More drug marketing by the back door – Servier take a bow

A colleague sent me this news item about research that shows SSRIs DON’T actually work – and they also ruin your sleep (bear with me – this is a good one).

BARCELONA, Spain — September 1, 2008. A Scottish study — Long-Term Antidepressant Treatment Without Active Management Hardly Induces Remission: presented at ECNP By Judith Moser, MD — identified a group of patients in primary care who are on long-term and stable treatment with selective serotonin reuptake inhibitors (SSRIs). A substantial proportion of patients displayed prevailing residual depressive and anxiety symptoms as well as sleep problems in spite of their treatment.

Alan Wade, MD, CPS Clinical Research Centre, Glasgow, Scotland, presented the study at a poster session on September 1 here at the 21st European College of Neuropsychopharmacology (ECNP) Congress.

Patients who were prescribed standard doses of antidepressants by their general practitioners without active management due to repeat prescriptions were identified from prescribing records in the West of Scotland.

Patients were invited to complete a questionnaire; 316 out of 893 questionnaires were completed and returned (35%).

 Each patient completed a Hospital Anxiety and Depression Scale (HADS). Simple Laekert questionnaires enquired about specific sleep symptoms; furthermore, the response to individual questions was analysed.

If patients are to have a good quality of life, it is important that the antidepressant treatment leads to remission with a minimal number of residual symptoms. 

Nevertheless, as the HADS results showed, most of the patients still displayed significant residual symptoms, despite the long-term treatment. 

Seventeen percent of patients still showed severe depression and 29% severe anxiety. No significant association was reported between the duration of SSRI treatment and the mean anxiety and depression scores.

Anxiety and sleep symptoms were prominent in over half of the population and interfered with the patients’ daily lives as reported by them. Only a minority of patients were satisfied with their sleep, and 29% perceived their sleep problem as a significant stressor.

The majority of patients (61.19%) had not reported their sleep problems to the general practitioner. Of those who had, 50.59% received a hypnotic medication. Treatment of insomnia often turned out to be helpful but led to long-term use in half of the patients. “The patients adjusted their lifestyles to this chronic illness,” Dr. Wade concluded. “They are just not actively treated well enough to get really well, so there are several questions to be asked in the future.”

Funding for this study was provided by Servier.

If only there was a new anti depressant that didn’t ruin your sleep… oh hold on… what’s this I wrote about in May this year when Depression Alliance found themsleves helping in the marketing effort for Valdoxan:

Interestingly, French company Servier, makes Valdoxan (agomelatine) which is an antidepressant, but with added qualities. Says Servier
“the drug’s unique profile could make it an exciting and innovative
product, but it will face stiff competition from top-selling
antidepressants already established in the market… As well as treating
the main symptoms of depression, the drug also helps to
improve daytime alertness by normalising the timing and continuity of
sleep, a problem that Servier says is common in patients.

That’s handy. So Valdoxan could be just the thing patients need – as
the new survey from Depression Alliance has discovered that sleep
disturbance is a real problem. But hold on, The development of this survey and the report into its findings were undertaken in partnership with and funded by Servier Laboratories Limited.

That’s a bit of a coincidence isn’t it?

And here’s another coincidence – Servier Laboratories this week [02 March 2006] confirmed the UK agency support behind its new anti-depressant, Valdoxan. Athena Medical PR
secured the contract to steer the brand to market. The drug is the
French firm’s first foray into the UK mental health arena, with
Valdoxan poised to enter the controversial and crowded market ‘during
2007′.

Valdoxan combines antidepressant efficacy with ‘favourable’ side effects – it has the additional benefit of sleep regulation in depressive patients, according to data unveiled last year.

Well that’s two pieces of ‘research’ (that Servier has funded) that will useful in its sales pitch for Valdoxan. I bet boxes and boxes of reprints of both pieces of ‘research’ have been mailed to GPs and handed over by Servier drug reps as they pass out the free samples of the new wonder antidepressant, Valdoxan.

16 Responses to “More drug marketing by the back door – Servier take a bow”

  1. anonymous Says:

    You’ve hit the nail on the head again ..

    “normalising the timing and continuity of
    sleep” ?

