Archive for the ‘vaccines’ Category

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

https://thevaccinereaction.org/2018/10/the-hpv-vaccine-on-trial-seeking-justice-for-a-generation-betrayed/

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

by Mary Holland, Kim Mack Rosenberg and Eileen Iorio

Published October 18, 2018

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 7^th 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 4^th 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:

Headache
Orthostatic intolerance
Syncope
POTS
Fatigue
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.

__________________

More on the HPV vaccine: https://madisonarealymesupportgroup.com/2018/09/24/more-deaths-after-hpv-vaccination/

https://madisonarealymesupportgroup.com/2018/09/29/shocking-flaws-in-gardasil-trial-design-prevents-safety-assessment/

https://madisonarealymesupportgroup.com/2018/09/03/editors-of-medical-journals-confirm-hpv-vaccines-cause-more-harm-than-good-science-author-facing-death-threats/

https://madisonarealymesupportgroup.com/2018/04/28/merck-accused-of-fraud-deceit-and-negligence-in-u-s-gardasil-case/

https://madisonarealymesupportgroup.com/2017/04/14/gardasil-and-female-reproduction/

https://madisonarealymesupportgroup.com/2017/02/16/gardasil-vasculitis-msids/

https://madisonarealymesupportgroup.com/2016/07/19/motor-and-sensory-findings-in-girls-who-received-gardasil/

https://madisonarealymesupportgroup.com/2017/10/02/sacrificial-virgins-hpv-vaccine/

https://madisonarealymesupportgroup.com/2017/07/02/hpv-after-vaccines/

Category:

Activism, vaccines

Altering Human Genetics Through Vaccination

I’ve been sitting on this article for a while but with the push for gene-editing on mice and insects feel compelled to share it now while the iron’s hot. To understand how this relates to Lyme/MSIDS, please see my comment at the end of the article.

https://worldmercuryproject.org/news/altering-human-genetics-through-vaccination/

June 28, 2018

Altering Human Genetics Through Vaccination

Children’s Health Defense Note: CHD has internal documents in which the FDA acknowledges that technology that allows for the creation of these new vaccines has outpaced their ability to predict adverse events. Shouldn’t our federal agencies be calling for a moratorium until we have that knowledge—especially since it is heavily reported that the CDC/FDA post-marketing surveillance systems are inadequate to pick up problems after licensure?

By Jon Rappoport, Contributing Writer, Children’s Health Defense

The National Institute of Allergy and Infectious Diseases (NIAID) has launched efforts to create a vaccine that would protect people from most flu strains, all at once, with a single shot.

Over the years, I’ve written many articles refuting claims that vaccines are safe and effective, but we’ll put all that aside for the moment and follow the bouncing ball.

Massachusetts Senator and big spender, Ed Markey, has introduced a bill that would shovel no less than a billion dollars toward the universal flu-vaccine project.

Here is a sentence from an NIAID press release that mentions one of several research approaches:

“NIAID Vaccine Research Center scientists have initiated Phase 1/2 studies of a universal flu vaccine strategy that includes an investigational DNA-based vaccine (called a DNA ‘prime’)…”

This is quite troubling, if you know what the phrase “DNA vaccine” means. It refers to what the experts are touting as the next generation of immunizations.

Instead of injecting a piece of a virus into a person, in order to stimulate the immune system, synthesized genes would be shot into the body. This isn’t traditional vaccination anymore. It’s gene therapy.

In any such method, where genes are edited, deleted, added, no matter what the pros say, there are always “unintended consequences,” to use their polite phrase. The ripple effects scramble the genetic structure in numerous unknown ways.

This is genetic roulette with a loaded gun. Anyone and everyone on Earth injected with a DNA vaccine will undergo permanent and unknown genetic changes…

Here is the inconvenient truth about DNA vaccines—

They will permanently alter your DNA.

The reference is the New York Times, 3/15/15, “Protection Without a Vaccine.” It describes the frontier of research—the use of synthetic genes to “protect against disease,” while changing the genetic makeup of humans. This is not science fiction:

“By delivering synthetic genes into the muscles of the [experimental] monkeys, the scientists are essentially re-engineering the animals to resist disease.”

“’The sky’s the limit,’ said Michael Farzan, an immunologist at Scripps and lead author of the new study.”

“The first human trial based on this strategy — called immunoprophylaxis by gene transfer, or I.G.T. — is underway, and several new ones are planned.” [That was three years ago.]

“I.G.T. is altogether different from traditional vaccination. It is instead a form of gene therapy. Scientists isolate the genes that produce powerful antibodies against certain diseases and then synthesize artificial versions. The genes are placed into viruses and injected into human tissue, usually muscle.”

Here is the punchline:

“The viruses invade human cells with their DNA payloads, and the synthetic gene is incorporated into the recipient’s own DNA. If all goes well, the new genes instruct the cells to begin manufacturing powerful antibodies.”

Read that again: “the synthetic gene is incorporated into the recipient’s own DNA.”

Alteration of the human genetic makeup.

Not just a “visit.” Permanent residence. And once a person’s DNA is changed, he will live with that change—and all the ripple effects in his genetic makeup—for the rest of his life.

The Times article taps Dr. David Baltimore for an opinion:

“Still, Dr. Baltimore says that he envisions that some people might be leery of a vaccination strategy that means altering their own DNA, even if it prevents a potentially fatal disease.”

Yes, some people might be leery. If they have two or three working brain cells.

This is genetic roulette with a loaded gun. Anyone and everyone on Earth injected with a DNA vaccine will undergo permanent and unknown genetic changes…

And the further implications are clear. Vaccines can be used as a cover for the injections of any and all genes, whose actual purpose is re-engineering humans in far-reaching ways.

The emergence of this Frankenstein technology is paralleled by a shrill push to mandate vaccines, across the board, for both children and adults. The pressure and propaganda are planet-wide.

The freedom and the right to refuse vaccines has always been vital. It is more vital than ever now.

It means the right to preserve your inherent DNA.

The author of three explosive collections, THE MATRIX REVEALED, EXIT FROM THE MATRIX, and POWER OUTSIDE THE MATRIX, Jon was a candidate for a US Congressional seat in the 29^th District of California. He maintains a consulting practice for private clients, the purpose of which is the expansion of personal creative power. Nominated for a Pulitzer Prize, he has worked as an investigative reporter for 30 years, writing articles on politics, medicine, and health for CBS Healthwatch, LA Weekly, Spin Magazine, Stern, and other newspapers and magazines in the US and Europe. Jon has delivered lectures and seminars on global politics, health, logic, and creative power to audiences around the world. You can sign up for his free NoMoreFakeNews emails here or his free OutsideTheRealityMachine emails here.

