Editorial: I was asked to MHRA (Britain’s FDA) to give a 20 minute presentation on Spontaneous Reporting Systems to a group looking at a birth defect related issue. This is close to what was said – minor items like the HRT trials got lost in delivery. The Slides numbered in the text are attached Here.
Are we anecdotes?
On this first slide (1) you can see a recent article from Vice, which along with other new media outlets often offers better reporting on a range of issues from the Islamic Caliphate to healthcare than traditional media. This article on Pfizer’s varenicline – Champix in the UK and Chantix in the US – runs to 10 pages with great illustrations.
The piece outlines the case of Chris Kunkel who went on Champix to stop smoking. He found that it killed the craving for nicotine very effectively. But after being on the drug for a few weeks an urge to kill himself came over him just like the urge to go and get a sandwich from the fridge. He took a huge number of pills but survived because his wife came home early and found him. He had no prior history of mental illness, no reason to think he was going to commit suicide. His case. as outlined, was convincing.
The article makes it clear that there have been thousands of other spontaneous reports like this that appear to make a strong case. But the article also makes clear there are a large number of Randomized Controlled Trials (RCTs) that have been meta-analysed by Pfizer which show no signal of an increased rate of suicidal or homicidal events on Champix. When these studies are analysed by experts independent of Pfizer, they too have found no evidence of a linkage.
This leaves independent experts saying that they as scientists have no option but to go with what the scientific literature shows. That the Chris Kunkel and other cases are simply anecdotes. It’s just as though someone gave an MMR vaccine to one of their children who later develops autism and claimed that the vaccine must have caused the problem. This is anecdotal.
Lightbulb moments
These are anecdotes is not a reasonable characterization of many of the reports of what happened on Champix and it is not the case with drug induced injuries in general.
The strongest evidence we have as to whether a drug causes a problem does not come from RCTs or any other controlled study but rather from good clinical accounts which include the elements of challenge, dechallenge and rechallenge.
This is the ‘Christmas tree light bulb’ test (2). When Christmas trees had real light bulbs rather than diodes, invariably when they were taken down after being stored for a year the lights didn’t work. The trick was to unscrew each bulb in turn until you unscrewed one and the bulbs came on. You could screw that back in again and the bulbs would go off again. So you removed it and threw it away and the lights worked fine. This is absolutely conclusive evidence that this was the dud bulb. Similar evidence is the strongest we have that a drug can cause a problem. It doesn’t tell us how often the drug causes the problem but nothing gives us this information.
The trouble is challenge – dechallenge – rechallenge cannot be undertaken easily in the cases of drugs given during pregnancy. It is against that background that companies claim that RCTs offer the only gold standard. That all other kinds of observational studies are flawed.
RCTs: The gold standard way to hide adverse events
Some of you may be aware of the Restoring Study 329 article that appeared in the BMJ 3 months ago. It is now among the articles with the highest impact of any article in the last 25,000 that the BMJ has published (3).
This illustration (4) taken from the article shows you at the bottom under the heading Keller et al what the original publication reported in terms of the suicidal events that happened in this trial of paroxetine given to adolescents.
In the box above it labelled SKB, SKB some years later conceded that there were more suicidal events than had appeared in the published article. In the box above that labelled FDA you see FDA stating that in fact they were of the opinion that there were more such events than GSK had now reported to them.
Finally in the box at the top labelled RIAT you see that in our publication we were of the view that there were yet more events than the ones FDA had found and in fact we think there are even more than what we’ve reported here.
This may hint at one reason why when experts analyse the Champix clinical trials they don’t find an increased risk. They are analysing the published literature for the most part and the published literature doesn’t necessarily show all that happened. The Study Reports companies increasingly post on websites do not offer the full data either.
On this next slide labelled Box 2 (5) you see some of the many ways we found that data can be hidden in controlled trials.
- The company may use an idiosyncratic coding system. In the case of Study 329 they coded the suicidal events as emotional lability.
- There can be a failure to transcribe the raw data into the forms then used to analyse what happened – 15% of the events went missing in this way.
- There are various different ways to group the events that may hide the problem from an outsider who is unaware of the issues and not especially motivated to look more closely.
- In the trials of many drugs from statins to antidepressants, it is common that concomitant drugs will be given to both the active treatment and the placebo groups and this dilutes any apparent signal from the active treatment.
