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Requirement for Extra Data for Alogliptin: FDA Incompetence will Hurt Takeda and Diabetics

June 30, 2009

Analysis of:FDA throws up roadblock for Takeda's diabetes drug | www.fiercebiotech.com

1. The FDA failed to review Takeda's new drug application for Alogliptin in a timely manner, despite being paid handsomely by Takeda to do so. 2. After causing the delay, the FDA then took advantage of that delay to add an extra requirement for approval of Alogliptin, which would not otherwise have applied to it. 3. The net result is a lengthy delay in approval of a promising new diabetes drug, which hurts patients, health care providers, and the very pharmaceutical industry we depend on for new drugs.

Costly diabetes drugs are better than generics

April 22, 2009

Analysis of:Are Costly Diabetes Pills Doing Any Good? | www.pharmalot.com

You get what you pay for. This time-honored saw is proven true again with diabetes medications, where newer, costlier, branded products have shown many advantages over most of the generic competition. For example thiazoledinediones and incretins are substantially better in many ways (less hypoglycemia for one) than the sulfonylureas, and the newer insulins, both faster (mealtime) and slower (once daily) are far more physiologic than regular and NPH insulin, both of which were too slow for mealtime and too fast for basal insulin.

Thiazides shown to be poor BP agents again, increasing diabetes risk.

April 22, 2009

Analysis of:Potassium loss from blood pressure drugs may explain higher risk of adult diabetes | www.fiercebiotech.com

Thiazides are already known to have important drawbacks, including increased risk of diabetes. This study adds evidence and credence to the increase in diabetes risk. Although few in the past have been serious about diabetes prevention (or avoiding promoting diabetes), there is growing interest by clinicians in doing so, and this study pushes the pendulum a little faster in the direction it is already going.

Missing Lessons in Torcetrapib Paradox

January 30, 2007

Analysis of:Torcetrapib tanks, but there is still a future in HDL cholesterol-raising therapies | www.theheart.org

The surrogate atherosclerosis end point studies with torcetrapib promise to give important, but likely complex clues regarding its paradoxical increase in CVD events and mortality.

Some promising HDL-raising approaches still appear to be eluding pharmaceutical R&D.

Niacin promises to be a big winner in the torcetrapib debacle.

When will we stop underprescribing niacin for atheroprevention?

January 26, 2007

Analysis of:An Old Cholesterol Remedy Is New Again | www.nytimes.com

With the demise of the clinical development of Torcetrapib we are forced to reevaluate our views of HDL raising.

We have had good HDL-raising drugs for many years, but they have gone underutilized and underappreciated.

Many cardiologists (often supposed by others to be lipid experts) have never or rarely used niacin, and so they are surprised and somewhat misguided on this issue.

Cypher & Taxol Drug Eluting Stents placed acutely post MI

September 19, 2006

Analysis of:NEJM Articles on DES in MI | content.nejm.org

These are the first large studies of DES in PCI for acute MI.
They study the two most popular DESs, unfortunately in two separated studies, not allowing accurate direct comparison between them.

 

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