HPV Vaccine – Injured and Misled in Clinical Trials

Excerpted from the book “The HPV Vaccine on Trial”, by Mary Holland, Kim Mack Rosenberg, Eileen Iorio.

In December 2017, the online magazine Slate published “What the Gardasil (Merck Laboratories’ HPV vaccine) trials may have missed”. With its publication, the article sparked renewed debate about HPV vaccine clinical trials. 1 The story focused on Kesia Lyng, a young Danish woman who participated in one of Merck’s Gardasil trials in 2002. 2 The article’s description of the clinical trials surprised many, but brought a sense of relief to other young people who, like Kesia, had experienced ill health after the vaccine. They could recognise their experience in hers.

When she was eighteen and still in high school, Kesia received a brochure in the mail about a clinical trial of a vaccine that could prevent cervical cancer. She didn’t know it was possible to get vaccinated against cancer. She had heard that getting regular Pap tests was the best way to prevent cancer because most problems could be detected early and treated. The brochure said that the vaccine had no side effects, as it had already been thoroughly tested. It said, “FUTURE 2 er IKKE et bivirkningsstudie”, which translates as “the FUTURE 2 study is NOT a side-effect study” (original emphasis on “NOT”). This piqued their interest, particularly as the vaccine had already been shown to be safe.

Source: Excerpt from the recruitment brochure for the “Future 2” study sent to all women aged 18-23 in Denmark, 2002. 3 “The FUTURE 2 study is NOT a side-effect study” (original emphasis on “NOT”).

Only six months before Kesia received this booklet, her grandmother had died at the age of 68 from cervical cancer. Kesia adored her grandmother; she was Kesia’s world. Her grandmother was the glue that held the family together. Kesia has the fondest memories of her whole family celebrating the holidays at her grandmother’s house. She missed her grandmother terribly. She wanted to do something, and getting the flyer seemed like a fluke.

The brochure said that half of the clinical trial subjects would receive the vaccine and half would receive saline, which seemed to be standard practice. When he inquired further, he discovered that the clinical trials would be conducted at his local hospital in Hvidovre, just outside Copenhagen. It seemed like an easy way to do something positive and help in the fight against cervical cancer. She signed up.

Kesia’s parents were sceptical, although they appreciated her desire to do something constructive. They did not want her to take unnecessary risks. They discouraged her from participating in the trials, but Kesia was determined. She was proud to participate so that she could help others avoid a similar painful loss. She had never heard of HPV before the study, but it sounded like a breakthrough. She learned that the name of the study, FUTURE 2, stood for “Women united to unilaterally reduce endo/ectocervical disease”. She couldn’t wait to get started. Not least, he would earn around $500. That was a lot of money for an 18-year-old!

THE STUDY BEGINS

Kesia enrolled in Study Protocol 015, a clinical trial, and received her first injection in September 2002. At this appointment, doctors examined her and took blood and urine samples. She was told she would receive either the Gardasil vaccine series of 3 injections or three saline placebo injections, which would have no effect. Because the study was double-blind, neither she nor the researchers would know which injections she received until the trial was over. Kesia was nervous. Part of her wanted to get the saline placebo, but another part wanted to get the vaccine to be protected against HPV. The nurse reassured her that if she got the vaccine, it was perfectly safe; her mind was put at ease.

The first injection hurt a lot. Later that day, she felt tired and her arm was weak. An unusual feeling came over her whole body; not dizzy, but strange and disconnected. She had a strange feeling in her arm for weeks after the injection. But, in the end, she reasoned that she was doing something that might one day help women all over the world. She thought it was just a normal reaction to the vaccine.

Two months later, Kesia returned for her second injection. It was at this visit that she talked more with the doctors. She was asked how she did after the first injection. The nurse read out a checklist of possible symptoms related to the injection site and other minor symptoms. Kesia had not received any information from the clinical staff when she received her first injection about how to record unusual reactions; she was not asked to follow up. She did not keep a diary and could not remember every pain she had had in the previous month. She was told that headaches and fevers were normal, so she took the second injection without hesitation. It was more painful than the first, but it took her mind off it. She had the same reaction as before: she was very tired and her arm was weak. Her body felt very strange,

However, shortly after this second appointment, Kesia developed flu-like symptoms, muscle aches and a strange headache. At times, Kesia felt as if her head was in a vise. She started having trouble sleeping for the first time in her life. She felt exhausted, but it would take hours to fall asleep and she rarely fell asleep for long, waking up every hour. She tried everything, but nothing helped. Lack of sleep was the worst part of Kesia’s illness. It was so stressful and upsetting to be so exhausted and unable to find relief. Kesia didn’t realise it, but this was going to be her new night-time experience for the next fourteen years.

