PharmaFiles #11
What are Adverse Events and How Pharma Systematically Underreports It
Anyone who works in Big Pharma knows this. Before any actual work is done, new employees must attend an "Adverse Event Training". Once they have completed this training, they must pass a simple quiz, get certified, and sign off. Then, they can start working.
So, what is an "Adverse Event"?
In most countries, Government Regulators require Pharma employees, regardless of rank and position, to report any Adverse Events related to the Drugs they are selling. An "Adverse Event" can be triggered anytime, 24x7, even after office work hours.
For example, if someone is having dinner with a friend and the friend says, "Hey, I'm taking your company's product, and I can't sleep well!".
That is an Adverse Event.
Or "Hey, I'm taking this drug, and it doesn't seem to work for me".
That is also an Adverse Event.
It can also be triggered from a 3rd party point of view, like, "Hey, my mother is taking this product and losing her appetite".
That is also an Adverse Event.
It can also be triggered when the product produces positive side effects like, "I took this pill for a headache, but it increases my marathon performance!".
That is also an Adverse Event.
So you can imagine what an Adverse Event is. Depending on countries, most Government Regulators require pharma employees to report Adverse Events within 3-7 days of "hearing it", but in the case of "Death" or some defined Serious Adverse Event like heart attack, within 24 hours.
In short, we call it "AE" for Adverse Events or "SAE" for Serious Adverse Events. It is crucial because failure to report Adverse Events can lead to many legalities, even to the point where the entire Pharma license is pulled for a specific country!
This is why they make new pharma employees complete a quiz and sign it off to protect themselves from legalities. If something happens, they can blame the employee by showing the regulators a paper trail that this employee has been adequately trained but didn't comply.
Paperwork in Pharma is all about leaving "proper" paper trails and eliminating unwanted ones. For example, another policy implemented in most Big Pharma companies in recent years called the "Records Retention Policy". The "Records Retention Policy" ensures that all written communication and paperwork are eliminated if they are not required to be "officially" kept. Some Big Pharma companies even go to the extent of automatically deleting all employees' email boxes on any emails beyond 30 days. Again, this is to avoid paper trails if something happens and they are asked to produce emails.
Officially, they claim that the "Records Retention Policy" is made to comply with Regulations because companies are legally required to keep records up to a certain number of years, depending on the document type. Unofficially, it is used to eliminate unwanted paper trails.
There was a vast but largely unknown scandal in the early 2000s when Medical Sales Reps started carrying electronic devices. First, you must know that Sales Reps visit 6-15 doctors daily. In countries like Taiwan - they try to see 15 doctors a day; in Australia, it's around 2-3 doctors a day.
In the past, Medical Reps used to write everything down on paper after visiting a doctor. It was straightforward to eliminate paper evidence back then.
Sometime in the 90s, Medical reps started carrying electronic devices. When that happened, the Reps started capturing Adverse Events on these devices through emails or their Customer Relationship Management App!
It created a huge problem internally for many Big Pharma because they are first supposed to verify every Adverse Event case. Usually, adverse events are verified by the Pharmacovigilance Department (we call it PV), but this is a heavily underfunded department. Some countries with 500 sales reps only employ 3 to 5 PV colleagues to manage Adverse Events.
Imagine a rep visiting a doctor eight times a day and discussing with doctors. If you have 500 Medical Reps, that equates to 8 discussions x 500 representatives x 200 working days, approximately 800,000 doctor interactions in a year.
Now that you understand what an Adverse Event is, imagine how many times a doctor brings up an Adverse Event to a Medical Rep.
"Well, this product doesn't work for my patient", or
"My patient developed some side effects".
If 10% of these discussions came with an Adverse Event, that's 80,000 adverse events in a year, and all these Adverse Events will need to be verified by the PV department.
However, if you audit any pharma companies today, you will see that almost ZERO adverse events come from any Sales Reps.
It is inconvenient for a Sales Reps to write it down on paper, go back to the branch and report it to Pharmacovigilance.
But when Medical Sales Reps started carrying electronic devices in the 2000s, it became convenient, and they started recording Adverse Events electronically. The number of adverse events exploded.
In a few countries, a few scandals started breaking out when Regulatory Audits occurred. They found thousands and thousands of Adverse Events recorded in emails and Customer Relationship Management Systems. However, none of these Adverse Events was seen or verified by PV. One country even threatened to kick one of the Big Pharma out.
After those incidents broke out, there were top-down directives to immediately cease Medical Reps' usage of emails and Customer Relationship Management Apps.
If you are a pharma rep in the early/mid-2000s, you may wonder why you don't get a company email. Unfortunately, this scandal was unknown to most, even to most pharma employees.
Anyway, when the directive to cease using CRM systems occurred, it also created a problem for sales and marketing because they needed the efficiency of a CRM system to rank doctors instead of going back to paper.
So, in the end, they decided to revamp the entire App by removing all "free text fields" and replacing them with "Dropdowns". This way, they can prevent Reps from keying in any "Unwanted AEs". In those days, we spent many hours discussing dropdown values.
Technology has advanced so far that they don't even need a lot of "dropdown menus".
The picture below is taken from an iPad app that Medical Rep uses to present information to doctors. You'll see three hidden buttons if you zoom in on the closed top right of the screen. Every time a rep talks to a doctor about a specific key message in a slide, they click one of these buttons secretly without the doctor's knowledge. It captures the doctor's reaction.
These three buttons capture the doctor's reaction to every single slide presented to the doctors. They mean the following:
Green = Positive
White = Neutral
Red = Negative
This way, Sales Reps capture the doctor's "sentiments" without capturing any Adverse Events. These are all system-fixed values, so the Medical Reps have zero chance of capturing Adverse Events!
Below is the screen that shows the result after discussing it with the doctor. Every slide in the presentation has a "Reaction" attached to it. This information is synchronized to the back end so that the back office will re-work any Key Messages that are generally negative. This is also how Big Pharma surgically influences the opinions of doctors.
This brings us back to VAERS. VAERS stands for Vaccine Adverse Events Reporting System, a tool developed by the Center for Disease Control and Prevention (CDC) in the US for healthcare professionals to capture adverse events related to vaccines.
It is illegal to falsify data in VAERS.
VAERS is also a very laborious system for Healthcare Professionals - they take about 15-20 minutes to key in a single case because there are a lot of fields such as where, when, what, batch serial numbers, product name, code, description of events, patient name and so forth).
It is widely known in the medical community that VAERS is underreported because it is way too time-consuming for Healthcare Professionals to key in the data. The best estimates of underreporting come from Steve Kirsch; through modelling, he estimates that it is under-reported by a factor of 41x.
Below is data shown in VAERS showing vaccine deaths since 1990. So, suppose you look at the VAERS data and multiply it by 41 to get a better picture of how many reported deaths from the vaccine. That approximates how many deaths have occurred in the last two years after the COVID Vaccine was launched.
