Lost in Medication: The Crusoe Report 3
Lost in Medication. Ask your doctor about the sexual side-effects of your meds. Based on Adam and Eve painting by Lucas Cranach the Elder in 1526
Editorial Note: This follows Restoring Health part 1 and What’s Poisoning Health part 2 of the Crusoe Report in response to the Witty Magna Carta posts.
A medicine is a mix of a chemical that pharmaceutical companies produce and knowledge about how to use the chemical – that we produce.
Making even basic chemicals was beyond us for millennia. But once the process was cracked, discoveries and inventions came thick and fast. Making chemicals that could be used to treat diseases was beyond us for even longer but the pace of discovery began to pick up in the middle of the nineteenth century. The realization of what needed to be done to give a chemical a chance of becoming a medicine led to the hunt for a Magic Bullet. But even as the process became more rational the role of serendipity remained and remains enormous as the discovery of penicillin and so many other medicines demonstrates.
Huge amounts of knowledge are buried in the production of these chemicals that might be drugs. Some of that knowledge came from the pharmaceutical industry, especially the knowledge about how to mass produce the new chemicals to a quality standard. A lot came from university, institute or other research laboratories.
Patents or prizes?
The emergence of these new medicines led to vigorous disputes as to how much an industry like the chemical industry needed to be incentivized to produce new drugs. Venice was the first economy to use patents and the English adopted the idea as a reward system in 1624 to stimulate commerce. At this point patenting seemed a better bet for something like building up a business that traded in goods rather than a means of fostering discovery. When there was a need for a radical breakthrough, Prizes looked like a better bet. The best illustration of this is the story behind the Prize offered for the discovery of how to determine Longitude won by John Harrison in the 1740s.
At a time when chemical companies could produce little of any value to medicine, the French revolutionaries, ordinarily hostile to all things English, and with other things on their mind like guillotining a King, figured it was a revolutionary thing to do to allow patents on medicines. The Germans initially frowned on this idea but later opted for process patents – I could get a patent on my way to make Prozac but not on Prozac itself. If you find a different way to make Prozac, you could make it. The Americans who were much later to the game, from the get-go let companies have product patents – if I patent Prozac you can’t make it even by another method. I have a monopoly on it.
Process patents seem more the thing for the modern age with its emphasis on intellectual property rights than product patents that actively discourage innovation. And for a century the American pharmaceutical industry lagged behind all others, until political developments leveled the playing field and forced the Europeans in the 1960s to play by product patent rules and then the rest of the World to do so too through TRIPS in the 1980s, after which drug development slowed down.
Making a medicine
But here’s the rub, whatever patent system or Prizes we offer them, companies just produce chemicals. It is we who produce medicines. A medicine is a chemical with information and the information comes from us.
In the 1950s, the information came from doctors giving us the new pill and both of us monitoring what happened. That was the ideal but some of them gave us a pill without telling us it was new, and some of the guys handing out these new drugs were people you probably wouldn’t want to take something new and potentially dangerous from. Whether we were fully on board or not though, this was a system where the knowledge was produced in a hands-on way by us and our doctors. If the drug didn’t obviously do something useful or clearly did something harmful it was either removed from the market or the knowledge of what could go wrong found its way pretty directly into clinical practice.
These new chemicals interfered with biology in a way that only poisons had done before. The need to get the information component right was brought home horrifically in 1961 when thalidomide stripped babies of their arms or legs and deformed them in multiple other ways.
Producing Health can never be just a matter of Consuming Chemicals.
The wages of fear
A wave of panic washed over the political establishment at the sight of armless babies. There was a reflex need to be seen to raise the bar for pharmaceutical companies bringing drugs to market. If these companies were going to make money out of people at their most vulnerable, they would have to pass through the eye of a needle. They would have to show in clinical trials that their drugs worked. And those of us who entered these trials would have to be informed that the drug was something not yet on the market so that we could make up our own mind whether to take the risks or not.
This sounds like and is portrayed as something good being drawn from an appalling tragedy, except that clinical trials had only just been invented and no-one realized they weren’t up to the task, except Louis Lasagna, one of their inventors and their main promoter – (See Marilyn’s Curse and related Lasagna series posts).
It took time for the problems to appear. In the 1960s, whether in trials or just by trial and error, the knowledge that made these new drugs into treatments that saved lives came from us. The doctors who gave the drugs were local – they knew us and our communities. In the first trials the doctors were treating patients they knew and when the trial was over and they broke the blind they were able to make sense of the findings in terms of the things they remembered seeing or hearing about directly from the patient.
And so in the decades just after the greatest cataclysm in human history, the risks we took in taking new drugs, whether in trials or just under the observation of our doctors, on behalf of people we knew, ushered in the most extraordinary period of medical advance in all of human history.
But it is exactly this space to mull over what you are seeing and hearing or experiencing that trials have now now left as road kill as they have become the fuel for Fast Medicine.
