat, 01 Jun 2013 04:00:00 +0100

A new report by a group of Irish lawyers draws attention to links between Irish medical education in Bahrain and ongoing human rights abuses in the Gulf Kingdom. Sharmila Devi reports. (Source: LANCET)

Respondeat superior: What are your responsibilities?

Malpractice Verdicts — Fri, 31 May 2013 18:19:00 +0100

Douglas Mossman, MD (Source: Malpractice Verdicts)

Preliminary Ruling of the Court of Justice of the European Union in Neurim Pharmaceuticals (1991) Ltd. v. Comptroller–General of Patents on Supplementary Protection Certificates in Europe

Biotechnology Law Report — Wed, 29 May 2013 03:01:46 +0100

Biotechnology Law Report , Vol. 0, No. 0. (Source: Biotechnology Law Report)

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Tobacco Company Efforts to Influence the Food and Drug Administration-Commissioned Institute of Medicine Report Clearing the Smoke: An Analysis of Documents Released through Litigation

PLoS Medicine — Tue, 28 May 2013 04:00:00 +0100

Conclusions Tobacco companies strategically interacted with the IOM to win several favored scientific and regulatory recommendations.Please see later in the article for the Editors' Summary (Source: PLoS Medicine)

Am I liable? The problem of defining falsity under the False Claims Act.

American Journal of Law and Medicine — Sat, 25 May 2013 10:35:01 +0100

Authors: Kim L PMID: 23678790 [PubMed - in process] (Source: American Journal of Law and Medicine)

A time to step in: legal mechanisms for protecting those with declining capacity.

American Journal of Law and Medicine — Sat, 25 May 2013 10:35:01 +0100

Authors: Arias JJ Abstract Current estimates approximate that the population over sixty-five years of age will increase from 40 million in 2010 to 72.1 million by 2030. As society ages, the number of elderly with cognitive deficits that impair decision-making abilities will also increase. This will place additional burdens on families and probate courts seeking to balance individual autonomy with necessary protections. A legal determination of incompetency is a prerequisite to a judicial order appointing a guardianship or other protective mechanism. The current legal-medical model for competency determinations fails to reflect the complexities of declining capacity in an aging population. A global structure for competency determinations leaves a critical gap between competent and i...

Retiree out-of-pocket healthcare spending: a study of consumer expectations and policy implications.

American Journal of Law and Medicine — Sat, 25 May 2013 10:35:01 +0100

This study is the first comprehensive examination of Americans' expectations regarding their out-of-pocket spending on healthcare in retirement. We surveyed over 1700 near retirees and retirees to assess their expectations regarding their own spending and then compared their responses to experts' estimates. Our main findings are twofold. First, overall expectations of out-of-pocket spending are mixed. While a significant proportion of respondents estimated out-of-pocket costs in retirement at or above expert estimates of what the typical retiree will spend, a disproportionate number estimated their future spending substantially below what experts view as likely. Estimates by members of some demographic subgroups, including women and younger respondents, deviated relatively further from the...

The politics of information: informed consent in abortion and end-of-life decision making.

American Journal of Law and Medicine — Sat, 25 May 2013 10:35:01 +0100

Authors: Suter SM Abstract The politics of reproduction dominate the political landscape now more than ever. One area of controversy has been informed consent statutes for abortion, which have been praised by the pro-life movement but derided by the pro-choice movement. More recently, legislatures have begun to enact informed consent statutes with respect to end-of-life decision making, an area almost as politically controversial as abortion. Like many abortion disclosure laws, some of these have been entitled "Right to Know" statutes. Yet, the supporters and opponents of each set of statutes tend not to be the same, aligning to a large extent based on their place in the culture wars over life and death. In this Article, I strive not only to show the remarkably similar critiques ea...

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Construct Measurement Quality Improves Predictive Accuracy in Violence Risk Assessment: an Illustration Using the Personality Assessment Inventory

Behavioral Sciences and the Law — Thu, 23 May 2013 04:00:00 +0100

Much of the risk assessment literature has focused on the predictive validity of risk assessment tools. However, these tools often comprise a list of risk factors that are themselves complex constructs, and focusing on the quality of measurement of individual risk factors may improve the predictive validity of the tools. The present study illustrates this concern using the Antisocial Features and Aggression scales of the Personality Assessment Inventory (Morey, 1991). In a sample of 1,545 prison inmates and offenders undergoing treatment for substance abuse (85% male), we evaluated (a) the factorial validity of the ANT and AGG scales, (b) the utility of original ANT and AGG scales and newly derived ANT and AGG scales for predicting antisocial outcomes (recidivism and institutional infracti...

Predictors of retention in a drug-free unit/substance abuse treatment in prison.

International Journal of Law and Psychiatry — Tue, 21 May 2013 04:00:00 +0100

Authors: Casares-López MJ, González-Menéndez A, Festinger DS, Fernández-García P, Fernández-Hermida JR, Secades R, Matejkowski J Abstract The high rate of dropout from treatment programs is a recurring problem in the field of drug dependence. The purpose of this study was to identify the predictors of retention in a prison-based drug-free unit (DFU). The relationships among subscales of the Addiction Severity Index (ASI) as well as motivation and personality profiles and length of stay in a DFU, of 57 prisoners admitted for the first time to the program were analyzed. The mean dropout rates were 52.9% at six months and 67.8% at one year. The mean length of stay was 195.05days. Predictors of retention at six months included the ASI Family Composite Score, the motivation subsca...

When and why should mentally ill prisoners be transferred to secure hospitals: A proposed algorithm.

International Journal of Law and Psychiatry — Tue, 21 May 2013 04:00:00 +0100

Authors: Vogel T, Lanquillon S, Graf M Abstract For reasons well known and researched in detail, worldwide prevalence rates for mental disorders are much higher in prison populations than in general, not only for sentenced prisoners but also for prisoners on remand, asylum seekers on warrant for deportation and others. Moreover, the proportion of imprisoned individuals is rising in most countries. Therefore forensic psychiatry must deal not only with the typically young criminal population, vulnerable to mental illness due to social stress and at an age when rates of schizophrenia, suicide, drug abuse and most personality disorders are highest, but also with an increasingly older population with age-related diseases such as dementia. While treatment standards for these mental disor...

