I was invited by Yulia Mikhailova to deliver a Guest Lecture to the New Mexico Technical Institute on Wednesday February 2. The talk began and appeared to be going smoothly, when halfway through the Zoom room was hacked with the hackers saying and writing a lot divisive and hateful things. A later post will say more. The talk has been re-recorded and hopefully a recorded Q and A will follow soon.
The recorded talk Who’s Afraid of Science is here and the slides and text are below for a talk that offers the message that science, democracy and love are intimately interlinked .
WHO’S AFRAID OF SCIENCE?
It’s a great pleasure to be speaking to you here today. I hope at the end of this talk you will realize that really doing science is scary but I also hope your fear will lead you to want to do it even more.
In 1649 England had a World Turned Upside Down – a Storming the Capitol – moment. The King, Charles I, had his head chopped off. Not by an invading army. Not by a usurper to the throne but by his subjects who wanted a different form of government.
In 1660, the monarchy was restored. Charles II brought something new into being – The Royal Society – an initiative that has played a huge part in how we are governed now.
The Royal Society established the ground rules of Science. It would appeal to the data people could see in front of them. Whether you were Xtian, Hindu or Muslim, Jew or Atheist, you left these badges at the door and had to explain what you saw in front of you without appealing to a Book or Authority. You were encouraged to run the experiment again, adapt the apparatus, or make sure there was no trick – what you couldn’t do was refuse to come to a conclusion.
We view going by the data now as central to science and who we are. But Scientists overlook an equally important event 44 years’ earlier, when in 1618 Walter Raleigh had his head chopped off.
Raleigh’s execution was not an experiment to see if we could live without heads. He had been convicted on the basis of people who didn’t like his politics saying things about him which were used in evidence against him – but crucially these people did not come into court to be cross-examined.
Legal systems worldwide recognized the injustice of this and introduced Rules of Evidence. Hearsay could not be used as evidence. The only evidence that can be used in court is material that can be put in front of jurors who can see the people or material being examined and cross-examined.
The process of forcing 12 people with very different biases to come to a verdict about what is in front of them is the very essence of science.
A verdict is obviously provisional – this is the view that best fits the facts we were presented with but clearly if the facts change then we reserve the right to change our mind. This might appear to contrast with what we now think of as the objectivity of science, but scientific views are similarly provisional with participants in the scientific process encouraged to attempt to overturn the verdict with replicable data.
Just like the scientific approach lands us on the moon and helps us explode atomic bombs, so the judicial process has to be rigorous because ultimately on the basis of these verdicts we execute people. I am not talking about humanities here or social science. I am talking specific verdicts that bring life, death, or incarceration in their wake.
Do you think studying monolayers of cells will tell you
why you fall in love with a girl?
I began in Neuroscience when the major figures had been trained by people like Walter Hess, who won the Nobel Prize for Medicine in 1949 – people who knew that whatever you found out about cells or neurotransmitters everything was ultimately about function. Life and death.
And of course, I was desperately trying to understand girls and how to get them to fall in love with me.
Serotonin was just coming into the frame when I started and I began looking at serotonin reuptake in people who were depressed – before we had SSRIs – triggered by this Jouko Tuomisto article here.
Doing serotonin reuptake and related assays gave me a feel for the importance of methods and how little things can change an interpretation. Toumisto found lower serotonin reuptake in depression. I found that it depended on the time of day you ran the assay. If you did more than one assay per day the picture looked quite different. Laboratory data usually raises more questions than provides answers.
Work on serotonin introduced me to the idea of biobabble. When the SSRIs came on the market it was clear the talk about chemical imbalances and low serotonin was just marketing copy. It had and has no scientific meaning
My lab research gave me the credentials to interview the grandees in psychopharmacology. I could ask questions that let people from the lab, the clinic and industry feel able to open up.
Here you see Arvid Carlsson who won the Nobel Prize for discovering the role of dopamine. He also made the first SSRI – zimelidine. He was one of 100 psychopharmacologists interviewed.
Companies came my way because I looked like just the kind of person to educate doctors about the new drugs. Industry people were the most candid about these new drugs not being as effective as the old ones but pretty confident they could market them. Doctors were also relaxed with me – I was one of them. Everyone opened up.
The Dutch here translates as Nothing is out of Hand – that is Everything is in Control.
