Making medicines safer for all of us

Adverse drug events are now the fourth leading cause of death in hospitals.

It’s a reasonable bet they are an even greater cause of death in non-hospital settings where there is no one to monitor things going wrong and no one to intervene to save a life. In mental health, for instance, drug-induced problems are the leading cause of death — and these deaths happen in community rather than hospital settings.

There is also another drug crisis — we are failing to discover new drugs. [Read more...]

Archive for February 2013

Prescription-only Homicide and Violence

These are the speaking notes for two talks given in Chicago on Monday February 18th and Tuesday February 19th. The S2, S3 in the text refers to slides which are available on the Video Gallery. Video will be posted when available.

The first slides features where we have created a Violence Zone and want you to get anyone who may have been made violent or had their behavior disturbed by drugs to report – we will give you a megaphone to help ensure that what has gone wrong for you doesn’t blight someone else’s life also.

What stops us recognizing how drugs cause violence

This talk is about the things that impede recognition that drugs can cause adverse effects – and in particular stand in the way of recognizing they can cause violence.

You see here (S2) a child taking medicines from the medicine cupboard. In 1960 this would have been a barbiturate sleeping pill and it would have killed your child. Now you can replace this with Distaval – the new and safe sleeping pill.

Distaval is thalidomide which caused a major tragedy around 1960. In 1962 we put mechanisms in place to ensure that you would be safe from this happening again. The main safeguard was randomised controlled trials – RCTs. Companies now had to prove their drug worked before it would be allowed on the market. This is the major thing politicians and doctors think is keeping you safe – maybe you do too.

The person responsible for RCTs was Lou Lasagna whom you see here. He was one of the first people to do clinical trials, the first to put the placebo effect on the map, he wrote the modern version of the Hippocratic oath which doctors take when they qualify. Which of course, as you know, has the famous phrase ‘First do no harm’ (S4).

Dancing with pythons

There was recognition then that dealing with industry was like dancing with a python. They Dance with Pythons in Malaysia – S5. The trick is to make sure the python cannot anchor its tail onto anything because if it does it can squeeze you to death. This woman made a mistake and was later squeezed to death.

Lasagna made the same mistake and we are being squeezed to death by the clinical trials that he put in place that industry now run. We are squeezed by the fact that they withhold the data that comes from the risk you take in these trials.

RCTs do more harm than this. Here you see S6 a doctor and a pilot. Both report on adverse events. When a pilot reports a near miss or a problem she is believed – things change on the basis of her report. When a doctor reports on a near miss or a problem this is regarded as an anecdote and is discarded. Nobody pays heed to what the doctor says because clinical trials have persuaded everyone that you cannot believe the evidence of patients or doctors eyes.

Regulators never say a drug causes a problem

But there is an even more profound problem (S7). Any of you who are waiting for Health Canada, FDA or academics to agree that a drug has caused a problem will be waiting forever. The response from companies and regulators to thalidomide was that how do we know that it’s not preventing spontaneous miscarriages so that these children who wouldn’t have been born if their mother hadn’t been on the drug are now being born. They did not concede the obvious – that the drug was causing the problem.

Thalidomide is still on the market and still causing birth defects – this is not a baby from the 1960s this is a baby from Brazil in the 1990s where over a thousand babies have been born with birth defects.

The handling of the problems around thalidomide is in fact the norm. Let me introduce you to Matt Miller (S8). Matt was a 13 year old boy who had just changed schools and was feeling nervous. His parents prompted by the teacher brought him to a doctor who put him on Zoloft. Seven days later he hung himself in the bathroom between his parent’s bedroom and his bedroom. Trust me when I tell you the Zoloft caused this suicide.

The response from regulators and companies was that this could have been auto-erotic asphyxiation (S9). They went so far as to scour the carpet in the bathroom to collect potential evidence for seminal stains. Companies and regulators will NEVER say that a drug has caused a problem.

Shoot yourself in the foot – Report an adverse event to a regulator

They also make it difficult to report a problem. Look at the case in your handouts (S10-15). This is an American woman living in Michigan. She contacts GSK because she was on Paxil, became pregnant and found after six months that her baby had truncus arteriosus. She had a termination. This woman comes from an intensely Christian community where terminations are not acceptable (see American Woman).

She is hoping to get pregnant again but wants to know whether Paxil is safe. If not she wants to stop it.

GSK may have sent her the datasheet and told her to go and talk to her doctor. ‘We encourage patients to take questions to their doctor because your physician knows your condition and is best suited to answer your questions’. The datasheet says nothing about birth defects on Paxil and the doctor will have been told nothing. In fact all doctors are subject to an intense propaganda campaign saying that the only risk of birth defects stems from untreated depression.

