NEJM â Collection Updates for Medical Ethics

PERSPECTIVE: Withholding Information from Patients â When Less Is More

Thu, 04Â FebÂ 2010 00:00:00 -05:00

As clinicians who strongly value truth telling and active patient involvement in medical decision making,1 we have lately been reflecting on the circumstances in which physicians consciously (and sometimes unconsciously)...

PERSPECTIVE: American Values and Health Care Reform

Thu, 28Â JanÂ 2010 00:00:00 -05:00

With the national debate over health care reform careening between tired, well-rehearsed talking points, on the one hand, and deep-in-the-weeds debates over technical details, initiatives, and financing mechanisms, on the...

PERSPECTIVE: Medicine's Ethical Responsibility for Health Care Reform â The Top Five List

Thu, 28Â JanÂ 2010 00:00:00 -05:00

Early in 2009, members of major health careârelated industries such as insurance companies, pharmaceutical manufacturers, medical device makers, and hospitals all agreed to forgo some future profits to show support...

PERSPECTIVE: Carrots, Sticks, and Health Care Reform â Problems with Wellness Incentives

Thu, 14Â JanÂ 2010 00:00:00 -05:00

Chronic conditions, especially those associated with overweight, are on the rise in the United States (as elsewhere). Employers have used both carrots and sticks to encourage healthier behavior. The current...

PERSPECTIVE: Uncomfortable Arithmetic â Whom to Cover versus What to Cover

Thu, 14Â JanÂ 2010 00:00:00 -05:00

Much of the current debate about expanding health insurance coverage avoids addressing an uncomfortable trade-off: with a limited budget, making benefits more generous means being able to cover fewer people....

PERSPECTIVE: Industry Influence on Comparative-Effectiveness Research Funded through Health Care Reform

Thu, 31Â DecÂ 2009 00:00:00 -05:00

Much attention has been focused on the ongoing efforts in Washington to pass a health care reform bill. Comprehensive health care should reduce the use of ineffective and suboptimal medical...

PERSPECTIVE: Abortion Politics and Health Insurance Reform

Thu, 31Â DecÂ 2009 00:00:00 -05:00

President Barack Obama has made it clear that he does not want abortion politics to sabotage health care reform. In his September 10 speech about health care to a joint...

SOUNDING BOARD: The Agenda for Continuing Medical Education â Limiting Industry's Influence

Lewis Morris, J.D., and Julie K. Taitsman, M.D., J.D. — Thu, 17Â DecÂ 2009 00:00:00 -05:00

Most physicians must complete accredited continuing medical education (CME) programs to maintain their medical licenses, hospital privileges, and specialty board certifications. Data from the Accreditation Council for Continuing Medical Education...

PERSPECTIVE: The Breadth of Hopes

Thu, 10Â DecÂ 2009 00:00:00 -05:00

Hoping is a fundamental human activity. As a pediatrician who cares for children with life-threatening, complex chronic conditions, I hear the word âhopeâ on a daily basis: âI hope we...

PERSPECTIVE: Lobbying, Campaign Contributions, and Health Care Reform

Thu, 03Â DecÂ 2009 00:00:00 -05:00

With health care reform in the air, interest groups are spending huge sums of money to influence the final legislation and other matters pending in Washington. Since 2006, the health...

SPECIAL ARTICLE: Outcome Reporting in Industry-Sponsored Trials of Gabapentin for Off-Label Use

Thu, 12Â NovÂ 2009 00:00:00 -05:00

Background: There is good evidence of selective outcome reporting in published reports of randomized trials.

Methods: We examined reporting practices for trials of gabapentin funded by Pfizer and Warner-Lambert's subsidiary, Parke-Davis...

EDITORIAL: Uniform Format for Disclosure of Competing Interests in ICMJE Journals

Thu, 05Â NovÂ 2009 00:00:00 -05:00

Disclosure of financial associations of authors of articles published in biomedical journals has become common practice. The information provided in these disclosures helps the reader to understand the relationships between...

SPECIAL ARTICLE: Accuracy of Conflict-of-Interest Disclosures Reported by Physicians

Thu, 08Â OctÂ 2009 00:00:00 -05:00

Background: The recent public reporting of payments made to physicians by manufacturers of orthopedic devices provides an opportunity to assess the accuracy of physicians' conflict-of-interest disclosures.

Methods: We analyzed the reports...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Good Law from Tragic Facts â Congress, the FDA, and Preemption

George J. Annas, J.D., M.P.H. — Thu, 17Â SepÂ 2009 00:00:00 -05:00

The New York Times heralded âA Win for Injured Patients,â1 while the Wall Street Journal said that the U.S. Supreme Court was âPre-empting Drug Innovation.â2 To the New York Times,...

CORRESPONDENCE: Medical End-of-Life Practices under the Euthanasia Law in Belgium

Thu, 10Â SepÂ 2009 00:00:00 -05:00

To the Editor: The legalization of physician-assisted death for terminally ill patients is a controversial medical and societal issue.1 In Belgium, where euthanasia was legalized in 2002, we conducted a...

CORRESPONDENCE: Residents' Duty Hours and Professionalism

John D. Rybock, M.D. — Thu, 27Â AugÂ 2009 00:00:00 -05:00

To the Editor: The Accreditation Council for Graduate Medical Education (ACGME) is currently reevaluating its 2003 rules1 regarding duty hours, in light of the recent recommendations2 from the Institute of...

SOUNDING BOARD: Disclosure of Financial Relationships to Participants in Clinical Research

Thu, 27Â AugÂ 2009 00:00:00 -05:00

In keeping with previous statements by a number of prominent groups,1234 the Institute of Medicine has recently stressed the need for vigilance in managing conflicts of interest to ensure the...