___________________

**Comment**

Frightening information, indeed, and reminiscent of Brave New World.

Hopefully regarding DNA based (gene-editing) vaccines, the evidence for harm is self-evident.

Regarding how this specifically could affect Lyme/MSIDS patients, the vaccine issue should STILL be self evident in the harm it could cause chronically/persistently infected people, but secondly, they are gene-editing mice and mosquitoes and releasing them into the wild in hopes of eradicating Lyme and Zika with unintended consequences: https://madisonarealymesupportgroup.com/2018/10/11/new-england-scientists-explore-new-method-for-eradicating-lyme-disease/

In brief, gene editing has shown unintended consequences of mutations, enhancement of other pathogens, cancer in humans, and very real ethical issues.

Lastly, while many think the only problem some have with aborted fetal tissue in vaccines is only an ethical one, I was told by people with far more experience than I, that putting human DNA from a certain gender into another human of a different gender, could also have unintended consequences – transgenderism.

Please read my entire comment at end of article within link. This is scary business. Please speak out in your sphere of influence.

Category:

Activism, Genetic Mutations, Inflammation, Lyme, research, vaccines

Vaccine Safety & Efficacy Studies That are the Bases for Marketing Authorizations are a Complete Methodological Mess

http://www.greenmedinfo.com/blog/vaccine-safety-and-efficacy-studies-are-bases-marketing-authorizations-are-comple

“Vaccines are held to the highest standard of safety. The United States currently has the safest, most effective vaccine supply in history. Vaccines undergo a rigorous and extensive evaluation program to determine safety and effectiveness.” (U.S. Department of Health & Human Services. https://www.vaccines.gov/basics/safety/informed/. accessed on 28 January 2017)

Claims that vaccines “undergo rigorous and extensive testing”, that they are “held to the highest standard of safety”, etc., are lies. The sad truth is exactly the opposite. The studies that are the bases for marketing authorizations are a complete and utter methodological mess. They are designed so very badly that they do not allow the detection and evaluation of short-term, let alone long-term vaccination effects. Such methodologically so inadequate studies should never be part of the process of granting marketing authorizations. I have to emphasize here that the mass utilization of untested vaccines, i.e. vaccines that haven’t been reliably tested, isn’t rare. On the contrary, granting a marketing authorization to vaccines without methodologically sound studies of safety and efficacy is a rule, not an exception.

“The design of a study, the procedures used and the very execution of a project are the elements which determine to a great extent the quality of scientific work and the (in)validity of its results. Poor research design and methodology lead to lack of credibility of findings and, in case of medicinal products, to a potentially erroneous evaluation of efficiency, safety and profitability of the pharmaceutical preparation. The entire scientific research process, from planning to publication, is subject to a string of identified and well described mistakes, distortions and partiality. The latter can be an unintended consequence of poor mastering of the research process or lack of experience. Proneness to error, which is intrinsic to scientific work, also opens the door to deliberate and well thought exploitation of this possibility with the intention to manipulate” (Gajski 2009, p. 66).

If we summarize all that is wrong with the majority of safety and immunogenicity studies, including the ones submitted in the process of gaining a marketing approval, we get a truly chilling picture: instead of rigorous scientific studies in the true sense of the word, we have studies that are methodological mess. Studies that are, obviously intentionally^[1], designed so poorly that they would be barely fit for a college assignment, if that. They are designed in such a way that they cannot reveal the actual safety and efficacy profile of individual vaccine, they do not allow for any reliable and correct evaluation of vaccines. Consequently, despite claims about “rigorous scientific studies”, millions of children are routinely injected with untested vaccines whose true safety and efficacy profiles remain largely unknown.

Below I briefly summarized the most common and typical methodological “flaws”.

1. Preclinical safety studies are often not done. And if they are done, they are so poorly designed and limited in their scope, that they are almost useless. However, preclinical (animal)^[2] studies are of immense importance; they are the only way to truly research vaccines’ side effects and should form an integral and unavoidable part of any registration process.

It is true that animal studies have their own set of problems (for example, it is often difficult to find an adequate animal model, results cannot be 100% applied to humans, etc.) but they do allow:

invasive and frequent examinations and tests,
autopsy,
longitudinal studies (over 3 generations or more).

Those are the three most important aspects. Researchers should sincerely and actively search for all kinds of side effects, including theoretical/hypothetical ones. Instead, they are actively shutting their eyes and looking the other way. Many injuries, abnormalities, pathologies, etc. can only be revealed by a proper autopsy, so this should form an integral part of every study. And in many instances, with each passing generation, effects (both good and bad) of certain substance become more pronounced, wider in scope and higher in intensity. To discover the true range of possible side effects, one has to look not only for long term effects as such (for example, effects that become apparent in few months or years), but also research how it would affect the third, fourth, fifth generation^[3].

2. Pharmacokinetic studies are not required for vaccines. They aren’t required for any vaccine component, not even for adjuvants (EMA, 17 May 2005, p. 4; WHO, 17–21 November 2003, p. 14). Consequently, such studies – i.e. studies of the time course of drug absorption, distribution, metabolism, and excretion – aren’t done. In other words, vaccines are granted a marketing authorization without a single study about how their components act in the body, how are they absorbed, how and where are they transported, how they affect various organs, where are they deposited, how are they excreted, etc.

Of course, the lack of preclinical safety studies and pharmacokinetic studies is not the only problem. Tomljenovic and Shaw (2011a, 2630) stated that “to the best of our knowledge, no adequate studies have been conducted to assess the safety of simultaneous administration of different vaccines to young children. Another issue of concern is the lack of any toxicological evaluation about concomitant administration of aluminum with other known toxic compounds which are routine constituents of commercial vaccine preparations, e.g., formaldehyde, formalin, mercury, phenoxyethanol, phenol, sodium borate, polysorbate 80, glutaraldehyde. In spite of all this, aluminum adjuvants are generally regarded as safe and some researchers have even recommended that no further research efforts should be spent on this topic despite a lack of good-quality evidence […] to the best of our knowledge, no adequate clinical studies have been conducted to establish the safety of concomitant administration of two experimentally-established neurotoxins, aluminum and mercury, the latter in the form of ethyl mercury (thimerosal) in infants and children”.

3. Observation period is extremely short, often only 5–15 days after each vaccine dose and rarely more than 30 days. Such study cannot detect any medium- and long-term side effects. On the basis of a few weeks’ observation, vaccines are declared “safe” and pumped into millions of children worldwide.