The risks in destroying knowledge
The initial rationale for trials was that they would be run on drugs or in situations where it was just not obvious that the treatment was helping or that the risks were worth taking. For things that were evident, there was no need for further evidence.
When things aren’t evident and we decide to run a trial, we take a calculated gamble on something risky – and probably well over ninety percent of trials that get run involve risks not worth taking.
To test something out you first need to hypnotize doctors and patients. The blinding in a trial means more than the idea that neither the doctor nor the patient know what the drug is – they can often guess. It means you limit their vision. You get both to focus intensely on whether there is any sign of benefit – to the exclusion of all else. Drugs do a hundred different things but in a trial everyone is guided to ignore the ninety-nine other things and focus on just one thing – does this drug work for whatever it is the company is interested in.
In fact we have introduced another complication which is we ask does it work for depression or to stop heart attacks. Just as SSRIs do, a drug might so obviously blunt or numb reactions that you don’t need a trial to demonstrate this – or so obviously lower cholesterol levels that you don’t need a trial to show this. This blunting or lowering cholesterol can be helpful or not, but rather than call this working, we want to see if this helps depression or prevent heart attacks. When the trials finally squeeze out an answer that you can’t say these SSRIs are of no benefit, we in fact have no idea how the benefit has come about. Or if the trial finds that lowering cholesterol makes no difference, we have no idea why not.
Look at it this way. Alcohol can be very good for social anxiety. Everyone who takes it for this purpose knows what they are doing, and knows how it helps. If we ran a trial of alcohol for social anxiety, and on some rating scale could show some benefit, you would be asked to forget any ideas you had about how alcohol might be helping and just accept a company line that it “works” and therefore you should be taking it – for the rest of your life in all probability.
In the same way, our knowledge of how SSRIs help – they numb – is discarded in favor of the company or expert knowledge that these things work. Into this knowledge vacuum, companies were able to insert all kinds of baloney about serotonin and continue to offer up the hocus-pocus of chemical imbalances – See So Long and Thanks.
The great hypnosis
The great hypnosis involves a post-hypnotic suggestion – that out of the trial will come gold standard knowledge of what drugs do.
We are being told forget our ability to produce knowledge – to produce medicines. They have put us through a machine that erases any inconvenient observations we may have. Our only role now is to consume the pills they give us and to swallow without question the information they provide with them. We have been made into consumers; we are no longer seen as producers.
The hypnosis is pretty dense. In SSRI trials, one hundred per cent of us had genital numbing and a change in sexual function but less than 5% of us apparently noticed this or at least had it recorded by the doctor – many of these trialists are third raters you wouldn’t want to be treated by. To this day we don’t know how many of us return to normal sexually or emotionally after taking an SSRI even just for the 6 weeks of a trial.
So when your son or daughter rocks up to a doctor (visiting is too twentieth century) with the disturbing information that they have stopped functioning sexually, that they could smear chili paste on their genitals and they wouldn’t feel a thing so numb are they, he will check the product label and not finding anything like this there will tell them it’s all in the mind, or this is their depression speaking.
The more they protest, the firmer the noose of neurosis will tighten around their neck.
If you were in one of these trials where your attention was diverted away from the effects of these drugs on sexual functioning or when you tried to make an observation the doctor didn’t record it, the fact that you took risks in a trial for the benefit of your family and friends and community is now being used to skewer your family and friends, just as surely as your work in a lead smelter for most of the twentieth century poisoned any family or friends you had living nearby.
At least working in a smelter you were paid for the work you did.
Many of the trials on which our safety now depends have now moved to places like Bhopal in India or the townships of South Africa where the patients may not exist or if they are injured they can be disposed of without any trace of the problem appearing on the record. The “knowledge” that comes from these trials is deemed by the FDA, the MHRA, AllTrials, the Cochrane Collaboration and Barack Obama as the only real knowledge there is. Your experience by comparison is anecdotal – irrelevant.
If you’re a politician who hasn’t lobbied to make access to clinical trial data freely available, you’re a politician who would lobby to keep the lead smelter running in your district and the level at which lead in blood is regarded as dangerous as high as possible. Hey if kids poisoned by lead are hyperactive – well isn’t that what we have Ritalin for?
The garden of good and evil
Earth teems with life. It’s difficult not to be productive amidst this abundance. It takes the degraded circumstances of a concentration camp to turn humans into just consumers and even there the human spirit can find meaning.
In the Garden, there were trees we could eat from that our parents and others had spent lots of time cultivating, whose fruit were Medicinal. But there was also a Tree, the Fruit of which Wisdom made clear we should avoid. Consuming this Fruit, which we hadn’t been involved in husbanding, we were told would lead to Exile.
The Fruit of this Tree looks Medicinal – but it’s not life giving.
