Dieser Blog handelt von den Risiken- insbesondere dem erhöhten Suizidrisiko - der neueren SSRI- Antidepressiva, wie ZOLOFT und Prozac (Fluctin). ZOLOFT wird von Pfizer hergestellt. Diese Medikamente werden immer noch leichtfertig auch bei nur leichten Depressionen verschrieben, obwohl sie hierbei nicht wirksamer sind als Placebos. Sie können aber schwerwiegende Entzugserscheinungen hervorrufen und dürfen daher nur unter ärtzlicher Aufsicht abgesetzt werden.
James Holmes, a young man with no record of violence, murdered 12 people watching Batman in a Colorado cinema in 2012.
Did an SSRI antidepressant, prescribed by a doctor, play a part in the killings?
He slumps wild-eyed across the desk from detectives, with a mess of badly dyed red hair, his clothes hanging off him.
James Holmes looks every inch the monster who coldly executed 12 innocent people and injured dozens more at a midnight screening of the Batman film, The Dark Knight Rises.
Holmes had carried out the killings with an arsenal of weaponry he had accumulated in the preceding weeks. He had planned the shootings down to the tiniest detail, even booby-trapping his own apartment with home-made bombs to divert police resources while he launched the attack.
Watching a recording of his interview at the police station, conducted just hours after he carried out one of the worst mass shootings in recent US history, who could feel anything but loathing for this callous 24-year-old graduate student? When asked how to spell his surname, Holmes cockily replies, “Like Sherlock”.
When left alone with paper bags on his hands to secure forensic evidence, he’s caught on camera using them to talk to one another, like sock puppets.
The only hint he may have some inkling of what he’s just done is when he asks a detective, “There wasn’t any children hurt?” In fact, six-year-old Veronica Moser-Sullivan was the youngest of Holmes’s victims that night in July 2012 - killed as she watched the movie premiere with her mother at the packed cinema in Aurora, Colorado.
Americans have become wearily accustomed to mass shootings. Usually, in the days and weeks that follow, some kind of warped explanation emerges - be it terrorism, revenge or a predisposition to violence. It’s highly unusual for the perpetrator to be taken alive. Usually they are killed or kill themselves at the scene.
Holmes survived, and as the evidence stacked up it looked like another tragic collision of mental breakdown with America’s lax gun laws.
Holmes's Glock 22 Pistol photographed on the bonnet of his car
Why else would a clever, shy guy with no history of violence, from a loving home, carry out such a heinous attack? Holmes had no enemies, no terrorist ideology to drive him on.
But the student had been seeing a psychiatrist at the University of Colorado Denver and this was no barrier to him buying a handgun, tear gas, full body armour and a semi-automatic rifle.
.223 M&P rifle photographed outside the cinema
Before he faced a court of law, Holmes was evaluated by a number of psychiatrists. No two doctors reached exactly the same conclusion. There were diagnoses of schizophrenia, schizoid personality disorder, schizotypal disorder – or no diagnosable disorder at all. Some thought Holmes couldn’t legally be held responsible for his crime, on grounds of insanity. Others disagreed, arguing he still knew right from wrong when he carried out the shootings.
When these questions came before a jury two years ago, the verdict was unanimous. Holmes was found guilty on all counts of murder and multiple counts of attempted murder.
Judge Carlos Samour Jr said:
It is the court’s intention that the defendant never set foot in free society again. Get the defendant out of my courtroom please.”
He was led from the dock to jeers of “loser”, as his bewildered parents Bob and Arlene looked on, to begin one of the longest prison terms in US history - 12 life sentences plus 3,318 years in prison. He only narrowly escaped the death penalty.
Holmes is being held in solitary confinement at a maximum security prison in an undisclosed state, because the nature of his crimes make him a target for other prisoners. That’s how he will spend the rest of his days.
Like any other casual observer skimming over the court reporting online, I thought justice had been done, and that this was where Holmes’s story ended. Then I spoke to psycho-pharmacologist and long-time campaigner on the potential dangerous side effects of antidepressants, Prof David Healy.
Healy had been hired as an expert witness in the James Holmes case and had visited him in jail before the trial. The public defender appointed to represent Holmes wanted Healy to evaluate whether the antidepressant sertraline (also known as Lustral in the UK and Zoloft in the US), which Holmes had been prescribed, could have played a role in the mass murder.
