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New Study Finds A “Wide Range of Devastating Risks” Associated With The HPV Vaccine

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A new study published in Clinical Rheumatology exposes how vaccine manufacturers used phony placebos in clinical trials to conceal a wide range of devastating risks associated with HPV vaccines. Instead of using genuine inert placebos and comparing health impacts over a number of years, as is required for most new drug approvals, Merck and GlaxoSmithKline spiked their placebos with a neurotoxic aluminum adjuvant and cut observation periods to a matter of months.

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Researchers from Mexico’s National Institute of Cardiology pored over 28 studies published through January 2017—16 randomized trials and 12 post-marketing case series—pertaining to the three human papillomavirus (HPV) vaccines currently on the market globally. In their July 2017 peer-reviewed report, the authors, Manuel Martínez-Lavin and Luis Amezcua-Guerra, uncovered evidence of numerous adverse events, including life-threatening injuries, permanent disabilities, hospitalizations and deaths, reported after vaccination with GlaxoSmithKline’s bivalent Cervarix vaccine and Merck’s quadrivalent or nine-valent HPV vaccines (Gardasil and Gardasil 9). Pharmaceutical company scientists routinely dismissed, minimized or concealed those injuries using statistical gimmicks and invalid comparisonsdesigned to diminish their relative significance.

Of the 16 HPV vaccine randomized trials, only two used an inert saline placebo. Ten of the sixteen compared the HPV vaccine against a neurotoxicaluminum adjuvant, and four trials used an already-approved aluminum-containing vaccine as the comparison.

Scientific researchers view double-blind placebo trials as the gold standard for testing new drugs. To minimize bias, investigators randomly assign patients to either a “treatment” group or a “control” (placebo) group and then compare health outcomes. The standard practice is to compare a new drug against a “pharmacologically inert” placebo. To minimize opportunities for bias, neither patients nor researchers know which individuals received the drug and which the placebo. However, in clinical trials of the various HPV vaccines, pharmaceutical researchers avoided this kind of rigor and instead employed sleight-of-hand flimflams to mask the seriousness of vaccine injuries.

Of the 16 HPV vaccine randomized trials, only two used an inert saline placebo. Ten of the sixteen compared the HPV vaccine against a neurotoxic aluminum adjuvant, and four trials used an already-approved aluminum-containing vaccine as the comparison. One does not have to be a scientist to understand that using aluminum-containing placebos is likely to muddy the comparison between the treatment and control groups. Critics of the HPV vaccine have pointed to the aluminum adjuvant as the most likely cause of adverse reactions, and some researchers have questioned the safety of using aluminum adjuvants in vaccines at all, due to their probable role as a contributor to chronic illness. The aluminum-containing placebos appeared to provoke numerous adverse reactions among the presumably unwitting patients who received them, allowing the pharma researchers to mask the cascade of similar adverse reactions among the groups that received the vaccines. Although both placebo and study groups suffered numerous adverse events in these studies, there were minimal differences between the two groups. The similar adverse outcomes in both groups allowed industry researchers and government regulators to claim that the vaccines were perfectly safe, despite manifold disturbing reactions. The Mexican researchers’ meta-review confirms the difficulty of ascertaining vaccine-attributable differences from this mess; the researchers identified only a few indications of “significantly increased systemic adverse events in the HPV vaccine group vs. the control group” across the 16 pre-licensure trials.

The HPV promoters found it more difficult to employ deceptive devices in the 12 post-marketing safety reviews, and the Mexican authors summarize some of the more noteworthy findings. In Spain, they found a ten-fold higher incidence of vaccine-related adverse events following HPV vaccination compared to “other types of vaccines.” In Canada, they found an astonishing one in ten rate of hospital emergency department visits among HPV-vaccinated individuals “within 42 days after immunization.” Still, the industry researchers did what they could to minimize these injuries. The Mexican reviewers criticize the authors of the various post-marketing studies for failing to ask essential questions, to evaluate the many serious adverse events, or to elaborate on their often-troubling findings.

Abbreviated Trial Times

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Typically, FDA requires drug companies seeking approval for a new drug to observe health outcomes in both the placebo and study groups for 4-5 years. Vaccine manufacturers take advantage of FDA regulatory loopholes that allow fast-tracking of vaccines and cut that period down to a few weeks or even a few days. This means that injuries that manifest, or are diagnosed, later in life—most neurodevelopmental disorders, for example—will escape attention entirely.