It’s profoundly alienating because of one more feature to the Clinical Trial process, at least within the current regulatory system, which is that it locates the problem, the taint, the original sin in us. If trials show ADHD responds to Ritalin, it must mean the kid is defective.
Which lets politicians say or maybe nudge – “Why look at goddamned lead levels – you want to drive jobs out of this country? If you want to make this world a better place, just keep taking the pills. All of them”.
If Medicine is to be Safe, we need to reclaim our birthright as producers of Medicines.
To be continued.
See comments – J Rees’ article is Here.
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Joe on August 3, 2015 at 6:46 pm said:
On the same issue from the July 25 edition of The Economist, “Spilling the beans – Failure to publish the results of all clinical trials is skewing medical science” at
http://www.economist.com/news/science-and-technology/21659703-failure-publish-results-all-clinical-trials-skewing-medical
Two important one-day conferences about the dangers of psychiatric medication, on the theme of “More Harm than Good”, are to be held next month.
The first of these takes place on Wednesday Sept 16 in Copenhagen, and is hosted by Prof Peter Gøtzsche (right), director of The Nordic Cochrane Centre. Other speakers will include Dr Peter Breggin and Robert Whitaker, as well as a number of bereaved parents, including Sara Bostock, Leonie Fennell and Stephanie McGill Lynch.
Two days later, on Friday Sept 18, the Council for Evidence-based Psychiatry (CEP) hosts a conference at Roehampton University, London. Peter Gøtzsche, Peter Breggin and Robert Whitaker will feature once more, along with Dr Joanna Moncrieff, Prof Peter Kinderman, Prof John Abraham and Dr James Davies.
AntiDepAware will be represented at both conferences.
“he will check the product label and not finding anything like this there will tell them it’s all in the mind, or this is their depression speaking.” When I got persistent sexual dysfunction from fluoxetine even drug label didn’t help too much. Doctor just said it is not suitable for my country (I live in Poland and showed him USA version).In my opinion the problem it is not only in ignorance but in total lack of real responsilibty What can I do to him or to pharma company when every single lawyer I talked to, just doesnt want to pick up case beacuse it is pretty impossible to win ?
The point about ignoring the lead smelter next door, and just giving Ritalin to the kids who can’t concentrate or sit still, is right on time. Rather than admit a blockbuster drug can cause problems, too many docs are learning to focus on the deficiencies of the patient who gets the problem.
So instead of asking why the hell we’re putting people on opioids for chronic muscle or joint pain, they want to identify the “addiction-prone” patient who is most likely to abuse their beloved Oxy. Instead of wondering if kids should take antidepressants, they have to find the “bipolar” children and teens who can’t tolerate them (and feed them even riskier drugs). And Praluent, that very pricey (and rather scary) biologic drug just approved for high cholesterol? It was supposed to be for a small group of patients with a genetic problem – but it’s already being promoted for the “statin intolerant.”
That’s why I’ve started to cringe every time I hear about Personalized Medicine. Okay, certain drugs, maybe for cancer, might be so great that it’s worth developing genetic tests to predict who will and won’t benefit from them. But to put all our hopes (and billions of dollars) into figuring out which third-rate antidepressant will screw up each person’s unique biology the least? To me that feels like killing the healthy chicken to make chicken soup for the sick chicken.
It’s the same for toxic environments as toxic drugs, of course. People are told that if Adderall makes them feel cheerful and productive rather than getting them “high”, that proves they have Adult ADHD. Maybe we ought to ask: What’s wrong with a workplace where every third person “needs” amphetamines to get the job done?
Let’s look at this discourse of yours Dr Healy,
Drugs have come lately to psychiatry. What you lay out below existed long ago, has always existed in psychiatry. “We are being told forget our ability to produce knowledge – to produce medicines. (treatments) They have put us through a machine that erases any inconvenient observations we may have. Our only role now is to consume whatever they give us and to swallow without question the information they provide with them. We have been made into consumers; we are no longer seen as producers.
The hypnosis is pretty dense.”…In psychiatry the inconvenient has always been set aside such that in spite of the fact that in ECT studies placebo is always equal to or superior to `real; memory/cognitive damage is recorded as serious and permanent; cell death is recorded in scans in ALL subjects; and only16-46% get ANY relief and that for under 4 weeks, there is NO critical analysis from the profession.
What may not be recorded with drugs IS recorded for ECT, Dr Healy, but this seems to remain unnoticed by you. You say…”many of these trialists are third raters you wouldn’t want to be treated by. To this day we don’t know how many of us return to normal sexually or emotionally after taking an SSRI even just for the 6 weeks of a trial.”…But we DO know that virtually nobody returns to normal intellectual function following ECT as evidenced by neuropsychological testing and current day MRI scans…”So when your son or daughter (or in ECT, mother, grandmother or child as well) rocks up to a doctor (visiting is too twentieth century) with the disturbing information that they have stopped functioning,”…slowed down, can’t learn, have forgotten years, decades of their lives, their education, their families, skills and talents, will you check the product label/literature including your own books and articles and not finding anything (you)…”like there,”…will you tell them…”it’s all in the mind, or this is their depression speaking.”
