Sensing the end of the Roman Republic and unhappy at the approach of Empire, Cassius approached Brutus to save the Republic.
“The fault, dear Brutus, is not in our stars,
But in ourselves, that we are underlings.”
The Republic was a Democracy, with a Government answerable to its Electors. Caesar’s conquests meant that the Roman Government was now responsible for swathes of people who would never elect it but who needed to be managed through an apparatus involving Roman Law and military jurisdiction.
The Republic was a place where every Elector could believe that his fate lay in his own hands – that his position was not pre-ordained (in the Stars). He did not have to be an underling.
In an Empire, the apparatus ordains your place and one way or another it is that of an underling.
In the late 1950s, perhaps because he was based partly in Rome, sensing a change in his native America, Gore Vidal warned that the Republic was changing into an Empire. He warned his countrymen that while the world had admired them for their values up till that point, while almost everyone aspired to be an American, they would soon face a world where an increasing number of people would cheer were the Empire to Fall.
The advent of Empire turns values inside out. The transformation in American values was stunningly demonstrated a few years later.
Taking his inspiration from the Foundation of the American Republic, Ho Chi Minh established the Democratic Republic of Vietnam, and in his inaugural address quoted from the Declaration of Independence:
“All men are created equal. The Creator has given us certain inviolable Rights: the right to Life, the right to be Free, and the right to achieve Happiness”
He called on America to help him overthrow the French but by 1963, American Legions were pouring in to put down the Republic and secure Vietnam for “Our way of life and our values”.
Crossing the Rubicon
It can be difficult to pinpoint transitions. The Rubicon that led from a Medical Republic to a Pharmaceutical Empire was crossed in 1962 with the passage of the Amendments to the Food and Drugs Act. This act put in place an apparatus of controlled trials, prescription-only status and disease indications that laid the basis for a global pharmaceutical hegemony, although the drift to Empire could still have been stopped at this point.
It took a while for anyone to notice the threat to the Republic. In the 1970s, sensing a growing threat Ivan Illich inveighed about our approaching Medical Nemesis. One of the few to have a clearer sense of the problem was Louis Lasagna, who was in significant part responsible for the 1962 amendments (See Not So Bad Pharma and The Empire of Humbug and the following 6 posts).
Looking back at the 1980s we can now see the coming Empire as a $30 Billion clinical trials industry run by a new breed of satellite companies (CROs) took shape, as a process was put in place that rapidly led to over 90% of academic articles about on-patent drugs being ghostwritten, as the US patent system was extended globally in the form of TRIPs, and how in 100% of cases the data from controlled trials, that had previously been readily available in the Republic of Science, was sequestered.
The new Empire swallowed the Medical Republic. And values turned inside out.
In the Medical Republic an article like that of Marty Keller and colleagues (Study 329) stating that a drug was Safe and Effective would be taken to mean safe and effective for patients. In the Pharmaceutical Empire, the words mean Safe for GlaxoSmithKline and Effective at generating profits.
When a drug scare hits the headlines and regulators talk about the risk-benefit ratio for the drug still being favorable, they are talking about managing the risks to companies rather than to patients.
In the Republic, medicine’s reach was limited to diseases like melancholia, tuberculosis or heart attacks. In the Empire, healthcare manages SSRI, Statin and Bisphophonate deficiency disorders. Left untreated these will kill the company.
In the Republic Controlled Trials were about limiting the use of drugs; in the Empire Controlled Trials fuel the Therapeutic Bandwagon.
In the Republic Guidelines offered guidance about what not to do; in the Empire Guidelines are Diktats – what must be done.
In the Republic patients entering trials signed Informed Consent forms; in the Empire they apparently sign Confidentiality Agreements.
In the Republic, the CEO of a pharmaceutical corporation might try to meet with the head of an academic medical department or professional grouping but would not have been surprised to be left waiting at the door. In the Empire, heads of university departments are lucky if they can get access to centurions fairly far down the Pharma pecking order.
In the Republic, the leaders of a medical group would welcome a call to the field to insist on the absolutely central notion of science – access to data.
In the Empire, you can expect a recent President of the American Psychiatric Association to get ad hominem:
“The group (Le Noury et al) is a self-appointed watchdog,” Jeffrey Lieberman, chair of psychiatry at the Columbia University College of Physicians and Surgeons, told BuzzFeed News. “One wonders what the motivation is, and how objective they’re going to be.”
Lisa Cosgrove and Bob Whitaker in their recent book Psychiatry under the Influence describe this effect as an illustration of economies of influence.
The change has transformed the former Medical Senators into Minions.
And we, the former Electors, have become Consumers. We consume the security the Empire offers. As Margaret Atwood would say:
We have been given Freedom From in exchange for Freedom To.
Sense about science
Simon Wessely and Clare Gerrada are the power couple of British Medicine. He is the current President of the Royal College of Psychiatrists, and she is a recent President of the College of General Practitioners. When faced with questions about over-prescribing of antidepressants by GPs, she is quick to insist that GPs rarely treat distress and that almost all prescribing is for genuine illness and the drugs work well. He gives similar messages in respect of psychiatry.
