New Italian articles on PSSD
Posted: Sun Feb 21, 2021 10:25 am
Some antidepressants can lead to permanent sexual dysfunction, and Pssd is a syndrome about which little is yet known - Jan 25, 2021 https://it.businessinsider.com/alcuni-a ... cora-poco/
Also because of the pandemic, more and more people in Italy suffer from mental disorders such as depression. Many of these patients are treated with SSRI antidepressants: the acronym indicates a series of widespread molecules, at the base of well-known drugs such as, for example, Prozac and Seropram. Drugs that can lead, among the side effects, to disorders related to the sexual sphere. But for some years now, several patients have detected problems of this kind even long after they have stopped taking these drugs: this condition is known as Pssd, Post-SSRI Sexual Dysfunction, an iatrogenic syndrome (i.e. caused by a medicine) with serious repercussions on the quality of life, especially for younger people.
"Technically, these drugs are called SSRIs, an acronym that stands for 'selective serotonin reuptake inhibitors,' and are used in the treatment of a range of mental disorders, such as depression but also panic attacks or anxiety syndromes," Dr. Angelo Barbato, psychiatrist and researcher at the Research Unit for Quality of Care in Mental Health, part of the Department of Neuroscience at the Mario Negri Institute for Pharmacological Research, explains to Business Insider Italia. "The use of these drugs has increased a lot in recent years: in Italy in the last 15 years it has doubled, and the latest data collected say that every day 2.5 million compatriots take these drugs."
Some of them have developed sexual dysfunction after ending treatment. "The problem is just that. In fact, it is known that while taking these drugs can give problems such as difficulty in erection and reduced libido. 60-70% of those who take these drugs develop these side effects, which are dose-dependent and tend not to be persistent. This was already known. Now it has emerged that there are disorders of this type even in those who have stopped the treatment, with symptoms a bit more complex such as reduced sensitivity of the genital area, reduced ability to feel pleasure or anhedonic orgasms, that is achieved without feeling pleasure," Barbato says.
What revealed the existence of the syndrome were "the spontaneous statements of people who took the drugs and then reported these problems," the researcher recalls. "At some point, these reports were brought to the attention of researchers and psychiatrists, who collected a case history and in 2018 submitted a dossier to the drug control agencies (the Food and Drug Administration in the US and the Ema in Europe, ed.) asking that these side effects be included in the leaflet that illustrates the characteristics of the product." As far as Europe is concerned, "the EMEA carried out a preliminary investigation and subsequently gave indications to the countries to include this type of information in the package leaflet. This happened a year ago and Aifa, the Italian drug agency, has acquired the Ema's recommendation: so people who take these drugs should be informed of this risk by the doctors who prescribe them", Barbato says.
The syndrome still has several obscure aspects. "It is known that this effect occurs but our information stops there. We don't know in how many cases it occurs, we don't know if it regresses or not, we don't know what other factors may aggravate or reduce the risks of these drugs, and because SSRIs are many we don't know if there are some that give this problem and others that don't," summarizes the researcher. "I am part of a research group that looks at studies of psychotropic drugs, their efficacy, safety, and risks. Then there is a collateral group that deals with studying the mechanisms through which drugs manifest their effects, both beneficial and adverse. We also verify the prescriptive appropriateness, that is, how much the drugs really serve or are used inappropriately. This problem is widespread because the use of these drugs is growing."
According to Barbato, "the pandemic has worsened the mental health status of the population and there is a tendency for doctors to prescribe drugs of this type indiscriminately. Ninety-five percent of all prescribed antidepressants fall into the SSRI category and are overused: not all depressions respond to drugs, but psychological treatments are not widespread and many people resort to drugs, with limited benefits and a high risk of adverse events. Eighty percent of people with depression are prescribed such a medication, and of these we estimate that barely 20% have any real benefit. We therefore believe that an information process involving the doctors concerned is necessary: only a few days ago we had a meeting on the subject at the Ministry of Health."
The research project of which Dr. Barbato is a part has several goals. "In particular we want to: a) find out if prescribers are aware of this problem and if patients are informed about it: users have the impression that doctors, and especially psychiatrists, are not well aware of the situation and we want to do a survey among psychiatrists to make this verification b) study how many people have reported these effects after taking drugs and how they occur, what is the duration, which drugs are more at risk c) study what mechanisms of the central and peripheral nervous system determine these effects".
