NEJM â Collection Updates for Legal Issues in Medicine

PERSPECTIVE: Tobacco Control and Free Speech â An American Dilemma

Thu, 28Â JanÂ 2010 00:00:00 -05:00

On June 22, 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act. This landmark legislation, which passed the House by a vote of 307 to 97...

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...

OTHER POINTS OF VIEW: It Is Patients Who Most Need Tort Reform

Thu, 17Â DecÂ 2009 00:00:00 -05:00

There is a poor correlation between competence of care and malpractice lawsuits.1 The arbitrary-seeming nature of malpractice litigation places a dark cloud over all medical practice, encouraging wasteful defensive medical...

PERSPECTIVE: The Supreme Court, Process Patents, and Medical Innovation

Thu, 10Â DecÂ 2009 00:00:00 -05:00

On November 9, the U.S. Supreme Court heard oral arguments in Bilski v. Kappos, one of the most closely watched cases in the Court's current term. The central question involves...

PERSPECTIVE: Mandatory Vaccination of Health Care Workers

Thu, 19Â NovÂ 2009 00:00:00 -05:00

Mandatory vaccination of health care workers raises important questions about the limits of a state's power to compel individuals to engage in particular activities in order to protect the public....

PERSPECTIVE: Balancing Innovation, Access, and Profits â Market Exclusivity for Biologics

Thu, 12Â NovÂ 2009 00:00:00 -05:00

Twenty-five years ago, Congress enacted the WaxmanâHatch Act to facilitate the approval by the Food and Drug Administration (FDA) of low-cost generic drugs that are bioequivalent to approved brand-name drugs....

PERSPECTIVE: Physicians' Views of the Massachusetts Health Care Reform Law â A Poll

Thu, 05Â NovÂ 2009 00:00:00 -05:00

In 2006, Massachusetts enacted the country's first law mandating near-universal health care coverage,1 and the state now has the lowest proportion of uninsured residents in the United States. The Massachusetts...

PERSPECTIVE: Litigation amidst Reform â The Boston Medical Center Case

Thu, 05Â NovÂ 2009 00:00:00 -05:00

Nearly 175 years ago, Alexis de Tocqueville wrote in Democracy in America, âThere is hardly a political question in the United States which does not sooner or later turn into...

PERSPECTIVE: Lost in Transmission â FDA Drug Information That Never Reaches Clinicians

Thu, 29Â OctÂ 2009 00:00:00 -05:00

The 2009 federal stimulus package included $1.1 billion to support comparative-effectiveness research about medical treatments. No money has been allocated â and relatively little would be needed â to disseminate...

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...

BOOK REVIEW:

Thu, 23Â JulÂ 2009 00:00:00 -05:00

Much has changed in the field of reproduction since 1978, when Louise Brown, the first âtest-tube baby,â was born. In the United States, approximately 1 in 80 births is now...

EDITORIAL: Tobacco, Public Health, and the FDA

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. — Thu, 23Â JulÂ 2009 00:00:00 -05:00

More than a decade ago, David Kessler, then Commissioner of the Food and Drug Administration (FDA), launched a bold initiative to regulate tobacco. He believed that since nicotine is an...

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...

PERSPECTIVE: A Higher Bar â Vermont's New Law on Marketing Prescribed Products

Thu, 02Â JulÂ 2009 00:00:00 -05:00

As Congress continues to discuss the reform of physicianâindustry relations, individual states are enacting new laws. In July 2009, regulations on the conduct of pharmaceutical and medical-device manufacturers take effect...

PERSPECTIVE: The Role of Medical Liability Reform in Federal Health Care Reform

Thu, 02Â JulÂ 2009 00:00:00 -05:00

Although enthusiasm for health care reform is resounding in Washington these days, the specific shape reform will take and the compromises that will have to be made along the way...

PERSPECTIVE: Litigation, Regulation, and Education â Protecting the Public's Health through Childhood Immunization

Thu, 11Â JunÂ 2009 00:00:00 -05:00

Recently, three special masters of the U.S. Court of Federal Claims issued carefully reasoned, strongly worded opinions rejecting claims that medical and scientific evidence could demonstrate causal links between thimerosal-containing...

PERSPECTIVE: When Vaccine Injury Claims Go to Court

Thu, 11Â JunÂ 2009 00:00:00 -05:00

In February 2009, the National Vaccine Injury Compensation Program (VICP) released decisions for the first three test cases heard under the program's Omnibus Autism Proceeding. In each of the cases...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Handguns, Health, and the Second Amendment

Leonard H. Glantz, J.D., and George J. Annas, J.D., M.P.H. — Thu, 28Â MayÂ 2009 00:00:00 -05:00

The right to possess firearms by private citizens has been a major political issue in the United States since the founding of the country. James Madison, for example, argued that...

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...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: New York City's War on Fat

Michelle M. Mello, J.D., Ph.D. — Thu, 07Â MayÂ 2009 00:00:00 -05:00

In February, a federal appeals court handed public health officials in New York City an important victory in their ongoing war on obesity and chronic disease.1 In the past 3...

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...

SPECIAL REPORT: Progress and Deficiencies in the Registration of Clinical Trials

Alastair J.J. Wood, M.D. — Thu, 19Â FebÂ 2009 00:00:00 -05:00

Clinical trials are essential to understanding the efficacy of medical interventions. The ethical underpinnings of this type of research involving human subjects, codified in the Belmont Report1 and the Declaration...

PERSPECTIVE: Commercial versus Social Goals of Tracking What Doctors Do

Thu, 19Â FebÂ 2009 00:00:00 -05:00

On November 18, 2008, the U.S. Court of Appeals for the First Circuit upheld the constitutionality of a New Hampshire statute that was the first in the nation to restrict...

PERSPECTIVE: Prescribing Records and the First Amendment â New Hampshire's Data-Mining Statute

Thu, 19Â FebÂ 2009 00:00:00 -05:00

In November 2008, the U.S. Court of Appeals for the First Circuit upheld against constitutional attack a New Hampshire statute that prohibits data miners from selling information about physicians' prescribing...

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: 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, 27Â NovÂ 2008 00:00:00 -05:00

Paul Lombardo's book is an authoritative history of the U.S. Supreme Court's infamous decision, Buck v. Bell (1927), which held that Virginia's mandatory sterilization law did not violate Carrie Buck's...

BOOK REVIEW:

Thu, 27Â NovÂ 2008 00:00:00 -05:00

Hardly a week goes by without a person who is alleged to be mentally ill committing some act of violence â and it is always covered by the media. What...

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,...

PERSPECTIVE: Drug Development for Neglected Diseases â The Trouble with FDA Review Vouchers

Thu, 06Â NovÂ 2008 00:00:00 -05:00

September 2008 marked the beginning of a new federal program intended to promote the development of pharmaceutical products for so-called neglected diseases â infectious diseases that disproportionately affect poor populations...

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...

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...

PERSPECTIVE: Guns and Suicide in the United States

Thu, 04Â SepÂ 2008 00:00:00 -05:00

This past June, in a 5-to-4 decision in District of Columbia v. Heller, the Supreme Court struck down a ban on handgun ownership in the nation's capital and ruled that...

EDITORIAL: The FDA and Tobacco Regulation

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. — Thu, 04Â SepÂ 2008 00:00:00 -05:00

Soon the U.S. Senate will vote on a bill1 with unprecedented implications for the health of the American people. The bill would, for the first time, grant authority to the...

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...

PERSPECTIVE: Medicare Showdown

Thu, 07Â AugÂ 2008 00:00:00 -05:00

In a stunning rebuke of President George W. Bush, the House and Senate voted July 15 in a strong bipartisan fashion to override a veto he had issued only hours...

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...

EDITORIAL: Guns and Health

Jeffrey M. Drazen, M.D., Stephen Morrissey, Ph.D., and Gregory D. Curfman, M.D. — Thu, 31Â JulÂ 2008 00:00:00 -05:00

The Supreme Court has launched the country on a risky epidemiologic experiment. The announcement by the Court last month of its decision in District of Columbia v. Heller,1 which struck...

SPECIAL ARTICLE: Smoke-free Legislation and Hospitalizations for Acute Coronary Syndrome

Thu, 31Â JulÂ 2008 00:00:00 -05:00

Background: Previous studies have suggested a reduction in the total number of hospital admissions for acute coronary syndrome after the enactment of legislation banning smoking in public places. However, it...

PERSPECTIVE: FDA Regulation of Tobacco â Pitfalls and Possibilities

Thu, 31Â JulÂ 2008 00:00:00 -05:00

After more than half a century of debate and discussion, it is likely that during the coming year, Congress will pass legislation bringing tobacco products under the regulatory authority of...

BOOK REVIEW:

Thu, 24Â JulÂ 2008 00:00:00 -05:00

In Gaetano Donizetti's opera L'Elisir d'Amore (The Elixir of Love), the itinerant Dr. Dulcamara peddles a âmarvelous elixir that awakens love,â and in a vocally demanding patter song proclaims that...

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...

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...

PERSPECTIVE: Shuffling toward Parity â Bringing Mental Health Care under the Umbrella

Thu, 10Â JulÂ 2008 00:00:00 -05:00

For half a century, advocates and reformers have sought to ensure that mental illnesses are addressed in the same way as all other illnesses. Considerable progress has been made, and...

PERSPECTIVE: Why Doctors Should Worry about Preemption

Thu, 03Â JulÂ 2008 00:00:00 -05:00

A leading drug company may be poised to win a landmark legal victory next fall. If the drug manufacturer, Wyeth, prevails in a case soon to be argued before the...

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: 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;...

EDITORIAL: Peer Review in the Balance

Thu, 22Â MayÂ 2008 00:00:00 -05:00

For many years, the editors of the Journal have relied on peer review to ensure the scientific quality of the articles that we publish. Of the thousands of manuscripts submitted...

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: Vaccines and Autism Revisited â The Hannah Poling Case

Thu, 15Â MayÂ 2008 00:00:00 -05:00

On April 11, 2008, the National Vaccine Advisory Committee took an unusual step: in the name of transparency, trust, and collaboration, it asked members of the public to help set...

PERSPECTIVE: The FDA, Preemption, and the Supreme Court

Thu, 01Â MayÂ 2008 00:00:00 -05:00

Everyone would like to be immune from lawsuits. Legislatures sometimes provide immunity in order to advance important social policy goals. For example, by providing health care professionals with immunity under...

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...

SOUNDING BOARD: Pharmaceutical Promotion to Physicians and First Amendment Rights

Aaron S. Kesselheim, M.D., J.D., and Jerry Avorn, M.D. — Thu, 17Â AprÂ 2008 00:00:00 -05:00

In mid-February, the Food and Drug Administration (FDA) proposed a change in its rules governing pharmaceutical promotion that would widen the ability of drug manufacturers to distribute information on unapproved...

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...

EDITORIAL: Handgun Violence, Public Health, and the Law

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. — Thu, 03Â AprÂ 2008 00:00:00 -05:00

Firearms were used to kill 30,143 people in the United States in 2005, the most recent year with complete data from the Centers for Disease Control and Prevention.1 A total...

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...

PERSPECTIVE: Interpreting the Right to Bear Arms â Gun Regulation and Constitutional Law

Thu, 03Â AprÂ 2008 00:00:00 -05:00

On March 18, 2008, the U.S. Supreme Court heard oral arguments in District of Columbia v. Heller, a case challenging handgun-control statutes adopted in 1976 in Washington, D.C. The question...

PERSPECTIVE: Guns, Fear, the Constitution, and the Public's Health

Thu, 03Â AprÂ 2008 00:00:00 -05:00

It is 1992, and schoolmates Yoshihiro Hattori and Webb Haymaker have been invited to a Halloween party. Yoshi, a 16-year-old exchange student and avid dancer, wears a white tuxedo like...

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...

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: 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...

EDITORIAL: A Pivotal Medical-Device Case

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. — Thu, 03Â JanÂ 2008 00:00:00 -05:00

This spring the Supreme Court of the United States will decide whether premarketing approval of a medical device by the Food and Drug Administration (FDA) immunizes the manufacturer against product-liability...

PERSPECTIVE: Over the Counter but No Longer under the Radar â Pediatric Cough and Cold Medications

Thu, 06Â DecÂ 2007 00:00:00 -05:00

In recent weeks, over-the-counter cough and cold medications for children have received unprecedented attention from regulators, physicians, the media, and parents. This scrutiny represents a long-overdue reassessment of products that...

EDITORIAL: Lenalidomide â The Phoenix Rises

Alan F. List, M.D. — Thu, 22Â NovÂ 2007 00:00:00 -05:00

Perhaps the darkest memory in modern pharmaceutical history is that of the devastating effects of thalidomide exposure on fetal development. More than four decades later, thalidomide reemerged from the ashes...

PERSPECTIVE: The Fate of SCHIP â Surrogate Marker for Health Care Ideology?

Thu, 22Â NovÂ 2007 00:00:00 -05:00

To appreciate the power of the U.S. presidency â even when its current occupant's approval rating is only 31% â one need look no further than the political brawl over...

PERSPECTIVE: The Ongoing Regulation of Generic Drugs

Thu, 15Â NovÂ 2007 00:00:00 -05:00

Today, generic drugs account for 63% of all U.S. prescriptions for drugs (see Figure 1). Since generic drugs sell at substantially lower prices than their brand-name counterparts, they save consumers...

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: 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: Learning from Failure in Health Care Reform

Thu, 25Â OctÂ 2007 00:00:00 -05:00

Since 1994, inaction and incrementalism have governed U.S. health policy, with the predictable result that both health care spending and the number of uninsured Americans have reached record levels. Indeed,...

PERSPECTIVE: Thimerosal and Vaccines â A Cautionary Tale

Thu, 27Â SepÂ 2007 00:00:00 -05:00

In 1997, Frank Pallone, a U.S. congressman from New Jersey, attached a simple, 133-word amendment to a Food and Drug Administration (FDA) reauthorization bill. This amendment gave the FDA 2...

PERSPECTIVE: Cases in Vaccine Court â Legal Battles over Vaccines and Autism

Thu, 27Â SepÂ 2007 00:00:00 -05:00

Do childhood vaccines cause autism? This scientific question has now become a legal one â perhaps inevitable in our society. Some families with autistic children are pursuing legal channels in...