These messages look one way in a Republic but look quite a different way in an Empire. If the drugs work well and Evidence Based Medicine is all its cracked up to be – who needs doctors. Nurse are cheaper. Defending doctors needs a very different message. It needs an Expertise Based Medicine.
The existence of a group like Sense about Science of which SW is an advisor also looks very different in an Empire setting.
Sense about Science began in Britain 15 years ago with donations from Corporations in the Risk Management Business – from Monsanto through Nuclear Power to Pharma. These donations have vanished from sight now, replaced by endorsements from all major UK universities and journals like The BMJ and support from Charitable Foundations.
SAS’s stated mission would have appealed to someone like SW who had come under attack from a lot of fringe groups in the 1990s for taking a balanced data-driven approach to Chronic Fatigue Syndrome (M.E.).
But SAS has now become a node to handle any messages in the media that might hurt the interests of a company or corporate sector – such as anything to do with vaccination or my recent editorial on So Long and Thanks for all the Serotonin. BMJ sent this article (as they send all articles) to SAS who got in touch with SW to rustle up statements from Jeff Lieberman types which can be disseminated widely to the media either for citing or as a means to close down stories:
You might not want to take Healy’s work seriously in the light of what these senior figures in the field are saying.
Sense about Science has since spread to Canada, Australia and now the United States and everywhere the mission is the same.
AllTrials & AllData
SAS was a founder of AllTrials. This sounds like AllData – the hashtag for Restoring Study 329 – but at the moment it is quite the opposite.
There has been close to radio silence from AllTrials in the face of the call for AllData, aside from one stunning press release that more or less credits GSK with the efforts to Restore Study 329.
17th September 2015
Many supporters of AllTrials will be interested in a study published in The BMJ today, a reanalysis of previously hidden clinical trial data. The new research used data from a 1990s clinical trial of the GlaxoSmithKline (GSK) antidepressant drug paroxetine. Today’s findings contradict a 14-year-old analysis of the data referred to as Study 329, which found paroxetine to be safe and effective for treating adolescents with major depression.The new research is the first reanalysis of a drug study under the RIAT (Restoring Invisible and Abandoned Trials) initiative, which calls on companies and academic funders to publish detailed trial information for independent scrutiny. The RIAT team was able to access the original clinical trial data using GSK’s patient-level data access portal, where researchers can request access to this information.
Tracey Brown, Director, Sense About Science and co-founder of AllTrials:
“When all trials are registered and results reported, it becomes possible for researchers to work out what data are available. GSK has gone further and made its patient level data available to researchers. It is disappointing that there are still so many companies not reporting trials. Researchers, doctors, patients and, in July, their shareholders have said they want transparency about trial results. This will confirm their views.”
Sir Iain Chalmers, coordinator of the James Lind Initiative and co-founder of AllTrials:
“Among pharmaceutical companies, GSK under its current management has led the way in promoting clinical trial transparency and provides a practical mechanism to make trial re-analyses possible. The reanalysis of Study 329 illustrates the knowledge dividends from the company’s new policies and contrasts strikingly with the scientific misconduct that characterised the company’s behaviour under previous management. Today’s GSK has shown moral and scientific leadership that puts to shame many in the academic community.”
Pontius Andrew?
Faced in 2012 with questions about the $3 Billion fine imposed on GSK, triggered by a sequence of events starting with Study 329 – is it just the cost of doing business? – Andrew Witty snapped back:
“Although corporate malfeasance cases end up looking very big, they often have their origin in just… one or two people who didn’t quite do the right thing. It’s not about the big piece. The 100,000 people who work for GSK are just like you, right? I’m sure everybody who reads the BMJ has friends who work for drug companies. They’re normal people… Many of them are doctors”.
Everything about Study 329 suggests that Andrew is comprehensively wrong. Corporate malfeasance happens when the system is set up so that the efforts of 100,000 well-meaning people get transformed into the worst of outcomes and it then takes the efforts of a few brave people within GSK to alert the outside world to how things are going wrong.
In tackling these issues, I’ve had more help from colleagues in industry and more grief from clinical colleagues so I’m sure the 100,000 people who work for GSK are at least as good as the rest of us – just as Roman legionnaires were no different to the rest of us – and that some of them are very brave indeed.
Good rather than evil is more likely to happen when people buck the system. The Nazi Oskar Schindler may have been a much better person than Eugenio Pacelli (Pope Pius XII).
“The fault, dear Andrew, is in our stars,
Not in ourselves, that we are underlings.”
It’s the pre-ordained system (our Stars) within which we work that dictates how we behave or the outcomes of our behavior. Systems can twist good intentions such as those of Louis Lasagna into a disaster and lead you to execute someone even when your wife tells you the previous night you are making a bad mistake.
Rip van Keller
As I read it, Marty Keller and his colleagues, the authors of the first published interpretation of Study 329 figured they were operating in a Republic. Their study was designed in 1992 to address substantial issues – were the SSRIs going to be significantly different to older antidepressants.
Their correspondence points to bewilderment at the turn of events.