Two men who came into my life in 1990 shaped it from there on. When the SSRIs came onstream I used them before my peers interested to get a sense for how they worked. A senior university academic wanted to be less obsessive which SSRIs can help with. So, we tried the just released Prozac. He came back intensely agitated and thinking about killing himself. We stopped Prozac – the problem cleared up. We waited a month and then I mentioned there was another drug that was good for OCD we could try. We tried it and all the suicidal feelings came flooding back. We stopped and they cleared up again.
A just retired senior executive had been put on Prozac and ended up with me because he’d gone to a local quarry to drown himself, changed his mind and then tried to walk out into the sea but it’s difficult to drown yourself off the North Wales coast – the sea is too shallow. The Prozac was stopped and he improved but confessed to other thoughts about killing himself.
I put him on an older antidepressant, but also a serotonin reuptake inhibitor, and could see him become visibly more tense and agitated over a few days. We stopped the drug and he was fine again.
I wrote these two cases up in the article you see here and presented them at several meetings. There was no other way to explain what had happened, other than the SSRI did it. Both men when challenged with the drug had problem that cleared when the drug was stopped and reappeared when a similar drug was introduced. I sent a draft to Lilly, who make Prozac, asking if they had any thoughts on what was going on. They didn’t, which seemed odd.
At the same time as my article came out, Lilly published this article by Charles Beasley et al. It came out in the BMJ on the same day Lilly presented the case in the article at an FDA hearing September 20, 1991 – just over 30 years ago.
From a year before, there had been convincing reports of people given Prozac, becoming suicidal, with the problem clearing when Prozac was stopped, and reappearing when it was restarted. In terms of cause and effect, there was no doubt the drug caused the problem – it would be like reintroducing oxygen into the air pump and seeing a dying bird come back to life.
FDA were forced to have a hearing on antidepressants and suicide, at which Lilly pitched their RCTs stating:
- the plural of anecdote is not data
- it’s the disease not the drug
- are you going to believe the anecdotes or the science?
The Beasley article shows more suicidal events on Prozac, but the paper said these were not statistically significant and BMJ were happy with a statement that the problem didn’t exist.
FDA talked about heart-breaking cases reported to them but concluded the science didn’t support the drug causing the problem.
It’s common to hear distinctions between the Art and the Science of Medicine. This is caught in this famous painting of the good doctor – who is not doing anything but waiting with the sick child and their family. But of course, once he or she could do something waiting without doing it would not be a good idea – none of us would go to a doctor like this.
Although as Philippe Pinel said, there is an art in being able to do something in medicine but an even greater in knowing when not to do it.
Those in the social or human sciences, soft scientists, talk about the richness of the qualitative context compared with the experimental context of the hard sciences, where hard scientists want to eliminate confounders. But this pre-Risperdal Janssen Advert assumes no one in medicine pays much heed to that.
But we need to avoid confusing controlling confounders with standardization. Standardization can help us control confounders but standardization without judgement calls gives us Big Mac hamburgers rather than really good hamburgers.
At some point the need for judgements, verdicts – diagnoses comes into the frame.
The first rating scale for behaviour was the Hamilton Rating Scale for Depression. Here is Hamilton saying:
It may be that we are witnessing a change as revolutionary as was the introduction of standardization and mass production in manufacture. Both have their positive and negative sides
He saw the scale as an aid to make sure physicians checked on most of things that might be abnormal in depression while interviewing a patient. An aid to help a doctor do a good interview.
An aid to help you live the life you want to live or to get you to live the life Pfizer want you to live?
If you cleave to the checklist you will do very standardized but possibly disastrous interviews. For instance, on the Hamilton Scale, there is an item on suicide which could stem from the illness or from the drug. This needs a judgement call – if caused by the drug you should rate the person as Zero – if caused by the illness you might rate 3 or 4. Ditto for sex, for sleep. Just checking yes for suicidality risks going badly wrong.
Checklists like these however became viewed as scientific instruments. They look better to hospital managers than David Healy asking you about the football last night or your family.
For drug companies, rating scales ensure you do an interview that produces figures which are the most seductive way to get people on their drug. The interview helps you to help them to live the life Pfizer want them to live.
Rating scales and operational criteria like DSM eliminate Judgement – and if you do that you are no longer doing science.
This is true for any measure – peak flow rates, bone densities, blood pressure or lipids, or sugar. It may be important to do something about some figures, but the goal is to help people to live the life they want to live – not getting them to live the life Pfizer want them to live.
