Are You Aware Siliq Can Cause Suicide?

Print Friendly
February 20, 2017 | 12 Comments

Comments

  1. My word, what a lot of detailed reading! Is Siliq heading our way in the UK too? Or are the population of the USA the guineapigs in this matter?
    IF, and I shall repeat, IF all parties adhered to the conditions as laid out for Siliq REMS, I suppose there is a chance that anyone coming across an invitation to try this medication could feel rather reassured that they were in safe hands. How long though before someone starts cutting corners? For example, take it upon themselves to declare a low dose as ‘safe’ and REMS, at such a ‘safe’ level, to be unnecessary. A long list of ‘should dos’ is hardly going to stop unscrupulous use I fear.
    Looking at this from a patient’s point of view – how sure can we be that any of the above information will be conveyed to an unsuspecting user? Let’s say that the prescriber follows the conditions to the letter – how likely are they to fully inform their patient of the possible side effects.
    I fear that a lot of changes are needed before the ‘benefits’ will outweigh the ‘risks’. I fail to see the possibility of the necessary changes in attitude happening any time soon. RxISK will be contacted as much as it ever has been for yet another drug I suspect!

    • Dear Mary — The REMS program for this drug ain’t perfect by a long shot. But it goes way beyond what’s been done for antidepressants, anticonvulsants and other drugs used for “psych” troubles.

      Here’s a link to the contract each patient must sign:
      http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-02-15_Patient_Prescriber_Agreement_Form.pdf

      And the wallet card s/he must get to carry as a reminder:
      http://www.accessdata.fda.gov/drugsatfda_docs/rems/Siliq_2017-02-15_Patient_Wallet_Card.pdf

      Looking at that wallet card, I can’t help but choke up a bit. Many are the good folks who would still be with us if they had been given a simple warning like that with regard to their Paxil/Seroxat …

      • Thanks for your info, Johanna, but I’m still not convinced that things will be much safer for the poor Siliq users despite the contracts and wallet card.
        Of course, I cannot comment on things in the USA but I have a feeling that I know how things would work out in our country. Someone would feel that they were suddenly having suicidal thoughts and would ( hopefully) remember about their wallet card. They would phone NHS Direct to report their feelings and would be told that they definitely need to be seen by a doctor. This would be an appointment with the Out of Hours Doctors Service ( these things always seem to flare up at night don’t they!). At the said appointment, the doctor would find the patient in urgent need of admission – but, since this is mental health, the opinion of the liaison nurse from the Psychiatric Unit is needed. Their first, and last, words will always be “We have no available beds”. Would things REALLY be any different just because of a contract and wallet card? I doubt it very much. I just hope that the US situation is not as dire as ours is at present.

        • No, Mary, the situation in the USA is if anything worse. Nothing remotely resembling “an appointment with the Out of Hours Doctors Service” is available to 99% of us! It makes me drool with envy to imagine it. As for whether a hospital ER (A&E) will take you in (and whether they will pay any attention to your little card about a skin drug they never heard of) it’s a total crapshoot based mainly on your neighborhood and which insurance you carry.

          But I can tell you, based on my own experience, that just knowing your terrible feelings are *drug induced* rather than a sign of your own “terrible mental illness” can SAVE YOUR LIFE all by itself. It saved mine during my worst days on Cymbalta — and I did not even have a doctor who believed me. Just words on a computer screen, which I clung to.

          No, I don’t think Siliq users are adequately protected by this warning system. Especially since their drug is injected and lasts two weeks — they can’t simply stop.

          But never, ever doubt that simple information can save a life. Knowing it, you can believe in yourself and hang on. Not knowing it, you may not make it through the next few hours. That is why withholding this information from patients — and even teaching doctors to deny it — is such a terrible crime.

          • Johanna, I totally agree with you that having the knowledge is, indeed, a lifesaver in many respects. That should be your right – so that you can choose to take or leave well alone. I feel that phrases such as ‘suicidal thoughts’ etc. are often used in a rather flippant way – as if they were just a minor hindrance, whereas, in fact, they totally take over a person’s life. My argument is that, in both our countries it seems, IF drugs which carry such dangers are allowed to be prescribed, it should ONLY be WHEN that country is capable of providing adequate support and care for ANY who adversely react to the said drug. In that way, there would be some level of ‘safety’ in place for the prescribed users. Shouldn’t we expect the ‘prescribers’ to ensure such standards of care could be met before they prescribe it in the first place?