SPECIAL REPORT: Premature Release of Data from Clinical Trials of Ezetimibe

Robert M. Califf, M.D., Robert A. Harrington, M.D., and Michael A. Blazing, M.D. — Thu, 13Â AugÂ 2009 00:00:00 -05:00

The recent controversy about whether the cholesterol-lowering drug ezetimibe causes cancer raises urgent questions about the systems we use to develop drugs and medical devices and then to evaluate their...

PERSPECTIVE: Practicing Medicine in the Age of Facebook

Thu, 13Â AugÂ 2009 00:00:00 -05:00

In my second week of medical internship, I received a âfriend requestâ on Facebook, the popular social-networking Web site. The name of the requester was familiar: Erica Baxter. Three years...

PERSPECTIVE: Keeping the Patient in the Equation â Humanism and Health Care Reform

Thu, 06Â AugÂ 2009 00:00:00 -05:00

Over the past decade, two major movements have emerged in medicine, both intended to improve patient care. The medical humanism movement seeks to understand the patient as a person, focusing...

BOOK REVIEW:

Thu, 30Â JulÂ 2009 00:00:00 -05:00

In this book, sociologist RenÃ©e Fox and social historian Judith Swazey give us their views on bioethics. The result is not a history of bioethics, although there are many historical...

BOOK REVIEW:

Thu, 30Â JulÂ 2009 00:00:00 -05:00

Since the inception of bioethics as a discipline almost 40 years ago, its scholars and practitioners have devoted much of their time and attention to two sets of issues â...

PERSPECTIVE: Who Has Capacity?

Thu, 16Â JulÂ 2009 00:00:00 -05:00

âSomeone else should get the liver,â the patient told me, âsomebody with kids or a family.â Mr. D. was lying in his hospital bed with his hands folded atop his...

PERSPECTIVE: Finding Money for Health Care Reform â Rooting Out Waste, Fraud, and Abuse

Thu, 16Â JulÂ 2009 00:00:00 -05:00

In their quest to enact health care reform legislation, Democrats' major challenge is securing the money to pay for greatly expanded insurance coverage and more government regulation in the face...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Protecting Privacy and the Public â Limits on Police Use of Bioidentifiers in Europe

George J. Annas, J.D., M.P.H. — Thu, 09Â JulÂ 2009 00:00:00 -05:00

Since 9/11, police and military around the world have sought to increase their arsenals of bioidentifiers, and privacy advocates have sought to cabin their use. In what may turn out...

BOOK REVIEW:

Thu, 11Â JunÂ 2009 00:00:00 -05:00

One of the oft-heard adages in medical education is that professional values are âcaught and not taught,â which implies that learners integrate important values in a way that resists formal...

BOOK REVIEW:

Thu, 11Â JunÂ 2009 00:00:00 -05:00

Ronald Munson has written three novels, and his literary talents shine in The Woman Who Decided to Die, a collection of 10 stories about the human drama that surrounds agonizing...

BOOK REVIEW:

Thu, 04Â JunÂ 2009 00:00:00 -05:00

The mystery and complexity of autism lead many to use metaphor in their attempts to describe it. Bear with me as I do the same. These two books lead the...

PERSPECTIVE: Controlling Conflict of Interest â Proposals from the Institute of Medicine

Thu, 21Â MayÂ 2009 00:00:00 -05:00

As Congress considers mandating the disclosure of industry gifts and payments to physicians on a searchable federal government Web site,1 others have been developing proposals for reforming physicianâindustry relations, and...

PERSPECTIVE: Globalized Clinical Trials and Informed Consent

Thu, 14Â MayÂ 2009 00:00:00 -05:00

The increasing globalization of clinical research trials calls for more effective ethical and legal rules to protect both research subjects and scientific integrity.1 Some observers noted more than a decade...

CORRESPONDENCE: Developing Unbiased Diagnostic and Treatment Guidelines in Psychiatry

Lisa Cosgrove, Ph.D., Harold J. Bursztajn, M.D., and Sheldon Krimsky, Ph.D. — Thu, 07Â MayÂ 2009 00:00:00 -05:00

To the Editor: In 1984, the Journal was one of the first medical journals to establish a policy requiring disclosure of financial interests for all authors of research articles. During...

BOOK REVIEW:

Thu, 30Â AprÂ 2009 00:00:00 -05:00

Euthanasia and Law in Europe is an examination of physician-assisted dying or physician-performed euthanasia and the laws concerning these practices in European jurisdictions where the issue has been most visible....

BOOK REVIEW:

Thu, 23Â AprÂ 2009 00:00:00 -05:00

In this book, Ian Whitmarsh interprets data from an investigation of the genetics of asthma in Barbados. It has been shown that asthma is influenced by many factors, both genetic...

BOOK REVIEW:

Thu, 09Â AprÂ 2009 00:00:00 -05:00

Clinical research in developing countries has generated considerable discussion. Especially controversial are the use of a placebo instead of the best proven treatment as a control, and the availability of...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Shifting Terrain in the Regulation of Off-Label Promotion of Pharmaceuticals

Thu, 09Â AprÂ 2009 00:00:00 -05:00

In regulating the promotion of unapproved, or off-label, uses of approved drugs, the Food and Drug Administration (FDA) has sought to strike a balance between supporting the ability of physicians...

EDITORIAL: The Medical Device Safety Act of 2009

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. — Thu, 09Â AprÂ 2009 00:00:00 -05:00

Patient safety is a national concern. Major stakeholders throughout our health care system agree that every step must be taken to ensure that medical interventions, used with the intention of...

