NeuroTalk Support Groups

NeuroTalk Support Groups (https://www.neurotalk.org/)
-   Multiple Sclerosis (https://www.neurotalk.org/multiple-sclerosis/)
-   -   Letter from FDA to TEVA (Copaxone) (https://www.neurotalk.org/multiple-sclerosis/166813-letter-fda-teva-copaxone.html)

Blessings2You 03-20-2012 10:30 AM

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

Kitty 03-20-2012 01:53 PM

This just shows us how deceptive the drug companies can be. :mad: Anything to make a buck.......:rolleyes:.

SallyC 03-20-2012 02:30 PM

Thanks Blessings.

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

barb02 03-20-2012 04:03 PM

Interesting!

Dejibo 03-20-2012 04:58 PM

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!

Blessings2You 03-21-2012 05:43 AM

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.

Harry Z 03-21-2012 09:45 AM

Quote:

Originally Posted by SallyC (Post 862607)
Thanks Blessings.

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

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.

Harry

karilann 03-21-2012 10:41 AM

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.

Kitty 03-21-2012 10:52 AM

Quote:

Originally Posted by karilann (Post 862820)
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. :rolleyes:

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.

Blessings2You 03-21-2012 10:58 AM

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?

karilann 03-21-2012 10:59 AM

Quote:

Originally Posted by Kitty (Post 862826)
That's the 64 thousand dollar question. Or should it be 64 million dollar question.....gotta figure in inflation. :rolleyes:

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.

This is exactly what bothers me I realize they do have some science behind their claims, but I still feel like a experiment rat. And this little mouse is gambling on the odds out of fear.

Harry Z 03-21-2012 06:44 PM

Quote:

Originally Posted by Blessings2You (Post 862828)
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?

From the drug companies who make them! The sales pitches can be intense and certain "incentives" are often made to the docs in order to try and ensure that the doc prescribes "their" drug and not the competition's.

A shift in market share by just a couple of percent can make a huge change in the company's revenue so the sales schemes are very intense.

missj 03-22-2012 10:59 AM

and this

http://www.globes.co.il/serveen/glob...35509&fid=1725

Kitty 03-22-2012 11:20 AM

They all (the big pharma companies) jut make me sick (literally and figuratively!:rolleyes:). Anything for a profit. :mad:

Blessings2You 03-23-2012 03:03 PM

I've always been of the persuasion that I'm taking the bigger risk by NOT taking medication or treatment. Now I'm apprehensive about both.

Kitty 03-23-2012 03:35 PM

Quote:

Originally Posted by Blessings2You (Post 863421)
I've always been of the persuasion that I'm taking the bigger risk by NOT taking medication or treatment. Now I'm apprehensive about both.

That's the argument my Neuro always makes to me. I just let him talk......I'm going to do what I know is best for me anyway. He doesn't have to live with the horrible side effects or the ridiculous cost. I'll tell him that when they can be honest about the success rate and the percentages for success go up (30% is not going to make me want to try it again) then maybe I'll think about it again.

Since they don't even know how the DMD's work that's about the only argument they have to try and keep people using them.

wkikta 03-24-2012 04:46 PM

Teva has always been very aggressive on marketing Their Medication as being the best, never showed any proof of it though. That is the reasoning behind the Letter. They want to see proof of the claims.

Harry Z 03-27-2012 09:37 AM

Quote:

Originally Posted by wkikta (Post 863731)
Teva has always been very aggressive on marketing Their Medication as being the best, never showed any proof of it though. That is the reasoning behind the Letter. They want to see proof of the claims.

Unfortunately, Teva isn't the only drug company guilty of this kind of conduct. Biogen/Idec also got a stern warning letter from the FDA for similar unsubstantiated claims they made for Avonex.

Harry

Kitty 03-27-2012 09:58 AM

They need to quit wasting research dollars on studies about how mice respond better to a med if they're listening to music :rolleyes: :rolleyes: :rolleyes: and concentrate on either a) making a DMD that actually works or b) finding a cure.

SallyC 03-27-2012 10:44 AM

Amen Kelly!!!!!!!!!!!

Debbie D 03-27-2012 04:09 PM

Doesn't all this just make your rear end tired??

Sometimes I wish we could all band together, go on strike & picket outside the drug companies' headquarters...


All times are GMT -5. The time now is 12:06 AM.

Powered by vBulletin • Copyright ©2000 - 2025, Jelsoft Enterprises Ltd.

vBulletin Optimisation provided by vB Optimise (Lite) - vBulletin Mods & Addons Copyright © 2025 DragonByte Technologies Ltd.