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The GMO Agenda Takes a Menacing Leap Forward with EPA’s Silent Approval of Monsanto/Dow’s RNAi Corn

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Article written by Written by Sayer Ji, founder of Greenmedinfo.com, a reviewer at the International Journal of Human Nutrition and Functional Medicine, Co-founder and CEO of Systome Biomed, Vice Chairman of the Board of the National Health Federation, Steering Committee Member of the Global Non-GMO Foundation

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Without much more than a whisper from the mainstream media, Monsanto’s newest Frankenfood has received full EPA approval and will be arriving on dinner plates by the end of the decade. The implications of this are harrowing, to say the least.

While you may not have made up your mind on the dangers of GMOs, you likely feel entitled to know when you’re consuming a food that is the product of laboratory research. For this reason, I am reporting on Monsanto’s latest food technology, unfortunately, already in the pipeline. And quite silently so. I write this with a certain degree of solemnity, if not also a tinge of regret, because, for three years, I have heard rumblings of Monsanto’s next project – RNA interference technology. It was actually the late Heidi Stevenson, my friend, colleague, and founder of the platform Gaia Health, who first alerted me to the dangers of RNA interference-based tinkering with our food supply when she reported on the near disastrous approval of GMO wheat using RNA interference technology in Australia. Thankfully a few brave scientists and informed public stood up and, together, averted the disaster. But since then, both the dangers and the breakneck speed of development of this technology have gone largely ignored, even among activists deep in the non-GMO movement. In order to truly appreciate the gravity of the situation, and why the EPA’s approval of RNAi corn intended for human consumption, is so concerning, it will first require a little background information on the fascinating topic of non-coding small RNAs, and their formidable relevance to our health.

How Non-Coding, Small RNAs Link Together The Entire Biosphere

One of the most important discoveries of our time is that all plants, including those we use for food and animal feed, contain a wide range of RNA molecules capable of inhibiting gene expression or translation. These non-coding RNA molecules neutralize targeted messenger RNA molecules (mRNAs), which prevents their translation into a protein, i.e. they “silence genes.”

Compelling research has surfaced suggesting that not only do these genome-regulating small RNA molecules exist in our foods, but that they are capable of surviving digestion, and being absorbed into our bodies fully intact where they alter, suppress or silence genes, post-transcriptionally. Moreover, some of these small RNAs — primarily microRNAs (miRNAs) and small interfering RNAs (siRNAs) — are believed to be cross-kingdom mediators of genetic information, making it possible for RNAs in one species impacting many others through both their active and passive exposure to them.

Food therefore is essentially an epigenetic modifier of gene expression, making it a form of information, and not only a source of bodily building blocks and caloric energy, as conventionally understood. As such, any significant changes to food or feed staples within our food chain could have powerful impacts on the physiological fate of those consuming them, essentially rewriting the functionality of our genomic hardware via software like changes in RNA profiles. The entire biosphere, therefore, is held together in a web-like fashion through these molecular RNA messengers, lending a plausible mechanism to the biotic aspect of Lovelock and Margulis’ Gaia theory of Earth as a self-regulating, meta-organism. You can learn more by reading my article Genetic Dark Matter, Return of the Goddess, and the Post-Science Era.

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Monsanto and Co Capitalizing on RNA interference Technology

While this discovery will have profound implications for the field of nutrition and medicine, it has also created enormous interest among biotech and agricultural firms, namely, Monsanto and Dow, looking to capitalize on the design of proprietary products using interference (RNAi) technology. In mid June, last month Monsanto received EPA approval for a type of corn genetically altered to produce an RNA-based pesticidal agent (aka, a plant-incorporated protectant (PIP)) which lethally targets a metabolic pathway within the corn rootworm, known within the industry as the “billion dollar bug.” Branded as Smartstax PRO, the newly minted GMO plant produces a small, double-stranded RNA known as DvSnf7 dsRNA which disrupts a critical gene within the rootworm, causing its death. This was added on top of four other “stacked” GMO traits, such as the ability to produce two other pesticidal proteins (Cry1A.105 and Cry2Ab2), as well as survive exposure to both glyphosate (aka Monsanto’s Roundup 2) and Glufosinate (aka Dow’s Libertylink), highly toxic herbicides. Roundup, for instance, has demonstrated carcinogenicity in the parts per trillion range. Yet, the EPA considers it perfectly safe for consumers to ingest many orders of magnitude higher concentrations than that, proving its function as a cheerleader and not a regulator of the industry that controls our food supply.

