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New study: Vaccine Manufacturers & FDA Regulators Caught Hiding Risks of HPV Vaccines

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New Documentary: Watch: The Truth about vaccines – bit.ly/2uKN1FO

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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.

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.

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Abbreviated Trial Times

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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The Science Of Healing Trauma With Plant Medicine – Dr. Jeff McNairy Explains

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In Brief

  • The Facts:

    Ayahuasca has assisted thousands of people with an array of mental health disorders. There is real science that can explain how this "medicine" is able to actually change the brain.

  • Reflect On:

    Ayahuasca is not for everyone, and it will not fix you. It might, however, show you what you need to see in order to release what is no longer serving you in life and holding you back.

Over the past decade or so, the use of ayahuasca by western cultures has absolutely blown up. Chances are you’ve either taken it yourself or know someone who has. You may have heard some incredible and transformative stories about how this indigenous plant medicine has assisted many of those struggling with depression, addiction, anxiety and many other ailments.

It has been difficult to explain how this plant actually works to help alleviate symptoms of trauma, and many stick to simply regarding it as a mystical experience that shows you whatever it is that you need to see in order to heal your wounds. However, there is a scientific way to explain what is actually happening within the brain and body when ayahuasca is ingested. Some people with a more logical method of receiving information might prefer to know the actual physical “why” as to what is happening. In the video below, Dr. Jeff McNairy explains this.

Dr. Jeff McNairy is part of the Rythmia family, the world’s first fully licensed medical facility that offers ayahuasca. The entire CE team had the opportunity to go back in 2016 and it was a wonderful experience for us all.

Personally, I have processed a lot of my own trauma with the assistance of this potent plant medicine. It was able to show me things that I hadn’t realized had such a profound impact on my life, things that I had simply written off as unimportant. There were many things that I had stuffed down, locked away and refused to look at over the years that ultimately were the cause for my struggle with depression, addictive behaviours and anxiety. With the assistance of ayahuasca, a light shined on these areas that I had locked away in my subconscious, which helped me to see where healing was still required.

Is Ayahuasca For You?

Whether you are drawn to ayahuasca or not is okay, it’s not for everyone. But if you have a serious desire to uncover more layers of who you are and why you are the way you are, and you’re drawn to this medicine, then it may be for you. Ayahuasca can be a great tool for those who have suffered trauma, but it is important to know that ayahuasca won’t fix you, however it can lead you to understand what it is you need to know in order to fix yourself. It has the capacity to show you whatever it is that you are not seeing from a different perspective, opening your eyes to what you may not have been able to see before.

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It is no coincidence that ayahuasca has emerged within westernized cultures around the globe during this important time of transition. Not only is it assisting people to reconnect back to their soul’s essence, but it is also increasing our regard for our environment and our Mother Earth as a whole.

On another note, here’s an interesting quote from Joe Martino:

Psychedelics were used back in a time when the level of consciousness of the planet was not as high, which helped give insight to shamans so they could share it with their communities. It was meant for use in extreme cases where heavy trauma or addictions existed and people could not use other ways to work through their emotional challenges. Here in present time, we use them in a western fashion as THE GO TO for moving through all of our challenges. I’m here to remind you that you have so much power and ability as a being that in most cases, you don’t need any of these things to evolve. I’m not suggesting don’t do it, I’m simply saying truly ask your heart what you want, and don’t get caught up in the grand allure and peer pressure. (source)

Use Responsibly

It is important to seek out and use ayahuasca that is harvested using sustainable practices and served by shamans who have the utmost respect for the sacred medicinal brew. As its popularity has increased, so has the opportunity to exploit it, so do your due diligence when it comes to determining if ayahuasca is right for you and who will be serving you this medicine.

Related CE Article: Why Psychedelic Drugs Are Not A Shortcut To Enlightenment

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Some Doctors Claim Babies Should Share Their Mother’s Bed Until The Age Of 3

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In Brief

  • The Facts:

    A study involving 16 infants monitored the babies while they slept in their mother's bed. It's not the only study examining the benefits of close contact between mother and child shortly after birth.

  • Reflect On:

    How much of what we do today in a conventional way, especially with regards to childbirth, is the best way to do it?

When it comes to parenting, everyone seems to have an opinion, and rightfully so, especially if you are yourself a parent. But what about controversial topics? Is there a right or wrong way to raise your children? Are there certain things that you should or should not be doing? Of course, some things are more important than others. But new advice given by a paediatrician suggests children should sleep in bed with their mothers until they reach the age of three. 