But where Sally Laden under oath described her relationship with GSK honestly, while Marty Keller’s body language made it clear he was painfully aware of how it would look, under oath in 2006 he resorted to a convenient amnesia rather than telling it as it was.
GSK were working with the cream of the bunch. There are some wonderful people in the group such as Rachel Klein, Gabrielle Carlson and Stan Kutcher.
There are many people in this group – and among their contemporaries – who could tell us more about what it’s like to go to sleep in a Republic and wake up in an Empire.
Whether from someone in this or another generation, we need help to find a way out of being Underlings.
PS
One of my consultants (SC) has drawn my attention to the following promotional material for the recent movie Minions:
Evolving from single-celled yellow organisms at the dawn of time, Minions live to serve, but find themselves working for a continual series of unsuccessful masters, from T. Rex to Napoleon. Without a master to grovel for, the Minions fall into a deep depression. But one minion, Kevin, has a plan – the plan does not involve taking an SSRI.
The Minions adopt Vivien Greene’s slogan:
“Don’t wait for the storm to pass, learn to dance in the rain”.
It doesn’t get more ambiguous than this – “Vivien Greene has been consulted by many corporate leaders anxious to marry her visionary message with the corporate bottom line”.
The world today, is under the influence(Of drugs). This epidemic started in the mid sixties
of the past century. What started it? The New Left, with its Peace Now movement. Mescaline and L.S.D. Today the whole world is Shrouded in Drugs and Substance abuse.
How can we help to rescue the World? By Detoxification. How can that be done? STAT?
Niacin served in Patient Centered Medical Home(PCMH). Reference: The Health Care
System of Japan.
Difficult to agree with this. There is a huge difference between LSD and related drugs which caused people to question their place in the social order – their role as underlings – and antipsychotics and antidepressants which are more likely at best to restore you to your place in an unchanged social order and in some instances to tranquilize you so your voice isn’t heard. These are not issues that are going to be sorted by Niacin even if put in the drinking water.
In the 1960s, the protest in the US was against the State, in Europe it was pro the State and against Capitalism
DH
Comedy genius with more truth in it than most people would like to admit….
“Today a young man on acid realized that all matter is merely energy condensed to a slow vibration, that we are all one consciousness experiencing itself subjectively, there is no such thing as death, life is only a dream, and we are the imagination of ourselves. Heres Tom with the Weather.”
― Bill Hicks
“They lie about marijuana. Tell you pot-smoking makes you unmotivated. Lie! When you’re high, you can do everything you normally do just as well — you just realize that it’s not worth the fucking effort. There is a difference.”
― Bill Hicks
Nice article. Of course, at the end of the Roman Republic everyone could see what was happening – now most people don’t know what’s happening and it is more than fifty years later. Perhaps we just need in this instance to insert the word “stealth” for “health”. Or how about “st-health”.
I think we are all non plussed about why it has come to pass that it is preferable for each of these types not to consider or accept the failure to protect human life, at all costs.
The nodal element has taken precedence, but, now we have Study329.org which disproves, without doubt, that ‘certain elements within a system’ got it wrong.
These elements are not particularly strong, on their own, but, as a collective group seem to hold sway.
We are each born with a Contract for Life, which does not include death, in its small print.
We are slowly and surely turning it all around and if I was one of those picked out, in “When in Rome, do as the Romans do”, I am not sure I would like all this carnage on my conscience.
But, then, conscience is not the name of this game…..
Is it, that accessorising corporate manslaughter from GlaxoSmithKline, the children followed by the adults, is a worthy individual cause, or, collectively, does it salve them?
And why is not conscience the name of the game?
Of what avail are the words of the Pope, then?
Why be a doctor if what you write on your little pad is something that you know not exactly what it might or might not really do (not what the drug rep. might have told you), or that you know might do harm but it is the only weapon you have, the only way to make your living? What is the point of this sort of job, then, and how might you live with yourself? How might you, yourself, play a role in causing change to happen, in causing no harm?
When will the little white pad writer cadre rise up? Those of us who have lost family members – the innocents who have not been forgotten by us – are waiting for some sort of justice, some sort of sign that conscience finally is the name of the game. We have been radicalized by the robbing of our precious ones. Our loved ones – given prescription drugs and believing that these would help, not kill.
There is little expectation that the corporate game will change any time quick, until forces from outside the gates upend it. But for those with the little white pads, who must understand what they know and don’t know, what of them?
…and to quote Margaret Atwood (in a New York Times article today regarding her new book) on her novels (but applied to prescription drugs in this instance)…”I take a very simple position, which is that it should say on the cereal box what’s inside, and if it says bran flakes it should be bran flakes.”
A good quote – maybe it should also say what happens if you exceed a safe amount, reduce the amount or have an allergy to any amount ( of bran flakes or what you will)!
