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 Pharma Tales

The Antidepressant Era: The Movie

The Antidepressant Era was written in 1995, and first published in 1997. A paperback came out in 1999. It was close to universally welcomed – see reviews 1, 2, 3, 4, 5, 6, 7, 8, 9, 10. It was favorably received by reviewers from the pharmaceutical industry, perhaps because it made clear that this branch of medical history had not been shaped by great men or great institutions but that other players, company people, had been at least as important.

Nobody objected to it, perhaps because at this point I had not agreed to be an expert witness in a pharmaceutical induced injury case. There were likely no PR companies who had a brief to manage Healy. I knew before The Creation of Psychopharmacology came out in 2002 that the response to it would be very different.

Disease mongering & the myth of lowered serotonin

Many of the ideas in The Antidepressant Era had appeared earlier. The idea that a lowering of serotonin (chapter 5) was a marketing myth and had nothing to do with science, first appeared in my doctoral thesis in 1985, and later in Psychopharmacological Revolutions in 1987. The idea that companies market diseases as a way of marketing medicines (chapter 6) first appeared in 1990 in Notes toward a History and The Marketing of 5HT.

The Antidepressant Era in turn contained many of the elements of Pharmageddon – the key role of the 1962 amendments to the Food and Drugs Act which, through product patents, prescription-only status for new drugs and the role of clinical trials, have created modern healthcare.

Is Valium a better drug than Prozac?

In 2000 I was approached by Duncan Dallas, an independent television producer from Leeds who wanted to do something critical on the antidepressants. Prozac was still at this point widely seen as a miracle of modern medicine, rather than an inferior drug to older antidepressants. Bioethicists and social scientists were still lining up to herald the creation of the New Man through modern genetics and modern psychotropic drugs.

Saying that what we were witnessing was a triumph of modern marketing rather than modern science caused a frisson in most circles. There were no natural allies – not in psychopharmacology or biological psychiatry but not in social science circles either.

But this is what Duncan wanted. The Antidepressant Era, the movie, opens with some of the hype around SSRIs, has astonishing footage of Roland Kuhn and Alan Broadhurst, two of the key people behind the discovery of imipramine, and outlines the overthrow of the benzodiazepines and their replacement by antidepressants.

It shows how rating scales and screening are used in psychiatry to create problems for which a drug becomes the answer. It was the first program to wheel on stage the marketing men who created the social anxiety campaigns that sold Paxil, and it outlined the role of DSM III in the creation of depression.

Duncan’s version has a wonderful artistry. The book opens with a quote from George Oppen’s The Skyscraper. The “movie” closes with the same quote.

The building of the skyscraper

The steelworker on the girder
Learned not to look down, and does his work
And there are words we have learned
Not to look at,
Not to look for substance
Below them. But we are on the verge
Of Vertigo.

There are words that mean nothing
But there is something to mean.
Not a declaration which is truth
But a thing
Which is…

Oh, the tree, growing from the sidewalk –
It has a little life, sprouting
Little green buds
Into the culture of the streets.
We look back
Three hundred years and see bare land.
And suffer vertigo.

Downfall – Adolf who?

Its central moment is an astonishing sequence featuring the then President of Hoffman-la-Roche, Adolf Jann, embarking on a rant that looks now like an uncanny forerunner of the famous Adolf Hitler rant in the movie Downfall. The rant that launched a thousand You-Tubes. Adolf Jahn thumps his fist on the table, voice rising, as he angrily tells an interviewer in effect “You – none of you – can do without us – just try”. See section at 20 minutes 50 seconds to 22 minutes.

There is nothing specific to Jann or Roche here. This was and is the common credo of the pharmaceutical industry. This is what the CEOs of GSK, Pfizer, Merck and Lilly are saying to governments today. Healthcare is not sustainable unless we develop drugs that get people well so they aren’t a burden on the State, and if healthcare is not sustainable democracy may not be either. Facilitate us or society as you know it goes down the drain.

It would be a mistake to see this as a horrible modern manifestation of rapacious capitalism. Socialists from George Bernard Shaw in the early twentieth century onwards have turned to biology as an answer to social problems. If we cannot get mankind to agree to change for the better, perhaps we can improve on mankind. This belief powered the efforts of governments to eliminate the unfit from the late nineteenth century through to the eugenics movement and underpins some of our hopes for the New Genetics.

Eugenics looks terrible in retrospect while modern genetics looks like our only hope – but the same impulse underpins both. There is no better example of what good history is about than this. Anyone writing the history of eugenics should really portray its prime movers in the same light as we now portray the heroes of the the Human Genome Project.

We should always remember that the nominees for the 1937 Nobel Peace Prize included both Gandhi and Hitler. There was a time when one looked at least as likely as the other to contribute to modern civilization.

Revolution’s little helper

The same dynamic made Valium look like a very dark drug in 2000 – so that even its name was withdrawn. Prozac in contrast looked like the gateway to the hoped for shiny uplands of the future, when by the mid-1990s Prozac should have been seen as a far darker drug than Valium.

Valium entered a world in which psychiatry in many ways led medicine as it had done for almost a hundred years. Psychiatry was the first branch of medicine to have specialist hospitals and specialist journals. And Valium really did work remarkably well. Far from being simply a superficial treatment it likely led to the disappearance of catatonia and saved a lot of lives.

Valium probably did a lot to stimulate the Revolution of 1968. The conventional wisdom now is that Valium was Mother’s Little Helper and in this role that it played a part in the imprisonment of women in suburbia. In fact, Valium and other benzodiazepines undo conditioned avoidance. They were advertised initially as being among other things useful for salesmen – to overcome their inhibitions. They almost certainly disinhibited many women to speak out against patriarchy. They helped students breach the double-binds that Ronnie Laing and others in the 1960s were preaching were holding back society.

Prozac and the SSRIs in contrast far more often produce an apathy that is destructive to engagement in society as Who Cares in Sweden shows. Prozac, Paxil, Zoloft, Efexor, Pristiq, and Cymbalta are far more likely to lead to suicide and murderous violence including school shootings than Valium ever did. And the SSRIs lead to just as many cases of dependence as the benzos ever did.

Tamiflu – PharMessiah?

Are we incapable of learning? Will we always be seduced by the latest PharMessiah?

The Antidepressant Era, the movie, contains an extraordinary comment on just this that no one could have foreseen when it was finished in 2001. It almost looks like the Scriptwriter in the Sky must have inserted the clip of Adolf Jahn telling us that if we don’t facilitate him and Roche society will collapse. We can only afford to keep our economy and society going if he and his company are let develop new drugs.

Well Roche got to develop Tamiflu. Where Valium was the headline drug in the 1980s for the problems a rampant pharmaceutical industry might pose, Tamiflu is now. Governments throughout the Western world stockpiled billions of dollars worth of Tamiflu on the promise that it would prevent the transmission of influenza and other viruses, and would either keep people in work or get them back to work faster, thus saving our economies huge amounts of money.

Except the drug now appears to be close to worthless and to have always been so. It seems that the impression that Tamiflu might help could only have been created because companies can hide the existence of many and in some cases most of their clinical trials and hide the data from all of them, ghostwriting the ones that are published in a manner that keeps all data out of the public domain.

Facilitate us too much and we will lead to your Downfall.

Dependence Day

dependence

Author: Johanna Ryan, Labor Activist with Illinois Workers Compensation Lawyers (Chicago)

Last month I watched as forty Iraq and Afghanistan vets led an antiwar march to the gates of the NATO summit in Chicago, and handed back their medals. At the rally, they described the toll the wars had taken on the troops as well as the people of Iraq and Afghanistan, and demanded their “right to heal.” Chief among the problems on their minds were post-traumatic stress disorder, suicide … and psychotropic drugs.

“It’s really appalling that when our brothers and sisters get home and they ask for help, the only help they can get is some type of medication, like Trazodone, Seroquel, Klonopin— medication that’s practically paralyzing, medication that doesn’t allow them to conduct themselves in any type of regular way,” veteran activist Aaron Hughes told Democracy Now. “And yet those are the same medications that service members are getting redeployed with, and conducting military operations on, and the same medications that we are trying to reintegrate into the world with.”

Facing the fog of war through a fog of drugs

Conducting military operations? On Seroquel? There must be some mistake, I thought. But a little research confirmed Aaron’s accounting: the United States armed forces are increasingly marching on pharmaceuticals. Twenty percent of active-duty troops are on psychotropic medications, including 17% of the combat troops in Afghanistan.

