"Prozac, used by 40m people, does not work say scientists"

[Diraker]

http://www.guardian.co.uk/society/2008/feb/26/mentalhealth.medicalresearch

Prozac, the bestselling antidepressant taken by 40 million people worldwide, does not work and nor do similar drugs in the same class, according to a major review released today.

The study examined all available data on the drugs, including results from clinical trials that the manufacturers chose not to publish at the time. The trials compared the effect on patients taking the drugs with those given a placebo or sugar pill.

When all the data was pulled together, it appeared that patients had improved - but those on placebo improved just as much as those on the drugs...

Nothing IMO surprising but it's interesting information. There was some mentions of "pill popping" or "pharmaceuticals" something similar on these forums. Figured if anyone wants to talk about that, here we go; this is a real article about it, rather than just opinions being tossed around. There's also a link to the actual study (although I haven't looked at it yet).

Somewhat related is that recently the guy who shot up that geology class supposedly went off his medications. I wonder if he was just coming off his placebo and if creating false placebos (expensive as well) could be considered criminal or immoral in light of people getting killed when they don't get their sugar pill. There are many examples of folk on medications freaking out and killing people when they "go off their meds".

I worked with the mentally disabled and honestly I am a bit scared of some of them. Perhaps irrationally so.

[Mutt]

time for a cull!

[Zorat]

I hate pharm companies something fierce. They have a drug to fix everything and the doctors have bought into it left and right. Pills for everybody! :I

What the fuck happened to staying healthy by exercising and eating right?

[Mourne]

So, it's like a placebo or what?

[Koltas]

So, it's like a placebo or what?
I think whether or not it actually is a placebo is irrelevant since it mimics one regardless.

[Cinnabar]

I think whether or not it actually is a placebo is irrelevant since it mimics one regardless.

That's not what the review said at all.

[Ablate]

Restless Leg Syndrome, Frequent Piss Break Syndrome. Hell yea baby, gimme the pills.

[Gnioss]

The study examined all available data on the drugs, including results from clinical trials that the manufacturers chose not to publish at the time. The trials compared the effect on patients taking the drugs with those given a placebo or sugar pill.

:blanked: ...

Is this not what the FDA is for? I guess I was under the mistaken impression that before a drug could be marketed and sold it had to be proven that it actually did something. Is it really up to the manufacturer to say LOL WOOPS GUESS IT DOESNT RLY WORK :bounface: THATS OK DONT WORRY ABOUT TELLING ANYONE.

[Cinnabar]

:blanked: ...

Is this not what the FDA is for? I guess I was under the mistaken impression that before a drug could be marketed and sold it had to be proven that it actually did something. Is it really up to the manufacturer to say LOL WOOPS GUESS IT DOESNT RLY WORK :bounface: THATS OK DONT WORRY ABOUT TELLING ANYONE.

What that means is that the results were submitted to the FDA but not for peer-review.

[Koltas]

That's not what the review said at all.
that was my own opinion

[Gnioss]

cinn pls tell me what this article really means. Does this mean prozac really doesnt do anything in most situations?

[Dong]

Yeah, there's a drug 40 million people have been taking and they're just now realizing that it doesn't work.

Sounds believable!

[Kigek]

Another article:
http://www.sciencedaily.com/releases/2008/02/080225213742.htm

I would advise not to outright assume that fluoxetine (Prozac) has no use for the majority of its users. These results needs to be replicated by others before it can be even considered credible.

[Diraker]

From Kigek's link.


By including data from unpublished as well as published trials, the researchers set out to avoid bias that might come from non-publication of disappointing findings.

The study summary cited in the OP took results from other studies, including the hidden studies; the studies that had results that came up short.

So to me there's two stories here. One, that some anti-depressants are no better than placebos (for most people) and that 2) the pharmaceutical companies hide their research when it yields unfavorable results.

Anyway I forgot to mention in my OP that when I was working with the mentally disabled that if the clients ever told me about going off their meds or asking me my opinion on stuff I would say, "follow your doctor's instructions". So I am not advocating for people to stop taking their meds or to dismiss all medicines or to go around and tell their doctors to fook off. As they say, "ask your doctor". I'm no Tom Cruise.

