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Data is Not Information

May 30, 2008

Analysis of:Metabolic Syndrome Not Useful in Predicting Cardiovascular Risk | www.medpagetoday.com

The PROSPER Trial is important because it is not.There are many ways to diagnose the Metabolic Syndrome offered by "Expert Consensus", and that is the red flag to make the disticntion between data and information. Information is actionable, data is just that- data, and must be interpreted. Researchers and academics produce studies and data, practitioners and health care providers act on sound information. There is nothing is this study that a practitioner can currently use to change therapy approach. The authors point to "associations" and "risk patterns" in a relatively small group of mature individuals, in whom only 28% met their criteria for the definition of metabolic syndrome. We have an epidemic of diabetes, obesity hyperlipidemia and hypertension, not to mention widespread lifetsyle mismanagement. This spells opportunity for therapy, a need for new and better drugs and better techniques for lifestyle improvement. We don't need studies of dubious value and nebulous results.

A Diamond in the Rough

May 19, 2008

Analysis of:New data show Tekturna HCT® is twice as effective at reducing blood pressure than the diuretic HCT alone | www.novartis.com

Since its launch those involved in the treatment of hypertension have been hoping for more data on the effectiveness of Tekturna. Results of this study add evidence that the product is just beginning to solidly position itself in the antihyptertensive armamentarium, and is therefore encouraging. But good science is not enough; Tekturna still needs substantial outcome data to succesfully compete in the market segment. That data needs to include reduction in cardiovascular disease events, improved compliance, persistence and adherence as well as cost-effective patient, Provider and formulary acceptance. Missing also is information on special populations such as those with renal disease. Intuitively this product should compete well, it is a wonderful example of the expansion in knowledge of and molecular therapy for hypertension, but as yet this uncut diamond therapy lacks the sparkle that transforms a potential into a blockbuster.

Income Streams and Salmon

May 19, 2008

Analysis of:Warning over drug trial’s effects on testing | www.ft.com

IMS, a publically traded healthcare consutancy has concerns about the CATT study, funded by the National Eye Institute. Given their award winning reputation, one might worry that IMS has uncovered a real problem. Think again. 1. Among IMS' main customers are those who seek pharmaceutical intelligence for the purpose of succesful drug launches, effective marketing strategies and competitive edges; in other words, the drug companies. 2. Providers and Payers have long bemoaned the lack of relevant comparison studies among similar drugs in a given pharmaceutical class. The CATT study provides exactly that, and who is worried? Macular degeneration is a terrible and very costly disease. Rather than a problem, it is a responsibility of the Payers to learn the best most cost effective therapies. The Pharmaceutical Industry's record on study transparency and bias is not so good; CATT is a natural outcome of that record. 3. It's not drug development fear, it's Income Stream protection.

Love'em Hate'em but Use Them

November 19, 2007

Analysis of:Wyeth Receives FDA Approval of Protonix for Delayed-Release Oral Suspension | pharmalive.com

Proton Pump Inhibitors (PPI's). Patients generally love them, Gastroenterologists can't do without them and Insurer's target them as overused and expensive. Nevertheless, in spite of banishment to the third tier (or worse), Prior authorization), and some OTC and generic availability, Wyeth (WYE) has achieved a breakthrough, or at least a coup in proton pump suppression. Moreover, they may have resuscitated a failing pipeline. An oral suspension (liquid formulation) will be very well received by many interested in acid suppression, and even more so by investors who wish to see the giant's pipeline finally spit out a welcome drug. You can love them, hate them, and try to eliminate them from therapy, but in the end, patients will demand them, and now a whole new therapeutic vista has opened to support their use.

