Making medicines safer for all of us

Adverse drug events are now the fourth leading cause of death in hospitals.

It’s a reasonable bet they are an even greater cause of death in non-hospital settings where there is no one to monitor things going wrong and no one to intervene to save a life. In mental health, for instance, drug-induced problems are the leading cause of death — and these deaths happen in community rather than hospital settings.

There is also another drug crisis — we are failing to discover new drugs. [Read more...]

Author Archive for David Healy

Something happened to Science

Editorial: One of my regular readers dropped me an email after the last post saying that the Montelukast Withdrawal Syndrome post on RxISK was wonderful but Something Happened on the same day was incomprehensible.  The title was a give-away.  Something Happened but it doesn’t seem to me that anyone knows quite what.  Here’s another take on Something Happened and a currently blank sheet of paper might have yet another take next week. Another angle on this are the RxISK posts on Transgender Meds – where something is happening – but what?

A moral crisis may have been inevitable with the creation of the printing press.  The crisis took shape when Martin Luther nailed his theses to a Cathedral door in 1517. It could not be avoided after 1649 when Charles I of England was decapitated.

The word hierarchy derives from hieros (the holy) – and refers to the primacy of the moral or the sacred. An absolute sovereign held a moral rather than just a political order in place.  The monarch was responsible for justice and benevolence within the monarchy. Justice involved decisions based on wisdom.  The requirements of benevolence meant that we were all, from the monarch down, responsible for the welfare of others in addition to ourselves, and all were answerable to God.

Charles had his head chopped off for moral reasons – for straying too far from godly living.  After his decapitation the moral order was going to have be held in place in a different way.

Even though it was a drive to be more religious and moral that led to this outcome, somehow religion alone didn’t seem capable of filling the void. The world that needed governing by then had become more complex than any previous monarchy or theocracy had faced.

The Individual

Supported by the role of techniques in triggering science, from Descartes in 1649, through Locke and  Kant, Enlightenment philosophers claimed they could fill the void.  They created the ideal of an autonomous subject reasoning in a detached way about us and our place in the universe. The flourishing of science made this option seem compelling to many.  A new individual was born who at least in one part of their lives didn’t just take the word of the Ruler as Gospel or the Gospel as Rule.

In this new dispensation, the requirements of justice and benevolence led to constitutional government, the idea of universal human rights, an independent judiciary, the development of contracts and later welfare systems.

These are achievements to take pride in, but the changing times triggered a “Romantic” reaction.  The romantics held there were important values and forces the philosophers and scientists and liberals were missing. The decapitation of Louis XVI in 1793 and the French revolution made liberal civilisation seem like a thin crust beneath which molten passions swirled.

The detached approach was taking us into a world of instruments and procedures. For the romantics there was more to life than this.  We needed wisdom rather than just detachment and would need to supplement philosophy or science with something else to believe in.  Some turned to Nature, others to Art, some to the People and others to other forces rolling through history that religion had harnessed but disinterested rationality seemed less capable of managing.

Harnessing was something monarchs and religion had done. Managing is what technocrats aim at.

All techniques and procedures embody an intelligible element, an algorithm, just as everything that functions from bacteria and viruses to thermostats and computers do. The question is whether there is more to humanity than a complex collection of intelligible elements.  In caricature form, science and technocracy says there is nothing more.

On a political level, Marxism and psychoanalysis were in this sense romantic – religions reborn in a scientific age. Both had technical aspects that gave them the appearance of science, or a footing within the sciences, but at bottom the materialism of dialectical materialism and the libido of psychoanalysis were mystical concepts rather real-world entities with a precise meaning.

Modernism

The twentieth century brought a new twist.  The modernism of science and its turn to techniques and procedures led to bureaucracy on the one hand and a new modern individual on the other – the displaced individual.  She has become a stranger in a strange land rather than a child of the universe.

This showed up in modern art, where from T.S. Eliot through to Borges and Calvino rather than stories we had stories told through story-tellers. In painting from the impressionists onward we had art that showed its artifice. In architecture, we ended up with buildings that showed their plumbing on the outside.

Unsurprisingly the same happened to science – in this case it was termed post-modernism.  The scientific process and scientific events and their protagonists were all now situated in a story. Discoveries were no longer pure and simple but rather constructs held in place by methods. The objections of scientists to being situated within not just a story but a story-telling is in part what led to the Science Wars.  The other part was the clumsiness of the social scientists.

It should have been possible to seduce the scientists in the way Christians had been seduced.  While many Christians were distraught about the nineteenth century transformation of the Bible into a set of stories (Ta Biblia) rather than one master narrative (Biblos), for many others the investigation of the Bible produced an even more interesting set of stories.  Our new understanding allowed us to celebrate the emergence of a much more person-centered world than had been found in previous hierarchies – whatever about the ultimate meaning of that world ushered in by the events the stories described.

The rhetoric, if not the DNA of science, suggests that faced with uncertainties scientists are less likely to react fundamentalistically than some religious. So, on the face of it, bringing them around should have been possible.  But maybe even with the perfect art we would still have had a problem.

Something Else This Way Comes

Perhaps from say 1980 onwards, there was something else at play. This is what Roy Porter’s review of Listening to Prozac says to me – there must have been something else going on.

All through the 1990s and beyond, the surprise for me was that social scientists were being bowled over by what seemed, in the case of things like Prozac, huckster’s trinkets.  They seemed as happy to hand over Manhattan for a bunch of the new trinkets as the Indians were when the Dutch turned up just before 1649.

What else might have been going on?

One option is science.  The pace of advance picked up relentlessly from the 1940s.  The atom bomb turned the world upside down.  We crossed a threshold and now we for the first time posed a greater threat to Nature than Nature posed to us.

This was at least as obvious in medicine, as in any other branch of life, which from the discovery of DNA to the Human Genome Project seemed to be handing us the means to remake ourselves.  We could make the New Man, and be better-than-well.

But could science, even as epic as this, be the source of our problems?  Science is visionary.  It might destroy an old order, but it also reaches for a new one. While it doesn’t necessarily make individual scientists any better human beings, it doesn’t make them worse either and pooling our fallibilities as science does has unquestionably advanced our situation in many respects while causing other problems.

Another option also stemming from the Enlightenment lies in the procedures we began to put in place rather than the instruments we developed.

From 1800 or so, it became clear that procedures would be applied to government.  This was a move that came from the people – from the bottom of up.  We had weights and measures so that even a King couldn’t arbitrarily decide what a certain amount of produce weighed and was therefore worth – we couldn’t be as easily cheated by power.

The production of goods, including medicines began to be standardised and regulated.  Professionals like doctors, and others, began to be accredited.

Where England developed the idea of constitutional government and now thinks of itself as the cradle of democracy, the application of procedures to government probably flourished most vigorously in Prussia and underpinned the unification of 39 different States with different religions into Germany.

The ultimate expression of this lay in the Holocaust which became the event it was because of the marriage of terrible intention with efficient bureaucracy.  The bureaucracy also played a part in its undoing, when without the appropriate authorisation the camp apparatus refused to release the trains, used to transport “workers” to the camps, to take German troops to the Eastern front.

The first hints that a bureaucracy might be spiritually damaging perhaps lies in Dostoyevsky but the most devastating portraits of its soullessness came from Kafka in the 1920s.  Their warnings had no effect. By the 1930s, totalitarian bureaucracy had emerged as a new force in the world.

It’s important to distinguish the primacy of procedures from the people.  The assumption in the West after the War was the Nazis were perverted, deviant, psychopathic, evil and we needed checks and balances in place to keep Germans on the rails.  But any of the psychological testing done on Germans, even concentration camp guards, showed them to be if anything better balanced and more normal than the American soldiers liberating the camps.  And the bureaucracy that had led to the Holocaust was a triumph of checks and balances that now seemed needed to prevent it happening again.

The early successes of Germany in the War led most allied countries, particularly America to figure that the future lay with management – aka bureaucracy or totalitarianism. Far from learning the lessons of the War, troops returning home got a free pass into universities places to learn management science.

This in part underpinned the upheaval of the 1960s where students and others protested against the encroaching of a new apparatus.  There were protests against science that seemed to be undermining our understanding of ourselves, and a turn to “religion” in the form of cults, but the deeper protests were against the apparatus and conformity.

On the surface Marx and Freud were pitted against liberalism and science – this was a replay of Romance against Science.

But beneath the surface, Marx and Freud and science were being replaced by a neoliberalism and neomedicalism.  Today’s recovery movements and trauma focused therapies in mental health care are cut from the same cloth as the pharmacotherapies they oppose.  Both appeal to operational criteria, both shun judgement, both play by the same rules.