    Are these drugs truly so magical now that they can miraculously know how to make our bodies and minds “normalize the timing and continuity of sleep”, wow! That’s almost a bigger load of stinky bullshit than “well tolerated” , “depression is a chemical imbalance” and all the other utter crap GSK told us about Seroxat for so long!

    Servier, take a bow. you truly are assholes! And just like GSK , you spread disinformation and utter poo about your bogey drugs!

    • George Petropoulos Says:

      Valdoxan messed up my circadian rhythm (caused me insomnia), made me anorgasmic and had a barely noticable effect on my depression. I have been taking it for two months. I’ll go back to Wellbutrin.

  2. anonymous Says:

    And yes “drug marketing by the back door” couldn’t be anymore apt, considering the absolute crap that comes out of drug companies, I’d say that their “back door” is in dire need of a gigantic plug, the shit that they market as science smells worse than a manure factory in summertime.

  3. /\/\arty Says:

    I sense a great deal of frustration from the author of this blog and in the first 2 comments. As someone who tried 25+ psychopharmacological drugs and live permenantly with some SEQUELS induced by some of those meds, I DO understand those frustrations. BUT… I don’t see the point in bashing Servier and its new antidepressant when it’s not even on the market yet. No doubt the pharma industry marketing ploys are extremely unethical and sometime just disgusting BUT Servier is –F A R– from being the worst offender in the industry. So, considering that there’s A LOT of sufferers without working/tolerable medication and that this antidepressant – IS – promising in term of side effects profile and that it offers a new mechanism of action while retaining the same level of reponse and responders … What is the point of bashing Valdoxan ?

    Did any of you actually talked with someone who’s been in one of Agomelatine clinical trials ? I did. Some people who never respond to any antidepressants responded to it. They all report VERY FEW side effects, no weight gain, NO SEXUAL SIDE EFFECTS and (I admit I don’t quite understand this one..) the sleep is unusually refreshing (more energy in the morning) and this effect supposedly help significantly helped them (I repeat: I, too, don’t get this one yet) .. And, I think every GSK Paroxetine / SSRIs haters (I’m one of them) should love this one: there is NO WITHDRAWAL SYMPTOMS AT ALL … nothing, niet, nada. Sure, on papers all those caracteristics of Agomelatine sounds like cool aid, but when it comes out of the mouth of real people who tried it, some who are fighting in desesperation with their pdoc and Servier/Norvatis to get the right to get back on it before it’s marketed (Some are even considering investing large amount of money (10k USD+) to have some chemist synthesize AGO!)… when it’s been reported by them .. well … that’s another story. Try to find some people who’s been in one of the SSRIs trials and came out screaming everywhere that it changed their life and was the only thing that made them feel NORMAL .. as you already know, GOOD LUCK !

    If Agomelatine is just HALF of what it is reported to be by the real people who tried it.. JUST HALF.. then I can forgive Servier to use whatever twisted stategy they wish to use to get this drug approved by the EMEA (European equivalent of the american FDA) as soon as possible.

    Come on guys.. I’m sure we can, at least, all agree that new NON-SRIs (SSRIs, TCAs) options are more than welcome for people who can’t live without an antidepressant and needs to be on it chronically. Being depressed is already awfull, no needs for extra weights and a killed sex life. Years of Paroxetine (Paxil/Seroxat) killed PERMENANTLY half of my libido, reduced my erection capacity, anesthesied my genitelia and killed my orgasm .. I, for one, welcome any drugs having the potential to put the SSRIs to rest ! .. It WILL NOT be a miraculous antidepressant BUT how could we not welcome an antidepressant who will saves so many people from ‘SSRI balls dropping syndrome’ and from ‘Withdrawl Hell’ ?

    Next gen highly selective and side effect free 5-HT2C (or 2a) Antagonists has this potential and Agomelatine is the first of the batch.. the first nail into the SSRIs coffin.

    Remember: The enemy of your enemies is your friend.

    /\/\arty
    Feel free to come discuss this or just plainly flame me at the forum I hang out to; dr-bob.org .. old crappy site, I know😛 .. but there’s a lot of knowledgeable people there.

    • George Petropoulos Says:

      I have bee taking Valdoxan 25mg for 2 months. It messed up my circadian rhythm (caused insomnia), caused anorgasmia and had only a barely noticeable effect on my depression. It also elevated my liver enzymes. I’m trying to go back to Wellbutrin. There are withdrawal symptoms.

