Glaxo, Pressured by Spitzer, Publishes Paxil Data

[dArKeR]

NEW YORK (Reuters) - GlaxoSmithKline Plc, responding to a lawsuit claiming it suppressed negative data about its antidepressant Paxil, published results of trials showing the drug is broadly ineffective in children and adolescents and could increase risks of suicidal behavior.

The British drugmaker released data from nine pediatric trials on its Web Site after New York Attorney General Eliot Spitzer filed suit two weeks ago accusing Glaxo of fraudulently suppressing the information.

Glaxo has denied the allegations, saying it publicized the results either in medical journals or at scientific meetings. The data released by Glaxo earlier this week showed Paxil to be mostly ineffective in treating youngsters.

http://story.news.yahoo.com/news?tmpl=story&u=/nm/20040616/hl_nm/health_glaxosmithkline_dc_1

[Warpy]

1. Eliot Spitzer is just about the only guy looking out for us

I sincerely hope Kerry nominates him for Attorney General. I sincerely hope he takes the job.

That office needs a thorough deodorizing after the corruption brought by Asscroft.

[jpgray]

7. If he's looking for guv, maybe Kerry should let him stay in NY

Otherwise I agree.

[Nlighten1]

15. No kidding...

It won't happen though.

[loudsue]

2. Glaxo also failed to expose re: Paxil is HELL to come off of!

It causes HORRIBLE side effects when someone tries to come off of this crap. It's done some people a lot of good while they're taking it, but 90% of doctors who prescribe it have NO IDEA what kind of hell insues when they take people off of it....so they end up putting their patients back ON the stuff.

It's the drug from hell, and Glaxo should have their asses sued twenty ways to Sunday.

:kick::kick::kick:

[rexcat]

4. Glaxo stated that the following...

"Drug abuse and dependence: Premarketing clinical experience did not reveal any tendency for a withdrawal syndrome or any drug-seeking behavior. There have been 2 cases of men without a history of major psychiatric disorder developing severe behavioral symptoms when paroxetine was withdrawn..."

With any Rx drug, clinical trials are limited (it is impossible to test everyone in the world prior to submission to the FDA). Everyone reacts a little differently to a given drug. What grips me is there are many MDs out there who will prescribe drugs that are outside their therapeutic area of expertise and their patients are willing to go along with it without the benefit of questioning the MD. When one is taking multiple medications (that includes herbals and over the counter meds since they all have pharmacological effects on the body) there can be interactions that have negative consequences to the health of the individual.

We all need to remember that there are no magic pills out there that are going to cure all of our ills. Unfortunately not everyone remembers this when they go to their doctor.

[luaneryder]

8. You too?

It took me six months to get off the poison. The suicidal thoughts are not just for adolescents, but I can see how it would affect them worse than an adult. Anyone out there contemplating using Paxil: get ALL the facts first from people who have been on the shit. The doctors, pharmacists and drugmakers will not tell you that it is extremely physialogcially addictive.

[David__77]

10. It is extremely difficult to quit Paxil.

I recommend that people doing so switch to the liquid version that is available, and when one gets to 10mg, reduce the amount to 8, 6, 4, 3, 2, and 1 mg. for two weeks for each dosage level. "Electric shock" sensations, fever symptoms and general disorientation can result even in this case, but I believe that a very slow tapering is the best solution. Switching to another SSRI does nothing to mitigate the withdrawal side-effects.

[mountainvue]

13. Yup.

Try SAMe. It works much better.

[rexcat]

3. Glaxo is in the process of disclosing all other

"negative" clinical trial data for all drugs evaluated by the company. It would appear that they got the message loud and clear. The down side to this is they are the only Pharma company doing so at this time.

I have worked on a lot of clinical trials that failed for a number of Pharma companies. I hope that other Pharma companies take the initiative to disclose as Glaxo appears to be doing now.

edit for spelling

[maggrwaggr]

5. I took Paxil once

and it's a doozy of a drug.

I felt very very odd the entire time I was on it. Completely detached and forgetful. I suppose I wasn't depressed, but I wasn't much of anything else either. I was completely useless on it, kind of like a content zombie.

I hated it.

[ElectroPrincess]

6. Yes, exactly ! Thank goodness you were not on a high dose.

I think the best descriptor is "listless." A few folks, including family members, I've had the opportunity to talk with on this subject all report negatives from being Rx Paxil. Granted: Some people's body chemistry mixes well and helps alleviate stress, obsessive-compulsiveness or ease the manifestations of depression. But the Doc must tread carefully, i.e., medicate with the lowest dose possible to ease symptoms.

What cracks me up - in a bizarre way - is that there's valid empirical evidence to indicate tolerance and therefore profoundly debilitating WITHDRAWAL symptoms(shhh! the drug manufacturer uses different terminology) when patients abruptly stop taking nominal doses of Paxil (as little as 20 mg and up).

Even when patients are slowly weened off of Paxil, they're still prone to potentially debilitating effects such as nausea, headaches, mood swings, etc. I'm only a lowly Masters' graduate but I'd keep Bipolar Dxed folks away from this medication like the plague. I hope that researchers take the time to discern if those children who attempted suicide might have leaned toward bi-polar instead of uni-polar depression.

[depakid]

9. Paxil has been marketed deceptively

and that's been a major source of the problem (actually, it's a major problem with ALL pharmaceuticals- we end up paying higher prices for the privilege of viewing their equivocal TV ads).

Not only has Glaxo concealed evidence of harmful side effects (as have the makers of other SSRI's like Zoloft) but the FDA has given them a free pass- and even supressed evidence compiled by its own researchers of increased risk of suicide among adolescents.

What's worse is that through their marketing efforts, primary care physicians are encouraged to dispense samples like candy when a patient presents with clinical depression or dysthymia. Since most of them are untrained in psychiatry- they don't take adequate histories, and so have no idea if their patient may in fact be bipolar... and believe me, patients aren't likely to complain when they're on the "up" side of their cycle.

Unfortunately, it's extremely common to be dx'd bipolar only after having been given an anti-depressant- usually an SSRI. If the patient isn't familiar with the signs of hypomania (and most aren't) this can quickly spiral out of control. At that point, the tendency is to stop cold turkey- which is a big mistake. People have to taper off these meds or else they almost always suffer debilitating or uncomfortable "withdawl" effects- including suicidal ideation.

The bottom line on Paxil and Zoloft is that they are probably the most overprescribed drugs on the market. People should think long and hard before taking either one of them.

[maggrwaggr]

11. it disgusts me to no end they give this stuff to kids

as a father that just makes me really angry.

[mountainvue]

14. I was on

40mg a day at one point. Blob.

[nonbelief]

12. Glaxo, Spitzer and Paxil?

Sounds like a comedy trio from the Andromeda Galaxy...