No… “the more they protest, the firmer the noose of neurosis will tighten around their neck.
If you were in one of these trials where your attention was diverted away from the effects of this”…treatment on your memory for instance, or when…”you tried to make an observation the doctor didn’t record it, the fact that you took risks in a trial for the benefit of your family and friends and community is now being used to skewer your family and friends, just as surely as your work in a lead smelter for most of the twentieth century poisoned any family or friends you had living nearby.”
Consistency? Dr Healy, what do you say?
Deirdre
What I consistently say – and said recently in at an ISEPP meeting in LA is that what I as a doctor can do for you that your granny or lifestyle coach, priest or guru can’t do is I can poison, mutilate or shock you. That poisoning, mutilation and shocking must be expected to come with problems – none of which should be ignored – and its only when the condition you have warrants taking the risks – with you fully informed of the risks – and both of us monitoring for things going wrong that I as a doctor should treat or you should engage with treatment.
When it comes to telling you about the risks of ECT – I would tell you and tell anyone that ECT is linked to memory problems but part of the problem is that that no one who gets ECT is drug free and the benzos, antipsychotics and antidepressants you may also be on are likely causing memory problems (memory problems are the commonest complaint I get from people on antidepressants for instance who have never had ECT) so one of the hazards after ECT will be you will almost certainly have memory issues but aside from the short-term problems that no-one has ever denied are linked to ECT, it may be difficult for me or you to work out which of the longer term ones are linked to ECT rather than to any pills you are on. I have talked to many people who are very anti-ECT and when they describe their memory problems, these are much more consistent with antipsychotic or benzo induced problems that with ECT.
In terms of the research you mention – there are no scan data showing damage and there are no animal or other studies showing brain damage, whereas there are scan and animal studies showing damage on antipsychotics. In the case of scans and ECT this may be partly because it is close to impossible to run a study in which you can isolate out the effects of ECT. I know because I worked on a protocol to do just this and found it was not readily do-able.
In terms of letting other voices be heard, one of the best books written from an anti-ECT point of view is Linda Andre’s Doctors of Deception – this only got published because of my intervention and support for its publication.
In the case of the History of Shock Treatment parts of which were written by Ned Shorter and parts by me – the Sections on Informed Consent were written by me and are a paean of praise for the many people damaged by shock who over the years have worked hard to get a recognition or the hazards written into consent forms. I even had nice things to say about CCHR, Thomas Szasz and Peter Breggin en route.
I have never called for a treatment to be removed. They are all dangerous. But with the right collaborative arrangement good can be done. After my talk at ISEPP, several people in the audience mentioned privately that they had had ECT in the past and it had helped them. I know many other people who have also been helped by it – and have friends and relatives who haven’t been helped in any respect. Finally I’ve done more than anyone else here in N Wales to ensure that people who should not be getting ECT don’t get it.
David
I notice that you say there is evidence of brain changes/damage due to use of antipsychotics. Is this also true of SSRIs and, if so, how does such damage manifest itself? Thought-provoking blog by the way.
I’m glad ECT has been raised as a topic because recently I decided to ‘put my hand in the wound’, if you like, and really think about it. Cards on the table: I ‘had’ ECT 6 times over three years – 36 zaps in total. I hated it – most vehemently the first time. I was utterly terrified that I would lose my memory – and I did. I was confused and addled for a couple of weeks after each batch and have permanently lost memories of events immediately preceding/during the zaps (including my son’s graduation ceremony – and that loss is very hard to bear). And, ECT didn’t ‘work’ for me – although objectively, the first time, everyone said how much brighter I seemed, until everything fell apart again.
But – 12 years on – my long term memory is completely unaffected. What I had failed to realise was that the dreadful cocktail of drugs was blurring my memories of the past – and once they had (mostly) gone, the past began to unroll again. Like lifting a carpet – my childhood is there, so my sister and I can exchange reminiscences, my life before becoming a mental patient – all there. So, the Royal College of Psychiatrists Leaflet which states that memory loss is ‘transient’ – is, strictly speaking, largely accurate, despite me sitting in the ward in 2000, in a steaming fury, painstakingly writing ‘THIS IS NOT TRUE!’ on each leaflet.
And now, while having no memory of my son walking across the podium to collect his degree certificate is painful – it’s not half as bloody awful as not being able to hold his daughter for more than a few minutes because my arms are too weak, my wrists too sore and my balance too uncertain. Or not being able to manage the noise and movement of a toddler without having to crash out in a dark room, after an hour. All the consequence of brain damage caused by drugs, not electricity.