Preventive Detention of Sex Offenders: The American Experience versus International Human Rights Norms

Behavioral Sciences and the Law — Mon, 20 May 2013 04:00:00 +0100

This article examines an American SVP scheme as it has been implemented over 20 years, contrasts the international perspective, and offers some speculation about the path of reform for American SVP schemes. Copyright © 2013 John Wiley & Sons, Ltd. (Source: Behavioral Sciences and the Law)

Can sexual offenders be treated?

International Journal of Law and Psychiatry — Mon, 20 May 2013 04:00:00 +0100

Authors: Bradford JM, Fedoroff P, Gulati S Abstract There are many misconceptions about sexual offender treatment. This is not only a problem in the lay press and media but is also a problem amongst mental health professionals. In part, this relates to the inadequate teaching about sexual deviation in medical schools and psychiatric residency programs and even in forensic psychiatric fellowships. Other disciplines, such as psychology, have educated mental health professionals in a more balanced way related to the assessment and treatment of sexual offenders but still the understanding, knowledge and acceptance that sexual offender treatment is available, is evidence-based, and is successful as shown in treatment outcome studies is still misunderstood. This review covers the evidenc...

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Symptoms and treatment of mental illness among prisoners: A study of Michigan state prisons.

International Journal of Law and Psychiatry — Fri, 17 May 2013 04:00:00 +0100

This study reports on a representative sample of prisoners in Michigan correctional facilities to determine the prevalence of psychiatric illness and the delivery of mental health (MH) services. Mental health assessments were conducted with 618 incarcerated subjects using the interRAI Correctional Facilities (interRAI CF). Subjects were randomly sampled based on four strata: males in the general population, males in administrative segregation, males in special units, and females. The interRAI CF assessments were merged with secondary data provided by the Michigan Department of Corrections (MDOC) containing information on MH diagnoses or services that the subjects were receiving within the facilities, demographics, and sentencing. Study results show that 20.1% of men and 24.8% of women in M...

Introduction to this Issue: International Perspectives on Preventive Detention

Behavioral Sciences and the Law — Thu, 16 May 2013 04:00:00 +0100

(Source: Behavioral Sciences and the Law)

Secure Preventive Detention in Germany: Incapacitation or Treatment Intervention?

Behavioral Sciences and the Law — Thu, 16 May 2013 04:00:00 +0100

Recidivism and Characteristics of Highly Dangerous Offenders Being Released from Retrospectively Imposed Preventive Detention: An Empirical Study

Behavioral Sciences and the Law — Tue, 14 May 2013 04:00:00 +0100

This study examines the recidivism of offenders who are considered to be highly dangerous but who, as a result of a decision of the German Federal High Court, have not been in preventive detention because it was imposed retrospectively (Group II preventive detention cases; § 66b StGB). Taking into consideration the restrictions imposed by the study, the data were evaluated regarding their usefulness for predicting the likelihood of reoffending. The results of this study suggest that it could be useful to describe criteria for the not very severe reoffending group. Copyright © 2013 John Wiley & Sons, Ltd. (Source: Behavioral Sciences and the Law)

Challenges and solutions for conducting research in correctional settings: The U.S. experience.

International Journal of Law and Psychiatry — Tue, 14 May 2013 04:00:00 +0100

This article presents the challenges of conducting correctional research in health and healthcare delivery. Legal, ethical, and pragmatic barriers are reviewed. Further, practical solutions that allow meaningful research to be conducted are presented. Such research can create a foundation for developing both public policy and clinical practice. PMID: 23683885 [PubMed - as supplied by publisher] (Source: International Journal of Law and Psychiatry)

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Legal aspects of administrating antipsychotic medications to jail and prison inmates.

International Journal of Law and Psychiatry — Tue, 14 May 2013 04:00:00 +0100

This article discusses the various federal, state, and international legal standards applicable to both informed consent and forcible medication, and their implementation in the correctional setting, focusing on issues related to the United States. PMID: 23683884 [PubMed - as supplied by publisher] (Source: International Journal of Law and Psychiatry)

The Supreme Court Takes On the Patent Eligibility of Human Genes: AMP v. Myriad

Biotechnology Law Report — Tue, 14 May 2013 03:01:50 +0100

Biotechnology Law Report , Vol. 0, No. 0. (Source: Biotechnology Law Report)

Investigating the Effects of Repeated Miranda Warnings: Do They Perform a Curative Function on Common Miranda Misconceptions?

Behavioral Sciences and the Law — Mon, 13 May 2013 04:00:00 +0100

In Miranda v. Arizona (), the Supreme Court of the United States required that custodial suspects be apprised of their Constitutional rights against self‐incrimination. The Court could not have anticipated the rampant popularization of Miranda warnings in subsequent movies and television dramas. Influenced by public media, many arrestees assume that they already “know” their rights, with no awareness of their misconceptions. The current investigation examines whether repeated exposures to Miranda warnings performs any “curative” function (i.e., dispelling common Miranda misconceptions held by pretrial defendants). The accumulative effects of five different Miranda warnings were tested over a several‐hour period on 260 detainees. For the nearly half (113 or 43.5%) with three or ...

Subjective experience of early imprisonment.

International Journal of Law and Psychiatry — Sat, 11 May 2013 04:00:00 +0100

CONCLUSIONS: During pre-trial custodial detention, there is a greater range of experience than generally previously reported. The simple expedients of prison staff developing good relationships with prisoners, and facilitating these between prisoners, could be life-saving. Highly positive experiences may be more an indictment on community services than an endorsement of imprisonment. PMID: 23672946 [PubMed - as supplied by publisher] (Source: International Journal of Law and Psychiatry)

Violent criminal recidivism in mentally disordered offenders: A follow-up study of 13-20years through different sanctions.

International Journal of Law and Psychiatry — Sat, 11 May 2013 04:00:00 +0100

Authors: Lund C, Hofvander B, Forsman A, Anckarsäter H, Nilsson T Abstract OBJECTIVE: To describe criminal recidivism, especially violent recidivism, in a long-term follow-up of mentally disordered offenders sentenced to different types of sanctions. SUBJECTS AND METHODS: A population-based Swedish cohort of male offenders referred to pre-trial psychiatric investigations between 1988 and 1995, was sentenced to forensic psychiatric treatment (n=163), prison (n=120), or noncustodial sanctions (n=52). They were followed from the beginning of their sanctions until the end of June, 2008, through official health and crime registers. Survival analyses were used to compare time until violent recidivism across different sanctions and mental disorders, and predictors of violent recidivism w...

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Cultural competence in correctional mental health.