  4. /\/\arty Says:

    Just wanted to add ..

    Whoever who says depression is often linked with sleeping problems and for whatever purpose .. it’s still true, isn’t it ?

    Also, SRIs (SSRIs, SNRI, TCA) and MAOIs .. DO degrade your quality of sleep as they all suppress, to different level, the REM phase. Seroxat/Paxil is the worst in this regard in SRIs Land and NARDIL (Phenelzine), a MAOIs, is the worst by FAR as it suppress the REM phase TOTALLY. Whoever who understand what the REM phase is about and the consequence suppression has on memory formation/maintenance understand the value of the ADs (on the market and in the pipelines) which doesn’t affect REM sleep.

    AGAIN, whoever report/explain that and for whatever purpose … IT’S STILL TRUE.

    If you don’t believe it is.. then you didn’t do all your homework and I suggest you make a couple more trip to ‘Abstract Land’ @ Pubmed.com as it is a fascinating subject…

    @Anonymous: “normalising the timing and continuity of
    sleep” ? What you’re interested in is the circadian rhythm , ‘Melatoninergic System’, Melatonin, Melatonin receptor M1, M2, M3, the Clock Gene (Circadian Locomotor Output Cycles Kaput), the link between depression/bipolar disorder and the Clock Gene, Melatonin Agonist (Check Ramelteon)… Seasonal affective disorder (SAD) related to the Circadian rhythm and Melatonin is also of interest.

    /\/\arty

  5. anonymous Says:

    To the last poster above (arty)

    Whether Servier’s new “wonder drug” is a slight improvement on SSRI drugs is not the issue here. The issue is the deviousness of “back door drug marketing” , “marketing disguised as scientific studies” etc etc.

    An even bigger issue if the fact that “medication does not cure the human condition”. Depression is largely manifested by “life circumstances” , no matter what anti-depressant is prescribed , the source of depression and the trigger of depression is largely down to emotions, human nature, inability to deal with trauma, poor life skills and a lack of individual support in times of crisis.

    Prescribing any anti-depressants for peoples problems will always cause more problems because the drugs do not cure or solve the core issues. The core issues can only be dealt with by recognizing there is something wrong , and this has to come first from the individual. Talk-therapy is a far more effective and less hazardous way of dealing with the complexities of “depressive illness”. Drugs might provide short term “chemical relief” for some people, but in the long term they do more harm than good. The issues arising from such use (or abuse) of antidepressants can be dependence, addiction, withdrawal, a worsening of suicidal thoughts, cognitive damage, personality changes etc etc.
    The risks are not balanced fairly with the “benefits”.

    • George Petropoulos Says:

      Please note that Valdoxan’s half life is only 2-3 hours and yet Servier reccomends a single nightly dose. This doesn’t make sense. A pdoc told me that I might as well use over-the counter melatonin. He believes it is as potent as agomelatine with less danger for the liver.

  6. Lynn Says:

    Marty,
    If you think you can slide your obvious advertising statements by us by coating them with your alleged experiences, you must think we’re stupid. You are obviously doing advertising for this new drug, and NO ONE who had actually experienced the symptoms you claim to (which I have to some extent) would argue FOR a new brain drug. Also, the phrasing you used was obviously from company literature. People who have been damaged by pharmaceutical companies and government laziness or venality know not to trust a pharm company with their minds, nerves, etc. ever again. Your manipulation was more than obvious.

  7. cache-monkey Says:

    Lynn,

    I ran across this while searching for agomelatine. I find it puzzling that you seem to assume that Marty is advertising the drug because he (a) hopes/believes that it might work and (b) he uses technical jargon.

    You are welcome to simply go over to dr-bob.org and look up his archived posts. I think that will find that he is involved in a number of medication-related threads and is generally curious about whether and how they work, as well as the sometimes-horrific side effects they cause. If you search the archives, you will actually find a couple threads where people posted their experience in clinical trials, with Marty (and a number of folks) asking for more details.

    A more general concern for the original poster is: why are you bashing Servier for investigating a drug that it is trying to get approved? This is standard scientific practice in pharmaceutical research. Do placebo-controlled trials to show basic efficacy. Then do active-comparator trials to see whether it is any better or worse than existing drugs. If it ends up worse, well maybe you then run the risk of not having a drug approved.

