Making medicines safer for all of us

I’ve been a fan of Placido Domingo for 40 years or more.  His role alongside Teresa Stratas in Zeffirelli’s La Traviata (if its emotion you want – one of the greatest movies ever made) can still bring tears to my eyes.  I always liked his voice more than Pavarotti’s, Carreras, or others – and he looked much better as Alfredo. Pretty well everyone else suffered when I heard them in roles I’d previously heard done by him.  Then there was his concert tour raising funds after a Mexican earthquake.

So, it came as a shock when news emerged recently of women claiming to have been sexually harassed by him.  There are now 20 women in the frame.  The claims centre on inappropriate touching or kissing and concerns about a climate in which women might fear their careers would be derailed if they rejected his advances.

Domingo’s response has been that “I strongly dispute recent allegations made about me, and I am concerned about a climate in which people are condemned without due process”. The overall response from his “team” has not been that nothing happened but that any events are being misrepresented or misinterpreted.

Domingo has already stepped down from or been dropped from a number of American positions but European opera houses have not yet followed suit.

The link to drugs came when a BBC interviewer quizzed one of the American journalists linked to the ongoing stories. Chasing the ongoingness, she put it to her print colleague – shouldn’t we presume innocence and wait till we know the facts before he is hounded off stage completely.  She didn’t quite say what we have at the moment are anecdotes, don’t we need evidence.

Her interviewee took this point head on.  (The following is a paraphrase). Look, she said, we didn’t run these stories without a lot of investigation and checking with lawyers.  This isn’t hearsay.  Women have put their names forward.  They can be sued if what they are saying is false.  Given the numbers of women who have come forward, something has unquestionably happened – enough to warrant opera houses and Domingo and everyone reviewing their position.

Me Too

The key element here as noted in a RxISK post two years ago Stigma and Recovery soon after the Me Too movement began was women stepping into the light of day, overcoming their fear of being seen as a loser and the guilt or shame that lands on victims rather than perpetrators.

The “methodological” question is this.  If one woman, putting her name in the frame, makes a claim about a Domingo, Weinstein or Leonard Cohen, is she to be believed?  The lawyers and journalists will have done a lot of background work to assess the plausibility of the case. The more they uncover convincing stories of other women put in the same position, the more plausible the original claim becomes – except in circumstances where its well known “he” likes women and comes on to them – like Leonard Cohen.

When it’s one woman, the man can claim there is a motive or dismiss the claim in some other way. Quite aside from Brexit, the British establishment totally shot themselves in the foot some years back entertaining claims of a pedophile and murder ring within Westminster. Saint Tom Watson stood up in Parliament, and under cover of parliamentary privilege, claimed the police and others found the allegations credible. None of the powerful people in the frame were particularly sympathetic – not like Cohen or Domingo, more like Weinstein.  But to someone who deals with claims like this regularly, it looked obviously fantastic, and should never have gotten anywhere at least not in the public domain.

In the case of one woman, whether we believe her or not likely depends on whether we have been in the same position or we like the “myth” of him we have been sold.  Is there a way to get to a point beyond reflex sympathies, where we are justified in figuring the events likely happened so that rather than a group splitting down the middle in terms of their support for him or her, they will mostly side with her or him (there will always be some hold-outs).

Do we get there if two women put their name in the frame having been checked out thoroughly by the media?  Or three?  When does the weight of numbers become significant?  What do we do with the hundreds of women who claim they never had anything but wonderful interactions with Domingo or Cohen?

What do we do when the climate changes so that child abuse is established as happening but we are then faced with women claiming abuse in childhood that could never have happened and it seems likely the claims are based on memories recovered in therapy? The recovered memory debacle may have become an epidemic primarily because it took place in private settings, rather than in the media spotlight or legal domain (although in some weird legal cases men did end up in jail on the basis of evidence later viewed as incredible). But it brings out a point that an acceptance that abuse happens, can lay the basis for even quite outlandish claims being entertained.

All of this mobilizes a deep misogyny, bringing into play stereotypes about women being manipulative and deceitful. So where, if anywhere, is the solid ground in all this?

