GLG News by Surgeons who Perform Lap-Band Procedures

Carlos DujovneAffiliate Professor of MedicineOREGON HEALTH & SCIENCE UNIVERSITY - CC

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

November 13, 2008

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

Carlos DujovneAffiliate Professor of MedicineOREGON HEALTH & SCIENCE UNIVERSITY - CC

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

September 29, 2008

Analysis of:Many Trial Reports on FDA-Approved Drugs Go Unpublished | www.washingtonpost.com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

Carlos DujovneAffiliate Professor of MedicineOREGON HEALTH & SCIENCE UNIVERSITY - CC

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

June 23, 2008

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.

Carlos DujovneAffiliate Professor of MedicineOREGON HEALTH & SCIENCE UNIVERSITY - CC

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 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.

Forrest RubensteinCardiac, Thoracic and Vascular SurgeonST. MARY'S HOSPITAL, STREATOR, OF THE HOSPITAL SISTERS OF THE THIRD ORDER OF ST. FRANCIS

Preventing Bariatric Surgery Deaths

January 25, 2008

Analysis of:Pinning Down Mortality Rates After Bariatric Surgery | www.medscape.com

 Bariatric surgery is a major operative procedure that caries significant morbidity and mortality risks due to the comorbid diseases seen in this patient population.  This procedure is increasing in frequency as more patients are willing to have it and more surgeons are becoming proficient. The mortality rate is ~ 1 % at 1 year and 6% at 5 years which is greater than the population at large.

Carlos DujovneAffiliate Professor of MedicineOREGON HEALTH & SCIENCE UNIVERSITY - CC

Dying patient denied access to experimental drugs is contrary to common sense and discovery of new treatments.

January 23, 2008

Analysis of: No right to experimental drugs for dying patients: Supreme Court | news.yahoo.com

One, twenty years ago I was the chairman of the government affairs committee of the American Society for Clinical Pharmacology and Therapeutics; under that role my committee was successful lobbying for approval new investigational drugs for possible treatment of AIDS. We were successful in getting the FDA to approve the testing of those drugs to dying AIDS patients. Such approval led to the discovery and successful drugs we have available today for the treatment of AIDS. Two, This scenario can be easily applied to patients that are dying from any other incurable diseases where drugs that have the potential for serious toxicity cannot be ethically tested in human volunteers or patients with the same disease but not yet at a terminal stage.

Carlos DujovneAffiliate Professor of MedicineOREGON HEALTH & SCIENCE UNIVERSITY - CC

Merck Developement of Anacetrapib not as Risky as it may appear!

January 17, 2008

Analysis of:Merck & Co.: Engaging in Risky Business? | www.pharmaweek.com

My expertise in the clinical research of Torcetrapib and reports presented at the latest American College of Cardiology meetings made me conclude that the failure of  Torcetrapib in rendering clinical benefits were related to intrinsic problems of the drug which effected the nature of the HDL which levels in blood were extraordinarily elevated.     Other CETP inhibitors may eventually be proven save and effective and be approved by the FDA.

Carlos DujovneAffiliate Professor of MedicineOREGON HEALTH & SCIENCE UNIVERSITY - CC

Merck Developement of Taranabant not as Risky as it may appear!

January 17, 2008

Analysis of:Merck & Co.: Engaging in Risky Business? | www.pharmaweek.com

Those like myself who have more extensive knowledge on the rational used by the FDA to reject the approval of Rimonabant and know the differences between Rimonabant and Taranabant do not believe that there is an error in judgment by Merck in developing their new cannabinoid receptor antagonist. This approach to control obesity is one of the most promising available today.

Carlos DujovneAffiliate Professor of MedicineOREGON HEALTH & SCIENCE UNIVERSITY - CC

Liraglutide benefis in obesity not as greater as authors claim when compared to Orlistat

November 26, 2007

Analysis of:New Phase 2 Study Shows That Liraglutide Leads to Significant Weight Loss in Obese People | pharmalive.com

As past Principal Investigator in most clinical trials wit Orlistat I can offer a different interpretations of tthe resuls of the comparayive study just announced,as follows.1.The result on diabetes or glucose regulation were earlier with Liraglutide,possibly because it has specific antidiabetic(besides weight loss)effects.Howeber the overall benefit was not greater than that 0f Orlistat at 1 and 2 years.

Forrest RubensteinCardiac, Thoracic and Vascular SurgeonST. MARY'S HOSPITAL, STREATOR, OF THE HOSPITAL SISTERS OF THE THIRD ORDER OF ST. FRANCIS

CMS regulations penalize hospitals for taking care of sickest patients

August 28, 2007

Analysis of:New Medicare Regulations Adopted To Reduce Certain Hospital Infections And Medical Errors | www.medicalnewstoday.com

This article presents the new CMS guidelines that deny higher payments for the additional costs associated with treating patients for certain hospital - acquired infections and medical errors. While these are laudable goals, to assume that all infections are the result of poor medical practice is an oversimplification. The development of nosocomial infections also has to do with the patients disease processes such as diabetes, morbid obesity, immunosuppression, tobacco abuse, etc. While few physicians would argue against enforcing these rules for documented mistakes (medication errors, transfusion mistakes, and objects left in patients bodies), most recognize there is a certain baseline of these other infections which cannot be avoided. Hospitals should only be penalized when their risk adjusted incidence exceeds a standardized baseline.

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