But – and this is a question for all psychiatrists – why do patients hate having ECT so much? Why do we all feel violated, intellectually? Why do we all firmly believe that we’ve been damaged on some deep level? Why do we feel that we’ve never been the same since? I saw One Flew Over the Cuckoo’s Nest – but, to be honest, my instinctive, visceral fear of the zaps was far deeper that having been affected by a film. There is a collective, societal fear of having electrodes pinned to your forehead which goes back to Mary Shelley’s Frankenstein and beyond. She didn’t create the fear of creating a monster from electricity – it seems to have been ready and waiting – she merely tapped into it.
But I’m not sure even that is a really adequate explanation.
I’ve seen ECT work a miracle: a young Mum, so wretched and mad that she couldn’t recognise her baby son. We had ECT together, travelled by taxi to the local ECT suite, sat and waited for the zaps. Watching her the next morning cuddling the baby, and then, a bit later starting to walk him out in the pram – was truly miraculous. It maybe didn’t last, but I can’t close my eyes to the fact that Katy was brought back from some unspeakable place.
Debate about a treatment which, to my mind, is far, far less damaging than the effects of long-term chemicals, needs urgently to address why it is so profoundly terrifying to those of us who’ve been through it?
Good question Sally! I hope some docs listen to the answers, it may teach them things that go way beyond ECT. I too had it, and it didn’t help me. Like you, the loss of memory was temporary but frightening and demoralizing nonetheless. For an odd, quirky and desperately unhappy young person who sometimes felt her only redeeming characteristic was to be Very Bright, it seemed utterly damning. The only thing you and others value about yourself, the only thing that gives you self-respect, is now to be rubbed out! For your own good, naturally.
But I think it must be the same for anyone, even if they were very sociable or never thought to be terribly bright. Isn’t the loss of memory the loss of self? Isn’t that why we all fear Alzheimer’s so much? And for the vast majority it is temporary, but it’s also true the vast majority are not beset with urges to murder on Zoloft.
Maybe the answer lies in a more in-depth and honest dialog with people who have “natural” or organically-produced seizures. Some of them have transient mystical experiences or feelings of great serenity too. They also have many ill effects, which tend to get worse the more seizures they have. We could probably learn from both.
I’m very encouraged to read David’s “narrow” description of the problems for which he thinks ECT can do great good. Even “very bad” depression is not always an indicator, as I read you David — it has to be of a particular type.
It’s also incredibly refreshing to hear a doctor admit that there are ANY cases in which ECT does no good. Almost all doctors I meet repeat the same thing, like drones: “It’s the Gold Standard.” The best, the absolute tops for depression. I can name almost any pill and say it did not help me, and doctors will accept that, nodding sagely and saying “well, some do not respond.” But when I tell them I had ECT and it did no good, they just gape at me like goldfish–and change the subject. It’s like telling them I used to walk upside down and breathe carbon monoxide instead of air. They can’t process it, and I think they very quickly soothe themselves by deciding I am wrong.
For about 6-7 years there was one drug that would produce the same “goldfish” reaction: Cymbalta! Hopefully the news that Cymbalta doesn’t fix everyone no longer produces a state of temporary catatonia in doctors.
For anyone interested in medicine in society, and especially how doctors are marketed to, maybe this is an even more interesting question: Why do a few treatments, particularly ECT, inspire this almost religious faith in so many doctors? What’s the secret?
David, I like this. Covers much of what you have said previously, but it comes together powerfully.
We rarely can do medicine using dead reckoning. Rather we have to keep interacting with our navigation systems to work out where we are going, and where we are. Current practice in much of the NHS is geared around single interactions — ‘you have eczema, now go back to the community, and here is a script, and an information sheet’ — rather than any attempt to keep taking in information about ‘how things are going’. This of course runs counter to traditional medical practice, and often it seems is borrowed from the business model of fast food restaurants.
The latest wheeze in some places is for nurses to report back to management if they think any follow up appointments were ‘necessary’. [All so the new patient targets can be met]. As you know there in also interception of doctor-doctor referrals.
Attached something I wrote awhile back. Not much original in it, but not totally devoid of meaning, and I think it has some relevance to what you are saying.
I still worry about about small or rare but devastating effects of commonly used treatments that in clinic I would judge safe over the short term, but not over the long term. (like systemic retinoids)
Jonathan Rees’s article on Why we should let EBM RIP is now attached to the bottom of Crusoe 3
David
J. Rees. I read the article, and I’m very glad to see other intellectuals (other than D. Healy) can see the problems with EBM/RCT’s and how they are “hijacked” for marketing purposes. (Even diseases themselves are invented in marketing purposes)
Now I did not understand some of it due to not having English as my native language, nor being very Bright due to 15 years of Seroxat.