Further Smokescreens

Martínez-Lavin and Amezcua-Guerra point to clinical trial data posted on the FDA webpagefor the quadrivalent Gardasil vaccine approved in 2006. Those clinical trials deployed a panoply of the kind of cunning deceptions used by industry and government researchers. Unlike many of the other HPV vaccine clinical trials, these clinical studies employed a true saline placebo.

Across the Gardasil clinical studies, a group of 15,706 females ages 9-45 and males ages 9-26 received the quadrivalent Gardasil vaccine. A control group of 594 individuals received an inert saline placebo. The industry researchers never explain the tiny relative size of the saline placebo group; it’s noteworthy that small size would have the effect of keeping unwanted signals weak. But a second control group of 13,023 received a so-called “spiked” placebo loaded with an aluminum adjuvant (amorphous aluminum hydroxyphosphate sulfate or AAHS). The large size of this “spiked placebo” group suggests that the decision to keep the saline placebo group small was strategic.

Putting aside the thorny ethical question of whether study participants were told that they were being injected with a neurotoxin with probable associations with Alzheimer’s, dementia and other forms of brain disease, the inclusion of both saline and aluminum placebos provided these researchers a chance to do some genuine science. But the FDA webpage shows the troubling gimmick that was then employed by the FDA and Merck, which seems deliberately designed to blur datasets in order to mask adverse effects during the clinical trials. The table showing relatively minor injection-site adverse reactions—one to five days post-vaccination—displays three distinct columns for the three groups: Gardasil recipients, the aluminum “placebo” recipients, and saline placebo recipients (see table below). In the table, “Intergroup differences are obvious,” in the words of the Mexican researchers. For example, roughly three and a half times more girls/women experienced injection site swelling in the Gardasil group compared to the saline group (25.4% vs. 7.3%). In fact, by all five measures, both the Gardasil recipients and the aluminum placebo recipients fared two to three times worse than the saline recipients.

When it came time for Merck to report on the occurrence of more serious reactions, “Systemic Adverse Reactions” and “Systemic Autoimmune Disorders,” for example, the company scientists switched to a very different format. In these tables, the third column that reported results for the saline placebo recipients disappears. Instead, Merck combined the groups receiving the spiked aluminum placebo into a single column with the group receiving the genuine saline placebo (see example below). The merger of the two control groups makes it impossible to compare results for Gardasil versus the saline placebo or the aluminum placebo versus the saline placebo. In this way, Merck’s researchers obliterated any hope of creating a meaningful safety comparison.

Risks and Benefits

Given aluminum’s known neurotoxicity and its association with debilitating autoimmune conditions, it is unsurprising that there are no observable differences between the Gardasil and AAHS/saline groups. But, despite the researchers’ efforts to paper over adverse effects, they were not able to conceal the devastating health injuries to their human guinea pigs. The bottom line of these trials reveals a shocking truth: An alarming 2.3% of both their study and control groups had indicators of autoimmune diseases! These data are even more alarming when one considers that the observation period was curtailed after only six months. With this level of risk, it would seem that no loving parents would allow their daughter to receive this vaccine—particularly given the comparatively low risk posed by HPV in countries with appropriate cervical cancer screening tests. Even in countries such as India, where cervical cancer mortality is high due to late detection, leading Indian physicians argue that comprehensive screening should be the country’s top priority rather than the “panacea” of HPV vaccination.

Consider the math: According to the National Institutes of Health (NIH), an estimated 2.4 women per 100,000 die of cervical cancer in the US each year. On the other hand, the FDA’s Table 2 (above) shows that 2.3 per 100 girls and women developed an “incident condition potentially indicative of a systemic autoimmune disorder” after enrolling in the Gardasil clinical trial. It is difficult to understand how any rational regulator could allow more than two in 100 girls to run the risk of acquiring a lifelong autoimmune disorder, particularly when Pap smears are already doing an effective job of identifying cervical abnormalities. The NIH notes that the incidence and death rates for cervical cancer in the US declined by more than 60% after introducing Pap smear screening.

Based on the numerical outcomes of that study, the Mexican researchers calculated the likelihood of being actually “helped or harmed by the 9-valent HPV vaccine.” Their “worrisome” finding is that the “number needed to harm” is just 140, whereas 1757 women would need to receive the vaccine for a single one of them to enjoy its projected benefits.

Martínez-Lavin and Amezcua-Guerra make their own effort to illustrate the zany risk-benefit ratios associated with these vaccines when discussing the results of one of the 16 clinical trials. That study compared approximately 14,000 women who received either Gardasil 9 or the original quadrivalent Gardasil. Based on the numerical outcomes of that study, the Mexican researchers calculated the likelihood of being actually “helped or harmed by the 9-valent HPV vaccine.” Their “worrisome” finding is that the “number needed to harm” is just 140, whereas 1757 women would need to receive the vaccine for a single one of them to enjoy its projected benefits.

