adjanimals wrote:I know this may not be taken well.
With all due respect to Dr. Bihari. I think $500 is a crock of BS for a phone consultation. I know the man is busy but lets bring it down to reality. My neuro at my visit thursday 9/2 shot LDN down. He won't prescribe it without some proof. In some way I think he's right. Why hasn't Dr. Bihari published his results. He did say if I find someone to prescribe it he wants to know how I'm doing. He also shot down the Goat Serum. He's supose to specialize in MS.
CCmom wrote:Hi, all! You would be amazed at how many people are actually using Dr. Bihari for the consultations to get LDN. I know of a couple who used him, the lady for MS and the husband preventatively. There is another message board that I utilize solely for LDN users, and the ones who actually use Dr. Bihari make a list of questions from the other post-ers to ask him when they have their consults.
I, too, agree that his fee is monumental. But it is a personal choice, and there are other options out there, and more doctors (neuros and PCP's) that are prescribing LDN every day after seeing the changes in their patients stability with this disease, no matter how they initially got started on it...
When I started researching LDN for my son, I can tell you that I made several phone calls to Dr. Bihari's office with questions, since I was hard pressed to find info on it's usage in an adolescent. His assistant was very very helpful, very informative, and they did not ask for one penny. He gave me the info I needed to make my choice.
I guess what I would say is that Naltrexone is already an FDA-approved substance, so there is no real reason to even pursue FDA approval. It wouldn't make sense. Off-label prescription is the way to go here, obviously. Neurologists write them all day long for stuff like Neurontin- with some scientific evidence they would likely do the same with LDN.
The argument was about scientific validity- and even one clinical trial should give some clues about that. That's what I meant. Dr. Bihari has claimed a 98% efficacy rate. That can *easily* be tested.
All the FDA ever does is find out if a drug is obviously unsafe (rare side effects, even fatal ones, are often missed until well after approval) and that it does SOMETHING- that it has some effect. The magnitude of effect is not specifically measured or necessary for FDA approval. If they cared about that to any degree (especially as compared to already-existing drugs) a lot of drugs would not be approved.
I would disagree that there is "no way LDN is a placebo effect". Anything is possible. I agree it's unlikely, but the only way we find out is through trials.
[/quote]Even if LDN turns out to be the discovery of the century, does anyone actually think it is "98% effective"? Claims like this do nothing but make Dr. Bihari look like a quack, which is regrettable.
$50 million is probably the estimated amount of all costs related to a drug approval process from preclinical phase to a pivotal phase III trial (excluding the actual product development costs). With LDN (and other off label drugs) a single double blinded trial might be enough to convince FDA, and I am sure it wouldn't cost $30-40 million.
Actually, it is rather easy to estimate costs of a clinical trial. Let's
say that to treat and to study a single patient in a clinical trial for a year costs $20.000 (MRIs, neuro exams, lab tests, EDSS and other tests once a month; analysis; administration). There were only 251 patients in the pivotal phase III trial of Copaxone, so larger trial population shouldn't be needed: 251 x 20.000 = 5020.000.
Maybe it wouldn't cost more than $5 million to run a decent double blinded trial of LDN (or any other off label drug). Of course it still might be too much for even the most idealistic sponsors.
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