To bring to light the Pssd were the stories of those who suffer from it, like Laura (fictional name), who for 7 years is living with this problem. "In Italy, we have a chat group with which we keep in touch, as well as a website and other spaces on social networks where we discuss symptoms and any treatments tried; we keep up to date on the progress in recognition and scientific research and we also organize fundraisers to contribute to research." In the PSSD community, the young woman reveals, "there is honestly a lot of despair, these are really difficult conditions to accept and endure because they deprive you of fundamental components that outlined your personality and what you took for granted to be part of your human being. The package inserts recently have been updated with a brief warning and this can help people weigh the pros and cons a little better when prescribing." The problem remains for those already suffering from this syndrome. "We urgently need to get more attention from the medical and scientific world. If the answer to PSSD could be found, both in the sense of understanding its etiology and in the sense of finding a cure, these drugs, which are so prevalent, could be used by everyone in a safer and more informed way."
New Evidence on Post-SSRI Sexual Dysfunction (PSSD) - Feb 20, 2021 http://www.laltramedicina.it/notizie/nu ... ssri-pssd/
SSRI antidepressants, selective serotonin reuptake inhibitors, and SNRIs, selective serotonin and norepinephrine reuptake inhibitors, comprising numerous active ingredients, are the most widely used classes of psychotropic drugs today; not only are they the drugs of first choice for mood disorders such as major depression, but they are also prescribed for a variety of other disorders, such as anxiety, panic attacks, eating disorders, sleep disorders, in pain therapy, in some forms of headache and even as a treatment against premature ejaculation. Sexual side effects caused by these molecules are really very common: post-marketing studies report a prevalence that exceeds 50% among patients who use them; among the most common symptoms we remember the decrease in libido and the difficulty in reaching orgasm or anorgasmia.
In addition to these side effects, which were assumed to be reversible upon discontinuation of treatment, a new evidence has emerged from the reports of patients and has made its way into the medical literature, starting from the first case reports dating back to 2006, which describe cases in which, after having made a "regular" use of these drugs and discontinued them, patients have not had any remission of sexual symptoms and indeed, in some cases those symptoms have appeared or worsened at the time of suspension.
Disappearance or reduction of erogenous sensation and sometimes tactile sensation in the genital area, arousal and erection, and anhedonic orgasm, i.e., mechanical and without pleasure, and other orgasmic disturbances, are some of the most common symptoms of post-SSRI sexual dysfunction (PSSD), a persistent syndrome affecting a subgroup of patients who have used serotonergic drugs; those who remain affected emphasize that, prior to such treatment, they had never experienced such symptomatology. A difficult condition to sustain, psychically traumatic and painful that, in males and females, even very young ones, jeopardizes their identity, what were their expectations and desires, of which sexuality and what revolves around it were naturally an integral part, as well as sentimental relationships that come to terms with something unexpected. Those who suffer from PSSD often compare it to a horrifying "permanent chemical castration", which they were never warned about before treatment, and which many physicians to whom they turn for help easily do not recognize the possibility, leaving the patient with "in addition to the damage, the mockery" and for which, worst of all, no cure is known today. The voices of patients and the commitment and courage of some specialists who have taken the problem to heart led the European Medicines Agency (EMA) in 2019 to conduct a careful review of the scientific literature and spontaneous reports received over the years, leading to the decision to require all SSRI and SNRI pharmaceutical companies to update drug indications with a new warning: "Cases have been observed in which symptoms of sexual dysfunction have persisted after discontinuation of treatment."
A clue, this, although evasive, which may be useful for those who will have to choose, weighing pros and cons, whether to undergo these treatments, and a meager "recognition" for those who, for years, was already supporting the dramatic and "unfair" condition. Over the course of 2020, one after another, the package inserts of these drugs have been updated. Patients, often faced with inadequate medical answers compared to the evidence they experience firsthand, are finding themselves online, where they compare and keep in touch with each other, form groups and associations nationally and internationally, open websites and organize fundraisers to contribute to the scientific research that is beginning to take hold. https://www.gofundme.com/f/27l8qmes5c.