Implications for Aluminum Adjuvants

Merck found that astronomical casualty counts were equal among both Gardasil and aluminum “placebo” recipients. The inescapable implication is that aluminum adjuvants may be a principal culprit in the flood of injuries reported for the various HPV vaccines. This conclusion, if true, requires reevaluation of the use of aluminum adjuvants in several other vaccines, including some given to infants. Aluminum adjuvant levels have mushroomed since the 2003 removal of thimerosal from three pediatric vaccines. The following chart, prepared by Dr. Sherri Tenpenny, illustrates the stunning amount of aluminum in vaccines.

Multiple peer-reviewed studies have connected aluminum exposures to a range of autoimmune and neurological disorders, including dementia and Alzheimer’s disease, that have become epidemic coterminous with these aluminum exposures. A review in the European Journal of Clinical Nutrition warns of dangerous accumulation of aluminum in the brain when, as in the case of vaccination, “protective gastrointestinal mechanisms are bypassed.” It’s time to go back to the drawing board on HPV vaccines and aluminum adjuvants. More importantly, FDA needs to start requiring the same rigorous pre-licensing safety testing for vaccines that it has long required for other drugs. All existing vaccines, particularly those containing aluminum, should be safety-reviewed according to these more stringent standards.

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We interviewed Franco DeNicola about what is happening with the shift in consciousness. It turned out to be one of the deepest and most important information we pulled out within an interview.

We explored why things are moving a little more slowly with the shift at times, what is stopping certain solutions from coming forward and the important role we all play.

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Boy or Girl – Baby Gender Selection Issues

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Some parents have the possibility to opt for gender selection; however, being able to decide whether to have a baby boy or girl is a controversial issue.

Many couples expecting a baby do not think it’s a big issue whether they have a boy or a girl; however there are several medical, social, and personal reasons that could influence parents to recur to some form of gender selection.

Like many other controversial practices, the legality of gender selection, also known as sex selection, varies from country to country.

The Legality of Baby Gender Selection

The United States has perhaps some of the most relaxed laws regarding baby gender selection in the world. Most European countries and Australia, on the other hand, have bans on sex selection and only allow it for medical reasons. For example, if a parent is a carrier of a mutation or gene with more chances of manifesting itself in a certain gender, baby gender selection is valid. However, if parents simply wish to balance the ratio of boys and girls in their family, they are not allowed to recur to sex selection.

This has generated a form of medical tourism in which couples from countries where gender selection is illegal, like the UK, travel to the US in order to be able to choose whether to have a baby boy or girl.

On the other hand, sex selection is illegal in the two most populated countries on Earth, China and India. In these countries, baby gender selection has been performed clandestinely for many years and for reasons other than family balancing or avoiding genetic diseases. In these societies, having a baby boy is preferred mainly for cultural and economic reasons. Parents believe that boys have better chances of earning income and eventually support them when they reach an old age.

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Methods of Baby Gender Selection

There are two major types of gender selection methods: the first one is called sperm sorting, and involves separating X-chromosome sperm from Y-chromosome sperm by flow cytometry, a purification technique in which chromosomes are suspended in a stream of sperm and identified by an electronic detector before being separated. Intra-uterine insemination or in-vitro fertilization can then be performed with the enriched sperm. The success rates for this method vary from 80% to 93%.

The other method, called pre-implantation genetic diagnosis, consists in generating several embryos through in-vitro fertilization, which are then genetically tested to determine a baby’s gender. The chosen embryos can then be implanted. This method has a success rate of almost 100%; however, it can be quite expensive, costing up to $15,000.

Issues Regarding Baby Gender Selection

While there are few objections against baby gender selection when it is performed for medical reasons, it has become a highly controversial issue when it is used for balancing the number of boys or girls in families. Some people raise the obvious ethical question of whether people who opt for gender selection are “playing God” by manipulating whether to have a baby boy or girl. Others believe that new parents will raise a baby more appropriately if he or she belongs to their preferred gender.

Gender Imbalance Caused by Baby Gender Selection

Gender selection has caused demographic concern in China and India since it has contributed to generate a gender imbalance in the populations of those countries. In some regions of China, for example, the sex ratio for newborns is 118:100, boys to girls. This phenomenon has in turn been associated with social problems such as an increase in violence and prostitution.

