CIGX_VIPGROUP posting:
"From: CIGX_VIPGROUP@yahoogroups.com [mailto:CIGX_VIPGROUP@yahoogroups.com]
Sent: Thursday, November 20, 2014 3:51 AM
To: CIGX_VIPGROUP@yahoogroups.com
Subject: [CIGX_VIPGROUP] Some explanation about how we got where we are re anatabine
I received an email recently from "one of us" seeking comment on the subject (see it below) broached. I am going to publish our interaction because I am sure many are thinking about the same things, and because my last answer may be my most complete and concise summary of what has "gone before" with regard to the ins, outs, ups, and downs of anatabine citrate/CigRx/Anatabloc to now (by me). To be sure, all bases are not covered and it is rather compact, but perhaps helpful.
===== [email to me]
As the remaining supply of A-bloc dries up on the free market, and
people that have benefited from its use begin a new phase of
life without it, would it make sense for all of us to begin
a writing campaign to the FDA expressing our Need for this
product to sustain a standard of health we enjoyed while
having access to the product?
When the FDA declined the initial approval of Belviq (a weight loss
drug by ARNA), the decision making board was
swayed/influenced by inaccurate information from someone on
the board who many felt was being bought off by ARNA's
competitors. The long and short of it was the FDA
subsequently received a high volume of emails and letters
addressing the wrong they were committing. Once the
truth was revealed, the FDA ultimately approved the
product.
Would a voluntary writing campaign to the FDA from thousands of
satisfied Users of A-bloc be beneficial? Is this
something that could be coordinated through a Facebook
account that provides the name(s) and address(es) of the
person/people, at the FDA to contact? Or, would a
repeated message on the "clown board" containing
whomever to contact at the FDA suffice?
I think the FDA would have their eyes opened regarding the
beneficial impact this "drug" has provided so many
people, and again, with no side effects. If nothing
else, it may expedite their decision making process to get
this product back out to the market once the legal hurdles
have been covered.
I would gladly send a couple emails each week until the product was
made available again, but am not sure who to contact.
Is it possible RCPI could inform us who they are
working with at the FDA? Would a writing campaign of
testimonies antagonize the FDA and have a negative
impact?
===== [I reply]
14 11 17
.... I'll try to do this more justice when I finish my current effort along these same lines (as I have said, in the "private group"), writing to the company with suggestions (about done, I hope). Well, looks like I may have said most of what I have to say about it.
I presume you realize the difference here between something like ARNA's and RCPI's positions. ARNA had sought approval of a drug through usual channels and FDA decided against it at first go-round. RCPI's supplement was offered for sale, and so done, according to FDA's reckoning, without proper preliminaries taken care of vis a vis FDA. The supplements were NOT taken off the market by any FDA action, but voluntarily by the company (admittedly in part in reaction to a "warning" by FDA).
In light of all that has gone before, I feel sure the FDA would take a "baffled" stance, right or wrong, in response to a public clamor [for its "return"] because they were not directly responsible for the removal, and because they of course believe their interpretation of law and rules (DSHEA, etc.) is the correct one (and therefore the supplements cannot be marketed legally, now ... explnation below).
Even in recognition of that, I must say that concise, carefully worded communications to them as to the need for the availability of an anatabine citrate (AC hereinafter) product of any kind for the continued improved health of the thousands who have found relief may still be in order.
Unfortunately, I feel that part of the problem in such reports is the incredible wide range of disease (in the broadest sense) that AC treats. I doubt the FDA has any idea that it is literally dealing with, here, the new ... AND IMPROVED ... "aspirin" (from only the consumer's perspective) ... without side effects in most, and with much wider and stronger effect in those who suffer a particular (NF-kB-connected) malady or maladies. PLUS it decreases the appetite for smoking, drugs, and even food for many. PLUS it may treat Alzheimer's and TBI ... and MS and other major disease bugaboos in many. [addendum: PLUS it may be preventive in cases of Alzheimer's, TBI, and perhaps many other brain maladies, and there is even more.]
I wrote a VERY long and detailed letter to FDA last February covering some 24 points, with a paragraph or more about each, in regard to their warning letter, AC, and its impact on the public. When I was done, with regard to my reports of efficacy and public need, I thought to myself that "they're going to think I'm crazy" ... but I sent it anyway (to the agency division that sent the warning letter, their address obtainable from that source).
From that perspective I sometimes think we could hardly blame FDA or anyone else for thinking we are all a bit loony.
I am very split as to thoughts about the usefulness of such communications [addendum: as writing campaigns by many individuals, re need], but one side of me does believe that the more they hear of it treating a particular malady(s) in someone, specifically LONG TERM, CONTINUOUSLY, AND WITHOUT SIDE EFFECTS, the better. In such communications, were I to make them, I would emphasize those three points together, and state that there is nothing else like it on the market in any form, whether drug, supplement, or whatever, and that there is a need for FDA to work with any company willing to try to advance the usefulness and availability of this healing substance, anatabine citrate, to the public in any form, be it supplement, drug, or whatever. Emphasize that this is a safe, highly effective in many, substance that solves, for those many, major issues of illness and productivity and quality of life.
It is heartening always to hear from people thinking so hard and so well in trying to tackle this vexing problem. Your thoughts are appreciated.
===== [email reply to me, in part]
... I guess I was under the impression the FDA more or less forced RCPI into shutting down A-bloc.