The results are not pretty. Eighteen vets commit suicide each day. The Veterans Administration reports 1,000 suicide attempts, and 10,000 calls to its suicide hotline each month. Last year, 301 active-duty soldiers took their own lives. A 2010 Army internal report on the suicide crisis estimated that prescription drugs were involved in one-third of soldier suicides. Their estimate is probably conservative. “We have never medicated our troops to the extent we are doing now …. And I don’t believe the current increase in suicides and homicides in the military is a coincidence,” said Bart Billings, a former military psychologist who hosts an annual conference at Camp Pendleton on combat stress. (“A Fog of Drugs and War,” Kim Murphy, Los Angeles Times, April 7, 2012.) Rates of domestic violence, murder, child abuse and other violent crimes are also rising in military base communities across the nation.

Clearly there are multiple reasons for this epidemic. The Iraq and Afghanistan wars themselves are the bedrock cause. The stress increases as soldiers are forced into second, third and fourth combat deployments. However, the military’s increasing reliance on drugs has at best failed to “manage” a grim situation, and may have made it worse.

Zoloft and a rifle

Prior to 9/11, the military did not send soldiers into combat on psychotropic drugs. In many cases, they were a bar to serving in the military at all. But as the Iraq and Afghan conflicts expanded and multiple combat deployments became the rule, the military embraced the idea that medications could keep troops “deployable.” Drug companies took their place in the military-industrial complex, positioning their products not just as medicine for wounded veterans, but as fuel that could keep exhausted and traumatized soldiers on the battlefield.

SSRI antidepressants became widely prescribed for symptoms of post-traumatic stress disorder as well as depression and anxiety. The evidence that this was good medicine was thin, especially for patients being medicated and sent back into a traumatic situation. All these drugs carry warnings that they can cause agitation, hostility and suicidal and homicidal impulses. In 2007 the FDA expanded its suicide warning for children and teens to include young adults ages 18 to 24 – the group that forms the backbone of the Army. “All of these drugs increase suicide risk, which is why it’s probably not good to give it to guys who carry guns,” said Brown University professor David Egilman. By 2007, one in eight soldiers surveyed in Iraq and one in seven in Afghanistan said they had taken sleeping pills or antidepressants.

The careful monitoring needed to use these drugs safely just doesn’t exist in a war zone. While the Pentagon insisted that medicated troops were only deployed after they’d been “stabilized”, many were on a plane to Iraq or Afghanistan within four weeks of getting their prescriptions. Soldiers suffering from acute stress in combat have often been prescribed drugs and returned to the front lines in as little as three days. (“A Potent Mix: Zoloft and a Rifle,” Lisa Chedekel and Matthew Kauffman, Hartford Courant, May 16, 2006). Therapy is often totally unavailable, and mental health staffing is so short that psych evaluations and “monitoring” is often done by videoconference.

A total mental breakdown

In the PBS Frontline documentary The Wounded Platoon, young soldiers from Fort Carson, Colorado shared their experiences during the 2006-2007 surge: “I was having, like, a total mental breakdown,” said Kenny Eastridge; “…They put me on all kinds of meds too, and I was still going out on missions. They had me on Ambien, Remeron, Lexapro, Celexa, all kind of different stuff. They tried different medications at different doses and nothing would work.” When stationed away from the base, Eastridge said, he would run out of meds. “It was hard to find someone who wasn’t on Ambien,” recalled medic Ryan Krebbs. “It helps you sleep. It also gets you pretty high. You have trouble remembering things. It lowers your inhibitions, all that stuff. They shouldn’t give soldiers Ambien in Iraq.”  Several soldiers told Frontline that their platoon became trigger-happy, opening fire on Iraqi civilians for any reason or no reason.

More recently, Army doctors have found what they thought was a better fix for the  insomnia, nightmares and rages of soldiers under stress from multiple deployments: antipsychotics, chiefly Seroquel. Pentagon spending on Seroquel doubled from 2003-2007, with larger increases in demand for the highest doses.

Spending on Topamax, an anti-convulsant, quadrupled as military doctors added it to the cocktail for thousands of soldiers diagnosed with traumatic brain injuries. And a rising number of active-duty troops were returned to duty on Oxycontin, Percocet and other narcotic painkillers. Meanwhile, in an effort to keep its medicated troops from running out of pills in theater, the Army’s Central Command authorized soldiers to ship out for Iraq and Afghanistan with 180-day supplies of their medications – making it all too easy to swap and share meds, or to take double doses on a bad day.

When death comes in the night

In 2008, in separate incidents, four young veterans in West Virginia died in their sleep from multiple drug toxicity. Twenty-three year old Andrew White was on a cocktail that included Klonopin, Paxil, opoid pain medications and up to 1,600 mg of Seroquel per day. In the weeks leading up to his death, Andrew gained forty pounds and suffered from tremors, slurred speech and disorientation. His father, Stan White, claims to have identified eighty-seven similar deaths among soldiers on Seroquel.

Veterans and their families are rebelling against this grotesque system of “care”. They have had some small victories – the VA recently announced it would hire another 2,000 mental health staff, and the Department of Defense placed some restrictions on use of Seroquel by active-duty personnel – but much more is needed. If the rest of us support their fight for humane and effective care from the VA, perhaps it could become a model for the civilian mental health system we desperately need.

Every Drink Spiked

This post is written anonymously.

I outlined how my daughter Petra came to take Cymbalta on this blog a few months ago (see Petra’s story; also see Symbolta of Sorts). This post tells of events that led to her coming off.

Petra is an enthusiast for motor sport events. She has been on track days, hill climbs and driver training events. She is a member of an Italian car club. She is a safe, smooth and confident driver, who has held a driver’s license since age 17 – for over six years now. She has had no disqualifications or accidents.

speedometer drunk

Cymbalta and alcohol affected her judgment

Shortly after starting Cymbalta, she noticed that alcohol seemed to affect her judgment while driving. So she stopped driving if she had had any drink. This was easy because at the time she would tend to drink quite heavily or not at all.

One afternoon she had two glasses of beer (8 oz each) while listening to music at a city venue. The event ran for most of the afternoon. She felt happy to drive home. On the way home she was stopped for a random breath test and to her horror recorded a 0.05 Blood Alcohol level on the police breathalyzer. Fortunately, the police officer decided that since the reading was exactly 0.05 and probably falling, she could wait in her car for a while and then continue home.

Close to disaster

This was very close to a disaster. In Australia a reading of 0.05 or higher means that your driver’s license may be suspended pending a court hearing, which is likely to result in a fine plus automatic license disqualification for a minimum of 3 months. The loss of independence and convenience and the loss of something that she takes pride in would have been a real blow.

I purchased an alcometer. A standard drink for Australian purposes is one that contains 10 gm (about 12.5 ml) of alcohol. One such standard drink can be expected to raise Blood Alcohol Content (BAC) by about 0.025 grams per 100ml of blood. BAC levels are commonly thought to fall at the rate of about 0.02 per hour.

We confirmed on several tests that Petra would return a reading of 0.04 per 375 ml of beer (this was 1.4 standard drinks). This was the first problem. The second was that the reading didn’t fall at the expected 0.02 per hour and her BAC would consistently show 0.08 for 2 beers and 0.12 for 3 beers consumed over 2-3 hours.

Her blood alcohol levels were a shock

Petra’s friends, brother and myself all had much lower readings. The consistency of the tests was good. I also tested our device against a police roadside check and obtained the same result as the police device. Finding that Petra returned readings in excess of 0.2 after the consumption of several alcoholic beverages over quite long periods of time was a shock and a big concern. Clearly alcohol was going to be a serious problem for her under these circumstances.

Just girls!

Petra raised this with her doctor, whose response was dismissive – your device was ‘probably inaccurate’. A local pharmacist observed that some young women return much higher readings than expected and that this was probably ‘normal for them’. Our solicitor said that ‘Magistrates are not interested in young women who claim to have only had 2 drinks’.

Petra has now stopped Cymbalta. She says that alcohol does not now seem to affect her anywhere near as much.

So we ran the test again, with the same device as before. This time she returned a reading of 0.03 soon after the consumption of 2 x 375 mls beers, where the figure was 0.08 for the same drinks while taking Cymbalta. This is almost the same as her brother’s reading of 0.02 for the same consumption.

She then had one 375 ml drink with lunch and we checked how quickly her levels fell. She returned a reading of 0.00 1 hour and 35 mins after the start of lunch.

This has probably led to loss of life…

Conclusion: Cymbalta more than doubles the effect of alcohol for some people at least. This could lead to and probably has led to regrettable consequences including harm to self and others, loss of driving licenses, fines, and other losses.

Eli Lilly’s prescribing information for Cymbalta is as follows:

7.16 Alcohol

When Cymbalta and ethanol were administered several hours apart so that peak concentrations of each would coincide, Cymbalta did not increase the impairment of mental and motor skills caused by alcohol.