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: The Battle over SCHIP

Thu, 06Â SepÂ 2007 00:00:00 -05:00

Reauthorization of the State Children's Health Insurance Program (SCHIP), which was considered a routine matter until recently because of the program's success in expanding coverage to children of the working...

EDITORIAL: No Child Left Uncovered

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. — Thu, 06Â SepÂ 2007 00:00:00 -05:00

In the grand tradition of bare-knuckle American politics, the reauthorization of the State Children's Health Insurance Program (SCHIP), which provides health coverage for low-income children, has become part of a...

PERSPECTIVE: The Rosiglitazone Story â Lessons from an FDA Advisory Committee Meeting

Thu, 30Â AugÂ 2007 00:00:00 -05:00

On July 30, 2007, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) convened to discuss...

PERSPECTIVE: Regulation of Follow-on Biologics

Thu, 30Â AugÂ 2007 00:00:00 -05:00

Biopharmaceutical products, with U.S. sales in 2006 amounting to about $40.3 billion, are increasingly central to the treatment of major health problems affecting Americans.1 Since modern biopharmaceuticals date back to...

SPECIAL ARTICLE: A Decade of Direct-to-Consumer Advertising of Prescription Drugs

Julie M. Donohue, Ph.D., Marisa Cevasco, B.A., and Meredith B. Rosenthal, Ph.D. — Thu, 16Â AugÂ 2007 00:00:00 -05:00

Background: Evidence suggests that direct-to-consumer advertising of prescription drugs increases pharmaceutical sales and both helps to avert underuse of medicines and leads to potential overuse. Concern about such advertising has...

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...

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...

PERSPECTIVE: Legal Power and Legal Rights â Isolation and Quarantine in the Case of Drug-Resistant Tuberculosis

Thu, 02Â AugÂ 2007 00:00:00 -05:00

The recent case of Atlanta attorney Andrew Speaker has focused attention on the role of compulsory isolation and quarantine in tuberculosis control. In May, after being diagnosed with a drug-resistant...

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...

HEALTH POLICY REPORT: Insuring All Children â The New Political Imperative

John K. Iglehart — Thu, 05Â JulÂ 2007 00:00:00 -05:00

Efforts by the 110th Congress, which is commanded by Democrats eager to reduce the record number of people without health insurance, coupled with other federal and state initiatives,123 have thrust...

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...

EDITORIAL: Teratogenicity of SSRIs â Serious Concern or Much Ado about Little?

Michael F. Greene, M.D. — Thu, 28Â JunÂ 2007 00:00:00 -05:00

In the fall of 2005, GlaxoSmithKline called attention to recently collected safety data indicating an increased risk of major congenital malformations among infants exposed during organogenesis to GlaxoSmithKline's selective serotonin...

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: 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...

PERSPECTIVE: New York to Trans Fats: You're Out!

Thu, 17Â MayÂ 2007 00:00:00 -05:00

Ferrara CafÃ© in Manhattan's Little Italy is a century-old bakery steeped in tradition, but executive pastry chef Dennis Canciello has recently been tinkering with the recipes of two of the...

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: Politics, Parents, and Prophylaxis â Mandating HPV Vaccination in the United States

Thu, 10Â MayÂ 2007 00:00:00 -05:00

Cancer prevention has fallen victim to the culture wars. Throughout the United States, state legislatures are scrambling to respond to the availability of Merck's human papillomavirus (HPV) vaccine, Gardasil, and...

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...

PERSPECTIVE: PDUFA Reauthorization â Drug Safety's Golden Moment of Opportunity?

Thu, 26Â AprÂ 2007 00:00:00 -05:00

âThis [is] a golden moment of opportunity to improve fundamentally the way FDA regulation considers and responds to the evolving understanding of risks and benefits of drugs.â So claims the...

PERSPECTIVE: Drug Safety Reform at the FDA â Pendulum Swing or Systematic Improvement?

Thu, 26Â AprÂ 2007 00:00:00 -05:00

Every 5 or 10 years, Congress enacts major legislation addressing pressing issues at the Food and Drug Administration (FDA). This year, the biggest reforms since at least 1997 are expected....

PERSPECTIVE: Paying for Drug Approvals â Who's Using Whom?

Thu, 26Â AprÂ 2007 00:00:00 -05:00

Years ago, an administrator at a community hospital explained to me how well his institution's grand-rounds program worked. âThe drug companies find the speakers, pay their honoraria, and provide free...

PERSPECTIVE: Approving the Vagus-Nerve Stimulator for Depression

Thu, 19Â AprÂ 2007 00:00:00 -05:00

The vagus-nerve stimulator (VNS), a device that is implanted by a neurosurgeon and sends intermittent electrical pulses to the brain, has been marketed in the United States since 1997 as...

PERSPECTIVE: The FDA and the Case of Ketek

Thu, 19Â AprÂ 2007 00:00:00 -05:00

Three years ago, the Food and Drug Administration (FDA) approved the drug Ketek (telithromycin), lauding it as the first of a new class of antimicrobial agents that circumvent antibiotic resistance....

HEALTH POLICY REPORT: Medicaid Revisited â Skirmishes over a Vast Public Enterprise

John K. Iglehart — Thu, 15Â FebÂ 2007 00:00:00 -05:00

Medicaid, the federalâstate program that provides protection against the costs of acute and chronic illness for almost one of every five Americans, has once again come under closer scrutiny from...

HEALTH POLICY REPORT: Regulatory and Judicial Oversight of Nonprofit Hospitals

Thu, 08Â FebÂ 2007 00:00:00 -05:00

The modern hospital bears little resemblance to its ancestors. The charitable institutions of the 19th century mainly tended, rather than treated, the sick, and they served mostly poor patients, whereas...

PERSPECTIVE: Thailand and the Compulsory Licensing of Efavirenz

Thu, 08Â FebÂ 2007 00:00:00 -05:00

Of the many medicines for human immunodeficiency virus (HIV) infection, efavirenz, a nonnucleoside reverse-transcriptase inhibitor that became available in the late 1990s, is one of the most important. For the...

PERSPECTIVE: Taking TRIPS to India â Novartis, Patent Law, and Access to Medicines

Thu, 08Â FebÂ 2007 00:00:00 -05:00

In August and September 2006, patients with cancer, lawyers for patient advocacy groups, and representatives of nongovernmental organizations (NGOs) converged on the offices of Novartis in Mumbai, India, to protest...

PERSPECTIVE: HIV Injustice in Libya â Scapegoating Foreign Medical Professionals

Thu, 14Â DecÂ 2006 00:00:00 -05:00

On December 19, 2006, a Libyan court is scheduled to announce its verdict in the trial of five Bulgarian nurses and one Palestinian doctor who have languished in prison for...

PERSPECTIVE: The Ethics and Politics of Compulsory HPV Vaccination

Thu, 07Â DecÂ 2006 00:00:00 -05:00

On September 12, 2006, 3 months after the Food and Drug Administration licensed a vaccine against human papillomavirus (HPV), Michigan lawmakers became the first in the United States to propose...

PERSPECTIVE: Observational Studies of Drug Safety â Aprotinin and the Absence of Transparency

Thu, 23Â NovÂ 2006 00:00:00 -05:00

The full safety profile of a new drug is rarely known at the time of approval by the Food and Drug Administration (FDA). Most drug-development programs designed for treatments of...

PERSPECTIVE: Dangerous Deception â Hiding the Evidence of Adverse Drug Effects

Thu, 23Â NovÂ 2006 00:00:00 -05:00

September 30 is becoming a day of infamy for drug safety. On that date in 2004, Merck announced that rofecoxib (Vioxx) doubled the risk of myocardial infarction and stroke, and...

HEALTH POLICY REPORT: Medical-Process Patents â Monopolizing the Delivery of Health Care

Aaron S. Kesselheim, M.D., J.D., and Michelle M. Mello, J.D., Ph.D. — Thu, 09Â NovÂ 2006 00:00:00 -05:00

Patents have helped promote innovation for centuries, but the modern application of patents to the field of medicine raises legal and ethical questions. Patents covering pharmaceutical products and medical research...

EDITORIAL: Blueprint for a Stronger Food and Drug Administration

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. — Thu, 26Â OctÂ 2006 00:00:00 -05:00

Over the past 5 years, a series of recalls of high-profile prescription medications has aroused serious concern about the safety of the nation's drug supply. Faced with a crisis of...

PERSPECTIVE: Protecting the Health of the Public â Institute of Medicine Recommendations on Drug Safety

Thu, 26Â OctÂ 2006 00:00:00 -05:00

Soon after rofecoxib had been withdrawn from the market in September 2004, hearings of the Senate Finance Committee and editorials in the lay and medical press raised serious questions about...

HEALTH POLICY REPORT: FDA Regulation of Stem-CellâBased Therapies

Dina Gould Halme, Ph.D., and David A. Kessler, M.D. — Thu, 19Â OctÂ 2006 00:00:00 -05:00

In the interest of public safety, the Food and Drug Administration (FDA) has jurisdiction over the production and marketing of any stem-cellâbased therapy involving the transplantation of human cells into...

PERSPECTIVE: Surviving Sepsis â Practice Guidelines, Marketing Campaigns, and Eli Lilly

Thu, 19Â OctÂ 2006 00:00:00 -05:00

Practice guidelines approved by expert panels are intended to standardize care in such a way as to improve health outcomes. In recent years, the developers of such standards have started...

PERSPECTIVE: Single-Cell Storm

Thu, 19Â OctÂ 2006 00:00:00 -05:00

Scientists at Advanced Cell Technology, a California company, reported in August that a single cell taken from an eight-cell human embryo can sometimes be coaxed to produce embryonic stem cells,...

PERSPECTIVE: Stem-Cell Politics

Thu, 19Â OctÂ 2006 00:00:00 -05:00

In Missouri this election season, former Republican Senator John Danforth, an Episcopal priest and abortion opponent, is citing the New Testament in support of a state constitutional amendment protecting the...

PERSPECTIVE: Body of Research â Ownership and Use of Human Tissue

Thu, 12Â OctÂ 2006 00:00:00 -05:00

Nearly 20 years after the California courts decided Moore v. Regents â a seminal case concerning a patient's interest in the profits derived from patents on a cell line generated...

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Hunger Strikes at Guantanamo â Medical Ethics and Human Rights in a âLegal Black Holeâ

George J. Annas, J.D., M.P.H. — Thu, 28Â SepÂ 2006 00:00:00 -05:00

Being Human, a collection of readings assembled by President George W. Bush's Council on Bioethics, contains a powerful description of the force-feeding of Soviet political prisoner Vladimir Bukovsky, who was...

PERSPECTIVE: Delaying Generic Competition â Corporate Payoffs and the Future of Plavix

Thu, 28Â SepÂ 2006 00:00:00 -05:00

In August, pharmacies began selling a cheaper, generic version of the blockbuster antiplatelet agent Plavix (clopidogrel). This was good news for patients with cardiac disease or stroke who cannot afford...

PERSPECTIVE: Bit Player or Powerhouse? China and Stem-Cell Research

Thu, 21Â SepÂ 2006 00:00:00 -05:00

For more than a decade, China has been shocking the West. Although it is still poor and officially Communist, the world's most populous country has turned old convictions on their...

PERSPECTIVE: The Politics and Promise of Stem-Cell Research

Thu, 21Â SepÂ 2006 00:00:00 -05:00

On July 19, 2006, President George W. Bush exercised his constitutional prerogative to veto a congressional act for the first time in the 6 years he has been in office....

SOUNDING BOARD: A Proposal for Radical Changes in the Drug-Approval Process

Alastair J.J. Wood, M.D. — Thu, 10Â AugÂ 2006 00:00:00 -05:00

Drug development is the process by which new therapies are created and brought to market to treat diseases. It is hard to imagine that such an activity would not be...

PERSPECTIVE: Preimplantation Diagnosis for Genetic Susceptibility

Thu, 10Â AugÂ 2006 00:00:00 -05:00

On May 10, 2006, the regulator of assisted reproduction in the United Kingdom â the Human Fertilisation and Embryology Authority (HFEA) â decided to include susceptibilities to certain cancers in...

PERSPECTIVE: Access before Approval â A Right to Take Experimental Drugs?

Thu, 03Â AugÂ 2006 00:00:00 -05:00

A surprising court decision this past May has advanced an effort to allow terminally ill people to purchase experimental drugs after initial safety testing but before they have been shown...

EDITORIAL: Paying for Performance in the United States and Abroad

Arnold M. Epstein, M.D. — Thu, 27Â JulÂ 2006 00:00:00 -05:00

The British sometimes have been characterized as steadfast, measured, tolerant of bus queues and surgical waiting lists, and perhaps even a bit stodgy. Parts of this portrait may be accurate,...

PERSPECTIVE: The Price of Growth in the Medical-Device Industry

Thu, 27Â JulÂ 2006 00:00:00 -05:00

In one of the most dramatic corporate acquisitions in recent memory, Boston Scientific, a large manufacturer of medical devices, outbid industry giant Johnson & Johnson to purchase Guidant Corporation earlier...

PERSPECTIVE: Language Barriers to Health Care in the United States

Thu, 20Â JulÂ 2006 00:00:00 -05:00

A 12-year-old Latino boy arrived at a Boston emergency department with dizziness and a headache. The patient, whom I'll call Raul, had limited proficiency in English; his mother spoke no...

HEALTH POLICY REPORT: Employer-Sponsored Health Insurance in the United States â Origins and Implications

David Blumenthal, M.D., M.P.P. — Thu, 06Â JulÂ 2006 00:00:00 -05:00

Varied as they may be, most U.S. readers of the Journal probably share at least one thing: employer-sponsored health insurance is vital to their well-being. For their part, most physicians,...

PERSPECTIVE: Plan B, Reproductive Rights, and Physician Activism

Thu, 06Â JulÂ 2006 00:00:00 -05:00

Last year, I gave one of my patients a prescription for emergency contraception. When she presented it at a Wal-Mart pharmacy, she was turned away empty-handed. This mother of three,...

