Health Warning: Let me put down some markers before riffing on the Grassy Knoll theme. I am a committed believer in what may now be a last millenium concept – the medical model. I think antidepressants – the older tricyclics and ECT, not the more recent SSRI and other antidepressants – can save lives. I figure conflict of interest, crucially important in other areas of life, is of minor importance if not irrelevant in science. Although by science I mean something that can only happen in the presence of publicly available data.
In the case of the antidepressants and other drugs, do people sit down in closed rooms to hatch a plot against “the people” for the sake of profits? Yep, they do. Is this a conspiracy theory? No, its out in the open – nothing personal just business.
Is concern about the operations of the Science Media Center legitimate? Yep. Is it because they’re engaged in a conspiracy? Well – they are in the business of managing perceptions. Is that a conspiracy – even if a well-intentioned one? Difficult call. Anyone who bases their case on Robert Gibbons and related stuff as Pariente and others in SMC have done is either cynical or thick. Sticking a litmus strip into the SMC bilge around Panorama caused the litmus strip to dissolve.
The vast bulk of the academic literature on on-patent drugs, excepting the diminishing number of articles talking about adverse effects, is ghostwritten. Is this a conspiracy? Nope it out in the open but no one spots it on radars in front of them because for most its still as unbelievable as UFOs, or the idea we might incinerate millions of women, children, musicians, artists and scientists.
The entirety of the data from clinical trials of on-patent drugs is unavailable. No-one gets to see it. Is this a conspiracy? Its force majeure – that’s French for fuck off.
The Presidents of American and European Physicians Associations (as well as Royal Colleges) remain quiet about this. Is this a conspiracy? No. Its political maturity, as modeled by Pius XII in the 1940s.
Spitzer
On June 2 New York State’s Attorney General Elliot Spitzer filed a fraud action accusing GlaxoSmithKline of “repeated and persistent fraud” for concealing known problems with efficacy and safety of Paxil (paroxetine) for children and adolescents. He claimed GSK hid the fact that its Paxil trials failed to show efficacy in adolescents and in some cases it was more likely to cause suicidal thinking.
There was a basis for the charge given that Study 329 and other company pediatric trails may represent the greatest divide in all of medicine between what the academic literature says about the drugs and what the data actually show. There was also a smoking gun document unearthed by Panorama which appeared to show GSK intended to deceive doctors and patients with the publication of the Keller paper in 2001.
Spitzer held a press conference arguing his action would change the course of medicine for ever. All companies would be pressured into making their data available to doctors – as it should be. The media attention helped propel him to the Governorship two years later.
On August 26, GSK announced that it had resolved its case with New York. It would pay a small amount of money and publicly disclose all of its clinical drug trials about the safety of paroxetine for children in a “Clinical Trials Registry”.
Showing a mastery of the art of turning problems into opportunities, GSK’s press release stated:
“We are pleased that the Attorney General believes the Clinical Trial Register we have been developing will provide useful information to the medical and scientific community,” said Mark Werner, Senior Vice President for US Legal Operations at GlaxoSmithKline. “We believe that GlaxoSmithKline’s initiative to launch this register is a responsible step in ensuring transparency of our clinical trial data.”
Spitzer was left seething.
He became Governor in 2006, but two years later he was forced to resign after being found in a compromising situation. The first season of The Good Wife and the last episode of Law and Order are thought to have based on these events. There was no end of speculation as to who was behind his downfall.
The Spitzer action didn’t change medicine one iota. It may have helped a few weeks after with pushing through a Black Box Warning that FDA up till the last minute was dead set against. But from GSK’s point of view, Paxil was off-patent, and the warnings may have helped sales of its Lamictal for bipolar disorder – a failure to diagnose which they knew a bunch of doctors were straining at the bit to say was the real reason all these kids were becoming suicidal.
Conspiracy? You have to admire GSK’s nimbleness.
Montgomery
In the late 1980s Stuart Montgomery in London hooked Eli Lilly into a placebo controlled trial of Prozac in patients with recurrent brief depressive disorder, aka intermittent brief depressive disorder, aka borderline personality disorder. The data are unavailable. An article was published years later concealing the suicidality data but tucked away in it was mention of the fact that placebo was roaringly better than Prozac.
A few years later Montgomery persuaded GSK to run the same trial in the same patient group, probably using some of the exact same patients, comparing Paxil (Seroxat) to placebo. The trial ended early. No data were ever published. There was a much higher suicidal event rate on Paxil.
A few years after that again GSK ran a trial in Belgium in the same patient group. Who know what the real figures are – I’ve seen several different sets. In all of them there are very high suicidal act rates on Paxil and placebo – which was the point of the trial.
In 2006, under pressure on the suicidality front, GSK put out a press release, containing these figures.
Paroxetine Events/Patients | Placebo Events/Patients | Risk | |
---|---|---|---|
Major Depression | 11/2943 | 0/1671 | Infinite |
Brief Depression | 32/147 | 35/151 | 0.9 |
Total | 43/3090 | 35/1822 | 0.7 |
What this shows is that you can use a problem you know your drug causes to hide a problem your drug causes. This is effortlessly easy to do by mixing superficially similar but in fact different patient groups together. It can be done for Parkinson’s disease, Back Pain, Cancers, and works particularly well when both the disorders and their treatment cause a problem. It’s a harder trick to pull off when you use duloxetine for urinary incontinence and end up with suicidal women.