Kesia’s flu-like symptoms and sleeping problems persisted that winter. There was no requirement for her to return to the hospital. She missed a lot of school due to fatigue and constant pain, but tried to catch up. She had to retake some tests. As the third shot approached and she still hadn’t fully recovered, she thought maybe she shouldn’t continue with the trial. Her parents agreed and tried to dissuade her from continuing. But there was something about being part of this incredible trial that excited Kesia, so she continued.

To this day, Kesia vividly remembers her third date. She remembers the long hallway she walked down to the room where she would receive the shot. Looking back, there was something about it that lingered in her mind: the smells, the noise, the feeling of mistrust, though she couldn’t pinpoint why. At her appointment, she told the doctor that she didn’t feel well and was often tired and in pain. She asked if perhaps she should delay the shot. The nurse assured her that what she was feeling had nothing to do with the vaccine and that she could have the third dose without a problem. The nurse asked if Kesia had had any reactions after her second dose. Apart from the headaches, fatigue and muscle aches from her ongoing illness, Kesia could not remember the exact details of the last six months. She told the nurse about the headaches, which she had four or five times a week, all day long. The nurse told her not to worry and that some headaches were normal. She completed the paperwork and gave Kesia her third and final injection.

After this appointment, Kesia felt dizzy for the first time. She felt nauseous and her arm hurt more than ever. Over the next few weeks, however, her health deteriorated sharply. She went to see her doctor and when she told him that she had participated in a clinical trial of a new vaccine, he became concerned. He made a note in her file, and Kesia saw that he put two exclamation marks next to it. He asked her to go back and talk to the trial staff about her symptoms because all her blood tests were fine. Kesia returned to the hospital for a follow-up visit one month after her last injection. She tried to talk to the trial staff again about her symptoms based on her doctor’s concerns, and this time they listened more carefully. She told them that she was struggling to maintain a normal daily life and that this was not something she had experienced before. But they again told her that her symptoms were not what they would expect to see with the vaccine and that she should continue to see her regular doctor. Kesia accepted this explanation; after all, they were the experts and she knew that the safety of the vaccine had already been proven. She tried to put it out of her mind that she had a 50-50 chance of having received the saline placebo and not the vaccine.

VACCINE OR PLACEBO

As the months passed, Kesia became so ill that all she could think about was her next doctor’s appointment. She missed so many exams in her last year of high school that she was unable to graduate with her classmates. She had to put her dreams and plans on hold until she could feel well enough to get through the day without a headache or pain in her joints and muscles. It was a daily struggle to get out of bed, let alone attend school or college.

Kesia loved her high school, which focused on practical skills and crafts such as sewing, art and design. She wanted to go to university to become an interior designer or a glamorous window dresser for a fancy shop in Copenhagen. Or maybe she could be a journalist; she loved writing. She also dreamed of one day owning a coffee shop with her best friend. She had always been excited about the endless possibilities of her future, but now her whole life was on hold. She didn’t like having to rely on the government for financial and medical expenses. She lost count of the doctor’s visits. He vowed to finish his exams someday and graduate from the high school he loved. He never thought the months would turn into years and the years would turn into more than a decade.

When trial investigators unmasked the trial in 2007, a year after the FDA approved Gardasil, Kesia learned that she had received the vaccine after all. She was relieved that the trial was over. If she had received the saline injection, she would have been strongly urged to return to the hospital to receive all three vaccines, which would have been difficult now that she was so sick. She heard no more from the clinical trial staff, although she agreed to be part of the follow-up studies.

Some close friends and family members began to ask Kesia questions about a possible link to the clinical trials, but she would not listen. She was so convinced that she had made a positive contribution to cervical cancer research that she got angry when anyone suggested it. She wanted the vaccine to be a success so that other women would not die of cervical cancer like her grandmother. She was very proud of her contribution to helping find a way to prevent cancer. Gradually she began to forget about the clinical trials. She didn’t want it to be the vaccine.

PUTTING THE PUZZLE TOGETHER

Despite her illness, Kesia managed to hold on to her life. The many doctors she saw could never find a reason for her incessant pain and fatigue. Resigned to thinking that this was the way life would be, she found a way to tolerate the symptoms. She found love, married and had two beautiful children. She worked part-time outside the home when her health permitted, but sometimes she couldn’t. She loved being a mother and thought she was a good mother. She loved being a mother and felt that her most important work was at home, taking care of her children.