Drugs

This is exactly the issue at stake with the adverse effects of drugs.  One of us comes forward with stories about PSSD or PGAD and we are dismissed.  See PSSD and Patient Experiences for the most comprehensive and chilling account of what can happen. Patients can be manipulative and deceitful you know.

Its difficult to get our names in the frame.  Unlike the women who were always free to put their name in the frame, and have recently appreciated the power of doing so, if we report the problem on a drug to regulators they remove our name.  We can’t get into a position able through cross-examination to demonstrate there is no other way to explain what is happening us other than the effect of some drug.  We aren’t able to let others know – have anyone say Me Too.

See Decernimus Ergo Summus.

But even if we could, a group of us together would remain a collection of anecdotes rather than a force to be reckoned with.  The drug will be innocent until proven guilty.  In this case, the court system is run by the companies producing the drug who claim that the only way to produce significant evidence is through controlled trials which only they have the resources to run – and whaddya know none of the trials done have shown this problem.

This is the case even though, if one thing is more certain than men thinking about sex with women (or men) its the fact that drugs are poisons.

There is a risk benefit overlap between men and drugs.  Men seem set up to make advances and women to desire advances that they will choose between. Even if this system mostly works as planned, it is almost certain to produce problems at the margins.  These problems can be managed by women speaking out, especially when they do so collectively.

In the same way, there is a potential benefit from the poisons we call drugs. Handled with some discrimination, bringing good out of the use of a poison can be magical but with a system like this its inevitable things will go wrong.

In contrast to Me Too, we used to be able to manage these problems but now we can’t.  We’ve switched into Not Me Guv mode.  While women look like they are getting somewhere handling men, both women and men are going backwards when it comes to handling drugs.

And the main reason for this is we have lost the ability to link our names to an event in the public domain – to stand up and say – fine I’m willing to be cross-examined and live with the verdict of a jury of average people (especially if I have a Portia to be my advocate).

The corporatocracy/androcacy has found ways to make it impossible for anyone to stand up and say “Here I stand I can do no other”.  Impossible to nail theses to a cathedral door without being laughed at.  Oh how the Pope could have done with controlled trials back in 1517.

Finding a way to make our individual experience count again is the central problem of the age – a way to ensure that if we report something happening on treatment we are not regarded as guilty until proven innocent.  We are not victimized.

But people can be manipulative.  Once the possibility a drug has caused a homicide or a crime comes on the radar, all sorts of people do claim the drug made them do it when it didn’t.

So in addition to being able to report an experience, judgement calls need to be made.  We need to take a stand on our judgement calls about the best way to explain this event – he crossed a boundary or he didn’t and this drug wiped out a sex life or it didn’t.  When we are unable to say he crossed a boundary or the drug has caused a serious problem we are living a lie imposed on us by someone else.

This is the final post in the Bruce Willis series – see Osama, Obama and Reckless.  It’s the point behind the series.  And it comes on the 28th anniversary of the original event.

Train Tracks

Its 1991.  Two trains are heading toward each other on the same piece of track.  One has a shiny badge that was new for trainspotters – Evidence Based Medicine (EBM).  It had been assembled in part in Canada’s McMaster University by David Sackett and Gordon Guyatt among others and in the UK by Iain Chalmers and others.  Richard Smith (photo), then the editor of the British Medical Journal (BMJ), was an enthusiast for this new marvel.

In 1980s, pharmaceutical companies were perceived like Sauron in Mordor as growing in strength.  Organisations like No Free Lunch appeared.  Physicians were hearing they should be wary of the Wooden Horse sitting outside the gates of medicine.

A medicine under siege breathed a sigh of relief when EBM arrived in town and seemed to solve the problem.  Doctors were given weapons to fight pharmaceutical companies with.  The vampires with their sales and marketing tactics would shrink back faced with the crucifixes and garlic of evidence held up in front of them.

It wasn’t put like that.  More a case of in the face of the obvious, the lion would voluntarily lie down with the lamb. Bash industry? Not us.  Just scientists here.

