{"id":21575,"date":"2023-10-30T18:23:48","date_gmt":"2023-10-30T16:23:48","guid":{"rendered":"https:\/\/antidote-europe.eu\/?p=21575"},"modified":"2023-10-31T12:28:03","modified_gmt":"2023-10-31T10:28:03","slug":"interview-with-michelle-julien","status":"publish","type":"post","link":"https:\/\/antidote-europe.eu\/en\/interview-with-michelle-julien\/","title":{"rendered":"Interview with Michelle Julien"},"content":{"rendered":"

Interview with Michelle Julien, medical trials participant.<\/strong><\/p>\n

Michelle Julien is an essayist author of several books, and founder of StopVivisection.info, a website that is no longer available. Among her published works is the fascinating book \u00ab\u00a0The Hidden world of Medical Trial participants\u00a0\u00bb (original title in French \u201cLe Monde ignor\u00e9 des testeurs de medicaments\u201d, Editions du Cygne, 2008).<\/b><\/p>\n

 <\/p>\n

Foreword<\/b><\/p>\n

 <\/p>\n

Antidote Europe considers it important to make known this unique and courageous personal testimony by Michelle Julien, published in 2008. The following interview dated October 2023, documents her experience as an insider who participated in phase 1 clinical trials. The <\/span>views expressed in this interview are solely those of the author and do not necessarily reflect those of Antidote Europe. For example, it is relevant to note that despite the fact that science and technology continue to evolve, regulatory authorities continue to require that animals and often young healthy volunteers still be used to test pharmaceutical products intended to treat the sick, who constitute a very diverse population, in terms of age, genetic makeup and comorbidities.<\/span> The pharmaceutical industry could, if it so wished, replace the old paradigm with human relevant 21st century technologies, which are now available but not widely used. An excellent example of such technology is the human organ on a chip, such as the liver on a chip, which has already demonstrated its capacity to predict severe adverse drug reactions that animal testing was unable to achieve. This is a very significant finding because drug induced liver damage is the primary reason for drug withdrawal from the market. It should now be self-evident that it is time to stop using animals and healthy human volunteers in the light of current knowledge of human biology.<\/span><\/p>\n

 <\/p>\n

Antidote Europe (AE)\u00a0:<\/b> Thank you for accepting to share your experience as a healthy human \u00ab\u00a0volunteer\u00a0\u00bb who participated in several clinical trials in France and in the UK. Could you tell our readers what motivated you to take part in these trials\u00a0?<\/span><\/p>\n

 <\/p>\n

Michelle Julien (MJ)\u00a0:\u00a0<\/b>Since my youth, I have been opposed to animal experiments. As a teenager, I remember those campaigns against the use of animals in cosmetics testing \u2013 of awful images especially involving rabbits. One day, during a conversation with Mai, a colleague who worked with me part-time at Eurodisney, on how to make some extra money \u2013 she told me about taking part in cosmetics tests for \u00ab\u00a0women like me\u00a0\u00bb, in other words, with pale complexion. Mai was Vietnamese and felt that it was unacceptable that these tests should be performed only on Caucasians. She also told me about paid medical trials that only men were permitted to participate in. I was immediately intrigued by the fact that medical drugs were tested on men and only men, and why. I thus discovered that what was happening to animals was also happening to people. Like most people at the time, I believed that animal experimentation was conducted in order to \u00ab\u00a0avoid\u00a0\u00bb using human subjects \u2026<\/span><\/p>\n

 <\/p>\n

AE\u00a0: <\/b>Would you say that the other participants who were with you in the clinical trials were as concerned and as aware as you on the subject of animal experimentation\u00a0?<\/span><\/p>\n

 <\/p>\n

MJ\u00a0:\u00a0<\/b>The very first<\/span> section on the first page of the informed consent form – that the volunteers must read and sign as proof of their willingness to participate in the protocol \u2013 describes the side effects seen in animals (dogs and monkeys, but those observed in rodents are not mentioned)\u00a0; as well as side effects seen in people, where the protocol has already been tested on humans \u2013 which is usually written down (in my time)\u00a0: \u00ab\u00a0men, United States\u00a0\u00bb. I should add that, as a woman, I was never enrolled in a new drug application, i.e. <\/span>\u00ab\u00a0first in Man clinical study\u00a0\u00bb<\/span><\/i>.<\/span><\/p>\n


\n<\/span>None of the male volunteers that I spoke to showed any interest in the subject of animal experiments. In fact, it probably made them feel reassured that animal tests had already been performed \u2026 But what seemed to really reassure them was the participation of women in the same protocol as them, and even more so, elderly people. As an example, during my final clinical trial involving type 2 diabetes, the age group included participants between 46 and 65 years of age (usually, the majority of healthy volunteers should not be over 45 years old \u2013 but for this protocol, people were recruited between 18 to 65 years old). Once, a young first-time volunteer whispered in my ear\u00a0: \u00ab\u00a0When I saw that they were recruiting elderly people, I told myself that I should be quite safe\u00a0\u00bb.\u00a0<\/span><\/p>\n