[Siridean]

I took Prozac right after it came out. The doctor prescribed it because it supposedly had no negative side effects. Boy was he wrong! It caused all kinds of health problems from numerous phobias, hyperactivity and high blood pressure. I felt like I was on "drugs".

It took a few weeks for all the side effects to go away and it was the last time I tried any anti-depressant (this was my 3rd drug. the first made me too lethargic, the second caused me to break out in hives).

My personal belief is that too many people take these drugs for too long a period of time. IMO the point of an anti-depressant is to keep someone from committing suicide while they are in therapy to solve the problems causing the depression. Its supposed to be a temporary solution, not THE solution.

I haven't suffered from depression in years. For me, the best treatment for depression was finding healthy coping mechanisms. Ironically, online gaming is one of my healthy coping mechanisms. PvP is great for venting your frustrations and reducing stress. :p:

[Cinnabar]

cinn pls tell me what this article really means. Does this mean prozac really doesnt do anything in most situations?

The review itself concludes that compared to placebo, there is a clinically significant effect only in patients with severe cases of depression, but that that can be attributed to less response to placebo rather than greater response to the anti-depressants.


**However, keep in mind that this is only one article and that's never enough to declare an answer right or wrong.

[Cinnabar]

2) the pharmaceutical companies hide their research when it yields unfavorable results.


That is incorrect in this case otherwise the researchers would have never been able to obtain the trial results. Like I pointed out to Gnioss, the information was submitted to the FDA; just not for peer-review.

[Mourne]

I don't know why but I hate your avatar Cinn lol. It makes me want to punch that bitch.

[Mourne]

I meant sig...not avatar. Avatar is cool.

[Cinnabar]

I don't know why but I hate your avatar Cinn lol. It makes me want to punch that bitch.

I used it on the ubi forums forever and then just recently found it again. :smile_ok:

[Infuriare]

As I work for the largest biotech company, and have been involved on a couple submissions to the FDA as well as large clinical trials, I can tell you that this type of thing is why the CMS is taking more of a role than previously with the FDA. The CMS, which is the center for medicare and medicaid services, is more of a driver than the FDA for change and that's mainly because they hold the purse strings.

The requirements for drugs right now trying to make it to market have to go through a whole different rigor than was previously the case, and it's because the CMS is tired of reimbursing and encouraging drug makers to make the next viagra / prozac / whatever. You need to now show that you are more efficacious and cheaper to make than the current market to even enter the market, which is probably a good change. This will promote more head to head trials and more data in general on what the drugs do.

My company is actually doing the largest phase 3 trial that's ever been done right now, and it'll be one of the largest filings ever sent to the FDA / CMS because of it. Yes, there are companies that try to fudge the data though, but it's not all of pharma. Most of the ones that I've heard of aren't the actual company but the CRA firms that they hire to run the studies, because there's usually incentives for finishing on time and with clear results.

But, as Cinn says, one article doesn't mean that the drugs don't work. I'd be curious to see what the FDA does from this though, as they're very reactionary right now. You slip up even the slightest and your drug could be pulled.

[Mutt]

What is cali going to do without its prozac?

[Zorat]

http://www.penny-arcade.com/comic/2008/02/08

:D

To be honest though I don't think drugs are bad at all. They are just a tool and damn useful ones in the right circumstances. The problem is that I feel much of the time the solution doesn't need the drugs and my perception is that pharm companies are generally try to create drugs to "fix" things that would be better served using other methods...

[Zorat]

Ewps, I mesed the link and I guess I cant edit my posts. Doooh.

One more try:

http://www.penny-arcade.com/images/2008/20080208.jpg

[Cinnabar]

lol, that comic is too true. Unfortunately not everyone's biochemistry is the same so there isn't a single fix for everyone.

[Elora]

I was on Prozac for about a year, except it was called Sarafem… they made it pink and purple and marketed it for women. For me, it had more to do with hormonal imbalances than depression. It worked on the issues I was having (stopped trying to kill myself for no reason – again, not depression related), but boy did I hate the side effects. I couldn’t stop crying. I didn’t really feel anything… no joy, no sadness… but kept bursting into tears anyway. That stuff is evil.