BOOK REVIEW:

Thu, 26Â MarÂ 2009 00:00:00 -05:00

The core assumption of Managing Relationships with Industry is that âwith very few exceptions, physicians are ethical, patient-centered professionals.â Hence, the authors â three lawyers and one physician â aim...

PERSPECTIVE: Denial

Thu, 19Â MarÂ 2009 00:00:00 -05:00

The medical student is watching closely. In an overfilled clinic, time is scarce and the teaching staccato. I point out a malignant lymph node here, an enlarged liver there. She...

PERSPECTIVE: Eliminating Racial and Ethnic Disparities in Cardiac Care

Thu, 19Â MarÂ 2009 00:00:00 -05:00

The Institute of Medicine (IOM) includes âequityâ as one of six key domains of health care quality, yet equal treatment for Americans of all races and ethnic groups remains an...

CLINICAL DECISIONS: Care of an Unresponsive Patient with a Poor Prognosis â Polling Results

Thu, 05Â MarÂ 2009 00:00:00 -05:00

In late January, we presented the case of an unresponsive, 56-year-old homeless patient who had a ruptured aneurysm, a high probability of cancer, and a best prognosis of severe disability...

BOOK REVIEW:

Thu, 05Â MarÂ 2009 00:00:00 -05:00

Some of us may think that ethics are unimportant in surgery, but the authors of The Ethics of Surgical Practice demonstrate that surgeons operate daily in the theater of moral...

BOOK REVIEW:

Thu, 12Â FebÂ 2009 00:00:00 -05:00

Most hospitals have ethics committees, and most of these committees use a consultation model to respond to requests for advice and counsel about specific clinical cases. Ethics consultants have different...

PERSPECTIVE: The Supreme Court, Preemption, and Malpractice Liability

Thu, 05Â FebÂ 2009 00:00:00 -05:00

The U.S. Supreme Court is currently considering the case of Wyeth v. Levine, whose central question is whether approval of a pharmaceutical product's label by the Food and Drug Administration...

PERSPECTIVE: PhysicianâIndustry Relations â Will Fewer Gifts Make a Difference?

Thu, 05Â FebÂ 2009 00:00:00 -05:00

The most common industry payments to physicians have taken the form of gifts, such as meals, tickets to sporting or cultural events, and pens, mugs, and other tchotchkes that prominently...

CLINICAL DECISIONS: Care of an Unresponsive Patient with a Poor Prognosis

Thu, 29Â JanÂ 2009 00:00:00 -05:00

A 56-year-old homeless man was found having a seizure and was transported to the hospital. He was found to have a subarachnoid hemorrhage and acute hydrocephalus. He underwent intubation, and...

PERSPECTIVE: Fighting On

Thu, 29Â JanÂ 2009 00:00:00 -05:00

She had been living with multiple myeloma for more than 7 years before she showed up in our intensive care unit (ICU). It had not been easy, but she had...

PERSPECTIVE: Online Disclosure of PhysicianâIndustry Relationships

Thu, 22Â JanÂ 2009 00:00:00 -05:00

The Cleveland Clinic and some of its leading physicians have been criticized for their financial associations with industry and the limited disclosure of these relationships to patients and the public....

PERSPECTIVE: The Fast-Food Fund

Thu, 15Â JanÂ 2009 00:00:00 -05:00

At the end of our clinic meeting, one of the doctors announced that she was taking up a collection. Not the usual someone's-getting-married, someone's-having-a-baby, someone's-leaving collection; this one was for...

PERSPECTIVE: The Neurontin Legacy â Marketing through Misinformation and Manipulation

Thu, 08Â JanÂ 2009 00:00:00 -05:00

Old drugs usually fade away. Sometimes, however, they leave surprising legacies. In 1997, for example, a study comparing the effects of brand-name and generic formulations of levothyroxine led to an...

PERSPECTIVE: Money and the Changing Culture of Medicine

Thu, 08Â JanÂ 2009 00:00:00 -05:00

Rapidly rising health care costs over recent decades have prompted the application of business practices to medicine, with the goals of improving efficiency, restraining expenses, and increasing quality. In the...

BOOK REVIEW:

Thu, 18Â DecÂ 2008 00:00:00 -05:00

Ethical Issues in Neurology is firmly grounded in clinical practice and empirical data and is supported by conceptual and practical frameworks for action. James Bernat begins his book with theory...

PERSPECTIVE: Physician-Assisted Death â From Oregon to Washington State

Thu, 11Â DecÂ 2008 00:00:00 -05:00

In November, residents of the state of Washington voted 58% to 42% to allow physician-assisted suicide.1 The Washington Death with Dignity Act is modeled on a similar law that has...

EDITORIAL: Physicians and the First Amendment

Thu, 04Â DecÂ 2008 00:00:00 -05:00

In the November elections, the citizens of three states resoundingly defeated initiatives aimed at curtailing reproductive rights. In Colorado, a proposed amendment to the state's Constitution would have given the...

BOOK REVIEW:

Thu, 20Â NovÂ 2008 00:00:00 -05:00

In the 1970s and 1980s, the first wave of disability theorists began to criticize medical professionals and bioethicists for using a medical model of disability. They argued that those who...

BOOK REVIEW:

Thu, 20Â NovÂ 2008 00:00:00 -05:00

This book is about heads of state â presidents, shahs, prime ministers. Author David Owen seeks to examine the relationship between the health of leaders and the quality and integrity...

PERSPECTIVE: The Genetic Privacy of Presidential Candidates

Thu, 20Â NovÂ 2008 00:00:00 -05:00

In the wake of the often bitter presidential election, with its emphasis on negative campaigning and intermittent controversies over the release of candidates' health information, it is not too soon...