Anyone like Stuart Montgomery could have sat down and explained to the company what the pay off was going to be from what might have looked like a crazy move.
Company trials are full of moves like this. Is this a conspiracy? No – its a game. On our side, we expect our academics, like Dr Wessely who bills himself as an expert in these kind of things, to spot what’s going on and prevent the buggers from scoring goals.
Goldacre
In 2012, GSK was hit with the then biggest fine in corporate history. As part of its response, as with Elliot Spitzer it took the moral high ground and made a big deal about banning free pens to doctors and eliminating payments to detailers (sales reps) by results. All payments to reps, along with the reps, were being eliminated anyway so this one was easy.
But for Andrew Witty to end up on the front page of the BMJ, just a few weeks after agreeing to the biggest fine in corporate history, billed as the acceptable face of the pharmaceutical industry and the Great White Hope, was a lot more impressive. It must have brought a smile to lots of faces, whatever about the Good Guys in the Department of Justice.
In between paying the fine, and canonization, AllTrials had launched. Most people heard access to trial data but AllTrials proposed nothing like this. They were focused on efficacy as adjudged by experts not data as trawled by people. And in a dangerous world, efficacy sells drugs. Its the nuclear option. Why take risks – nuke it. There is nothing about AllTrials that is not going to increase the sales of drugs. And all sorts of the great and good were swinging their thuribles and chanting “Transparency”, Transparency” around the new sacrament.
Andrew jumped on board. What was not to like about this? Nobody rooting through the data to find evidence of a Third Shooter.
Did Ben Goldacre and Iain Chalmers conspire to offer him a Get out of Jail Free card. Its irrelevant. All it needs is someone in GSK to be able to spot a Get out of Jail Free card in front of their nose and able to persuade the CEO to grab it. And 100,000 people work for GSK so there was every chance this would happen.
The Business Model
The business model of the pharmaceutical industry is:
Pay us what we want because we do research to produce new drugs and if you don’t pay us we will stop doing this and you will die.
Its the next best thing to the barrel of a gun.
They don’t invest the money in making new drugs. The track record in this area is worse and worse. The money goes into maintaining power. With sufficient lawyers, regulators and academics, its a bit like retaining so many monkeys, you can be sure of ending up with a Mozart symphony or Shakespearean play from time to time. The other thing as any great sports coach will tell you is Focus. Industry have a focus – the bottom line.
Medics on the other hand and shrinks in particular are the least focused people in the world – except for those who jump ship into private practice.
Watching Medic behavior however is a good way to check which way the wind is blowing. When there is a dominant power, a bully, medics usually line up to right of the bully. Its called identification with the aggressor. When the Catholic Church held an iron grip on thinking in Ireland, far from offering a voice of liberalism, Irish Medicine took ethical positions on abortion, contraception and everything else to do with sex to the right of the Church. It often left Church leaders looking rather – well Andrew Witty like.
Anyone who expects doctors to save them would probably have thought the Maginot Line looked wonderful, and voted for the canonization of Pius XII.
(Was that a conspiracy? Well he did have a woman who looked after him and she was German, wryly described by some as the most powerful German in the Vatican…..).
(Yanis Varoufakis’ Adults in the Room is a wonderful take on what its like to deal with a dominant power and the ventriloquist’s dummies, the Irish or Lithuanians, who do the speaking for them. Or how people will be clapping your back one minute over a stein of beer and then selling you out the next).
TM says
It’s a case of GSK knowing when to spin each scandal that engulfs them into a PR opportunity they can benefit from- they are really quite good at it. It will be interesting to see what the serious fraud office have to say when their investigation into GSK concludes in 2018. I think GSK will get off, simply because they have gotten off in every other charge leveled against them from as far back as I have researched. The MHRA investigated them for the Seroxat scandal (and the deaths of kids because of off label prescribing of Seroxat- and GSK’s lack of warning) in the late 2000’s. Of course GSK got off because of a supposed ‘loop hole’ in the law (these loop holes are really handy for allowing corporations to get away with corporate manslaughter). The details of their investigation were never made public, instead we had the MHRA (the regulator of the industry- supposedly) letting GSK away with a crime so unimaginably immoral that it beggars belief.The MHRA itself is headed by a former GSK employee (Ian Hudson) who had a significant interest in Paroxetine (while he worked at GSK). Paroxetine/Seroxat has been under a maelstrom of scandals for over a decade, yet the MHRA remain quiet- I wonder why?. Then we have GSK being fined 3 Billion in 2012 (largely thanks to Greg Thorpe’s legal complaint), and on the surface this looks like justice right? 3 Billion is a lot of money, however 3 Billion is pocket change to GSK, and no executives went to jail. This wasn’t justice – this was an a joke – on us- the patients/public. Greg Thorpe has said himself, (in comments on my blog) that the Department of Justice fine was a sham, it was a ‘gift’ to GSK. Eric Holder, lead prosecutor, swung through his GSK/Covington and Burlington revolving door so fast that his seat was barely cold in the Department of Justice (Covington and Burling are one of GSK’s many corporate lawfirms).