I do think there’s too much diagnosing of anxiety and depression, though. If you’re honestly suffering, I feel for you. It has to be hell. But a couple of blue days doesn’t warrant drugs and I think doctors are far too eager to write out a prescription rather than look for other solutions.

[Roxie]

I took Prozac right after it came out. The doctor prescribed it because it supposedly had no negative side effects. Boy was he wrong! It caused all kinds of health problems from numerous phobias, hyperactivity and high blood pressure. I felt like I was on "drugs".

It took a few weeks for all the side effects to go away and it was the last time I tried any anti-depressant (this was my 3rd drug. the first made me too lethargic, the second caused me to break out in hives).

My personal belief is that too many people take these drugs for too long a period of time. IMO the point of an anti-depressant is to keep someone from committing suicide while they are in therapy to solve the problems causing the depression. Its supposed to be a temporary solution, not THE solution.

I haven't suffered from depression in years. For me, the best treatment for depression was finding healthy coping mechanisms. Ironically, online gaming is one of my healthy coping mechanisms. PvP is great for venting your frustrations and reducing stress. :p:

This is one of my hot button topics because I have been taking crazy pills for years. I am pretty sure that if I stopped taking them tomorrow, I wouldn't be a functional person. If I was weened off them gradually as suggested when one wants to stop taking their medication, I still wouldn't be a functional person. One of the best things I ever did for myself, Dong, and my family was to seek help through my general practitioner and through a psychiatrist. For some people, anti-anxiety and depression medications are a temporary solution to an issue, but for others, they are a permanent fixture in their life. Sad, maybe, but it angers me when some yahoos try to make generalizations about these types of drugs without any long-term need for or experience with them.

[Roxie]

I was on Prozac for about a year, except it was called Sarafem… they made it pink and purple and marketed it for women. For me, it had more to do with hormonal imbalances than depression. It worked on the issues I was having (stopped trying to kill myself for no reason – again, not depression related), but boy did I hate the side effects. I couldn’t stop crying. I didn’t really feel anything… no joy, no sadness… but kept bursting into tears anyway. That stuff is evil.

I do think there’s too much diagnosing of anxiety and depression, though. If you’re honestly suffering, I feel for you. It has to be hell. But a couple of blue days doesn’t warrant drugs and I think doctors are far too eager to write out a prescription rather than look for other solutions.

Elora, I agree with you about this - there are some misconceptions about what real depression is and society does seem to be over medicated for depression, anxiety, ADHD, etc.

[Dong]

In other news, a new study says that tin foil hats do not actually protect against government and/or pharmaceutical company brainwashing.

[Drekor]

In other news, a new study says that tin foil hats do not actually protect against government and/or pharmaceutical company brainwashing.
You now have to inject the tin foil hat directly into your veins.

[Ablate]

I never got any drugs for my depression.

[Diraker]

The actual meta-study is pretty interesting. The link is in the article and I'm gonna just quote the "editor's summary"

http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050045&ct=1

Editors' Summary

Background.

Everyone feels miserable occasionally. But for some people—those with depression—these sad feelings last for months or years and interfere with daily life. Depression is a serious medical illness caused by imbalances in the brain chemicals that regulate mood. It affects one in six people at some time during their life, making them feel hopeless, worthless, unmotivated, even suicidal. Doctors measure the severity of depression using the “Hamilton Rating Scale of Depression” (HRSD), a 17–21 item questionnaire. The answers to each question are given a score and a total score for the questionnaire of more than 18 indicates severe depression. Mild depression is often treated with psychotherapy or talk therapy (for example, cognitive–behavioral therapy helps people to change negative ways of thinking and behaving). For more severe depression, current treatment is usually a combination of psychotherapy and an antidepressant drug, which is hypothesized to normalize the brain chemicals that affect mood. Antidepressants include “tricyclics,” “monoamine oxidases,” and “selective serotonin reuptake inhibitors” (SSRIs). SSRIs are the newest antidepressants and include fluoxetine, venlafaxine, nefazodone, and paroxetine.

Why Was This Study Done?

