A century ago Freud and Jung made us aware of the biases underpinning what patients say. Not everything should be accepted at face value. In particular claims of abuse may not be based on reality. We needed experts – analysts – they claimed to tease out what is real from what is not.
The Catholic Church was once intensely hostile to Freud, but when it came to child abuse adopting a Freudian approach was very convenient. But while Freud essentially denied that real abuse was taking place and got away with it in his life-time, the Catholic Church has learnt to its cost that many claims of abuse are real.
This intensely dramatic picture shows a former Pope convening the US cardinals in Rome. They were ostensibly there to put the problem of child abuse in the Church to right but it now seems that the meeting was about managing the consequences for the Church rather than for any of its victims.
Habemus papam?
There is no pope in medicine. The Presidents of National Associations perhaps once came close. Now someone like Andrew Witty comes closest to fitting the bill.
Whatever about a Pope, there are lots of Cardinals. These usually come with the title professor. Just as with the analysts, these professors have had a training that stresses that you cannot believe everything you are faced with. In this case it’s more a matter of not believing the evidence of our own eyes as it is doubt about what someone says. We see patients balloon in weight in front of us or voice suicidal thoughts that clear when the treatment is stopped but the Cardinals are the people who on behalf of the Pope tell us this is not happening.
How often eagerness to see a positive response can mislead
The primary training these Cardinals now get is in evidence based medicine (EBM). Psychoanalysis was once a significant advance, as was EBM. Both made us keenly aware of the biases that both doctors and patients bring to therapy – how often their eagerness to see a positive response to a treatment can mislead them as to what is going on.
Psychoanalysis made us more aware of the importance of fetishes – especially sexual fetishes. A fetish is a part that substitutes for a whole. Adherence to psychoanalysis ultimately itself became a fetish that impaired many doctors’ abilities to engage with the real complaints of their patients.
EBM has fetished RCTs in a way that endangers our ability to handle many of the real problems our patients have and our ability to tackle the abuse to which they are subject.
If the skepticism that underpins controlled trials were applied primarily to the claimed benefits of treatments – the original purpose of these trials – there would be little problem. But instead these trials have become a means to deny the harms that drugs cause. Your observation that your patient has been injured by treatment is an anecdote, we are told. There is no evidence here.
Our Cardinals feel sympathetic for your problems but advise you in the interests of the Church at large to keep quiet. You will be doing the Devil’s work if you speak out about things you know nothing about.
Remaining quiet for how long?
We have reached a critical juncture. On the one hand we have evidence from company run trials, up to half of which remain unpublished and over 80% of which are ghostwritten, and close to 100% of which the data are unavailable for independent scrutiny. On the other hand we often have evidence of a problem appearing on a drug, that clears when the drug is stopped and reappears when it is restarted.
This kind of evidence until recently was thought to be the strongest causal evidence there was in clinical practice. In over 80% of cases evidence like this turns out retrospectively to have been right. So which is the more dependable when treatments go wrong, the evidence from company trials or the evidence from doctors and patients own eyes?
When they hear Evidence Based Medicine most people think they are hearing Data Based Medicine. It is an irony that trials are used to drown out good observations from individual case studies when such case studies are often the one group of studies in modern medicine where we actually have the data – the person who was injured and their clinical record.
It seems, if only for rhetorical purposes, we need a way to demonstrate how unreasonable it is not to take such reports seriously. If the Church is to survive, we need some Cardinals to take up this cause.
Meanwhile back in the church of GSKology…
In the Church of GSKology, the striking parallels between the way the Catholic Church is handling abuse cases in the Archdiocese of Minneapolis and GSK are handling access to clinical trial data were pointed out.
The legal system in Minneapolis though seems to be sorting the Catholic Church out. Judge van de North has just ordered the Archdiocese of St Paul and Minneapolis and the Diocese of Winona to release the names of 58 priests “credibly linked to episodes of child abuse”. (Although the story seems to have vanished from the Star Tribune site – http://www.startribune.com/lifestyle/234042431.html).
The legal system is not getting to grips with the Church of GSKology or with Astra-Zeneca in Minneapolis in anything like the same way.
In the case of Study 329, GSK got patients to sign consent forms saying they would not receive treatment that differed from standard clinical practice, when in fact the plan was to force titrate these children up to imipramine 300 mg per day.
At the end of the study there was a statistically significant increase in the rates of suicidality on Paxil compared to placebo.
Children have been abused. Whose duty is it to inform these now grown children. Pope Andrew?
Or the doctor involved in the trial or their institutions?
- Marty Keller, or if not him, Brown University?
- Barbara Geller from St Louis?
- Rachel Klein from New York?
- Neal Ryan from Pittsburgh?
- George Papatheodorou or CAMH where he was working then?
- Stan Kutcher from Dalhousie?
- Gabrielle Carlsson from Stony Brook?
- Graham Emslie from Dallas?
- Karen Wagner from Dallas?