4. Placebo (saline solution) is practically never used. Instead either an older version of a vaccine, a vaccine from different manufacturer or a vaccine’s solution without antigens (but with all the other substances, including aluminum) plays a role of “placebo.” Such studies are then shamelessly and manipulatively called “placebo-controlled.” All this despite the fact that adjuvants cause a large percentage of serious side effects (aluminum adjuvants, for example, cross the blood-brain barrier and more or less permanently lodge in brains, where they can cause inflammation, swelling, demyelination, etc.).

This strategy enables researchers (and producers, and institutions, and all the other players in this sordid story) to literally state that “the new vaccine is as safe as placebo” or that “the rate of side effects was comparable to those from placebo”. In this way they can relatively successfully camouflage the true (high) rate of side effects. This is again a nice example of “how to lie without actually telling a lie.”

This problem was also pointed out by Tomljenovic and Shaw (2011a, 2630–2632): “…for the purpose of evaluating safety and efficacy, vaccine clinical trials often use an aluminum-containing placebo, either containing the same or greater amount of aluminum as the test vaccine. Without exception, these trials report a comparable rate of adverse reactions between the placebo and the vaccine group (for example, 63.7% vs. 65.3% of systemic events and 1.7% vs. 1.8% of serious adverse events respectively). According to the U.S. Food and Drug Administration (FDA), a placebo is ‘an inactive pill, liquid, or powder that has no treatment value’. The well-established neurotoxic properties of aluminium therefore suggest that aluminum cannot constitute as a valid placebo. […] While direct application of aluminum adjuvants to the central nervous system (CNS) is unquestionably neurotoxic, little is known about aluminum transport into and out of the CNS, its toxicokinetics, and the impact on different neuronal subpopulations following subcutaneous or intramuscular injections. The reason for this is that under current regulatory policies, evaluation of pharmacokinetic properties is not required for vaccines. This issue is of special concern in context to worldwide mass immunization practices involving children whose nervous systems are undergoing rapid development. Furthermore, an immature developing blood brain barrier (BBB) is more permeable to toxic substances than that of an adult. In addition, there are critical periods in neurodevelopment that occur within first few years of postnatal life during which exposure to neurotoxic insults may induce central nervous system (CNS) damage. In that respect, it is worth noting that any potential CNS damage caused by aluminum in children may not be evident until a later stage of development”.

5. Since there is no true placebo, there is also no true control group. Vaccinated children are never compared to unvaccinated ones. Especially not to truly unvaccinated ones (i.e. to children that have never received any vaccine). Supposedly, it would be terribly unethical if a group of study children would receive a true placebo and remain unvaccinated for at least a few months. However, it is perfectly “ethical and rational” to inject millions of children with multiple doses of vaccines whose safety has never been tested. It is “ethical and rational” to vaccinate children with these untested vaccine, loaded with neurotoxins, while they are still developing, while their immune and nervous system are still very vulnerable.

6. Side effects are literally observed. There are no blood tests, no neurological examinations^[4] or any other adequate examinations. Only fever and swelling at the injection site are measured. Everything else is simply “observed”. By parents, who report their observations on diary cards. It is truly ironical that parental observations are accepted in the course of the study, yet are ridiculed, disregarded and negated in all other situations (like, for example, when concerned parents return to their doctor and report about child’s changed behavior, screaming, regression). Even when study children exhibit clear symptoms of potential neurological injuries (like high-pitched crying, irritability, somnolence, etc.), they are not properly examined. And as a rule, almost all reactions, especially the more serious ones, are “believed to be unrelated to the vaccine”.

7. Majority of clinical trials is financed by producers^[5]. And in the process of granting a marketing approval, all studies are financed and conducted by the producer. It would be very naive to think that this does not affects trial results. Independent research is scarce these days, but still, it “has repeatedly warned that drug companies may manipulate clinical trial designs and subsequent data analysis and reporting to make their drugs look better and safer […] Keeping in mind that ‘the primary interest of a pharmaceutical company is developing and selling pharmaceutical product’, one must ask whether rational vaccine policy decisions should be based on conclusions derived from an uncritical acceptance of flawed vaccine safety and efficacy estimates provided by the vaccine manufacturer” (Tomljenovic and Shaw 2012d, p. e13).

8. Study reports are often too incomplete. But, as pointed out by Gajski (2009, pp. 66–67), “the methodology and design of clinical trials can only be judged on the basis of trial reports. Even though there are rules of reporting, methodology is often described poorly and incompletely, with important data and, in particular, side effects’ reports missing. Manipulation with procedures and data in scientific research is a well-known phenomenon. Excluding a few persons from the sample or adding a singular event can already ensure statistical reliability and produce the desired results. In fact, even complete forgeries can find their way through the filter of the most prestigious journals, as shown by a study published in The Lancet journal in 2005. The study demonstrated beneficial effects of anti-inflammatory drugs on the incidence of the oral cavity cancer. However, later it was proven that the author simply made up the study, the patients and the course of their disease”.

In order to obtain at least an approximately reliable and realistic evaluation of a vaccine’s properties and actions, every study or summary thereof (including summaries of medicinal products’ characteristics) should contain at least the following information:

time and place of the performance of the study;
individual stages of the study with a detailed description of the design and course (including the timeline) of every stage;
the number of persons included in each stage and their characteristics (age, health condition, etc.), the size and characteristics of each category of the persons involved;
inclusion and exclusion criteria;
reasons for withdrawal from the study and the number of persons who withdrew from every individual stage;
detailed description of the executed procedures, e.g. in case of side effects, an accurate description of how long after each dose of vaccine the side effects were observed and recorded and how (whether they were only recorded and reported on cards by parents or whether any tests were performed – blood or neurological tests, magnetic resonance, etc.; if so, what were the results);
the vaccination regime, what was used as placebo, the constituents of all applied substances, including the placebo;
detailed description of the implemented protocols according to individual stages, including definitions of terms and criteria and explanations of deviations;
a detailed numerical representation of all results, including all partial results according to individual stages and categories of participants.

9. Only healthy children are included in trials. While this is a rational choice (also from the methodological point of view) the problem is that in reality, practically all children are vaccinated or are supposed to be vaccinated, including the ones with existing neurological or immunological disorders, autoimmune diseases, etc^[6]. All these conditions can be caused by vaccination; if a child already suffers from one of them (either due to previous vaccinations or due to other causes) it is highly probable that vaccination would seriously aggravate his condition.

10. Vaccine is declared effective on the basis of its ability to induce the production of antibodies. However, the presence of antibodies does not equal protection, immunity, efficacy. Vaccine might even be completely ineffective, despite its ability to induce the production of antibodies. Thus, adequate^[7]animal studies in which both vaccinated and unvaccinated (control) animals would be exposed to infectious agents should be mandatory part of registration process. Instead, such studies are practically never conducted, much less submitted in the registration process.

