Prozac doesn't work better than placebo

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Prozac, used by 40m people, does not work say scientists
Analysis of unseen trials and other data concludes it is no better than placebo

Sarah Boseley, health editor
The Guardian, Tuesday February 26 2008

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.

The only exception is in the most severely depressed patients, according to the authors - Prof Irving Kirsch from the department of psychology at Hull University and colleagues in the US and Canada. But that is probably because the placebo stopped working so well, they say, rather than the drugs having worked better.

"Given these results, there seems little reason to prescribe antidepressant medication to any but the most severely depressed patients, unless alternative treatments have failed," says Kirsch. "This study raises serious issues that need to be addressed surrounding drug licensing and how drug trial data is reported."

The paper, published today in the journal PLoS (Public Library of Science) Medicine, is likely to have a significant impact on the prescribing of the drugs. The National Institute for Health and Clinical Excellence (Nice) already recommends that counselling should be tried before doctors prescribe antidepressants. Kirsch, who was one of the consultants for the guidelines, says the new analysis "would suggest that the prescription of antidepressant medications might be restricted even more".

The review breaks new ground because Kirsch and his colleagues have obtained for the first time what they believe is a full set of trial data for four antidepressants.

They requested the full data under freedom of information rules from the Food and Drug Administration, which licenses medicines in the US and requires all data when it makes a decision.

The pattern they saw from the trial results of fluoxetine (Prozac), paroxetine (Seroxat), venlafaxine (Effexor) and nefazodone (Serzone) was consistent. "Using complete data sets (including unpublished data) and a substantially larger data set of this type than has been previously reported, we find the overall effect of new-generation antidepressant medication is below recommended criteria for clinical significance," they write.

Two more frequently prescribed antidepressants were omitted from the study because scientists were unable to obtain all the data.

Concerns have been raised in recent years about the side-effects of this class of antidepressant. Evidence that they could prompt some young people to consider suicide led to a warning to doctors not to prescribe them for the under-18s - with the exception of Prozac, which was considered more effective than the rest.

In adults, however, the depression-beating benefits were thought to outweigh the risks. Since its launch in the US in 1988, some 40 million people have taken Prozac, earning tens of billions of dollars for the manufacturer, Eli Lilly. Although the patent lapsed in 2001, fluoxetine continues to make the company money - it is now the active ingredient in Sarafem, a pill sold by Lilly for premenstrual syndrome.

Eli Lilly was defiant last night. "Extensive scientific and medical experience has demonstrated that fluoxetine is an effective antidepressant," it said in a statement. "Since its discovery in 1972, fluoxetine has become one of the world's most-studied medicines. Lilly is proud of the difference fluoxetine has made to millions of people living with depression."

A spokesman for GlaxoSmithKline, which makes Seroxat, said the authors had failed to acknowledge the "very positive" benefits of the treatment and their conclusions were "at odds with what has been seen in actual clinical practice".

He added: "This analysis has only examined a small subset of the total data available while regulatory bodies around the world have conducted extensive reviews and evaluations of all the data available, and this one study should not be used to cause unnecessary alarm and concern for patients."

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Link to study's website[/URL]

[quote]Editors' Summary

Background.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.[/quote]

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Quote:

What Did the Researchers Do and Find?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.

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Quote:

Additional Information.

Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050045.

The MedlinePlus encyclopedia contains a page on depression (in English and Spanish)

Detailed information for patients and caregivers is available on all aspects of depression (including symptoms and treatment) from the US National Institute of Medical Health and from the UK National Health Service Direct Health Encyclopedia

MedlinePlus provides a list of links to further information on depression

Clinical Guidance for professionals, patients, caregivers and the public is provided by the UK National Institute for Health and Clinical Excellence

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I honestly cannot plow through all that Walter!!!

Are they saying that there was something wrong with the original trials that got Prozac licenced, or that the drug company deliberately concealed the results of some trials, or that current trials have not replicated the results claimed by manufacturer?

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Well, the researchers discovered that the drugs, generally work no better than dummy pills, and said exercise and therapy should first be prescribed instead.

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What are the benefits of taking both Prozac and Viagra?

If you don't get any , you don't give a fook Laughing

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The drugs, as the Verve sang, don't work - although there is no evidence to suggest they make you worse.

The Guardian, Times and Independent all splash with the findings of the first comprehensive study of four selective serotonin reuptake inhibitors commonly prescribed for depression, better known by their brand names of Prozac, Seroxat, Serzone and Efexor.

Unlike previous surveys, this one took in both published and unpublished evidence. For the majority of patients, the SSRIs "work no better than a placebo", the Times says.

British doctors, who write 16m prescriptions for SSRIs each year, are astonished. "We have taken it on trust that a person who takes an SSRI ... and gets better has done so because of the drug," a London GP writes in the Times.

The paper's science editor says the results suggest that "some people are genetically amenable to SSRIs". The Independent attacks "publication bias" - the tendency of scientific journals to publish findings that show positive results.

GPs are already being encouraged to prescribe counselling rather than antidepressants as a first-line treatment, the Guardian says. These findings will reinforce that trend.

The Guardian: see above

Times: Why it is often better to prescribe conversation than antidepressant pills

Times: Drug efficacy could be all in the genes

[Courtesy of The Wrap, one of Guardian Unlimited's paid-for services.]

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Walter Hinteler wrote:

Well, the researchers discovered that the drugs, generally work no better than dummy pills, and said exercise and therapy should first be prescribed instead.

Doh!!!! That much I could decipher.

Is this addressed to Prozac specifically, or all SSRI's in general?

Is this ONE study? Are they accusing the Prozac folk of hiding/manufacturing evidence?

Placebos generally work pretty damned well......many drugs don't do much more than placebos do (especially if they are the right colour for the right condition, or cause the taker to experience some discomfort).

