Saturday 22 June 2013

Clinical Notes: Cause of Death Often False

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By John Gever, Deputy Managing Editor, MedPage Today

Causes of death listed on official records have long been suspect, and a survey of medical residents in New York City found good reason for that. Also this week: a promising lymphoma drug fails.

Resident Survey: Don't Believe Official Cause of Death

Half of medical residents in New York City said in a survey that they had written a diagnosis of death they believed was false, researchers said.

Led by Keith Rose, MD, of St. Luke's-Roosevelt Hospital Center in New York City, the survey was completed by 521 residents in internal medicine, general surgery, and emergency medicine at 26 institutions across the city.

One problem appeared to be that septic shock was not accepted as a cause of death in the record system used in New York -- 70% of respondents said they had listed an alternative cause of death because septic shock was not an option, according to the researchers' report in May 9 issue of the the CDC's Preventing Chronic Disease publication.

Some 40% indicated that personnel in the admitting office had instructed them to record a cause of death other than what the respondents considered to be true, and about 30% said the medical examiner told them what to put.

Also of note, only 20% of residents knew they could use terms such as "probable," "presumed", or "undetermined" on the death certificate, and only 3% had ever amended a death certificate on the basis of later information.

Lilly Pulls Plug on Lymphoma Drug

Eli Lilly and Co. said it would stop development of enzastaurin, after a phase III study in diffuse large B-cell lymphoma patients failed to show a benefit against placebo.

The firm had tested the drug in a variety of cancers. An earlier study in ovarian cancer was also negative, but it had shown promise for other diseases including lymphoma.

Enzastaurin is a serine-threonine kinase inhibitor that inhibits tumor angiogenesis by targeting protein kinase C-beta and the PI3K/AKT pathway.

The lymphoma trial had enrolled patients at high risk of relapse after chemotherapy including rituximab (Rituxan). Lilly had hoped the drug would prevent or delay relapses relative to the placebo group.

You Could Put Your Eye Out

Following a Consumers Union report slamming eyelash extensions as unsafe, the American Academy of Ophthalmology issued a statement largely agreeing.

The academy "cautions consumers about the dangers of cosmetic eyelash extensions and the adhesives used to apply them to eyelids," according to the statement.

Infections of the cornea or eyelid, swelling of the eyelid, and potentially permanent loss of eyelashes are the specific risks, the statement indicated.

Consumers should make sure that salon workers practice good hand hygiene and should also "check the eyelash adhesive ingredients before use." However, the statement did not indicate what consumers should specifically look for.

FDA Approves Computerized Propofol System

A computer-assisted, personalized sedation system for delivering intravenous propofol, sold under the name Sedasys by an Ethicon Endo-Surgery division of the same name, was approved by the FDA, the firm said.

The device is designed to "enabl[e] physician-led teams to administer minimal-to-moderate propofol sedation, personalized to the needs of each patient, by precisely integrating drug delivery and comprehensive patient monitoring," Sedasys said in a statement.

It is indicated for delivering 1% propofol solutions to patients undergoing colonoscopy and upper GI endoscopy procedures. Sedasys estimated that 15 million patients would be candidates for such sedation annually in the U.S.

Actual product launch is slated for early 2014, the company said.

Treat Asian Bird Markets Like Hospital Rooms?

Researchers in Great Britain and Vietnam suggested that transmission of avian influenza -- whether H5N1, H7N9, or others yet to emerge -- could be stemmed by targeting certain live bird markets for daily disinfection.

Guillaume Fournie, DVM, MSc, PhD, of the Royal Veterinary College in Hatfield, England, and colleagues performed a computer analysis indicating that a relatively small number of live bird markets serve as local hubs for the Asian poultry industry. These can be identified by interviewing sellers to determine their travel habits and where they buy and sell birds.

After-hours disinfection of these hub markets on a daily basis would go a long way toward keeping bird flu outbreaks from spreading to other regions, as has been the case with H5N1 strains.

However, the effectiveness of such interventions is uncertain, and the researchers did not attempt to test it themselves. Their report appeared in the May 6 Proceedings of the National Academy of Sciences.

FDA Warns on Kadcyla Name

Nothing is known to be wrong with the new breast cancer drug sold as Kadcyla, but its generic name could cause confusion, the FDA said.

The officially approved generic name is ado-trastuzumab emtansine, the FDA said, but many electronic records systems, medical publishers, and other third-party information sources have called it simply trastuzumab emtansine without the ado- prefix.

This could lead to errors in prescribing, with patients given trastuzumab (Herceptin) instead of the newer drug, the FDA said.

"It is important for drug information content publishers to identify drug products by the FDA-approved proprietary (brand) and nonproprietary names that are used in FDA-approved drug labels. This will help prevent medication errors and ensure adverse events are reported for the correct product," an FDA statement said.

Product Recalls

The FDA announced several drug and device recalls last week, including these:

As always, the FDA urged healthcare professionals to report adverse events associated with medical products to the agency's MedWatch system.

John Gever

Senior Editor

John Gever, Senior Editor, has covered biomedicine and medical technology for 30 years. He holds a B.S. from the University of Michigan and an M.S. from Boston University. Now based in Pittsburgh, he is the daily assignment editor for MedPage Today as well as general factotum on the reporting side. Go Pirates/Penguins/Steelers!

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