Re-Analysis of Medical Study Reverses Conclusions -- Paxil Unsafe For Teenagers

An anonymous reader writes: The NY Times is covering a new paper in the journal BMJ which re-analyzed data from a 2001 paper, coming to the opposite conclusions of the earlier study. The BMJ paper covers the effectiveness and safety of two antidepressant drugs for adolescent use, and the authors were able to re-analyze the original data after the release of previously confidential documents. The BMJ editors call into question some of the integrity of previous publishing, noting that none of the authors listed on 2001 paper actually wrote the original manuscript, and call for results of clinical trials to be made freely available so the science community can verify and self-correct results. The BMJ has released the study and provided an accompanying press release (PDF).

Comments

Why do teens *need* all these drugs???

[cayenne8]

Good Lord, We had no inclination of taking the slew of pharmaceutical drugs back in my day as a teen. Ok, sure, we had plenty of "parking lot" drugs we often had fun with...but as far as systemized drugging of kids, we did just fine without all the anti-depressants turning kids into zombies so early ln life.

I can't imagine we're doing these young teens and pre-teens any good with all this. We didn't need it in the past and we all came out well adjusted (always a few exceptions), so why in God's name do we feel the need to start drugging kids from such an early age ?

It is just big Pharma selling more wares, getting folks hooked early?

Between "Attention deficit disorder" (formerly known as being "a boy")...and now anti-depressants, can a kid that was once considered normal growing up and developing with all the fun times and turbulent times grow up today without the first inclination be to DRUG THEM?

Re:Why do teens *need* all these drugs???

[hyperar]

Because pharma companies want money?

Re:Why do teens *need* all these drugs???

[gstoddart]

Sure, but if fabricating science to sell a product for an application not approved or supported by the science really needs to be the kind of thing which leads to very significant legal action and penalties.

Essentially they fabricated a study to support a use of a drug, and the conclusions in that study were not founded .. because it wasn't a real study.

Sorry, but that's pretty much a criminal activity in my books.

Re:Why do teens *need* all these drugs???

[gmack]

Don't blame just "Big Pharma" Parents prefer the drugs because it's less humiliating than thinking something went wrong with their parenting and at any rate it's a less time consuming fix that going to a physiologist. Teachers prefer the drugs because they let them keep kits seated for longer. Doctors prefer the drugs because it's easier than trying to get a child/teen to eat properly.

Big Pharma can hardly be blamed for selling us all something we begged them for in the first place.
 

Re:Why do teens *need* all these drugs???

[Alicat1194]

I was put on Paxil (Aropax in Australia) at 16. It was literally life-changing. Previously I had random panic attacks, with no specific trigger - sometimes up to 4 a day. Leaving the house to go anywhere but school without triggering an attack was impossible, and even school could be hit-and-miss. Add OCD to the mix, and lets just say, it wasn't exactly a lot of fun.

Two weeks after beginning paroxetine, I went to a friends house for a sleep over for the first time in just under a decade. I remember leaving my house without any feelings of anxiety or dread, and remarking to my Mum that "this is how normal people must feel!".

Yes, I'll agree that in some cases these drugs are prescribed too quickly, and too easily, and they aren't side-effect free (hellooo ridiculously easy bruising!). But for the rest of us, they're worth their weight in gold (ie: the only way you'll take them off me is from my cold, dead, anxiety-sweat drenched hands).

Re:Why do teens *need* all these drugs???

[cayenne8]

I know these drugs help some folks.

But I have to guess your situation is a very niche one....an extreme outlier to most kids' situation.

Normal anxiety and angst is a part of growing up and learning to deal with things. I'm afraid that way too often today, what should be normal levels of this type stress, is being treated with drugs, instead of teachings of how to live and deal with this.

Extreme cases like you have, of course require more tx, but I would still guess that your extreme case is in the minority of the human population numbers.

Re:Why do teens *need* all these drugs???

[kheldan]

..OK, I agree in part with what you're saying. However much I believe that these conditions (depression, ADD/ADHD) are real, I also believe that two factors have contributed greatly towards the proliferation of medications to 'treat' them: One, it makes the pharma-industrial complex loads of profit. Two, the bean counters that de-facto run the healthcare industry love the stuff, because it's far cheaper than cognitive therapy to teach people to fix their own problems.

