Better Regulation of Industry-Sponsored Clinical Trials Is Long Overdue

Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. In this paper, we argue not for more but for better regulation, based on the goal of rapidly producing innovative and safe products that represent significant advances in medical care. Data on industry-funded, late-stage clinical trials demonstrate an urgent need for dramatic changes in how these trials are designed, conducted, and analyzed. On the one hand, current patent rules can dissuade development of innovative new products with smaller markets and press trial designers to create positive results too rapidly. But at the same time, numerous studies show that when the pharmaceutical industry sponsors clinical trials, the results are systematically biased in favor of the sponsor's product, often to the detriment of patients and the public. The reasons for this bias are both complex and unavoidable, and the ways in which clinical trial design, conduct, and reporting can be inappropriately influenced are so varied and nuanced, that efforts to manage this conflict of interest and prevent harms are inevitably unsuccessful. Instead, we conclude such conflict should be avoided and a strong firewall should exist between drug developers and the final stages of clinical testing in humans. All financial support for phase III clinical trials should pass through a public-private partnership organization — perhaps tied to a broader clinical effectiveness research enterprise — which would be charged with designing, funding, and monitoring late-stage human clinical trials of new pharmaceutical products.     

The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations

Pharmaceutical companies increasingly perform clinical trials in developing nations. Governments of host nations see the trials as a way to provide otherwise unaffordable medical care, while trial sponsors are drawn to those countries by lower costs, the prevalence of diseases rare in developed nations, and large numbers of impoverished patients. Local governments, however, fail to police trials, and the FDA does not monitor trials in foreign countries, resulting in the routine violation of international standards for the protection of human subjects. This Note proposes independent accreditation of those institutions involved in clinical trials--the institutional review boards which oversee trial protocol; the organizations, such as pharmaceutical companies, which sponsor the trials; and the research organizations that conduct the trials. Accreditation, similar to that used in the footwear and apparel industries, would increase the transparency of pharmaceutical trials and would enable the United States government and consumers to hold trial sponsors accountable for their actions.     

Health care for older persons in England and the United States: a contrast of systems and values

This article extends previous comparisons of access to health care for older persons in England and the United States by comparing rates of avoidable hospital conditions as a proxy for primary care access and by examining the distribution of care within these older populations. Drawing on hospital data from the two countries, we find that older persons in the United States, particularly those over the age of seventy-five, receive far more revascularizations than do older persons in England. Differences in the use of lower-joint replacement are not as great, but we are unable to assess differences in the need for these procedures. Although older persons have greater access to specialty care in the United States, there appears to be much better access to primary care in England. We are unable to draw comparisons on the extent of inequalities in access to health care, although in the United States there is evidence of inequalities in access by race, and in England we confirm earlier studies that find inequalities by level of deprivation. These findings are discussed in the context of the political debates over access to care and rationing in the two countries.     

Sub-Saharan African randomised clinical trials into male circumcision and HIV transmission: methodological, ethical and legal concerns

In 2007, WHO/UNAIDS recommended male circumcision as an HIV-preventive measure based on three sub-Saharan African randomised clinical trials (RCTs) into female-to-male sexual transmission. A related RCT investigated male-to-female transmission. However, the trials were compromised by inadequate equipoise; selection bias; inadequate blinding; problematic randomisation; trials stopped early with exaggerated treatment effects; and not investigating non-sexual transmission. Several questions remain unanswered. Why were the trials carried out in countries where more intact men were HIV-positive than in those where more circumcised men were HIV-positive? Why were men sampled from specific ethnic subgroups? Why were so many participants lost to follow-up? Why did men in the male circumcision groups receive additional counselling on safe sex practices? While the absolute reduction in HIV transmission associated with male circumcision across the three female-to-male trials was only about 1.3%, relative reduction was reported as 60%, but, after correction for lead-time bias, averaged 49%. In the Kenyan trial, male circumcision appears to have been associated with four new incident infections. In the Ugandan male-to-female trial, there appears to have been a 61% relative increase in HIV infection among female partners of HIV-positive circumcised men. Since male circumcision diverts resources from known preventive measures and increases risk-taking behaviours, any long-term benefit in reducing HIV transmission remains uncertain.     