Whether she has got the email from the company or not the woman responds asking is there any evidence that women on Paxil can have healthy babies. She ends up by pleading ‘where can I get this kind of information?’

It’s extraordinary that she got her email through to anybody. GSK have many phone numbers that don’t lead anywhere. The real phone numbers that would get through to them are hard to find. The phone numbers you see on DTC adverts or adverts in medical journals don’t reach GSK. The phone numbers that come with the drug often don’t reach anything to do with the drugs any more.

But since 2001, company adverts now advocate that you get in touch with FDA’s MedWatch system and talk to your doctor if you have a problem. What better way of doing things can there be than this. It almost looks like turkeys voting for Xmas.

Except that companies have a legal duty to follow up adverse events, to check and see what happened in order to work out did their drug cause the problem. Health Canada does not have this obligation, and so diverting reports to the regulators saves money, reduces legal liability and relegates any reports of adverse events to anecdotes. The same happens when companies refer you to your doctor but IT WON’T HAPPEN if you take your report to

One rule for investors, another rule for mothers

So our Woman got through to GSK and they have a duty to follow up. What happened? S16 – two weeks later you see a letter saying: ‘In order to follow things up we have to contact your doctor, can you please give us his details’. But the letter went to a postbox and was never collected. Somehow the company has managed not to follow up.

Despite this, as you see here S17, companies have to categorise problems like this as unrelated, unlikely, possible, probable or almost certain.

In this lady’s case her report was categorised as almost certainly caused by Paxil.

Here is Dr Jane Niemann (S18) of GSK being asked under oath should this woman have been told that GSK had decided Paxil had caused the problem and she says no. She’s asked, ‘As a doctor, do you think this woman should have been told?’ And she says ‘No’.  She’s then asked, ‘As a mother, do you think this woman should have been told? And she says, ‘Yes, I do’.

Two years ago (S19) the Supreme Court in the Matrixx case decided that if you’re an investor in GSK you have a right to be told the adverse effects profile of a company’s drug. You have no rights if you’re a patient or a doctor but you do as an investor.

Shower and bidet

So how do we clean this mess? We can take a top down or bottom up approach, a shower or a bidet approach (S20). is a bidet approach (S21). It’s all of us collecting what we observe is happening to us on drugs because the top down approach hasn’t worked. If we’re going to clear this mess it’s going to require all of us to report and build a database that companies and regulators and the media cannot ignore.

Unlike regulators we aim at getting quality reports of events and taking you through a causality assessment like the ones companies do – but we will also put local knowledge in local hands.

You see here FDA reports for Paxil which you can get on RxISK (S22). This drug has liver problems – in Japan. Our belief is that it is the Japanese who are going to be able to answer the question as to what’s going on.

In the same way we will put data in your hands so that if a problem is happening here and not in Detroit we figure that someone in either here or in Detroit is going to answer the question what’s going on here. Is it some interaction with other pill, or the local cuisine, or air pollution that is leading to the problem? We believe YOU have the expertise to solve most problems. You do not want to think that academics have this expertise. Regulators certainly don’t – they are just bureaucrats.

Thalidomide and Lasagna – The ultimate symbol

Back in 1962 Lasagna put a shower approach in place – RCTs (S23). Controlled trials will keep you safe. But, as of 1962, only one drug had been through a controlled trial before it came to the market. That trial had shown that this drug worked well and was safe. The drug was thalidomide (S24).

In addition to the above, other factors impair our ability to link drugs with effects including violence.

From Stockholm to Albuquerque

In 1973 the CreditBanken in Stockholm was raided and the staff kept hostage for five days (S25). When finally freed the media were astonished to find the liberated hostages talking warmly about their captors. This led to recognition that if you are isolated with a threat to your life, held hostage by kind captors, you identify with your captors and develop Stockholm Syndrome.

When we’re ill and put on a prescription only pill we’re isolated, with a threat to our life and our doctors who are the only way out are increasingly trained to be nice to us. This blocks our ability to say things that we think may cause them to be unhappy – such as this pill is causing me to feel suicidal or violent.

Prescription only arrangements do something else. The Crystal Meth at the heart of “Breaking Bad” causes terrible sex addiction and violence (S26). But it began life as Methidrine a pill for nerves. It was replaced with the more potent Dexedrine which in turn was banned before later being brought back, as you all know, as a treatment for ADHD. On prescription-only this monster comes with almost no problems it seems, while available on the street it causes terrible problems.

Even worse than Crystal Meth are dopamine agonist drugs like Ropinirole – which cause much more profound sexual addiction and dangerous behaviors such as gambling and promiscuity. But because they’re available on prescription the hazards of these drugs took 25 years to come to light.