By the way, ADD/ADHD are not just 'boy' conditions, I've known at least one female who had them as well, and in her case, she wasn't able to cope with day-to-day life anywhere near as well before Adderall. Myself I was diagnosed with ADHD as an adult -- but by that time I'd developed so many coping mechanisms that medication really didn't need to be used; it did, however, answer lots and lots of questions about how an why thigns happened for me over the course of my life -- knowledge which I applied to my already-existing coping mechanisms to further refine them. Once you understand ADD/ADHD, you realize that you can leverage it into an advantage in your life instead of something that holds you back.

Anyway.. used to suffer from depression also (in part a side effect of dealing with ADHD). Learning to address the actual problems instead of 'putting a band-aid' on them with medication proved to be far more effective, but much more work initially; regardless I'm an advocate of cognitive therapy in one form or another far more than I am of medication, which in my opinion should be used only on a short-term basis while you're learning to deal with what's bothering you.

No doubt, I'll get lots and lots of heat for daring to voice my experience and opinions on this subject. I don't care. There are better long-term ways to deal with these problems than being on medication the rest of your life, and I feel people need to know this. There are rare exceptions, of course, where medication is the only way to keep someone from destroying themselves, and I acknowledge that here, too. But anyone that says medication is the only way to deal with these problems has been brainwashed into believing that.

[[[Bracing for the incoming hate]]]

Re:Why do teens *need* all these drugs???

[gstoddart]

Troll?? Really?? This is from the last link in the summary:

Results The efficacy of paroxetine and imipramine was not statistically or clinically significantly different from placebo for any prespecified primary or secondary efficacy outcome. HAM-D scores decreased by 10.7 (least squares mean) (95% confidence interval 9.1 to 12.3), 9.0 (7.4 to 10.5), and 9.1 (7.5 to 10.7) points, respectively, for the paroxetine, imipramine and placebo groups (P=0.20). There were clinically significant increases in harms, including suicidal ideation and behaviour and other serious adverse events in the paroxetine group and cardiovascular problems in the imipramine group.

Conclusions Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs. Access to primary data from trials has important implications for both clinical practice and research, including that published conclusions about efficacy and safety should not be read as authoritative. The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base.

Unless you work for GSK or are one of the original authors, my summary of the conclusions is pretty damned accurate: they fucking lied about badly done science.

Re:Why do teens *need* all these drugs???

[macs4all]

Essentially they fabricated a study to support a use of a drug, and the conclusions in that study were not founded .. because it wasn't a real study.

Sorry, but that's pretty much a criminal activity in my books.

But in the collusive atmosphere that is the relationship between Big Pharma and the FDA, it's known as "Just another workday".

Witness the story of the now-rejected Centocor/Lilly Anti-Septic Shock Drug, HA1A, or "Centoxin". My best friend's father died in September, 1992 after being given Centoxin in lieu of the standard treatments for Septic Shock (steriods, aggressive antibiotics). He was part of the "second" Centoxin study (the one that was HALTED by the FDA, due to an unacceptable death rate...)

The "collusion" comes when the FDA, who discovered that Centocor was "cooking the books" on the FIRST study, didn't simply turn over Centocor (and Lilly) to the DoJ, instead of "giving them another chance to LIE better" with a SECOND study.

Worse yet, when my friend was asked to give "informed consent" to administer Centoxin, it was represented as the ONLY POSSIBLE TREATMENT for Septic Shock (however, they never mentioned that it ONLY worked on gram-negative sepsis, and that it HAD to be given within 120 MINUTES of the onset of symptoms, which they already knew YEARS before that study, and which time had LONG passed in his case); however, a quick cruise through the Physician's Desk Reference (PDR) lists SEVERAL antibiotics (such as Amoxicillin/Clavulinate, Clindamycin and Inipenem, to name a few) which are listed as treatment for Sepsis, and then Steroids and other anti-inflammatory drugs are given to reduce the deadly inflammatory response (primarily from the release of Interuekin-1 (IL1), IIRC) (sometimes your immune system is your worst enemy!), to try to stop your body from killing its own organs.

