Caught in the Firing Line: Nurse Prescribers

Back in early Covid times, I was asked by Cecile aan de Stegge to talk at a meeting:

Suicide and its Prevention.
Contemporary and Historical Perspectives in Nursing, 1880–2020

This finally happened in May 2022.  Cecile asked me to talk on the issues around suicide and antidepressants, which seemed particularly pertinent as an increasing number of cases that go wrong involve nurse prescribers – not because the nurses do not do the job as well as doctors but because an increasing number of prescribers are nurses.

The lecture Caught in the Firing Line was recorded.  The post gives the text.

Lecture

This talk covers 3 current US medico-legal cases that raise issues for all of us, as clinicians or patients, as prescribers or takers of prescription drugs. I list some of those issues at the end and will end the talk early so you can ask me questions about the cases and the issues.

One 

A happily married man with three children, in his early 50s, the owner of a health service business, was under stress and sleeping poorly.  He went to a family doctor who prescribed sertraline 50 mg.  A week later, he was worse. The family doctor referred him to the premier psychiatric treatment facility in the area. This facility had 54 psychiatrists. He was seen and his dose of sertraline was increased. Two weeks later, he was worse, as measured by a rating scale, and his dose was increased to 200 mg – 4 times the original dose. A week later he was even worse and was switched to escitalopram.

On the day he was next due to be seen in clinic, he shot his wife and three children and himself.

The clinic argued they were not to blame – that no one can foresee violence stemming from mental illness.  That it would not be appropriate to go around warning everyone who might come in contact with anyone put on antidepressant medication that this person might be a threat to them. The case has gone through an Appeal Court to the State Supreme Court.

Before he was treated this man did not have a condition that posed a risk to anyone. He was put on medicines that come with Black Box warnings about agitation and suicide.

The hazards of antidepressants ordinarily do not appear out of blue. They emerge several days or weeks later. They are preceded by evident deterioration over the course of several days or weeks while on treatment. This man’s clinical course is a textbook example of the kind of evident deterioration that SSRIs can cause.

Far from dealing with a condition that poses little risk, and where any risks are unpredictable, the patient’s ultimate clinical state after 5 weeks of treatment was one of delirium – a state where harm is predictable. The only unpredictable thing is the nature of that harm and the sequence of events leading to it.

There is a clinical duty to bear in mind the possibility of treatment induced adverse effects, to enquire about whether this possibility is being realized, to take reasonable steps to safeguard the patient and others if there is evidence the hazards are being realized, and for the sake of the service, if not the patient, to document those steps.

The medical notes indicate this man was getting progressively worse. His family saw an obvious deterioration in him. Increasing toxicity was overwhelmingly more likely (100-fold more likely) to be the cause of this than any disease progression.

This man was being treated in a premier clinic but the clinicians were nursing staff.  I do not know if the psychiatrists there have all become managers, whether the service had a policy to cater for suspected treatment hazards. He was seen by no doctors. So, if the Supreme Court action fails, you’d imagine the nurse will likely be blamed.

Two  

A lady in her late 50s sought treatment for anxiety and depression from the Health and Welfare system in Idaho. She was being treated on the State rather than by a premier facility.

Two decades earlier she took Prozac for a week before stopping because it did not suit her. Amitriptyline and citalopram subsequently did not suit her – both are SSRIs. In 2018 she had just been prescribed citalopram when she arrived at the Health and Welfare clinic. This was switched to Prozac, because she was clearly not responding to it.

Within 48 hours, by phone, she reported Prozac did not suit her, but was advised to continue.  Two weeks later, in clinic, she reported she had not taken all her Prozac because it did not suit her.  She was again advised to continue.

Reports like this to a clinic by phone, or in person two weeks after an initial assessment, will often not mention suicidality. Medication induced toxic states are not ones in which a crystal-clear thought of suicide emerges. They are states of increasing agitation, accompanied by apathy, or emotional blunting, so that housework, and even personal cleanliness, may be neglected. This is what this lady reported at the two-week assessment point.