In the New York Times today, the following appeared: “Hours after meeting with sexual abuse victims in Philadelphia, Pope Francis on Sunday night again strongly condemned priests who molested children as “sacrilegious” and publicly acknowledged that bishops had covered up abuse cases.” He is still identifying as sinful activities that are, in fact, criminal and for which any non-clerical perpetrators would be leading very unpleasant lives in thoroughly nasty prisons. Can someone, then, explain to me how it is that the actions of GlaxoSmithKline, that led to a more than $3 billion dollar fine for, among other things, concealing safety concerns that undoubtedly led to unknown numbers of deaths, has a directorship that has skated past the consequences of admitted crime, namely prison? It seems that, in the US at least, financial crime warrants years in jail (see Bernie Madoff) but deaths of children and adults caused by the actions or innactions of a mega-rich corporation get no real attention. Perhaps the actions of GSK were just a venial sin after all.
Or perhaps a venal sin and we live in a world where Greed is good?
DH
https://truthman30.wordpress.com/2014/05/30/no-conflict-of-interest-to-see-here/
I think this deserves a re-post:
No Conflict Of Interest To See Here…
“AllTrials – little credibility?
“What’s worse, Prof Healy says, is that the European Medicines Agency (EMA) has adopted the same scheme, placing the ‘GSK model’ firmly on the path toward respectability and universal acceptance. If true – and the EMA is denying any “change in direction” over transparency in response to concerns expressed by the European Union Ombudsman – then the credibility of AllTrials is about to crumble to nothing”
“I’ve got huge respect for Andrew Witty”
(Ben Goldacre Nov-2012)
Following on from my recent post about Ben Golacre’s generic and flippant comments on my blog yesterday, here’s some more food for thought-
GSK president (of R and D), Patrick Vallance, was one of Ben Goldacre’s tutors when he was in UCL Medical School – a fact I stumbled upon because Ben Goldacre mentioned it himself in a footnote on one of his blog posts about GSK data transparency in 2012. ( see here ).
Ben says:
“(Oh, and footnote: Patrick Vallance, GSK’s current supreme medical
person? If you were at UCL medical school doing your clinical
training, in the late 90s, like me, then he was the clinical
pharmacology prof who taught us how to prescribe. Nice guy, smart
guy.)”
Ironically, it was that blog post which first brought Ben Goldacre to my attention, and it was one of the reasons why I wrote about Ben initially. I just could not comprehend why on the one hand Ben seemed to be somewhat critical of GSK, but on the other- completely enamored with GSK CEO Andrew Witty. His tweets gushed sycophantic praise like you would expect from a school boy who had just been validated by his boyhood rock idol or soccer hero. When GSK said they would sign up to Alltrials, many bloggers and patient activists were perplexed as to why this would be a ‘Cartwheel’ moment for Ben. Surely, we thought, when dealing with a drug company like GSK who are notorious for misleading and deceiving, it would be wiser to be more cautious?
Similar to his character endorsement of Vallance, Ben referred to Andrew Witty as a nice guy; as if to portray an image of Witty as someone who was innocuous and harmless. These are hardly the personality traits of someone who runs a multi-billion dollar global cut throat business – which had incidentally been fined 3 Billion for fraud by the Department of Justice the previous year. Part of the fine involved off-label prescribing of Paxil (Seroxat) which can be related back to the promotion of GSK’s infamous study 329 (A fraudulent study which has yet to be retracted and also which led to the deaths of many children).
CEO’s of pharmaceutical companies are not innocent, harmless kittens, as Ben Goldacre seems to perceive them (or at least that’s what he is maybe trying to convince us of). Pharma executives have to be utterly ruthless because their business model demands it. They cannot permit themselves to have compassion for people who are harmed by the company that they run. If they were kind, soft, humane beings they wouldn’t last a second as a pharmaceutical executive. It’s a job that requires a certain type of person (some would say maybe even only sociopaths could rise to such a high level in pharma). So either Ben really believes that Andrew Witty is a harmless kitten, with only the best of intentions for mankind, a man whose mission in life is to spread, light, love and data transparency, or something else entirely is going on… nobody could be that gullible surely? Could they?…
It all seemed very strange to me at the time, but now that I have had a few (lame but somewhat insightful) responses from Ben on my blog, and read all of David Healy’s and 1boringoldman’s posts about the Alltrails debacles, I think I have a good sense of what Alltrails and Ben Goldacre are about. I also understand now what both bloggers have been trying to draw attention to…
When I wrote my first post, I wanted to get Goldacre’s attention, because I wanted him to explain to me why – as a supposed patient advocate- which he advertises himself to be- does he consistently praise GSK? Why was he not highly critical of them? Particularly considering they have been one of the worst (or perhaps even THE worst) offenders in regards to hiding trials, manipulating evidence, harming patients (including deaths from Seroxat and Avandia etc) and a whole myriad of unethical, immoral and illegal corporate crime which has spanned decades by now. Why would Ben be so insistent on trusting them, when it was quite clear to those of us who have been documenting and researching GSK- over the years – that they are one of the most devious corporations on the planet?
How could Ben be so blind and naive?
Well, it seems to me that despite denying any connection to GSK- Goldacre does have some links to GSK, mainly through his association with his old tutor Pat Vallance. Vallance has worked for GSK for 8 years now and it is Vallance who is driving GSK’s transparency model- a (rather dubious) model which Goldacre and his colleague – Iain Chalmers fully support.