17.10 Alcohol

Although Cymbalta does not increase the impairment of mental and motor skills caused by alcohol, use of Cymbalta concomitantly with heavy alcohol intake may be associated with severe liver injury. For this reason, Cymbalta should not be prescribed for patients with substantial alcohol use

There is no mention of the risks Petra ran and others seem likely to be running.

DH comment

It is difficult to explain this finding but if valid there is no reason to think these risks are confined to Cymbalta. The testing that drugs undergo does not test for this possibility. There are routine drug and alcohol driving simulation tests which an hour after alcohol often show better performance on the combination of drug and alcohol than on alcohol alone – but no-one tests what might be happening several hours later.

Cymbalta and many other drugs can have an effect on liver function. At present this seems the likeliest way to explain this effect.

In the meantime, anyone on any medication who thinks they might have been affected should check themselves out. Anyone who has ever had a driving conviction may have a case to have their conviction overturned on the basis of company negligence. The same may apply to anyone who has ever lost a job or had an accident at work.

Anyone paying increased premiums on their insurance as a result of a drink driving accident or offence may have a case to reclaim their insurance payments.

There is an urgent need to establish the genetic bases behind effects like this. It is likely that not just Petra but others in her family would be similarly affected, and so it is not just the affected person who needs checking.

The implications for employers of possible accidents at work apparently linked to alcohol but not primarily caused by alcohol are immense.

The already high risks of birth defects and miscarriages in women of child-bearing years stemming from antidepressants, and possible mental handicap in their children, would be compounded in this case by additional increased risks from alcohol. A woman taking a single glass of wine, of which several a week should be harmless, might be exposing her child to riskier concentrations than she thought.

There are clearly issues here for health and other insurance companies covering occupational hazards at large corporations such as General Motors.

We are interested in every report we can get of people having problems that might be attributed to intoxication by alcohol and drugs as well as all possible reports of drug induced cravings for alcohol – See Out of my Mind: Driven to Drink. Please add your accounts to these posts to help get recognition for these issues.

American Woman

On Thursday, May 31, 2001, a woman whose name is known only to GlaxoSmithKline emailed the company:

I was absolutely distraught

“My name is… I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I’ve been taking Paxil, which is truly a miracle drug. I’ve been panic-free with this drug and have been able to go on with a normal life.

“I was married in October of 2000. My husband and I found out we were pregnant at Christmas time. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have a termination.

“The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time). To say the least, I was absolutely distraught with this news. I thought this was something that I did, was because I stayed on the Paxil for selfish reasons.

“I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies. My husband and I are ready to try again to get pregnant in the next month or two. I am so nervous. I don’t want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby I want to know upfront. And I will somehow stop taking it for the time being.

“Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me. I just want to continue to have a normal life and have the child that I always wanted. Please contact me as soon as possible.

“Please don’t forget about me, Thank you.”

We are attaching a copy of our product information leaflet

GSK responded on Thursday May 31st:

“Thank you for your inquiry. We are attaching a copy of our current product information for Paxil. Please review the section on use during pregnancy. Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition. Because patient care is individualized, we encourage patients to direct questions about their medical condition and treatment to their physician. We believe that because your physician knows your medical history, he or she is best suited to answer your questions.

“Our drug information department is available to answer any questions your physician or pharmacist may have about our products. Your healthcare professional can call our drug information department at 1-888…”.

[As of 2001 the label for Paxil made no mention of the number of reports of congenital abnormalities associated with Paxil. Company policy at the time was not to tell doctors or patients or pharmacists how many reports of congenital abnormalities had been reported with Paxil usage].

I do not want to put my unborn child through anything that would hurt him/her

On Friday, June 1, 2001, the unknown woman wrote again:

“This response is in regards to an e-mail that I had sent you previously. I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.

“I am in no way insinuating your product did this to my child. I love the product, and I don’t think I could have gotten through my panic attacks without the wonderful help of this miracle drug. I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her.

“Please, if you do not have this information, where is this information held? Does anyone do studies like this? Please, any information you may give me would be great. Thanks again for your help.”

Almost certain

On June 13, 2001, an internal division within GSK monitoring adverse event reports looked at this congenital abnormality and made a judgment about the link to medication. Their judgment was that it was “almost certain”.

Who is this woman? Can you help us find her?

Margaret’s Story

(The story outlined below is authored by ‘Margaret’. Since this was first written there have been a number of developments and an update to ‘Margaret’s Story’ will follow – DH).

Our son went to his GP with poor sleep because of worries at work. His doctor said he was depressed and put him on a combination of Cipramil (SSRI antidepressant) and Temazepam (a sleeping pill). A week later he took his own life. We now question both the diagnosis and the combination of medications – a mixture of uppers and downers.

Many of those who take their lives have recently attended the doctor. It must be important to see if there are any links between the use of medication and death. In the time since his death we have had a steady correspondence with the Department of Health and MHRA in an attempt to clarify how anyone can come to be placed at risk of suicide from their treatment. We would consider ourselves to be well-informed but we had no idea that mind-altering drugs are prescribed so widely with negligible safeguards.

The system… is deemed to be adequate

Early on we discovered enough about Cipramil and other SSRIs to give us cause for concern. This has been the driving force behind our enquiries since. We have written to a succession of Ministers of Health and received replies from the offices of Andy Burnham and Mike O’Brien saying in effect that the current system, with regard to maintaining the best practice in the use of SSRI antidepressants, is regularly reviewed and is deemed to be adequate.

We were directed to the regulator, the MHRA, and this led to a back and forth between the MHRA and Department of Health and ourselves. We have been sent an abundance of correspondence that invariably buries whatever issue we address in a welter of references to complying with the European Union and the CSM Working Group, along with directions to seek further information at the NICE website or MHRA’s own website etc.

This is not acceptable for someone seeking advice in plain English to find that it isn’t readily available. There is no apparent will to put information about SSRIs in the public domain. It has to be sought out and cannot easily be found. Updated information, it seems, gets posted to locations not easily accessible to the public at large.

The unalienable right for all patients and their carers to know about risks

Virtually every time I have corresponded with the Department of Health or MHRA I have referred to the BNF guidance that:

“the use of antidepressants has been linked with suicidal thoughts and behaviour. Where necessary patients should be monitored for suicidal behaviour, self-harm or hostility, particularly at the beginning of treatment or if the dose is changed”.

This two-sentence warning, and what I feel is the unalienable right for all patients and their carers to know about risks, has been at the heart of my enquiries. But it has never been addressed. The MHRA drew my attention to the NICE advice:

“Depression and anxiety commonly co-exist, and insomnia is a core symptom of depression. Whereas antidepressants usually take two to four weeks to take effect, benzodiazepines are effective anxiolytic and hypnotic drugs with an immediate onset of action. Therefore benzodiazepines could be expected to produce early improvement in some symptoms of depression, although they do not have an antidepressant effect.”

This advice ties together depression, anxiety and insomnia. It seems to direct the physician towards the use of antidepressants as a cure-all. The implication is that a benzodiazepine could help the patient initially until the antidepressant reaches a “therapeutic” level. But NICE does not recommend long term augmentation of antidepressants with benzodiazepines. As ever, the message is confused.

If the drugs take two weeks and more to work for good, then they take the same time to harm

The NICE advice, it seems to me, is being used as a fig-leaf to cover the failure to address the more dangerous period of early uptake or dosage amendment (which the MHRA choose to interpret as ‘at the point of increase’, not the dreadful time of withdrawal experienced by those with long-term repeat prescriptions who wish to stop, or those who do not sustain regular dosage). Significantly, NICE does not address the question of whether there are critical points in usage. It seems that so many interpret their advice as meaning that if the drugs take two weeks or more to work for good, then they take the same time to harm.

When, on the day he died, our son presented at an A&E unit, he saw a doctor who was not a psychiatrist. He was informed of our son’s medication details and has since stated that, although he was aware of the suicide risk of Cipramil he did not alert our son to this. Part of the hospital’s explanation for this lapse was adherence to the “two weeks to improve therefore two weeks to deteriorate” mantra embodied in the NICE advice.

Where this originally comes from is still a mystery. Our son was left without hope or insight that would have told him he was in a temporary state of crisis that could be addressed with proper medical assistance. The NICE advice is at odds with the BNF warning, and so conflicting messages are being sent to those seeking guidance.

All leaflets should contain a suicide risk warning

Much of our correspondence has centred on the failure of the PIL – the patient information leaflet – as a means of communicating risk. The MHRA assured me that all leaflets should contain a suicide risk warning, combined with the advice to appoint a relative or friend to read the leaflet and monitor the patient. I found that the Cipramil leaflet in my possession did not have the combined message. The suicide risk was mentioned, though not at all well highlighted. The advice to appoint a monitor was not there.