PERSPECTIVE: South Dakota's Abortion Script â Threatening the PhysicianâPatient Relationship

Thu, 20Â NovÂ 2008 00:00:00 -05:00

Under a law that went into effect in July, physicians in South Dakota must tell any woman seeking an abortion that she is terminating the life of âa whole, separate,...

BOOK REVIEW:

Thu, 06Â NovÂ 2008 00:00:00 -05:00

Psychotherapists endeavor to help people bear the burdens of their lives and become more fulfilled in their relationships and societal roles. Modern approaches to psychotherapy take many forms and use...

PERSPECTIVE: Moving Forward on Reproductive Health

Thu, 30Â OctÂ 2008 00:00:00 -05:00

Reproductive health policy has been mired in debates over abortion and sexuality, leaving unresolved a cluster of reproductive health problems. For a country of such wealth and technical prowess, the...

PERSPECTIVE: Reproductive Freedom and the Next President

Thu, 30Â OctÂ 2008 00:00:00 -05:00

In a dramatic speech on the floor of the U.S. Senate in July 2006, Senator Barack Obama (D-IL) described a visit from a constituent whose 2-year-old son, Ryan, had cerebral...

BOOK REVIEW:

Thu, 23Â OctÂ 2008 00:00:00 -05:00

Sterilization is a medical procedure that can immediately evoke concern about violations of medical ethics. Enthusiasm for sterilization may start with beneficence and the desire for social justice, but sterilization...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Toxic Tinkering â Lethal-Injection Execution and the Constitution

George J. Annas, J.D., M.P.H. — Thu, 02Â OctÂ 2008 00:00:00 -05:00

Michel Foucault opened his 1975 book Discipline and Punish with a particularly gruesome account of a French execution in 1757 that involved tearing the flesh away with hot pincers and...

EDITORIAL: Identifying and Addressing Safety Signals in Clinical Trials

Thomas R. Fleming, Ph.D. — Thu, 25Â SepÂ 2008 00:00:00 -05:00

Interventions for the prevention or treatment of disease that are based on our understanding of the pathobiologic features of the illness can provide benefit in how a patient feels or...

PERSPECTIVE: Assessing the Cardiovascular Safety of Diabetes Therapies

Thu, 11Â SepÂ 2008 00:00:00 -05:00

The Endocrinologic and Metabolic Drugs Advisory Committee for the Food and Drug Administration (FDA), of which I am a member, convened in early July to consider whether data on long-term...

PERSPECTIVE: The Ethics of Interrogation â The U.S. Military's Ongoing Use of Psychiatrists

Thu, 11Â SepÂ 2008 00:00:00 -05:00

In May 2006, the American Psychiatric Association (APA) adopted a position statement prohibiting psychiatrists from âdirect participationâ in the interrogation of any person in military or civilian detention â including...

PERSPECTIVE: Military Medical Ethics â Physician First, Last, Always

Thu, 11Â SepÂ 2008 00:00:00 -05:00

The global war on terror has brought renewed attention to the question of whether physicians in the U.S. military are physicians first, soldiers first, or physicianâsoldiers, or whether some other...

PERSPECTIVE: Drug Warnings That Can Cause Fits â Communicating Risks in a Data-Poor Environment

Thu, 04Â SepÂ 2008 00:00:00 -05:00

In 2005, after receiving case reports of suicides by patients taking anticonvulsant medications, the Food and Drug Administration (FDA) asked the manufacturers of 11 drugs in this class to report...

BOOK REVIEW:

Thu, 28Â AugÂ 2008 00:00:00 -05:00

The Oxford Textbook of Clinical Research Ethics is a resource suitable for a course in research ethics and would also be helpful for those starting a career in clinical research....

BOOK REVIEW:

Thu, 28Â AugÂ 2008 00:00:00 -05:00

This book is an autopsy of errors. Drawing on his 20 years as chief of epidemiology in the division for the prevention of the human immunodeficiency virus (HIV) and the...

EDITORIAL: Cardiac Transplantation in Infants

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. — Thu, 14Â AugÂ 2008 00:00:00 -05:00

For children born with inoperable congenital heart disease or advanced cardiomyopathy, cardiac transplantation is the only therapeutic option. Each year in the United States, approximately 400 heart-transplantation procedures are performed...

ORIGINAL ARTICLE: Pediatric Heart Transplantation after Declaration of Cardiocirculatory Death

Thu, 14Â AugÂ 2008 00:00:00 -05:00

In three infants awaiting orthotopic cardiac transplantation, transplantation was successfully performed with the use of organs from donors who had died from cardiocirculatory causes. The three recipients had blood group...

PERSPECTIVE: The Dead Donor Rule and Organ Transplantation

Thu, 14Â AugÂ 2008 00:00:00 -05:00

Since its inception, organ transplantation has been guided by the overarching ethical requirement known as the dead donor rule, which simply states that patients must be declared dead before the...

PERSPECTIVE: Donating Hearts after Cardiac Death â Reversing the Irreversible

Thu, 14Â AugÂ 2008 00:00:00 -05:00

Once, all transplantable organs were procured after a donor's heart had stopped irreversibly. Assuming that one accepted the dead donor rule, irreversible heart stoppage triggered organ procurement. Around 1970, the...

PERSPECTIVE: The Boundaries of Organ Donation after Circulatory Death

Thu, 14Â AugÂ 2008 00:00:00 -05:00

Organ donation after circulatory (or cardiac) death has become an accepted medical practice over the past 15 years.1 Programs permitting such donations satisfy two needs: they provide organs in addition...

BOOK REVIEW:

Thu, 07Â AugÂ 2008 00:00:00 -05:00

In 2001, President George W. Bush established the President's Council on Bioethics and appointed Leon Kass as its chair. Under Kass's direction, the council issued reports on caregiving, stem-cell research,...

