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...]

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Go Figure: Sally’s Problem with Whinging about Medicines

99 percent

Two weeks ago in response to the last post in the Study 329 series, Sally MacGregor added the comment – that features as a post below. It’s spot on. The problem is how to avoid being marginalized, becoming part of a 1%. How to capture the attention of the 99% for whom the meds work just fine thanks. There will be more on this theme over the next few posts.

The whole point about the revisited Study 329 for me was that it was so meticulously and scrupulously carried out by a team of researchers, in a way that left no wriggle-room for it to be dismissed as ‘bad science’. (Even though some have tried). So it stands as a solid, irrefutable, excellent piece of science, which will be cited in the literature, and, crucially, is likely to pop up on Google. It’s kind of embedded now, which seems to me to be its lasting legacy. That it concerned GSK and paroxetine is secondary – Eli Lilly were just as murderously and indifferently mendacious – and in the UK get much, much less publicity for their callously commercial behavior.

The difficulties in getting through the hoops to the BMJ must have been incredibly frustrating, but – is anyone outside the ‘Study 329’ inner circle, or people who suffered from paroxetine, truly interested in the fact that someone’s husband was related to someone else who might have hindered the path to publication. It GOT published – which is the really important thing.

No one I know, service users included, had even heard of Study 329 – although several friends were very interested in the RIAT paper – mainly as a concrete example of meretricious Big Pharma mendacity. Hell – I’d never heard of Study 329 until 2013.

I’m playing devil’s advocate to a degree but sometimes I think we have to get real about life outside, where the chemical imbalance theory still reigns supreme, and if the public perceive any problem at all with antidepressants it is far more likely to be along the lines of ‘well he/she wasn’t taking their medication, that’s why they went berserk’.

No one will like me saying this – but I am sometimes reluctant to point people in the direction of David’s blog and Rxisk because, coming at it from a newcomer’s perspective, people don’t understand why AllTrials is suspect, (no one ever slows down and explains, for one reason) what on earth the BMJ did wrong, why Fiona Godlee is Nurse Ratchett, or what on earth is the point of laboriously transcribing an exchange between Goldacre just to show he’s an unreliable twat… And those new visitors will probably never repeat the experience.

Drawing new people in, from places other than those (like me) who’ve been dreadfully harmed is really important: doctors, researchers, scientists, our children, relatives, neighbours, philosophers, writers, journalists. We honestly HAVE to broaden the debate otherwise it simply becomes an incestuous gathering of victims and activists, who already know all there is to know about the damage. If visitors from outside don’t feel welcome, or just don’t understand what everyone’s going on about, then what on earth is the point?

Believe me, I’ve tried getting people to engage with Rxisk and David’s blog but it hasn’t worked – for all the reasons I’ve just stated. But they are surely the truly important people to get on board? Otherwise both forums just end up with ‘I am a victim’ hand-wringing on a big scale which does nothing to spread the message…no one apart from Johanna offered me any help with my ‘Take a Rxisk report to your GP’ request – and that was a challenge thrown out by David, which I didn’t especially want to do, but was willing to give it a go.

Similarly, with the Complex Withdrawal site (which I’m deeply interested in, as it might just offer some hope in the future for people like me) – I asked around, as requested, got some small bits of information from my hairdresser and a friend who’s a beautician– but there is no where sensible to put it, and the comments section has (yet again) been mainly co-opted by people offering well meaning but probably useless dietary advice or repeating, yet again, their stories. Surely the challenge was to GET MORE AND DIFFERENT people involved in collecting information?

It seems to me that every single attempt to move forward just dies – because no one slows down long enough to consolidate the practical ideas which might just make a difference to future victims. It’s too late for me, but I’d like to do my best to see that help is there for all those still to come. We can carry on preaching to the converted till the cows come home, but seems to me far more important to educate, persuade, chip away at societal views about antidepressants (non addictive, no such thing as withdrawal etc etc) without making people who take them feel alienated and ashamed.

I’m fed up with bashing away and for anyone who wants to reply ‘I did not like this comment’ – go figure.

Club 329: Part 4

Leonie

Editorial Note: This post perhaps should be called: There’s Something about Leonie. The image above is of a Rapid Response she submitted to a BMJ editorial by Richard Smith and Fiona Godlee that BMJ published and unpublished and republished and re-unpublished. The full story is here. It again hinges around Study 329.

The full transcript of her exchanges with Ben G is below. It’s important. It suggests AllTrials see the side effects of drugs as irrelevant.

Leonie

Hi, this is to do with, specifically to do with Study 329. The BMJ took a year to publish the Restoring Study 329, the reanalysis of Study 329. I was just wondering what you thought of the fact that, would it be a factor that the BMJ clinical editor is married to a partner in Ropes and Gray, the same law-firm that GSK paid to defend them in the US department of justice action?

Ben Goldacre

I don’t know – also I don’t care. Honestly, conflict of interest, it happens – and it is clearly problematic. I don’t find it interesting, in the same way as I don’t find fraud interesting. So, I’m not saying that it’s not important.  I’m just saying, it’s not my thing. Conflict of interest is also what people who don’t understand trial design talk about, and it’s kind-of all that we talk about. So, all of the, almost all of the popular discourse around problems in research in medicine that you see mentioned it’s almost all about financial conflict of interests and I just feel like that’s really, that’s all we talk about, it’s well covered by the .. but it’s not, it’s doesn’t set me on fire.

I don’t think you can honestly say the BMJ are the bad guys in the world of suppressing medical research, and if anything, they’ve got a reputation of being, a kind of sanctimonious obsessives about research integrity.

And when you say it’s been a year to publish the reanalysis of Study 329, But firstly, I don’t think we needed a reanalysis of Study 329, honestly – it was a rhetorical act. It was interesting that someone went out and did it. But we knew that within six months of the trial being published, that the trial was crap. We knew within six months of the trial being published that it had been misreported and all of the stuff that I had showed you on that slide that Study 329 misreported it’s from a paper by Jureidini that came out almost as soon as Study 329 did. So we already knew, we already knew Study 329 was crap and study 329 was published 20 years ago.

I’m glad that someone did a reanalysis of the underlying data, to show, yet again, that it was dodgy and I’m glad that they got some media coverage, for showing, yet again, that Study 329 was dodgy, and showing that people switch outcomes. But actually, I’m more interested in the fact that there has now been 29 cohort studies, showing that on average about a third to a half of all trials switch main outcomes. It’s not about Study 329, it’s about these endemic structural problems throughout the whole of healthcare that we can fix. And I don’t know what fix you’ve got in mind, cos the fix that I’ve got in mind in the misreporting of outcomes, is, we need to hold journals to account when they misreport outcomes, and we need to stop then doing that bad stuff.  But I don’t know what you do about, I don’t know who ?? person is.. but I don’t know what we should do about that?

Leonie

But it’s still unretracted?

Ben Goldacre

Study 329? You think the BMJ should retract Study 329?

Leonie

I think it should be done by somebody.

Ben Goldacre

But the BMJ didn’t publish Study 329.

Leonie

No, but, GSK then.  Whoever, whoever wrote it.

Ben Goldacre

Yeah, I mean I think it should probably be retracted. BUT, again, what’s the purpose of a retraction, because anybody switched on knows that Study 329 was crap – and, also are we going to retract the tens, possibly hundreds of thousands of clinical trials that also switched their main outcomes?  I mean, maybe we should, but that’s a really big piece of work and why would we, why would we be more interested in Study 329, than the tens or hundreds of thousands of trials which we know switched outcome?  I mean this is a systemic structural problem. I mean Study 329 has rhetorical value for getting the media interested and engaged. But why are we trying to retract that one trial, rather than a hundred thousand trials that also switched outcome?

Unknown Male

I just want to ask a similar question, about Study 329 as well. Is outomce switching not basically fraud then? Is it not fraud, switching?

Ben Goldacre

Fraud?

Guy

Would you call it fraud?

Ben Goldacre

So, it’s really interesting isn’t it.  I think, it’s very, very interesting how the lines have been drawn between fabricating your data, actually going into the spreadsheet in excel and deleting the number that’s there, for the, for the patient’s blood-pressure, and typing in a new one. That’s fraud.

But, all of these different design shortcomings, which we know, are associated with over exaggerating treatment benefits and downplaying side-effects. That’s not regarded as fraud. I think that’s really, really interesting and it’s not a, it’s not a position that I’m sure, that I think I can respect. Because what I think is when you get the wrong answer you hurt people, and it’s your job to get the right answer.

Guy

In the case of 329, wasn’t there a lot of teenagers damaged? Young people were prescribed the drug on the basis of it.

Ben Goldacre

Yeah, but, like, why are you talking about teenagers and Paroxetine? We’re talking about the whole of medicine. Like, so what’s special about 329? What’s special about ..