The whole system is rotten to the core, and has been for a very long time.
https://truthman30.wordpress.com/2015/08/24/gsk-eric-holder-and-the-revolving-door-syndrome/
https://truthman30.wordpress.com/2015/08/28/whistleblower-greg-thorpes-7th-ammended-complaint/
https://truthman30.wordpress.com/2012/10/29/kent-woods-mhra/
https://truthman30.wordpress.com/2013/11/11/dr-ian-hudson-mhra/
mary says
All of this makes it abundantly clear that beating these companies and their hangers-on is seen, by them, as an impossibility – maybe it almost is without a complete change of tack. I can only see the possibility of changing matters if we keep chipping away at ground level. WE, the general public, are the ones who keep taking their drugs – without US, they are doomed. WE don’t necessarily want the world rid of their wares – just properly informed choice. Maybe we are too kind ? – we say what we say so that things remain as is for those for whom these drugs don’t seem to cause too many problems. Maybe it’s time TO say GET RID OF THEM and make ‘the other side’ fight to keep them? At the moment, they remain rather sanctimonious with their “I don’t listen to anything anti-medication” and “They’ve saved my life”. NOT LISTENING helps no-one and neither does closing a debate down without giving the other side a fair hearing. We need ALL who have been on these drugs and survived, by the skin of their teeth in many cases, to come out of the woodwork and help us to shout out about the harms possible with use of these poisons. Don’t ask me how this can be done for I don’t have any suggestions – other than to say that Sally’s idea, on a previous blog comment, of starting by finding out who/where is doing most of the prescribing etc. should be a good starting point.
TM says
Good suggestions, and it seems what with Pharma’s (almost) complete control of healthcare, the regulators, and even in some aspects- a massive influence upon- the law/government policy/universities/academia etc, something radical needs to happen or else patients/the public will continue to be harmed without any consequence to those who do the harming. However, it is not an easy thing to change. This massive apparatus of organizations and individuals is benefiting a lot of people- monetarily and ideologically etc. Without mobilization (offline) they will just continue on business as usual. All of this has been covered online in various forums etc. My blog itself has covered every aspect of how the pharmaceutical industry (specifically GSK), and psychiatry, have colluded in rotting patient rights, eroding ethics and in the process destroyed many lives. The SSRI issues are the tip of the iceberg, the ‘evidence base’ of medicine is entirely corrupted. It is a sign of just how corrupted things are when we have organizations like The Science Media Center spewing out biased propaganda though a well funded propaganda medium- even before they have seen the ‘evidence’ ( the James Holmes documentary for example). What hope is there for social justice or patient rights/informed consent, or even transparency and ethics, when we are up against that kind of devious connivance?
Fran says
DH, you say: “I think antidepressants – the older tricyclics and ECT, not the more recent SSRI and other antidepressants – can save lives.”
What do you mean by “save lives”? And where is the evidence?
David Healy says
Yes. Next post
D
annie says
This is a very large ‘Family Tree’ ..
They have their Tree and we have our Tree.
If you put this Blog and Comments, so far, on an A3 sheet of paper and starting at the top with the Great, Great, Godfather and then drew your lines down, there are the players involved in this game.
If you did the same thing with our Tree, the diagram would be considerably smaller with less and less lines joining us all up.
Do you see my point .
Seroxat is hanging by a thread under ‘Pharmaceuticals’ in the GSK Library of Drugs and there are possibly more court cases and more newspaper articles and more blogs about Seroxat than any drug in living history ..
This is one piece of Data that is irrefutable and unarguable and proven ..
Is it possible to recruit 21 000 extra staff for mental health services?
Authors: Gareth Iacobucci
Publication date: 15 Aug 2017
Short on paper ..
http://careers.bmj.com/careers/advice/Is_it_possible_to_recruit_21_000_extra_staff_for_mental_health_services%3F
and do we want them..?
Shelley Jofre @ShelleyJofre 2h2 hours ago
I’d like to hear from yp in Scotland (or their parents) prescribed antidepressants under age of 18 who found them helpful #mentalhealth
This problem has spawned whole industries and networks and government agencies to run with the tide .. and along came Shelley ..
http://news.bbc.co.uk/1/hi/programmes/panorama/meet_the_team/3159941.stm
Heather says
I totally agree Mary, well put.
I don’t mean this to sound critical, but whilst the Panorama film ‘A Prescription for Murder’ was good as far as it went, it wasn’t what I was hoping for. I had thought we were going to see a film filled with many accounts of ruined or lost lives, featuring all those like Katinka Blackford Newman, probably not so sensationally ruined as poor James Holmes, but maybe more easy for the general public to feel akin to. I’m very much hoping she will get a chance to do perhaps a follow up Panorama with that kind of content, maybe drawing on all or many of those cases listed on her ‘The Pill that Steals Lives’ website. Maybe the BBC only wanted the sensationalism of JH’s awful story. But I do so hope we get another crack at this. One critiscm from I think Wessley, was that no other patients were featured. Well, I think between us we could find plenty of nearer to home dreadful experiences that might shake Big Pharma’s holier than thou tree a bit, and have some of their lucrative fruit fall off.
Mary is right, if we stop buying the stuff, stop asking for it, sales will go down and we’ll eventually begin to make some impression on their bottom line. We won’t all die if we don’t have their wretched expensive poison. There are lots of ways to help ourselves get better from diseases, and to cope with our mental health, and the less brain washed and clear thinking we are, the better we can succeed. People managed back in the 1900s, they had home remedies, tried and tested. Those things are still there if we can be bothered to seek them out.
mary says
I agree with what you say about the Panorama programme Heather – I felt it could have been in two parts for a better jerk to Joe Public’s opinion on these matters. Part 1 could have been the James Holmes story, with its very important question mark in its title. Part 2 could have been the less severe cases – the ‘near misses’ if you like – which would have nailed the reality better I feel. The problem, I think, may well be in getting hold of cases where the people concerned are willing to take part. I know for a fact that that is true of one case – where they were interviewed by Katinka ( who pleaded with them to come out in the open with their story) but were only willing for the story to be told with complete anonymity. These, I feel, are the very cases missing from the story at present.
annie says
‘Out of the Blue’ deaths and research by Uni of Man .. centre for suicide prevention ..
