Posted by chemist on May 14, 2005, at 5:47:38
In reply to Re: .... » chemist, posted by Chairman_MAO on May 12, 2005, at 20:43:54
hello there, apologies for the delay in getting back...my post was in response - if that is the correct word - to what the orignial post claimed and/or promoted...your post (specifically) was, unfortunately, the victim of my almost invariant habit of simply replying to a thread and clicking both the ``notify me..'' and ``include name of previous poster'' buttons: your post as i note does point to the company, and no others, as being the entity to point a finger, should one feel the need.
the issue of the labeling remains a mystery to me, and is not something that is available - in my search - through the regulatory channels that emanate from the FDA via the web. and i was addressing the mysterious and non-communicative recently-enrolled PB poster who initiated the thread, in a general sense: i also admit to being more than a little guilty of being biased towards addressing with vigor posts such as the original.
whether or not the FDA, another party (public or private), or other force is involved with the marketing of this drug for a particular reason is not a question i can answer, nor does it appear to be easily (if at all) found within the resources to be disseminated to the public via the government or (and i did check, only to uncover press releases and not much else) the companies involved in making, marketing, distributing, and profiting from emsam if/when it makes it to market.
that selegiline - regardless of how it is administered - is a type B MAO inhibitor in the 5 to 20 mg dosing regime, and a selective dopamine uptake inhibitor in higher doses in not subject to much more debate, in my opinion. the route of delivery - transdermal - should bypass the gastic circuitry as reported, within reason. the literature contains studies that indicate that the tyramine reaction(s) are scant or rare: however, these reactions have occurred.
the original post leans more than a little in the direction of ``a wonderful drug is being held from the needy and because i can only glean information from the financial departments of the pharmaceutical companies involved - and not the scientific arms - there is obviously something amiss.''
unfortunately, the first response to the post - from Chairman_MAO - includes the phrase that ``I am utterly convinced that big pharma has its hand in this labelling fiasco,'' and is followed by the prediction that *if* EmSam is introduced to the marketplace without the labeling which would otherwise send the drug into ``MAOI oblivion,'' then EmSam will ``utterly decimate most antidepressants on the market today.'' the drugs to be decimated are named as ``SSRIs, etc.'' the conclusion that large pharmaceutical companies that produce any antidepressant - and market it - are not uninvolved in the delay of EmSam to market is unavoidable, whether meant that way or not. singling out Wellbutrin as a medication for which there would be no use to those who cannot take it - because of overactivation - if EmSam was available (a ``better drug that produces a more savory effect'') does bolster the original post.
there is no evidence that the drug will/will not decimate the SSRI (or other) antidepressant market, nor is there any evidence to support or prove false any claim a distribution partership with BMS is anything other that a business arrangement. the original poster claims that BMS is involved for reasons that include the perceived might that it has in pushing drugs to market which are otherwise held in limbo at the FDA: while one can easily and correctly note that i cannot prove that this is not the case, i can - as well as any other person - easily prove that the employees of the pharmaceutical companies (specifically, those in the ``investment'' portions) are not disclosing inside information. i made some calls of my own, and as a person with no ties to any of the numerous parties involved with EmSam, i failed to reach the sections of Mylan, Somerset, Watson, and BMS where a person in the ``investment department'' - a fictional designation, by the way, at all companies involved - would provide to me information concerning exactly why there was a delay in EmSam being marketed and, further, the role of including BMS for reasons other than a large distribution/marketing partner.
all the best, chemist
> Oh, I certainly never claimed that Somerset was any different from any other pharmaceutical company; I always thought their pricing for Eldepryl was usurous. I am also confused; was most of your post re: my post actually in response to the original poster, or what I wrote?
>
> What I was getting at specifically was labelling for the patch, not the tabs/caps. Certainly there should be SOME kind of warning about the POSSIBILITY of a tyramine reaction, but as I understand it the FDA wanted to put labelling on it indicating a tyramine RESTRICTION was necessary, a la irreversible, nonselective MAOIs.
>
> Am I correct about this? I was kinda confused about what you were saying specifically to me or in response to what I wrote, and what you were writing to someone else/the board on a whole. :)
poster:chemist
thread:496583
URL: http://www.dr-bob.org/babble/20050510/msgs/497641.html