Guy

Is it not the canary in the coal mine, no?

Ben Goldacre

Is it what?
Guy

Like, it’s the most publicised example of a corrupt study?

Ben Goldacre

Emm, yeah. It is this year, yeah.

Guy

Sorry. Why is it not important?

Ben Goldacre

Why is study.. No,  Study 329 is important but I don’t understand why you’re so interested in Study 329, when we’re talking about structural problems throughout the whole of health.

Guy

Well it’s just one of your examples, that you had in your slides.

Ben Goldacre

Yeah, I’m happy – I’m totally fine with that but I think, I think it’s a real strategic error and a backward step, to be preoccupied with one study, when you’ve identified structural problems throughout the whole information architecture of evidence based medicine. When you’ve identified a problem that hits, like a third of all trials, then I’m not sure that I care about ..

Guy

Can I just ask another question, because I find it this stuff interesting. You’re talking about antipsychotics and antidepressants, and you know, the dodginess of some of the trials, but, do you not think the medicalizing human distress is also the bigger problem?

Ben Goldacre

That’s about informed choice. So I get a sense of, that maybe you’re coming from a particular standpoint in mental health and that’s a partial view but I think with, with any treatment the right thing to do is to say, look, for the problems that you have, there is very good evidence, that this is a medicine which exists, which is been invented, which is available on prescription. From the best evidence we have, overall it looks like it has the following benefits and the following harms and it’s for you to choose whether you’d like to take it.

Now that works really well for most treatments, except it’s not done properly. So first of all you need to get better at disseminating information, not just to doctors but to patients, as I said… That would be my funding priority for a whole year to get better shared decision making between doctors and patients and then you can say, well look, with this statin, you get the following objective benefit with the risk of the following side-effects, you make your own choice.

And the thing that we know, from all the research on decision making, is that different people make different choices. So some people when they’re offered Statins say “ ..I don’t want to be medicalized… Even if the does overall reduce my chances of heart-attack, stroke and death, by two percent over the next ten years, I’m not interested”. But, some people will say “Yeah, I definitely want that drug, are you insane? Why wouldn’t I take that drug – I want to live?” So different people make different choices on the basis of the same information and I don’t know if it’s for me, to bring my own personal views and prejudices, which are actually, between you and I, and the room, more aligned to yours, than to most of the psychiatric profession, but I don’t think it’s for me to bring my own prejudices to bear on that. I think it’s for me to help my patients make an informed choice on the basis of the best currently available evidence and if they want to take an antidepressant, where the best currently available evidence shows that it will reduce your Beck Depression Inventory score by 2 out of 30 points, which is a modest, but nonetheless true benefit – then, that’s a choice for them to make, it’s not for me to bring my prejudices about medicalization of society to bear on that. That, that’s a choice for them.

Lady asks a question (edited out)

Ben Goldacre

But I really want to know what you think about?

Guy

I just think when you’re saying about informed choice, a lot of people were prescribed antidepressants 15 years ago, maybe 20 years ago in the 90’s or whatever – they didn’t have informed choice, the side effects only came out when the general population of millions of people were prescribed them. So you’re talking informed choice now, but there wasn’t then… so.. so

Ben

Yeah, I agree, it’s really shit isn’t it

That’s what we want to fix with proper trials and proper side effect monitoring and all of that but that’s very different than the broader, sort of cultural view you seem to have of medicalizing human distress.

Guy

I think the pharmaceutical industry have medicalized human distress, yeah.

Ben

There’s no doubt that people have marketed pharmaceutical products for medical problems for medical treatment. But nonetheless if this treatment will knock two points off your..

Guy

But you’re talking about scales and stuff that’s not applicable to people’s subjective experiences of these emotional problems.

Ben

Well it’s not perfect but it’s the best that there is and an informed patient will make an informed choice, they will look at their depression metric and they’ll know what those questions are and they’ll look at at and see well we can knock two points off that- and they can look at that and go well what would that actually mean? Yeah you’re right actually that could just mean just not waking up in the morning two days a week..

Guy

It’s all subjective…

Ben

So people can make an informed choice, and if they don’t make an informed choice, well that’s their decision too, and people throughout society on all treatments vary hugely on whether they want to be involved in shared decision making, and that’s their right…

Guy

It doesn’t happen in reality though. Well certainly not in Ireland- maybe in the UK, but in Ireland it’s not happening.

Ben

Well that’s what we want to happen. But also you have to be really careful about imposing your prejudices on other people.

Guy

I’m not imposing my prejudices on other people.

Club 329: Part 3

Shane Clancy

Editorial Note: This post by Leonie Fennel carries on from parts 1 and 2 in this series. There will be one more post.

I dreamt I met my son Shane last night – in a jewelry shop, of all places. I was admiring the beautiful costume jewelry, when I overturned the dainty display and went clambering to pick up all the pieces. It seems I don’t escape my klutziness in the land of my dreams (or my love of all things bling).

The shop doorbell tinkled and in walked Shane who had been gone for so, so long, as handsome and animated as ever. All thoughts of scattered jewels were instantly forgotten while I launched myself at him. Shane’s younger brothers and sister appeared behind me (it is a dream after all) and he laughed happily while telling them stories of what he’d been up to. They all looked on, transfixed, fascinated as always by their big brother – listening attentively for once. All the while my arms were wrapped around him, with my head buried in his chest, clinging on for dear life, crying happy tears and feeling a joy in my heart that somehow seemed so alien.

Then I woke up and cried all over again when I realized it just a silly, silly dream and my lovely Shane was still dead – it’s ‘Marbh’ in Irish but means the same, deceased, dead, unadulterated and irrevocably dead.

Seven years and I’m still haunted. Haunted by the ‘what ifs’. What if I hadn’t insisted that Shane see a doctor? What if the doctor had not believed in the biological model of treating heartache? What if we had insisted on knowing all the facts BEFORE he took an SSRI, not afterwards? What if we had known Study 329 was a crap trial before 2009, not afterwards? What if Shane’s arms around me were actually real, not just a dream? ENOUGH. Back to a modicum of normality. I don’t know why I shared that with you, apart from the fact that the feeling of Shane is burned into my mind today.

Pandora

As this is my second post, I should point out that my previous one effectively opened a virtual Pandora’s box, by annoying Ben Goldacre. He said I misrepresented his talk in Dublin – which of course I didn’t. He also said that David Healy was ‘fully responsible’, presumably for publishing the post on his website – have to be careful of misrepresentation here but I’m a little offended at the suggestion that I’m not entirely responsible for myself. To be perfectly honest, I’m not quite sure what all the fuss was about – but it seemed to have had a Streisand effect, which I suppose is a good thing. I think I’ll leave Drs Healy and Goldacre to debate the finer details, although I’d love to see them debating in the same room. Wonder if I’d get an invite if I promised to take a responsible adult as a chaperone, although Dr Dishy has now officially disowned me!

Moving on

Tragedies similar to Shane’s are increasing every year, largely due to the increase in the prescribing of psychotropic drugs. Last week, very near to where I live, we heard police cars racing past with their sirens blaring and helicopters flying around overhead. It turned out that a man who lived nearby had tried to strangle his four children. Thankfully they all survived, but it was a close call, with two of the children being airlifted to hospital. Reports suggest that this man is a nice guy who loves his children dearly, so how do we marry these two opposing images? Every year we see the same tragedies, filicides, siblicides and infanticide, all with the same SSRI-induced hallmarks – yet very few ‘get it’.

When I hear of awful incidents like this latest one in Wicklow, the first thought that goes through my head is “Please, let these kids survive”. The second is “I wonder if this poor man was recently prescribed an SSRI or was he in withdrawal?” That most medics wrongly believe that psychiatric drugs are not addictive only exacerbates the problem. Hence, this latest incident is all too similar to many previous ones in Ireland, where the outcomes were not always as fortunate.

Despite the FDA and EMA warnings, on the rare occasions when medication is implicated, medical professionals will spout ‘autonomy’ and ‘informed consent’ – as if this is an actual possibility. Tell me, what medic tells a patient presenting with distress, that the proposed treatment may cause suicide, violence, emotional blunting, akathisia and among many other awful effects? Oh yeah, let us not forget the sexual dysfunction. Who will tell a vulnerable patient that the most dangerous time with psychiatric drugs is upon starting, changing dose (up or down) or discontinuation? Tragically, in the case of withdrawal, many healthcare professionals will justify these incidents by saying it’s the ‘mental illness’ returning – stating that If these people took their meds as prescribed, there wouldn’t be a problem. Thus, was this Wicklow native and his family given even the tiniest degree of informed consent? If this ‘out of the blue’ case turns out to be yet another instance of prescripticide, I can only hope that this man’s family, who know him better than anybody, will understand that these drugs can be the catalyst.