- There is usually no effort to analyse the events that happen during the taper phase of a trial – often the most dangerous phase.
Even if done by angels
But even if the trials were done by angels, so there was no hiding, no miscoding, nothing untoward, RCTs can still hide adverse events. In the case of the Champix studies it may be that plunging people into nicotine withdrawal is a dangerous thing to do and that compared with that Champix treatment comes up as being somewhat better even if Champix itself can cause people to become suicidal.
Is this bizarre possibility possible? Yes it is. You see here the proceedings of a symposium held in Cambridge in 1959 a year after imipramine the first antidepressant was launched. On the next two slides you see delegates to the meeting talking about the fact that imipramine which treated the kinds of patients that would otherwise have been referred for ECT, severely depressed patients, could in the opinion of these clinicians also cause people to become agitated and suicidal and that the problem cleared up once the drug was removed. I can show you more quotes than the ones you see here but there was no argument from anyone at the meeting against the notion that this wonderfully helpful drug could also cause people to become suicidal (6, 7, 8).
That sets up the scenario you see in this next slide which is that if imipramine is an effective treatment for severe depression in the way that the SSRIs for example aren’t, then it will reduce the rates of suicidal events that happen in this trial compared to placebo even though it’s a drug that can cause people to have a suicidal event (9). If you were to put imipramine into the kind of trials that the SSRIs were put into, that is trials of patients with mild depression, you get the same result as you get with the SSRIs – namely that on the active treatment there is an increased rate of suicidal events compared to placebo (10).
This kind of problem happens every time an illness and a drug can cause a superficially similar thing. It means that controlled trials are not a good way to discover whether a drug is causing a problem or not (11).
I could show you a range of other tricks that companies can do with controlled trials. There are several ways to use the problem a drug causes to hide the problem that the drug might be causing.
The basic message on this Fishing slide is that if you don’t know what the problem is to begin with, RCTs won’t help you. RCTs are principally useful when you know what you are doing in the first instance and they are used to demonstrate that you know what you are doing (12).
Even then they may come up with the wrong answer but as in the case of the HRT studies where they suggested that it might not be a good idea for everybody in the entire universe to be taking HRT, even if the answer is wrong it puts the onus back where it should be which is on large and powerful corporations who have a lot of resources to pinpoint the populations where the benefit is likely to exceed the risk if they want to continue to make money out of vulnerable people.
Observational studies
So if controlled trials don’t sort the issue out for us as to whether a drug causes a problem, what are the other options? There are a variety of case controlled studies, cohort studies and nested cohort studies.
In the case of SSRIs and autistic spectrum disorder (ASD) there are 5 such studies as you see here (13). When you analyse these you find that there is an almost two fold increase in the risk of a mother having a baby with ASD when she has been on an SSRI compared to when she has not been on an SSRI.
The standard company response to data like you see here is that in a few of the studies the confidence intervals touch the 1.0 line and their view is that because they do that there’s no increase in risk in these studies and because we have a mixture of studies some of which show an increase in risk and others which show no increase in risk, therefore in fact there is no problem.
On the next slide you see 17 studies which have looked at what could be termed developmental delay (14). I’ll just quickly draw your attention to the Malm et al study 7 lines down.
Broadly speaking when you sum all of these studies, you get a result which shows that there is a close to a doubling of the rate of developmental delay in children born to women taking SSRIs during pregnancy.
On the next slide you see a very provocative image of holocaust denialism (15). Texts like this ask you to note that General Eisenhower wrote a 600 page book about events from June 1944 through to the end of the War and didn’t once mention concentration camps. Do you think that if what people claim was really happening that he wouldn’t have mentioned it?
The issue here is not to impute motives of Holocaust Denialism to companies but to show you how a problem can be structured so that that is the de facto outcome you get.
Faced with a problem like ASD companies convene panels of experts within the company – the epidemiology group, the animal testing group, the pharmacological group, the pharmacovigilance group, the risk management group and others – all of whom will be given a portion of the problem to look at from their point of view. All groups are asked is there incontrovertible evidence from your point of view of a problem. All will answer no there isn’t. This is a system where it’s almost impossible for a problem to register.
The person coordinating this will often be a person who knows nothing about any of these areas. Their job is to coordinate. When faced with for instance evidence of the developmental delay studies this coordinator if asked whether it would be appropriate to include studies of developmental delay with the ASD studies would say “Well, we didn’t do that”.