Kesia does not have a television and does not keep up with social media. In March 2015, Denmark was abuzz after the release of a controversial Danish documentary about the HPV vaccine, The Vaccinated Girls. 4 The film narrated girls who suffered many neurological and physical symptoms after vaccination with Gardasil. Two Danish doctors, Drs Brinth and Mehlsen, gave interviews and explained why they were concerned that the vaccine might be contributing to unusual illnesses, including postural orthostatic tachycardia syndrome (POTS) and other autoimmune conditions. People told Kesia about it, but she didn’t look. More than a year later, when she was sitting with her husband watching an online news channel, things clicked. She overheard a woman talking about getting vaccinated shortly after it was approved. As the woman described her reaction to each shot, Kesia’s heart stopped. It was like listening to her own story: the same timeline, the same symptoms. In that moment, Kesia felt as if the rug had been pulled out from under her.

Controversial Danish documentary on the HPV vaccine, testimony from people severely harmed by the vaccine https://www.bitchute.com/video/v9dGSBrgsTIq/

How could this happen if the vaccine had been “proven” safe? Every time she told the trial nurse about her symptoms, the nurse assured her that they were unrelated. On the one hand, she was angry and upset; on the other hand, she was relieved to find someone else who could understand what she was going through and could even help her.

He barely slept that night. The next day, she went online to start looking for answers. She contacted the Danish vaccine victims’ support group and spoke to Sara, who eventually became her dear friend. They talked for a long time and Sara understood. She had heard it before. For Kesia, however, it was the first time she did not feel crazy. It had been thirteen years of living with pain and listening to doctors deny that her condition was real.

In April 2016, she finally sat down with her husband to watch The Vaccinated Girls. She was not prepared to watch Danish teenagers suffer precisely what she had lived through for more than a decade. She wept for what she had suffered, but even more for what was happening to all the other girls since the clinical trials. If the doctors in the trials denied any connection between her symptoms and the vaccine, it makes sense that doctors would continue to deny them. She was determined to share her story.

SESILJE

Just a few miles away in Copenhagen, another young woman was going through a similar awakening. Sesilje (pronounced Cecelia) had also been in the FUTURE 2 study and, like Kesia, her health has also suffered since then. The two young women met through the victim support group in July 2016. Sesilje’s story is remarkably similar to Kesia’s, with one significant difference: Sesilje received the placebo. What could have made Sesilje so sick if she had received saline? It didn’t add up.

Sesilje had received the same leaflet as Kesia about a clinical trial at her local hospital in Frederiksberg, Copenhagen. Like Kesia, Sesilje thought it would be exciting to contribute to an important medical effort to protect women from cancer. Sesilje, a 21-year-old university student at the time, could also use the extra money. She read that the trial used saline as a placebo. Sesilje expected to receive the placebo because she was studying for exams and didn’t want to take undue risks. But she had no way of knowing whether she would be in the vaccine or saline group, as the study was double-blind. Thinking of all the good the trials could do and the money, he decided to participate, as the brochure said the vaccine was safe.

Source: Excerpt from the recruitment brochure for the “FUTURE 2” study sent to women aged 18-23 years in Denmark, 2002. 5

Sesilje did not notice any strong reactions after the first shot, although it was quite painful. She had an unusual menstrual period the month after the vaccination, but did not think it was related. The doctors did not give her any booklet or form to record the symptoms. They mentioned that she would feel reactions at the injection site and maybe a headache. The bleeding was just a coincidence, she thought.

A month later, Sesilje returned to the hospital for her second injection. And as with Kesia, the doctors asked about a checklist of reactions. Sesilje felt comfortable proceeding, as her reactions had been mild. She was told that she should see her personal doctor about her menstrual period, as it was unrelated. She would not return for another six months until her third injection was due. She was told to call if she had any questions, but again was given no way to record any reactions she might have.

It was after this injection that she noticed unusual symptoms, not just the heavy period. Her skin ached, she had headaches and felt like she had the flu. Her stomach hurt a lot and she lost twelve pounds in a matter of weeks. She went to her doctor, but he couldn’t figure out her symptoms. Sesilje couldn’t understand; she had always been healthy.

When Sesilje returned for her third injection, the trial staff again told her that her recent health problems were unrelated. She should continue to see her own doctors and follow their advice. They assured her that it was safe to proceed.