In 1984, the US pharmaceutical industry generated $24 Billion of revenue per year.  A decade later, a single drug alone could generate $10 billion per year.  The pharmaceutical industry had found a way to make the powder in their capsules worth more than its weight in gold.

Prozac which launched in 1988 was one of the exemplars of the other train rolling down the track toward the shiny new EB Medicine.  If you wanted a decent drug – something that would be at least as strong as the pills we already had, and ideally safer, or maybe able to treat something we had not been able to treat before, this wasn’t that pill.  It was less effective than already available and cheaper pills and there were good grounds from the get-go to think it and anything related to it might be hazardous.

Should have been no contest.  EBM should have rolled right over Prozac.

Especially as Prozac was almost derailed before it had fully picked up speed.  Pesky patients went and got themselves suicidal on it. An article appeared in the American Journal of Psychiatry in 1990 outlining 6 cases of people with suicidality that had emerged on treatment.  The paper came from Harvard. One of the authors, Jonathan Cole, was just about as distinguished and at the same time sensible as anyone could be. Thousands of patients lined up across the US claiming they had become suicidal on the drug.

The company had three responses – these are anecdotes, its the disease not the drug and it’s all just being rustled up by the Church of Scientology.

September 1991

The trains met in September 1991 – thanks to Richard Smith.

Central to Lilly’s efforts to defend Prozac was a meta-analysis (a new term then – part of a lexicon EBM was introducing) of the clinical trials of Prozac, looking at rates of suicidal events on the drug.  Very few journals had seen data handled like this before.

Whether the novelty of an article like this meant it didn’t work for the first journal it was sent to, or the very obvious increase in risk on Prozac, it was turned down and ended up with the BMJ.

The BMJ reviewers demurred at the proposed title which suggested Prozac reduced the risks of suicide.  The claim was made on the basis that Hamilton Rating Scale scores fell on the drug but ignoring the fact there were more suicidal events on Prozac.

Looking at the paper later published in the BMJ, with Charles Beasley as first author – HERE – in placebo controlled trials there were 5 suicidal events in 1398 patients taking Prozac and 1 in 645 taking placebo.  More on Prozac – but it was not statistically significant – which everyone was told meant there were no suicidal events on Prozac in other words. Move on – nothing here to look at

However looking at the small print the placebo suicidal event happened in the washout period so there were in fact no events on placebo and the risks on Prozac were statistically infinitely greater than the risk of placebo.  It doesn’t look like the reviewer can have looked at the small print.

Richard Smith (for whatever reason) certainly didn’t look closely. He had in his hands a major company signing up to embrace the EBM he was promoting at every turn.  If all companies ended up following (being forced to) this example, the world would spin more happily on its axis from here on.

Oh Happy Band of Brothers, you will be able to tell your children that you were here with me and the BMJ on St Candida’s Day.

The article came out in the September 20 1991 edition of the BMJ. coinciding with FDA hearings on Prozac and suicide.  Given the patient groups springing up all over the place in the wake of Prozac’s launch, with hundreds of reports to FDA of suicides or suicidal events, FDA was forced into a public hearing.

At the hearing, company people and company experts (people), notably Charlie Nemeroff, were brandishing the Beasley paper – look it says here in the BMJ there is no risk from Prozac.  Which are you going to believe the anecdotes or the science.  The plural of anecdote is not data.

The Little People

The FDA committee recognised the compelling testimonies from the little people whose husbands or children or parents had blown their brains out or who had died in other horrific ways. A few weeks after starting Prozac, Joseph Wesbecker, who featured in the news last week, two years and one week before, had killed 12 at the Standard Gravure plant in Kentucky, before blowing his own brains out.

But their hands were tied.  There was no basis in the science to say Prozac had caused this.

It wouldn’t even be a good idea to warn about a possible risk because that might put people off seeking treatment and the benefits they could get from Prozac.

Prozac sales had been falling.  They recovered after the FDA hearing.

Become Invisible

The effect on medicine and the rest of us was far-reaching.  Journals like the BMJ stopped taking articles like the Teicher and Cole paper outlining 6 convincing cases of suicidality induced by Prozac. FDA had just ruled this is not evidence.  Journals might be sued for publishing them – besides which they made no money from them.