    If it’s better, yes, that’s something that can be marketed. But isn’t it possible that there’s a legitimate basis for marketing/approval in that the quality of life of a substantial number of people might be improved? Maybe it’s helpful to think of a non-mental-health scenario. My grandmother was losing weight very rapidly on glucophage, which she was taking for borderline type-II diabetes. Based on research studies (probably funded by pharamaceutical companies) her doctor was able to switch her to another glucose regulator that didn’t cause her to waste away. Did the maker of the second med (can’t remember the name) benefit from this: yes. But, so did my grandmother.

    A final question: I don’t follow how the study you are quoting indicates that SSRIs “ruin your sleep”. Depression and insomnia have long been known to go hand in hand and a number of researchers actually believe that sleep problems are the root of depression (e.g. http://psychologytoday.com/articles/pto-20030715-000001.html). The text you quote states that people were having sleep problems “in spite of their treatment” with SSRIs. So maybe they weren’t SSRI responders, or maybe they agomeltine helped address a deeper sleep issue that contributed to their depression.

    One thing that I will agree with you on: SSRIs don’t work for many people, as evident by the “substantial proportion” of patients with on-going issues. Therapy, exercise and lifestyle changes can go a long way.

    But based on what I’ve seen, some people definitely benefit from meds, particularly if they’ve been depressed for a long time. (Maybe it’s the whole neourogenesis vs. atrophy hypothesis…) So now a medication comes along that has actually been documented to better than SSRIs for some people and with fewer side effects. Why harsh on the company that is developing it?

  8. anonymous Says:

    Just to address a few points by cache monkey .

    “The text you quote states that people were having sleep problems “in spite of their treatment” with SSRIs. So maybe they weren’t SSRI responders, or maybe they agomeltine helped address a deeper sleep issue that contributed to their depression”

    SSRI responders? that’s a new one, is that similar to the new Pharmaceutical psych drug phrase which they seem to be hawking of late, “treatment resistant” . If someone doesn’t respond well to an SSRI, it means the drug is not working for them, if someone gets ill on an SSRI it means the drug has made them ill. You can gloss it up with whatever excuse of an angle or agenda you want to, but the fact is , a large proportion of people do not do well on meds for depression. That’s because depression stems from emotions, feelings and reactions to truama! Most of it psychological! It really is that simple. IF you deal with the psychological and emotional side you are dealing with the cause of depression, If you prescribe meds for the “chemical” side (serotonin etc) then all you are doing is fiddling with the symptoms.

    Depression is a form of intense and overwhelming grief , despair , disillusionment and disappointment, it is also unexpressed anger and rage, feelings turned inwards. You can’t medicate the human condition, when are psychiatry and the pro-med pharma people going to understand that? Maybe, they don’t understand it because it is not in their interest to understand it , why don’t they promote talk therapy , diet and exercise and life style changes instead of drugs? Would it be because those things cannot be patented?

    “One thing that I will agree with you on: SSRIs don’t work for many people, as evident by the “substantial proportion” of patients with on-going issues. Therapy, exercise and lifestyle changes can go a long way.”

    Thanks, and you’ve just reiterated my first point for me!

    “But based on what I’ve seen, some people definitely benefit from meds, particularly if they’ve been depressed for a long time. (Maybe it’s the whole neourogenesis vs. atrophy hypothesis…) So now a medication comes along that has actually been documented to better than SSRIs for some people and with fewer side effects. Why harsh on the company that is developing it?”

    The only people who “benefit” from meds are those whom respond to a numbing of emotions and an obliteration of personality. If that to you seems like it is a good enough response then you are absolutely delusional.

    Of course it would seem like they work in some people, give anyone a chemical mood stabilizer and their mood would change. Alcohol does the same for some people, so does E , Speed, Acid , Cocaine and heroin, let’s recommend them for depressed people too shall we????

    “So now a medication comes along that has actually been documented to better than SSRIs for some people and with fewer side effects. Why harsh on the company that is developing it?”

    I think people are so sick and tired of the useless ” biological sick brain model” , and they are also sick and tired of deceitful pharmaceutical companies who have done nothing to advance the understanding and care of depression and other emotional disorders. They are sick of the lies, they are sick of being exploited for profit and they are sick of being told they are sick. They are just so damn fed up with it all, that’s why they criticize the industry and its practices.