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Walter Hinteler wrote:

The drugs, as the Verve sang, don't work - although there is no evidence to suggest they make you worse.

The Guardian, Times and Independent all splash with the findings of the first comprehensive study of four selective serotonin reuptake inhibitors commonly prescribed for depression, better known by their brand names of Prozac, Seroxat, Serzone and Efexor.

Unlike previous surveys, this one took in both published and unpublished evidence. For the majority of patients, the SSRIs "work no better than a placebo", the Times says.

British doctors, who write 16m prescriptions for SSRIs each year, are astonished. "We have taken it on trust that a person who takes an SSRI ... and gets better has done so because of the drug," a London GP writes in the Times.

The paper's science editor says the results suggest that "some people are genetically amenable to SSRIs". The Independent attacks "publication bias" - the tendency of scientific journals to publish findings that show positive results.

GPs are already being encouraged to prescribe counselling rather than antidepressants as a first-line treatment, the Guardian says. These findings will reinforce that trend.

The Guardian: see above

Times: Why it is often better to prescribe conversation than antidepressant pills

Times: Drug efficacy could be all in the genes

[Courtesy of The Wrap, one of Guardian Unlimited's paid-for services.]

The bolded bit ought to be considered very worrying. Depression frequently resolves without intervention, and anyone prescribing for it ought to

a. Know that

b. Be aware that therapy (and, as you commented) exercise, is at least as effective for most 'depression". But not for all.

Now you've sent me to the goddam articles, cos I don't trust media reports of scientific stuff!!!

Ok...the two articles I looked at didn't say the drugs are ineffective for MOST.

They said they minimally more effective than placebos for many, and no more effective for some.

They suggest the SSRI's may be extremely effective for some.

Not that I am arguing that anti-depressants are over-prescribed, and that for many there are much better options.

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I didn't link the original report properly - sorry.

Here's the link tot the study again

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

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I can say with 100% certainty that Prozac changed the way I behaved. I got very angry and violent.

I think that these drugs only work if you have a chemical imbalance. Otherwise, it probably is all in your head.

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Bella Dea wrote:

I can say with 100% certainty that Prozac changed the way I behaved. I got very angry and violent.

I think that these drugs only work if you have a chemical imbalance. Otherwise, it probably is all in your head.

Lol! That's where the chemical imbalance would be.

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:-)

Interesting stuff.

So it seems like a) it could really help certain people but b) it's WAY over-prescribed, which c) throws off the stats? Is that what you're getting so far, dlowan?

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sozobe wrote:

:-)

Interesting stuff.

So it seems like a) it could really help certain people but b) it's WAY over-prescribed, which c) throws off the stats? Is that what you're getting so far, dlowan?

I think one of the articles suggests over-prescription may throw off the stats.....as the over-prescription means that numerous people who won't respond get counted, and this lowers the average measured effectiveness; ie, if prescriptions were better targeted, then their would be less people for whom there was no, or very little effect, but I haven't got to thje article Walter posted the link to in his last response.

Another query I have is whether the doses being prescribed by GPs were in the clinical range.

When I was last around adult mental health discussions, GPs, at least here in Oz, were notorious for prescribing at well below the clinical range...ie they were prescribing in doses known to be ineffective. We'd see many really significantly depressed adults, who'd been on drugs for it for years, with no improvement (and I mean serious....like marked motor-retardation) who got better as soon as they were treated by people who knew what the goddam clinical range of the drugs were!!!!!

Again, I really support the idea that the drugs are way over-prescribed, but I have not yet read anything new or surprising in Walter's articles, nor have I yet read anything to support the headline that they have "no effect on most people given them". I am off to bed, but I will check more articles later.

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dlowan wrote:

When I was last around adult mental health discussions, GPs, at least here in Oz, were notorious for prescribing at well below the clinical range...ie they were prescribing in doses known to be ineffective. We'd see many really significantly depressed adults, who'd been on drugs for it for years, with no improvement (and I mean serious....like marked motor-retardation) who got better as soon as they were treated by people who knew what the goddam clinical range of the drugs were!!!!!

GPs are woefully undereducated about mental health, IMO.

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dlowan wrote:

Now you've sent me to the goddam articles, cos I don't trust media reports of scientific stuff!!!

Ok...the two articles I looked at didn't say the drugs are ineffective for MOST.

They said they minimally more effective than placebos for many, and no more effective for some.

They suggest the SSRI's may be extremely effective for some.

Thanks for digging through it and clarifying.

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Yes.

I trierd to edit my last post to add this:

For instance, the GP reported in one of the articles, whose comments I bolded, clearly knows nothing at any serious depth about depression (which is no surprise)....GP's are generalists.

Also, most doctors (at least here) will be far more comfortable giving a drug than they will be at looking at something else to do, and, again here, they tend to have a woeful knowledge of alternatives....or they think that attending as half day CBT workshop makes them effective practitioners of that therapy!!!!!!!!! Evil or Very Mad

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DrewDad wrote:

dlowan wrote:
Now you've sent me to the goddam articles, cos I don't trust media reports of scientific stuff!!!

Ok...the two articles I looked at didn't say the drugs are ineffective for MOST.

They said they minimally more effective than placebos for many, and no more effective for some.

They suggest the SSRI's may be extremely effective for some.

Thanks for digging through it and clarifying.

I think Walter has added a link which may provide more support for the headlines....but I won't get to it tonight.

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My aunt has been for four months in a psychiatric hospiatl - and was just released a couple of hours ago to a nursing home.

Prozac didn't help her - but Cipralex [Lexapro]. Which is just another SSRI.

(Since it given in combination with others, and since I don't recal what and how they changed these during that period, I can't say at all, how and why what worked better or not.)

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Prozac doesn't work better than placebo

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