A premium was put on ghostwritten clinical trials with no access to the trial data and even more on meta-analyses – companies paid vast fortunes for reprints of these making BMJ and other journals profitable indeed wealthy if they wanted.

Richard Smith could have demanded access to the raw data in exchange for publication in BMJ.  He didn’t.

But he got a sales-force for EBM.  Companies now encouraged doctors to prescribe according to the evidence and to stop paying heed to the appearances of people in front of them or to what they say.  Everyone knows that patients and doctors can’t work out what drugs do – only controlled trials can do that.

Patients became invisible – just as doctors and everyone else in healthcare did too.  If practice is going to be scientific it has to be according to the evidence, embodied in guidelines which dictate what drug is given in what sequence.

If this is the case of course who needs high cost prescribers.  We can have nurses, pharmacists, AMPs or whoever – told keep to the evidence based guidelines or you get fired.

And we can replace everyone with locums.  Who needs relationships if whoever is there sticks to the “Evidence”.

As a result it now takes 30 years to get recognition of the common problems on patent drugs cause.

Gallileo

Clinical Science is incompatible with a top-down-archy.  Hierarchy is not the right word here – as hieros means sacred or moral.  Its Gallilean or nothing.

The first task is to work out whether the drug this person took has caused the effect they now mention or not.  Having reviewed all the evidence if we both think it has and this is at odds with what the Evidence Base appears to suggest, the second scientific task is to explain the discrepancy.  In the case of the SSRIs and suicide, there was no discrepancy once we got to see the clinical trial data.  If it is to have any credibility, EBM has to be Data Based Medicine.

Waving or Drowning

Well done Richard on a Bruce Willis award.

Editorial Note: The image featuring Samantha Cameron and her husband, David, comes from the front cover of Private Eye, a British satirical magazine, who might have thought twice about adding to the pressure on Cameron if they had known what was going to happen next.  This is the third in a Bruce Willis series – See Osama saves Millions and Obama kills Millions.

Its September 27 2014. A conservative MP (member of parliament) and minister in the government, Brooks Newmark, has just resigned.

The coalition government, with the Conservatives (Tories) as the lead party, are in a growing crisis.  A UK Independence Party (UKIP) had formed in the early 1990s but was getting nowhere fast.  In 2006, Nigel Farage took over as leader and moved it from being a single issue Get out Europe campaign to a broader anti-immigrant, right wing populist party.  In local elections in 2013 and even more so in European elections in May 2014, UKIP made substantial gains largely at the expense of the Tories.

There was a general election scheduled for 2015. A number of Tory MPs had an affinity for UKIP’s anti-immigrant and anti-European positions.  There was speculation some might defect to UKIP – who had no MPs.

The way the English political system works, it can be difficult to break in even if a new party is supported by millions of voters, so there was no guarantee that UKIP with even 10% of the vote around the country would get any MPs.  Supporting a party is one thing, voting for a party who has no MPs is another.  If they already had some MPs it would transform the psychology of voting.

In August 2014, a first Tory MP, Douglas Carswell, defected to UKIP ratcheting up the pressure on Cameron and rattling the Tories.

On September 27, another, Mark Reckless, defected.  The Tories seemed to be facing annihilation.  Ed Milliband, the Labour party leader, seemed likely to be the next Prime Minister.  If you wanted to take a Labour party leader with you on holidays and had your choice of any of them from 1945 to now, I’d opt to take Milliband (or maybe Michael Foot). But its not enough in politics or maybe even in life to be decent, or even a human being – you have to be lucky.

While Reckless was defecting, Brooks Newmark entered stage left.

Brooks had been caught in a jaw-dropping sting.  A male newspaper reporter posing as a woman engaged him in texting that became sexting and finally a picture of Newmark’s private member.

The Reckless defection was bad news but Newmark’s reckless act seemed to set the seal on the Tories.  It had the whiff of decay that goes with a political party whose time was up.

