Lexapro

[ZenSojourner]

Well I work in the field too and I would strongly disagree that companies prefer to have drugs with side-effects so that they can make more money.

I don't think that's what's being said at all. Rather that side effects are not considered of primary importance by drug manufacturers, and doctors tend to prescribe more meds to deal with the side effects. This is very well documented in the medical literature and it's how many elderly patients end up on 20 or 30 meds. My dad was on a med that had the side effect of causing tremors; they put him on another med to control the tremors. That med had the side effect of causing stomach problems; they put him on a med for stomach problems; etc etc etc ad nauseum.

The reason there are so many side effects is that the drug acts at many more places other than where you need it to act for its benefit. They aren't really "side effects" but are what we would call extensions of the pharmacology of the drug or exaggerated pharmacology.

BULL. That's the very definition of side effect, an effect that you don't want coupled with the one that you do. Calling it "an extension of the pharmacology of the drug" is like calling a bug in a program a "feature".

But trust me when I say that companies are definitely trying to find more exact mechanisms.

I'm sure if they stumbled across a more exact mechanism they would happily exploit the hell out of it. However the truth of the matter is that drug studies are manipulated and massaged in order to minimize the impact and frequency of side effects. It's all about approval and marketing.

Another well documented fact is that once a drug is released, side effects in the general population are more frequent, broader in scope, and potentially more severe than were reported in the drug studies. A certain amount of this can't be helped - there are always going to be side effects that pop up when your sample size is millions that you would be unlikely to run across when your sample size is 100. But the truth is that side effects are routinely down-pedaled and soft-shoed in order to get through the approval process, and to make the drug more palatable and hence more marketable to the public. There is a mechanism in place for doctors to report side effects post-approval, but very few use it. A lot of docs seem to be unaware that the mechanism even exists, and even if they do know about it, they don't know how to access it.

Doctors have also been brain-washed into believing that side effects are always "rare" which they generally equate to "non-existent". As a person who has suffered from many many weird and bizarre side effects (drug sensitivity runs on BOTH sides of my family) I can attest to the fact that docs more often than not tend to discount patient reports of side effects.

Recently my father was having problems with low BP. We had moved recently and he didn't have new docs yet. During a hospitalization for an entirely different matter, the hospital doc took him off ALL his heart meds, citing the low BP as the reason. This doc did not review his med list, he just took him off ALL his heart meds, meds he has been on for 15 years and has always tolerated well. His low BP not only did not remit, his CHF got much, much worse (go figure, how could that happen?). It was left to ME to review his med list, discover that some doc had put him on Wellbutrin, find the literature listing low BP as a potential side effect, and then wrangle with the doc to drop the Wellbutrin and put him BACK on the heart meds. What was the doc's response when the side effect of low BP related to Wellbutrin was pointed out to him? "Side effects are very rare".

It has been documented that side effects among the general population post-marketing run 3x to 10x what is reported in the pre-approval testing. So they're not rare, but Big Pharma wants us to think they are. So they under report, massage the data, find reasons to drop people who have adverse reactions so they don't "dirty" the data for approval.

Take Prozac for instance. Upon review, FDA officials discovered that researchers had dropped 76 of 97 cases of reported suicidality from its post-marketing surveillance data submitted to the FDA. DURING pre-marketing drug testing, similar cases had been excluded based on the flimsiest of excuses. I loaned that report to a friend so I can't look up the exact circumstances, but incidents of activation (emotional stress that can lead to suicidality) and actual suicidality were dropped from the data set based on some self-serving double talk, sort of like calling a side effect "an extension of the pharmacology of the drug".

Furthermore, Prozac is almost 20 times more likely to result in a suicide attempt than other antidepressants. (Spontaneous Domestic Reports January 1982-July 1991. [PZ-1548, See pp. 5-14]). This was known before marketing and it was hidden via data manipulation and under reporting in order to get Prozac through the approval process.

Prozac was a bonanza for Eli Lilly, and in fact when their monopoly on it ran out, they repackaged it as a treatment for PMS so they could extend their monopoly on it. (http://web.mit.edu/newsoffice/1997/pms.html)

Serafem (Prozac repackaged for treatment of PMDD but often prescribed for PMS) is reported by Eli Lilly to have "similar side effects" to Prozac. This is more Big Pharma double-talk, since Serafem is the exact same drug in the exact same dosage, only tinted a pretty pink, it has the EXACT same side effects as Prozac.

The problem is that the way Prozac was foisted off on the American Public is par for the course.

So sorry, but trusting Big Pharma, and you indirectly as their mouthpiece, is not in the cards here.

*EDIT*

I did find some of the info on Prozac's approval process online

http://www.baumhedlundlaw.com/media/timeline.html

These are exerpts from ELI LILLY documents during testing phases, pre-approval, and post-marketing.

ELI LILLY KNEW there were major risks associated with Prozac. The only thing this spurred them to do was to find ways to double-talk it, downplay it, and hide it.

[Crankin]

I tend to agree with everything ZenSoujourner said (in a much more eloquent way than I could).
You are lucky if you can take SSRIs or any other medication with no side effects. I have side effects with everything. If I ever get heart disease or several other things that require medication, I will be in serious trouble because I can't take things that have the stuff that causes "serious digestive problems." It's in so many things that it seems crazy. I almost had to be hospitalized when I tried Fossomax about 7 or 8 years ago. Last year, when I was having all my medical issues, I tried two SSRIs... bad, bad, bad. I felt worse than the original problem that lead me to trying them. Let's see, oh yes, I am also allergic to iodine, hence IV contrast dye, so if i ever need a cardiac stress test, angiogram, etc who knows what they will do. Guess I'd better keep riding!

