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Re: Nardil from Australia = 1950's version.JV djmmm

Posted by Spotcheck on April 13, 2004, at 22:48:10

In reply to Re: Nardil from Australia = 1950's version.JV, posted by djmmm on April 13, 2004, at 20:56:59

djimm:

I think that a select few people have created this non-effective Nardil "hysteria" and it has spread like wildfire (through that OTHER med forum) I do miss that orange candy coating...my
GOD does the newer Nardil taste bad.

Spotcheck:

If this is what you think, then in my estimation alone, you know relatively little about medication pharmacology especially in tablet form. You see what really determines how any active ingredient, like phenelzine sulfate, is metabolized is not the phenelzine sulfate, djimm. The excipients or inactive ingredients that accompany the active ingredient do that.

djimm:

"Im not an idiot. I am aware of the role of inactive ingredients."

I never called you an idiot djimm, because I simply would not do that.

Spotcheck:

Otherwise, I should be to take straight Phenelzine Sulfate, put it in a glass of water (guess what? It will not even dissolve uniformly in H20 in my experiments) and you could drink that down, and it work just like the old Nardil.
Well, sadly that is not the case my friend.

djimm:

"Then you are a poor chemist..phenelzine sulfate dissolves readily in water (Evidence for carcinogenicity to animals)IARC Monographs, 24, 175-184, 1980"

Well done, and I stand corrected. It does dissolve much faster in ethyl alcohol though even though this does not erase my error.

Spotcheck:

Consider this well: of the 15 original excipients in old Nardil, which I can and will enumerate if necessary, only 3 remain the same in the new Nardil, and the number of excipients dropped to 9 in the new Nardil as well. When a generic drug is made, there is no telling how well it will be metabolized.

djmmm:

"You may not have an accurate grasp of the role of inactive ingredients, or the role of the FDA (when a drug formulation has changed)"

That's entirely possible, I must confess. However, I would like to know more since I might well need the information. Can you direct me to a source that would better inform me?

Spotcheck:

"Did you not read KV's post to SuzyQ1 about the same problems in Tofranil, I believe, he said? Therefore, when Pfizer made this change, she was virtually guaranteeing that some small percentage of customers would not metabolize it well -- if at all and that is indeed the reality of this situation."

djimm:

"I just don't believe that...It doesn't make sense..for a company to change inactive ingredients, then inform the consumer that in some people the medication will not work at all... does this make sense to you??"

djimm, they really don't inform anyone. The results I am talking about are empirical and based on people's experiences. In this particular case, I have allot of experience. What makes you think that any drug company announces it is changing to a generic drug? All they do is provide a package insert. That's all they have to do, in fact. In the case of new Nardil, they did not inform anyone -- not pharmacists and not doctors, and that's why this row began in fact.

Spotcheck:

If I had a laboratory that was well equipped, I could make a generic Phenelzine that was in vitro bioequvalent to the old Nardil and so would pass the FDA under the ANDA = Abbreviated New Drug Application, which requires no animal or human trials, that your body would not metabolize.

djimm:

"That just isn't the entire truth...true with an ANDA, you must demonstrate bioequivalence."

Exactly! That's precisely why it so easy to create generic using an ANDA. No animal or human trials are required. I can take you to the FDA and demonstrate this, if you would like.

"The easiest and most common way to do this is with a specified number of HUMAN volunteers. The FDA requires that even ANDA generic meds must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the original patent drug(Waxman-Hatch Act)...regardless of the inactive ingredients.
The "new" Nardil was subject to the same strict guidelines as any other drug."

First, I simply disagree with you about what is required to get a drug passed the FDA using an ANDA. That much I have researched, unless Waxman is more recent, and has not yet been posted to the FDA's website. Then, I would be in error.

However, that was never my argument with respect to Nardil, djimm, because Pfizer used what is called an SNDA -- Supplemental New Drug Approval, not an NDA nor an ANDA. It only requires limited human trials.

Spotty:

I actually already did with my H2O example. Then, we would see for yourself if your hypothesis of hysteria above is correct or incorrect.

djimm:

"--well since you failed to dissolve phenelzine sulfate in water..."

It works much better in 200 proof ethyl alcohol. However, even if I was mistaken about the water, that does not rebut what I said here, and I suspect you know it too.

Spotcheck:

Yes, would be in rough shape exactly as these people are. So please do not make such rash assumptions henceforth, all right?

djimm:

--I have read the original threads (on a different site) and I can also recall several completely ridiculous statements, one of which claimed that the "new" nardil was Phenelzine HCL, not sulfate...and this ridiculous fallacy was repeated several times in various threads, and believed to be the truth by many.

Well, if you are referring to a site both of have read then I agree, but the truth is that in tablet form, Phenelzine Sulfate is always used. So, I have no problem with you statement, since I agree.

djimm:

--FWIW, it is hysteria...

Spotcheck:

I wish that was true, djimm. I really do wish that was the God's honest truth, because nothing would please me more. Unfortunately, it is not the truth and I need to prove this then let us agree right here and now to get in touch via e-mail and I will prove it to you. You can reach me at Twinoppose@hotmail.com - if you wish.

djimm continued....

"drug companies change inative ingredients all the time. What manufacturer would mass produce a medication that is inferior to an older version?"

Whew, I can see that we really do need to talk somewhere else. However, at the risk of losing my neck here, they do not mean it to happen this way, djimm. It just does happen, because of the very role that excipients play in the metabolism of any complicated medication. I thought that I had made this abundantly clear in my first post in fact. If not, I am genuinely sorry that I did not better communicate my message.

djimm:

"What manufaturer would waste millions of $$ in research/development and RISK not only their reputation, but the mental health of ten's of thousands of it's consumers?"

Any company that faced this choice: either discontinue making a very old MAOI, that is rarely ever prescribed by a psychiatrist and almost never as the first medication, or produce a drug that was essentially a generic drug, which have been know to cause some people problems. Shoot it happened to me with one of the first generic Amitriptyline. I was taking Elavil, and I unknowing was prescribed a generic, and it simply did not work as well. I confirmed in myself a couple of times.

djimm:

"--There is NO Nardil conspiracy, and no amount of bombastic, pseudo-scientific jargon will ever convince me otherwise."

Of course there is no conspiracy djimm, nor did I ever say there was about Nardil. I have never considered it a Conspiracy at all. What I did, say however, is that whenever you change the excipients of any medication, you very likely Will get some people who do not metabolize it. And that spells trouble.

Now, if you are genuinely interested in engaging ina more in depth look into this subject where we could both learn something then please e-mail me and we will discuss privately so that Dr, Bob does not have to be the Matador. Agreed?

Spotcheck:

Dr. Bob, I apologize in advance if you think the tone of this post is too antagonistic. It is my intention to explain something important to this individual in particular and also to drive home with an example that would create this effect him him/her. Chastise me if you must.

djmmm:

-LOL..don't worry, no offense taken here..and that's what matters, right?

Absolutely! All I wish to do is better explain myself to you. Kindly contact me and we can do exactly that!


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URL: http://www.dr-bob.org/babble/20040412/msgs/336164.html