EMA Acknowledges Persistent Sexual Dysfunction After SSRIs & SNRIs

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June 11, 2019 | 47 Comments

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  1. How depression pills can wreck your sex life: Fresh warning for patients

    https://www.dailymail.co.uk/health/article-7125745/How-depression-pills-wreck-sex-life.html

    By Jo Waters For The Daily Mail

    11 June 2019

    The EMA’s move has been welcomed by patients and experts who’ve supported them — as Katinka Blackford Newman, a documentary filmmaker and author of The Pill That Steals Lives, explains: ‘The EMA decision will help get this information about the risk of sexual problems — short- and long-term — out there. This is a victory for campaigners, who have been lobbying so hard on this.’

    David Healy, a professor of psychiatry at Bangor University and founder of RxISK, says the agency’s decision reflects increasing recognition of the harm that SSRIs can cause.

    ‘We submitted a petition to the EMA and the U.S. Food & Drug Administration a year ago, calling for these side-effects to be mentioned on drug labels and leaflets,’ he says.

    ‘There is compelling evidence that SSRIs can cause longstanding sexual dysfunction but, at the moment, this is not mentioned on drug labels or on any of the information leaflets.

  2. It’s a big day for all of us, I hope it’s our first victory on the way to overcoming this horrible disease. For this reason, I would like to thank everyone who took part in this process.
    Thanks to our commitment, hundreds of people may be able to avoid this terrible fate, maybe even we saved someone’s life.
    I would like to ask everyone for further efforts to fight the PSSD. We need research, money and a lot of effort to finally try to take up the topic of treating this disease, not just prevention. We need to get out of this hell.

  3. Congratulations to all those involved, and all those suffering the misery of PSSD/PGAD.

    Recognition of a life changing, on occasion life terminating ADR, may afford some small step in palliation.

    BBC Radio 4. Sunday 5th April 2015. “Inside The Sex Offenders Prison”.

    “Another more radical strategy has been piloting for the last five years – is drug therapy – Anti-Libidinal Medication or SSRIs, – which are antidepressants, are being given to a selected group of prisoners to help deal with their obsessive sexual thoughts, and reduce their libido”.

    (I have taken as much care as I possibly can to try to ensure accuracy in the program reference, and in the quotation transcribed during listening to the broadcast).

  4. Dear Dr. David Healy and Team,

    Thank you for your efforts, time and energy you put in helping the damaged and ignored people suffering with PSSD/PGAD. It’s a big step forward for us all.

    We also need to make clear to everyone that PSSD is far from being a purely sexual dysfunction. I know psychiatry will probably try to downplay it as always to keep on with their dark industry and pharma profits.

    PSSD is one of the most debilitating conditions which is accompanied by the total loss of human emotions, personality, motivations, desires, cognitive capacities, memory, previous hobbies, lifestlye and physical health which leaves the victim often completely disabled and suffering 24/7 with brain/nervous system symptoms. It is only comparable with a traumatic brain and nervous system injury. Job loss, home loss, career loss are not rare outcomes.

    I’m personally suffering from dementia-like symptoms and chronic fatigue syndrome ever since the exposure to 11 SSRI pills… Mitochondrial damage is confirmed, brain shows significant brain injury and slowing affecting many brain areas. I expect these issues to be reflected as well in the leaflets. It’s truly a crime against humanity.

    • Hi Janie

      Thanks for more enlightenment on PSSD and its effects. I had no idea that it may also cause a total loss of human emotions.

      It all sounds horrific.

      I also read that you are suffering from ‘dementia-like symptoms and chronic fatigue syndrome ever since the exposure to 11 SSRI pills… Mitochondrial damage…’

      Like many no doubt I had imagined that if I had a brain scan there must be damage evident, also with my dementia-like symptoms – but I am not getting too concerned about this and hoping time will help if not heal.

      (When incredibly frustrated trying to think, and post Seroxat as a young adult, a few traumas on these drugs including overdose, also prescribed a lot of them post Seroxat, imagine that a specialist might be surprised to see the outline of a single white flag barely blowing in a map of Dresden post the aerial assault).

      Another commentator, Christian Forbear, had damage (and a form of dementia actually) diagnosed as well.

      I thought the damage these drugs can cause (or cause for some perhaps) wouldn’t show on a scan?