Professor David Healy, psychiatrist, psychopharmacologist, scientist, and author, has been engaged on the research and outreach front on the topic of PSSD since 2012, when he noticed through his website Rxisk.org - which collects reports of adverse drug events - an unexpected number of reports of PSSD and also PGAD: persistent genital arousal disorder, which predominantly affects women and can be triggered precisely by the use and discontinuation of SSRIs and SNRIs. For these conditions, the etiology is currently unknown and there are no known resolving treatments. In 2018, Dr. Healy opened a fundraiser, the Rxisk Prize https://rxisk.org/prize/, designed to reward anyone who finds a cure for PSSD, with the goal of boosting research and drawing media attention to the problem. The prize now exceeds 100 thousand dollars. On the Italian front, important news dates back to 2020, when the Mario Negri Institute for Pharmacological Research began planning the first phases of research, such as a study on psychiatrists' awareness and an epidemiological study, plus further ideas aimed at understanding the etiology of the syndrome.
One of the etiological hypotheses on PSSD that have been advanced over the years, namely that of neurosteroid imbalance in the nervous system following exposure to SSRIs, is being investigated by Professor Roberto Cosimo Melcangi at the University of Milan on an animal model. His research activity has already focused on another iatrogenic syndrome with symptoms quite similar to those of PSSD, namely post-finasteride syndrome. In a 2018 review, Melcangi hypothesized that the two syndromes may have etiological factors in common.
PSSD: emblem of something wrong in today's healthcare system
In PSSD itself, Dr. David Healy sees an emblem of what is a much broader problem that affects us all. A problem composed of an intertwining of factors that underlie the very functioning of the current drug-health system. To begin with, today "scientific validity" officially refers to RCTs, clinical trials: the results returned by them are considered the "evidence" that allows the approval of drugs. This is despite the fact that clinical trials are designed by the same pharmaceutical companies to meet a primary endpoint that is certainly not to detect the risks and damages caused by the drugs they want to market. To make matters worse, raw data from clinical trials are guarded by pharmaceutical companies and inaccessible to anyone else, even regulators such as the EMA or FDA. Articles in the literature are also written not by the actual authors of the clinical trials but by clever ghostwriters, tasked with highlighting what is wanted to be known. Dr. Healy is confident that the so-called evidence on which today's medicine is based is actually the largest collection of fake news on the planet. Data about drug risks are easily omitted or downplayed.
To support this dangerous "implant" there is also a conception of the drug by doctors and the health system that has forgotten a fundamental principle: a drug is primarily a poison, from which it is possible to derive a great benefit. Entering a substance in the body will interact with it causing a myriad of effects and of these, let's say, one hundred effects, one could be the desired one, while the other 99 undesired ones, which could be for us much more relevant than what we are looking for. In prescribing a drug and in taking it, a moral act, a judgment, a human encounter between doctor and patient is required. This is care.
But in recent decades, more and more, the Western world is witnessing a shift from health care to health services: systematic prescriptions of drugs that are supposed to prevent all sorts of health problems, but without considering all the harmful effects of those drugs that accumulate in the body and make us sick. In some industrialized countries life expectancy has begun to decline and to this overprescription of drugs Dr. Healy attributes a central responsibility that is being dangerously overlooked. Those who are harmed by drug treatment, as in the case of PSSD, witness a disconcerting scenario: they become practically invisible. The doctor to whom one turns, not finding documentary "evidence" in the medical literature, disavows the patient's testimony. Moreover, any report to the pharmacovigilance authorities will be considered as an "anecdote". People harmed by drugs are victims of an entire health system that, after having subjected them to risks without any act of "judgment", prefers to abandon and deny them, when these people, in the flesh, are themselves the most concrete and real evidence of the possible consequences of treatments.
In his latest book "The Shipwreck of the Singular" https://samizdathealth.org/shipwreck-of ... castaways/ David Healy explains how the healthcare system has evolved to reach this critical point that now requires our attention, but also a shared and courageous effort in the name of safeguarding all of us.
Those who wish to follow the conference can do so by clicking on this link: https://m.youtube.com/watch?v=mySezuvPBGk
______
Try to involve the media in your country by taking a cue from these articles: write emails to sites that deal with scientific news, medicine, health etc ... and accurately present the PSSD topic, also giving willingness to tell your testimony (also in anonymous form on the article to be published).
