(paxil)paroxetine Hcl Discrepencies

GENERATION SAVED INC
28 pilgrim lane
willing boro nj,08046

with respects to the 6,145 published total (advertisement) the numbers do not add up. 1.) because: what is meant by pre-marketing assessment and pre-marketing "clinical trials".........I am asking because, by definition, I thought the above two categories are the same. for it is only when you get to the controlled trials, as they results are observed, then, I believed that is the difference begin. my difficulty with that is the difference does not exist. why do I say that? becauser they are both premarket
2.) as per the for the 542, 469, 522 and 735, which adds up to 2,268 and not 6,145, as stated in the controlled trials, and incorrectly stated in the pre-marketing assessment, This is an absolute discrepancy, which is absurd.
This precedent variable throws off all credibility for the controlled trial(s) numbers as well.

Under precautions, the ad states by "officially" confirming that "There is no evidence of mutagenicity with Paxil."
Now, I want to start by saying, c'mon people, did the lab techs or whomever type of managerial authority validating the proofread that was done for the ad to be posted even realized what was written right before that sentence. I'll

and then the ad says that "the clinical significance of these findings is unknown." I mean, what kind of ninety-nine cent clinical operations were those. because, going back to basics, In general biology II, better known as "the cell" [and even in Anatomy and physiology, or even in a simple course like human structure and functions] I could have sworn the professor, the lab instructor, and the text defined cancers as mutagenic occurances, along the gene lines neighborhood for that locale. And so you do not even welcome the potential (and not to mention the probable) whims that these same mutations may serve as triggers and catalysts to some of those same observed occurences, such as with the neuronal firings of the neuronal synapses, as was observed for occurences in the nervous systems? Now maybe you may want to correct me as to what the definition of mutagenicity means again. because, affirming or even indirectly asserting reticulum cell sarcomas, and Lymphoreticular tumors [...as with the male rats] are not "...evidence of mutagenicity..." is not only ninety-nince cent work, heck I wouldn't even give it thirty-nine cent or even nine cent, as a medical research student. And I'd reconsider giving it even point nine (.9) cents worth of lab trials value. I mean THIS IS A SHAM!!

3) As a(n) mention (sort of a 'passing-by'): how come libido decrease was observed as a(n) social anxiety observance, as well as a(n) panic and 'gad' disorder observance in the incidence trials for the commonly observed controlled adverse effects, and you did put it for the 6-week placebo controlled trials (which are supposedly the same succeeding trials in that in one you do not let the participant know and in the other you don't--respectively ) but not in the non-placebo controlled trials incidences. because there under under the 6-week placebo, and still under controlled trials, lo and behold there it is. Because, your lab techs should know, unless this is orchestrated, ['cause after all you know (the 'money' is obviously good)] that theirs and the managerial authority in overseeing clincal trials all know that their justifications of the ad-published 20 to 50 mg/day nor that 1% stated frequency are significant variables. Now, do you want to know how I knew that (smile!)

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they were both of

and they were of about the same frequency. So, all I am saying is if you're gonna do it and cater to a certain market or even to the general, at the least and just because... do it RIGHT!! even if for the sake of money. THIS IS CRAZY....I CAN'T BELIEVE I AM SEEING THIS!
Even more frightening, in giving the consumer the "what to expected list" as far as what to expect [Ok, I'll spell it out] as you call 'em "the observed events" YOU DO NOT EVEN CONSIDER GIVING THEM ALL (not to mention any outstanding) POTENTIALS AND PROBABLES. Those such as the basis of your approach which in fact lies in the 'integrated application of four [basic] elements: the stimulus control, the constant's management (here being the behaviors), the contigency management and self-monitoring, as these are supposed to be [required] standards in result reporting anyway. anyway I am done, you people just better go back to the lab...I am deadly serious, [no pun intended] on the consumers now!!!

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very cordially yours,

business cheif C.O/Manager
[one]..satan it's your time{time up pal}

 

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i am so sick of big, major-monoply drug companies. they make me want to spit. i also think that the U.S. should adopt socialized medicine, even at the chagrin of all the uppity doctors.

