Prozac is the safest drug for depressed children. Why this is a myth.

By Jerome Burne

There can be few people who think that putting an increasing number of children on SSRI anti-depressants is really a good idea but then reflect that it’s just one of those things. Cash strapped NHS; time-poor GPs; waiting lists of months for therapy; drugs cheap; they may help some.

But we know these drugs can make children suicidal and that they are marginally effective at best. If they did work well, the drugs companies wouldn’t have had to go to such extraordinary lengths in torturing statistics and rigging trials to produce favourable results. Some of the ways this is routinely done is revealed in a feature of mine in the Daily Mail today.

But only one of these drugs – Prozac (fluoxetine) – is licensed for children and adolescents under the age of 18 on the grounds that it is more likely to help and less likely to harm than the others. But is it?

Recently I was sent documents which strongly suggest that this is a fallacy; that Prozac’s supposed greater benefit and safety for children is the result of just as vigorous data rigging as all the rest.

Bringing up the bodies

The Daily Mail feature is based on research, published in the BMJ last month  by Professor Peter Gotzche, an expert in drug data manipulation. He describes what he found when he burrowed into the full data collected during trials of half a dozen SSRIs. These reports often run to thousands of pages and contain details of trials never normally seen. It is here the bodies are buried, out of sight of doctors and their patients.

The number of children and adolescents being prescribed an antidepressant has doubled in the last decade – an estimated 100,000 prescriptions in the UK. Presumably the majority of them are for Prozac.

So it is appalling that the data I’ve been sent is not secret or unknown, it has simply been ignored. One part is the evidence used to licence Prozac in the first place in 2001, which now looks remarkably shaky. The other is a journal article published last year that shows how key studies that supposedly support Prozac were very misleading.

The journal article is by a Swedish researcher – Dr Gӧran Hӧgberg of the Child and Adolescent Psychiatric unit at the Karolinska Institute in Stockholm. Five years ago he was shocked at the results of doing something very simple. He compared the abstracts (summaries) of seven trials that have given Prozac the green light, with what was in the full report. There were major differences. The abstracts – all that most medics read – painted a much rosier picture by leaving out key findings.

Suicidal events with Prozac higher than expected

In the detached understated language of science, this is what he found. ‘We concluded that a major, albeit underreported, finding….was the significant increase of suicidal events in in the adolescent on antidepressant medication in comparison with the group on the placebo.’

Notice the understatement – ‘albeit underreported’ Just how much greater was the risk if you were an adolescent on Prozac, the safest SSRI, compared with a placebo? ‘The proportions of suicidal events were 11% and 2.7% respectively.’ So, more than three times greater.

The discrepancies Hӧgberg spotted were subtle but the cumulative effect was to downplay the risks of suicidal events on the drug. For instance in the first study in 2004 the abstract reported that nearly a third of the children had suicidal thoughts at the start of the trial but that they all improved significantly whichever treatment they got. Impressive.

What was missed out was that there were more reports of suicidal events in the Prozac group than among those on a placebo

Leaving out the comparison between the drug and the placebo, which is the clearest way of isolating the effect of the drug, was also a failing of several other abstracts.

Seventeen suicides not mentioned

The most striking omission came in a study published in 2009 entitled: ‘Assessment of safety and long-term outcomes’. The abstract said: ‘No difference between the groups in rates of suicidal events.’ In fact the study had found 17 suicidal events in the in the Prozac group and none in those getting either CBT (cognitive behaviour therapy) or a placebo.

Hӧgberg makes a final point: “None of the seven abstracts …mentioned the fact that there were four times more suicidal events with fluoxetine than with the placebo …this difference was statistically significant.”

In other words the information about Prozac and children that should, at the very least, have set alarm bells ringing in the offices of psychiatrists and regulators, was there in the research they were relying on all along. They just didn’t notice.

It’s worth noting a point about the language used in this research. The ‘suicidal events’ which Hӧgberg refers to, include thinking about suicide, behaviour that involves preparing for suicide and actual suicide.

A confusion that is killing children

There is a professional debate around the relationship between thinking and preparing and doing it. Professor Gotzsche is clear on this: “Not everyone who thinks about it or prepares for it actually commits suicide but far too many do, he says “This confusion is killing children.”

