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.... » Chairman_MAO

Posted by chemist on May 12, 2005, at 11:56:42

In reply to Re: History of emsam as I know it » yldouglas, posted by Chairman_MAO on May 11, 2005, at 20:16:03

hello there, chemist here...apparently we were penning responses at the same time, and i did not come across your take until now....big pharma does, as you assert, have a very big hand in the labeling fiasco in this case, although as emsam is not approved the fiasco is more pointedly directed at the capsule and tablet formulations (brand name Eldepryl) marketed by Somerset...this is all academic, however, as it is not just slightly entertaining that a new PB post is presenting nothing more than an advertisement for emsam: it is misleading and worse, some readers will actually believe what is stated.

having an intact relationship with a pharmaceutical company, i have (perhaps) a bit of an eye for nonsense given the one-way, lifelong, and ironclad non-disclosure and non-competition paperwork that places all liability on the employee should they divulge any information that could lead to a competitor gaining a financial edge.

i am not allowed to discuss the names and positions of the people i have worked with and any specifics beyond what one can glean from their website, and this is the tip of the iceberg. i can assure you that the money handlers at BMS and any other well-capitalized company are just as ignorant of what is happening in the labs as the scientists are about finances.

the securities fraud and industrial espionage aspects are real; the story related in this thread is an impossibility or a matter that should be pursued by the companies, the SEC, and the FDA (my request for communication is to increase my net worth, as i want access to the inside information!), and is (from a scientific point) quite inaccurate.

further, although the search engine is hardly known to turn up the proper goods at the outset, a simple google search will reveal all the information presented in the post, with the exception that the details posted at mylan, watson, bms, and somerset appear to contain actual and accurate information.

i suggest a jaunt to the FDA site, particularly

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

which is easily reached (CDER Archives) from www.fda.gov. there, you can actually locate the drug Eldepryl, and learn about the NDA/ANDA/BLA business (and other meaningful acronyms), and make an informed decision.

once one arrives at the governing body for drug regulation in the u.s., you can download the PDF dated (action date, meaning date of action of - here - approval of the labeling change) august 6, 1997. it is free for the downloading, and one can see - if they have not bothered to do so yet are quick to point a finger at the big pharmas (Somerset is hardly one of them) - that the correspondence chain clearly shows that Somerset dragged their feet for 7.5 months, followed by another 8 months to include very bland, sparse, and important wording requested by the FDA in the interest of better informing physicians and patients.

first and foremost, the emsam patch is not approved, nor is the approvable letter an easy find - the best i can determine is that through the entire FDA web domain, a search with the word emsam yielded 11 hits, and several appear to concern canine tooth heath (yes, really).

eldepryl - in the labeling revision documents - is treated very fairly, if one takes the time to read the official, scanned, and posted letters and data. i refer you to page 7 of the document, where an adverse interaction between selegiline and ephedrine; and two hypertensive ``cheese reactions'' at 5 mg p.o. b.i.d. selegeline taken with tyramine-rich foods had been reported.

the FDA requested that Somerset make a labeling change to indicate that there is a risk of such reactions on may 15, 1996. Somerset took their time and replied to the FDA on January 2, 1997 that the changes were made in the Warnings, Information for Patients, and Precautions sections of the labeling information. the FDA sent two letters and instigated one teleconference over the 7.5 months it took the drug company to add (literally) a few sentences to a package insert. a miscommunication (the words of the FDA) was blamed for Somerset not including this information in the Clinical Pharmacology section - a very nice gesture on the part of the FDA, by the way - and the FDA requested that Somerset complete the challenging task of penning less than one paragraph indicating that 3 people who were arguably pushing the envelope are the sum total of the cohort who have experienced serious complications. 3 people - one who took ephedrine and two who might have been predisposed to any hint of a ``cheese reaction'' - is not a number that is likely to have impacted sales.

the wording in the new label changes - which was apparently very difficult for Somerset to implement, and even then, the ``miscommunication'' caused a further 8-month delay - is strongly worded in regards to the small number of patients (3) reporting adverse effects, that reactions such as these are rare at low doses but can become more of a risk with higher doses, and that 3 cases are not conclusive or indicative of the safety of the medication yet Somerset feels it is prudent to mention it anyway (this is, of course, not true, as the process took an excruciating 15 months: the FDA insisted).

so, do indeed blame the pharma, who would just as soon not mention any adverse effects at all, if their sluggish response to a directive that is in the best interest of the health of the patients as well as in the self-interest of diverting liability from Somerset is any indication...

the next question is: what would one prefer? that a request made to add a watered-down and cautious addition to a label not be honored, or that the manufacturer of the medication reveal even a small number of adverse effects - actually, an almost unheard of small number of adverse effects - that are in the best interest of those taking the medication?

and the tyramine (or some other) interaction is bound to occur in at least one patient: common sense and for many of us personal experience indicate that even the ``safest'' medication will adversely effect at least a very small number of patients.

the claim that only persons involved in the financial sections of the pharmaceutical companies have provided information concerning emsam - especially information way out of their collective area of expertise and to a stranger, no less, who contacted these parties and found that they were willing to hand out company secrets - is beyond absurd. thus, i eagerly await contact from this poster so i can better position myself with my broker for the day that the letter of approval comes through - if it comes through.

yes, big pharma was in fact behind this fiasco, and given the poor record Somerset has shown in the instance detailed above, why would any person who is aware of the 15 months they took to add information that is useful to patients, doctors, and the company even begin to consider the next offering?

*** note: i am not associated with a competing interest of any of the companies involved in marketing the drug(s) discussed herein. my comments concerning inside information are in jest (those pertaining to building my cash reserves, the rest are not in jest) and i do not have investments in any of the companies mentioned here. my comments are speculative, intended to inform any person who cares to read or heed what i have written, and point out - as chairman MAO has - that the pharmas are indeed to blame in this case, as it is more than clear that the FDA was taking the high road while Somerset did little or nothing to disclose what was requested. ****

all the best, chemist


> I am thoroughly convinced that big pharma has its hand in this labelling fiasco. If there's no tyramine restriction, EmSam will utterly decimate most antidepressants on the market today; it simply would feel much better for many people than SSRIs, etc. It's simply a better drug that produces a more savory effect. There would be virtually no reason that anyone who could tolerate activating meds, such as Wellbutrin, would want to take it when they could take EmSam.
>
> With the tyramine restriction, they'll be able to pigeonhole it into "MAOI oblivion" which orthodox year-2005 psychiatry seems to consider more dangerous than swimming in the river styx.
>
> "Babylon system is the vampire, sucking the blood of the sufferers."
>
> --Bob Marley


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URL: http://www.dr-bob.org/babble/20050510/msgs/496864.html