Up until the 1980s, we brought our problems to doctors – seeking help to live the lives we wanted to live. After that they began to give us problems with out lipids and other risks and the amount of medicines being consumed rose dramatically and we increasingly began to live the lives companies wanted us to live.
A stopwatch can be a wonderful motivator to achieve a dream – breaking the 4-minute barrier for the mile. But, it just provides data from one fraction of our lives. If we remain on top of that, that’s fine – but what about weighing scales? Just after they were introduced we got the first descriptions of anorexia nervosa. In the 1920s, weighing scales had norms for ideal weight attached to them and eating disorders mushroomed. They migrated into our homes in the 1960s and eating disorders became epidemic.
It’s very difficult to ignore figures for weight. Without data from every other aspect of our lives at the same time, we risk being trapped by this one data source. We become neurotic.
Can we leave bone densities thin, peak flow rates low, lipid levels high? Yes, we can. You think of post-mortems as something that reveal what we died from – they more often reveal what we can live with.
Figures create risks and pharma makes money from treating risks rather than diseases. We are seduced into taking drugs when we are healthy.
The Covid dashboards are a great mechanism to generate perceptions of risk and fear. The vaccines of course treat risks – not disease.
The Meatloaf title Paradise by the Dashboard Light is what Pfizer sees but its Hell by the Dashboard Light for us – this now extends to the evaluation of lectures and ensures we pander to people rather than challenge them.
It’s extraordinary how little we have put into treating SARS-Cov, and its associated pneumonia. As Goldman-Sachs recently said Curing diseases is not a good business model.
Randomized Controlled Trials (RCTs) were introduced in 1962 following the thalidomide crisis. We thought they would make it harder for pharmaceutical companies to bring ineffective drugs on the market and this would make us all safer. Few notice that its mostly pharma companies who hold RCTs up as offering gold standard knowledge of what drugs do.
Here you have Tony Hill, the man who created RCTs, 20 years after the first one saying that they can be helpful for assessing one of the 100 things a drug does – something we might be able to use for treatment purposes.
This by definition means RCTs are not a good way to evaluate a drug. These days saying something like this is like telling you the Bible, the Koran or the US Constitution aren’t reliable. Tony Hill would be accused of misinformation – as would I in giving you this lecture.
Slide 18 But watch this.
In a depression trial, investigators focus intensely on one thing – does Prozac have an effect on mood. Pretty well everything else is ignored. The statistics we use don’t work unless there is an intense effort to collect everything we can about this one outcome.
And so, depression trials miss something that happens to almost everyone who takes an SSRI within 30 minutes of the first pill – your genitals go numb. You can search the RCTs on these drugs and all you will find is that perhaps 5% of people have sexual issues on these drugs.
If we just depend on RCTs, we end up knowing almost nothing about a drug. It gets worse.
The idea that an RCT shows there is a favourable Risk-Benefit ratio for a drug or vaccine can only hold true if the thing we are looking at is the commonest thing this vaccine does – like a parachute for instance. The commonest thing is a life saved and the Risk Benefit is favourable but we don’t need an RCT for parachutes.
Claiming a favorable Risk-Benefit ratio, if what we are hoping for is pretty rare, as in SSRI trials, and if we don’t know what we are missing, such as an obliteration of our ability to make love, perhaps for all time, is psychotic.
With RCTs and rating scales, we supposedly strip away context in order to control confounders.
Imipramine was the first antidepressant. The older tricyclic antidepressants are stronger than SSRIs. It beats them in RCTs. It can treat melancholia – they can’t. Melancholia comes with a high risk of suicide.
Imipramine was launched in 1958. A year later at a meeting in England, Danish psychiatrists made it clear that while it was a wonderful treatment it made some people suicidal.
Let’s do a thought RCT of imipramine versus placebo in melancholia. Even though it can cause suicide, we would expect it to reduce the number of suicides because it treats the condition. This RCT would be great evidence antidepressants do not cause suicide.
Here is the data on the trials in mild depression that brought the SSRIs and SNRIs on the market – you see a doubling of suicidal events compared to placebo. Companies resorted to all sorts of maneuvers to hide this risk.
This is what imipramine looks like in the same mild depressions. Now it too causes suicides. So RCTs tell us nothing about cause and effect – they can give us diametrically opposite answers. This is because these aren’t drug trials. They are Treatment Trials and in any clinical Trial, the condition confounds the effects of the drugs – and these confounders hide drug effects.
