“This result is remarkable for two reasons; firstly, it normally takes us more than a week to get over a 100 responses and secondly we have never had such a one sided result. Dog house seems to be the correct adjective in this case!”
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Yesterday’s post and survey:
“Teva,the producer of glatiramer acetate, has asked the FDA not to approve BG-12, citing safety concerns. Teva filed a citizen’s petition requesting that the FDA refrain from approving any new drug for the treatment of MS until the FDA has considered the recommendations of the appropriate expert advisory committee. No meeting of the FDA’s Advisory Committee for BG-12 is planned. Importantly, no Advisory Committee was needed for teriflunomide, which has recently been licensed. So why Teva’s change of mind? Do they have MSers interests at heart?”
“A form of BG-12 called fumaderm has been used in psoriasis for many years with no major adverse events emerging. I assume the FDA has looked at fumaderm’s long-term safety profile and the BG-12 MS data and felt an Advisory Committee is not needed.”
Press releases with more details:
Kevin Grogan. Teva tries to foil approval of Biogen MS pill. Pharma Times, January 11, 2013.
CoI: multiple
What the hell are they playing at?
Obviously just a brethtakingly cynical attempt to wring the last drops of profit out of the superannuated Copaxone whose patent expires in 2015.It's behaviour like this that gets Pharma a deservedly bad name.
Exactly, I was stunned at the cold-blooded shameless impertinence. Just ruthless – let's boycott Teva and switch to Avonex those of you who are taking it! I have been taking fumarate for about 7 months now and it has no grave side effects whatsoever!
'Citizen's petition'? How can they expect anybody to take it seriously!
They should have called it a shareholders petition; clearly the longer they keep BG12 from the market the more money they make from Copaxone. Talk about a cheap shot.
Quite. They're also p***ed that their next generation MS drug Laquinimod was comprehensively outperformed by BG12. I suspect that this action will do them no favours in the MS community.
How can Teva, and Israeli company, file a citizen's petition to a United States government agency?This is really disgusting, and so transparent. I take Copaxone, but the actions of Teva constantly make me consider going to something else. Forget about the flyers I constantly get in the mail touting how great Copaxone is (even though its efficacy is a paltry 30%). Forget about how they keep jacking up the cost. Now, they're trying to delay a promising treatment. I just hope the FDA tells them where to go.Sorry for the rant.
Apparently Obama gets a call from the Prime Minister of Israel very day. High proportion of neurologists in the US are Jewish. The Jewish lobby in the US has huge power.
heres hope to many being sued atlast along with the professionals
Sued for what? It seems our resident troll has been learning to write with the cap s lock off?
I so agree!
I'm with you…shocking behaviour. Maybe they are frightened that BG12 will get front line approval and then you get a choice of something tangible or as M above says something paltry, which takes 9 months to take effect based on prof Gs comments.
Bring on the BPA!!!!!!
It is perhaps appropriate that this months debate in the Multiple sclerosis Journal isIn the coming year we should abandon interferons and glatiramer acetate as first-line therapy for MS.
Brilliant debate and about time too! Copaxone and interferons are just outdated like black and white TV or carriges. Live with it Teva.
atlast things are comming to light with all the rubbish drugs 🙂
the sooner all these drug companys are sued the better along with others too
Sued for what may I ask? or has our resident troll learnt to write in lower case?
wait and see
We have be listening to this sort of nonsense for well over a year now and I am waiting to see the litigation start. Hope the litigators have deep pockets because Pharma do:-)
Er, I've been on Rebif since 2000 – my MS isn't aggressive enough to take the newer, stronger drugs. I don't want to have to stop taking it because it's old and not effective.Statistics are that – statistics. There'll be people who do really well on these older drugs who don't want to take the risk of PML or similar potentially fatal conditions/ diseases. I feel very nervous Mouse Doctor- don't abandon something just because it's old. You and Prof G are influential voices. People who are ill with MS deserve better treatments – yes, but without the risk of death.People chose Copaxone because they are nervous (or been convinced) that the interferons will give them dreadful side-effects. Teva's action is disgusting. It's not the first Pharma company to have tried this tactic and it's wrong – no, it's immoral.