Goldacre denied that GSK and Alltrials are in any sort of partnership at all but this document, written by Vallance and Chalmers (and with support from Ben Goldacre), would perhaps seem to suggest otherwise:
https://davidhealy.org/wp-content/uploads/2013/10/GSK-and-Chalmers-Lancet1.pdf
My reservations about Goldacre go back to 2003 and it has alway been about rescuing the government/pharmaceutical complex, beginning with the defence of MMR (apologies if some of the links no longer work).
http://www.ageofautism.com/2012/09/best-of-aofa-whats-behind-ben-goldacre.html
He’s supposed to look like an intellectual powerhouse (he’s a brand in himself) but it is remarkable how much of it is based on ad hominem. When called on to defend the faulty epidemiology of MMR safety, for example, he is silent – he still just shifts the argument on to the bad people who don’t understand science.
Perhaps he will surprise me now and call for a congressional hearing into the claims of MMR whistleblower William Thompson, but I somehow doubt it.
Without pointing fingers in any direction, the history of lack of consequences for malfeasance in corporations such as BigPharma reminds me of the B-Scan 360.
What leads an exorbitantly paid C.E.O. to cheat, steal and lie? Perhaps he’s a psychopath, or at least a sociopath, a person with a psychopathic personality whose behavior is antisocial, often criminal, and who lacks a sense of moral responsibility or social conscience. Now there is a test, the B-Scan 360, that can help make that determination. The B-Scan was conceived by Paul Babiak, an industrial psychologist, and Robert Hare, the creator of the standard tool for diagnosing psychopathic features in prison inmates. The B-Scan is the first formalized attempt to uncover similar tendencies in captains of industry, and it speaks to a growing suspicion that they may be especially adept at scaling the corporate ladder.
According to Babiak and Hare, white-collar psychopaths are not apt to become serial rapists or murderers. Rather, they are prone to being ‘subcriminal’ psychopaths: smooth-talking, energetic individuals who easily charm their way into jobs and promotions but who are also exceedingly manipulative, narcissistic and ruthless. The purpose of the B-Scan is to smoke out these “snakes in suits.” Babiak and Hare point out that the nature of modern business—the relentless merging and acquiring—provides a fertile environment for havoc-wreaking psychopaths, who thrive on chaos and risk-taking. As Hare put it in one interview, “If I couldn’t study psychopaths in prison, I would go down to the Stock Exchange.”
And remember that if you choose to stay in the rat race, you’re still a rat.
Brilliant post !
I honestly wonder if All trials was the genius idea of Witty. I can’t believe that the people who head All trials are actually trying to use the resurrection of study 329 to praise GSK.
GSK have All trials eating out of their hand.
All is not what it seems here…
I have been blogging about Alltrials, Ben Goldacre, Sense About Science and GSK, for a while now..
https://truthman30.wordpress.com/?s=ben+goldacre
At one point I thought that GSK were misleading Goldacre and Sense About Science and that Ben and Alltrials were just merely gullible and naive..
however since reading their statements on their website about study 329
Now I’m not so sure…
Something very strange is going on.. perhaps Goldacre would like to explain why Alltrials (and he himself) have not commented upon the impact of Seroxat in the under 18 demographic? It was, after all- prescribed to hundreds of thousands of under 18’s- even though GSK were aware it would be harmful? If Ben is the patient advocate he claims (in fact he sells this image to the public) to be then why is he not uttering statements condemning Seroxat and GSK’s behavior?..
Does Goldacre still think that Witty is a nice guy? and a good guy?
Something really stinks here..
Actually the whole thing stinks to high heaven..
If my instincts are wrong, then correct me Ben..
the silence is deafening..
I would like to have a little chat with this Mr. Goldacre, face-to-face. What might he say to me, a forever-grieving parent? One wonders if he would actually try to be glib….
Once I sat next to a Pfizer official, at a PDUFA hearing in 2007 before the House Oversight Committee in D.C…. Of course, he got what he was hoping for – all the prescription drug safety new language stripped out of the bill at the eleventh hour.
However, after I asked him who he worked for and why he was there, and I told him why I was there, he changed his seat within two minutes. Perhaps Mr. Goldacre would similarly just run away, the way Dr. Tom Loughren used to do when grieving family members tried to approach him at FDA hearings….
Simon Wessely has consistently recommended Gradual Exercise Therapy (GET) or a special kind of CBT for patients with M.E, despite post-exertional malaise being a primary symptom of M.E, and very high reports of patient harm coming after these ‘therapies’ being used on them.
From the paper “Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome” http://iacfsme.org/ME-CFS-Primer-Education/Bulletins/BulletinRelatedPages5/Reporting-of-Harms-Associated-with-Graded-Exercise.aspx
An excerpt from the Abstract; “However, exercise-related physiological abnormalities have been documented in recent studies and high rates of adverse reactions to exercise have been recorded in a number of patient surveys. Fifty-one percent of survey respondents (range 28-82%, n=4338, 8 surveys) reported that GET worsened their health while 20% of respondents (range 7-38%, n=1808, 5 surveys) reported similar results for CBT.”
