The HPV Vaccine on Trial: Seeking Justice for a Generation Betrayed

The HPV Vaccine on Trial:  Seeking Justice for a Generation Betrayed

Following is an excerpt from a well referenced book on HPV vaccine reprinted in TVR with the permission of the book’s co-authors. Learn more about this recently published book here and here.

Cancer strikes fear in people around the globe. So a vaccine to prevent cancer – as the human papillomavirus (HPV) vaccine is touted to do – seemed like a game-changer. Since 2006 when the US approved the first HPV vaccine, over 125 countries have introduced it to prevent cervical and other HPV-related cancers. The three HPV vaccines bring in over $2.5 billion in annual sales for Merck (Gardasil, Gardasil 9) and GlaxoSmithKline (Cervarix). They have been a pharmaceutical juggernaut, yet scandal has followed worldwide. The HPV vaccine is on trial – literally and figuratively – around the world in courts of law and public opinion.

No one disputes that cancer is a ravaging disease that leads to death, if uncontrolled. But the fact that cancer is a grave disease does not necessarily mean that a vaccine purporting to prevent it is safe and effective for everyone. The US Food and Drug Administration, the US Centers for Disease Control and Prevention, the European Medicines Agency, the World Health Organization, and many other public health agencies have embraced the HPV vaccine as a safe and effective way to prevent HPV-related cancers. Here are a few representative statements:

FDA: Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks.

CDC: The HPV vaccine is very safe, and it is effective at preventing HPV. Vaccines, like any medicine, can have side effects. Many people who get the HPV vaccine have no side effects at all. Some people report having very mild side effects, like a sore arm from the shot. The most common side effects are usually mild.

WHO: The WHO’s Vaccine Safety Committee considers HPV vaccines to be extremely safe.

EMA: The benefits of HPV vaccines continue to outweigh the known side effects.

These official statements contrast starkly with the reports of devastating injuries and death that we recount in this book. You’ll get to know these and other children and young adults.

Christina Tarsell, 21 years old.
Chris was an undergrad at Bard College, New York. A talented athlete, artist, and honor student, she received three Gardasil doses when she was twenty-one. Shortly after the third dose, she died in her sleep. After eight years of hard-fought litigation in the only judicial forum available, Chris’s mom “won” – the Court of Federal Claims finally acknowledged that Gardasil more likely than not caused the heart attack that led to Chris’s untimely death. You can see Chris, and a memorial to her, in the photo insert.

Alexis Wolf, 13 years old.
In 2007, when Alexis was in 7th grade, she began the Gardasil series. After the second dose, her health deteriorated. After the third, she could no longer focus, sleep, eat, or behave normally. She started to have many seizures every day. She was put in psychiatric hospitals. A year and a half after her symptoms began, Alexis tested at a 4th grade level. Today, at 25, Alexis still suffers from severe neurological injury, including daily seizures. You can see pictures of Alexis both before and after receiving the vaccine in the photo insert.

Joel Gomez, 14 years old.

Joel was an athletic, healthy teenager when he got two Gardasil doses in 2013. Without warning, Joel died in his sleep after the second dose. Joel’s family sued for compensation in the Court of Federal Claims. The family’s expert witness, Dr. Sin Hang Lee, testified that Gardasil likely caused his heart attack. The Department of Justice settled the case, awarding the family almost the full statutory death benefit.

Abbey Colohan, 12 years old.
In a small town in western Ireland, Abbey received the first dose of Gardasil at school. Abbey fainted immediately and then had seizures for more than an hour. Two days later, she passed out again. Abbey started to have chronic pain, fatigue, and frequent fainting spells. Abbey’s teen years have been consumed with illness and hardship. Ireland’s health service denies that Abbey had an adverse vaccine reaction at school.

Colton Berrett, 13 years old.
Colton was an athletic, kind, helpful teenage boy. He loved all outdoor sports. Colton started the three-dose Gardasil series when he was thirteen. Shortly after the third dose, he became paralyzed from the neck down and had to use a ventilator. Through intensive physical therapy, Colton eventually recovered some mobility but remained on a round-the-clock ventilator. He committed suicide two months before his eighteenth birthday. In the photo insert you can see pictures of Colton that convey far more than words ever can.

Lucy Hinks, 13 years old.
Lucy was a healthy English teenager when she began the Cervarix series in her school. Shortly after the third shot, Lucy’s health plummeted. She could barely walk, slept 23 hours a day, and could not think straight. She could not attend school and had to be spoon-fed. Her parents described her as being in a “walking coma.” Through many therapies and treatments, Lucy has substantially recovered but still suffers from chronic fatigue.

