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...]

Archive for Hiding the bodies

Where Does Change Come From?

By the Rivers of Babylon

Societies keep order. They have to.

For millennia, religion has been key to achieving this. Religions may aspire to make men free and able to live a full life but they also embody a set of rules designed to keep chaos at bay.  A Superego whose mission is to keep an Id in check.

This has been particularly clear in the religious regulation of procreation and family life.  While there have been challenges from romantic love, and eroticism was sometimes incorporated into religion, until very recently societal needs to contain the chaos eroticism might bring meant the institution of marriage triumphed over individual choice. To stray was to sin.

We couldn’t have catholic girls falling in love with protestant boys, sunni girls with shia men, or chinese women with anyone from outside the group – although Judaism solved this slightly by having identity pass down through mothers.

The Erotic

The French Revolution was close to the first Revolution.  Almost all prior events had been rebellions where one nation or tribe rebelled against the rule of another or for instance a protestant people had rebelled against a catholic overlord.  In Paris in 1789, pretty well for the first time, a people rose up against their own.

Within the Revolution, there was an earthquake – the Reign of Terror – when the liquefaction that lies beneath burst through the veneer of civilization. The rulers became intensely scared about the people and located crime and criminality within the rabble.  What we did was sophisticated what they did was wrong.

The Marquis de Sade was one of the symbols of the upheaval.  He had been imprisoned in the Bastille and later in an asylum for his erotic works, before being liberated and becoming a member of the Assembly. Nevertheless his works were burnt on his death and it was to take almost two centuries for Sade to be tamed and admitted into the canon of literature.

With the re-imposition of civilization in the years after the Revolution, the clash between the new bourgeois propriety and eroticism grew particularly acute. Madame Bovary chafed within the confines of bourgeois life in provincial France, just as April Wheeler did in Revolutionary Road a century later.

In between Emma Bovary and April Wheeler, in 1869, Leopold von Sacher Masoch’s Venus in Furs gave the purest of statements of the revolutionary potential of eroticism.  The relations between the sexes it said could never be right until she has the same education, status and power as he.

Tumescent eroticism fueled the suffragette movement but to the surprise of early feminists women’s growing awareness of themselves as a political force was not enough to stop the Great War.  Women seemed no more capable than the working class of acting as a coherent force.

April Wheeler died just before eroticism was tamed good and proper. In the 1960s love became free thanks to oral contraceptives. It became part of a new consumer culture.  Between shopping and sex we could all consume almost without consequence it seemed until AIDs darkened the horizon in the 1980s.

Those who sought to capture our attention with the need for personal and social reform, from Protestant Evangelists and the Catholic Church on the right to Marxists on the left, despaired. With so much to consume, where would the impetus to reform come from? Who even had time for revolution? The Internet has probably put paid completely to the prospects of a Revolution driven by eroticism.

Jazz

In 1917, in the midst of the Great War, the year of the Russian Revolution, jazz was born. It had been preceded, John the Baptist like, by ragtime, which the social establishment had united in labeling degenerate.

For centuries, perhaps millennia, music had managed to unite thoughts of order and aspirations toward freedom. From Bach through to the late nineteenth century, a great flourishing of music had underpinned revolutions – best caught perhaps in Beethoven’s Ninth Symphony. But within music the forces of order began to constrain the emotional possibilities and by the end of the nineteenth century classical composers increasingly sought a new language, experimenting with atonality and other deviations from normality, almost like the Marquis de Sade, to force people to confront things rather than go to sleep. But they largely lost their audience in the process.

As this experiment was failing, Jazz took the rules and form of classical music and subverted them.  Every individual player was given the liberty to improvise within a common framework.  No two performances would ever be the same. Order in music was dissolving and a new freer form was apparently being born. Marxists at least celebrated its emergence.

Through to the 1950s in the West, jazz was synonymous with freedom. It was still the music of freedom through to 1980 in Eastern Europe.  Once endorsed by thinkers from both Left and Right as the music of emancipation, jazz performers today still link what they are doing to freedom.  But it had lost its edge in the West by 1960, descending into intellectually sophisticated improvisation not much more accessible that the experiments of classic music on the one hand or into rock and pop on the other, with the latter being the new conformity.

And by this time, the Revolutionary potential of American democracy seemed spent. It was time for a March on Washington.

Mad Pride

In the 1960s, Revolution was again in the air. But by this point, jazz and eroticism had lost their revolutionary edge.  They were replaced by mental illness as the New Black.

Two hundred years previously, in the 1760s, Jean-Jacques Rousseau had made the first links between social alienation and mental alienation.  Where previously civilization had been seen as the beautiful, Rousseau made the case that we were born free and the natural was where beauty lay. Social conventions had alienated us from our true selves.  Beauty might lie in wilderness.

At this point, words collided. The raving and delirious states that led civilization to figure some of those who were most affected should be incarcerated for their own good was at the time of the Revolution referred to as mental alienation with the doctors who would treat the alienated called alienists.

In the midst of the Reign of Terror Philippe Pinel, otherwise a fan of Rousseau’s, was faced with a Jacobin party fresh from liberating the prisoners from jails entering the asylum in search of alienated patients whom, a la Rousseau, they assumed were only there because they did not fit into social norms.  Finding a patient who seemed to fit the bill, they liberated him – only to bring him back a few days later conceding that he really had something wrong with him.

Pinel went on to create the disease model of mental illness according to which mental illness, whatever it was, was not a form of protest.

There things stayed for over a century and half until the Revolutions of 1968.  All of a sudden, mental disorders became a prism for a Revolution against colonization.  Middle class College students protested their colonization by their parents. Women sought freedom from male colonization. Everyone became increasingly aware of ever more insidious effects of colonization by white middle aged middle class men.

The mentally ill were the ultimate symbol of this colonization. Psychosis was a political rather than a medical state.  It was what happened if you didn’t protest. Ronnie Laing and Thomas Szasz toured campuses with this political message, which led to protests erupting on the streets from Tokyo, through Paris to Chicago.

But mental illness was all too tamable.  Notwithstanding Mad Pride, being mental is now the ultimate symbol of conformity. Rather than threatening anyone, women show they are coping by letting everyone know they are taking an antidepressant. Puerperal depression, which had been seen as a protest against a change of role or emerging awareness that the man you were living with was not someone you wanted to live the rest of your life with, has become an endocrine disturbance.

Now that we are all mentally ill, there is nothing subversive or revolutionary about the idea that we are becoming unhinged. We no longer think we don’t need to adjust our sets, there is something wrong with reality. We now need society and the order it imposes not to solve our problem but to guarantee a continuing supply of the little objects of desire we use to keep our (or society’s) inner demons in their proper place.

Where might change come from in this modern world?

To be continued.

Burn Baby Burn

Editorial Note: This is the third part of a talk giving to the BNPA on February 22.  It follows on from Tweeting While Psychiatry Burns and Tweeting While Medicine Burns.  The final group of slides are HERE

The talk you have just heard was first given in Toronto on Thursday November 30 2000 to mark the 75 anniversary of the University Dept and 150 anniversary of the Queen Street Mental Hospital (Slide 1).  The Chads were still hanging in Florida while the Supreme Court tried to decide whether Bush or Gore had won.

I had recently been hired by the University of Toronto and I and a number of others had been invited to contribute to a meeting to celebrate the occasions.

I led off the program with the talk pretty much as you’ve heard it.  The word for word original is HERE.

One of the other speakers was this dude – Charles Nemeroff.  Nemeroff was quite happy at this point in time to be featured as the Boss of Bosses (Slide 2).  He wasn’t the boss of bosses because of any scientific or clinical contribution of which there was none.

In line with these Mafia connotations, at the meeting Nemeroff approached one of the key people involved in my hiring and suggested they get rid of Healy.  According to Nemeroff later, this individual wet his pants. The University later claimed my colleagues were disturbed by the talk and would have found it difficult to work with me.  They also claimed Healy had said Antidepressants cause Suicide which was like crying Fire in a crowded theater.

The talk was as you’ve heard it.  It was a talk about lack of access to data not about antidepressants and suicide. It was the plot of a book then in press – The Creation of Psychopharmacology (Slide 3).  Harvard University Press don’t do wild or off the wall.