Many patients were and are angry at him for suggesting that M.E is a mythical illness, that is he is on record as arguing that ME is merely “a belief” that one has a disease called ME and that it is “part of the world of myth” (9th Eliot Slater Memorial Lecture, 12th May 1994).
I would suspect that any doctor recommending a treatment that has a good chance to make you sicker will not be popular with any patient group.
Its a long time since I’ve looked at the CFS literature but my impression was that SW’s approach was sensible and evidence based. Its highly likely that at some point we’ll find triggers to some of the states people end up in and this will remove any taint of myth but whether we find triggers or not trying to get people moving again has to be a good bet for many if not all.
It’s probably always possible, especially now, to find something everyone has said somewhere that contradicts or appears to cast doubt on what they say in general. Also without having the context to SW’s statement about myths it can be difficult to know just what is being said. Things certainly got heated though. And one of the unfortunate consequences of this is that groups like Sense about Science had an increasing appeal to many in academia and journals as a way to manage debate about health issues in the public domain.
The conundrum is this. All medical and surgical treatments are inherently damaging. The art lies in inflicting damage aimed at bringing about a greater good. But some people will just be left damaged. And angry. Medicine has to be able to tolerate that anger at least if it cannot find it within itself to embrace it. Defensiveness is often explained away on the basis of needing to look after the interests of the many others who might benefit and whom it is important not to deter from seeking treatment. This is understandable but is a drawing up the wagons.
DH
It is understandable that those left “damaged” may indeed feel very angry – but anger itself can be destructive, especially if left to fester. Handed a prescription that truly changed his life ( and not in a good way), our son could quite easily have felt ” uncontrollable anger”, way beyond his time on the SSRI, towards those concerned in its prescribing and its consequences, but he doesn’t – all he will say is ” my GP did what he thought was best, for me, from what he’d been told”, “my solicitor did his best but he wasn’t believed,” and ” imprisonment made me stronger – you have to stand up for yourself in there”. I doubt very much if I could feel the way he does after such an ordeal and feel very proud of his strength and determination to improve his lot. Still a long way to go but every new idea is accepted, tried and acted upon or discarded according to its suitability for his needs. Guess what? – he’s left me to do the “anger” bit on his behalf!
Just watching J Corbyn’s speech to conference – would fit in well with your latest blog David! An excellent speech in my opinion – very refreshing.
Thanks for the reply, Dr Healy.
I agree about getting people moving again, but the point is that most M.E specialists and patients agree that ‘pacing’ is by far the safest and most successful way to do it.
This is ignored by certain sections who believe that the pain is because of a fear of exercise, who believe the patient should be pushed harder and harder, ignoring the multi system dysfunction this brings, leaving many patients bed-bound and worse off than before.
I think one of the problems with the treatment is that it is very “by the numbers” not taking into account that each patient is different. Another problem is that the bed-bound patients are unlikely to feature in any clinical studies, especially involving physical activity, thus biasing treatment guidelines towards the more able/active in the spectrum.
Anyway don’t want to take this too much more off topic, I appreciate the willingness to listen and respond, I’ll leave a couple of hopeful studies you or the readers might be interested in, which seem to show that at least people are now looking in the right area for biomarkers, and a narrowing down of the search for more insight.
B-Lymphocyte Depletion in Myalgic Encephalopathy/ Chronic Fatigue Syndrome. An Open-Label Phase II Study with Rituximab Maintenance Treatment
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0129898
Article: http://simmaronresearch.com/2015/03/major-study-suggests-early-immune-activation-may-drive-chronic-fatigue-syndrome/
Distinct plasma immune signatures in ME/CFS are present early in the course of illness
http://advances.sciencemag.org/content/1/1/e1400121
the Science Media Centre response http://www.sciencemediacentre.org/expert-reaction-to-biomarkers-for-cfsme/
Prof Jonathan Edwards,
Emeritus Professor of Connective Tissue Medicine,
commented on the science media centre response:
“The Science Media Centre seemed to have excelled themselves in missing the point.
The crucial difference with this study is that it is not a study that tries to get results that fit with a pet theory. It is a study that went out looking for what was there. And something did seem to be there.”
Anyway well done Dr Healy, for your empathy and strong priciples, and well done for this good news on study 329, it must have felt like a Sisyphean task at times.
I can certainly say I have read quotes attributed to Simon Wesley where he claims certain illnesses that I believe to be genuine, are in peoples heads. And in my opinion, stating things like that publicly is an incredibly insensitive and arrogant thing to do no matter how sensible or evidence based the initial approach. It comes from over confidence in modern science and completely ignoring anecdotal evidence.
My own non-expert recommendation to anyone suffering from a ‘mythical’ illness is get your gut checked for permeability and temporarily modify your diet to exclude all known allergens, processed food and most importantly grains. Even if you are certain you are not allergic and have eaten these foods for your whole life.
This isn’t a half ass change like most people make after dietary recommendations by the doctor – it has to be carried out very strictly like your life depended on it. I could start to list the ‘diseases’ that this will have a MAJOR impact on but that would take far too long as it covers most of them. No I’m not a doctor….just talking from experience (3 years eating only clean, natural food leading to an almost complete reversal of three officially diagnosed chronic conditions that apparently have no real cure and can only be managed with drugs).