PERSPECTIVE: versus Reality â Abortion and Women's Health

Thu, 06Â JulÂ 2006 00:00:00 -05:00

Sandra Jones was on her way to a Nebraska operating room to have an abscess drained when she learned that, once again, she had defied medical odds. Six months earlier,...

PERSPECTIVE: For Sale: Physicians' Prescribing Data

Thu, 29Â JunÂ 2006 00:00:00 -05:00

Since the early 1990s, health care information companies have bought electronic records of prescriptions from pharmacies and other sources and linked them with information about doctors that is licensed from...

LEGAL ISSUES IN MEDICINE: Bioterror and âBioartâ â A Plague o' Both Your Houses

George J. Annas, J.D., M.P.H. — Thu, 22Â JunÂ 2006 00:00:00 -05:00

Since September 11, 2001, the threat of bioterrorism has caused Congress and the President to dramatically increase research funding for countermeasures, including funding for new biosecurity laboratories. The new kind...

PERSPECTIVE: Condoms and Sexually-Transmitted Infections

Thu, 22Â JunÂ 2006 00:00:00 -05:00

Polarization of opinion about condoms may finally be starting to abate, as scientific evidence mounts that their use can reduce the risk of most sexually transmitted infections, including human immunodeficiency...

HEALTH POLICY REPORT: Obesity â The New Frontier of Public Health Law

Thu, 15Â JunÂ 2006 00:00:00 -05:00

The law is now firmly established as a powerful instrument of public health.1 Some of the most important public health victories in the United States in the past century â...

PERSPECTIVE: New Technology, Old Dilemma â Monitoring EEG Activity during Executions

Thu, 15Â JunÂ 2006 00:00:00 -05:00

On April 21, 2006, Willie Brown, Jr., was executed by lethal injection in North Carolina for the 1983 killing of a convenience-store clerk. The execution might have received little attention...

LEGAL ISSUES IN MEDICINE: Intelligent Judging â Evolution in the Classroom and the Courtroom

George J. Annas, J.D., M.P.H. — Thu, 25Â MayÂ 2006 00:00:00 -05:00

Religious arguments have permeated debates on the role of the law in medical practice at the beginning and the end of life. But nowhere has religion played so prominent a...

PERSPECTIVE: Making Patient Safety the Centerpiece of Medical Liability Reform

Thu, 25Â MayÂ 2006 00:00:00 -05:00

We have visited doctors and hospitals throughout the country and heard firsthand from those who face ever-escalating insurance costs. Indeed, in some specialties, high premiums are forcing physicians to give...

SOUNDING BOARD: The Patient's Right to Safety â Improving the Quality of Care through Litigation against Hospitals

George J. Annas, J.D., M.P.H. — Thu, 11Â MayÂ 2006 00:00:00 -05:00

It is the consensus of experts in the patient-safety field that little has changed to improve the safety of hospital care since the Institute of Medicine's 1999 report, To Err...

SPECIAL ARTICLE: Claims, Errors, and Compensation Payments in Medical Malpractice Litigation

Thu, 11Â MayÂ 2006 00:00:00 -05:00

Background: In the current debate over tort reform, critics of the medical malpractice system charge that frivolous litigation â claims that lack evidence of injury, substandard care, or both â...

PERSPECTIVE: Access to the Scientific Literature â A Difficult Balance

Thu, 13Â AprÂ 2006 00:00:00 -05:00

During the past decade, scientific publications have increasingly become available on the Internet, where they can be used by far more readers than print journals have ever reached. In The...

PERSPECTIVE: Politics and Independence â The Collapse of the

Thu, 30Â MarÂ 2006 00:00:00 -05:00

On February 20, 2006, when John Hoey, editor-in-chief of the Canadian Medical Association Journal (CMAJ), returned to the Ottawa headquarters of the Canadian Medical Association (CMA) after a vacation, his...

PERSPECTIVE: The Supreme Court and the Purposes of Medicine

Thu, 09Â MarÂ 2006 00:00:00 -05:00

What role should physicians have in defining the purposes of their profession â the functions that medicine should and should not serve? Many observers hold that medicine's aims are for...

LEGAL ISSUES IN MEDICINE: Congress, Controlled Substances, and Physician-Assisted Suicide â Elephants in Mouseholes

George J. Annas, J.D., M.P.H. — Thu, 09Â MarÂ 2006 00:00:00 -05:00

The U.S. Supreme Court's decision in Gonzales v. Oregon to reject the U.S. attorney general's authority to prohibit physicians in Oregon from prescribing Schedule II drugs for their terminally ill...

SPECIAL ARTICLE: Changes in Abortions and Births and the Texas Parental Notification Law

Theodore Joyce, Ph.D., Robert Kaestner, Ph.D., and Silvie Colman, B.B.A. — Thu, 09Â MarÂ 2006 00:00:00 -05:00

Background: On January 1, 2000, Texas began enforcement of a law that requires physicians to notify a parent of a minor child seeking an abortion at least 48 hours before...

PERSPECTIVE: Adopting Orphan Drugs â Two Dozen Years of Treating Rare Diseases

Thu, 02Â FebÂ 2006 00:00:00 -05:00

In 1982, when the Orphan Drug Act was passed as an amendment to the Federal Food, Drug, and Cosmetic Act,1 few suspected the extent to which this law would alleviate...

SOUNDING BOARD: Reform of Drug Regulation â Beyond an Independent Drug-Safety Board

Wayne A. Ray, Ph.D., and C. Michael Stein, M.B., B.Ch. — Thu, 12Â JanÂ 2006 00:00:00 -05:00

Recent withdrawals from the market of high-profile drugs have led to a reexamination of the process of drug regulation and have stimulated concern that the current process is inadequate for...

PERSPECTIVE: The Big Chill â Inserting the DEA into End-of-Life Care

Thu, 05Â JanÂ 2006 00:00:00 -05:00

On October 5, 2005, the U.S. Supreme Court heard oral arguments in Gonzales v. Oregon. On the surface, this case is about the legitimacy of physicians' prescribing of medications under...

EDITORIAL: Registries and Registration of Clinical Trials

Charlotte Haug, M.D., Peter C. GÃ¸tzsche, M.D., and Torben V. Schroeder, M.D. — Thu, 29Â DecÂ 2005 00:00:00 -05:00

The arguments in favor of the registration of clinical trials are now familiar.1234 Chief among these addresses the practice of selective reporting, whereby negative or detrimental studies are not brought...

EDITORIAL: Trial Registration Report Card

Jeffrey M. Drazen, M.D., and Alastair J.J. Wood, M.D. — Thu, 29Â DecÂ 2005 00:00:00 -05:00

One measure of medical progress is new treatments. The discovery of a novel therapy takes time and money, but more important, it requires the mutual effort of groups that, while...

SPECIAL ARTICLE: Trial Registration at ClinicalTrials.gov between May and October 2005

Deborah A. Zarin, M.D., Tony Tse, Ph.D., and Nicholas C. Ide, M.S. — Thu, 29Â DecÂ 2005 00:00:00 -05:00

Background: Clinical trial registration allows interested parties to obtain information about ongoing and completed trials, but there are few data indicating the quality of the information provided during the registration...

EDITORIAL: Professional Behavior â A Learner's Permit for Licensure

Lynne M. Kirk, M.D., and Linda L. Blank — Thu, 22Â DecÂ 2005 00:00:00 -05:00

At probably no point in the history of modern medicine have physicians and medical educators been pulled by so many demands of accountability from such diverse constituencies. Although these demands...

SPECIAL ARTICLE: Disciplinary Action by Medical Boards and Prior Behavior in Medical School

Thu, 22Â DecÂ 2005 00:00:00 -05:00

Background: Evidence supporting professionalism as a critical measure of competence in medical education is limited. In this caseâcontrol study, we investigated the association of disciplinary action against practicing physicians with...

LEGAL ISSUES IN MEDICINE: Jumping Frogs, Endangered Toads, and California's Medical-Marijuana Law

George J. Annas, J.D., M.P.H. — Thu, 24Â NovÂ 2005 00:00:00 -05:00

Mark Twain wasn't thinking about federalism or the structure of American government when he wrote âThe Celebrated Jumping Frog of Calaveras County.â1 Nonetheless, he would be amused to know that...

PERSPECTIVE: Hostile Use of the Life Sciences

Thu, 24Â NovÂ 2005 00:00:00 -05:00

All technological advancements â from knives and forks to airplanes and rockets â have been exploited for destructive ends. Inherent in every scientific discovery is the âdual useâ dilemma: the...

PERSPECTIVE: Biomedical Research and Biosecurity

Thu, 24Â NovÂ 2005 00:00:00 -05:00

Even as they have advanced our understanding and treatment of disease, the achievements of modern biomedical research have also increased people's ability to misuse discoveries in ways that could threaten...

PERSPECTIVE: Women's Health and the FDA

Susan F. Wood, Ph.D. — Thu, 20Â OctÂ 2005 00:00:00 -05:00

Science commits suicide when it adopts a creed.

â Thomas Henry Huxley1

On August 31, 2005, I resigned my post of assistant commissioner for women's health and director of the Office of...

PERSPECTIVE: An Offshore Haven for Human Embryonic Stem-Cell Research?

Susan Okie, M.D. — Thu, 20Â OctÂ 2005 00:00:00 -05:00

U.S. scientists studying human embryonic stem cells face unprecedented political, regulatory, and financial barriers created by the Bush administration's restrictive policies and by the ongoing national debate over the ethics...

PERSPECTIVE: Medicaid â Implications for the Health Safety Net

Diane Rowland, Sc.D. — Thu, 06Â OctÂ 2005 00:00:00 -05:00

Today, Medicaid helps to finance health and long-term care for more than 55 million low-income children and parents, people with severe disabilities, and elderly Americans, at an annual cost of...

PERSPECTIVE: The Justice Department's Case against the Tobacco Companies

Thu, 08Â SepÂ 2005 00:00:00 -05:00

The case brought by the Department of Justice against the tobacco industry â the largest civil litigation in U.S. history â has become mired in controversy. Projections suggest that about...

PERSPECTIVE: FDA Standards â Good Enough for Government Work?

Jerry Avorn, M.D. — Thu, 08Â SepÂ 2005 00:00:00 -05:00

The clichÃ© âgood enough for government workâ implies that lower standards are acceptable for a job sponsored by a public agency. But in biomedical research, the opposite is usually true....

SOUNDING BOARD: Regulating AcademicâIndustrial Research Relationships â Solving Problems or Stifling Progress?

Thomas P. Stossel, M.D. — Thu, 08Â SepÂ 2005 00:00:00 -05:00

Biomedical research takes place in university health centers, in government laboratories, and in the laboratories of pharmaceutical and medical-device companies, but only industry translates the research into products. Until the...

PERSPECTIVE: Linking Compensation to Quality â Medicare Payments to Physicians

John K. Iglehart — Thu, 01Â SepÂ 2005 00:00:00 -05:00

Sometime after Congress reconvenes in September, it will consider legislation to eliminate a scheduled reduction of 4.3 percent in Medicare fee-for-service payments to physicians â but there is a trade-off....

PERSPECTIVE: Banning Genetic Discrimination

Henry T. Greely, J.D. — Thu, 01Â SepÂ 2005 00:00:00 -05:00

On February 17, 2005, the U.S. Senate passed bill S. 306, the Genetic Information Nondiscrimination Act of 2005, by a vote of 98 to 0. The previous day, the White...

PERSPECTIVE: Medical Marijuana and the Supreme Court

Susan Okie, M.D. — Thu, 18Â AugÂ 2005 00:00:00 -05:00

Angel McClary Raich, a California woman at the center of the recent Supreme Court case on medical marijuana, hasn't changed her treatment regimen since the Court ruled in June that...

SOUNDING BOARD: Medicare and Chronic Conditions

Gerard F. Anderson, Ph.D. — Thu, 21Â JulÂ 2005 00:00:00 -05:00

When the Medicare program became operational in 1966, its primary orientation was the treatment of acute, episodic illness.12 The design of the program's benefits, coverage policies, payments to providers, and...

PERSPECTIVE: The Controversy over Guidant's Implantable Defibrillators

Robert Steinbrook, M.D. — Thu, 21Â JulÂ 2005 00:00:00 -05:00

On October 4, 2001, Joshua Oukrop, a Minnesota teenager with hypertrophic cardiomyopathy and a high risk of sudden death from ventricular fibrillation, received an implantable cardioverterâdefibrillator (ICD). The device was...

PERSPECTIVE: Financial Conflicts of Interest and the Food and Drug Administration's Advisory Committees

Robert Steinbrook, M.D. — Thu, 14Â JulÂ 2005 00:00:00 -05:00

Advisory committees to the Food and Drug Administration (FDA) help the agency make decisions about the approval of medications and medical devices, among other issues. Membership on these committees is...

PERSPECTIVE: Doctors and Interrogators at Guantanamo Bay

M. Gregg Bloche, M.D., J.D., and Jonathan H. Marks, M.A., B.C.L. — Thu, 07Â JulÂ 2005 00:00:00 -05:00

Mounting evidence from many sources, including Pentagon documents, indicates that military interrogators at Guantanamo Bay have used aggressive counter-resistance measures in systematic fashion to pressure detainees to cooperate. These measures...

PERSPECTIVE: Stem-Cell Research â Signposts and Roadblocks

Susan Okie, M.D. — Thu, 07Â JulÂ 2005 00:00:00 -05:00

Embryonic stem-cell research, more than virtually any other scientific field, has been mired in political and ethical controversy. In recent weeks, however, important movement has occurred on ethical, scientific, and...

PERSPECTIVE: DNA as Evidence â The Technology of Identification

Peter Gill, Ph.D. — Thu, 30Â JunÂ 2005 00:00:00 -05:00

In 1983, in a village near Leicester, England, a local girl named Lynda Mann was found raped and murdered. Three years later, a second girl, Dawn Ashworth, was found dead...

PERSPECTIVE: Genetic Justice

Mark A. Rothstein, J.D. — Thu, 30Â JunÂ 2005 00:00:00 -05:00

On December 21, 2004, Brandon Moon was released from prison in El Paso, Texas, after having served 16 years of a 75-year sentence for three counts of aggravated sexual assault....