  9. steve Says:

    I was on an ssri for about one week. My sleep was imediately affected; I couldn’t sleep and I felt like I was going crazy. I stopped taking the drug against the advise of the doctor. She said I would have to ween myself off over a period of weeks. I had only been taking it for a week! I had to stop simply so I could sleep. I have no doubts that SSRIs interupt sleep.
    Steve

  10. /\/\arty Says:

    First a word to Cache-Monkey:
    Thanks Cache-Monkey for having taken the time to search me on the web and report here that I was a real human being and not a corporate machine😛 .. I wonder if you go to dr-bob.org to. If you do I would guess Cache-Monkey isn’t your nickname there. Feel free to write me there to let me know who you are.

    Now to everyone else:
    Everyone in the scientific community that you seems to dispice agree that there are many forms of depressions and that some are SITUATIONAL (Psychologically driven). Nobody has any doubt about it and most searchers thinks it represents the majority of depressions. Now… denying the existance of BIOLOGICAL (neurologically driven) is so absurd that it’s robbing you of any credibility in regard to the subject at hand. Are you REALLY thinking there’s no such thing as mental illnesses having biological roots ? You realize Schizophrenia isn’t a lack of intelligence, an emotionnal blocade, a way of whoring for attention or a punition sent by god because of masturbation excess, right ? What about Bipolar disorder type 1 & 2 ? Someone’s bipolar because younger daddy and mommy divorced ? And OCD ? The guy who check if its door is locked -SEVEN-HUNDRED- time per day .. his uncle PeeWee, who was a locksmith, touched his peepee when he was 6 ? ……. everything that can go wrong in the human body go wrong in some individuals (ever checked how many diseases, disorders and syndrome exist ?) but somehow the brain would be the ONLY part of the body to experience somekind of disorders ? .. I guess you recognize Alzheimer and Parkinsons as legitimate disorders.. but WHY ? maybe it’s just 2 others marketing ploy by big pharmas who invented those ” ” diseases ” ” to cash more money ? Oh wait… that would be hard to ‘invent’ since there’s no such thing as psychologically based (natural/benign) Alzheimer or Parkinsons … right ?

    – Frustrations toward past medications experience ?
    – Religious/Sectious pseudo-science believes ?
    – Lack of knowledge or will to learn ?

    The world is a complex place my friend, I suggest you DEAL WITH IT. Here’s some facts to start with:

    1. Some people doesn’t have ANYTHING wrong with there lives, yet still suffer very deep depression/anxiety for no SITUATIONAL reasons.

    2. Most of those sufferers benefit from psychotherapy and vitamins as much as diabete sufferers: Not enough ? No amount of ANYTHING (no, not even this, that or those .. NOTHING) help them enough except some therapy which targets directly or indirectly neuronal activities.

    3. Pharmaceutical companies don’t give a crap about anything but profits and it happens that there’s profit to be made in developping new drugs which as some beneficial effects on those sufferers.

    4. Sufferers don’t care WHY big pharmas develops new drugs: they want them, they need them. More of them (more mechanisms of action) and more of the same but better (less side effects, less intrusive and more effective).

    5. Sufferers do because it’s that OR perpetual mental pain until death OR imminent DEATH. When you have the choice between many bad things you choose the one which sucks LESS, in this case for many it means the meds you like to hate.

    I don’t want by any means belittle your health issues, but if you can’t understand why, when and how some people DOESN’T have the choice and need to take the pills to survive (not only for them, but more often than not for their familly btw !) .. then BREAKING NEWS: you’re not THAT suffering, you are in fact a good candidate for psychotherapy and so you may well get over it before you die ! While it may look like an insult, what I’m really telling you is that you may not be stupid -> Your understanding of this complex subject is limited, and so justified, by your point of view which is the equivalent of a Diabetes Type 2 sufferers: your problem is easily managed by simply cutting on sugar and so you can’t, because of your lack of knowledge and/or analytical skills, see WHY any diabetes sufferers would want to inject himself with INSULIN … denying Diabetes Type 1 (people who LACK insulin) as only an inventions of pharmacological company to sell some Insulin …