Dr. Nils Bergman, from the University of Cape Town, South Africa, argues that for optimal development, healthy newborns should sleep on their mother’s chest for at least their first few weeks. After that, he believes they should stay in bed with mom and dad until they are three or even four years old.

Because there has been a lot of fear propaganda created around the risk of cot death — the notion that a parent might roll over and suffocate their child — co-sleeping is generally not advised, and in fact, a recently published British study found that almost two-thirds of the cases of SIDS occurred when the bed was being shared.

But, according to Dr.Bergman, “When babies are smothered and suffer cot deaths, it is not because their mother is present. It is because of other things: toxic fumes, cigarettes, alcohol, big pillows and dangerous toys.”

A study involving 16 infants monitored the babies while they slept in their mother’s bed. It found that the baby’s heart was under three times as much stress when he or she slept alone. While sleeping in a cot, they had a more disrupted sleep and their brains were less likely to cycle and transition between the two types of sleep, called active and quiet.

In the cots, only 6 of the 16 babies had any quiet sleep at all, and their sleep quality was much worse.

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Dr. Bergman continued to explain how changes to the brain that are brought on by stress hormones can actually make it more difficult to form relationships and close bonds later in life.

Another study published in the journal Biological Psychiatry monitored results from 73 premature infants receiving Kangaroo Care, or skin-to-skin contact with their mothers, and another three premature infants received standard incubator care. The subjects of the study were monitored over a 10-year period, and the results were as follows:

KC increased autonomic functioning (respiratory sinus arrhythmia, RSA) and maternal attachment behavior in the postpartum period, reduced maternal anxiety, and enhanced child cognitive development and executive functions from 6 months to 10 years. By 10 years of age, children receiving KC showed attenuated stress response, improved RSA, organized sleep, and better cognitive control. RSA and maternal behavior were dynamically interrelated over time, leading to improved physiology, executive functions, and mother–child reciprocity at 10 years.

The National Childbirth Trust supports bed sharing provided the parents have not been drinking, smoking, or using drugs, or if they are obese, chronically ill, or suffer from chronic exhaustion, all of which could cause them to roll over onto the baby or otherwise impact their health.

Overall, it’s a very controversial issue. Many swear by bed sharing, and it certainly used to be standard practice before cribs became so common and affordable. There are many upsides to this, but it is also important to be aware of and consider the potential dangers.

We all know babies need to be snuggled and cuddled and given love; they need to feel safe and secure, and how could they possibly feel this all alone in another room in a crib? When you actually think about it, it seems pretty backwards.

Every parent is just doing what they feel is best for their baby, but the opinions of others tend to get in the way. We’ve all heard those comments like, Oh you shouldn’t pick up that baby, you need to let them cry, they are going to have attachment issues, how are they going to develop their independence? Well, they are babies; they can’t care for themselves and they need to be taken care of. It is a natural urge for the mother to take care of her child.

What are your thoughts on this? Did you co-sleep with your child? Did you ever feel it was unsafe? Do you prefer your child to sleep in a crib? Let us know!

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Yale Study Reveals 1 in 3 Drugs Have Safety Issues Even After FDA Approval

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In Brief

  • The Facts:

    A study published in the Journal of the American Medical Association conducted by a team of researchers from Yale University discovered that nearly one in three drugs that the that the FDA tests and approves ends up having safety issues.

  • Reflect On:

    Are prescription drugs as safe as they're marketed to be?

In 2014, Harvard University stated that prescription drugs are the 4th leading cause of death, yet pharmaceutical companies continue to hide behind their profits and promote their products as safe. Doctors and even their patients are willing to turn a blind eye to many of the adverse side effects of drugs, opting for the “bandaid” effect they provide instead of seeking alternative treatments and preventative methods.

A study published in the Journal of the American Medical Association and conducted by a team of researchers from Yale University studied the effectiveness of the FDA’s drug approval process. The team discovered that nearly one in three drugs that the FDA tests and approves ends up having safety issues.

Research Finds Serious Issues With FDA Drug Approval Process

In order to establish whether or not pharmaceutical drugs are safe for consumers, the FDA implements drug testing and clinical trials. These trials typically test fewer than 1,000 patients over a short timeframe, usually around six months or less. The Yale researchers suggested that safety issues could only truly be detected if more patients were studied over a longer period of time, speaking to the ineffectiveness of the FDA’s testing.

To identify how to effectively determine any safety issues with pharmaceutical drugs, the Yale researchers studied data on new drugs approved between 2001 and 2010, with follow up through 2017. Their findings proved that approximately 32% of new drugs approved by the FDA had notable safety issues.