There is no better example of this than the transformation of Buddhism into McMindfulness. Buddhism was an intensely moral exercise; McMindfulness is amoral, a product that needs to make its way in a market.

We all now sign up to the dictatorship of procedure. To being managed. To an imprisonment in an Iron Cage.  This becomes clear when someone like Roy Porter semi-endorses Prozac.

I wanted to hear him say there is more to life than this.  But if he had, it might have sounded like Chris Patten, the last British governor of Hong Kong who, recently protesting about the encroaching of Chinese procedures on Hong Kong, said Britain should stand up to the Chinese as a matter of honour.

Honour and sanctity and virtues like these made sense in the world of Charles I but what could they conceivably mean now?  The good official, the ethical official is the one who keeps to the rules, to the procedures, even when lives are going up in smoke.

The Theory of the Managed Enterprise

Government is now a business, a management exercise, rather something visionary.  We have rulers rather than leaders – technocrats a.k.a. bureaucrats.

In The Theory of the Business Enterprise, Thorsten Veblen said business and science are not good bedfellows. The scientists want to pursue things that interest them. The businessman wants to maximise the opportunity to make money from the product on the market rather than explore one that might not make it.

Science was robust enough to survive this tension until businesses became corporations (bureaucracies) after the War. The science now, at least in medicine, is totally managed.  The new dispensation wants technicians not visionaries.  And as for ethics, and morality, it seems a managed scientist like Peter Kramer has no difficulty with the entire literature being ghostwritten and all data being sequestrated and everything possible being done to sell the product – even as the bodies go up in smoke.

But you’d have thought someone like Roy Porter might have said – wait a minute, what about the Holocaust or was that all Fake News?

The next instalment might or might not clarify some bits of this 

Something Happened – to Science and to Us

In March 2015, the cover of National Geographic featured a picture of the moon-landing with a title The War on Science and a strapline: climate change does not exist; evolution never happened; the moon landing was fake; vaccination can lead to autism; genetically modified food is evil.  See Here.

Even before elections in Europe and America in 2016 gave us Fake News, a progressive commentariat had lumped climate change deniers and anti-vaxxers together as a threat to rationality and science.  This has now extended to anyone who ends up drug-wrecked or device-wrecked.

There is a deep background here.  For science to develop an accommodation had to be reached.  God’s truths were revealed in two books not one – The Book (Biblos) and in the Book of Nature.  Religion offered a framework for belief.  Science operated through doubt.

This doubt spread in the nineteenth century to the Bible itself. We began to doubt the Bible and started believing in science.

The Second World War, the Nazi death camps, and the Atomic Bomb produced a crisis for those who believed in progress.  So too did the history of science which pointed to a progressive replacement of the “truths” at the heart of science. Questions arose about whether it is possible to be objective about history.

The mid-century shocks gave rise to post-modernism which contested the claims of scientists to truth. When the history of science showed that much of what scientists swore was truth one year was discarded the next, how could they claim truth for what they were saying now.

Cybernetics also shaped post-modernism, as caught by Marshall McLuhan’s phrase – the medium is the message. Information had begun to hyper-circulate and instant feedback rather than the content of messages would now dictate how we behaved. The signifiers were becoming as important as the signified. Again raising the question that is all too acute now – if so, where does objectivity lie?

Cargo Cults

For some, science lacked an anchor in philosophy, and without this could not be assumed to have a meaning, and certainly not a moral arc bending toward truth. Others noted that “truth” derives from trust and asked if science, especially the human sciences, could flourish in a society that was not true or free?

Postmodernist questioning of the natural sciences triggered the Science Wars. Physicists and physiologists who viewed science as real faced post-modernists, for whom scientific articles had become texts of uncertain truth value. The scientists called post-modernism a Cargo Cult. In World War II, US Air Force planes flying into Pacific islands disgorged all sorts of goods. The islanders were so impressed by these flying cornucopias that, after the military left, they maintained the runways and control huts, and flew the American flag, in the belief the right appearances would lead to the right results.  These were the Cargo Cults – see image above.

The scientists turned to the Latin word for truth – Veritas – from which we get verification procedures. For them, verification procedures, the rules of the game, may be added to but are never reversed or undone and it is this that means planes fly. Post-modernism can conjure up airstrips and a flag but can’t get off the ground.

Medicine involves both trust and verification? Medical modernism began in Paris around 1800.  From then, slowly at first, there was extraordinary progress, culminating in 1950s advances that seemed very far removed from a Cargo Cult.

But by 1968, Ivan Illich, Michel Foucault and others claimed a new technical medicine was arrogating to itself the right to pronounce on life, death, and disability. Medicalization was alienating us from our true selves rather than liberating us. An apparatus was replacing our natural moral instincts with a bureaucratic morality.

Battle lines were drawn over “the medical gaze” with one side seeing this gaze as a good, and the other as dehumanizing. The rhetoric pitted scientists, physicians and capitalism against post-modernists and socialism. The issues were vigorously contested – up to 1990.

Post-ism

It’s too simple to say the turn to quantification and operationalism in medicine triumphed. But for whatever reason, “critique” fractured into post-ism – post-structuralism, post-modernism, and now post-humanism.

While there had been a growing appreciation of the originality of the historical Marx, around 1990, with the fall of the Berlin Wall, the emergence of Prozac, talk of the Human Genome Project, the twentieth century discourse analysis and post-ism spin-offs from Marx’s work seemed an empty sociobabble that matched the psychobabble of psychoanalysis – and just as dispensable.

Just when it became credible to say that what passed for biomedicine offers the appearances of science rather than the real thing, that drugs are obviously being fetished, and the health care planes are stalling in flight, Michel Foucault and his successors bought into a biobabble – or in this case a bio-sociobabble.

Foucault pushed biopower and biopolitics and everyone else starting pushing bio even though those pushing it had little idea what they were saying.  This was terribly obvious to anyone who had worked in a lab, or on anything that had a link to real biology.

The last thing any of us needed in the face of a tidal wave of new drugs – statins, osteoporosis drugs, SSRIs, ADHD drugs, hypogylcemics and others – none of which saved lives was to have more babble but that’s what we got.  (Googling biobabble turns up the image below with some chinese characters attached to it.  I’m not sure what it is but it looks appropriate).

When Guidelines can recommend medicines that are less effective and more expensive than older drugs, when the ability to Care is being replaced by conformity to mission statements that say: “Because our name is on it, We Care”, we need Adults in the Room.  We have anything but.  Wonderful people like Roy Porter – see What Happened  – Nicholas Rose and others diverted into a toothless commentary on what was happening to us.

Any questioning of the changing climate in health is resisted by pro-vaccine and pro-drug climate change denialists from the BMJ and NEJM to the BBC, the NYT and Guardian, co-ordinated by outsourced industry PR groups like Sense about Science or the Science Media Centre, who mobilize the media and politicians to quarantine people with problems that have arisen from the vaccines they have given their children and the drugs they have taken themselves – because they were pro-vaccine and pro-drug.

The 1980s critiques of claims for the reality of diseases and the efficacy of treatments had some basis to them and they forced doctors to justify themselves, which is no bad thing – especially as most drugs are now given for non diseases.

But now pharmaceutical marketers can rewrite the text that is the human body from year to year with afflictions such as osteopenia, erectile dysfunction, and pediatric bipolar disorder conjured up by ghostwriters with not a peep from anyone. By the time anyone catches up, if ever, a new text will be in place.  Its straight out of Orwell.

You’d have thought that it would be a simple enough matter to stop ghostwriting and make clinical trial data open to scrutiny but there is not a Minister of Health in the Western World willing to get involved.

The media are good at rotten apple in barrel problems but are unwilling to take on rotten barrel problems and at this point if they make programs about rotten apples they add to the problem by distracting attention from the barrel.

BBC’s File on Four prides itself on taking on the Mafia, the Israeli Secret Service, and all kinds of scary people – but ducked out of tackling NICE and their recommendations about antidepressants given to kids.  What is it about NICE that I don’t understand that causes the BBC, Guardian and NY Times to soil their pants?

Google Cults

Through to 2000, we were at risk from a marketing good enough to conjure up air-strips and flags that fooled doctors. Our problems have become dramatically worse since our social media companies came into being on the back of weaponizing behaviourist ideas first put forward by John Locke and Alexander Bain, and later Ivan Pavlov and B.F. Skinner.

Previously it was the natural sciences that kept planes in the air – not the human sciences despite all the hot air they produced.  But social media behaviourism has developed into a set of human science techniques good enough to keep planes flying.  We and our doctors can now be tracked and manipulated nearly as precisely as the particles in Cern’s Hadron Particle Collider.