Lastly, the opinion of a lone member of the Irish Police force “There is only one thing I know that enables a parent to want to kill their children, SSRI antidepressants”. Whether this latest case is SSRI-induced, we will just have to wait and see. I’ll keep you posted.

Club 329: Part 2

Untitled

Following last week’s post, Club 329: Part 1, Ben Goldacre went into orbit claiming his views on medicalization and Study 329 had been misrepresented. He offered a SoundCloud as evidence. The link can be found in the comments after the last post. Seems to me Leonie got the content of the Q & A right.

In the course of listening to the BG SoundCloud though something else came into view. Leonie began questioning him about the links between one of the BMJ editors and the law firm Ropes and Gray who had represented GSK in the Department of Justice case that led to a $3 Billion fine for GSK. This didn’t seem to worry Ben. He’s not worried about Conflict of Interest – nor am I. His view on Fraud is unclear.

There was something else in the recording that caught my interest. BG didn’t figure the question of BMJ taking over a year to publish Study 329 was an issue. You couldn’t possibly make out that BMJ are the bad guys in the business of suppressing good science, he said. If anything they have a reputation for being too sanctimoniously obsessive about research integrity.

As BG says people react differently to things. If you and he were both facing a course of treatment, some piece of trial data about a drug might speak to him and not you and vice-versa. Maybe the Study 329 story doesn’t speak to him and others of you out there – doesn’t give you a feel for GSK or BMJ.

Perhaps a completely different story will work for those of you to whom Restoring Study 329 doesn’t speak.

A curious development

Six months into a tortured year long review process for Restoring Study 329, something odd happened. On February 9 2015, I was approached by the BMJ:

I’ve long been interested in the controversy over the role of serotonin in mental illness and wonder if you would like to write an editorial for us on: “What is the evidence that serotonin plays a role in depression?”

I replied:

More than happy to think about doing this for you. But I probably need to make something of a pre-conflict of interest conflict of interest statement, which you will need to consider.

The idea of serotonin in depression is inextricably linked to the marketing of the SSRIs. There is vanishingly little evidence that serotonin is involved in depression – but I can probably put more evidence on the table for its role than almost anyone can.

The idea of a role for serotonin in depression has been an extraordinary marketing trope – one that is critical to perceptions when it comes to the way the role of SSRIs in suicidality and birth defects is viewed. Because of this latter aspect and my role in some of these debates many people viewing an editorial by me would probably have a blood boiling moment. That’s just viewing the existence of an editorial – might not be too bad if they read it.

BMJ decided to run with it, but then seemed to have a crisis. They got back to me with an extensive conflict of interest declaration and there was a considerable delay after I got this back to them before anything else happened. Given all the fuss BMJ were making about Conflicts of Interest on Restoring Study 329, it was difficult not to think there was some link.

Finally they ran with the editorial but had difficulties with the title. So, So Long and Thanks for all the Serotonin became Serotonin and Depression. The Marketing of a Myth. It did well in terms of impact factor despite the fact that Sense about Science, with which Ben Goldacre is closely linked and which kicked off AllTrials with him, mobilized to get dissing comments about it from the Royal College of Psychiatrists and others.

Sense about Science spends a good deal of time mobilizing responses to material that might seem not supportive of corporate interests – see the Sense about Science series of posts to which BG also took exception.

Curiouser and curiouser

But there is a more interesting story behind this one that I only know about by accident.

A short while before the BMJ approached me, I had been sent an article – on the Myth and Marketing of Serotonin. It was a very good read. At least as good as mine if not better. One of the authors asked what I thought about the possibility of BMJ being interested. I said I thought it was unlikely.

Despite my advice, the authors went ahead and submitted anyway – on February 7 2015. They got a quick reply.

We are in the process of commissioning an editorial for The BMJ, looking specifically at the role of serotonin in depression, and so you will be able to send in a rapid response to that directly.

When dealing with BMJ you can get the feeling they (the editors) are using authors to run their own agenda. You might get in touch with a draft article on Access to Clinical Trial Data and they get back saying “sorry we’ve just had something else from someone else on this topic”. The something else when it appears a good deal later turns out to be a neutered version of what needs to be said.

Many people figure journals shouldn’t have an agenda. In fact the first medical journal, the Lancet, began with an agenda – against food adulteration. The later appearing BMJ ran its own campaign against nostrums – around 1900. These campaigns put these journals at considerable risk of reprisals. BMJ sees itself under its current editor as on a mission. It’s more recent campaigns, far from putting the journal at risk, have been for Evidence Based Medicine and Against Overdiagnosis, along with AllTrials to which pharma has signed up.

Whatever the BMJ mission its not a mission to tackle adverse events – the modern equivalent of adulteration or nostrums. It was close to paralyzed in the case of Study 329 by having to conceded a drug might have a side effect.

The educational articles BMJ runs on most drugs contain little or no mention of adverse events. While it published Restoring Study 329 after a gun was put to its head, its educational articles on antidepressants play down any risk of suicide, are comfortable with giving antidepressants to children, never mention withdrawal, and deny links to birth defects.

But here’s the rub. The article that was better written than mine was written by Leonie Fennel and Maria Bradshaw – neither of whom have healthcare or neuroscience backgrounds. Both write like angels. Leonie was a hairdresser before a family tragedy mobilized her to find out more about the drugs that led to the death of her son and others. The latest version can be accessed on ResearchGate and an earlier version is attached here.

You’d have to think BMJ couldn’t cope with the idea of a hairdresser joining the club. Only credentialed nerds need apply.

Leonie’s input along with that of people like Anne Marie Kelly who have done so much to establish the role of SSRIs in promoting alcoholism proves again and again – and is the inspiration behind RxISK.org – that motivation counts for more than expertise.

When my article came out, Sense about Sense mobilized against it – having been sent a copy by BMJ, with whom they, BG and GSK are part of an AllTrials coalition.

Parts 3 and 4 to come.

Club 329: Part 1

Ben Goldacre

Editorial Note: This post is by Leonie Fennel. It’s one of two involving Leonie.

Last week, Dr Ben Goldacre gave a public lecture in the Royal College of Surgeons in Dublin (organised by the 3U Partnership and the very lovely Dr Ruth Davis). Dr Goldacre is a doctor, academic, campaigner and writer; he is also a psychiatrist and self-professed nerd. I was eager to hear what he had to say, not least as the subject-matter was ‘Bad Trials’ – so off I toddled to Stephen’s Green with a friend in tow, a psychotherapist. He, like me, has a personal interest – he has witnessed first-hand the devastation that can be caused by nothing more than a GP’s farraginous prescribing. He is also a very kind, funny, charming companion, so I was delighted to have any excuse to meet up with him. I’d also say he’s a handsome chap but the husband I abandoned for the day wouldn’t be too impressed.

Having read Goldacre’s ‘Bad Pharma’ book, we were both curious to hear what he had to say. Incidentally, he once called my English friend Fid a ‘Smeary Conspiracy Theorist’ – so apart from guaranteed entertainment, I wasn’t too sure what else to expect. In fact, his talk was fast-paced and as excitable as he is – he hops around like a Duracell bunny on speed and lets out intermittent roars, which effectively kick-starts the heartbeats of anyone not paying attention. Nevertheless, he attempts to make data and statistics fun, a nigh-on impossible task.

Needless to say, as the subject concerned ‘bad-trials’, he specifically mentioned GlaxoSmithKline’s notorious Study 329, although bizarrely managed to do so without mention of GSK (usually both are referenced synonymously). He seemed like an amicable chap and was quite happy to answer questions afterwards in the Q & A session.

I was interested to explore his views on Study 329 and asked his opinion on why the BMJ took a year (of much wrangling) to publish Le Noury et al’s reanalysis of it – and did he think it had anything to do with the BMJ’s clinical editor being married to a partner in Ropes and Gray, the same law-firm hired by GSK to defend the action brought by the US Dept. of Justice, where Study 329 was a central element.

Goldacre said that he didn’t know and didn’t care – that fraud and Conflicts of Interest were not of interest to him. He asked what the fixation with Study 329 was, as it was just one of the many trials where data was misrepresented?

He expressed the opinion that everyone knew from early on that the original study 329 was flawed and nobody really relied on it. I sincerely doubt that the authors would agree with him on that, but he is entitled to his opinion. The oddity as the photo shows he was talking about outcome switching which is what happened in this originally well-designed trial.

He went on to say that the reanalysis (Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence) was nothing new. It only did what had largely been done before and confirmed what everyone actually already knew.

Expressing my concerns that Study 329 was still not retracted, he asked what I wanted to happen, that all papers that are re-analysed and found wanting, be retracted? Erm, yes!

My friend, the dishy therapist, then said that wasn’t the crucial point being that 329 harmed so many children? Ben said once people have informed consent, they can make their own choices – like this is a common practice. He pushed Ben on the now-common practice of problematizing distress, with Ben suggesting that people need to be careful not to push their own biases onto others.

