This Is MS Multiple Sclerosis Knowledge & Support Community

So what's next? Our Neuro, when trying to tell my wife to get on Tysabri, more or less said that we now know that the interferons weren't much use. Luckily, she got pregnant, so the decision was postponed until the fall of 2005 after birth.

Now what? I think you'll see a lot of patients go back their neuro's and demand something off label - statins or abx's. Which in a way may be a blessing.

What's your next move. If we were in the game right now, i think we would demand off-label abx. Definitely not back to avonex.

feesher

Ok..........I can't resist.

There is always desipramine, IF we can get it "moving"!

Deb

OddDuck ,

do you know of any way to get desipramine without prescription ?
or collaborating neuro is a must for that ?
Thanks.

Nope, you can't get it without prescription.

It doesn't take a neuro, but I'm certain you won't be able to get any physician to prescribe it for you for any type of MS treatment off-label. The liability would be enormous.

Plus, I "could" be wrong and it could flop in research, BUT.........well, I won't repeat myself.

I'm SO sorry. If you have an "experimental" neuro, though, perhaps they "might" consider letting you try other drug options off-label (?) It all depends on the type of risks your neuro is willing to take.

Deb

Its always worth remembering to proceed with caution with off label drugs. Their safety profile will have been established with healthy volunteers as well as the group of people the drug was originally targetted for (which will probably not include people with MS)

I suppose doctors are nervous of adverse effects with these treatments and thats why they are so difficult to get hold of! Mine wont even let me tell him about them, let alone consider prescribing them.. you are too young, you have life ahead of you... they may make you infertile.. we dont know the long term risks blargh blargh blargh blargh
I dont have children, because im too damn tired to look after them., so it wont hurt to be on a different drug, but what if it makes me better and i feel like i want children.. i feel like i am going around in circles

anyway

Take Care

R

As you know from past discussions I am skeptical that physicians are all that worried about off-label prescriptions. I think I have been offered 5-6 in the last year without asking. It's common medical practice.

Example: I take Xanax for insomnia and restless-legs syndrome symptoms. My neuro's a conservative, irritating man who won't even consider the antibiotics. But he prescribes the Xanax, although It's not FDA approved for either use.

Desipramine has a lot of uses and if it was requested for depression AND "because I have seen evidence that it may be helpful in MS", I am sure a lot of PCPs would be willing to prescribe it. My girlfriend was offered some for chronic back pain by her PCP. Anyway if the doctor is conservative another syndrome or diagnosis could be used as the reason for prescribing. They can write down that they are prescribing it for depression and be "covered" in terms of off-label prescribing (although I'm not convinced that many of them are all that worried about that- mine isn't...)

rasnet6 wrote:Its always worth remembering to proceed with caution with off label drugs. Their safety profile will have been established with healthy volunteers as well as the group of people the drug was originally targetted for (which will probably not include people with MS)

I suppose doctors are nervous of adverse effects with these treatments and thats why they are so difficult to get hold of! Mine wont even let me tell him about them, let alone consider prescribing them.. you are too young, you have life ahead of you... they may make you infertile.. we dont know the long term risks blargh blargh blargh blargh
I dont have children, because im too damn tired to look after them., so it wont hurt to be on a different drug, but what if it makes me better and i feel like i want children.. i feel like i am going around in circles

anyway

Take Care

R

R

I don't know how else to put this, but why do you place your health and life in the hands of a physician who treats you like that? I mean, you are an adult, aren't you?

I know what you mean.. I am an adult, what is even more annoying is that I work in drug reasearch, performing safey and efficacy studies on drugs in development... (hence my comments on the safety of drugs!) As far as i am concerned that makes me more qualified than my GP ever will be!!

I suppose i just turn into jelly when i see him.. he is crap (and that is being nice to him!!) I hate to cause anyone bother and he makes me feel like i am causing him trouble. He is just one of the many that dont understand.............

R

Bless your heart! I know what you mean about some doctors. And we have to have one, don't we? So we do our best to ride out their storms of ego and indifference. As surely as power corrupts, I think some docs just get carried away on a power trip, thinking that we're supposed to perceive them as gods or something. (If they only knew how many of us sit there listening to their nonsense, silently thinking "Bullsh*t!")

I'm assuming that you don't really have a viable choice in the matter of physicians.....but if there is a choice, now or in the future, I sincerely hope that somehow you can get the medical care you deserve, with an able, open-minded physician who sees the doctor-patient relationship as being more of a partnership; one of trust, frankness, and mutual respect...

Meanwhile, best of luck and hang in there! And please forgive my bluntness in my first post..that was really rude and I'm sorry . I just get carrried away when I see doctors treating their patients so dismissively....it's not right, and it's not necessary either, in my opinion.

It is very annoying having to deal with those who think they stand on higher ground!! I meet far too many of those kind of people......