I received a grudging reply that steps were “being taken by the MHRA to ensure the PIL for this particular Citalopram [Cipramil] product is updated to include the full warning”. No acceptance that the current system fails and no wish to revise existing practices. I had wrongfully assumed that all PILs had to replicate a master produced by the MHRA for each drug – not so. There is no apparent will to raise the level of the suicide warning in the PILs for antidepressants.

When I asked why the two sentence advice from the BNF could not be in the public domain I was told that “it is not feasible to have a public campaign to inform all patients about the side effects associated with all of the medicines on the UK market”. I replied that SSRIs could be classed as a group and are used by so many patients that it was well worth circulating vital information about potential risks. I received no reply to this comment.

According to the Office of National Statistics, 39 million prescriptions were issued for antidepressants in 2009. Even factoring in a calculation for repeat prescriptions, the number of patients using antidepressants runs into millions. This establishes them as a considerable proportion of patients who need to be as well-informed as possible, given the suicide risk their medication can give rise to.

Who decides who lives and who dies?

I wrote to Anne Milton, Under Secretary of State for Public Health, expressing my concerns and dissatisfaction with the response of the MHRA and also copied the current Minister for Health, Andrew Lansley, into a letter I wrote to the MHRA. I was then switched to the Department of Health and I was told that the

“Department believes a balance has to be reached between raising awareness and deterring people from taking antidepressants which can and do prove to be very effective treatments …..”

This “effective treatment”, if it exists, is being achieved at the cost of the lives of a vulnerable minority, no reference to this of course. Who decides who lives and who dies – shouldn’t we know about these risks, especially when knowing about them means that more might live?

The Department believes that my concerns over public awareness have been well covered in the press and the scientific media. Really? The Department has deemed that

“the PIL is a patient aid and does not replace the discussion between the prescriber and the patient. It is good clinical practice to discuss the potential risks as well as the benefits of a treatment, prior to issuing a prescription”.

Plainly, nobody has told the prescribers this. It appears to me that ill-informed and pressurized GPs are just as much victims of the current failing system as the patients. The emphasis on targets has led to foreshortened consultation time and quick-fix prescription of medication.

In a bizarre twist I was directed towards the General Medical Council

Then in a bizarre twist I was directed towards the General Medical Council (GMC) by Department staff as “….the training and development of medical professionals is the role of the GMC.”  The Department says it does not investigate the conduct of doctors but

“the GMC seeks to promote high standards and ensure that medical education and training reflects the needs of patients, the service, students and trainees. Your concerns about the lack of knowledge regarding antidepressants should also be directed to the GMC”.

I approached the GMC. They did not respond to my query as to whether or not the seemingly counteractive combination of antidepressant and sleeping medication is deemed to be accepted practice. They have chosen to deal with this as a fitness to practise issue and gave me a deadline by which time they wished to receive the names of the GP and A & E doctor involved in our son’s case. Otherwise they would assume that I wish no further investigation. I have refused to comply, as I don’t see the doctors as being to blame.

As a result the GMC now consider that they are not the best agency to deal with my concerns. I have been told that they “are not a part of the NHS or Department of Health and have no powers to affect generalized policies. Concerns about the system, that is NHS procedures or the way that medics are trained, does not generally fall within our remit.”

This seems to be a complete contradiction to the promise of the Department of Health that training and development of medics is in the remit of the GMC – they are talking totally at cross purposes.

The Department will be unable to enter into further correspondence with you on this matter

The GMC directed me to the Parliamentary and Health Services Ombudsman, our local MP and, ironically, back to the MHRA. Exasperating to say the least. The Department of Health meanwhile now tells me that

“unless there are any subsequent developments surrounding the labelling of UK prescription medications, the Department will be unable to enter into further correspondence with you on this matter.”

The authorities refuse to listen or respond. At a time when the situation is fluid and changing as more information emerges about adverse drug reactions, the authorities are set in concrete or stagnant. If you are not satisfied with their reply, then it is your fault and you are not to bother them again. This institutional heedlessness parallels the stance of the pharmaceutical companies when a patient is not responding well to their drug – it must be down to the patient and not the drug.

The system is failing patients and doctors. Doctors are not trained to look out for or to deal with adverse drug reactions. Medication is not accompanied by adequate patient information and the doctor is not instructed to outline clearly the potential dangers to the patient. We can’t improve the system unless we recognize the inadequacies.

Out in the real world, precious lives are being lost to horrific avoidable deaths.

Out of My Mind. Driven to Drink

alcohol

Author: Anne-Marie

(This story epitomizes what RxISK.org is all about. It shows one woman extraordinarily getting to grips with a problem she has on treatment. The hope when RxISK is up and running is that we will be able to make it easier for people like Anne-Marie to engage with their doctors to solve problems like this. Unfortunately even though clearly a drug-induced problem Anne-Marie does not want to be identified – DH).

I have been asked to write this story to raise awareness about a strange side effect of treatment and my efforts to get to the bottom of it.

Before my problems began I had been working as a health care assistant at my local hospital in Surrey for five years. I enjoyed my job. I had a stable life. I owned my own home and car.

Following the sudden and devastating death of my father I became anxious and over a period of a year developed a fear of choking which got worse to the point that I was avoiding food and losing weight. I realized I needed help.

I went to my GP and was prescribed paroxetine 20mg in liquid form because I couldn’t swallow the tablets. I had nausea, dizziness, felt spaced out and detached but was assured by my doctor that these symptoms would settle down.

After a few months things did start to improve. I noticed my eating had returned to normal. I felt much more energized and more confident and was able to complete a day’s work without feeling drained and exhausted. I started socializing again.

The warning reassured me it was safe enough to have a few drinks with friends

To begin with I was concerned about drinking alcohol on the medication. I checked the patient information leaflet which gave, what seemed to me, to be a mild warning that “although it is always advisable to avoid alcohol whilst taking medication there is no known interactions with Paroxetine and alcohol”. This reassured me that it was safe enough to have a few drinks with friends.

At first I was only having a few glasses of wine but slowly over time I drank more and more. I began saying and doing things I had no memory of later. I got banned from restaurants and bars in my local town and became an embarrassment to my friends. Eventually some of my close friends and family distanced themselves from me. I was losing everyone around me and losing control of my life but I just didn’t care. I felt like I was in a dream and that none of this was real.

I became verbally aggressive and my behavior was reckless. On one occasion I climbed out of a velux window and onto my roof. I was not trying to kill myself. I didn’t even consider the dangers of what I was doing.

I began to get into trouble with the police, in the main for continual nuisance phone calls to the police station. This happened on a regular basis when I was drinking. Sometimes I would ring them 20 to 30 times a night on their non-emergency number with only a very vague memory of doing so. It resulted in me getting arrested on numerous occasions.

I began to feel that something was very wrong

After getting arrested several times I began to feel that something was wrong. I started taking time off work. I got cravings for alcohol that were so intense I felt I was possessed. I would start drinking and couldn’t stop. I’d continue until I was either arrested or I collapsed into a coma. Things were getting very out of hand. I felt alone with my problem and couldn’t understand why I was behaving like this. I felt that no one understood what was happening to me or cared.

I began to research on the internet to find an answer and I found other people reporting cravings for alcohol on SSRI medication on many websites. This really shocked me. Yet no one in the medical profession seemed to be taking any notice of it. Why? The first time I saw a psychiatrist I was told that it was due to my drinking problem.

Terrible overwhelming uncontrollable cravings

I knew I was drinking too much but I also had terrible overwhelming uncontrollable cravings for alcohol. I printed some of the information from the internet out and gave this to my doctor and tried to explain that I thought the medication was giving me intense cravings for alcohol.

My doctor was very sympathetic but not convinced. Again I was told that I had a drink problem and was in denial. He did however agree to change my medication and prescribed me 20mg of citalopram. I was referred to my local drug and alcohol clinic.

Following the switch to citalopram over the course of a couple of months, I felt less aggressive. However my cravings for alcohol were as strong as ever and I still couldn’t stop drinking. Things spiraled further out of control. I spent time in prison, was suspended and eventually sacked from the job I loved. Even a couple of alcohol free months in rehab, where I was provided with overwhelming help and support, wasn’t enough to stop the pattern continuing as soon as I returned home.

By now I had given up on the experts… who accused me of denial

By now I had given up on trying to tell my medical team that I thought it was my medication that was causing the problems. I was accused of being in denial over the alcoholism but I was certain that these intense cravings for alcohol were being induced by the SSRI.