It struck me as odd that BG seemed disturbed by the discussion turning to study 329 – yet he had specifically brought it up himself. I thought it even odder that he didn’t give the re-analysis by Le Noury et al any credit at all. I got the distinct impression that while his forte may be in data and stats, the enormous numbers harmed by these fraudulent trials were given little consideration.

How can anyone say that people can make an autonomous choice to take a drug, when the (usually ghost-written) studies are manipulated to give positive results, while hiding serious harms?

The mammoth undertaking by Le Noury et al deserves huge recognition for exposing just this – that truly informed consent is impossible unless the full facts are provided.

Editor’s Note: Ben Goldacre has taken exception to this characterization. He comments below. His tweets on the issue can be found BG tweets

The Pill That Steals Lives

The Pill That Steals Lives

Katinka Blackford Newman talks about her new book

Its now nearly three years ago since I woke up and found myself in a mental hospital in North West London. I looked down and saw wealds on my arms where I had torn my skin apart. There was a mirror in the tiny room where I’d spent most of the last four weeks going through agonizing cold turkey from being taken off five antidepressant and antipsychotic drugs. I stood on the metal bed and struggled to recognize my body beneath the blue hospital gown. I used to be a keep fit fanatic, my body lithe and toned. Now I was three stone heavier. But that was the very least of my problems.

What the hell has happened, I wondered. I had a vague recollection of the last year, which I later called the year my life was stolen. It had started when I had hit a wall of despair while going through a divorce. Sleepless nights took me to a psychiatrist who prescribed an antidepressant. Within hours I was hallucinating, believed I had attacked my children and in fact attacked myself with a knife. I ended up in a private hospital where doctors clearly thought I had a screw loose when I told them I was being filmed and that there was a suicide pact with God. The psychosis ended when I said I wanted to stop taking the escitalopram but doctors insisted I take more pills. This began a terrible decline where I couldn’t leave the house, dress myself, finish a sentence. But the worst thing of all was that I couldn’t feel love for my children, Lily and Oscar, who were 10 and 11 at the time.

At the end of a year I was about to end it all. As a last resort I tried to get myself readmitted to the same private hospital, but my insurance had run out. And that was how I ended up sectioned at this NHS hospital that had made the decision to take me off all the drugs. (Lithium, olanzapine, sertraline, Prozac, lamotrigine,) I was climbing the walls, screaming, shouting, and begging my family to get me out of there. If I’d been suicidal while on the drugs, withdrawal made me far worse.

But that day, as if by magic, I woke up and I was fine. And that was where I found myself a few days before my 48th birthday in October 2013. My kids, by then, had become scared of the monster I had become and were living with my estranged husband. I had, in effect, lost everything. Well, not everything, because, actually I had the most important thing back that day. And that was me.

I needed to unravel what had happened. Before I became a dribbling lunatic unable to finish a sentence, I had been a TV documentary director. In fact I had begun my career doing hard-hitting investigations for the BBC.

It didn’t take me long to find out about RxISK. When I logged on to their site, I was aghast. There was story after story of cases far worse than mine.

I realized I had been lucky; very lucky. I decided to run a half marathon and raise money for RxISK. In the process I came across a man who made a lasting impact on me. David Carmichael who now works for the media department of RxISK, killed his son when he became psychotic after taking Seroxat (Paxil). I met others like him, who had killed on these pills. I learnt of the hidden trials that show these drugs are no more effective than a placebo, the fact that Pharma have paid out billions in settlements to people who have killed on these drugs. I contacted experts and whistleblowers around the world and started making a film pilot to pitch to broadcasters.

But there was something missing. I’d tried to put what happened behind me, to not talk about it. The impact of this was that I felt detached and unable to make proper friendships. A year of my life had been stolen and I was pretending that it had never happened.

Then all that changed. I met by chance someone who was a literary agent. He was fascinated by my story and asked if I’d ever consider writing a book. I laughed and said the most I’d ever written was a cheque.

He persisted and suggested I write a chapter. As soon as he read it and liked it, something very strange happened. I’m not religious, or even particularly spiritual. But actually, it was as if a force that wrote that book for me possessed me. I would be woken up at 2 a.m., driven towards my computer, and I simply could not stop writing.

I wrote about the year of drug induced hell, but also I was writing in the present tense about the film pilot I was making. By now I’d decided to make this as an authored film featuring my experiences as well as others.

Something told me I had to keep writing, not just about this, but also about everything that was happening in our lives at that time.

Whether it was taking Oscar to the orthodontist or me going on Tinder dates, everything that was unfolding in our post divorce lives in Harlesden North west London was written about in a daily diary.

I can’t explain this but I knew something very big was about to unfold.

I didn’t know what, but 5 weeks later, it happened.

I made a discovery that will have ramifications about mental health all over the world.

The only person that knew about this was my agent, who I was sending the chapters to as soon as I finished them.

As I clicked the send button on the email containing the chapter with my discovery, I wondered how long it would take before he rang. It was less than an hour, and he’s a busy man.

We met for lunch on my birthday on 19 October 2015 just 6 weeks after I’d begun the book. He asked if he could take the book that afternoon and pitch it to publishers.

We signed a deal a few weeks later with John Blake publishing who said they could get the book out very quickly.

The book is published on 7 July 2016

Its available for pre-orders on Amazon https://www.amazon.co.uk/Pill-That-Steals-Lives-Antidepressants/dp/1786061333 and on many other sites.

For further info please visit www.thepillthatsteals.com and twitter @pillthatsteals

Editorial Note: Sufficient pre-orders of a book promote it to the display desk in shops, so in terms of getting the word out it would be helpful if as many as possible can pre-order.

Study 329: Republic to Empire

GSK House

Editorial Note: This post is from Sally MacGregor. In depositions and lectures I commonly state that I have had more support and information from colleagues working for industry than from clinical colleagues.

I loved the analysis of the derailment of medicine and research through the comparison between a Republican and Empire structure, and the take-over of the former by the latter (See Data WarsMinions No Longer). It highlighted a moral/ethical dilemma that I thought about throughout the riveting unrolling of Study 329 and its re-write. How do good people become corrupted?

Unless you buy into the idea that every one of the million or more people who have ever worked for a drug company is inherently lacking any moral compass, then it is imperative to wonder what happens such that one giant corporation can ruthlessly and without any expression of regret kill people in the interests of profit. Corporations aren’t some weird, otherworldly entity, a life form that has developed somewhere in the outer reaches of the galaxy, like the Daleks that terrified me at the age of 8. Corporations are people. From the chief executive down to the people who make the products on a factory line – they are all human.

One might attribute hubris, overweening greed and psychopathy to those at the very top but not, I think, to all the tens of thousands of employees. Thoughts of Nazi Germany spring to mind – the millions of ‘ordinary’ Germans who kept quiet, or turned a blind eye to the persecution of the Jewish people and the Holocaust. Maybe there is something similar at work, but it doesn’t quite fit the whole picture for me.

I can describe the last throes of Republic and the transition to Empire from a personal perspective: when my husband was offered his first job after university in the early 1980s, with a now defunct American pharmaceutical company, we thought he was going to be putting his biochemical training to good, practical purpose – albeit in animal medicines. Dealing with problems like enteritis in pigs or finding better ways of managing flea infestations in cats and dogs. It wasn’t exactly noble – but it seemed a useful way of earning a crust.

At that time, in the early 1980s, the animal health division was headed by a veterinary surgeon and many of the older scientists at American HQ were exiles from Nazi Europe. One, Irv, long since dead, had escaped from Germany in 1939, and met and married a fellow escapee who had got out on the Kindertransport scheme, here in the UK. They’d settled on the East Coast of the US, near the company’s research HQ in Philadelphia when Irv began work for the company as a chemist. They stayed there for 50 years. He was a scrupulously honest person who sometimes drove his colleagues mad with his meticulous attention to small detail. He was a Democrat through and through, and utterly horrified by the corporate dishonesty revealed during the Enron scandal. Music was his first love but he was always ready to talk politics, books and the theatre. He and his wife were humane, cultured people. They were also deeply grateful and loyal American citizens. The only time we ever differed was when they were both shocked to the core by a spate of flag burning in the early 1990: some protest or other in the US, which seemed perfectly low key, and quite amusing to us but really shocked them both. I wish I could discuss what has now emerged about the embedded corruption of Big Pharma with Irv.

During the 1990s the pharmaceutical industry sank into turmoil: Rob’s company was, I think, the first to be the subject of a hostile take-over by another US giant. It wasn’t a pleasant way to lose your job: there were over 3,000 people working at the UK base alone. The managing director and division heads in the US knew about the bid from AHP and had been fighting secretly for the company’s survival. They lost.

