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FDA Acknowledged That Vaccine Technology Outpacing Ability to Predict Adverse Events

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 Lyn Redwood, R.N., M.S.N., Executive Director, World Mercury Project

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Recently, top-tier autoimmunity researchers described vaccine safety science as a “hazardous occupation.” In their view, this is because uncompromising vaccine proponents are instantly ready to mount vociferous personal attacks on anyone who raises questions about any aspect of vaccine safety, even if the questions are buttressed by impeccable, high-quality science. Vaccine safety was not always such a taboo topic. In 1961, a leading polio researcher put forth the view in Science that “even after licensing, a new vaccine product must be considered to be on trial” because of the many “new variables” that accompany large-scale vaccine production and rollout.

uncertainties about new vaccine technologies could easily result in a “black box” situation of unforeseen and unpredictable vaccine outcomes.

A leading Food and Drug Administration (FDA) official contended in 1999  that modern advances in vaccine technology were rapidly “outpacing researchers” ability to predict potential vaccine-related adverse events” and argued for closer attention to safety issues from the earliest stages of vaccine development. “One of the important things is that the technology used to make these vaccines actually exceeds the science and technology to understand how these vaccines work and to predict how they will work,” stated Dr. Peter Patriarca, MD, Director of the Viral Products Division of the FDA Center for Biological Evaluation and Research (CBER). “So this has the potential for ending up in a situation which I call a “black box” vaccine” referring to a situation of unforeseen and unpredictable vaccine outcomes.”

Dr. Patriarca also voiced concerns that with live attenuated vaccines “there is the potential for these vaccines, many of which have been poorly characterized to recombine with viruses that may be present in the vaccine.  Some of these viruses are latent and persist for a while, so it is very important to assure that these things are safe before they are given to people.”

In the two decades since the FDA official’s prescient words of warning, numerous published studies have highlighted vaccine safety concerns that were either unexplored or neglected prior to the introduction of the vaccines in question. Troubling issues have included the presence of adventitious agents and contaminants in vaccines and the rise of new allergies associated with synthetic vaccines. Studies also highlight major gaps in the methods, protocols and timelines used to assess vaccine safety.

First rotavirus vaccine debacle

The checkered history of rotavirus vaccines in the U.S. confirms the vital need for new vaccines to remain “on trial” after their launch in the general population. In 1998, the U.S. government licensed the first rotavirus vaccine, RotaShield, a tetravalent live-attenuated vaccine that used a genetically engineered rhesus monkey rotavirus along with three rhesus-human reassortant viruses. Other rhesus-based rotavirus vaccines previously had “failed to prove safe for administration in infants.” According to a detailed account of RotaShield in the Milbank Quarterly, the vaccine’s manufacturer, Wyeth, bragged about the vaccine as one of its “new, breakthrough therapies” and expressed the hope of establishing a large, profitable market in the U.S. as a prelude to marketing RotaShield in developing countries.

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…reports to the Vaccine Adverse Events Reporting System (VAERS) pointed to a substantially increased risk of bowel intussusception, a potentially fatal (though usually rare) condition involving intestinal enfolding and obstruction.

Despite the initial optimism, Wyeth had to commercially withdraw RotaShield one year later, when reports to the Vaccine Adverse Events Reporting System (VAERS) pointed to a substantially increased risk of bowel intussusception, a potentially fatal (though usually rare) condition involving intestinal enfolding and obstruction. For infants in their first year of life, intussusception risks increased 20 to 30 times within two weeks of receiving the first dose of RotaShield.

According to the Milbank Quarterly description, a 1997 pre-licensing regulatory review meeting led by the FDA’s Vaccines and Related Biological Products Advisory Committee had given Wyeth’s hired hand (a university professor) “a minute or two maximum” to discuss intussusception risks. There were “no follow-up questions…and no further discussion…during the remainder of the meeting,” despite the scientist’s expressed concern that “with larger numbers perhaps a causal relationship might emerge.” Nor did attendees consider intussusception at subsequent meetings of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP), where, despite the professor sharing her intussusception data, vaccine cost-effectiveness was the focus of discussion. It was not until an estimated 500,000 children received at least one million doses of RotaShield that the FDA suspended the vaccine, at first temporarily and then permanently, without ever explaining the “precise mechanism” by which RotaShield caused intussusception. Ironically, the government subsequently trumpeted the RotaShield story as proof that “the systems established to detect and respond to vaccine safety concerns are effective.”

The second rotavirus vaccine debacle

Two new genetically engineered oral rotavirus vaccines entered the vaccine marketplace in 2006 and 2008, respectively: RotaTeq, a pentavalent (five-strain) bovine-human reassortant rotavirus vaccine made by Merck, and Rotarix, a live-attenuated single-human-strain rotavirus vaccine manufactured by GlaxoSmithKline (GSK). Although pre-licensure trials found no evidence of an association between the two vaccines and intussusception, post-licensure monitoring later indicated a statistically significant increased risk of intussusception events for all rotavirus vaccines. Unlike with RotaShield, FDA merely instructed Merck, in 2013, and GSK, in 2014, to update their labeling and prescribing information to include brief statements about increased intussusception risks but otherwise allowed the two vaccines to remain on the market.