Why not? “My brief was to only look at studies that had ASD specified in the article.
Do you not think that developmental delay is much the same thing? “I don’t know. I know nothing about these things, we simply stuck to articles that had ASD in their body”.
This is standard company approach and may explain what researchers find when they go into company archives and seem to be faced with overwhelming evidence that the company knew there was a problem but denied all knowledge.
A structure of this kind is put in place in the name of Objectivity. In practice it makes it impossible for the company to see the bigger picture.
In public when a company is faced with the data from the previous slides for ASD or any problem. They say (16):
- The ASD rate in these studies doesn’t exceed the background rate in the wider population
- There is no evidence that ASD (leaving out neuro-developmental delay (NDD) or that NDD is leaving out ASD) is caused by SSRIs.
- There is no evidence that ASD is caused by Prozac, or by Paxil – Seroxat or by Zoloft and if not caused by any individual SSRI cannot be caused by SSRIs.
- The risks are not statistically significant and therefore do not exist.
- They will claim that depression causes ASD, just like it causes birth defects and suicide and dependence and ingrown toenails.
- They will claim only RCTs give conclusive answers. This unthinking mantra allows companies to get away with a lot.
Registries & objectivity
In terms of adverse events, there is one more option – pregnancy registries. These are a specific birth defect option and arguably the best option. FDA and some companies have put limited registries in place (17). These have been piecemeal and voluntary. To really look at what is going on we need to exploit the possibilities of Big Data. Every woman who gets antenatal care has the details of the pregnancy and every drug she is taking recorded as is, including over the counter medication. If such material were made available in e-form, including data on the children followed out to five or ten years, we would be better able to pinpoint issues than we are now.
Who should analyse the data? A lot depends on your vision of what is needed.
Regulators and companies have been the traditional people to interrogate post marketing data but their brief has never been exploratory (18). The SSRIs have now been on the market 25 years and the data linking them to Developmental Delay is just emerging – when we could have had warnings of this possibility 20 years ago.
For instance, take the Malm et al study that I mentioned earlier. This was a large epidemiological study by a good group of researchers who as a footnote at the end of their article noted a 10 fold increase in Foetal Alcohol Spectrum Disorder (FASD) in children born to women taking SSRIs during pregnancy. They clearly had no idea what to make of this (19).
This incidental finding is exactly the kind of thing that needs someone other than an epidemiologist to spot possible connections. SSRIs can cause compulsive alcoholism, so the Malm finding is not surprising to some of us – including to pharmaceutical companies who are running trials of S2 and S3 blockers as a treatment for alcoholism because they are persuaded the link is solid.
It clearly was a surprise to Malm and would be to most epidemiologists or regulators. Spotting connections like this needs a convergence of different skill sets – exactly the opposite model to the one companies and regulators have in place. For any event that is new, almost by definition, motivation counts for more than expertise as expertise is expertise in what has happened that will often block perceptions of something new that breaks the mold. There is no more motivated group of people in this universe than mothers or mothers to be.
At the heart of the proposal that women should be the main interrogators of pregnancy registry data lies the question of objectivity (20). Objectivity doesn’t come from mechanical exercises like RCTs or case controlled studies. It comes from having the best data you can get and having people with a range of biases look at that data to see if a consensus emerges. The range of “biases” can help a group see why what may appear to be a link really isn’t one and how things that might seem to make no sense initially actually do make sense. It’s when people with different starting points agree that we get objectivity. It comes from just the opposite approach to the one Companies and Regulators take – in the name of objectivity.
It is nineteenth century paternalism to think that women will be scared by some oddity tumbling out of such a database and that they will act rashly as a result. Women as a group spend more time risk managing than men and will look for consensus and operate on the basis of that consensus. Telling women that they shouldn’t have access to this data is rather like telling them that they shouldn’t have control of their own bodies, that men or the state are going to decide for them. This might be the case in the Caliphate but here in London?
David,
I may have misunderstood but I am not sure that if a parent saw their toddler become ill and go in to decline after a vaccination that their observations should be derided anymore than the man who wants to commit suicide after taking Champix. I don’t doubt that SSRIs should be implicated in the rise of autism but we are talking about >x100 and I doubt whether the effect that you have described, while significant, could account for that. Doubling the rate for a sub-group of parents (say 10% of them) won’t get you there. I would say further, that we have to be even more careful institutionally of infants who cannot articulate what’s going on if a medication has a negative effect on them.