Although the US Food and Drug Administration (FDA), the UK National Institute for Health and Clinical Excellence (NICE), and other licensing authorities have approved SSRIs for the treatment of depression, some doubts remain about their clinical efficacy. Before an antidepressant is approved for use in patients, it must undergo clinical trials that compare its ability to improve the HRSD scores of patients with that of a placebo, a dummy tablet that contains no drug. Each individual trial provides some information about the new drug's effectiveness but additional information can be gained by combining the results of all the trials in a “meta-analysis,” a statistical method for combining the results of many studies. A previously published meta-analysis of the published and unpublished trials on SSRIs submitted to the FDA during licensing has indicated that these drugs have only a marginal clinical benefit. On average, the SSRIs improved the HRSD score of patients by 1.8 points more than the placebo, whereas NICE has defined a significant clinical benefit for antidepressants as a drug–placebo difference in the improvement of the HRSD score of 3 points. However, average improvement scores may obscure beneficial effects between different groups of patient, so in the meta-analysis in this paper, the researchers investigated whether the baseline severity of depression affects antidepressant efficacy.

What Did the Researchers Do and Find?

The researchers obtained data on all the clinical trials submitted to the FDA for the licensing of fluoxetine, venlafaxine, nefazodone, and paroxetine. They then used meta-analytic techniques to investigate whether the initial severity of depression affected the HRSD improvement scores for the drug and placebo groups in these trials. They confirmed first that the overall effect of these new generation of antidepressants was below the recommended criteria for clinical significance. Then they showed that there was virtually no difference in the improvement scores for drug and placebo in patients with moderate depression and only a small and clinically insignificant difference among patients with very severe depression. The difference in improvement between the antidepressant and placebo reached clinical significance, however, in patients with initial HRSD scores of more than 28—that is, in the most severely depressed patients. Additional analyses indicated that the apparent clinical effectiveness of the antidepressants among these most severely depressed patients reflected a decreased responsiveness to placebo rather than an increased responsiveness to antidepressants.

What Do These Findings Mean?

These findings suggest that, compared with placebo, the new-generation antidepressants do not produce clinically significant improvements in depression in patients who initially have moderate or even very severe depression, but show significant effects only in the most severely depressed patients. The findings also show that the effect for these patients seems to be due to decreased responsiveness to placebo, rather than increased responsiveness to medication. Given these results, the researchers conclude that there is little reason to prescribe new-generation antidepressant medications to any but the most severely depressed patients unless alternative treatments have been ineffective. In addition, the finding that extremely depressed patients are less responsive to placebo than less severely depressed patients but have similar responses to antidepressants is a potentially important insight into how patients with depression respond to antidepressants and placebos that should be investigated further.

To me the last part is most interesting.

[Koltas]

http://www.photodump.org/stored20/lenn.gif

[Mutt]

I never got any drugs for my depression.because you are in canada where they tell you to get some sun, get some exercise, and get some

[Zorat]

Koltas wins.

[Diraker]

Just a blog entry about how pharmaceutical companies bury unflattering data. And also how there could be a relatively easy legislative fix to help make it harder to bury important data.

http://www.badscience.net/?p=619#more-619

and a quick quote

The pharmaceutical industry is very imaginative, after all, and registers also help to manage some of the other less obvious ways in which they distort the literature. For example, sometimes companies will publish flattering data two or three times over, in slightly different forms, as if it came from different studies, to make it look as if there are a lot of different positive findings out there: registers make this instantly obvious.

Worse than that, companies often move the goalposts, and change the design of a trial after the results are in, to try and massage the findings. This, again, is impossible when the protocol is registered before a trial begins.

The entry also talks about misconceptions about the study (the study linked in the OP). e.g.

It has been misreported as a definitive nail in the coffin: this is not true. It was a restricted analysis [see below] but, more importantly, on the question of antidepressants, it added very little. We already knew that SSRIs give only a modest benefit in mild and moderate depression and, indeed, for some time now, the NICE guidelines themselves have actively advised against using them in milder cases since 2004.

[Cinnabar]

Submitting distorted or falsified literature isn't limited to the pharmaceutical industry(which you didn't say but readers might get that impression). Many scientists will skew numbers a little in their favor or even go so far as to falsify information, largely because their future funding(and paycheck) is on the line. Part of the point of the peer review process is to help filter this out and when scientists do get caught doing this, they get crucified by the rest of the community.

[Mutt]

lol so its like the taping in the NFL. Everyone does it, but when one guy gets caught denounce him to high hell