 

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AGREED

they will all pay!!

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I get kind of sick of people complaining about drug companies. Do you all realize that it costs hundreds of millions of dollars to develop a new drug? Not to mention the unimaginably vast quantities of money that the drug companies waste every year trying to develop drugs that eventually prove to be unsuccessful. The drug companies have to charge a lot for their products if they're going to stay in business. People in the United States like to complain about how much cheaper drugs are in Canada, but they don't seem to realize that if all governments imposed price ceilings on drugs like Canada does, there would very soon be no new drugs because no drug company would want to invest huge amounts of money in research that they could never make a profit off of.

Guess what: if a product requires years of work by highly trained scientists with supercomputers and ultra-modern lab equipment, it's going to be expensive. This is especially true for products like drugs, where relatively few people will be using any given product. If you invest $500 million to develop a new type of computer chip, you can be sure that sooner or later most everyone will be using it; this isn't the case with drugs, where at any given time there might only be a few hundred thousand people who will buy your product.

 

NASOR

Now, before I begin, I thought about writing a little short-story novel again, [obviously as with last night] but you know, I reconsidered

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so instead of torturing anyone else again, here is the response to your dissertation there (without further adue) the one (1) and only point to discuss (or point of discussion) is as follows:

P.1) This is to ASSERT and REAFFIRM that this was not a complaint, but a hopeful appeall to and/or for a localization and movement towards RE-EVALUATING the lab or clinical (if you will) results of the already ongoing effort by Smithkline-Beecham to improve this drug. (NOW BEFORE I CONTINUE, HERE IS THE ACTUAL [AND 'ACTUAL' IS STRESSED HERE] 'SMOKING GUN'.) One of the JAMA 2001 issues (if not all of them, and maybe for probably as long as SB had the slot for the Ad), which have the Paxil demographics inside, for the rights of consumers [you know...as required by federal laws], have more than enough new improvements (over the course of the recent publishings) as per the results of the observations--that of the observed effects, that is, to prove the point I am making, so that we can move on with life ('cause you do remember, it's short you know [and not to mention as these drugs, like Paxil, are making it shorter].
I read your response, and with all due respects, (and don't feel offended now), but by the time I got to your third sentence, I shockingly, not to mention mysteriously, found my mind rudely wandering off in a halucengenic mode of loud echoes of the word 'Duhhhh'! because, I mean, I truly believe you missed the whole and total gist of it, again, no offense!
I do totally recognize and realize your point on the pricing and the privilige to make money, to put plain, AND WOULD NEVER [as they say] "KNOCK A MAN'S HUSSLE." I am ALL for the "Rugged Individualism" type of capitalistic system aspects of it--that of the

(you mentioned in your comments) as this is a provisional clause that are the very rules and regs addressing these provisions that our Commerce & Trade laws already provides. For if it weren't so This country would actually be a regulated 'Capitalist' system and not a free one, that sometimes I think it may not be.
But in closing, I wish for YOU to REALIZE AND RECOGNIZE that:

THIS IS NOT A TALK OF EXERCISING CAPITALISM
plainly put, "about money' because, my faithful listener, (and here is where you need to read the Ad too.

this is about QUALITY CONTROL/QUALITY ASSURANCE!
The End!

p.s. and that's all it is my man, that's all it was and that's all it ever was. Because, simply reading the observed effects on both controlled trials as well as that for placebo, AND uncontrolled trials, as such with "the premarketing assessment" and "premarking Clinical trials

 

I was responding to pumpkinsaren'torange's post about 'big dug companies,' 'uppity doctors,' and socializing medicine. I suppose I should have made that more clear by quoting his post at the beginning of my post, but I thought that it would be obvious. My mistake. In any case, I wasn't trying to hijack your thread or dispute whatever it is that you are claiming about drug quality control.

 

yeah...and, that's ANOTHER thing!

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What are you saying? Are you angry that developing drugs in expensive?