Irony in Drug Therapy

November 12, 2007

Analysis of:Health Canada Approves Natural Supplement for Management of Cholesterol | www.therapeuticsdaily.com

Throw away the crustacean and save the shell? We have a plethroa of drugs that safely and effectively lower cholesterol and LDL. True, they have limitations, but those weaknesses will not be served by natural supplements. In general they tend to be: Less potent; More expensive; Very popular with certain groups; Far less studied than traditional drugs. One might think that unloading drug therapy from Managed Care plans' drug line item cost would be secretly welcomed. It probably will be. That however is one of the several ironies with such products. That which makes the Insurer happy does not usually fly with the Prescriber. Unloaded cost does not diminish risk, hence prescibers will not likely support the effort. Some will remember that the parent compound chitosan, has been around as an externally used coagulant. Lower the cholesterol but increase coagulability? Hmmm... I'll bet that part of the drugs action hasn't been thoroughly investigated! Eat the shrimp, toss the shell.  

Less Could be More...a Sign of Hope

November 6, 2007

Analysis of:Theravance Announces Initiation of Phase 2 Clinical Program with its MABA Compound in COPD | www.genengnews.com

Epidemiologic data clearly defines an alarming increase in Chronic Obstructive Lung Disease (COPD) especially among women and younger age groups, both targets of intensive cigarette marketing. The possibility of a designer drug with a dual mechanism of action rings true for several reasons. Unlike asthma, which can be intermittant or "in remission" for years at a time, therapy for COPD is chronic and lifelong. Drug compliance is known to be better with therapeutic minimalism. This product would be the first of a new drug class, and while Novartis (Novartis AG ARD NVS) is propelling its indacaterol, another 24 hour beta agonist, to market, it is a single agent drug. First market entries generally fare well, especially if promoted by a company such as Glaxo, (GSK) with a huge respiratory franchise and a wealth of respiratory marketing experience. For those who treat COPD, this is truly exciting news.

Pfizer (PFE-N) Reinvents and then Opens a New Pandora's Box

October 22, 2007

Analysis of:Pfizer Abandons Exubera, Posts 77% Earnings Decline | online.wsj.com

Traditional analysis is correct regarding Pfizer's decision to withdraw inhaled insulin (Exubera) from the market. The fallout from the cascade of bad decisions and market misunderstanding points to the need to underscore one important point, value. Election year politics equates value to regulation. Without value, Prescribers and patients tend to lose trust, investors and partners just lose. Prescribers must attach a therapeutic value to a new formulation of an old drug to complete the market success loop. The premise that a huge cohort of precribers, payers and patients would embrace an awkward, unsightly and high maintenance device to avoid an insulin needle, while ignoring potential risks dominated the launch and re-launch of this drug franchise. Value is elusive when the market is flooded with insulin delivery devices that are small, unobtrusive, inexpensive and physiologic. Pump science will soon enter the continuous implantable stage and open new vistas. Did anyone plan?

An Experiment in Therapeutic Finance!

October 9, 2007

Analysis of:Aclasta Receives European Approval As First Once Yearly Treatment For Postmenopausal Osteoporosis | www.medicalnewstoday.com

European approval of Aclasta (Reclast in the U.S.) will be in effect, an experiment in therapeutic entrepreneurial management. Only Novartis did the studies to acquire approval of the IV formulation of this bisphosphonate in the U.S., and presumably the E.U. Notwithstanding several excellent medical therapeutic questions, the delivery mode establishes a need for IV infusion centers, administration costs and recall registries. In the U.S. this will be of paramount importance since a huge segemnt of the target population, the Medicare eligible, can have the therapy approved and paid for by Medicare part B, slowing progress to the infamous donut hole. The comparative market success of the drug abroad and in the U.S. will be very interesting to watch, as will be the medical results and impact on quality and Total Cost of Therapy. Insurance and industry analysts should watch carefully as this is a marker for future endeavors.

The Pipiline is not depressed!

October 7, 2007

Analysis of:Lu AA21004 shows highly significant results in clinical phase II trial | www.pipelinereview.com

Lu AA21004 is the first in a new class of antidepressants that hopefully will reinvigorate the pipeline. Drugs for depression remain a huge cost for Insurers, and the market has not seen a new class of antidepressant therapy for some time. Current therapies have a variety of unpleasant side effects and drug-drug interactions. A new class of drugs will hopefully provide more choice. The current workhorses for antidepressant therapy, the SSRI’s have suffered loss of prescribing enthusiasm because of recent reports of suicidal ideation, and Black Box Warnings especially for younger patients.

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