Before I had searched for others with similar problems, now I began searching for answers. First I googled alcohol cravings induced by paroxetine and then by citalopram. The first web pages I came across were from the depression forums and similar websites where people where sharing their stories about the same alcohol cravings and looking for answers. I came across the International Coalition for Drug Awareness, the Seroxat Users Support Group and the Seroxat Secrets website where many people were reporting the same thing.

I decided to start looking at research papers but I couldn’t find any on SSRIs and alcohol cravings. I then read a message on one of the forums that mentioned a Yale study from 1994 that had a link to serotonin. This pointed me toward reading about alcoholism and the serotonin system.

There were no easy answers to this

I read many papers that I only vaguely understood. I had to learn all about serotonin receptors, transporters and neurons to understand the research papers I was reading. I had to leave it several times and go back to it as my head was hurting trying to understand it. I nearly gave up looking several times but couldn’t because I knew the answer was there somewhere. I learnt that there were seven serotonin receptors and was very disappointed to learn that there were even more receptors connected to these receptors. There was also only one receptor though that had a gateway to dopamine which was the S-3 receptor. I now needed to learn what all these different receptors did and to see if any were connected to cravings for alcohol. There were no easy answers to this.

Had I really been like this for ten years?

I wanted to wean myself off citalopram. I knew it was ruining my life. In the first month I couldn’t believe the change in me. I felt as if I had been given back my sight and hearing again. I felt in awe of everything around me. Had I really been like this for ten years and hadn’t realized it? Almost immediately the cravings for alcohol reduced by about 50%.

But withdrawal wasn’t easy and I went through two months of distress with extreme mood swings, panic attacks, sensitivity to noise, feeling like I had the flu with aches and pains. I couldn’t cope with this so went back to my GP and was put on mirtazapine 15mg, which was later upped to 30mg as I was experiencing restless leg syndrome at the lower dose. (I had seen on the internet that another woman had a similar experience as me on 15mg mirtazapine which disappeared at 30mg).

I realized that mirtazapine may have the answer

My cravings went completely. I realized that mirtazapine may have the answer. I knew it worked differently to the SSRIs.

I looked up medications for alcoholism and came across a drug called ondansetron, which works by blocking the S3 receptor and eliminating cravings. I discovered that mirtazapine also blocked S3 receptors.

I searched for alcoholism and S3 receptors and found that the S3 was the only serotonin receptor that had a gateway to dopamine and a paper ‘Functional Genetic Variants That Increase Synaptic Serotonin And 5HT3 Receptor Sensitivity Predict Alcohol And Drug Dependence’. I was amazed. It makes sense that if some people have a genetic link to alcoholism mediated through the serotonin system that SSRIs might increase this sensitivity and mirtazapine block it.

I have also just found another research article that was carried out on mice back in 1990’s that also found that if S3 was blocked in mice it stopped the mice from drinking alcohol.

I now know what happened to me

It’s taken me a lot of time, reading and learning but I now have understanding of why I had such intense cravings for alcohol whilst taking SSRIs.

It makes me angry that we never had warnings like they do in the United States. Why were we not being protected here in the UK with appropriate warnings in the same way? If my GP had known that SSRIs could cause cravings for alcohol in some people he would have taken me off these drugs at the very first signs of drinking.

This would have saved me years of suffering and maybe helped many other people too. I’m sure that this is a problem that is more common than people realize. In addition to all the people I have come across reporting these effects on various internet websites, I have met many people who have had similar problems or who know of people who have also had problems on these drugs.

People on these drugs are vulnerable anyway and it is worrying to think how many could be drinking to excess across the country because of a craving for alcohol caused by treatment. It’s absurd to give the impression these drugs are relatively safe with alcohol if the tablets cause some people to experience intense cravings. It’s worrying also that both the drug and alcohol can independently cause confusion, disorientation, hypomania, aggression, and obsessional and bizarre thoughts and behaviors and that the combination in some people can make this much worse.

It has now made me look to other people’s experiences for information regarding drugs as they seem to be more accurate and honest in their findings than companies, regulators or doctors.

It’s crazy that patients have to get together on the internet to compare their side effects and discuss their problems because there is nowhere else to go. It has made me look to other people’s experiences for information now regarding drugs as they seem to be more accurate and honest in their findings than companies, regulators or doctors.

I didn’t realize until I came off the medication how bad I was. I feel ashamed and guilty for what I put people through. I have lost my job, had to move home, have a criminal record and lost the respect of family and friends. This could all have been avoided if there had been proper warnings in place and effective communications between different authorities.

I saw my retired GP in Asda recently and he asked me if I was back in Nursing. I told him no, I will never be able to go back now after what has happened to me. He said nothing and walked off. I didn’t mean to sound as if I was blaming him but I think he felt that was what I was doing. I felt guilty afterwards. I don’t blame my GP at all, I blame the drug companies and MHRA. What annoys me is that even the Department of Health wrote back to my MP basically laying the blame on the GP who they said should have noticed any changes in my behavior.

I want to tell my story as a warning to anyone who may be craving alcohol on SSRIs. I also want to tell people that sometimes it’s a mistake to leave it to the experts. And finally I want to tell doctors that your patients can often see that the information you are getting is wrong — we don’t blame you for this, we just want you to listen to us.

(The extraordinary twist in the tail here is how the regulator manages both to deny the existence of this problem and blame the doctor at the same time. This is becoming ever more common in modern healthcare systems — DH).

Since posting this it has become clear there are hundreds of people who have experienced something similar – if you have been one of them could you add your experience to this thread.

The Story of SSRI Stories

Rosie Meysenburg’s story

For anyone interested in the effects of drugs, the website SSRI stories has been an inspiration. Rosie Meysenburg, its creator, was recently diagnosed with cancer and is terminally ill. The story of how she came to create SSRI stories shows what people can do to hold the powers that be to account.

—David Healy


DH:  How did you get started with SSRI stories?

RM:  I had spent ages trying to quit smoking. Eventually, in 1992, my doctor persuaded me to try Prozac. I took it for eight weeks during which time my behavior got stranger and stranger and I ended up in hospital. I had no idea what caused the problem until my husband, Gene, suggested it might be the Prozac. So I called the Mental Health Association here in Dallas and asked, “Do you know anyone else who has had a reaction to Prozac? Is there somebody I could talk to?” She said, “Oh, we have a number here for the Prozac Survivors Support Groups.” So she gave me their number and I called them. They talked to me for a long time on the phone and sent me a ton of literature. Well I couldn’t believe it — there were testimonies from Dr. Teicher and others.

I had a manic reaction to Prozac taken for smoking cessation.

I got my medical records and they showed the doctors thought I had a manic reaction to Prozac although I don’t think it was manic; I think it was more nutty. I was angry about the fact that they knew it was the drug but hadn’t told me but there wasn’t too much I could do then — this was 1993. After that I wrote a letter to the FDA which they used in Motus vs. Pfizer — a letter that asked if they could put the same warning on their package insert as Germany had.

Then the Internet started in 1997 and I sat down and I went through the phone book and I called practically every physician in the city in which I lived. I’m a determined person. I asked them if I could find anything about Prozac on the Internet that would show that it could cause harm would they be interested? About 22 of them said yes they would be. I went into Alta Vista — the search engine before Google — I typed in Prozac. There wasn’t too much else you could type in except Zoloft and Paxil. And sometimes I’d put “plus suicides” or “plus murder” whatever and I came up with all kinds of things. This is how I started my message board — it was to these people and some of them were very interested, which kept me going.

Then Mark Miller who lost his 13-year-old son to a Zoloft-induced suicide became involved. He put up a website for Ann Tracey — I didn’t really know who she was. I found her on the Internet and so I sent her some emails and she wrote back. She said, “The Zoloft suicides? Can you find a phone number for these people, Rosie?” So I had a domain where you can find phone numbers and I found them and she called them and told them what had happened to their children. We had a whole list of phone numbers. We did that until about 2004.

Ann started pursuing another line of business although she still tried to find time to help on the SSRI cause. But then the FDA announced online — we watched the FDA announcements like a hawk — a meeting concerning antidepressants/suicide and children. We had about 25 names of parents of children who had committed suicide.

The FDA was astounded.

I think the FDA was astounded. They started out with the five minutes they were going to give to each parent to present their case. Then they went to three minutes and finally two minutes. I mean the FDA has these meeting every day and two or three people show up for issues like how many nuts should we put in the cookies? If you’re allergic to peanuts, what should the warning be? I think by law they are required to put an FDA meeting notice in one newspaper and they happened to put it in the Arlington, Virginia, newspaper because my husband Gene talked to a man whose son had committed suicide who saw the FDA announcement in the newspaper and then pretty well everybody came from either finding out about it by themselves or from contact through Ann Tracey, Mark Miller, or myself.