Re:Why do teens *need* all these drugs???

[Alicat1194]

How do you know that you would not have had the same repsonse if not a better one if you were given a placebo??

Oddly enough, my mother did try placebos at one point (she was a nurse, so was in to that sort of stuff). She would give me what I later found out was a small amount of milk with vanilla essence in it, and tell me it was "medicine". It worked to calm the panic somewhat, but not prevent it from occurring (and oddly enough, I'd rather it just didn't occur full-stop).

However once I hit puberty pretty much everything went out of the window (thanks hormones!). Even now I have noticed that I'm more likely to have problems during certain points in the hormone cycle.

Add to that that I've been on three different versions (paroxetine, sertraline and venlafaxine), and had very different experiences from each. If I was only experiencing the placebo effect, I'd expect to have a similar outcome from each, but that wasn't the case (Paroxetine was good, but lost efficacy. Sertraline was awesome for the OCD (stopped it dead), middling on the anxiety, and made me an emotional mess. Venlafaxine is good for the anxiety, but only passable for the OCD).

Re:Why do teens *need* all these drugs???

[tburkhol]

Good Lord, We had no inclination of taking the slew of pharmaceutical drugs back in my day as a teen. Ok, sure, we had plenty of "parking lot" drugs we often had fun with...but as far as systemized drugging of kids, we did just fine without all the anti-depressants turning kids into zombies so early ln life.

But I have a right to be happy all the time. I live in the greatest country earth has ever known and my parents provide me with every possible comfort and advantage. Coasting through life as I have, without any serious challenges or impediments, I should be the happiest kid on earth. If I'm not, it's clearly a neural imbalance, and there's a drug for that.

Re:Why do teens *need* all these drugs???

[avandesande]

That's BS. My son was diagnosed with HFA and PDD when he was in grade school and the psychologist wanted to put him on a course of 5 drugs. She had the little pharmaceutical pads, pens, etc all over her office. Of course we refused but she pushed hard.

I am confident that he would have been ruined if we had relented. Don't tell me that there isn't a profit motive here for pharmaceutical companies! Without the advertising for drugs (for those who are younger this used to be outlawed) and doctors pushing the stuff there would be very few parents clamoring for the stuff.

Re:Why do teens *need* all these drugs???

[Alicat1194]

I'll admit, my situation was a little weird, and we did try other options before going the drug route (CBT, relaxation techniques, exercise, etc). I was also lucky in that my parents were very invested and involved, and took the time to work with me to try and fix it without pharmaceutical intervention. If they'd been more time-poor, or less involved (as a lot of parents these days seem to be), it's possible that drugs would have been the first choice, rather than the last.

I also think it depends on the country and medical system you're part of - before my doctor would agree to prescribe anything I had to go to a psychiatrist for evaluation. Australia is also pretty well regulated, so we don't get "talk to your doctor" type advertising, which may have an impact

Re:Why do teens *need* all these drugs???

[sjames]

That article also touches on how drugs get so expensive. We hear all about how many very expensive studies come to nothing and how the one success has to pay for all those failures. But in the case of Centocor, they had the golden opportunity to avoid the big costs by admitting early on that it wasn't all it should be. But they had "go fever" by then and so wasted boatloads of money trying to ram it through approval anyway. Perhaps if they would stop looking at their early studies as obstacles to be overcome and see them as valuable information to be considered instead, they wouldn't have to make up for so many losses when they have a success.

Re:Why do teens *need* all these drugs???

[DerekLyons]

Good Lord, We had no inclination of taking the slew of pharmaceutical drugs back in my day as a teen.

So?
 
You aren't (by implication) a teen anymore. You may not however be old (or mature) enough to grasp that times change.
 
When I was a teen, lo these many decades ago, society was different too... and not necessarily better. Tying one on an Friday night and then driving home was completely acceptable. Even though it killed people. A guy getting a girl drunk and raping her was just "boys will be boys" - and if she wore anything that might be considered 'sexy', she was a slut and it was her fault for "leading him on anyway".
 
I have no desire to go back to those days.
 

