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February 19, 2008

Chinese Heparin Debacle May Cause World Wide Shortage for Dialysis Providers

Analysis of: China Plant Played Role | online.wsj.com
This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Analysis By:
Joe Atkins, RN, MBA, CNN, CHT
Chief Executive Officer, Medical Concepts & Innovations
Implications: Although patient deaths are of grave concern, the impact of a heparin shortage stand to put around 400,000 US dialysis patients at risk.  Heparin is the "oil of hemodialysis" and without it, hemodialysis would come to a standstill. There are alternatives available, such as Andiomax and Lovenox, however, they are not practical for the hemodialysis community owing to the fact that they do not have an antagonist, such as propomine sulfate, to counteract their anticoagulative properties. Since Baxter presently produces 50% of all the heparin in the world, and they are vunerable, it would behove their competitors to increase production and corner the market.

Analysis:  Although Baxter and the FDA have made an agreement, not to suspend production of heparin, there is still a grave concern over the quality of the base product being imported.  Heathcare providers are now complaining about the 5,000 unit and 10,000 unit vials, which, supposedly, are not a concern.I find it strange that the article talks about the FDA and Baxter trying to prevent a heparin shortage in the dialysis community, being that a shortage and panic already exits.  Every distributor I know has had their entire inventories purchased and large dialysis providers are hording heparin.Distributors are presently making a killing, some selling heparin anywhere from two to five times it's original value.The truth is that a shortage of heparin already exits in the dialysis community in the USA, which cares for around 400,000 patients.  Our only hope is for other heparin manufacturers to boost their production.  I only hope that their base souce of heparin is not from China and is produced in an FDA INSPECTED and approved facility.

Other Analyses of the Same Source Article:
China's Regulatory Shortfalls cuts into US Big Pharma Profits
February 20, 2008, Author: GLG Expert Contributor
FDA Will Have to Change
February 19, 2008, Author: GLG Expert Contributor
Heparin Also Used in Pets
February 19, 2008, Author: GLG Expert Contributor
China is the largest exporter of drugs or drug's ingredients and FDA does not have resources to check the quality of the majority of the imported as well as the USA produced generic drugs.
February 19, 2008, Author: Carlos Dujovne, MD, Professor of Medicine and Director, OREGON HEALTH & SCIENCE UNIVERSITY - CC
Outsourcing FDA inspection
February 18, 2008, Author: GLG Expert Contributor
Use of Imported Intermediates or Final Materials for US Drugs Certain to Continue
February 18, 2008, Author: GLG Expert Contributor
Periodic Inspections by WHO/FAO Codex Alimentarius Teams
February 18, 2008, Author: GLG Expert Contributor

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