It’s also worth making it clear how influential these studies had been. They all came from a major, long running study known as TADS (the Treatment of Adolescent with Depression Study), funded by the American National Institutes of Mental Health. It cost 17 million dollars and included 439 children between 12 and 17 who had been diagnosed with major depression. It looked like research you could believe in.

But TADS isn’t important just because it was big and expensive; it also played a major role in creating the notion that Prozac was the go-to drug for depressed kids. When the first report from TADS came out in 2004 the whole idea of giving antidepressants to children was under heavy attack. GlaxoSmithKline had been discovered hiding trials that showed Seroxat wasn’t effective for children and raised their risk of suicide.

That year the FDA had held hearings on increased risk of suicide in children with SSRIs and ordered a black box warning about it. But Prozac had already got a licence even though critics at the time claimed that this was more to do with the favourable way the trials were designed than genuine superior performance.

Concerns about Prozac safety date back ten years

The results of that first TADS study made it look like Prozac did the business. It was a big trial and after twelve weeks the kids getting a combination of Prozac and CBT had a response rate of 71% compared to 35% for the placebo.

Critics at the time pointed out that during the trials in involving CBT the researchers hadn’t been blinded (they’d known who had been getting CBT) and that when Prozac and a placebo had been directly compared there had been no difference. It’s depressing to note that this is the same criticism that Hӧgberg was making ten years later. But back in 2004 TABS turned the tide.

So what about the data that was used to get Prozac licenced for children in 2001? How good was it? It’s still important because the revelations about suicide with SSRIs didn’t become public until 2002/3. So ironically although Prozac is presented as the drug that is least likely to raise children’s suicide risk the trials used to licence it didn’t consider suicide at all.

This is clear from the other document I received recently which was crucial to the licensing of Prozac for kids. It is an assessment by an FDA (Food and Drug Administration) expert of the reliability of the trials sent to them by the makers of Prozac – Eli Lilly – to prove it was safe and effective.

Prozac fails to shine in licensing trials

Its bio-medical statistics are way above my pay grade but certain points from the review stand out. It concludes that Prozac should be approved but it is far from an enthusiastic endorsement.

Not only did the drug fail to meet its primary goal – to be more effective than a comparable drug at improving subjects’ depression scores – but it barely succeeded in its other aim, to increase the time before a relapse. The reviewer wryly commented that promoting the drug for this purpose ‘may not be appropriate’.

What’s striking, given these failures is how far the company went to rig the trials to boost their chances – patients who responded well to a placebo were excluded and so were those who responded poorly to the drug. But even these tricks, which Professor Gotzsche also found in his recent BMJ review, were not enough to provide a convincing win.

And there was something else that makes you wonder why anyone thought Prozac was beneficial for depressed children in general, let alone safer. There was a sub-group of patients with anxiety as well as depression in the trials, who responded particularly well to the drug. Without their positive ratings Prozac’s benefit dropped significantly.

Could Prozac stunt a child’s growth?

There was evidence from the trials that Prozac stunted growth which worried the reviewer that it might have damaging effects on ‘growth development and maturation with longer exposure’.

After all these reservations it is curious that the reviewer baldly concluded: ‘I believe the trials provide evidence that fluoxetine benefits pediatric patients with depression.’

It might be relevant to point out that the scientist who did both of these Prozac licencing trials was Dr Graham Emslie of University of Texas-Southwestern Medical Center. Emslie was also one of the authors on the infamous Study 329 which claimed that another SSRI – Seroxat – was safe and well tolerated for use on children when it found nothing of the sort.

A later analysis found there were ‘clinically significant increases in harms, including suicidal ideation and behaviour’. The company GSK was eventually fined three billion dollars for fraudulently promoting Seroxat. There are more details on Study 329 here.

Time for an independent review

The subsequent history of the FDA reviewer, Dr Andrew Mosholder, is also interesting. In2003, he discovered that antidepressants led some children to become suicidal. His findings were leaked to the press and the FDA responded by preventing Dr Mossholder from speaking to an advisory committee about his analysis – very possibly the one on suicides held in 2004. A year later an independent investigation concluded he had been right.

It’s impossible not to wonder how many lives might have been saved had Dr Mosholder known about the suicide link before he nodded Prozac through as suitable for children.

I’m not the person to make a final judgement on Prozac and children but given the rate at which its use and the death toll is rising, it is surely time for an independent review to decide if the drug’s special status is still justified.