We didn't need it in the past and we all came out well adjusted (always a few exceptions)

No, we didn't "all come out well adjusted". Some did. Others turned into recluses. Others carried on day by day but suffered a half life in silence. Others turned to alcohol, or weed, or... worse. Yet others could no longer bear the pain because society has a deep stigma against not being "well adjusted" and chose the ultimate way out. You only think they turned out "well adjusted" because you've rejected the notion that things might be other than their surface appearance out of hand.
 
I have at least three classmates who might have made it out of their early twenties if back then assholes like you hadn't made idiot claims like "we had no inclination to diagnose and treat mental illnesses and we turned out well adjusted". I have two cousins my age who might be useful members of society rather than living in a bottle if they hadn't been taught growing up that "real men don't seek treatment", an attitude born of the same ignorance you spout.
 
I have no desire to go back to those days either.

Re:Why do teens *need* all these drugs???

[WalrusSlayer]

Of course extreme cases are a minority. That changes nothing. These kids, the extreme cases, need the medicine. Need.

This is similar to the largely pointless debate on antidepressants in general. Anyone who hasn't had clinical depression has no fucking clue what it's like. I was one the most motivated, self-starter, hard-working, emotionally balanced people out there, until my life circumstances changed immensely in my 40's. It took me a long time to recognize that I had clinical depression, since the slide was so gradual and I never ever could envision myself having this problem. Fortunately the first med I tried was extremely effective, and I was just shocked at how far I had slid once I was more like myself again. Oh the time I wasted while in the fog of depression and not even really knowing it. Life's too short.

The same is true with ADHD. Unless you have kids with true ADHD, you're clueless. I never imagined having to deal with a medication regimen with my own kids. If we could get off this train, we would, but they are essentially learning disabled without them. This is not "kids will be kids". It's a real disability, and ADHD children are very fortunate to be growing up in a time where it can be treated such they can live more fulfilling lives.

Or in other words: "what he said". It's easy to be an armchair Public Health Expert when you aren't affected by the condition in question. Real life is a lot messier.

Re:Why do teens *need* all these drugs???

[mescobal]

As a Psychiatrist and long-time Slashdot reader I feel really disappointed reading the reactions of people whose oppinion in technical matters I respect a lot. But after > 20 years of "in-the-trench" psychiatry (public and private settings) I've seen (BY FAR) more good than harm as consequence of our practice. I can say I helped a number of people, lots of them using SSRI. We are aware of the industry and its tactics, and the wax-and-wane of science. But most of my colleagues act in good faith following procedures tested in our gold-standard double blind placebo-controlled trials. Medicine CAN do harm sometimes, that's not new. But when you add all up, there's a net benefit. Just my 0.02

Re:Why do teens *need* all these drugs???

[Razed By TV]

General response:
About a month ago, I saw an article on Huffington Post by a doctor claiming that diphenhydramine was not effective for getting to sleep/staying asleep and that there was no research supporting its use . I said to myself, "this sounds like bullshit." So I googled it, and found studies supporting its use. So some doctor may have gotten himself a lot of advertising by giving lots of people bad advice. That was the first thing I thought of when I saw this article.

It may in fact be true that paroxetine is not useful in treating most adolescents. On the other hand, it may be that some people just want to make a name for themselves. (Not that I trust GSK, either...)

Responding to Alicat1194:
I've had depression and been off and on all sorts of medications. I was on Paxil for a few months during my teenage years, and while it didn't magically fix my problems, it did make life much more tolerable, especially with anxiety. 10+ years later, during another episode of depression, I was diagnosed as having bipolar depression (family history plus I developed mania from citalopram. Escitalopram did not induce mania previously, strangely enough.) My current therapist is reconsidering the bipolar diagnosis. I've been through lithium and a couple mood stabilizers, and I'm now back on Paxil. The others had little to no effect. I credit Paxil more than any other drug for improving my mental state. Of course, at this point, I am no longer an adolescent.

To GP:
I think that the pressures on teens are higher now than they use to be. Instead of go to school, then get a job or go to college, there is maintaining an online social presence, figuring out how you're going to support yourself when wages haven't kept up with inflation, and the increase of college costs with a decrease in returns from a higher education.