So we went to the 2004 meeting and the FDA placed a black box warning regarding suicidality and children under the age of 18, and then in 2006 that same black box warning for the 24-year-olds and under. I looked at my computer in my saved box and I had 1,000 messages; probably 300 were suicides and another 250-300 were murders, and then there were assaults and all kinds of different things.

DH:  When was this?

RM:  This was May 2006. I had over 1,000 media articles regarding antidepressants and murder, murder-suicides, suicides, assaults, school shootings, road rage, air rage, etc. My husband Gene set up the initial database for me.

“Thank you. I understand now what happened.”

I spent probably 20-25 hours a week doing that and the rest of time I spent with family and friends. I posted every post that’s up there. Can you believe it — 4892! Curious the way I feel about SSRI Stories. On the contact page for SSRI Stories everybody thanked me. I said to Gene that there will be a lot of people just saying, “Oh you’ve got to be kidding me; this cant be true.” Instead I’ve received these emails from the contact page of SSRI Stories with people saying “Thank you. I understand now what happened to my brother or my sister.”

When I first started my message forum I got a threatening letter from somebody when I had my own name up there, although I still kept up with my message board. Now that I’m dying I guess I’m less worried about them beating up on me over Prozac you know. I used to be worried about all these shooters out there but now I don’t care who knows my name.

Now that I’m dying I guess I’m less worried about them beating up on me over Prozac.

I am pretty sure FDA have ignored SSRI Stories. But when I look at the stats, Homeland Security goes in there quite a bit and looks at some of the cases. A lot of people are coming in from the military. The big thing I’ve had is people making comments on sections because my stat counter gives the web address. For instance one comment said, “My friend John Smith didn’t know why we were having all these school shootings and he went into SSRIs Stories and now he knows why.” I think it’s helped raise awareness, and I see a lot of people making comments because they come up in the stat counter with the URL or their website and I can click on their website and they’ll say things like, “Have you seen SSRI stories? It’s unbelievable but I think it’s true.” Stuff like that.

So I don’t know how many people have actually looked at SSRI Stories. As far as the index goes we’ve had maybe 300,000 or 400,000 people look at it, which isn’t a lot but which is still quite a bit. On the individual stories we’ve had close to 1 million people looking at them. It seems like in the individual stories approximately one out of every four people will go from the individual story into the index or cover page.

More people are being injured out there by this than we realize

But I can’t really say what kind of impact SSRI Stories has had. What I feel is that more people are being injured out there by this than we realize. Someone I know told me he has a neighbor on one side just died on Paxil and Zoloft, while on the other his neighbor just died on Celexa. Before that neighbor died she said she thought the police were taping her and she had begun to drink heavily and to act crazily.

DH:  Did your friend not know your work and warn his neighbors?

RM:  Well he only found out afterward. He could see the personality of one of his neighbor’s change but he didn’t know for sure and he felt he couldn’t go into it in-depth because this was his neighbor and he was embarrassed. Beside even when I was on Prozac I failed to spot the connection.

One day I went up to the bank and there was a lady there. She began talking about Prozac to me and she said that when she was on Prozac she killed her dog and then, right there at the bank counter, she started crying. I said “Why did you kill your dog?” and she said that he’d become incontinent and all of a sudden on Prozac she got aggravated with that so she took him to the vet and had him put to sleep. And then she started crying. She said her dog was her best friend. And I said to her, “What was it about the Prozac that made you do this?” And she said it made her more aggressive. It makes you more unfeeling and more aggressive. Of course, she only had her dog put to sleep. I’m not saying she committed a major crime. Her pet was incontinent. He was probably old and would have died soon anyway but the point is that this is happening to a lot of people.

He burned down 10 churches and… will spend the rest of his life in jail.

About two or three months ago there was a case in a town near Dallas where a 20-year-old man, who was taking Champix and Prozac at the same time, went around in the middle of the night and burned down 10 churches.  No one of course had been killed because the churches were empty but the jury gave him life in prison. This article on SSRI stories talks about Prozac and Champix and it does say the perpetrator blamed the Champix because he didn’t know if he’d actually done it or if he’d dreamed it. But you see the Prozac can cause you to kind of go into a manic rage also and out of this you get a pyromania, or a kleptomania or nymphomania, and then on the Champix he was kind of like in a dream state. Anyway he’s 20 years old and will spend the rest of his life in prison.

DH:  Why did the issue of people becoming violent get your attention?

RM:  Well because you know in United States it’s always been a tradition not to print suicides. The only way you can tell is if they have a little clue in the obituary or if it says “he died suddenly.” Whereas, the UK and other countries do print suicides. They’ll say “committed suicide.” That’s why I have so many cases from people in Australia and Canada of suicides but very few from the US. However if it’s a controversial suicide or suicide of a famous person, people will want to know what happened to them, and then they’ll print it because everyone will say “Oh my gosh, this famous actor died. How did he die?” But I’m just talking about ordinary people who aren’t high profile. Also the big problem in the US is the drug advertising and of course the media is dying. Some of the newspapers have gone out of business — the only thing that keeps them alive is the drug ads.

The US has lost Freedom of the Press in an unusual way.

The U.S. has lost Freedom of the Press in an unusual way. The newspapers and TV cannot mention that the perpetrator was on an SSRI because the media is afraid the pharmaceutical companies will pull their ads.

DH:  Why do you think people are so reluctant to think that the drugs may be causing a problem?

RM:  I think it’s because they don’t ever stop to think that it might be the medication. I mean in the sense that I was on Prozac for nine weeks while I was losing my mind but I never once thought of the Prozac. My husband, Gene, was the one who finally figured out what was happening to me.

Why are we so slow to finger the drug?

DH:  Why are we so slow to finger the drug?

RM:  Because we’ve never really had a prescription drug before that’s caused so much violence and murder and mayhem. We’ve had the antibiotics for years and, of course, the illegal drugs. They were mostly made illegal because they were addictive, but we often think they cause psychosis, especially cocaine and methamphetamines. Pretty potent. However none of the school shooters were on those illegal drugs. That’s something.

DH:  Why, given so many school shootings being linked to these drugs, do you think the coin hasn’t dropped? What is it about the United States that makes people so reluctant to think the drugs could be responsible?

RM:  They say that in United States anybody who wants to can have a gun. So they blame the guns. And we did have one school shooting where the person was not on an SSRI in Kentucky and reporters write about this case all the time but neglect to mention the other school shooting. Strange. In Columbine, that second kid Dylan Klebold’s records were sealed, so nobody knows his toxicology. But you know there have even been 3 or 4 girls that did these shootings. And not all of the 65 school deaths were shootings — some were stabbings. And nobody seems to catch on. I don’t want to say nobody because while I go to my other stat counter, Go-stats, I’m amazed at the number of people that have typed in the words “antidepressant plus school shootings,” but there’s nobody in power seeing this.

Bill O’Reilly says there is an epidemic of women school teachers molesting their male students.

Bill O’Reilly, a famous TV talk show host, says there is an epidemic of women school teachers molesting their male students. He says that his program receives at least one report a week. SSRI Stories has 16 media articles of women school teachers who molested their male students while on medications for depression. One case, in Canada, was even a “won” case in the sense that the jury decided the SNRI Effexor had caused this type of weird nymphomaniac behavior.

We have won 29 legal cases so far, that we know about. If you go into SSRIS stories cover page and click on won cases you can see them all there. About 8 were homicides and 12 were murder attempts. One was an air rage case in a diplomat from England. There was a very early Zoloft case and a murder that was won 1994 that I found in the archives. Nobody had heard about it. It happened in South Carolina. So that means at least 29 judges or juries have decided to acquit on the grounds that the antidepressant caused the criminal behavior.

The other thing that gets me about these SSRIs is, not only do people become violent, they become extremely violent especially the women. They become so terribly violent they will stab somebody 200 times. There was the case in England of the man who stabbed his wife 200 times and then walked next door and stabbed his neighbor’s furniture another 200 times. So this is what’s kind of scary about it. We have about six people on death row here in United States, I think four of them are women who killed their children while they were on Prozac or Zoloft or something. One was a physician’s wife out in California and she killed her three children and then tried to kill herself and didn’t die and now she’s on death row.

DH:  Do you think there’s anyway for us to raise the profile of these cases and create a resource for people to get help?

RM:  That’s another bothersome issue — nobody’s put up a list of attorneys or physicians or anything. I did ask one or two people to help me post but nobody wanted to — they’re all so busy. Everyone’s so busy and it takes a lot of time. I can’t do the kind of work it would take to set up a list of physicians or attorneys but in future time somebody might be able to set that up.