Big Panacea can now be confident that even if outcomes on treatment get worse there will be no consumer (medical) concern, because the consumers are so controlled they cannot conceive of alternatives. There is almost no possibility of discrepant data emerging to trigger an unwelcome thought. The control of information in this market is total.

Perhaps the greatest irony of all is this. Friedrich Hayek has been the bete noire for all post-ism practitioners. Faced with The Road to Serfdom, the foundational text of neoliberalism, they reach for the garlic and the crucifix.  But no-one has captured the climate within our current totalitarianism as well as Hayek in his description of Eastern European science in 1944:

“The general intellectual climate which this produces, the spirit of complex cynicism as regards truth which it engenders, the loss of the sense of even the meaning of truth, the disappearance of the spirit of independent inquiry and of the belief in the power of rational conviction, the way in which differences of opinion in every branch of knowledge become political issues to be decided by authority are all things which one must personally experience – no short description can convey their extent”.

Rubber Hits Runway

Post-ism failed at a critical moment.  It lacked a rubber hits the runway moment.

No-one in the last three decades analyzing the discourse of biomedicine has ever engaged with a drug wreck.  None of those now agonizing about the objectivity of history or qualitative research have looked at the history taking or qualitative interviewing critical to caring when someone presents with a problem on treatment. No-one ever steps out of line and says – that drug has caused this person the problem they think it has caused.

Its almost impossible to imagine a mission statement to the effect that – We Care means that if need be we will take on pharmaceutical corporations and governments.

Will anything change now that life expectancy is falling?

Something Happened was Joseph Heller’s follow-up to Catch-22.  It sank without trace.  Even George Clooney might not know about its existence. Here are some quotes.

I suppose it is just about impossible for someone like me to rebel anymore and produce any kind of lasting effect. I have lost the power to upset things that I had as a child; I can no longer change my environment or even disturb it seriously.

I frequently feel I’m being taken advantage of merely because I’m asked to do the work I’m paid to do.

Some people are born mediocre. Some achieve mediocrity.  And some have mediocrity thrust upon them.

 

Ordinarily Well: Storm in a D Cup

Ordinarily Well: The Case for Antidepressants  Peter Kramer 2016

This book was very difficult to review. In Ordinarily Well, Dr. Peter Kramer makes two arguments that I agree with. One is that clinical observation—the interaction by which a medical professional learns about a patient—counts for something. The other is that clinical trials, or evidence-based medicine more generally, are not a replacement for clinical wisdom. He values antidepressants, in particular the selective serotonin reuptake inhibitor (SSRI) class of drugs, and so do I.

Applying support for clinical observation and skepticism about controlled trials to the question of whether antidepressants work, Kramer concludes that these treatments work very well. En route, he focuses on the claims of psychologist Irving Kirsch, among others, that based on clinical trial data, the benefits of antidepressants are all in the mind—a placebo effect. Kramer makes a straw man of Kirsch, but I agree with Kramer that antidepressants do things that are not all in the mind. I too reject Kirsch’s arguments that most of what antidepressants do stems from a placebo effect.

So where did my difficulties in reviewing the book come from? The trouble for me is that Kramer’s clinical vision seems strangely rose-tinted. He is an advocate of using antidepressants to treat depression, but he doesn’t seem to see any of the problems antidepressants cause. The fact that over half of the patients put on them don’t take them beyond a month should be telling. For those who do stay on treatment, he claims, no one has difficulties going off antidepressants with a gradual reduction in dosage. I, however, have patients suffering badly months or even a year later. In the case of any enduring problems, Kramer puts these down to the effects of the illness being treated rather than the medication.

There is no discussion in this book of significant problems that the use of antidepressants can cause. These include SSRI-induced alcoholism, SSRI-induced birth defects, including autism spectrum disorder, or permanent post-SSRI sexual dysfunction. In a 336-page book, the topic of SSRI-induced suicidality gets dealt with in one page. I think many surviving relatives would be astonished to hear that once the psychiatrist Martin Teicher had identified the problem of treatment-induced suicide, it became manageable. Kramer claims that “no case [he has had], not one, has looked like those Teicher has described, drug driven.”

Kramer asks us to believe in clinical observations—his observations. Not yours or mine or anyone’s that might cause the antidepressant bandwagon to wobble. He cites me at multiple points, so he is well aware of my work. But he doesn’t engage with the evidence that I and others have put forth, based on both clinical observations and other material, that SSRIs can unquestionably cause suicides and homicides, and do so to a greater extent than they prevent any of these events.

On the issue of children, suicide, and the black box warnings that antidepressants now carry, Kramer notes that “some of the data have trended the other way, although authoritative studies correlate increased prescribing with reduced adolescent suicide.” This fails to acknowledge that the drugs haven’t been shown to work in this age group. There is no mention that suicidal acts show a statistically significant increase in clinical trials in this age group. Kramer also does not indicate that among all ages, when all trials of antidepressants are analyzed together, they show increased rates of death (mainly from suicide) compared to non-treatment. He seems to have no feel for how compromised the “authorities” are that he uses to downplay the risks.

There are good grounds to be skeptical of the evidence-based medicine that Kramer uses to make his case. Quite aside from the fact that almost all the research literature produced by clinical trials is ghost written by pharmaceutical companies, and the data from them entirely inaccessible, controlled trials aren’t designed to show that drugs work. They work best when they debunk claims for efficacy, rather than the reverse. What’s more, the structure of clinical trials and their statistical analyses are the best method to hide a drug’s adverse effects. Ordinarily Well does not address these significant problems.

If a drug really works, then clinical observation should pick it up. We can tell antihypertensives lower blood pressure, hypoglycemics lower blood sugar, and antipsychotics tranquilize within the hour—all without trials. We can see right in front of us that antipsychotics badly agitate many people within the hour and that SSRIs can do so too. But we cannot see anyone get better on an antidepressant in a way that lets us as convincingly ascribe the effect to the drug. There is much to be said for clinical observation, but also a lot to wonder about when clinical trials suggest that drugs work but we can’t actually see it. For anyone keen to defend clinical observation, Kramer’s book poses real problems and would leave many figuring we need controlled trials instead.

I live and work in the United Kingdom and am acutely aware of some differences between America and Europe that also made it difficult to review this book. There is much more “bio-babble” in America than in Europe, from talk of lowered serotonin to chemical imbalances to neuroplasticity and early treatment preventing brain damage—all of which Kramer reproduces. I felt a John McEnroe “you cannot be serious” coming on at many points. The tone in which some of these points are made suggests that everyone reading them will find what is being said self-evident, when in fact it’s gobbledegook.

All medicines are poisons, and the clinical art is bringing good out of the use of a poison. It strikes me as un-American to even suggest that a drug might be a poison, and Kramer’s book gives no hint of this; the book is, in this sense, deeply non-clinical. He is giving an account of a mythical treatment, as far removed from real medicine as an inflatable sexual partner is from the real thing. It seems to me that he would not see or hear many of the patients I see, or at least would not credit their view of what is happening to them on treatment. This book will misinform anyone likely to take an antidepressant.

It will also cause problems for physicians. This book does not balance the risks and benefits that are intrinsic to medical wisdom. If antidepressants are as effective as Kramer claims, and are as free of problems as he suggests, there is no reason why nurses and pharmacists couldn’t prescribe them. Given that they are much less expensive prescribers, the surprise is that health insurers haven’t moved in this direction.

There is a way to bridge the gulf between Kramer and myself, which involves clinical observation. Most of the beneficial effects Kramer describes can be reframed in terms of an emotional blunting, or the numbing of all emotions, not simply the bad ones. Just like people on an SSRI will nearly universally report genital numbing within 30 minutes of taking their first SSRI—if they’re asked—people will also report some degree of emotional numbing—if asked. They don’t necessarily feel better; they simply feel less.

Unlike the somewhat mystical brain re-engineering Kramer invokes, this emotional blunting can be verified by clinical questioning. If clinical trials were designed to assess whether patients are numbed by these drugs, there would be little need for the fancy statistics that pharmaceutical companies use to claim the targeted benefits of their drugs, since emotional blunting would be evident through clinical questioning. And Irving Kirsch’s arguments about placebo would be irrelevant.

If SSRIs numb emotional experience, this would explain why they help some and not others, and explain the results we see in clinical trials, which are similar to the results that might be expected from a trial of alcohol versus placebo in the milder nervous states in which antidepressant trials have been run. This, then, would present us with a question: what do we think about emotional blunting as a therapeutic tool? Emotional blunting is not a romantic option. It’s a much more ordinary one. If that is the process by which antidepressants work, it does patients an enormous disservice to avoid discussing it entirely, which this book does.

