Physician's First Watch: Archives

Health, United States, 2011— CDC's Annual Statistics Treat for the Data-Obsessed

The National Center for Health Statistics has released its 35th annual compilation of statistics on health in the U.S. This year's edition features a section on socioeconomic status and health.

If you like numbers (or just winning office bets), we highly recommend this.

LINK(S):

Health, United States, 2011 website (Free)

Published in Physician's First Watch May 16, 2012

FDA Panel Recommends Rapid, At-Home HIV Test

An FDA advisory panel voted unanimously on Tuesday to recommend approval of the first rapid, over-the-counter HIV antibody test.

The panel said the OraQuick In-Home HIV Test is safe and effective. However, some research suggested it had low sensitivity, about 93%. False-negative results could lead people with HIV to take fewer precautions, Reuters points out.

The oral swab test produces results in about 20 minutes and, if approved, is expected to cost less than $60.

LINK(S):

Reuters story (Free)

Associated Press story (Free)

FDA summary of test (Free PDF)

Published in Physician's First Watch May 16, 2012

Drug to Prevent Alzheimer's Will Be Tested in a Large Extended Family at Risk

Patients may ask about news reports on a 5-year clinical trial — that's just starting — of a drug to prevent Alzheimer disease. The drug, Crenezumab, blocks formation of amyloid plaques.

The New York Times says Crenezumab will be tested in some 300 members of an extended Colombian family who carry a specific genetic mutation associated with early-onset Alzheimer's. The drug is a mouse-derived, humanized monoclonal antibody against beta-amyloid.

LINK(S):

New York Times story (Free)

Wikipedia entry on Crenezumab (Free)

Published in Physician's First Watch May 16, 2012

After 30 Years, Still Warning About the Direction of U.S. Healthcare

Dr. Arnold Relman, who first warned in a 1980 essay against the rise of the "new medical-industrial complex," offers another warning, this time in BMJ. (Clinical Conversations has an interview with him. Listen via the link below.)

While Relman's 1980 essay called for more study of an emerging situation in which market forces were distorting the U.S. healthcare system, he now describes a system headed inevitably toward bankruptcy and in need of major reform. Physicians, fully aware of what their reimbursements will be, have strong incentives to be "overly generous" in recommending services, he writes, but they remain mostly "unfamiliar with the charges made to insurers [and others] for the services they recommend."

He recommends, among other things, the reorganization of the U.S. system into "private, non-profit, multispecialty group practices, in which physicians are paid largely or entirely by salary." He predicts "fierce resistance" to reform "from all those with vested financial interests in the status quo."

LINK(S):

BMJ article (Free abstract)

Clinical Conversations interview (Free)

NEJM 1980 article (Free abstract)

Published in Physician's First Watch May 15, 2012

New Label Warnings for Fingolimod

The FDA announced on Monday new warnings about potential cardiovascular effects of the multiple sclerosis drug fingolimod (Gilenya), following a review of clinical trial data prompted by the death of one patient after the first dose of the drug.

The agency noted that the death was not definitively tied to fingolimod, but that the drug causes a biphasic drop in heart rate, at about 6 hours and at 12 to 20 hours after the first dose.

Fingolimod is now contraindicated for patients with certain heart conditions or events within the previous 6 months (including MI, stroke, and transient ischemic attack) and in those who take Class Ia or Class III antiarrhythmic medications.

The FDA also now recommends that cardiovascular monitoring be extended beyond 6 hours after the first dose in certain higher-risk patients.

LINK(S):

FDA MedWatch safety alert (Free)

New fingolimod label (Free PDF)

Published in Physician's First Watch May 15, 2012

Exercise Testing in Asymptomatic Patients After Revascularization: Worth the Effort?

Exercise echocardiography in asymptomatic patients after revascularization can identify those at high risk, but these patients do not necessarily benefit from repeat revascularization, according to a retrospective study in the Archives of Internal Medicine.

Researchers studied some 2100 asymptomatic patients who underwent exercise echocardiography roughly 4 years after percutaneous coronary intervention or coronary artery bypass grafting. Of 13% of patients with ischemia on exercise testing, one third had a subsequent revascularization during nearly 6 years of follow-up. While patients with ischemia had a greater mortality risk, repeat revascularization of these patients did not improve survival.

