Our results challenge current policy and law advocating instructional advance directives as a means of honoring specific patient wishes at the end of life. Future research should explore other methods of improving surrogate decision making and consider the value of other outcomes in evaluating the effectiveness of advance care planning.

Off-label prescribing is an integral part of contemporary medicine. Many patients benefit when they receive drugs or devices under circumstances not specified on the label approved by the Food and Drug Administration (FDA). An off-label use may provide the best available intervention for a patient, as well as the standard of care for a particular health problem. In oncology, pediatrics, geriatrics, obstetrics, and other practice areas, patient care could not proceed without off-label prescribing. 1 When scientific and medical evidence justify off-label uses, physicians promote patients' interests by prescribing products off label.Off-label prescribing can also harm patients, however. The potential for harm is greatest when an off-label use lacks a solid evidentiary basis. A 2006 study examining prescribing practices for 169 commonly prescribed drugs found high rates of off-label use with little or no scientific support. 2 Researchers examining off-label use in U.S. children's hospitals concluded, "[W]e still have incomplete knowledge about the safety and efficacy of many medications commonly used to treat children across a range of drug classes and clinical diagnoses." 3 More than half the respondents in a survey of academic medical centers reported that innovative off-label prescribing raised concerns in their institutions, such as lack of data, costs, and unfavorable risk-benefit ratios.4 When substantial uncertainty exists about off-label applications, patients are at risk of receiving harmful or ineffective treatments.Legal authorities recognize physicians' discretion to prescribe products off label. 5 In the existing regulatory framework, once the FDA approves a product for marketing, physicians may prescribe it for indications or patient populations not included on the label. They may also prescribe drugs at dosages or using methods of administration not specified on the label. 6 Omission from the approved label does not mean that the FDA disapproves of an off-label use, it simply indicates that the agency has not reviewed that use. Of course, like other parts of medical practice, off-label prescribing can lead to malpractice liability if it fails to conform to accepted standards of care. 7 In a perfect world, all uses of drugs and devices would be supported by solid research. The existing regulatory system fails to impose this high standard, however, and the private sector often lacks incentives to conduct rigorous evaluations of off-label uses. In the current situation, the medical community has primary responsibility for determining when off-label prescribing is appropriate for patients. But appropriate off-label prescribing can be challenging for physicians today, because of time pressures, information overload, and the involvement of industry in research and education about off-label uses.Responsible off-label prescribing requires physicians to: (1) evaluate whether there is sufficient evidence to justify an off-label use; (2) press for additional information and research when NIH Public Access

When patients have progressive and incurable dementia, should their advance directives always be followed? Contra Dworkin, Dresser argues that when patients remain able to enjoy and participate in their lives, directives to hasten death should sometimes be disregarded.

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Authorising euthanasia and assisted suicide with advance euthanasia directives (AEDs) is permitted, yet debated, in the Netherlands. We focus on a recent controversial case in which a Dutch woman with Alzheimer's disease was euthanised based on her AED. A Dutch euthanasia review committee found that the physician performing the euthanasia failed to follow due care requirements for euthanasia and assisted suicide. This case is notable because it is the first case to trigger a criminal investigation since the 2002 Dutch euthanasia law was enacted. Thus far, only brief descriptions of the case have been reported in English language journals and media. We provide a detailed description of the case, review the main challenges of preparing and applying AEDs for persons with dementia and briefly assess the adequacy of the current oversight system governing AEDs.

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While experts have made recommendations, information is needed regarding what genome sequencing results patients would like returned. We investigated what results women diagnosed with breast cancer at a young age would want returned and why. We conducted 60 semi-structured, in-person individual interviews with women diagnosed with breast cancer at age 40 or younger. We examined interest in six types of incidental findings and reasons for interest or disinterest in each type. Two coders independently coded interview transcripts; analysis was conducted using NVivo 10. Most participants were at least somewhat interested in all six result types, but strongest interest was in actionable results (i.e., variants affecting risk of a preventable or treatable disease and treatment response). Reasons for interest varied between different result types. Some participants were not interested or ambivalent about results not seen as currently actionable. Participants wanted to be able to choose what results are returned. Participants distinguished between types of individual genome sequencing results, with different reasons for wanting different types of information. The findings suggest that a focus on actionable results can be a common ground for all stakeholders in developing a policy for returning individual genome sequencing results.

The term “therapeutic misconception” was coined in 1982 by Paul Appelbaum, Loren Roth, and Charles Lidz. Appelbaum and his colleagues interviewed participants in several psychiatric studies, including a drug trial with a placebo control arm. Appelbaum's group found that many people were unaware of the differences between participating in a study and receiving treatment in the clinical setting. Rather than understanding these differences, study participants tended to believe that therapy and research were governed by the same primary goal: to advance the individual patient's best interests. Appelbaum's group labeled this mistaken belief the therapeutic misconception.