GLG News by Attending-level Nephrologists in the US who are in GLG Member Programs

Smiley ThakurTransplant Nephrologist TRANSPLANT & NEPHROLOGY NORTHWEST PLLC

Why the doctor can't see you now

December 2, 2008

Analysis of:Why the doctor can't see you now | seattlepi.nwsource.com

This article addresses government policy, taxation, insurance, and socialization implications on future patient access to physician care.

Richard AmerlingAssociate Professor of Clinical MedicineAlbert Einstein College of Medicine

The Dark Side of Fosamax

July 25, 2008

Analysis of:Drugs to Build Bones May Weaken Them | www.nytimes.com

Considering the effects of fosamax and other bisphosphonates on bone remodeling, it is not at all surprising to see problems arising with the long term use of these agents.  

Richard AmerlingAssociate Professor of Clinical MedicineAlbert Einstein College of Medicine

So Much for Health "Insurance"

July 10, 2008

Analysis of:Pricey Drugs Put Squeeze on Doctors | online.wsj.com

It's intresting that nowhere in this article was the topic of true insurance for catastrophic illness brought up.  The problem with our current health insurance market is that for most it is pre-paid care, not insurance against a rare, but catastrophic, event. 

Richard AmerlingAssociate Professor of Clinical MedicineAlbert Einstein College of Medicine

Our Kids on Statins...........Not!

July 10, 2008

Analysis of:8-Year-Olds on Statins? A New Plan Quickly Bites Back | www.nytimes.com

With the pipeline for new drugs running dry, it is no surprise that pharmaceutical companies are looking to expand indications for existing products still under patent protection.  What better way to do this than by creating entirely new patient populations out of whole cloth?

Steven FishbaneChief of Nephrology, Medical DirectorWinthrop University Hospital

Amgen, ESA Safety in Oncology, and FDA's ODAC Panel

March 3, 2008

Analysis of:Anemia Drugs Raise Death Risk for Cancer Patients | blogs.wsj.com

1- This analysis adds to the formalized analysis of the safety literature on ESA use in oncology. 2- Its timing will impact on the FDA CDER ODAC meeting scheduled to review Amgen and Ortho Biotech's ESA drugs.

Steven FishbaneChief of Nephrology, Medical DirectorWinthrop University Hospital

FDA Panel of Injectafer Safety, Impact for Galenica and AMAG

January 28, 2008

Analysis of:Galenica in 2007: a new record year for strategy and business | www.galenica.com

1- Raises the upcoming FDA safety meeting on Injectafer (Ferinject). 2- Issues related to hypophosphatemia and cardiovascular health raised. 3- Quaestion of impact for ferumoxytol (AMAG) and other IV iron drugs.

Smiley ThakurTransplant Nephrologist TRANSPLANT & NEPHROLOGY NORTHWEST PLLC

The silencing of the labs

June 19, 2006

Analysis of:Protecting Special Interests in the Name of “Good Science” | jama.ama-assn.org

The Data Quality Act (DQA) is a two sentence addition to a bill enacted in 2000. It directs the Office of Management and Budget (OMB) to provide a way for parties to impact the way government agencies review scientific research. This tool has been used primarily by industry to challenge and silence scientific results that affect their core business interests.

Recent examples include:

1. The tobacco industry creating “scientific uncertainty” regarding tobacco’s health effects and currently blocking actions on environmental smoke

2. Coal and oil industries blocking climate change legislation

3. Asbestos industry opposing asbestos regulation

4. The Salt Institute and US Chamber of Commerce challenging NIH data on reducing salt intake.

Smiley ThakurTransplant Nephrologist TRANSPLANT & NEPHROLOGY NORTHWEST PLLC

Can you tell the difference? AMGEN fears clinicians will view Aranesp and CERA as equivalent.

June 14, 2006

Analysis of:ITC agrees to investigate Roche’s importation of CERA | www.nephronline.com

AMGEN is vigorously opposing the arrival of Roche’s Continuous Erythropoetin Receptor (CERA) on American shores. CERA is currently in use in Europe. Roche’s approval with the FDA is pending.

CERA is a pegylated erythropoietin (peg-EPO). It incorporates a large polymer chain and has different receptor binding characteristics than Aranesp. This provides it with a longer half-life. AMGEN filed a patent infringement lawsuit November 8, 2005.

The US International Trade Commission has now weighed in and will evaluate whether Roche is violating six of AMGEN’s patents.

Smiley ThakurTransplant Nephrologist TRANSPLANT & NEPHROLOGY NORTHWEST PLLC

Niche for new phosphate binder unclear

May 24, 2006

Analysis of:Zerenex in Phase II Clinical Development for Treatment of Hyperphosphatemia in ESRD Patients | www.eneph.com

The need for another phosphate binder is debatable.  Genzyme’s DCOR trial claims ESRD patients taking calcium containing binders for more than two years or those over age 65 have increased mortality versus those taking sevelamer. TUMS is very inexpensive. PhosLo is more expensive than TUMS but is as well tolerated. Patients can develop calcium absorption from these binders and this can limit their usefulness, however. Sevelamer is an effective non-calcium containing binder and fits the niche of backup agent quite well. Its ability to cause acidosis is overrated and not a reason to discontinue therapy. For patients failing sevelamer, lanthanum, a rare earth metal, is a highly effective phosphate binder. Concern regarding the long term use of this agent lies in the history of using other metals i.e. aluminum, to bind phosphate. Aluminum accumulates in bones and may take up to ten years to be detected. The longest bone safety data available for humans on lanthanum is only for 4.5 years.

Zerenex is unlikely to be as inexpensive as TUMS/PhosLo and patients deserve a trial of this effective treatment first, in my opinion.  The DCOR trial results will be hotly debated when they are published in a peer reviewed journal, hopefully later this year.  If concerns rise regarding  the mortality risk of calcium binders and Zerenex is priced below sevelamer, it may effectively compete with sevelamer for market share. 

Smiley ThakurTransplant Nephrologist TRANSPLANT & NEPHROLOGY NORTHWEST PLLC

The doctor won’t see you now.

May 24, 2006

Analysis of:Medicare forecast renews calls for pay reform | www.amednews.com

Practicing physicians are caught in the spread between the rising cost of doing business and declining reimbursement for services. By the end of 2016, physicians may be earning 37% less than they currently do, according to projected reimbursement rate declines. Physicians may have to be satisfied with less of a planned decrease e.g. -3% instead of -4.7%, as the best compromise Congress can attain. Certainly, a net increase in physician payments isn’t something anyone is contemplating. The best physicians could hope for, in this author’s opinion, is for reimbursement to remain, on average, at its current level. A rise in the cost of doing business over the next nine years by 22% is an extension of slow increases physicians are already experiencing.

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