Physician's First Watch: Archives

Anti-Seizure Drug Linked to Retinal Abnormalities, Skin Discoloration

By Amy Orciari Herman

The anti-seizure drug ezogabine (Potiga) can cause discoloration of both the skin and the retina, the FDA warned on Friday. It's unknown whether these changes are permanent or whether the retinal discoloration can lead to vision impairment.

The skin discoloration includes blue pigmentation, most often around the lips or in the nail beds, but at times more widespread on the face and legs. In addition, scleral and conjunctival discoloration has been reported. If ophthalmic changes occur, the FDA says, ezogabine should be discontinued unless there are no other treatment options. In cases of skin discoloration, alternative treatments should be considered. The FDA cautions against abrupt discontinuation.

All patients taking ezogabine should have baseline and periodic eye exams that include visual acuity testing and dilated fundus photography, the agency advises. Additional eye testing (e.g., fluorescein angiograms) may also be performed.

Healthcare providers should report any ezogabine-related adverse events to the FDA's MedWatch program.

LINK(S):

FDA MedWatch alert (Free)

FDA safety communication (Free)

MedWatch adverse event reporting program (Free)

Background: Physician's First Watch coverage of ezogabine approval (Free)

Published in Physician's First Watch April 29, 2013

Cancer Drug Prices 'Unsustainable,' International Researchers Charge

By Joe Elia

The cost of cancer drugs has drawn protest from an international group of leukemia specialists. Their statement, published in Blood, is signed by some researchers whose work is supported by the very drug company, Novartis, that is the focus of their denunciations.

Using imatinib (Gleevec) as an example of what's wrong, the authors point out that its price tripled from $30,000 per year in the U.S. at its 2001 introduction to over $90,000 in 2012. This occurred even in the face of competition, which is also priced, they write, "at astronomical levels." The authors observe that free-market economics has failed to reduce the prices of cancer drugs and offer "collusive behavior" as one explanation for the failure.

In the belief that "unsustainable drug prices" may be causing harm to patients, the 120 signers offer to organize regular meetings to address these concerns.

Novartis, responding through an official, said it welcomes the dialogue.

LINK(S):

Blood commentary (Free PDF)

Novartis response in Blood (Free)

New York Times story (Free)

Published in Physician's First Watch April 29, 2013

Featured in Journal Watch: Good Riddance to Funky Toenails

By The Journal Watch Editors

Impressive cure rates were achieved in two randomized, controlled trials of efinaconazole 10% solution for distal subungual onychomycosis.

LINK(S):

Journal Watch Dermatology summary (Free)

Published in Physician's First Watch April 29, 2013

Shortage of TB Skin Test Antigens: CDC Offers Advice

By Cara Adler

A nationwide shortage of the two FDA-approved tuberculin purified-protein derivatives used for tuberculin skin testing (Tubersol and Aplisol) is expected to last at least until late May, according to an article in MMWR.

Tubersol's manufacturer reported to the CDC that 50-dose vials will be unavailable through the end of May and that 10-dose vials remain in short supply. Aplisol's manufacturer reported restricted supplies, with local shortages as providers switch to Aplisol when Tubersol is not available.

In the meantime, CDC officials recommend that clinicians use interferon-gamma release assay blood tests for detecting Mycobacterium tuberculosis infection. In addition, clinicians may reserve tuberculin skin tests for contact investigations and other "priority indications," or they may use Aplisol (if available) instead of Tubersol.

LINK(S):

MMWR article (Free)

CDC fact sheet on interferon-gamma release assay blood tests (Free)

Published in Physician's First Watch April 26, 2013

New York Times Magazine Looks at Breast-Cancer 'Overawareness'

By Kelly Young

The New York Times Magazine's cover story this week, "Our Feel-Good War on Breast Cancer," examines problems related to the nation's focus on early detection.

The story says mammograms do not easily detect the more lethal forms of the disease when they are still treatable; they do find cancers that might not spread but are treated anyway.

One researcher says that compared with Europe, the U.S. has a "mastectomy craze;" women who might not need a mastectomy medically might opt for one to regain a sense of self control. The researcher says, "There is so much 'awareness' about breast cancer in the U.S. I've called it breast-cancer overawareness. It's everywhere. There are pink garbage trucks. Women are petrified."

