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Old 03-20-2012, 10:30 AM #1
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Default Letter from FDA to TEVA (Copaxone)

I've just read through this quickly and haven't studied it in order to form an opinion, but it's interesting, and described as a "warning". The letter was dated March 14.

http://www.google.com/url?sa=t&rct=j...YIhmr-eCdWqfcg
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Old 03-20-2012, 01:53 PM #2
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This just shows us how deceptive the drug companies can be. Anything to make a buck........
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Old 03-20-2012, 02:30 PM #3
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Thanks Blessings.

My only surprise is that the FDA actually reprimanded Teva. It's probably just a Tsk Tsk, though.
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Old 03-20-2012, 04:03 PM #4
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Interesting!
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Old 03-20-2012, 04:58 PM #5
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Furthermore, the claim, “No other RRMS therapy can demonstrate long-term results like
COPAXONE
®
,” misleadingly suggests that Copaxone is superior to other RRMS therapies.
FDA is not aware of adequate and well-controlled clinical trials demonstrating that
Copaxone is safer, more effective, or otherwise superior to other treatments for RRMS. If
you have data to support these claims, please submit them to FDA for review

HA Copaxone got spanked! several other examples of "quit it" in there too. Love it!
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Old 03-21-2012, 05:43 AM #6
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For the record: I found this when I was specifically searching for info about Copaxone. I have no idea if similar warnings were ever sent to manufacturers of other MS drugs. Hmmmmm.
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Old 03-21-2012, 09:45 AM #7
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Quote:
Originally Posted by SallyC View Post
Thanks Blessings.

My only surprise is that the FDA actually reprimanded Teva. It's probably just a Tsk Tsk, though.
Hi Sally,

Companies such as Teva, Biogen/IDEC etc periodically receive a slap on the wrist for falsely marketing their MS drugs. The sales reps can be quoted as saying that "this is part of the business". As long as they get their bonuses, who cares!!

This letter, however, is one of the longest and harshest I have seen in some time so it will be interesting to see what Teva does about it.

I've been stating for years that the CRAB drugs are nowhere near in efficacy what they state. This is but another example of how these drug companies "milk" the MS community. The cost of the drugs after 20 years continues to rise. Most products, after 20 years, are discontinued or their price has been largely reduced. Too bad this can't be said for the CRABs.

Take care.

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Old 03-21-2012, 10:41 AM #8
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This is freakin scary.
How am I suppose to look at this? My doctors like the effectiveness of the CRABS....
However; I have not heard any of my doctors talk about the CRABS like an advertisement......
Wish I could print this off and have a frank discussion with my Neuro, but that will never happen.
It would also be interesting to see how the M.S. Society views this type of advertisement.
Now I need to find another source that talks about the effectiveness of the drugs .....just for my own peace of mind.
I've taken Betaseron since 2003 and have had no relapses since.....don't know if thats a coincidence or not???????????

My next doc appointment I will ask the question about the claims of the CRABS and his opinion in relation to the results from his patients.
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Old 03-21-2012, 10:52 AM #9
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Quote:
Originally Posted by karilann View Post
I've taken Betaseron since 2003 and have had no relapses since.....don't know if thats a coincidence or not???????????
That's the 64 thousand dollar question. Or should it be 64 million dollar question.....gotta figure in inflation.

If you would have had one or two or five relapses your Neuro would have probably said "switch to Avonex" or "switch to Rebif" or even "switch to Copaxone". Since you've not had a relapse they will claim the Beta is doing a wonderful job. You may not have had a relapse if you took no medication. That's just the nature of MS. There's no way to know for certain either way. And the pharmaceutical companies know this.

It's so hard to know who or what to believe anymore. Of course the pharmaceutical companies are going to present their product in the best light. They want profits.....and unless folks are taking their meds they don't see profits.
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Old 03-21-2012, 10:58 AM #10
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This isn't the loaded question that it's going to sound like, but where do the doctors get the information about the meds they prescribe to their patients?
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