I tried responding to your message last night but after spending a fair amount of time doing so, I got a "Internet Explorer" fatal error and lost the entire post that I had made. Arghhhh....I then did the next best thing....went to bed )))
OddDuck wrote: I know.....a person just can't afford to conduct a clinical trial without either grant funding or support from a *gulp* pharmaceutical corporation! (And you have to appeal to a pharma's pocketbook, market share, and profit margin, to get them on board, I believe.) I know that personally.
Interesting story...when Elaine approached several pharmaceutical companies and asked if they were interested in working with Prokarin, one of the first questions they asked was not if it would ever work but "how much did you plan on charging for it?" When she told them somewhere around $ 250.00 a month they immediately made a "180" while mumbling that amount wasn't anywhere close to what they would even begin to contemplate.
The thing that strikes me as sort of strange in a way, is that even though Elaine may not have intended it to come across this way, I have to say that I myself had the distinct impression that their website was inferring that Prokarin was something that may affect actual MS disease modification, not simply symptomatic relief. Might that be a potential difficulty, also? The mistaken "impression" that is perhaps accidentally being presented?
I can only say that I have spoken to Elaine on a number of occasions and she is very well aware that Prokarin is for symptom treatment. At the same time, though, she has been using Prokarin for 7 years now and she is symptom free and works a very long day. The FDA also keeps tabs on her website and if she says anything that isn't proper, they let her know.
I can imagine it would be difficult to get the NMSS to put any drug on their list of symptomatic treatments for MS. That's practically like an unspoken "endorsement", I would think. That's neither here nor there, but just a supposition about their possible perspective on it.
The NMSS states that they do not endorse or recommend any of the listed treatments on their website. Getting anything listed is difficult. One thing that really irritated Elaine is that when she met with them on one occasion, it was suggested that more backing might come to Prokarin if her company had some "benefits" to give to the NMSS. Of course, the inference can never be proven but when they said that to her, she knew that she was dealing with the wrong people.
The majority of drugs used off-label, though, Harry, have FDA approval for use - just not always for use directly in MS. There are government regulations that dictate when and how (under what conditions) a physician may legally prescribe an FDA approved drug for "off label" use. My impression was that Prokarin has NO FDA approval at all for use. Have they attempted to gain approval from the FDA as an "orphan drug"? Even that might help, if Prokarin qualifies.
The main ingredients of Prokarin, histamine diphosphate and caffeine citrate, both have been FDA approved for decades. Prokarin is officially listed as a compounded drug and can be used "off label" because of this. The FDA is very aware of it and have spoken to Elaine about it. In fact, histamine treatment in an IV format, was given to thousands of MS patients back in the late 40's and early 50's by Dr. Jonez...with a great deal of success BTW. There were no adverse affects to the thousands of patients that he treated. Unfortunately, he died suddenly in 1952 and all of his research and work with MS came to an abrupt halt, never more to be resurrected.
As for getting orphan drug status....that is very difficult to do. You have to prove that the drug that you want the status for is better than the orphan drug already in existence, which would Betaseron and Avonex, both of which have the status. And that costs millions to do.
I do wish Elaine and her company all the best in their quest! As I said before, I support as many options available to MSers as is possible, be it via actual disease modification, or via symptomatic relief.
I doubt that Prokarin will make any great strides unless more docs prescribe it. And unless someone comes forth with a few million dollars to do some trials, that isn't likely to happen. For the time being, there are a few thousand people who are using it with a great deal of success. I can't imagine what my wife Marg's life would be without it!
I hope your weekend has gone great. Take care.