 <\/p>\n

AE\u00a0: <\/b>Could you describe the kinds of clinical trials you took part in\u00a0?<\/span><\/p>\n

 <\/p>\n

MJ\u00a0:\u00a0<\/b>On several occasions,<\/span> I took part in a medical treatment for type 2 diabetes, at a time (the 1990s) when the use of statins was booming. All of the big drug companies wanted to get their share of the pie, by means of marketing <\/span>Me Too <\/span><\/i>drugs<\/span> (1). The obesity pandemic, together with all of the associated comorbidities (hypertension, cardiovascular disease, etc.) represented a huge windfall for the pharmaceutical industry, even more so today than ever before\u00a0! Indeed, my final protocol involving a statin treatment for type 2 diabetes took place sometime after the tragic TGN1412 incident in the UK in 2006 (2).\u00a0\u00a0<\/span><\/p>\n

 <\/p>\n

Another clinical trial involved a treatment for epilepsy. This would be the first and only time that I felt I was actually serving a useful purpose, in the sense that epilepsy is a <\/span>genuine<\/span><\/i> disease and not something brought through unhealthy lifestyle habits and\/or addiction. I also took a treatment to lower blood pressure and a treatment to combat gastric reflux (proton pump inhibitors) : simply more boring <\/span>Me Too <\/span><\/i>drugs<\/span>\u2026<\/span><\/i><\/p>\n

 <\/p>\n

AE\u00a0: <\/b>Do you consider<\/span> \u00ab\u00a0healthy volunteers\u00a0\u00bb to be sufficiently well informed and protected when providing their informed consent\u00a0?<\/span><\/p>\n

 <\/p>\n

MJ\u00a0:<\/b>\u00a0Without a doubt, the participants are aware that they are taking part in a clinical trial that will not directly benefit their own health. They are informed about the type of drug, the route of administration (oral, intravenous) along with the name of the drug company, with the aim of treating a particular disease, as well as the trial conditions: required number of days and nights of hospitalization, number of blood samples to be taken, use of an intravenous cannula, etc.<\/span><\/p>\n


\n<\/span>Each informed consent form contains the Nuremberg Code (written by lawyers and legally binding), as well as the Helsinki Declaration (an ethical code of conduct authored by the World Medical Association). I was unaware of the Nuremberg Code, until I took part in my first clinical trial ; however, I immediately understood its reference to the Nuremberg Tribunal and in particular the experiments conducted by nazi doctors on prisoners, whom they considered as \u00ab\u00a0guinea pigs\u00a0\u00bb.<\/span><\/p>\n


\n<\/span>Regarding your specific question as to whether participants are \u00ab\u00a0sufficiently well informed\u00a0\u00bb my reply is as follows\u00a0: even the clinical investigators (those who oversee and conduct the protocols to ensure they are carried out to the letter) are not fully informed. Why\u00a0? Who finances these clinical trials\u00a0? The sponsors. Who analyses the test results obtained by the clinical investigators\u00a0?\u00a0 The sponsors. You also ask me if the participants are \u00ab\u00a0sufficiently well protected\u00a0\u00bb. One must ask the question, who is it that oversees and authorizes these clinical trials\u00a0? It is the regulatory health authorities, whose heads have close ties to the pharmaceutical industry ? Nevertheless, let us not forget that the main objective of a clinical trial is to obtain marketing authorization for a new medical product.\u00a0 It is therefore in the best interest of the pharmaceutical industry to avoid injuries or deaths in clinical trials, which would be very bad for business\u2026<\/span><\/p>\n

 <\/p>\n

AE\u00a0: <\/b>Were there incidents that you found particularly disturbing in the course of your participation in any of these clinical trials\u00a0? Can you provide some examples ?<\/span><\/p>\n

 <\/p>\n

MJ\u00a0:<\/b>\u00a0The behaviour of some of the doctors when inserting an intravenous cannula.\u00a0 I gave the title of \u00ab\u00a0butcher\u00a0\u00bb to one of the doctors : that should tell you something about the lack of due care and diligence on the part of some of the doctors with respect to the wellbeing of the participants. The lack of basic hygiene among certain doctors was also apparent. For example, I remember taking part in a trial involving gastric reflux, which required the insertion of a stomach tube to monitor stomach pH before swallowing a pill. A long and thin tube is inserted by the clinical investigator through a nostril directly into the stomach. It was obvious that this doctor had not even bothered to wash his hands beforehand, as I could smell the stench of cigarette tobacco on his fingers. As a matter of fact, few doctors are good role models for public health. This might explain why some doctors would far sooner prescribe drugs to their patients, rather than provide advice to improve lifestyle habits.<\/span><\/p>\n