…the researchers discovered that RotaTeq and Rotarix were contaminated with DNA from two porcine circoviruses—PCV1 (in Rotarix) and both PCV1 and PCV2 (in RotaTeq). Both GSK and Merck later confirmed these findings. The PCV2 pathogen is associated with severe wasting and immunodeficiency in pigs.

Meanwhile, the much-vaunted industry and governmental safety systems that ushered the two rotavirus vaccines to market failed to detect an additional and highly concerning problem, which an academic research team “unexpectedly” identified in 2010. While conducting “a novel, highly sensitive analysis not routinely used for adventitious agent screening,” the researchers discovered that RotaTeq and Rotarix were contaminated with DNA from two porcine circoviruses—PCV1 (in Rotarix) and both PCV1 and PCV2 (in RotaTeq). Both GSK and Merck later confirmed these findings. The PCV2 pathogen is associated with severe wasting and immunodeficiency in pigs.

Although the short- and long-term dangers from PCV1 and PCV2 are as yet unknown, the pioneers of genetic engineering foresaw horizontal gene transfer—the direct uptake and incorporation of genetic material from unrelated species—as a clear risk of genetically engineered vaccines. Unlike chemical pollutants, nucleic acids are infectious and can invade cells and genomes, multiplying, mutating and recombining indefinitely. Potential hazards of horizontal gene transfer include generation of new disease-causing viruses and bacteria (or reactivation of dormant viruses); spread of drug and antibiotic resistance genes among viral and bacterial pathogens; and random insertion into genomes of cells resulting in cancer.

If this contamination had been discovered prior to licensure of the rotavirus vaccines, FDA would not have licensed the vaccines—why should it be any different now?

At issue, in the example of RotaTeq and Rotarix, are the dangers of incorporation of adventitious PCV contaminants from live rotavirus vaccines into the human host or host-related bacteria (such as the gut flora)—dangers unrecognized and, therefore, unexplored before the two vaccines went to market. There is also additional cause for concern based on research demonstrating that the pathogenic potential of PCV2 to cause an AIDS-like disease in pigs is unleashed when there is simultaneous vaccine-induced immune system activation. In light of this research, the current recommendationto administer PCV2-contaminated rotavirus vaccine along with five other vaccines—hepatitis B (HepB), diphtheria-tetanus-acellular pertussis (DTaP), Haemophilus influenzaetype b (Hib), pneumococcal conjugate (PCV) and inactivated poliovirus (IPV)—represents a high-risk scenario for disease in humans. If the contamination had been discovered prior to licensure of the rotavirus vaccines, FDA would not have licensed the vaccines—why should it be any different now?

At a 2010 meeting convened by FDA to discuss the PCV contamination, a GSK executive went so far as to concede that “evolving technologies can lead to new findings that were not known at the time of licensure.” Nonetheless, the GSK researchers expressed little worry, having framed the presence of the PCV DNA in their vaccine as a simple “manufacturing quality issue” rather than a safety risk. GSK even put a positive spin on the matter, suggesting that the PCV investigation “could serve as a model for risk assessment in the event of new technologies identifying adventitious agents in the manufacturing of other vaccines.”

Are unforeseen outcomes inevitable?

Shortly after the GSK discovery, FDA recommended that physicians temporarily suspend use of Rotarix and switch to RotaTeq, but when Merck’s vaccine was found to contain similar contaminants, FDA reversed course and allowed continued use of both. Instead of calling for new safety studies and completing a new risk-benefit analysis (taking into consideration that mortality from rotavirus disease in the U.S. is very low), the FDA once again reassured the public that the benefits of rotavirus vaccination outweighed any “hypothetical” health risks of PCV contamination. The agency’s sole follow-up action was to rubber-stamp updates to the Merck and GSK package inserts to “reflect the presence of Porcine Circovirus Type-1 and -2 DNA in the vaccine[s].”

Can the assertion that the benefits outweigh the risks be taken at face value? Consider the history of the oral polio vaccine, which has used seed stocks contaminated with multiple strains of simian virus 40 (SV40) for over four decades. SV40 has been detected in the brains of deceased cancer patients who received the oral polio vaccine, and a 2002 Institute of Medicine report cited strong biological evidence that SV40 can transform normal cells into malignant cells. Whether the porcine circovirus contamination that afflicts the two current—and highly engineered—rotavirus vaccines will turn out to have insidious long-term health effects remains an unanswered question. Nonetheless, history indicates that we should not be surprised when novel and difficult-to-control vaccine technologies generate unforeseen outcomes.

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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.

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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.

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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.

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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.

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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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