Margaret’s story

March, 31, 2012 | 20 Comments

Comments

  1. Perhaps the MHRA are less enthusiastic about making a huge deal about the suicide risk because untreated depression is a far greater suicide risk than SSRIs, and there is ongoing debate about whether the American experience with the FDA black box warning increased suicide rates due to decreased SSRI uptake.

    • So the people that kill themselves due to these drugs are what? Disposible, acceptable loss…what are you saying, that they died for the greater good?

      And you know untreated depression is a far greater risk than SSRI’s how?

      • @Neil
        “So the people that kill themselves due to these drugs are what? Disposible, acceptable loss…what are you saying, that they died for the greater good?”
        Of course no one is disposable. But unfortunately, all drugs have side effects. People should be warned about possible side effects, and if they weren’t it’s a horrific shame; but it’s the clinician’s fault, not the drugs. Nobody asked them to sacrifice themselves “for the greater good”, they died trying to cure themselves for their own good.

        “And you know untreated depression is a far greater risk than SSRI’s how?”
        Because the SSRI link is controversial and not reproduced in all studies or meta analysis, despite the impression you might get from reading this site, whereas the link between depression and suicide is eminently reproducible.

        @Maria
        “…depression is linked with suicidal thinking, the links with completed suicide are weak. …Those on psychiatric drugs however for both psychiatric and non-psychiatric disorders self harm and suicide at an alarming rate. ”

        I’m afraid I’ll need some citations for those claims. The WHO have evidently not updated their pages on suicide or depression so it must be very recent indeed.

        • “People should be warned about possible side effects, and if they weren’t it’s a horrific shame; but it’s the clinician’s fault, not the drugs”

          A horrific shame… So your saying its the clinicians fault then. You local GP has all the facts about every drug? Or maybe you think because its mentioned somewhere in the PIL in 4pt text using medical jargon its the patients fault. The risks were there for them to see as long as they have good internet skills and a few weeks to do the research. Its any ones fault but the companies or regulators?

          And why do you think it is that most clinicians have next to no idea that these horrible side effects even exist. Even the ones that specialize in the field!

          I am speaking from personal experience here so yeah you can trash my anecdote all you want, which of course is the way now of SBM isn’t it? We all live in a world were we cannot accept anything in our reality unless a couple of suspect RCT’s say its so. How the future will laugh at us.

          Of the three GP’s, one Psychiatrist and one CPN I have talked to recently, all have said that there is NO WAY my wife’s adverse affects have anything to do with the drugs, despite them being listed on the PIL, despite the problems going away only after the drugs had been discontinued.

          When my wife asked her GP to send a yellow card to MRHA, her GP ordered blood tests to explain away soem of the physical issues. He completely dismissed her drastic personality change and destruction of her family. When the blood test came back ok, he ordered more blood tests saying there where a few things he didn’t check for. I am going to be interested to see what he does when these test come back clear. Will he suggest its all in her head…that is were my money is.

          Where exactly do these professionals get their information from? Drug reps maybe?

          In a cruel twist of fate, 7years ago I was best man at the wedding of the man who went on to sell the very drug that nearly destroyed my family. When I told him about the adverse reactions we had experienced, he claimed it was the first even he had even heard of it.

          “SSRI link is controversial and not reproduced in all studies or meta analysis, despite the impression you might get from reading this site”

          SSRI’s are contorversal full stop, as are the studies and analysis, surely you know this. As for non medicated depression and suicide, … clean data on suicide from depressed patients who have NEVER been medicated. I read a little about that subject in Anatomy of an Epedmic but it was a while ago so I can’t quite remember what the data said exactly. But I would be really interested to see that. Really interested. NEVER medicated now, not just poeple not on medication at the time, otherwise I am not interested.

          Jamie, everything is not ok with the current situation. Sites like this are hopefully a tiny step towards putting that right.

  2. Surely Margaret’s son deserved to be told that the symptoms he was experiencing were a possible side-effect of the drug? Then again; what if the medical staff are not aware of this? There is a big possibility that if they were aware, then Margaret’s son would still be alive. I hold a different view; I cannot understand how doctors could not be aware that suicide ideation can accompany SSRI’S. Surely the doctors have Google? The side-effect ‘suicide ideation’ is also listed, at least with Cipramil, in the Doctor’s trainee manual.
    I too have written to the Irish equivalent of the MHRA, the Irish Medicine’s Board (IMB) to raise my concerns about the serious lack of warnings in the PIL’s. They have done nothing to rectify this as yet, but this is hardly surprising as the IMB are 87% funded by the pharmaceutical Industry. I also made a complaint to the Medical Council of Ireland (MCIRL) about the care or lack of care that Shane received in the last 17 days of his life. The MCIRL said they did not have the SSRI expertise to deal with Shane’s case and would have to get an outside ‘independent’ report. I informed them that you did a detailed Report for Shane’s Inquest and insisted on E-mailing it to them. Anyway, they also got an ‘independent’ report from an Oxford University Professor, Philip J. Cowen, who happens to do an awful lot of work for Lundbeck (the makers of Citalopram). I did point this out to the MCIRL. The unsurprising result was that the MCIRL eventually decided there was no case to answer.

