Neutro said, "...canadian MG association to contact a french or belgian drug wholesaler and to import them? ... "

Nice to see you, Maurice. Mytelase was rare here however, I remember a woman from "Montreal" who said a physician (Prof.) in France prescribed it.

I'm out of the loop, but I like your idea, and I will do what I can to inform some MG Associations, as well as Muscular Dystrophy Canada. It would seem to me that a pharmaceutical company would want to make every effort to sell this drug. It could also be that there was limited demand here. I would suggest that many MGers would be willing to give it try.

As Reynolds mentioned, perhaps an influx of calls or mail to the pharmaceutical company for those wanting this drug?

Cheers....

Thank you Maurice.

I agree with your resoning. I too wonder why the MG Foundation didn't simply create a drug bank for Mytelase so the few people who needed it could still get the medication.

I did speak to the FDA, they would be the ones in charge of allowing the importation. They were very receptive to letting it be imported. The only thing that makes the drug from France illegal is the label. Put a new label on the bottle and it could be sold in the US.

This problem is so simple to fix, we just have to find the right person to help us fix it.

Maurice when you say it is $8 a bottle for fifty, do you mean pills or bottles?

And please keep in touch, we may need your help. I could use an excuse to visit Paris. :D

We have tried calling the company and the US MG foundation and they say just take Mestinon. Well those people I have talked to are allergic to Mestinon and can not take it. I am allergic to Mestinon and dread taking it again. I suffered with it for years because my doctors did know Mytelase even existed. A friend found mention of the drug and suggested I try it. It was life changing. I was told the daily severe diarrhea was just part of taking an acetocholase inhibitor. but it wasn't. I never have that side effect on Mytelase.

Currently the MG foundation has a letter on their site saying it's gone, stop bothering us. Yes, I am paraphrasing.

I am taking the sugestion to call my senator.

Reynolds, sorry for the confusion, I meant 8 US$ per bottle of 50 pills...
Maurice.

wow. that's really reasonable. Santofi said they could not import the drug for the patients who needed it because it was terribly expensive.

out of curiosity I checked their financials. From 2002 to 2012 their profits quadrupled. So it's not like they are hurting for money.

I can't help thinking there is some one out there who can solve this problem.

I guess I just keep working on it.

Thank you for answering my question.

So if that's what it costs you, what would it cost a foreigner per bottle?

As far as mestinon causing diarrhea, you can take imodium (loperimide). It doesn't cross the blood brain barrier, so it doesn't make you drowsy. It has saved my life for sure.

I have Celiac's so I can't take the bromides. I had an awful rash. Mestinon was pure misery for me, and it just never worked right.

I saw my neurolgist yesterday. He put in orders with the pharmacy at his hospital and they are going to try to import mytelase. I had mentioned to my oncologist that I was having trouble getting mytelase and she replied that they imported cancer medications from overseas all the time and there was no reason they couldn't import the Mytelase. First person I met who thought there was a way to do it. My oncologist and neurologist are friends and I know they talked about my case and the problem getting mytelase. Who knew getting cancer would come in handy? :)

So long story short the pharmacy at the hospital does the importing and they are going to see if they can find a way to import mytelase.

What I learned is Neurologist rarely import drugs and have no idea how to do it. Oncologists import cancer medications weekly and know exactly how it's done. So tell your neurologist to contact the oncologist he knows and ask how they do it. The nurse practitioner usually does this, at least in the US. And use the hospital pharmacy or the one the oncologist uses. You want a big pharmacy that imports regularly, not your local pharmacy. Once the drug gets to the big pharmacy they can mail your meds to you.

Your neurologist will need to write a letter saying why you need this drug and that there is no other treatment that will do. That letter will have to go to the out of the country pharmacy to be included in the package with the medication. And they must ship it either UPS or FedEx. If you don't use one of those two shippers the drug will not arrive in a timely mannor.

I have no guarentee this will work. But it does seem worth trying. Everyone will have to try this route for themselves. I wish I had found a way to just straighten out this mess for everyone.

I will keep everyone informed with what I learn.

Reynolds, one reason for the cost of Mytelase in US could lie in high import taxes, protectionism...?
You should also add shipping charges, but that should be miminal.
Maurice.

As I understood it there would not be import fees on the drug. But I could be wrong. It's all very complicated. Like anything that involves going through governments.

Sanofi made Mytelase here and I think my insurance paid almost $200 dollars for the last bottle of 100 I got.