You can find a detailed and in-depth analysis of studies that were submitted in the process of granting the marketing authorization for some of the vaccines (e.g. Infanrix, M-M-R II, M-M-RVaxPro, HBVaxPro, Procomvax, Recombivax-HB) in my book Ideological Constructs of Vaccination.

The book Ideological Constructs of Vaccination addresses, in evidence-based detail, the shakiness, dubiousness, often even falseness of the most common, self-evident and deeply rooted claims about vaccines – about their safety, efficacy, rigorous testing and regulation, etc. – thus depicting a disturbing image of states’ and scientific institutions’ operation. It is based on the author’s doctoral thesis with the same title.

In the first part, the author, Dr. Mateja Cernic, points out the socio-political aspects of vaccination, from the legal regulation of vaccination to discourses, ideologies and representations of vaccination critics by the media. This part is important, as it enables readers to learn about vaccination policies and practices and helps them understand why there are such fierce battles between the supporters and opponents of vaccination.

The second part, which focuses on ideological constructs of vaccination, represents the main body of the book, where the most common claims about vaccination are systematically analyzed. It presents, among other things, certain mechanisms through which vaccines influence an organism (e.g. damage the nervous system and the immune system). All claims are systematically supported by references to scientific articles, government documents and official statistics.

The decision whether to vaccinate their children or not is one of the most important decisions parents make in connection to their children’s health and life. Therefore, it should never be taken in haste, without consideration, but rather after a thorough examination of the issue. The book Ideological Constructs of Vaccination can help you with that decision. Read it BEFORE your next vaccination appointment.

What others said about the book:

Dr. Stephanie Seneff, a Senior Research Scientist at the MIT

“This book is proof that the anti-vax movement is science-based! This new book is a masterpiece that presents detailed scientific arguments for why vaccines are not the panacea that they are claimed to be. It is a much welcomed addition to the growing body of literature revealing the damage the vaccination program is doing to our children. It is particularly effective in its portrayal of the ideological constructs that are used without basis to defend vaccines and keep the general population uninformed of the reality in terms of risk/benefit tradeoffs. The arguments are well supported by an extensive bibliography. You should buy extra copies of this book ready to hand out to any of your friends who claim that there’s no science behind the anti-vaccine movement!”

Dr. Jayne LM Donegan, MBBS DRCOG DCH DFFP MRCGP MFHom

“It is a minutely researched, scholarly and very readable piece of work that will not disappoint the most thorough researcher or parent who is wanting to have the multiple topics and references to do with vaccination and health policy in one logically ordered resource. For anyone wanting to have a comprehensive, one volume, reference work to read about every aspect of vaccination science and policy, this is the one to get. I cannot recommend it too highly. Buy it and read it. You will be pleased that you did.”

More on: https://www.amazon.com/Ideological-constructs-vaccination-Mateja-Cernic/dp/1909736104

Footnotes

[1] Since practically all vaccine studies (those used in the process of granting a marketing authorization and those published in scientific publications) have more or less the same methodological design and since we are talking about fundamental methodological flaws (especially when it comes to safety studies) this is the only rational explanation. And let me be perfectly clear about this: I do not think and I am not implying that researchers conducting these studies don’t have enough expert knowledge, that they don’t know how to conduct a proper study. On the contrary, they are masters of their trade, possessing vast knowledge about the subject. And it is precisely this knowledge that allows them to design studies portraying entirely false and misleading vaccine profiles without actually falsifying anything. People usually fail to understand or at least fail to appreciate that the same knowledge that allows one to conduct an impeccable, high-quality and rigorous study, also allows one to conduct a study that produces false results without any actual falsification involved. This holds true for all scientific disciplines, from sociology to medicine. And is one of the biggest and most overlooked problems of modern science.

[2] Generally, I am strongly against animal studies. Often they are nothing more than torture of helpless animals without any real value. But, unfortunately, in some instances, animal studies are necessary – researching pharmaceuticals, truly researching them, is often such a case.

[3] Three generations are minimum, and five generations should be sufficient. For more information about this, dive into the field of epigenetics.

[4] It is true that usable examinations, like for example magnetic resonance imaging (MRI), are far too invasive and damaging in their own right to be done on study population, especially frequently. There is no good solution to this problem (methodologically adequate animal studies are probably the best compromise). However, at least blood samples could be taken regularly (one of the things to look for are signs of inflammation) and some minimally invasive testing could/should be used at least on those children who exhibit symptoms of neurological injuries (unusual, high-pitched cry is one such symptom).

[5] In 1980, 32% of biomedical research in the United States was financed by the industry, and in 2000, it was 62%. Currently, most trials are industry sponsored, both in the EU and in the United States (Gøtzsche 2013, p. 57).

[6] Advisory Committee on Immunization Practices (ACIP) has published a list of “conditions incorrectly perceived as contraindications to vaccination (i.e., vaccines may be given under these conditions)”, which includes conditions such as stable neurologic conditions (e.g., cerebral palsy, well-controlled seizures, or developmental delay), autoimmune disease (e.g., systemic lupus erythematosus or rheumatoid arthritis), immunosuppression, etc. (ACIP, https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html#modalIdString_CDCTable_1; page last updated 12 July 2017).

[7] One of the (obvious) conditions that would have to be met is choosing the appropriate animal species, whose susceptibility to certain disease is similar to that of humans. Another condition that should be strictly met is using only those species that do not produce their own vitamin C. High enough doses of vitamin C can cure and clear almost every infection and significantly contribute to the chance of not developing it in the first place (for more about vitamin C, see Levy, 2011).

Dr. Mateja Cernic got her PhD in sociology in 2014 at the School of Advanced Social Studies – SASS (Slovenia, EU). Since 2011, she has worked at the same faculty as an Assistant Lecturer covering various subjects. Her main research interests lie in the areas of power, control, ideologies and discourses in everyday life and medicine. She first became interested in the topic of vaccination around 10 years ago – many years before the birth of her first child and without any previous personal negative experience.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of GreenMedInfo or its staff.

Category:

Activism, vaccines

Drug Companies Pay FDA & NIH to Fast Track & Market Vaccines

https://thevaccinereaction.org/2018/09/drug-companies-pay-fda-and-nih-to-fast-track-and-market-vaccines/

Drug Companies Pay FDA and NIH to Fast Track and Market Vaccines

by The Vaccine Reaction Staff

September 28, 2018

When it comes to cozy business relationships between government and industry, there is nothing like the lucrative one that Congress has encouraged federal health agencies to create with the drug and vaccine industry. One hand washes the other.

