GLG News by Niaspan Prescribers for Raising HDL

Charles GlueckDirector of Cholesterol CenterJewish Hospital

Study: Lab test can prevent severe blood clots in testosterone patients

September 30, 2011

A recent study finds that a blood test can prevent disastrous blood clots in men receiving testosterone therapy.

Dan StrejaClinical Professor of MedicineUNIVERSITY OF CALIFORNIA, LOS ANGELES

Actos has little to worry about Avandia lawsuits

May 10, 2011

Analysis of:Glaxo May Settle 1,000 More Lawsuits Over Avandia, Patients’ Lawyer Says | www.bloomberg.com

The FDA has practically eliminated Avandia based on either an analysis considered by everybody faulty or on data that were never released to the public. Actos has a different cardiovascular safety profile and Takeda should not and probably will not settle any lawsuits concerning risk of heart attack.

Dan StrejaClinical Professor of MedicineUNIVERSITY OF CALIFORNIA, LOS ANGELES

Aspirin cuts heart attack but not strokes, but not in everybody

April 24, 2011

Analysis of:Aspirin cuts heart attacks, but not deaths or strokes: study | www.reuters.com

Aspirin is a great drug to take for prevention of heart attacks but is not for everybody: - In women aspirin prevents strokes but not heart attacks - In patients with diabetes and no heart disease it does not seem to work - In patients with poor circulation to the legs it is not strong enoughThe lack of prevention of death might be due to the fact that the patient studied had less heart attacks but did not oblige the investigators by dying for them. Given the right patient aspirin remains a great drug.

Dan StrejaClinical Professor of MedicineUNIVERSITY OF CALIFORNIA, LOS ANGELES

Analysis of most prescribed drugs is no surprise

April 24, 2011

Analysis of:What Drug Did Doctors Prescribe Most Last Year? | blogs.wsj.com

In times of cost constrains this is no concern. There are additional factors to explain the numbers, some of them related to FDA wisdom:-       Multiple new drug applications in metabolic area have been turned down-       Propoxiphene was withdrawn increasing dramatically the use of hydrocodone-       Atorvastatin is already generic in other countries Others are related to strategy of the Pharmaceuticals:-       Lipitor keeps the market share against simvastatin by issuing $4.00 coupons-       Advair and Plavix are heavily advertized directly to the consumer As fewer drugs are approved and many drugs are getting old the overall picture is a logical consequence.

Ronald InnerfieldVice President of Clinical AffairsEvidence Based Medicine, Inc.

Metanalyses, Metapsychoses

September 30, 2009

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

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.

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.

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