As we know there is now a whistleblowing CDC scientist, William Thompson, who wants testify before Congress that they hid in one study carried out in Atlanta a sub-group of African American children, who were three and half times more likely to develop autism having received MMR vaccine before 36 months, and also according to tapes in the same study suppressed a diagnostic sub-group of children who developed “isolated autism” (that is autism without intellectual deficits). Nor was it the only study in which the data was massaged to hide the effect, for instance a notorious one where the co-ordinator between the CDC and Denmark is now on the run for embezzlement and they weighted the vaccinated group by including children who had not yet been vaccinated and children who had not yet been diagnosed.
http://www.ageofautism.com/2014/08/cdc-frauds-connections-between-the-destefano-paper-and-the-thorsen-affair.html
And btw they played exactly the same trick at the CDC with the Verstraeten thimerosal study. Or we have studies in which they matched children who had the vaccine and got autism with children who had the vaccine and didn’t and then concluded that the vaccine didn’t cause autism ie exactly like saying tobacco doesn’t cause lung cancer because not everyone who smokes gets lung cancer.
So, I don’t think the MMR case is a good counter example as something self-evidently ridiculous (but perhaps that wasn’t your intention). We need on the same basis to pay far more attention to what happens to infants and toddlers post vaccination, rather than ignore them (as we’ve been taught) and pay more regard to anyone who reports anything. In the UK anyone who actually listened to parents (as Wakefield did) would most likely end up before the GMC like Wakefield, and that is huge institutional bias.
John
John
There is no implication here that the parent’s obvservations should be disregarded. What I am trying to point out is that just the same observations where they include challenge, dechallenge and rechallenge provide the very strongest evidence there is – stronger than RCTs.
Re MMR – I’m quoting from Vice here – this is how these issues are portrayed in the media
David
“Re MMR – I’m quoting from Vice here – this is how these issues are portrayed in the media”
David, that’s fine. Also we have case with MMR where the child recovered somewhat after the first only to be knocked over the head by the second. I spent a lot time, incidentally, challenging advice on an NHS (MMR the Facts) website to give a second dose when there was a severe reaction to the first.
John
Should read:
“Also we have cases with MMR where the child recovered somewhat after the first dose only to be knocked over the head by the second.”
John, in regards to the second dose of measles, mumps and rubella (MMR) vaccine, according to the manufacturers’ data (GSK and Merck), most seronegative individuals are likely to be immune after the first dose of live MMR vaccine, which can be verified via antibody titre testing, i.e. a blood test.
Since June 2012 I have been arguing that parents should be offered the option of antibody titre testing to check immunity after the first dose of live MMR vaccine, rather than be compelled to have their child arbitrarily revaccinated with a second dose of MMR vaccine.
I have written to Australian politicians, the Australian National Health and Medical Research Council, the Australian Medical Association, the Australian Technical Advisory Group on Immunisation, the US Advisory Committee on Immunization Practices, the Secretary of the US Department of Health and Human Services, and vaccine promoter Paul Offit, plus others, on this matter. (See my webpage with links to my correspondence: http://over-vaccination.net/letters-challenging-over-vaccination/measlesmumpsrubella-mmr-live-vaccine/ )
None of these parties have acted to ensure parents are offered the option of antibody titre testing before arbitrary revaccination with the second dose of live MMR vaccine.
In Australia parents are not advised of the option of antibody titre testing after the first dose of MMR vaccine, and from January 2016 they will be compelled to have the second dose of MMR vaccine for their children to access government benefits, i.e. they are being coerced into having questionable medical interventions for their children.
It is absolutely despicable what is going on, the way in which the right to ‘informed consent’ before the medical intervention of vaccination is being trashed. Where do we turn to get justice on this matter?
