Fumaric Acid question?
Question:
Hello I have sent several messages regarding fumaric. For the l;ast about 15 years I have taken 6 pills a day. It is approved by the Dutch authorities as special cases. It is not approved by the Ministry but the sichnes insurers refund all charges. The pills cost about sounds a lot, but the insurers know that one day’s hospitalisation is is $ 500,== in Holland (on top of that cost for medicines and specialist treatment) . I spent 3 weeks at a time in hospital so you can work out the benefit to the insurers. There must be lots of my letters in the group somewhere, but if necessary I can post some more with the address of my supplier in Holland. I have tried I think most medicines but nothing has been as effective as the fumaric pills.
Response:
>In article > I also would like to know how >come FDA just >can’t accept something that was approved by a similar agency in >a developed >country like Germany.What are they trying to protect us from?
PS. This may or may not be relevant (on the drug approval/drug industry) . Make up your own mind and cross-reference it. http://www.pnc.com.au/~cafmr/online/research/drug.html Steve * Sent from RemarQ http://www.remarq.com The Internet’s Discussion Network * The fastest and easiest way to search and participate in Usenet – Free!
Response:
>that might be available here in the States without prescription might be >of "iffy" quality:
Fumaric acid monoethyl ester is available in the USA from Ecological Formulas , Concorde, CA. Tel 925 827 2636 They are a reputable company. Steve. * Sent from RemarQ http://www.remarq.com The Internet’s Discussion Network * The fastest and easiest way to search and participate in Usenet – Free!
Response:
> Thanks for the helpful information. Do you know if there are any > plans to submit to the US FDA for approval? > Janet
That was my next question too. I also would like to know how come FDA just can’t accept something that was approved by a similar agency in a developed country like Germany.What are they trying to protect us from?If it is good for the Germans and there is an extensive experience prescribing it,10000 people are taking the medicine,what is a better clinical trial than that? Why not just take it and approve it?I am sure they are not trying to protect American companies,since most major pharmaceutical companies are European owned anyway. Maybe I should call my Senator to check on that. Meesha
Response:
In article
I also would like to know how come FDA just >can’t accept something that was approved by a similar agency in a developed >country like Germany.What are they trying to protect us from?
Why does the FDA allow a poison psoriasis drug like MTX, that is also used for aborting pregnancy, and not allow a common foodstuff additive like fumaric acid ? Why does the safest asthma medication known for the past 35 years (Intal), have a prescription only schedule (and exorbitant price btw) while a proven asthma killer drug (Beta2-agnostic Primatine [adrenalin]) is approved for over-the-counter ? The FDA is inconsistant and I believe that ultimately the reason is money and who is effectively lobbying the FDA and how powerful the lobby is and what representative interests the FDA have in the respective drug companies and what patents may be applied. How else do you explain something so outwardly irrational ? Follow the money…… I’d be interested to know what the good senator says. Better check who pays HIM before you believe him, though. Steve * Sent from RemarQ http://www.remarq.com The Internet’s Discussion Network * The fastest and easiest way to search and participate in Usenet – Free!
Response:
>Now to clarify you’re clarification of my clarification, which >clarified Dave W’s clarification, clarifying my post and now >clarifying this post……now what was I going to say! <grin> >I think the clarification worked. LOL!
Uh, now *I’m* confused. – Dave W. http://members.aol.com/psorsite/
Response:
> My relatives are going to Germany next month,will they be able to buy it > there without prescription?And will they have any problem going through the > customs with the stuff? > Meesha
The FAEs ( nothing to do with the fumaric acid from the therapeutical point of view )are available in Germany only under medical prescription. The brand name is Fumaderm initial and Fumaderm. It comes from Fumedica ( Herne ). Phone: ( 02323 ) 1496 – 0. Another address I have is Dr. Wolff ARZNEIMITTEL D- 33532 Bielefeld Phone ( 0521 ) 8808-05 In Germany is the first treatment of choice now against severe and recalcitrant P. In Italy is not approved yet but you can get it under a special prescription. Hope this helps Dr. Oscar in Italy
Response:
> Hi, > Fumaric (the Tablet/Medicine) is a proprietary product manufactured > ONLY in the Netherlands by "Tio Pharmaceuticals". > There is know way that anyone will procure Fumaric Medicine without a > prescription written by a Dermatologists or Specialist Dr. > Further, there needs to be controlled supervision and regular blood > tests scheduled while taking this medicine, by a qualified Dr. > The product is not available in Germany or elsewhere in the medical > form to my knowledge! Hope that clears this aspect of it up?
Dear readers, the drugs Fumaderm initial and Fumaderm (which contain fumaric acid esters) are approved and registered for the treatment of severe forms of psoriasis in Germany. Fumaderm is (of course) available only on prscription. The German approval by the "BfArM" (the German FDA) is the only approval for fumaric acid esters worldwide. Although even in Germany there are lots of unregistered und unapproved fumaric preparations, Fumaderm is taken by nearly 10.000 patients every day. Best regards Joerg __ Dr. rer. nat. Joerg Boettcher Tel.: 02323 1496-16 FUMEDICA GmbH FAX: 02323 1496-20 44628 Herne http://www.fumedica.de
Response:
>>Now to clarify you’re clarification of my clarification, which >clarified Dave W’s clarification, clarifying my post and now >clarifying this post……now what was I going to say! <grin> >I think the clarification worked. LOL! >Uh, now *I’m* confused. >- Dave W. >http://members.aol.com/psorsite/
Oh good, everything’s back to normal now! 
Janet * Sent from RemarQ http://www.remarq.com The Internet’s Discussion Network * The fastest and easiest way to search and participate in Usenet – Free!
Response:
- Hide quoted text — Show quoted text – >Dear readers, >the drugs Fumaderm initial and Fumaderm (which contain fumaric acid esters) >are approved and registered for the treatment of severe forms of psoriasis >in Germany. Fumaderm is (of course) available only on prscription. >The German approval by the "BfArM" (the German FDA) is the only approval for >fumaric acid esters worldwide. Although even in Germany there are lots of >unregistered und unapproved fumaric preparations, Fumaderm is taken by >nearly 10.000 patients every day. >Best regards >Joerg
Hello Joerg, Thanks for the helpful information. Do you know if there are any plans to submit to the US FDA for approval? Janet * Sent from RemarQ http://www.remarq.com The Internet’s Discussion Network * The fastest and easiest way to search and participate in Usenet – Free!
Response:
> Hello Joerg, > Thanks for the helpful information. Do you know if there are any > plans to submit to the US FDA for approval? > Janet
Hi Janet, unfortunately Fumaderm was approved as a mixture of different fumaric acid esters. The approval procedure started back in 1985 and at that time there were 25 years of experience with these mixtures. Today this sounds quiet strange because the authorities do not like these drug mixtures very much. So it will not be easy (maybe impossible) to receive a FDA approval for Fumaderm. Similar reasons prevent an approval in other european countries so far. But for the people around Germany it is not impossible to receive Fumaderm. The need nothing more than a prescription (and a lot of money because Fumaderm is quiet expensive). We are able to sent Fumaderm to any pharmacy in Europe. Unfortunately again this shipping seems to be a problem for the USA. I
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