Rob and everyone else turned up for work one Monday to be met by personnel (as Human Resources used to be known) and representatives from the invading forces. All the managers were asked for their car keys, escorted to their desks and watched while they collected the photos of the kids and any other personal items. Then they were escorted rapidly off the site and sent home. Rob was back by 10 am. They were watched as they cleared their desks, in case angry and upset (now ex) employees scooped up papers with data and information that could be used in revenge against the invading Empire, or those with IT know-how might bugger the computer system with a rapidly inserted virus.

Redundancy the American way was a humiliating experience. And nothing was ever the same again. No one ever felt secure from that point onwards.

The UK site was raped and pillaged by the invading hordes, its commercial assets split and sold off to other companies in a frenzy of ‘reorganisation’. The UK base had been the second biggest employer in a large area, which has never recovered, economically. The site was gradually torn down; the land sold piecemeal for housing and where Rob’s office building stood there is now a Drive-Thru Kentucky Fried Chicken outlet, which employs 30 people on zero-hours contracts.

Some like Rob found another job, some never did. Rob went to work for a Swiss company that, within 6 months had merged with another to make, at that time, in 1996, the biggest pharmaceutical company in the world. We’d faced redundancy twice within a year. At the time we had two children about to go to university, our house like many others in the UK was in negative equity due to soaring interest rates and a collapsing housing market. We were financially vulnerable – like everyone else. When he was offered a job at HQ we had little real choice, despite the fact that it was in Switzerland.

Scientists and department heads were replaced by people with backgrounds in ‘business management’, and PhDs gave way to MBAs as the gold standard qualification for employment. Pressures grew to maximize profits: it would be foolish to pretend that loyalty to the company hadn’t always been a requirement, and that the profit margin had always came first – but from the mid 90s onwards the moderating influence of people like Irv just evaporated. The atmosphere at work became highly focused on meeting targets, deadlines, and budgets. There was simply no room for skepticism or questions: once you were perceived as awkward you knew you were likely to be kicked out.

The people who had to go out and sell the products on the frontline – the sales force – were probably subject to the most intense pressure of all. And were most vulnerable to being sacked. I read the Eli Lilly internal documents posted on Mad in America, detailing operation Viva Zyprexa! The Empire was out to conquer new lands – primary care physicians. The crib sheets detailing how the sales force were to lie about the fact that Zyprexa caused diabetes make grim reading (particularly grim for me maybe, as I developed diabetes and lipid dysregulation after years of Zyprexa/olanzapine). But as sickening is the appalling cheerleading at the ‘product launch’ meetings, the crude offsetting of one team against another and the psyching up of the reps to ‘Go out there and kick ass!’ OK, maybe reps aren’t the brightest people in the world but they were being groomed for aggressive selling, just as 16-year-old lads are groomed to kill when they enter the army. A macho, bullying environment where you either sink or swim. No room for people who might have qualms about the morality of what they are being asked to do and who have families to care for and mortgages to pay every month.

I asked Rob whether his company would have launched an internal damage limitation exercise like GSK/SKB did around the Panorama programs about paroxetine: Of course he said – and that it would have probably been successful. Employees would have been reassured that the company – their company- would never have deliberately harmed children. Success of the exercise would have been sustained partly through loyalty to the company but mainly because no one could afford to think too closely about whether it was true. Ask too many questions and you would be out on your ear with no chance of getting a reference for a future job.

If this sounds like an apologia for those working in the pharmaceutical industry – it isn’t. Some people do very bad things in any arena which are simply unforgiveable on any level: it’s hard to forgive the doctors and nurses who propped up a failing, abusive hospital in Mid Staffs by ignoring the pain and distress of patients. It’s very hard for me, remembering some of the casual brutality to which I was subjected as an inpatient in several mental hospitals. Even harder to think that the industry which bought our food and paid the bills wreaked such appalling damage on our family.

But unless you dig under the surface and wonder how such things happen, think about the context: the atmosphere of fear engendered by bullies who are probably being bullied themselves, then it’s too easy just to be angry. Anger is good – but not enough on its own. I think it’s important to put Study 329 in its cultural and economic context; try and peel away the layers of the onion and get at some understanding of why what happened, happened. Saying ‘oh that’s just capitalism in action’ is true, but in the end offers no chance of doing things differently at some point.

Empires fall, eventually, however powerful. I hang on to Abraham Lincoln’s words (although I prefer Bob Dylan’s version)

“You can fool all the people some of the time, and some of the people all the time, but you cannot fool all the people all the time”

Pharmaceutical Rape: Ending our Tolerance

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Editorial Note: This is the final part of Laurie Oakley’s series on Pharmaceutical Rape. All six parts with better imagery (no-one is enthusiastic about the Martin Shkreli images) and extra text are available here as a PDF Download.

Pharmaceutical violence

Pharmaceutical violence is a social issue as well as medical problem that demands a social response and medical intervention. To address what is now an ongoing human rights catastrophe and to help survivors recover from what has happened to them, it is important that we shift all of our focus to the systems that perpetrate pharmaceutical rape. We need to ensure that full responsibility is taken for the practices that lead to these iatrogenic harms. The essential way of assuring systemic change is to have an organized community response. This can occur through petitioning for a governmental task force, the enactment of new legislation, remedial actions through the courts, the initiation of comprehensive educational programs, new training protocols for health care providers, and various community-based efforts. Government officials, the courts, educational systems, medical professionals, and the public need to work together in order to bring about systems accountability. As we begin to fully recognize how pharmaceutical violence affects all parts of society, we can develop comprehensive responses as well as individual approaches to end all forms of pharmaceutical violation. Patients along with supportive doctors can come together to make this happen.

Medical allies

A medical ally is someone who commits to working toward ending the systemic practices that perpetuate pharmaceutical violence. An ally becomes willing to:

  • Educate oneself on the full scope of corporate pharmaceutical influence in government, academia, healthcare (including front groups), and the media;
  • Listen to and learn from the stories of people who have experienced harms;
  • Examine one’s own beliefs, prejudices, and assumptions about medical and mental healthcare systems, and the role of pharmaceuticals and pharmaceutical companies in healthcare;
  • Recognize potential feelings of guilt, shame, and defensiveness and work toward understanding what might lay beneath them, taking time to grieve/heal as part of the process;
  • Learn strategies for challenging the speech, behaviors, policies, and institutional structures that perpetuate iatrogenic outcomes via pharmaceutical influence;
  • Act collaboratively with survivors to change the systems that support pharmaceutical rape and pharmaceutical rape culture.

Hubs for support and activism

The RxISK Community

RxISK is an organization committed to breaking the silence around the social injustice of pharmaceutical violation. It is a go-to website for reporting and researching the adverse effects of medicines for patients, healthcare providers, and pharmacists. It is also a place where people can tell their stories, find support, and learn from the stories of others. The Data Based Medicine organization that sponsors RxISK was formed by an international team of medical experts who recognize the dangers inherent in medicine when public access to clinical trial data has not been granted by the multinational pharmaceutical companies. RxISK is a free, independent drug safety website where prescription drugs can be researched to see what side-effects have been reported in the 5.9 million reports submitted to the FDA, Health Canada, and RxISK. Users are able to download a RxISK Report to take to their doctors to discuss whether the effects they are experiencing might be linked to the prescriptions they are taking.

Mad In America

The Mad In America (MIA) Online Forum was launched in 2012 and is a growing international community of people interested in a plethora of topics surrounding the rethinking of psychiatry, including psychiatry’s embrace of medication prescribing. Central to MIA’s mission is to provide a platform for the voices of those with lived experience within psychiatry, voices that have historically been stifled. MIA offers professional continuing education (CEUs) and continuing medical education (CME) courses that are based on research that is free from commercial interests. Topic areas include psychiatric medications, long-term effects, and alternatives that promote long-term recovery and better overall outcomes. The project operates under the non-profit umbrella of The Foundation for Excellence in Mental Health Care.

Grief Recovery Institute Educational Foundation

The Grief Recovery Institute Educational Foundation (GRIEF) is a 501(c)(3) organization specializing in helping people who are dealing with grief. The organization is headquartered in Sherman Oaks, California, with locations in Canada, England and Sweden. Its mission focuses on disseminating accurate and helpful information about grief and the possibility of recovery from the impact of death, divorce, and other significant emotional losses. Grief Recovery outreach programs are facilitated by individuals who become certified specialists in this particular method and groups can be made available in all parts of the world.

Because the Institute’s founders, John James and Russell Friedman, recognize that sadness and grief are predictable and natural human responses to loss, they have spoken out against the medicalization of grief that often leads to the use of pharmacological treatments soon after a loss.

I include Grief Recovery here because of the significant losses many of us have experienced as a result of taking prescribed medications: the loss of health, loved ones, careers, dreams, trust, sense of safety, and more. Whether through the Grief Recovery Institute or some other method, it’s important that we take time to grieve. By joining with others who are also grieving we break our isolation and, not insignificantly, our sharing may inform others of risks in medicine everyone deserves to know about. 

