Dr. Smiley Thakur MD, FRCPC

GLG News^SM Analyses by Smiley Thakur

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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.

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.

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.

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. 

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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