The politics of access to treatment

There’s a further problem. Everyone today wants access to treatment. I approached ACLU about the fact that there are people in prison who are likely there because their drugs caused them to become violent but didn’t even get an acknowledgment from ACLU that I had written (S27).

In the same way the Boston Women’s Collaborative don’t want to hear that antidepressants could cause birth defects or mental handicap in children. They only want pregnant women to have access to antidepressants and are part of a movement that has pushed the use of antidepressants in pregnancy up to record levels.

When it comes to violence, a range of political forces are using school shootings as an opportunity to press for gun control (S27). Those pushing this case are not likely to want to hear about a role that drugs may have played in causing school shootings.

Some of the cases I’m going to talk about involve husbands murdering wives. We do have to take into account that even before Prozac the commonest detected murder was a husband murdering his wife. The commonest murder may be a wife murdering her husband (S28).

Finally, as you will see here, when the first warnings about antidepressants causing suicide and violence came out in 2004 the American Psychiatric Association took a stand saying that APA believes antidepressants save lives (S29). To this day they still find it difficult to accept the evidence that these drugs cause more lives to be lost than they save – nowhere more so than here in Chicago.

Do drugs cause violence?

The antidepressants now come with black box warnings of suicide and in some jurisdictions such as Canada they come with warnings of violence also. Exactly the same mechanisms that lead to suicides lead to violence. In one case you have violence directed inward and in the other directed outwards. These mechanisms are akathisia, emotional blunting and psychosis.

Yvonne Woodley whom you see here (S30) went on an SSRI for minor stress and when she got worse the dose was put up and when she got even worse the dose was put up again. This was very clear akathisia. She then committed suicide.

The UK medical director for Lundbeck, who make the drug she was on, was asked by the coroner two questions: “Do you believe that Citalopram can cause someone who would not otherwise do so to take their own life?” (S31). He answers ‘Yes’.

When companies are asked this question ordinarily they refer the media to academics or doctors who are not legally obliged to say “yes” in answer to the first question. Or they will answer the question: “Did your drug cause Yvonne Woodley, to commit suicide?” This is a question can always be answered “No”. But if asked the direct question “Can your drug cause someone to commit suicide?” companies legally have to answer “yes”.

How do drugs cause violence?

The mechanisms that lead a drug to cause suicide are the same that produce violence. The first of these is akathisia. Here (S32) you have great descriptions of the agitation antidepressants can cause. These came from the use of a drug called Reserpine given to normal people as an antihypertensive. There is no mental illness here to cloud the picture.

The next mechanism is emotional disinhibition or blunting. This has been recognized by takers for a long time as you see here in this Peanuts cartoon, and yet another cartoon here from 2005 (S33-36).

I don’t have a slide for the voice of God – to represent the fact that drugs can cause you to hear a voice or become delusional and lead to violence this way. This is strictly speaking delirium rather than psychosis.

SSRIs in the dock

The modern story about drugs and violence begins here in 1989 when Joseph Wesbecker in a mass shooting killed eight of his co-workers before killing himself. He had been on Prozac for a month and the drug had unquestionably altered his behaviour. The company appeared to get a verdict saying that Prozac was not guilty when in fact it turned out the case had been settled (S37).


Things changed with this case involving Don Schell (S38). Don Schell was a 60 year old man who over 14 years had several brief episodes of anxiety that lasted at the most for a few weeks. In 1990 shortly after it came out he was treated with Prozac but had a very poor response and may have begun to hear voices while on it.

Eight years later an entirely different doctor gave him Paxil having diagnosed poor sleep and anxiety. 48 hours afterwards Schell who you see here put 3 bullets through the head of his wife, 3 bullets through the head of his daughter and 3 through the head of his grand-daughter who were visiting before killing himself. His son-in-law Tim Tobin took a case against GSK and won a jury verdict (S39).


In the same week that verdict came in, the case of David Hawkins was heard. David Hawkins was a 74 year old man with a 20 year history of minor episodes of nervousness, no violence. In one of these he was treated with Zoloft and had a bad response to it. His doctor recorded “Do not give this man SSRIs” (S40).

A number of years later feeling unwell he was seen by a locum doctor who didn’t know the history and didn’t read the notes and put him on Zoloft. He didn’t know that he was being put back on a pill that he had reacted poorly to before. He felt worse after one pill and thinking that more would help took four and the next morning strangled his wife to death. The judge and prosecution agreed with Tania Evers for the defense that but for the drug it was unlikely this would have happened (S41).


Here you see Merrillee Bentley, a 32 year old mother of two (S42). She had been anxious for years. She was finally put by her doctor on Paxil and the dose was put up. She did even worse on that and so was switched to Efexor. She got worse and the dose was pushed up and up to 350 mg per day. The notes record that on Paxil and later Efexor she became visibly more agitated.