The Atlantic, one of the only mainstream news outlets to report on the topic, pointed out how surprisingly low key the approval process was:

“The EPA’s decision attracted little attention from the press or even from environmental groups that reliably come out against new genetically modified crops.”

Bill Freese, The Center for Food Safety’s science policy analyst, told the Atlantic he was caught off guard by EPA’s decision to only allow 15 days of public comment, and the fact that it did not post its decision to the Federal Register, as it customary, especially considering how unprecedented the use of a RNAi insecticide in a plant intended for human consumption is. Monsanto anticipates the new corn will be on the market by the end of the decade.

One would imagine that such revolutionary technology would require short and long-term (decades) of safety testing before licensure. Instead, as is often the case with big-ticket market agendas, the product is being rushed to market. There are already significant biases in place within the EPA and USDA in regard to nucleic acids – assumptions that exempt them from cautionary considerations. RNA is considered Generally Accepted As Safe (GRAS), but this is because it is defined and perceived only as a physical substance rather than as the powerful signaling/informational molecule it is. The EPA’s approval of RNAi food crops ignores the fact that it takes a multi-generational timescale to understand the influence of epigenetic modifiers on the genome of a species, much less the human species, whose timescale is orders of magnitude beyond animal models used to establish much of the risk/benefit data used in pre-approval evaluations. RNAi interference technology promises specificity — one RNAi molecule change equals one gene suppressed — but ignores the virtually infinite possibility of unintended, adverse effects in what are incomprehensibly complex biological systems. Indeed, researchers have warned that RNAi can not only profoundly affect gene expression, but that the changes it induces can permanently alter a species through inherited traits 1:

“Once a silencing effect is initiated, the effect may be inherited. The biochemistry of this process varies depending on the organism and remains an area of active research with many unknown aspects. Nevertheless, it is known for example that human cells can maintain the modifications necessary for TGS, creating actual or potential epigenetic inheritance within tissues and organisms (Hawkins et al., 2009). In some cases the dsRNA pathways induce RNA-dependent DNA methylation and chromatin changes (TGS) that persist through reproduction or cell division, and in other cases the cytoplasmic pathways remain active in descendents (Cogoni and Macino, 2000).”

GM Technology and Unintended Consequences

Indeed, critics of RNA interference technology make the point that RNAi technology aims to target the production of a specific protein by identifying the sequence in question. But two or more genes can have sequence homologies. This means, as applies to the use of RNA interference in medicine, a gene that is targeted to turn off a “disease-causing gene” could have a number of off-target effects, one of which w

Criticisms of RNAi in the agricultural sector are long-standing among the highly informed. For instance, Jonathan Latham, Ph.D. and Allison Wilson, Ph.D., wrote a seminal paper on the topic over a decade ago titled “Off-target effects of plant transgenic RNAi: three mechanisms lead to distinct toxicological and environmental hazards,” wherein 3 of the primary safety concerns are addressed: 1) Off target effects leading to non-specific down-regulation of plant RNAs 2) Off target effects affecting non-target invertebrates feeding on plant material 3) potential effects on mammals. In mammals, long (>30 bp) perfectly duplexed RNAs (such as are typically produced by plant RNAi transgenes) are Pathogen Associated Molecular Patterns (PAMPS) and are consequently highly potent triggers of innate anti-viral defences. The effects of long dsRNAs on mammalian cellular functions are typically profound and extend to complete inhibition of protein translation and cell death. Nevertheless, the implications of such molecules in  the mammalian diet have hardly been tested.

That’s quite a serious list of concerns. As you can see, concern #3 includes the possibility that these dsRNAs may lead to protein translation and cell death. Clearly if the EPA has declared Monsanto and Dow’s new RNAi corn safe for human consumption, they would need to prove this a non-issue.

Monsanto Falling On Their Own ‘Peer-Reviewed’ Sword

Surprisingly, Monsanto itself has produced one of the most damning papers on the topic yet. Several years ago I stumbled upon a study funded by Monsanto that raised a number of red flags for me. Titled, “Endogenous small RNAs in grain: Semi-quantification and sequence homology to human and animal genes,” researchers employed by Monsanto in their St. Louis, MO, laboratory analyzed the presence of endogenous small RNAs in common food and feed staples — soybeans, corn, rice — discovering that hundreds of these plant RNAs had a perfect 100% complementary match to human genes as well as other mammals.