      • They do show up on QEEG and SPECT as well (maybe PET, but not many have done it, and I assume it would show up in FMRI). SPECT can show low blood flow in many brain areas. I had QEEG only, it looks at function or loss of it.

        Loss of emotions is horrific too, it is called anhedonia, you can find easily accounts if you google. That is also a very common damage by antidepressants.

        • May I add that one of the most difficult areas of withdrawal is, in fact, the RETURN, of your emotions. Having been totally lacking in emotion, the patient ( only the lucky ones though I guess) slowly sees the glimmer of hope of the return of his old human self – only not to have a clue how to cope with it. It takes time, and lots of it, to re-learn the techniques of coping with an array of thoughts, feelings and emotions that had left you soon after your first pill. We, who are well, take so much for granted – watching another getting to grips with the return of his emotions is humbling to say the least.

  5. Today is another important day in our campaign to break to an unseeing, disbelieving world the news that no-one wants to hear – SSRI and SNRI antidepressants, the go-to pills for all one’s ills, cause severe, longstanding and often permanent harm.

    A great achievement, the Risk Team. Congratulations on your hard, dedicated work. All the more important because in no other area of our campaigning is the subject matter of sexual dysfunction addressed and without you this group of patients would not have had a voice.

    As ever, in any campaign, we always wish each step had reached a bit further, made more of an impact, but we are getting somewhere and we have to keep plodding our way there. We may all have different ideas of where “somewhere” actually is. High on my list is informed consent, and the EMA’s position is another stride in that direction.

    I want to take this opportunity, if I may, to recap where we are and what we have achieved so far, up to today’s announcement, with regard to antidepressants. This is prompted by an impression I have formed from social media that each high of a small success is followed swiftly by a deeper low of pessimism.

    In England we have the PHE review, the catalyst for which was the campaigning done by All Party Parliamentary Group for Prescribed Drug Dependence. We await the PHE report. In Scotland we have a petition which has influenced the formation of a Short Life Working Group, and we await their findings. In Wales we have a petition which has led to a debate in the Senedd and the Government accepting 9 out of 10 of the Petition Committee’s recommendations. We now have to apply pressure to get those effectively implemented.

    Underpinning and informing those groups, a number of reports have been published which have contributed to building up a picture of harm to patients. John Read and James Davies published a systematic review of the incidence, severity and duration of antidepressant withdrawal effects, and concluded that 56% of people experienced withdrawal and 46% of those reported them as severe.

    Luc Montagu and James Davies published the results of the University of Roehampton study which found that 47% experienced withdrawal symptoms for more than one year; that on a scale of severity from 0-10 (10 being the most severe withdrawal), the mean average was 9 points; and that 30% reported being off work indefinitely as a result of antidepressant withdrawal.

    Mark Horowitz and David Taylor, both of whom have lived experience of SSRI withdrawal, published their findings on the effects and difficulties of tapering SSRIs.

    Dr Anne Guy, Marion Brown and I did an analysis of 158 stories sent in as written evidence to the Scottish and Welsh Petitions and found a compellingly consistent pattern of failures in the treatment of people prescribed antidepressants and benzodiazepines which mostly linked back to the paucity of accurate information in the NICE guidelines.

    All this work has thrown into relief not just the lack of accurate guidance for prescribers but the extent to which the published guidelines are actually dangerously inaccurate. The research, the patient’s stories of lived experience, the push of campaigning from different quarters, and of course the good old Daily Mail, have exerted consistent pressure on the Royal College of Psychiatrists, leading to last Thursday’s announcement of their new position statement on antidepressants and depression. All the research I have mentioned above, plus the petitions, are referenced in their 23 page statement. The Royal College has finally added its voice to ours that withdrawal can be severe and the NICE guidelines must be updated urgently.

    In time we may look back and find that the antidepressant scandal has been brushed under the carpet in the same way that the benzo scandal appears to have been. I feel, though, that each small success we have with SSRIs is a notch on the bedpost of recognition for the benzos too because we can keep drawing parallels. “It’s not the first time, guys. You’ve done this to us before and you are doing it again. This isn’t an innocent accidental one-off. It’s a systemic pattern. And the system stinks.”