Have you ever wondered how some new drugs and vaccines vault to the front of the line of the FDA’s licensing process using fast track approvals? One way is through a federal law, the Food and Drug Administration Amendments Act passed by Congress in 2007, which allows a company developing a treatment for a neglected or rare pediatric disease to pay the FDA for a priority review voucher (PRV). Although FDA approval is not guaranteed, most of the time a PRV secures fast track approval in six rather than 10 months.¹ ²

According to the FDA, to earn a priority review designation, a pharmaceutical product must pose “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.” The company seeking approval must also provide “evidence of safety and effectiveness in a new subpopulation.”³

The PRV was created and included in the 2007 law to provide an incentive to companies developing non-profitable drugs for rare pediatric diseases, but has proved to be a windfall for companies producing vaccines.

Selling PRVs to Get Jump on Securing Market Share

Under the law, drug companies developing treatments for neglected and rare pediatric diseases may sell the PRVs they have purchased from the FDA to other companies, including vaccine manufacturers, for millions of dollars to fast track the licensure of completely different, profitable drugs and vaccines. When sold, the PRVs designed to help small companies fund their development of non-profitable disease treatments can give extreme advantages to multi-national corporations developing and selling other high priced drugs and vaccines.

“If you develop a new drug for malaria, your profitable cholesterol-lowering drug could go on the market a year earlier,” said Bill Gates at the World Economic Forum in Davos in 2008. Describing the 2007 law creating PRVs, Gates pointed out that, “This priority review could be worth hundreds of millions of dollars.”⁴ The Bill and Melinda Gates Foundation has invested hundreds of millions of dollars in the vaccine industry.⁵

Early PRV approval from the FDA gives drug companies several months of additional sales because the first licensed drug or vaccine in a category to reach the market often becomes the front-runner, leaving competitors in the dust. For example, Regeneron and Sanofi bought a PRV in the hopes that its cholesterol drug Praluent would beat Amgen’s Repatha to market.⁶ Gilead paid $125 million for a PRV and AbbVie paid $350 million, in addition to the $2,706,000 paid to the FDA for the shortened review.⁷

As Gates pointed out, companies that purchase PRVs stand to make millions on pharmaceutical products that the FDA fast tracks to market. PRVs, then, appear to be primarily making money for drug companies rather than truly helping patients suffering with rare and neglected diseases.

Congress Gives Pharma Edge Over FDA Regulators

The FDA is charged with the legal duty to regulate the food and pharmaceutical industries to ensure that prescription drugs, vaccines and other biological products, medical devices, and certain types of foods are safe, labeled properly and effective before being released for use by the public.⁸ Reportedly, FDA officials objected to the priority review program, which was included in the 2007 law passed by Congress without soliciting input from FDA staff.⁹ According to an unnamed FDA source,

“FDA does not get a true seat at the table” during the legislative process so “well-meaning academics, advocates, and legislators ‘sold’ FDA to the highest bidder in setting up this program.”¹⁰

Critics of the PRV program point out that it does not really encourage drug development for rare diseases. Since medical reviewers in FDA cannot be easily moved from one review division to another in order to handle PRVs, it creates added workload strain to an overtaxed regulatory agency that is understaffed. The program also makes it easier for pharmaceutical products, for which there are existing treatments, such as for diabetes or cholesterol, to move to the front of the approval line at the expense of other, more important ones for which there are no treatments.

For example, Janssen used a PRV to accelerate the approval of Tremfya (guselkumab) to treat plaque psoriasis, a lucrative drug category competing with the best-selling psoriasis drug, Humira.¹¹ Drug giants Gilead Sciences and Jazz Therapeutics have also bought PRVs.

Prescription Drug User Fee Act Paves Way for PRVs

Of course not all of the accelerated FDA reviews that big drug companies are enjoying involve priority review vouchers created under the 2007 law. In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA) to accelerate FDA licensing approvals of new drugs and vaccines.¹² It was the first law to allow pharmaceutical companies to pay the FDA to let them by-pass normal licensing procedures so they could fast track new products to market. The Act was reauthorized by Congress as PDUFA VI in the Food and Drug Administration Reauthorization Act of 2017 (PL 115-52).¹³

More than half of the FDA’s budget is now funded by the pharmaceutical industry through PDUFA fees.¹⁴ This raises serious questions about the integrity of the FDA licensing process when Congress has allowed drug companies to, in effect, bribe the FDA to lower licensing standards in order to grease the skids for certain drugs and vaccines to be fast tracked to licensure.¹⁵

Gardasil Vaccine’s Fast Track Licensing Under PDUFA

Recently, the FDA granted Priority Review to Merck’s new Supplemental Biologics License Application (sBLA) for Gardasil 9 vaccine under PDUFA. In a June 13, 2018 press release, Merck stated that the FDA has set a PDUFA, or target action, date of Oct. 6, 2018 for a decision about whether Merck will be granted “an expanded age indication for Gardasil 9 for use in women and men ages 27 to 45 to prevent certain cancers and diseases caused by the nine human papillomavirus (HPV) types covered by the vaccine.”¹⁶

Dr. Alain Luxembourg, a Merck official said, “Women and men ages 27 to 45 continue to be at risk for acquiring HPV, which can lead to cervical cancer and certain other HPV-related cancers and diseases. We look forward to working with the FDA on the review of this application for GARDASIL 9, which, if approved, would enable more people to have access to the vaccine.”

Serious reactions to Gardasil (and Cervarix, another HPV vaccine), including autoimmunity, brain dysfunction and infertility, have been reported in the U.S. and countries around the world and are documented in the medical literature.¹⁷ ¹⁸ ¹⁹ ²⁰ ²¹ As of July 2018, there have been more than 57,000 HPV vaccine adverse events reported to the federal Vaccine Adverse Event Reporting System (VAERS) since 2006, including more than 15,000 emergency room visits, 5,600 hospitalizations and 358 deaths. Reported reactions include syncope (sudden loss of consciousness), Guillain Barre Syndrome (GBS), seizures, acute disseminated encephalomyelitis (ADEM), rheumatoid arthritis, lupus, thyroid disorders, deep vein thrombosis and blood clots, pancreatitis, postural orthostatic tachycardia syndrome (POTS), disabling fatigue, muscle and joint pain, memory loss and speech problems.²²

In June 2006, the National Vaccine Information Center (NVIC) publicly criticized the FDA for fast tracking Gardasil to licensure before it had been fully evaluated for serious side effects and recommended for all 11-12 year old girls by the Centers for Disease Control (CDC).²³ ²⁴ Merck’s pre-licensure clinical trials used an aluminum containing “placebo,” even though aluminum is an ingredient in Gardasil and can cause inflammation and nerve cell death.²⁵

The next year, Congress passed the PRV legislation reinforcing and expanding the fast track licensing process.