Also because of the pandemic, more and more people in Italy suffer from mental disorders such as depression. Many of these patients are treated with SSRI antidepressants: the acronym indicates a series of widespread molecules, at the base of well-known drugs such as, for example, Prozac and Seropram. Drugs that can lead, among the side effects, to disorders related to the sexual sphere. But for some years now, several patients have detected problems of this kind even long after they have stopped taking these drugs: this condition is known as Pssd, Post-SSRI Sexual Dysfunction, an iatrogenic syndrome (i.e. caused by a medicine) with serious repercussions on the quality of life, especially for younger people.
"Technically, these drugs are called SSRIs, an acronym that stands for 'selective serotonin reuptake inhibitors,' and are used in the treatment of a range of mental disorders, such as depression but also panic attacks or anxiety syndromes," Dr. Angelo Barbato, psychiatrist and researcher at the Research Unit for Quality of Care in Mental Health, part of the Department of Neuroscience at the Mario Negri Institute for Pharmacological Research, explains to Business Insider Italia. "The use of these drugs has increased a lot in recent years: in Italy in the last 15 years it has doubled, and the latest data collected say that every day 2.5 million compatriots take these drugs."
Some of them have developed sexual dysfunction after ending treatment. "The problem is just that. In fact, it is known that while taking these drugs can give problems such as difficulty in erection and reduced libido. 60-70% of those who take these drugs develop these side effects, which are dose-dependent and tend not to be persistent. This was already known. Now it has emerged that there are disorders of this type even in those who have stopped the treatment, with symptoms a bit more complex such as reduced sensitivity of the genital area, reduced ability to feel pleasure or anhedonic orgasms, that is achieved without feeling pleasure," Barbato says.
What revealed the existence of the syndrome were "the spontaneous statements of people who took the drugs and then reported these problems," the researcher recalls. "At some point, these reports were brought to the attention of researchers and psychiatrists, who collected a case history and in 2018 submitted a dossier to the drug control agencies (the Food and Drug Administration in the US and the Ema in Europe, ed.) asking that these side effects be included in the leaflet that illustrates the characteristics of the product." As far as Europe is concerned, "the EMEA carried out a preliminary investigation and subsequently gave indications to the countries to include this type of information in the package leaflet. This happened a year ago and Aifa, the Italian drug agency, has acquired the Ema's recommendation: so people who take these drugs should be informed of this risk by the doctors who prescribe them", Barbato says.
The syndrome still has several obscure aspects. "It is known that this effect occurs but our information stops there. We don't know in how many cases it occurs, we don't know if it regresses or not, we don't know what other factors may aggravate or reduce the risks of these drugs, and because SSRIs are many we don't know if there are some that give this problem and others that don't," summarizes the researcher. "I am part of a research group that looks at studies of psychotropic drugs, their efficacy, safety, and risks. Then there is a collateral group that deals with studying the mechanisms through which drugs manifest their effects, both beneficial and adverse. We also verify the prescriptive appropriateness, that is, how much the drugs really serve or are used inappropriately. This problem is widespread because the use of these drugs is growing."
According to Barbato, "the pandemic has worsened the mental health status of the population and there is a tendency for doctors to prescribe drugs of this type indiscriminately. Ninety-five percent of all prescribed antidepressants fall into the SSRI category and are overused: not all depressions respond to drugs, but psychological treatments are not widespread and many people resort to drugs, with limited benefits and a high risk of adverse events. Eighty percent of people with depression are prescribed such a medication, and of these we estimate that barely 20% have any real benefit. We therefore believe that an information process involving the doctors concerned is necessary: only a few days ago we had a meeting on the subject at the Ministry of Health."
The research project of which Dr. Barbato is a part has several goals. "In particular we want to: a) find out if prescribers are aware of this problem and if patients are informed about it: users have the impression that doctors, and especially psychiatrists, are not well aware of the situation and we want to do a survey among psychiatrists to make this verification b) study how many people have reported these effects after taking drugs and how they occur, what is the duration, which drugs are more at risk c) study what mechanisms of the central and peripheral nervous system determine these effects".