International Journal of Law and Psychiatry — Fri, 10 May 2013 04:00:00 +0100

Authors: Kapoor R, Dike C, Burns C, Carvalho V, Griffith EE Abstract Cultural competence is an essential aspect of competence as a mental health professional. In this article, the framework of cultural competence developed in general psychiatry-acquiring knowledge, attitudes, and skills necessary to understand the interaction between culture and the individual-is applied to the prison setting. Race and ethnicity, extremes of age, gender, and religion are highlighted and examined as elements of the overall culture of prisons. The model of the cultural formulation from the DSM-IV is then adapted for use by clinicians in the correctional setting, with particular emphasis on the interaction between the inmate's culture of origin and the unique culture of the prison environment. PMI...

Variations in prison mental health services in England and Wales.

International Journal of Law and Psychiatry — Fri, 10 May 2013 04:00:00 +0100

This study provides an overview of mental health in-reach services in prisons in England and Wales, including variations between them, through a telephone survey of senior staff in all prisons and young offender institutions in England and Wales. 73% of prisons took part; of them 13% had no in-reach team at all (usually low security establishments) and the majority of services were run by NHS teams, usually according to a generic community mental health team (CMHT) model rather than other specialist models. Team size was unrelated to prison size. Each nurse covered around 500 prisoners, each doctor over 3700. Many provided few or no healthcare cells and 24-h psychiatric cover (including on-call cover) was uncommon. Despite developments in recent years, mental health in-reach services still...

Malingering in the correctional system: Does incentive affect prevalence?

International Journal of Law and Psychiatry — Fri, 10 May 2013 04:00:00 +0100

Authors: McDermott BE, Dualan IV, Scott CL Abstract Incentives to malinger vary greatly dependent on the context, as does the prevalence. Malingering in the medico-legal context of the criminal courts is generally for one of two purposes: to present as incompetent to stand trial or to successfully plead not guilty by reason of insanity. Estimates of the prevalence of malingering in these contexts vary between 8 and 21%. The prevalence of malingering increases dramatically in a general offender sample, where the external incentive is likely to be substantially different. Malingering in this context can be as high as 56% and generally occurs to obtain a more desirable housing situation or desired medications. Our study examined data from two distinct samples to evaluate incentives to...

Suicide prevention in correctional facilities: Reflections and next steps.

International Journal of Law and Psychiatry — Thu, 09 May 2013 04:00:00 +0100

Authors: Hayes LM Abstract Data from a recent national study of inmate suicides indicates that the suicide rate in county jails throughout the United States has steadily decreased. Despite this progress, the author argues that rather than developing and maintaining comprehensive policies and practices, policymakers and correctional administrators appear preoccupied with the notion that suicides can only be prevented when inmates are on suicide precautions. Measures such as closed-circuit television monitoring, suicide-resistant jail cells, safety smocks, and new technology are popular tools to keep certain inmates safe. There is more to suicide prevention than simply observing suicidal inmates and waiting for them to attempt suicide. The author argues that suicides are prevented an...

Perspectives and Opportunities for Precompetitive Public–Private Partnerships in the Biomedical Sector

Biotechnology Law Report — Tue, 07 May 2013 03:02:39 +0100

Biotechnology Law Report , Vol. 0, No. 0. (Source: Biotechnology Law Report)

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Prisons and mental health: Introductory editorial: Hospitalizing mentally ill patients.

International Journal of Law and Psychiatry — Sat, 04 May 2013 04:00:00 +0100

Authors: Felthous AR PMID: 23651702 [PubMed - as supplied by publisher] (Source: International Journal of Law and Psychiatry)

After Myriad Oral Argument, Supreme Court Set to Decide Patentability of Isolated Human DNA Molecules

Biotechnology Law Report — Fri, 03 May 2013 03:01:48 +0100

Biotechnology Law Report , Vol. 0, No. 0. (Source: Biotechnology Law Report)

Can a Patient Designate His Doctor as His Proxy Decision Maker?

PEDIATRICS — Wed, 01 May 2013 04:00:00 +0100

We present a case in which those issues arose, and sought comments from Sabrina Derrington, a pediatric palliative care physician; Arthur Derse, an emergency department physician and lawyer; and Phil Black, a pulmonologist. (Source: PEDIATRICS)

Make Sure Your Loved Ones Get It When You're Gone: The Need for Estate Planning

Journal of the American College of Radiology : JACR — Wed, 01 May 2013 04:00:00 +0100

When someone mentions the phrase “estate planning,” it can invoke images of lawyers, complex legal documents, and wealthy billionaires. Many incorrectly assume that they are either too young or lack the net worth necessary to warrant establishing an estate plan. But the truth is, whether you are a new radiologist just starting your career or a radiologist who has been in practice for many years, you should have an estate plan in place so that you dictate how your assets will be distributed after your death, rather than allowing the government to make the decision for you. (Source: Journal of the American College of Radiology : JACR)

Forensic paleontology: a tool for "intelligence" and investigation.

Journal of Forensic Sciences — Wed, 01 May 2013 04:00:00 +0100

Forensic paleontology: a tool for "intelligence" and investigation. J Forensic Sci. 2013 May;58(3):651-7 Authors: Sacchi E, Nicosia U Abstract Paleontology and facies analysis proved to be useful tools in activities of intelligence and investigation on some criminal cases, as well as in in-court activities, thus defining the "forensic paleontology" area of study. The definition was given by analyzing its possible specific applications and excluding some marginal activities. The reliability of forensic paleontology was then assessed in light of the results achieved in some actual cases and in an ad hoc simulation. The investigated cases concerned intelligence and ordinary law enforcement activities. Special attention was paid to crimes against the cultural heritage. Ex post ...

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Women prisoners, mental health, violence and abuse.

International Journal of Law and Psychiatry — Wed, 01 May 2013 04:00:00 +0100

This article examines the specific experiences of women in prison, focusing on previous (and continuing) physical and mental abuse, the consequent health care requirements of women prisoners, the policy response and the availability of suitable health care in prisons across the EU. It draws from an extensive review of the literature on women prisoners across Europe that was part of an on-going European Project funded by the DAPHNE programme of the European Commission, entitled 'DAPHNE Strong'. It also uses the field research from the project collected via surveys and in-depth interviews with key personnel in organisations that work with women prisoners or ex-prisoners and staff with a strategic overview of activity from the ministries of justice, police, prison service and women's support ...

Doctors, lawyers, and disability benefit claims.

