Mon-02-02-2015, 07:54 AM
(Sun-01-02-2015, 22:16 PM)jmcarlo83 Wrote: Caroline i also wanted to ask you if fumaderm works so well and has been around for so long, why do you think it never made its way here to the states?
Hello jmcarlo,
That is mainly because the development did not come from Big Pharma, but from a doctor (dr. Schweckendieck) that first was not understood by regular medics. Then a small drug production firm picked it up on the one side, that led to the production of Fumaderm in Germany and on the other side it was picked up in the Netherlands by doctor Kunst which led to the creation of Psorinovo.
Both products are already around for many years (30) in Germany and the Netherlands. Supported by smaller groups of doctors with a broader view on the patient than only its disease. The products are still hardly accepted by normal medicine as they did not pass the normal tryout protocol that belongs to new medicines. In the mean time all gathered knowhow and history should be enough to skip all these tests, but the regulators are stubborn and will not accept that. So the availability for e.g. Psorinovo is now only at one place in the Netherlands, Fumaderm is a bit more available, and you only get it if you really put the thumbscrews on your dermatologist, even while the guidelines of 2011 state that DMF is a first line medication for the treatment of psoriasis and PsA.
So you have to be a very active and knowledged patient.
Nobody in the States has picked this up in the past 30 years, maybe also because your FDA is very restrictive.
Recently Biogen created Tecfidera. They made their own production process (there is a description of it available) and did the required tests aiming on the MS market. They claim that this is why it is so expensive.
But..... I don't understand that as, reduced to a simple process:
- DMF is available on the market for $160/kg, which is extremely cheap. Which means that the production process can never be really expensive.
- Trials on patients cannot cost much money, you have to register 2 or more groups of patients, you can do that even with a simple excel, and you have to provide them with the medication, which is also not a complex process.
- Then check and control these patients for quite a period. To me this also seems a limited and not complex procedure.
- For the rest it should be filling out some forms
It seems that Matari has info from another side.
(Mon-02-02-2015, 02:24 AM)mataribot Wrote: It has do with the pharmaceutical companies... There are two different variants currently in trial for psoriasis and PsA.
Hi Matari,
Can you tell more on this ?
Which variants are being tried?
Is it all DMF-like?
Tell me more !
Caroline