  6. Really delighted to hear this for others and congratulations to all involved.

    I suffered from sexual dysfunction for over 20 years on the drugs which of course negatively affected relationships, PGAD upon withdrawal (but it eventually stopped) and I had some sexual recovery.

    In that respect I was lucky. I can’t imagine what it must be like to suffer from PSSD (along with the rest of the damage).

    Also today, “An Alabama Governor Signs Chemical Castration Bill into Law”
    (Someone convicted of a sex offense against a child under the age of 13 to now begin chemical castration a month before being released from custody).

    https://edition.cnn.com/2019/06/10/politics/chemical-castraction-alabama-governor-signs-bill/index.html?fbclid=IwAR1NmVJ9kV7oLGZWJPCrVZV08UmfxagFe1QXOj5G-jQuPkghhrcsoq7KpYU

    I won’t share my thoughts on what should be done to the perpetrators of Study 329, which was child abuse.

    Nor my thoughts on what should be done to those late to warn innocent people and children of post-SSRI sexual dysfunction (PSSD) and persistent genital arousal disorder (PGAD) if this was (also) known earlier.

    If this was also known by Pzifer during young Matt Miller’s case, ‘sub-human’ would be far too generous.

    The parents of my partner’s teenage daughter (a lovely very sensitive child – freaked out at the moment, even on Sertraline, by Global Warming and what we should do; who I suspect, albeit a lay person, from listening to her, was suffering from woundedness rather than a mental illness) appeared to have been given no warnings of anything at all regarding Sertraline.

    She suffered from the beginnings of akathisia if not full akathisia after missing one pill (immediately reinstated).

    This young woman should also be beginning her sexual awakening (her lack of confidence also compounded by the serious weight gain) and developing her unique identity and sense of self.

    Thank you on her behalf also for your work.

    I will also be adding this ‘confirmed’ news to the facts and information I have accumulated for her parents in the hope that they will sit with her doctors and consider all the possible benefits and risks and with regards to a longer term plan for her care.

    (Over my almost iatrogenically killed and now completely drug wrecked mind and body will this lovely young lady’s health and her life follow a similar trajectory 20 years later).

  7. Congratulations to you all – you are up there with the best of them The lowest of them now need to recognise that lies and corruption will be outed even if it takes years and so sadly lives lost.

  8. The ‘chickens’, which you suggested at our Open Meeting a week ago, were about to hatch, have successfully done so. We must not think about how far things could have gone – TODAY, we must relish the knowledge that steps have been taken in the right direction. In any such review, those who do the reviewing must be allowed to reject as well as accept. as long as the ‘accepted’ outweigh the ‘rejected’ I count it as a huge success. You must all feel so pleased that here, at last, the letters PSSD etc. are on their way to public viewing in patients’ leaflets. Tomorrow is the time to start working towards the next goal!

  9. This is indeed a truly wonderful breakthrough, well done to all who diligently drove this on to get the result. Very helpful too to read Stevie Lewis’ account of ‘where we are now’ to remind us what has been achieved.

  10. Great news!! Very grateful to RxISK. THANK YOU.

    Do we have access to the section 4 and 4.8 that they reference in the EMA summary?

  11. whocaresinsweden.com
    12 hrs ·

    SSRI förstör sexuallivet för den deprimerade!
    Rekommenderas av socialstyrelsen …
    Man rekommenderar antidepressiva medel, så kallade SSRI till deprimerade fast de förstör sexuallivet med allt vad det innebär. Fast det drabbar ju inte den som skriver ut…
    … See more

    Ssri destroys sexual for the depressed!
    Recommended by socialstyrelsen…

    You recommend antidepressants, so-called ssris to depressed though they destroy sexual with all what it means. But it doesn’t affect the one who print…

    Join and make an effort. Spread the link to the documentary who cares in Sweden. It has already saved many by understanding the seriousness and helped a kin or friend

    Nogracias Retweeted

    David Healy‏ @DrDavidHealy 17h

    A warning worth heeding from the European Medicines Agency

    http://www.pssdforum.com/viewtopic.php?t=3026&start=10

    This is amazing news and and an enormous step forwards for us all. We can use this when contacting researchers and professionals and also in our own individual appointments. It means that people have to believe us. This could lead up some amazing progress if we play our cards right. This is such a big step forwards!

    https://rxisk.org/prize/

  12. Why oh why did this take so long to be acknowledged. Just criminal!
    Cant find the info on the ema site when I clicked on the above link.
    Anyone give a direct link to it.

