Drugs company hid evidence that antidepressant *caused* suicide in teenagers

[edam]

This is why you can't trust drugs companies.

report here

It doesn't just cause suicide in teenagers. I took Seroxat whenI was depressed as an adult and within 8 weeks I had taken 3 overdoses. I cheered up when I came off it. Nasty stuff.

"GSK will not face criminal prosecution"

How predictable. These pharmacos are bastards IMO. They place financial success over and above the safety and health of vulnerable people. I am not at all surprised at the report, sadly.

crikey, dh used to work on seroxat for gsk. i dont remember him ever saying it was dangerous.

mind you , the only thing he ever mentioned about work was the new hiv drug that works a few months ago.

I agree you can't trust drug companies but I don't think they managed to hide anything, it's been well known for years that Seroxat and Prozak are not good drugs for young people.

I also took Seroxat and it was the scariest period of my life. Doctors simply did not believe me when I told them I was worse than before. I finally just stopped after some severe psychotic episodes and then had horrendous withdrawal symptoms. I was told I was imagining it.

I am very angry about this.

there was some discussion of this on the radio 4 news at lunchtime today including details of how some young people on seroxat took their own lives. One girl was prescribed seroxat for menstrual problems and within days of being put on it she committed suicide. How terrible.I can understand your anger constance.

Just saw another snippet about this on the news - the drug manufacturer won't be prosecuted for this as they were'nt legally wrong, only morally!!!!!!

I suspect the drug was tested primarily on adults and was never intended to be prescribed on children (or even young adults in their early twenties) so - and this is only a presumption - it wasn't tested as thoroughly on it's effects on under-developed childrens brains.

Feel awful for families who have lost loved ones .

constance, that is awful but sadly not a surprise. I played a very minor role in exposing this story and there was complete refusal on the part of those in authority - including the Royal College of Psychiatrists, who I am relieved to see have changed their ruddy tune - to accept that there might be anything wrong. Dowright denials that any withdrawal syndrome existed. It was all in the patients' imagination, apparently...

nametaken, it is only known now because some dogged researchers and lawyers managed to uncover the data. It's taken this long for the bloody drug regulators in the UK to realise/admit they can do sod-all about it!

I'm sure it is shitty for some adults, too.

Balanced review of the programme here:

www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1124413

Gosh edam, there's so much I want to say (you'll know in which context) but I won't. I'm most interested in the complete refusal of those in authority to accept there might be anything wrong. That often does seem to be the biggest problem in these stories.

Of course there is a conflict of interest for drugs companies and I hope regulations will be introduced such that all trials are registered and all results reported. However, it seems that the drug should never have been perscribed to children in the first place: "GSK has always completely rejected allegations that it improperly withheld data on the drug. It said Seroxat had never been approved by EU or US regulators as a medicine for those under 18, and that the company had therefore never marketed the drug for that age section. It also said its trial results had been submitted to regulators and were presented publicly in journals and on its website."

I don't know how it is ethically possible to do drugs trials on children & guess that a very small number may have been involved, rendering the results meaningless.

In general the link between ADs and suicide is not simple. I had a friend who killed himself after a long period of what now seems like untreated depression. In the days and weeks leading up to his death he was back to his old self, the dark cloud had lifted & he was able to see a solution to his troubles Apparantly this is not unusual. So links with suicide could, sometimes, be a result of the drugs working.

Upwind, that is hardly balanced. Cowan's sneering at David Healy is just pathetic. Healy stuck his neck out, risking the sort of professional ostracism that has been the fate of other scientists who dared to speak unpalatable truths, when the authorities were absolutely refusing to acknowledge that there could be any problems at all. The Royal College of Psychiatrists and the drug regulators were adamant there were no problems and all was well and anyone who said different was a fantastist.

Notice Cowan's declaration of interests at the end? He's clearly not one to bite the hand that feeds him.

And the 'oh, these people would have killed themselves anyway' line is just so convenient when you are talking about a drug for depression. The evidence is MORE people kill themselves on Seroxat than on placebo. Hence it has a real effect, you can't just blame the patients for being mad.

It's akin to the line that doctors cling to when they kill their patients through making a mistake or actual negligence 'Oh, they were ill, they would have died anyway'.

As for off-licence prescribing, it's hardly uncommon. Glaxo knew the drug was being used for children. THey also knew they had evidence that Seroxat was downright lethal for those patients. But they didn't tell anyone. They hid the truth.