手术并发症发生因素与医疗过错鉴定

医疗损害案件中因手术并发症而导致的占了很大的比重。发生手术并发症的发生原因可归结为医疗与患者两个方面。医疗方面的因素主要包括手术人员的责任心不强、医学基础知识欠缺、医疗技术生疏、诊断失误、术后护理及管理缺陷等;患者方面的因素主要有自身解剖变异、个体体质差异等。手术并发症产生的原因大多是可以被认知的,在此基础上判断产生手术并发症的医疗行为是否有过错时不能一概而论,应遵循一定的标准。建议按照医学理论和实际操作能力划分为两个标准,预见义务采用＂医学水平＂标准;防范义务采用＂医疗水平＂标准。通过两个＂标准＂来综合考量手术并发症才是科学的。     

Detecting Feigned Attention-Deficit/Hyperactivity Disorder (ADHD): Current Methods and Future Directions

Feigned attention-deficit/hyperactivity disorder (ADHD) in adults is a significant issue in clinical settings, particularly regarding academic accommodations and access to controlled substances by university students. This article discusses the definitions, base rates, external incentives, psychometric detection strategies, and ethical implications of feigned ADHD. ADHD is characterized by a pattern of developmentally inappropriate inattentive, overactivity, and/or impulsivity, often persisting into adulthood. Estimates of the prevalence of non-credible ADHD in university settings range from 25 to 50%. Feigned ADHD may be detected with symptom and performance validity measures. The existing empirical research has failed to produce a clear psychometric solution to this important differential diagnosis. Identifying feigned ADHD is a difficult task, possibly because of the highly transparent, face-valid diagnostic criteria, and an atypical malingering strategy that evades established detection methods. Performance validity tests remain the best available method for identifying non-credible presentation during psychological evaluations of ADHD. Future practice recommendations should consider educational policy, diagnostic criteria, and psychometric research, including the development of self-report measures that reliably differentiate between genuine and feigned ADHD.     

Barcelona 2002: law, ethics, and human rights. The need for harm-reduction approaches in Eastern Europe and the former Soviet Union

In a region where HIV is spread primarily by injection drug use, harm-reduction strategies must be the mainstay of prevention efforts. In her plenary presentation to the XIV International Conference on AIDS on 9 July 2002, Kasia Malinowska-Sempruch asserts that if the world does not turn its attention to the emerging and exploding epidemic in Eastern Europe and the former Soviet Union, the region will suffer the same fate as Africa. The presentation explains that while their economies continue to struggle, the countries in the region have seen their public health systems crumble in the face of the twin health crises of injection drug use and HIV infection. The presentation demonstrates how current repressive laws and practices with respect to drug use serve only to fuel the epidemic. It describes harm-reduction approaches (such as needle exchanges and drug-treatment programs) and provides examples of how NGOs in the region have been attempting to implement such approaches, often with little or no support from governments. Finally, the presentation outlines other measures required to respond to the epidemic in the region, including ensuring that people infected with HIV can access care, treatment, and support services.     

Prevention for those who can pay: insurance reimbursement of genetic-based preventive interventions in the liminal state between health and disease

Clinical use of genetic testing to predict adult onset conditions allows individuals to minimize or circumvent disease when preventive medical interventions are available. Recent policy recommendations and changes expand patient access to information about asymptomatic genetic conditions and create mechanisms for expanded insurance coverage for genetic tests. The American College of Medical Genetics and Genomics (ACMG) recommends that laboratories provide incidental findings of medically actionable genetic variants after whole genome sequencing. The Patient Protection and Affordable Care Act (ACA) established mechanisms to mandate coverage for genetic tests, such as BRCA. The ACA and ACMG, however, do not address insurance coverage for preventive interventions. These policies equate access to testing as access to prevention, without exploring the accessibility and affordability of interventions. In reality, insurance coverage for preventive interventions in asymptomatic adults is variable given the US health insurance system''s focus on treatment. Health disparities will be exacerbated if only privileged segments of society can access preventive interventions, such as prophylactic surgeries, screenings, or medication. To ensure equitable access to interventions, federal or state legislatures should mandate insurance coverage for both predictive genetic testing and recommended follow-up interventions included in a list established by an expert panel or regulatory body.     

Access to health care for illegal immigrants: a specific organisation in France

Health care is a fundamental human right in Europe, and all Member States recognise everyone's right to the access to preventive healthcare and to receive medical care in the event of sickness or pregnancy. Nevertheless, this right is focused on citizens and the application to migrants, particularly undocumented migrants, varies widely in the EU. The French legislation is organized with a humanitarian approach. In this article, the authors present the French system of social protection, the "Couvernture médicale universelle" or CMU, which provides the same protection to asylum seekers and documented immigrants as to nationals, and the "Aide médicale d'état" or AME, that is open to every person who does not fulfil the legal conditions to obtain the CMU, such as illegal immigrants. Created in 1995, recently access to the AME has been restricted. A claim of discrimination has been rejected by the Conseil d'Etat and 215,000 persons received the AME in 2009. The expenses incurred by the AME increased by 17% in 2010, and there is a debate in Parliament to limit care and to ask the recipient for a financial contribution.     