Tennessee Medicine — Wed, 01 May 2013 04:00:00 +0100

Authors: Skeie PT PMID: 23691869 [PubMed - in process] (Source: Tennessee Medicine)

Jury Panel Member Perceptions of Interpersonal‐Affective Traits of Psychopathy Predict Support for Execution in a Capital Murder Trial Simulation

Behavioral Sciences and the Law — Wed, 01 May 2013 04:00:00 +0100

Recent research with college undergraduate mock jurors suggests that how psychopathic they perceive a criminal defendant to be is a powerful predictor of whether they will support a death verdict in simulated capital murder trials. Perceived affective and interpersonal traits of psychopathy are especially predictive of support for capital punishment, with perceived remorselessness explaining a disproportionate amount of variance in these attitudes. The present study attempted to extend these findings with a more representative sample of community members called for jury duty (N = 304). Jurors reviewed a case vignette based on an actual capital murder trial, provided sentencing verdicts, and rated the defendant on several characteristics historically associated with the construct of psychop...

Prevalence of mental disorders among detained asylum seekers in deportation arrest in Switzerland and validation of the Brief Jail Mental Health Screen BJMHS.

International Journal of Law and Psychiatry — Tue, 30 Apr 2013 04:00:00 +0100

DISCUSSION: As in other prison populations prevalence rates for mental disorders were markedly above the general population. The specific pattern with high rates of phobic as well as post-traumatic stress disorders may reflect the very often traumatic backgrounds of this population. Whereas the results for the validation of the BJMHS were even better than in other similar studies and the instrument proved to be practicable and helpful to detect serious mental illness, sensitivity for a screening tool of around 80% is still too low. Additionally the fact that other serious mental disorders are not covered emphasizes the importance of other elements in the screening process, including the need to have well-trained staff, and to have a low threshold for psychiatric examination. PMID: 2364...

Is there a recognizable post-incarceration syndrome among released "lifers"?

International Journal of Law and Psychiatry — Tue, 30 Apr 2013 04:00:00 +0100

Is there a recognizable post-incarceration syndrome among released "lifers"? Int J Law Psychiatry. 2013 Apr 30; Authors: Liem M, Kunst M Abstract It has been suggested that released prisoners experience a unique set of mental health symptoms related to, but not limited to, post-traumatic stress disorder. We sought to empirically assess whether there is a recognizable post-incarceration syndrome that captures the unique effects of incarceration on mental health. We conducted in-depth life interviews with 25 released "lifers" (individuals serving a life sentence), who served an average of 19years in a state correctional institution. We assessed to what extent the symptoms described by the participants overlapped with other mental disorders, most notably PTSD. The narratives i...

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Pharmacotherapy of impulsive aggression: A quality comparison of controlled studies.

International Journal of Law and Psychiatry — Tue, 30 Apr 2013 04:00:00 +0100

Authors: Felthous AR, Lake SL, Rundle BK, Stanford MS Abstract The present study assessed the quality of pharmacotherapy trials to treat impulsive aggressive behavior. While a search of the literature found 55 peer-reviewed published studies on the pharmacotherapy of aggression, only 23 met criteria for inclusion in the quality analysis. To be included in this review, the study must have had at least one comparison group to control for placebo effects. The study must have also adequately defined and diagnosed the presence of impulsive aggression or intermittent explosive disorder. The primary reason studies were excluded from the quality analysis was that impulsive aggression was not specifically defined as the behavior being treated (25 of 32, 78%). The results of the quality anal...

Reflective decision-making and foster care placements.

Psychology, Public Policy, and Law — Mon, 29 Apr 2013 04:00:00 +0100

Juvenile dependency courts have a crucial role in overseeing the foster care system. Dependency court cases require a series of complex judicial decisions, and juvenile dependency judges must make decisions each day with limited information and in a relatively short time—a context inclined to allow implicit bias to influence decision-making. Within this context, two court interventions were implemented by the National Council of Juvenile and Family Court Judges: a training on implicit and institutional bias that included a focus on reflection and deliberation in decision-making and a judicial “benchcard” for use during preliminary protective hearings. Using randomized control trial and quasi-experimental designs, this study finds that the training intervention was associated with mor...

Attention deficit hyperactivity disorder in a Canadian prison population.

International Journal of Law and Psychiatry — Mon, 29 Apr 2013 04:00:00 +0100

Authors: Usher AM, Stewart LA, Wilton G Abstract Previous research has shown that a significant percentage of offenders are affected by adult attention deficit hyperactivity disorder (ADHD) and its related symptoms, however it is unknown the extent to which this disorder affects federal inmates in Canada and the impact ADHD has on key correctional outcomes. Four hundred and ninety-seven male federal offenders were assessed at intake over a fourteen month period using the Adult ADHD Self-Report Scale (ASRS). Approximately 16.5% scored in the highest range, which is consistent with the clinical threshold for diagnosis for the disorder; a further 25.2% reported sub-threshold symptoms in the moderate range. ADHD symptoms were found to be associated with unstable job history, presence o...

The role of university-based forensic clinics.

International Journal of Law and Psychiatry — Sat, 27 Apr 2013 04:00:00 +0100

Authors: Heilbrun K, Kelley SM, Koller JP, Giallella C, Peterson L Abstract As forensic psychiatry and forensic psychology have grown and matured, the range of specialized services provided by each has expanded. In addition to traditional services such as forensic mental health assessments in criminal, family, and civil contexts, forensic specialists are now involved in delivering services in the community that include (in the criminal justice context) assessment for diversion into specialized probation or problem-solving courts, rehabilitation needs upon reentry (including specialized parole), and risk assessment for particular populations such as sexual offenders. Specialized forensic treatment services include those provided to clients under the jurisdiction of problem-solving c...

Measuring IPDE-SQ personality disorder prevalence in pre-sentence and early-stage prison populations, with sub-type estimates.

International Journal of Law and Psychiatry — Sat, 27 Apr 2013 04:00:00 +0100

This study aimed to determine the prevalence of personality disorder (PD) traits within a local urban high-turnover adult male prison with a remand/recently sentenced population in London, UK. The International Personality Disorder Examination - Screening Questionnaire (IPDE-SQ) self-administered questionnaire (ICD-10 version) was completed by 283 prisoners (42% completion rate). 77% of respondents reached the threshold for one or more PDs. The most common PD types were Paranoid PD (44.5%), Anankastic PD (40.3%), Schizoid PD (35%) and Dissocial PD (25.8%). These results confirm and extend existing knowledge regarding the prevalence of PD in prison populations into a high-turnover, urban, remand population. The stark comparison with community samples indicates that a more equitable standard...

