GLG News by Physicians in the U.S. who Treat Chronic Obstructive Pulmonary Disease (COPD)

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

Will Merck's New Asthma Drug Make the Big Time?

July 6, 2010

Analysis of:FDA Approves Merck's DULERA® Inhalation Aerosol | www.reuters.com

The FDA recently approved Merck's Dulera, inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) combination, for moderate to severe asthma control. This agent is the third combo inhaler, after Advair and Symbicort; thus it starts with an immediate disadvantage in the market. Furthermore, timing seems most inauspicious in light of the FDA's current phobia with the entire class of LABA agents. Any potential profits may be negated by the expense of conducting mandatory long-term safety trials.

Edward LisbergDirectorAsthma and Allergy Center of Chicago, S.C.

Qforma's Online Database: Exposing Pharma's Physician Marketers?

May 15, 2009

Analysis of:In patients' hunt for care, doctor database 'a place to start' | www.usatoday.com

undefinedundefined undefined If the Qfarma database makes public those physicians with significant financial conflicts of interest, will this lead to more intense regulatory  scrutiny of these physicians?  Does this online database place at risk the industry practices?

Edward LisbergDirectorAsthma and Allergy Center of Chicago, S.C.

LABA daba done?

December 11, 2008

Analysis of:FDA: Long-Acting Asthma Drugs Increase Asthma Risks | online.wsj.com

Some information of note, the current FDA briefing document (http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4398b1-00-index.htm) is a publication entirely created by GSK,  Novartis, and AstraZeneca and not an independently created FDA review.  It merely is a summary of trials data already published; in as much, there may be other unpublished data by these pharma co's that may be relevant but will not be part of the debate.  Absent from the FDA document are the FDA reviewer's comments..?redacted.  Furthermore, none of the individual SAE reports are included for review and analysis; we are again left only with pharma's version and clinical trials interpretation. 

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

FDA Poised to Damage Asthma Pharmacotherapy Advances

December 10, 2008

Analysis of:FDA: Long-Acting Asthma Drugs Increase Asthma Risks | online.wsj.com

The use of long-acting beta-agonists (LABAs) in the treatment of persistent asthma has become one of the most controversial issues of respiratory disease management during this decade. Both salmeterol and formoterol have been shown in numerous clinical trials of asthma to dramatically improve pulmonary function, symptoms scores, and need for rescue medication. However, some long-term safety studies have demonstrated increased risk of severe asthma exacerbations when these LABAs are used as monotherapy without concomitant inhaled steroid therapy. Based on this data, the FDA is considering the withdrawal of LABAs from the US market. I anticipate the FDA will come to their senses and appreciate the significant benefit that combination LABA/ICS therapy has in the vast majority of moderate and severe asthmatics for whom they are appropriately prescribed. In my opinion, cessation of LABA therapy for asthma would return us to asthma mortality rates not seen since the 1990s.     

Robert ArisProfessor of MedicineUniversity of North Carolina at Chapel Hill School of Medicine - CC

Oral Treprostinil: An effective medicine hiding in a study with a challenging design?

November 18, 2008

Analysis of:Freedom-C Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Fails to Meet Primary Endpoint | ir.unither.com

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 oral dosing. While in hindsight, this may have not been ideal, the trial holds a lot of promise that treprostinil will be effective since there was a nice dose-response curve and the higher doses clearly appeared to be effective. Oral Treprostinil is probably very similar to subcutaneous and intravenous prostanoids (remodulin and flolan) that require a slow uptitration of dose to allow the patient to become tolerant to the side effects. Thus having smaller doses for titration, which were available later in the trial, probably would have allowed for greater success had these doses been available earlier in the study.

Robert ArisProfessor of MedicineUniversity of North Carolina at Chapel Hill School of Medicine - CC

Mild PAH improved by early treatment with bosentan

July 18, 2008

Analysis of:Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. | www.sciencedirect.com

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 limitation in physical activity. Understanding "slight" is not so easy in clinical practice and there has been some reservation in treating "slightly" ill patients with very expensive drugs without better outcome studies in this target group. Thus the results of the EARLY study (Lancet June 2008) are welcome news to the PAH community.  Analyses were done with 168 patients and showed significant improvements in pulmonary vascular resistance and a strong trend (p = 0.075) toward improvement in 6 minute walk distance in bosentan-treated patients.  These results will certainly compell clinicians to treat patients with "slight" PAH more aggressively.

Robert ArisProfessor of MedicineUniversity of North Carolina at Chapel Hill School of Medicine - CC

Peer reviewed literature on Ambrisentan, a selective ETRA for PAH

June 10, 2008

Analysis of:Ambrisentan for the Treatment of Pulmonary Arterial Hypertension | circ.ahajournals.org

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 physcians to fully embrace the findings.  And the journal Circulation is a top notch publication with "rigorous" reviewers.  Thus this publication will be well received by the PAH community and can be assimilated into the overall database of knowledge on PAH.

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

Will Xolair Become Obsolete in the Treatment of Allergies?

June 10, 2008

Analysis of:Investigational Anti-IgE Antibody Promising as Extracorporeal Allergy Therapy | www.medscape.com

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 potential to replace omalizumab as effective anti-IgE therapy with just one dose, even in patients with very high initial levels of total IgE. The potential market share for such a treatment is enormous since at least 25% of the population suffers from Ige-mediated diseases such as allergic rhinitis, asthma, atopic eczema, and food allergy.

Warren BotnickPresidentPSS Clinical Research

Exciting Prospect for Alternative Treatment of COPD and asthma

September 19, 2007

Analysis of:Newly Discovered Fatty Acids May Lead To Novel Treatments For COPD And Asthma | www.medicalnewstoday.com

Eicosanoids appear promising in the treatment of such airways diseases as COPD and asthma, which affect millions worldwide.  Any alternative to current anti-inflammatory therapy, which consists almost entirely of forms of corticosteroids, would almost certainly be welcomed and adopted in widespread fashion.

Warren BotnickPresidentPSS Clinical Research

Ceftobiprole for Community-Acquired Pneumonia is Breakthrough in Therapy

September 19, 2007

Analysis of:Basilea Announces Positive Top-line Data from Phase III Study of Ceftobiprole in Community-acquired Pneumonia Requiring Hospitalization | www.pipelinereview.com

Cephalosporins have been standard therapy for pneumonia for many years, but to date this class of drug has been ineffective against MRSA.  Ceftobiprole appears to represent a breakthrough in this regard.  I would expect the drug to be well tolerated and, for the most part, to cause few major adverse effects.  However, the use of ceftriaxone as a comparator is odd, as this would not be used as monotherapy by most physicians in the USA for patients with CAP who are sick enough to warrant hospital admission.

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