Simon Wesley like most of the medical and academic community have their heads in the sand as to just how much modern illness is man made. It’s only a matter of time though as the research into inflammation and the gut appears to be heading fairly quickly in the right direction. The resistance from the medical community will be strong as it will be tantamount to admitting they have been party to great harm to mankind over the past 40 years. The resistance from biotech will be stronger as they are the main culprits while also being the people with the expensive drug treatments for these conditions. You might think I am nuts right now, but you won’t in 10 or 15 years time – I am supremely confident about that.
You could say that they can’t be blamed for something that hadn’t been discovered yet, but really when you look into this in any depth, this has been known for many years (in some cases you could even say 2000 years). In fact, it is mind-blowingly obvious once you accept a few simple things. When the pieces finally fell into place for me I literally did a face-palm.
Have they stopped teaching medical students the meaning of psychosomatic? Of course many disorders are “in your head”, in particular chronic pain that has become centralized when the actual injury has healed but real pain persists and is virtually untreatable by drugs although Dilaudid and its cousins are being handed out like M&Ms.
To advocate a good diet, moderate exercise and adequate hydration (the most often overlooked) as treatment for what I shall call generalized misery – unlike the real but relatively rare melancholia – is to brand oneself as the nut in the corner. And, anyone ever heard of phantom limb pain another “in your head” agony that really can’t be treated with drugs except by stunning the patient into oblivion.
Irene, have you heard about the treatment for phantom limb pain discovered by Ramachandran? It seems to work for some with cramping and muscular-type phantom pain?
https://en.wikipedia.org/wiki/Mirror_box
I read about in his book, “Phantoms in the brain”, which was a really good introduction to some of the mysteries of the brain.
On the subject of gross exploitation of the community by the medical industry, see the program ‘Wasted’, aired in Australia last night in the ABC’s Four Corners’ timeslot: http://www.abc.net.au/4corners/stories/2015/09/28/4318883.htm
The promo for the program states: “When we head to the GP most of us assume ‘the doctor knows best’. But the truth is, many of the scans, test and procedures ordered by medical practitioners are wasteful, unnecessary and potentially harmful…Healthy people are needlessly being turned into patients with tests and scans leading to treatments which at best have no effect, and at worst, cause harm.”
The program reports Australia spends “about $155 billion a year on health. And about a third of that, $46 billion, each year is being squandered. But it’s not just about the money.” A/Professor Adam Elshaug says: “We know that patients are being harmed by receiving tests and treatments that they should never have received.”
The transcript for the program is accessible via this link: http://www.abc.net.au/4corners/stories/2015/09/28/4318883.htm#transcript
While the program uses examples of over-diagnosis and over-servicing re back and knee pain, coronary artery disease, and prostate cancer, the examples provided are just the tip of the iceberg…
With respect to “doctor knows best” John Mandrola at http://www.medscape.com/viewarticle/849689 is worth reading. He relates the story of a pregnant, economics professor who expected that the treatment she would receive would, in most respects, work like any economic decision. First, there would be an actual choice—not a decree. Then, accurate data would frame the decision and multiple paths would be presented, each with their pluses and minuses. In the end, her preferences would guide her choice.
Was she wrong.
Nothing better than asking the questions…
#alltrials
Twitter
1. 11h
David Healy @DrDavidHealy
Are GSK now Open Data Heroes .. or has #AllTrials fallen for Emperors New Clothes? https://davidhealy.org/study-329-data-wars/ … #Study329 pic.twitter.com/HCbJMBKO8m
Retweeted by Lorraine Moss
2. 12h
David Healy @DrDavidHealy
Odd statement from #AllTrials. Chief lesson of #Study329 seems to be .. the Wonderfulness of the New GSK. Thoughts? https://davidhealy.org/study-329-data-wars/ …
Retweeted by Andrea
3. 11h
David Healy @DrDavidHealy
Are GSK now Open Data Heroes .. or has #AllTrials fallen for Emperors New Clothes? https://davidhealy.org/study-329-data-wars/ … #Study329 pic.twitter.com/HCbJMBKO8m
Et cetera……read all about it on Retweets..on Alltrials..
http://twitter.com/DrDavidHealy/status/648563831824715777/photo/1
“Although corporate malfeasance cases end up looking very big, they often have their origin in just… one or two people who didn’t quite do the right thing. It’s not about the big piece. The 100,000 people who work for GSK are just like you, right? I’m sure everybody who reads the BMJ has friends who work for drug companies. They’re normal people… Many of them are doctors”.
This quote makes my blood boil. I don’t know how many times I have read that argument or something similar from the sceptic/lobbyist/big business apologist community.
People are far more easily likely to do things that are harmful to others when they are in groups than they are as individuals. It’s not that hard to get your head around Andrew! And initially I got that info from someone who is involved with Sense about Science… Oh the Irony.
But that’s the thing about lies and misleading information – it can always be used against you at some point in the future.