People evaluating drugs before RCTs knew this. People doing RCTs don’t. When a patient becomes suicidal in a trial you have to use your judgement to work out what is happening but RCTs, like rating scales, are all about not letting investigators use their judgment.
This is not just the case for depression – it’s true in every clinical situation where drugs and conditions cause superficially similar effects – diabetes and glitazones both cause heart failure, osteoporosis and bisphosphonates both cause fractures
Here is what a drug trial looks like. Companies ran these studies in the 1980s and found that SSRIs make healthy volunteers suicidal, cause dependence and sexual dysfunction. These Drug Trials enabled companies to engineer their Treatment Trials to hide these problems.
You’ve seen the son of this slide before. In all Antidepressant RCTs there was a 2-week washout period during which patients were whipped off prior medicines. We now know this was a tricky thing to do – it gives lots of suicides. But companies argued as the patients were on nothing, these events should be counted as placebo events – as the diagram here illustrates – along with events after the trial was over.
This slide shows data straight from a 2006 GlaxoSmithKline paper. GSK’s SSRI paroxetine was in trouble – the RCTs data for Major Depressive Disorder seem to show paroxetine causes suicidal events. The real data I think are worse that GSK admit to here.
But never fear RCTs come to the rescue. GSK also did trials in people with Intermittent Brief Depressive Disorders – IBDD. These are borderline personality disorder to most people – patients who have suicidal events much more often than anyone else. But these patients can meet criteria for depression and could be entered into Depression RCTs.
Now Lilly had done a trial of Prozac in these patients – it didn’t work. GSK also did a trial of paroxetine which didn’t work and had a 3-fold higher suicidal act rate than placebo. GSK then did another trial in a similar group of patients. Why?
The answer is here. Here are IBDD data from the two GSK trials. I have seen other data for these two trials which make paroxetine look worse but let’s stick with GSK’s story. We could even add 16 more events to the paroxetine arm and still get the same magical outcome
When you add the IBDD data to the MDD data – all of a sudden paroxetine doesn’t cause suicidal events it protects against them. This is called Simpson’s paradox.
Something like this is going to happen in every trial of a treatment in a heterogenous condition – back pain, breast cancer, diabetes, hypertension, osteoporosis, parkinson’s disease. We can use an effect a drug causes to hide an effect a drug causes.
RCTs are not a good way to work out what is going on. It also means that statistical significance and confidence intervals have no anchor in the real world in a Clinical Trial.
In 1999 I was asked to speak at a company symposium in London – speakers would need to produce articles for a supplement. I said yes and soon after had an email with my article. It was a great Healy article saying the things Healy says in the way he says them with Healy references. No one who knew my stuff would pick it out as not mine.
I emailed back saying I figured on writing my own. There was surprise at the other end but they said okay. I sent it to them and they said this is rather good but there are some important commercial messages in the other one – we’ll get Siegfried Kasper to put his name on it.
Here it is – only one word changed from the original paper – the name of author Kasper. Everybody in Vienna knows this but it’s done no harm to SK’s career. You can find materials saying you can trust doctors like Kasper because they have written a 1000 articles or more.
A year later I was in Pfizer’s archive where even the loo-paper was stamped confidential. I came across this document covering the articles on Pfizer’s SSRI Zoloft being managed by Current Medical Directions – a medical writing company.
Inside there are pages listing the articles published or being written on Zoloft for the anxious, the depressed, the young, the old etc. Here’s the Post Traumatic Stress Disorder – PTSD – page.
On the right you see that the articles were already written for these essentially negative studies saying the drug worked wonderfully well. One would go to NEJM – the other to JAMA. And on the left – you see TBD – authors names are To Be Determined. Pfizer’s marketing department will work out who would be the best sales academics for the drug.
This is not just a mental health issue. It holds for all treatments across medicine.
Here is Study 329, a study of paroxetine v placebo in adolescent depression. It’s authorship line is to die for and it’s in the journal with the highest impact factor in child psychiatry and says paroxetine works wonderfully well and is entirely safe for children who are depressed. Any doctor reading this would race out to put all teens s/he could find and put them on this drug.
This internal GSK document from 1998 shows the company knew the trial had shown the drug didn’t work and proposed taking out the good bits of the data and publishing those which is the article you have seen. New York State took a fraud action against GSK on this basis. GSK were also fined $3 billion by the Dept of Justice, which led to access to the trial data and what you are going to see next.