She took her children for a drive in the car, stopped, plugged a hosepipe into the exhaust and turned on the engine. She gave up when the children talked about being itchy. She drove further and tried again. She didn’t know that her car had a catalytic converter. She turned herself into the police who charged her with attempted murder.

Her drugs were stopped, she returned to normal. The judge concluded that but for the influence of the drug she would not have done this.


MC’s case involves a 23 year old man with a history of cocaine misuse (S43). He was prescribed Paxil to try and stop him taking cocaine. He stopped cocaine but began drinking more heavily. We now know SSRIs can cause alcoholism (see Out of my Mind: Driven to Drink). This led to a break up between himself and his partner. He lived with his parents but every so often came to stay at her house.

This evening they both drank, they had a quarrel. She insisted he sleep downstairs, she went to bed. He took his pills. Next he arrives covered in blood with the baby at the police station. The police went to his house and found his partner stabbed brutally to death. He has no recollection of what has happened.

The mystery centers on the changes at the heart of Side Effects. It turns out that at this time Paxil was the drug most commonly linked to sleep walking and the next most commonly linked was Zopiclone the hypnotic he was on (S44). These drugs are also linked to nightmares, Paxil is the most commonly reported drug linked to nightmares. They are also commonly linked to sleep terrors. As you can see the SSRIs very heavily represented as are statins which are also a group of drugs linked to violence.

Despite a history of sleep-walking that only started with his meds, MC was convicted of homicide.


Here’s Jake Bennett a 66 year old taking Librium and Doxepin – remarried to a younger woman. It was an argumentative marriage but not violent (S45). She was unhappy with the fact that he was just too sleepy. She had been trying to empty out his Doxepin pills, and this led to them both going to the doctor, who recommended a switch to Prozac.

Over the following few weeks Jake became paranoid that his wife was again interfering with his pills. She mentioned this to many of her friends – and that she was getting a little more alarmed about being in the house with him. Two months later he stabbed her brutally to death 200 times. He was found not guilty by reason of insanity. The insanity cleared once the Prozac was stopped but he remains in prison hospital for the rest of his life because, even though the Prozac was stopped, nobody was prepared to take the risk that it really was just the Prozac.


Leslie Demeniuk here was the 30 year old mother of twin boys (S46). She self-diagnosed with panic attacks. At her local clinic she was given Zoloft by the nurse. Over the next month she became suicidal and began to drink – SSRIs can cause you to drink to excess. She was switched to Paxil and 48 hours later she killed both of her twin boys with bullets to their heads. She overdosed herself heavily but did not succeed in killing herself. When she came to the police were there.

Older Men in Britain

Not featured here is an 80 year old man I saw who had a minor stroke. He didn’t rehabilitate as quickly as his doctors wanted. They regarded the fact that his bed wasn’t coming vacant as an indication that he was depressed. They put him on an SSRI. When he didn’t respond instantly they called me to see him.

I found a man who didn’t seem to be depressed. I stopped the SSRI and came back after a few days to see him. He told me “I’m fine and very relieved now… You see that man across there? I don’t know who he is, but while I was on those pills I had a terrible urge to get up in the middle of the night and go over and kill him. Those feelings have gone completely now that I’ve stopped that drug.”

The next man (S47) was fifty years married, no history of violence or nerves. He became anxious. His doctor put him on Citalopram. He kept a diary during the ten days he was on this that shows him clearly becoming more agitated and restless and beginning to voice thoughts that if he continued to get worse he was going to end up in the madhouse. He began to talk about killing himself to friends. Ten days on the drug he battered his wife to death. He called the police and was jailed.

I wrote a report stating he was not guilty. His legal firm advised him to cut a deal with the prosecution – he would only get 3 years. When released his daughter took him into her home but the community from which he came shunned him. They saw a convicted criminal and no-one would have any dealings with him.


Here you see Christopher Pittman and his grandfather (S49). Chris preferred living with his grandparents than with his father and after an argument with his father in Florida he ran away to his grandparents in South Carolina. He was picked up by the police and taken to a facility for young people where he was reviewed, said to have no mental illness, but was still put on Paxil.

His grandparents came to visit him and he was discharged to them (S50). He was switched to Zoloft because their doctor had no Paxil samples. He went to a school he had gone to before. But where before he had got on extremely well, now he had fights and arguments in school and on the school bus. When they went to church he was restless and couldn’t keep still and was told by his grandparents if this kept up he would have to go home to his father in Florida. Later that night he claims he heard a voice telling him to shoot his grandparents. He took his grandfather’s gun and shot both of them while they were lying in bed and then burned the house down.