But what really lit my fire when Reading was that you actually proposed alternative ways to go about, rather than the todays “collective consensus”, that almost ‘bullies’ doctors into following the staked out path.
Each protest that comes with a proposal how to make things better, is a good way of protesting.
Any system in wich the doctor is free to consult the latest ‘intel’ on a treatment is far superior to what we now have. If SSRI’s was a ‘miracle’ to mental Health in 1988, perhaps they’d been used with caution by the year 2000 when I was put on them. If my doctor had had the chance to hear both positive AND negative sides of them.
But… I have to date never Heard a Swedish Psychiatrist speak of SSRI in negative terms, not even when I acredit them my prolonged illness.
It’s like the old saying (may vary from country to country) “If you look for something hard enough, you will find it..”
So if they look for a positive effect of SSRI’s, they sure as H can make the numbing one.
But any intelligent person also knows that if the numbing becomes too great, it will become a huge problem. Because we all know (though we never really consider it in real Life) how often our emotions are the ones who helps us make desicions through Life.
And just like in the example with alcohol, we tend to socialize better on just the right amount, but when consumption goes overboard so does the behaviour.
So where one person is just about enough numbed up to get on with Life, other will become emotionally stripped humans. And who, in their right mind, can say a human without their emotions is a functioning human?
So when scientists becomes so focused on finding “approximitely” what the pharmaceutical Company sponsoring them set out to find, they will gladly do so ignoring other and more telling patient responces.
The general public (like me) still has this notion that every drug is tested beyond reason for any and all effects it might have. When reality is they only test it for immidiate safety (no test person must die on the spot) and any effect that can be called positive by their biased interpretation. And any grey-area surrounding these 2 outcomes of a trial are just filled out with PR-nonsense from the companies marketing department.
And I (the consumer) swallow not only the magic pills, but the promise of miracles to come from it.
When the Mensahib did not come from the lips of my Indian Doctor, who took over our very Dr. Finlay’s and Dr. Cameron’s Casebook Practice and never looked up when you went in and who was learning his new computer skills……slow.slow.slow.
A pal of mine from playgroup, said to him “if you don’t wash your dirty finger nails, there is no way you are laying a hand on my child” as she went to visit for something to do with her child.
You never said that, said I.
I did, she said.
So, this Gentleman of the Realm, wrote a referral to a Mental Hospital saying I had ‘psychological’ problems. No word of a lie, he did.
Why?
I have no idea.
The rest of the story could make your toes curl.
Whilst NICE, MHRA tie themselves in knots trying to disassociate themselves from SSRIs with Learning Modules and other utter trash, we should always remember that their module/model has absolutely nothing to do with Clinical Trials or EBM or anything else.
It is a Concept, devised to protect themselves and if that’s what they do…fair dues…but, as, we all know EBM is RIP.
Try putting that over to anyone in this circle, MHC, and you can hear the shrieks of protest 500 miles away…..
or, in Oves case, perhaps a few more miles…Won in Translation…Nice, ove…..
….because of this coup….
Today at 1:09 PM
Hi all,
I’ve wrestled the keyboard away from the AllTrials staff to send this email because, after two years of work – from tiny beginnings – with your help, the campaign has had a ridiculously good two weeks. It’s a cliché, so revoke my writing license, but this is all down to you and to your support.
Firstly, as you will hopefully have seen, major pension funds and investors managing a total of over €3.5 trillion in funds are now working with us to hold companies to account on their trials transparency plans. People who care about companies’ behaviour, as part of their day to day work, now care about withheld trial results. This means companies’ compliance with legislation and their own promises will be monitored like never before. €3.5 trillion is a big number, and one that companies will take notice of. Because of this coup, AllTrials was covered extensively in the financial press, with very long leaders in the FT and the Economist, alongside coverage in the Wall Street Journal and other international business press. This gives the issue a whole new audience, and a whole new level of seriousness. More investors have been in touch, asking to join, and asking for help taking up the missing trials issue with the companies they invest in. There’s much more to be done here, and we will relish it.
Then we launched the campaign in the US. The responses from American organisations have been overwhelming. The US is a very different place to the UK, or Europe, and we’ve realised there is huge value in having a whole office there, managing relationships with patient groups, companies, professional bodies, and journalists. Just like when we launched in the UK, people in all kinds of organisations have told us they’re glad AllTrials is starting in the States, because they have been worried about this issue for a long time, but didn’t know what to do about it, especially as raising the issue can feel (appallingly!) controversial.
There’s huge potential to build a campaign in the US, and a lot at stake. Meanwhile, as we were doing all of this – just to remind you – we were also involved in the court case with Richmond Pharmacology that could have set progress on transparency in the UK into a sharp reverse.
Why am I telling you all this? Because the first good evidence on missing trial results in medicine was published in 1980. The first strong prominent call for a trials register was in 1986. Since then there have been dozens of studies published on the prevalence of missing data, and endless broken promises, but the problem has not been fixed. Academic publications are a necessary first step to getting a global public health problem like this fixed. But they are not enough on their own.