- Michael Strober from UCLA?
- Greg Clarke from Portland?
- Elizabeth Weller from Columbus?
There were lots of others pulled in to the exercise, pleased perhaps to get their name on a paper. Boris Birmaher for instance.
Rumor has it there are a bunch of bioethicists and lawyers who have got greatly exercised about things going wrong in a St Paul and Minneapolis Astra-Zeneca clinical trial. Perhaps some of them could weigh in on the issue of what should happen next in the case of 329. GSK and A-Z are both British companies – perhaps this is a British thing.
What are the duties of companies, doctors, universities and clinical institutions in a situation like this?
The Entrepreneurial Franchising Effect of Drugs Inc and Incorporation of all things in Health Care has polluted and corrupted the concept of doctors fulfilling their duties. Patient care is lost in Capitalism.
It is not now a question of who is burying Paxil Study 329, and who knows about it.
It is now a question of who doesn’t know about it.
Clearly, David Cameron, doesn’t know about it.
It is now ten years since litigation began against GlaxoSmithKline and in that time we have been trodden on and side-stepped and almost casually told to stop complaining.
We have not stopped complaining for ten years. And, so we are a little bit put out that David Cameron has chosen GlaxosmithKline to be part of a trade mission to China.
David Cameron doesn’t know anything about Paxil Study 329, he knows nothing about Seroxat, he knows a bit about China and GSKgate.
Paxilgate is way down the line of things David Cameron might worry about.
But, he does have rather a bad habit of keeping company with advisors with murky histories, who have a habit of disappearing.
We have been injured for years and years, with the experiment on children, and today, now, there will be hundreds of people desperately trying to get out of the hideous place that Seroxat has put them.
Seroxat should have been taken off The Market in 2002 when all the negative publicity flared up.
In fact, it should not have reached The Market at all…….
The MHRA have had every opportunity to take it Off The Market.
GlaxosmithKline, the MHRA are still allowing too much suffering from Seroxat and although sales are well down compared to other anti-depressants, there is always some sucker out there whose doctor will recommend Seroxat and subject their patient to a life of purgatory………and, with the somewhat, usual, narcissistic attitude from a doctor……
From avarice and cowardice through to bravado, there is a patronising pretence.
Playing fast and loose with clinical trials is one thing, playing fast and loose with us is another, but playing fast and loose with David Cameron is very, very dangerous.
One day, in the future, David Cameron will get hot under his collar and ask why he wasn’t told about all the litigation and all about Seroxat and all about how he was made into a complete fool in ‘China’ and how his election prospects diminished under a glare of negative publicity because important people neglected to tell him of a rather disturbing secret about Paxil Study 329, which has yet to hit a headline in the UK.
The final question on the Church of GSKology can be answered with another question.
Who is blocking the UK litigation and why?
Perhaps British lawyers should be a bit more Gotzsche about it?
Seroxat is a hot potato.
Witty, another bloody………..suicide………………………..?
This video by Irish singer-songwriter Sinead O’Connor seems to bring a lot of the issues together. It comes courtesy of blogger Leonie Fennell, whose son Shane Clancy killed himself and another man after seventeen days on citalopram, an SSRI antidepressant.
http://wp.me/pUfFP-2Pn
Sinead questions the diagnosis of “bipolar disorder” given her by an Irish psychiatrist who, she said, seemed to think her worst psychiatric symptom was her harsh criticism of the Catholic Church! She reports being put on “toxic” doses of medication, which caused rapid weight gain and left her feeling heavily sedated, and given no warning of the trouble she would have withdrawing from these meds. Well worth a look.
Hi Dr Healy,
Can you shed some light on “until recently” in “This kind of evidence until recently was thought to be the strongest causal evidence there was in clinical practice.” Is there some referenced work recently published on this and if so can you advise please of the citation? It is an important issue.
Clifford
Any authoritative source on the issue like the Federal Judicial Manual still regards challenge-dechallenge-rechallenge as the best bet. But companies have managed through the repetition of RCTs are the gold standard to create the impression that CDR is just anecdotal – see the Burn in Hell post. RCTs are a gold standard way to Hide Adverse Events
David
Thanks. So it is not so far a concerted attempt to rewrite principles of evidence but merely the creation of a false conception of a consensus by repetition before the great (evidentially) “unwashed” (albeit the possibly otherwise highly medically qualified).
Not the first time nor the last time that kind of thing has been done.
The “anecdotal” evidence bit is wearing thin these days though.
What is the difference between scientist A with demonstrably perfect recall reciting each measurement of an experiment and scientist B with a very bad memory reciting each measurement from his lab book?
Answer: you cannot be sure scientist B did not write any measurements down incorrectly and she cannot remember whether she did or not.
David,
In the context of CDR reports and more you may find of some assistance a paper I co-authored with Professor Donald Miller:
“The Real World Failure of Evidence-Based Medicine”
http://tinyurl.com/puzfzax