  13. Thanks! to the Rxisk Team, all signatories on the petition and all of us that we are committed as possible.
    This step was essential.
    It is a demonstration that by making one’s voice heard, persevering and joining forces, things can move.
    So now we have to do it more than before, because “Uomo avvisato e’ mezzo salvato” (Italian “Forewarned is forearmed”), but we will not heal with an extra wording on a piece of paper, we must find researchers who commit themselves to understand the syndrome and to seek a valid cure.

  14. I wanted to leave this message on dailymail, but only a part was made visible:

    For someone, these pills are good: I believe it. For someone, these pills are very bad, that’s it: it happened to me.
    When I took citalopram, my mood had improved, but I decided to take them off because I wanted to regain my sexuality, which was part of me, of my identity and my vital drive. When I realized that my sexuality did not return after the suspension, it was the most terrible trauma of my life. I lost the ability to experience arousal and sexual pleasure at the age of 26.. 5 years ago. I can get orgasm without pleasure, it seems like a paradox, right?
    Boys and girls even younger than me have their sexuality erased as if they had undergone irreversible chemical castration, many of them at the same time have emotional blunting, anhedonia and cognitive dysfunction given by the antidepressant taken previously.
    I hope that now that, finally, EMA has added the wording of persistent sexual dysfunctions, more researchers will wonder how a substance can create such permanent damage. I and others with pssd need to know that research is advancing for us too and to find a cure. I pray anyone who has the power to do something for us who are suffering this unjust and terrible condition: do not leave us without hope of healing.

  15. Finally. The day has come when PSSD has been officially acknowledged by medicine. I have waited over a decade for this day.

    No longer can Psychiatrists and GP’s hide behind “PSSD is not officially acknowledged by medicine” like i was told for many years.

    Well done to the Rxisk team and all those who participated in getting this horrible condition finally acknowledged.

  16. Now that the EMA acknowledges PSSD, I wonder if the Wikipedia post on PSSD will be put back up after it was taken down…

    • Alan – There seems to be two sites on Wikipedia , one with huge chunks of material left out so I guess someone ‘edited’ them out. I googled and found Rxisk challenged Wikipedia 5 years ago about this so someone should be eating their sox at Wikipedia
      Managed to put ‘edits’ yesterday though which are still there today:-
      Under Selective Serotin Reuptake Inhibitors Wikipedia;-
      =edit= Side Effects -under Sexual Dysfunction; –
      After consideration of the evidence forwarded to the EMA by Professor David Healy and his team the authority has acknowleged Persistent Sexual Dysfunction (PSSD) and Persistent Genital Arousal Disorder (PGAD) after SSRI’s and SNRI’s. The Warnings and Precautions have been updated to reflect this. (EMA Website 10June 2019 and Rxisk.org June 2019).
      Also repeated this under the Premature Ejaculation Heading as entry stated ‘ SSRI’s are effective for the treatment of premature ejaculation . Chronic administration is more efficacious than on demand use’.

      Have put the same =edit= on Persistent Genital Arousal Disorder page =edit= Epidemiology.

  17. A big thank you to all the brave people at RXISK for an outstanding result.
    Your hard work has indeed, paid off!
    This has been an incredible achievement that many have been patiently waiting for.
    A momentous occasion, for all involved.
    Keep up the exemplary work!

  18. Are there some loopholes to look out for?
    Under the ‘Recommendations’ heading the PRAC has agreed that all the products considered should submit a variation in 2 months to amend the product information as described in :- Summary of Product Information 4.4 ‘Special Warnings and Precautions for Use’

    Are these Special Warnings going to be given on information leaflets? Because This section is more comprehensive than what follows in ‘Information Leaflet for Patients’.
    Considering how toothless the UK regulatory body has been is it likely to hold things up here? as .’it is the responsibility of the medicines regulatory authorities in the member states to oversee these PRAC Recommendations. Marketing Authorities are ‘expected’ to take action according to the recommendations.

  19. Christopher Lane‏ @christophlane 2h

    Post-SSRI Sexual Dysfunction — at last European regulators recognize a medical condition. Will their U.S. counterparts reach a similar conclusion? My latest @PsychToday

    Post-SSRI Sexual Dysfunction Recognized as Medical Condition
    European regulators recognize a medical condition. Will their U.S. Counterparts?

