May 14, 2010


Last November, the company asked the FDA not to approve any ANDA for Copaxone until the product is fully characterized. It further maintained it isn't possible for a generic applicant to show that its product has the "same active ingredient" as the drug "because neither Copaxone nor any significant subset of its polypeptides has been fully characterized, and because it is unknown which of Copaxone's potentially millions of protein-like polypeptides are clinically active and responsible for its therapeutic effects in reducing the frequency of relapses in patients with relapsing-remitting multiple sclerosis," according to the FDA's response, available at

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Ya gotta love being a guinea pig. I've just found out that my dear copaxone may be behind some of my high blood pressure and liver abnormalities. Not that anyone knew about this, apparently. It's endearing to be on medications which even the developer has no idea about how they work. It's reassuring to think they don't actually know WHAT IT IS MADE OF. It's such a pleasant thought to inject this stuff into my body every day while taking a whiff of optimism juice, hoping it will work, having no idea what "working" really means.

I've had experience with this before. I "did" Vioxx for pain before. I was on Effexor, queen of the iatrogenic disease causing drugs, which also remains unexplained as to how it does its magic. I was on Lipitor, until I got leg muscle spasms (might have been MS, now that I think of it), and put on ASA until they realized it would more likely kill me than save me.

And now as I step into my second half-century of life, as medically managed as anyone can possibly imagine, I'm offered these medications, told they are good, given my prescriptions and told to smile and be a good girl and take them. 

Yeah, I suppose on balance they are probably keeping me alive. But really now, folks. Couldn't I just chew on some nice alfalfa?

1 comment:

Travelogue for the Universe said...

I love copaxone (or placebo) on my study plus avonex or plabebo. I believe it is like synthetic bee stings. Hard to nail down but effective. The proteins would be destroyed in the GI tract. I hope they don't have side effects but I worked for years in neuro and the functional outcomes are better than without treatment.