Jerome Burne

Jerome Burne

Jerome Burne is the editor of HealthInsightUK. He is an award-winning journalist who has been specialising in medicine and health for the last 10 years and now works mainly for the Daily Mail. His most recent book “10 Secrets of Healthy Ageing” was written with nutritionist Patrick Holford. He blogs at “Body of Evidence” – jeromeburne.com. 2015: Finalist for 'Blogger of the Year' award from Medical Journalists' Association.

18 Comments

  • Despite these appalling shenanigans as far as I am aware GSK, and other offenders, have not been fined by the UK’s regulator, while receiving billion dollar fines for the same kind of thing elsewhere. This could fund the NHS’s shortfall.

  • This is true also in Ireland. These findings point to prima facie fraud’ not just by the medical establishment and its minions, but by shills, officials trusted by the public to monitor them. Unlike genocide it is a continuous crime, pierces qnd poisoning the very heart of our humanity.

  • My 17 year old only child killed himself 15 days after starting Prozac. No diagnosis of any mental disorder, no history of suicidal thoughts, nothing. Both Mylan Pharmacueticals and my government have undertaken causality assessments and concluded the drug was the probable cause of my child’s death. Have they taken any action as a result? None whatsoever. They just keep handing out the pills to children all over the world.

  • I am aware what is going for many years.The main preoccupation of society is to keep society sick!
    Self -esteem
    Positive self-esteem is not enough in itself self-knowledge is important in order for young people to develop not only optimistic view of themselves but also realistic.
    One of the society’s greatest shortcomings has been the failure to teach children about justice.It is the failure to teach empowerment,about understanding and attitudes that drive equality and justice.
    What psychiatrist frequently neglects is issues of emotional education,such as how to cope with failure or how to deal with feelings of anger and sadness.
    Adolescence is the transition to adulthood,so there is a need to prepare them for the new role as an adult,including making a decision about future.It is irresponsible to medicate young people…suppose psychiatrist showed us a way whereby we would truly love one another and be at peace,be at love.Can I think any more practical than that?But instead they think about medicating children,big profits are more important than humanity.

    A psychiatrist is at various stages of readiness when they’re ready perhaps?The integrity of medical professional and medical journal who publish findings that paroxetine was safe but actually caused children to become suicidal is most shameful;using young people as a scapegoat.The psychiatrist must promote public understanding of psychological issues that bear on social policies to ensure that the findings should be used in the service of human betterment.

  • Educate yourself!
    Youtube makes it easy to sample Peter Gotzche – along with David Healy, and Robert Whitaker. Look up the ‘Open Dialogue’ project for a positive boost of sanity amidst a corrupted medical ‘science’.
    The false science runs on the wish that something be true and then persists in the fear of exposure, with loss of reputation and revenue – when it is proven to be unfounded.

  • I am now a bereaved mother thanks to a psychiatrist choosing to ignore the information. Our Jake dead after 46days on Prozac, even after me telling the psych that he had difficulty after 6 days..Thank you Jerome for doing this article, hopefully somebody somewhere will take notice…If I had my way the prescribing psychiatrist would be getting charged with manslaughter….

  • Why is it still legal for giant pharmaceutical companies to continually kill our children? And here in America it’s an epidemic. We should be ashamed at the abuse we are subjecting our children to by prescribing Prozac or any psychiatric drug. After being prescribed at least 60 different psychiatric drugs over a 35 year span and how they completely ruined not only my life but destroyed my family lives as well is not a phenomenon, it’s happening across the Globe. But it’s the mentally torturous withdrawals from these drugs that induced almost every mental illness listed in the DSM including homicidal rages is what’s unconscionable. And mental health & psychiatry refers to this as ‘care’. It’s inhumane to subject children to endure what I have had to endure and I know, they say that the suicidal ideations SSRI’s induce only relates to people under 24. Well, this is a flat out lie because they induced suicidality in me until I was 57 years old. Enough is enough! Thankfully, I’m drug free today and I would NEVER, EVER touch another psychiatric drug again for as long as I live.