Expanding Gardasil’s Market With Taxpayer Money

Merck is now the sole source manufacturer of HPV vaccine in the U.S.,²⁶ although the well-known reactivity of HPV vaccine, together with its questionable effectiveness, has resulted in low vaccine uptake because of a reluctance by parents to give the vaccine to their children.²⁷ ²⁸ There have been Gardasil vaccine injury lawsuits in Japan and France.^{29 30} In 2016, judges in India’s Supreme Court demanded answers after children died during a trial of Gardasil and Cervarix vaccines.³¹

In July 2018, the British Medical Journal published an indictment of a May 2018 Cochrane Collaboration clinical trial review of HPV vaccines that came to the conclusion that HPV vaccines,

“do not increase the risk of serious adverse events, miscarriage or pregnancy termination.”³²>

A trio of well-credentialed epidemiologists authored the BMJ critique, detailing how the Cochrane group in charge of the review cherry picked 26 randomized clinical trials – all funded by vaccine manufacturers – to include in the review.³³ Charging that the Cochrane review could not be considered “Trusted evidence” because it was influenced by reporting bias and biased trial designs, they pointed out that Cochrane used the biased review to publicly pronounce that HPV vaccine “causes no serious side effects,” even though the published review incompletely assessed serious and systemic HPV vaccine adverse events and failed to assess vaccine-related safety signals.³⁴

The muddy record of HPV vaccine safety and parental resistance is clear and federal health officials are planning to use taxpayer money to launch a stepped up nationwide HPV vaccine promotion campaign in the U.S.³⁵ At the same time, Merck is still determined to get its money’s worth by selling Gardasil in other countries, like Australia and China.³⁶ ³⁷

The recent request to FDA to fast track an expanded use license for Gardasil is not Merck’s first attempt to enlarge the patient pool and market for its lucrative HPV vaccine. After a priority review in 2008, the FDA rejected the company’s application for Gardasil approval in females aged 27 to 45 years. But Merck is nothing if not persistent.³⁸

A dose of Gardasil costs between $168 and $205 in the U.S.³⁹ Like many drugs that enrich the drug industry due to high prices, much of Gardasil’s development was funded by the U.S. government and taxpayers, and the vaccine continues to receive taxpayer funding.⁴⁰ ⁴¹

In 2013, the NIH gave half a million dollars to the University of Texas SW Medical Center Dallas to try to

“identify an optimal and feasible self-persuasion intervention strategy to promote adolescent HPV vaccination in safety-net clinics”

also known as sell more vaccines.⁴² Nor was that the only marketing grant.

The University of Texas El Paso received $422,716 from the NIH to do similar free marketing and

“pilot test a future intervention to promote adoption of the HPV vaccine in the Latino community” while “considering cultural factors.”⁴³

In 2013/2014, Yale University received $390,389 from the NIH to

“identify and describe barriers to HPV vaccination completion among lower income racial and ethnic minorities” and “generate ideas for future interventions that will be culturally relevant and have the greatest potential for impact.”⁴⁴

In 2017 and 2018, NIH (National Cancer Institute) awarded Vanderbilt University Medical Center a total of $1,173,628 to fund a study project entitled

“Increasing HPV Vaccine Uptake in Community-Based Pediatric Practices” for the purpose of identifying “the optimal approach to implementing an evidence-based intervention for the uptake and completion of HPV vaccine among adolescents receiving care in the community, guided by implementation science theory.”

In plain language it means that the NIH grant is being given to a Vanderbilt researcher to develop strategies to sell more Gardasil vaccine. The problem, according to the grant is, “despite clear and indisputable value in cancer prevention, uptake and completion of the HPV vaccine series has lagged far behind the goal of 80%.”⁴⁵

NIH Grants to Universities to Create Ways to Sell More Vaccines

The federal government helping the drug industry to market more vaccines is not limited to Gardasil and HPV vaccines. Another grant, this one to Emory University for $767,107 for fiscal year 2017, targets pregnant women and their children for vaccination using sophisticated sales and marketing techniques.

The Emory grant reads,

“Overall, the proportion of children not receiving all recommended vaccines or whose parents are consistently limiting visit-level vaccine administration is increasing… Additionally, despite evidence showing the effect of vaccinating pregnant women in reducing disease among infants too young to be fully vaccinated, maternal immunization rates remain low.”⁴⁶

Grantees at Emory will explore how to sell more vaccines by using “vaccine champions, expanded reminder-recall systems,” “standardized talking points” and “interactive tablet computer (iPad) education application for pregnant women to view while waiting for care.”

Vaccine hesitancy and refusal is being addressed with a 5-year NIH grant for $1.7 million to Georgetown University researchers working with researchers from University of Georgia, Pennsylvania State and Emory University

“to identify areas of the country where vaccine refusal is on the rise.”

A Georgetown University press release announcing the NIH grant in November 2017, stated,

“With anti-vaccine activists growing in number and influence in recent years, public health professionals have become increasingly interested in identifying where and why people refuse vaccines and how this behavior drives the spread of vaccine-preventable disease.”⁴⁷

Although the CDC tracks rates of vaccine refusal at the state level, the grant will be used to utilize datasets that can track vaccine refusal at the ZIP code level. Georgetown’s lead researcher on the grant commented,

“While there is previous work on what motivates individuals to engage in vaccine hesitancy, we don’t know much about the populations that tend to have higher rates of this behavior. But public health policy is made at the population-level. And our work will help us understand how to design and target effective population-level policies.”

NIH Grant to Study Safety of Childhood Vaccine Schedule

Finally, at least one NIH grant suggests that the federal agency is going to take a look at vaccine safety knowledge gaps associated with the childhood vaccine schedule, which vaccine safety advocates have spoken about for years. Those big gaps in vaccine safety research were highlighted by the Institute of Medicine in a 2013 report, Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence and Future Studies.⁴⁸ Acknowledging that

“a few of the existing studies show that there are cases in which the risk of adverse events depends on the vaccine schedule used,”

NIH has awarded a grant of $392,999 to Harvard Pilgrim Health Care, Inc. to evaluate the safety of the federally recommended childhood vaccine schedule and alternative schedules.