  2. This REMS Policy hinges on the Wonky ~~~~~

    The Valiant Clinical Trials hinges on the basis that those adults who committed suicide were already depressed because of their Psoriasis and this is what the FDA have discounted as Death Data but have brought in REMS as a type of Black Box Warning to pre-judge any post-judging…they are not seemingly harmless like Ro-accutane was purported to be for acne..

    How well-heeded was FDA/Paxil..

    This is the Access Data FDA.GOV January, 2017 information on Paxil:

    http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020031s074lbl.pdf#page=43

    ****
    “Physicians are expected to refer individuals reporting these symptoms to a mental health professional.”

    https://plaquepsoriasis.com/news/siliq-brodalumab-new-drug-approved/

    The biggest concern with Siliq in the clinical trials was its effect on the mental health of those taking it.  There was an increase in amount of suicidal ideation and behavior during the trials for those taking Siliq.  Some completed suicides were also reported.  This risk was increased for individuals who had a history of previous suicidal ideas and behavior, as well as depression.  Because of this, the drug has been approved with an FDA-ordered accompanying boxed label warning. In spite of this warning, the FDA notes that there is no established causal relationship between the drug and increased risk of suicide.

    *Refer
    *Expected
    *Mental
    *Symptoms

  3. Oh Annie, it gets better and better doesn’t it! Big Pharma now getting to be one step ahead by issuing warnings of possible problems – therefore, if anything happens on their drugs, no blame can be set at their door. They then say, just to be sure that sales are not lost, that, actually, their drug is quite safe.!
    The idea that any doctor, noticing adverse reactions, is able to notify a mental health professional and get timely support for the patient is laughable. Whilst waiting, no doubt the patient will be given an antidepressant – the result of which puts us right back in the thick of the problem! The only difference will be?…..that you have been warned!

  4. Sil-eek..

    The world doesn’t stop turning and neither do we!

    GSK ‏@GSK Feb 17

    The world doesn’t stop turning and neither do we! @ethicalp shares how we’ve changed to meet society’s expectations: http://gsk.to/2lLlYac

    “The real test to pass is not a lawyer test, it’s a society question: is it right that the company who’s selling you the product is paying you to talk about the product that they’re selling you? Does that feel right? Does it create a perception?” asks Witty. “Our conclusion was that it did create a perception, and our conclusion was it was right to stop.”

    http://www.ethicalperformance.com/bestpractice/article/213

    Antidepressants may not be perfect, but they DO save lives: Expert reveals how life-changing the drug can be when used in the right way 

    Professor Carmine Pariante has treated thousands of patients with depression
    Despite expert claims the pills have devastating side-effects, he stands by them
    They work when used correctly, especially alongside psychological therapy

    By Professor Carmine Pariante For The Daily Mail
    Published: 22:06, 20 February 2017 | Updated: 09:04, 21 February 2017

    http://www.dailymail.co.uk/health/article-4243156/Antidepressants-not-perfect-save-lives.html

    “Yet we shouldn’t forget these severe side-effects occur only in a minority, who probably have the abnormal reaction to these drugs written in their genetic make-up.”

    says ‘Chief Spokesperson’ for GlaxoSmithKline @ ‘Media Relations’…

  5. The clinical trials on Siliq were jointly run by AstraZeneca and the American company Amgen. But when the initial results came in Amgen bailed out entirely, leading to the early termination of the trials. The “stunning” suicide results – six completed suicides and dozens of episodes of suicidal thinking and behavior – were the biggest factor, but the cardiovascular results were pretty scary as well: a significant number of excess heart attacks and other MACEs, or Major Adverse Cardiovascular Events. AstraZeneca filed for approval of the drug, only to inform the FDA a few months later that it had sold the rights to Valeant Pharmaceuticals at a pretty steep discount.