PERSPECTIVE: The Lessons of Vioxx â Drug Safety and Sales

Henry A. Waxman, J.D. — Thu, 23Â JunÂ 2005 00:00:00 -05:00

On November 23, 2000, the results of the Vioxx Gastrointestinal Outcomes Research study, known as VIGOR, were published in the Journal. This randomized, controlled trial showed that rofecoxib, an inhibitor...

PERSPECTIVE: Torcetrapib and Atorvastatin â Should Marketing Drive the Research Agenda?

Jerry Avorn, M.D. — Thu, 23Â JunÂ 2005 00:00:00 -05:00

In light of the success of the statin drugs, interest in preventive cardiology has shifted to new frontiers of pharmacologic intervention: defining optimal levels of low-density lipoprotein (LDL) cholesterol, inhibiting...

PERSPECTIVE: The Celestial Fire of Conscience â Refusing to Deliver Medical Care

R. Alta Charo, J.D. — Thu, 16Â JunÂ 2005 00:00:00 -05:00

Apparently heeding George Washington's call to âlabor to keep alive in your breast that little spark of celestial fire called conscience,â physicians, nurses, and pharmacists are increasingly claiming a right...

EDITORIAL: Is This Clinical Trial Fully Registered? â A Statement from the International Committee of Medical Journal Editors

Thu, 09Â JunÂ 2005 00:00:00 -05:00

In September 2004, the members of the International Committee of Medical Journal Editors (ICMJE) published a joint editorial aimed at promoting registration of all clinical trials.1 We stated that we...

PERSPECTIVE: Patients in a Persistent Vegetative State â A Dutch Perspective

Inez de Beaufort, Ph.D. — Thu, 09Â JunÂ 2005 00:00:00 -05:00

He is 31 years old now â Henk-Jan, the son of Gerard and Ineke Stinissen. He is the son Ineke Stinissen never knew. In 1974, as the result of a...

PERSPECTIVE: Managing Conflict at the End of Life

M. Gregg Bloche, M.D., J.D. — Thu, 09Â JunÂ 2005 00:00:00 -05:00

The media spectacle that surrounded the dying of Terri Schiavo is now two months past, and America's culture warriors have moved on to other battlegrounds. Much has been said about...

SPECIAL ARTICLE: Academic Medical Centers' Standards for Clinical-Trial Agreements with Industry

Thu, 26Â MayÂ 2005 00:00:00 -05:00

Background: Although industry sponsors provide approximately 70 percent of the funding for clinical drug trials in the United States, little is known about the legal agreements that exist between industry...

PERSPECTIVE: Gag Clauses in Clinical-Trial Agreements

Robert Steinbrook, M.D. — Thu, 26Â MayÂ 2005 00:00:00 -05:00

Gag clauses in clinical-trial agreements prevent investigators from examining the data independently or submitting a manuscript for publication without first obtaining the consent of the sponsor. Sponsors with a financial...

LEGAL ISSUES IN MEDICINE: Unspeakably Cruel â Torture, Medical Ethics, and the Law

George J. Annas, J.D., M.P.H. — Thu, 19Â MayÂ 2005 00:00:00 -05:00

Torture is a particularly horrible crime, and any participation of physicians in torture has always been difficult to comprehend. As General Telford Taylor explained to the American judges at the...

LEGAL ISSUES IN MEDICINE: âCulture of Lifeâ Politics at the Bedside â The Case of Terri Schiavo

George J. Annas, J.D., M.P.H. — Thu, 21Â AprÂ 2005 00:00:00 -05:00

For the first time in the history of the United States, Congress met in a special emergency session on Sunday, March 20, to pass legislation aimed at the medical care...

PERSPECTIVE: The Million Dollar Question

Timothy E. Quill, M.D. — Thu, 21Â AprÂ 2005 00:00:00 -05:00

If you haven't seen Million Dollar Baby and plan to do so, stop reading. There is much to like about the film. As a father of athletic young women, I...

PERSPECTIVE: Terri Schiavo â A Tragedy Compounded

Timothy E. Quill, M.D. — Thu, 21Â AprÂ 2005 00:00:00 -05:00

The story of Terri Schiavo should be disturbing to all of us. How can it be that medicine, ethics, law, and family could work so poorly together in meeting the...

PERSPECTIVE: Physician-Assisted Suicide â Oregon and Beyond

Susan Okie, M.D. — Thu, 21Â AprÂ 2005 00:00:00 -05:00

In February, the U.S. Supreme Court agreed to consider the legality of the Bush administration's effort to outlaw physician-assisted suicide in Oregon, raising the possibility that a ruling by the...

PERSPECTIVE: The Cutter Incident, 50 Years Later

Paul A. Offit, M.D. — Thu, 07Â AprÂ 2005 00:00:00 -05:00

On April 12, 1955, Jonas Salk's polio vaccine â made by inactivating poliovirus with formaldehyde â was declared to be safe and effective. The trial of Salk's vaccine had included...

PERSPECTIVE: The Uncertain Future of Specialty Hospitals

John K. Iglehart — Thu, 07Â AprÂ 2005 00:00:00 -05:00

In November 2003, Congress enacted legislation that imposed an 18-month moratorium on the development of new specialty hospitals that are partly owned by physicians who refer their patients to them.1...

PERSPECTIVE: Herbal Medicine in Europe â Relaxing Regulatory Standards

Peter A.G.M. De Smet, Pharm.D., Ph.D. — Thu, 24Â MarÂ 2005 00:00:00 -05:00

Herbal medicine is big â and relatively mainstream â business in Europe: in 2003, European countries spent almost $5 billion (at manufacturers' prices to wholesalers) on over-the-counter herbal medicines. But...

PERSPECTIVE: Safety in Numbers â Monitoring Risk in Approved Drugs

Susan Okie, M.D. — Thu, 24Â MarÂ 2005 00:00:00 -05:00

In most cases, when a new drug is approved, almost everything known about its safety in humans is based on the responses of a few thousand people who took it...

PERSPECTIVE: What Ails the FDA?

Susan Okie, M.D. — Thu, 17Â MarÂ 2005 00:00:00 -05:00

Testifying before a spellbound audience in a Senate hearing room this past November, scientist and whistle-blower David J. Graham charged that his employer, the Food and Drug Administration (FDA), is...

PERSPECTIVE: Overbilling vs. Downcoding â The Battle between Physicians and Insurers

Aaron S. Kesselheim, M.D., J.D., and Troyen A. Brennan, M.D., M.P.H. — Thu, 03Â MarÂ 2005 00:00:00 -05:00

In September 2004, a federal appeals court upheld a class-action lawsuit on behalf of physicians who charged that their patients' insurance companies had conspired to curb reimbursement for the physicians'...

PERSPECTIVE: Individual Rights versus the Public's Health â 100 Years after v.

Thu, 17Â FebÂ 2005 00:00:00 -05:00

On February 20, 1905, ruling in Jacobson v. Massachusetts, the U.S. Supreme Court upheld the right of the city of Cambridge, Massachusetts, to mandate vaccination against smallpox. Rejecting the contention...

LEGAL ISSUES IN MEDICINE: Family Privacy and Death â Antigone, War, and Medical Research

George J. Annas, J.D., M.P.H. — Thu, 03Â FebÂ 2005 00:00:00 -05:00

Death ends the doctorâpatient relationship, and legally the patient's right of privacy dies with the patient. Other privacy interests survive, the most central of which are those of the patient's...

PERSPECTIVE: Illness and Secrecy on the Supreme Court

Susan Okie, M.D. — Thu, 23Â DecÂ 2004 00:00:00 -05:00

Last October, soon after the opening of the current Supreme Court term, a lawyer who often argues cases before the Court noted with surprise that Chief Justice William Rehnquist was...

LEGAL ISSUES IN MEDICINE: Extremely Preterm Birth and Parental Authority to Refuse Treatment â The Case of Sidney Miller

George J. Annas, J.D., M.P.H. — Thu, 11Â NovÂ 2004 00:00:00 -05:00

Disputes between physicians and patients over medical care have tended toward resolution in both the courts and ethics committees, with each of these bodies ultimately deciding that the informed, competent...

SOUNDING BOARD: The Limits of Conscientious Objection â May Pharmacists Refuse to Fill Prescriptions for Emergency Contraception?

Julie Cantor, J.D., and Ken Baum, M.D., J.D. — Thu, 04Â NovÂ 2004 00:00:00 -05:00

Health policy decisions are often controversial, and the recent determination by the Food and Drug Administration (FDA) not to grant over-the-counter status to the emergency contraceptive Plan B was no...

LEGAL ISSUES IN MEDICINE: Financial Conflicts of Interest in Physicians' Relationships with the Pharmaceutical Industry â Self-Regulation in the Shadow of Federal Prosecution

Thu, 28Â OctÂ 2004 00:00:00 -05:00

The past two years have witnessed extraordinary regulatory ferment in the area of conflicts of interest involving physicians, especially conflicts arising in relationships with the pharmaceutical industry. Professional regulatory bodies,...

HEALTH POLICY REPORT: Doctors and Drug Companies

David Blumenthal, M.D., M.P.P. — Thu, 28Â OctÂ 2004 00:00:00 -05:00

When a great profession and the forces of capitalism interact, drama is likely to result. This has certainly been the case where the profession of medicine and the pharmaceutical industry...

PERSPECTIVE: Registration of Clinical Trials â Voluntary or Mandatory?

Robert Steinbrook, M.D. — Thu, 28Â OctÂ 2004 00:00:00 -05:00

Should the public registration of clinical trials be voluntary or mandatory, as bills introduced earlier this month in Congress would require? What trials should be included? Proposals for mandatory registration...

PERSPECTIVE: Health Care Coverage and Drug Costs â The Candidates Speak Out

George W. Bush and John F. Kerry — Thu, 28Â OctÂ 2004 00:00:00 -05:00

The editors asked President George W. Bush and Senator John F. Kerry to respond to two questions regarding health care in the United States. The questions and their responses follow.

(Figure)

The...

PERSPECTIVE: Corporate Treatment for the Ills of Academic Medicine

Alan M. Garber, M.D., Ph.D. — Thu, 14Â OctÂ 2004 00:00:00 -05:00

These are anxious times for academic medical centers, which have reacted to recent developments with measures that were beyond contemplation in a more optimistic past. Confronted by the challenges of...

PERSPECTIVE: Medical Marijuana, Physician-Assisted Suicide, and the Controlled Substances Act

Robert Steinbrook, M.D. — Thu, 30Â SepÂ 2004 00:00:00 -05:00

The Controlled Substances Act is a 1970 law designed to prevent drug abuse and trafficking and to control the authorized distribution of narcotics, barbiturates, and other scheduled drugs. Nearly 35...

PERSPECTIVE: The Tobacco Buyout and the FDA

Steven A. Schroeder, M.D. — Thu, 30Â SepÂ 2004 00:00:00 -05:00

An unlikely alliance between tobacco growers and tobacco-control advocates will be tested this fall, as a congressional conference committee attempts to reconcile separate versions of tobacco legislation that the House...

PERSPECTIVE: Prescription-Drug Prices

Richard G. Frank, Ph.D. — Thu, 30Â SepÂ 2004 00:00:00 -05:00

In 2002, the United States spent $162.4 billion on prescription drugs. Government has traditionally played a smaller role in purchasing prescription drugs than in paying for health care services overall,1...

LEGAL ISSUES IN MEDICINE: The Supreme Court's Limitation of Managed-Care Liability

Wendy K. Mariner, J.D., M.P.H. — Thu, 23Â SepÂ 2004 00:00:00 -05:00

On June 21, 2004, in the combined cases of Aetna Health Inc. v. Davila and CIGNA HealthCare of Texas Inc. v. Calad, the U.S. Supreme Court effectively immunized managed-care organizations...

PERSPECTIVE: Back to the '90s â The Supreme Court Immunizes Managed Care

M. Gregg Bloche, M.D., J.D. — Thu, 23Â SepÂ 2004 00:00:00 -05:00

Should the law let patients sue health plans for damages when plans deny coverage and bad results ensue? A June ruling by the U.S. Supreme Court has returned this question...

PERSPECTIVE: Match Point?

Alexi A. Wright, M.D., and Ingrid T. Katz, M.D., M.H.S. — Thu, 16Â SepÂ 2004 00:00:00 -05:00

Last month, a federal district judge in Washington, D.C., dismissed the first antitrust lawsuit filed by medical residents. In an unusual twist, Congress retroactively granted residency programs and hospitals immunity...

PERSPECTIVE: Conflicts of Interest at the NIH â Resolving the Problem

Robert Steinbrook, M.D. — Thu, 02Â SepÂ 2004 00:00:00 -05:00

Since December 2003, the National Institutes of Health (NIH) has been battered by accounts of the outside financial arrangements between some of its employees and pharmaceutical companies â and hence...

PERSPECTIVE: The Antibiotic Pipeline â Challenges, Costs, and Values

Richard P. Wenzel, M.D. — Thu, 05Â AugÂ 2004 00:00:00 -05:00

In 1941, Skinner and Keefer vividly chronicled an astonishing 82 percent mortality among 122 consecutive patients who had been treated for Staphylococcus aureus bacteremia in the preantibiotic era.1 Of the...

PERSPECTIVE: Public Registration of Clinical Trials

Robert Steinbrook, M.D. — Thu, 22Â JulÂ 2004 00:00:00 -05:00

For many years, the registration in a public data bank of all clinical trials â from start to completion and reporting of results â has seemed a quixotic quest of...

LEGAL ISSUES IN MEDICINE: Forcible Medication for Courtroom Competence â The Case of Charles Sell

George J. Annas, J.D., M.P.H. — Thu, 27Â MayÂ 2004 00:00:00 -05:00

The right to refuse treatment is firmly recognized in U.S. law.1 Competent persons have the legal right to refuse treatment, even life-sustaining treatment, and incompetent patients can also refuse treatment...