I just hope this attempt to bring the drug in works.

I called my senator's office and they called me back. It seems this is getting to be a regular problem.

Drug companies are stopping production of medications for rare diseases because they don't make money. Or they don't make enough profit on them. They were going to be looking into this and talking to other senators.

So maybe those of you in the US would like to call your senator's office. It would be nice if we could help others in the same boat. And help ourselves too.

От 26 години съм с Миастения Гравис. Първите 11 години бях на Неостигмин, Калимин 60, Местинон 60 и Оксазил, и не се чувствах добре - не можех да се обслужвам. От 15 години съм на Мителазе 10 мл и се обслужвах сам, а сега съм на Калимин 60 и нямам сили, трудно ми е да говоря, да се храня и да пия вода. Уплашен съм и не знам какво да правя.

Здравейте и добре дошли. Разбираме, че ги е страх, защото няма по-mytelase. Моля те, остани, така че да не се чувстват сами. :)

Google Translate

Hello and welcome. We understand that you are scared because there is no-mytelase. Please stay, so you do not feel alone.

THANK YOU CHEMAR! :)

oh no. I am so worried for her. for all of us really. is it time that we try to get some media exposure?

Hello Reynolds, The bottom line, and you said as much in September of 2012,
is good old supply and demand.

http://myasthenia.org/LinkClick.aspx...nQ%3D&tabid=40

Reynolds, This is really grasping at straws, but perhaps the FDA has a similar program. I can't see this flying with any physician here, however, I wonder if it would in the US?

"...Special Access Program (SAP) for Drugs and Medical Devices not Available in Canada: The Special Access Programme (SAP), via exemptions set out in C.08.010 and C.08.011 of the Food and Drugs Act and Part 2 Section 69-78 of the Medical Devices Regulations, allows physicians and dentists to gain access to health products for human use that have not been granted market authorization in Canada. Decisions to authorize this access are based on the circumstances and details of each situation. If authorization is granted, Health Canada provides a Letter of Authorization (LOA) to the manufacturer of the drug or device authorizing its sale to the requesting practitioner. A copy of this letter is sent to the practitioner. A copy of this letter must be sent with the shipment to allow timely entry of the drug/medical device into Canada..."

http://www.hc-sc.gc.ca/dhp-mps/compl...iu-uif-eng.php

Santfi has been making this medication in every country they sell it in. I think that does make the drug very expensive and much of it goes to waste. It used to be, when Mestinon was not so widely used, Roche would make the entire world's supply in New York and they would export it to the rest of the world. Every country in the world will allow sale of a US made drug.

So my theory is they could be making the drug here and allowing it to be exported to those who need it around the world. This would allow them to make less of the medication with more people buying from the same batch.

While it is supply and demand, it does seem terribly callus to allow people to fade away and maybe even die when an effective treatment exsists.

This is just so cruel.

I have spoken to the FDA and they did tell me they will let it in. They are all for it. Santfi would not agree. The easiest way to get it is for the drug company to import it themselves. Santfi said it would cost too much money.

So now we are trying to set up a method to get it from France. I have heard nothing on that front. I have no idea if that will work or not. I suspect it is probably another dead end.

The latest news I have is Santofi has stopped making Mytelase in France. So we won't be getting it from there.

In good news Alfresha in Japan has begun to make Mytelase. So now we are going to try and find a way to import it from them. If you look at their web page you will see they tagline is Taking on the challenge of 'unmet medical needs.'

Cross your fingers folks, we are getting a little closer.

Gone, Gone, Gone
 

Hello. The final word I have is Mytelase is gone from the US market and will never be coming back. I have tried to import it from Japan for a year and it is clear that is not possible. I am sorry to say we are never going to see this drug again.

I wish I had better news.

Why don't you write a letter to Michael Pearson of Valeant Pharmaceuticals? CC it to the the head of Alfesa? Ask if they might work together to bring the drug back to the US? Explain how it makes some MGers better than Mestinon.

http://www.alfresa.com/eng/about/concept.html

http://www.valeant.com/about/board-of-directors

It's certainly worth the effort.

Annie

I think someone here should go to the media.... CNN, NYTimes...
how the Big Pharma is leaving MGers in the dust.

Might just turn a tide?

I might do it. I just tangled with Valeant, without good results (Mestinon syrup still tastes like celery, but now with an added clove flavor, not the FDA promised raspberry flavor).

If I have time, I'll take a crack at an article—if my teething puppy will let me. ;)

Annie