Chris was 12 when all this happened. He was tried as an adult. The newspaper coverage focussed on the question of Evil or Chemically Compelled (S51). The jury found that the Zoloft that affected Chris. But that he was guilty of murder.

Judge Pieper you see is disturbed by the implications (S52). “There is no case in South Carolina that addresses involuntary intoxication by prescription drugs…It seems to turn the whole medical system on its side if you can’t rely on the medication your doctor prescribes. It potentially forces you into a situation of lifetime commitment if that drug induces effects of which you are unaware. There is something disconcerting about that, albeit probably of a legal nature that is troubling me (S53).”  Disconcerted or not, Pieper imposed a 30 year sentence on Chris Pittman.

Drug induced frenzy or delirium – The original insanity defence

There is a technical term for the medico-legal issue at stake – an automatism. This is a disturbance of the mind or brain such that the mind an ordinary person would be unlikely to withstand. One of the best examples of this is sleep-walking. If you walk in your sleep and commit a murder you cannot be found guilty because you didn’t intend to commit murder (S54).

In the same way if under the influence of a drug like LSD you step out of a 24th floor window people will not regard that as suicide because you couldn’t have intended to commit suicide.

Prescription drugs introduce an interesting complication of this – the issue of involuntary intoxication.

These issues were discussed and resolved by Sir Matthew Hale, the Lord Chief Justice of England in 1676. You see him here and you see his book which is used much more in the US than in the UK (S55).

Hale outlined the original insanity defence – “If a person by the unskillfulness of his physician, or by the contrivance of his enemies, eat or drink such a thing as causes a temporary or permanent delirium – this puts him into the same condition, in reference to crimes as any other delirium and equally excuses him” (S56).

Most of the insanities of the time were linked to fevers and other physical illnesses such as poisons or drugs. If you are delirious for whatever reasons, you are not guilty. An easy concept then – and now.

This is the original insanity defence and it works perfectly for states of delirium. The problems with the insanity defence began with this man Daniel McNaughton, who didn’t look delirious when he tried to kill the person that he believed was the prime minister of England (S57). He was operating under the influence of a delusional belief. Courts have struggled ever since with the issue of when to excuse people who are deluded. This is a different issue to excusing people who are delirious.

Data on drug induced violence

Let’s move on to some data. Here are data from the Drug Safety Research Unit in the UK showing that roughly 1 in every 200 people put on an SSRI go on to a violent action (S58).

Close to all the scientific literature about all these drugs is ghost written. You see here (S59) part of a brochure of articles prepared for Pfizer on Zoloft by Current Medical Directions, a medical publications agency based in New York. Here on the right, you see the papers have been completed and on the left the authors of these completed papers remain TBD.

In the brochure there are articles in preparation on Zoloft for children. Pfizer later attempted to get Zoloft to the market for children. Here are the data from two ghostwritten Zoloft studies, which combined make it clear that Zoloft poses a much bigger risk than placebo for aggression and states linked to it (S60).

On this slide (S61) you see, Study 329, one of the most famous studies of all time which has an authorship line to die for and was published in the leading journal in child psychiatry. However, none of the authors is on this authorship line. This article was ghost written.

The published data were at odds with the company’s internal assessment of what the trial showed. Here (S62) you see three years previously they face a problem – the results are so awkward they can’t give the data to the FDA even though they will get half a year’s worth of patent extension if they do – close to a billion dollars. What they will do instead is to take the positive data from the study and publish those – and this becomes study 329 which you have seen in the previous article.

This led New York State to take a fraud action against GSK which the company resolved by claiming it posted all of its studies up on the company website. People get the impression that the company’s posted their data on the website. It hasn’t. But from the data there and submissions to regulators we can glean the following data on Paxil and aggression.

This slide (S63) shows you the hostile events that happened on Paxil and placebo in placebo-controlled trials of Paxil. You will see that overall Paxil compared to placebo leads to a doubling of hostile events. Hostile is code which includes aggression, homicide, homicidal ideation and homicidal acts.

You will note that in PMDD trials the risk is infinitely greater on Paxil than leaving PMDD untreated (S64).

Violence in healthy volunteers

Of even greater interest are the healthy volunteer trials you see here. These were done before the drug was ever on the market and you see that there are very clear indications long before – this was in the 1980’s – that the drug could make people aggressive.

In 1983 Pfizer ran a healthy volunteer trial of Zoloft in Leeds (S65). Six women were randomised to Zoloft and six to placebo. All the women taking Zoloft dropped out after a week with agitation and anxiety of various forms and in one case notes about aggressive impulses. Pfizer concluded in 1983 ‘Our drug has caused this and this is a well-known feature of SSRI drugs’. This is 1983 – 9 years before marketing.