My talk received the highest rating on the day by the audience which seems at odds with later university claims.  Nemeroff was the lowest (Slide 4). His talk was largely an advert for paroxetine (Paxil – Seroxat) and how it was more of an SNRI than people thought which didn’t seem particularly appropriate for the occasion, but perhaps interesting in that he seemed to be thinking about being an expert for GSK in the forthcoming Tobin trial.

Escape to New York

Nemeroff flew to New York that Thursday night.  The following morning, Friday, at a Suicide Prevention meeting he told colleagues that Healy had lost his job.

Unaware of any of this, I flew to New York on Friday morning and that afternoon was a few blocks away from Nemeroff.  Neither he nor I knew this.  I was in Pfizer’s archives where even the loo paper was marked confidential. Articles in the public domain for years were stamped confidential.

But extraordinarily this document wasn’t (Slide 5).  This page comes from a portfolio of articles on Pfizer’s Zoloft. covering the writing of articles on Zoloft for ingrown toenails, for anxiety, for the elderly, for the young and how it was cheaper than older treatments that cost only a fraction of its price.  This page shows you that there were two articles on PTSD being ghostwritten for leading journals.  The articles were written, the journals selected, the company just had to decide on who the authors were going to be.  TBD stands for To Be Determined.

Based on this portfolio of articles we were later able to show that heading toward 100% of articles in the peer reviewed literature on on-patent drugs are ghostwritten. In 100% of cases there is lack of access to the data.  This is true across medicine.  It applies to respiratory, neurology and cardiac medicine as much as to psychiatry.

What it means is that for instance the NICE guidelines which are based on these articles are Junk. Complete and utter junk. But increasingly our trainees and everyone else are trapped by Guidelines like these. We will lose our jobs if we don’t adhere to them.  This is what has led to the opioid epidemic in the US.

Tweeting

A few days after I gave this talk, I was informed that I had lost my job – I wasn’t a good fit and the department would lose money.

Over the last sixteen years when visiting the US, I have been struck at what can only be called a Medical McCathyism. Everyone in healthcare is scared to open their mouths.  While the average American is probably still prepared to stand up for themselves than the average European, when it comes to doctors at times it feels like the land of the craven and the home of the slave.  Just last week, however, the President of Royal College of Surgeons in Britain made a case that medicine in Britain is heading exactly the same way.

Pretty soon after this talk, the worry has to be most of us in the US, UK and Europe are going to lose our jobs – at least going to lose the kind of jobs many of us thought we were taking up when we entered the field.

If the drugs are as effective as we are told and as free from side effects as we are told, you can replace high cost prescribers with nurses, pharmacists and pretty soon with robots.  This is in fact happening quite rapidly.

In the 16 years from 1952 to 1968 the world changed in astonishing ways.  In the 16 years since I first gave this talk, it seems to have changed almost as much again.

So when some future historian in a very few years from now, looks back at this period and wonders about the senior figures in the field – the Jean Delays (Slide 6) – in the UK they will have Sir before their name – will say they say it was a time when the field’s significant figures tweeted while psychiatry burned?

 

Note

The slides here changed from the original 2000 slides at two points.  The weighing scales slide is now in color. In 2000 it was black and white.  And the Risk Hammer now replaces a Hamburger – hamburgers were scary images in 2000 with BSE.

The original words are HERE.

Later on Monday, the day of posting, Barney Carroll emailed this comment and the article that goes with the photo of the Boss.

I stumbled upon this photograph on Twitter today, courtesy of David Healy. It’s a pair with the classic fawning article about Nemeroff, which I will attach as well. The article is written by James LaRossa who bought the rights to Psychopharmacology Bulletin in the mid to late 1990s and then hired Nemeroff to turn it into a vehicle for infomercials. These bring back such fine memories!

Boss of Bosses  Charles B Nemeroff, MD, PhD

Charlie Nemeroff is sitting quietly at the speaker’s table, ignoring the bustle going on around him. His face betrays nothing – neither boredom, nor interest, or apprehension. Only the blinking of his eyes distinguish him from a statue. When he hears his name he rises very slowly, and begins to move to the lectern with deliberate strides, gathering speed as he goes, brightening now. He breaks into a grin and begins speaking the minute he approaches the microphone and, before the hush of the room takes hold, he has won the crowd with a disarming and deliberate manner that cuts simply to the heart of the most complex issues in neuropsychiatry.

Charles B Nemeroff, MD, PhD, chairman of the Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine in Atlanta, finds himself addressing a room of crowded colleagues hundreds of times each year. Even in the ultra-competitive world of medicine and academia, Nemeroff is admittedly the most coveted academic speaker in psychiatry in the United States. His prolific authorship (he has published 600 research reports and reviews) along with a sheer enormity of research grants, awards, and scientific board appointments, has afforded him unprecedented celebrity within the psychiatric community.

Nemeroff’s academic and intellectual largess translates to a small and influential group of close friends, including fellow department chairmen Alan Schatzberg (Stanford), Marty Keller (Brown), Dwight Evans (U. Penn), Bob Hirschfeld (U. of Texas, Galveston) and NIMH heavyweight Dennis Charney, all of whom spend a great deal of professional and personal time together. Psychiatry is a highly charged topic these days, and these six thought leaders walk a fine line between controversy and political correctness, often made possible by their strong allegiances both to topics and to one another.

The ethics surrounding the implementation of placebo-control trials is one of psychiatry’s most supercharged political issues, as is addressed in more detail in this issue of TEN. “From a scientific point of view, the best data on efficacy of any treatment is best derived from placebo-controlled trials,” Nemeroff says. But with diseases like cancer and stroke, placebo trials become unethical. Thus, “the FDA in most cases has allowed for comparison between novel treatments for devastating disorders with traditional already-approved treatments.” If a novel agent proves efficacious against an existing agent, it gets approved. But “that has not been the case in psychiatry. And we have to raise questions about the use of placebo in conditions like mania, where patients are terribly ill. [In these cases] one wonders why it isn’t sufficient to have evaluation based on ‘just-as-good-as’ or ‘better-than’ currently available treatments and better side effect profile.”

Nemeroff is among the most coveted advisors to the pharmaceutical industry. Predictably, rumors about his alliances, or lack thereof, abound. It is safe to say that his views are expressed in a forceful manner he is a passionate person ­ and he fully expects to lead the corporate strategy of those he advises. Those who do not heed his advice are often recipients of his wrath. Consequently, Nemeroff is often in favor with the most successful drug makers, since those firms are doing the lion’s share of research, which he often directs.

Privately, Nemeroff is circumspect about the role between private and public funding. Working with industry can “be a win-win. There is a shared vision but also separate mission. The university mission is a troika: research, teaching, clinical service; whereas the pharmaceutical industry [mission is to] discover new drugs and to market them effectively. Sometimes those goals are simpatico and sometimes they’re not.” As an example of a situation where industry funding works to the benefit of the scientific community, Nemeroff recounts a new teaching council that he started recently with a grant from Janssen called The Young Faculty Development Program, where young professors get the opportunity to learn about clinical issues and academic life. And he talks also about the differences he sees between today’s young clinicians and those of his generation. ”In the past, there was a clear schism between psychoanalytically oriented psychiatrists and so-called biological psychiatrists. Today, this mindframe dualism seems silly… Patients of course have both minds and brains.” The fact of the matter is that psychosocial factors… can certainly affect how the brain functions and we also   know that the brain itself changes. The nature/nurture controversy is really no controversy, as we’ve improved our understanding of the brain.”

The Bronx-NY-born Nemeroff is most content being both a researcher and a physician. As an example, he recounts a part of the very day of this phone interview. “[Earlier today] I saw four patients, one on emergency consult; at the same time, I was dealing with a number of issues related to an NIMH grant of the psychobiology of early trauma. What can be better than being a teacher and a researcher and a physician?”

James La Rossa Jr. & Genevieve Romano

Tweeting while Medicine Burns

Editorial Note: This is part 2 of a 3 part lecture given on February 22 that began with Tweeting while Psychiatry Burns.  The text and slides continue from last week. The slides for this part are Here. The numbering continues from last week. 

When his office was ransacked, Delay’s world was turned upside down but psychiatry and doctors are still here – so we won, didn’t we?

