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Robert ArisNovember 18, 2008
Oral Treprostinil: An effective medicine hiding in a study with a challenging design?
Analysis of: Freedom-C Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Fails to Meet Primary Endpoint | ir.unither.com
Author: Robert Aris, Associate Professor of Medicine, University of North Carolina Chapel Hill - CC
This phase III study was done without the benefit of conventional drug development with Phase I and Phase II studies (which would have provided more information about the effective dose) preceding it because pharmacokinetic date from IV and SC dosing studies were used to extrapolate for the...
October 6, 2008
cold medications overdose- med fault or Dr. fault?
Analysis of: FDA urged to recall cold medicines for youngsters | news.yahoo.com
Author: GLG Expert Contributor
There is a alot of information in the media  about the dangers of givng OTC cough medication to young children . Many children have ended up in the emergency room after "over-ingesting" "cold remedy products that include OTC antihistamines, decongestants and  cough suppressants. Also when...
Robert ArisJuly 18, 2008
Mild PAH improved by early treatment with bosentan
Analysis of: Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. | www.sciencedirect.com
Author: Robert Aris, Associate Professor of Medicine, University of North Carolina Chapel Hill - CC
While functional class II (FC II) PAH patients have been included in previous clinical trials, the EARLY trial is the first study to concentrate (ie recruit exclusively) FC II PAH patients.  This is important because the definition of functional class II is that a patient has a sight...
June 23, 2008
Electronic Health Records - implementation hurdles
Analysis of: Most Doctors Aren’t Using Electronic Health Records | www.nytimes.com
Author: GLG Expert Contributor
Electronic Health Records (EHR) are like a marriage, but are difficult to implement.  They are expensive, time-consuming and require a paradigm shift from ALL employees of the practice.  Half of all attempts fail; similar to getting married.  They do save costs of transcription and filing/pulling...
Robert ArisJune 10, 2008
Peer reviewed literature on Ambrisentan, a selective ETRA for PAH
Analysis of: Ambrisentan for the Treatment of Pulmonary Arterial Hypertension | circ.ahajournals.org
Author: Robert Aris, Associate Professor of Medicine, University of North Carolina Chapel Hill - CC
This Circulation paper is the first peer reviewed data on the 2 pivotal Phase III trials on ambrisentan that lead the FDA to approving it for the treatment of PAH in July 2007. This paper is critically important since all new research needs to withstand the rigor of peer-review for...
June 10, 2008
Will Xolair Become Obsolete in the Treatment of Allergies?
Analysis of: Investigational Anti-IgE Antibody Promising as Extracorporeal Allergy Therapy | www.medscape.com
Author: Mark Vandewalker, Allergy Specialist and Partner, Allergy & Asthma Consultants Of The Ozarks Ltd
This recent report characterizes a newly discovered anti-IgE monoclonal antibody (mAb12) which appears dramatically more potent than omalizumab (Xolair) in its ability to reduce systemic IgE levels. If further studies confirm this enhanced reduction of IgE and IgE-bearing cells, mAb12 has significant...
May 12, 2008
does straterra work?
Analysis of: FDA Approves Strattera® for Maintenance of ADHD in Children and Adolescents | newsroom.lilly.com
Author: GLG Expert Contributor
we really have had little luck with straterra in  our office.  Even at high  doses,  the drug rarely does the trick
May 12, 2008
merck does the work
Analysis of: FDA Approves ROTARIX(R) Rotavirus Vaccine | www.pipelinereview.com
Author: GLG Expert Contributor
the vaccines may be similar, but I'll stick with the Merck product
May 12, 2008
bubbles always BURST
Analysis of: Speculators knock OPEC off oil-price perch | www.atimes.com
Author: GLG Expert Contributor
what goes up must come down.  This speculation in oil has happened many times during my lifetime and it is the same with all commodites (remember the holland tulips).  Yes, many have and will make fortunes in commoditiy trades, but in the end the real intrinsic value comes through.  When...
April 14, 2008
FDA Analysis of Singulair- Wait until the evidence is in.
Analysis of: FDA investigates suicide with Merck drug | www.physorg.com
Author: GLG Expert Contributor
The FDA is investigating Merck's Singulair for a possible link to suicidal thought and action.  With over 28 million prescriptions last year and a 12 year record of safety in children and adults, the evidence must be evaluated closely before coming to any conclusion. Of note antihistamines, including...

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