corner
Healthy Skepticism
Join us to help reduce harm from misleading health information.
Increase font size   Decrease font size   Print-friendly view   Print
Register Log in

Healthy Skepticism Library item: 14398

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Off-label Medicine Combinations are Predominant Treatment of Schizophrenics According to PLoS Article
Enhanced Online News 2008 Sep 23
http://eon.businesswire.com/portal/site/eon/permalink/?ndmViewId=news_view&newsId=20080923005075&newsLang=en


Full text:

In a new paper published in the online open-access journal PLoS ONE, http://dx.plos.org/10.1371/journal.pone.0003150, 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.

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. The economic implications of off-label medication use are substantial for public sector payers as well as for the revenue of the pharmaceutical industry.

“The data presented in the article 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 because 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.

Gabriel Sciences and David Pickar, MD

Gabriel Sciences is a biotech company with the mission to advance treatment and understanding of mental illness through its translational research, including collaborative opportunities with academic medicine. David Pickar MD, founder, is former Chief of the Experimental Therapeutics Branch at National Institute of Mental Health (NIMH) with current adjunct appointments as Professor of Psychiatry at Johns Hopkins University School of Medicine and Uniformed Services University of Health Sciences.

Contacts

Gabriel Sciences
David Pickar, 301-263-1313
Fax: 301-229-1815
dpickar@gabrielsciences.com
www.gabrielsciences.com or www.davidpickar.com

 

  Healthy Skepticism on RSS   Healthy Skepticism on Facebook   Healthy Skepticism on Twitter

Please
Click to Register

(read more)

then
Click to Log in
for free access to more features of this website.

Forgot your username or password?

You are invited to
apply for membership
of Healthy Skepticism,
if you support our aims.

Pay a subscription

Support our work with a donation

Buy Healthy Skepticism T Shirts


If there is something you don't like, please tell us. If you like our work, please tell others.

Email a Friend








Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909