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Sexually Violent Predators: Toward Reasonable Estimates of Recidivism Base Rates

Behavioral Sciences and the Law — Thu, 25 Apr 2013 04:00:00 +0100

The sexual recidivism rate of sex offenders is a controversial issue. Perhaps as controversial is the sexual recidivism rate of the select group of sex offenders who are examined pursuant to sexually violent predator (SVP) statutes. At present, reliable estimates of SVP recidivism are unavailable. We propose that reasonable estimates of SVP recidivism can be reached by considering three available pieces of data: (i) a likely recidivism rate of the general population of sex offenders; (ii) procedures typically followed by jurisdictions that civilly commit sex offenders; and (iii) classification accuracy of procedures. Although sexual recidivism rates vary across jurisdictions, the results of our analyses suggest sex offenders referred for examination pursuant to SVP statutes recidivate at s...

Behavioural Stimulation and Sensation-Seeking among prisoners: Applications to substance dependency.

International Journal of Law and Psychiatry — Wed, 24 Apr 2013 04:00:00 +0100

CONCLUSIONS AND IMPLICATIONS FOR PRACTISE: BStim-SS presents as a valuable concept to apply to forensic populations. It captures the need for behavioural and emotional stimulation and lends support to Reward Discounting theory as valuable concept to apply across substance dependency. Implications for practise include: PMID: 23623718 [PubMed - as supplied by publisher] (Source: International Journal of Law and Psychiatry)

Motivational Influences in Persons Found Not Criminally Responsible on Account of Mental Disorder: A Review of Legislation and Research

Behavioral Sciences and the Law — Tue, 23 Apr 2013 04:00:00 +0100

This paper provides a review of the legislative reforms and case law that have impacted the defense of Not Criminally Responsible on Account of Mental Disorder (NCRMD) in Canada over the past three decades. As in other jurisdictions internationally, we observe that legislative reforms of procedural, as opposed to substantive, aspects of the NCRMD defense have impacted the manner in which NCRMD criteria are applied in common practice. More people are being declared NCRMD in recent years, and there is greater heterogeneity in the offending and psychiatric profiles of these individuals, suggesting that NCRMD criteria are being applied more liberally over time. In light of the substantial growth of the forensic mental health system over the past two decades, witnessed both in Canada and abroad...

Risk Assessment in the Law: Legal Admissibility, Scientific Validity, and Some Disparities between Research and Practice

Behavioral Sciences and the Law — Tue, 23 Apr 2013 04:00:00 +0100

Risk assessment expert testimony remains an area of considerable concern within the U.S. legal system. Historically, controversy has surrounded the constitutionality of such testimony, while more recently, following the adoption of new evidentiary standards that focus on scientific validity, the admissibility of expert testimony has received greater scrutiny. Based on examples from recent appellate court cases involving sexual violent predator (SVP) hearings, we highlight difficulties that courts continue to face in evaluating this complex expert testimony. In each instance, we point to specific problems in courts' reasoning that lead it to admit expert testimony of questionable scientific validity. We conclude by offering suggestions for how courts might more effectively evaluate the scie...

Probability of Criminal Acts of Violence: A Test of Jury Predictive Accuracy

Behavioral Sciences and the Law — Tue, 23 Apr 2013 04:00:00 +0100

The ability of capital juries to accurately predict future prison violence at the sentencing phase of aggravated murder trials was examined through retrospective review of the disciplinary records of 115 male inmates sentenced to either life (n = 65) or death (n = 50) in Oregon from 1985 through 2008, with a mean post‐conviction time at risk of 15.3 years. Violent prison behavior was completely unrelated to predictions made by capital jurors, with bidirectional accuracy simply reflecting the base rate of assaultive misconduct in the group. Rejection of the special issue predicting future violence enjoyed 90% accuracy. Conversely, predictions that future violence was probable had 90% error rates. More than 90% of the assaultive rule violations committed by these offenders resulted...

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Bill would give doctors access to confidential complaints against them

bizjournals.com Health Care:Biotechnology headlines — Mon, 15 Apr 2013 18:44:58 +0100

Legislation that would give Texas doctors the right to a copy of confidential complaints has the support of the Association of American Physicians and Surgeons. Senate Bill 1193, filed by State Sen. Donna Campbell, R-New Braunfels, would also require the Texas Medical Board to supply physicians with reports it compiles while investigating cases, including credentials of experts. "This gives doctors the same legal protections as lawyers, dentists and politicians when defending against a complaint… (Source: bizjournals.com Health Care:Biotechnology headlines)

Tackling the Global NCD Crisis: Innovations in Law and Governance

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

35 million people die annually of non‐communicable diseases (NCDs), 80% of them in low‐ and middle‐income countries — representing a marked epidemiological transition from infectious to chronic diseases and from richer to poorer countries. The total number of NCDs is projected to rise by 17% over the coming decade, absent significant interventions. The NCD epidemic poses unique governance challenges: the causes are multifactorial, the affected populations diffuse, and effective responses require sustained multi‐sectorial cooperation. The authors propose a range of regulatory options available at the domestic level, including stricter food labeling laws, regulation of food advertisements, tax incentives for healthy lifestyle choices, changes to the built environment, and direct re...

Law as a Tool in “The War on Obesity”: Useful Interventions, Maybe, But, First, What's the Problem?

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

This article explores the effectiveness of legal interventions to promote healthier eating/drinking and exercise in responding to obesity. Undue emphasis on weight loss and prevention of excess gain have largely been failures and have fueled prejudice against fat people. A major challenge lies in shifting norms: away from stigmatization of the obese and towards more nutritious eating/drinking and increased activity with acceptance of bodies in all shapes and sizes. Part of the enormity of this challenge lies in the complex effects of law and its relationship with norms, including unintended consequences of regulation. To illustrate such complications, the paper examines two interventions and the actual effects that they have produced (or could under differing conditions): junk food taxes, ...

Global Health, Vulnerable Populations, and Law

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

Given the fragility of individual and population wellbeing in an interdependent world threatened by many overlapping crises, the suggestion is made that new legal mechanisms have the robust potential to reduce human vulnerability locally and globally. (Source: The Journal of Law, Medicine and Ethics)

Protecting Rights and Building Capacities: Challenges to Global Mental Health Policy in Light of the Convention on the Rights of Persons with Disabilities

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

The World Health Organization (WHO) has identified mental health as a priority for global health promotion and international development to be targeted through promulgation of evidence‐based medical practices, health systems reform, and respect for human rights. Yet these overlapping strategies are marked by tensions as the historical primacy of expert‐led initiatives is increasingly subject to challenge by new social movements — in particular, disabled persons' organizations (DPOs). These tensions come into focus upon situating the WHO's mental health policy initiatives in light of certain controversies arising under the Convention on the Rights of Persons with Disabilities (CRPD), particularly as it applies to persons with mental (psychosocial) disabilities. I examine two such cont...

