Battle Against Big Pharma

by Isabella Cavaliere in Nottingham, Nottinghamshire, England

Battle Against Big Pharma

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This project is using Flexible funding and will receive all pledges made by December 15th 2018 at 9:12am

To raise enough capital for a lawsuit regarding a clinical trial involving 12'000 participants that were deceived and abused.

by Isabella Cavaliere in Nottingham, Nottinghamshire, England

What I am about to describe is not an anomalous case, in fact what has become apparent from my own experiences and those of past whistleblowers, is that the Pharmaceutical Industry are professional cowboys when it comes to covering up and cherry-picking information to suit their needs, to get their drugs onto the market so they can return a hefty profit at the expense of the general public's welfare.

This is why, if I can raise the money for a lawsuit over this case, the true nature of the Pharmaceutical Industry will be uncovered for all to see and we will be able to instead devise a healthcare system that genuinely has our best interests at heart. The issues run so much deeper than simply a dysfunctional National Health Service.

This case involves not only the company that I was working for at the time I discovered the corruption and deceit but also the company that developed the drug, as well as the FDA, who approved the drug for the trial. It would have been apparent to any medical professional that was to read the protocol for the study, that the reasoning behind testing the drug was bogus and of no value to any potential patient.

I am not sure how much is appropriate to say here for legal reasons, but my contract stated that if there are valid legal implications, I am within my rights to break the confidentiality agreement. I have had this hanging over me for quite some time now and feel my experience whilst working for Worldwide Clinical Trials (WCT) must be shared and acted upon. So here goes…

During my time working on the clinical trial in question, my role was a Clinical Data Associate at WCT, which is a company contracted to handle the data (participants test results such as weight, waist measurements, blood samples etc.) that is generated from the trials. After ‘cleaning’ the data, as they like to call it, it is passed over to statisticians who analyse the results and give the drug a yes or a no.

For a drug to be studied in a clinical trial, it has to first be approved by the appropriate regulatory body, in this case, it was the FDA. Any scientist with an analytical mind that was to take a good look at the protocol for this trial, would have quickly picked up on what a load of bullshit it was, so I am certain that there are corrupt allies within the FDA that allowed this drug to get the go-ahead to be studied further, after previous studies on it failed due to the high rate of suicide.

The protocol makes absolutely no sense and is crammed full of complex terminology and explanations, purposefully designed to overwhelm the reader. They wanted all of the people working on the trial to blindly assume it was all correct and could be trusted since it was designed to look beyond their comprehension, so was expected go unquestioned by those in the lower ranks.

The protocol was full of contradictions when it came to explaining how the data should be reported on the database we used, and it was apparent that none of the staff at the clinical sites that were working directly with the participants, had ever read it, been trained by it, or had any idea about how the results were supposed to be reported. There was no consistency in how the data was reported in different countries or even different clinical sites within the same country.

Any minor problem that the data associates came across was to be swiftly passed on to the mysterious ‘Clinical’ team, who went on to fiddle with the database to make whatever the discrepancy was, fit accordingly. I was not buying any of it and I always tried to figure out the issues for myself using reason and rationale. Unfortunately, it is impossible to come to logical solutions for problems that are based on false or manipulated data, no matter how well they tried to make it correlate, it just didn’t add up.

The database was a complete mess and would have been impossible to analyse, since there was no standardisation in the reporting of terms that were entered into free text boxes. Many different spellings and names were used for the same conditions and there were often many random commas or grammatical errors scattered between terms, which would prevent them from coming up in search results. This trick seemed to be used particularly with the more serious health conditions that were arising throughout the course of the study.

Any change that is made to the database is tracked and logged by audit trails, but after enquiring with a colleague, I now have reason to believe that it is possible for them to edit and delete the audit trails, so since they removed me from the study, I have no idea what the data may look like since I was working on it.

I now wish that I had not been so honest with them about all of the issues I was coming across, because as I raised each and every one of them with my line manager, within the next few days all of the data I had questioned would be magically removed from the database or manipulated. For example, all comments relating to violence, aggressive behavior, sexual misconduct, jail/ prison/ incarceration, were removed since I raised concerns and questioned them; they were instead covered by the vague umbrella term ‘study administrative reason’.

Since this drug affects serotonin (5HT-2b receptor), similar to an anti-depressant, there are many psychological side-effects, including anxiety, panic-attacks, increase in heart rate/ palpitations. To get away with these side effects, they basically tried to make out they were a result of the cardiovascular conditions they were trying to treat, such as heart attacks and hypertension. They purposefully selected participants that have pre-existing heart conditions or were at high risk of developing them, including diabetes patients, to try to conceal the true causes of the negative effects induced by the drug. The whole charade was sickening and infuriating!!

It took over 10 years (I am not sure of the exact amount of time, likely even longer) and many millions of dollars to get the drug to this point, which is a hell of a lot of time and money for the developers to lose right at the last ‘hurdle’ (Phase IV trial). Owing to this, they are using any means possible to get the drug through to market, so they can get a return on all of the money they have wasted researching the drug up to this point. Since it failed all previous attempts as a weight loss drug, it was instead being trialed as a drug for obesity and diabetes for people with cardiovascular conditions, though reasonings for how this serotonergic drug worked in relation to treating these conditions was not clear at all.

