Featured Research

from universities, journals, and other organizations

Off-label Medicine Combinations Are Predominant Treatment In Survey Of Schizophrenics

Date:
September 12, 2008
Source:
Public Library of Science
Summary:
Researchers report that 74.5 percent of 200 community-based schizophrenic patients, who were interviewed and evaluated (including a review of clinical records), were treated with off-label medication treatments. Specifically, 42.5 percent of subjects reported they were simultaneously treated with more than one antipsychotic drug, an unapproved treatment for schizophrenia. The most common unapproved drug combination was the use of both an antipsychotic drug and a mood stabilizer (45 percent of patients).

Off-label medication use, the clinical application of prescribed drugs for indications other than those approved by the relevant drug regulatory agency (in the US, the Food and Drug Administration—FDA), is widespread in many areas of medicine but is particularly common in psychiatry.

While off-label uses are legal and in many instances may be in the best interests of patients, they have not received the same degree of independent scrutiny through randomized clinical trials as have approved indications. A drug approved for marketing may be labeled, promoted and advertised by the manufacturer for only those uses for which the drug's safety and effectiveness have been established by the FDA.

In a new paper, published in the online, open-access journal PLoS ONE, David Pickar and colleagues, of Gabriel Sciences, report that 74.5% of 200 community-based schizophrenic patients, who were individually interviewed and evaluated (including a review of clinical records), were treated with off-label medication treatments. Specifically, 42.5% of subjects reported that they were simultaneously treated with more than one antipsychotic drug, an unapproved treatment for schizophrenia. The most common unapproved drug combination was the use of both an antipsychotic drug and a mood stabilizer (45% of patients). This combination of drug classes was predicted by the diagnosis of schizoaffective schizophrenia, history of having physically hurt someone and high symptom ratings.

The sample of schizophrenic patients studied in this report was derived from multiple outpatient settings and reflect demographies of seriously ill patients with schizophrenia. For example, there was a slightly higher male prevalence (59.5%); largely, patients were never married (75%); a majority live in supervised dwelling (54.5%); nearly half had had involuntary hospitalizations (47.5%), and had made a suicide attempt (48%); the mean age of onset was 19.9 years. The economic implications of off-label medication use are substantial for public sector payers as well as for the revenue of the pharmaceutical industry, whose promotion of off-label drug use is of considerable concern.

"These data underscore the limitations of both first and second generation antipsychotic drugs and the desire of clinicians to improve outcome in schizophrenic patients. The off-label status of the drug treatments are problematic as, studies required to establish support are both expensive and expose risk to the company's market by the possibility of new or serious adverse events and/or not being able to establish efficacy. Since a company is not allowed to promote an off-label use, the importance of so-called opinion leaders, who are free to independently discuss treatment approaches, increases substantially. The financial opportunities for both the company and the opinion leader can lead to blurred boundaries," observed senior author David Pickar, MD, President of Gabriel Sciences and Adjunct Professor, Johns Hopkins Medical School.

The authors and Gabriel Sciences have no financial, consulting or other relationship with any pharmaceutical company whose products were addressed in this paper. Dr. Pickar has no financial, consultative or speaking bureau relationship with any pharmaceutical company that has a marketed drug for any indication. Dr. Pickar is an equity shareholder of Houston Pharma. Dr. Pickar is the inventor on a two patents, Antipsychotic Composition and Method of Treatment, US Patent #5,492,907 and US Patent #5,663,167 for which the assignee is The United States of America as represented by the Department of Health & Human Services. Ms. Vinik has no financial, consultative or speaking bureau relationship with any pharmaceutical company that has a marketed drug for any indication. Dr. Bartko has no financial, consultative or speaking bureau relationship with any pharmaceutical company that has a marketed drug for any indica tion.


Story Source:

The above story is based on materials provided by Public Library of Science. Note: Materials may be edited for content and length.


Journal Reference:

  1. Pickar D, Vinik J, Bartko JJ. Pharmacotherapy of Schizophrenic Patients: Preponderance of Off-Label Drug Use. PLoS ONE, 2008; 3 (9): e3150 DOI: 10.1371/journal.pone.0003150

Cite This Page:

Public Library of Science. "Off-label Medicine Combinations Are Predominant Treatment In Survey Of Schizophrenics." ScienceDaily. ScienceDaily, 12 September 2008. <www.sciencedaily.com/releases/2008/09/080909204832.htm>.
Public Library of Science. (2008, September 12). Off-label Medicine Combinations Are Predominant Treatment In Survey Of Schizophrenics. ScienceDaily. Retrieved July 24, 2014 from www.sciencedaily.com/releases/2008/09/080909204832.htm
Public Library of Science. "Off-label Medicine Combinations Are Predominant Treatment In Survey Of Schizophrenics." ScienceDaily. www.sciencedaily.com/releases/2008/09/080909204832.htm (accessed July 24, 2014).

Share This




More Health & Medicine News

Thursday, July 24, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Condemned Man's US Execution Takes Nearly Two Hours

Condemned Man's US Execution Takes Nearly Two Hours

AFP (July 24, 2014) America's death penalty debate raged Thursday after it took nearly two hours for Arizona to execute a prisoner who lost a Supreme Court battle challenging the experimental lethal drug cocktail. Duration: 00:55 Video provided by AFP
Powered by NewsLook.com
China's Ageing Millions Look Forward to Bleak Future

China's Ageing Millions Look Forward to Bleak Future

AFP (July 24, 2014) China's elderly population is expanding so quickly that children struggle to look after them, pushing them to do something unexpected in Chinese society- move their parents into a nursing home. Duration: 02:07 Video provided by AFP
Powered by NewsLook.com
Hundreds in Virginia Turn out for a Free Clinic to Manage Health

Hundreds in Virginia Turn out for a Free Clinic to Manage Health

AFP (July 24, 2014) America may be the world’s richest country, but in terms of healthcare, the World Health Organisation ranks it 37th - prompting hundreds in Virginia to turn out for a free clinic run by “Remote Area Medical”. Duration 02:40 Video provided by AFP
Powered by NewsLook.com
Idaho Boy Helps Brother With Disabilities Complete Triathlon

Idaho Boy Helps Brother With Disabilities Complete Triathlon

Newsy (July 23, 2014) An 8-year-old boy helped his younger brother, who has a rare genetic condition that's confined him to a wheelchair, finish a triathlon. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins