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Editorial
Realizing Genomic Medicine
The current series of Genomic Medicine review articles concludes in this issue of the Journal with the publication of an article on cognitive impairment and autism by Mefford and colleagues. The topic of this article is an appropriate capstone for the Genomic Medicine series: it highlights the…
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Perspective
The Public, Political Parties, and Stem-Cell Research
Until recently, it seemed as if the question of future federal funding for embryonic stem-cell research had been settled. The Obama administration had lifted President George W. Bush's previous restrictions on funding, and the legality of that decision was upheld by federal courts. But the 2012…
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The 2012 presidential election campaign has created uncertainty about federal funding for human embryonic stem-cell research, with most Republican candidates suggesting that they would substantially reduce such funding. Where do U.S. voters stand on this issue? This Perspective summarizes polling results.
Perspective
The Coming Explosion in Genetic Testing — Is There a Duty to Recontact?
The question of whether a duty exists to recontact patients about new genetic information has been debated for several decades without consensus, but the emergence of new technologies compels us to reconsider this complex matter. Ordering a "genetic test," such as a chromosome analysis or a search…
Perspective
Risks of Presymptomatic Direct-to-Consumer Genetic Testing
Geneticists have long cited the risks of direct-to-consumer (DTC) genetic testing, highlighting the danger for consumers who make complex medical decisions without adequate clinical guidance. On May 10, 2010, the Food and Drug Administration (FDA) voiced its concern by sending a letter informing…
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Perspective
Preparing for a Consumer-Driven Genomic Age
Advances in genomic technologies permit the simultaneous analysis of millions of variants across the genome and may soon allow for meaningful estimation of one's risks of developing cancer, diabetes, and other common diseases. These advances are converging with the movement toward consumer-driven…
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Perspective
Screening Student Athletes for Sickle Cell Trait — A Social and Clinical Experiment
On April 13, 2010, the legislative council for Division I of the National Collegiate Athletic Association (NCAA) approved mandatory testing for sickle cell carrier status (sickle cell trait) for all student athletes participating in Division I sports. Students are to begin being tested for the…
Perspective
The Havasupai Indian Tribe Case — Lessons for Research Involving Stored Biologic Samples
On April 20, 2010, Arizona State University (ASU) agreed to pay $700,000 to 41 members of the Havasupai Indian tribe to settle legal claims that university researchers improperly used tribe members' blood samples in genetic research. The settlement closes a difficult chapter for both parties but…
Editorial
Ten Years On — The Human Genome and Medicine
On a June day nearly 10 years ago, the leaders of the United States and the United Kingdom, accompanied by the leaders of the public and private teams deciphering the human genome, announced that a draft sequence had been completed. That occasion was rich with promises of new and more powerful ways…
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Perspective
Gene Patenting — Is the Pendulum Swinging Back?
Are human genes and the process of comparing DNA sequences patentable? These questions were raised by a group of researchers, pathologists, patients with cancer, and medical professional organizations challenging some of Myriad Genetics' patents covering the BRCA1 and BRCA2 genes and their use in…
Editorial
Individual Genomes on the Horizon
Physicians have long recognized that pinpointing specific causes of disease in individual patients enables therapies that are the most likely to confer benefit with the fewest adverse effects. We also recognize the potential for disease prevention through identification of specific risk factors and…
Sounding Board
Disclosure of Financial Relationships to Participants in Clinical Research
In keeping with previous statements by a number of prominent groups,– the Institute of Medicine has recently stressed the need for vigilance in managing conflicts of interest to ensure the integrity of clinical research. The Institute of Medicine adopts a position similar to that of the…
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The authors review the potential goals of disclosing investigators' financial relationships to research participants and discuss the limitations of disclosure in achieving these goals. They note that equity interests are especially problematic and should be limited or avoided rather than simply disclosed.
Perspective
Why Doctors Should Worry about Preemption
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 U.S. Supreme Court (Wyeth v. Levine), drug companies could effectively be immunized against state-level tort litigation if their products…
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Perspective
Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices
When the Food and Drug Administration (FDA) approved the Medtronic Sprint Fidelis implantable cardioverter–defibrillator (ICD) lead in 2004 on the basis of bench testing but no human clinical data, there was no public outcry. Physicians rapidly incorporated the new electrode into their practice,…
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Editorial
A Pivotal Medical-Device Case
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 litigation in state courts. This decision, we believe, is a matter of particular importance…
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Perspective
Politics, Parents, and Prophylaxis — Mandating HPV Vaccination in the United States
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 to the likely introduction of GlaxoSmithKline's not-yet-approved HPV vaccine, Cervarix,…
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Correspondence
Mandating HPV Vaccination — Private Rights, Public Good
To the Editor: Those who oppose mandating vaccination against human papillomavirus (HPV) as a condition for school entry generally open the debate with two fundamental questions. First, how can the government interfere in the medical decisions parents make for their children by compelling…
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Perspective
Body of Research — Ownership and Use of Human Tissue
For better or worse, we have irretrievably entered an age that requires examination of our understanding of the legal rights and relationships in the human body and the human cell. — Moore v. Regents of the University of California, California 2nd District Court of Appeals, 1988 Nearly 20 years…
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Perspective
Access before Approval — A Right to Take Experimental Drugs?
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 to work. A three-judge panel of the U.S. Court of Appeals for the D.C. Circuit was considering a lawsuit by the…
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Sounding Board
The Patient's Right to Safety — Improving the Quality of Care through Litigation against Hospitals
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 Is Human.– The report noted that in order to be successful, "safety must be an explicit organizational goal that is…
Many experts believe that the threat of malpractice suits impedes the use of error-reporting systems to make hospitals safer. Annas argues that more lawsuits, not fewer, are needed. He believes that the courts should recognize a right to safety so that hospitals that fail to implement measures to improve safety could be sued when patients are injured owing to preventable errors.
Perspective
The Supreme Court and the Purposes of Medicine
What role should physicians have in defining the purposes of their profession — the functions that medicine should and should not serve? Many observers hold that medicine's aims are for doctors and patients to decide, without interference from the state. But in fact, government limits medicine's…
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