PERSPECTIVE: Disclosure of Industry Payments to Physicians

Thu, 07Â AugÂ 2008 00:00:00 -05:00

Most physicians in the United States have financial relationships with industry, ranging from the acceptance of meals to the receipt of large sums of money for consulting, speaking, or conducting...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Doctors, Drugs, and Driving â Tort Liability for Patient-Caused Accidents

George J. Annas, J.D., M.P.H. — Thu, 31Â JulÂ 2008 00:00:00 -05:00

No one should drive if their performance is compromised by drugs. Everyone has a duty to drive reasonably, and all drivers are legally responsible for accidents they cause by driving...

PERSPECTIVE: The Genetic Information Nondiscrimination Act â A Half-Step toward Risk Sharing

Thu, 24Â JulÂ 2008 00:00:00 -05:00

Consider three Americans â one with an increased genetic risk for colon cancer, one with a family history of colon cancer, and one with a colonoscopic finding of several large...

PERSPECTIVE: Tier 4 Drugs and the Fraying of the Social Compact

Thu, 24Â JulÂ 2008 00:00:00 -05:00

The growing number of biologic drugs for cancers and other serious conditions is a harbinger of things to come â in more ways than one. These drugs demonstrate that basic...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Wellness Programs and Lifestyle Discrimination â The Legal Limits

Michelle M. Mello, J.D., Ph.D., and Meredith B. Rosenthal, Ph.D. — Thu, 10Â JulÂ 2008 00:00:00 -05:00

âPersonal responsibilityâ has become a recurrent theme in debates about health care financing.1 In addition to asking consumers to make better-informed choices in seeking care, many payers are focusing on...

SOUNDING BOARD: Informing Candidates for Solid-Organ Transplantation about Donor Risk Factors

Thu, 26Â JunÂ 2008 00:00:00 -05:00

For the first time in 15 years, there has been documented transmission of the human immunodeficiency virus (HIV) through solid-organ transplantation.1 Although transmission of infectious agents through transplantation is rare,2...

SOUNDING BOARD: Over-the-Counter Sales of Statins and Other Drugs for Asymptomatic Conditions

Mary E. Tinetti, M.D. — Thu, 19Â JunÂ 2008 00:00:00 -05:00

Merck recently submitted its third application to the Food and Drug Administration (FDA) to allow it to sell its cholesterol-lowering drug lovastatin in 20-mg tablets over the counter.12 Targeted consumers...

PERSPECTIVE: Keeping Pace with the Times â The Genetic Information Nondiscrimination Act of 2008

Thu, 19Â JunÂ 2008 00:00:00 -05:00

When the first federal legislation to prevent the misuse of genetic information was introduced in 1995, many in the health care, research, and policy communities considered the measure to be...

PERSPECTIVE: Redefining Quality â Implications of Recent Clinical Trials

Thu, 12Â JunÂ 2008 00:00:00 -05:00

Simple approaches to patient care are better â except when they are not. Recent clinical studies are leading to a reexamination of the paradigm whereby efforts to prevent vascular disease...

PERSPECTIVE: Coagulation and Adulteration â Building on Science and Policy Lessons from 1905

Thu, 05Â JunÂ 2008 00:00:00 -05:00

It's always instructive and often painful to contrast the impressive development of medical science with the more fitful evolution of health policy. The former marches forward more or less systematically;...

PERSPECTIVE: Exploiting a Research Underclass in Phase 1 Clinical Trials

Thu, 29Â MayÂ 2008 00:00:00 -05:00

In November 1996, the Wall Street Journal reported that Eli Lilly was paying homeless alcoholics from a local shelter to participate in safety testing of new drugs at its trial...

PERSPECTIVE: DTCA for PTCA â Crossing the Line in Consumer Health Education?

Thu, 22Â MayÂ 2008 00:00:00 -05:00

On November 22, 2007, viewers of the nationally televised Thanksgiving Day football game between the Dallas Cowboys and the New York Jets witnessed the launch of the first direct-to-consumer advertising...

PERSPECTIVE: Etiquette-Based Medicine

Thu, 08Â MayÂ 2008 00:00:00 -05:00

Patients ideally deserve to have a compassionate doctor, but might they be satisfied with one who is simply well-behaved? When I hear patients complain about doctors, their criticism often has...

EDITORIAL: Full Disclosure and the Funding of Biomedical Research

Thu, 24Â AprÂ 2008 00:00:00 -05:00

Clinical studies have become very expensive to conduct, and multiple sources of funding often support a single study. Biomedical journals routinely disclose all sources of funding of the research they...

PERSPECTIVE: Playing âKick the FDAâ â Risk-free to Players but Hazardous to Public Health

Thu, 24Â AprÂ 2008 00:00:00 -05:00

The Food and Drug Administration (FDA) is responsible for regulating $1 trillion worth of consumer products, or 25% of the U.S. consumer economy â the food we eat, the cosmetics...

PERSPECTIVE: Trying Times at the FDA â The Challenge of Ensuring the Safety of Imported Pharmaceuticals

Thu, 24Â AprÂ 2008 00:00:00 -05:00

In recent years, the Food and Drug Administration (FDA) has faced three serious challenges to its ability to ensure the safety of the country's medical devices and drugs. The first...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Perspectives on Medical Outsourcing and Telemedicine â Rough Edges in a Flat World?

Sanjiv N. Singh, J.D., and Robert M. Wachter, M.D. — Thu, 10Â AprÂ 2008 00:00:00 -05:00

Low-cost labor, time zone differences, and telecommunication advances have âflattenedâ the world of business and services1; however, health care has been relatively insulated from these world-flattening forces until recently. In...