Access to health care for undocumented migrants: a comparative policy analysis of England and the Netherlands

The presence of undocumented migrants is increasing in many Western countries despite wide-ranging attempts by governments to increase border security. Measures taken to control the influx of immigrants include policies that restrict access to publicly funded health care for undocumented migrants. These restrictions to health care access are controversial, and evidence suggests they do not always have the intended effect. This study provides a comparative analysis of institutional, actor-related, and contextual factors that have influenced health care policy development on undocumented migrants in England and the Netherlands. For undocumented migrants, England restricts its access to care at the point of service, while the Netherlands restricts through the payment system for services. The study includes an analysis of policy papers and semistructured, in-depth interviews with various actors in both countries. Findings confirm the influence of such contextual factors as immigration considerations and cost concerns on health care policy making in this area. However, these factors cannot explain the differences between the two countries. Previously enacted policies, especially the organization of the health care system, affected the kind of restrictions for undocumented migrants. Concerns about the side effects of generous treatment of undocumented migrants on other groups played a substantial role in formulating restrictive policies in both countries. Evidently, policy development and implementation is critically affected by institutional rules, which govern the degree of influence that doctors and professional medical associations have on the policy process.     

Setting the legal standard of care for treatment and evidence-based medicine: a case study of antenatal corticosteroids

This article argues that liability for negligent medical treatment should be predicated upon a standard of care reflecting what is medically and scientifically reasonable. Legal science (jurisprudence) and medical science (evidence-based medicine) should be reconciled to improve patient care and outcomes. The use of antenatal corticosteroids in obstetrics during the 1990s illustrates how most jurisprudence for setting the standard of care for treatment is ill equipped to meet the fundamental aims of tort law. The proliferation of evidence-based medical practice provides a unique opportunity for the law to encourage best medical practice when setting the standard of care for treatment. It is argued that, eventually, the law should recognise clinical practice guidelines as the prima facie standard of care for treatment. This will provide legal certainty, appropriate medical practitioner accountability, and ultimately improve patient care and outcomes.     

Error and exaggeration in the presentation of the significance of a DNA match in criminal trials in Malaysia

DNA evidence is now widely used in criminal trials across jurisdictions, including Malaysia. One important issue to be considered is how the significance of a DNA match that uses statistical calculations should be presented and explained in a criminal trial. This article demonstrates how the presentation of the significance of a DNA match in criminal trials in Malaysia has been tainted with error, exaggeration and bias towards the prosecution case based on the reference to case law. It also provides recommendations in order to ensure that the significance of a DNA match is properly presented in the criminal trials in Malaysia.     

我国刑事简易程序改革的宏观思考

当前,如何在保障公正的基础上,通过适用简易程序提高诉讼效率,这是我国司法改革的重要内容。吸收各国的简易程序改革的经验,从宏观的角度上思考,我国的简易程序应当由单一化走向类型化,由职权推进式走向权利选择式,由审判阶段的简化走向审查起诉阶段的简化,由程序简化式走向诉讼阶段省略式。     

我国有限合伙立法路径探究

在现代经济生活中,有限合伙作为风险投资机构的最佳组织形式,其独特价值日益凸现,无论是英美法系还是大陆法系国家对其都有成文立法规定。然而,目前在我国尚无专门法律的引导、规制和保障。为此,遵循民商立法理论,借鉴国外立法经验,结合我国现实状况,确立有限合伙立法思路,探索有限合伙立法途径,从而构建有限合伙立法路径,创制利于创业投资的良好法制环境,健全和完善我国民商事主体法律制度,有力促进社会主义市场经济健康发展。     

Barcelona 2002: law, ethics, and human rights. Introducing ARVs in resource-poor settings: challenges and consequences

In most industrialized countries, AIDS mortality has plunged sharply with the advent of antiretroviral therapy. Yet the majority of people living with HIV/AIDS do not have access to modern HIV care, and some experts have argued that introducing such therapy is not a ranking priority. In this article, which is based on a plenary presentation at the XIV International AIDS Conference, Paul Farmer presents the experience of an integrated HIV prevention and care project in rural Haiti, and explores the challenges to national AIDS programs and other bodies in the "least developed" countries as more resources are made available for HIV prevention and care.     

Access to the health records of deceased patients: Why the law is in need of review

A glance at the cases that came before the UK Information Commissioner's Office (ICO) in the period between 2005 and 2008 immediately shows that a consistently high number relate to access to the health records of deceased patients. What accounts for this interesting state of affairs? This paper aims to demonstrate that the law regulating this increasingly important area is a patchwork of case law, statutes and professional guidelines that do not always lend themselves to a congruous and seamless amalgamation. This has in turn resulted in the need for creative interpretation and at times legal gymnastics on the part of the ICO and medical professionals. We argue that in an age where allegations of medical negligence are proliferating (and access to the health records of the deceased could help confirm or dispel suspicions of wrongdoings leading to the death) and where genetic information about a deceased relative could offer valuable support to a living patient's preventative care, diagnosis and treatment plans, the law regulating access to the health records of deceased patients in the UK can no longer afford to be unclear and confusing. There is, therefore, an urgent need for review.     