It seems like a logical solution for governments around the globe to legalize baby gender selection but to analyze the personal reasons why each couple intends to select a baby boy or girl. Gender selection for medical reasons should even be encouraged, since it could prevent serious genetic diseases such as cystic fibrosis, Huntington’s disease, and Haemophilia A. Balancing the gender ratio of a family should be accepted if by doing this, a healthy family environment is created. On the other hand, China and India have shown that baby gender selection as a result of a bias towards a particular gender can not only create a gender imbalance in the population, but contribute to social problems as well.

Free Franco DeNicola Screening: The Shift In Consciousness

We interviewed Franco DeNicola about what is happening with the shift in consciousness. It turned out to be one of the deepest and most important information we pulled out within an interview.

We explored why things are moving a little more slowly with the shift at times, what is stopping certain solutions from coming forward and the important role we all play.

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Organic Certification: What the USDA Organic Label Means

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In Brief

  • The Facts:

    Organic and natural labels mean different things, and various types of labels tells you what percentage of ingredients are actually organic. We'll explore what to look for.

  • Reflect On:

    Do you sometimes buy products thinking they are organic or fully natural based on their wording? Have you later found out that those products aren't natural or organic at all? Read labels more closely at grocery stores to be aware.

Don’t get conned by fraudulent claims of “natural” or “organic.” Learn what to look for, and why it’s important, to ensure you’re getting the quality you are paying for.

The industrial age of the 20th century brought about changing agricultural practices that have generated increasing alarm about the effects of these practices on the environment and health. The use of chemical fertilizers and pesticides, antibiotics, hormones, irradiated and genetically altered food and fiber products has created a groundswell of rightful concern. It has led to the growing demand for non-toxic, organic products that many are willing to pay a higher price for to ensure the healthful purity of food and clothing provided for their families.

With such profit opportunities, it’s little wonder that the lucrative organic product market has suffered abuse with so-called “organic” labels being fraudulently placed on products that have not earned the right. As a result of pressure from farming and consumer groups, legislation for the standardization of organic certification was introduced in the 1980s. It has been updated to include more vigorous enforcement and control methods since, with the current standards established in 2002 by the USDA.

The Standards of USDA Organic Certification

Specific standards must be met in order to legally claim a product as USDA certified organic. Organic producers must utilize methods that conserve water, maximize soil health, and reduce air pollution. The specific standards to earn USDA organic certification include:

Free of synthetic chemicals such as insecticides, herbicides, fertilizers, hormones, antibiotics, and additives

Free from irradiation and genetically modified organisms

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Agricultural products grown on land that has been free of prohibited substances for a period of three years

Animals used for meat, eggs, milk or other animal products must be exclusively fed foods that are organically grown, may not be given antibiotics or hormones, and must have access to outdoors.

Clean and sanitized harvesting and processing equipment throughout the process from harvest to finished, packaged product

Detailed chain-of-handling records from the field through final sales

Physical separation of certified organic products from non-organic products throughout the process of production

Regular on-site inspections from USDA-approved inspectors to ensure compliance

Understanding the Certified Organic Label

Once the rigorous process of certification has been completed, organic producers may place the USDA certified organic seal on their products. Currently, there are four levels of certified organic products, with a specific definition of the percentage of organic ingredients the final products contains. They are as follows:

• 100% organic: all production methods and ingredients are USDA certified organic.

• Organic: at least 95% of the production methods and ingredients are USDA certified organic with remaining ingredients included on the National List of allowed ingredients.

• Made With Organic Ingredients: at least 70% of the ingredients are USDA certified organic with remaining ingredients included on the National List of allowed ingredients.

• No organic wording or seal: less than 70% of the ingredients are USDA certified organic and no claims may be made on the front or back of the product.

Manufacturers or producers who knowingly label a product “organic” when it does not meet the USDA standards are subject to fines up to $11,000 per violation.

Why Organic Certification is Important

When you see the official USDA organic certification seal on food, clothing, and bedding products, you can be assured that these products have met the meticulous standards required and are free of chemicals, toxins, antibiotics, and hormones. When you see the USDA certified organic label, you will understand the value of the higher priced organic products as compared to non-organically produced products.

With the current stringent organic certification requirements enforced by regular inspections from USDA accredited agents, the USDA certified organic label has great meaning and importance to the consumer. Look for the label to know that you are getting the quality you are paying for.

Free Franco DeNicola Screening: The Shift In Consciousness

We interviewed Franco DeNicola about what is happening with the shift in consciousness. It turned out to be one of the deepest and most important information we pulled out within an interview.

We explored why things are moving a little more slowly with the shift at times, what is stopping certain solutions from coming forward and the important role we all play.