The most common method of suicide was hanging/ strangulation (554, 60%), followed by jumping/multiple injuries, i.e. jumping or lying in front of a train or other vehicle (89, 10%), jumping from a height (56, 6%), or other multiple injuries (25, 3%).
There were 66 (7%) deaths by self-poisoning (overdose). Opiates were the most commonly used substance taken, in 17 deaths; others included barbiturates (n=10), beta blockers (n=9), antidepressants (n=6), and paracetamol or paracetamol/ opiate compounds (n=5).
National Confidential Inquiry into Suicide and Homicide by People with Mental Illness July 2017
http://research.bmh.manchester.ac.uk/cmhs/research/centreforsuicideprevention/nci/reports/cyp_2017_report.pdf
Contact with services
Figure 6 shows the pattern of lifetime and recent contact with front-line services and their recognition of risk. Forty-two percent were in recent contact with any agency, and in 23% of these, risk was viewed as moderate or high—in the others it was unrecorded or seen as low.
‘Out of the blue’ deaths
In 3 deaths the young person had had no contact with services, no history of self-harm, no suicidal thoughts, and no contact with a GP or at A&E for mental health problems. Eighty-four (29%) had never expressed suicidal thoughts nor previously self-harmed. In these 84 ‘out of the blue’ deaths there was a general pattern of significantly fewer stresses and early life experiences (e.g. a family history of mental illness, bullying) compared to the under 20s sample as a whole (Table 8). Many (57, 68%) had no known contact with any agencies.
publicly available data ..
John Stone says
I would guess that part of the problem with medical doctors is the command structure: indeed, you cannot have students trying to re-invent the wheel. But a few years ago in the BMJ there was an article by ethicist Julian Savulescu of the mysterious Uehiro Foundation in Oxford. Savulescu argued amid general outrage that doctors should suspend their consciences when faced with bureaucratic dictat. Rather ineptly he even quoted Shakespeare’s Richard III not realising that he was actually supposed to represent evil incarnate: the attribution was to Shakespeare, not to the character, which is not sophisticated reading but also abnegating responsibility to authority (in this case allegedly Shakespeare’s) ..
http://www.bmj.com/content/332/7536/294
But despite the outrage I imagine that when faced with ethical dilemmas most doctors will still do as they are told.
annie says
A Good One – on the line ..
Mental Health Cop
A venn diagram of policing, mental health and criminal justice
https://mentalhealthcop.wordpress.com/2017/08/15/mental-health-expert/?utm_content=buffer5f10b&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer
we need to get a grip! What if that person now takes more than they were prescribed to take, already on a high dosage or are self-medicating, using other substances and they end up developing serotonin syndrome?! That sort of thing can prove fatal if properly qualified people aren’t advising patients what to put in to their bodies and you should alter medication only under clinical guidance or supervision, for various reasons …. and all because some PC over-reached their expertise, if they actually had any to start with.
Heather says
A Dilemma. Advice please on how to proceed….
This post of DH’s is so compelling, so concerning, so calmly reasonable and believable. So depressing too, I must admit, in all its honesty.
I would love to share it with near neighbours of mine – nice people, a little older than me but not much, and immensely proud of their nice daughters, one of whom is a pharmacist who now works as I believe, a KOL for an agency which sends her flying all over the world to magnificent venues to proclaim the benefits of the latest pharmacutical delights to them. Anyone meeting this youngish mother of 3, talking to her, not knowing what her job is, would find her self effacing, gentle, quietly ‘nice’ and very intelligent.
After our son died, this couple were enormously kind to me. The wife is a very sociable person and had started, some years before, a patchwork and knitting and (most importantly) nattering group of local ladies who I also liked very much. I had been going weekly to sit and stitch and gossip with this little crew for two years or do when he got noticeably (to outsiders) ill and died. I had shared with them my worries on and off over time about my son, but in measured amounts as I didn’t want to bore (not like I unashamedly do here, for which I apologise). They were a source of happiness and belonging for me. The mother of the KOL daughter however endlessly regaled us with proud tales of where else her girl was lecturing this week, and what a gigantic salary she was on, being raised again and again as her success (I suppose, her sales figures) grew. I didn’t really take this all on board till our son died and we started learning, mostly via RxISK, and other parents bereaved too by meds, what these Pharma companies were actually up to.