If I abandoned things because they are old I would had to leave myself :-).
who is behind BG12? and where the hell is their lawyer/lobyist?
Biogen…I am sure they are sorting out the hitmen as we speak:-)
but still, Fumaderm is not as safe as always revealed: 5 PML cases in Germany and nephrotoxicity not fully disclosed by Biogen. So, maybe TEVA is not too wrong.
This is new for me.. is there more info about fumaderm & PML?
New for me too & I doubt it's true. A BG12 PML link would have been big news.
but unfortunately it's true – one case was presented at last year's biggest German neurology congress and there are 4 other cases. Biogen, of course, does not like to talk about this. Guess why FDA has extended the review by three months?
Fumaderm is one product and BG-12 manufactured by Biogen are a different matter. If/when PML occurs in people treated with BG-12 rest assured we will hear about it just like we heard about PML in someone on Gilenya….however they had been on tysabri recently before the PML started. Of course Biogen will not want to trigger alarm bells. Maybe Prof G can comment, if he is not gagged by confidentiality.
here (Q&A session), the Biogen CEO is talking about these PML cases…http://jpmorgan.metameetings.com/webcasts/healthcare13/directlink.php?ticker=BIIB
@MouseDoctor:Fumaderm = dimethylfumarate and monoethylfumarate salts (salts are irrelevant for immunomodulatory mode of action)BG-12 = dimethylfumarate basically, it's the same…
This is what Biogen CEO said in the podcast:There are 180,000 patient years experience with Fumaderm in psoriaris in Germany, over a long period of time, & there have been 4 cases of PML.This is equivalent to the background PML rate in autoimmune disease.Of the 4 PML cases:- 1 had taken a number of other immunesuppressive treatments – 1 had sarcoidosis and been on treatments for that- 2 cases were lymphopenic
I take Copaxone and am doing just fine with it. However, if Teva was successful in delaying other drugs to market, I would find another DMT. My insurance payment to Teva is the only power I have over the situation, and I'd leverage it.
I take copaxone and find Teva's action rediculuous. It doesn't surprise me though, big pharma are about making money as we have seen so many times. I'm in the UK and think I will probably have no choice but to continue with GA as its unlikely NICE will allow BG-12 on the NHS. The price elsewhere for any of these drugs on insurance is just silly, I do consider myself lucky even with the situation as is in the UK!! It should be better than this, how do we start getting there? Kick back to BP for off labelling??
Let's hope Teva learn a lesson from this affair. Teva should have consulted us MSers before making such a decision to act on our behalf. I can't wait to switch from Copaxone to BG12.
I wonder if the 4 who voted yes are in any way associated with Teva?I would imagine their PR department have a full time job on their hands dealing with this PR disaster.
My thoughts too
Anyone have any news about Nano particle cure for MS where researchers found it effective on mouse, but dont have money to pursue the research for humans.
If they have done it in mice only talking about cure is premature and is stuff aimed at generating cash…….we talked/posted about the super saline last week..this is Nano technology. Maybe this is the story.This type of media hype is the central problem with MS research. It creates so much expectation…often without any delivery of the goods
Another comment on this disgraceful action here. http://neurogram.wordpress.com/2013/01/10/teva-crosses-the-line/
The makers of Rebif are taking a different tack in the DMD economic wars. I recently got a letter in the mail advertising their new $0 co-pay program. If you're on private insurance in the U.S., they'll pick up all of your co-pay, making the medicine free to the patient. At least this strategy is not going to alienate MSers. However, on a macro level, I'm not sure these co-pay assistance programs are really beneficial to patients, and certainly not to the health care ecosystem at large. They seem to be a sneaky way to increase the amount that drug companies can charge insurance companies without losing the business of patients who can't make a 20% co-pay on $1000+/month drugs. They presumably milk the insurance companies for more than they lose on the financial assistance programs.
It's a last strategy to squeeze the last drops of profit out of Beta-Interferon before this and Copaxone are replaced by the new more effective DMTs.Purely cynical, though not as bad as the Teva example.