    Valeant’s reputation is getting so bad that management is said to be considering a name change. This company has been focused on buying up existing drugs and jacking up the prices to whatever the market will bear—much like Martin Shkreli but on a larger scale. In recent years less than 3% of their budget has gone for actual research and development, leading even the corporate trade group PhRMA to disavow them as being more like a hedge fund than a “truly innovative” drug development company (like PhRMA’s oh-so-virtuous members).

    “The psoriasis market is crowed but extremely lucrative.” That’s how the investors’ newsletter Seeking Alpha summarized the prospects for Siliq and Valeant. David is right: owning the rights to a Monoclonal AntiBody or MAB, in the USA at least, is pretty close to owning a license to print money. The current price of Cosentyx (secukinumab), an IL-17A antagonist that’s expected to be Siliq’s main competition, is over $100,000 a year. Even if Siliq’s risky reputation means it never rises above #5 or #6 status in the “psoriasis market,” Valeant will make big money.

  6. Carmine Parianti

    Sil.ick ‘friends’:

    https://twitter.com/ParianteSPILab

    Carmine Parianti

    Do Antidepressants Save Lives? A Comment On The 2016 Interim Report On Suicide Prevention By The House Of Commons Health Select Committee

    http://www.huffingtonpost.co.uk/carmine-pariante/do-antidepressants-save-l_b_14616018.html?

    Dream on…

    Simon Wessely‏@WesselyS Feb 20

    Excellent piece in @Mailonline. No drug is perfect but antidepressants do more good than harm says @ParianteSPILab

    SPILab:

    Helen Tsamis No they don’t. They destroy.
    Like · Reply · Yesterday at 03:05

    Helen Tsamis They made me deathly sick
    Like · Reply · Yesterday at 03:05

    Jacques Wagner A waste of money and it doesn’t help. Its a quick ‘fix’ for your doctor nothing more. Makes it worse. Read the side effects, which includes ‘depression’ as a side effect… Many better ways to manage depression which is often misdiagnosed and always over medicated. Dont waste your time
    Like · Reply · 1 · Yesterday at 04:46

    Karen Kennedy I do not believe the lies! Who is really behind this article.

  7. You say watch out for REMS becoming more evident in relation to drug use now, and that with RoAccutane you have to sign up to agreeing not to get pregnant whilst on it, (nor for a month afterwards). But in USA they also have the I-pledge Form which you have to read with your prescriber and sign up to, not only dealing with pregnancy but also stating that you know this drug could make you feel so suicidal that you will take your own life. We assume this distances ROCHE from any liabilities from the suicides that occur during and following it’s use.

    When we lobbied the UK Government about this and triggered the latest MHRA Inquiry/Report into psychiatric effects of RoAccurane, one of the main requests we made was to have the I-pledge system in UK, like the one in USA. We realise that it would take out ROCHE’s liability but weighed against that was the feeling that any user, by sitting and having these side effects carefully explained to them, would at least be aware of the risks of devastating side effects. Our hope was that for those with only slight acne, (for whom it should never be offered anyway) the patient would realise there was a lot at stake by taking it.

    The MHRA Report in November 2014 states that their team of experts decided on balance that the I-pledge in UK is not needed because (a) it would take up too much of the physicians’ time to read it with each potential patient, and (b) it would alarm the patient and put them off using the medication….. So REMS, apart from pregnancy problems ( like Thalidomde it can produce deformed babies) doesn’t seem to apply here, unlike Siliq. Does this mean that a drug in use for over 30 years, (firmly considered by many bereaved families to have caused suicides) is permanently excused from the latest REMS safeguarding rules? Shouldn’t we all be pressing for new safeguarding alerts for ALL drugs, including psycholeptics? If patients had to sit with their GP and sign that they understand what, say, SSRIs could do to their brains etc, might many not decide not to bothe to swallow them and go for other socially prescribed remedies instead, which a GP could also offer. Also, might clinicians be less keen to scribble out a drug prescription which takes less than a minute, and instead hand out a local information sheet offering all kinds of self help and companionship resources? This would also only take a moment and their surgeries could also display such information.

    When we’ve pressed local GPs about this, they say they can’t be seen to be promoting this kind of thing as they haven’t officially verified its effectiveness.
    So, how do they feel certain they’ve verified SSRIs etc and their effectiveness? As if we didn’t know…..

Leave a Reply