Corporate Medicine

We didn’t win. Both psychiatry and anti-psychiatry were swept away and replaced by a new corporate psychiatry. In 1967, the year before Delay was upended, JK Galbraith argued we no longer have free markets with companies making products we need.  Instead corporations now shape our needs to meet their products (Slide 12).  It works for cars, oil, and everything else, why would it not work for medicine? Prescription only status makes medicine easier than any other market – a comparatively few hearts and minds need to be won.

Within psychiatry, two factors played a part.  One was the emergence of Big Science. This graph from 1974 (Slide 13) shows the correlation between affinity for D-2 receptors and the clinical potency of antipsychotics.  It was one of the most famous images in modern psychiatry until replaced by fMRI scan images.

The image remains as accurate today as when it was first published.  But these binding data introduce something else as well, for which neither Seeman nor Snyder, nor others who developed radiolabeled techniques can be held responsible.  They introduced a new language, a language of Big Science.  Where previously psychiatrists and antipsychiatrists and patients were using the same language, this no longer applied after 1974.  After 1974, to get into the debate you had to have a manifold filter and a scintillation counter.

This as it turned out was not a science that worked in the interests of patients. No longer answerable it seems to how the patients in front of us actually looked, following the science, we moved on to megadose regimes of antipsychotics that may have harmed as many brains as were ever injured with psychosurgery.  Science won’t necessarily save us, it must be applied with wisdom.  We have moved into an era when we depend on our experts in a new way – we depend on them to be genuine. Conflict of interest began to play as an issue.

Big Risk

Another factor stems from figures like Rene Descartes (Slide 14), Blaise Pascal and others, who were behind the development of statistics and probability theory. This laid the basis for the Enlightenment.

Statistics initially referred to government statistics – a process of mapping peoples rather than just the land. This led on to the notion of the rule of the people by the people, the creation of social science and epidemiology, along with public health and insurance.

The same forces led around 1900 to the first attempts to map the human individual, their attitudes and abilities, personality, or intelligence.  Sales such as the IQ scale led to new concepts of norms and deviations from those norms and psychologists emerged to take a place in the educational system, the legal system, and in the government of ourselves – it was this that underpinned the psychodynamic revolution (Slide 15).

This was not just the replacement of theology and philosophy – the qualitative sciences – by a new set of quantitative sciences.  The new sciences set up something else.  They set up a market in futures.  A market in risks.  We were on our way to becoming a Risk Society (Slide 16).  In the case of the IQ test for instance, deviations from the norm were now something that predicted problems in the future.  Parents sought out psychologists in order to improve the futures for their children.  This was how we would govern ourselves in the future.  Through the marketplace.

Drugs entered this new market in many different ways.  The oral contraceptives for instance are clearly not for the treatment of disease.  They were a means of managing risks.  Where once, the risks of eternal damnation had been those that concerned people, now it was a much more immediate set of risks – we switched one set of future risks for another (Slide 17).

The best selling drugs in modern medicine don’t treat disease.  They manage risks.  This holds for the antihypertensives, the statins to lower lipids and other drugs (Slide 18). It holds for antidepressants, which have been sold on the back of efforts to reduce risks of suicide (Slide 19).

All the Evidence that’s Fit to Print

The development of probability theory also gave rise to clinical trials.  We are now in an “Evidence Based Medicine” era. What can go wrong if we have clinical trial evidence to demonstrate what works and what doesn’t (Slide 20)?

But clinical trials in psychiatry have never shown that anything worked.  Penicillin eradicated a major psychiatric disease without any clinical trial to show that it worked.  Chlorpromazine and the antidepressants were all discovered without clinical trials.  You don’t need a trial to show something works.  Haloperidol and other agents worked for delirium and no one ever thought to do a clinical trial to support this.  Anesthetics work without trials to show the point.  Analgesics work and clinical trials aren’t needed to show this.  Clinical trials nearly got in the way of us getting fluoxetine and sertraline.

Trials demonstrate treatment effects.  In some cases, these effects are minimal.  The majority of trials for sertraline and for fluoxetine failed to detect any treatment effect.  In clinical practice many of us are under no doubt that these drugs do work.  But if our drugs really worked, we shouldn’t have 3 times the number of patients detained now compared with before, 15 times the number of admissions and lengthier service bed stays for mood and other disorders that we have now.  This isn’t what happened in the case of a treatment that works, such as penicillin for GPI.

Aside from this, professors of psychiatry have been jailed for inventing patients, much of the scientific literature is now ghost written, many trials are not reported if the results don’t suit the companies sponsoring the study, while other trials are multiply reported making it difficult to work out how many trials there have been. Within the studies that are reported, data such as quality of life scales on antidepressants have been almost uniformly suppressed.  More generally there is no access to the data. To call this science is misleading.

Medical Robots

But these are not the most important consequences for medicine of clinical trials. The critical development is contained in the following quote from Max Hamilton in 1972 about his rating scale:

“it may be that we are witnessing a change as revolutionary as was the introduction of standardization and mass production in manufacture.  Both have their positive and negative sides” (Slide 21).

Anyone who has used the Hamilton Rating Scale for Depression will wonder what is this man talking about when he talks about a revolutionary aspect to using a checklist like this.  Maybe as a communist, he was sensitive to things that we are not sensitive to now.

Rating Scales have been such feature of psychiatric trials so long now that it is perhaps difficult to see that there are revolutionary aspects to what happened.  We use these checklists in all walks of life from sexual behavior, to children’s behavior. Where once there was life’s rich variety, now our children fall outside all sorts of norms when checked against these lists.  And when they do parents desperately want to bring their children back inside appropriate norms.  We bring them to psychologists and to doctors.

The figures on treatment effects from rating scales used in our clinical trials have set up a new market.  When you consider that as far back as 2000 we were treating children from the ages of 1 to 4 with “Prozac” and “Ritalin”, you realize that we are not treating diseases here (Slide 22).  Pharma makes markets but until recently they have not sold psychotropic drugs to children.  The explosion of drug use in children is a manifestation of the force that fills the sails of pharma marketing.  It comes from us. What parent could not want to minimize future risks for their child?

Anorexia offers an analogy for what is involved (Slide 23).   Clearly people have starved themselves for millennia for all kinds of reasons. But Anorexia nervosa emerged in 1873 a few years after the first weighing scales.  Eating disorders increased in frequency in the 1920s when weighing scales migrated into drug stores complete with a plate featuring norms for ideal weight.  In the 1960s, the frequency increased yet again with new variants mushrooming – as we all bought portable scales for our bathrooms.

Competing theories have focused on the possible psychodynamics of the problem, the biology of the problem, or socio-political aspects of the problems.  None of these recognize the role of scales and norms for weight and deviations from the norm and an awareness that deviations in the direction of what had formerly been thought to be healthy and beautiful carried risks.

This problem applies to any situation in which we have a datastream frm one area of our life but not others.  It applies to figures for GDP which run the risk of seriously distorting society in general.  The problems seem likely to get worse with the proliferation of Health Apps.

But there is another consequence for medicine itself. Figures like scores on a Hamilton Scale set up algorithms – If X, then do Y.  The figures drive the prescription of drugs.  But the use of checklists like this looks scientific to managers who run health systems.  They want staff to stick to checklist questions in clinical encounters rather than have doctors or nurses talk to patients.  Its scientific after all in a way that conversations are not.  And doing things this way means doctors can be replaced by nurses and pharmacists and everyone in the near future will be replaceable by robots.

Serial Killing

Harold Shipman (Slide 24) was one of the greatest serial killers ever. He killed over 200 people with opioids.  Shipman’s case illustrates that situations where trust is important can provide the conditions for extraordinary abuses.

One of the conditions where trust applies is in prescription only arrangements.  This arrangement was introduced to restrict bad drugs but now applies exclusively to the good drugs.  Since 1951, the idea is physicians would quarry information out of pharmaceutical companies on behalf of their patients and would provide the counter-balancing wisdom to market forces.

Since 1951, pharmaceutical companies have grown to be the most profitable on the planet.  There has been a change from companies run by physicians and chemists to companies run by business managers who rotate in from Big Oil or Big Tobacco, advised by the same lawyers who advise Big Oil and Big Tobacco.