When the series ended in 2003, Sesilje was told she had to wait until 2007 to find out whether she had received the saline placebo or the vaccine. Her symptoms persisted, but no doctor could find out why. She developed an allergy to her deodorant and various skin creams. She went to a dermatologist, who told her to switch brands, which didn’t help. As part of her studies in medical research, Sesilje was surrounded by health professionals, but no one could explain why she was so sick. Like Kesia, she learned to cope.

In 2007, when the blind of the clinical trial was opened, Sesilje learned that she had received the saline placebo. This silenced the voice in the back of her mind that the vaccine was somehow related to her illness. Since he had received an inactive placebo, the cause must have been something else. At a follow-up visit with the clinical trial staff, she told them that her gynaecologist had recently discovered that she had abnormal cell growth on her cervix. She asked the trial doctors for information about whether she had had an HPV infection at the start of the trial in 2002. She thought they might know this information because she had had a gynaecological examination before her first injection. She was concerned that this might have something to do with her current diagnosis.

Sesilje was upset by this response because she had to decide on her treatment options for cervical dysplasia and did not have enough information. However, the staff strongly advised her to get vaccinated because she might have an increased risk of cancer. Although she had scruples, she felt enormous pressure from the staff to get the three Gardasil injections. Because she was more afraid of the cancer than the vaccine, she did it.

Then Sesilje’s health plummeted. In the autumn of 2007, she discovered that she had a tumour on her pituitary gland. Could this be the reason for all her health problems? Although she was frightened, she was somewhat reassured that she might have found the cause. She was still struggling with daily life, but now it seemed a little easier to understand.

Sesilje had played football in her spare time, but was forced to stop because she was losing her balance; it wasn’t safe to be on the pitch. She really missed being active, but her health had to come first. Her periods continued to be abnormal; something was not right.

Still, Sesilje was able to work at a job she loved and got married. Things were going well when she could handle the pain and fatigue. She was worried about her pituitary tumour, but there was nothing the doctors could do except manage it. Despite menstrual problems, she conceived her first child in 2012. She experienced excruciating headaches during pregnancy, but doctors told her they were just migraines. Shortly after the birth of her son, Sesilje discovered that the tumour had ruptured unexpectedly. She was worried, but it slowly disappeared as if by magic and never came back. Her doctors were amazed. Her little baby may have saved her life, she thought.

Sesilje adjusted to life as a new mother and hoped her pain and fatigue would go away, assuming the tumour had been the cause. But the symptoms worsened. She was confused and scared. Fortunately, her baby kept her busy. She tried not to complain. She went back to work and managed as best she could.

In 2015, everything changed. She read online that the Gardasil clinical trials had used an aluminium solution as a control, not saline, as she had been told. Sesilje worked in clinical research, so she knew this should not have been permissible. She was sure she had been told that the control was saline, it was even printed in the leaflet she received years ago.

She was determined to investigate this, if only to prove that the online information was incorrect. She hoped to confirm that the placebo was “saltvand”, which means “saline solution” in Danish. Instead, he discovered that there was no saline placebo group. What he had read online was correct: the control contained aluminium. Her heart sank. She knew what this meant: because the vaccine also had the same solution as the control, she had received six injections containing aluminium, three as “placebo” and then three as vaccine.

I knew that aluminium was an active ingredient. I knew it has a measurable effect on people. I had read studies but I was not sure how toxic it was. At that moment, Sesilje knew that aluminium had been toxic to her. Her mind flashed back to the last twelve years of ill health that began just after her first shot. She knew that the saline solution alone could not have caused her symptoms. It all started to make sense.

How could the Danish authorities approve FUTURE 2 with an aluminium-based adjuvant as a control group and how could they allow trial participants to be told that the control was saline? How could this happen in Denmark, where the health authorities rigorously scrutinise clinical trials? I did not understand how the doctors, assuming they knew the control was aluminium, could have dismissed her symptoms. She was healthy before the trial and terribly ill after it started. Wasn’t the purpose of a trial to look at clinical symptoms?

In the following video it is shown that the HPV vaccine Gardasil, in clinical trials conducted by the manufacturer (Merck) caused 1 in 40 vaccinees to contract an autoimmune disease that could last a lifetime. https://www.bitchute.com/video/qF54EmZg3MRt/

Sesilje still didn’t know what to do, but her life had changed. She began to find out all she could about the clinical trials and Merck’s patented aluminium adjuvant, the substance that stimulated the immune system to make the vaccine work. She could find no safety information anywhere. She wondered if women in the vaccine group were experiencing the same problems.