When I went to the Director of Data Management at WCT to try to gain a better understanding of the mechanism of action of this drug within the body and how exactly a therapeutic response was supposed to be generated, I was promised a full explanation by a medical specialist, however, they failed to provide me with any further help or information about how the drug works (because it doesn’t!). After multiple attempts to gain more information, I was at first ignored, then passed on to people within the department who were not working on the study, so had no relevant information to provide; before finally being passed on to HR. The drug in question is called lorcaserin (trade name Belviq) and if there are any scientists reading this I urge you take a look at it further and draw your own conclusions as to how the hell a drug that is similar to an anti-depressant in action, is supposed to have any therapeutic effect in relation to cardiovascular disease and diabetes.

When I first read the protocol, the most striking part of how this drug was said to work, was by inducing anorexia nervosa-like thinking patterns to control satiety and feeding behavior. I remember bringing this up with a colleague on my lunch break and the next time I went back to check the protocol, this information appeared to have been removed entirely. Once a protocol is published for use during the study, it is required to be the finalised document to which no changes can be made; but clearly, they do not care for abiding by their own regulations.

This study was the largest that WCT had ever worked on and it involved over 12’000 humans. By the time they ended the study, over 800 of the 12’000 participants had either withdrawn consent or had stopped taking the study drug, which rendered their results unusable.

Judging by the article in the Guardian on 27 Aug 2018, this information seems to have been conveniently omitted since they are claiming the results are still based on 12’000 participants. I am assuming they have cherry-picked data from a small pool of participants that have results that back up what they wanted to prove.

The article in the Guardian also said that lorcaserin is a weight loss drug (the new ‘Holy Grail’ of weight loss apparently!), however, the trial of this drug was said to be testing effects on diabetes, obesity and cardiovascular disease, NOT weight loss.

If any of the participants wanted to leave the study due to an ‘inadequate therapeutic response’ they were specifically told that the point of the study is not for weight loss, but to measure some terribly explained effects on diabetes and cardiovascular disease. They were strongly encouraged (manipulated) to remain on the study for their own good.

There are also many participants in the study that are ‘lost’. All participants that couldn’t be found by the end of the study, were submitted to a company called OmniTrace, who thoroughly search all publicly available records to try to find out if they are alive. I am worried that there could be people that are ‘lost’ that lived alone and became victim to the depression and suicidal-inducing effects of the drug. There were many suicidal ideations and even suicide attempts recorded on the database. There were also many participants that became too anxious to even leave the house to make it into the clinical site for their study visits. Many a time, a ‘study visit’ would be classed as getting through to the participant on the telephone.

When I started looking into the data too much and they realised that I was going to be a problem, the company resorted to crude methods to try to push me out of the company, to make it seem as though I left voluntarily. Rumors about my private life were spread, inappropriate comments were made, even by the managers and on my final day in the office, even going as far as messing with the database on my personal account, filling it with inappropriate comments and making it impossible for me to complete any work. The stress of this day sent my head into such a spin that I could not think straight for the rest of day. In addition to the stress from what I was uncovering and realising every day I spent working on the study, I was catapulted into depression, which led to me having to give up my flat in Nottingham, which was devastating and caused major disruption to my life. My parents did not believe anything that I told them about what had happened at my workplace and told me I must be ‘making it all up in my head’. This was infuriating and caused even more stress when I was made to go back to stay with them.

I think WCT thought that must have been the last of me, since I had to take leave from work until I had recovered enough from the breakdown. But I returned to continue working on the trial from my parents’ house in Yorkshire.

I did not stop looking into the data and it was not long before I was removed from the study. I was given the option to either work on a different study or to leave the company there and then, but still be paid until the end of my contract. I asked to be put onto a different study, but when they next corresponded with me, I was not allowed to continue working on any study and they put me on a Garden Leave contract, which meant I could have no contact with any employee of the company until the contract ended.

I have no idea how much it costs to take two companies and the FDA to court but I suspect it will be quite a hefty sum. So, I have made an estimate at around £1 million, though this could change depending on the course of things and I will keep you informed as things become clearer.

If it happens to cost less than this, the surplus will go towards building an alternative healthcare system that does not give so much power to Pharmaceuticals and psychopaths.

Anything at all that you can spare to put towards this lawsuit is massively appreciated and your donation will go towards shaping the future of our currently failing healthcare system.

If there are any people out there that are reading this, that participated in the lorcaserin study with Eisai Pharmaceuticals/ TIMI Research Group, I would really appreciate you coming forward to share your experiences during your time on the study. Please contact me at the following email: poisonivyflows@gmail.com

I hope the devastating effect of this study can be turned around into something positive and world-changing for all of us. This is a worldwide issue and I hope enough attention can be brought to this case to make a real impact. It is long overdue and time we took back our power from the hands of a system abusing our health and well-being, to make us slaves to the system. Please help to spread the word about this case and help me wake up the masses in relation to the ways we are manipulated and controlled by an elite minority; who live lives of unlimited luxury and freedom, while the rest of us live in an oblivious and sub-standard state, maintaining the current power structure.

Thank you for reading, I hope you will join me on my mission for real change and liberation of the masses.

Let's make 'Battle Against Big Pharma' happen