What the publisher can teach the patient: intellectual property and privacy in an era of trusted privication

This article begins with a premise that intellectual property and privacy have something significant and yet understated in common: both are about balancing a creator's desire to control a particular set of data with consumers' desires to access and redistribute that data. Both law and technology influence such balancing, making it more or less palatable to use data for particular purposes--whether one is an individual making a copy of a popular song for a friend, or a hospital selling a list of maternity ward patients to a day care service. In the shadow of the Internet's rapid development and concomitant easing of barriers to data sharing, holders of intellectual property are pairing increased legal protection with the technologies of "trusted systems." I describe how these technologies might allow more thorough mass distribution of data, while allowing publishers to retain unprecedented control over their wares. For instance, an e-Book seller might charge one price for a read-only copy that could not be printed or forwarded and charge an additional fee for each copy or printout made. Taking up the case of medical privacy, I then suggest that those who worry about the confidentiality of medical records, particularly as they are digitized by recent congressional mandate, might seek to augment comparatively paltry legal protections with trusted systems technologies. For instance, a trusted system could allow a patient to specify how and by whom her records could be used; within limits, she could allow full access to her primary care physician, while allowing only time-limited access to emergency care providers, non-personally identifiable access to medical researchers, and no access at all for marketing purposes. These technologies could allow for new kinds of privacy protection, without sacrificing the legitimate interests of the consumers of medical records.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS). Office of the Secretary, DoD. Notice of expansion of cancer treatment clinical trials demonstration project

This notice is to advise interested parties of an expansion of a demonstration project in which the DoD provides CHAMPUS reimbursement for eligible beneficiaries who receive cancer treatment under approved National Cancer Institute (NCI) clinical trials to include NCI sponsored cancer prevention clinical trials. Participation in these clinical trials will improve TRICARE/CHAMPUS eligible beneficiary access to emerging new therapies that have significant promise for the prevention and successful treatment of cancers. DoD financing of these procedures will assist in meeting clinical trial goals and arrival at conclusions regarding the safety and efficacy of emerging therapies in the prevention and treatment of cancer. At this time, there is insufficient demonstration data for a full evaluation of costs associated with enrollment in clinical trials. Expanding the current demonstration to provide reimbursement for costs associated with NCI sponsored clinical trials for cancer prevention will augment current patient accruals to clinical trials and allow for data collection in order to perform a comprehensive economic analysis. This demonstration also affects TRICARE, the managed health care program that includes CHAMPUS. This demonstration project, which is under the authority of 10 U.S.C., section 1092, will expire December 31, 1999.     

The future of claims to resist removal by non-nationals suffering from HIV/AIDS

The focus of this article is to consider the difficulties facing non-nationals suffering HIV/AIDS to resist removal to their countries of origin where there is no or inadequate medical treatment. The link between HIV/AIDS and migration will be explored illustrating the vulnerability of displaced people to the virus. The current UK legal position for those attempting to resist removal in such circumstances will be explored. The article will explore two potential avenues that may prevent removal of non-nationals with HIV/AIDS to countries with limited access to the necessary treatment. In the first instance consideration of Article 3 European Convention on Human Rights (ECHR) will be made with particular emphasis on mother and child claims. The second argument will examine the potential for refugee claims under Article 1A (2) Refugee Convention 1951 where an applicant may be able to demonstrate a well-founded fear of persecution because of membership to a particular social group. The authors will particularly emphasise the argument that in certain countries sufferers will experience ostracism and victimisation where its severity may amount to treatment contrary to Article 3 ECHR and persecution under the Refugee Convention. Vanessa Bettinson and Dr Alwyn Jones, senior lecturers, De Montfort University. The authors would like to thank Professor Tony Barnett at London School of Economics for his useful and invaluable thoughts and comments. We would also like to thank our colleague Gavin Dingwall and the students in our 2006/07 Immigration and Refugee Law seminars for their very helpful feedback.     

Retail medical clinics: increasing access to low cost medical care amongst a developing legal environment

Retail medical clinics are an innovation in health care with the potential to increase access to low-cost basic health care services while changing the delivery model for routine, non-urgent medical care. However, the few states that attempted to directly regulate retail medical clinics have been met with criticism by the FTC due to the proposed legislations' anticompetitive undertones. The relationship between retail medical clinics and the host stores or pharmacies that house them has the potential to spark fraud and abuse concerns. Retail medical clinics must abide by state-specific regulation on scope of practice of the various mid-level practitioners who work for the clinics, particularly to minimize exposure to litigation and keep within the clinics' intended purpose of a supplement to primary care physician offices. The author concludes that the consumer benefits of cost and convenience, combined with the potential for growth and expanded consumer base from a retailers' perspective, make the legal challenge inherent in running a retail medical clinic well worth the effort.