    Christopher Lane Ph.D.

    https://www.psychologytoday.com/gb/blog/side-effects/201906/post-ssri-sexual-dysfunction

    A response to the EMA ruling is also expected from the U.S. Food and Drug Administration, which was petitioned at the same time using the same data that encouraged the European-wide decision. The federal agency indicated thus far that “no decision had yet been made” and that its review was “still ongoing.”

    Given the depth, range, and statistical power of the research, it would be remarkable if the agency reached a conclusion different from its European counterpart.

    • the article in Psychology Today does not seem to go on the Facebook page where it would be under the eyes of 7 and a half million people..

  20. Thank you
    Dr. Healy and his Team!
    I’m so ‚proud and glorious’ for this!..

    This is a big step forward and finally we’ve got ‚a Foot at the Door!‘
    THANK YOU SO MUCH!!!!!

    *sry,english is not my native language

  21. 4/6/19 -Prestatyn peer support Open Meeting with Dr David Healy as guest speaker – report now on website, prescribedmedicationwithdrawalpeersupportprestatyn.org ; video of same on Facebook linked account.

  22. I apologise for writing off topic but I wanted to draw people’s attention to the amazing piece of investigative journalism on Channel 4 ‘Dispatches’ this week, Monday evening 17th June, in which we learnt of the illegal trade of importing stolen prescription medicines from Europe, mostly stolen from Italian hospitals by the Mafia and sold on around Europe and ultimately, at inflated price, in some instances, into the NHS. The astounding revelation for me was that the MHRA finally, after a lot of shillyshallying about denial, but after persistent digging by the tv team, admitted they knew about this, had done so for a long time, and also about some of these medicines being rendered ineffective or fake too. The MHRA came out of this investigation appearing totally unfit for purpose, but insisting, as we so often hear from them and drug companies, that they take the safety of medicines very seriously…. This is the best and bravest programme I have seen on tv in a long time, I am reminded of several instances when I think it was Carla on this blog has cited bad effects she and her family suffered from what she suspected was fake medicine. The warning from this programme was that we should all be wary about even what is being dispensed by legitimate pharmacies in U.K. and in hospitals. An example of dire and life threatening effects from an epilepsy drug was given, as the introduction. Maybe Annie could cleverly find us a link to re-watch the episode of Dispatches?

  23. How safe are your medicines?: Channel 4 Dispatches

    News Release

    https://www.channel4.com/press/news/how-safe-are-your-medicines-channel-4-dispatches

    Monday 17th June, 8pm, Channel 4

    In a statement, initially, the MHRA said they had ‘no evidence of falsified medicines reaching patients…’ But we challenged this and 48 hours later they changed their stance.  
    They said: “…we have no information on what happened to affected medicines after they reached UK pharmacies”.
    Then four days later a further admission, not only did they know some of these stolen medicines had gone to patients, in some cases they had sanctioned it but only “after careful consideration of the risk to patients”.
    As the truth was finally squeezed out of the Agency, a day later they were forced to act, telling us they were launching an urgent investigation.
    In a statement to Dispatches, the MHRA Chief Executive, Ian Hudson said: “I take our responsibility very seriously and that is why I have ordered an internal review… to make sure that if there are any areas that need strengthening we address these as a priority.”

    Programme/Dispatches

    https://www.channel4.com/programmes/dispatches

  24. Hi Heather R,
    Thank you for mentioning this conundrum, that many consumers are unaware of.
    What about other countries, around the world?
    This is a terrifying problem to come to terms with, as when you are dealt a flawed batch of medicine(s), as we have experienced, no one is there to help you. The blame is ultimately placed on something else or it is too hard to prove? (What nonsense!)
    If everything is robust, as those in power lead us to believe, why is this horrendous problem, still falling through the cracks?
    We get damaged and there is no one out there to be our voice.
    If this problem exists, what are we going to do about it?

  25. “We also asked if it might be possible to get a supporting letter from a healthcare professional, as we thought this might make a difference in terms of the reports being taken seriously.”

    No kidding!

    Seriously, they nevertheless should take patient’s reports as data like any other, without needing to have a doctor in the loop.