 

truly, it need not be THAT expensive to do the research, i do believe you understand that logic. also, and, this is just my opinion, i believe that the drug companies are a major monopoly ..i also believe that they could have had a cure for cancer and few other diseases years ago. but, think about it...if they provided all the patients with a cure for cancer, they wouldn't make all the billions of dollars off of the patients anymore..think of all the money they'd be losing.

 

Guess what: if creating a product requires years of work by highly trained scientists with supercomputers and ultra-modern lab equipment, it's going to be expensive. I guess you missed that last time.

This is a common paranoid fantasy. I suppose you also think that the oil companies are suppressing car engines that run off water.

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I have no problem with companies trying to make money ...that's why they're in business . Socialized medicine is not condusive to quality care , innovative advancement of related medical technologies and medications . It (socialized medicine) would lead to stagnation... for it would displace incentive .

However , I do think that presently some pharmaceutical companies have a overwhelming detrimental effect on patient health , curriculum at universities and doctor methodologies . A very similar example would be like , outright bribery existing in politics . Money and carreer advancement sways most people . Doctors are not immune for monetary inducements .
For a profession that has the lives of their clients in their very hands ....this is unacceptable and enethical .

Paxil has been shown to be both ineffective and only marginally effective in studies that included placebos .
One thing that is not disputed is that Paxil ( as other ssri's ) can have serious adverse effects , like anxiety , Hypertension, emotional lability , vertigo , cerebral anemia , concentration impairment , acne , Nausea and vomiting , ...kind of depressing , eh ?

 

:
*** pardon me, but i never said it WASN'T going to be expensive, it's just that it doesn't HAVE to be as expensive and out-of-hand as it's getting. fyi: a lot of that "expense" is getting pocketed in various underhanded ways. i suppose you'll deny that, too. i may be "paranoid", but, you're in denial.

rather, i call it a healthy dose of skepticism, and, i'm not the only one who holds that regard in the science field.

**naw, everyone knows it's the car corporations that are suppressing the builiding/adapting of an auto's engine with the powers to run on pure h20.

 

>> with respects to the 6,145 published total (advertisement)
>> the numbers do not add up. . .
>> as per the for the 542, 469, 522 and 735, which adds up
>> to 2,268 and not 6,145, as stated in the controlled trials,
>> and incorrectly stated in the pre-marketing assessment,
>> This is an absolute discrepancy, which is absurd.

The Prescribing Information for Paxil states that the numbers 542, 469, 522, 735, and 676 are each individual trials for OCD, panic disorder, social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder, respectively. It also states that some groups are "in overlapping categories". This means that
1) a + b + c + d + e will not give you a total number of trial participants, and

2) not all patients that participated in a clinical trial are included in the summary. Open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, and fixed-dose and titration studies were all included in the Phase II and Phase III clinical trials for Paxil, while typically the results for only controlled or double-blind studies (depending on the drug) are shown in the summary.

>> Under precautions, the ad states by "officially" confirming
>> that "There is no evidence of mutagenicity with Paxil." . . .
>> even realized what was written right before that sentence.

What was written right before that sentence?


>> then the ad says that "the clinical significance of these
>> findings is unknown." . . . defined cancers as mutagenic
>> occurances, along the gene lines neighborhood for that
>> locale. And so you do not even welcome the potential (and
>> not to mention the probable) whims that these same
>> mutations may serve as triggers and catalysts to some of
>> those same observed occurences . . . Now maybe you may
>> want to correct me as to what the definition of mutagenicity
>> means again. because, affirming or even indirectly asserting
>> reticulum cell sarcomas, and Lymphoreticular tumors [...as
>> with the male rats] are not "...evidence of mutagenicity..."

If you are getting at what I think you are getting at, you are stating that 2 different types of cancerous growth appeared, while the ad says "there is no evidence of mutagenicity". This could mean that, thought the cancers were there, they did not appear in an abnormal proportion in a controlled clinical trial. If they occured at the same rate in the control group and the expiremental group, then the findings are inconclusive.