In the case of tobacco industry, it now seems clear the advice was not to research the hazards of smoking, as to do so would increase the legal liabilities of the corporations involved (Slide 25).  Similar advice given to the managers of our pharmaceutical corporations would be completely incompatible with prescription-only arrangements.  Advice like this converts prescription-only arrangements into a vehicle to deliver adverse medical consequences with legal impunity.

Prescription only opioids are now linked to 30,000 deaths per year in the USA. This happens because clinical trials have been cleverly built into guidelines to mandate the use of opioids for minor pains where wisdom would say this was a bad idea. These trap doctors because their managers will now sack them if they don’t keep to guidelines. We have institutionalized Shipman.

I happen to believe that Prozac and other SSRIs can lead to suicide.  These drugs may have been responsible for 1 death for every day that “Prozac” has been on the market in North America.  Many of you will probably not agree with me on this – but you haven’t seen the information that I have seen.  However we can all agree that there has been a controversy and since the controversy blew up, there has not been a single trial carried out to answer the questions of whether “Prozac” does cause suicide or not.  Designed yes, carried out – no.

Fake Science

With the mapping of the human genome, we have the possibilities of creating new markets (Slide 26).  We need this data and the data from clinical trials to govern ourselves.  The genetic data will tell us about some of the underpinnings to our beliefs – why we believe some of the things we do in the religious and political domains. But the products of this research along with trial data will belong almost exclusively to pharmaceutical corporations, and at present this democratically important data is being deployed against the interests of democracy.

It is also increasingly been managed through organizations like Sense about Science who run Science Media Centers to ensure we are all fed the interpretation of the latest science that best suits corporate interests.

In Slide 27 you see another image of the future. In the course of the last 70 years, plastic surgery evolved into cosmetic surgery.  Plastic surgery began as a set of reconstruction procedures aimed at restoring a person to their place in the social order.  It evolved into cosmetic surgery when the reliability with which certain procedures could be carried out passed a certain quality threshold.

The word “quality” is pervasive in healthcare today.  Quality in modern healthcare however does not refer to genunine interactions between two people as it did in the 1960s.  Quality nowadays is used in an industrial sense to refer to the reproducibility of certain outcomes.  Big Mac hamburgers are quality hamburgers in this sense — they are the same every time.

Viagra gives good indication of what will happen when we get to this stage.  Viagra is a drug that produces quality outcomes – reproducible outcomes.  When this happens, it becomes possible to abandon the disease concept.  Pharma talks openly instead about lifestyle agents.  This is the world that lies in store for us.  It is not the world of traditional medicine, where drugs treat diseases to restore the social order.  It is a world in which medical interventions will potentially change that order.

But cosmetic also suggests fake – that behind the appearances things might be rotting. The boxes that proliferate in healthcare today are being ticked ever more faithfully but behind the appearances our services are disintegrating.

1952 – 2000

This returns us to the picture of Delay and his colleagues (Slide 28).  If some relatively minor person from the UK or US – a white man visited Delay with a research proposal – Pichot and Deniker would be summoned and might be left standing behind Delay for an hour while he discussed matters with the visitor – Pichot on the right and Deniker on the left.

This was not an experience that Deniker or Pichot experienced as some exquisite form of torture or as a humiliation.  It was a different time.  Honor and loyalty counted for more then than the search for individual authenticity we now have.  The hierarchy and the collective was something these men believed in.

What this shows is that there are forces at play that can change not only the kinds of drugs we give, not only the conditions we think we are treating, but our very selves who are doing the giving.  These forces can change us just as profoundly as we can be changed by a handful of LSD containing dust.

to be continued..

 

Tweeting While Psychiatry Burns

Editorial Note:  This is part 1 of a lecture given at a British Neuropsychiatric Association meeting in London on February 22 under the heading of Psychopharmacology: 1952 – 2017.   The lecture will feature here in 3 posts of which this is the first.  Slides 1 -11 can be found HERE.

The Birth

This picture is taken from a newspaper in 1952.  It features Jean Delay wearing navy coat, with Pierre Pichot on his right and Pierre Deniker on his left (Slide 1).

Within the hospital behind them, the ice has just melted.  Following the ideas of Henri Laborit, they had been giving chlorpromazine which blocks the body’s responses to being chilled down. The hope was that radical cooling would chill patients out in a way that would be useful in the treatment of nervous problems.  This was called Hibernotherapy – which always sounds good to an Irishman.

The nurses observed that neither the ice nor the Irish were needed – chlorpromazine given on its own was a chill pill.  The nurses were written out of a script that had Delay and his team discovering the antipsychotic effect of chlorpromazine, the discovery that underpins modern psychiatry.

The photograph has always suggested to me a father after the birth of a first child rushing out to tell the world the good news. But this is far from a spontaneous photograph.  There is a rigid hierarchical arrangement here.  Delay is distinguished by his navy blue coat, which he and only he wore around the university and hospital ground.  When he was later elected to the Académie Française, he would wear the ceremonial sword that went with membership whenever possible.  He would have been a Sir in the UK. He is talking to Pichot rather than to Deniker, the discoverer of chlorpromazine because Pichot is, strictly speaking, the second most senior person in the Department.

There are things happening in the background, however, that will change everything.   In the course of World War II, psychiatrists in the military have discovered that group therapies can have a dramatic impact on the nervous disorders produced in soldiers by the War.  These therapies work best it seems where they involve a dissolution of the hierarchies of both pre War European social life and Army life.  The more informal the setting, the better.

The other thing that is happening stems from another war that began in 1914 – a War on Drugs.  This began with the Harrison’s Narcotics Act, which made the opiates and cocaine available on prescription-only.  In 1951, a Humphrey-Durham Amendment to the 1938 Food Drugs & Cosmetics Act made all the new drugs produced by the post-War pharmaceutical revolution, the new antibiotics, antihypertensives, antipsychotics, antidepressants, anxiolytics and other drugs, available on prescription-only.

One of the consequences of this is that chlorpromazine and the later antidepressants bring about a de-institutionalization of – psychiatrists. Not their patients.

Not everybody is happy with the new arrangement.  Many complain that a system designed for addicts is not appropriate for the citizens of a free country.

A combustible set of ingredients has been put in place that will lead to an explosion. It only took 16 years for the explosion to come.

Revolution

In slide 2, you see Tokyo University on fire.  Tokyo sits at the apex of the Japanese hierarchy.  The students have occupied the Dept of Psychiatry and stay for ten years. Psychiatric research in Tokyo is brought to a halt. The most powerful psychiatrist in Japan, the professor of psychiatry in Tokyo, Hiroshi Utena, is forced to retire.

Why this only 16 years after chlorpromazine had liberated the insane from their straitjackets?  Delay boasted chlorpromazine restored humanity to the asylums.   Previously, lunatics had been guarded by jailers, who treated them brutally.  Now it was possible for therapists to see the humanity of their patients and talk to them.  The level of noise in the asylum has fallen.

However, the times have seen the emergence of an antipsychiatry that responded that real straitjackets had simply been replaced for chemical straitjackets – the camisole chimique.  The silence within the walls of the asylums is the silence of the cemetery.

A revolution is in progress stemming in great part from the new drugs and the interaction between these drugs and the social order in which people live.  The drugs have played or threaten to play a huge part in a changing of the social order.

The discovery of chlorpromazine was the discovery of a drug that acted on a disease in order to restore a person to their place in the social order. But out of the same test tubes and laboratories came LSD and the psychedelics, Valium and the benzodiazepines.  These were not drugs that restore people to their place in the social order.  These were drugs that had the potential to transform social order.

By 1968, another drug, the oral contraceptive, had begun to transform the social order by changing relations between the sexes (Slide 3).  In 1968, for the first time, the French clothing industry produced more trousers for women than for men.  By 1968, feminism had appeared to challenge the colonization of women’s minds by men.

1968 saw the culmination of a project begun by Rousseau and Voltaire, the Enlightenment.  This was a project, which supposedly dethroned kings and gods.  It claimed that the people should be ruled by the people and that an individual’s place in society should depend on merit. But white middle aged and middle class men were still in control.  Women, the young, other ethnic groups had no place — until 1968.