Researchers will evaluate

“the timing of individual vaccines; the timing between doses of the same vaccine; the interaction effect between vaccines and concurrent health conditions or pharmaceutical medications; the interaction effects of different vaccines given on the same day; the ordering of different vaccines; and the effect of cumulative summary metrics such as the total number of vaccines or the total amount of some vaccine ingredient.”⁴⁹

The NIH funded project will also cover

“study designs for the comparative evaluation of the CDC recommended schedule, popular alternative schedules and completely unvaccinated children. Methods will be developed for both adverse events with an early onset, which are the easiest to study, and for adverse events with a late onset, including serious chronic conditions.”

So, while giving the green light to speedy vaccine approvals and aggressively marketing vaccines that yield big profits for drug companies, public health officials know there are outstanding questions about just how safe government recommended vaccines really are for infants and children being required by law to use them. It will be interesting to see if the design of the study funded by NIH and conducted by Harvard Pilgrim Health Care, Inc. will truly qualify as good science the public can trust or turn out to be just another transparent sales pitch that wastes the taxpayer’s money.

References:

¹FDA. Food and Drug Administration Amendments Act (FDAAA) of 2007. DHHS Mar. 29, 2018.
²Ridley DB, Regnier SA. The Commercial Market for Priority Review Vouchers. Health Affairs 2016; 35(5). (Also see Priority Review Vouchers).
³FDA. Priority Review. Jan. 4, 2018.
⁴Polity. Davos: Gates: Speech on creative capitalism. Jan. 25, 2008.
⁵Cáceres M. Gates Foundation Invests in for-Profit Ventures. The Vaccine Reaction Oct.12, 2017.
⁶McCully M. What happened to the value of priority review vouchers (PRV)? Locust Walk Mar. 2, 2017.
⁷Pagliarulo N. Gilead snaps up Sarepta’s priority review voucher for $125M. Biopharmadive Feb. 21, 2017.
⁸FDA. What does the FDA do? July 24, 2018.
⁹Silverman E. FDA wants to nix voucher program for rare pediatric disease drugs. Pharmalot/STAT Mar. 3, 2016
¹⁰Ibid.
¹¹Gaffney A, Mezher M, Brennan Z. Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers. Regulatory Focus (RAPS) July 23, 2018.
¹²FDA. Prescription Drug User Fee Act (PDUFA). July 23, 2018.
¹³Dabrowski A, Thaul S. Prescription Drug User Fee Act (PDUFA): 2017 Reauthorization as PDUFA VI. Congressional Research Service Mar. 16, 2018.
¹⁴Ramsey L, Friedman LF. The government agency in charge of approving drugs gets a surprising amount of money from the companies that make them. Business Insider Aug. 17, 2016.
¹⁵Llamas M. Misplaced Trust: Why FDA Approval Doesn’t Guarantee Drug Safety. Drug Watch July 9, 2018.
¹⁶Merck. FDA grants priority review to Merck’s supplemental biologics license application (SBLA) for GARDASIL®9 in women and men ages 27 to 45 for the prevention of certain HPV-related cancers and diseases. Businesswire June 13, 2018.
¹⁷MedAlerts. HPV4 and HPV9 (Gardasil) Vaccine Adverse Event Reports to VAERS as of June 14, 2018.
¹⁸Palmieri B, Poddighe D et al. Severe somatoform and dysautonomic syndromes after HPV vaccination: case series and review of literature. Immunol Res 2017; 65(1): 106-116.
¹⁹Chandler RE, Juhlin K et al. Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase. Drug Safety 2017; 40:81-90.
²⁰Schofield JR, Hendrickson JE. Autoimmunity, Autonomic Neuropathy, and the HPV Vaccination: A Vulnerable Subpopulation. Clin Pediatr 2018; 57(5): 603-606.
²¹Colafrancesco S, Pericone Ce et al. Human Papilloma Virus Vaccine and Primary Ovarian Failure: Another Facet of the Autoimmune/Inflammatory Syndrome Induced by Adjuvants. Am J Reprod Immunol 2013; 70(4): 309-316.
²²MedAlerts. Search the VAERS Database: HPV2, HPV4, HPV9 vaccine adverse events. July 14 2018.
²³National Vaccine Information Center. Merck’s GARDASIL Not Proven Safe for Little Girls NVIC. NVIC Press Release June 24, 2006.
²⁴Debold V, Downey C, Fisher BL. Human Papilloma Virus Vaccine Safety: Analysis of Vaccine Adverse Events Reporting System Reports (Part 3). National Vaccine Information Center Aug. 14, 2007.
²⁵Mold M, Shardlow E, Exley C. Insight into the cellular fate and toxicity of aluminum adjuvants used in clinically approved human vaccinations. Scientific Reports 2016; 6(31578).
²⁶Sagonowsky E. GSK exits US market with its HPV vaccine Cervarix. Fierce Pharma Oct. 21, 2016.
²⁷The Pharma Letter. US HPV Vaccine Uptake Low Compared to Other Adolescent Vaccines. Feb. 13, 2018.
²⁸Newman PA, Logie CH et al. Parent’s uptake of human papillomavirus vaccines for their children: a systematic review and meta-analysis of observational studies. BMJ Open 2018; 8.
²⁹Reuters. Sanofi sued in France over Gardasil vaccine. Nov. 24, 2013.
³⁰Aoki M. Suit opens in Tokyo court over cervical cancer vaccine side effects. The Japan Times Feb. 13, 2017.
³¹Rosenberg M. Where is the vaccine safety grey area? Epoch Times Jan. 27, 2017.
³²Arbyn M, Xu L et al. Prophylactic vaccination against human papillomavirus to prevent cervical cancer and its precursors. Cochrane Library Database of Systematic Reviews May 9, 2018.
³³Jorgensen L, Gotzsche P, Jefferson T. The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias. BMJ Evidence-Based Medicine July 27, 2018;
³⁴Cochrane. Media coverage of new Cochrane Review on HPV vaccine for cervical cancer prevention in girls and women. May 9, 2018.
³⁵National Vaccine Advisory Committee (NVAC). Strengthening the Effectiveness of National, State and Local Efforts to Improve HPV Vaccination Coverage in the United States: Recommendations from the National Vaccine Advisory Committee. Public Health Reports Aug. 9, 2018.
³⁶Gartland A. Australia rolls out Gardasil 9 amid reports that HPV vaccination is causing death, injury, and infertility. ChangingTimes Oct. 12, 2017.
³⁷Sagonowsky E. Boosted by China Launch, Merck’s Gardasil Turns in Big First Quarter Performance. Fierce Pharma May 8, 2018.
³⁸Liu A.|10 years after a rejection, Merck returns to the FDA with a Gardasil 9 age expansion bid. FiercePharma June 19, 2018.
³⁹CDC. Current CDC Vaccine Price List. July 2, 2018.
⁴⁰Padmanabhan S, Armin T, Sampat B et al. Intellectual Property, Technology Transfer and Developing Country Manufacture of Low-cost HPV vaccines – A Case Study of India. Nature Biotechnology 2010; 28 (7): 671–678.
⁴¹Joshi, PP, Roberts, L. Hann, D. NIH’s Role in Developing an HPV Vaccine: A Retrospective Analysis. Portfolio Analysis Poster Meeting. NIH Division of Program Coordination, Planning and Strategic Initiatives (DPCPSI) July 2014.
⁴²National Institutes of Health. NIH Grant to JA Tiro and AS Baldwin, University of Texas, SW Medical Center. Developing a self-persuasion intervention promoting adolescent HPV vaccination.
⁴³National Institutes of Health. NIH Grant to J Lechuga, University of Texas. Mother-daughter joint decision making to obtain the HPV vaccine.
⁴⁴National Institutes of Health. NIH Grant to LM Nicolai, Yale University. Disparities in HPV vaccine completion: Identifying and quantifying the barriers.
⁴⁵National Institutes of Health. NIH to PC Hull, Vanderbilt University Medical Center. Increasing HPV vaccine uptake in community-based pediatric practices. Project Information History (2017-2018). NIH Research Portfolio Online Reporting Tools (RePORT).
⁴⁶National Institutes of Health. NIH Grant to SB Omer and DA Salmon, Emory University: A Comprehensive Pre-Natal Intervention to Increase Vaccine Coverage.
⁴⁷Georgetown University. NIH Study to Determine If Childhood Disease Rates Higher in Vaccine Refusal Areas. Press Release Nov. 9, 2017.
⁴⁸Institute of Medicine. Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence and Future Studies. Jan. 16, 2013.
⁴⁹National Institutes of Health. NIH Grant to M Kulldorff, Harvard Pilgrim Healthcare, Inc. Methods for Evaluation of Vaccination Schedules.