Editorial Note:

This review was done for an American journal in 2016.  It links to Kramer v Kramer and a prior review by Roy Porter – What Happened.

Why the image?  Well the world is moving so fast now that inflatable sexual partners seem very last millenium. It’s all virtual reality.  You too can take Prozac and now be spanked by Stormy Daniels.

Kramer v Kramer

Editorial Note:  Kramer v Kramer had been a hit movie a decade earlier.  Listening to Prozac offered a chance to have a review called Kramer v Kramer but the journal – Psychological Medicine – was not amused and ditched the title. Here’e the review written at the same time as the Porter and others. In a later post I will try to explain what puzzles me about the Porter and other reviews.

Listening to Prozac

For what will surely prove to be a brief (although potentially recurring) period, the history of Western psychiatry is at present bracketed between books by authors with the surname Kramer; beginning with Heinrick Kramer’s Malleus Maleficarum and closing with Peter Kramer’s Listening to Prozac. Asking the Kramer vs Kramer question – which of these two parents would more of the children chose to live with – would not, one suspects, provide an overwhelming vote in favour of “progress”.

It seems unlikely that either Kramer consciously set out to produce or perpetrate myths but both would appear to have done so rather successfully. In the case of Peter Kramer, there is for example the myth, that seems to have caught hold of the imaginations of many of the reviewers of this book, that scientists at Eli Lilly deliberately set out to design a drug to selectively block serotonin reuptake with a view to treating depression more effectively. While it is probably the case that Eli Lilly did produce the first of what are now called the selective serotonin reuptake inhibitors (Footnote), they appear to have had little idea of what to do it once they had produced it. Depression was far from their minds. In contrast Astra although somewhat slower to synthesise a serotonin reuptake inhibitor appear to have had a much clearer idea of what they were doing and introduced zimelidine for the treatment of depression 5 years earlier than Prozac. Furthermore Prozac is not selective to serotonin reuptake inhibition in the sense that it also acts on a range of other neurotransmitters. There are other serotonin reuptake inhibitors currently on the market that are more specific inhibitors of serotonin reuptake and others that are more potent inhibitors of serotonin reuptake and arguably, therefore, the particular “cachet” that Prozac has may owe something to its effects on transmitters other than serotonin.

Kramer goes on to imply that our ability to selectively manipulate particular neurotransmitter systems has brought us to the brink of a cosmetic psychopharmacology revolution. In these days of designer babies and debate about the prospects of gene implantation, it was perhaps inevitable that some of the effects of compounds like Prozac on personality would be characterised in this way. This argument ignores the fact, however, that cosmetic psychopharmacology, as defined by the examples used in this book, was a flourishing industry in the 1940’s and 1950’s and that it subsequently vanished with the advent of newer compounds. A great number of people, particularly women, during this period, were taking amphetamines. These were at least as specific in their mode of action as Prozac and brought about comparable changes in the kinds of sub-clinical conditions that Kramer is concerned about.

Based in part on such observations, a comprehensive theory of personality, with a set of predictions as to the effects of drugs in particular individuals, was proposed by Eysenck in the late 1950’s. This theory has subsequently been developed by Gray and Zuckerman and biochemical flesh has been put on its psychological bones by Cloninger, van Praag and others. At present, the evidence in favour of the proposals these authors put forward is lacking but quite apart from the specific merits of any of these proposals, there is an an implicit assumpion common to all of them of a dimensional view of mental health/illness.

This is an issue that greatly exercises Peter Kramer as he takes the view that if we acquire the capacity to shift people along dimensions, then it’s not clear that there will be anything to stop us wanting to shift everyone toward a particular pole. Quite apart from the fact that there is a considerable over­ simplification involved in extrapolating from the effects of drugs at one end of a dimensional system to their effects on individuals at other points on a dimension, there is also the question that hasn’t been asked in this book as to why dimension­al models of mental illness, which were extremely popular in the 1950s and 60s and indeed were implicit in all of psychodynamic theorising, should have been so comprehensively eclipsed by a categorical view of mental illness in the 1970s and 80s.

The answer to this must lie in part in the current structure of regulation within health care and the requirements of the insurance industry, particularly in the United States of America. So, however much a Peter Kramer may attempt to rally the masses to rise up with the cry that they have nothing to lose but their inhibitions, the politics of mental health are such that his call is unlikely to lead to any significant change until such time as some drug company produces a compound more specifically effective for more discrete sets of inhibited states than Prozac currently is.

Even then the prospects for the development of a psychopharmacologically based social engineering are guarded. Consider the case of the selective serotonin reuptake inhibitors and sex. It seems clear that these and other drugs active on the serotonin system have relatively specific effects on sexual functioning. There are also company sponsored studies which indicate, for example, that up to one third of men suffer from premature ejaculation problems, many of which might respond to Prozac or the other serotonin reuptake inhibitors for instance. But no company is at present pursuing such an indication – even though the market of people who might reliably respond to such interventions is likely to be considerably larger than that that might respond reliably to “cosmetic” interventions.

Unlike Heinrick Kramer’s volume which did not flinch from analysing the influence of those parties with an interest in mental health, where Peter Kramer’s book falls down is in its lack of critical edge. A number of reviewers have praised him for not drawing back from the big questions – the ethical issues (1,2,3). Clinical reviewers are likely to wonder what ethical problems there can be in treating depression (4,5). As a piece of dis­course, however, a more interesting issue may be the rather whimsical way in which Kramer addresses the big questions.  He has virtually nothing bad (or even critical) to say about anyone or any issue – the claims of a number of researchers are laid out and all are treated sympathetically, even when these are mutually contradictory.

In moving beyond clinical vignettes and taking on current research in this way, he departs from what is the latest genre – books written in “the Oliver Sack’s tradition” – to become something more of a pamphleteer. In this, he is following in the footsteps of the most famous or perhaps infamous medical pamphleteer, Julien Offray de La Mettrie. The parallels are close. One of La Mettrie’s most famous pamphlets was entitled Discours Sur le Bonheur. He also foresaw the day when we would be able medically to intervene effectively to shape behaviour, at which time medicine would supplant philosophy. La Mettrie’s pamphlets, however, were not whimsies – they were critical and acerbic. Vilified as the father of both modern atheism and totalitarianism, La Mettrie has sunk without trace. This presumably is a fate that Peter Kramer’s more whimsical style seeks to avoid and, as a consequence, we potentially face being recurrently bracketed between Kramers (Footnote].

Footnote and References

Prozac was perhaps the fourth SSRI to be made and was the fifth to market – behind zimelidine, indalpine, fluvoxamine and citalopram.

Kramer did go on to produce Ordinarily Well in 2016. A review follows.

  1. Bracewell M (1993). Escape Capsule. The Observer Life 7th Nov, pp 30-31.
  2. Bury M. (1994) Listening to Prozac.  British Association for Psychopharmacology Newsletter, Spring 1994.
  3. Porter R (1994).  Listening to Prozac.  Times literary Supplement.
  4. Clare A (1994). Sugaring the Pill.  The Sunday Times Books April 3rd.
  5. Freeman H (1994). Listening to Prozac.  Guardian Books April 5th

 

What Happened?

In the early to mid 1990s something happened.  The view that many social commentators and academics offer is that neo-liberalism swept into town, dissolved society and turned us all into individuals.  This is a non-explanation in that no-one can spell out what neo-liberalism is – so the explanation boils down to something happened.

The something is caught in a review of Peter Kramer’s Listening to Prozac by Roy Porter.  Roy was the one of the leading historians of medicine in the world at the time.  He came from a left leaning point of view and was committed to history from the bottom up – or as he put it the Bidet as opposed to the Shower approach to history.

But here in this review of Listening to Prozac, dated March 3 1994, which may have been published somewhere, Roy, like many others, appears to have been somewhat defanged.

See what you think. I find it difficult to understand how a Roy Porter and others didn’t see Listening to Prozac as just plain crass.  (It’s worth reading if only for the snippet on line 4).

Peter D. Kramer Listening to Prozac

Prozac, the anti-depressant that has taken America by storm, has become the legal counterpart to cocaine in the ‘greed is good’ Reaganite years. Introduced by Eli Lilly in 1987, this prescription drug has been swallowed by up to eight million Americans, including Donald Trump, Gary Hart and ‘half of Hollywood’; a million prescriptions a month are being filled, and it’s grossing $1.2 billion a year. It’s hard not to write about Prozac in the language traditionally reserved for movies – indeed it gets a plug in the latest Woody Allen film.