PERSPECTIVE: Dying and Decision Making â Evolution of End-of-Life Options

Timothy E. Quill, M.D. — Thu, 13Â MayÂ 2004 00:00:00 -05:00

I recently helped my father to die. He was an engineer, independent, always on the go and in charge. He began to deteriorate rapidly from an ill-defined dementing illness, and...

EDITORIAL: The FDA, Politics, and Plan B

Jeffrey M. Drazen, M.D., Michael F. Greene, M.D., and Alastair J.J. Wood, M.D. — Thu, 08Â AprÂ 2004 00:00:00 -05:00

The recent decision by the Food and Drug Administration (FDA) to postpone a decision on the proposal to switch levonorgestrel emergency contraception (sold under the brand name Plan B) to...

HEALTH POLICY REPORT: Science, Politics, and Federal Advisory Committees

Robert Steinbrook, M.D. — Thu, 01Â AprÂ 2004 00:00:00 -05:00

About 1000 committees advise the federal government. Many of them address scientific, technical, and medical issues. There is a continuing dispute about whether the administration of President George W. Bush...

PERSPECTIVE: Counterfeit Drugs

Paul M. Rudolf, M.D., J.D., and Ilisa B.G. Bernstein, Pharm.D., J.D. — Thu, 01Â AprÂ 2004 00:00:00 -05:00

In May 2002, thousands of vials of Procrit (epoetin) labeled as containing 40,000 units were found to contain only 2000 units, and later that year, other vials of Procrit were...

PERSPECTIVE: Bioethics and the Political Distortion of Biomedical Science

Elizabeth Blackburn, Ph.D. — Thu, 01Â AprÂ 2004 00:00:00 -05:00

In late September 2001, I was asked to serve on the President's Council on Bioethics. My initial instinct was not to accept, because I was concerned that the Bush Administration...

LEGAL ISSUES IN MEDICINE: The Pharmaceutical Industry versus Medicaid â Limits on State Initiatives to Control Prescription-Drug Costs

Thu, 05Â FebÂ 2004 00:00:00 -05:00

The need to manage escalating health care costs while maintaining reasonable access to care is becoming the salient challenge in U.S. health care policy. Insurance coverage is patchy and incomplete,...

SPECIAL REPORT: Tobacco Control in the Wake of the 1998 Master Settlement Agreement

Steven A. Schroeder, M.D. — Thu, 15Â JanÂ 2004 00:00:00 -05:00

Tobacco takes an enormous toll on the health of the public as the cause of 440,000 deaths annually in the United States and 4.8 million deaths worldwide.12 An estimated 8.6...

HEALTH POLICY REPORT: Medical Malpractice

Thu, 15Â JanÂ 2004 00:00:00 -05:00

Few issues in health care spark as much ire and angst as medical-malpractice litigation. Physicians revile malpractice claims as random events that visit unwarranted expense and emotional pain on competent,...

SOUNDING BOARD: Abortion, Health, and the Law

Michael F. Greene, M.D., and Jeffrey L. Ecker, M.D. — Thu, 08Â JanÂ 2004 00:00:00 -05:00

The signing into law of the Partial-Birth Abortion Ban Act of 2003 by President George W. Bush has brought to the surface, yet again, the bitterly divisive subject of abortion....

EDITORIAL: Inserting Government between Patient and Physician

Jeffrey M. Drazen, M.D. — Thu, 08Â JanÂ 2004 00:00:00 -05:00

In the patientâphysician interaction, the physician applies his or her skills and then makes recommendations that he or she believes are in the patient's best interest. Sometimes the picture is...

PERSPECTIVE: Peer Review and Federal Regulations

Robert Steinbrook, M.D. — Thu, 08Â JanÂ 2004 00:00:00 -05:00

Federal regulations that affect science and health are frequently controversial. Whether the topic is air pollution, stem-cell research, clean needles for injection-drug users, or pharmaceutical advertising, powerful economic and social...

PERSPECTIVE: Advance Care Planning

Muriel R. Gillick, M.D. — Thu, 01Â JanÂ 2004 00:00:00 -05:00

One hundred years ago, the odds that a visit to the doctor would result in a measurable improvement in a patient's condition were slim. But the mere fact that modern...

SOUNDING BOARD: Systematic Identification of Drugs That Cause Birth Defects â A New Opportunity

Allen A. Mitchell, M.D. — Thu, 25Â DecÂ 2003 00:00:00 -05:00

Patients, prescribers, and policymakers often assume that the most serious short-term adverse effects of a drug are identified in pre-marketing studies, so recognition of unexpected harm after widespread use raises...

HEALTH POLICY REPORT: AcademicâIndustrial Relationships in the Life Sciences

David Blumenthal, M.D., M.P.P. — Thu, 18Â DecÂ 2003 00:00:00 -05:00

Relationships between academic institutions and industry in the life sciences continue to fascinate, perplex, trouble, and embarrass academic investigators, university administrators, industrial companies, and government policymakers. No matter how many...

EDITORIAL: Grants, Politics, and the NIH

Jeffrey M. Drazen, M.D., and Julie R. Ingelfinger, M.D. — Thu, 04Â DecÂ 2003 00:00:00 -05:00

Investigator-initiated grants are the engine driving our biomedical research machine. This process is exemplified by the National Institutes of Health (NIH) and its grant-review system for extramural research â arguably...

HEALTH POLICY REPORT: Due Process in Investigations of Research Misconduct

Michelle M. Mello, J.D., Ph.D., and Troyen A. Brennan, M.D., J.D., M.P.H. — Thu, 25Â SepÂ 2003 00:00:00 -05:00

In the United States, we have long relied on scientists' professional commitment to truth and honesty to ensure that scientific fraud does not occur. Although there are federal regulatory procedures...

EDITORIAL: Welcome to the Genomic Era

Alan E. Guttmacher, M.D., and Francis S. Collins, M.D., Ph.D. — Thu, 04Â SepÂ 2003 00:00:00 -05:00

This issue of the Journal includes the last installment in a monthly series on genomic medicine that began in November 2002.1234567891011 The series has focused on the ways in which...

EDITORIAL: Disparity between Solid-Organ Supply and Demand

Anthony J. Langone, M.D., and J. Harold Helderman, M.D. — Thu, 14Â AugÂ 2003 00:00:00 -05:00

More patients die awaiting solid-organ transplantation than currently receive viable organs. Perhaps a victim of its own success, transplantation is the treatment of choice for failed organ function. Despite the...

PERSPECTIVE: Trial Design and Patient Safety â The Debate Continues

Robert Steinbrook, M.D. — Thu, 14Â AugÂ 2003 00:00:00 -05:00

On July 3, 2003, nearly a year after it first became involved, the Office for Human Research Protections (OHRP) of the Department of Health and Human Services released its decision...

REVIEW ARTICLE: Ethical, Legal, and Social Implications of Genomic Medicine

Ellen Wright Clayton, M.D., J.D. — Thu, 07Â AugÂ 2003 00:00:00 -05:00

As detailed in other articles in the Genomic Medicine series, genomics has contributed greatly to our understanding of the molecular basis of disease and, to a lesser but growing extent,...

PERSPECTIVE: Death by Voluntary Dehydration â What the Caregivers Say

Sandra Jacobs — Thu, 24Â JulÂ 2003 00:00:00 -05:00

Researcher Linda Ganzini, M.D., says she was âstunnedâ after tallying the questionnaire results reported in this issue of the Journal (pages 359â365): Among the hospice nurses in Oregon who were...

EDITORIAL: Legislative Myopia on Stem Cells

Jeffrey M. Drazen, M.D. — Thu, 17Â JulÂ 2003 00:00:00 -05:00

The U.S. House of Representatives has voted to ban research on, and the use of, medical treatments derived from embryonic stem cells. This bill is shortsighted and has the potential...

PERSPECTIVE: Cloning and Stem Cells â Handicapping the Political and Scientific Debates

George Q. Daley, M.D., Ph.D. — Thu, 17Â JulÂ 2003 00:00:00 -05:00

On August 9, 2001, President George W. Bush delivered an extraordinary prime-time television address to the nation that was devoted exclusively to an arcane topic of basic biomedical research: human...

PERSPECTIVE: The New Medical Malpractice Crisis

Thu, 05Â JunÂ 2003 00:00:00 -05:00

A major medical malpractice crisis is unfolding in the United States today. The American Medical Association has identified 18 states in which physicians and institutional health care providers are having...

HEALTH POLICY REPORT: Medicare and Drug Pricing

John K. Iglehart — Thu, 17Â AprÂ 2003 00:00:00 -05:00

For more than a decade, Medicare's administrators, backed by the White House, have made periodic attempts to reduce the excessive amounts the program pays for the relatively few pharmaceutical products...

LEGAL ISSUES IN MEDICINE: HIPAA Regulations â A New Era of Medical-Record Privacy?

George J. Annas, J.D., M.P.H. — Thu, 10Â AprÂ 2003 00:00:00 -05:00

Although the regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regarding the privacy of medical records are new,1 the concept of using federal law to protect...

PERSPECTIVE: The Cost of HIPAA Compliance

Peter Kilbridge, M.D. — Thu, 10Â AprÂ 2003 00:00:00 -05:00

The deadline for compliance with the regulations for patient privacy in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is now upon us, and hospitals and physician groups...

SOUNDING BOARD: Research Involving Cognitively Impaired Adults

Jason H.T. Karlawish, M.D. — Thu, 03Â AprÂ 2003 00:00:00 -05:00

Although the federal government funds research to improve the lives of critically ill adults and of the people who care for them, recent investigations show that it does not provide...

SOUNDING BOARD: The Integral Role of Clinical Research in Clinical Care

Steven M. Grunberg, M.D., and William T. Cefalu, M.D. — Thu, 03Â AprÂ 2003 00:00:00 -05:00

The ethical justification for clinical research as currently conducted has been questioned on the grounds that physicians do not make a strict and unequivocal distinction for their patients between clinical...

LEGAL ISSUES IN MEDICINE: The Right to Health and the Nevirapine Case in South Africa

George J. Annas, J.D., M.P.H. — Thu, 20Â FebÂ 2003 00:00:00 -05:00

Thanks to activists in South Africa, the right to health as a human right has returned to the international stage, just as it was being displaced by economists who see...

SPECIAL ARTICLE: Readability Standards for Informed-Consent Forms as Compared with Actual Readability

Thu, 20Â FebÂ 2003 00:00:00 -05:00

Background: Institutional review boards (IRBs) are charged with safeguarding potential research subjects with limited literacy but may have an inadvertent role in promulgating unreadable consent forms. We hypothesized that text...

SOUNDING BOARD: Is the Match Illegal?

Sanders H. Chae, M.D., J.D. — Thu, 23Â JanÂ 2003 00:00:00 -05:00

The recent announcement that a class-action lawsuit has been filed against the Accreditation Council for Graduate Medical Education (ACGME) and several teaching hospitals on the grounds that âthe Match,â or...

SPECIAL ARTICLE: Risk Factors for Retained Instruments and Sponges after Surgery

Thu, 16Â JanÂ 2003 00:00:00 -05:00

Background: Risk factors for medical errors remain poorly understood. We performed a caseâcontrol study of retained foreign bodies in surgical patients in order to identify risk factors for this type...

SOUNDING BOARD: Botanical Medicines â The Need for New Regulations

Thu, 19Â DecÂ 2002 00:00:00 -05:00

In 2001, $17.8 billion was spent in the United States on dietary supplements, $4.2 billion of it for herbs and other botanical remedies.1 The popularity of these products has increased...

REVIEW ARTICLE: Herbal Remedies

Peter A.G.M. De Smet, Pharm.D., Ph.D. — Thu, 19Â DecÂ 2002 00:00:00 -05:00

Herbal medicine is an increasingly common form of alternative therapy in the United States. 02121929.XML A 1997 survey estimated that 12.1 percent of adults in the United States had used...

SPECIAL ARTICLE: Effects of a Law against Early Postpartum Discharge on Newborn Follow-up, Adverse Events, and HMO Expenditures

Thu, 19Â DecÂ 2002 00:00:00 -05:00

Background: Concern about harm to newborns from early postpartum discharges led to laws establishing minimum hospital stays in the mid-1990s. We evaluated the effects of an early-discharge protocol (a hospital...

PERSPECTIVE: Herbal Medicines â What's in the Bottle?

Thu, 19Â DecÂ 2002 00:00:00 -05:00

We are in the midst of a public health experiment that much of academic medicine has failed to acknowledge until recently. In spite of the greatest health and longevity in...

EDITORIAL: A Broader Concept of Medical Errors

Thu, 12Â DecÂ 2002 00:00:00 -05:00

No one disputes the goal â a health care system that can reliably provide high-quality care with minimal waste to all in need. Disagreement begins with the question of which...

SPECIAL ARTICLE: Views of Practicing Physicians and the Public on Medical Errors

Thu, 12Â DecÂ 2002 00:00:00 -05:00

Background: In response to the report by the Institute of Medicine on medical errors, national groups have recommended actions to reduce the occurrence of preventable medical errors. What is not...

LEGAL ISSUES IN MEDICINE: Moral Progress, Mental Retardation, and the Death Penalty

George J. Annas, J.D., M.P.H. — Thu, 28Â NovÂ 2002 00:00:00 -05:00

Two major aspects of the death penalty in the United States directly involve physicians: how the death penalty is carried out and who is subject to execution. As a matter...

HEALTH POLICY REPORT: Reporting of Adverse Events

Lucian L. Leape, M.D. — Thu, 14Â NovÂ 2002 00:00:00 -05:00

When the Institute of Medicine (IOM) issued To Err Is Human,1 the recommendation to expand reporting of serious adverse events and medical errors, particularly mandatory reporting, received the most attention...

SOUNDING BOARD: Collaborating with Industry â Choices for the Academic Medical Center

Thu, 24Â OctÂ 2002 00:00:00 -05:00

The relationships between academic institutions and private companies are strengthening. The decision of several large pharmaceutical companies, and many biotechnology companies, to build major new laboratories near U.S., European, and...

SOUNDING BOARD: Academic Freedom in Clinical Research

Thu, 24Â OctÂ 2002 00:00:00 -05:00

âIs the universityâindustrial complex out of control?â The editorial that appeared under this eye-catching title in Nature in January 2001 came to the conclusion that links between academia and industry...