The author, who's had breast cancer herself, concludes: "All that well-meaning awareness has ultimately made women less conscious of the facts: obscuring the limits of screening, conflating risk with disease, compromising our decisions about health care, celebrating 'cancer survivors' who may have never required treating."

LINK(S):

New York Times Magazine story (Free)

Published in Physician's First Watch April 26, 2013

Featured in Journal Watch: Antibiotic Prophylaxis Before Dental Procedures for Patients with Total Joint Replacements

By The Journal Watch Editors

The personal and public health harms of widespread antibiotic use probably outweigh the dubious benefits for patients with total joint replacements who are undergoing dental procedures.

LINK(S):

Journal Watch General Medicine feature (Free)

Published in Physician's First Watch April 26, 2013

Updated Guidelines Issued for Medical Exams in Cases of Sexual Assault

By Amy Orciari Herman

The U.S. Department of Justice has updated its National Protocol for Sexual Assault Medical Forensic Examinations, according to a DOJ news release.

The revised "SAFE Protocol" places greater emphasis on the victim's physical and emotional needs, rather than criminal justice issues. It also offers more guidance on treating patients with special needs, such as those with disabilities; those with language barriers; and those who identify as lesbian, gay, bisexual, or transgender. In addition, the update recommends that clinicians offer victims emergency contraception, or at least information on how to obtain it.

The document also examines the scope and limitations of confidentiality.

LINK(S):

DOJ news release (Free)

DOJ guidelines (Free PDF)

New York Times story (Free)

Published in Physician's First Watch April 26, 2013

Hormone Discovery May Allow Better Insulin Production in Diabetes

By Joe Elia

A hormone identified in mice (and present in humans) increases the proliferation of insulin-secreting β cells, even in the presence of insulin resistance, a study published in Cell finds.

Betatrophin, produced by liver and fat cells, "specifically promotes pancreatic β-cell proliferation, expands β-cell mass, and improves glucose tolerance," according to the study's abstract. The authors, who explain their work in an online video, believe that betatrophin could augment or replace insulin injections in diabetes.

LINK(S):

Cell article (Free abstract)

Harvard Stem Cell Institute video (Free)

Published in Physician's First Watch April 26, 2013

Epidemiology of H7N9 Cases Shows Low Risk of Secondary Transmission

By Joe Elia

A study of the first 82 confirmed cases of H7N9 avian influenza infection finds no evidence of any human-to-human transmission, according to a study in the New England Journal of Medicine.

Over three quarters of the cases had a history of exposure to live animals, mostly to chickens. However, because of two family clusters, the authors can't completely rule out human-to-human transmission.

With a case-fatality rate of 21%, the virus is less lethal than H5N1, which had a mortality rate over 50%. The report's authors say H7N9 is affecting a wider age range of patients than the earlier virus — the patients in this case series ranged in age from 2 to 89 years.

The authors conclude that "the risk of secondary H7N9 virus transmission, including to health care personnel, is low at this time."

LINK(S):

NEJM article (Free)

Published in Physician's First Watch April 25, 2013

Biventricular Pacing Outperforms Standard Pacing in Patients with Atrioventricular Block

By Amy Orciari Herman

In patients with atrioventricular block, biventricular pacing offers greater clinical benefit than conventional right ventricular pacing, according to an industry-funded study in the New England Journal of Medicine.

Nearly 700 patients with atrioventricular block, mild-to-moderate heart failure, and a left ventricular ejection fraction of 50% or lower received pacemakers or implantable cardioverter defibrillators and then were randomized to receive either biventricular or right ventricular pacing. During roughly 3 years' follow-up, the primary composite outcome (all-cause mortality, an urgent care visit for heart failure, or progression of heart failure) occurred less often with biventricular than with right ventricular pacing (46% vs. 56% of participants).

In Journal Watch Cardiology, Mark Link notes that the findings are consistent with those from previous trials. He concludes: "The body of evidence is thus approaching critical mass to render future trials comparing right ventricular pacing and [cardiac resynchronization therapy] unethical."

LINK(S):

NEJM article (Free abstract)

Journal Watch Cardiology summary (Free)

Published in Physician's First Watch April 25, 2013