If it was a member of my family dealing with a GP like mine - i would be going berserk, demanding they confront them and sort things out. Its funny cause i wouldnt dream of doing that myself. I think the MS makes me want to hide.. if it was anything else i am sure i would demand he listened to me!!

Anyway.. hide your blushes and dont worry about being blunt... I am a blunt kinda person too and its a language that is far easier to understand!!

take care

R

Feesher,

The situation that Biogen has created with Tysabri is just beginning to unfold and is but another reason as to why so many people voiced their concerns over the rushed approval process.

You have about 3000 people who were getting the drug during the trials for 2 years plus 5000 who have used the drug since its approavel and now they have to come off it, cold turkey.

You have an unknown number of patients whose neuros took them off a CRAB to start Tysabri, told them the CRAB wasn't really much good but now may have to put them back on the CRAB again!

You have countless docs who were pushing Tysabri to their patients, stating that this was the best MS drug ever but now have to retreat.

We are likely going to have some class action litigation against Biogen by the vulture-like lawyers.

And the most devastating effect is the crushing blow to thousands of MS patients who followed Biogen's slick marketing/sales press releases promising them results beyond anything ever seen before in MS medicine!

If only they could have waited for the two year data, listened to the warnings by some MS neuros and taken a slower approach to the whole process.

Harry

feesher wrote:Our Neuro, when trying to tell my wife to get on Tysabri, more or less said that we now know that the interferons weren't much use.

If this is indeed what your neurologist said, then I believe that he may have misinterpreted the recent events regarding Tysabri. Interferon-B is fine on its own. The problem was combining it with Tysabri.

NHE

NHE,

If this is indeed what your neurologist said, then I believe that he may have misinterpreted the recent events regarding Tysabri. Interferon-B is fine on its own. The problem was combining it with Tysabri.

I'm going to respectfully disagree with your comment re: the combination use of an interferon with Tysabri as the problem. Biogen's VP of medical research stated that Avonex has 650,000 patient year use behind it and to his knowledge, there has never been a case of PML associated with its use. So the problem possibly doesn't look like it has anything to do with with an interferon but instead with the mechanism of Tysabri.

Of course, nobody knows this for sure and a lot of speculation is going on at the moment. Trying to find the answer to this is going to take a lot of work and this may keep Tysabri off the market for quite some time, if not forever.

Harry

Tysabri is very likely to be back by the end of the year, although combination therapy will probably be prohibited.

In the past medical patients have protested the fact that the FDA took so long to approve drugs. "This hurts people, because they need these drugs now!"

Now some people are complaining that they are being fast tracked when it seems appropriate. "They rushed Tysabri to market!"

I am appropriately skeptical of the FDA and the pharmaceutical companies. However it appears to me that the initiation of combination therapy is really the only thing that consumers have to complain about.

These adverse effects are a tragedy, of course. But, there are risks involved with every treatment. A pharmaceutical company cannot force your doctor to prescribe Tysabri, and no once can make you take Tysabri if you don't want to.

Establishing drug safety takes years, and everyone who has taken Tysabri so far certainly is made aware of the risks through proper informed consent.

Why complain about something being "rushed to market" when you don't have to take it?

There is a (natural) temptation to make Tysabri the effigy which we burn in collective frustration for the existence of multiple sclerosis. I think this probably "feels right" but does not reconcile easily with the facts.

It looks to me that monotherapy with Tysabri will be highly effective for some, and it is my hope that it will be back on the market soon.

I repeat: None of this has anything to do with the supposed rushing of Tysabri to the market. Rare side effects are COMMONLY missed in the FDA clinical trial process. We just notice this one, because it's a drug for a condition we're involved with.

Daunted,

The time frame for Tysabri's return is totally unknown at this time and that came from Biogen's VP of medical research.

Fast tracking a drug to market has its place in certain situations.But when it comes to a drug as potent as Tysabri, fast tracking isn't the way to go. Biogen and been warned by some very prominent MS docs out there and the warning was about exactly the kind of problem Tysabri is now experiencing.

And per Biogen, they don't think Avonex had anything to do with the problem. Avonex has enjoyed 650,000 patient months of use without any known incident involving PML or other type of serious infection. So the focus of the initial investigation is going to center on Tysabri and PML.

Yes, there are risks involved with any treatment but you can minimize their effects by completing the basic trial length time and this simply was not done with Tysabri. While the patients in the trials had to sign consents acknowledging the risk, the 5000 Tysabri users who have used the drug after approval expect a higher level of safety and this unfortunately hasn't happened. That's what prompted the vulture-like lawyers into starting litigation already.

Why complain about something being "rushed to market" when you don't have to take it?

That comment doesn't deserve a reply!!!

Rare side effects are COMMONLY missed in the FDA clinical trial process. We just notice this one, because it's a drug for a condition we're involved with.

It's just when they are missed by not having the trials completed as scheduled before FDA approval do you run into a BIG problem.

Harry