This Is MS Multiple Sclerosis Community: Knowledge & Support

Hi there,
This may not be new information for everyone, but I just wanted to make sure everyone was aware of this option. After being frustrated about which neuros in Chicago actually know anything about LDN, let alone prescribe it, I decided to go right to the source. I called Dr. Bihari's office and talked with his assistant Bill, who was very helpful. I was initially thinking of actually going to NYC, but Bill told me that I could have a 1 hr. phone conference with the doctor. The cost is $500. The LDN that they prescribe all comes from the same NY pharmacy, as they feel that so many places just don't know how to compound it properly. Then they mail it to you. To prepare for the phone meeting, I just need to send him my last MRI and list the questions I have.

Has anyone out there had such a conference with Dr. Bihari? If so, I'd like to hear how it went.

We did the phone consultation with Dr. Scott in LaCrosse, Wisconsin, and it was fine. Lasted about 45 minutes, very informative, and the cost was $150. If you want more info, let me know. We use Skip's for compounding in Boca Raton FL...They are the most reputable I know of, after lots of investigating!

Kim

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Kim R.

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.

I kind of agree that $ 500.00 for a phone consult is rather steep. But the patient has a choice to make and one knows the cost in advance.

As for publishing information about drugs.....well, it isn't as easy as some people may think. In order to publish something in the world of medicine you need to do some very expensive trials/research on a drug. And that usually leads into the hundreds of thousands of dollars even for the most basic of studies. Most doctors don't have anywhere near that kind of money to do this. Dr. Bihari has supposedly asked for support and trials for LDN for a number of years but nobody with the resources to do this has come forward as yet...why?.......there isn't any money to made with LDN at this point and that pretty much keeps everyone at a distance.

Your neuro is also very typical of most MS specialists. They have a tendency to treat the disease and not the patient and are usually very inflexible when it comes to trying some other treatment for the patient. In many cases these docs can't offer anything to their MS patient but at the same time won't step outside their envelope and try something that may provide some benefit. There is a lot of peer pressure in the area of MS medicine and although some docs will state something privately, they won't do so publicly for fear of peer backlash.

Harry

$500 an hour works out to a yearly salary of roughly ONE MILLION DOLLARS.

I take homemade Revia based LDN just because I am probable and can't get real treatment yet, but I am totally willing to accept that it could be a placebo effect.

But if he's grossing a million dollars a year from LDN, would you expect him to be a good scientist in regard to its limitations and lack of evidence?

The claims for LDN are pretty outrageous- NO RELAPSES ever, then the person misses a day, then they relapse. Give me a break.

I'm open to the idea that LDN does something to people with MS, but Dr. Bihari has not impressed me. I think it's quite possible that he's a) an opportunistic profit seeker, b) simply a believer in LDN because his clinical experience leads him to believe it works (which any grad student knows is not a scientific method of evalution) or , c) the Galileo of MS who has discovered a very effective treatment, if we would only listen to him.

Time will tell.

Daunted,

There isn't much doubt that Dr. Bihari is making as much as he can from his experience with LDN. I believe that he is in his early 70's and to demand the fees that he does at this stage of his career is a bit disturbing. I know that several of his peers are quite upset that he is doing phone consults for MS patients and then prescribing the LDN. There was some talk that these peers (docs) might try and have his license pulled but I guess that hasn't happened as yet.

Bihari also holds a utility patent for LDN in that he has a fair amount of control when it comes to the application of using the drug for MS and/or its research. At this stage of LDN development there likely isn't anyone around that knows more about the drug and its effect with MS so its difficult to challenge him on it.

Hopefully the number of docs that are possibly going to do some initial clinical trials with LDN will start doing this by the end of the year.

Harry

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.

Hope everyone is having a wonderful weekend! Off to the beach for me! Got to grab all of this sun shine that I can get, it's been raining for far too long!

Kim

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Kim R.

No offense to anyone, but in my opinion, paying $500 and speaking directly to Dr. Bihari makes it all the more likely to be a placebo effect.