I took seroxat for several months and felt very strange: confused, agitated, and missed an important exam (which is very unlike me). There is probably a spectrum of side effects which medical researchers and doctors have ignored (as was the case with the Pill).

This report interests me in the context of the other recent antidepressant story- that they are no more effective than placebo. Clearly, they have powerful effects: it appears that the medical profession are in denial about what at least some of those effects are. (Incidentally, other SSRIs have worked for me fairly well over the years but it could be that I count as one of the 'severe' depressives for whom it is claimed they do work better than placebo).

Indeed Edam, but the point is that people are unlikely to commit suicide if extremely depressed. ADs which work might make them more likely to do it. It is in no way obvious that this more of a problem with seroxat than other ADs.

ADs do have real effects over placebos - it could be that as they work they increase suicide risk. More ADs are being prescribed to children & not enough research has been done on the negative effects. See this clinical review

I never suggested the trial patients would have killed themselves anyway - just that the drugs might make them more likely to do so when they do work.

allegrageller - the recent study you are talking about was wildly misreported. It was biased through very short trial lengths not allowing the drugs time to work and it also based all its conclusions on a single trial which we were told nothing about.

Glaxo, when challenged (and the RCP) did use the 'they would have killed themselves anyway' line, though.

And it seems a very odd idea to give severely depressed people drugs that are likely to make them commit suicide. In what way is that helpful? You might as well prescribe meths to a patient with liver failure.

SSRIs were ridiculously talked up when they first came out, and now they are being ridiculously overcriticised, I think.

It's like when the press create a celebrity out of nothing, and then fashions change and they hound the same person to get evidence of their imperfection.

I took Seroxat for a long time and found it more helpful than any other AD. I had no significant side effects.

Even if it is the case that it has been responsible for some suicides, it is still a helpful drug for a great many people. So rather than demonising it we just need to make sure that thecriteria for prescribing it are appropriate and observed.

Agree Threadwom.

Edam - the drugs are not "likely to make them commit suicide", they may however slightly increase the risk. A lot of useful medications and drugs may have dreadful side effects.

Sadly it is not uncommon for people who suffer from depression to conclude that life is not worth living. It is just that when severely depressed they are less able to follow through with it. Glaxo & the RCP may have been right.

This just highlights that handing out drugs should not be seen as a simple solution. Those doctors who chose to perscribe ADs to children off-licence did so knowing full well that there could be serious side effects and proper trials had not been carried out.

What's an increased risk of suicide if it's not 'more likely'?

There's a diff between 'likely' and 'more likely'!

Now you are splitting hairs! No-one ever said nobody with depression has ever committed suicide. Question is, A. does this drug make it more likely, and B. hould doctors and patients know about this? Glaxo spent years answering A. no and B. No.

As it happens, they also manufacture a drug I have to take every day (for a completely different condition). So I'm not wishing them out of existence. But I do think their behaviour on this one was evil.

Not really splitting hairs. I'm sure there are lots of useful drugs which doble the risk of some serious something-or-other -- double it from something like 1 per 700,000 to 2 per 700,000. They make it more likely but not likely!

Tho I entirely agree that the supression of info is wicked.

These drugs do not have a licence for prescription to under 18s, so doctors prescribe under their own responsibility.
All data as far as I'm aware was collected from five trials (with seroxat) and no correlation was found in the individual trials, but emerged after all the data was looked at as a whole, that feelings of suicide were possibly increased by the drug. No suicides occurred - thank God. I believe this is the reason that the regulatory body did not get this info sooner, but all findings were submitted when they were known. This is the reason why no licence for under 18s.
I may be wrong on some of this, but I don't think so.
It makes me sad that there is such an anti press ready to 'expose' these stories, but you have to take them with a pinch of salt, sometimes, or journalists wouldn't sell story and newspapers wouldn't be read, unless controversy.
Big pharma are business and in the business of finding drugs to ease burden of disease, which they do to a very large extent and are only successful because of this. All drugs have side effects - all of them, and the regulatory bodies weight this up when granting licences. Please know that. We have the most stringent regulatory process both here and in U.S. and as science and medicine become more advanced, then so do the benchmarks in safety and toxicity testing that must be gone through before a new drug is approved, which is only right and proper.
Extensive trials are carried out, but sometimes it is only when a drug is widely prescribed that some side effects become apparent. Even so, some people do gain a benefit from the drug, and some people have a problem, which is where the GP needs to alter treatment accordingly - not always done.
If there have been any instances where data has been concealed they will be found and dealt with. Believe that.