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The Role of Law in Ameliorating Global Inequalities in Indigenous Peoples' Health

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

This article explores aspects of law's potential for ameliorating the health deficit which Indigenous peoples experience around the globe, with a focus on international law and international legal forums. It considers the challenges and benefits of using these tools and forums to affect changes within domestic systems. (Source: The Journal of Law, Medicine and Ethics)

A Survey of International Legal Instruments to Examine Their Effectiveness in Improving Global Health and in Realizing Health Rights

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

Many global health issues, almost by definition, do not recognize state borders and therefore require bi‐lateral, or more often multi‐lateral international solutions. These latter solutions are articulated in international instruments (declarations, conventions, treaties, constitutions of international bodies, etc). However, the gap between formal adoption of such instruments by signatory states and substantive implementation of the articulated solutions can be very wide. This paper surveys a selection of international legal instruments, including those where the sought after positive outcomes have been achieved, and those that have been ineffective, with little or no real progress being made. The paper looks for commonalities, both in the nature of the problems and the forms of the in...

Human Rights and Maternal Health: Exploring the Effectiveness of the Alyne Decision

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

This article explores the effectiveness of the decision of the Committee on the Elimination of Discrimination against Women in the case of Alyne da Silva Pimentel Teixeira (deceased) v. Brazil, concerning a poor, Afro‐Brazilian woman. This is the first decision of an international human rights treaty body to hold a state accountable for its failure to prevent an avoidable death in childbirth. Assessing the future effectiveness of this decision might be undertaken concretely by determining the degree of Brazil's actual compliance with the Committee's recommendations, and how this decision influences pending domestic litigation arising from the maternal death. Alternative approaches include: determining whether, over time, the decision leads to the elimination of discrimination against wom...

The Debatable Role of Courts in Brazil's Health Care System: Does Litigation Harm or Help?

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

Recent studies of the Brazilian case suggest that successful litigation can have regressive effects and negatively impact the health care system. While the data to support this claim is not conclusive, this paper assumes that such immediate regressive effects are indeed taking place, but asks if these are the only consequences that should be analyzed in assessing the impact of right to health litigation in Brazil. The answer is no. The current perspective adopted to assess right to health litigation in Brazil is too narrow. Other consequences can and should be considered in analyzing the overall impact of litigation. To go beyond the set of questions asked by the existing experts on the topic, this paper analyzes whether the right to health litigation in Brazil has the potential, and could...

Is There a Human Right to Private Health Care?

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

In recent years we have noticed an increase in the turn to rights analysis in litigation relating to access to health care. Examining litigation, we can notice a contradiction between on the one hand the ability of the right to health to reinforce privatization and commodification of health care, by rearticulating claims to private health care in terms of human rights, and on the other hand, its ability to reinforce and reinstate public values, especially that of equality, against the background of privatization and commodification. While many hope that rights discourse will do the latter, and secure that access to health care should occur on the basis of need as opposed to ability to pay, it has actually been used to attempt to advance arguments that will allow access to private or semipr...

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Tobacco Control Litigation: Broader Impacts on Health Rights Adjudication

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

This paper argues that there are instances in which tobacco control litigation is strengthening the justiciability of the right to health and health‐related rights. This is happening in different parts of the world, but in particular in Latin America. In part this is because, to a certain extent, tobacco control litigation based on fundamental rights overcomes the traditional arguments against economic, social and cultural rights adjudication: the anti‐democratic argument, the lack of technical competency argument, the problem of the misallocation of scarce public resources and the problem of the implementation of judicial decisions. As we analyzed in this paper, tobacco control cases based on fundamental rights are allowing courts to elaborate on broader standards of judicial adjudica...

Pharmaceutical Knowledge Governance: A Human Rights Perspective

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

Industry control over the production and distribution of pharmaceutical safety and efficacy data has become a serious public health and health care funding concern. Various recent scandals, several involving the use of flawed representations of scientific data in the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. This paper analyzes why this is a human rights concern and what difference a human rights analysis can make. The paper first identifies the challenges associated with the current knowledge deficit. It then discusses, based on an analysis of case law, how various human rights associated interests can be invoked to support the claim that states have an obligation to actively contribute to independent knowledge governance, f...

Patents and Human Rights: A Heterodox Analysis

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

This article argues that this is the wrong question to ask. Following an analysis of both patent and human rights law, this article suggests that the better approach is to focus on national debates over the best calibration of patent law to achieve national objectives. (Source: The Journal of Law, Medicine and Ethics)

The High Price of “Free” Trade: U.S. Trade Agreements and Access to Medicines

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

The United States' pursuit of increasingly TRIPS‐Plus levels of intellectual property protection for medicines in bilateral and regional trade agreements is well recognized. Less so, however, are U.S. efforts through these agreements to influence and constrain the pharmaceutical coverage programs of its trading partners. Although arguably unsuccessful in the Australia‐ U.S. Free Trade Agreement (AUSFTA), the U.S. nevertheless succeeded in its bilateral FTA with South Korea (KORUS) in establishing prescriptive provisions pertaining to the operation of coverage and reimbursement programs for medicines and medical devices, which have the potential to adversely impact future access in that country. More recently, draft texts leaked from the current Trans Pacific Partnership Agreement (TPPA...

Transnational Trade in Human Eggs: Law, Policy, and (In)Action in Canada

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

In this paper, we provide as accurate a picture as possible of transnational trade in human eggs involving Canadians. We explain the legal status in Canada, and call for reform in the regulation, of such trade. (Source: The Journal of Law, Medicine and Ethics)

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Global Trade and Assisted Reproductive Technologies: Regulatory Challenges in International Surrogacy

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

International surrogacy is an increasingly common phenomenon and an important global health challenge. Legal rules are a key consideration for the participants in international surrogacy arrangements. In some cases the law can help to resolve the complex issues that arise in this context, but it is important to consider the role played by law in contributing to the complex conflicts that such arrangements can generate. (Source: The Journal of Law, Medicine and Ethics)

What's Missing? Discussing Stem Cell Translational Research in Educational Information on Stem Cell “Tourism”

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

Stem cell tourism is a growing industry in which patients pursue unproven stem cell therapies for a wide variety of illnesses and conditions. It is a challenging market to regulate due to a number of factors including its international, online, direct‐to‐consumer approach. Calls to provide education and information to patients, their families, physicians, and the general public about the risks associated with stem cell tourism are mounting. Initial studies examining the perceptions of patients who have pursued stem cell tourism indicate many are highly critical of the research and regulatory systems in their home countries and believe them to be stagnant and unresponsive to patient needs. We suggest that educational material should include an explanation of the translational research p...

