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Need for cardiac evaluation in patients receiving novel cancer treatments

February 19, 2008

Analysis of:Kidney Cancer Drug Linked to Higher Rate of Heart Problems | www.washingtonpost.com

Patients with rare malignancies, especially those with already metastatic diseases, are being treated with novel oncologic agents.  However, as is being seen with many drugs, the hemodynamic consequences of these agents, in many cases a rise in blood pressure, may lead to cardiovascular consequences.  Patients with a history of hypertension, coronary artery disease, hyperlipidemia, and/or tobacco abuse, who may be particularly prone to the adverse effects on the heart of such therapies may need pre-emptive screening prior to the initiation of treatment.  The primary goal of therapy is to extend life, but if the therapy is successful, the need to maintain quality of life will become important too.

Frivolous patent chanlleges: is there a reasonable solution?

December 19, 2007

Analysis of:AstraZeneca Files Patent Infringement Actions in Response to Crestor(TM) ANDAs | www.pipelinereview.com

Challenges to pharmaceutical patents prior to the "official" expiration of the patent are proliferating; if they are allowed to stand, that is, if the "original" patent is successfully voided one of the crucial financial incentives to novel pharmaceutical research will be abridged and the "profit" motive devalued.

You can never get something for nothing!

November 22, 2007

Analysis of:Study Shows Weight-Loss Drug Rimonabant is Associated with Severe Adverse Psychiatric Events | pharmalive.com

The meta-analysis of the rimonabant trials points to an increase in psychiatric diagnoses. What is missing in this report is the numberical and statistical significance of the findings.  This debate needs more rigor; the type of rigor that is applied to cardiac endpoints, needs to be applied here.  There needs to be an agreement on conventional endpoints where psychiatric disease is in question.  Of note, why is anyone surprised?  These drugs work on the endocannabinoid system which has known CNS effects.  It is not surprising that these receptor blockers would have an effect.  What we need to know is who is most susceptible to these adverse effects.  Do they have certain demographic characteristics so that the drug is not used in a high-risk patient.  Obesity is a world wide epidemic, let's put rigor into the science so these products can be developed and made available to patients who will benefit.

Pfizer Stumbles.....but the concept of non-injectable insulin is a good one!

October 19, 2007

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

Ask any patient with diabetes what they want for a therapeutic option and they'll tell you non-injectable insulin.  They understand that all the other medications are a poor substitution for the replacement of pancreatic insulin and they are tired of taking multiple pills each day. So why did Exubera fail?  Because of a poor marketing strategy...highly atypical of Pfizer bue emblematic of their recent poor leadership and decision making.  Another company with a better delivery system will make inhaled insulin a success!!!

Rush to alternative stent materials.....justified or not?

October 19, 2007

Analysis of:Enrollment Reaches 110 Patients In Investigator Initiated, Randomized Trial Of OrbusNeich's Genous(TM) Bio-Engineered R Stent(TM) | www.medicalnewstoday.com

The failure of drug eluting stents in the eyes of the public and in the medical community is probably not a failure of the device as much as a failure of patient managment.  It is clear that atherothrombotic vascular disease requires a life-long commitment to blood pressure, cholesterol, and blood sugar control, weight reduction and smoking cessation but also, and perhaps most importantly especially in PCI patients, a committment to lifelong antiplatelet therapy.  Until such a strategy is pursued and incorporated into clinical trial strategy any "clinical study" will be flawed.

Implications for use of Galvus in the U.S. after European approval is granted

October 3, 2007

Analysis of:Galvus(R) receives European approval as new treatment for type 2 diabetes with broad range of indications | www.pipelinereview.com

The approval of Galvus in Europe increases the pressure on the FDA to approve its use in the United Status.

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