===== [I reply]
Well, yes and no, re "forced". IF RCPI didn't want or need the drug path right now I am sure they would continue with selling the supplements and arguing with FDA [over law and rules and requirements]. There is a good argument that the "required" prior-to-market (supplement) notification called an NDIN (new dietary ingredient notification) was not required for anatabine, despite FDA's "take" on the rules.
However, under that circumstance, [addendum: assuming continuing supplement sales, & argument with FDA] the FDA could have tried to force RCPI's hand at any moment with a court action to stop the supp. sales.
Then it is possible, and perhaps (but ???) likely, that RCPI COULD have obtained a stay of an FDA order to stop sales while the argument dragged out in court, probably for years (yet that "stay" would NOT have been guaranteed, and a sudden halt in supplement sales by FDA action in court may well have ensued anyway).
The co. tried, in an attempt to "cover all bases", to submit a belated "NDIN" in June [of 2014] (the NDIN was, according to FDA's take on things, necessary 75 days PRIOR TO FIRST supplement sales, FOUR YEARS earlier, prior to first CigRx sales [in June of 2010]). I am sure that this was just "a trial balloon" to see what FDA's reaction would be.
As stated in the recent publicity this early fall (and in 10-Q) from RCPI, the FDA's answer pretty much "sewed the matter up" regarding supplement sales, because RCPI DOES VERY MUCH need the drug path now (the 'BIG DEAL" of all this), and thus needs FDA's cooperation in that effort.
[addendum: this paragraph re-written]
FDA said that an IND application [addendum: an application for designating anatabine citrate as an "Investigational New Drug"] that had been filed in 2011, one that long predated the June 2014 belated NDIN effort, meant that the belated NDIN effort had to fail (anyway, even not considering that it was years late).
That is because the rules DO state that one cannot use something as an ingredient for a supplement for which an IND has been filed prior to submitting an NDIN &/or or marketing of the supplement.
An IND application is a measure that, properly, protects drug firms in the development stages of a drug, insuring that someone doesn't decide to "jump the gun" on their expensive effort, having learned of the compound from the IND filing, by putting the same substance in a supplement first. There are other purposes for such also, such as filing one to protect one's interests if trying a new substance, such as anatabine citrate, in a clinical trial, such as the one Mullan announced in 2011 for anatabine in Alzheimer's.
Incidentally, I believe but I cannot be certain (because FDA does not reveal sources of IND apps.) that that 2011 IND app. was made by Dr. Mullan himself, to (be able to legally) do the Alz trial at Roskamp Institute.
FDA said that the prior 2011 IND app. (? by Dr. Mullan himself, for the Alz trial, to make it legal and legit?) meant that from that time (2011), with regard to supplement use, FDA must consider anatabine citrate (AC hereinafter) a new drug.
So would FDA given Star the OK to continue supplement sales in light of the four-year-late NDIN "were it not for" that 2011 IND? I very seriously doubt that.
Even so, it COULD STILL be argued by RCPI (now) that the sale of sale of AC in a supplement before the IND was filed (in CigRx, 2010) meant it was OK to use in a supplement, and that argument would be airtight ... IF Star had filed the NDIN in 2010, 75 days prior to CigRx sales (in June of 2010) (assuming FDA did not object within the 75 day period).
However, Star (at the time) did NOT do so, not because of oversight (I believe and presume), but because (apparently, my "educated guess") doing so would likely have raised OTHER objections to the supplements, that FDA has not even mentioned yet ... had the NDIN been (timely) filed.
For example the matter of the need for the anatabine citrate (AC) to be SYNTHETIC in Star's supplement use. FDA apparently does NOT accept (in addition to other objections) "bio-equivalence", meaning substituting a synthetically derived substance to use in a supplement which is substituted for "the same ("real") thing" derived naturally, by extraction.
Star/RCPI uses, and must use, synthetically derived AC instead of a natural extracted compound in the supplements. Although it appears that RCPI MAY be able to use such natural extraction, from tobacco if desired, in a DRUG form if cheaper, the FDA prohibits using anything derived from tobacco in supplements.
That ("bioequivalence") is ANOTHER court argument that waits to rage over supplement formulation (a big and long standing argument between FDA and the whole supplement industry). Star HAD to use synthetically derived AC because the only fiscally feasible source in nature for extraction is tobacco, and NOTHING (mere prejudice of long standing, by law) from tobacco can be used in a supplement (but obviously, vis a vis nicotine replacement products, tobacco derivatives CAN be a drug).
SOOOoooo, this year, for RCPI, it boiled down to, do we (RCPI) continue the supplement route (as was decided by the previous management) and hang on, knowing that at any moment FDA could move to shut down our whole business plan, even while we argue the matter in court (for years, no guarantee of winning), or do we just wave the white flag, and take the KNOWN legit route, WITH FDA cooperation, by developing this as a drug now, thankful that the supplement experience/"experiment" provided so much positive feedback as to the likelihood of success of such an effort. Our new management, wisely I must think, took the latter path.
That's the briefest explanation of all this I've ever done, and I've left some information hanging (and missing) ... and I think it's easy to see why few have much understanding at all as to just what has "gone on", with regard to all this, in the last 4 years. It IS EXTREMELY COMPLEX (or so would I say). .....
Just keeping "NDIN" and "IND" straight is a mind bender!
And so the notion of whether or not FDA "forced" Star/RCPI to stop supplement sales, or whether circumstance (law/DSHEA, rules, and FDA's arguable take on them, and RCPI's NEED for anatabine citrate drug development now) and past decisions by Star did, is definitely one, I think, that depends on the "eye of", the perspective of, "the beholder"."
