Off-Label Prescribing: A Call for Heightened Professional and Government Oversight

Under current U.S. law, physicians may prescribe drugs and devices in situations not covered on the label approved by the Food and Drug Administration. Those supporting this system say that requiring FDA approval for off-label uses would unnecessarily impede the delivery of benefits to patients. Patients do benefit from off-label prescribing that is supported by sound scientific and medical evidence. In the absence of such evidence, however, off-label prescribing can expose patients to risky and ineffective treatments. The medical community and federal authorities should more actively promote patients' interests in receiving beneficial off-label treatments. To exercise responsible self-regulation, members of the medical community must determine whether available evidence justifies specific off-label uses and must promote information-gathering when the evidence is inadequate. Physicians should also discuss with patients the uncertainties accompanying off-label uses. Federal authorities should more closely monitor the effects of off-label prescribing and adopt other measures to reduce harm and enhance benefits produced by off-label prescribing.     

Practice guidelines and malpractice litigation: collision or cohesion?

Practice guidelines are standardized specifications for managing particular clinical problems and are intended to improve the outcomes of medical care by increasing adherence to standards of care. They are also meant to make medicine more cost-effective by eliminating unnecessary procedures. A relatively recent phenomenon, the practice guidelines now emerging will have implications for malpractice, which also intends to bring about better care. They will probably not revolutionize the procedures that courts use to determine negligence, but judges will integrate guidelines into their decision-making process. This development should be welcomed. Guidelines should prove to be useful as either inculpatory or exculpatory evidence of negligence. They are unlikely to generate much new litigation, although there is some potential for suits against those who issue guidelines, especially if guidelines are not revised as the technology of medical care changes.     

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.     

Irrationality, evidence-based medicine and the standard of care

The determination of the legal standard of care in Australia for medical diagnosis and treatment has gone through three apparent phases in modern times: the Bolam era, the post-Rogers v Whitaker era, and the current Civil Liability Acts era. It is conventionally accepted that the two shifts linking these phases were a jettisoning of the Bolam principle in Rogers and a return to a modified Bolam principle in the Civil Liability legislation, with the post-Rogers interregnum being a time of a court-imposed standard. This story is somewhat inaccurate. The Bolam test relied more on practice accepted at the time as proper by a responsible body of medical opinion rather than the practice of a "responsible body of medical men". The ability of post-Rogers courts to override medical evidence was more a rhetorical power than an actual one. And the irrationality condition, which reserves the right to override medical opinion under the Civil Liability Acts, is more dependent on sound evidence than the terminology might suggest. It is not so much that the legal standard of care has changed in dramatic ways as that the content of competent professional opinion has evolved as medical research and practice have developed. There is greater continuity than is usually granted, throughout the three phases, of the standard's reliance on current best evidence and opinion. This is more easily seen with the advent of evidence-based medicine.     

State of the art of guidelines

Guidelines have existed in medicine for many centuries. Galen's doctrine of laudable pus sent many to an early grave, but variance in treatment put the practitioner in a difficult position, especially if all did not go well. Currently, guidelines proliferate, allegedly based upon careful evaluation of evidence culled from a variety of sources. However, obedience to guidelines is variable internationally and nationally, thus raising questions about their enforceability. They are, of course, not legally enforceable, but courts may be influenced by them, and variation must be evidence-based. Guidelines cannot logically be regarded as being set in stone; if that were the case, then there could be no innovation and medicine would not advance.     

网络环境下的法医学循证

法医学是当前司法鉴定中的重要组成部分,其研究内容广泛,具有高度的专业性。随着网络技术的发展、信息资源的增加以及人们法律意识的增强,法医学必然会面临许多新问题,对诉讼证据的要求标准也越来越高。鉴于此,在法医学领域应建立起循证的理念,通过循证的方式在法医学以及相关领域内寻求最合适的解决法医学实务中具体问题的证据,循证不但能够及时解决法医学领域的现行问题,其对于法医学的进步与发展也将具有重大的推动作用。本文综述了循证的基本理论及其在法医学领域的作用,以及循证的途径、方法、证据的评价,并探讨网络环境下法医学循证的应用价值。     

我国医疗损害责任中医务人员注意义务的标准

医务人员的注意义务是衡量其在医疗活动中是否存在过失的前提，我国即将实施的《侵权责任法》对医务人员的注意义务的标准未作详尽规定，本文通过比较普通法系国家和日本相关的规定，从而指出我国医务人员的注意义务的标准。     

论我国立法和司法对法定外在标准的过度依赖——以我国医疗损害责任鉴定与诉讼实践为例

我国法中存在着在侵权法问题的判定上过度依赖"法律法规"、"行业标准"和"诊疗规范"的倾向。这些"外在"标准替代了法官对法律"内在"规则的审视和适用。行业标准替代了法律标准。比如,在医疗过失判定标准上,法官过度依赖"诊疗规范",忽视了基本法律标准——注意义务违反说和"合理医生"标准——的探寻和适用。我国法应纠正此种现象,注意对法律规则,比如医疗过失和因果关系判定规则的细心构建,以给法官具体指导。"法律法规"、"行业标准"和"诊疗规范"在侵权法中是判定过失的重要标准,但不是终局性和根本性标准。     