In 1968, antipsychiatrists protested against the colonization of the minds of ethnic groups by white Europeans (Slide 4), the colonisation of the poor by the rich, the colonization of the minds of the young by the old.  They castigated the new drugs as a means of controlling the young.  Madness was the protest of the colonized.

Dependence

The anti-psychiatrists had a number of powerful weapons in their armory.  One was ECT.  As Thomas Szasz put it – what the rack and the stake was to the Inquisition, ECT is to organized psychiatry.  Its visibility gave it a pivotal role in the pivotal movie One Flew over the Cuckoo’s Nest (Slide 5).

Another weapon was Tardive dyskinesia. This was first described in 1960.  By 1968, it was clear that it was a common and disabling side effect of antipsychotic drugs.  It was neither the most common nor the most disabling but it was the most visible (Slide 6).

The response from much of psychiatry was the same response as from psychoanalysts to criticism against psychotherapy.  When the treatment failed to work, they claimed it was the disease, not the treatment that was at fault.  Similarly psychiatry blamed the disease rather than the drugs.  Just as we have since done with the SSRIs and suicide.

However, the visibility of Tardive dyskinesia was a real problem. By 1974, SmithKline & French had settled their first legal case for over $1 million. With this settlement, a generation of antipsychotic discovery came to an end.  It was to be almost 20 years before any more new antipsychotics emerged (Slide 7).

Meanwhile in 1957, Leo Hollister (slide 8) had run a double-blind placebo-controlled trial of chlorpromazine in patients with no nervous conditions at all, demonstrating that it produced marked physical dependence. There were hopes chlorpromazine might be useful for TB which led to the trial.  On stopping after 6 months without benefit, many of those taking it had clear withdrawal problems.

By 1966, a large number of studies had confirmed that there was a marked and severe physical dependence on antipsychotics present in large numbers of people taking them, even at low doses for a short period of time. This led to the concept of therapeutic drug dependence. A concept that blows a hole in most theories of addiction we have.  These drugs produce no tolerance, no euphoria.  They produce post-discontinuation changes as long lasting – as in Tardive Dyskinesia – as the changes underpinning current disease models of addiction.

But the recognition of antipsychotic and antidepressant dependence vanished around 1968, when the War on Drugs was declared.

Psychopharmacology was faced with a political problem.  The problem was how to distinguish drugs, which restored social order from drugs, which subverted the social order.  The ‘decision’ was made to categorize as problematic and dependence producing any drugs, which subverted the social order.

This political rather than scientific decision set up a crisis when physical dependence on the benzodiazepines emerged.  This broadened to an extraordinary crisis, which led to the obliteration of the anxiolytics and indeed almost the whole concept of anxiolysis.  By 1990, physicians in Britain and elsewhere regarded benzodiazepines as more addictive than heroin or cocaine – without any scientific evidence to underpin this perception (Slide 9).

Another problem was that while the antipsychotics did help restore people to life outside the asylum, the drugs were also used for the purposes of control. In Britain today we detain people at 3 times greater rate than 60 years ago. We admit people at a 15 times greater rate than 60 years ago.  On average, patients are spending a longer time in service beds than ever before in history.  New conditions such as personality disorders are being admitted to hospital and the management of violence and social problems has become an issue for psychiatry (Slide 10). The figures are more consistent with a de-institutionalisation of psychiatry.  Unselfconsciously, psychiatrists claim we are treating more patients than ever before.  We are.

This is not what happens when treatments work.  In the case of TB and GPI, the beds closed and the staff were redeployed.

1968

This all combined to lead to the greatest possible symbol for the times.  On the next slide, you can see the protests in Paris – the epicenter f the 1968 Revolution.  The students are on the march.  Without knowing the story you already know where they are heading. Their march takes them to the office of Jean Delay, which they ransacked.   Delay doesn’t retire immediately but he is a broken man.  He has no sympathy for the new world, in which students can expect to address their professors in informal terms (Slide 11).

Venomagnosia

Editorial Note: I was asked to review Peter Kramer’s Ordinarily Well: The Case for Antidepressants for ISIS.  The in print review is HERE.  There is a sister post on RxISK – with a better cartoon and where the word Venomagnosia s explained – Come Back When you Have a Medical Degree.

This book was very difficult to review. In Ordinarily Well: The Case for Antidepressants, 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.

The First Vaccine Wars

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Editorial: This is a final post in the current vaccine series.

In 1798 Edward Jenner in Britain demonstrated that vaccination with cowpox was a safer way to confer immunity to smallpox than variolation with smallpox. It quickly spread. In Britain, variolation was banned in favor of vaccination in 1840. In 1853, vaccinations were made compulsory with fines for refusal. Enforcement was in the hands of a new set of Welfare Officers.

The first vaccine wars broke out in Britain soon afterwards. Just as with variolation, there were ethical, religious and epidemiological doubters.

  • The vaccine came from cows – hence the name.
  • Vaccination sessions introduced pus from one person into a scarification produced on another. There were claims syphilis, tuberculosis and other diseases were transmitted in this way – with good evidence for syphilis.
  • Middle class mothers had difficulties when their babies were inoculated with pus from a working class child – in public sessions.
  • While vaccines could be got for free from the medical officers linked to workhouses, many felt this was pauperising.

Many of the Welfare Officers turned a blind eye to non-compliance. Resistance grew. It came from the ranks of Abolitionists (abolition of slavery) or supporters of the Temperance or Co-operative movements.

The visible scarification and link to cows were portrayed as the Mark of the Beast as foretold in the Book of Revelation. Links were made between food and blood adulteration.

  • Anti-vaccinators threw the full range of sanitarian arguments for the importance of hygiene and role of constitutions into the mix. Vaccinators deployed germ theory.
  • Anti-vaccinators saw germ theory being used to justify a Treaty with Dirt. Vaccinators talked about the feckless negligence of the labouring classes.
  • Anti-vaccinators claimed the upper classes didn’t contract smallpox because of their better food, and air.

Everyone viewed the problem in moral terms and as coming from below.

Anti-Vaccine League

An Anti-Compulsory Vaccination League (ACVL) was set up in 1866 followed by a National ACVL in 1874, after an 1871 Act made non-compliance impossible. Vaccinations were required for some employment. Refusing to have a child vaccinated led to a fine or jail in the event of being unable to pay. In jail, vaccine refusers found themselves yoked to felons and prostitutes. Some vaccination officers went to jail rather impose the Act.

There were mass demonstrations against government policy, with up to 100,000 at a demonstration in Leicester in 1885 at which an effigy of Edward Jenner was decapitated.

This was a replay of the English Civil War of the 1640s. The protesters were non-conformists. Compulsory vaccination they claimed was indistinguishable from compulsory baptism or circumcision. What was needed was tolerance of belief and a Medical Reformation to deliver Free Trade rather than a medical monopoly – although homeopathy saw vaccines as a vindication.

The Liberal Party (then the progressive party) was split down the middle between those who held to traditional beliefs and those who thought a party prepared to intervene to control child labour could also intervene to protect children with vaccines.

A review commission was convened in 1892. The government branded the anti-vaccine lobby as soft-headed, spiritualists, over-influenced by journalism and public opinion.

But by 1898, unlike for other infections no-one had identified a smallpox bug. The ideas of the later Nobel Prize winner Elie Metchnikoff were picked up by orthodox medicine and gave rise to talk about optimising immune responses with Opsonin – an idea lampooned in The Doctors Dilemma by George Bernard Shaw. Shaw, an anti-vaccinationist, portrayed medicine in Adam Smith’s terms as a conspiracy against the laity.

Between the lack of a bug, and clear lies about adverse effects such as syphilis, there were grounds to doubt medical and government bona fides.

Conscientious objection

A new Vaccination Act was adopted in 1898 that continued the policy of compulsion but allowed for conscientious objection provided a parent could Satisfy a magistrate they had grounds to opt out. But what is a conscience? There were no X-rays to demonstrate its existence. This provoked a Liberal crisis.

The idea of Conscientious Objection was also contagious. It became an even bigger issue a decade later when the Great War broke out.

The socialists were anti-vaccination and a founding principle of the Labour Party formed in 1900 was the abolition of compulsion – the socialists were against State Medicine.