I don't disagree that recreational drugs have therapeutic value. However, the current social climate makes them unsavory, and the kids who have the means will seek therapy. These kids end up on a pill, as there is no authority advocating marijuana use.

The Scientologists Got This One Right

[macs4all]

I normally can't stand the pompous, pseudo-intellectualism and general asshattery that permeates throughout the Scientology pseudo-religion and all that are involved therein; but they are spot-on when it comes to the over-prescribing of dangerous psychomeds, and SSRIs are universally at the head of that list.

SSRIs are E-VIL, period. And unless you have one of the VERY few conditions for which they ARE effective, most notably, OCD (but NOT bipolar disorder nor depression!), they should be used sparingly, or even better, not at all.

Disclaimer: IANAD.

Re:The Scientologists Got This One Right

[gstoddart]

but they are spot-on when it comes to the over-prescribing of dangerous psychomeds

Even a broken clock is right now and then by sheer luck.

Why Scientology disregards this shit is still batshit crazy rantings, and has nothing to do with science ... it has everything to do with the aliens trapped in your brain you haven't paid Scientology to remove yet.

That insane ramblings of people who believe stupid things occasionally coincides with actual facts doesn't lend any credibility to those insane ramblings of people who believe stupid things.

Sorry, but a "religion" written by a science fiction author who basically said "the real money is in starting a religion" isn't credible just because they disagree with anti-depressants.

The culmination of this belief system is Tom Cruise jumping on a couch spouting off about what he'd been trained to say.

Re:The Scientologists Got This One Right

[Spamalope]

I was prescribed Paxil due to a misdiagnosis. Wow, that was awful. Whatever positive things it was supposed to do never happened, but if you wanted your sex drive destroyed and to have every sleeping moment be the most vivid dreams it did that for me. Of course, all of the dreams were directed by Steven King and I woke up screaming in a cold sweat but they were vivid. And if I could get back to sleep I'd have another just as bad on a new topic (they didn't repeat). I watched a friend be driven into paranoia by SSRIs. As the affects of the drug ripped her life apart, her doctor kept increasing her dose to 'fix it'. When last I heard from her, she'd lost her license, been fired and lost most of her friends -- an addicts journey except that she was following her doctors instructions.

It's interesting to me to see that some people have really been helped. That suggests that doctors need much narrower guidelines for prescribing these drugs.

Prudence and judgment...

[frank_adrian314159]

It would not seem prudent that one should be significantly altering neurochemistry during periods of high levels of neuroplasticity. On the other hand, we've been altering our own neurochemistry for entertainment purposes forever. As such, I'm sort of meh on the whole thing. We all do chemicals each day - even if it's only by ingesting food, water, and air.

I doubt good (and, yes, there are a lot of good ones out there, if you actually look) doctors are handing out SSRI's like candy to kids. When they do, it's usually at the urging of a mental health counsellor and with prodding from parents. As such, it's not prescribed that much (in this age range). It's not like it's Methylphenidate (whose overprescription, in my opinion, is a much bigger issue).

Re:Prudence and judgment...

[afidel]

As such, it's not prescribed that much (in this age range).

That is VERY wrong:

Despite this, more than 2 million prescriptions were written for U.S. children and teenagers in 2002, link

Is medicine actually science anymore?

[Nutria]

The amount of fraud and incompetence in medical and psychological "studies" (along with the utter *fail* of peer review make me think that Medicine and Psychology drove off the rails into Snake Oil World many decades ago.

speaking from experience, i can understand.

[nimbius]

as a kid I took Paxil briefly for depression, but never received any therapy so it was basically worthless. the drug was pretty brutal. I could function at school, but at 14 i felt like i was a drugged 40 year old junkie. I was exhausted all the time and had a near constant headache. between the nervousness and weight loss after the first year, i certainly wasnt depressed anymore but i was an emotional tire fire. I became violently opposed to the idea of dating, physical contact, or interpersonal relationship and extremely paranoid around adults. I still dont rememeber why this was, but I kept a notebook log of places to avoid and things people said.

And it got worse. Kicking paxil after highschool took an entire year of auditory hallucinations, nightmares, suicidal thoughts, crying, you name it.