Heparin contaminant is a modified cheap diet supplement for joint pain - "it didn't come straight from the pig"
The Food and Drug Administration stated yesterday that a contaminant - over-sulfated chondroitin sulfate, a substance derived from animal cartilage, found in recalled batches of the blood-thinner heparin was deliberately altered in a way that mimicked the real substance.
Janet Woodcock, head of the FDA's drug division, said the substamce was not medically approved ***and was a lower cost product than heparin. Chondroitin sulfate is sold as a cheap and widely used dietary supplement in it's unmodified form to relieve joint pain or osteoarthritis - often with glucosamine.
"It does not appear to be a natural contaminant that got in there. We don't know how it was introduced or why," she said. Woodcock noted that the over-sulfated substance was deliberately processed and chemically modified so it would act like heparin - "It didn't come straight from the pig".
In some samples of Baxter's active ingredient, the contaminant made up between 2% and 50% of the total material, Dr. Woodcock said.It is heparin sold by Baxter that has resulted in the reports of over 700 adverse reactions and 19 deaths.
The FDA could not say whether iot was added by mistake or to lower costs.
Lord Patel's favourite Senator, Iowan Republican Charles Grassley, ever alert to the malign forces at work in commerce , said the investigation has "provided additional evidence of the need for a robust foreign inspection program within the Food and Drug Administration."
In fiscal 2007, there were a total of 714 Chinese facilities making drugs or drug ingredients for the U.S. market.
Charles Hubbard who was head of the FDA intil 2005 is reported in WAPO saying , "I have no doubt that there are other contaminated or counterfeit drugs like heparin coming into the country, because there's really no system in place to stop them,"
This case mirrors the discovery last year that Chinese suppliers had put low cost melamine into gluten used by American pet food manufacturers to make animal food appear more nutritious. Thousands of American pets became sick or died as a result. Which as far as Lord Patel is concerned is good. The only good dog is a dead dog - 4 legged shit machines.
*** Chondritin sulphate is approved for use in Europe as a symptomatic slow-acting drug for ostearthritis (SYSADOA) with evidenced efficacy and safety demonstrated by clinical trials in osteoarthritic patients. This also provides reference for chemical purity.
The bioavailability of chondroitin sulfate ranges from 15% to 24% of the orally administered dose.
The rationale behind the use of chondroitin sulfate is based on the belief that osteoarthritis is associated with a local deficiency in some natural substances, including chondroitin sulfate.
There is no proof that either glucosamine or Chondritin sulphate , taken singly or in combination, will actually slow the degenerative process or restore cartilage in arthritic joints. A recent a recent study by ConsumerLab.com in the US showed that almost half of the glucosamine/ chondroitin supplements tested did not contain the labelled amounts of ingredients.