Prof David Healy
I have worked with David Healy in the past on a number of investigative films for the BBC’s current affairs programme, Panorama.
These films revealed cases where people with no previous history of suicidal thoughts or violence went on to seriously harm themselves or others after being thrown into a state of mental turmoil by the newer generation of SSRI antidepressants, such as paroxetine and fluoxetine.
Before meeting Holmes, Healy doubted the pills had played a part. But by the end of his prison visit he had reached a controversial conclusion.
He was never called to give evidence at the trial of James Holmes, but he told me in August 2016 that he would have told the court:
These killings would never have happened had it not been for the medication James Holmes had been prescribed.”
David Healy
SSRIs are thought to work by boosting serotonin levels to the brain.
Stephen Buckley, from mental health charity Mind, says:
Millions of people take SSRIs and other antidepressants and many find them useful in managing their mental health problems. Side effects from medication can be serious but it’s important to recognise that severe side effects are incredibly rare.”
He adds that no-one should stop taking medication suddenly, without advice from a health professional.
“If anyone is concerned that they may be experiencing harmful side effects they should speak to their doctor or pharmacist about alternatives.”
Prof Wendy Burn, president of the Royal College of Psychiatrists, says: “In all treatments – from cancer to heart disease – medicines which do good can also do harm. This applies in psychiatry. Current evidence from large-scale studies continues to show that for antidepressants the benefits outweigh the risks.”
David Healy maintains that while antidepressants can be a lifesaver for some, for others they can cause more harm than the original problems they were prescribed to treat.
But what makes a young man plan over months a mass shooting, then carry it out with cold precision? Could antidepressants possibly do that?
‘He was too good’
Arlene and Bob Holmes sat through every day of their son's trial but rejected all approaches to talk in public about their son out of respect for the victims and their families.
However, a book that Arlene wrote, When the Focus Shifts: The Prayer Book of Arlene Holmes 2013-2014, gives an insight into her thoughts in the run-up to the trial in April 2015.
Arlene and Bob Holmes arrive at the court building
In one section, she describes the effects of taking the lowest dose of an SSRI antidepressant in March 2014:
I have become fatter, ‘flatter’, dumber, number. Less tearful, yes. Unfortunately, less of everything. The sunset and the beach no longer lift my spirits.”
She continues: “I sit through church service and sift through the Bible, uninspired. I’m fuzzy. Weird dreams. Crying used to be a release. Now I cannot cry, or laugh. I hate this feeling.”
Arlene Holmes, a nurse, wrote that she stopped taking the pills before the trial, telling her doctor she wanted to be able to feel things and to cry if she wanted to.
If she had a bad experience with an SSRI antidepressant, what would she make of David Healy’s view of her son’s case?
I contacted the couple’s lawyer explaining my own background in investigating antidepressants and suggesting that Arlene and Bob Holmes might hold information that could, ultimately, help prevent future tragedies.
A few weeks later an email from Arlene dropped into my inbox. Short and to the point, it requested more information and asked me not to share her contact details with anyone.
“Some people bear my family ill will,” she wrote.
When we finally spoke on the phone, it became clear Arlene and Bob had never seriously considered the effect antidepressants might have had on their son’s behaviour. In fact, they hadn’t even known of David Healy’s involvement as a pre-trial expert witness.
Persuaded that exploring their son’s case in depth may ultimately help others, they reluctantly agreed to a filmed interview. It wouldn’t help their son - they know he will spend the rest of his life in prison.
Approaching their low-rise detached home in a neat suburb of San Diego, what struck me was the sheer ordinariness - a man out washing his car, another mowing his lawn, kids playing baseball in the park. Inside, the Holmes’ house is modest, understated – just like Arlene and Bob.
“We are an introverted family,” says Arlene. “We are not showy but we like having people around. We care about the larger picture in society and we are Christians, we go to church.”
If you had told me this would happen to us I just wouldn’t have believed it.”
Arlene Holmes
The couple have struggled to understand how their boy could cause so much hurt and pain to others.
“Not in your wildest dreams would you think your son would shoot strangers,” says Arlene. “For someone who loved kids and dogs and always did his homework and his chores. You can’t believe it is possible for anyone to cause that much harm, let alone the man you raised.”
She says they never saw any signs of violence, and that her son had not shown any interest in drink or drugs.