For information, my submission on the No Jab, No Pay Bill provides further background: https://drive.google.com/file/d/0B9ZVuVqOGTd5MUtKZzhjSXBPY00/view
I find this a very thought-provoking post. As a retired teacher who taught for almost 40 years, I find the possible link between SSRI use / alcohol dependence and autism/foetal alcohol syndrome fascinating. I recall my first class of 30 seven year olds where one little girl was definitely dyslexic (by today’s standards – unheard of in those days!) and one boy had signs of ADHD (again , by today’s standards). By the time I retired 10 years ago, any given class of 30 pupils would have a good few children with ‘dyslexia type problems’ another good few with ‘attention deficits’ and yet another group would have ‘behavioural problems’. These were apart from a number equivalent to at least 1 per year group in need of a Statement of Special Educational Need. I know 40 years is a long time but something, somewhere was causing these differences in the ability of children to cope within a ‘learning environment’. I have long thought that it has to do with the change in our relationship with alcohol. Drinks seem to have an ever-increasing alcohol content and consumption increases year on year – resulting, in my opinion, in more and more children born with foetal alcohol syndrome. FAS, in turn, is being mis-diagnosed as Autism or ‘Autistic Spectrum Disorder’ (in my opinion). The sooner we learn to be satisfied without the inclusion of ANY of these drugs in our lives the better will be the outcome for our youngsters (again…in my opinion!).
Mary, I can believe why you said that.
I remember a couple of years ago we used to have such good debates on this blog. I remember a good ding dong with Richard Lawhern and then there was Ann-Marie who alerted us to how ssris could develop into alcohol dependence.
The only reason for teachers to learn about children’s disorders is because Pharmaceutical Companies have trained everyone to talk their language and to give their pills for it.
The World Brain Washing Goes on like a Spinning Wheel with Entrapment for All.
The Worlds Biggest Insult to all those harmed by Seroxat/Paroxetine/Paxil in this unapologetic video containing Ben Goldacre with GlaxoSmithKline
https://www.gofundme.com/alltrialsUSA
…..watch it again….and again…and again
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Here is the great conundrum. This video is wonderfully produced. The points it makes are great. But partly because of the slick GSK involvement the prospect opens up that what’s going on is an effort to capture transparency. Tinker, Tailor, Soldier, Spy?
DH
Tinkering, tailoring, soldiering, spying……
https://twitter.com/BenGoldacre
ben goldacre @bengoldacre 13 mins13 minutes ago
Yes. Whereas with http://www.openprescribing.net we have simply delivered a fully working tool for £50k @darkgreener
A short walk through Open Prescribing with Ben Goldacre
University of Oxford
https://openprescribing.net/
I really enjoyed this – and the illustrations – specially “You can take a bureaucrat to papers but can’t make him think”!
A few thoughts: back in the day, the 1950s, psychiatrists were genuinely interested in the unexpected effects of medication (hence noting the adverse effects of imipramine). Certainly my father-in-law, working throughout the 50s and 60s made meticulous records of his patients: their circumstances, symptoms and treatment – including things that surprised him. He was also struggling with the new interest in statistical analysis of treatments: trying to get some basic data about efficacy etc – but was constantly frustrated. Partly with his own mathematical inexperience – but also because frequently he just couldn’t detect anything statistically important, working on such a small scale. But, his observations about which patients benefited (or not) from ECT, for instance, or the fact that many inpatients dropped their medication as soon as they went home because of ‘intolerable side effects’ seem about as objective as you can get.
In terms of gathering data about adverse effects: I never believed that any post marketing reports ever got done – who would make them? No psychiatrist or GP in my experience, particularly if I’m right in thinking that if a side effect (nausea for instance) was already on the Patient Information Sheet there was no obligation to report? (might be wrong about that). Even less likelihood if the doc thought that restlessness, agitation, insomnia and suicidal thoughts were a standard part of the illness. Chicken/egg situation. I was always confused by the mantra that the most dangerous period for suicide was when the patient began to feel better (as a result of the medication) – and thus had the energy to act on the impulse to kill themselves – I could never make sense of that – because, if you really were starting to feel better – surely you wouldn’t want to polish yourself off…..? Or am I missing something.
So, the sheer scale/numbers of known adverse effects will never show up – because no one is capturing the data.
A friend of mine (who does know something about statistics) said, when I commented that anecdotal evidence seemed on the whole more accurate to me – don’t we then end up with homeopathy, because so many people (anecdotally) find it helpful…that stumped me. I suppose water, generally, doesn’t kill people however.
The reply to the homeopathy question is no one should use a parachute until a controlled trial proves it works. The reason trials are needed for homeopathy is the outcomes are debatable and as a result we need to manage wishful thinking and our tendency to see benefit where there is none. When someone turns blue on a drug and goes back to normal when the drugs is removed and turns blue again on re-exposure to the drug – then the outcomes aren’t debatable and a controlled trial isn’t needed/
The argument about feeling better and suicide a fig-leaf. It applied to ECT which has an anti-parkinsonian effect so that people who were mute and stupurose start moving and they may at that point still be suicidal. The early descriptions of suicide on imipramine explicitly contrasted what was happening with the Rollback phenomenon – this is not the same as with ECT they said.