The more I got into it the more sorry I felt for the perpetrators

When I first got caught up in the SSRI debacle I felt so sorry for the victims — people that were murdered or committed suicide. But the more I got into it the more sorry I felt for the perpetrators. So many of them were so young. Ben Garris was a young boy at the age of 15 who took Zoloft and it made him suicidal so they placed him in a prestigious hospital, Shepherd Pratt, and switched him to Prozac. He told them that he felt violent and they wrote in the hospital notes that he felt violent but they said he was being manipulative. He told me in his letter that he also told them to protect the other patients because he felt so violent. But they didn’t write that in the notes. Anyway he ended up killing a nurse who was on duty there. He got life in prison without the possibility of parole. So he was 16 when he went to prison and he’ll be there until he dies.

And there was a 13-year-old girl in Iowa who killed her great aunt. Stabbed her to death. She was on Prozac. She was given life in prison and the reason I knew it was that my sister sent me the article from the Des Moines Register that said she was on Prozac and that she was the youngest person to be sentenced to life in prison in Iowa. These are just some of the cases of the children.

DH:  Have you had any help from any group or anyone?

RM:  When I first started thinking about setting up SSRI Stories on the Internet, I sent a prototype of the way SSRI Stories would look to Sara Bostock who had lost her beautiful talented daughter to a Paxil-induced suicide. Sara believed that the prototype needed to have a “movable database,” and she hired a computer person to fix the prototype. She also paid for the server for over five years and helped me by posting 200 of the stories that I had saved in my computer. She even invented the name “SSRI Stories.” She believed in SSRI Stories and this gave me the energy I needed to carry out the work on the website. So SSRI Stories owes a lot to her and also to Ann Tracy for her early work.

But, no, other than these two people and my husband being my technician, nobody has come forward to help. There are other people doing a lot of work on psychotropic drugs but they are worn out themselves keeping different sites going. One person did write to me offering to help but I don’t know anyone who can keep up with SSRI stories because of changes in Google.

I don’t know anyone who can keep up with SSRI stories because of changes in Google

For years I went into Google and it said up above images, “Google News,” etc. I would click on Google News Advanced Search. Then when I clicked on Google News I would type in the word “antidepressant” and for that day it would say, for example, March 1, 2010, two hours ago something about an antidepressant that maybe killed somebody. I would quickly scan that to see if it was one of our cases. Then that would say four hours ago, six hours ago, and I could do that day till I was done with that day. I would type in “antidepressant” and “antidepressants,” and “anti-depressant” and “anti-depressants,” and I could get it all for that day. Then I’d type in “medication plus depression,” then I’d type in “medication plus depressed,” and “medication,” and so on. And I’d type in Prozac, Zoloft, Paxil, Celexa — there were nine of them I typed in — and they would come up one hour ago, three hours ago from all over the world. That was what was amazing.

Now when you go to Google news and type in the word “antidepressant” it will come up first of all with Wikipedia. Then it will say four days ago, then two days ago, then six hours ago — it’s 18 times as much work. With just one person trying to do it and then getting sick, it’s got to be too much. Before I was sick, when they changed that, I went ahead and set up a Google alert. Do you know what Google alerts are? I would type in “antidepressant plus murder” and I would type in my email address and have them send me a Google alert for “antidepressant + murder.” That’s an email that they sent to me personally. I was able to work off that for about eight months. I would probably get about 75 of those a day, most of them didn’t have anything to do with antidepressants plus murder. They’d say someone was murdered back in 1910 or something but too bad they didn’t have antidepressants then.

I would have to go through a lot of those that said nothing but then all of a sudden I would come across one that did — that’s how I came across the case of the schoolteacher who was acquitted of molesting a minor male student because of her Effexor usage. After that I typed into Google “Effexor + teacher,” “Prozac + teacher,” “Celexa + teacher,” etc. Then I’d get into a lot of things like a teacher says Effexor is a great drug for whatever.

DH:  How old were you when you created SSRI stories?

RM:  Well I’m 74 now, and I put up my first 1000 cases that I’d saved for 10 years in 2006 — so I was 69. I was in good health then.

DH:  What did you work at?

RM:  I was a music teacher. I went to Catholic University of America in Washington and then transferred to Drake University and got my bachelor of music education in Iowa. I taught for three years and then moved to Omaha where I met Gene. We got married and moved to Houston, Texas. He worked on the moon shot back in 1963, 1964. We lived there till 1968 and then we moved to Dallas. I got in touch with Andy Vickery of Houston over the Sargeant Steven Christian case here in Dallas. So I knew Andy Vickery and Rick Ewing before I even put up my message board.

DH:  You’re a former music teacher who at the age of 69 creates SSRI stories. What could other people do to make a difference?

RM:  Well I think other people should be watching the personalities of people.

Watch the personalities of people.

If they see a sudden change in the personality of somebody they’ve known for years they need to ask them “Are you on a medication?” If you ask a person “Are you taking a drug?” they often think you mean an illegal drug. So it’s a very delicate question to ask. I think when a family has a person who starts on a medication and their personality changes, they don’t realize it is the medication causing this. They just think that the illness is getting worse.

We have so many cases where, “Well, he started on Prozac and his illness was getting worse so we took him to the doctors and he doubled the dose.”

We have all kinds of cases like that. So I think people need to be aware of what SSRIs can do and how they can cause this personality change.

DH:  What you’re answering though is what we need to do about this group of drugs. What I’m asking is what can people do to change the system? You’ve been an extraordinary example to people of what they could be doing.

RM:  I wish that there was a group working on the SSRIs because it’s affecting so many people — perhaps as many as one out of three. There is a WEB MD article on SSRI Stories that states that one out of three people may become worse on antidepressants and even become bipolar. I mean in some the effects are just mild personality changes, they get kind of grumpy you know. But there are ones that are serious, I don’t know how often that happens, but it’s a lot.

Another thing is that the suicide rate has not really gone down in the United States. It declined a little in the 1990’s because of the good economy but the government statistics from the years 2005 to 2007 shows it’s gone up for all ages except 24 — the Black Box warning worked!

Terrible things are happening

And terrible things are happening to these poor wounded warriors in Iraq and Afghanistan. They’re giving these kids antidepressants and sending them out in battle where they’re committing suicides and homicides and everything. That man from Sherman, Texas, that went into the clinic in Bagdad and shot five people dead. Remember that one? He was on PTSD drugs, one of them an antidepressant, and they had just changed his dosage the day before. Also, what was the psychiatrist taking who shot and killed 14 American soldiers at Ford Hood, Texas? They did mention in Gulf News that he was the type of psychiatrist who tended to medicate himself.

Some of the atypical antipsychotics like Seroquel and Risperdal can also cause violence and that should be brought out too. And then there’s Chantix, which has so many cases of violence. How many people are taking Chantix? Probably not very many. It’s just for people who want to quit smoking. One person did say to me, and it was a doctor, that yes Prozac is number two on the list in that recent article by Tom Moore, but everybody takes Prozac. In other words he was thinking because of the number of people, there isn’t really a problem. I said well what about Chantix, and he just nodded in a puzzled fashion. Physicians tend to be skeptical.

DH:  Why?

The physician does not recognize what’s happening

RM:  This is what I’ve noticed from the people who have contacted me through SSRI stories. The physician does not recognize what’s happening. The patient is started on Prozac. They go to the physician and the physician says, “How are you feeling?” “Oh I feel tremendous, I feel great.” That’s wonderful, but what’s happening then is that person is going home and they are deviant, they’re divorcing their husband or wife and they’re taking off on a motorcycle — I’m not kidding this is a true story — to go to Florida and live with some beach bum who tends bar. They’re leaving their two children behind and their husband and the doctor didn’t have a clue. Because they said they felt great. That’s what’s so weird.

A lot of people type in “SSRIs and divorce.” I’m amazed the number of people who do that, or “Zoloft ruined my marriage” — I can remember that from many people. Somebody else typed in something like “Paxil made me crazy.” Those are the people who are reaching SSRI Stories, but who are they? They’re just the man in the street and not any powerful group. So we need a group to work on all of these different angles, the divorce, the hypomania, the pyromania, the kleptomania, nymphomania — I think that’s what’s happening to these woman schoolteachers. What they don’t realize is that people who go into mania and hypomania have an increased libido.

It’s the children that disturb me the most.

But it’s the children that disturb me the most. There is a post on SSRI Stories about a 15-year-old girl who was forced by her father to take Paxil and then to double the dose. A few days later she slit her younger brother’s throat and buried him in the back garden. I cannot imagine a young girl doing this. These are some of the really tragic cases and they are being hidden.