A smart pill for the daily ills of modern society was long overdue. The sixties favourite, Valium (‘mother’s little helper’) had proved habit-forming; many of the later innovations Anafranil for obsessive-compulsive disorder, Xanax for panic anxiety – triggered serious side-effects. Prozac, by contrast, has seemed to many just what the doctor ordered. A laboratory drug drawing upon advanced psychopharmacological research, Prozac (fluoxetine hydrochloride) works by boosting the action of serotonin (the so-called mood transmitter) in brain cells. Seemingly non-addictive and unusually benign, it has the power to lift the depressed, to make the shy outgoing, the anxious assertive and perfectionists accepting. Sufferers said it made you ‘better than well’, at long last they ‘felt themselves’.

After the euphoria, a reaction has predictably set in. Tragic cases were reported Del Shannon’s suicide and a Kentucky mass-murderer who was on the drug. Prozac ‘survivor groups’ have been formed. And pundits have conjured up the fearful spectre of the mass prescribing, on demand, of this potent chemical kick: isn’t the Brave New World dystopia finally being realized by the little green and white capsule that has starred on the front page of Newsweek?

Peter Kramer’s book is a provocative contribution to the debate. A professor of psychiatry at Brown University, and an enthusiastic champion of the drug, Kramer supplies extensive case materials suggesting it gives both the clinically depressed and the sub-clinically ‘blue’ the boost they need to thrive at work, at home and in bed, and hence grow in self-esteem and independence. Kramer is confident about Prozac’s safety.

But it’s not so much its clinical discussions that makes Listening to Prozac intriguing reading, but rather the clarity and candour with which Kramer explores the wider issues. Prozac is a striking symbol of the new, seemingly all-conquering, but highly problematic biological materialism. If Freudianism dominated American psychiatry to the 1950s, emphasising inner conflict, and if the ’60s saw the heyday of a liberal egalitarianism stressing nurture not nature, the ’80s brought a reductionist backlash with a vengeance that recast individual differences in biochemical and increasingly genetic terms. The striking efficacy of Prozac reinforces this trend. You’re depressed? It’s not primarily because you’re poor, out of work, oppressed, abused or trapped in the rat-race; it’s because your brain has a chemical imbalance – and one proof of that is that Prozac rectifies it.

Psychiatry itself, Kramer argues, is thus becoming drug- driven – the shift, so to speak, from ‘listening to patients’ to ‘listening to Prozac’. Traditional psychiatry developed a taxonomy of mental illnesses; the new psychiatry, Kramer holds, may recognize disorders in terms of the drugs that treat them: you must have depression because anti-depressants work for you. Many of course deplore these trends as short-cut psychiatry – fixes rather than healing. Medications like Prozac, critics claim, make you high without ever gaining insight into why you were low, unlike psychoanalysis which properly insisted that understanding must precede recovery. But Kramer can plausibly rejoin that psychotherapy has all too often made the depressed dependent and victimized the victims. By contrast, psychopharmaceuticals work fast; by ‘revving people up’, they facilitate escape from the maelstrom of despair. In the end, psychotherapy may be far more addictive than pills.

Prozac’s power to modify personality bolsters the belief that biochemistry underpins not just mental illness but temperament in general. If this ‘neurohumoralism’ be true, then, Kramer submits, why should physicians restrict themselves to treating the sick? Why shouldn’t neuropharmacology routinely and openly be in the business of prescribing pills to make people feel the way they want?

It’s this suggestion of course that meets indignant resistance. To some it seems to threaten the Hippocratic dignity of the medical profession, reducing the physician to a pusher. To others it unleashes terrifying prospects of the mind and mood control envisaged in Anthony Burgess’s Clockwork Orange or Walker Percy’s Thanatos Syndrome. Suffering (not only puritans will argue) has positive functions and should not be short-circuited. Stiff upper lip Englishmen may note that Prozac is a characteristically American product, tailor-made to adjust people to crazily competitive capitalism – as evidence of one of his Prozac successes, Kramer boasts that a formerly depressed patient is now dating three men a weekend!

The issues Prozac raises are serious, and it is to Kramer’s credit that he airs them freely and frankly. He is right to detect hypocrisy in expressions of pious horror at the idea of psychiatrists dispensing feel-good pills, when all sorts of other fixes are readily available in bars, over the counter and on street corners, and millions are daily body-building with steroids or having face-lifts and breast-implants. We have permitted medicine to branch into cosmetic surgery: can it then be honest to berate ‘cosmetic psychopharmacology’ and the personality-sculpting it offers? Isn’t the critics’ predilection for psychotherapy over psychopharmacology simply ‘no pain, no gain’ snobbery? If happiness on demand is going to be the West’s expectation, we need to decide whether our dream peddlers are going to be pharmaceutical corporations, Bolivian drug barons – or who?

Kramer forecasts the medicalization of everyday life and feels quite comfortable with it (he would, wouldn’t he?, critics will claim). We may be less sanguine, but it’s a prospect we’d better face. Neuropharmacological advances, breakthroughs in diagnostic technology, the economics of medibusiness, the new consumerism and capitalism’s instant hedonism all these pressures are bound to make the next century the age of the drug.

The issue is not whether we like it but how we will live with it. Kramer’s optimism may not appeal to all, but his forthrightness in facing medicine’s changing agenda is undeniably refreshing.

Roy Porter

329: A Study in What?

Editorial Note: This post will be an easy and obvious read if you’re Irish.  If you’re not, with Google or whatever it should be accessible and indeed the little bit of extra effort may make it a more rewarding read.  There is a warning below in respect of one item you might choose to Google. There is also one made up word that won’t appear in Google – until after this post is published.  A closely related word does appear – which is just fine.

Study 329

Study 329 was the most famous Randomized Clinical Trial (RCT) in history.  This study of paroxetine given to children and adolescents, who were supposedly depressed, led to a publication in 2001 in the Journal with the highest impact factor in Child and Adolescent Psychopharmacology.  The paper had an authorship line to die for including Marty Keller, Neal Ryan, Stan Kutcher and others.  Its claim that paroxetine worked well and was safe led to mass sales of the drug.

Turns out the study was ghostwritten, there was no evidence the drug worked and there were triple the number of suicidal events on paroxetine compared to placebo – along with other problems. It also became clear that several years before, in 1998, GSK had internally conceded their drug didn’t work for children but figured they would pick out the good bits of the study and publish them.

FDA were happy to overlook the fact the drug didn’t work, it would seem, but New York State weren’t and took a fraud action against GSK, the marketers of paroxetine.

One consequence of this fraud action, resolved in 2004, was that in 2014 a team got access to the data behind the trial and published a reanalysis of the data.  Study 329 became the only trial in history for which there are two contradictory published articles.  The restoration of 329, to something like what the original publication might more appropriately have said, was finally published in the BMJ in 2015.

The BMJ ordinarily publishes articles within weeks but in this case there was a year long extension to the 329 date.   The British medical establishment essentially had a nervous breakdown over 329. The details of what happened can be found on Study 329.org and even more detail will be available in a racy pacy juicy book later this year – telling you who was sleeping with who behind the scenes.

329 a Study

After a referendum in 2016, Britain was supposed to leave the European Union on 329.  329 has come and gone. A process that was supposed to be efficient and smooth has led to a nervous breakdown. There are claims of fraud and lies, scaremongering and ghostwriting on all sides.  What’s up?

A large poll of voters’ statements about why they voted the way they did, taken as they exited from referendum polling booths in 2016, found that sovereignty was the most commonly cited issue by leave voters.

If you’re Irish, you might wonder about this. Britain was still able to bomb Iraq, Libya and Syria without anyone in the EU stopping them.  Sovereign to do what exactly?

Choclatistas

Britain joined the EU on January 1 1973.  This was the day the Chocolate Wars began. Other European countries argued British “chocolate” contained vegetable fats rather than just cocoa and couldn’t be called chocolate. A Thirty Years War followed that contributed to British perceptions that Europe meant rule by Brussels’s bureaucrats. European choclatistas on their side saw nation based artisanal enterprises threatened by multinationals bent on replacing wholefoods with processed foods.

Retrospectively, even if these moral high-ground arguments were being put forward by people who brought us the Mafia and other locally sourced movements, many people would probably concede European chocolate was just better.

But whatever you think of the chocolate, behind this War lay the role of regulation in modern life. When regulators license a drug, they apply criteria in just the same way as they apply criteria to butter or chocolate. Meet the criteria and you can claim your product is butter, chocolate, an analgesic or an anti-hypertensive.