“In retrospect, I think he was too good. Maybe I should have worried about the fact he was so good, but as a mother you can worry about just about anything.”
Bob Holmes, a retired statistician, is a man of few words.
“He was never interested in guns or really even a violent kid, that’s why it was surprising. It came out of nowhere. He seemed happy enough, just pretty much a normal everyday kid growing up, so...” Bob’s voice trails off as though he can’t bear to finish the thought.
They say there had been ups and downs along the way but little to mark them out from any other family.
They moved home when James was 13 and he found the transition hard. He was quiet but he had friends and took part in sports. He cruised through his academic work at school and, later, as an undergraduate.
Bob and Arlene speak about taking James to a counsellor:
The first real hump in the road was when Holmes applied to six top universities to study for a doctorate in neuroscience. Academically bright, his shyness in interviews appeared to work against him. He was rejected by all of them.
“He came home and he just kind of didn’t do much of anything for a while, and he just kind of hung out,” says Bob.
Arlene says her son was sleeping a lot and not going out much.
“So I got mad and I said, ‘You are done with college, you need to do something.’”
Holmes took his mother's advice and found a job working night shifts in a pill factory while he applied to more universities.
In 2011, he accepted an offer to study neuroscience at University of Colorado Denver and started in the autumn. Not his first choice, says his mother, but it all seemed to be working out fine.
“He still was happy to be at Colorado, talked to us about eventually settling and he eventually borrowed money to buy a town house on the outskirts of Denver,” she says.
So when you hear something like that, the last thing in the world that you would ever think is that something as bad as a shooting could possibly happen. He was planning a future there.”
Very few of Holmes's former friends are willing to talk, but one – a young man who knew him well as an undergraduate – spoke to me on condition of anonymity. The Holmes he knew and liked was just as Bob and Arlene described - shy, polite, frugal and smart.
They used to play video games together – strategy games, not the violent kind, he says. There was the occasional beer, but no drugs, parties or girls.
“We were pretty nerdy,” he says.
Discovering someone he was close to could commit mass murder had been “a profound experience”. When he heard what his friend had done, he knew something must have happened to him.
“I still don’t know how to make sense of it,” he says.
Hillary Allen
Someone who spent time with Holmes in the crucial months before the shootings was Hillary Allen, a fellow graduate student on the neuroscience programme at CU Denver.
In class he didn’t really take notes, so that was something that made me jealous because I was vigorously writing notes down… it seemed like he got a lot of work done in his lab and he seemed very successful. I remember thinking like, ‘Wow, James is very smart, he’s very intelligent’”
Sometimes the friendship was hard work.
“He was kind of quiet and kept to himself. He did have a kind of a quirky sense of humour,” says Allen.
“We were part of a group of scientists so I think everyone’s a bit odd. Maybe he was a little bit more odd than the rest of us, maybe more socially awkward.”
Socially awkward. It's a phrase that comes up time and again to describe Holmes. It’s what led him to make contact with the university counselling department in the spring of 2012, just months before the shootings.
Cracks had started to appear in Holmes’s apparently effortless success. Over the Christmas break he was diagnosed with glandular fever. Tired and ill for the first couple of months of 2012, he kept going to classes, but his work was going downhill.
The shy and anxious Holmes found giving presentations in front of his classmates particularly hard.
His first proper relationship with fellow graduate student Gargi Datta had also come to an end. Datta didn’t want to speak to me, but according to Arlene Holmes the break-up hit her son hard.
I think he loved her. He did say that she wanted to still see him again, which he found difficult to understand since they were broken up
“It was a cordial break-up. That's the word he used, 'cordial'. They both parted as friends.”
It was Datta who suggested Holmes seek help at the campus student wellness centre. On 21 March 2012, James Holmes had his first appointment there with psychiatrist Dr Lynne Fenton.
Sifting through the mountain of court testimony and evidence, this date sticks out.
Does it – as the prosecution would argue – mark the point at which Holmes first acknowledges he’s struggling mentally in the perfect storm of his relationship breakdown, academic problems and long-standing social anxiety? A storm that explains why he decided he had nothing to lose and everything to gain from killing as many people as he could?
Or was that date significant - as David Healy would say - because it was the day Lynne Fenton prescribed to James Holmes the antidepressant, sertraline?