Pharmaceutical Rape: Discrimination

Papilla Estela by Remedios Varo

Ed Note: This is the fifth and penultimate post in Laurie Oakley’s Pharmaceutical Rape series.

Pharmaceutical violence is a social injustice that can intersect with every other type of oppression and form of discrimination. Dehumanizing in its own right, pharmaceutical rape (and the cultural/medical denial of it) compounds the distress already experienced by persons in socially marginalized groups as well as in individuals who are dependent, frail, or otherwise in their most vulnerable states. Many (but not all) who experience other forms of institutionalized oppression turn to healthcare systems where they are too often subject to retraumatization and further stigmatization.

This includes:

  • Women – Pharmaceutical harms could be considered a structural form of violence against women alongside domestic violence and sexual assault. Women are specifically targeted with advertising for SSRI anti-depressants marketed as several different medications (that are not outwardly identified as SSRI’s) for common issues such as premenstrual discomfort and hot flashes. Certain birth control products, hormone replacement therapy drugs, medications to prevent osteoporosis, and other medications are encouraged for widespread, routine use while the FDA’s post-marketing surveillance system (MedWatch) is failing. Risks of harm are therefore downplayed and patient reports of harms are often met with skepticism. The life-injuries resulting from cavalier prescribing practices, and especially the systemic denial and trivialization of harms, have a deleterious effect on women, and reinforce the overall oppression of women in society.
  • Pregnant Women (and the unborn) – Anti-depressant use in pregnancy is known to double the risk for miscarriage and to cause birth abnormalities. These risks are downplayed and anti-depressants are routinely prescribed to pregnant women. Narcotics are also commonly prescribed to women for pregnancy-related back pain leading to neonatal complications for newborns. Where adverse-effects of medications are haphazardly overlooked while prescribing is encouraged, gross physical violation is occurring. Industry failure to disclose known drug dangers affecting the unborn child can be considered a covert attack against the bodies of women and children for the purposes of monetary gratification.
  • Children – The widespread and routine, off-label prescribing of psychiatric medications to children when no tests have been performed in this population results in pharmaceutical injury that is difficult to quantify. While some harms are obvious, the full effects of these drugs on large numbers of children in their crucial stages of development are unknown. In 2009, approximately 1% of children in the general population in the U.S. were prescribed psychotrophic medicines for conditions like attention deficit disorder and depression; 2% of children in families receiving Medicaid were prescribed these drugs, compared to an estimated 12 to 13% of children in the foster care system who are medicated with powerful antipsychotics and other mind-altering medicines. Since 2009, these numbers have only continued to rise. This structured pattern of chemically treating the emotions of children in lieu of alternatives (such as seeking to understand the root of behavior and supporting children non-pharmaceutically), constitutes a form of child abuse that is a moral injury to individuals, their families, as well as to whole societies. A critical mind will also note that all children are being targeted with an ever growing list of vaccination requirements that are developed by and financially lucrative for the industry-government-medical trade alliance that is routinely failing to warn the public and patients about known, significant risks.
  • Individuals with Disability – Pharmaceutical violation against the disability population is common as the medicalization of disability has led to increased prescribing in this subset. Societal structures and attitudes toward disability impose daunting barriers that these individuals struggle against daily. Pharmaceutical harms add to the struggle and impair one’s ability to address these and other institutionalized oppressions. Those with developmental disability in particular are subject to the systemic, gross overprescribing of psychiatric and other drugs that can tragically end one’s quality of life and in many cases lead to an early death.
  • Persons of Minority Race or Ethnicity – Racial and ethnic minorities within the dominant society are subject to institutionalized oppression that can result in profound, insidious trauma. Both obvious and not-so-obvious aggressions have significant health effects for individuals who end up in medical and mental healthcare systems where many receive additional blows. Unacknowledged pharmaceutical violation is a compounding factor in the physical and psychic trauma affecting minorities. It lends to the further destruction of family and community bonds that are essential for addressing and healing from massive social injustices.
  • Persons Identifying under the LGBTQIA Umbrella – Inequity and discrimination affecting transgender and gender non-conforming people make them particularly vulnerable for multiple types of structural violence, including pharmaceutical violation. Familial and/or societal rejections culminate in both physical and mental health consequences for which individuals are often prescribed medications. Many are further disempowered by adverse out-comes while receiving medical treatments. This often unrecognized harm has an overall dampening effect on the collective health and political will necessary for group members’ ongoing struggle for social justice and equality.
  • The Elderly – Persons become increasingly vulnerable with age: many older people face neglect, risks of elder abuse, and exploitation. The systemic prescribing of multiple medications (polypharmacy) in this population amounts to an additional serious form of abuse that is rampant and ongoing. Many lives are severely altered and/or prematurely ended by such prescribing. Though medications like anti-psychotics and benzodiazepines are known to put the elderly at risk, these and other questionable drug treatments are still being used at alarming rates. Serious abuses in their own right, these practices make the elderly (if they survive) more vulnerable to all other risks.
  • The Incarcerated (including nursing facilities and psychiatric hospitals) — Pharmaceutical rape in institutional settings is especially insidious as power imbalances are intensified and harms are often delivered through systemic coercion and forced medicating. Medication compliance is often a requirement for one to be considered to have “good behavior.” Many elderly in nursing facilities have been routinely prescribed dangerous, antipsychotic medications to control behaviors for the convenience of agency staff. Psychiatric survivors tell harrowing stories of having to endure the adverse effects of psychiatric drugs (including discontinuation syndromes after cessation) when medications have been forced upon them in institutionalized settings.
  • Persons labeled Mentally Ill (including victims/survivors of other abuses or violence) – Those who are prescribed psychiatric drugs are generally the hardest hit by pharmaceutical violence. Psychiatric drugs often have effects on cognition that make it difficult for the person to recognize the full scope of what is happening to them. Many are lost in mental healthcare systems for years while suffering the effects of multiple drugs. The stigma attached to being labeled with mental illness often causes one to lose esteem in the eyes of society, medical professionals, and even family members who may deem one less credible. This dehumanizing reality locks an individual into a cycle of further distress and additional treatments with psycho-tropic medications. Tragically, many feel helpless to address this injustice as these medications can wreak havoc on the mind and body, therefore leaving one with little agency with which to advocate for change.
  • Disabled Veterans – Prescribing rates are high for active military members and veterans alike as doctors attempt to treat service related conditions like chronic pain and post-traumatic stress. There have been serious concerns about sky-rocketing suicide rates in returning veterans in connection with high levels of psychotropic drug prescribing as well as concerns about the over-prescription of powerful narcotics in the absence of offering alternatives. Many veterans who had looked forward to returning to the safety of home have ended up spending their post-active duty years overwhelmed with effects of medications.
  • Men with “Middle Age” Issues – While not a minority group, it is worth mentioning that drugs developed and targeted to men dealing with things such as hair loss and erectile dysfunction can carry significant risks that cause damage far exceeding the original problem. For instance, Propecia (finasteride) has led to permanent sexual dysfunction in some individuals. A recent study strongly suggests that men who take drugs like Viagra for sexual performance have a doubled risk of developing malignant melanoma, an aggressive skin cancer. Too often, the dangers of these medications become clear years after they have been approved for use, which is too late for many individuals.
  • Participants in Clinical Trials – Again, not a minority group per se, however those who participate in pharmaceutical research studies pay for the advancement of science with their health and sometimes with their very lives. The violation occurs when the clinical trial data gained from those harms is altered or hidden in favor of more positive data. This positively spun science is then used to get medicines approved and widely prescribed to the general public. The flagrant mishandling of scientific data, from tampering in clinical trials to its central role in the ongoing education of doctors, is the very back-bone of pharmaceutical rape.

Industry decision makers and those who collude with them deflect attention from the systemic practices that lead to pharmaceutical rape by pointing to the life-enhancing and lifesaving potential of treatments that have been developed to benefit millions. It is true that nearly all of us have benefited from the innovations of modern medicine. It is also true that a failure of adequate warning, as well as system-wide refusal to acknowledge common adverse outcomes, has led to destructive, life-altering consequences for millions. Those who are injured have become a hidden class, a forgotten and often persecuted minority. Given that so many had been seeking relief from the effects of other oppression and marginalization, this constitutes nothing less than a reprehensible humanitarian disaster. Meanwhile, the medically privileged do not have to think about the ways the systems that benefit them deliver life-altering outcomes to others, and this willful oblivion is the basis upon which all social injustice thrives. While this type of injury can happen to anyone, it is not always recognized when medication is making one sick.