Your product might kill people, be an inferior butter or bone-thickening drug but it’s not the role of the regulator to keep people alive (other than through any contribution banning egregiously false advertising claims might make), nor to mediate between artisanal and multinational sectors of the market, nor to do politics. The role of regulators is to apply criteria.

When trading blocs such as China, America or Europe rub up against each other now, the issues to be negotiated are rarely about politics, and all about achieving regulatory alignment.  The criteria applied to feta cheese, diesel emissions and drugs determine the room to move an American, Chinese or European president has.

Where both liberals and communists in the 19th century envisaged the State withering away, by the time we hit the 1960s we had nuclear bomb proof regulatory systems that seem unlikely ever to wither away.  America’s FDA is a good example of this. Having no regulations for food or drugs is no more an option than removing all signage from roads and junking driving codes.

While companies have preferential access to the regulatory apparatus through appeals and other processes, and regulators are encouraged to partner industry, and consider the impact of regulations on jobs, this is not a global capitalist conspiracy in the sense of deals that no-one else could support done behind closed doors and imposed on us.  The initial drive to regulation came from us, the people, and our effort to control the power of the sovereign.

There is input from experts, including some representing consumer interests, to the regulatory process and the resulting regulations are publicly available, even if industry discussions with regulators are not.  In the case of drugs, FDA advisory panels are composed mostly of notionally independent doctors and the meeting transcript is publicly available.

Somehow though in the case of recent antidepressants, everyone on FDA panels appraising Spravato and Brexitanalone, bar Kim Witczak, who is not a doctor, and Julie Zito, who is not a prescriber, voted in favour.  Even though Brexitanalone is an ancient drug being hyped up 20 years ago as something that would transform Snow White into a bronzed, skinny, Libidy-chasing third millennium woman.  Me too and three and four might have been her motto – at least that’s the way the pre-marketing hype was tending 20 years ago.  (For Spravato see here and here).

Its not as though we don’t notionally have our guys on these panels.  The panel was stuffed full of what you might imagine were our guys.  Yet somehow….

Our guys never get to see the data.  They depend on FDA to look over it, which at best FDA do literally – they look over it. If we got to see the data afterwards, or at least some scientists did – this after all is supposed to be science and science hinges on data – and our guys knew we could see it, they might man up, other than at those exceptional times that call for political maturity – when faced with a dwarf-eating Snow White.

Its the lack of access to the data that’s key and the myth that RCTs are a good way to evaluate drugs – they aren’t but they provide good boxes to tick.  Clinically RCTs are useless.

With drugs and foods, industry score in another way.  Once a drug is approved they can deploy armies of lawyers to work on possible meanings of “organic”, “artisanal”, “locally sourced”, “chemical imbalance” or “mood-stabilizer”.

Sovereign

In the 1980s, Pharma was among the first industries to push for a global harmonization of regulations. This underpinned a globalization of the industry. The general view was, and may still be, that any problems with this necessary feature of modernity are balanced in health, that most sensitive of areas, by the presence of physicians to act as a counter-weight to industry and as advocates for consumers.

The bottom line though is that even Europe is not sovereign.  It does what America decides.  FDA approved fluoxetine (Prozac) for kids despite recognising the trials showed it didn’t work and that it caused suicidality.  The European Medicines Agency (EMA) and Britains MHRA followed suit and approved fluoxetine for kids.  WHO included fluoxetine in its list of essential drugs for children.  NICE and other guidelines recommended and recommend fluoxetine and other SSRIs for children despite there never having been a single positive trial.

Sovereignty would mean being able to say – look none of these (mostly chlorinated) drugs have been shown to work for children. That doesn’t mean they can’t be used but if we’re going to keep people safe, in this case children, we have to at least be able to call it as it is. Put like this, the idea that Britain is somehow going to regain some lost sovereignty by leaving Europe is clearly nuts.

It is probably unfair to say MHRA is about as craven as a regulator can be.  Its not the job of a regulator to be brave. It is more accurate to say British physicians as about as craven as physicians can be – well at least as craven as European and American physicians.  If physicians stood up to be counted they could make a difference – regulators would have to listen.  But if British physicians did this, there’d be a lot less Sir’s around the place.

The British have a wonderful system to keep people in place – offer to give them letters after or before their name.  Works a treat and costs nothing.

The Backstop

Back when Absolute Monarchs were still the in-thing, England invaded Ireland.  A doctor, William Petty, was given the job of surveying Ireland and its people. Petty created the first GDP for any country anywhere, created the first public health and hints of Evidence Based Medicine and proposed the first Free Trade agreement between any two countries – Ireland and England. Given the Brexit mess now, and all the claims about Free Trade, this is an irony like no other.

Petty’s ideas gave rise to liberalism and public health. His influence came to head, as it were, with the decapitation of Louis XVI in the French Revolution and the replacement of absolute power by regulated power.

It once seemed that this regulated power could always be undone.  There are no better illustrations of this than the 19th century interplay between Ireland, then Europe’s most destitute country, and England, the world’s most powerful. After Ireland was forcibly absorbed by Britain in 1800, Daniel O’Connell, realizing that power in this new world was constrained by laws, and boasting he could drive a Horse and Carriage through any English law, campaigned to get the Irish to hang together peaceably.

His campaign demonstrated a weakness inherent in England’s apparent strength and led to Catholic emancipation in Ireland (not yet in England) and on to a series of Irish inventions including the boycott, and the hunger strike that (give or take a little bit of violence) against the odds delivered freedom to the Irish to oppress themselves – even to the extent of handing over sovereignty to others.  (Its probably not for nothing that the abbreviation for Ireland – IRL – also stands for In Real Life)

But since somewhere in the 1980s, in medicine anyway, the regulatory apparatus has become as it were a learned intermediary between us and industry. Just as companies invoke doctors as learned intermediaries when things go wrong, they now claim to have adhered to all the rules and regulations and that those who work in industry are more rule-abiding and ethical than the average doctor or regulator – just as German soldiers were at least as ethical and professional as American troops in 1944.

The more we drift toward Google cars and away from Horses and Carriages, the worry has to be that piercing this System will be harder and harder.

In terms of drug wrecks, the key factor has been losing access to the data from the RCTs in which we have participated. This data should be as inalienable as our vote. Industry power stems from its seizure of our data. If we take our data back so that our consent must be sought for its use, and we decide when and under what arrangements it is in our interests to co-operate, we take back not just data but power.

We need a medical version of that recent Irish invention – the backstop.  Bottom line is doctors shouldn’t prescribe drugs for which they don’t have access to the data.  There should be a hard border between us and chemicals like this. We have nothing to lose by getting our doctors to insist on this.  Since the 1980s, there have been vanishingly few drugs that industry has produced that we need – Triple Therapy for AIDS, Gleevec for certain leukemias and maybe Solvadi for Hep C.  As things stand there won’t be many more as industry have figured that making drugs that cure disease is bad business.

We could learn something from Study 329 and 329 a Study.  Lets put a backstop in place and see who blinks first.  We wouldn’t need to take the drastic cutting off their eyelids measures that DUP politicians contemplated in the build up to Brexit 329.  Industry would blink first.

(Google “DUP cutting off eyelids” if this is not familiar to you.  Make sure you put DUP in the search term – I take no responsibility for the consequences if you don’t.  The DUP are a Northern Irish unionist party whom most English people think want a union with the South of Ireland.  They are seen by most English people as causing them endless Troubles).

 

Something Stupid This Way Comes

The picture shows Franz Mesmer magnetising a patient.  In between his hands and her head and heart there is a set of little slivers of  metal, capable of being magnetised – shown by the fact they are all lined up the same way.  The therapist was able to influence magnetic fields and could realign bits inside her similarly, undoing whatever blockages were causing her problem – whether she had a paralysis, was hysterical or whatever.

When Mesmer moved from Vienna to Paris, a Royal Commission, put in place by Louis XVI to look into magnetism, concluded there was no evidence for a magnetic influence but a lot of evidence for an influence from the doctor’s suggestions – patients could be mesmerised not magnetised.

Or hypnotised as we’d say now.

The French Royal Commission was set up because Mesmerism suggested the entire social order was held in place by magnetism or hypnosis and we, the sleep-walkers, could conceivably be woken up.  We could be Woke.

Mass Hypnosis

There is an idea out there that only some people can be hypnotised, when in fact we can all be especially when we are in groups – as the Austrians and other German speakers proved in the 1930s and 1940s, and religious revivals and other popular movements repeatedly show.

Whether some of us are more susceptible or not, and whether the hypnosis is being done on an individual basis or not, once induced a key thing is to get the person to do something stupid.  That way the hypnosis deepens.