Patients will often quietly stop treatment and even lie to their prescriber about this, but in many cases, they get trapped. If they are uncertain what is happening, the prescriber can seem to be the way out of their difficulties and obeying a prescriber can seem the right course of action.

She drove to the clinic a week later and shot herself in the face in the clinic carpark. The nature of her problems and their timeline is consistent with what is known about SSRIs and suicide induction. There were no factors in this case pointing to anything other than Prozac and the lack of warning about its hazards as the cause of this attempted suicide.

The difficulties reported by this lady were registered by her prescribers but were put down to other factors.  Her anxiety was put down to work difficulties. She was drinking more and blamed for this when alcohol is a way to manage SSRI agitation.

Stopping Prozac would have solved this problem or switching to mirtazapine as was later shown.

This lady’s case was in the hands of a series of nurse practitioners who in depositions all agreed that they knew about the Black Box Warnings and that these warnings were a national standard of care in respect of what this lady should have been told and that they had failed to notice warning signs of a developing problem.

In this case, the nurses are not being hung out to dry, even though they missed the glaringly obvious. A statute in that State means that officers of the government cannot be found legally liable. This is being challenged by this lady’s lawyers.

Three A 

A nurse veered across the road into oncoming traffic and badly injured an older woman travelling in the opposite direction. The nurse was relatively unharmed but appeared confused. She gave no clear account of where she came from and claimed the other car had hit her. She was over the legal limit for alcohol but could not explain how this happened. As she was on probation for driving under the influence of alcohol some years previously, she risked a jail term, loss of her job, and custody of her daughter. The events were out of character.

She had been put on SSRIs in her teens with little evidence they helped.  She had graduated to drug and alcohol abuse but then settled down, did nurse training, was holding down a job, had a young daughter but had separated from the daughter’s father. Her history in her 20s had left her with health problems, a bad back, fibromyalgia, raised blood pressure along with anxiety.

She was on analgesics, opioids, antihypertensives and a variety of antidepressants. She reacted badly to Tramadol which is closely related to Venlafaxine. She was switched to Venlafaxine which helped with pain but stopped working. While on it she had a Driving Under the Influence of Alcohol offence.

She was switched to duloxetine, Cymbalta, which agitated her and was stopped because she had become pregnant. She was well while pregnant on nothing. After the birth, she had a blue spell and duloxetine was restarted. Over a period of ten weeks, she became disinhibited and stopped duloxetine saying it helped with her pain but was making her manic.  A year later, after several other drugs were tried for pain, she returned to duloxetine – she and her prescriber thought things might be different now that she did not have postpartum depression.

Cymbalta

At one point I was to be a lead investigator at a North Wales site for a Eli Lilly trial of duloxetine, which was slated to be Lilly’s successor to Prozac. The trial and duloxetine were abandoned. Boehringer-Ingelheim went on to develop and market it for bladder stabilization in Europe as Yentreve.

Lilly focused on R-Fluoxetine (Zalutria) instead but FDA turned this down because it caused cardiac QT interval problems which clearly Prozac must also do.  Lilly turned back to duloxetine, ran trials and applied to FDA to market it as an antidepressant and bladder stabilizer.

FDA said no to it as a bladder stabilizer – in trials too many healthy women had gone on to suicidal acts or completed suicide on it.  There was a crisis when Traci Johnson a 19 year old woman in a healthy volunteer trial of the drug committed suicide.

But FDA still approved it.  And Lilly magicked up a fibromyalgia marketing niche for it, possibly originally designed for Zalutria.

At a debate in the Maudsley at the time, on whether psychiatrists have a thought in their head other than what is put there by one pharmaceutical company or another, I predicted that Cymbalta soon would be a billion dollar blockbuster.  The audience were mortally offended at the thought.

Three – B

Initially Cymbalta helped our nurse but after a few weeks her behaviour changed at work and at home. She became irritable, labile and her timekeeping fell off. Because of her DUI offence she had regular alcohol tests and all were normal. The crash came at the end of a week when she seemed to be deteriorating badly.