The real day to day business of the AllTrials campaign is a grind. It is admin. It is bottomless.
This is how change happens: endlessly setting up meetings and seminars around Europe and the States, hours on conference calls and webinars, days pouring over impenetrable policy positions and dull consultation documents, constant coordination with teams in the States and UK, and collaborators around the world, dreary travel for staff to spend 2 hours face to face persuading and befriending, unending phone calls, and more. As someone who sits on his arse writing academic papers – like the people I criticised in the previous paragraph – I am humbled to see AllTrials staff do real work. Their work, paid for by you, is the kind of stuff that cannot be done as a hobby. It has moved the campaign onto another level, and made this issue unignorable.
Obviously I am asking you for money. That’s because I can now see, more than ever before, that change happens because good people, with experience at creating change, devote their full time career and working week to making it happen. Everything that AllTrials has achieved so far has only happened because of your collective support, your targeted emails to policy makers, your endorsement, your help in getting your organisations signed up, and your money, that pays for the grinding work to be done.
If we stopped tomorrow then you and I, and everyone involved, could probably all award ourselves a point. But we have not won, there is more to do, and we are at a tipping point. If you can give any sum of money, to keep AllTrials staff doing the kind of boring, tireless, repetitive campaign work – the stuff that would make you or I scream our tongues out with boredom – then please, please do. Their phone bill is due, their Windows XP install needs updating, and Sile needs an economy class ticket for yet another Groundhog Day meeting, with yet another person, who might just help everyone do the right thing by patients, and get all trials reported.
Dr Ben Goldacre
http://www.alltrials.net
It seems to me that trials are just a way for the pharmaceutical companies to find out anything bad and hide it. My son was put on SSRI’S to stop him from collapsing due to a neurological condition. Nobody knows how this works, but it does. The SSRI have some action on the brain that reduces the amounts of collapses dramatically.
Brilliant.. no more collapsing paralysed but the side effects meant he suffered severe SD, dry mouth so bad he had sores in his mouth, urinary retention, spasms, obtrusive thoughts, depersonalisation and an episode of psychosis that ended up with him facing prison and a court case that lasted a year. When he did complain of side effects he was told either that the drug couldnt cause it or it will disappear once youve been on them a while. Yes the SSRI did do the job with the collapsing but the drug destroyed his life.
He is now starting to regain some of his former self, he feels emotion again and that is all down to David Healy and the help he has given my son.
So Thank you David for giving me my son back. Thank you for this blog, the research, the lectures, talks. Thank you for the incredible amount of time, dedication and hard work you put into raising awareness and fighting for transparency in medicine. Thank you for putting up with all the back stabbing and attempts to discredit you. Thank you for helping people who are vulnerable and would slip through the system and be left to rot.
A trip down memory lane…..
I was desperately looking for someone to help me…nobody told me this alarming reaction would not happen again…I was terrified to go to sleep, in case it happened again….the sympathetic replies from these Two Gentlemen kept me going…they might not have thought they were doing a lot, but it meant the world to me…it kept me going through the long dark days when I felt the whole world was against me.
I may have sounded measured and calm, but, I was freaking out and desperate and confused and was persuaded that I was a complete suicidal lunatic who shouldn’t be in charge of a bin lorry let alone be a parent.
In a way, they won. They cut me down to the size they wanted. I wished I had never met any of them. I couldn’t believe this was happening. Out of nowhere, in a matter of weeks my whole life crumbled and it was vital I recovered fast or what was indeed shocking could have been even more shocking. I had to nurture a child tortured with despair and I am very proud that I didn’t make a song and dance about it and that she has turned into a swan and is turning heads and brains in Victoria, BC
The lady, doctor, in particular, made me feel so ashamed so that if I had been a ‘genuine’ suicide, I would have crawled out of the surgery and thrown myself into the loch.
Would she have been satisfied, then?
But, even the most accomplished can slip up and slip up she did.
Her arrogance and lashing tongue proved her undoing.
When you meet people like this they can get cocky and cockiness is neither becoming nor dignified, as we have seen elsewhere in the saga of Glaxo and mothers little helper…..
28 May 2003
Subject: Seroxat
To: Contact@mind.org.uk
For the attention of Mr. Richard Brook
Chief Executive
MIND
I am delighted to hear that the MHRA are to hold an inquiry into the side-effects/withdrawal effects of Seroxat.
The statement “The health benefits of SSRIs are still considered to outweigh the risk of adverse drug reactions” absolutely has to be investigated by the Committee on Safety of Medicines.
I am speaking from my own experience as a Seroxat user. I have seen all the evidence published by newspapers and on the Panorama programme, the Seroxat web-site and the fact that Hugh James Solicitors, Cardiff have over 4,000 seroxat users on their client list.