The very best example of this in the world today happens routinely when people go to a doctor.

When s/he puts you on a medicine, he gets you to focus on just 1 of the 99 things this chemical will do – the essence of hypnosis.  You will not link any of the 99 other things to his drug his voice murmurs – the loss of your ability to make love, your muscle aching, your ruptured Achilles tendon, the feathers you are growing.

If one of those 99 other things is difficult to ignore, maybe you are about to skin yourself alive you are so agitated, or you are compulsively injecting an opioid, the way to deepen the hypnosis is to tell you that this is another illness.

If you are suicidal, this is because you have a bipolar disorder someone missed – here take this as well.  If you are injecting opioids this is because you have an addictive disorder someone missed but we can get the addiction services to treat this while we continue to treat your pain – with an opioid.  If the latest antidepressant doesn’t help, this is because we didn’t realise you don’t have depression, you have an entirely different disorder – Treatment Resistant Depression (TRD).  Here take Spravato – Do Not go Gentle.

What this stupidity should bring home is that it’s your doctor who is under hypnosis not you.

The scene is not your doctor as Mesmer with you as the one mesmerised but the pharmaceutical industry, maybe one of the Sackler brothers, or the health service company your doctor works for in the role of Mesmer – your doctor is the one there in the pink dress.

As with all hypnosis, the spell involves an “If X, then Y”.  In this case if the figures for X  are high, whether cholesterol, glucose, depression scores, give Brand Y – or low as in bone thinning.

Maintaining the Spell

Key to your doctor, nurse, physicians’ associate or pharmacist staying “under” is keeping anything personal out of the interaction.  One way to do this is to encourage him to use rating scales – so much more scientific than just a conversation.  Or as many measuring instruments as possible rather than putting his hands on you or looking closely at you.

Having a computer on his desk, ideally with your record in the form of an electronic medical record (EMR) to occupy his attention is important.  If he’s too occupied with this to spot that you’ve grown feathers, this is ideal.

Another method is group practice, so you rarely see the same person twice and no-one is in a position to notice the change in you from before the drug to after.

The most important thing is to avoid any opportunities for your doctor to make a judgement call.  Hypnosis is like sleep-walking – people can do very complex things but ask them to make a judgement call and they either can’t or they wake up.

Brainwashing

Of course another way to get your doctor is to behave as the powers-that-be want him to behave is to brainwash him – that peculiar form of hypnosis that appeared in the 1950s.  The guideline apparatus is perfect for this. Even the most independent guidelines, are effectively written by pharma.  If pharma run all the trials and ghostwrite the publications, they write the Guidelines – Guidelines work from published trials and nothing else.

But besides the doctors who will faithfully follow the Guidelines because they are guidelines, the rest can also be hypnotised or brainwashed by another function of Guidelines.  As one of the quips about US troops taken prisoner in the Korean War, who went on TV to denounce the USA, had it, you don’t need to brainwash people to get them to say things like this – you just have to aim a gun at them off-screen.

Guidelines are the gun – don’t keep to guidelines doc and you will be out of a job.

Wake Up

How do we get doctors to wake up?

First you need to realise that no matter how awake your doctor appears, he is sleep-walking.

Second, don’t let doctors measure or screen anything unless it has to do with a problem you brought them.  If you happen to be there and they suggest measuring something – your peak flow rate, bone density or whatever – just say No.  If they suggest measuring something linked to a problem you brought them – think about saying No.

Third, don’t go along with your doctor when he suggests something stupid.  If something is going wrong on treatment, its almost certainly the treatment that has caused it.  Don’t buy the line that this is another illness.

Fourth, ask them who they are having an affair with – something, anything that disrupts what might seem like a conversation but it more likely to be a stereotypy.

Fifth, get them to make a judgement call about something that counts – anything.

Something in the Air

The title comes from Macbeth – from the witches one of whose finger-tips start tingling and who says Something Wicked This Way Comes.

We are heading toward a creepy MacMedicine, where companies want you on as many drugs as possible every day of the year – none of which save your life or improve your life expectancy.  The lesson that pharma took from AIDS is that cures are bad for business.

Your doctor can’t be hypnotised as easily with something serious like AIDS and or with a treatment like Triple Therapy that saves lives. Better a statin or an antidepressant any day of the week.

 

 

 

All the Better for the Fishes

Jose Mario Bergoglio in Chile 2018:

To believe in us you have to have Faith, but for me to believe in you you have to bring me proof

Over 150 years ago, describing most of the medicines then available as junk, Oliver Wendell Holmes came up with one of the most famous phrases about medical practice, when he said that:

If all the materia medica (drugs) could be sunk to the bottom of the sea it would be all the better for mankind, and all the worse for the fishes

Recently in Belfast, at a BMA meeting, medical delegates discussed the issue of doctors committing suicide.  There was panic in the air.  Doctors it seems need support.  They should not have to take on an occupational risk like this, delegates said.

There is no evidence that anyone at the meeting was willing to look in the mirror.  Its highly likely most if not all of these medical suicides happened to doctors on pills, a high proportion of which were likely caused by the meds these doctors were on.

A post here some months ago Even Doctors also get killed by Akathisia raised this issue. There have co-incidentally been a number of penetrating comments about this post recently.

The people who are most to blame for this are doctors.  Its doctors who have been handing out these pills and ignoring if not ridiculing patients when they report back that the drug has made them dysphoric, akathisic, suicidal or even homicidal.

Or the treatment has hooked them – See Welsh petition.

Or has caused permanent sexual dysfunction – See Encountering Doctors

A huge proportion of the drugs that every doctor has prescribed during the last ten years have been prescribed on the basis of Fake News – ghostwritten articles and without access to the data from the trials of these drugs.  Doctors could have refused to prescribe without access to the data – but haven’t.

Life expectancy is now falling in America and Britain.  This was entirely predictable given that the science behind prescribing is all Fake Science and given that doctors have been willing to put their patients on 5, 10 or more Fake Medicines every day – where in the 1980s few people were on more than 1 and we had the data behind the one that people were on and the literature was written by who it appeared to be written by.

But there are no BMA resolutions about what we are going to do about our patients’ falling life expectancies. Doctors are worried about themselves – not apparently aware that their patients might hold the answer to what is killing them.

Catholicism

This point can be pushed further. The last year has seen increasing anger about abusive priests and the Church that has sheltered them. This crisis began in Ireland in the 1980s and came to a head in Chile last year.  The Church has been scrambling ever since to manage the fallout. Jose Mario has managed fairly well since his slip in Chile with occasional flips into blaming some of his critics as enemies of the Church.

Its not clear that many people would shed too many tears about the death of an abusive priest or the death of a bishop who had knowingly moved that priest around from parish to parish without getting to grips with the issues.

What is much less well known is that medicine has its share of abusive doctors.  The best known is Harold Shipman but there have been lots of others.  Robert Kaplan’s book Medical Murder tells some of these stories.  A recurrent feature in these cases has been the facility with which the medical authorities have quietly moved doctors from one jurisdiction to another without investigating too closely.

Its not just doctors. The psychologist James Coyne is a very recent example of someone whose shocking behaviors several universities chose to turn a blind eye to and hoped to solve by facilitating a move elsewhere.

But doctors are more dangerous than priests or psychologists.  They openly kill us like Shipman or as Oscar Wilde might have said – lose us carelessly.

The question is how best to treat the profession’s nervous breakdown?  Counselling or mindfulness or even higher rates of pay seem to be the options doctors are lobbying for.

A better bet in terms of restoring morale might be if someone could get the profession to take on a mission – demand access to trial data, believe patients when it comes to adverse events and engage with our falling life expectancies rather than the stressful burn-out inducing handing out meds you don’t believe and wouldn’t take yourself and then ignoring the evidence of harms – because to do otherwise would be “suicide”.

Short of doing this you’d have to say it were better for mankind if doctors were sunk to the bottom of the sea and better for the fishes.

Its not as though anyone will have to push them overboard with their feet encased in concrete to ensure they sleep with the fish – they are busy slipping their own feet into the concrete mix as is.  If medicines are so effective and safe then nurses and physicians associates and pharmacists and robots soon will be a lot cheaper prescribers than doctors

 

 

 

 

DH 2 DH

January 28 2019.

Open letter to David Haslam, NICE

Dear David,

Our paths nearly crossed at an IAPT meeting in London in 2016 but you opted not to speak in a session that had me covering “Some Questions for NICE” – a lecture covering issues that have given rise to this letter.

We brushed by each other in May 2018 when Chris Van Tulleken, in The Doctor who gave up Drugs, based on input from me, is shown contacting NICE about antidepressants and children. NICE refused to comment but claimed they were revisiting this topic.