To bring to light the Pssd were the stories of those who suffer from it, like Laura (fictional name), who for 7 years is living with this problem. "In Italy, we have a chat group with which we keep in touch, as well as a website and other spaces on social networks where we discuss symptoms and any treatments tried; we keep up to date on the progress in recognition and scientific research and we also organize fundraisers to contribute to research." In the PSSD community, the young woman reveals, "there is honestly a lot of despair, these are really difficult conditions to accept and endure because they deprive you of fundamental components that outlined your personality and what you took for granted to be part of your human being. The package inserts recently have been updated with a brief warning and this can help people weigh the pros and cons a little better when prescribing." The problem remains for those already suffering from this syndrome. "We urgently need to get more attention from the medical and scientific world. If the answer to PSSD could be found, both in the sense of understanding its etiology and in the sense of finding a cure, these drugs, which are so prevalent, could be used by everyone in a safer and more informed way."
New Evidence on Post-SSRI Sexual Dysfunction (PSSD) - Feb 20, 2021 http://www.laltramedicina.it/notizie/nu ... ssri-pssd/
SSRI antidepressants, selective serotonin reuptake inhibitors, and SNRIs, selective serotonin and norepinephrine reuptake inhibitors, comprising numerous active ingredients, are the most widely used classes of psychotropic drugs today; not only are they the drugs of first choice for mood disorders such as major depression, but they are also prescribed for a variety of other disorders, such as anxiety, panic attacks, eating disorders, sleep disorders, in pain therapy, in some forms of headache and even as a treatment against premature ejaculation. Sexual side effects caused by these molecules are really very common: post-marketing studies report a prevalence that exceeds 50% among patients who use them; among the most common symptoms we remember the decrease in libido and the difficulty in reaching orgasm or anorgasmia.
In addition to these side effects, which were assumed to be reversible upon discontinuation of treatment, a new evidence has emerged from the reports of patients and has made its way into the medical literature, starting from the first case reports dating back to 2006, which describe cases in which, after having made a "regular" use of these drugs and discontinued them, patients have not had any remission of sexual symptoms and indeed, in some cases those symptoms have appeared or worsened at the time of suspension.
Disappearance or reduction of erogenous sensation and sometimes tactile sensation in the genital area, arousal and erection, and anhedonic orgasm, i.e., mechanical and without pleasure, and other orgasmic disturbances, are some of the most common symptoms of post-SSRI sexual dysfunction (PSSD), a persistent syndrome affecting a subgroup of patients who have used serotonergic drugs; those who remain affected emphasize that, prior to such treatment, they had never experienced such symptomatology. A difficult condition to sustain, psychically traumatic and painful that, in males and females, even very young ones, jeopardizes their identity, what were their expectations and desires, of which sexuality and what revolves around it were naturally an integral part, as well as sentimental relationships that come to terms with something unexpected. Those who suffer from PSSD often compare it to a horrifying "permanent chemical castration", which they were never warned about before treatment, and which many physicians to whom they turn for help easily do not recognize the possibility, leaving the patient with "in addition to the damage, the mockery" and for which, worst of all, no cure is known today. The voices of patients and the commitment and courage of some specialists who have taken the problem to heart led the European Medicines Agency (EMA) in 2019 to conduct a careful review of the scientific literature and spontaneous reports received over the years, leading to the decision to require all SSRI and SNRI pharmaceutical companies to update drug indications with a new warning: "Cases have been observed in which symptoms of sexual dysfunction have persisted after discontinuation of treatment."
A clue, this, although evasive, which may be useful for those who will have to choose, weighing pros and cons, whether to undergo these treatments, and a meager "recognition" for those who, for years, was already supporting the dramatic and "unfair" condition. Over the course of 2020, one after another, the package inserts of these drugs have been updated. Patients, often faced with inadequate medical answers compared to the evidence they experience firsthand, are finding themselves online, where they compare and keep in touch with each other, form groups and associations nationally and internationally, open websites and organize fundraisers to contribute to the scientific research that is beginning to take hold. https://www.gofundme.com/f/27l8qmes5c.