Mania
First page of Holmes's notebook
In his first meeting with Lynne Fenton, Holmes was hard to engage but described his anxiety around people. And during that 45-minute session worrying details emerged that he’d never talked about with his family.
Holmes said he was having thoughts of killing people three or four times a day.
Although it sounds alarming, Fenton didn’t regard him as dangerous at that point. The thoughts were abstract, there was no plan or, it seemed, any real intent. She prescribed the antidepressant sertraline to ease his anxiety and obsessive thoughts.
Holmes in custody
In later prison interviews with court-appointed forensic psychiatrist Dr William Reid, Holmes said he’d had intrusive thoughts like this since his teens. Not of actually killing people, rather of wishing them dead to escape from awkward social situations.
According to Reid, these kinds of intrusive thoughts are not uncommon.
“He wasn’t talking about a vengeful hatred,” he says. “He was talking about an aversion to mankind. Being around much of mankind was uncomfortable to him and it wasn’t very rewarding to him so he wanted to avoid it.”
With hindsight, it provides a clear motive, according to Colorado District Attorney, George Brauchler, who successfully prosecuted the case. He says Holmes had a long-standing hatred of mankind – that’s why he killed so many people.
As he puts it, Holmes was “evil”.
District Attorney, George Brauchler
Brauchler says Holmes kept his evil desires at bay until it became clear he wasn’t going to get what he wanted to be happy.
He’s not going to get that PhD, he’s not going to find that woman to love and have that house with those two kids and the dog. And that’s when he turns his sights on this lifelong passion that he’s had to kill other people and that’s when we see him start to set these things in motion.”
It’s a persuasive argument, and one some experts, and ultimately the jurors, had no trouble in accepting. But the timeline of what happened between Holmes’s first prescription of sertraline and the shootings wasn’t explored at trial.
When you scrutinise that timeline, it raises serious questions about the role of the widely prescribed antidepressant.
Page from Holmes's notebook
Just before he carried out the shootings, Holmes posted to Fenton a notebook he had written in. At times rambling, it gives some contemporaneous insight into his troubled mind. Both William Reid and David Healy agree it’s a valuable piece of evidence.
Holmes wrote about the initial effects of going on sertraline.
No effect when needed. First appearance of mania occurs, not good mania. Anxiety and fear disappears. No more fear, no more fear of failure. Fear of failure drove determination to improve, better and succeed in life. No fear of consequences.”
The first evidence that his thoughts of killing were turning real came in an online conversation with Gargi Datta on 25 March, four days after starting on sertraline.
At Holmes's trial, Datta testified that at first she thought he was joking.
But as she challenged him, the details of his delusional theory spilled out.
This theory about increasing his so-called “human capital” by actually killing people was quite different to the abstract thoughts he'd had up until then about wishing people dead to get out of uncomfortable social situations.
Psychiatrists I’ve spoken to agree it was delusional, a sign of psychosis.
Datta was asked in court if he’d ever said anything delusional before this chat. She confirmed he hadn’t.
Forensic psychiatrist Dr Philip Resnick, from Ohio, was engaged as a prosecution expert. He was not called to give evidence at trial.
Dr Philip Resnick
In his first interview on the subject, he told me the "human capital" conversation with Datta was a key moment.
“I don’t think we have evidence of a plan to do it [kill] with an intention to do it before the human capital theory,” he says.
Holmes went back to see psychiatrist Lynne Fenton two days after telling Datta about human capital but he didn’t mention it to her. He did tell Fenton the medication hadn’t helped his obsessive thoughts. She doubled the dose of sertraline from 50mg to 100mg.
David Healy believes this made Holmes’s mental state worse:
There’s every evidence that if the drugs are suiting a person that an increase in the dose might be helpful - and I use these drugs even though they can cause a problem.”
He adds: “But when they are causing a problem, increasing the dose is a recipe for disaster.”
Nearly a fortnight after the dose increase on 9 April, the previously shy and awkward Holmes made a move on his classmate, Hillary Allen. His texts to her became uncharacteristically bold. One hot day he messaged her about the clothes she was wearing in class.
“Oh Hillary, Why yuh gotta distract me with those short shorts...?”
“I remember receiving that and just like kind of blushing and being like, I don’t remember what I said, but kind of trying to laugh it off and just trying not to create an awkward situation,” she says.
For David Healy, this was further evidence of the effect sertraline was having on Holmes.