PERSPECTIVE: Regulating Off-Label Drug Use â Rethinking the Role of the FDA

Thu, 03Â AprÂ 2008 00:00:00 -05:00

The Food and Drug Administration (FDA) provides a barrier to market entry and use of unproven and unsafe products. For prescription drugs, the FDA approval process requires substantial evidence of...

SPECIAL ARTICLE: Drug-Review Deadlines and Safety Problems

Daniel Carpenter, Ph.D., Evan James Zucker, B.A., and Jerry Avorn, M.D. — Thu, 27Â MarÂ 2008 00:00:00 -05:00

Background: The Prescription Drug User Fee Act (PDUFA) imposes deadlines for the completion of drug reviews by the Food and Drug Administration (FDA). Critics have suggested that these deadlines may...

PERSPECTIVE: Consent for Organ Donation â Balancing Conflicting Ethical Obligations

Thu, 20Â MarÂ 2008 00:00:00 -05:00

Organ transplantation is truly one of the miracles of modern medicine, saving the lives of many patients and improving the quality of life for many more. Given the ever-increasing gap...

PERSPECTIVE: Semper Fidelis â Consumer Protection for Patients with Implanted Medical Devices

Thu, 06Â MarÂ 2008 00:00:00 -05:00

When the Food and Drug Administration (FDA) approved the Medtronic Sprint Fidelis implantable cardioverterâdefibrillator (ICD) lead in 2004 on the basis of bench testing but no human clinical data, there...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Scientific and Legal Viability of Follow-on Protein Drugs

David M. Dudzinski, M.D., J.D., and Aaron S. Kesselheim, M.D., J.D. — Thu, 21Â FebÂ 2008 00:00:00 -05:00

Since recombinant human insulin (Humulin) became the first recombinant-protein drug approved by the Food and Drug Administration (FDA) 25 years ago, nearly 100 recombinant-protein therapeutics, including other hormones and monoclonal...

PERSPECTIVE: Harming through Protection?

Thu, 21Â FebÂ 2008 00:00:00 -05:00

About 80,000 catheter-related bloodstream infections occur in U.S. intensive care units (ICUs) each year, causing as many as 28,000 deaths and costing the health care system as much as $2.3...

PERSPECTIVE: Quality-Improvement Research and Informed Consent

Thu, 21Â FebÂ 2008 00:00:00 -05:00

Tens of thousands of patients die each year because of hospitals' failure to adhere consistently to standard procedures of safe and effective medical care. Accordingly, improving the quality of routine...

PERSPECTIVE: Physicians and Execution â Highlights from a Discussion of Lethal Injection

Thu, 31Â JanÂ 2008 00:00:00 -05:00

Should physicians participate in lethal injection for carrying out capital punishment?...

EDITORIAL: Physicians and Execution

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. — Thu, 24Â JanÂ 2008 00:00:00 -05:00

This spring the U.S. Supreme Court in Baze v. Rees1 will rule on the constitutionality of the three-drug regimen currently used for lethal injection in most state executions. The Eighth...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Rules for Donations to Tissue Banks â What Next?

Leonard Glantz, J.D., Patricia Roche, J.D., and George J. Annas, J.D., M.P.H. — Thu, 17Â JanÂ 2008 00:00:00 -05:00

Michael Crichton's Next1 is a fictional creation of multiple catastrophes emanating from the real-life case of John Moore, in which the California Supreme Court ruled in 1990 that Moore did...

PERSPECTIVE: Letting the Genome Out of the Bottle â Will We Get Our Wish?

Thu, 10Â JanÂ 2008 00:00:00 -05:00

It may happen soon. A patient, perhaps one you have known for years, who is overweight and does not exercise regularly, shows up in your office with an analysis of...

PERSPECTIVE: Dr. Pou and the Hurricane â Implications for Patient Care during Disasters

Thu, 03Â JanÂ 2008 00:00:00 -05:00

During the flood after Hurricane Katrina in August 2005, health care providers in marooned New Orleans hospitals worked in almost unimaginably difficult conditions while awaiting rescue. Nowhere was the situation...

PERSPECTIVE: The Good Patient

Thu, 20Â DecÂ 2007 00:00:00 -05:00

The visit to my doctor was not terribly out of the ordinary. I had waited several months, hoping the pain would remit, but the throbbing in my shoulders, initially episodic...

PERSPECTIVE: The View from the Other Side â Patients, Doctors, and the Power of a Camera

Thu, 20Â DecÂ 2007 00:00:00 -05:00

By the time Galen Buckwalter's physician knocked on the exam-room door, Buckwalter's video camera had been recording for nearly 40 minutes. He had booked the appointment because his shoulders were...

ORIGINAL ARTICLE: Outcomes 18 Months after the First Human Partial Face Transplantation

Thu, 13Â DecÂ 2007 00:00:00 -05:00

Background: We performed the first human partial face allograft on November 27, 2005. Here we report outcomes up to 18 months after transplantation.

Methods: The postsurgical induction immunosuppression protocol included thymoglobulins...

CLINICAL PRACTICE: Assessment of Patients' Competence to Consent to Treatment

Paul S. Appelbaum, M.D. — Thu, 01Â NovÂ 2007 00:00:00 -05:00

A 75-year-old woman with type 2 diabetes mellitus and peripheral vascular disease is admitted with a gangrenous ulcer of the plantar aspect of her left foot. A surgical consultation results...

PERSPECTIVE: Doctors and Drug Companies â Scrutinizing Influential Relationships

Thu, 01Â NovÂ 2007 00:00:00 -05:00

On September 6, 2007, Senators Charles Grassley (R-IA), the ranking member of the Committee on Finance, and Herb Kohl (D-WI), chairman of the Special Committee on Aging, introduced the Physician...