What happened?  One possibility is that our patient was trying to commit suicide. The only way to avoid jail is to be found not guilty by virtue of an automatism.  As automatisms are ordinarily understood, this would not apply in her case. There is however a case to be made that Cymbalta caused here to be delirious.

It may also have caused her to take a drink – See Driven to Drink.

And it may have caused her to have raised blood alcohol levels – See Petra’s Story and Every Drink Spiked.

This lady’s medical care for several years before this, including all prescriptions of antidepressants had been in the hands of a nurse prescriber.

The legal system looks it might have great difficulties believing FDA would approve a drug that could cause delirium.

Common Background Factors

There are few ways to convey to doctors what is wrong in cases like these. The only thing that gets medical attention is to say “if these drugs work so well and are so free of hazards you guys are out of business” Health service companies will see you as expensive prescribers compared with nurses or pharmacists.  Nurses of course risk being replaced soon by robots on the same basis.

The problem is the drugs don’t work well and aren’t free of hazards and both companies and regulators do a lot of things legislators have no idea about. Such as:

1. The prescription drug literature is ghostwritten, hyping benefits and hiding hazards.
2. RCTs are not a good way to evaluate a drug
3. There is no access to the data from company trials.
4. Regulators (FDA, EMA) do not have or get to see the data from these trials.
5. Companies often report Negative Trials as positive.
6. Regulators approve treatments even when more people die on active treatment than on placebo.
7. Regulators approve medicines on the basis of Negative Trials and agree not to let prescribers or health services or patients know about this.
8. Regulators say nothing when companies publish Negative Trials as positive and make adverse effects of treatment, including death, vanish.
9. Even when there are more deaths on active treatment than on placebo, regulators do not warn about hazards claiming they do not want to deter people from seeking a benefit (that is a commercial benefit to companies rather than lives saved or restored function).

We prescribe poisons, hoping to bring good out of their use. We could use alcohol to treat social phobia or nicotine to treat OCD or ulcerative colitis. These are over the counter because we believe they are less risky than prescription drugs. Everyone knows that they are poisons and that if you take them chronically, you will age and die prematurely.

The same has to be true for some of the prescriptions drugs we are on and anyone my age on average is on 5 to 10 of these – drinking and smoking and snorting every day of the year for decades.

As outlined in Shipwreck of the Singular, life expectancies were falling and our reproductive replacement rates were below zero – before Covid.

Whether you are a prescriber, or a patient, company trials are used to displace our experience as a way to evaluate a drug or what is happening on a drug. Medicine used to be and still should be like law – where we make a judgement call based on the evidence in front of us. But we are reaching a point where if you insist that your judgement in an individual case is likely right despite what the guidelines say, you risk being out of a job.

If you want to keep your job, it’s safer for you to let the patient die.

And if it is safer to let the patient die, you are going to sleep better if you don’t notice problems on treatment. Better to think the patient must have had a malignant condition – there are some people no-one can save.

Polypharmacy is a great help in this regard.  It makes it harder to link a treatment to a problem.

I have taken these problems to Supreme Courts, health ministers, guideline makers etc and laid them out in Court cases.  No-one denies a single point you have heard here – not the lawyers for GSK or Pfizer. But no-one does anything.

Perhaps its time to think about raising the matter with those who are worried that white people are being replaced. It is mostly white people who are on drugs. Perhaps someone from the Great Replacement camp needs to ask Pharma what is going on.

Or perhaps, the American Right could embrace a national health service so non-whites could get access to the same number of drugs as white people.

My sense is the answer has to involve a fostering of communities because it is in communities that answers other than an ever increasing turn to pills lies.

The painting above Edouard Manet’s Le Suicidé is from the Meeting Brochure.

People Acknowledgement

People Acknowledgement © Nina Otulakowski April 2022

See Black Robe, White Coat.

RxISK acknowledges that the experiences of those who have been harmed by medical treatments are the cornerstone on which it is built. This cornerstone has been rejected by a set of invaders who now claim control over our healing spaces. These invaders pose a threat to our spirits and our bodies.