Aside from the fact that you have a guy who is now actively beginning to think and plan about harming others in a way that he just hadn’t been doing before, you have a change of personality. This is a totally different person.”
At his fourth appointment with Lynne Fenton on 17 April, Holmes told her his homicidal thoughts had increased, though he still didn’t tell her about his human capital delusion. Fenton’s notes of that meeting documented a decline in his mental state.
“Psychotic level thinking… Guarded, paranoid, hostile thoughts he won’t elaborate on,” she wrote.
Whatever effect the sertraline was having, it certainly wasn’t helping. Healy firmly believes the psychotic-level thinking Fenton noted was a consequence of the medication.
At this appointment, Fenton upped the dose to 150mg. At Holmes's trial she told the court this was the dose she had always been aiming for.
“It isn’t on her radar that this drug could be causing the kinds of problems that he’s having,” Healy says.
Fenton declined to be interviewed, but a statement from the University of Colorado Denver says patient-doctor confidentiality laws forbid her from talking about Holmes’s care without his consent, which he has not given.
The ‘mission’
By May, Holmes's “mission”, as he later described it, got real. He began spending large amounts of money accumulating
weapons. In the notebook he wrote:
Starts small. Buy stungun and folding knife. Research gun laws and mental illness. Buy handgun. Committed. Shotgun, AR-15, 2nd handgun…”
By this time, Holmes’s coursework had badly deteriorated. He gave a disastrous final presentation and then failed his exams. He was offered the chance to re-sit but on 11 June dropped out of university. Just before that, he had one last meeting with psychiatrist Lynne Fenton and her colleague.
Holmes's final presentation
They were so concerned by his state of mind at this appointment they offered to keep treating him free of charge, but Holmes refused. Fenton had the power to detain Holmes under a mental health hold, but she told his trial she felt there were insufficient grounds.
She did contact the campus security team to ask for criminal-record and weapon-permit checks. Holmes was given the all clear. He never told Fenton about the weapons he’d bought or the plans he was making.
Fenton also called Holmes’s mother.
“She said, ‘Do you know that he is not going to continue in school?’” Arlene tells me. “I thought that was the purpose of her phone call, and I said, ‘Did he ask you to call me?’ And she said, ‘No he didn’t want me to call you and he didn’t want you to worry.’
I was reassured by her phone call, rather than alarmed. I said, ‘My husband and I both work, we can pay you out of pocket to keep seeing him, I’m glad he’s getting some help for social anxiety.’ I didn’t know that she would never see him again, which is what happened.”
Arlene Holmes
Not only did he stop seeing Fenton, he also stopped taking sertraline. We can’t be sure exactly when he stopped but his final prescription would have run out around 26 June. The shootings were on 20 July.
For some experts who believe sertraline may have played a role in reducing Holmes’s fear of consequences and even prompted delusional thinking, this gap in the timeline prevents them from blaming the drug for what happened.
The fact that Mr Holmes was off it for three weeks even though he had the abrupt ending, means to me that it was unlikely, or I can’t say impossible, but played a very small role rather than a major role.”
Philip Resnick
The Royal College of Psychiatrists says: “Up to a third of people who stop SSRIs have withdrawal symptoms which can last between two weeks and two months… for a small number of people they can be quite severe.”
Prof Peter Tyrer, a UK-based expert on personality disorders who has been involved in evaluating the effectiveness of SSRI antidepressants since they first came on the market three decades ago, says stopping them suddenly is very unwise.
Prof Peter Tyrer
“It’s well established that you have a withdrawal problem and these adverse effects that you may have had even when starting the drugs. They all come back with a vengeance and if you’re still having them when you stop the drugs they come back even more strongly.”
He adds: “It can be six or seven weeks before the effects wear off, and in some cases – and this is one of the problems with these drugs – sometimes they last even longer than that.”
After stopping the drugs, Holmes started doing things he’d never done before. He dyed his hair red, created a profile on a swingers’ sex website, and started to draw detailed plans of the shootings in his notebook.
Holmes's internet dating profile photo
Holmes also visited the cinema in Aurora, and by the beginning of July went to a shooting range in the Rocky Mountains. There he began practising with the weapons he’d bought.
On 8 July, classmate Hillary Allen got some odd texts from him.
“The floodgates are open... It’s in your best interests to avoid me, am bad news bears,” Holmes wrote.