Transplant Tourism: The Ethics and Regulation of International Markets for Organs

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

“Medical Tourism” is the travel of residents of one country to another country for treatment. In this article I focus on travel abroad to purchase organs for transplant, what I will call “Transplant Tourism.” With the exception of Iran, organ sale is illegal across the globe, but many destination countries have thriving black markets, either due to their willful failure to police the practice or more good faith lack of resources to detect it. I focus on the sale of kidneys, the most common subject of transplant tourism, though much of what I say could be applied to other organs as well. Part I briefly reviews some data on sellers, recipients, and brokers. Part II discusses the bioethical issues posed by the trade, and Part III focuses on potential regulation to deal with these issu...

Medical Tourism's Impact on Health Care Equity and Access in Low‐ and Middle‐Income Countries: Making the Case for Regulation

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

This article reviews relevant evidence that exists and concludes that there are signs of correlation between medical tourism and the expansion of private, technology‐ intensive health care in LMICs, which has largely remained out of reach for the majority of the local patients. In light of this health care inequity between local residents and medical tourists in LMICs, we argue that the presumption should not be in favor of medical tourism and that governments have a legitimate interest in seeking to regulate this industry to ensure that the net effects for their citizens is positive. Moreover, sending countries, particularly those in the developed world, have the responsibility to adopt public policies to diminish demand on the part of their citizens for medical tourism and to work with...

Evaluating Equity Critiques in Food Policy: The Case of Sugar‐Sweetened Beverages

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

Many anti‐obesity policies face a variety of ethical objections. We consider one kind of anti‐obesity policy — modifications to food assistance programs meant to improve participants' diet — and one kind of criticism of these policies, that they are inequitable. We take as our example the recent, unsuccessful effort by New York State to exclude sweetened beverages from the items eligible for purchase in New York City with Supplemental Nutrition Support Program (SNAP) assistance (i.e., food stamps). We distinguish two equity‐based ethical objections that were made to the sweetened beverage exclusion, and analyze these objections in terms of the theoretical notions of distributive equality and social equality. First, the sweetened beverage exclusion is unfair or violates distributi...

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Making Residency Work Hour Rules Work

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

In July 2011, the ACGME implemented new rules that limit interns to 16 hours of work in a row, but continue to allow 2nd‐year and higher resident physicians to work for up to 28 consecutive hours. Whether the ACGME's 2011 work hour limits went too far or did not go far enough has been hotly debated. In this article, we do not seek to re‐open the debate about whether these standards get matters exactly right. Instead, we wish to address the issue of effective enforcement. That is, now that new work hour limits have been established, and given that the ACGME has been unable to enforce work hour limits effectively on its own, what is the best way to make sure the new limits are followed in order to reduce harm to residents, patients, and others due to sleep‐deprived residents? We focus ...

Brightening Up: The Effect of the Physician Payment Sunshine Act on Existing Regulation of Pharmaceutical Marketing

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

With the passage of the Physician Payment Sunshine Act as part of the federal health care reform law, pharmaceutical manufacturers are now required to disclose a wide range of payments made by manufacturers to physicians. We review current state regulation of pharmaceutical marketing and consider how the federal sunshine provision will affect existing marketing regulation. We analyze the legal and practical implications of the Physician Payment Sunshine Act. (Source: The Journal of Law, Medicine and Ethics)

Transparent Vessels?: What Organ Donors Should Be Allowed to Know about Their Recipients

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

A live organ donor needs to be informed carefully about the risks and benefits of her donation for both herself and her recipient, but a key ethical question is how much the donor is allowed to know about the recipient. To decide this question, we must first decide whether, out of respect for autonomy, the donor should decide how much she wants to know, or whether the transplant team, as the professionals, should decide what information is relevant to the donor's decision. I argue that the transplant team should control the process. While the donor has the right to know enough about her recipient to assess the risk to herself and the prospects for a successful donation, she is not entitled to any further information, no matter how much she wants it. In particular, I argue that donors are n...

Physician Participation in Executions, the Morality of Capital Punishment, and the Practical Implications of Their Relationship

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

Evidence that some executed prisoners suffered excruciating pain has reinvigorated the ethical debate about physician participation in executions. In widely publicized litigation, death row inmates argue that participation of anesthesiologists in their execution is constitutionally required to minimize the risk of unnecessary suffering. For many years, commentators supported the ethical ban on physician participation reflected in codes of professional medical organizations. However, a recent wave of scholarship concurs with inmate advocates, urging the law to require or permit physician participation. Both the anti‐ and pro‐physician‐participation literature share a common premise: the ethics of physician participation should be analyzed independently from the moral status of capital...

Abuses and Apologies: Irresponsible Conduct of Human Subjects Research in Latin America

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

This paper explores the vulnerability of Latin American human subjects, and how their vulnerability is ignored due to the complexities and inconsistencies of oversight committees and institutional policies. Secondly, the concept of apology is examined and its meaning to victims of past research abuses. (Source: The Journal of Law, Medicine and Ethics)

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Reconsidering the Legality of Cigarette Smoking Advertisements on Television Public Health and the Law

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

Television advertisements depicting the use of electronic cigarettes have recently exposed minors to images of smoking behaviors. While these advertisements are currently legal, existing laws should be interpreted or expanded to ban the commercial depiction of smoking behaviors with any product that resembles a cigarette to shield minors from potentially influential advertising. (Source: The Journal of Law, Medicine and Ethics)

The Barnes Case: Taking Difficult Futility Cases Public

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

Futility disputes are increasing and courts are slowly abandoning their historical reluctance to engage these contentious issues, particularly when confronted with inappropriate surrogate demands for aggressive treatment. Use of the judicial system to resolve futility disputes inevitably brings media attention and requires clinicians, hospitals, and families to debate these deep moral conflicts in the public eye. A recent case in Minnesota, In re Emergency Guardianship of Albert Barnes, explores this emerging trend and the complex responsibilities of clinicians and hospital administrators seeking to replace an unfaithful surrogate demanding aggressive therapy. Use of the courts requires the coordinated commitment of significant institutional resources, management of intense media scrutiny ...