When the light really began to Dawn for me, I asked to speak with the ‘nice’ daughter who I’d met occasionally when she visited. I wanted to know her ‘key opinions’ on, for instance, isotretinoin. All of a sudden, things became tricky. Mother said daughter was much too busy for me to meet her. An awkwardness has developed. I tried continuing to attend the group meetings to sew and chat but found I couldn’t stomach hearing the latest news of yet another wage rise for the daughter who was off abroad again doing a major assignment presentation to doctors internationally. I had inquired from her mother if she was a ghostwriter and was told no, she was ‘much senior’ to that. So, I stopped going, and there is an embarrassed awkwardness in this small hamlet now. One or two know how I feel but don’t know what to say. There is nothing really they can say, as I am in my small corner and they in theirs. The gossip however is that our son’s mental health was iffy, no fault of the good hearted pharmaceuticals so honourably marketed to save lives. I am in a dilemma. I know I can’t get through to these people. They would have snorted with derision at the Panorama programme about James Holmes. So there is a glass wall between us now. And to justify themselves, they vilify my son behind their knitting needles. I am sad but must I stick to my guns and keep giving out our leaflets, blogging on our own website. My dilemma is that surely of so many of us. How on earth do we get them to see that what DH has spelled out here is real, it’s wrong, and they are blindly glazed over to it due to its perceived honourable ‘niceness’?
mary says
Heather, for what it’s worth, in my opinion, YOU CARRY ON. YOU have nothing to hide, nothing to be ashamed of and EVERYTHING to give. ONE DAY the truth will be out – we may be long gone but others will be left. As David has already said in reply to previous comments, there is research regarding Ketamine which, if it’s ever marketed, will compare itself favourably against the known ( but hidden) perils of SSRIs. These companies who are topdogs at present would then have to follow suit and try to better the situation or lose out completely in the AD field. Those who mock David and stick like leeches to the pharma companies at present would change camps without hesitation if priorities changed. Man is fickle – especially if something hits him in the wallet (or bank account, or stocks and shares or freebies etc.)!
annie says
Practice What Your Patient is Thinking
What it feels like to be compulsorily detained for treatment
BMJ 2017; 358 doi: https://doi.org/10.1136/bmj.j3546 (Published 16 August 2017) Cite this as: BMJ 2017;358:j3546
http://www.bmj.com/content/358/bmj.j3546
Taking a patient’s autonomy is life changing. This account shows the importance of careful handling of the situation both before and after the event
It was a Bic—the biro—that changed my life. I’ve wondered since if the doctor using it knew that many years later his signature that day would still have impact.
Bob Fiddaman says
I think the term, “Antidepressants can save lives”, is all well and good but it should always be followed with, “but they can also end lives.”
More often than not, particularly due to recent events, we have seen the “Antidepressants save lives” line thrown out by RCP and MHRA. It’s a line that may hold truth but it’s irrelevant when discussing the opposite issue, ergo that, for some, they can end lives.
It seems to be a kind of “shut up” defence that the industry churns out when the safety of antidepressants is questioned.
Dr’s will also make this claim because they see patients who have hit rock bottom. Experience tells them that patient X improved over a period of time because of the antidepressants he/she was prescribed. This is good evidence and, of course, should not be ignored.
On the flip side, prescribing Dr’s may have experienced the complete opposite where the prescription of antidepressants did little for patient Y.
Patient Y dies by suicide and the reason was either 1. He/she was so depressed that they would have taken their lives regardless of being prescribed or not or, 2. They didn’t respond to one drug but may have responded to another.
A Dr will rarely blame the drug for inducing the suicide because, in essence, he will then have to deal with guilt. You know, the drug I prescribed my patient contributed to their death.
Nobody wants to carry that guilt so a defence mechanism kicks in (see points 1 and 2)
Then, to convince oneself that points 1 and 2 carry weight, the Dr can reassure himself (and not future patients) that “Antidepressants save lives.”
If they do, indeed, save lives then, at best, there is only anecdotal evidence that shows this.
Again, flipping the coin here, there is also anecdotal evidence that antidepressants have induced death. There would be much more if Dr’s treating the likes of patient Y assessed the situation from a non-personal point of view. Fear of lawsuits and malpractice, however, sways that assessment as does the guilt that a Dr may feel at contributing to a patient’s death.
So, to recap: Yes, there may be anecdotal evidence that antidepressants save lives so people can actually make this claim but it must always be followed with the other “anecdotes”, the ones from surviving family members.
RCP, MHRA, in fact, the whole industry, need to acknowledge both sets of anecdotes. Their current stance is that, with deaths induced by antidepressants, correlation does not equal causation. The same can be said for the claims that they save lives, treatment response does not equal life-saving.
It’s impossible to measure because, before treatment, suicidal thoughts does not necessarily mean that the patient will go on to complete suicide if they are not treated. Those that do may have also completed suicide if they were treated with antidepressants. It’s difficult to judge.
Far be it for me, or anyone else, to tell people that they don’t need antidepressants or argue that my belief is they don’t save lives. I do think, however, that the induced suicide warning needs to be as ‘popular’ as the “saves lives” line, in fact, probably more popular.
It would be refreshing if the industry started by saying, “These pills aren’t for everyone, in some cases, they have increased suicidal thinking and patients have gone on to kill themselves. We don’t actually know why this happens but we do know it’s a result of the chemicals inside the drug. However, there is also evidence that they have helped people with suicidal thoughts.”
I think that’s fair game.
I look forward to the next ‘Grassy Knoll’ installment.
annie says
And along came Shelley Jofre@ShelleyJofre ..
Medication can cause problems as well as tackle symptoms and patients r monitored v closely, Dr Lockhart on @BBCRadioScot on antidepressants
Antidepressants “safe & effective” treatment, Dr Lockhart tells @BBCRadioScot @rcpsych
Please get in touch if you’ve been helped by antidepressants when under 18. Antidepressant use rises in under-13s
Four times more under 13s prescribed antidepressants last year than 7 years ago. ScotGov say it reflects rise in yp getting help #GMS 6.35am
Are/Were you under 18 in Scotland, prescribed antidepressants and found them helpful? I’d like to hear from you.