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WHO Finds Global Lack Of Inactivity Rising Especially In Wealthier Countries — What You Can Do

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In Brief

  • The Facts:

    Inactivity is on the rise and it's the cause of a wide range of health concerns. Our population is only becoming more inactive, not less, and it's time to change that.

  • Reflect On:

    There are many factors of our modern world that make us less active. Our jobs, driving rather than walking/biking, too much screen time. What can you do differently to bring more activity into your life? What story stops you from starting?

The World Health Organization (WHO) estimates that more than a quarter of the entire population on this planet are not getting enough physical exercise, this number has barely improved since 2001. There are many factors that contribute to this, but just how much damage are we doing by failing to be active?

The lack of physical exercise raises the risk of many health problems, such as heart disease, type-2 diabetes and various types of cancers.

Interestingly, according to their study published in The Lancet Global Health, higher income countries, such as the UK, were among the least active population. Women were also found to be more sedentary throughout the world, excluding two regions in Asia.

The study looked at self-reported data on activity levels from 358 population based surveys covering 168 countries and included 1.9 million people.

The populations of higher income countries, which include the UK and USA showed an increase in the proportion of inactive people and had actually risen from 32% in 2001 to 37% in 2016, in the lower income countries it remained at 16%.

Those who were classified as inactive did less than 150 minutes of moderate exercise and around 75 minutes of intense activity per week.

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It was found that women were less active than men overall, except for in South and Central Asia, the Middle East, North Africa and higher-income Western countries. The authors believe that this was caused by a few different factors including extra childcare duties and cultural perspectives that may have made it more difficult for them to exercise.

Why More Inactivity In Wealthier Countries?

According to the researchers, in the wealthier countries, many of the jobs have transitioned to more office or desk jobs, meaning a more sedentary type of lifestyle. On top of that much of the population of these countries drive automobiles or take public transit to and from work which in many cases accounts for a lot of their time.

In the lower income countries, many of the jobs require the people to be more active, are physically demanding and people often have to walk to and from their jobs.

The WHO has had a goal to reduce the global levels of inactivity by 10% by 2025, the authors of the study feel that at the rate we are currently going, this target will be missed.

Lead author of the study, Dr. Regina Guthold said, “Unlike other major global health risks, levels of insufficient physical activity are not falling worldwide, on average, and over a quarter of all adults are not reaching the recommended levels of physical activity for good health.”

Regions with increasing levels of insufficient physical activity are a major concern for public health and the prevention and control of non-communicable diseases.”

Co-author, Dr. Fiona Bull added, “Addressing these inequalities in physical activity levels between men and women will be critical to achieving global activity targets and will require interventions to promote and improve women’s access to opportunities that are safe, affordable and culturally acceptable.”

According to the WHO,

Exercise guidelines for 19- to 64-year-olds

How much?

  • at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity every week
  • strength exercises on two or more days a week that work all the major muscles
  • break up long periods of sitting with light activity

What is moderate aerobic activity?

  • Walking fast, water aerobics, riding a bike on level ground or with a few hills, doubles tennis, pushing a lawn mower, hiking, skateboarding, rollerblading, volleyball, basketball

What counts as vigorous activity?

  • Jogging or running, swimming fast, riding a bike fast or on hills, singles tennis, football, rugby, skipping rope, hockey, aerobics, gymnastics, martial arts

What activities strengthen muscles?

  • lifting weights, working with resistance bands, doing exercises that use your own body weight, such as push-ups and sit-ups, heavy gardening, such as digging and shovelling, yoga

What activities are both aerobic and muscle-strengthening?

  • circuit training, aerobics, running, football, rugby, netball, hockey

Final Thoughts

I was surprised to see that the WHO didn’t touch on inactivity due to too much screen time — watching television, Netflix, Facebook scrolling, messaging, texting, browsing etc. Certainly, the increase in screen time plays a roll with the amount of inactivity, especially in the higher income countries. If you are someone who spends too much time staring at a screen, then it is important to consider the above information. Can you limit your screen time and replace it with something active? Or would you consider jumping rope, or rebounding while watching the television? Our health is our greatest wealth and having awareness about an issue is the first way to create change and take responsibility for our lives.

Could you walk or bike to work instead of drive? What about trying a new sport? Could you commit to adding a few hours each week of physical activity? These small decisions could have a profound impact on your health, longevity and overall well-being.

Much Love

Free Franco DeNicola Screening: The Shift In Consciousness

We interviewed Franco DeNicola about what is happening with the shift in consciousness. It turned out to be one of the deepest and most important information we pulled out within an interview.

We explored why things are moving a little more slowly with the shift at times, what is stopping certain solutions from coming forward and the important role we all play.

Watch the interview here.
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