“The next time I actually heard about James at all was when the shooting happened,” says Allen.
Holmes brandishing a gun and wearing dark contact lenses
I was in complete disbelief that it was actually James. Then immediately my mind goes back to those messages and thinking like, ‘Oh my gosh,’ like this was real, like he was actually like really, really struggling with something.”
What Holmes was struggling with – mental illness, the side effects of his legally prescribed medication or a combination of the two – we may never know for sure.
I’ve found no evidence Holmes planned to kill before he took antidepressants and plenty afterwards to suggest his mental state went rapidly downhill.
Peter Tyrer says: “His symptoms were exactly right for giving sertraline... but with his underlying personality, with that sort of person... some of the underlying predispositions can come out more strongly, and in the case of Holmes these were very dangerous indeed.”
In a statement Pfizer, the company that developed sertraline, said: “Based on currently available scientific evidence, a causal link between the use of sertraline and homicidal behaviour has not been established. Sertraline has helped millions of patients diagnosed with major depression and anxiety disorders, including Obsessive Compulsive Disorder and Post-Traumatic Stress Disorder.”
Many people across the world report that antidepressants have been a lifesaver. But as ever-increasing numbers are prescribed, is it time to recognise that in a rare few cases they could actually contribute to murder?
It’s an emotive but important question and one the courts seem ill-equipped to handle. In the course of my research, I’ve found cases in the UK of people, with no previous history of violence, who killed or attempted to kill after taking SSRI antidepressants. The issue was not explored in court and they were jailed for their offences. The guilt and shame of what they’ve done prevents them from talking publicly.
Peter Tyrer believes the courts need to take more account of rare but serious side effects.
“Although it makes the whole process a bit more complicated, I think that is going to become necessary in the future,” he says.
Wendy Burn, of the Royal College of Psychiatry, says: “Any patient who is unsettled… should not abruptly discontinue their prescribed treatment. Instead, they should make an appointment with their family doctor or mental health professional to discuss any concerns they might have. They should together make a joint decision about whether to continue antidepressant treatment.
“This decision should be made on their own individual experience and should be informed by how effective their treatment has been in helping to reduce depressive and anxiety symptoms, any side effects which might have occurred, and the risks of a recurrence of illness, if treatment is stopped prematurely.”
Warum schweigen die Lämmer? – Demokratie, Psychologie und Empörungsmanagement“ (Vortrag von Prof. Rainer Mausfeld)
geschrieben von Jascha Jaworski am 29. Juni 2015 @ 07:00 in Gesellschaftskritik,Links | 3 Kommentare
Am 22.6. hat der Psychologe Prof. Dr. Rainer Mausfeld im Rahmen eines Kolloquiums des Insituts für Psychologie an der Universität Kiel einen Vortrag gehalten, der sich mit dem Thema Demokratie, sowie den Methoden des Meinungs- und Empörungsmanagements auseinandersetzt. Das Video zum Vortrag, sowie zur anschließenden Diskussionsrunde wird von uns nachfolgend verlinkt.
Prof. Mausfeld ist Wahrnehmungs- und Kognitionsforscher und hat sich als Wissenschaftler, der sich in gesellschaftlicher Verantwortung stehen sieht, u.a. kritisch mit der Rolle von Psychologen bei der Entwicklung von Methoden der „weißen Folter“ auseinandergesetzt (siehe z.B. ZEIT/2009[1]). Vor einiger Zeit war er zudem zu Gast bei Phönix in der Sendung „Im Dialog“ und sprach mit Michael Krons über das Thema „Kampf gegen den Terror“[2].
Vortrag vom 22.6. im Rahmen des Institutskolloquiums an der Universität Kiel:
Warum schweigen die Lämmer? – Demokratie, Psychologie und Empörungsmanagement.