Calendar of Events

The Journal of Law, Medicine and Ethics — Fri, 12 Apr 2013 04:00:00 +0100

(Source: The Journal of Law, Medicine and Ethics)

The Parable of Bowman and the Self-Replicating Seeds

Biotechnology Law Report — Wed, 10 Apr 2013 03:01:43 +0100

Biotechnology Law Report , Vol. 0, No. 0. (Source: Biotechnology Law Report)

Navigating the legal and ethical foundations of informed consent and confidentiality in integrated primary care.

Families, Systems, and Health — Mon, 08 Apr 2013 04:00:00 +0100

This article describes findings from ongoing research and analysis of current literature in addition to discussions with leaders in the field, communications with lawyers and administrators of advocacy and government agencies pertaining to integrated primary care (IPC). Standards of care are established based on a myriad of factors, including professional codes of ethics, case law, state and federal laws, professional standards, existing best practices, current professional guidelines, administrative rules and regulations, and licensing board regulations. Regulations may differ for behavioral health and medical providers, posing challenges in IPC settings. This article provides a review of these regulations, particularly 42CFR Part 2, a federal law governing confidentiality for substance a...

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Rep. Paul Wants Patients to Have Access to Unapproved Drugs; Policy Has Been Rejected by the Courts; Whether Manufacturers Can Produce Enough in Doubt

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:27 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 22-23. (Source: Biotechnology Law Report)

23andMe Accepts FDA Regulation

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:26 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 22-22. (Source: Biotechnology Law Report)

Are Conflicts of Interest Adequately Disclosed?

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:26 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 23-23. (Source: Biotechnology Law Report)

Public Release of Confidential FDA Data Probed

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:25 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 19-19. (Source: Biotechnology Law Report)

Report on Biosimilar Industry

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:25 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 19-19. (Source: Biotechnology Law Report)

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Other Indications Approved for Humira

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:25 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 22-22. (Source: Biotechnology Law Report)

Ban of Company Officers from Industry and Its Duration Must Be Justified

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:24 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 20-21. (Source: Biotechnology Law Report)

EMA Committee Recommends Approval of Gene Therapy Product

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:23 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 19-20. (Source: Biotechnology Law Report)

MolecularMD Submits PMA for Genetic Test for Leukemias

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:23 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 21-21. (Source: Biotechnology Law Report)

Gaucher Drug Rejected in Europe; Should Orphan Drug Status for Another Company's Drug Apply on Grounds of Cost?

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:22 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 17-17. (Source: Biotechnology Law Report)

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FDA Denies Responsibility for Drug Shortages; Production Problems, Business Decisions, Raw Materials Shortages Far More Important, Agency Says

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:22 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 20-20. (Source: Biotechnology Law Report)

New Generic Names Requested for Biosimilars

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:21 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 17-18. (Source: Biotechnology Law Report)

FDA Claims for Its Mini-Sentinel Program May Be Overly Enthusiastic

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:21 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 18-18. (Source: Biotechnology Law Report)

FDA Reforms Part of ObamaCare Act

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:20 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 18-18. (Source: Biotechnology Law Report)

Benefits of GAIN Act Outlined

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:20 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 18-19. (Source: Biotechnology Law Report)

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Vietnam Considering Genetically Modified Crops

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:20 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 40-41. (Source: Biotechnology Law Report)

Argentinian Farmers May Pay Owed Royalties on Monsanto Crops

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:19 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 41-41. (Source: Biotechnology Law Report)

BIO Calls for Better Presentation of Data on Genetically Modified Animals; DOCUMENT: AquAdvantage® Salmon: Draft Environmental Assessment [Excerpts]

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:19 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 41-42. (Source: Biotechnology Law Report)

Does Inherency Have a Place in Determinations of Obviousness?

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:18 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 3-16. (Source: Biotechnology Law Report)

Paper Claiming Cancer and Early Death from Genetically Engineered Maize Widely Criticized and Debunked by Scientists; Lead Author Is a Prominent Opponent of Biotechnology

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:18 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 42-43. (Source: Biotechnology Law Report)

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California's Proposition 37 Defeated by Voters; Would Have Required Labeling of All Processed and Genetically Modified Foods; Higher Incomes for Organic Farmers an Apparent Goal

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:18 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 43-44. (Source: Biotechnology Law Report)

[Draft] Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Approval of Human Drug and Biological Products

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:17 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 58-80. (Source: Biotechnology Law Report)

United States of America v. Alfred Caronia (United States Court of Appeals for the Second Circuit [Docket No. 09-5006-cr])

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:16 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 81-102. (Source: Biotechnology Law Report)

AquAdvantage® Salmon: Draft Environmental Assessment [Excerpts]

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:16 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 103-110. (Source: Biotechnology Law Report)

Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:13 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 54-57. (Source: Biotechnology Law Report)

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Irish EPA to Field-Test Blight-Resistant Potatoes

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:12 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 38-39. (Source: Biotechnology Law Report)

Gates Foundation Gives Innes Centre Grant to Develop Genetically Modified Crops

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:12 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 39-40. (Source: Biotechnology Law Report)

Wal-Mart Grocery Will Sell Genetically Modified Sweet Corn

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:12 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 40-40. (Source: Biotechnology Law Report)

Bt Cotton Not Harmful to Human Health or Soil, Says Indian Expert

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:11 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 37-37. (Source: Biotechnology Law Report)

Scientific Expert Says “There Is No More Risk in Eating [Genetically Modified] Food Than Eating Conventionally Farmed Food”

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:11 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 39-39. (Source: Biotechnology Law Report)

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Benefits of Genetically Engineered Crops Detailed

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:10 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 37-37. (Source: Biotechnology Law Report)

New Clearances and Reviews of Genetically Engineered Crops

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:10 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 37-38. (Source: Biotechnology Law Report)

Massachusetts Court Looked at Safe Harbor Provision Too Narrowly

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:10 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 51-53. (Source: Biotechnology Law Report)

Life Technologies Is Infringing Patents on Sequencing Technology

Biotechnology Law Report — Thu, 04 Apr 2013 21:10:09 +0100

Biotechnology Law Report Feb 2013, Vol. 32, No. 1: 48-49. (Source: Biotechnology Law Report)