>> 3) As a(n) mention (sort of a 'passing-by'): how come libido
>> decrease was observed as a(n) social anxiety observance,
>> as well as a(n) panic and 'gad' disorder observance in the
>> incidence trials for the commonly observed controlled
>> adverse effects . . .

I have no idea what you are talking about here. I am having trouble decphering sentences without sentence structure, punctuation, or capitalization. Maybe you can fill me in.

 

I, too, would like some clarification...

 

Glad I'm not the only one. /g/

 

ACTUALLY, I DONNO WHAT YOU'RE TALKING ABOUT

HEY what the hell do that mean 'bout your statement

first of all you lost me.
second of all, you didn't read...
third and last (but not the least) that wasn't stated man, that's bull shit!
in your second comment where u said

and etc.., you know what the hell you said!
'cause i'll have u know that, that was the discrepancy #1 (being one of the main reasons why I decided to spend precious time addressing in pointing it out.

- 'bout ur question asking "what was written before that sentence?"

I was refering to the fact that the ad mentioned two different sarcomas observed [of which the last time I checked sarcomas were supposed to be cancerous type of occurences]
and to make it worst for you [in showing everyone, yourself the first] how you wasted your time in even consdering responding to me, you help me in making my point by shooting yourself down.
read what u said again, and let me do the honours... [here] I'll quote it for you

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?
~ Now, what hell was,
or even better... [hell] let me rephrase....
WHAT IN THE CLEAR BLUE..... DO YOU THINK YOU WERE DOING?:m: Now, I know u weren't smoking it...'cause it should have made 'ya more clear minded.
I mean, lets do it again... and PLEASE, listen to what u said...[let me highlight]
u actually said that though the cancers were there!
they did not appear in an abnormal proportion...
I mean, what the hell.....man!
it is an observance, it should not have made a difference whether it controlled observation, abnormal....[or even normal :bugeye:
for that matter.
look anyway, that was just confusing man, and I do not know who the hell u are, telling me a professional, "oh, here's where I went wrong... or misunderstood, or whatever other shit like that.

 

Re: ACTUALLY, I DONNO WHAT YOU'RE TALKING ABOUT

>> second of all, you didn't read...

Maybe if you could construct even a semi-coherent sentence, I would be able to understand you a bit better.

>> third and last (but not the least) that wasn't stated man,
>> that's bull shit! in your second comment where u said
>> and etc.., you know what the hell you said!
>> 'cause i'll have u know that, that was the discrepancy #1
>> (being one of the main reasons why I decided to spend
>> precious time addressing in pointing it out.

You said, "the 542, 469, 522 and 735, which adds up to 2,268 and not 6,145, as stated in the controlled trials, and incorrectly stated in the pre-marketing assessment, This is an absolute discrepancy, which is absurd." I pointed out that not all of the clinical trial participants are included in the summary and, therefore, aren't included in the advertisement. There is no discrepancy.

>> I was refering to the fact that the ad mentioned two
>> different sarcomas observed [of which the last time I
>> checked sarcomas were supposed to be cancerous type
>> of occurences] I mean, lets do it again... and PLEASE,
>> listen to what u said...[let me highlight] u actually said
>> that though the cancers were there! they did not appear
>> in an abnormal proportion... I mean, what the hell.....
>>man! it is an observance, it should not have made a
>> difference whether it controlled observation, abnormal....
>> [or even normal for that matter.

Let me dumb it down a bit. By stating that the malignancies did not occur in an abnormal proportion, I mean that [for example] 2 of the patients in the control group developed some type of cancer, while 2 of the patients in the experimental group developed some type of cancer. Since the cancer did not appear in the experimental group in a higher proportion than it appeared in the control group, we cannot tell if paroxetine did or did not cause or contribute to the cancer growth. Since the findings are inconclusive, this must be stated in the trial summary.


>> and to make it worst for you [in showing everyone,
>> yourself the first] how you wasted your time in even
>> consdering responding to me, you help me in making my
>> point by shooting yourself down.