Thanks to connections she made on social media, Sesilje discovered that there were many women like her, except that they had received the vaccine after it was officially on the market. Like Kesia, Sesilje contacted the victim support group and, in July 2016, Sesilje and Kesia met.

They both felt cheated by taking something without proper consent and were now suffering the consequences. They were distressed because no one had believed that their symptoms were related to the vaccine trial. If only they could have made the trial staff see the connections, perhaps they could have helped prevent the suffering of countless others. Kesia and Sesilje share the survivors’ sense of guilt.

BRINGING THE STORY TO LIGHT

When journalist Frederik Joelving began researching the Slate article, he sought to interview women who had participated in the clinical trials. Kesia heard about Joelving’s work and jumped at the chance to share her story. Although Kesia had no documentation at the time, she and Joelving gathered information from her medical records and Freedom of Information Act (FOIA) requests. Both journalists and the public use FOIA requests to access data from government agencies. It took Joelving eight months to complete his exhaustive investigation.

Kesia and Sesilje learned from these documents and others that the clinical trial investigators knew, or should have known, that the placebo was not a saline solution. They read the original study protocol for “V501-015” or FUTURE 2 which explained precisely that the placebo was Merck’s proprietary adjuvant amorphous aluminium hydroxyphosphate sulphate hydroxide sulphate, or AAHS, not saline. 6 In addition, the Clinical Trial Protocol, while accurate in many ways, omitted from the descriptions of the vaccine and placebo the other ingredients contained in the approved vaccine: polysorbate 80, sodium borate and L-histidine. 7 If the trial investigators did not even know these ingredients were there, how could the participants have known?

The Protocol stated that safety testing was the number one objective of the clinical trial. Yet Merck had assured potential trial volunteers in the brochure they had received that the control was saline and that FUTURE 2 was not a “side-effect trial” because the vaccine had already been proven safe. Was that why its side effects were not taken seriously, because even the trial administrators did not know exactly what they were injecting into the participants? The doctors did not collect any medical records from Kesia’s or Sesilje’s doctors and did not record any details to explain why they thought the symptoms were unrelated. The reason Kesia and Sesilje felt safe to participate in the trial was that Gardasil had been shown to be safe.

When they met others who participated in the Danish trials, they realised they were not alone. But what about trial sites in other countries? They knew that Merck had FUTURE 2 sites all over the world. Did doctors follow the same protocol everywhere? The protocol states that 10 percent of participants received a “vaccination report card” to record adverse effects in the first fifteen days after each vaccination, but only in the US. 8 Why didn’t the Danish girls receive a report card? They had many more questions.

Chistopher Exley PhD, Keele University, aluminium adjuvants can be transported to the brain by macrophages. Aluminium adjuvants can reach the brain (Khan 2013, Crepeaux 2015, Crepeaux 2017, Shaw 2009, Flarend 1997). Particles of aluminium adjuvants can pass through the blood-brain barrier in the brain, transported by macrophages (Khan 2013). https://www.bitchute.com/video/fJcwKK0plSeB/

Kesia and Sesilje have met many other injured women from clinical trials. Together, these women support each other and many are starting to get better. They have found some doctors who believe them and are trying to help. But as they continue their research, they see a pattern: These events keep happening everywhere this vaccine is tested.

“The HPV Vaccine on Trial,” by Mary Holland, Kim Mack Rosenberg, Eileen Iorio.

References:
Frederik Joelying, “What the Gardasil Testing May Have Missed,” Slate, December 17, 2017, https://slate.com/health-and-science/2017/12/flaws-in-the-clinical-trials-for-gardasil-made-it-harder-to-properly-assess-safety.html.

  1. Ibid.
  2. Danish FUTURE II recruitment brochure (2002), a copy of which is in the authors’ files.
  3. Signe Daugbjerg and Michael Bech, The Vaccinated Girls (no longer available on-line or archive), formerly at https://www.youtube.com/watch?v=G02i-r39hok. Youtube has already censored them, see video summary above.
  4. Danish FUTURE II recruitment brochure, note 3 above.
  5. V501 Protocol/Amendment No: 015-00, at 23, https://es.scribd.com/document/367386168/V501-015-00-PRO-VD?secret_password=j4BXCUs76g4wRtDxk5cy
  6. Ibid.
  7. Ibid., 9
    https://www.sciencedirect.com/science/article/pii/S0264410X17308083?via%3Dihub
    https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/724330
    https://red.cienciaysaludnatural.com/cursos/peligros-de-la-vacuna-contra-papiloma-vph/

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