D
Some really stunning news on pregnancy and suicide from the UK – at least some of it very relevant. First, suicide is the leading cause of “maternal death” (meaning perinatal death I assume) in the UK. Second, “perinatal suicides” are not only on the rise, but the methods are said to be more violent than what is otherwise typical for women.
The article puts this down to lack of specialist care for pregnant women and new mums who show signs of distress. I’ve no doubt that’s true. But I also ask: what care (including psych meds) were they getting from GPs or non-specialist psychiatrists? And really, if they’d been sent to specialist care, would the specialists have done something different?
http://www.theguardian.com/society/2015/dec/08/half-perinatal-suicides-women-prevented-better-care
I know David’s conclusion, looking at the evidence, is that classic “postpartum psychosis” is much less common than it used to be, and this is one big reason why specialist mother-and-baby units have been shutting down. But I wonder if those units once provided caring supervision for women with lots of milder problems too — first time mums feeling overwhelmed, women in really rough home situations, etc. Women who are now sent home with a nice fat antidepressant Rx instead?
I also wonder how much of a problem “suicide while pregnant” was, prior to the Age of Psychopharm. Is that on the rise? These days it’s hard as hell to get a breakout of pre-birth and post-birth suicide, it’s become policy to lump them together. I also wonder if suicides among pregnant women and new mums were more “violent” than those of other women in the past? Apparently they are now …
…..profound sadness…..we’re brave….love China……
Sir ~Andrew ~Witty on CCTVAmerica
http://www.cctv-america.com/2015/12/04/glaxosmithkline-ceo-on-price-wars-and-pfizerallergan-deal
He comes over well
DH
There is a new comment to Is Motivation Worth More Than Expertise?.
Comment Link: http://www.madinamerica.com/2015/12/motivation-is-worth-more-than-expertise/#comment-79424
Author: kim
Comment:
“Telling women that they shouldn’t have access to this data is rather like telling them that they shouldn’t have control of their own bodies, that men or the state are going to decide for them. This might be the case in the Caliphate, but in London?”
This is the case throughout medicine and particularly in psychiatry, I hate to say. As a 60+ female I have experienced a lifetime of such an attitude from adolescence through pregnancy and childbirth, menopause and any health/mental health issue I have experienced along the way.
Men DO believe they have the right to control our bodies (and our minds).
Thank you for your stance regarding objectivity needing to include all perspectives to actually be objective, and for your work to date on the dangers of psych meds.
But with psych meds…no matter how long and loud many of us (both male and female) have screamed about the horrendous effects of these drugs, doctors simply will not listen. If we attempt suicide after being put on them, it is never the drug’s side effects but always our underlying “illness unmasked”. If we have our first ever psychotic break after being put on anti-psychotics or Z-meds, we were clearly psychotic all along, despite holding down exec level jobs, having fulfilling professional and family lives and being totally symptom-free. Our dirty secret, our lifelong defect, has been unmasked and we will never be allowed to forget it.
We can do a challenge, just as one would do with allergic reactions and again and again show that it is the drugs, but because it is anecdotal and not an RCT (and we are mad people) it is discounted, and we can be forced to stay on meds and stay horrendously ill FOR THE TERM OF OUR NATURAL LIFE.
…and if we are women of child bearing age, our children will be sentenced while still in utero. Men (almost overwhelmingly in positions of power) do have that power in Western society and they are very determined to hold onto it. It is a caliphate in disguise.
Thanks for calling it out.
The tip of the iceberg and more waffle from ‘those at the top’…
http://www.bbc.co.uk/news/health-35051845
“Second Class, Citizens…in our NHS”..?
