Study Group: Byetta Prescribers for Diabetes (US)

GLG News^SM Analyses by this Study Group's Leading Experts(?)

Metanalyses, Metapsychoses

September 30, 2009

Analysis by:Ronald Innerfield, Vice President of Clinical Affairs,

Analysis of:Controls to blood sugar 'cuts stroke risk' | www.barchester.com

There have been many epidemiologic studies showing a very tight correlation between baseline A1c and cardiovascular mortalityDespite this, five major randomized prospective studies have failed to show any macrovascular benefit for tighter glucose controlThe logical conclusion is that glucose is, therefore, a marker for increased mortality but not a modifiable risk factor thereofThis is why FDA has mandated cardiovascular safety for new antidiabetic agentsData dredging persists, however

Crestor's results in the Jupiter Study likely to change medical-economic perspectives in statin choices.

November 13, 2008

Analysis by:Carlos Dujovne, Professor of Medicine and Director,

Analysis of:CRESTOR Demonstrates Dramatic CV Risk Reduction in a Large Statin Outcomes Study | www.astrazeneca.com

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 patients with otherwise lower risk of ASCVD offered $0% reduction y many ascvd endpoints.4:There were no statistical differences in side effect compared to placebo.5:The dosage was 20 mg /day (an intermediate dose below the approved max dose of 40 mg/day

Mutiple causes for no publications of many reports on FDA approved drugs.Some problems and solutions.

September 29, 2008

Analysis by:Carlos Dujovne, Professor of Medicine and Director,

Analysis of:Many Trial Reports on FDA-Approved Drugs Go Unpublished | www.washingtonpost.com

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 sponsor company are of potentially damaging financial  for the sponsor.C)There is no FDA regulation that prohibits a sponsor to deny access to data and freedom of publication to Investigators of the trial not employed by them. Some of the possible solutions for these problems are:A)Complete freedom of access and publication of data by investigators.B)Sponsors of studies be obligated to submit result regardless of outcome,to FDA.C)Studies shall be easily searchable in a Google style manner at  FDA files,by naming a company ,a drug ,a condition,etc,etc.

Exenatide may provide practical and cost convenient efficacy in tratment of Metabolic Syndrome patients

June 23, 2008

Analysis by:Carlos Dujovne, Professor of Medicine and Director,

Analysis of:After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 2008 | newsroom.lilly.com

More than 50% of patients have the 3 ccomponents to qualify for diagnosis of Metabolic Syndrome.Twwo of the components,Diabetes and Obesity are present in 20-25% of them and are difficult to control.Exenatide seems to provide that benefit.

China is the largest exporter of drugs or drug's ingredients and FDA does not have resources to check the quality of the majority of the imported as well as the USA produced generic drugs.

February 19, 2008

Analysis by:Carlos Dujovne, Professor of Medicine and Director,

Analysis of:China Plant Played Role | online.wsj.com

1:Most of our legislators are forcefully endorsing generic drug usage and importing cheaper drugs.2:As a physician specialist in Clinical Pharmacologist I am fully aware or the safety and efficacy pitfalls of poorly manufactured  drugs and have done clinical research documenting the risks of patients treated with them.3:For that reason I strongly advised my patients to buy branded drugs by reputable Pharmaceutical Companies who have much to loose if found to manufacture poorly made drugs.

View All GLG News by members of this Study Group