EDITORIAL: Institutions, Contracts, and Academic Freedom

Thu, 24Â OctÂ 2002 00:00:00 -05:00

Clinical research in the United States is commonly performed under contracts between institutions and commercial sponsors. Often the investigator who actually does the research is not a direct party to...

SPECIAL ARTICLE: A National Survey of Provisions in Clinical-Trial Agreements between Medical Schools and Industry Sponsors

Thu, 24Â OctÂ 2002 00:00:00 -05:00

Background: Concerned about threats to the integrity of clinical trials in a research environment increasingly controlled by private interests, the International Committee of Medical Journal Editors (ICMJE) has issued revised...

SPECIAL ARTICLE: Experiences of Oregon Nurses and Social Workers with Hospice Patients Who Requested Assistance with Suicide

Thu, 22Â AugÂ 2002 00:00:00 -05:00

Background: Oregon's 1997 Death with Dignity Act legalizes physician-assisted suicide. To date, information about patients who have requested this option has come from surveys of physicians. Although 78 percent of...

EDITORIAL: Physician-Assisted Death â A Last Resort?

Thu, 23Â MayÂ 2002 00:00:00 -05:00

During the past decade, patients with the uncommon disease amyotrophic lateral sclerosis (ALS) have had a prominent role in the debate about physician-assisted suicide and voluntary active euthanasia. In Canada...

LEGAL ISSUES IN MEDICINE: Cloning and the U.S. Congress

George J. Annas, J.D., M.P.H. — Thu, 16Â MayÂ 2002 00:00:00 -05:00

In the immediate aftermath of the birth of Dolly the sheep, the national debate over the banning of human cloning focused almost exclusively on the issue of safety. President Bill...

SOUNDING BOARD: European Perspectives on Therapeutic Cloning

Thu, 16Â MayÂ 2002 00:00:00 -05:00

Although recent advances in stem-cell research hold promise for therapeutic use, this promise has been accompanied by social, political, economic, legal, religious, and ethical questions. These questions have touched a...

SOUNDING BOARD: Stem Cells â Scientific, Medical, and Political Issues

Thu, 16Â MayÂ 2002 00:00:00 -05:00

It is rare that a scientific subject causes controversy not only among scientists but also among politicians and the public. Stem-cell biology is such a subject. The media reports new...

SOUNDING BOARD: The Case â Withdrawing Life Support from Incompetent Patients Who Are Not Terminally Ill

Thu, 09Â MayÂ 2002 00:00:00 -05:00

Almost all patients want their family members to make decisions about life-sustaining treatment for them if they become incompetent.12 Asking family members to make such decisions is standard clinical practice...

HEALTH POLICY REPORT: Improving Protection for Research Subjects

Robert Steinbrook, M.D. — Thu, 02Â MayÂ 2002 00:00:00 -05:00

In March 1996, Hoiyan Wan, a 19-year-old nursing student and a healthy volunteer in a study at the University of Rochester, died two days after undergoing bronchoscopy as part of...

LEGAL ISSUES IN MEDICINE: Bioterrorism, Public Health, and Civil Liberties

George J. Annas, J.D., M.P.H. — Thu, 25Â AprÂ 2002 00:00:00 -05:00

The prospect of having to deal with a bioterrorist attack, especially one involving smallpox, has local, state, and federal officials rightly concerned.12 Before September 11, most procedures for dealing with...

SOUNDING BOARD: The Future of the Global Tobacco Treaty Negotiations

Thu, 21Â MarÂ 2002 00:00:00 -05:00

Government officials around the world now recognize what industry executives have long understood â the tobacco business is fundamentally a global enterprise.1 The sale of raw leaf and finished products,...

LEGAL ISSUES IN MEDICINE: Medical Privacy and Medical Research â Judging the New Federal Regulations

George J. Annas, J.D., M.P.H. — Thu, 17Â JanÂ 2002 00:00:00 -05:00

Americans support both protecting the privacy of medical records and encouraging medical research. Thus, it is not surprising that a move to change practices in these two areas has generated...

LEGAL ISSUES IN MEDICINE: The Limits of State Laws to Protect Genetic Information

George J. Annas, J.D., M.P.H. — Thu, 02Â AugÂ 2001 00:00:00 -05:00

During the 2000 presidential campaign, Al Gore characterized the DNA code as a secret code like that of the Nazis. In his words, âwith the completion of the Human Genome,...

EDITORIAL: Sacred Secrets â The Privacy of Medical Records

Thu, 02Â AugÂ 2001 00:00:00 -05:00

Personal medical information is far from private in the United States. Insurers use identifiable medical records for risk rating, employers use them for hiring and firing, health systems for quality...

LEGAL ISSUES IN MEDICINE: Testing Poor Pregnant Women for Cocaine â Physicians as Police Investigators

George J. Annas, J.D., M.P.H. — Thu, 31Â MayÂ 2001 00:00:00 -05:00

In 1989, Supreme Court Justice Thurgood Marshall surmised that âdeclaring a war on illegal drugs is good public policy . . . [but] the first, and worst, casualty of war...

EDITORIAL: Brain Death â Well Settled yet Still Unresolved

Thu, 19Â AprÂ 2001 00:00:00 -05:00

If one subject in health law and bioethics can be said to be at once well settled and persistently unresolved, it is how to determine that death has occurred. Once...

LEGAL ISSUES IN MEDICINE: Conjoined Twins â The Limits of Law at the Limits of Life

George J. Annas, J.D., M.P.H. — Thu, 05Â AprÂ 2001 00:00:00 -05:00

Conjoined twins have been the subject of scientific exhibits, medical study, human curiosity, and even entertainment, but until the year 2000, conjoined twins had never been the subject of a...

LEGAL ISSUES IN MEDICINE: âPartial-Birth Abortionâ and the Supreme Court

George J. Annas, J.D., M.P.H. — Thu, 11Â JanÂ 2001 00:00:00 -05:00

Abortion has long been, and remains, the most politicized medical procedure in the United States. It has been the subject of more state and federal legislation than all other medical...

SOUNDING BOARD: Protecting the Public Health by Strengthening the Food and Drug Administration's Authority over Tobacco Products

Thu, 14Â DecÂ 2000 00:00:00 -05:00

For years, public health experts hypothesized that cigarettes that had less tar would also be less hazardous. However, recent studies have actually shown an increase in the relative risk of...

SOUNDING BOARD: Tobacco, the Food and Drug Administration, and Congress

Thu, 14Â DecÂ 2000 00:00:00 -05:00

Smoking has been the number-one target of public health professionals in the United States for more than a decade because it is the leading cause of premature death. Nonetheless, no...

LEGAL ISSUES IN MEDICINE: What Recourse? â Liability for Managed-Care Decisions and the Employee Retirement Income Security Act

Wendy K. Mariner, J.D., M.P.H. — Thu, 24Â AugÂ 2000 00:00:00 -05:00

Should managed-care organizations be accountable to patients injured by the company's negligence or wrongdoing? The general rule is that all organizations, including managed-care organizations, are legally liable for causing personal...

LEGAL ISSUES IN MEDICINE: Ulysses and the Fate of Frozen Embryos â Reproduction, Research, or Destruction?

George J. Annas, J.D., M.P.H. — Thu, 03Â AugÂ 2000 00:00:00 -05:00

On his 10-year voyage back to Ithaca from the Trojan War, Ulysses was warned by Circe to take precautions if he wanted to hear the Sirens' transfixing song, or there...

EDITORIAL: Pain and Public Policy

Thu, 20Â AprÂ 2000 00:00:00 -05:00

Some physicians, patients, and policy makers conceive of illness in purely biologic terms. According to this view, social, economic, and legal forces are irrelevant to symptoms and behavior; only tissue...

SPECIAL ARTICLE: Effect of Eliminating Compensation for Pain and Suffering on the Outcome of Insurance Claims for Whiplash Injury

Thu, 20Â AprÂ 2000 00:00:00 -05:00

Background: and Methods: The incidence and prognosis of whiplash injury from motor vehicle collisions may be related to eligibility for compensation for pain and suffering. On January 1, 1995, the...

SOUNDING BOARD: The Institute of Medicine Report on Medical Errors â Could It Do Harm?

Thu, 13Â AprÂ 2000 00:00:00 -05:00

The recent Institute of Medicine (IOM) report on the quality of care, entitled âTo Err Is Human,â has awakened much of the health care system to the challenge of reducing...

SOUNDING BOARD: Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants

Thu, 16Â MarÂ 2000 00:00:00 -05:00

Scientific methods for determining truth differ from judicial methods. Scientists confer, develop theories, and then test their theories by performing data-based research. If important findings appear to be inconsistent with...

SPECIAL REPORT: Legalized Physician-Assisted Suicide in Oregon â The Second Year

Thu, 24Â FebÂ 2000 00:00:00 -05:00

Background: and Methods: In 1997, Oregon legalized physician-assisted suicide. We have previously reported data on terminally ill Oregon residents who received prescriptions for lethal medications under the Oregon Death with...

EDITORIAL: Physician-Assisted Suicide and Euthanasia in Practice

Thu, 24Â FebÂ 2000 00:00:00 -05:00

Many readers of the Journal who closely follow the national debate over euthanasia and assisted suicide may find themselves wondering why there has been so little discussion of the actual...

SPECIAL ARTICLE: Physicians' Experiences with the Oregon Death with Dignity Act

Thu, 24Â FebÂ 2000 00:00:00 -05:00

Background: Physician-assisted suicide was legalized in Oregon in October 1997. There are data on patients who have received prescriptions for lethal medications and died after taking the medications. There is...

SPECIAL ARTICLE: Clinical Problems with the Performance of Euthanasia and Physician-Assisted Suicide in the Netherlands

Thu, 24Â FebÂ 2000 00:00:00 -05:00

Background: and Methods: The characteristics and frequency of clinical problems with the performance of euthanasia and physician-assisted suicide are uncertain. We analyzed data from two studies of euthanasia and physician-assisted...

SOUNDING BOARD: The Problems with Punitive Damages in Lawsuits against Managed-Care Organizations

Thu, 27Â JanÂ 2000 00:00:00 -05:00

Five years ago, a jury in southern California awarded $89 million to the estate of Nelene Fox because her insurer, Health Net, did not approve treatment with autologous bone marrow...

SOUNDING BOARD: Rethinking the Role of Tube Feeding in Patients with Advanced Dementia

Thu, 20Â JanÂ 2000 00:00:00 -05:00

A byproduct of the aging of the population has been a dramatic rise in the rate of Alzheimer's disease and other types of dementia. A conservative estimate is that there...

EDITORIAL: Violence against Women â A Challenge to the Supreme Court

Thu, 16Â DecÂ 1999 00:00:00 -05:00

This issue of the Journal includes two reports on risk factors for violent injuries to women. The findings of Kyriacou et al.1 and Grisso et al.,2 from caseâcontrol studies in...

EDITORIAL: Caring for the Dying â Congressional Mischief

Thu, 16Â DecÂ 1999 00:00:00 -05:00

Five years ago, the citizens of Oregon voted by a narrow margin to legalize physician-assisted suicide for certain terminally ill patients. There followed a variety of efforts to nullify the...

LEGAL ISSUES IN MEDICINE: The Last Resort â The Use of Physical Restraints in Medical Emergencies

George J. Annas, J.D., M.P.H. — Thu, 28Â OctÂ 1999 00:00:00 -05:00

Public awareness of the use of restraints in medicine has been greatly heightened by a five-part investigative series on physical restraints in psychiatric hospitals by the Hartford Courant and reaction...

SOUNDING BOARD: What's the Price of a Research Subject? Approaches to Payment for Research Participation

Thu, 15Â JulÂ 1999 00:00:00 -05:00

Successful clinical research depends on the ability to recruit research subjects. Tension between the need to recruit subjects and the obligation to offer them certain types of protection has made...

LEGAL ISSUES IN MEDICINE: Waste and Longing â The Legal Status of Placental-Blood Banking

George J. Annas, J.D., M.P.H. — Thu, 13Â MayÂ 1999 00:00:00 -05:00

Waste is not always what it seems. In his Cold War novel Underworld, for example, Don DeLillo explores the multifaceted qualities of waste. âWaste,â he notes, âis the secret history,...

SOUNDING BOARD: Ethical and Human-Rights Issues in Research on Mental Disorders That May Affect Decision-Making Capacity

Thu, 06Â MayÂ 1999 00:00:00 -05:00

For research with human subjects, the more things change, the more they remain the same. In the 50-odd years since the 10 principles of the Nuremberg Code were set forth...

SOUNDING BOARD: Are Research Ethics Bad for Our Mental Health?

Thu, 06Â MayÂ 1999 00:00:00 -05:00

Patients with mental illness are much better off now than they were only a few decades ago. Diagnostic methods are more reliable, and treatments are more effective. Only a minority...

SOUNDING BOARD: Is Informed Consent Always Necessary for Randomized, Controlled Trials?

Thu, 11Â MarÂ 1999 00:00:00 -05:00

Consider this paradox: if a physician reads a case report about a novel method of ventilation for critically ill patients and wants to try it in the next several patients...

SPECIAL REPORT: Legalized Physician-Assisted Suicide in Oregon â The First Year's Experience

Thu, 18Â FebÂ 1999 00:00:00 -05:00

Background: and Methods: On October 27, 1997, Oregon legalized physician-assisted suicide. We collected data on all terminally ill Oregon residents who received prescriptions for lethal medications under the Oregon Death...

EDITORIAL: Liberty and the Control of Tuberculosis

Thu, 04Â FebÂ 1999 00:00:00 -05:00

When there is a proven, effective treatment for a dangerous disease, most physicians will try hard to persuade their patients to accept that treatment even if it is unpleasant and...

SPECIAL ARTICLE: The Use of Legal Action in New York City to Ensure Treatment of Tuberculosis

Thu, 04Â FebÂ 1999 00:00:00 -05:00

Background: and Methods: After an increase in the number of cases of tuberculosis, New York City passed regulations to address the problem of nonadherence to treatment regimens. The commissioner of...