Antidepressant use rises in under-13s
8 hours ago
From the section Scotland
http://www.bbc.co.uk/news/uk-scotland-40942741
They also show that 41% of them were prescribed sertraline and 13% citalopram, which are the recommended second-line treatments if fluoxetine is “not tolerated”.
Ten adolescents, aged 13-17, were prescribed paroxetine despite NICE guidelines saying “paroxetine should not be used for the treatment of depression in children and young people”.
The Scottish government has said it believes doctors are using medication correctly.
Mental Health Minister Maureen Watt said: “Any prescribing is a clinical decision and there is good evidence that GPs assess and treat depression appropriately.
“We have worked hard to reduce the stigma faced by people with mental health problems. As this stigma declines we would expect more patients to seek help from their GPs for problems such as depression.
“People with mental illness should expect the same standard of care as people with physical illness and should receive medication if they need it.”
The minister added: “The number of items prescribed has been increasing consistently over the last ten years.
“This reflects the substantial increase in demand for child and adolescent mental health services.”
‘The dose I was on was wrong and I wasn’t made aware of the risks’ ..
susanne says
The Yellow Card Scheme publishes interesting stats on how many adverse effects are recorded from different regions by medics/hospitals/users etc – the difference is staggering. There needs to be a different way of reporting.
Sertraline is 5th out of the 11 recorded in the list of Top 10 Suspect Drugs
In Top 10 Suspected Reactions – there is no mention of it and in adverse reactions there is no mention of suicide or harming – no warnings about other SSR’s
The British Psychiatric Bulletin reveals how medics are using a simple check list which fits nicely into a ten minute consultation – drawn up by Pfizer to diagnose depression. How surprising that prescriptions for drugs have massively increased.
There is another check list being used to re diagnosis people who suffer long term depression, as having bi-polar illness. This applies to people who have been prescribed drugs for up to a year or are still depressed after taking several different drugs. Anti depressants are supposed to be used for short periods – there is nothing in that study question why the drugs were over prescribed and what effect this had. A ‘clean’ investigation is impossible once the drugs have been taken for such a long time. Drugs are almost always the only ‘treatment’ for a diagnosis of bi-polar – how predictable.
By the way, in my region there is TV Prog ;The New GPs’ which seems to have plenty of services for referrals for counselling. drug and alcohol services – very rarely someone is subjected to a check list or immediately prescribed anti depressants only. Is it giving a true picture?
annie says
Here is the National overall picture ..
Mhra.gov.uk/drug analysis profiles
Total number of reactions: 11851 – Total number of ADR reports: 4753
Total number of serious ADR reports: 3101 – Total number of fatal ADR reports: 139
Displays show a breakdown of all 4753 UK spontaneous reports received for SERTRALINE.
Displays show a breakdown of 4753 selected from 4753 UK spontaneous reports received for SERTRALINE.
Reports processed up to: 30-Jun-2017
Sertraline
https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=./UK_EXTERNAL/NONCOMBINED/UK_NON_000592467712.zip&agency=MHRA
Paroxetine
https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=./UK_EXTERNAL/NONCOMBINED/UK_NON_000191079758.zip&agency=MHRA
Total number of reactions: 35303 – Total number of ADR reports: 10884
Total number of serious ADR reports: 6780 – Total number of fatal ADR reports: 192
Displays show a breakdown of all 10884 UK spontaneous reports received for PAROXETINE.
Displays show a breakdown of 10884 selected from 10884 UK spontaneous reports received for PAROXETINE.
Reports processed up to: 30-Jun-2017
Rxisk
https://rxisk.org/drug/sertraline/oral-pill/
https://rxisk.org/top_100_reactions/Sertraline/
– making medicines safer for all of us
Heather says
Annie, brilliant stuff. Can you find the figures for RoAccutane/Accutane/isotretionoin?
annie says
Heather, an abundance of info for you.
I hope you can find something useful out of this lot ..
Public assessment report
November 2014
Review of isotretinoin and psychiatric adverse reactions
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/391670/isotretinoin_and_psychiatric_disorders_PAR_Final_web.pdf
The Commission advised that careful consideration be given to communicating the findings of the review and the improvements to the patient information leaflet. It was considered important that the potential risks of psychiatric reactions should be put into perspective with information about the risks associated with the condition itself, highlighting the co-incidental occurrence of these psychiatric disorders within this age group and the importance of seeking help if problems occur.
ISOTRETINOIN
Single constituent brand names: ACCUTANE, ALLIANCE PHARMS ISOTRETINOIN, BEACON PHARMS ISOTRETINOIN, ISOTRETINOIN [not otherwise coded], ISOTREX, RANBAXY UK ISOTRETINOIN, ROACCUTAN, ROACCUTANE, ROACUTAN, SCHERING HEALTH ISOTRETINOIN
Multiple constituent brand names: ISOTREXIN
Multiple constituent brand names: ISOTREXIN
Total number of reactions: 5691 – Total number of ADR reports: 2532
Total number of serious ADR reports: 1894 – Total number of fatal ADR reports: 77
Displays show a breakdown of all 2532 UK spontaneous reports received for ISOTRETINOIN.
Displays show a breakdown of 2532 selected from 2532 UK spontaneous reports received for ISOTRETINOIN.