In practice magistrates could issue a certificate of exemption but many had a conscientious objection to conscientious objectors.

The objectors didn’t like a law that made them licensed law-breakers rather than equal citizens. They invoked the 1689 Tolerance Act that brought the Civil War to an end by giving Dissenters the right to legally affirm allegiance.

Liberals were on both sides of the argument. The Liberal Party returned to power in 1906 and introduced a new act in 1907. This continued compulsory vaccination, and exemptions. But it removed the word Satisfy. This took discretion out of the hands of magistrates. Within two years, it was estimated that 25% of the children in Britain were unvaccinated, with 50% in some regions, and 90% in pockets. Smallpox never returned.

Smallpox fever

In 1930, the smallpox germ was detected – see image.

In 1936, the concept of herd immunity was born, but little was heard of it before the development of measles and rubella vaccines in the 1960s.

In the 1946 NHS Act, the Labour Party abolished compulsion for vaccinations.

The Torch of State Medicine passed to the American Centers for Disease Control (CDC) who chasing smallpox in South East Asia in 1975 conducted “an almost military style attack on infected villages”:

“In the hit-and-run excitement of such a campaign, women and children were often pulled out from under beds, from behind doors, from within latrines… People were chased, and when caught vaccinated… We considered the villagers to have an understandable though irrational fear of vaccination… We just couldn’t let people get smallpox and die needlessly. We went from door to door and vaccinated. When they ran we chased. When they locked their doors, we broke down their doors and vaccinated them”.

Religion?

There are times we prefer to take our chances with what the universe might have in store for us rather than run with the herd. This risks reprisals from the herd. Regardless of what name the community puts on the religion it believes in, community beliefs are conservative and favor civic duty, and loyalty. Having occasional animals stray from the herd is one thing, having the herd split is another, especially when a technical system appears to offer an efficient solution to a significant problem. In this case, splits can almost only be permitted on “religious” grounds.

Technical systems, especially in healthcare, do not tolerate pluralism. They reach for guidelines and standards. The vaccination controversies are emblematic of this. Today more than ever the System is working mightily to understand vaccine resistance – in order to “manage” it.

Despite the latest in consumerology and public relations, objectors in 2016 are dismissed in terms almost identical to those in use in 1906.

At the heart of this debate is the question – Who Chooses?

File under Phile: Anecdotes are not Science

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Editorial Note: The Post-Truth Rumorology post attracted a comment by Annie that deserves featuring.

She cites a really good Daily Mail article in which Melinda Messenger talks about intervening when her daughter is scheduled to have the HPV vaccine. The DM article drew this response from Dr. David Robert Grimes – a physicist at the University of Oxford – “Mothers should listen to the experts”.

Grimes: Mothers should listen to the experts not Dr Google

Cervical cancer is one of the few cancers we can prevent, which is why this vaccination program is so important and why all parents should ensure their daughters receive this potentially life-saving inoculation, writes Dr Robert Grimes, Science Writer and Cancer Researcher at the University of Oxford.

Gardasil, the form of the vaccine currently used in the UK, has been extensively tested for years and recipients constantly monitored for potential adverse effects.

More than 200 million doses have been administered over the past ten years, with research and trials dating back to 1991. The vaccine has proved to be a safe and effective intervention with an extremely low complication rate.

Only last year, a report based on data from more than a million recipients concluded the vaccine had a ‘favourable safety profile’. But still claims of ‘vaccine damage’ continue to circulate online, to be stumbled upon by the many who daily consult Dr Google, instead of turning to highly trained health professionals for advice.

Much of it comes from anti-vaccine campaigners, not content with the damage already done by the discredited, downright dangerous claims linking the MMR vaccine to autism. Among the groundless assertions are that the HPV vaccine causes thrombosis and chronic fatigue.

I cannot blame anyone whose child becomes ill or permanently exhausted for searching for an explanation and cause.

However, if you are giving a medical intervention to everyone at a certain age, as in this case, it is a medical certainty that some people get sick in the days, weeks or months afterwards. It would, of course, have happened whether or not they had received the treatment. It is merely coincidence.

Perhaps another issue with the vaccine, for some parents at least, is having to face up to the fact that their children will likely become sexually active in the not-too- distant future.

But, although pretty natural, such squeamishness doesn’t give you the right to deny your child, or the people they may become intimate with, the protection provided by this vaccine.

This most recent scaremongering, from the American College of Paediatricians concerning a risk of premature menopause, is equally without merit.

This is not some august medical body (in fact, that’s the American Academy of Paediatricians), but rather a group of conservative activists opposed to abortion rights, gay marriage and pre-marital sex.

Their claim is motivated more by ideology than by any evidence, and is simply not supported by the overwhelming weight of scientific evidence. There is no link between the HPV virus and premature ovarian failure, so it makes no sense to suggest that the vaccine may cause this condition.

Yet still, there have been a number of legal challenges mounted against the manufacturers of Gardasil, supported by the ‘Regret’ group in Ireland.

The case made it all the way to the Irish High Court, and although it was refused, the movement shows no signs of abating.

We need only cast our minds back to the damage done by scare stories about the MMR vaccine to be reminded how dangerous this can be.

Those who are not vaccinated against the HPV will have a much higher risk of contracting cancer than they would have of becoming ill as a result of having the jab, so, from a parenting perspective, it’s a no-brainer.

What we must avoid at all costs are these tales of personal misfortune, which are ultimately unrelated to the vaccine, getting in the way of an inoculation programme that could save many thousands of lives.

Editorial Note: Dr Grimes is not a doctor. He is closely linked to Sense about Science for whom vaccinations can do no harm.

Twittersphere

Annie also picked out some DRG Tweets. In response to Caron Ryalls

(a) No idea who you or your daughter are (b) Going to go out on a limb & say no medical records say HPV vaccine caused ill health

Caron Ryalls‏@caronryalls

U publicly claim my daughter’s ill health is unrelated 2 HPVvax but U hv no access 2 her medical records @drg1985!

Linked to the Daily Mail article: David Robert Grimes ‏@drg1985

The @DailyMailUK just ran page 3 model’s fears over HPV vaccine. Utter drivel. I was quoted in reply, w/ name mangled. Not linking.

..it’s utterly irresponsible of @DailyMailUK to run this crap, especially as I clearly stressed dangers of false balance to DM reporter.

And the sad thing is, the ramblings of a celebrity will garner far more press and panic than me or any scientist. Do better, @DailyMailUK

..it’s precisely this kind of thing that makes scientists weary about talking to the press; science is an afterthought. @DailyMailUK

Age of consent

The Messenger article was well done. Neither Motivation nor Expertise are always right, we ideally need both. But if forced to choose between them, and in particular when motivation is linked to a mother looking after her children, in our current post-truth world of which pharmaceutical companies are the masters – as Study 329 demonstrates, I personally would lean toward motivation.

What was a surprise for me in the article was that while Messenger was sent a consent form by her daughter’s school and made it clear she did not consent, on the day the vaccinators are there if a 12 or 13 girl consents the vaccinators can over-ride a parent’s objections.

The Victoria Derbyshire show last week also featured a pre-teen who figured they were in a mis-sexed body. They were looking forward to being 13 when they could essentially demand the alt-hormones.

But if a teenage girl walks into a beautician in Britain and wants her ears pierced, unless she is 16 nowhere will do it without parental consent, and in Scotland it would be illegal.

“Anecdotes are not science”

A common theme in comments like DRG’s is that anecdotes are not data or science.

The original phrase was the Plural of Anecdotes is Data. This was coined in 1969 by Raymond Wolfinger. It is at the heart of the Big Data industries. If this weren’t true Google and Facebook wouldn’t exist.

The idea that the Plural of Anecdotes is not Data appears to originate from the CEO of Nutrasweet after his company’s product became embroiled in a cancer scare. It has been the mantra of corporations defending products ever since. (Please let us know if you can find earlier uses).

The response “Anecdotes are not Science” to claims of harms came into existence earlier. It was being widely used by spokesmen for the Pedophile Information Exchange during the 1970s when they infiltrated the Gay Liberation Front and Britain’s National Council of Civil Liberties. The NCCL was then steered by figures like Patricia Hewitt and Harriet Harman, who feature in the photo above. Hewitt and Harman were later among the leadership of the Blair Government.