    I then decided to write to the Irish Human Rights Commission (IHRC), as under the 1937 Constitution of Ireland, Shane had a fundamental ‘right to life’. After reviewing my correspondence with the IMB, MCIRL, Shane’s medical records, Citalopram PIL’s, Doctor’s statements and both reports, the IHRC decided to take some action…
    In December 2011, the IHRC wrote to the Medical Council requesting that, inter alia, patients are informed of the potential side effect of suicide ideation with SSRI’s and for closer monitoring and ongoing supervision when SSRI’s are initially prescribed.
    The IHRC suggested that consistency of care of persons presenting with symptoms of depression would be served by ensuring that the following matters are expressly required to be explored and addressed by the medical practitioner with their patient:
    (i) Discussion of alternate therapies
    (ii) Referrals for counselling/psychiatric review
    (iii) Within medical practices seek to ensure the same doctor deals with the person at all stages if at all possible;
    (iv) Oral explanation of risks/side-effects of SSRI’s in advance of prescription, together with relevant written information;
    (v) Guidelines regarding prescribing SSRI’s from initial stage through ongoing treatment;
    (vi) Level of monitoring and ongoing supervision required when SSRI’s are initially prescribed
    (vii) Maintenance of adequate consultation notes; and
    (viii) The necessity to obtain a full patient history before prescribing SSRI’s
    It remains to be seen whether the IMC has acted upon this, somehow I doubt it.
    Leonie

  3. I remember meeting with the CEO of the MHRA, although it was a meeting to do with SSRi withdrawal, he told me he would write to the BNF to relay my concerns about the lack of advice given for tapering methods. That was a few years ago, it’s pretty much unchanged.

    David Healy, the author of this blog, also met with them a year or so after. He presented them with a withdrawal protocol…

    It still remains on the MHRA table collecting cobwebs.

    Margret’s story is tragic, made even more so by the limp-wristed lickspittles at the MHRA who, once again have seen to be dragging their heels in the hope that a grieving parent will just ‘go away’.

    The DoH are no better…neither are health ministers.

  4. Actually Jamie, more recent research by the World Health Organisation shows that while depression is linked with suicidal thinking, the links with completed suicide are weak. Around the world, governments estimate that up to half the population will suffer a depressive episode. An infinitesimal proportion of those people kill themselves. Those on psychiatric drugs however for both psychiatric and non-psychiatric disorders self harm and suicide at an alarming rate. The argument that untreated depression is a greater suicide risk than psychiatric drugs doesn’t therefore stack up.

  5. No, Jamie, as Maria states, your argument doesn’t stack up. It wouldn’t stack up if SSRI’s were prescribed solely for severe depression, but when they’re dished out for complaints ranging from backache to PMS, then your argument becomes completely irrelevant.

  6. The huge deal for the MHRA is that they are funded by drug companies who put profit before patient safety. How much funding have the drug companies or health authorities put into proper assessment of the SSRI risk once in general use? They will always wish to conclude that the problem must be the patient not the drug, it is in their shared interest to do so.
    The MHRA has not put an effective system in place for recording the statistics for SSRI-linked suicide. Plainly they do not wish to see the results.

  7. In an analysis of placebo controlled trials submitted to FDA on antidepressants used for anxiety indication Khan et al (2002), J of Affective Disorders 68, 183-190, report 11 suicides in 12,914 patients on antidepressant, versus 0 suicides in 3,875 patients taking placebo. The worst of the antidepressants was clomipramine which is a potent serotonin reuptake inhibitor.

    • But that difference is almost certainly not statistically significant. If the rates were exactly the same in placebo as for antidepressant, we would only expect to see 3 suicides in the placebo group. A difference of 3 rare events in 3875 people is not enormously different from chance!

      From the paper:
      “We conducted a series of Chi-square tests to assess statistically significant differences among anti-anxiety agents (both investigational and active comparators) treated patients compared to those treated with placebo for incidence of suicide and suicide attempts. The only statistically significant pattern was a higher risk for suicide attempts for those assigned to active comparators (alprazolam or clomipramine) in the anti-panic agent studies (X2=7.75, df=2, P=0.021). The available data do not allow us to evaluate risk for those assigned to alprazolam compared to those assigned to clomipramine.”
      And if you look at the figures that risk (which may be due to the benzo comparator anyway) is coming from one (1) extra unsuccessful suicide attempt in the active comparator group. This paper does not seem supportive of the idea that antidepressants cause suicide attempts.