In the immortal words of a former Irish premier Charles Haughey, as weaponized by his greatest political enemy, we had entered GUBU country – grotesque, unprecedented, bizarre and unpredictable. (Worth googling to get the full-story).

(The political wisdom until recently had been that there’s no recovery from GUBU – but it seems like politicians have learned to embrace and maybe even love GUBU, perhaps in part as a consequence of Cameron’s next move).

The Private Eye image shows Samantha eyeing something like a Tory private member working out how to advise her partner who seems to have missed the plot.

In order to keep the Tories from disintegrating, and take the wind out of UKIPs sails Cameron offered a referendum on EU member-ship. If you really want to withdraw from the EU, don’t vote UKIP – they have almost no MPs and can’t deliver it.  The only party who deliver are the Tories.  This desperate promise wasn’t made to win the election, it was made to avoid the Tories being annihilated.

On the night of the election a few weeks later as the polls closed the general anticipation was that Milliband would be entering Downing Street the following day.  A few minutes later, the first exit poll predicted the Tories would win an overall majority.  You could have heard a pin drop in the TV studios.

David Cameron was about to become the first Tory Prime Minister to be elected with a majority in over 20 years. Perhaps the “I can walk on water” moment went to his head.  One of his first actions was to agree to follow through on a promise – he would commit the country to a referendum the following year.

The original Brooks Newmark event in its own right was nothing like as GUBU as the events that led Haughey to try and articulate how fate can twist.  The time honoured – truth can be a lot stranger than fiction – didn’t seem enough.  The events in Ireland that left the smoothest of political liars struggling for words began a sequence that has close to destroyed the Catholic Church globally.

But events in Britain since September 27 increasingly seem to bear the mark of GUBU. Who knows what pillars of modern life will come tumbling down before the malignant sprite or whatever it is decides its time for a nap.

Who needs conspiracy theories?  They’re a relatively recent invention that in their efforts to make sense miss out on how bizarre things can get sometimes.  Taking Occam’s razor to any explanation of the human situation favours a view that there really are Olympian Gods who trigger events out of boredom or perhaps just unleash malignant sprites to stress test human plans.

This post continues a series of Bruce Willis unintended consequences posts, of which there will be two more.  There is a degree of truth in all of them.

As outlined in last week’s Osama Saves Millions, Yusuf Hamied stepped in at a critical point in the unfolding global AIDS story and in offering Triple Therapy at a dollar a day decisively shifted the storyline. His company, Cipla, was an Indian pharmaceutical company dealing primarily with generic drugs.

The link between Hamied and Bill Haddad that led to Hamied’s Triple Therapy proposal was embedded in politics.  The generic pharmaceutical industry in the United States was closely linked to the Democratic Party. In 1964, Haddad had stood for Congress as a Democrat with the price of drugs as his main campaign platform.  He had run the Kefauver 1956 vice-presidential campaign and later Kefauver hearings on the pharmaceutical industry.  He was involved in the 1960 and 1968 Kennedy campaigns.

When he approached Hamied, he was the Chair of the GPIA – the generic pharmaceutical industry association. The generic version of PhARMA.  As early as 1984, he had said that if the branded industry didn’t bring drugs like AZT on the market the generic industry would – and AZT was the first drug licensed under the Orphan Drugs Act, of which Haddad was a leading instigator.

The Clinton administration efforts in the 1990s to get healthcare reform through Congress were closely tied to the fortunes of the generic pharmaceutical industry.  The irony was that Republicans, not Democrats, were supposed to favor markets and dismantling monopolies as the best way to deliver better quality and cheaper products but when it comes to pharmaceuticals things often turn inside out.

Once Hamied cut the Gordian knot holding back Triple Therapy, Bill Clinton, then the former president, became the biggest promoter of Cipla and soon afterwards all Indian pharmaceutical companies, including Ranbaxy.  He made many visits to India, with Indian politicians and executives apparently dazzled by their new fellowship with a political superstar.

Apparently.  Pretty quickly Ranbaxy and some other companies smelt a killing.  They began filing for generic approval in US and European markets for drugs about to come off patent.  Not just filing but filing for first generic approval as this was worth substantially more than later approvals.