SOUNDING BOARD: Human Rights and Health â The Universal Declaration of Human Rights at 50

Thu, 10Â DecÂ 1998 00:00:00 -05:00

War, famine, pestilence, and poverty have had obvious and devastating effects on health throughout human history. In recent times, human rights have come to be viewed as essential to freedom...

SOUNDING BOARD: New Guidelines for Coding Physicians' Services â A Step Backward

Thu, 03Â DecÂ 1998 00:00:00 -05:00

In July 1998, the Health Care Financing Administration (HCFA) intended to implement a revised and more complex set of guidelines specifying how physicians should code and document âevaluation and managementâ...

EDITORIAL: Evaluation and Management Guidelines â Fatally Flawed

Thu, 03Â DecÂ 1998 00:00:00 -05:00

Earlier this year, the Health Care Financing Administration (HCFA) and the American Medical Association (AMA), through its Current Procedural Terminology editorial panel, jointly issued draft guidelines for documenting cognitive services...

SOUNDING BOARD: Competitive Athletes with Cardiovascular Disease â The Case of Nicholas Knapp

Thu, 26Â NovÂ 1998 00:00:00 -05:00

A variety of congenital cardiovascular abnormalities are the principal causes of sudden death in young competitive athletes,12345 and some of these tragedies have been widely publicized.6 The identification of important...

LEGAL ISSUES IN MEDICINE: Protecting Patients from Discrimination â The Americans with Disabilities Act and HIV Infection

George J. Annas, J.D., M.P.H. — Thu, 22Â OctÂ 1998 00:00:00 -05:00

The Americans with Disabilities Act (ADA) was passed in 1990 to expand the reach of the Rehabilitation Act of 1973 and make discrimination on the basis of disability unlawful.1 The...

EDITORIAL: Infanticide

Thu, 22Â OctÂ 1998 00:00:00 -05:00

Accounts of parents who kill their infants date to the beginning of recorded history.1 As recently as the early 1800s in Europe, up to a third of live-born infants were...

SPECIAL ARTICLE: Risk Factors for Infant Homicide in the United States

Thu, 22Â OctÂ 1998 00:00:00 -05:00

Background: Homicide is the leading cause of infant deaths due to injury. More than 80 percent of infant homicides are considered to be fatal child abuse. This study assessed the...

EDITORIAL: Assisted Suicide and Alternatives in Amyotrophic Lateral Sclerosis

Thu, 01Â OctÂ 1998 00:00:00 -05:00

For an uncommon disease, amyotrophic lateral sclerosis (ALS) commands a great deal of attention from the media, especially in the debate about physician-assisted suicide. Yet there has been no systematic...

SPECIAL ARTICLE: Attitudes of Patients with Amyotrophic Lateral Sclerosis and Their Care Givers toward Assisted Suicide

Thu, 01Â OctÂ 1998 00:00:00 -05:00

Background: and Methods: Amyotrophic lateral sclerosis (ALS) is a neuromuscular disease that causes gradual paralysis, respiratory failure, and death, usually within three to five years after it has been diagnosed....

LEGAL ISSUES IN MEDICINE: The Shadowlands â Secrets, Lies, and Assisted Reproduction

George J. Annas, J.D., M.P.H. — Thu, 24Â SepÂ 1998 00:00:00 -05:00

Americans love babies and technology, and most Americans applaud the ability of the new assisted-reproduction techniques to help infertile couples have children. But these techniques have also given birth to...

LEGAL ISSUES IN MEDICINE: Partial-Birth Abortion, Congress, and the Constitution

George J. Annas, J.D., M.P.H. — Thu, 23Â JulÂ 1998 00:00:00 -05:00

The political debate over abortion during the past 25 years has shifted among various dichotomous views of the world: life versus choice, fetus versus woman, fetus versus baby, constitutional right...

SPECIAL ARTICLE: What Are the Potential Cost Savings from Legalizing Physician-Assisted Suicide?

Ezekiel J. Emanuel, M.D., Ph.D., and Margaret P. Battin, Ph.D. — Thu, 16Â JulÂ 1998 00:00:00 -05:00

In the Washington v. Glucksberg and Vacco v. Quill decisions rejecting a constitutional right to physician-assisted suicide, the Supreme Court allowed each state to decide whether to legalize the intervention.1...

SOUNDING BOARD: Why We Should Ban Human Cloning

Thu, 09Â JulÂ 1998 00:00:00 -05:00

In February the U.S. Senate voted 54 to 42 against bringing an anticloning bill directly to the floor for a vote.1 During the debate, more than 16 scientific and medical...

SOUNDING BOARD: Human Cloning and the Challenge of Regulation

Thu, 09Â JulÂ 1998 00:00:00 -05:00

The birth of Dolly, the sheep cloned from a mammary cell of an adult ewe, has initiated a public debate about human cloning. Although cloning of humans may never be...

EDITORIAL: Fatal Impact â Concussion of the Heart

Thu, 18Â JunÂ 1998 00:00:00 -05:00

When he died on a winter evening in 1995, Matthew Messing was only 16 years old. It happened while he was playing in a high-school ice-hockey game in Quincy, Massachusetts....

SPECIAL ARTICLE: A National Survey of Physician-Assisted Suicide and Euthanasia in the United States

Thu, 23Â AprÂ 1998 00:00:00 -05:00

Background: Although there have been many studies of physician-assisted suicide and euthanasia in the United States, national data are lacking.

Methods: In 1996, we mailed questionnaires to a stratified probability sample...

EDITORIAL: Should Human Cloning Research Be Off Limits?

Thu, 26Â MarÂ 1998 00:00:00 -05:00

Cloning captured public attention when Scottish scientists startled the world by announcing the birth of a sheep named Dolly that had been cloned by combining the nucleus of an adult...

SOUNDING BOARD: Inappropriate Drug-Donation Practices in Bosnia and Herzegovina, 1992 to 1996

Thu, 18Â DecÂ 1997 00:00:00 -05:00

Humanitarian assistance to people suffering as a result of catastrophes generally includes large charitable donations of drugs from sources such as private individuals or companies, nongovernmental organizations, United Nations agencies,...

SOUNDING BOARD: The Rule of Double Effect â A Critique of Its Role in End-of-Life Decision Making

Thu, 11Â DecÂ 1997 00:00:00 -05:00

According to the ethical principle known as the ârule of double effect,â effects that would be morally wrong if caused intentionally are permissible if foreseen but unintended. This principle is...

SOUNDING BOARD: The Threat to Medical-Records Research

Thu, 13Â NovÂ 1997 00:00:00 -05:00

The potential for misuse of personal information by insurers and employers has heightened concern about the confidentiality of medical records. Despite the absence of documented abuses related to approved research...

SPECIAL ARTICLE: Fifty Years Later: The Significance of the Nuremberg Code

Evelyne Shuster, Ph.D. — Thu, 13Â NovÂ 1997 00:00:00 -05:00

1. The voluntary consent of the human subject is absolutely essential.

This means that the person involved should have legal capacity to give consent; should be so situated as...

SOUNDING BOARD: The Supreme Court and Physician-Assisted Suicide â Rejecting Assisted Suicide but Embracing Euthanasia

Thu, 23Â OctÂ 1997 00:00:00 -05:00

In rejecting a constitutional right to physician-assisted suicide earlier this year,12 the U.S. Supreme Court appeared to preserve the distinction between the withdrawal of life-sustaining treatment and assisted suicide or...

SOUNDING BOARD: The Supreme Court Speaks â Not Assisted Suicide but a Constitutional Right to Palliative Care

Thu, 23Â OctÂ 1997 00:00:00 -05:00

The Supreme Court has unanimously ruled that there is no constitutional right to physician-assisted suicide.12 Unexpectedly, however, the Court did much more than simply uphold the New York and Washington...

LEGAL ISSUES IN MEDICINE: The Bell Tolls for a Constitutional Right to Physician-Assisted Suicide

George J. Annas, J.D., M.P.H. — Thu, 09Â OctÂ 1997 00:00:00 -05:00

For Whom the Bell Tolls, Ernest Hemingway's novel about the Spanish Civil War, ends with its American hero, Robert Jordan, mortally wounded and trying to decide whether to commit suicide...

SOUNDING BOARD: The Tobacco Settlement

Thu, 09Â OctÂ 1997 00:00:00 -05:00

The fate of the proposed tobacco settlement and, in turn, the health and longevity of generations of Americans now lie in the hands of the Congress. The settlement is the...

SPECIAL ARTICLE: The Effect of Enforcing Tobacco-Sales Laws on Adolescents' Access to Tobacco and Smoking Behavior

Thu, 09Â OctÂ 1997 00:00:00 -05:00

Background: Enforcing laws banning tobacco sales to minors is widely advocated as a way to reduce young people's access to tobacco and tobacco use. Whether this approach is successful is...

SOUNDING BOARD: Biomedical Research and Insider Trading

Thu, 28Â AugÂ 1997 00:00:00 -05:00

On April 10, 1997, the Securities and Exchange Commission filed the first case ever brought against a biomedical researcher on the basis of allegations of insider trading.1 The case involved...

SOUNDING BOARD: Biomedical Research and Insider Trading

Thu, 28Â AugÂ 1997 00:00:00 -05:00

On April 10, 1997, the Securities and Exchange Commission filed the first case ever brought against a biomedical researcher on the basis of allegations of insider trading.1 The case involved...

LEGAL ISSUES IN MEDICINE: Reefer Madness â The Federal Response to California's Medical-Marijuana Law

George J. Annas, J.D., M.P.H. — Thu, 07Â AugÂ 1997 00:00:00 -05:00

Marijuana is unique among illegal drugs in its political symbolism, its safety, and its wide use. More than 65 million Americans have tried marijuana, the use of which is not...

LEGAL ISSUES IN MEDICINE: Patients' Rights in Managed Care -- Exit, Voice, and Choice

George J. Annas — Thu, 17Â JulÂ 1997 00:00:00 -05:00

The ability of consumers to complain effectively about services and products is a key ingredient of the market. In Exit, Voice, and Loyalty,1 economist Albert O. Hirschman argues that the...

EDITORIAL: Psychiatry and Assisted Suicide in the United States

Thu, 19Â JunÂ 1997 00:00:00 -05:00

After years of debate over the ethical and legal issues in physician-assisted suicide, empirical research is beginning to infuse a realistic clinical perspective into this previously theoretical controversy. Studies reveal...

SPECIAL ARTICLE: Physician-Assisted Death in Psychiatric Practice in the Netherlands

Thu, 19Â JunÂ 1997 00:00:00 -05:00

Background: In 1994 the Dutch Supreme Court ruled that in exceptional instances, physician-assisted suicide might be justifiable for patients with unbearable mental suffering but no physical illness. We studied physician-assisted...

EDITORIAL: Practicing Medicine without a License â The New Intrusions by Congress

Thu, 12Â JunÂ 1997 00:00:00 -05:00

Something new is happening in Washington: Congress is practicing medicine. In recent months, Congress overwhelmingly passed legislation forcing health plans to pay for 48-hour hospital stays for women delivering babies,...

SOUNDING BOARD: Disability and Physician-Assisted Suicide

Thu, 05Â JunÂ 1997 00:00:00 -05:00

On January 8, 1997, the U.S. Supreme Court heard oral arguments in Vacco v. Quill 1 and Washington v. Glucksberg,2 the two cases concerning whether a state may prohibit persons...

SOUNDING BOARD: Subpoenas and Science â When Lawyers Force Their Way into the Laboratory

Thu, 06Â MarÂ 1997 00:00:00 -05:00

Scientists who want no part of lawyers and the judicial system may learn to their horror that a court can subpoena their research results, and perhaps even compel them to...

SPECIAL ARTICLE: Physician-Assisted Suicide and Patients with Human Immunodeficiency Virus Disease

Thu, 06Â FebÂ 1997 00:00:00 -05:00

Background: Data are limited on the attitudes and practices of physicians regarding assisting the suicide of patients with human immunodeficiency virus (HIV) disease.

Methods: Between November 1994 and January 1995, we...

EDITORIAL: Federal Foolishness and Marijuana

Thu, 30Â JanÂ 1997 00:00:00 -05:00

The advanced stages of many illnesses and their treatments are often accompanied by intractable nausea, vomiting, or pain. Thousands of patients with cancer, AIDS, and other diseases report they have...

LEGAL ISSUES IN MEDICINE: Tobacco Litigation as Cancer Prevention: Dealing with the Devil

George J. Annas, J.D., M.P.H. — Thu, 23Â JanÂ 1997 00:00:00 -05:00

Tobacco companies have come to personify the devil, and strategies to exorcise tobacco smoking from the United States proliferate. Tobacco's demonic status is even reflected in popular fiction. John Grisham's...

EDITORIAL: Competent Care for the Dying Instead of Physician-Assisted Suicide

Thu, 02Â JanÂ 1997 00:00:00 -05:00

While the Supreme Court is reviewing the decisions by the Second and Ninth Circuit Courts of Appeals to reverse state bans on assisted suicide, there is a unique opportunity to...

EDITORIAL: The Supreme Court and Physician-Assisted Suicide â The Ultimate Right

Thu, 02Â JanÂ 1997 00:00:00 -05:00

The U.S. Supreme Court will decide later this year whether to let stand decisions by two appeals courts permitting doctors to help terminally ill patients commit suicide.1 The Ninth and...

SPECIAL ARTICLE: Relation between Negligent Adverse Events and the Outcomes of Medical-Malpractice Litigation

Thu, 26Â DecÂ 1996 00:00:00 -05:00

Background: We have previously shown that in New York State the initiation of malpractice suits correlates poorly with the actual occurrence of adverse events (injuries resulting from medical treatment) and...

LEGAL ISSUES IN MEDICINE: Cowboys, Camels, and the First Amendment â The FDA's Restrictions on Tobacco Advertising

George J. Annas, J.D., M.P.H. — Thu, 05Â DecÂ 1996 00:00:00 -05:00

The Marlboro Man and Joe Camel have become public health enemies number one and two, and removing their familiar faces from the gaze of young people has become a goal...