    I can already hear you telling me lack of Insulin is real while lack of Serotonin is NOT… OF COURSE IT’S NOT ! Most medically educated people KNOWS SO WELL that it’s not the real ethyology (mechanism of the disease) that they don’t even discuss it between them because it’s too much obvious! … it’s a non-issue ! You see, in modern medical science you need a theory to justify the approval/prescription of a drug and when you know that you don’t know how your new drug act on something (like disease/pain/else) what do you do if you absolutely need to specify a theory ? YOU CHOOSE THEN SIMPLEST ONE and that happen to be *** WHERE *** the drug act, not HOW the drug act .. which you don’t know anyway ! So let’s take the SRIs (SSRI, TCAs etc) … we know it act on the 5-HT transporters (SERTs) and ***ONE*** of the simplest, most easilly understandable effect of that action is INCREASED SYNAPTIC SEROTONIN … so because you, as a pharmaceutical company or as part of the scientific community, need to work/progress/make money AND because sufferers NEEDS something that helps even if very unperfect/poorly understood AND because NOBODY is willing to wait 50 YEARS just so we can understand precisely how the drugs WORKS (but only in the labs rodents) SINCE 50 YEARS … you just use that oversimplistic explanation of the mechanism of action … Tadam! It’s not a secret or a conspiracy .. it’s a 50 years shortcut so that everybody gets what they want, sufferers the first .. is that way of doing things perfect ? ohh no. Necessary ? Yes. Moral ? 50/50: YES because chronic sufferers wouldn’t have ANY drugs at all if it wasn’t of this way of doing things and NO because many (MUCH!) people who needs help to cope with life adverse present or past events (Situational, non-biological) ends up taking those drugs while their pratician should have prescribe them vigorously some therapy before even thinking of drugs. And that part, I’m sure you agree with me.. is the real problem with the whole antidepressant thing…. More science, more drugs and the ‘shortcut’ aren’t … What need to change is the practice of prescription: 1. The evaluation of a mentally suffering patient should be done by someone who isn’t involve in the prescription process and so has no benefit$ whatever is the diagnostic. 2. GENERAL practioner should NEVER have the right to prescribe antidepressants or antipsychotics, only a Psychiatrist AFTER a totally independant evaluation has been done by a third party without any interest in except the 120$ hours evaluation meeting. 3. Antidepressants or other psycopharmaceutical drugs should NEVER be prescribed WITHOUT psychotherapy .. never. 4. Practicians/Psychiatrist should NEVER have ANY CONTACT WHATSOEVER with the pharmaceutical marketters or even ADs ! .. just technical sheet with scientific facts. 5.Drugs should NOT be marketted on TV/Magasine/Internet directly to people. Add this with number 4 and Yes, this means NO ADs at all for nobody ! 6. Pharmaceutical companies should be held responsible for permanent damage/Sequel automatically and without the need to go to court. 7. Patients and familly members (at least 1) should be explained in details the risks associated with the drug: dangerous side-effects, possible permanent sequels, withdrawal hell etc …

    As I don’t come here really often, feel free to come flame me at Dr-bob.org ..

    my nickname is….
    /\/\arty

  11. Lee Says:

    Actually I think Servier sounds a bit ahead of the rest of the pharma companies. At least they are trying to make something that is different, and are recognizing the issues, unlike other pharma companies, who ignore it until they’re sued.

    So they made a medication that they think is different from the SSRI’s. Good. It’s about time.

    I’ve been through the doctor rigamarole, and hate antidepressants. I’ve seen bullshit when it comes to psychiatry.

    But I haven’t heard huge complaints from people taking medication made by Servier. I’ll try to find a stablon secrets website but I don’t think I will.

  12. el3ctr0nika Says:

    Servier is a wonderful company. Along with agomelatine (Valdoxan), they also developed and marketed tianeptine (Stablon) and amineptine (Survector).

  13. Interesting Says:

    I’ve researched depression and anxiety for years.
    All I can tell you is this –
    Depression/anxiety/obsessions are hormone related. *Dig for more neurotransmitter information and how closely they are related to hormones.*
    There will not be a “wonder drug”. At least not in the near future. At least, not until money becomes “less important”.
    Even current hormonal tests, give you a boundary *lower and upper limit*, for every single person. We are all different.
    That is why some people achieve remission on a drug, that makes someone else psychotic.
    Heck, even serotonin cannot be measured right now!


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