A commentator points out that "routine periodic stress testing in asymptomatic patients following coronary revascularization is associated with high rates of resource utilization and high costs." He concludes: "Until well-supported data become available supporting such a strategy, routine testing in asymptomatic patients is probably not worth the effort."

LINK(S):

Archives of Internal Medicine article (Free abstract)

Archives of Internal Medicine comment (Free)

Published in Physician's First Watch May 15, 2012

CT Colon Screening Without Laxatives Reliably Finds Lesions Above 10 mm in Size

Computed tomographic colonography (CTC) without use of laxatives finds significant favor among patients, but lesions smaller than 10 mm may escape detection, according to a multicenter study in the Annals of Internal Medicine.

U.S. investigators examined some 600 patients. First, all underwent CTC with use of a marker (but not laxatives) that allowed feces to be "subtracted" from the image. The same patients underwent optical colonoscopy 5 weeks later, with laxative preparation.

The sensitivity for detecting lesions 10 mm or larger was roughly the same with both methods: 91% for CTC and 95% for colonoscopy. For smaller lesions, however, sensitivity was much less: for lesions 6 mm or larger, for example, CTC scored only 59%, versus 76% with optical colonoscopy.

Patients preferred CTC over colonoscopy by a nearly two-to-one margin.

LINK(S):

Annals of Internal Medicine article (Free abstract)

Published in Physician's First Watch May 15, 2012

FDA Advisers Recommend Four-in-One 'Quad' Pill for HIV

An FDA advisory panel voted 13 to 1 on Friday to support approval of a new single-treatment regimen for HIV. The once-daily pill, known as the "Quad," combines four drugs — emtricitabine, tenofovir, elvitegravir, and cobicistat — and is for treatment-naive adults.

Journal Watch HIV/AIDS Clinical Care Editor-in-Chief Dr. Paul Sax — who presented study results on the Quad earlier this year — says two phase III clinical trials "clearly demonstrated that the Quad was noninferior (but not superior) to current standard-of-care regimens for HIV therapy, and if approved will be a welcome new option for initial treatment."

Panelists said more research is needed to determine the drug's safety and efficacy in women, Reuters reports. They also recommended monitoring patients for potential renal problems.

The FDA is expected to make a final approval decision by August 27.

LINK(S):

Reuters story (Free)

Manufacturer press release (Free)

Journal Watch HIV/AIDS Clinical Care meeting report on Quad trials presented at CROI 2012 (Your Journal Watch subscription required)

Published in Physician's First Watch May 14, 2012

New Definition of Addiction Could Lead to Sharp Increase in Diagnoses

Addiction may be more broadly defined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, which could lead to "millions more people being diagnosed as addicts and pose huge consequences for health insurers and taxpayers," according to the New York Times.

Under the new definition, fewer symptoms would be required to diagnosis drug or alcohol addiction. For example, people who crave alcohol and drink more than they mean to would be considered "mild addicts." In addition, "behavioral addiction — not otherwise specified" might be used to diagnose addictions to things like shopping and sex.

One critic said such "overly broad" diagnoses would create "false epidemics," the Times reports. Proponents of the changes, meanwhile, contend that a broader definition would translate to earlier intervention and, in turn, fewer serious complications and less expensive treatments.

LINK(S):

New York Times story (Free)

Recent Physician's First Watch coverage of DSM-5 changes (Free)

Published in Physician's First Watch May 14, 2012

Battery-Related ED Visits on the Rise Among U.S. Children

Every 3 hours in the U.S., a child presents to the emergency department with a battery-related injury — most often from ingestion — according to a Pediatrics study.

Using data from a nationally representative sample of U.S. EDs, researchers examined battery-related visits among children from 1990 through 2009. They found that an estimated 3289 such visits occur each year, most often among children aged 5 years or younger (nearly 80% of cases). The rate of visits rose over the study period, with the greatest increases seen in recent years. Ingestion accounted for roughly 75% of visits; button batteries were most frequently implicated.

The authors say child caregivers should tape shut all battery compartments. In addition, they point out that ingested button batteries can cause damage within 2 hours. They write: "Because button batteries may be mistaken for a coin, electrocardiogram electrode, or other external object on a chest radiograph, disk-shaped objects should be carefully examined for features such as diameter and a double rim to prevent delays in diagnosis."

LINK(S):

Pediatrics article (Free abstract)

Published in Physician's First Watch May 14, 2012