There was recently a very small trial on statins (using only 30 patients)... and immediately following it, there were a flood of posts on the various forums reporting that many doctors were willing to consider statins for MS patients.
Statin drugs are very well known by docs and if a small trial like this gets published, the info is going to be far more accepted. Naltrexone, from what I have read, isn't well known at all so it would likely take more than just one small trial to convince docs to consider it.
The trial of statins was ONLY 6 months LONG and it was UNCONTROLLED.
That's why most neuros wouldn't likely prescribe or consider it at this time.
LDN doesn't even have that level of evidence- and such an experiment obviously doesn't cost close to 5 million dollars- sheash, using finn's numbers from before, it could cost around $300,000.
And that brings up a very big question. How is it that a statin drug, which in the past has had absolutely nothing to do with MS, gets a small trial done on MS patients while LDN, which has been used by thousands on MS patients for a couple of years, can't get anyone interested? It simply doesn't make any sense and you have to wonder what is going on in the background in the drug research world. Why do statins, out of nowhere, get the attention of the NMSS but this same organization writes a scathing report in commenting on LDN without doing any kind of investigation into it? Too many questions and no answers!!
Why Dr. Bihari hasn't published his findings from his 31 patients, is unclear. Serial MRIs are nice but Swank got his research published without a control group or radiological evidence- the limitations are clear but the possibilities are illuminated.
I really don't know why Bihari hasn't pursued a research route on LDN but I suspect because his age and lack of resources may be the reason. Supposedly he has some 300 patients on LDN at the moment. If any readers out there have an answer to this, I surely would like to hear it!
As far as the FDA, Harry, I just have to disagree with you. Formal approval of LDN for MS might never be necessary.
If LDN is ever to be used and advertised for MS , FDA approval would be paramount. The FDA is quite strict about how a drug can be presented and from what I understand, you would not be able to mention LDN and MS in the same sentence without approval. At this stage of the game it is a mute point because unless LDN becomes far better known to the docs it won't even make it to the "off label" possibility. I continue to read about MS patients mentioning LDN to their neuro or GP and getting the response..."I've never heard about it." And that brings us back to the requirement of small initial trials to make it better known...but until now it just hasn't happened! And again I ask...why not? How can the statins or minocycline get these off label trials so quickly?
But I just think it's false that if a reasonable pilot of LDN could be
done for less than $5 million, it would already have been done- because it would cost less than 1/10th of that to perform a trial equivalent to the statin trial I mentioned above.
And that just brings up the same question as to "why not?" What' missing in the LDN equation that these other drugs have and LDN does not?
Again, I take LDN, but this is where we are in terms of science, not belief.
Yes, that pretty much sums up the current LDN situation. Up until now, all of the demand for LDN clinical trials is coming from those who are using it. It should be coming from the world of MS medicine but it certainly isn't. That may change soon but it is a very slow process.