Slide 34 The full story is on Study329.org
This legal action gave us access to company data no one ever sees. The efficacy data is pretty irrelevant, but it was still possible to show that no matter which way you cut the data paroxetine was not more efficacious than placebo.
The tricks used to hide the problems were the real interest in these data. The original article had 10 pages. Regulators see an 800-page Clinical Study Report (CSR) plus nearly 5000 pages of appendices – which no-one in FDA looks at. They now say they get Individual Patient Level Data – IPD – from companies. This is a spreadsheet with datapoints on individuals but these do not let regulators work out what is going on.
Behind these IPD in Study 329 we saw a further 77,000 Clinical Record Form (CRF) pages, and the material here was often inconsistent with the IPD. As you’ll see.
Point 2 points to data that didn’t get transcribed from the 77000 pages to the 5000 pages. Point 10 is patients on placebo got SSRIs – I can explain how. But I want to focus on coding issues.
The psychiatric adverse events all got grouped under neurological events – along with headaches and dizziness. This drowns out the signal from psychiatric adverse events.
We were sensitized to this by Elizabeth Loder, the BMJ editor handling our paper – which took over a year to publish with 7 review rounds and 7 reviewers – who objected to our every mention of headache. As it turned out she was a headache-ologist, who was an opinion leader for GSK but above all was the wife of an attorney working in Ropes and Gray who had been the lawyers defending GSK against the $3 billion fine.
If we strip out headache and dizziness, in the lower bar you see the number of suicidal events in the Keller paper – once you decode them from emotional lability. In the middle bar, GSK revised this after being asked to do so by FDA when a fuss blew up. In the upper bar you see that we found more again – and there were more than we missed as I’m about to tell you.
This slide points to something profound that has changed for all of us. It used to be accepted that people were moody and often went half crazy in their teens as they worked out what sense if any the world made. We thought it was important to go through this, as Homer tells Bart.
Now you get put on pills. There are 45 RCTs of antidepressants done for teens who are depressed – all negative. Even the two trials that led to Prozac being approved for children were negative. The 30 trials since 1990 have likely all been ghostwritten. They show the greatest divide in all of medicine between what the data shows and what the academic literature claims. RCTs are supposed to stop therapeutic bandwagons in their tracks but it looks like Antidepressants are now the second most commonly taken drugs by teenage girls and both these and stimulants are likely relatively commonly taken in this group.
And while Greta Thunberg and her generation try to clean up the environment, they are pumping more chemicals into their body than any prior generation in human history.
Here is a very famous photo. In a Pfizer trial of a psychotropic drug, a man poured petrol over himself and set a match to it, intending to kill himself. He died 5 days later from his burns. His death was coded as burns. But the company had to write a Serious Adverse Events narrative and if you saw that you could work out that he should have been coded as suicide.
Companies have found a way to get around the need to write a Narrative. Here is a young man on a street waving a gun. Its Kyle Rittenhouse. In Study 329 a boy of 15 was picked up out on the street waving a gun around and threatening to kill people. He was hospitalized and should therefore have had an SAE narrative but the company coded him as intercurrent illness.
Four children dropped out of Study 329 coded as intercurrent illness – all were taking paroxetine. Add them into the picture you have just seen and things look a lot worse.
What is intercurrent illness? This was almost certainly an adverse event on paroxetine but invoking an intercurrent illness that means you really should not have been entered into this study means there is no need to write a narrative. This loophole has been there for 25 years, and FDA have not moved to close it. It applies to all drug and vaccine trials also.
I told you the Prozac trials were negative. Here is part of FDA’s 2002 approval letter for Paxil. The key bit is typed up so you can read it. The date is important – the Keller paper was 2001.
You can see here GSK told FDA that Study 329 was negative and you see that FDA agreed to approve the drug on the back of three negative studies and also agreed that there was no need to mention this in the labelling. Why would FDA do this?
Here are the published results of adult trials of antidepressants nearly a decade earlier. The picture looks pretty good.
But as Erick Turner has shown, here is how these studies looked to FDA. A different picture. Companies don’t leave negative studies unpublished, they know FDA are happy to let them publish negative studies as positive. Why?
Perhaps GSK told FDA that if FDA let the world know Study 329 was negative, GSK might get sued for fraud – which they did and fined for $3 billion. FDA don’t feel inclined to blow this whistle.
