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GLG News by Pulmonologists (US)

Michael Wechsler, MD, Associate Physician in Pulmonary and Critical Care
Brigham and Women's Hospital Inc
Analysis of: FDA Investigating Possible Link Between Singulair and Suicide (www.foxnews.com)
Singulair helps millions of people suffering from asthma. While there are a few sporadic cases of suicide and depression among the millions of patients taking singulair, no causal link has been established and there is no clear mechanism of how singulair might even cause such effects.  In fact,...
David Engler, MD, Physician
David Engler, MD, Physician
The Allergy Clinic
Analysis of: ALVESCO(R) gains FDA approval for the U.S. market (www.pipelinereview.com)
State of the art care for asthma over the past 20 years has involved giving the patient steroids to treat "late phase asthma", the mucus, edema and inflammation that happens on the INSIDE of the airways. Alvesco is different from every inhaled steroid that has come before it.  It is less likely...
Analysis of: Wyeth Receives FDA Approval of Protonix for Delayed-Release Oral Suspension (pharmalive.com)
Proton Pump Inhibitors (PPI's). Patients generally love them, Gastroenterologists can't do without them and Insurer's target them as overused and expensive. Nevertheless, in spite of banishment to the third tier (or worse), Prior authorization), and some OTC and generic availability, Wyeth (WYE) has...
November 12, 2007
Irony in Drug Therapy
Analysis of: Health Canada Approves Natural Supplement for Management of Cholesterol (www.therapeuticsdaily.com)
Throw away the crustacean and save the shell? We have a plethroa of drugs that safely and effectively lower cholesterol and LDL. True, they have limitations, but those weaknesses will not be served by natural supplements. In general they tend to be: Less potent; More expensive; Very popular with certain...
Analysis of: Theravance Announces Initiation of Phase 2 Clinical Program with its MABA Compound in COPD (www.genengnews.com)
Epidemiologic data clearly defines an alarming increase in Chronic Obstructive Lung Disease (COPD) especially among women and younger age groups, both targets of intensive cigarette marketing. The possibility of a designer drug with a dual mechanism of action rings true for several reasons. Unlike asthma,...
Analysis of: Pfizer Abandons Exubera, Posts 77% Earnings Decline (online.wsj.com)
Traditional analysis is correct regarding Pfizer's decision to withdraw inhaled insulin (Exubera) from the market. The fallout from the cascade of bad decisions and market misunderstanding points to the need to underscore one important point, value. Election year politics equates value to regulation....
Analysis of: Aclasta Receives European Approval As First Once Yearly Treatment For Postmenopausal Osteoporosis (www.medicalnewstoday.com)
European approval of Aclasta (Reclast in the U.S.) will be in effect, an experiment in therapeutic entrepreneurial management. Only Novartis did the studies to acquire approval of the IV formulation of this bisphosphonate in the U.S., and presumably the E.U. Notwithstanding several excellent...
Analysis of: Critical Therapeutics Initiates Phase II Clinical Trial for Zileuton Injection (www.pipelinereview.com)
Several questions arise about injectable Zileuton.  Inhaled steroids still remain the mainstay of theray for asthma.  Will patients accept the use of an injectable drug for asthma - if it results in infrequent dosing, it may be an acceptable option for patients.  Liver function tests...
Michael Wechsler, MD, Associate Physician in Pulmonary and Critical Care
Brigham and Women's Hospital Inc
Analysis of: Critical Therapeutics Initiates Phase II Clinical Trial for Zileuton Injection (www.pipelinereview.com)
Zyflo is a great drug in its oral fornmaulation with goiod efficacy but has failed because one has to take it multiple times a day and because one has to monitor liver function. This new IV formulation should be as effective in the ER setting, but hurdles include poor drug marketing by Critical Therapeuitcs...
Analysis of: Lu AA21004 shows highly significant results in clinical phase II trial (www.pipelinereview.com)
Lu AA21004 is the first in a new class of antidepressants that hopefully will reinvigorate the pipeline. Drugs for depression remain a huge cost for Insurers, and the market has not seen a new class of antidepressant therapy for some time. Current therapies have a variety of unpleasant side effects...

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