What would stop a neurologist....

A board to discuss Revimmune as a potential therapy for multiple sclerosis

What would stop a neurologist....

Postby L » Wed Aug 20, 2008 6:59 pm

...from giving a patient high dose cyclophosphamide who requested it if the clinician felt it appropriate.

The drug is approved for other uses and treatments are often given, at the doctors discretion, for applications not officially approved (for example, Botox given for the treatment of spasticity).

It seems to be the case that HiCy can only be administered to MS patients as part of a clinical trial. Because it's such a serious drug?

Or perhaps I am wrong and a neurologist is entitled to arrange this treatment.

What do people think?
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Postby CureOrBust » Thu Aug 21, 2008 2:39 am

I am probably mistaken, but "HyCy" is a trademarked treatment, involving more than just a high dose of cyclophosphamide. People are currently treated for other conditions with high dose cyclophosphamide, but that isnt HyCy.

I would hazard a guess if you wanted high dose cyclophosphamide, you could travel to less regulated places (eg Mexico) and find someone willing to take money for the treatment (i.e. high dose cyclophosphamide as given for other conditions). But I am purely guessing here.
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Postby L » Thu Aug 21, 2008 6:45 am

I'm really not sure if secret forumlas are used. The press releases from Accentia are always marked 'Patent Pending.' Well, I did look at the USPTO site to do a patent application search but the keyword 'cylophosphamide' brought up thousands of applications and a search for 'Accentia' and 'cylophosphamide' brought up none so I gave up.

The two year, nine patient trial describes the treatment as 'Patients received 50 mg/kg/d of cyclophosphamide intravenously for 4 consecutive days, followed by 5 μg/kg/d of granulocyte colony–stimulating factor 6 days after completion of HiCy treatment,'

I get the impression that they might be 'patent pending' owing to the fact that it would be difficult to patent a procedure which uses common(ish) drugs.

I would be tempted to do it on my own... Hire a nice new build empty flat. Get the drugs on the black market. Follow through the procedures. Persuade my local hospital to carry out the necessary blood tests. Get an echo scan performed privately. Hope it all goes ok and go to A+E if it doesn't... This is, of course, incredibly risky but then if I carry on with my annual attacks whilst waiting for approval then I think I will be in a very sorry state indeed, and quite possibly the treatment would be less effective if I turn SP. Pretty exciting though! I think that I am joking but, worringly, I really am not sure.
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Postby L » Thu Aug 21, 2008 9:29 am

You are quite right Kyle, it's not the cure that Accentia are touting. But looking at the breakdown of the results of some of the trials, it's impressed me.

Leon posted these links to four pdfs:
http://www.msu.edu/~lyonro/hdcold.pdf
http://www.msu.edu/~lyonro/HDC.pdf
http://www.msu.edu/~lyonro/hdcnew.pdf
http://www.msu.edu/~lyonro/hdcnewest.pdf

And, examining them, it seems like a pretty good gamble.

To be quite honest, I'm not sure if I could afford treatment in Baltimore or Chicago. I believe that it will cost tens of thousands of pounds.

But I'm very interested in the treatments that you mention - what exactly are they?

Thanks!
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Postby RedPenguins » Thu Aug 21, 2008 10:03 pm

Kyle - hmmm....I wasn't aware that Revimmune/HiCy wasn't safe! Sheesh...and I thought I knew what I needed to know BEFORE I had it in July. Ha ha.

If you look at the stats and records and research and blah blah blah, you will see that HiCy is safer than a lot of the other MS drugs - as fas as death/fatality rates. (ie: no one has died from HiCy for MS)

And L - the reason you can't just check in anywhere and have HiCy isn't necessarily because of the drug itself. As Kyle states, the med itself is used for many treatments of many diseases....and is often used with bone marrow transplants. However, the PROCESS /protocol of HiCy is what is different - and why trials are being run and patents pending and blah blah blah.

They don't just hook you up and give you four days of the med and send you on your way. It's a little bit more than that.

However, I think more trials are being run - and will be spread throughout the US. I don't know when it will hit Europe. I also don't know if JH accepts any kind of international insurance....but might be worth looking into. Also might be worth a call/email to the folks at JH to ask them if anyone in your neck of the world is doing this type of treatment. Can't hurt, I guess?

I will also say this - while I am only 6-7 weeks out from treatment....I couldn't be more glad or more thankful that I had this treatment. And although my insurance picked up the tab - it was still quite costly to be in Baltimore for nearly 3 weeks and having people (friends) there to take care of me. It added up - probly around 10k. Not such an easy thing....and not everyone can do that....but hopefully one day this treatment will be readily available in many places - so that one doesn't need to be far from home and thus not have additional costs.

Kyle, I haven't had a chance to look at the links you posted....though I do know lots of things are in the pipeline...but I do know that nothing is a cure yet for MS - though it seems, as of now, that HiCy is the closest thing that is currently available.

I have a life back now......don't know what it will look like in a year - but I can be hopeful that if nothing else - I bought myself time till there is a cure....but more than likely - this might be it for me!!! :)

~Keri
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Postby L » Fri Aug 22, 2008 5:19 am

The methodology is described as 'Patients received 50 mg/kg/d of clophosphamide intravenously for 4 consecutive days, followed
by 5 μg/kg/d of granulocyte colony–stimulating factor 6 days after completion of HiCy treatment, until the absolute neutrophil count'

I'm suggesting that a neurologist could follow this procedure and I'm sure that an experienced oncologist would help with unforessen outcomes.

I'm wondering if there really is any special part to the protocol of treatment which couldn't be administered by a hospital and all the resources and experience within it.

I should imagine that trials are being run not only to clarify the protocol but also to add weight to a patent application, which must be a very difficul patent to secure since the drugs are widely used and approved. Might that not be the case?

I've investigated and I don't think that there is a legal problem to a clinician arranging any off label treatment. And since the patent has not yet been awarded, that shouldn't be a problem And since, or so it seems to me, the protocol seems quite straightforward and contingency plans must already be decided on since the drugs have been used in a similar fashion for different ailments, I'm inclined to believe that any Neurologist could arrange for this treatment to be given to a patient if they wished.

Anyway, it's all just theory and wishful thinking. I'm sure they wouldn't. I'd just dearly love to receive this treatment...
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Postby CureOrBust » Fri Aug 22, 2008 11:13 pm

Kyle wrote:Why dont you just fly to baltimore and have it done? I have read they are doing this in chicago as well.
I do not know "L"'s case specifically, but cost could be an impeding factor with no insurance; and then there are other people, not just "L". From my understanding, the drugs used are nowhere near the cost being charged; i.e. they are cheap.
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Postby CureOrBust » Fri Aug 22, 2008 11:21 pm

RedPenguins wrote:However, the PROCESS /protocol of HiCy is what is different - and why trials are being run and patents pending and blah blah blah.
I would take a stab that for them to perform this process out of trial conditions, it would be under "informed consent" and as such the patient would be informed of all steps / drugs in the process, before signing away their right to sue the hospital. I was fairly suprised at the detail in the documents Lyon posted, although I would also understand that the treatment process has since been improved.

RedPenguins wrote:I will also say this - while I am only 6-7 weeks out from treatment....I couldn't be more glad or more thankful that I had this treatment....
... I have a life back now....
what (apart from not worrying as much about MS, and the new hope) makes you say this? I cannot remember reading any posts detailing your improvements in EDSS or such thus far? can you give me a link to the post please?
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