I paid less than $100 for a years worth the LDN by ordering imported Revia. It's not quite as exact as dosing from pills, but I think it is very close. I measure it out quite carefully.

In any case I can't fathom what you get, despite a "cult of personality" effect, from talking to Dr. Bihari as opposed to anyone else. No doubt if pay him, he will prescribe LDN. He thinks it works for everything and that it is a great anti-cancer drug as well, so of course he will prescribe it.

I looked into LDN deeply and there are many inaccuracies and inconsistencies in the literature used to promote LDN- from Dr. Bihari and elsewhere. It makes me greatly question the value of a consultation with him.

Here's a couple of them (there are many more) just FYI if you are considering paying $500 for a LDN consultation.

Dr. Bihari is quoted at http://goodshape.net/LDN.html as saying that it costs "30 to 40 million dollars" to scientifically evaluate LDN for MS. He's either ignorant of the costs of clinical trials, or deliberately lying. Either possibility makes me doubt his integrity as an informed physician and promoter of LDN. (He said this in immediate response to the idea that LDN should be tested scientifically).

If LDN actually does what he says it does (immediately arrest progression of MS and stop further relapses), then a very short trial with a small number of participants would be all that is necessary. You need big numbers in a trial only if you are trying to demontrate a small effect.

IF LDN is for real, you could perform a trial on just 100 people (50 on LDN, 50 on placebo) and it should show incredible differences even at the one-year mark. That doesn't cost 40 million dollars to do.

And if you need a huge trial to show effects, he's mistaken about the efficacy of LDN.

This newspaper article (http://www.ldners.org/Articles/Brattleboro_Reformer.htm) was posted a lot a few months ago. It includes a statement by Dr. Bihari. The patient in question tried a 4mg dose, and didn't work too well. Then he FORGOT to take it one night, and then next day, he felt great. So he decided on a 1.5 mg dose. He's now stabilized.

Of course, according to Dr. Bihari, it doesn't work this way- LDN is out of your system in about 3 hours. But that didn't seem to matter in this article, for instance. Or to keep him from claiming a 98% rate of stabilization. (98%!!!!!!!!)

Again, I take LDN, and kudos to those who find that it works for them, but I also hate to see anyone ripped off- which is what a $500 consultation is, a rip-off.

Daunted,

I'm not going to dispute the $ 500.00 Bihari consultation fee as being too high because I certainly believe that it is. Far too much.

But I will challenge your comment that clinical trials for LDN costing $ 30 - 40 million is not accurate. In fact, I'm thinking it is too low as long as we are both talking about what it costs to get a drug FDA approved for a specific disease.

The most recent figures for FDA drug approval run a minimum of about $ 50 million! I think that is ludicrous but it's a fact of life and as long as the FDA calls all the shots, you have to play by their rules. That is why no drug company has come forth and started trials...the chance of getting a return on your investment is simply far too risky if at all even possible.

Sure some docs and clinics are going ahead and starting to develop protocols for small LDN studies. But that's all they are.....small studies to look at safety and the initial efficacy of the drug. And do you know that unless you register such a trial with the FDA as part of their official drug protocol, (and that costs plenty) you can't use the study results you get as part of a future longer term clinical trial program to obtain FDA approval. Like I said, it's their rules or nothing at all.

You are correct in saying that only small numbers of trial participants are needed to prove very effective results....as long as the expectation of positive results is very high....like about 80%. But that is a statistical procedure and not necessarily what the FDA accepts for any kind of approval consideration. If you expect a rather marginal result, then larger studies are done because there is a much better chance of getting the results that you need. Again, all to do with statistical procedures.

Are patients who speak to Bihari all getting placebo effect from LDN. I suppose a few are but there are far too many people benefiting from this drug to attribute it to placebo. In clinical trials, they usually use a 30% placebo effect in their final numbers. When you look at the CRAB drugs, they all pretty much give about a 33% positive effect. Some docs questioning the CRABs, including Dr. Behan, come to the conclusion that the CRABs have provided little if anything when you use these numbers. Who knows?

