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GLG News by General Cardiologists (US)

Ronald Innerfield, Vice President of Clinical Affairs

Ronald InnerfieldVice President of Clinical AffairsEvidence Based Medicine, Inc. What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Metanalyses, Metapsychoses

September 30, 2009

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

Joshua FeuerOwnerJOSHUA M FEUER What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

If it seems too good to be true...it probably is.

December 9, 2008

Generic Heart Drugs as Good as Brand-Name Counterparts | www.washingtonpost.com

This article implies that physician's have no justifiable reason for prescribing brand-name drugs. Unfortunately, it's not that simple.

Joshua FeuerOwnerJOSHUA M FEUER What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

“You've got to be very careful if you don't know where you are going, because you might not get there.” Yogi Berra

December 8, 2008

Patients Taking Lipitor Had a Significantly Reduced Risk of Cardiovascular Events Compared with Patients Taking Simvastatin, New Observational Study Shows | pharmalive.com

There is a question of bias in this study. It is not prospective, not randomized and not blinded and thus no valid conclusions can be made. The study should be ignored. It will have no impact on sales.

Carlos Dujovne, Professor of Medicine and Director

Carlos DujovneProfessor of Medicine and DirectorOREGON HEALTH & SCIENCE UNIVERSITY - CC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

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

November 13, 2008

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 Dujovne, Professor of Medicine and Director

Carlos DujovneProfessor of Medicine and DirectorOREGON HEALTH & SCIENCE UNIVERSITY - CC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

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

September 29, 2008

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 Dujovne, Professor of Medicine and Director

Carlos DujovneProfessor of Medicine and DirectorOREGON HEALTH & SCIENCE UNIVERSITY - CC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

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

June 23, 2008

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 Dujovne, Professor of Medicine and Director

Carlos DujovneProfessor of Medicine and DirectorOREGON HEALTH & SCIENCE UNIVERSITY - CC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

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

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.

Carlos Dujovne, Professor of Medicine and Director

Carlos DujovneProfessor of Medicine and DirectorOREGON HEALTH & SCIENCE UNIVERSITY - CC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

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

January 23, 2008

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.

Dan StrejaClinical Professor of MedicineUNIVERSITY OF CALIFORNIA, LOS ANGELES What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Outsourcing of compassionate use of drugs?

January 18, 2008

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

The Supreme Court has rejected the use of experimental drugs by the dying patients on the grounds that "The framers (of the US constitution) understood that the pursuit of life is an inalienable right that should not be abridged without due process of law." Over the years our patients with terminal illness have traveled outside the US to purchase hope when our management was offering none. Although in the majority of cases the hope was unjustified, the current decision will encourage healthcare providers residing outside the US to advertise for their services through the internet. The issue should be addressed by the legislators sooner rather than later. Drugs who improve quality of life, awaiting approval for survival indication or drugs looking promising in early clinical trials could be made available to dying patients with informed consent addressing our limitations.  

Carlos Dujovne, Professor of Medicine and Director

Carlos DujovneProfessor of Medicine and DirectorOREGON HEALTH & SCIENCE UNIVERSITY - CC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

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

January 17, 2008

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.

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