I am communicating with you because I feel a very strong need to add my voice to those who are being represented by the Committee. When you have nearly had your life destroyed by a drug prescribed by those in the medical profession, you feel angry and upset and powerless.
The fact that there is going to be an investigation will give thousands of people some confidence that their mental stability is no longer in question.
I know that you at MIND will appreciate how important this is.
I can talk of my own experience quite freely now as I no longer am taking Seroxat. The first two years on Seroxat were fine. I was on 20 mg. a day.
Feeling on top, I withdrew from Seroxat over a two week period. At this time, GPs had no idea of the withdrawal effects which would follow. I was great for a couple of weeks; in fact, delighted that I was standing on my own two feet. Very simplistically, even the taking of anti-depressants can make you feel dependant on something and not quite in control of your destiny.
However, after this delight the appalling withdrawal effects began. The worst of it is you become totally mentally unstable – it has been referred to as emotional chaos.
You see life, but you are no longer in it. You are a person who has unbeknownst to yourself mentally and physically fallen apart. You do not understand what is happening to you and nobody else does either. The mental state you are in defies description, depths of despair beyond repair – terrifying to yourself and those around you.
Last year, I was in a mental hospital. Within days of returning home, I had cut my wrists and taken an overdose. I remember the horror so very vividly of being unable to understand what had caused this manic behaviour.
The grief this has caused my family cannot be measured. There is no doubt in my mind that this whole dreadful saga may never be eradicated from our memories.
Perhaps this will be read and understood. A Seroxat person will never be the same person they were before. Too many horrors – a solitary confinement of a part of the mind that was once proud and felt it normal to be part of the human race.
I would like to be acknowledged as a person who had severe adverse reactions to a drug which is recognised as causing terrible reactions.
The health benefits may be good for most, but please don’t let us unlucky ones be ignored any more.
If I can assist the research programme in any way, please contact me.
I received the kindest, email, immediately, from Mr. Richard Brook
Mr. Richard Brooke resigned from MIND.
His opinions were not required to do with SSRIs.
Similarly…..an, immediate, reply
20 October 2004
Subject: response from Dr. Healy
Dear Annie
Thank you for your email. Unfortunately there’s very little I can suggest that would help. Some people have very drawn out withdrawal problems that can go on for ages afterwards. I think in the near future however the lack of credibility that you’re experiencing now is something that should change in that I think people are rapidly becoming more aware of the problem, so you should find yourself much less stigmatised than before.
Aside from this however I have no good news to offer you. Should a cure of some sort for these withdrawal problems, you can be sure that I’ll let everyone who’s contacted me know about it.
Yours sincerely
Dr David Healy
Bethan Williams
Secretary to Dr David Healy
Director of the North Wales Department of Psychological Medicine
Hergest Unit
Ysbyty Gwynedd
Bangor
Gwyned
LL57 2PW
On and on and on we go…and the trip of a lifetime still beckons…now, of course, my trip to the supermarket will be to buy something….and, not, burst in to frazzled tears choosing bread with my partner….which was the first indication that Seroxat had started it’s demonising work……and I ran out and this was the beginning of here we go loopy loo……..
Frances O. Kelsey, MD, PhD passed away last week.
I wondered why you wrote about her work on keeping thalidomide off the American market as a myth. Even if Morton Mintz’s reporting brought the subject to the masses, wasn’t she still the impetus. Meaning without her resistance he wouldn’t have had an article? Don’t they both deserve credit?
Frances Kelsey was clearly wonderful. But the story has become mythic in many ways – not just her bit to it. A number of others did far more in terms of raising the hazards – even for Americans – such as William McBride and Siegfried Lenz and Morton Mintz played a very considerable role in packaging the issues for the public in a way they could resonate with – and this was the Frances Kelsey story. She went on to do many other great things later in life so this wasn’t just a flash in the pan – but the events in 1962 have left an unintended legacy that we need to be able to revisit – and revisiting might not be made easier if others think that it involves disinterring the bones of a saint.
C
I may be approaching a subject already well discussed but, to those who have experienced serious adverse effects of psychotropic drugs, I am going to direct a couple of questions. Before being prescribed any drug, did you have a complete physical examination? In particular was there investigation of your kidney, liver and thyroid function? Did you obtain any information on the recommended/average dosage? Dosage is affected by age, weight, kidney and liver health, and other conditions. It may well be that your particular experience was caused by not only the wrong drug but the lack of information about the state of your general health, your age (the older you are the lower the dosage), and the best method of administration. I find that rarely is a complete physical required to rule out conditions that you may not be aware of but make certain drugs, especially psychotropics, contraindicated. I will not be surprised to learn that a full physical is seldom, if ever, required. And let’s not forget the influence of over-the-counter medications being taken for conditions such as the common cold, heartburn etc.