Witty speaks of “one or two people who didn’t quite do the right thing.” Yet, in the case of Eli Lilly’s Zyprexa, there were way more than one or two people sitting in conference rooms deciding how, over time, to continue to not do the right thing. When it emerged that people taking the drug were gaining enormous amounts of weight, getting diabetes, and dying of such things as profound hyperglycemia, the company started a campaign to “help” people with schizophrenia lose weight (if they were gaining on the drug) because, after all, we “all know” that people with schizophrenia “tend to gain weight”.
In the first known article about the risks of dying of the drug showed up in the Baltimore Sun (March 2003), and spoke of how the Japanese government had required Lilly to put a warning on the label for diabetes, hyperglycemia, and death, the company spokesperson was quoted as saying that this was a bad idea and they hoped the FDA would not follow suit because, after all, it might cause people to actually stop taking the medicine (Marni Lemons, Lilly spokesperson, March 2003 Baltimore Sun).
Most of the people in those conference rooms have gone on to greater glory – one is currently the President of Perdue University.
Certainly people are more likely to do harm in groups than individually but please let’s not forget that people are more likely to good in groups than as lone voices crying in the wilderness. Power in numbers, in both directions.
Snapped…….17 goals, one off side…….
Tweets from GSK
• Without health, there is no wealth – it’s the golden thread that pulls together the #GlobalGoals http://t.co/xa7hlYPvAK
1 hour ago
• Looking forward to talking biz and #GlobalGoals w/ @CCitizenship. Join Priya Madina from our government affairs team: gsk.to/1FDLB4s
1 hour ago
A new heading has slipped on to the GSK site
Instead of telling us to report to the MHRA and Yellow Card System, they have gone public by asking for our side effect sssssssssssssssssssssssssssss..
http://www.gsk.com/
Report a possible side effect
• Tell us about a possible side effect you may have experienced
http://www.gsk.com/en-gb/contact-us/report-a-possible-side-effect/
Select a region & country
United Kingdom
Pharamceuticals and Vaccines telephone number:
+44(0)800221441
Consumer Healthcare telephone number:
+44(0)8007838881
Pharmaceuticals and Vaccines email address:
UK PharmaSafety@gsk.com
Consumer Healthcare email address:
UK.CONSUMERHEALTHCARE@GSK.COM
At least GSK now agree the suicidality problem exists with their drug Paxil. See http://1boringoldman.com/index.php/2015/09/29/study-329-xii-premature-hair-loss/. Do they now recognize their responsibility going forward? Do they have the good sense to bring Medical Affairs front and center to call the shots over Marketing and Legal? Do they understand what they need to do?
The scientific need is for a GSK-funded, independent study of the predictors of Paxil-induced suicidality as well as other major behavioral side effects (akathisia, completed suicide, homicide). The study should include genetic markers in addition to clinical predictors. Medical Affairs receives adverse event reports from the field, and those cases could be made available to the project. The results should be clinically pertinent.
This isn’t rocket science, you know, but it could be a good-faith step by GSK.
Yes, let them face their problems, and somehow sort them, eventually they are going to have to.
And by doing so: give us survivors a fighting chance.
It’s not even about Money, by now, the damage done is on a collossal scale. The only way is to deal with this now, and avoid even more damage from being done in the future!
But…… this has been said for so many years.
In Another post, don’t remember who it was, showed his/her email correspondance with dr Healy from like 2002 disqussing Seroxat and its harms. 13 years on and we are still here. Or the Pictures on Truthmans blog, from 2004, showing “Paxil-protesters” with signs saying “Ban Paxil”.
How many has, in total, been in Contact with Healy with concerns about Seroxat/Paxil?
How many have had edverse events but been ‘silenced’ by their local GP or psychiatrist?
How many have been Active on forums perhaps as early as in the mid 1990’s talking about Seroxat, but by now are god-knows-where?
Nah, we will not be more than a questionmark in the historybooks.
It got too big to fall before someone reached for the emergency brake.
Maybe NIMH will do this once StarGazer goes to Google. Or maybe Stargazer will do it at Google. I think he can get what he needs from our Gmail accounts and I doubt the privacy policy no one reads will prevent it.
Very good points Bernard Carroll..
However, I don’t think that we will see anything like this from GSK..
Their corporate culture is sociopathic….
yes, more than 13 years on, we ARE still here …..still learning …..still being drugged to give us a better life (?) ……still being told that what we suffer now has nothing to do with the Seroxat of old …..still being told that all our problems are ‘in our minds’ ………but we ARE still here and, thankfully, have one place where we can turn when things overwhelm us –
A little like this you mean…….
GSK @GSK 18 hrs18 hours ago
#LeadingScience means blazing a trail: our Chief Medical Officer explains why we’re expanding access to trial data http://gsk.to/1FIddps
http://catalyst.phrma.org/clinical-trial-data-transparency-is-the-right-thing-to-do
Excerpt:
One or two requests have been to re-analyse data from old trials – which we support when carried out with scientific rigour……..
https://www.linkedin.com/pub/murray-stewart/5/4b/907
https://www.linkedin.com/pub/james-shannon/b/169/553?trk=pub-pbmap