\n<\/span>However, what I find most disturbing, even to this day, is society\u2019s attitude \u2013 including the general public and the media- towards healthy human volunteers. There is so much that could be said and challenged on the condescending and even contemptuous attitudes of some French journalists in particular\u2026<\/span><\/p>\n


\n<\/span>But as I need to be brief, I would like to provide just one example of what to me illustrates a systemic hypocrisy in our society regarding human experimentation \u2026 and animal experiments. On the first day that the test drug is administered, all of the participants in the protocol are grouped in the same room, under the supervision of the clinical investigator and one or two additional doctors. Next to me was a young man, around 18 or 19 years old, who had told me that this was his first time taking part in a clinical trial and that he needed the money to pay for his driver\u2019s license. Suddenly, the young man\u2019s father burst into the room shouting at his son to follow him out and giving the doctors a piece of his mind\u00a0: <\/span>\u00ab\u00a0Shame on you for treating my son like a guinea pig, why don\u2019t you experiment on animals instead\u00a0!!!\u00a0\u00bb<\/span><\/i>.<\/span><\/p>\n

 <\/p>\n

AE\u00a0: <\/b>In hindsight, would you still take part in a clinical trial today\u00a0? Why\u00a0?<\/span><\/p>\n

 <\/p>\n

MJ\u00a0:<\/b>\u00a0Yes, my reply is that I would still do it today because society needs insiders like me : to see, hear and then expose. I do agree that using healthy subjects in phase 1 clinical trials presents ethical problems, since by definition, these individuals are in perfect health and will not benefit directly. They are young (around 20-30 years of age) and male, which does not match the profile of the majority of those who require medication : older patients, often women, with comorbidities, which entails taking several different drugs daily. But what is even more concerning is that these clinical trials are now mostly outsourced to countries (China, India, Poland, Ukraine, Russia, etc.) where the legislation and the reporting by the media of accidents are not on the same level as that in the West.<\/span><\/p>\n


\n<\/span>On a personal note, these medical trials have taught me to take a critical look at the pharmaceutical industry and their drugs, as well as doctors, because I have come to understand, based on my participation in these trials, that the results are heavily skewed : this is less about good medical science and more about big profits \u2013 but certainly not for the test subjects ! It is this critical look that helped me not to succumb to the mass hysteria of Covid \u00ab\u00a0vaccination\u00a0\u00bb. I am already immune to the bullshit of the pharmaceutical industry\u00a0!<\/span><\/p>\n

 <\/p>\n

AE\u00a0: <\/b>Would you like to add any concluding remarks\u00a0?<\/span><\/p>\n

 <\/p>\n

MJ\u00a0:<\/b>\u00a0I would like to conclude by saying that the term \u00ab\u00a0clinical trial\u00a0\u00bb has never been so misused and so trivialised since 2021, following the media campaign for Covid \u00ab\u00a0vaccines\u00a0\u00bb. Most people now use the term as part of their regular vocabulary, whereas in the past, it was solely used by pharmacologists and other health professionals involved in medical research. Ironically, this whole Covid episode demonstrates that the general public continues to bathe in its comfort zone of beliefs and to deny reality : just who are the real \u00ab\u00a0guinea pigs\u00a0\u00bb and why\u00a0? Not wanting to deprive itself of a <\/span>pleasure permit<\/span><\/i> to visit the restaurant or the cinema, our society succumbed to mass acceptance of an injection of a product that was still in an experimental phase. At least, the real \u00ab\u00a0healthy human volunteers\u00a0\u00bb who agree to take part in clinical trials, do so in part on altruistic motives \u2026\u00a0<\/span><\/p>\n

 <\/p>\n

    \n
  1. A <\/span>me-too<\/span><\/i> drug is a product <\/span>which has nearly identical clinical outcomes to a pre\u2010existing\u00a0drug in the same class but is not necessarily safer or more effective than the existing product.<\/span><\/li>\n
  2. \u00a0TGN1412 is an experimental monoclonal antibody that was tested in monkeys at 500 times the dose administered to six healthy young men, who quickly found themselves in intensive care after receiving the drug, following a severe unexpected reaction.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Interview with Michelle Julien, medical trials participant. Michelle Julien is an essayist author of several books, and founder of StopVivisection.info, a website that is no longer available. Among her published works is the fascinating book \u00ab\u00a0The Hidden world of Medical Trial participants\u00a0\u00bb (original title in French \u201cLe Monde ignor\u00e9 des testeurs de medicaments\u201d, Editions du… Read more<\/i><\/a><\/p>\n","protected":false},"author":6,"featured_media":21573,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[23,153],"tags":[],"class_list":["post-21575","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles-caten","category-hom","has-post-title","has-post-date","has-post-category","has-post-tag","has-post-comment","has-post-author",""],"yoast_head":"\nInterview with Michelle Julien - Antidote Europe<\/title>\n<meta name=\"description\" content=\"Interview with Michelle Julien, medical trials participant. 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