EDITORIAL: Open Clinical Trials

Jeffrey M. Drazen, M.D., Stephen Morrissey, Ph.D., and Gregory D. Curfman, M.D. — Thu, 25Â OctÂ 2007 00:00:00 -05:00

On September 27, 2007, President Bush signed into law the Food and Drug Administration Revitalization Act, which aims to improve the FDA's ability to ensure the safety of the nation's...

PERSPECTIVE: Guilty, Afraid, and Alone â Struggling with Medical Error

Thu, 25Â OctÂ 2007 00:00:00 -05:00

Since 1999, health care professionals have been focusing on To Err Is Human, the Institute of Medicine report that sounded alarms about medical error. As we have strived to reduce...

PERSPECTIVE: Who Should Protect the Public? The Supreme Court and Medical Device Regulation

Thu, 25Â OctÂ 2007 00:00:00 -05:00

A decade ago, Charles Riegel was undergoing a coronary angioplasty procedure when a balloon catheter ruptured. Complete heart block developed, and Riegel lost consciousness and had to undergo emergency coronary...

PERSPECTIVE: Commercializing Clinical Trials â Risks and Benefits of the CRO Boom

Thu, 04Â OctÂ 2007 00:00:00 -05:00

In a trend that has received surprisingly little attention, contract research organizations (CROs) have gradually taken over much of academia's traditional role in drug development over the pastdecade. They've been...

PERSPECTIVE: Sidelining Safety â The FDA's Inadequate Response to the IOM

Thu, 06Â SepÂ 2007 00:00:00 -05:00

Having been commissioned by the Food and Drug Administration (FDA) to evaluate the U.S. drug-safety system, the Institute of Medicine (IOM) published a report, The Future of Drug Safety, in...

PERSPECTIVE: When Doctors Become Terrorists

Thu, 16Â AugÂ 2007 00:00:00 -05:00

We were lucky in London in June. A large car bomb was left just outside a crowded nightclub near Piccadilly Circus, and a second car bomb was parked nearby to...

PERSPECTIVE: Keeping Science on Top in Drug Evaluation

Thu, 16Â AugÂ 2007 00:00:00 -05:00

In many sectors of American life â energy, defense, finance, pharmaceuticals â the government stands poised between powerful industry groups and the needs of the citizenry. But in only one...

SOUNDING BOARD: The Tension between Needing to Improve Care and Knowing How to Do It

Thu, 09Â AugÂ 2007 00:00:00 -05:00

The past 7 years have seen unprecedented interest in patient safety and the quality of health care.123 As physicians whose careers are focused on improving quality and safety, we have...

EDITORIAL: Safer Drugs for the American People

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. — Thu, 09Â AugÂ 2007 00:00:00 -05:00

By wide margins, both the House and the Senate have now passed bills that aim to ensure the safety of the drug supply in the United States.12 Given the serious...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Cancer and the Constitution â Choice at Life's End

George J. Annas, J.D., M.P.H. — Thu, 26Â JulÂ 2007 00:00:00 -05:00

J.M. Coetzee's violent, anti-apartheid Age of Iron, a novel the Wall Street Journal termed âa fierce pageant of modern South Africa,â is written as a letter by a retired classics...

PERSPECTIVE: Letting Go of the Rope â Aggressive Treatment, Hospice Care, and Open Access

Thu, 26Â JulÂ 2007 00:00:00 -05:00

More Americans are choosing hospice for end-of-life care, but ironically, hospice patients increasingly are forced to give up effective palliative treatments along with aggressive medical intervention. For Joanne Doolin, a...

PERSPECTIVE: Understanding Hospice â An Underutilized Option for Life's Final Chapter

Thu, 26Â JulÂ 2007 00:00:00 -05:00

It was Mr. G.'s third exacerbation of congestive heart failure in the past 6 months. Eighty-three years old, he had New York Heart Association class IV heart failure, end-stage coronary...

PERSPECTIVE: Leaving against Medical Advice

Thu, 19Â JulÂ 2007 00:00:00 -05:00

It was the first day of my cardiology subinternship, and I was trying to catch details of the 29-year-old patient's complex history. Juan Perez, a heroin addict who had undergone...

PERSPECTIVE: Organ Donation after Cardiac Death

Thu, 19Â JulÂ 2007 00:00:00 -05:00

Although the numbers of organ donors and transplantations in the United States have more than doubled over the past 20 years (see line graph), the demand for organs continues to...

EDITORIAL: Rosiglitazone â Continued Uncertainty about Safety

Jeffrey M. Drazen, M.D., Stephen Morrissey, Ph.D., and Gregory D. Curfman, M.D. — Thu, 05Â JulÂ 2007 00:00:00 -05:00

On May 21, 2007, the Journal published a meta-analysis by Nissen and Wolski1 that indicated an increased cardiovascular risk associated with rosiglitazone (Avandia), a thiazolidinedione used to treat type 2...

PERSPECTIVE: The Art of Letting Go

Thu, 05Â JulÂ 2007 00:00:00 -05:00

âIs there any money we need to pay? Is that why you won't treat him?â

Her face wears a hunted expression; her slender frame is weighed down by fatigue and untold...