• 13h
Sense About Science @senseaboutsci
Already, we’re getting great support for #AllTrials US video! Check out people’s reasons for donating http://bit.ly/1Z0W0wA
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Update:
Already, we’re getting great support for our US video fundraising! Here are just some of the reasons why supporters are donating to AllTrials:
“Hiding half the data is how magicians do coin tricks and shell games. Why allow for-profit companies to do the same with trials on lifesaving drugs? Publishing all trials is simple common sense.” – Daniel Oberski
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• 6h
Thomas Hiemstra @Thomas_Hiemstra
Restoring Invisible and Abandoned Trials #RIAT #alltrials – facing the unreliability of clinical trials literature http://www.navarra.es/NR/rdonlyres/D0DD2C82-3B82-4EB8-A173-EEF198197F13/330071/Bit_v23n2_e2.pdf …
drug and therapeutics
bulletin
of navarre,
spain
Facing the
unreliability
of clinical trials
literature
Tom Jefferson
Honorary
researchfellow
Centre for evidence Based medicine.
oxford
oX2 6
http://www.navarra.es/NR/rdonlyres/D0DD2C82-3B82-4EB8-A173-EEF198197F13/330071/Bit_v23n2_e2.pdf
I have adamantly believed that psychiatric drugs are the MAIN cause of autism in this country ever since I began researching them. If they change our brain chemisty as much as they do they have to be changing the developing brain of the fetus. And if this is true, which I happen to believe it is then this is the largest healthcare fraud epidemic in American history. And I see no one taking responsibility for this debacle what so ever. They will continue to blame the patient for taking the drug as they continually do in psychiatry. We didn’t have this epidemic until SSRI’s were introduced in the 80’s. Nor when I went to school did we have school shootings because no one was on the drugs – yet. And when I read the article on Mad in America: Maternal Antidepressant Use Tied to Autism, this only confirmed my belief.
Something is causing the skyrocketing numbers of Autism, and why psychiatric science is unable to understand the literature in front of them is beyond me. If I can find it, read it, and understand it why can’t a Doctor? I am a no body and I see it as clear as day is night. Of course, I was also one of their guinea pigs for decades as they prescribed over 50 psychiatric drugs to cure my ‘chemically imbalanced’ brain they said I had. Why are they in such denial? Well, I actually know the answer to that question. It all boils down to money – Greed. And at who’s expense? Ours, of course. The patient and our beloved babies.
(Only just received my RxISK today so a bit late on replying). Just to comment on the SSRI and vaccination replies. John and Eliz are right to draw a parallel as the very same deceptive practices are evident in the vaccine industry, and one could argue even more so. Unlike SSRIs vaccines are mandatory, as Eliz points out, in Australia as well as many states in the US and some European countries (a couple in France just escaped a prison sentence for not vaccinating their child) so the profit margins are even higher when whole populations become recipients of a product. The point here surely is that Pharmaceutical companies, who are businesses with the sole aim (and legal aim in the US) to make profits, will seek to do that irrespective of the product they are selling. In other words, they will create a market and seek to ‘discourage’ any factors that might stymie profit potential. They do not suddenly become supremely honest and altruistic when producing vaccines. As yet there appears to be no convincing (depending on who is being convinced) research either to deny or link autism to either product, although there are plenty of studies which have been buried that do show a link. Isn’t there also a possibility that a cocktail of drugs and artificially produced viruses pumped directly or in utero, could produce developmental and related problems in a child? In other words, the over-use of medication/preventative medicine per se?
Hello, I just wanted to say that my son was diagnosed with ASD when he was 10, he is now 16. I took Seroxat during pregnancy for the first 2-3 months, before I confirmed I was pregnant. When I found out I was pregnant I stopped cold turkey, maybe not the best thing to do while pregnant because it was traumatic, but I knew how destructive Seroxat was to me and so had no hesitation to stop at once. I had to go back on Medication after I gave birth, and did so for a few more years. When I decided to stop withdraw, I did so very very slowly, it took me 4 years to withdraw, and was a living hell. I had legal aid and was part of the class action group to take GSK to court for severe withdrawals, but because in my past I had smoked Cannabis, I got dropped because they wanted 100% wins, and said GSK would have blamed the Cannabis for my withdrawal symptoms, although I never smoked Cannabis at that time. Been off Seroxat for years now, yes I made it through the hell. But I still never reurned to the person I was before Seroxat, I now have depression constantly, crying most days, don’t go out at all, where as before I couldn’t stay in. Seroxat stole my life, and my Son’s life, as far as I am concerned. I have no support from anyone in my Journey of life since taking Seroxat during or after Seroxat, not even my family. Just wanted to add my Son’s autism to the record/numbers of children affected by Seroxat.
Thankyou Lorraine.