Seit der Antike wird betont, daß Demokratie nur in dem Maße funktionieren könne, wie es gelinge, der Bevölkerung die politische Rolle eines bloßen Zuschauers zuzuweisen. Da die Masse ‚irrational‘ sei, bedürfe die Demokratie einer Lenkung durch eine Elite ‚verantwortlicher Führer‘. Dieser Elite komme die Aufgabe zu, die ‚irrationale Herde‘ zu leiten, ihr Schweigen zu deuten und im Sinne eines Erhalts der jeweils herrschenden Ordnung zu lenken. Folglich sei ‚Stabilität‘ in einer Demokratie nur mit Hilfe geeigneter Techniken zur Lenkung der öffentlichen Meinung zu gewährleisten. Staaten können mit Billigung und Unterstützung der Mehrzahl ihrer Bürger schlimmste Greueltaten – wie Folter, gezielte Tötungen und Völkermord – begehen. Daher stellt sich die Frage, warum dies in Demokratien nicht zu Empörungsreaktionen mit politischen Konsequenzen führt. Denn wir verfügen über ein natürliches moralisches Empfinden, so daß sich ein ‚Schweigen der Mehrheit‘ nur in dem Maße erreichen läßt, wie sich derartige Verbrechen moralisch unsichtbar machen lassen. Am Beispiel einiger unstrittiger und gut dokumentierter Fakten werden Techniken und Strategien aufgezeigt, wie sich schwerwiegende Menschenrechtsverletzungen für die Bevölkerung moralisch unsichtbar machen lassen und wie sich die aus Sicht der jeweils herrschenden Eliten gewünschte politische und moralische Apathie der Bevölkerung erreichen läßt.
vor wenigen Woche hat die Fraktion der Linken auf mein Betreiben hin eine Kleine Anfrage an die Bundesregierung gerichtet. Hierbei ging es um die zweifelhafte Zulassung der SSRI-Antidepressiva, insbesondere im Fall von Zoloft (Sertralin).
Doch die Bundesregierung sieht keinen Handlungsbedarf.
In einer Kleinen Anfrage äußerte die Linken-Fraktion erhebliche Bedenken bezüglich der Zulassung einiger Antidepressiva aus der Gruppe der SSRI. Inzwischen liegen die Antworten der Bundesregierung vor – doch nach Ansicht der gesundheitspolitischen Sprecherin der Linken, Kathrin Vogler, weicht das Bundesgesundheitsministerium in wichtigen Fragen aus, anstatt die Zweifel zu entkräften.
Kürzlich stellte die Links-Fraktion im Deutschen Bundestag eine Kleine Anfrage zu Antidepressiva – und hinterfragte die Zulassung insbesondere von einigen Selektiven Serotonin-Wiederaufnahmehemmern (SSRI). Manche seien in Fachkreisen schon seit ihrer Zulassung umstritten, erklärten die Abgeordneten um ihre gesundheitspolitische Sprecherin Kathrin Vogler. So habe es bereits 1990 Berichte über gesteigerte Suizidalität nach der Einnahme des Wirkstoffs Fluoxetin gegeben und das damalige Bundesgesundheitsamt habe das Präparat Fluctin® unter fragwürdigen Umständen zugelassen: Mindestens zwei Mitglieder der Zulassungskommission hätten Kontakt mit dem Pharmahersteller Eli Lilly gehabt, obwohl dies „streng verboten“ gewesen sei. Der damals zuständige Vorsitzende der Kommission habe im Jahr 2013 außerdem gegenüber der „Süddeutschen Zeitung“ erklärt, dass die Zulassung von Fluctin® nach den später vorliegenden Daten „keine gute Entscheidung“ gewesen sei.
Bei Zoloft® (Sertralin) sieht die Linke Hinweise, dass Probleme im Zulassungsverfahren gezielt verschleiert worden sein könnten: Rund 90 Prozent der Fälle von schweren Nebenwirkungen hätten im Zulassungsantrag keine Berücksichtigung gefunden. Daher fragte die Fraktion die Bundesregierung, ob das „Ausselektieren von 90 Prozent der Fälle von Suizidversuchen, vollendeter Suizide und Suizidalität“ nicht ein hinreichender Tatbestand sei, um die Gültigkeit und Aussagekraft der Bewertung durch das pharmazeutische Unternehmen in Zweifel zu ziehen. Eine umfassende Prüfung der Risiken von Zoloft® hat nach Einschätzung der Linken-Politiker „sehr wahrscheinlich nicht stattgefunden“ – sie fragen, warum das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) bisher die Zulassung nicht entzogen und auch sonst „bislang nichts unternommen hat“.
