It took longer than normal but the MHRA have finally responded to a FOIA I sent to them earlier this year.
The request strove to seek information regarding SSRI patient information leaflets, moreover, the terminology written on them that pertains to a "chemical imbalance".
I asked the MHRA when the marketing authorisation holders (MAH) of five SSRIs changed the labelling and patient information leaflets with regard to any reference referring to a "chemical imbalance" and what was the reason/evidence for this change.
For those that don't know, a systematic umbrella review regarding the serotonin theory of depression was widely publicised in journals and the mainstream media. The review found there is no evidence to support the idea that depression is caused by disturbance of the brain’s serotonin system.
This is something I've known for quite a long time, I even raised this lack of evidence for supporting the 'chemical imbalance' theory in my 2012 book, 'The Evidence, However, Is Clear, The Seroxat Scandal'.
After the review, authored by Joanna Moncrieff, Ruth E. Cooper, Tom Stockmann, Simone Amendola, Michael P. Hengartner & Mark A. Horowitz, hit the mainstream news, many psychiatrists took to social media to announce that they've never believed the chemical imbalance was true.
I found this surprising given the blog, 'Demand Chemical Imbalance Redaction' highlights many psychiatrists who still publicly refer to mental illness being caused by a chemical imbalance. Adrienne Nagy, who is the board president of NAMI Athens, Ohio, for example, said in 2020, "What that means is education about mental illness. We're continually trying to educate the public to know that mental illness is an illness like any other illness—it's a biochemical imbalance in the brain. It's no different than diabetes or heart failure."
This wasn't just a throwaway comment from Nagy, this was actually publicised in The Post, an independent, award-winning student-run news publication on Ohio University’s campus.
If Nagy is telling students in a widely read campus publication that mental illness is a biochemical imbalance in the brain, then, to me, that suggests Nagy wants those students to believe that what she is saying is true and factual.
NAMI, by the way, is the acronym for the National Alliance on Mental Illness, the USA's largest grassroots mental health organization.
So, back to the FOIA:
I asked the same question for all SSRI patient information leaflets (PILs)
The MHRA response throws up a rather interesting reply with regard to 'the psychiatry scientific literature'. Remember, most psychiatrists claim to have never used the 'chemical imbalance' theory when talking to patients.
Here's the MHRA response in full. You'll note that they are boxing clever here. They seem to be saying the term 'chemical imbalance' is rarely used in PILs but other references to imbalances and low serotonin are. They seem okay with that. They are also saying the terms used are for patients to understand the literature, which they suggest is 'complex'.
I don't know about you but being told I have a chemical imbalance, low serotonin or a disturbance of chemistry in my brain kind of tells me that my brain is broken and thus needs fixing. I think this would apply to anyone confronted with this terminology.
It appears, the MHRA are, indeed, suggesting scientific literature from the field of psychiatry adopted the 'chemical imbalance' term.
We all know who they adopted it from, right?
On the MHRA's summary response, let's take a closer look at what the PILs say:
1/
Cipramil "
is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a group of medicines known as antidepressants. These medicines help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness"
2/
Escitalopram:
"These medicines act on the serotonin-system in the brain by increasing the serotonin level. Disturbances in the serotonin system are considered an important factor in the development of depression and related diseases."
3/
Fluoxetine:
"Everyone has a substance called serotonin in their brain. People who are depressed or have obsessive-compulsive disorder or bulimia nervosa have lower levels of serotonin than others. It is not fully understood how Fluoxetine and other SSRIs work but they may help by increasing the level of serotonin in the brain."4/
Paroxetine:
"Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Paroxetine and other SSRIs work but they may help by increasing the level of serotonin in the brain."
5/
Sertraline: No mention of how and why they work but a strong warning of what they may cause.
"If you experience agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating and rapid heartbeat. These are symptoms of Serotonin Syndrome."
Source - The electronic medicines compendium (emc)
Bob Fiddaman