    • Why is insanity insane? Perhaps because another cause is accorded to a perception than its actual cause. Hence ‘disease’ is asserted and assumed for a dissonance within communication; indeed a breakdown of communication, and the symptoms are attacked and suppressed and denied their core value as communication – while the ‘protector-power’ invoked as guardian – becomes a guard against communication of truth – for such is a symptom received as a correction of communication.
      Deceit or pretence is inherent to the denial or avoidance of truth. At some level we know what we are doing – but that can be very well hidden and very deviously denied in a many layered defence upon which we feel self righteous or unfairly treated.
      Sickness or weakness of purpose is also a call to predators of one kind or another. In a collective sense we are calling attention to our definitions of consciousness and self through extremity of crisis. You have learned something and are witnessing from what you have learned. perhaps learned is not strong enough – you have been transformed.
      While there is a strong fear of fear and a corresponding wish to avoid or escape the underlying relational definitions that give rise to fear – there will be a market of providers and suckers for magic solutions – some of which may coincide with willingness to heal anyway – and some of which will further deny and suppress the problem so as to keep it from resolution.

  • My daughter started dying at age 10, the moment after she started taking the Prozac prescribed for mild social anxiety. Soon she developed suicidal thoughts–thoughts that never existed prior to taking this drug. We took her to the hospital. We left the hospital after 10 days with the Prozac prescription still in hand and absolutely no information nor warning was given to us that this drug increased the risk of suicidal thoughts and actions. Even though this was 2005-after the Black Box warning-we were still never told that the Prozac most certainly caused violent suicidal thoughts. Unfortunately because of the lack of information provided by the doctors, my daughter was prescribed Zoloft 9 years later. Zoloft is also an SSRI just like Prozac. My daughter died of a Zoloft induced “suicide” two days after taking the maximum Zoloft dose her doctor (killer) prescribed. These drugs kill people. The doctors who prescribe them without providing informed consent should be prosecuted for medical manslaughter when these adverse and fatal drug reactions occur.

  • Absolutely shocking! I was prescribed Prozac about 12 years ago and it was a terrifying experience. As is usual when starting new drugs, the Psychiatrist told me to bear with it as the side effects would wear off. I had to stop taking them as I couldn’t even stand up. I crawled to the bathroom I was so dizzy and disorientated. My head was spinning, rushes of suicidal thoughts through my head. I was actually crying out in mental anguish.
    I’ve taken several anti depressants since then and none have had that effect on me. Some have had other bad side effects, (Sertraline gave me really bad stomach pains and when I looked up the side effects it stated ‘cancer’ was one!). Doctors always tell you you’re in the minority or your side effect just doesn’t exist. When you research them however, there are plenty of people with the same experiences.
    Giving them to children?! They should be jailed.

    • Being a psychiatric survivor of being heavily drugged for 35 years, and finally (thank God!) off them all, I can tell you there are NO safe psychiatric drugs for children. They are not even safe for adults. This is nothing more than human genocide what Big Pharma, the FDA, and our U.S. Government is doing to not only our children here, but globally.

      I urge anyone and everyone to also view the documentary ‘Vaxxed’, the truth of Vaccines as soon as you can. (a whistleblower from the CDC) It’s still showing in selected theaters across America and not out on DVD yet.) Self education is the only tool we have because our Government is not informing us of the true dangers of psychiatric drugs or the vaccines. I urge everyone to arm themselves with ‘true’, ‘accurate’ information. It’s the only weapon we have right now if we want to protect our children.

  • Psychiatrist they are stuck with themselves,with their personalities,they must not forget that they have taken on bad habits:About time they stop and reflect and ask themselves why they respond the way they do?
    who are they trying to impress ?
    why don’t they response to people with care,or genuine respect?They have a lot of explaining to do.The moral problem remains,what they are going to do with their profession I hope they open up their history and respond to reality.Who influenced their character ?True morality rests on true humanity.It must be an ideal for all of us to reach true freedom ,to make our lives authentic and autonomous.There are no miracle cures…except the miracle cures that nature performs.

    Ideally, one should act for the motive that corresponds to what makes the action right .That means that one should act out of love of justice or truth or fairness.Drugs are dangerous and have a tendency to produce dependency what is going on is far more complex and obscure than any psychiatrist has thought up.A good doctor discourages long-term medication.It is unethical and very damage to young or older people… You cannot expect to build a high Vital Force on Prozac.Hippocratic precise aphorisms,food is medicine I am glad to see few writer have followed his legacy left behind twenty-five hundred years ago.
    N Kelly

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