Modernizing Medicaid eligibility criteria for children with significant disabilities: moving from a disabling to an enabling paradigm

Children with significant disabilities may qualify for Medicaid benefits, regardless of household income, if their state elects to offer the Tax Equity Fiscal Responsibility Act (TEFRA) option. However, a significant number of children with serious medical problems presently are being denied eligibility for, or terminated from, this Medicaid program. This Article describes the ways in which the existing health insurance system inadequately meets the needs of children with significant disabilities, recounts the history and development of the TEFRA Medicaid coverage option, and analyzes the eligibility criteria used by the various states. It proceeds to consider how disability should be legally defined in the health care context and proposes reforms to modernize the eligibility standards so that these benefits can be more effectively, efficiently, and fairly allocated. To accomplish this goal, the federal statute and regulation that define disability, as well as corresponding state laws, must be reformed so that the law can keep pace with advances in modern medical science, and people with disabilities are not, in effect, penalized for receiving currently accepted preventative care that maintains health but will never cure the underlying disease.     

The harms of human trafficking: demonstrating the applicability and value of a new framework for systematic,empirical analysis

This article uses human trafficking in Belgium to test a newly developed framework for assessing the harms of crime that has been applied previously to cocaine trafficking in the same country. We chose this criminal activity because of its policy relevance and to address apparent needs for systematic, evidence-based analysis. The framework uses quantitative and qualitative evidence to assess harms to individuals, private-sector entities, and others and to establish crime control priorities. The assessment process models the activity, evaluates the severity and incidence of harms, ranks priorities, and considers causality. We highlight three findings. First, trafficking victims can experience catastrophic harms, but the overall dimensions of human trafficking in Belgium appear to be modest. Second, the evidence suggests significant recent declines in the degree of exploitation and use of violence. Third, most harms to individual victims result directly from the activity, which sets it apart from other forms of trafficking.     

Commercialization of genetic testing services: the FDA, market forces, and biological tarot cards

Many women fear being diagnosed with breast cancer, and rightfully so. Despite the capabilities of modern medicine, the cumulative lifetime risk of getting the disease has risen to one in eight and, despite decades of research, no cures exist. In this Article, the authors explore the commercialization of so-called breast cancer gene tests, based upon genetic alterations linked to the disease. Although the authors fully address this specific technology, they use what constitutes the seminal case of predictive genetic testing to analyze the adequacy of the existing regulatory framework. The authors conclude that the present regulatory system is inadequate and places a dangerous amount of reliance on primary care physicians. Their conclusion is grounded in the observation that most primary care physicians lack sufficient knowledge about this evolving investigative technology--which is highly subject to misinterpretation, and, though potentially helpful to some "high risk" patients, offers questionable clinical value for the general public. The authors set forth numerous proposals to promote both the quality and clinical value of predictive genetic testing so that it conforms to public health standards and can be properly integrated as a reliable component of medical care in specific situations.     

Patient confidentiality statutes in Medicare & Medicaid fraud investigations

The Medicare and Medicaid programs have been burdened with health care providers' fraudulent and abusive practices since their implementation in 1965. To help states discover and prevent Medicare and Medicaid fraud, Congress has enacted statutes permitting access to patients' medical records in investigations of fraud. The majority of states have enacted physician-patient and psychotherapist-patient privilege statutes to protect confidential information from disclosure. Thus, the state's need for patient information conflicts with the patient's right of privacy. This Note discusses several court decisions that have wrestled with the tension between these two policies. The courts, after balancing the state interest in eliminating fraud against the patient's privacy interest, have often allowed disclosure of patient medical records. Although some courts have attempted to limit the extent of the information disclosed, few have set forth explicit standards to protect patient records from unwarranted disclosure of confidential information. This Note suggests guidelines for courts, legislatures and health care providers to uniformly limit the extent of this disclosure.     

Case histories in forensic medicine

Case histories make up a great part of publications in forensic medicine, especially forensic pathology, although considered low on the hierarchy of evidence based medicine because of its inherent anecdotal nature. Meanwhile some journals exclude case histories categorically from publication. The boom of case histories in forensic medicine has not only opportunity reasons (easily [even mental] and cheap to do) but also structural reasons: due to its tasks in case work many items of forensic medicine can not be simulated experimentally for ethical reasons (violent death, traumatic injuries, sexual assault, poisonings, influence of alcohol and drugs on driving ability and legal responsibility, medical malpractice, adverse events during medical care). In these fields the role of case histories is mainly the augmentation of experience based knowledge. However, quality aspects have to be considered and case histories should be the basis for systematic or hypothesis based research.     