[jobob]

What's your educational background and what do you do for a living, ZenS?

I have a PhD in biochemistry and I used to work as a research scientist, until I went over to the dark side (as it were) and I now work on patents at a biotech company which is developing protein-based pharmaceuticals.

Possegal is also a PhD in the pharmacology field - I don't remember what she does exactly (and if she said on this thread, I'm too lazy to go back right now and look).

What I'm getting at is that we both work in the field. And I know (and I assume PG also knows) people who work in "the trenches" , as it were, working on the development of pharmaceuticals which, if all goes well (big if), will improve and possibly save some lives in the future. And no, the people I know and work with are not conniving manipulators trying to pull a fast one over unsuspecting patients in order to turn a buck.

ZenS, you've had some very unfortunate experiences with your father's meds. I'm not downplaying that in the least, and it sounds like the current state of drug dispensing for elder patients is disgraceful.

But wrapping this up into a big indictment of pharmaceutical companies?

I'm curious how you reached your conclusions. You do have some sort of background in the medical / pharmaceutical area?

Because to be honest, some of your comments are so off the wall that, to use your own term, they're bull.

[ZenSojourner]

Jobob, I don't doubt that you may be well-intentioned. But good intentions do not make up for facts.

I cited specific evidence. You reject the evidence out of hand. Heck, you flat out pretend it doesn't EXIST. Snagging the example of my father's med problems and waving it around like a red flag as if it were the main issue is just an attempt to distract from the facts presented. My views of the pharmaceutical industry have little to do with my dad's condition and med problems, or even my own, but with the way Big Pharma has typically handled marketing and testing of drugs, a subject which I have followed for over 20 years.

Trying to imply that only people who have chemistry degrees and work in the pharmaceutical industry are suited to evaluate that industry is disingenous. I have a brain, and I use it. And yes, I have the educational background to be able to evaluate the facts. I have a background in biology, medical research, computer and engineering technology, and psychology.

Telling people they can't have an informed opinion because they don't work for a pharmaceutical company is ludicrous. Using loaded terms like "off the wall" to describe the facts presented doesn't change those facts. Go read the memos Eli Lilly was passing around in their attempt to soft-pedal the problems with Prozac; THAT'S off the wall.

That said, there is a distinction to be drawn between chemists/biochemists working directly on the development of a drug and the marketing weenies who make the decisions about how to present the drug to the FDA and to the public. By your own lights, since you don't work in marketing, you must not be qualified to speak to issues of marketing and decisions made at the corporate level.

I'm not going to argue with you about it. I am not accusing you personally or anyone else who has posted here of malfeasance; the problem lies outside of the venue of research, and is more correctly to be attributed to corporate policies and marketing concerns.

[jobob]

Fair enough.

I didn't address the memos you quoted since I didn't have my back brace on yet and my husband was nagging me to either put it on or go lay down (heh, laziness won, I chose the latter).

And I know you have a brain. I just wanted to point out that some here work in the pharma industry. Now, that said, I don't work in marketing which might be where some of you're issues are coming from. And I don't know jack about marketing.

I work in patents, which has is own issues, some of which I've come to question. The exclusivity that comes from patents, for instance. Sometimes I wonder if that's such a great idea. Drugs under patent cost a bundle, as opposed to generic drugs (for which the patents have expired). But then, how will the company that develops the patented drug in the first place recoup its cost and make a profit to make it worth the company's while? Many drugs, theoretically promising ones, don't make it past clinical trials and its a very large investment for each one so the pharma co's need some way to make up for not only the cost of developing the drug that is actually marketed, but all of the other drugs that never got that far but that they still spent a bundle on. Oh yeah, and have a reason to exist in this day & age (i.e., make profits, at least eventually) .

So that's where the exclusivity from patents comes in. If the pharma co didn't have that exclusivity period (roughly 20 years starting from when the patent application was filed, give or take a few years for a number of reasons [Ed. to add - the exclusivity period is way less than 20 years once the patented drug finally reaches the market btw]), then another company would be able to make and sell that drug right away without having to do the background research & development work, so they'd be able to sell it for a much lower cost and the original pharma co would never make anything off of their original investment.

But that doesn't help the consumers' bottom line much. What's the answer? Gah. Corporations vs public funding? I suppose if it were all government funded then there would be no need to cover costs and no profit motive (and Yes I'm laughing at myself as I'm typing this). Of course then taxpayers would be funding the pharma industry (waaay more than it does now) which would probably mean an increase in taxes and I shall not go there.

Complicated stuff, unfortunately.

[Triskeliongirl]

I've avoid chiming in here, but at this point I can't help it. I don't work in big pharma, and I know nothing about marketing. What I do know about is biochemistry, pharmacology and neuroscience. I have a PhD in biochemistry and I teach and run a research lab at a major research university.

The goal of developing better therapeutics is always to make drugs that will do what we want them to without side effects. I don't believe for a minute that big pharma markets drugs with side effects in order to sell more drugs. I agree with the earlier comments that the human body is so complicated, that it is extremely difficult to develop a drug that just effects what we want it to without any side effects. It's because our bodies use common pathways/mechanisms, etc. to carry out many different functions, that to specially inhibit only one of those functions and not any others is nearly impossible.

With that being said, I also think big pharma over markets pharmacological interventions, as an observer seeing all the commercials we are inundated with on TV. But we all have a choice, and whether we do or don't choose pharmacological interventions depends on the problem. I am hypothyroid and would not for a minute consider doing anything other than taking thyroid meds. But, I am also hypoinsulinemic, and find that as long as I don't challenge my body with too much carbohydrate, exercise, and maintain a normal body weight, that I can avoid taking insulin, so I do that.