To get there first required either a very swish technical operation or fraud.  Fraud was a lot easier, and cheaper and more reliable.  The FDA essentially didn’t have an inspection system for Indian pharmaceutical companies.  Companies didn’t have to do the experiments.  They could make up the data.

There were one or two FDA operatives in the field in India and China who despite having to announce their arrival to companies beforehand and having to be escorted around plants began to raise concerns – they were fired.

What was happening came to light because of whistle-blowers within Ranbaxy, especially Dinesh Thakur.

As the evidence of problems came to light, FDA were caught in a dilemma.  The Obama government had come to power and a supply of cheaper drugs was essential to proposals for healthcare reform. The findings of fraud were so egregious and the consequences of inaction for the health of patients exposed to Ranbaxy drugs so serious that doing nothing was not an option but bankrupting Ranbaxy with the kind of fines that seemed called for would be a serious blow to the Affordable Care Act.  After many twists and turns, Ranbaxy ended up with a relatively small fine.

Efforts to put a proper inspection system in place for the Indian and Chinese generic companies were quietly shelved.

Bottle of Lies

The story is vividly told in Katherine Eban’s Bottle of Lies.

I keep track of books like this for any light they might shed on aspects of the history of the pharmaceutical industry.  I was skeptical about the promotional blurbs, figuring this might well be another written in the branded-industry con-job, aimed at discrediting the generic industry.

If it is, its a very sophisticated one as Eban makes clear that brand name American companies are now moving their production operations to India and China where oversight is minimal to non-existent and we are likely at just as much risk from brand name products as generics as a result.

(And of course the most high profile price gougers of recent years have been generic companies like Mylan and Turing – a hedge fund in generic clothing).

Does this story make a difference to any of us.  Yes it does.  Pretty well every working week now I come across people with convincing stories of being given a generic drug made by a different company to their prior supplier and having a completely different response – or no response.  This can be very serious in the case of a patient on a diuretic whose drug stops working.

Two decades ago if a patient switched from a branded drug to a generic, and complained there were differences, most doctors rolled their eyes to heaven and dismissed the complaint.  But these problems are now being reported by people switching from one generic drug to another and are pretty gross and consistent.

Given that close to 85% of drugs used in the USA are now generics and 40% of the drugs used in Britain’s NHS are generics from India, this is not a minor issue.

Patients in the West are the lucky ones.  Eban’s book makes it clear that if you are a child with a life-threatening infection in Africa, the chances are the antibiotic you are given will be a dud and you will die.  A decade ago, there were concerns about Fake Medicines in Africa and elsewhere cooked up in bath-tubs but the bigger concern now is medicines from big name companies, where one batch might be okay but the next ineffective or dangerous.

This almost certainly applies to vaccines also.  There are no placebo-controlled trials of vaccines.  All we have are trials of adjuvant against adjuvant plus vaccine.  The adjuvants are mostly compounds with an Aluminium component whose role is to trigger a more vigorous reaction to the proteins of the vaccine.

But there is another component to vaccines – fluid.  The vaccine and adjuvant are dissolved in fluid. If this fluid contains a scrap of anything else, a protein, a metal, or anything, then the adjuvant can trigger a response to that also.  And if any of the vaccine batches are made up in India and China then it is almost for certain, the fluid will contain other materials.

In this way even a vaccine with a clear bill of health from controlled trials could cause significant damage.

As Clinton’s story decades earlier made clear, sometimes politics requires you to execute a mentally handicapped person. Chances are Obama’s healthcare efforts may have led to the death and disablement of millions.

Editorial Note: Think of this as a Bruce Willis set of posts. I’m no BW fan.  Nor a fan of the nuclear bomb. Chances are neither were the makers of the movie Armageddon.  But someone probably got a thrill out of forcing a bunch of people who hate BW and were members of CND cheering Bruce on when he set off with the atom bomb to destroy the asteroid threatening earth.  Ditto with the next few posts.  If anyone has suggestions for posts to add to the sequence – please send and perhaps even send a complete post.

