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April 30, 2008

FDA: Chinese Manufacturer of Tainted Heparin Involved in Fraud.

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: First, and foremost, the only working link for this article can be found at: http://www.reuters.com/article/domesticNews/idUSWAT00934620080415?feedType=RSS&feedName=domesticNews Although there is no proof offered in the article to substantiate the suggestion of fraud, there is enough circumstantial evidence to suggest that it is so.

Analysis: The FDA is allowing China to investigate the real reason why chondriotin was used as a substitute for porcine intestines, which provides the base ingredient for sodium heparin.  However, this is little comfort for the families of 81 patients who have died, as well as many, many others who became ill due to tainted heparin.

There is a grand opportunity for US companies to come to the aid of the FDA by offering to subcontract themselves as proxy inspectors of Chinese manufacturing plants.  The profit potential is huge.

I predict that any companies that offer such services will become extremely profitable.  If publicly traded, the stock of those companies that have the vision to get involved with the FDA will explode.

There was a time when I would have been against the enlistment of the private sector in FDA proxy inspections, however, the more I read, the more it has become clear that something is better than nothing, which is what's presently occuring in Chinese manufacturing of food and medical products.

Other Analyses of the Same Source Article:
Tainted Heparin Will Mean More Scrutiny of Drug Manufacturers
April 21, 2008, Author: Eric Gruff, PhD MBA, Principal, E4 Consulting

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