Professor David Healy, psychiatrist, psychopharmacologist, scientist, and author, has been engaged on the research and outreach front on the topic of PSSD since 2012, when he noticed through his website Rxisk.org - which collects reports of adverse drug events - an unexpected number of reports of PSSD and also PGAD: persistent genital arousal disorder, which predominantly affects women and can be triggered precisely by the use and discontinuation of SSRIs and SNRIs. For these conditions, the etiology is currently unknown and there are no known resolving treatments. In 2018, Dr. Healy opened a fundraiser, the Rxisk Prize https://rxisk.org/prize/, designed to reward anyone who finds a cure for PSSD, with the goal of boosting research and drawing media attention to the problem. The prize now exceeds 100 thousand dollars. On the Italian front, important news dates back to 2020, when the Mario Negri Institute for Pharmacological Research began planning the first phases of research, such as a study on psychiatrists' awareness and an epidemiological study, plus further ideas aimed at understanding the etiology of the syndrome.
One of the etiological hypotheses on PSSD that have been advanced over the years, namely that of neurosteroid imbalance in the nervous system following exposure to SSRIs, is being investigated by Professor Roberto Cosimo Melcangi at the University of Milan on an animal model. His research activity has already focused on another iatrogenic syndrome with symptoms quite similar to those of PSSD, namely post-finasteride syndrome. In a 2018 review, Melcangi hypothesized that the two syndromes may have etiological factors in common.
PSSD: emblem of something wrong in today's healthcare system
In PSSD itself, Dr. David Healy sees an emblem of what is a much broader problem that affects us all. A problem composed of an intertwining of factors that underlie the very functioning of the current drug-health system. To begin with, today "scientific validity" officially refers to RCTs, clinical trials: the results returned by them are considered the "evidence" that allows the approval of drugs. This is despite the fact that clinical trials are designed by the same pharmaceutical companies to meet a primary endpoint that is certainly not to detect the risks and damages caused by the drugs they want to market. To make matters worse, raw data from clinical trials are guarded by pharmaceutical companies and inaccessible to anyone else, even regulators such as the EMA or FDA. Articles in the literature are also written not by the actual authors of the clinical trials but by clever ghostwriters, tasked with highlighting what is wanted to be known. Dr. Healy is confident that the so-called evidence on which today's medicine is based is actually the largest collection of fake news on the planet. Data about drug risks are easily omitted or downplayed.
To support this dangerous "implant" there is also a conception of the drug by doctors and the health system that has forgotten a fundamental principle: a drug is primarily a poison, from which it is possible to derive a great benefit. Entering a substance in the body will interact with it causing a myriad of effects and of these, let's say, one hundred effects, one could be the desired one, while the other 99 undesired ones, which could be for us much more relevant than what we are looking for. In prescribing a drug and in taking it, a moral act, a judgment, a human encounter between doctor and patient is required. This is care.
But in recent decades, more and more, the Western world is witnessing a shift from health care to health services: systematic prescriptions of drugs that are supposed to prevent all sorts of health problems, but without considering all the harmful effects of those drugs that accumulate in the body and make us sick. In some industrialized countries life expectancy has begun to decline and to this overprescription of drugs Dr. Healy attributes a central responsibility that is being dangerously overlooked. Those who are harmed by drug treatment, as in the case of PSSD, witness a disconcerting scenario: they become practically invisible. The doctor to whom one turns, not finding documentary "evidence" in the medical literature, disavows the patient's testimony. Moreover, any report to the pharmacovigilance authorities will be considered as an "anecdote". People harmed by drugs are victims of an entire health system that, after having subjected them to risks without any act of "judgment", prefers to abandon and deny them, when these people, in the flesh, are themselves the most concrete and real evidence of the possible consequences of treatments.
In his latest book "The Shipwreck of the Singular" https://samizdathealth.org/shipwreck-of ... castaways/ David Healy explains how the healthcare system has evolved to reach this critical point that now requires our attention, but also a shared and courageous effort in the name of safeguarding all of us.
Those who wish to follow the conference can do so by clicking on this link: https://m.youtube.com/watch?v=mySezuvPBGk
______
Try to involve the media in your country by taking a cue from these articles: write emails to sites that deal with scientific news, medicine, health etc ... and accurately present the PSSD topic, also giving willingness to tell your testimony (also in anonymous form on the article to be published).