In 1991, at the Prozac hearings FDA were sitting on data for sertraline and paroxetine showing the same limited efficacy compared with older antidepressants, and increased suicidal event rates on all three SSRIs with all companies breaching FDA regulations to hide the problems.
FDA opted not to warn because warning would put people off seeking the benefit – from a treatment that according to them had a favourable benefit-risk ratio even though more people were dying on the active treatment than on placebo, and the adult benefits were not clearly different to the benefits in children.
From this point on the hazards of drugs began to vanish. Journals like the BMJ became scared to take case reports which previously had been the bedrock of medicine. Drugs and Therapeutics Bulletins vanished – replaced by Guidelines which only listed benefits.
Doctors have now lost a sense for drug induced toxicity, which is often coloured by anxiety or depressive symptoms. Faced with someone saying they feel anxious or depressed as you can do when you have the Flu, are pregnant, or have a toxic reaction to a drug, doctors increasingly give more of the drugs that are causing the problems in the case of psychotropic meds.
We have become Invisible to our doctors, not heard or seen the way we once were.
If we become invisible, healthcare staff do too. Managers don’t see or hear them dealing with toxicities that need expert input. Managers see drugs the evidence says work well and are free of problems and figure doctors can be replaced with cheaper prescribers – or perhaps robots soon. And, if things go wrong, it must have been the doctor’s fault.
When you are faced with a patient who thinks they have become suicidal on treatment – the first scientific task is to work out what is happening. This is a judicial task. Key to this is the conversation with the patient who may say ‘Doc I’ve been depressed and suicidal before but this was different – I think it’s the drug – it cleared when I lowered the dose’.
This is a scientific engagement with the data – the person. The one time you have access to all the data is at this point. If you conclude the drug has made the person suicidal but the published academic adverts do not support this, the next scientific task is to reconcile the mismatch.
In the case of SSRIs and suicide, you find:
- companies breached FDA regulations in hiding events
- companies misapplied statistical methods
- the entire literature on these drugs is ghostwritten
- there is no access to the people in these trials for independent scrutiny
- FDA don’t have and have never seen the data
If you Follow the so-called Science you end up in brain transplant country. As this cartoon from over 40 years ago shows, this is Mindlessness. When we get to the point of A.I. we will have arrived at a moment of real peril.
The Art of Medicine is not the soft bed-side manner side of Medicine with RCTs being the Science. The Science of Medicine lies in making hard judgement calls. The Artefact of medicine makes your life easy but will doom you and us. There cannot be an us if you follow the artefact.
There are 3 ways out.
Donald Trump weaponized the phrase Fake literature – the greatest concentration of Fake Literature now centres on the drugs your doctor gives you.
He also gave me another good idea. After a school shooting, he said we need a good guy with a gun outside all these schools. People were horrified but had no easy answer to the follow up – well if a good guy with a gun isn’t a good idea why do we have them outside the White House?
Drugs are like guns – they can be very helpful in certain situations. But we sense that letting them multiply up and leak into every situation is a recipe for problems.
Drugs and Guns are techniques – gadgets. All gadgets create an arms race. Whether the use of these gadgets enhance or diminish us is down to us – but if we stop thinking about what we are doing when we use them we are highly likely to be diminished.
Because of the gadgets we call RCTs, the drugs race is not about creating more effective chemicals – it’s about creating more effective propaganda. By definition this diminishes us.
The arms race brings out an important message. Efficacy has its limits. We can make weapons more and more effective to the point that they can’t be used.
The same holds true for drugs. If you are on more than 3 medicines, effectiveness diminishes. To get the most effectiveness you need to be on 3 or less. Over 40% of over 45s are on 3 or more drugs every day of the week – this figure includes the people who never come to see doctors and over 40% of over 65s are on 5 or more drugs every day of the week.
We know that life expectancy even before Covid was falling. We know that reducing medication burdens can increase life expectancy, reduce hospitalizations and improve quality of life.
Paring our rapidly escalating medication burdens back to 3 or less should mean taking the values of the patient into account – but we are not doing it.
We introduced RCTs hoping to use efficacy to improve safety. We’ve done just the opposite. Now there is a chance to improve safety by deprescribing in order to get efficacy.
Deprescribing tries to smuggle safety in the back door. If you knock on the front door and ask a doctor to help you work out what is happening on a drug, the climate in which you both will have to do this now claims hysterically that you are being subjective, misinformed and crazy if you don’t Follow the Science.