A shocking 71 of the 222 drugs approved within this timeframe were withdrawn, had a “black box” warning regarding the side effects, or required a safety announcement to the public about newfound risks. This begs the question: Why are these drugs being approved in the first place if they warrant so many safety concerns?

“That is very rarely a drug withdrawal, but more commonly a black box warning, or drug safety communication issued by the FDA to let physicians and patients know that new safety information has been determined,” explained Associate Professor of Medicine and Public Health Dr. Joseph Ross, who led the research team.

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The researchers also specified characteristics of pharmaceuticals that were more likely to pose a higher risk of safety issues to patients, including biologic therapies and drugs that were approved through the FDA’s accelerated approval pathway. The accelerated approval process often uses surrogate endpoints, which means that the researchers measured a factor other than survival, such as tumour size, to figure out whether the drugs should be approved.

“This [finding on surrogate endpoints] has the greatest relationship to policy today,” Ross further elaborated. “In the 21st Century Cures Act, there’s a push to have the FDA move to further support the use of surrogate markers … [but] they’re more likely to have concerns in the post-market setting.”

“While the administration pushes for less regulation and faster approvals, those decisions have consequences,” Ross stated. The Yale team’s previous studies exposed that the FDA approval process for drugs is much faster than that of other government organizations in Europe, which is interesting given the nature of the business in both countries. Prices of drugs are far higher in America than they are abroad, and Americans take a lot more drugs, meaning U.S. pharmaceutical companies make a lot more money.

The timing of this study is interesting too, as the FDA has been facing increased pressure lately to quicken the drug approval process. “It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up,” said Ross. “At the very least, the study should inform ongoing debate about premarket drug evaluation,” the researchers concluded.

Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, weighed in on the study, commending the researchers for their work. “It’s important to keep in mind that the post-approval safety issues cover the spectrum from relatively minor to serious,” Alexander said.

“A good next step would be to dig into the extremely serious safety problems, determine whether the FDA could have flagged them sooner and how they might have been missed,” he continued.

“All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective,” Alexander explained. “Nothing could be further from the truth. We learn tremendous amounts about a product only once it’s on the market and only after use among a broad population.”

Dr. Alexander makes a great point: Just because a drug is approved by the FDA, doesn’t mean it’s safe. In an ideal world, FDA approval would mean that the drug is entirely safe to use, but the reality is that the testing is not extensive enough to even determine the safety of the drug, let alone guarantee it.

Far too often, people place their doctors and health care practitioners on pedestals and fail to conduct their own research. Though I am not qualified to professionally advise anyone on their health, I certainly do not trust everything that my doctor recommends, which is largely because no doctor knows everything there is to know about health. It’s up to you to figure out your own health, not your doctor.

Though doctors can provide wonderful advice and can help immensely when diagnosing and treating illnesses, they can also drastically hinder your health. However, that’s not necessarily their fault, it’s often yours. The onus is on you to conduct your own research, get multiple professional opinions if need be, and ensure you are making informed decisions.

Further Proof of Misconduct at the FDA

In journalism, embargo refers to a “back-room deal” in which journalists and their sources agree not to publish an article prior to a specific date or time. The FDA goes one step further by implementing a “closely held embargo,” which gifts the organization complete control over all new FDA information privy to exposure for the American public.

The FDA’s use of the “close embargo” reveals that the institution likely wants to prevent reporters from leaking information. The biggest concern seems to be that, when officials begin giving the go-ahead for this special access, it makes it much easier for the agency to prevent stories they don’t like from being exposed.

The FDA hinders the public’s right to know about scientific fraud and misconduct as well. In an article for Slate wrote:

For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

You can read more about that in the following CE article:

FOIA Investigation Unearths Documents Showing How The FDA  Manipulates Media & Science Press

The FDA also works hand-in-hand with pharmaceutical companies, which you can read about in the following CE article:

Merck & The FDA Caught ‘Fast Tracking’ The Approval Of HPV Gardasil Vaccine Without Scientific Approval

To make matters worse, pharmaceutical companies also hold close ties to doctors, which you can learn about here:

This Website Tells You How Much Big Pharma Pays Your Doctor To Prescribe Drugs

To be clear, 128,000 people die every year in the U.S. from drugs prescribed to them, which is being done under the approval of the FDA and doctors. The reality is, drug companies make a lot of money from selling prescriptions, and so do those involved with them, including doctors.

At the end of the day, the medical industry is a booming business, one that thrives off sick people. These companies actually benefit when their drugs cause adverse effects, because they then have additional reasons to sell you even more drugs. The system is designed to help you in one way, and then disadvantage you in another. In essence, they want you healthy, but not too healthy, and until we educate ourselves and take control of our health, we will continue to perpetuate this cycle.

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