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July 7, 2011  Vol. 365 No. 1

Audio Summary of this Issue

Perspective
1-3
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In the recent Matrixx case, the Supreme Court decided that drug-company investors require increased access to statistically nonsignificant information regarding adverse drug experiences. Prescribers' access to the same level of information should also be increased.

3-5
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The FDA has established a new safety-reporting paradigm for drugs being studied in clinical trials. A new regulation provides guidance on causality assessments for adverse events and requires aggregate analysis prior to reporting for some events.

5-8

Clinica Family Health Services, a Denver-area community health center serving a low-income population, is on the front lines of a primary care revolution, constructing patient-centered medical homes by focusing on continuity, prompt access, and teamwork.

8-9

Despite the best of intentions to practice medicine that is based on Level I evidence, a physician comes to appreciate that the influence of a randomized, controlled trial pales in comparison with that of adverse events and outcomes witnessed firsthand.

Original Articles
11-20

In this study in South Africa, 1148 HIV-infected adults with TB were assigned to rifapentine–isoniazid weekly for 12 weeks, rifampin–isoniazid twice weekly for 12 weeks, isoniazid daily for up to 6 years, or isoniazid daily for 6 months. No regimen was identified as superior.

21-31

In this study from South Africa, more than 1300 BCG-immunized infants with or without HIV coinfection received isoniazid or placebo for 96 weeks, starting at about 14 weeks of life. The burden of TB remained high, and primary isoniazid prophylaxis was not efficacious.

32-43

Nesiritide was approved by the FDA on the basis of small clinical trials for the treatment of acute heart failure. In this large clinical trial, nesiritide did not improve outcomes in patients with acute heart failure, and it can no longer be recommended for this condition.

44-53

Patients with sickle cell disease underwent ECG with assessment of tricuspid valve regurgitant jet velocity (TRJV) to screen for pulmonary hypertension, followed by right heart catheterization if the TRJV was 2.5 m per second or more. Prevalence was 27% on the basis of ECG criteria but only 6% on the basis of catheterization.

54-61

Autosomal dominant chronic mucocutaneous candidiasis (CMC) is a severe immunodeficiency characterized by mucosal infections with fungi. Mutations affecting a particular region of the STAT1 signaling protein cause autosomal dominant CMC, probably through denting of the responses of type 1 and type 17 helper T cells.

Clinical Practice
62-70
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This article reviews the risks of osteoporosis and osteonecrosis associated with glucocorticoid use, which are present even in the absence of low bone mineral density, and discusses strategies to reduce the risk of fractures and the data to support the strategies.

Images in Clinical Medicine
71
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An 87-year-old woman presented for evaluation of progressive, nonpruritic, waxy papules and atraumatic ecchymoses in a periorbital (“raccoon eyes”) and perioral distribution. She was otherwise asymptomatic.

e1
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A 34-year-old nonsmoking man was referred for evaluation of a history of polycythemia that required monthly phlebotomy. His medical history was significant for congenital nephrogenic diabetes insipidus, with a urine output of approximately 12 to 15 liters per day.

Clinical Problem-Solving
72-77
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A 71-year-old woman presented with abdominal pain and night sweats. Four weeks earlier, headache, sinus pressure, and night sweats had developed, and amoxicillin was prescribed for presumed sinusitis. Her symptoms improved, but after 1 week, new abdominal pain developed.

Editorials
79-81

The promise of chemoprophylaxis for tuberculosis has yet to be fully realized. Until recently, testing for and treating latent tuberculosis infection have been limited largely to low-burden settings, where active tuberculosis has been under good control. ...

81-82

The concept of the “lost decade” is typically attributed to the Japanese economy in the 1990s, when there was exceptionally little or weak economic growth, amid unprofitable zombie firms and liquidity traps.1 With the financial collapse in the United ...

Health Law, Ethics, and Human Rights
83-89

A subset of trademark law, “trade dress,” provides the legal basis for drug manufacturers' exclusivity claims on the size, shape, and color of pills. The authors discuss the potential adverse effects of trade-dress protection and suggest strategies to address this problem.

Correspondence
90-91

To the Editor: Feldman et al. (April 14 issue)1 report on their randomized trial comparing percutaneous repair with surgery for mitral regurgitation. Interestingly, the percutaneous approach was associated with a higher rate of subsequent surgery for ...

91-92

To the Editor: The study by Cypel et al. (April 14 issue)1 on ex vivo lung perfusion (EVLP) before transplantation raises a number of concerns. The two types of lung donors — those in Maastricht category III (9 donors after cardiac death [without a ...

92-93

To the Editor: Studdert and colleagues (March 31 issue)1 report a weak relationship between nursing home deficiencies and incidence of tort claims, finding that the low-performing facilities (bottom 10% in their sample) are sued just slightly more often ...

93-94

In this case report, eosinophilic endomyocardial disease was diagnosed in a patient on the basis of immunohistochemical evidence of eosinophil granule protein deposition in the heart, even in the absence of eosinophilic infiltration on cardiac biopsy.