The AstroScience we now have has converted both you and your doctors into thinking drugs are sacraments – things that can only do good. Up to 1990 we thought drugs were poisons and the magic of medicine lay in bringing good out of the use of a poison but to do that I had to know I was giving you a poison and you had to know you were taking one.
The magic used to lie in you and me doing science – now it lies in the pill or the vaccine. Me and you doing Case Based Medicine offers the only science in clinical psychopharmacology.
One of my patients years ago dropped out of High School early, and had no background in healthcare, when she was put on an SSRI. She ended up convicted of drunk and disorderly behaviour, crashed her car, was jailed, lost her job. She figured it was the SSRI she had been put on. Her doctor and AA told her this line of thinking proved she was an alcoholic.
She was right and they were wrong. It took years but she went on the internet and ended up being able to tell me things about the serotonin system and what drug she should be put on instead of an SSRI. Few people knew what she had found – other than the pharmaceutical industry who were busy working on just this as possible treatments for alcoholism.
Rather than seeing 100 heart-sink patients in my waiting room, heart-sink because they don’t do what I tell them to do – I could see 100 free researchers who could help me discover things I never knew about. The job could be fun.
What I got from this is that Motivation is worth more than Expertise.
Here is Walter Raleigh convicted on the basis of Hearsay. If your doctor reports your problem on a drug to FDA or CDC, FDA remove identifying names. This converts the report into Hearsay – useless to you or anyone who has been similarly injured by the drug. Unless you can be examined and cross examined there is no way to establish what has happened. There is a lot of talk today about misinformation and people ask where it comes from – well FDA and CDC create it.
If your doctor even listens and reports . Chances are he will get nasty if you bring a problem – tell you, this is all in your mind. In the case of a problem like PSSD, he will say a drug that is out of your body for months cannot cause this.
Any doctor who is nasty is so ultimately because he is scared. If he admits a drug can cause a problem, he fears the regulators and guideline makers, and his colleagues and politicians and the media will be nasty to him. Even Greta Thunberg’s generation will mobilize against him. So, instead of him, you will feel the violence built into the system.
Patients with PSSD often go on to commit suicide. It’s partly because of the horrific problem. It’s partly also because of the ridicule they get at from doctors. And a deep sense that they are not just the victims of a drug but victims of a miscarriage of justice and science.
So this lady is in my waiting room. She is smelly and hunched and grim to look at. She has come to me with a problem. She has been on an SSRI and she now cannot make love. I tell her sure temporarily while on the pills you might not be able to make love but if you want to go away for a romantic weekend you can stop.
She says I have been off my SSRI for 3 months and I can take a hard bristled brush and rub it up and down my genitals and feel nothing. Here is a scientific riddle the answer to which is worthy of a Nobel Prize. Its not just finding out something new about biology – the answer will likely change our entire view of ourselves.
This lady in fact comes from an Arthurian Legend – Gawain and the Loathly Lady. Arthur has been trapped by a Black Knight who spares his life if he can answer a riddle – What do Women Most Desire. Having hunted the answer for months, Arthur and his court despair of finding the answer. Two days before he is due to die, Arthur and his troop meet this woman by the edge of the road who tells him that she can give him the answer to the riddle but one of his knights must become her husband. Gawain jumps down and offers himself up.
Gawain gets married. Everyone at the Court is desperately unhappy for him.
When they go up to the bedchamber Gawain can’t even bear to look at her. He turns and finds the most beautiful lady. She asks him – do you want me to look like this in the bedchamber or during the day in court. He has no idea what to say and says – whatever you want. Which turns out to be the right answer.
She like us wants to control her own life. Give her or you this and s/he or you can become the most interesting and, in that sense, attractive person imaginable. She wants your support to live the life she wants to live. There may be a disease that needs treating – but she doesn’t want you to tell her how to live a life, or want her negative emotions eliminated with a pill. She may be doing better at living life than you or I.
I’ve talked about deprescribing – a smart solution to our problems. I’ve talked about putting our name to adverse events – a solution that involves courage.
But here is another very strange and hard to put in words element – you have to believe in people. Science depends on collaboration with others. The more you collaborate the more interesting and the more you like the people you collaborate with, which leads them to like you too because you like them.
Science and democracy and love are intimately entwined.
Science does not thrive in the presence of absolute power, absolute truth, or where money dictates.