Maddie Moorman, 15 years old.
Maddie began the Gardasil series at the gynecologist’s recommendation. After the second shot, Maddie became bedridden and ill. She had debilitating headaches every day and could no longer remember things. Her mom declined the third shot for her. Through conventional and holistic treatment, Maddie’s health began to recover slowly, and she was able to complete high school and go to college. But some of Maddie’s symptoms never abated, including a constant buzzing in her head and the inability to think the way she could before. She took her own life at twenty-one.

We show that the HPV vaccine clinical trials paved the way for such tragic results. Here are some of the little-known facts we’ll explore:

HPV vaccines have never been proven to prevent cervical or any other cancer. Merck and GlaxoSmithKline, the manufacturers, did not have to prove that the vaccines prevent cancer. They were allowed to use precancerous lesions as “surrogate endpoints” in the clinical trials. Scientists do not know if the decline in cases of precancerous lesions will translate into fewer cases of cervical cancer in 20-30 years.

Even if they were 100% effective, which they are not, HPV vaccines do not prevent all cases of cervical cancer. The vaccines do not prevent infections from all HPV types associated with cancer, and not all cervical cancer is associated with HPV. HPV vaccines are not a replacement for cervical screening, yet evidence strongly suggests that young women are skipping screening in the mistaken belief that they no longer need it. HPV vaccine marketing hype appears to have contributed to a sharp drop off in cervical screening among young women.

None of the participants in the clinical trials received a true saline placebo. None of the clinical trials included a straightforward comparison of the effects of the vaccine against a true control. We use the term “fauxcebo” to describe the aluminum-containing adjuvants, other vaccines, and chemical mixtures that control subjects received instead of true saline placebos. These fauxcebos masked the adverse effects of the vaccines, making them appear safer than they would have if compared to true placebos.

Merck told young female clinical trial subjects that the vaccine had already been proven safe and that the placebo was saline. Both claims were false. A key purpose of the clinical trials was to establish safety, and the placebo was not saline. Clinical trial subjects suffered because of these lies.

The manufacturers never tested HPV vaccines on human fertility. Although this vaccine is given to adolescents throughout the world, the manufacturers acknowledge in their package inserts that they never tested the vaccine for fertility effects in humans – only rats. We look at the substantial evidence of severe adverse effects on fertility, including miscarriage and premature ovarian failure in girls and young women.

Evidence shows that certain ingredients in HPV vaccines, including sodium borate (also known as borax, a cleaning agent), may have negative effects on fertility. The European Chemicals Agency requires sodium borate to carry the following warning: “DANGER! May damage fertility or the unborn child.” In the US, borax is banned in food but allowed in vaccines.

The manufacturers never tested HPV vaccines to discover if they might cause cancer. The package inserts acknowledge that the vaccines have never been tested for “carcinogenicity.” But clinical trial data suggest that if women have HPV infections when they get the vaccines (and prescreening is not recommended), then they may be at higher risk for precancerous cervical lesions or worse. Some clinical trial participants later developed cancer, including cervical cancer.

The Gardasil clinical trials used a new metric, “New Medical Conditions,” as a way to claim that serious health problems after vaccination were unrelated to the vaccine or aluminum-containing fauxcebo. More than 50% of all clinical trial participants reported “new medical conditions,” including infections, reproductive disorders, neurological syndromes, and autoimmune conditions. The FDA did not question this novel metric or whether the vaccine itself might be contributing to these conditions.

Although 11-12 year olds are the target population for this vaccine (and it is approved for children as young as 9), the vast majority of clinical trial subjects were considerably older. Only a small percentage of participants were twelve or younger, and their age cohort lacked a true saline control placebo, as did the older age groups. Preteens, on the cusp of puberty, have significant biological differences from young adults, the primary age group in the clinical trials. Thus the target population was insufficiently studied before the vaccine received approval.

Doctors and scientists have published peer-reviewed articles on the adverse effects that many young women reported after HPV vaccination. Here is a non-exhaustive list:

Orthostatic intolerance
Cognitive dysfunction
Disordered sleep
Visual symptoms
Blurring of vision
Gastrointestinal symptoms
Neuropathic pain
Motor symptoms
Skin disorders
Voiding dysfunction
Limb weakness
Vascular abnormalities
Irregular period

Despite US government assertions that the vaccine is safe, the federal compensation program for vaccine injury has paid out millions of dollars in damages for HPV vaccine injuries. Families have received compensation for death, brain injury, multiple sclerosis, complex regional pain syndrome, Guillain-Barre syndrome, ulcerative colitis, and other severe, debilitating conditions. We delve into reported HPV vaccine injuries and the pursuit of justice.

