Be aware: Non-pharmaceutical medical interventions can be as harmful as pharmaceutical ones

I’m living proof of it!

The story begins

The story goes back over twenty years, when I was working for a biotech company developing a triptan. Find out more on triptan’s here: Triptans.

In short, triptan’s are used for the treatment of acute migraine headache and associated effects. The drug acts as a vasoconstrictor, to help combat dilation of the blood vessels in the brain, the suggested cause of a migraine.

The technical details can be found here:

Mechanisms of action of the 5-HT1B/1D receptor agonists

This is an extract:

“Triptans are antimigraine agents that bind to 5-HT1B and 5-HT1D serotonin receptors. Triptan binding to the vascular 5-HT1B receptors leads to vasoconstriction of the cranial arteries, which dilate during a migraine attack. When triptans bind to the neurogenic and central 5-HT1D receptors, they prevent the release of vasoactive neuropeptides by inhibiting trigeminal nerve activation and blocking the transmission of pain signals to the central nervous system.”

Not long after leaving my previous job and joining the company, I was told by my new boss that everything was on hold, as US FDA had picked up an issue with the safety studies related to potential carcinogenicity of the drug—the safety studies had not been carried out on a sufficiently high dose.

That left me in limbo. I was hired as head of logistics for commercial launch of the drug, and it was all on hold. As a family, we had moved house from Oxford to a housing price ‘hot spot’ just outside Guildford, with a substantial hike in mortgage payments.

I thought to give St John’s Wort a try

It was a worrying time, and I began to feel a bit down. Not deadly depressed, but my mood was not where I wanted it to be. Then I noticed an advertisement for St John’s Wort, saying it had mood enhancing properties, and was a natural remedy, not a prescription medicine. That’ll do for me, I thought.

The following day…

After taking just one tablet the night before, on arrival at work the following morning, I had a funny turn. I can only describe it as extreme weakness and a sensation akin to a feeling that all was not right. I was taken home to recover and the rest of the day I spent throwing up with a crushing headache. Not suspecting the ‘natural’ remedy, I took another tablet that night.

At around 3 am in the morning, I shot up from bed and shouted to my wife “I think I’m dying,” before collapsing to the bedroom floor, paralysed down my right-side and unable to speak. Seeing and hearing was fine, but no words came forth.

When the ambulance arrived, I heard the paramedics speculate it could be a subarachnoid haemorrhage. As I sat outside waiting to be loaded onto the ambulance, thoughts turned to how I was going to support my family?

The prognosis

I eventually began to regain feeling and use of my right-side, and speech, by the end of the day in a hospital bed. After a few more days in hospital, I left with a diagnosis of a transient ischaemic attack (TIA) and low dose aspirin to help prevent recurrence of the problem. When I looked up a TIA, this is what it said:

A transient ischaemic attack (TIA) or "mini stroke" is caused by a temporary disruption in the blood supply to part of the brain.

The disruption in blood supply results in a lack of oxygen to the brain.

This can cause sudden symptoms similar to a stroke, such as speech and visual disturbance, and numbness or weakness in the face, arms and legs.

But a TIA does not last as long as a stroke. The effects last a few minutes to a few hours and fully resolve within 24 hours.

This episode got me thinking how this could have happened. The St John’s Wort connection came to mind, as it is a vasoconstrictor, with the same mechanism of action as a triptan.

I thought “what if the batch of tablets I had taken had not been mixed properly during manufacture?”

“This could cause variation in the amount of active ingredient in each tablet?”

“Could I have received an overdose of the active ingredient due to lack of good manufacturing practice when the tablets were manufactured?”

“Could that have led to restriction of the blood supply to my brain?”

That’s a distinct possibility.

What is the moral of the story

The fact that a natural remedy is not a prescription medicine with declared side effects, does not mean it is automatically safe.

Additionally, anything that goes into a person’s body must be manufactured to exacting standards, otherwise harm can be caused. We know that in the pharmaceutical industry these days, the standards of Good Manufacturing and Distribution Practice (GMDP) have been found wanting numerous times.

So, what can we expect when there are no declared standards at all?

This should be food for thought for all of us.