Shot myself down, huh?

>> I do not know who the hell u are, telling me a professional,
>> "oh, here's where I went wrong... or misunderstood, or
>> whatever other shit like that.

First of all, if you were actually a clinical studies/ pharmaceutical/ medical professional, you would have clearly understood my original statements.

Second of all, you DID make you original post on a forum, and a scientific one at that. This means that your statements are open to correction and/or debate.

 

>> truly, it need not be THAT expensive to do the research

Research is becoming dramatically more expensive because of huch higher FDA standards than years past. Now the FDA even regulates the number of trial participants for paticular classes of pharmaceuticals, while 50 years ago clinical trials weren't even mandatory.

The smallpox vaccine is a perfect example of improved drug safety. As everyone knows, it was administered widely 30 years ago. So what is the problem now? The problem is that it kills 2-3 out of every 1,000,000 people, and causes severe, sometimes irreversable, adverse effects to about 35 others out of the same 1,000,000 people.

If one of the vaccines that we still use today, for example, the MMR vaccine (Measles, Mumps, Rubella), had the same occurance of adverse effects or death as the smallpox vaccine, it would never recieve FDA approval. At that rate, it probably wouldn't even have recieved FDA approval in the early 1980's. Our current standards are much, much higher than they ever were, and our nearly doubled average life expectancy (since 1900) is proof that these higher standards are improving the general health of the population.

 

PAY ATTETION

LOOK MAN,
I gonna stop all this babbling wit you, Ok, 'cause u ain't saying nothing. and if I pay attention to what ur saying we're just gonna back and forth.
with all those discrepancies [and in the ad too] to make it worse, (and God forbid if I had read the actual final reports), I demand that smithkline beecham pull that shit off the market--to the people that they're selling too. because, even in something as simple as an unproportionate/abnormal occurence with those 4 cases, (both with the 2 controlled and 2 in the experimental) it proves that this is a sham, SB can't make money like that. keep it real, not on others' expense, not to mention they dying as it is.

 

Re: PAY ATTETION

>> because, even in something as simple as an
>> unproportionate/abnormal occurence with those 4 cases,
>> (both with the 2 controlled and 2 in the experimental) it
>> proves that this is a sham, SB can't make money like that.

By stating that there were 4 patients in which malignancies occured, I was merely providing an example. Actually, there were no patients, not a single one, that experienced any type of cancer during the trials, or since the drug has been on the market. The cancer was only shown in rats and mice that were given 3.9 and 2.4 times the recommended human dose, respectively. Out of about 50,000 pharmaceuticals, I honestly can't think of a single one in which the animal studies (while the animals are given such an outrageous dose) did not show cancerous growth.

The maximum daily dose for paroxetine is 60mg per day. Lets assume that the AVERAGE human taking paroxetine weighs 200lbs (the average weight of a human is actually about 150lbs, but paroxetine users typically aren't average), or 90kg. How much does a rat weigh, 2 pounds? If a rat weighs 2 pounds, this is slightly less than 1kg. The LOWEST dose that the rats and mice were given is 1mg. This dose works out to be 1mg/kg of body weight.

If a human were to be given the lowest rat dose, the person would be ingesting 90mg of paroxetine per day. Except in the case of an overdose, a person will never take 90mg per day (much less 2,250mg -- the MAXIMUM animal dose) since the maximum daily dose is 60mg. Even still, only 1 out of 100 rats that were exposed to the 90mg equavilent dose showed any type of cancerous growth. To take 2,250mg a person would have to ingest 56 tablets in a single day -- almost twice as much as their prescription for the entire month.

>> with all those discrepancies [and in the ad too] to make it
>> worse, (and God forbid if I had read the actual final reports),
>> I demand that smithkline beecham pull that shit off the
>> market

The full prescribing information is available at:

http://us.gsk.com/products/assets/us_paxil.pdf

>> keep it real, not on others' expense, not to mention they
>> dying as it is.

If you know someone who is dying of ANY FDA approved medication, you should ensure that it is reported to the FDA.