Inzwischen liegen die Antworten der Bundesregierung vor. In klinischen Studien erfasste schwerwiegende wie auch nicht schwerwiegende Nebenwirkungen flößen „grundsätzlich in die Beurteilung des Nutzen-Risiko-Verhältnisses im Rahmen der Zulassung ein“, erklärt das Bundesgesundheitsministerium (BMG). Über das Pharmakovigilanzsystem würden Verdachtsfälle von Nebenwirkungen gemeldet, außerdem seien die Zulassungsinhaber zur Übermittlung regelmäßig aktualisierter Unbedenklichkeitsberichte verpflichtet.
Bundesregierung sieht keinen Handlungsbedarf
Bei Zoloft® habe der Hersteller bei Zulassung alle relevanten Wirksamkeits- und Sicherheitsdaten vorlegt, erklärt das BMG. Sie verweist außerdem darauf, dass geprüft werde, ob es einen kausalen Zusammenhang zwischen Nebenwirkungen und Arzneimittel gebe. „Im vorliegenden Fall können bereits die Grunderkrankung oder auch Begleiterkrankungen Ursachen suizidaler Ereignisse sein“, heißt es in der Antwort auf die Linken-Anfrage.
Die Zulassung des Arzneimittels Fluctin® im Jahr 1990 beinhaltete auch Hinweise auf die Notwendigkeit, bestimmte Patientengruppen zu Beginn der Behandlung wegen eines möglicherweise erhöhten Suizidrisikos ärztlich zu überwachen, betont die Bundesregierung. Außerdem solle – wenn nötig – eine begleitende Anwendung eines beruhigenden Arzneimittels eingeleitet werden.
„Quantitativ ergeben sich aktuell aus den Meldungen des Spontanmeldesystems zu Suiziden, Suizidversuchen, suizidalen Gedanken oder suizidalem Verhalten weder aus Deutschland noch auf europäischer Ebene Hinweise auf einen Anstieg der Meldungszahlen“, erklärt die Bundesregierung. „Für alle im Verkehr befindlichen Arzneimittel aus der Gruppe der SSRI ist das Nutzen-Risiko-Verhältnis nach derzeitigem Kenntnisstand weiterhin positiv.“ Teilweise identifizierte Risiken, wie das Risiko der Suizidalität, hätten die Behörden durch Ergänzungen der Packungsbeilage und Fachinformation begegnet. „Anhaltspunkte für die zu treffenden Maßnahmen nach § 30 AMG, d. h. Rücknahme, Widerruf oder Ruhen der Zulassung, waren und sind derzeit nicht ersichtlich“, schreibt die Regierung.
Laut Linken-Politikerin weicht die Regierung teils „komplett aus“
Doch die Linken-Politikerin Kathrin Vogler hat als Reaktion auf die BMG-Antwort weiterhin „extreme Zweifel“ am Zulassungsverfahren, wie sie gegenüber DAZ.online sagt. Dies betrifft insbesondere auch Kritik an möglichen Interessenskonflikten des BfArM-Präsidenten Karl Broich: Mehrere Fragen hierzu beantwortete die Regierung nicht ähnlich ausführlich wie andere Punkte, sondern mit einer allgemeinen Stellungnahme. „Über die Rücknahme, den Widerruf oder das befristete Ruhen einer Zulassung wird gemäß den gesetzlichen Vorgaben entschieden“, hieß es – und dass die Bundesoberbehörden sicherstellen, dass es keine unzulässige Beeinflussung gebe.
„Bei allen, auch konkreten Fragen zu Positionen und Veröffentlichungen des heutigen Präsidenten des Bundesinstituts für Arzneimittel zum Thema SSRI-Antidepressiva weicht die Bundesregierung komplett aus“, bemängelt Vogler. Auch von „unzulässigen Kontakten“ einiger Mitglieder der Zulassungskommissionen zur Industrie wolle die Bundesregierung nichts wissen. „Statt auch kritische Daten zur Kenntnis zu nehmen, stellt sich die Bundesregierung schützend vor die Pharmakonzerne“, erklärt die Linken-Politikerin. Für sie ist es ein Anreiz, am Thema dranzubleiben.
Das BfArM wollte auf Nachfrage von DAZ.online zu den Vorwürfen, die sich aus der Anfrage der Linken ergeben, keine Stellung nehmen. „Die von Ihnen angesprochene Beantwortung der Kleinen Anfrage enthält bereits zu allen angefragten Aspekten Informationen“, erklärte ein Sprecher mit Bezug auf die Antwort der Bundesregierung.