    This way, we would be able to do the following:

    Phase 1: Gather patient’s reports without a doctor in the loop.

    Phase 2: Put doctors in the loop for added credibility.

    Phase 3: Eventually firmly prove that effects reported by patients are real.

    Phase 4: Evaluate retrospectively whether or not patient’s report were accurate or not, in order to better assess what to do of patient’s reports in the future when it comes to other drugs or other treatment modalities.

    Not implementing such a scheme is simply organizing the distrust of voices of patients without giving them the opportunity to prove in the long run that they were not spouting bullshit. Which means the same madness will keep reoccurring with new drugs or new treatment modalities until there is precedent to properly assess how patients may be “lying” or not.

    I unfortunately have zero hope that our scientists will even consider approaching that theme scientifically.

    Because there is a dogma: the patient is an ass.

    • I have been treated with nothing but complete contempt by the medical establishment, when i have tried repeatedly to bring to their attention the enduring sexual problems i have been left with, caused by Citalopram.

      I was even taunted by a woman from the crisis team after making a suicide attempt after years of not being believed.

      Complete contempt is the only way i can describe my treatment by the medical establishment.

      • I have been through all of this I am not suicidal however it’s really hard on my relationship. I don’t blame my husband I blame the doctors for that. I am ready to sue someone! It’s criminal that this is happening to so many people! It makes me sick!

        • How long has this been going on for you Ruby?

          This has been going on for me for 12 years, and has really messed up my life in lots of different ways.

          I too would love to sue after everything that has happened.

          Everyday it makes my life very difficult.

  26. Sadly, there will always be an element of suspicion and doubt in my mind, that there are a few batches that are deliberately flawed, to:
    1. reduce the population
    or
    2. to create business $$$ once you are damaged
    or
    3. experiment
    or
    4. create total disharmony, turmoil, inferiority, power imbalance and total chaos in this universe.
    If some medicines ‘proclaim to heal’, why are so many people going ‘crazy’ in the process?
    Life, is like a game of chess.
    When you are on a long list of medicines or dealt a batch of ‘bad’ med(s), your health will never be the same.
    The winners (so they like to believe), are those who make money out of the damaged and sadly, the losers are those who are living in total fear because of the control that is exerted over them.
    A game of chance, that leaves the vulnerable and damaged in a state of continuous perplexion.
    Submit to the useless rules, for you cannot advance in life, if you are left behind with damaged health.
    How many people are doing their jobs with integrity and looking out for their ‘bro?’
    The pursuit of money and power, has made many forget why they are in their profession!

    • For anyone who think that batches of drugs might be contaminated or not contain what they should contain, a recent book Bottle of Lies by Katherine Eban is likely to confirm your worst fears.

      DH

      • In Cardiff pharmacy some years ago boxes of tablets were being sold with all information in another non European language including the information leaflet. Wonder if they all had a cut of the ‘profits’ as there was more than one chemist selling them

  27. Thank you David for recommending this book.
    I am certain the book: ‘Bottle of Lies by Katherine Eban’, will confirm my suspicions~ (Something which I have been pondering upon for quite a long time!)
    What is happening to this universe?
    It is very sickening how we allow Big Pharma to do this to us?
    Every reason why the Law has to create the necessary changes, so that many people’s lives are not put at rxisk.
    How many will be standing, med free, in this universe?
    If you are med free, it is like holding on to the Holy Grail.
    Western Medicine will do everything in their powers to make you sick and it sneakily creeps upon you, unaware.
    What ever happened to good -old fashioned care?
    When is ‘due diligence’ implemented especially, when something unforeseen happens?

  28. I had no clue about sexual side effects that SSRIs cause when I started them as a teenager. But I do now. PSSD is real.

    People deserve to make informed consent when they start these so called meds. I am really sad I wasnt informed.

    • Is it that hard to inform us what we‘re taking?..every dealer would get killed for that!…but the end will come for all of us!…and there is no going back!!!✊🖖

  29. How long could it take to aknowledge the paper?…could it be to take months or more for that?…i mean we all know that ‚they‘ don‘t like to do so..but the ema and mhra done this already!!^^

  30. Congratulations and thank you Dr. Healy and the team!

    Also, thanks very much to all those who have put their comments here. It elaborates to the wider world out there how many people are affected and that the symptoms are common, not one-off cases.

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