Harry

Harry,

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.

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.

Daunted,



That would seem a logical route to follow but when it comes to the drug world of MS, logic many times doesn't win out )

If LDN was a drug that was simply used to treat some MS symptoms then off-label use would be fine. But all the anecdotal evidence so far points to it doing far more than that and going to the extreme the claim of preventing disease progression. For that kind of use one would need LDN to be advertised as a treatment for MS and THAT is what would take FDA approval....and of course the associated horrific costs involved in trials.

I think what we may see in the next year or so is the small, independent trials done by some clinics and/or docs in order to get some scientific evidence. Once that is done, something can be published and once published, the info becomes available to the neuors. It's at this point one would hope that the neuros "might" use it for the treatment of their patients but we all know how "iffy" that could turn out to be. Then, if its use showed far more benefit to the patient, the heavy duty trials would have to begin for specific MS use. A long process filled with many obstacles along the way.



I believe it would take far more than one trial to convince anyone in the field of medicine to start using the drug. As for 98% efficacy....I don't think there is any drug that exists today that gives that kind of result. I suppose there is always a possibility that this is the kind of result that Bihari may get with his group of patients but that means nothing in the world of scientific proof.



Kind of makes you wonder why then it cost millions to get their approval for a drug. It is a very complicated process and I've heard comments that it goes beyond science and into the world of "business".



I don't believe I said that there is no way LDN doesn't have any placebo effect. I stated that there are far too many positive results from the thousands of users that would make its success solely a placebo result.

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You would think that Bihari would be more practical in his comments and claims but then again, I have heard some amazing comments from doctors over the years that make my head spin ))) Like Dr. C. Smith, a neurologist from Seattle who stated at a convention in Chicago a few years ago that 20 people died from using Prokarin!!! When challenged on this at a later date, he denied ever saying this but several people there stated otherwise. And we were told when growing up that the doctor was ALWAYS right )))

Take care.

Harry

Sorry, time to leave the board.

-finn

Finn,



The last time I read info on the related drug trial process with the FDA the minimum cost to get a drug approved was the $ 50 million level. I can only presume that level of cost involved something along the lines of an existing drug such as LDN. I'm going to speak to a contact I have who has been through negotiations with the FDA on the approval process and see if I can get a handle on these costs. I do know that a single, double-blind trial would get you exactly "zero" with the FDA.



From what I've been told, a trial like that is only part of the costs involved. If only $ 5 million were required then LDN would have been clinically tested months ago.




Instead of guessing and assuming on this I will get in touch with my contact and obtain some "hard" info on the subject. I'll get back to you when I have something more concrete.

Harry

Sorry, time to leave the board.

-finn

Harry, first of all I agree with much of what you have to say. I know you have way more experience than I with the MS landscape. Having said that...

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.

The trial of statins was ONLY 6 months LONG and it was UNCONTROLLED.

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.

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 had mentioned on another forum that if the response to LDN is so robust, it should be a simple matter to get his 31 patients to sign consent forms, open their charts to review, and document the results. Any grad student could accomplish this in a weekend. Why hasn't it been done?

As far as the FDA, Harry, I just have to disagree with you. Formal approval of LDN for MS might never be necessary. Psychiatric drugs are the best analogy, since those conditions are similarly ambigious as far as treatment response- once 20mg/day of Prozac was approved for depression, psychiatrists could prescribe 5mg/day for panic disorder.

(And at first, they had to make homemade Low Dose Prozac, just like I am doing with my Revia-based homemade LDN).

It didn't require a trial for FDA approval- instead they ran many off-label trials first, the practice began commonplace (routine, really), and eventually some-but not all- pharmaceutical companies specifically sought FDA approval for anxiety.

But even those that didn't, are still often routinely used at low doses.

The same could be done with LDN.

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.

Again, I take LDN, but this is where we are in terms of science, not belief.