  8. Jamie if you choose to read an increase in suicides that might have arisen by chance as not actually an increase you’re welcome to do so but its rather like regarding a gun as not loaded because some of the barrels are empty and if you take your chances you might be okay. If you can find me a regulator or company person who would join you in such a roulette, let me know.

    I suggest you read back through all the entries on the blog. If you think company coding of withdrawal suicides as placebo suicides in breach of FDA regulations was probably just innocent (likely applies to some of the supposed placebo suicidal acts in this Khan paper) that’s your prerogative. If you think company monitors were wrong to say their SSRI had caused healthy volunteers to become agitated, apprehensive and have violent thoughts – again fine. If you think there’s nothing abnormal about healthy volunteers commiting suicide on serotonin reuptake inhibitors and companies were wrong to settle the cases – well no-one knows who you are and no-one expects you to be able to justify your position.

    But I do expect regulators and companies to justify their position, and they haven’t. The next series of posts will cover this issue in greater detail.

    • It’s called statistical analysis, David, not Russian roulette. If you can’t show that your purported increase in suicide risk is actually a real increase and not simply due to the fact that a certain expected number of people in any group will commit suicide over a given period of time, there’s no reason to go after the drugs. Given that the Khan paper is about how anxiety is actually a bigger risk for suicide than had been thought, a 0% rate of suicides is probably down to the sample size not being big enough to reliably pick up rare events.

      Maybe the drugs companies have fiddled the figures; that’s a separate argument, and I’ll read your posts about it. Presumably since you cited those figures from Khan et al. to me, though, you think they’re valid. On any level of academic rigour beyond “it looks like a real increase to me”, they don’t support a link between antidepressants and suicide. The part you should be interested re: bias in is the fact that there is an apparent increase in risk (note that it has been analysed properly, but may be due to a benzo) which only appears when the drug is used as a comparator, not as active treatment.

  9. Jamie,

    Most studies are pooled to make them look good. Add a few negative studies to ‘positive’ studies and voila you have the results you need.

    You fail to recognise the long term issue as well. What happens to patients who have been on these types of drugs for a year or more?

    That’s when Post-Marketing Surveillance is supposed to come in to play – but it doesn’t really.

    Saying a drug causes x,y, or z isn’t enough. It should be investigated why it causes x, y or z.

    If 3875 people ate food at a restaurant and three of them died as a result of food being served at that restaurant, would that be just ‘chance’?

    We have a regulator logging yellow card reports but doing very little follow-up, we have an industry, who have made of 3,000 out of court settlements in the US on Seroxat withdrawal alone, almost 800 out of court settlements on Seroxat birth defects.

    Withdrawal issues and birth defects were known very early on but they chose to suppress that information.

    As patients we are entitled to informed consent, we should know all the facts and not just the ones cherry picked by pharma.

    Have you ever tried to ask for withdrawal advice from any pharmaceutical company Jame? Try it and get back to me with their advice.

    Fid

  10. Jamie – what you’re offering is not statistical analysis – you’re using doubt is our product as a defense to suggest that a substantial increase is no increase. See the Psychotic Doubt post.

    The Khan paper is extraordinary on a number of fronts. They say the common understanding in the field is anxiety poses no risk of suicide. This is consistent with the findings on placebo – zero suicides. If people in the UK committed suicide at the rate that patients on drugs with anxiety in the Khan study committed suicide there would be 62,000 suicides in the UK per year – a 10 fold higher rate than there is. They offer no basis for concluding that anxiety rather than the drugs pose a risk of suicide – I commonly show these figures and the Khan conclusion and get howls of laughter from medical audiences.

    Regarding the Khan figures I think the figures for suicide are correct and the suicidal act figures are likely wrong – based on the widely accepted fact that Khan et al’s comparable figures for suicidal acts in their depression trial meta-analysis were demonstrably manipulated by companies to minimize the problem – a minimization that Dr Khan and colleagues could readily have noticed in their depression study, indeed could hardly have missed, but did not report.

  11. According to the US NIMH, there are 11.3 suicide deaths per 100,000 people (.01%), or 33,900 US suicides per year. The rate of suicide has been substantially unchanged for 50 years, despite the widespread prescription of antidepressants in the last 20.

    Medicating 10% or 11% of the population to (unsuccessfully) stamp out a suicide rate of .01% is, at best, a misapplication of resources. Given the dramatic adverse effects of the drugs, it is an endangerment of the public health.

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