Unaware of this result we ran a healthy volunteer trial in North Wales using Zoloft also and two of our healthy volunteers, one of whom you see here, became aggressive on the drug. This, I’m sure you will agree, is a fairly normal looking woman. Not the kind that you would expect to become seriously aggressive (S66).

We’ve known for fifty years

How long has all of this been known? You see here one of the first meetings in England, on the new serotonin reuptake inhibiting antidepressants in this case imipramine. In 1959 a year after the drug was launched a meeting was held. At this the participants at the meeting discussed the fact that in the early days of treatment patients can become very agitated and are at risk of going on to commit suicide. You see here one of the delegates say they also have dreams of aggressive content (S67-70).

Psychiatrists committing suicide

We’ve seen that when concerns about suicide on antidepressants came up the APA responded by saying they believed that antidepressants saved lives. They should of course have written that psychiatrists saved lives (S71-72).

Let me take you back to the Woodley case (S73). You’ve seen the medical director of Lundbeck say that our drug can cause people to commit suicide. He went on to say that if people do commit suicide it’s the fault of their doctor. He said this with the doctors who had been treating Yvonne Woodley sitting in the inquest. One of these, Dr Milner, was then called to testify and you can see to the surprise of the coroner she says no, she doesn’t believe citalopram can cause anyone to commit suicide even though she has just heard the company say that it can (S74).

What you see in the next slide is a collage of photos – the victims from VA Tech, flowers laid at Sandy Hook and the doctor looking after James Holmes, in Aurora (S75). We could have turned these the other way around and had the photographs of the victims at Sandy Hook or at Aurora or the doctor from either of these scenes.

I want to end with another doctor who caused a stir recently when she was convicted after one of her patients hacked a man to death (S76). Danielle Canarelli was convicted of not recognising the hazard and not intervening early enough. Doctors worldwide were shocked at this. They could see the implications.

In the case of prescription drugs, what defence does a doctor have to fall back on? The risk of violence on these drugs has been known for 50 years. It’s known that even giving these drugs to healthy volunteers can cause them to become violent. The data has been out there in warnings in many countries for 10 years. It may be disputed but there is no doctor who can say that they simply couldn’t have been aware of this issue. If there are, they are simply not professional.

The violence and extreme behaviors zone

So back to RxISK. You see here that on RxISK we have created a Violence and Extreme Behaviors Zone (77-78). This gives you all the FDA data linking various drugs to extreme behaviors – for free.

But we need you to report. Controlled trials can never establish a link between a treatment and a complex behavior like violence. Proportional Reporting Ratios can give valuable information on which are the riskiest drugs. We believe that best way to establish whether a drug can cause aggression is by getting good quality descriptions of what happens and seeing what happens when the drug is stopped and then possibly restarted.

Victim support?

There is one final barrier to the recognition of violence on psychotropic drugs – the families of the injured and bereaved have to in some cases be prepared to let the apparent perpetrator walk free.

On the final slide (S79) you see Shane Clancy, who broke up with his girlfriend – and then decided he wanted to get back with her but she had move on to someone else. Shane was brought by his mother to the doctor who put him on Celexa. I know he took them because he developed side effects that almost no-one knows about. He also tried to commit suicide. So he was brought by his mother back to see the doctor who continued Celexa, and a few days later he killed his girlfriend’s new boyfriend and attempted to kill her and the new boyfriend’s brother before killing himself by stabbing himself frenziedly 23 times.

A rural jury of Irish men and women in their 50s and 60s, shop-owners, small business people and farming people returned an open verdict – this was not suicide and by implication not homicide. The familes of those assaulted by Shane cannot see him as a victim and have appealed the issue to the Irish Parliament and are trying to take it further.

It is almost unimaginable that people can be asked to exonerate the person who has killed those nearest and dearest to them. But equally in a time where we recognize the rights of victims, we need to recognize that if we don’t find a way to bridge this chasm then one set of victims – the families of the person who was on the drug – become the most cruelly isolated of all and are isolated by other victims.

Not So Black: Ablixa and Homicidal Side Effects

If you don’t want to know what happens in the movie Side Effects – do not read further. The post does not reveal all but does reveal important details.

So now we know Soderbergh’s movie Side Effects is not so Black/Noir after all – more Fifty Shades of Grey. Emily Hawkins (Rooney Mara) is put on Ablixa by her psychiatrist Jonathan Banks (Jude Law) and while on it kills her husband. She apparently murders him while sleep-walking triggered by Ablixa and sleep walking being a perfect defense against murder she is acquitted.

