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
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.
December 8, 2008
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.
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
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Many Trial Reports on FDA-Approved Drugs Go Unpublished | www.washingtonpost.com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.
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.
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.
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.
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.
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.
What is potential future for Sequenom in prenatal testing.
November 9, 2009
November 7, 2009
Express Scripts feeling Growing Pains
October 29, 2009
CDC Outlines H1N1 Test Guidelines
October 8, 2009
Why Health Care Costs Keep Rising—And What to Do About It
September 13, 2009