The year is 1980.  America, the land of the “free” and home of the “brave”, has the first hints of a Biblical plague.   Things rapidly get worse.  Panic sets in. Time for a God-fearing people to repent of all the things they have been doing wrong – like pricing people out of decent healthcare.  Time to support each other.

It never works out this way.  Church-going (and mosque and synagogue going etc) people are the first to save themselves first.  It was left to the outcasts to band together and push for a rational response to what was happening – one option being to deploy a nuclear bomb if one could be developed.

ACT-UP formed.  Over a decade its members held together – not without tension – and cut through bureaucratic red-tape, tons of political correctness and supposed scientific orthodoxy, and got into bed with all sorts of bed-fellows they would previously have not been seen dead with.

The result, partly down to luck, was Triple Therapy.  This didn’t happen because of controlled trials or any standard procedures – the benefits of the combination were discovered by patients and doctors juggling meds and seeing people come back to life. It was not a pharmaceutical company discovery.

But once it became clear that Triple Therapy worked, all of sudden normal rules applied and companies worked out how to make a fortune.  These patients would pay a fortune to save their life and most of the God-fearing fold would pay a fortune to reduce the risk to themselves.

Things were looking good until the Road-Runner moment when a grinning pharmaceutical industry realised it had run right off the cliff and the next move was going to be down.

There wasn’t just a bunch of wealthy Americans who could be gauged for $15,000 per year – nothing compared with the gauge rate now.  There were millions elsewhere, particularly in Africa.  It was almost impossible to work out how to gauge everyone.  The Africans couldn’t pay and were already dying in droves.  The price couldn’t be brought down to a level where they could pay as gauging Americans would no longer be possible.

The US government it seemed was wheelable in and was wheeled in by pharma to say it would sue the governments of other countries – like Brazil – if they infringed patents and made cheap copies of these ground-breaking US drugs.

When it got to the point that the Washington Post could ask whether there was anything more the American pharmaceutical industry could do to damage its reputation – sue Nelson Mandela perhaps – and industry did just this, the Road Runner was in free fall and looking at becoming a splat on the canyon floor.

Enter Osama

Until Osama bin Laden swooped in just beneath the falling pharmaceutical industry and whisked it to safety.

Blink at the wrong point in the movie and you’d have missed it.

In the wake of 9/11, there was panic all round.  The following month letters containing anthrax spores began circulating. Anthrax can be lethal and is difficult to treat.  The best treatment at the time seemed to be Bayer’s Cipro – ciprofloxacin, a fluoroquinolone antibiotic that nobody in their right mind should take unless they have to.  But worth a fortune because American doctors were dishing it out like there was no tomorrow.  The US government wanted to bulk buy but Bayer were haggling about the price.

Then all of sudden the log-jam broke.  Insiders blinked and said what’s the problem – the US government breaks patents the whole time.  Word leaked out that the US government had been routinely breaking patents for national security and other reasons since the 1950s and would be doing so for the foreseeable future.  Brazil and South Africa could breathe again.

Cipro to Cipla

As could India. Bill Haddad the chair of the general pharmaceutical industry association (GPIA) contacted Yusuf Hamied the CEO of Cipla, an Indian pharmaceutical company about the possibilities of making Triple Therapy at an affordable price.

After a lot of brinkmanship, Hamied finally put a dollar a day price on the table. This was still more than many Africans could afford but cheap enough that Bill Clinton and George Bush could not afford to be seen to walk by.

Without Osama bin Laden none of this is likely to have happened.

Mind you taking the same approach to analysing events, he could probably also be held responsible for Project Bioshield and the Global Health Security Agenda which dictate the volume of vaccines Westerners currently get and may be playing some part in rising autistic spectrum and auto-immune disorders.  Maybe as a result of all Americans ending up neurodiverse, at some point the soldiers of the Caliphate will be able to march in and occupy the World Trade Center – but that’s stretching things a bit too far surely.

There are much more solid grounds than this to think bin Laden and Hamied contributed to thousands of American deaths and counting…

To be continued.

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 

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.