SPECIAL REPORT: Evaluation of the Notification Procedure for Physician-Assisted Death in the Netherlands

Thu, 28Â NovÂ 1996 00:00:00 -05:00

Background: In the Netherlands, a notification procedure for physician-assisted death has been in use since 1991. It requires doctors to report each case to the coroner, who in turn notifies...

SPECIAL REPORT: Euthanasia, Physician-Assisted Suicide, and Other Medical Practices Involving the End of Life in the Netherlands, 1990â1995

Thu, 28Â NovÂ 1996 00:00:00 -05:00

Background: In 1991 a new procedure for reporting physician-assisted deaths was introduced in the Netherlands that led to a tripling in the number of reported cases. In 1995, as part...

EDITORIAL: Euthanasia in the Netherlands â Good News or Bad?

Thu, 28Â NovÂ 1996 00:00:00 -05:00

Euthanasia (the deliberate administration of a lethal drug to hasten death in a suffering patient) is officially a crime in the Netherlands, punishable by up to 12 years in prison,...

SOUNDING BOARD: Occupational Exposure to Blood among Medical Students

Thu, 10Â OctÂ 1996 00:00:00 -05:00

One of the most serious threats medical students face during their clinical training is the possibility of exposure to blood-borne pathogens, with the attendant risk of infection with the human...

SPECIAL ARTICLE: The Effect of Legislative Requirements on the Use of Breast-Conserving Surgery

Thu, 03Â OctÂ 1996 00:00:00 -05:00

Background: We studied the effect of state legislation requiring the disclosure of options for the treatment of breast cancer on the use of breast-conserving surgery in clinical practice.

Methods: The National...

SOUNDING BOARD: The Purpose of Advance Medical Planning â Autonomy for Patients or Limitation of Care?

Thu, 05Â SepÂ 1996 00:00:00 -05:00

Methods for advance medical planning were originally developed to ensure that patients' preferences would guide the nature and intensity of their future medical care. Increasingly, however, advance planning is viewed...

LEGAL ISSUES IN MEDICINE: The Promised End â Constitutional Aspects of Physician-Assisted Suicide

George J. Annas, J.D., M.P.H. — Thu, 29Â AugÂ 1996 00:00:00 -05:00

The debate over physician-assisted suicide has dramatically shifted to a discussion of constitutional issues. This spring, within a month of each other, U.S. Circuit Courts of Appeals on both coasts...

SOUNDING BOARD: The Legalization of Physician-Assisted Suicide

Thu, 29Â AugÂ 1996 00:00:00 -05:00

With the enactment of an Oregon statute permitting physician-assisted suicide,12 the recognition of a constitutional right to assisted suicide by two U.S. courts of appeals,34 discussed elsewhere in this issue...

SPECIAL ARTICLE: Evaluating the Health Risks of Breast Implants: The Interplay of Medical Science, the Law, and Public Opinion

Marcia Angell, M.D. — Thu, 06Â JunÂ 1996 00:00:00 -05:00

This is the story of the controversy over the safety of silicone-gelâfilled breast implants â a controversy that has raged in this country for nearly a decade and is still...

EDITORIAL: Euthanasia and Nursing Practice â Right Question, Wrong Answer

Thu, 23Â MayÂ 1996 00:00:00 -05:00

Public and professional sentiment about assisted suicide and euthanasia has led to intense debate, controversy, and confusion. In an era of unprecedented technological progress and postponement of death, considering actions...

SPECIAL ARTICLE: The Role of Critical Care Nurses in Euthanasia and Assisted Suicide

David A. Asch, M.D., M.B.A. — Thu, 23Â MayÂ 1996 00:00:00 -05:00

Background: Euthanasia and assisted suicide have received considerable attention recently in medical literature, public discussion, and proposed state legislation. Almost all the discussion in this area has focused on the...

EDITORIAL: The Politics of Human-Embryo Research â Avoiding Ethical Gridlock

Thu, 16Â MayÂ 1996 00:00:00 -05:00

In late January 1996, President Bill Clinton signed a continuing resolution to keep the government open. Among other things, the resolution prohibits the use of federal funds for research on...

SOUNDING BOARD: Benefits and Hazards of Reporting Medical Outcomes Publicly

Thu, 08Â FebÂ 1996 00:00:00 -05:00

As marketplace competition becomes the dominant force for change in the delivery of health care in the United States, its effects on the quality of health care are being sharply...

SOUNDING BOARD: Secrecy in Medical Research

Thu, 08Â FebÂ 1996 00:00:00 -05:00

The conduct of medical research is in increasing jeopardy. Scarce funds for research have been strained by the emergence of new problems requiring intensive work. But a more insidious problem...

SOUNDING BOARD: Euthanasia in Australia â The Northern Territory Rights of the Terminally Ill Act

Thu, 01Â FebÂ 1996 00:00:00 -05:00

On May 25, 1995, the parliament of Australia's Northern Territory passed the Northern Territory Rights of the Terminally Ill Act,1 making voluntary euthanasia legal. This act allows physicians to prescribe...

SPECIAL ARTICLE: Legalizing Assisted Suicide â Views of Physicians in Oregon

Thu, 01Â FebÂ 1996 00:00:00 -05:00

Background: Since the Oregon Death with Dignity Act was passed in November 1994, physicians in Oregon have faced the prospect of legalized physician-assisted suicide. We studied the attitudes and current...

SPECIAL ARTICLE: Attitudes of Michigan Physicians and the Public toward Legalizing Physician-Assisted Suicide and Voluntary Euthanasia

Thu, 01Â FebÂ 1996 00:00:00 -05:00

Background: There has been a continuing public debate about assisted suicide and the proper role, if any, of physicians in this practice. Legislative bans and various forms of legalization have...

NEJM â Collection Updates for Legal Issues in Medicine

PERSPECTIVE: Tobacco Control and Free Speech â An American Dilemma

PERSPECTIVE: Abortion Politics and Health Insurance Reform

OTHER POINTS OF VIEW: It Is Patients Who Most Need Tort Reform

PERSPECTIVE: The Supreme Court, Process Patents, and Medical Innovation

PERSPECTIVE: Mandatory Vaccination of Health Care Workers

PERSPECTIVE: Balancing Innovation, Access, and Profits â Market Exclusivity for Biologics

PERSPECTIVE: Physicians' Views of the Massachusetts Health Care Reform Law â A Poll

PERSPECTIVE: Litigation amidst Reform â The Boston Medical Center Case

PERSPECTIVE: Lost in Transmission â FDA Drug Information That Never Reaches Clinicians

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

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

BOOK REVIEW:

EDITORIAL: Tobacco, Public Health, and the FDA

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

PERSPECTIVE: A Higher Bar â Vermont's New Law on Marketing Prescribed Products

PERSPECTIVE: The Role of Medical Liability Reform in Federal Health Care Reform

PERSPECTIVE: Litigation, Regulation, and Education â Protecting the Public's Health through Childhood Immunization

PERSPECTIVE: When Vaccine Injury Claims Go to Court

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Handguns, Health, and the Second Amendment

PERSPECTIVE: Globalized Clinical Trials and Informed Consent

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: New York City's War on Fat

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

EDITORIAL: The Medical Device Safety Act of 2009

BOOK REVIEW:

SPECIAL REPORT: Progress and Deficiencies in the Registration of Clinical Trials

PERSPECTIVE: Commercial versus Social Goals of Tracking What Doctors Do

PERSPECTIVE: Prescribing Records and the First Amendment â New Hampshire's Data-Mining Statute

PERSPECTIVE: The Supreme Court, Preemption, and Malpractice Liability

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

EDITORIAL: Physicians and the First Amendment

BOOK REVIEW:

BOOK REVIEW:

PERSPECTIVE: South Dakota's Abortion Script â Threatening the PhysicianâPatient Relationship

PERSPECTIVE: Drug Development for Neglected Diseases â The Trouble with FDA Review Vouchers

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

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

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

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

PERSPECTIVE: Guns and Suicide in the United States

EDITORIAL: The FDA and Tobacco Regulation

PERSPECTIVE: Disclosure of Industry Payments to Physicians

PERSPECTIVE: Medicare Showdown

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

EDITORIAL: Guns and Health

SPECIAL ARTICLE: Smoke-free Legislation and Hospitalizations for Acute Coronary Syndrome

PERSPECTIVE: FDA Regulation of Tobacco â Pitfalls and Possibilities

BOOK REVIEW:

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

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

PERSPECTIVE: Shuffling toward Parity â Bringing Mental Health Care under the Umbrella

PERSPECTIVE: Why Doctors Should Worry about Preemption

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

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

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

EDITORIAL: Peer Review in the Balance

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

PERSPECTIVE: Vaccines and Autism Revisited â The Hannah Poling Case

PERSPECTIVE: The FDA, Preemption, and the Supreme Court

PERSPECTIVE: Playing âKick the FDAâ â Risk-free to Players but Hazardous to Public Health

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

SOUNDING BOARD: Pharmaceutical Promotion to Physicians and First Amendment Rights

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

EDITORIAL: Handgun Violence, Public Health, and the Law

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

PERSPECTIVE: Interpreting the Right to Bear Arms â Gun Regulation and Constitutional Law

PERSPECTIVE: Guns, Fear, the Constitution, and the Public's Health

PERSPECTIVE: Consent for Organ Donation â Balancing Conflicting Ethical Obligations

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

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

EDITORIAL: Physicians and Execution

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

EDITORIAL: A Pivotal Medical-Device Case

PERSPECTIVE: Over the Counter but No Longer under the Radar â Pediatric Cough and Cold Medications

EDITORIAL: Lenalidomide â The Phoenix Rises

PERSPECTIVE: The Fate of SCHIP â Surrogate Marker for Health Care Ideology?

PERSPECTIVE: The Ongoing Regulation of Generic Drugs

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

PERSPECTIVE: Doctors and Drug Companies â Scrutinizing Influential Relationships

EDITORIAL: Open Clinical Trials

NEJM â Collection Updates for Legal Issues in Medicine

PERSPECTIVE: Tobacco Control and Free Speech â An American Dilemma

PERSPECTIVE: Balancing Innovation, Access, and Profits â Market Exclusivity for Biologics

PERSPECTIVE: Physicians' Views of the Massachusetts Health Care Reform Law â A Poll

PERSPECTIVE: Litigation amidst Reform â The Boston Medical Center Case

PERSPECTIVE: Lost in Transmission â FDA Drug Information That Never Reaches Clinicians

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

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

PERSPECTIVE: A Higher Bar â Vermont's New Law on Marketing Prescribed Products

PERSPECTIVE: Litigation, Regulation, and Education â Protecting the Public's Health through Childhood Immunization

PERSPECTIVE: Prescribing Records and the First Amendment â New Hampshire's Data-Mining Statute

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

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

PERSPECTIVE: Drug Development for Neglected Diseases â The Trouble with FDA Review Vouchers

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

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

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

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

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

PERSPECTIVE: FDA Regulation of Tobacco â Pitfalls and Possibilities

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

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

PERSPECTIVE: Shuffling toward Parity â Bringing Mental Health Care under the Umbrella

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

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

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

PERSPECTIVE: Vaccines and Autism Revisited â The Hannah Poling Case

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

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

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

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

PERSPECTIVE: Interpreting the Right to Bear Arms â Gun Regulation and Constitutional Law

PERSPECTIVE: Consent for Organ Donation â Balancing Conflicting Ethical Obligations

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

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

PERSPECTIVE: Over the Counter but No Longer under the Radar â Pediatric Cough and Cold Medications

EDITORIAL: Lenalidomide â The Phoenix Rises

PERSPECTIVE: The Fate of SCHIP â Surrogate Marker for Health Care Ideology?

PERSPECTIVE: Doctors and Drug Companies â Scrutinizing Influential Relationships

PERSPECTIVE: Thimerosal and Vaccines â A Cautionary Tale

PERSPECTIVE: Cases in Vaccine Court â Legal Battles over Vaccines and Autism

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

PERSPECTIVE: The Rosiglitazone Story â Lessons from an FDA Advisory Committee Meeting

PERSPECTIVE: Legal Power and Legal Rights â Isolation and Quarantine in the Case of Drug-Resistant Tuberculosis

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

HEALTH POLICY REPORT: Insuring All Children â The New Political Imperative

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

EDITORIAL: Teratogenicity of SSRIs â Serious Concern or Much Ado about Little?

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

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

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

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

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

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

PERSPECTIVE: Politics, Parents, and Prophylaxis â Mandating HPV Vaccination in the United States

PERSPECTIVE: PDUFA Reauthorization â Drug Safety's Golden Moment of Opportunity?

PERSPECTIVE: Drug Safety Reform at the FDA â Pendulum Swing or Systematic Improvement?

PERSPECTIVE: Paying for Drug Approvals â Who's Using Whom?

HEALTH POLICY REPORT: Medicaid Revisited â Skirmishes over a Vast Public Enterprise

PERSPECTIVE: Taking TRIPS to India â Novartis, Patent Law, and Access to Medicines

PERSPECTIVE: HIV Injustice in Libya â Scapegoating Foreign Medical Professionals

PERSPECTIVE: Observational Studies of Drug Safety â Aprotinin and the Absence of Transparency

PERSPECTIVE: Dangerous Deception â Hiding the Evidence of Adverse Drug Effects

HEALTH POLICY REPORT: Medical-Process Patents â Monopolizing the Delivery of Health Care

PERSPECTIVE: Protecting the Health of the Public â Institute of Medicine Recommendations on Drug Safety

HEALTH POLICY REPORT: FDA Regulation of Stem-CellâBased Therapies

PERSPECTIVE: Surviving Sepsis â Practice Guidelines, Marketing Campaigns, and Eli Lilly

PERSPECTIVE: Body of Research â Ownership and Use of Human Tissue

HEALTH LAW, ETHICS, AND HUMAN RIGHTS: Hunger Strikes at Guantanamo â Medical Ethics and Human Rights in a âLegal Black Holeâ

PERSPECTIVE: Delaying Generic Competition â Corporate Payoffs and the Future of Plavix

PERSPECTIVE: Access before Approval â A Right to Take Experimental Drugs?

HEALTH POLICY REPORT: Employer-Sponsored Health Insurance in the United States â Origins and Implications

PERSPECTIVE: versus Reality â Abortion and Women's Health