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GLG News by General Cardiologists (US)

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Carlos DujovneNovember 13, 2008
Crestor's results in the Jupiter Study likely to change medical-economic perspectives in statin choices.
Analysis of: CRESTOR Demonstrates Dramatic CV Risk Reduction in a Large Statin Outcomes Study | www.astrazeneca.com
Author: Carlos Dujovne, Professor of Medicine and Director, OREGON HEALTH & SCIENCE UNIVERSITY - CC
1:Crestor is the most potent statin in the market,yet is 3d in sales behind Zocor and Lipitor.2:The efficacy supriority together with its capacity to lower CRP levels led to the highest rate of ASCVD prevention in the shortest period of time evr documented in statin trials.3:The trial in near 18,000...
November 11, 2008
A closer look
Analysis of: Taking Statins To The Next Level | www.forbes.com
Author: GLG Expert Contributor
The JUPITER trial showed that people with what is regarded as normal ('bad') cholesterol and elevated C-reactive protein benefit more from the choleterol lowering drug rosuvastatin (Crestor, Astra-Zeneca) than from placebo. The first question is: is this true only for this particular type of statin...
November 3, 2008
Process changes must take into account health care needs, not health care wants
Analysis of: Quickly Vetted, Treatment Is Offered to Patients | www.nytimes.com
Author: GLG Expert Contributor
     There will need to be some changes in the process by which the FDA evaluates drugs and devices. Quick vetting will require: 1. Safety: No signals of danger 2. Cost: No increase in cost, or actual savings 3. Benefits: When compared to current therapy, not placebo      ...
October 20, 2008
Successful Collaboration Is Better Than Individual Failure
Analysis of: Health Firms to Study Clots in Stent Patients | online.wsj.com
Author: GLG Expert Contributor
This plan to start a large trial to determine the optimal antiplatelet therapy. after [drug-eluting] stent implantation makes sense both scientifically and economically for the involved stent companies (Johnson & Johnson, Boston Scientific, Medtronic and Abbott). Sanofi-Aventis and Bristol Myers...
October 10, 2008
Signs That the Is Party Over?
Analysis of: Pfizer shifts focus to cancer and biotech drugs | ap.google.com
Author: GLG Expert Contributor
The growth of the big pharma companies in the past 20-30 years has to do with the fact that the medical community was willing to accept large trials (some with surrogate endpoints) as proof that a new treatment is good and that it can replace the old one. Since the problems with Troglitazone, Cerivastatin,...
October 2, 2008
Not All That Shines is Gold
Analysis of: Anemia Drugs Linked to Stroke Study Deaths: FDA | health.usnews.com
Author: GLG Expert Contributor
The anemia drug erythropoietin and its congeners have been used extensively in patients with renal failure and in patients with cancer to boost the red cell count. However, erythropoietin also helps reduce programmed cellular death and is involved in the growth of new vessels. Because of these features...
Carlos DujovneSeptember 29, 2008
Mutiple causes for no publications of many reports on FDA approved drugs.Some problems and solutions.
Analysis of: Many Trial Reports on FDA-Approved Drugs Go Unpublished | www.washingtonpost.com
Author: Carlos Dujovne, Professor of Medicine and Director, OREGON HEALTH & SCIENCE UNIVERSITY - CC
This article is not news for clinical researchers like myself that have performed hundreds of clinical trials in collaboration with the Pharmaceutical Industry. Some of the most common reasons for that are: A)Negative studies are difficult to get published.B)Negative results for the dug of the...
September 15, 2008
Another reason why government intervention doesn't work
Analysis of: Medicare overpaid on drugs with new generics, report says | www.latimes.com
Author: GLG Expert Contributor
The Medicare drug system was a political ploy. This just confrims it. The private insurers were unwilling to offer Rx coverage before then because they understood the economics of it.
August 28, 2008
The trial that is all about hype
Analysis of: Heart Stents No Better Than Drugs for Chest Pain Over Time | www.bloomberg.com
Author: GLG Expert Contributor
The general public hears the bullet that stents are no better than medications, but the reality that this trial (COURAGE trial) had major flaws, the main being that only 10% of the patients screened participated in the trial. 90% were excluded. Thus, the patients enrolled were not necessarily the typical...
August 20, 2008
Pancreatitis has the Potential to Kill (Byetta Sales)
Analysis of: FDA Alert: Hemorrhagic or Necrotizing Pancreatitis in Patients Taking Byetta | www.fda.gov
Author: GLG Expert Contributor
At first, it appeared that the reports linking Byetta and pancreatitis were likely due to an association between pancreatitis and the underlying pathology in patients receiving Byetta (obesity, diabetes, gall stones, and hypertriglyceridemia). However, the additional cases of (sometimes fatal)...

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