Reports processed up to: 30-Jun-2017
https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=./UK_EXTERNAL/NONCOMBINED/UK_NON_000285965613.zip&agency=MHRA
Freedom of Information Request:
https://www.whatdotheyknow.com/request/roaccutane_use
https://www.whatdotheyknow.com/request/264200/response/652877/attach/3/FOI%2015%20186%20reply.pdf?cookie_passthrough=1
Rxisk
https://rxisk.org/drug/isotretinoin/oral-pill/
https://rxisk.org/top_100_reactions/Isotretinoin/
Heather says
Many thanks for this Annie. The MHRA Report of Nov 2014 was the one our group of parents got Gov’t to set up, and when we got the results, we all reckoned it was a complete whitewash. The reported deaths are way below the actual, because coroners do not have to specify and report back centrally that a suicide victim had previously taken isotretinoin. So, these figures are a fudge really. But the links you’ve found are very helpful and interesting, we greatly appreciate your research, thank you. When meeting with Norman Lamb, Earl Howe and co, we parents were promised that the Head Coroner would be alerted to our concerns re the reporting. We don’t think this has happened. We ourselves try to write to every coroner on an isotretinoin-driven suicide Inquest, giving them data and listing previous cases. We never get a response, but that’s normal, they can’t correspond with the public. We just hope they read and at least ponder it a little. Like water dripping on a stone.
annie says
Frances, Healy at Odds Over Program on SSRIs and Violence
August 18, 2017
Allen Frances and David Healy have expressed differing opinions on A Prescription for Murder, BBC Panorama’s recent documentary on the association between antidepressants and violence. While Dr. Frances has criticized what he feels is an extremist stance, Dr. Healy has defended the importance of pointing out the causal role antidepressants can play in violent acts.
https://www.madinamerica.com/2017/08/frances-healy-odds-program-ssris/
Click here to read their email exchange.
https://davidhealy.org/whats-going-on-here/
+++commentsUK..
Sally Macgregor says
I’ve never got to the bottom of why the SSRIs et al are particularly implicated in suicidality /self-harm/aggression – is it down to their chemical structure? Or down to being far more widely prescribed, thus more people, more extreme effects? I was first prescribed Lustral (sertraline?) which made me so violently sick after just one pill, I was swapped onto an old tricyclic (amitriptyline). The GP said at the time that the old tricyclics were just as effective but the new drugs had ‘less side effects’. To me, at the time, heaving my guts up, that seemed absurd. What he actually meant was that ODing on an SSRI was less likely to kill you – which I think is true. So, it’s probably correct to say that in one respect the SSRIs were safer – even if, meanwhile, the drug companies were busy burying the other bodies where no one could ever find them. Big Pharma has always looked to hide the problems and work round uncomfortable evidence – they’re a business. It often doesn’t feel like it here, but GSK are not the only villains – try reading Eli Lilly’s internal documents in 2000/2001, instructing reps how to avoid the little problem of olanzapine/Zyprexa causing diabetes – outright lies, but the prospect of loadsa money was worth a hefty eventual fine. Big P simply writes the cost of litigation off as part of marketing costs – hell, for all I know a fine is tax deductible. None of that is a conspiracy – it’s called capitalism in action. And, it’s worth remembering the adage – no such thing as bad publicity – when Volkswagen was exposed as rigging car emissions – big scandal, much wringing of hands – did people stop buying their cars? No – they actually bought more. Just a thought.
I suspect the old tricyclics do work – sometimes. Not for me, but probably for a couple of people I know, one of whom had held out against any kind of AD for months of misery, but within a week or so of taking a tricyclic – began to feel better, which gave her a foothold and started the long slow climb out of acute depression. I sometimes feel on here that people condemn all psychiatric medication (and those who prescribe it) outright – somehow forgetting the utter, indescribable horror of depression. At the time I would happily have taken strychnine if someone had told me it would make me feel better. We spiral off on a tangent, vilifying all psychiatric drugs – when what we need is something that actually helps people in abject despair. ECT can help, I’ve seen it help, and should I ever get that ill again, I’d opt for a couple of sessions – even though I hated it at the time (and for anyone impelled to write and tell me how I have brain damage I don’t know I have – don’t bother). Ketamine looks interesting too – only of course as it’s a bad/illegal/street drug that’s a bit of a hot potato, although I guess a lot of (quiet) research is going on.
In a way, isn’t the crux of the problem not the drugs per se, but the lack of information about what they can sometimes cause – the heart of the matter: getting hold of the data which is what David has been trying to do for decades now.
The thing that gets missed with psychiatric meds – is the principle of the inverse harm/benefit ratio and the duty to warn: if a possible adverse effect is very very rare, but catastrophic then your medic is obliged to warn you. An injection of a drug into the eye to treat leaky blood vessels that will cause loss of sight has a 1:1000 chance of causing a stroke. So your doctor will (probably) tell you that – because although exceptionally unlikely, if it did happen it’s B.A.D bad. And you are given very clear instructions to return to the hospital asap should you experience any problems. Mental patients are almost never granted the same right to information, or careful monitoring of possibly disastrous consequences.
Plus of course the fact that all this discussion is taking place at a time when mental health services have never been in such disarray in the UK. It’s a mess, a bloody, bloody mess.
annie says
F D N H ..
F/DH ..