All participants in the Gardasil clinical trials who received a “placebo” rather than the vaccine were encouraged to receive HPV vaccines at the end of the clinical trial period. By doing this, Merck destroyed any opportunity for large-scale, long-term safety and efficacy studies of vaccinated versus the original control subjects.

Lawsuits have been filed against Merck, GlaxoSmithKline, and government health agencies around world, including in the US, India, Colombia, Japan, Spain, and France. Families want treatment for their injured children and young adults. They also want to hold the manufacturers accountable and to prevent future injuries to other children.

National and international health agencies are working hand-in-glove with the HPV vaccine manufacturers to promote, advertise, finance, recommend, and even compel children to get HPV vaccines. We have included examples of CDC and UK National Health Service ads for HPV vaccines in the photo insert.

The US government earns royalties from Merck and GSK for licensing HPV vaccine technology. Scientists at the National Institutes of Health, with others, participated in the invention of HPV vaccines. While receiving millions of dollars in annual royalty income from these corporations, the US government ostensibly holds the upper hand in regulating them. The conflict of interest is obvious.

The HPV vaccine saga began just as Merck was trying to turn the page on its criminal conduct with Vioxx, its failed painkiller drug. Just as Vioxx was raking in $2.5 billion in annual revenue — almost the same amount Gardasil and Gardasil 9 are now bringing in — Merck withdrew it from the market because it was causing heart attacks, strokes, and death. Merck had not disclosed known heart attack risk in its clinical trial data. In 2005, Merck paid multi-million dollar civil and criminal penalties and entered into a $4.85 billion settlement with injured plaintiffs. Congress, the Department of Justice, and the media investigated Merck for falsifying data, making false statements to regulators, making false marketing claims, failing to disclose material information to consumers, and more. In 2006, the FDA approved Gardasil, leading some to dub the HPV vaccine “Help Pay for Vioxx.” History repeats itself in the Merck Vioxx and Gardasil sagas.

In researching and writing this book, we spoke with more than a hundred people who shared with us their time, expertise, and deeply personal stories. We also spoke with many injured young people and their parents, as well as with parents whose children died. We are humbled that they trusted us with their stories and have done our best to give them voice.

We also reached out to doctors, scientists, and medical researchers. We met with advocates fighting for those who have been injured. We met personally with women who were subjects in the clinical trials and spoke with doctors who were principal trial investigators. We also contacted HPV vaccine proponents, including the FDA, and are grateful for their assistance. We reached out to Merck with a long list of questions on two occasions but received no replies.

We bring legal and financial backgrounds to this task. While we are not doctors or scientists, we believe that our perspective is critical to this debate. For too long, those with real and potential conflicts of interest in industry and government have dominated public discourse about vaccine safety.

Part I examines the clinical trials and the race to develop the vaccine. It analyzes surprising data that have received little attention to date. We also provide a primer on cervical cancer to explain its real risk factors. While we focus on the Gardasil clinical trials, we also look at Cervarix, GlaxoSmithKline’s version, and at Gardasil 9, the only currently available HPV vaccine in the US. (GSK took Cervarix off the US market, likely because of low sales. Merck replaced Gardasil with Gardasil 9, the new HPV vaccine against a broader range of HPV viruses.) We use official documents and the accounts of two young women injured in the clinical trials to examine their many flaws. We close Part I with a look at India, where clinical trials led to national outrage and a legal battle against the pharmaceutical industry and its partners.

Part II covers what happened after the vaccines hit the market. How do you sell a vaccine for an infection that clears almost all the time? We look at the marketing magic and “disease branding” that created a market out of thin air. We also share heartbreaking stories of injury and death. We follow several families’ fights for justice. We look closely at the US and Australia, powerhouses in HPV vaccine development, whose governments are leading the charge towards universal HPV vaccine uptake.

Part III is a deeper dive into the latest research on aluminum-containing adjuvants and other ingredients of concern, including DNA fragments. We discuss HPV transmission, the potential threat of “type replacement,” cervical screening in both high and low resource countries, and more. If you don’t need the deep science dive, skip ahead.

Finally, Part IV takes readers around the world to Japan, Denmark, Ireland, the UK, and Colombia. Each of these countries is a unique case study regarding the HPV vaccine, and the role that governments, media, and the law play. You’ll get a close look at the latest developments in each country yet also see the global threads in common.

We strongly advocate for informed consent and hope that this book will help people to make truly informed decisions about this vaccine. Only you can be the ultimate judge for yourself or your loved one.


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