Internalization of pharmaceutical oppression

Internalization occurs when people who experience adverse events believe in the misdiagnoses of their symptoms and end up embracing additional labels and further treatment for their medication side-effects. Those who have internalized pharmaceutical oppression alter their attitudes, behaviors, speech, and self-concept to reflect an acceptance of a pharmaceutically-induced and medically-maintained sick role. The internalization of this manufactured reality can create low self-esteem, self-doubt, and even self-loathing as the individual continues to experience perpetual and worsening illness despite one’s commitment and efforts to become well. (Especially true with diagnoses of a stigmatizing nature, e.g. psychiatric labels). Internalization of pharmaceutical oppression can also be projected outward as fear, criticism, and distrust of survivors and others who speak out and/or challenge the systems in which they receive care.

Statistics

Peter Gøtzsche, co-founder of the Nordic Cochrane Collaboration in Denmark, the world’s foremost body in assessing medical evidence, has estimated that adverse-effects of medications that are used as prescribed are the third leading cause of death in the United States and Canada after heart disease and cancer. Known cases are believed to account for hundreds of thousands of deaths each year.

Serious harm seems to be 10 to 20 fold more common than lethal harm. An estimated 700,000 events are reported per year, less than one third of the estimated actual occurrences. While drug side effects are said to be a leading cause of death, disability and illness, it is estimated that only 1 – 10 percent of adverse events are ever reported.

Reporting

The FDA’s post-marketing surveillance system is underused, underfunded and in serious disarray. While MedWatch is said to be an important tool for monitoring the effects of medications after limited studies and quick FDA approval, doctors are not trained to utilize this as an important aspect of their work. Only 1 to 10 percent of adverse-effects are ever reported. Reasons doctors cite for not reporting include uncertainty as to whether the drug caused the symptoms, not wanting to look foolish for reporting, and a feeling that they are already too busy. Because the missing information does not get shared and acted upon within the medical system, patients end up reporting to one another “underground” via internet message boards and other forums set up to support patients who cannot find help within medical and mental healthcare systems.

Investigating

When an individual reports a life-altering outcome, very rarely is there any kind of investigation. Pharmaceutical injuries that are not denied as such are simply regarded as flukes or mistakes. There has been no effort made for a serious and thorough investigation into the systems-wide problems that enable and encourage widespread pharmaceutical harms. No governmental task force or entity has taken responsibility for uncovering the full extent of the problem, advocated for the passing of legislation, or for any other changes to address these ongoing harms. Instead, pharmaceutical companies are occasionally found guilty of various errors, are made to pay fines, and then go on to rape again and again.

Prosecution and conviction

Justice is rare to non-existent for victims of pharmaceutical violence. Legal actions to date have done little to significantly alter the industry-government-medical behavior that is so devastating to individual patients and their families. The structured practices that systemically deliver harms remain in place while drug companies pay occasional fines and continue to earn billions.

Prevention

Currently there is nothing in place for the prevention of widespread pharmaceutical harms. Despite the appearance of drug industry cooperation, efforts for prevention via full transparency in the sharing of clinical trial data have been met with resistance by pharmaceutical companies. For this and other reasons, the process of informed consent in the medical setting fails. Alternatives to drugs, devices, and medical procedures are not lucrative options from a business standpoint and so doctors, by and large, have little incentive to focus on the safer alternatives they could be offering patients.

Treatment

There are no systems in place for treating those who report harms. Treatment begins with listening and recognition. Medical systems in denial currently offer victims very little in the way of validation, let alone knowledgeable and compassionate care. Many of these manufactured illness require immediate medical intervention which is sadly non-existent in most places. Person-centered protocols for discontinuing psychiatric medications are urgently needed for patients who want and/or need to stop taking them. Many mainstream doctors remain unaware of the dependency potential of several medications they routinely prescribe.

Pharmaceutical Rape: Doctors still know best

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Editorial Note: This is part 4 of Laurie Oakley’s series on Pharmaceutical Rape.

Many who experience life-altering, adverse outcomes after taking their medicines as prescribed do not receive acknowledgment of what they have experienced, let alone the medical care they need. Medical systems do not recognize many treatment related outcomes and patients are therefore denied knowledgeable, compassionate treatment for the iatrogenic illnesses they experience after following doctors orders. While health practitioners can generally make a good living within healthcare systems, thousands of patients end up on disability after adverse pharmaceutical outcomes. Without the support of a doctor to verify one’s condition, there are others who, tragically, end up on the streets.

Pharmaceutical privilege

The privilege of one who benefits within a system that uses pharmaceutical products to improve one’s own life and well-being while denying or remaining oblivious to harms suffered by others within same system.

Pharmaceutical oppression

Deriving benefit from and/or being complicit with healthcare systems while refusing to consider or acknowledge pharmaceutical harms suffered by others; routinely ignoring, denying, and/or explaining away harms reported by others.

Medical fragility

In regard to pharmaceutical rape, this is an emotionally reactive, often arrogant stance that is taken when an individual (medical professional or otherwise) is exposed to suggestions of widespread iatrogenic drug induced harms. It is defensiveness on the part of the individual who often exhibits behaviors that include automatic skepticism, extreme unease, an unwillingness to listen, impatience, condescension, anger and argumentativeness.

Persons who demonstrate this fragility are unable to consider or acknowledge a medical reality that challenges a status quo that benefits them. They automatically discount information or ideas that make them uncomfortable and often attack those who are making claims. This stance is rooted in deeply ingrained ideas about the power of science and the prestige of the medical profession, as well as in the “goodness” of modern medicine. For many, one’s very identity as a doctor or as a patient depends upon viewing the systems in which one gives or receives care as safe places of care. Reflecting on or seriously considering the many ways people are harmed by pharmaceutical products is intolerable, as one believes these kinds of things “just don’t happen” in modern medicine.

Medical professionals who think in this way dissociate themselves from the idea of systemic, iatrogenic harms, and instead think of the injuries they do recognize as solitary incidents resulting from the “bad” behavior of others (whether the patient, drug industry or other medical professional). Doctors tend to be high achievers with a perfectionist bent. While attaining the high degree of competency required to practice medicine, many also acquire a deep sense of earned superiority. Any challenge to this core identity, or to the systems in which one is enmeshed, is intolerable.

Story: doctors in denial

I never set out to become a medical heretic. That job was ascribed to me by certain pharmaceuticals that are said to work wonders for the majority of the human race, but not for me: miracle drugs like the SSRI anti-depressants and the ever safe benzodiazepines. So when I described to doctors all that had happened to me while on these medications, most stared at me as if I’d just grown a second head. My report, it seemed, was over-the-top.

One doctor congratulated me for kicking my “benzo habit” even though I had told her I’d taken only a small dose as prescribed by my doctor. When I tried to explain how tolerance withdrawal symptoms had been repeatedly misdiagnosed as somatization, and for that I had been given more psychiatric drugs over a period of several years while my physical and mental health deteriorated, she may as well have plugged her ears and shouted, la la la la la! Instead, she said, “uh huh,” before opening my chart and recording my history with benzodiazepines in the illicit drug use category.

After she left the agency, I started seeing a different doctor who listened to my stories in utter amazement. My experience was unlike anything he had ever heard in his many years of prescribing psychotropic medications. When I suggested that my ongoing, chronic insomnia might be a residual effect from having been prescribed a benzodiazepine for eight full years, he responded by saying there was no way of knowing for sure, and at one point even asked, if the benzodiazepine had helped me to sleep, why didn’t I just keep taking it?

Time for a new doctor.

I jumped from the frying pan into the fire. This new psychiatrist had a penchant for sighing and rarely looked at me. He mostly just shuffled papers and wrote things down. He wasn’t interested in knowing what my experiences with medications had been, my complex history, or anything else about me. He was interested in prescribing a certain medication for my insomnia which he pushed even after I had educated myself about side-effects and informed him I didn’t want to risk it. I did finally end up trying the medicine, which I didn’t like and didn’t continue. Then his impatience with me turned into disgust as he no doubt thought my fear of taking medications was irrational. He went on to tell me that millions of dollars and years of study went into the research and development of the drugs he prescribed and he was confident that they were safe.

—Rxisk. January 13, 2015

Pharmaceutical rape apology

An umbrella term for arguments suggesting that serious pharmaceutical violation does not exist or that it is not a widespread cause for concern. “Apology” in this context means defense or justification, like in Christian apologetics, not as a statement expressing regret.

Pharmaceutical rape apologists frequently view patients and doctors who recognize serious adverse events as misguided persons who are anti-science, conspiracy theorists, anti-vaccinationists, or some other type of deviant. Pharmaceutical rape apologists disbelieve pharmaceutical harms because evidence of harm is not forthcoming in the scientific literature. They deny any adverse outcome that does not conform with harms already commonly noted within the medical establishment, and dismiss reports of adverse effects when they have witnessed the drug in question work well for others.