Statements that we haven’t proven harm to children offered the press a shooting-fish-in-a-barrel opportunity to go after the Loony Left.

The PIE also showed a mastery of the ability to split hairs and other tricks that are now part of the corporate armory – No pedophile ever harmed a child, they were busy telling us in the 1970s – it’s child-molesters that do things like that.

The upshot was caught in this constructed photo of Patricia Hewitt – a decent woman as far as I know – who probably never actually said this.  But she ended up years later being portrayed as taking the same position that all politicians on the Left or the Right take in response to drug induced injuries and occupational injuries or environmental toxicity – we can’t or haven’t proven harm.  In most of these cases, like environmental toxicities and drug induced injuries, it turns out the harms to children are even greater than to anyone else.

The Vaccine arguments portray children’s immune and other systems as still developing suggesting they are more able to overcome these challenges than older people.  This is Anecdotal.

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Post-Truth Rumorology?

The HPV Vaccination in Japan

Stopping the spread of Japan’s antivaccine panic

Following the post last week on MedWatcher Japan’s efforts to bring the issue of HPV vaccines to light, my attention was drawn to a recent Wall Street Journal article which stated:

“Japanese women’s health is increasingly at risk as public-health policy is driven by conspiracy theories, misguided political interference and bureaucratic caution. This is particularly evident in the government’s handling of the human papillomavirus (HPV) vaccine to protect against cervical cancer.

In June 2013, just two months after the HPV vaccine was included in the National Immunization Program, the Japanese government made the unusual and perplexing decision to keep the vaccine in the NIP but suspend “proactive” recommendations for it. This was evidently in response to highly publicized accounts of alleged adverse reactions.

The result was that girls in the target age group, from the 6th grade of primary school to the third grade of high school, stopped receiving the vaccine. Vaccination rates dropped to below 1% from about 70%….

The Vaccine Adverse Reactions Review Committee, a task force established by the Japanese Ministry of Health, Labor, and Welfare’s Health Science Council, has repeatedly concluded that no causal link exists between HPV vaccines and professed symptoms, and that most reported cases were likely psychosomatic. A study of 70,960 vaccinated and nonvaccinated adolescent girls from Nagoya also found no significant association between 24 alleged vaccine-induced symptoms and the HPV vaccines….

In Denmark, Kusuki Nishioka, the Japanese doctor who first suggested the HPV vaccine caused brain injuries, appeared on television. The vaccination rate there has since dropped to about 20% from 80%.

The antivaccination movement is gaining traction in Japan. On July 27, 63 young women filed lawsuits against the Japanese government and vaccine manufacturers in the district courts of Tokyo, Nagoya, Osaka and Fukuoka, demanding compensation for alleged side effects from HPV vaccines….

These events are reminiscent of the biggest vaccine scandal in history. In 1998, Andrew Wakefield published “scientific data” in the Lancet as evidence that the MMR vaccine for measles, mumps and rubella caused autism.

Mr. Wakefield’s data was later found to be manipulated, but it was not until 2010 that his paper was retracted and his medical license revoked. Earlier this year, Mr. Wakefield released a movie called “Vaxxed: From Cover-Up to Catastrophe.” Robert De Niro, whose son is autistic, tried to premiere this movie at the Tribeca Film Festival. This once again fueled antivaccine sentiment in the U.S.

We can’t afford to sit back and allow a similar situation to develop in which unscientific claims jeopardize lives around the world. The Japanese government should reinstate its proactive recommendation for the HPV vaccine and set a positive example before irrational fear of the vaccine gains further momentum in other countries”.

The vaccine business

Once upon a time it was public health doctors who decided what vaccines became part of national vaccination schedules. In Japan and elsewhere the introduction of HPV vaccines to the vaccination program was engineered by the makers of vaccines. Vaccination is a business as much as or even rather than a matter of public health. See HERE.

When concerns appeared in Japan and the government suspended the heavy promotion of the vaccine it triggered an international response with the Center for Strategic International Studies, a body set up in the Cold War “dedicated to finding ways to sustain American prominence and prosperity as a force for good in the world”, publishing a report on HPV Vaccination in Japan authored by Heidi Larson and others. HL and colleagues are based in the London School of Hygiene and Tropical Medicine, one of the institutions that spawned AllTrials – somewhere with close links to Sense about Science.

You’d never guess from this document that the HPV vaccine was adopted in most countries after intense corporate lobbying. Instead, we are told:

According to experts in rumor psychology, rumors help people make sense of the world and offer an initial explanation for anxiety-provoking information and events. The longer situations of uncertainty and anxiety persist, the easier it becomes for rumors to spread and the more difficult they become to counteract.

Governments need to get in there, we are told, and be the first to provide information; they need to tell people we feel your pain; when people raise concerns they need to be encouraged to “talk to your doctor”, (who of course has been briefed by our side only). Governments are told they need to avoid a vacuum that might be filled by “people who don’t have the public’s best interest at heart”. They need to be on board with Project Fear.

HPV or not HPV that is the question

In Europe, especially in Denmark, there has been work in parallel to the MedWatcher Japan efforts, undertaken by Peter Gotzsche and Tom Jefferson who have filed a complaint with the European Ombudsman centered on maladministration by the European Medicines Agency of the safety data for HPV aimed at getting access to the data. Preliminary work on this material had shown real cause for concern – see Jefferson.

In response to the Wall Street Journal’s article above, Peter Gotzsche said:

Tom and a PHD student I employed two months ago are working with CRFs from the EMA on the HPV vaccines. To say that “most reported cases were likely psychosomatic” is an insult to these girls and their families. There are good data that make is pretty likely that most suffer from an autoimmune disease with antibodies against nerve tissue, but whether caused by the vaccine, a virus or something else needs to be found out.

We had a meeting about HPV vaccines on 24 Nov in Copenhagen. One of the presenters showed a slide that in Denmark, provided 100% of 12 year old girls get vaccinated, and that the vaccine is 70% effective, and protects against dying from cancer (which we don’t know but just think), then in the next 30 years, 10 will die if not vaccinated and 7 if vaccinated. Thus, even in the best of scenarios, the effect of the vaccine is likely to be very very small”.

What Gotzsche hasn’t said here is that company marketing of these vaccines has been full of rumors and scaremongering, portraying the vaccine as the last defense against a nasty and aggressive cancer, a defense that is close to completely successful and comes without problems.

In fact Pap Smears manage the problems very successfully, just as hand washing is our best defense against many other infections and both defenses come without a risk of neuropsychiatric adverse events. But we hear nothing about these approaches.

It’s not impossible that some of the Japanese cases are hysterical. The bigger problem we all have is that in the wake of the revelations about Tamiflu and Study 329 it is impossible to accept the bona fides of companies whose health depends on ensuring we get their treatments rather than rely on something else that is safer and costs almost nothing.

There is a certain sense in which the forces that fueled Brexit are fueling a Vaccinexit. If this happens the powers that be will have no one to blame but themselves. Peter Gotzsche and Tom Jefferson knew nothing about MedWatcher Japan before the post last week. The more people like this find each other, the more difficult it will be for the Heidi Larson’s of this world to manage the debate.

When the going gets tough, get a woman

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64 women to sue in 3 Japanese courts over health woes from cervical cancer vaccines

A group of lawyers for 64 women who are suffering health problems from cervical cancer vaccines said Tuesday the victims will file damages lawsuits against the government and two drug makers that produced the vaccines through four district courts on July 27.

Of the 64 women, 28 will lodge their suit with the Tokyo District Court, six with the Nagoya District Court, 16 with the Osaka District Court and 14 with the Fukuoka District Court, according to the lawyers.

Initially, the victims, mainly teenagers, will demand ¥15 million in damages each, for a total of ¥960 million, and increase the amount later depending on their symptoms. The victims’ health problems include pain all over the body.

The average age of the 28 planning to file their suit with the Tokyo court is 18. They received the vaccination when they were between 11 and 16 years old.

Noting that the cervical cancer vaccines have caused nerve disorders and other problems due to the excessive immune reactions they caused, the lawyers claimed that the government’s approval of the ineffective vaccines was illegal. The drug makers bear product liability, they added.