Category:

Activism, vaccines

Vaccine for Acne Targets Bacteria in the Skin’s Microbiome

https://thevaccinereaction.org/2018/10/vaccine-for-acne-targets-bacteria-in-the-skins-microbiome/

Vaccine for Acne Targets Bacteria in the Skin’s Microbiome

by Rishma Parpia

October 3, 2018

Story Highlights

Current acne treatments such as antibiotics, birth control pills, etc., have largely proven to be ineffective.

A proposed vaccine to treat acne targets toxins secreted by a specific bacteria, P.acnes, which lives on the skin and is a part of the skin’s natural mircobiome.

Concerns have been raised regarding the vaccine because of its potential to disrupt the equilibrium of the skin’s microbiome.

A new study published in the Journal of Investigative Dermatology reports that a group of scientists at the University of California, San Diego are in the process of developing a vaccine to treat acne. According to the American Academy of Dermatology (AAD), acne is a common, non-life threatening skin condition affecting up to 50 million people annually.¹

Acne is generally believed to begin during puberty but can occur at any stage of life. Late onset of acne is becoming increasingly common in women in their 30s, 40s and 50. Treating acne is a $3 billion industry in the United States, which includes everything from topical skin creams, cosmetic products to pharmaceutical drugs; however, current treatments have proved to be ineffective. Researchers are now saying that a new vaccine for acne appears to be promising for the future.²

Vaccine Targets Toxins Secreted from a Bacteria that is A Part of the Skin’s Natural Microbiome

It has long been believed that bacteria play a big role in triggering acne; therefore, antibiotics have always been the go-to treatment for acne. Nevertheless, many people who have used antibiotics for treating acne have found it to be ineffective, which essentially means that killing bacteria is not the answer.³

Past research has discovered that a bacterium known as Propionibacterium acnes (P.acnes) resides in the pores of the skin and releases a toxin known as Christie-Atkins-Munch-Peterson (CAMP) factor, that plays a role in the development of acne.⁴ Instead of targeting pathogens, which most vaccines are designed to do, the new acne vaccine would be the first of its kind to target this specific bacteria (P.acnes) that is already present in abundance on the human skin.⁴

Given that the CAMP factor is believed to be primarily responsible for the inflammation in acne lesions, researchers used mice models and ex vivo human skin cells to test whether they could inhibit inflammation by using antibodies to neutralize the CAMP factor.⁴ The findings suggest that using antibodies against the CAMP factor did in fact reduce the inflammatory response.⁴ Whether these same results can be replicated in human subjects is yet to be determined in future clinical trials.

Concerns Regarding the Effects of the Vaccine on the Skin’s Microbiome

Emmanuel Contassot, PhD at The University of Zurich in Switzerland who also authored an editorial accompanying the study, cautions that while such vaccines could be more effective than current acne treatments, such a vaccine could also be problematic to the skin’s microbiome. He states that,

“acne immunotherapies that target P. acnes-derived factors have to be cautiously designed to avoid unwanted disturbance of the microbiome that guarantees skin homeostasis [self-regulation].”⁵

He goes on to further explain that,

“Targeting P.acnes with a vaccine would be more specific and less toxic than chemical therapies but not all P. acnes bacteria is bad. It’s made up of different strains, and while some cause acne, others are beneficial. If it targets the wrong strains, the vaccine “might worsen patients’ condition by disturbing skin integrity.”³

A Band-Aid Solution to Acne

For such a common skin condition, acne is highly misunderstood and mistreated by health care professionals. Over the last few years, emerging evidence points to environmental factors such as diet, stress, etc., as the root cause of acne and not bacteria and genetics.⁶ Acne is a symptom of an underlying condition in the body that can easily be treated naturally.⁶ Just like many other drugs and vaccines on the market, this proposed vaccine is merely a band-aid solution to a problem that has been observed to be caused by factors that can be corrected without the use of a vaccine and pharmaceutical drugs, thus leading to better health.

This vaccine, yet again, is reflective of a medical model that continues to take on a reactive approach to health care by aggressively using vaccines and pharmaceutical drugs to suppress symptoms without addressing the underlying cause.

References:

¹American Academy of Dermatology. Skin Conditions by the Numbers. Aad.org.
²Wang et al. The Anti-Inflammatory Activities of Propionibacterium acnesCAMP Factor-Targeted Acne Vaccines. Journal of Investigative Dermatology 2018.
³Park A. Why Does Acne Still Exist? The Atlantic June 5, 2013.
⁴On the Horizon: A New Acne Vaccine. Science Daily Aug. 29, 2018.
⁵Cohut M. A New Vaccine Could Wipe Out Acne. Medical News Today Aug. 31, 2018.
⁶Mercola J. The Root Cause of Your Acne Your Doctor Will Never Tell You About. Mercola.com May 31, 2011.

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Activism, vaccines

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