Pharmaceutical violations are dramatically under-recognized. There is an enormous amount of misunderstanding and stigma associated with people who claim to have been harmed. Physician skepticism and outright denial prevents victims from having their claims validated, let alone officially reported to regulatory agencies. Instead of gaining support from a doctor to make sense of what has occurred, adverse effects are often trivialized or misdiagnosed as separate conditions (usually needing additional treatments).

Allegations of false reporting of injury often occur (within the realm of childhood vaccine administration, for instance). The medical establishment maintains that most pharmaceuticals, with rare exception, are safe and effective when taken as prescribed. There is very little room left for discussion of even the known risks of harm. Serious adverse events are said to be “rare,” yet when they occur, victims and/or their families often find it difficult if not impossible to convince medical authorities that the event is related to medication.

Pharmaceutical rape myths

  • The FDA protects the public.
  • Drug safety is assured through hard science.
  • Doctors have access to clinical trial data and are aware of all known risks.
  • Serious adverse events are extremely rare.
  • Development of drug dependence or addiction is unrelated to accepted prescribing protocols.
  • Adverse events are always recognized by doctors and a connection to the drug is normally made.
  • Harmful drugs are always recalled.
  • “Safe” drugs are always safe.
  • Pharmaceutical injury occurs only as a result of medication error or malpractice.
  • All vaccines are completely safe and effective.
  • A good relationship with one’s doctor protects one from a pharmaceutical injury.
  • Individuals who make claims about pharmaceutical harms are against all medications and do not value the contribution of pharmaceuticals to society.
  • Those who warn about pharmaceutical products are anti-science, refusing to listen to reason or to think rationally.

Secondary victimization

Secondary victimization is the re-traumatization of the pharmaceutically injured through negative social responses from medical, mental health and/or legal professionals, as well as from others (sometimes including one’s own family). This is a nearly universal experience for those who have been harmed and may be especially insidious for those who are diagnosed with mental illness, chemical dependency, as well as the vaccine injured (and their families). Behaviors associated with secondary victimization include:

  • Societal as well as individual denial of pharmaceutical harms. The tendency to remain oblivious in the face of evidence of harm.
  • The trivialization of pharmaceutical violation. A response to harm denying that real damage was done.
  • Skepticism and distrust of those who report harms instead of recognizing the harm potential of the treatment.
  • The misdiagnosis and false labeling of individuals who have experienced adverse effects from their medicine.
  • Reducing the patient to an “unusual anecdote.” Accepting evidence from controlled clinical trials only, to the exclusion of what the patient says about effects of a drug treatment.
  • Failure to report a patient’s adverse events.
  • Victim blaming: when the victim of a crime or any wrongful act is held entirely or partially responsible for that harm. It is your fault you were hurt because you did x, y, z. If you hadn’t done x, y, z, you would not have been harmed. You went to the doctor, you asked for medication, you consented to the treatment, you kept going back to the doctor, you didn’t do your homework, you should have known better, you should have listened to your body, I knew better and I didn’t do those things.
  • or, what you experience is your own illness: caused your poor diet, your lifestyle, your lack of exercise, your use of alcohol or other drugs, your age, your family genetics, etc. Claims are easily neutralized or discredited because health is subjective and adverse effects are easily attributed to other causes.
  • or, you are at fault because you are a drug addict, (even though the addiction came about through or was aided by what is considered legitimate prescribing).

Pharmaceutical violence typically leaves the individual with an array of new problems that were not present when the treatment in question was first initiated. Many hurtfully deny or disbelieve the iatrogenic nature of the person’s condition, and additional physical and/or mental effects caused by treatments often bring about additional stigmatization. The alienation suffered as a result of these acts is deeply felt:

“I am a wreck after 8 years on Effexor, but of course once on the drugs your credibility is gone, so who listens to a person with a psychiatric “label” even though the label is false? Not only victims, we are totally ignored, while the psychiatrists somehow get put on a [false] pedestal. Challenge them at your own risk of getting a “label.” No other doctors on earth have this sort of irrational power; just because they judge someone as this or that, often in a 10 minute appointment. I would like to know of just one person who ever went to a psychiatrist and didn’t get [labeled].”

—Commenter, DavidHealy.org. May 14, 2015

Post traumatic stress reactions and pharmaceutical violation

Unlike sexual rape, pharmaceutical violations almost always occur over a more prolonged period of time. Where a sexual assault survivor may experience a post traumatic stress reaction in the months and/or years following the event, pharmaceutical victims oftentimes experience these physical and psychological symptoms as adverse-effects while taking psychotrophic medications. Prolonged discontinuation syndromes upon stopping some medications are common and may overlap with a post-traumatic stress reaction from taking psychotropics. The trauma experienced from pharmaceutical violation can include disruptions to normal physical, mental, emotional, cognitive, and interpersonal behavior. Whether from a discontinuation syndrome or from the medications themselves (which are often reinstated to avoid this withdrawal-like condition), pharmaceutical survivors end up suffering, often for many years, with symptoms identical to PTSD.

Effects associated with both sexual rape and pharmaceutical violation include but are not limited to:

  • Diminished alertness
  • Numbness
  • Dulled sensory, affective and memory functions
  • Disorganized thought content
  • Vomiting
  • Nausea
  • Paralyzing anxiety
  • Pronounced internal tremor
  • Hysteria, confusion and crying
  • Bewilderment
  • Acute sensitivity to the reaction of other people
  • Profound inner turmoil
  • Poor health in general
  • Sense of helplessness
  • Hypervigilance
  • Inability to maintain previously close relationships
  • Experiencing a general response of nervousness known as the “startle response”
  • Persistent fear and or depression at much higher rates than the general population
  • Mood swings from relatively happy to depression or anger
  • Extreme anger and hostility
  • Sleep disturbances such as vivid dreams and recurring nightmares
  • Insomnia, wakefulness, night terrors
  • Flashbacks
  • Dissociation
  • Panic attacks
  • Reliance on coping mechanisms, some of which may be beneficial (e.g., philosophy and family support), and others that may ultimately be counterproductive (e.g., self-harm, drug or alcohol abuse)
  • Sense of personal security or safety is damaged
  • Feel hesitant to enter new relationships
  • Unable to re-establish normal sexual function
  • Discontinue previously active involvements, social groups
  • Acute somatoform disorders (physical symptoms with no identifiable cause)
  • Physiological reactions such as tension headaches, fatigue, general feelings of soreness or localized pain in areas of the body
  • Dissociation and trying to get back to life before the assault
  • Fears and phobias
  • Nightmares, night terrors
  • Violent fantasies of revenge may arise
  • A fear of being in crowds
  • A fear of being left alone anywhere
  • A fear of going out at all, agoraphobia
  • Paranoia
  • Suicide

Oliver’s story

Prior to taking Seroxat (Paxil), I had symptoms of tiredness and nausea. My general practitioner (GP) diagnosed me with anxiety and prescribed an anti-psychotic drug. Within 3 days I couldn’t eat or sleep due to severe agitation. I was vomiting, pacing the floors, and crying uncontrollably. My GP diagnosed this as an anxious state and started me on Seroxat. (During this time it was discovered that I was badly anemic and needed a hysterectomy due to severe blood loss. This was more than likely the cause of the original tiredness and nausea). Even though I had informed my GP of heavy bleeding, etc., it seemed easier for him to give my symptoms a label of anxiety and start me on a roller coaster of dangerous psychiatric drugs .

I remained on Seroxat for 6 years as every follow up I was just given more prescriptions. I decided to take myself off the drugs during my 6 years of use with disastrous consequences. I became obsessed with trying to hang myself and couldn’t function due to multiple horrendous symptoms, both mental and physical. Needless to say, I admitted myself to hospital as I had no idea what was happening to me. [I] felt better after Seroxat was reinstated.

I then decided to wean off again with instructions from my GP to taper for 9 months using alternate days[…]That was September 2004. I am now 8 years drug free and still living with damage incurred from taking Seroxat. The first 3 years of quitting were hell. Symptoms included anxiety, panic attacks, paranoia, agoraphobia, hives, itching, tingling, agitation, aggression, suicidal thoughts, homicidal thoughts, weak muscles, vision coordination issues, cognitive problems, dizziness, nausea, headaches, manic behaviour, racing thoughts, gastric upset, balance problems, burning sensations, heartbeat irregularities, palpitations, night sweats, insomnia, and total feelings of despair.

Eight years later to date I still have all these symptoms randomly. They come and they go, and although not as intense as the first years, it still gets pretty scary at times. Is this anything like prior to taking the drugs? No. I felt tired and nauseous. Was it worth taking this drug? No. The side effects of insomnia, muscle pain, blurred vision, weight gain, and feeling null and void of everything was worth nothing. Zero. Zilch. Will I ever recover? Who knows? GP’s offer no validation or support. Will anyone be accountable for the damage I have? No. Everything is denied.

—Rxisk.org. August 29, 2012