In 1517, Martin Luther nailed a defiant proclamation to the door of Wittenberg Cathedral. (See RxISK Reformation Day).
The issuing of indulgences, offering easier entries to Heaven, in return for money is popularly represented as being at the heart of the storm that followed. A significant part of the storm came from Luther’s stubbornness – his Here I Stand I Can Do No Other.
This simple summary misses out on a lot of important detail. There was more than one readily fixable thing the Catholic Hierarchy were doing wrong. Indulgences revealed a wider credibility issue. What was the basis on which the Church was making decisions?
Sure, those who believe in him, might figure God at some level ensures the hierarchy are not going to let the flock stray too far from safe ground. But even for believers who thought God would take care of Christians through the Holy Father, indeed had pretty well put the Pontificate in place for this purpose, there seemed to be too big a gap between what many Bible reading Christians, in particular, then divined as keeping to God’s purpose and what the Church seemed most concerned about – money.
Another Lutheran Moment
The History of a Medical Psychosis attempts to reveal or characterize the new Lutheran moment in the middle of which we now find ourselves.
This Moment calls for someone to nail a declaration to a Cathedral door, or its modern equivalent, a Moment that calls for all of us who are affected to state – Here We Stand We Can Do No Other.
This moment was triggered by events in Boston in 1989 as the Berlin Wall was falling. News of what had happened came with the publication of an article in the American Journal of Psychiatry, in which 3 Boston clinicians claimed fluoxetine caused 6 people to become suicidal. Analyzing the cases closely and following traditional clinical approaches for determining causality, this article nailed beyond doubt that fluoxetine could cause some people to become suicidal.
It was just as clear as getting a jury of Asians who have never heard about Xtianity to read the New Testament and answer whether it is all about helping the afflicted, the unfortunate, the downtrodden, the poor, and children for theirs is the Kingdom of Heaven, or whether it was a manifesto for getting people with money to invest in the Church and its ability to keep the rabble onside, in part by cowing them into submissions with displays of wealth and power.
There is only one answer to this.
Lots of other clinical groups reported similar findings, as the Boston group. In many cases people were challenged, dechallenged and rechallenged with Prozac, leaving little room to explain what happened them except that fluoxetine had caused it.
A Yale group reported that one in seven of 42 children given Prozac became suicidal. The Boston group had a 14 year old commit suicide – see Beware Doctors Bearing Gifts.
At the center of many cases were credible people who were able to tell their doctors that they had been depressed and suicidal before but that this was different. Marty Teicher, Carol Glod, and Jonathan Cole, the first to report the problem, to their credit believed their patients and listed this as an important element in their ability to establish cause and effect.
This was Evident Based Medicine.
It is absolutely the case that in all areas of medicine, perhaps mental health more than others, some patients will try to fool the doctor for all sorts of reasons, but if nine times out of ten you can’t believe the person who comes to you seeking help with a problem then medicine can’t work.
This is true of all areas of life – other than in prisons, police states and as it turns out in many areas of the medicine we now have 33 years later.
The Empire Strikes Back
In response, 18 months later BMJ published the first Indulgence, in which Lilly claimed an analysis of their clinical trials showed no evidence Prozac made people suicidal. The cases being reported by Teicher and many others, therefore, were sad but anecdotal.
It is well-known they told us that the plural of anecdote is not data.
Depression, they said, was obviously the problem not Prozac.
Clinical trials, they insisted, are the science of cause and effect.
Hey you doctor, you Joe Public, you journalist seeking your Pulitzer for reporting, you Clinton, Obama, Biden, and you Karol Wojtyla, Jorge Mario Bergoglio – are you going to believe the science or the anecdotes?
In fact, the original phrase is the plural of anecdotes is data – otherwise Google wouldn’t work.
The idea that depression is responsible for suicide attempts and suicides in healthy volunteers is hard to believe but companies can and have wheeled out experts to say just that.
But the key point here is that by any proper definition of science, the Teicher paper is the real science. The Lilly paper is an artefact.
Are you Subjects of the Empire (Empires don’t have citizens) going to believe the Science or the Artefact?
Science in medicine and anywhere else lies in making hard judgement calls. The made by algorithm approach, combined with inappropriate statistics, as demonstrated in the Lilly article, creates artefacts not science.
The problem we now have is everyone from Joe Biden to Jorge Mario are bowing down in worship of this Golden Artefact.
Submission Based Medicine
I usually say Lilly’s article created Evidence Based Medicine. Thirty years later it looks more appropriate to say it created Submission Based Medicine.
Lilly and other companies cooked the books – you can see how in The History of a Medical Psychosis. Even with the data cooked, if you read the 1991 BMJ article carefully, there is an excess of suicidal events on Prozac compared with placebo. So even with cooked data these Clinical Trials can be reconciled with what happened to the patients in Boston and elsewhere.
When you get access to the trial data rather than the cooked books, it is clear there was not just an excess of suicidal events on Prozac, and other SSRIs, but a statistically significant excess.
The Evident Based Medicine seen in Teicher’s article and uncooked Company Clinical Trials are completely consistent with each other.
Even if there was an incompatibility, however, resolving discrepancies is how we do science. If evident clinical encounters and the results of a trial seem to point different ways, this is supremely interesting, not a reason to discount one or the other body of evidence. The History of a Medical Psychosis shows you some of the ways these discrepancies can be reconciled.
Lilly however made no attempt at reconciliation. They were not in the business of being scientific – welcoming discrepant observations as a chance to move the science forward. Their argument was/is a religious one – a dogmatic one – they forbade us to believe the evidence of our own senses. Black is now White.
Papal infallibility rides again.
Or as Peter Drucker, the doyen of marketing, put it the goal of marketing is not to increase the sales of Prozac, it’s to own the market – to own the minds of the people. This was the moment Pharma took ownership of the market.
This ownership allows companies to dictate what the risks, the benefits and the trade-offs of drugs are. Allows them to force us to live the lives they want us to live rather than engage with the risky and unprofitable business of producing products that will help us to live the lives we want to live.
Following this Artefact is profoundly alienating. It creates a False We that comes in between two people, one of whom has sought help from another.
Since that moment in September 1991, we who take medicines have become progressively more invisible.
Shortly after the 1991 article, Lilly issued another Indulgence, when they offered to defend every doctor who gave Prozac and who had a patient die with a family claiming Prozac did it.
In 2000 Ian Hudson, then Chief Safety Officer for GSK, and later head of Britain’s version of FDA, told us that Paxil-Aropax-Deroxat-Seroxat-Paroxetine has no – NO – side effects. This was/is Evidence Based Medicine, he told a jury in Cheyenne. Unless an event has happened to a statistically significantly greater extent on a drug than on placebo, it hasn’t happened at all – no matter how evident it might appear to me or you.
This is the religion that Regulators, Politicians, the Media and pretty well everyone believes in now. Welcome to a world where poisons have become sacraments.
See Here We Stand We Can Do No Other – on RxISK for a very different but closely related take on these issues.
To be continued