A Review of Evidence-Based Biopsychosocial Laws Governing the Treatment of Pain and Injury

The impact of scientific findings on medical, psychological, and legal concepts has led to the adoption of laws and regulations that do not easily fit into the established legal categories of medical law or mental health law. Instead, this convergence of forces has resulted in laws and regulations mandating biopsychosocial treatment guidelines, where both medical and psychological cares are integrated within the framework of a single paradigm. Laws and regulations of this type have been adopted by a number of US states and Canadian provinces, and could be considered to represent a new category, for which we offer the term “biopsychosocial law.” Biopsychosocial laws currently pertain to medical treatment guidelines for workers’ compensation, a medical treatment system noted for high costs, high levels of litigation, and psychological involvement. There are a number of examples of biopsychosocial laws, but the most noteworthy are based on guidelines developed by the Colorado Division of Workers’ Compensation, the American College of Occupational and Environmental Medicine, the Work Loss Data Institute, and The Reed Group. These guidelines differ significantly with regard to features, conditions covered, and strength of evidence basis. However, all of these guideline systems were developed with the intent of providing good care while controlling costs, are evidence based, integrate the practice of medicine and psychology, and are legally mandated in certain jurisdictions. Taken together, these guidelines represent a growing convergence of scientific evidence, professional society positions, payor policies, and legal regulations. These forces are propelling a broad societal shift away from Cartesian assumptions that the body and mind are separate, and toward a biopsychosocial paradigm for the treatment of injury and illness.     

Obligation to advise of options for treatment--medical doctors and complementary and alternative medicine practitioners

An important aspect of health professional's duty of care is to advise patients of the available options of treatment so that the patient can choose the form of treatment that suits her or his requirements. As CAM becomes more evidence-based and accepted, medical doctors need to consider the extent to which they should provide patients with information about those types of treatments. If a CAM treatment option is evidence-based, there is a strong argument that medical doctors should advise of this option for treatment to satisfy their duty. CAM practitioners should also provide details of options for treatment within their own modality but are not obliged to advise of medical options.     

Altruism and Self Interest in Medical Decision Making

We seem to prefer that medicine and medical care be provided through altruistic motives. Even the pharmaceutical industry justifies its behavior in terms of altruistic purposes. But economists have known since Adam Smith that self-interested behavior can create large and growing social benefits. This is true for medical care as well as for other goods. First, I consider specifically the case of pharmaceutical promotion, both to physicians and to consumers. I argue that such promotion is highly beneficial to patients and leads to health improvements. I consider some criticisms of promotion, and show that they are misguided. I then provide some evolutionary explanations for our erroneous beliefs about medical care.     

Beyond "safe and effective": the role of the federal government in supporting and disseminating comparative-effectiveness research

Over the past century, medical advancements have resulted in tremendous health gains for Americans. Although the federal government has played a prominent role in ensuring that new treatments are safe and effective, questions about which medical treatments work best under which circumstances have largely remained unanswered. Thus, the federal government's recent major investments in comparative-effectiveness research have potential to play a significant role in helping both patients and health care providers navigate the vast array of available treatment options, as well as in improving the quality, efficiency, and delivery of health care system-wide. Yet, the controversial nature of the government's foray into comparative-effectiveness research also suggests that the path toward realizing these goals may be treacherous. This Article describes the rationales for federal support of comparative-effectiveness research and potential models for that involvement, analyzes the federal government's recent investments in the research, and concludes with predictions about the probable outcomes of these investments. While increased federal support for comparative-effectiveness research is unlikely to achieve all of the benefits anticipated by its supporters, it is a crucial step toward ensuring that Americans are able to take full advantage of the benefits of medical innovation     

Two faces of patient safety and care quality: a Franco-American comparison

Patient safety, and more broadly the quality of care, is typically discussed with reference to the reduction of preventable adverse events within hospitals and adherence to practice guidelines on care processes. We call it the 'care-centered approach' and recognize that the United States is a leader in the field. Another face of patient safety and care quality may be defined as the 'system-centered approach'. It focuses on access to a timely and effective continuum of health-care services--clinical prevention, primary care and appropriate referral to and receipt of specialty care. Although France's efforts to pursue a care-centered approach to patient safety are limited, its system-centered approach yields some benefits. Based on the evidence we have reviewed for access to primary care (hospital discharges for avoidable hospital conditions), mortality amenable to medical intervention and consumer satisfaction, in the United States and France, there appear to be good grounds for bolstering the system-centered approach in the United States.     

医疗过失鉴定需遵循的原则

医疗纠纷解决中的核心问题是医疗过失的技术鉴定问题,在鉴定实务中,确立判定医疗过失的原则,则是此核心中的核心。本文旨在探讨＂医疗过失评判的基本原则＂,以期规范和指导相关鉴定工作。作者认为,这些原则应包括：（1）遵循＂专业性判断＂的原则;（2）以＂注意义务作为医疗过失判断基准＂的原则;（3）以＂是否尽到与当时的医疗水平相应的诊疗义务＂为审查原则;（4）对＂医疗紧急处置行为的宽泛性＂原则;（5）＂告知-知情-同意＂的原则;（6）＂并发症的审查＂原则;（7）＂医疗意外的免责＂原则等。