PERSPECTIVE: Tackling Medical Futility in Texas

Thu, 05Â JulÂ 2007 00:00:00 -05:00

For several weeks this spring, national attention was focused on a mother's struggle to prevent the Children's Hospital of Austin from withdrawing life support from her infant son. Emilio Gonzales...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Compact versus Contract â Industry Sponsors' Obligations to Their Research Subjects

Michelle M. Mello, J.D., Ph.D., M.Phil., and Steven Joffe, M.D., M.P.H. — Thu, 28Â JunÂ 2007 00:00:00 -05:00

Public unease about industry's influence over clinical research has never been greater. Recent events have elevated concerns about financial ties among investigators, academic medical centers, and industry sponsors,1234 and disquieting...

REVIEW ARTICLE: Disclosing Harmful Medical Errors to Patients

Thu, 28Â JunÂ 2007 00:00:00 -05:00

Studies from more than six countries1234567 report a high prevalence of harmful medical errors. Most providers and patients realize that health care services are potentially hazardous and that errors sometimes...

PERSPECTIVE: Adapting to Duty-Hour Limits â Four Years On

Thu, 28Â JunÂ 2007 00:00:00 -05:00

On July 1, 2003, prompted by the medical profession's concerns about patient safety and the working conditions and education of resident physicians, the Accreditation Council for Graduate Medical Education (ACGME)...

PERSPECTIVE: An Elusive Balance â Residents' Work Hours and the Continuity of Care

Thu, 28Â JunÂ 2007 00:00:00 -05:00

Four years after national limits on duty hours for medical residents took effect â and nearly two decades after similar limits were enacted by New York State â conversations with...

PERSPECTIVE: Erythropoietin, the FDA, and Oncology

Thu, 14Â JunÂ 2007 00:00:00 -05:00

As has been the case for patients with chronic renal failure, treatment with erythropoiesis-stimulating agents (ESAs) has substantially raised the hemoglobin concentrations of hundreds of thousands of patients with cancer,...

PERSPECTIVE: Weighing the Hazards of Erythropoiesis Stimulation in Patients with Cancer

Thu, 14Â JunÂ 2007 00:00:00 -05:00

On May 10, 2007, the Food and Drug Administration (FDA) convened a meeting of its Oncology Drug Advisory Committee to discuss concerns about risks associated with the erythropoiesis-stimulating agents (ESAs)...

PERSPECTIVE: The Stem-Cell Market â Patents and the Pursuit of Scientific Progress

Thu, 07Â JunÂ 2007 00:00:00 -05:00

University of Wisconsin researcher James Thomson and his colleagues wowed the scientific community when they reported in November 1998 that they had isolated and cultured human embryonic stem cells.1 They...

PERSPECTIVE: Drug Risks and Free Speech â Can Congress Ban Consumer Drug Ads?

Thu, 31Â MayÂ 2007 00:00:00 -05:00

In 2004, the discovery that Vioxx (rofecoxib) was a risky drug put direct-to-consumer pharmaceutical advertising in the spotlight. The image of Dorothy Hamill lacing up her skates and gliding over...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: The Supreme Court and Abortion Rights

George J. Annas, J.D., M.P.H. — Thu, 24Â MayÂ 2007 00:00:00 -05:00

Since the Supreme Court's landmark 1973 abortion-rights decision in Roe v. Wade,1 the law has taken the lead in defining the contours of the continuing public debate over reproductive liberty....

EDITORIAL: Government in Medicine

Jeffrey M. Drazen, M.D. — Thu, 24Â MayÂ 2007 00:00:00 -05:00

Although I am not a provider of reproductive medical services, I was alarmed to read of the recent decision of the Supreme Court in Gonzales v. Carhart. Why should I...

PERSPECTIVE: The Intimidation of American Physicians â Banning Partial-Birth Abortion

Thu, 24Â MayÂ 2007 00:00:00 -05:00

A Dutch oncologist was describing to an audience of American physicians in Amsterdam the circumstances under which euthanasia was performed in the Netherlands at a time when the practice was...

PERSPECTIVE: The Partial Death of Abortion Rights

Thu, 24Â MayÂ 2007 00:00:00 -05:00

On April 18, 2007, the Supreme Court signaled a significant change in abortion jurisprudence. It held in Gonzales v. Carhart that a federal statute outlawing the use of âpartial-birth abortionâ...

PERSPECTIVE: The Mixed Promise of Genetic Medicine

Thu, 17Â MayÂ 2007 00:00:00 -05:00

In the early decades of the 20th century, most Americans considered cosmetic surgery to be just a few steps removed from quackery. Many observers saw the desire for cosmetic surgery...

PERSPECTIVE: Prohibiting Genetic Discrimination

Thu, 17Â MayÂ 2007 00:00:00 -05:00

Even before the sequencing of the human genome began in earnest, Americans started worrying about how information about their genetic makeup might be used in harmful ways, and policymakers began...

SPECIAL ARTICLE: End-of-Life Practices in the Netherlands under the Euthanasia Act

Thu, 10Â MayÂ 2007 00:00:00 -05:00

Background: In 2002, an act regulating the ending of life by a physician at the request of a patient with unbearable suffering came into effect in the Netherlands. In 2005,...

PERSPECTIVE: Legal Regulation of Physician-Assisted Death â The Latest Report Cards

Thu, 10Â MayÂ 2007 00:00:00 -05:00

In 2002, the government of the Netherlands explicitly legalized euthanasia and physician-assisted suicide. These controversial end-of-life practices had been openly tolerated and studied for many years before legalization, and Dutch...

PERSPECTIVE: Subjects or Objects? Prisoners and Human Experimentation

Thu, 03Â MayÂ 2007 00:00:00 -05:00

During the 1950s, inmates at what was then called Holmesburg Prison, in Philadelphia, were inoculated with condyloma acuminatum, cutaneous moniliasis, and viruses causing warts, herpes simplex, and herpes zoster.1 For...

SPECIAL ARTICLE: A National Survey of PhysicianâIndustry Relationships