Allen Frances @AllenFrancesMD 10m10 minutes ago
Allen Frances
“FIRST DO NO HARM” Hippocrates was responding to polypharmacy 2500 years ago Most important/most forgotten words in all medicine, then & now
Frank Blankenship August 18, 2017 at 12:06 pm
Very interesting exchange. I’d say Allen Frances can’t entirely keep his mask on. His drug salesman face is peeking out from behind his physician mask. Same physician mask expressing remorse for his part in the DSM-IV fiasco. Despite all his talk about reducing doses, aggression cannot be attributed, by him anyway, to SSRI anti-depressants, and this, to my way of thinking, greatly reduces the impact of his argument, especially when 10 % of the population at home and abroad are on these drugs. He worries about physicians not providing “needed” drugs. Come, come. With 10 % of the population on them, surely, Dr. Frances, you jest. When all is said and done, I kinda think you’ve got another one here more concerned about the wealth in his wallet than the health of his patients.
Come, come ..
annie says
arab news ..
GSK has consciously set out to take a lead in promoting the more progressive, compassionate side of the industry.
At GSK, that change is likely to be accelerated by the arrival of a new British chief executive of the group, Natasha Walmsley, who plans to visit the Middle East soon. “The old model couldn’t continue to exist, it had outlived its purpose,” said Miles.
http://www.arabnews.com/node/1147611/business-economy
annie says
Altostrata
SurvivingAntidepressants.org
http://survivingantidepressants.org/
PS Your last visit to SurvivingAntidepressants.org was 01/23/2012. If you haven’t posted for a while, please come back and let us know how you’re doing in your topic in the Introductions forum.
If you’ve recovered from withdrawal (congratulations!), we’d very much like to see your Success Story. This can help other people know what to expect when going off psychiatric drugs.
Deirdre Doherty says
Incredibly frustrating.
Also brings to mind a Chomsky quote:
“Either you repeat the same conventional doctrines everybody is saying, or else you say something true, and it will sound like it’s from Neptune”
Deirdre Doherty says
“New truth is often uncomfortable, especially to the holders of power; nevertheless, amid the long record of cruelty and bigotry, it is the most important achievement of our intelligent but wayward species” – Bertrand Russell, Religion and Science, 1935.
Just to say again that this blog is so helpful, everything that has been written on the blog and Rxisk. So many commenting also say what I can’t articulate and so well or eloquently.
Still get the feeling that my own case, not the worst/s, even after trying to convey the facts related to what actually happened to me or was happening to me to some family and friends at the time, remains as “unbelievable as UFOs, or the idea we might incinerate millions of women, children, musicians, artists and scientists”.
And I do ‘get’ them – or try at least to ‘get’ them or appreciate their world, their psychology.
Assuming there are many more like me or affected as I was, it took years even for me to fully process and re-address my sense of reality.
(So shocking – beyond physiologically, emotionally, other psychological damage – I often feel like, especially without recognition and validation, that I’ve been left in a suspended, if not as marked, state of shock/dissociation in fact).
Perhaps one of the reasons why we don’t hear from more, or they fade away for a time, other immediate stresses going on in their lives, like me.
(Maybe, beyond being or remaining under the influence, also lot of the ‘normalcy’ bias here when facing disaster; further reinforced if the catastrophic disaster only – immersed in your small ‘real’ world – hit you/your family).
Anyway, I’m going somewhere with this:
Maybe one way or approach could take inspiration from ‘A Modest Proposal?’
(The 1728 satirical essay written and published anonymously by Jonathan Swift in 1729 suggesting, the impoverished Irish might ease their economic troubles by selling their children as food for rich gentlemen and ladies. This satirical hyperbole mocked heartless attitudes towards the poor, as well as British policy toward the Irish in general; Wikipedia).
(A Modest Proposal) for Children’s Health-Care.
But without perhaps, the hyperbole. It’s not needed. Nothing anyone could point to that isin’t already true – out in the open. And ‘personalised’: what this effectively means, could mean, or will, mean for the reader and/or their loved ones.
A bit of a needed jolt-awakening regarding how the existing system has been designed generally or to actually look into what they may ‘protest’, or be horrified by, in what has already happened and is happening.. Another way to try and help people ‘get it’.
One ‘Modest Proposal’ for the Medical Sector; another in lay man language. And pulling in some the great metaphors and analogies, the most recent, related issues, trending in the media – also a ‘way in’ (including Dolin case with regards to generics).
Don’t know. And even if I had the wits and knowledge to pull it off, where and how to get it published with optimised exposure to each target, or most vulnerable, audience.
(And I don’t know, from the most sarc-angry place, its own ugliness, that’s a killer to live with too – if not as devious and ‘sub-human’ as so many Pharma lawyers – if I could resist pointing out, akin to the GSK tactics of turning the horrendous suffering and death of so many into promotional opportunities, how the escalating suicide rates and, ‘strangely’ in woman, may be helping the overpopulation problem).
As we, the general public have been effectively hoaxed in what history may consider to be one of greatest, most shameless and almost black comedic ‘hoaxes’ in medical history (and I would agree – as I imagine many people would – with another commenter that some of the tactics used should be considered tantamount to corporate manslaughter) also brings to mind something akin to the Sokal Affair….
Another way of exposing that for too long, pharmaceutical companies have duped (and been allowed to dupe) the medical sector with, effectively (and reference to the Sokal Affair) too readily accepted profit driven, ‘science’ based, pharmaceutical bullshit.
Worse, where even, long ago, some of the Shelleys or the average man on the street or jury could have picked up on some of the unethical, unscientific, illegal, barely believable tricks regarding people’s lives, children’s lives, if we, or at least doctors, or the medical profession, had the professional and human rights most people still simply assume we do.