This why I can’t read mystery stories anymore. If I wanted to read something, I will read a comedy. Every time Gene and I went to the movies or out with friends to movies we would go to comedies. I would have to see a comedy because I would sit all day long and find those cases and I needed relief from this. All I can say is that we need some group that’s big and powerful who will pick up all the different angles there are in SSRI Stories.

Petra’s Story: Cymbalta

This piece is the first of a series showing people struggling with the Kafkka-esque absurdities of modern healthcare. It is written anonymously. If you’d like to share your story, please contact us. — David Healy

A little over two years ago my daughter’s partner was killed in a tragic accident while in the company of my son. Naturally, this caused terrible grief and sadness for both families. Our family doctor counseled Petra to immerse herself in her work, read, walk, and be assured that time would gradually soften her pain. He prescribed some sleeping pills to help her get to sleep.

Petra went back to work after a week or so but was frequently unable to face it, and after struggling for a month or so took extended leave. Some three months later she saw another doctor at the same clinic who declared that Petra had Depression for which she prescribed an anti-depressant, Cymbalta.

Her doctor explained that her brain was not releasing enough of the chemicals that prevent depression.

Petra said that the drug made her feel sick but that her doctor had told her this would pass. Her doctor had explained that her brain was not releasing enough of the chemicals that prevent depression, and that the anti-depressant would prompt her brain to release more of these chemicals — after a while, her brain would resume releasing the right amounts.

This sounded plausible, if ambitious to me, but I was a little concerned at the nausea and read the notes that came bundled with the drug. Worried by the long list of possible side effects, some of them serious, I called the enquiries number on the leaflet and asked how likely these side effects might be. The very polite receptionist took my number and dutifully called back with the explanation that these things only had to be reported once and they could appear on the list and so the chances of most of the bad effects was close to nil. This satisfied my request and I thought no more about it for weeks.

Also troubling was the existence of self-help sites and forums for people who had problems getting off these medications.

Petra showed no improvement, still had bouts of nausea, was sleeping badly, and began smoking heavily, so I started to look for more information. Google searches returned a number of drug information sites that stated briefly that Cymbalta was effective and well-tolerated but other search results on Cymbalta, anti-depressants, and SSRIs hinted at disturbing side effects. A couple of sites seemed overly dramatic and poorly presented but their existence troubled me. Also troubling was the existence of self-help sites and forums for people who had problems getting off these medications. It became apparent that it would be necessary to find some independent authorities and I sought out some government sites. Some of these had information for patients and prescribing information that raised more questions than answers.

I found a link to the UK enquiry into health 2004 ‘The Influence of the Pharmaceutical Industry” and read many of the depositions, questions, and answers. This was detailed and had both sides of what was clearly an argument about Pharmaceutical company influence on the health of nations. The Pharmaceutical company representatives were not very convincing in their submissions.

I raised the issue with my wife, who shouted at me.

Having established in my own mind that there were serious problems with Cymbalta and probably any of the SSRIs I raised the issue with my wife, who shouted at me that

“She has a chemical imbalance in her brain, she needs the medication.” I was completely surprised by this reaction and provided some written material that outlined some of the problems with antidepressants. Jeannette declined to look at any of it. I suggested to my daughter that I had reservations about her medication but she was not interested, pointing out that her doctor would know all about the various medications.

In addition to smoking heavily, Petra’s consumption of alcohol also increased resulting in many unpleasant times for her friends and family. About four months after beginning to take Cymbalta, Petra tried to take her own life, two attempts, a fortnight apart. On both occasions after drinking heavily she took all the tablets she could find, sleeping pills and Cymbalta the first time, sleeping pills, Cymbalta and Benztropine on the second occasion. The Benztropine had been administered to help a dystonia that had developed on the first trip to hospital and had been provided in an unmarked bag in case the dystonia should recur. Petra later explained that she thought that taking her own life offered a slim hope of finding her beloved David again and afforded a way of escaping the sadness that she felt might never go away.

Naturally these suicide attempts upset me terribly and I feared that the Cymbalta may have contributed to them. The first pharmacist that I asked about Cymbalta cheerfully drew me a diagram of a single neuron with more serotonin recycled into the synaptic gap when Cymbalta was taken. Another pharmacist that I know very well conceded that the only information that she had originated from Eli Lilly and it wouldn’t surprise her if it was overstated or just plain misleading. This was the first supportive comment that I had heard.

The first doctor wrote me out a script on the basis that I was clearly depressed about the entire situation.

I spoke at length with six local doctors. Three seem thoroughly convinced of the merits of SSRI antidepressants. The first even wrote me out a script for mirtazapine on the basis that I was clearly depressed about the entire situation, from the tragic accident to my daughter’s reaction and treatment. This after being told that I had serious worries about antidepressants.

The second, Petra’s doctor, conceded that the treatment may amount to no more than placebo but cried, “…what else have I got ? Benzos ?”

The third was generally defensive and unwilling to discuss the matter.

Our semi-retired family doctor whom she had seen first was skeptical of the new antidepressants, and doesn’t prescribe them. The remaining two I sought out after getting their names from a psychologist friend. These are doctors who regularly refer patients for psychological input rather than instituting a drug regimen immediately. Surprisingly, one of them confessed that he did not understand the trial data summaries and was simply skeptical by nature and on the basis of past experience.

All of the doctors assured me that the alcohol and sleeping tablets were more likely to blame and that such events were not associated with long-term use of Cymbalta. It was suggested to me that suicide attempts were more likely early in treatment when increased energy made acting on suicidal thoughts more of a possibility before the anti-depressant factor emerged. I didn’t find any of this comforting. Petra maintains that the Cymbalta wasn’t to blame, but I don’t see how she can be sure of this.

I had confidence that the possibility of a Thalidomide issue was a thing of the past.

Before researching the topic, I had imagined that drug companies were mostly interested in finding new medicines and probably modifying existing ones to deliver better health outcomes for society. I understood that this might be expensive and that there would be no knowing when the next break through might occur. New treatments could be expected to be more expensive than older, less effective ones. I further imagined that considerable trouble would be spent ensuring the safety of any new drugs given disasters like Thalidomide. I was quite sure that there would be government agencies testing all new drugs in order to be certain of their efficacy and safety. I had confidence that improvements were being made all the time and the possibility of a Thalidomide issue was a thing of the past.

Given that only safe and effective drugs would be available, I was happy to leave the choice of drug to the doctor, assuming that clinical experience would guide him or her to prescribe the most appropriate treatment for each patient. Clearly this was the view that Petra held. She had also developed a trusting relationship with her doctor and was finding my reservations about her treatment to be offensive.

I found it incredible that depression and suicide could be side effects of a treatment for depression.

The first and most disturbing thing that I felt was established about Cymbalta and the SSRIs in general was the unacceptable incidence of suicide as a side effect. I found it incredible that depression and suicide could be side effects of a treatment for depression. This would be like a new brake fluid that worked 5% better than existing brake fluid except for the occasional complete brake failure. This has to be a ‘show stopper’ by any measure. The use of statistics from drug trials in an attempt to reduce this fatal flaw to statistical insignificance utterly failed to move me. The question now was how can such an absurd treatment find it’s way into general practice? Could these claims of suicide during drug trials be wrong?

I was appalled to find that actual suicides had occurred during drug trials and were written up in tabular form along with (fewer) suicides on placebo. It seemed possible that depression leads to suicide and the drugs were simply ineffective. But suicides on placebo ‘washout’ shouldn’t be counted as placebo suicides and the fact remains that more suicides happen on the drugs than on placebo. This is much worse than ineffective, this is a problem masquerading as a solution.

This is a problem masquerading as a solution.

Putting aside the suicides, is it possible that a lot of people benefit considerably from the drugs? I felt that this must be the case and that doctors must see a lot of people who feel much better for the treatment. It was at this point that I read Irving Kirsch’s book ‘The Emperor’s New Drugs” and had the surprisingly large placebo effect in mental illness confirmed. This explains how people could genuinely improve on placebo or equally well on a drug that had no therapeutic benefit. Once we factor in the effluxion of time, possible altered circumstances, the fact that a doctor has been consulted, positive reinforcement by the doctor, plus an expectation of cure or improvement by the patient, it becomes impossible to discern the contribution, if any of an active drug. Nevertheless, the combined effect of all these things looks like ‘the drugs work’.

I think this explains to my satisfaction why doctors might think the drugs work; this and all the ghostwritten articles and company experts at conferences.

Petra has now spent months trying to stop Cymbalta. This is another story we weren’t prepared for that we hope to update you about soon.