The first part of the movie is an expose of the pharmaceutical industry and greedy doctors. But in fact the industry and greedy doctors are the victims of wicked lesbians Hawkins and her former shrink, Victoria Siebert (Catherine Zeta Jones), who helps construct her alibi while both make a killing in the stock market by investing against Ablixa.

Not so noir

Do they get away with it – I’m not telling you. Their attempt to do so though is a twist in the tale that’s supposed to be Noir.

One of the best definitions of Noir comes from the humorist Tom Sharpe, who describes an incident in the South African navy when he and colleagues were scrubbing a ship, and one of their colleagues fell overboard just as an Admiral walked up the gang plank. Everyone had to stand-to for an inspection by the Admiral, and while they did so the sailor who had fallen overboard drowned.

In real life suicides and homicides on the SSRIs have almost certainly boosted the sales of these drugs. Far from a verdict against Ablixa leading to a collapse in its share price, the publicity would have increased sales, not least among women who might want to murder their husbands.

In real life mass homicides such as school shootings even when the press in the best traditions of pantomime try to draw the attention of the cast and politicians to the drugs in the background, produce more mental health screening programs, leading to more drugs being prescribed and more school shootings. That’s Noir.

So why should an investor worry? In real life the “girls” would have lost their shirts on this one – their play should have been on the share price going up.

Antidepressants and violence in Holland

Side Effects launched in a week that saw a Dutch court hear evidence that paroxetine (aka Aropax, Paxil, Pexeva, Seroxat, Sereupin) can cause violent behavior.

“The suspect bashed in his girlfriend’s head using a fire extinguisher and then shot a police officer. Other law enforcement officers then shot the suspect 5 times, but they still had a lot of trouble trying to restrain the suspect.

“The officers stated that they shot the suspect in the chest but it did not seem to have any effect. After the suspect had also been shot in the leg and shoulder, the suspect was still able to resist arrest. He still managed to hit another officer in the head using his gun. Officers even used pepper spray but that too did not yield any results. The officers stated that the suspect acted like a zombie.

“Court experts stated that it was highly likely that the behavior of the suspect had been caused by the use of Paroxetine”.

Why would a distinguished journal publish this?

In some jurisdictions such as Canada companies are legally obliged to say their drug can cause violence, a recent article in Psychopharmacology by Dutch academics Paul Bouvy and Marieke Liem denied the possibility of a link.

Bouvy and Liem correlated data on lethal violence in Holland between 1994 and 2008 against sales of antidepressants. The drug sales went steadily up and the number of episodes of lethal violence fell, leading the authors to claim that “these data lend no support for a role of antidepressant use in lethal violence”.

This is a marvelous example of an ecological fallacy, which is when someone claims that if an increase in the number of storks parallels an increase in the number of births that storks must be responsible for births.


The best known example of storkology in recent years were the graphs produced by tobacco companies showing rising life expectancies and even reduced deaths from respiratory illnesses in line with rising cigarette consumption. These were produced as part of a Doubt is our Product strategy to deny the risks of smoking.

Recent sightings of storks include claims that increased SSRI use is linked to falling national suicide rates. The articles making these claims offer data from the late 1980s but disingenuously omit some key facts. One is the fact that suicide rates in most Western countries were falling before the SSRIs were launched. Another is the fact that both suicide rates and antidepressant use rose during the 1960s and 1970s when antidepressants were being given to the most severely ill people at the greatest risk of suicide. This was when suicide rates should have fallen if antidepressants have any effects on national suicide rates (Reseland et al 2008).

Autopsy (post mortem) rates are also left out. The more autopsies done the more suicides and homicides are detected. Autopsy rates rose in the 1960s and 1970s and fell from 1980 before antidepressant consumption began to escalate dramatically. The rise and fall in autopsy rates perfectly mirrors the rise and fall in suicide rates (See Reseland et al 2008).

Why not the same argument for alcohol and violence?

Why would Psychopharmacology, a prestigious journal, take an article like this? Alcohol use has increased in Holland during this period but no-one is making the argument that increased alcohol use has led to a decline in acts of lethal violence or the further Bouvy and Liem argument that this means alcohol cannot cause violence.

SSRIs slow growth in children. During this period SSRI consumption among children has increased in Holland but the Dutch have become the tallest people in the world and are getting taller. Where is the article saying that the increasing height of the Dutch proves that SSRIs don’t retard growth?

In the case of violence, the published trials show antidepressants cause it, at a greater rate than alcohol, cannabis, cocaine or speed would be linked to violence if put through the same trial protocols that brought the antidepressants on the market.

And there is at least one clear and well-known factor, just like autopsy rates that can account for the findings – young men. Violence is linked to young men, and episodes of lethal violence are falling in all countries where the numbers of young men are declining.