What concerned him (me) was that pretty well everything in the antidepressants and children domain is ghost written and that every single trial including the 2 trials, which had been the basis of approval of fluoxetine for children in the US and the UK, were negative trials.

File on Four covering the same issue had the same material and message from me. They were rivetted but then claimed they couldn’t fit the material into their programme, opting instead, like Dr van Tulleken, to feature Andrea Cipriani, despite being made aware that Dr Cipriani’s work is necessarily based on ghost written material and that he had had no access to any of the data behind the studies he worked on.

Faced with difficulties in moving some substantial concerns forward, I opted for publication in a peer reviewed journal – the article is attached.

I have given a TedX talk on this topic – https://www.youtube.com/watch?v=vpTqei5hZ3g

And presented the issues in the Welsh Assembly –  https://youtu.be/oku_8t8MLek

Both talks cover material presented in several national and international fora – including how the NICE process fails us – to which I can now add the following for future talks.

On January 23rd, an email from NICE informed me that a draft guideline on depression in children and young people was up for consultation. I was not surprised to find physicians advised in the case of more serious disorders to consider a turn to fluoxetine, or combining fluoxetine and CBT, before turning to sertraline and citalopram if these treatments fail.

Then on the afternoon of the 24th, a follow-up email indicated that sections of the guideline were blocked off from comments. These sections included those I might have commented on. Hence this open letter to you, as you personally may be unaware of the issues.

The fluoxetine trials, which were used for paediatric approval in 2001, just like the paroxetine trials a year later, were negative on their primary outcomes. FDA recognised this for both fluoxetine and paroxetine and were willing to approve paroxetine and not mention in the label that the trials were negative, leaving an unchallenged ghost-written article in the public domain to claim paroxetine worked well and was safe. Essentially the same applies to fluoxetine.

Following the fluoxetine approval, a Panorama programme made it difficult to approve paroxetine, sertraline and other SSRIs.

I am not saying these drugs should never be used. There is evidence they may produce a benefit in paediatric OCD. I can envisage using them in conditions other than OCD. But these drugs cannot be used safely unless clinicians are aware of the true state of the evidence as regards both benefits and hazards, which include making young people suicidal, wiping out their ability to function sexually, perhaps forever, or hooking them to treatments forever.

The guidance mentions that in the case of fluoxetine the risk benefit ratio has proven favourable. This seems to mean provided there might be some benefit any risks can be taken. The data do not indicate that on balance the benefits outweigh risks. There are more negative trials for fluoxetine than any other SSRI.  In the case of the only notionally independent trial (TADS), the study that underpins your recommendation to combine fluoxetine and CBT, there were 34 suicidal acts on fluoxetine against 3 on placebo. I appreciate that this isn’t stated clearly in any of the 7 TADS publications but it is readily ascertained – see Hogberg et al, attached.

The guidance mentions sertraline, perhaps because Dr Cipriani recommended this for adults – on the basis of ghost-written articles and a lack of access to the data. FDA assessments suggest sertraline may be the weakest of the SSRIs for adults.

Citalopram is also mentioned as an option.  Again, the data are inaccessible, the articles ghost written, and one of the key trials has I believe the highest rate of suicidal events in paediatric SSRI trials. The company then marketing it, like GSK, ended up resolving a Department of Justice action against them for a substantial amount of money.

This situation echoes 2004/2005 when NICE personnel compiling the first guideline in this area, wrote an editorial in the Lancet, Depressing Research, questioning whether it was possible to produce guidelines when trial data is inaccessible and the published literature all ghost written.

I’m not clear what the Care in National Institute for Health and Care Excellence means. It may just refer to Care of the Elderly Services. I take Care to mean there is more to Health Care than just another Service Industry – something more like taking responsibility for others as when in the care of people with diabetes we used to tell patients they needed to prick the sides of their finger when taking a blood sample as they might need the pulp of their fingers should their eye sight fail later. As a family doctor, I expect you would agree that there is always going to be a need for those of us on the coalface of clinical care to be alert to the way those who seek our Care integrate technologies, such as a drug that might make you suicidal, into a life that has to be lived.

I have not added any honorifics to your name or mine. This letter is from one person to another, not one office to another.

Yours sincerely,

David Healy

 

Tinker, Tailor, Soldier, Surveillor

The recent moral panic around the Death of MR and the involvement of Instagram and Facebook in her death and maybe that of others is intriguing. Worthy of John Le Carre – at his Tinker, Tailor, Soldier, Spy best.

This may be a cynical attempt by the old media – the BBC or NBC, the New York Times or the Guardian to put pressure on new media like Facebook and Google. There are appearances of concern for the Russell family but no evidence of real concern about anything other than getting a story – or making a point. If there was real concern for the families of any of these teenage girls a lot more would have been done about the hazards of antidepressants before this.

Despite the appearances, it’s entirely possible that this crisis has been engineered by Facebook to gain an advantage. It brings to our attention the possibilities that Facebook or Google might be able to flag up people who are actively suicidal and be able to intervene.

Shortly before the Russell brouhaha began unfolding in the UK, the New York Times reported that Facebook and other media companies have been using their surveillance methods to pick up people who may be actively suicidal and intervening – Minority Report like – for instance sending Tom Cruise around to save a life .

An article by Mason Marks in the Yale Journal of Health Policy Law and Ethics recently – HERE – outlined a number of the hazards involved in this, ranging from compromising peoples credit records to detention and forced medication or triggering death by cop.  Forcing Facebook to delete images in the Molly Russell case helps make a case for using the technology to intervene in other cases and making it even more of a policeman in all of our lives.

The latest big thing are Home Hubs, Personal Assistants like Alexa, intelligence units aimed at making homes smart.  These units will register every emotional nuance we have, all our contacts and activities. We could drift very quickly into an uncomfortable position.  Not just those of who buy them but those who don’t – what have you to hide then?

If the Police can…

As things stand, as an expert witness in cases where a drug may have played a part in triggering a suicide or homicide, I have for years been presented with police searches on their computers showing the sites people have visited before and after going on an antidepressant.  This is a powerful aid in working out whether the homicidal or suicidal thinking began before or after treatment – or whether it changed in character.  If the police using old tech have been able to do this for years, its unquestionably the case that Facebook and Google and other companies can do it.

They unquestionably could contribute evidence as to the rates at which people going on antidepressants become suicidal or have a malignant change in their thinking.  They can easily establish whether the kind of imagery Molly Russell may have viewed was provided by people who had gone on an antidepressant and become suicidal even if she hadn’t.

But were not hearing about this.  Why not?

What we’re getting is a confected fuss that looks like it suits the interest of government for greater surveillance capabilities and the new media – no one is particularly worried about the old media these days, except putting them to some good use before saying adieu.

One more aspect to this story though is the indifference of Facebook and Google to whether any of us lives or dies. Their argument is that it’s not their brief to worry about things like this.  This would be an invasion of our sacred privacy.

The links we make and the traces we leave provide material that can be put to use (and they can make money from) but it’s exactly to same traces and links that are on the one side being blamed for MRs death but on the other side could be used to help save her. The argument is we cannot get one without the other.

Of course you can – you might respond. It’s a matter of making a judgement, a diagnosis, coming to a verdict. But judgements and verdicts are exactly what Google and Facebook do not do. For them everything is equivalent – there is no evil – there is no good. They operate like a thermostat that will turn off the heating at a certain temperature and on at another but do so without making a judgement about whether a higher or a lower temperature is good or not. It’s a function.

But still we set our thermostats as Google and Facebook set theirs with theirs designed to avoid making any changes that reduce their revenue stream.

And the money always comes from the herd rather than any individuals within it.

This is the scenario Lily, Pfizer and Merck depend on when they claim that anecdotes are not data and that whether clinical trials show a problem or not is the only thing that counts. An individual making a good case for a connection between an antidepressant and suicide is a voice crying in the wilderness.

Curious that a business that depends on the plural of anecdote being data doesn’t disrupt that.

All Muslim Now

The image above shows an outfit designed to avoid surveillance – to avoid being tracked around town. There is a growth industry in people buying anti-surveillance gadgets like shields to block their webcams on computer and phones – they can be bought on amazon.

It seems a younger generation are much more savvy and already taking steps to create ways of living with some freedom in our new surveillance states.

One of the cute things about the outfit above is it offers us all a chance to look Muslim, or perhaps the way Catholic nuns used to look 50 years ago.  We may be all KKKing yet or Hijabbing.  There’ll be a premium on a good pair of ankles, for men as well as women.