Masumi Minaguchi, one of the lawyers, said, “We aim to clarify the responsibilities of the government and the drug makers through the lawsuits so that the victims can live without anxiety:’

Cervical cancer vaccines were included in routine vaccination programs in April 2013. But the government stopped its recommendations for the use of the vaccines in June the same year after receiving reports on complaints of health damage.

Meanwhile, the Japan Pediatric Society and 16 other institutions in April recommended active use of the vaccines, saying it is clear they are effective in preventing cervical cancer.

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The organization behind this action is MedWatcher Japan, who have been one of the most effective organizations in the world at holding Pharma to account. Two of their key players Masumi Minaguchi and Hiro Bepu are seen here. Masumi Minaguchi is the lawyer taking this case.

In this case MedWatcher have capitalized on the fact the HPV Vaccine is given primarily to girls and women who are old enough to be able to complain when things go wrong afterwards.

The science behind the MedWatcher case is presented in their refutation of the Global Advisory Committee on Vaccine Safety position which can be accessed HERE.

The HPV vaccines look like being a problem for vaccine advocates in that they puncture the claim that vaccines are safe and the only risks stem from not giving them.

Earlier this year Merck admitted their Shingles vaccine could cause eye damage. Again the difference is that the people suffering the harm are old enough to make their voices heard.

The response from vaccine advocates in the case of HPV vaccines has been to push for giving these vaccines in infancy.

Vaccines are a conundrum. They can clearly be effective and most of us would want to avail of most of them. But where elsewhere in medicine, it is legitimate to be against over-medicalization, being against over-vaccination puts anyone who advocates it beyond the pale.

Why?

Go Figure: Where Does All the Pain Come From?

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Editorial Note: This anonymous comment featured toward the end of the Murder or Accident post. It seemed worth transforming into a post in its own right. In the week of the US vote, a key question facing voters is where does all the pain come from.

A colleague and I gave a talk to family docs this year and we discussed the opioid epidemic, including the 1% risk of addiction myth in Letters to the Editor at NEJM. One Key Opinion Leader (KOL) is now acknowledging that he may have overstated the safety of opioids but maintains that they still have a role in chronic pain, see Dr Russell Portenoy here: http://www.wsj.com/articles/SB10001424127887324478304578173342657044604

He strikes a controversial chord with others involved in treating the outcomes of chronic pain killer addictions, like Dr A. Kolodny, see here: http://www.medpagetoday.com/painmanagement/painmanagement/47855

Other KOLs like Dr Jane Ballantyne, have made 180 degree turns regarding opioid use in chronic pain, this article is well worth the read: http://www.nytimes.com/2012/04/09/health/opioid-painkiller-prescriptions-pose-danger-without-oversight.html?_r=0

Challenging myths that have so much resources poured into them to maintain is very difficult. We were all taught that pain was the “fifth vital sign” by the American Pain Society (around the same time OxyContin approval occurred). You can see the sordid history, including how patient satisfaction scores may have a role in this epidemic, here: http://www.kevinmd.com/blog/2016/04/the-opioid-epidemic-its-time-to-place-blame-where-it-belongs.html

The US Docs probably had some scare put into them by the successful legal case brought against a doctor (Dr Chin) in 1998 who was charged for not treating pain adequately. Incidentally, this was the same time as the heavy marketing machine was revving up for Purdue. http://articles.latimes.com/2001/jun/15/news/mn-10726

The appalling story about Purdue/Abbott’s role in this public health disaster is outlined nicely here:

https://www.statnews.com/2016/09/22/abbott-oxycontin-crusade/

There has been very vocal opposition from pain advocacy groups and physicians when British Columbia adopted the March 2016 CDC pain guidelines that discuss opioids and state they are not effective and should not be used for chronic pain and that doses should not exceed 50 mg equivalents of morphine.

Pain BC is encouraging patients who have been affected by these new regulations to complain to the College! https://www.painbc.ca/news/howdothesenewopioidguidelinesaffectyou. Nothing strikes fear into physicians quite like a good old College complaint!

Although the evidence of harm is abundantly clearly (lack of efficacy in chronic pain, massive overdose deaths, lives in ruin, 80% of heroin users report starting drug use with physician prescriptions), both people and doctors choose to ignore this and some doctors fear College investigators. Sounds a lot like Dr Chin all over again…

Big Pharma’s influence in Canada continues. See here for Purdue’s lobbying of the Federal Government: http://canadians.org/blog/who-behind-canadas-opioid-epidemic. A coalition of chronic pain and addiction specialists signed a letter earlier this year, requesting that Federal Health Minister Philpott consider making oxycodone only available as a tamper resistant formulation (of which Purdue holds the patent). Sixty percent of the signatories have ties to industry. http://www.theglobeandmail.com/news/national/ottawa-urged-to-reconsider-tamper-resistant-oxycodone/article29813367/?utm_source=twitter.com&utm_medium=Referrer:+Social+Network+/+Media&utm_campaign=Shared+Web+Article+Links

Dr David Juurlink may have said it best in the Globe and Mail piece referenced above:

“It’s time we stopped listening to pain specialists. Their messages, which were wrong, got us into this mess in the first place,” “Many of these physicians are deeply in the pockets of the companies that make opioids and that stand to profit immensely from the sale of these new products.”

Ontario released a new “Strategy to Prevent Opioid Addiction and Overdose” on October 12, 2016. This milquetoast framework to our public health crisis makes several vague recommendations, one of which is to make more substitution therapy available, specifically access to buprenorphine/naloxone (Suboxone). The document fails to provide suggestions for how to carry this out nor does it make mention of the potential public health risks. Studies have shown that Suboxone is ten times more likely to be diverted than methadone (i.e. not taken by the intended person and diverted to illicit market). We may want to ask Finland for some advice (buprenorphine, has been at the top of drugs misused in that country): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3154701/

The provision of methadone (the other substitution treatment available) in the province received well-deserved criticism from the “Methadone Treatment and Services Advisory Committee”. http://health.gov.on.ca/en/public/programs/drugs/ons/docs/methadone_advisory_committee_report.pdf. Page 11 details some of the most egregious concerns:

 Lack of access to comprehensive care in stand-alone fee for service clinics: Many of these clinics provide little more than urine drug screening and methadone prescribing and dispensing, leaving patients without access to primary care, mental health and addiction screening, brief intervention or counselling, and management of acute and chronic illnesses. Variation in the quality of clinical services: Some clinics require frequent attendance for urine drug screening and a brief office visit regardless of the state of recovery demonstrated by the patient. This is wasteful and can be harmful to patients’ recovery as attendance can be inconvenient and at times very challenging, particularly for those in rural and geographically isolated areas.”

Profit driven care has clearly moved the patient far way from being in the centre.
Some are sounding the clarion call of “another epidemic” happening where over 50,000 patients in Ontario are now on methadone https://substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-016-0055-4

Perhaps the most astonishing elephant in the room is “why are so many people in pain?” As a society we must look at the root drivers of this epidemic and that must also focus on prevention. We need to do some serious soul searching as a nation, as a community of peoples. We will need to address poverty, hopelessness, dislocation, safe housing, disintegration of community, lack of meaningful employment, adverse childhood experiences, resiliency, etc. if we have any hope of bringing this epidemic under control.

Comment

The links above are chilling. The video clip of Russell Pourtenoy is beyond belief.

It raises the question as to whether there is a growing amount of pain in the world as this US election suggests. The alternative is that doctors been adding to whatever pain and anxiety there is and to other dis-ease. While opioids and other pain-killers can give wonderful relief when given short term, as can benzodiazepines for anxiety, there is good evidence that given chronically opioids and benzos increase the amount of pain and anxiety we have – by altering physiological thresholds in the wrong direction.

Old style doctors, professionals, knew this. New style technocrats – we have the technology to fix your pain and anxiety – don’t know it.

It was and is an important part of caring for you to know the limits to what we can offer. But we now live in a world where choices like opioids are put on plate in front of you and your doctor and you are invited to choose. The right choice will supposedly deliver the jackpot – this is what marketing promises.

But somehow wisdom is never on the list of options – it can’t be – it’s not evidence based. It would be irrational to let you choose something that is not evidence based – like less medication or vaccines. That’s not a free choice.