Antidepressants and school shootings

School shootings were almost unheard of before the SSRIs appeared on the scene. Correlation is not causation but in between this and the next blog post I will be laying out the evidence that antidepressants cause violence up to and including homicide at two lectures in Chicago – including the evidence that real life antidepressants as opposed to Ablixa can in fact cause sleep walking and murder. A video of the lecture will be posted on as soon as possible afterwards.

Prozac and SSRIs: Twenty-Fifth Anniversary

25th Anniversary

One prescription for every man, woman and child

Prozac was approved in 1987 in the US, and launched in early 1988, followed by a clutch of other SSRIs. Twenty-five years later, we now have one prescription for an antidepressant for every single person in the West per year.

Twenty-five years before Prozac, 1 in 10,000 of us per year was admitted for severe depressive disorder – melancholia. Today at any one point in time 1 in 10 of us are supposedly depressed and between 1 in 2 and 1 in 5 of us will be depressed over a lifetime. Around 1 in 10 pregnant women are on an antidepressant.

No one knows how many new cases of depression there are per year partly because modern depression is a creation of the marketing of Prozac. Until recently what is now called depression was called anxiety, nerves or a nervous breakdown. SSRIs can help some cases of nerves but they are of no use for depression proper – melancholia. But the money for companies lies in treating nerves not melancholia – and as a result any of us with severe depression is likely to get worse treatment now than we once did. We’ve gone backwards.

How many hooked?

By 1999 the number of us taking SSRIs chronically equaled the number starting an SSRI each year. By 2003, over 6 million Americans were taking an antidepressant semi-permanently – along with over 6 million Europeans.

The number of prescriptions for antidepressants is increasing by 5-10% each year, while the figure for people starting each year remains the same. This means that there is an increase of 5% to 10% in the number of people hooked to antidepressants each year.

Lives lost

There is no research evidence to suggest that anyone’s life is saved by taking an antidepressant but if there are lives saved the research makes it clear that for every life saved there must be another lost. There are probably something between 1000-1500 extra suicides in the US each year, triggered by an antidepressant – an extra 2000 -2500 in Europe.

The data is similar for violence. There are probably between 1000- 1500 extra episodes of violence in the US each year that would not have happened without antidepressant input and between 2000-2500 extra episodes in Europe. Some of these will include school or other mass shootings which were unheard of twenty-five years ago.

Aborted families

About 4000 families in the US have children born with major birth defects each year because of antidepressants taken in pregnancy. Up to 20,000 women per year have a miscarriage because of these drugs and a large number have voluntary terminations linked to antidepressants. Miscarriages are among the biggest single predictors of later mental illness and substance misuse in women. In Europe these figures likely run at an extra 6000+ birth defects, 30,000+ miscarriages, and who knows how many extra voluntary terminations.

Most children born to mothers who have been on these drugs do not have obvious birth defects. But it increasingly looks as though these children may show cognitive delay and other autistic spectrum features.

The dead doctor sketch

Perhaps the greatest casualty of Prozac has been holistic medicine. Imagine you have numbness in an arm or pain in a shoulder. If referred to an orthopedic or neurology department you will have every conceivable scan or test to pinpoint the problem. Chances are the clinic will find abnormalities and attempt to put things right – abnormalities that are not the source of your problem. A good generalist, who knows your circumstances, relationships, difficulties at work and the community from which you come, can spot when aches and numbness stem from strain or tension – they see you rather than bits of you.

Prozac has killed Generalism. It did so by focusing attention on mood in the way neurologists hyper-focus on nerves. Psychiatrists have become the doctors who deal in heroic combinations and doses of pills rather than doctors who, like generalists, step back and take a broader view.

Prozac has also killed therapy – just like Prozac CBT has a hyper-focus on thoughts rather than the big picture. CBT has also become a conduit into antidepressant prescribing as therapists regularly suggest softening up a depression with pills.

Psychiatry leads the way

Many see or saw psychiatry as a medical backwater with grim, overcrowded hospitals, and a dim understanding of the disorders it treats. In fact it was the first branch of medicine to have specialist hospitals and journals, the first to discover the bases for and eliminate several serious disorders, the first to adopt rating scales and controlled trials. And with Freud’s son-in-law, Edward Bernays, it was the first to step into public relations.

Twenty-five years ago, no one could have imagined that the bulk of the treatment literature would be ghostwritten, that negative trials could be portrayed as glowingly positive studies of a drug, that controlled trials could have been transformed into a gold-standard method to hide adverse events, or that dead bodies could have been hidden from medical academics so easily. Twenty-five years ago no one would have believed that a drug less effective for nerves or melancholia than heroin, alcohol or older and cheaper antidepressants could have been brought on the market and that almost as a matter of national policy people would be encouraged to take it for life.