Why is this significant? Endogenous small RNAs, such as small interfering RNAs (siRNAs) and microRNAs (miRNAs), are effector molecules of RNA interference (RNAi), which is a gene suppression mechanism found in plants, mammals, and other eukaryotes. The implication, therefore, of Monsanto’s finding is that plant RNAs — were they capable of surviving digestion and accumulating in target tissues to physiologically relevant concentrations — are capable of epigenetically silencing hundreds of genes within the human body. Below you will find a list of the RNA/gene matches between rice and the human genome:

Despite the abundance of perfect 100% complementarity matches listed above, Monsanto’s conclusion was a conveniently pollyannish dismissal of the safety implications of these findings, stating that:

“The abundance of endogenous small RNA molecules in grain from safely consumed food and feed crops such as soybean, corn, and rice and the homology of a number of these dietary small RNAs to human and animal genomes and transcriptomes establishes a history of safe consumption for dietary small RNAs.” 

While this may be true for traditionally used plants, it does not follow that genetically modified organisms would necessarily be safe because non-GMO versions are. [The pseudo-scientific conceptual ploy of “substantial equivalency behind traditional and GMO cultivars has been the basis for the approval of GMOs since their inception.] Monsanto’s conclusion relates to the fact that it has invested a great amount of resources into developing proprietary RNAi-based organisms which help it to maintain and further expand its monopolizing control on the global food supply.

Additionally, one of their primary justifications for concluding the safety of endogenous plant RNAs on human health was that: “…there does not appear to be any evidence in the scientific literature suggesting that intact RNA is absorbed following ingestion.” This bold claim has been disproven. The Monsanto paper was written in 2008, 3 years before the groundbreaking discovery of Zhang et al published in the Cell Research, entitled,”Exogenous plant MIR168a specifically targets mammalian LDLRAP1: evidence of cross-kingdom regulation by microRNA,” wherein it was demonstrated that human subjects fed rice containing the microRNA MIR168a have measurable amounts of it present in their blood and tissue, and that it binds to the lipoprotein receptor adapter protein in the liver. More succinctly:

“These findings demonstrate that exogenous plant miRNAs in food can regulate the expression of target genes in mammals.”

Since then, a hotly contested debate has ensued, which is understandable, given the increasingly politicized and financially-motivated nature of scientific debate and findings.

Here’s Monsanto’s conclusion about the safety of RNAi-based food technology:

“Based on this evidence it can be concluded that RNAi-mediated regulation of gene expression in biotechnology-derived crops is as safe for food and feed use as conventional crops that harness RNAi-based gene regulation as one of several ways to achieve new plant traits. The safety of future crops generated through applications of RNAi should thus be evaluated for safety using the existing comparative safety assessment paradigm, which has been developed for biotechnology-derived Crops.”

First of all, the “evidence” they are referring to is based on an axiomatic absurdity: equating the absence of evidence with evidence of absence. In other words, you can’t prove this negative: “that a hazard does not exist” because positivistic proof of anything requires that you demonstrating something, not nothing.

Let’s also not overlook the conflict of interest statement at the end of their paper: “All authors are employees of the Monsanto Company. The  Monsanto Company is an agricultural company that produces,” which speaks to Monsanto’s long history of funding science that denies safety risks of their products, such as the Roundup-Cancer link, which now even the California EPA accepts as fact.

The Heart of the Problem

In a seminal paper published in 2016 in Trends in Microbiology, entitled, “How Our Other Genome Controls Our Epi-Genome,” it is proposed that the very RNAs biotech/agrochemical companies like Monsanto and Dow are tinkering with in our food should be reconsidered as part of the definition of our species versus the conventional view that it is just something informationally inert that we eat and exists “out there.” Using a revised version of Da Vinci’s Vitruvian man, as pictured below, they propose that there are 4 inseparable parts of our species: 1) human cells 2) human microbiota and other bacteria 3) Fungi and Viruses 4) Food.

As you can see, because of the interconnectivity and “social networking” functionalities of RNAs packaged in microvesicles called exosomes, all four parts of this new definition of man become united in an indivisible whole. Because these RNAs packed in edible exosomesepigenetically active, the food we eat “literally talks to our mRNA and DNA,” as I have explained in greater detail here:  “Amazing Food Science Discovery: Edible Plants ‘Talk’ To Animal Cells, Promote Healing.”

As we have seen in Monsanto’s own paper on the topic, foods contain hundreds of small RNAs whose 100% complementarity match with human genes imply they can directly impact, and even silence those genes. This silencing is not necessarily “bad,” but it is clear that we are tinkering with a design that we are only just beginning to understand, much less know how to ascertain the risks of and properly regulate. But, considering that Monsanto’s research reveals how intricately connected the human and the food genomes are are — and furthermore, that post-2008 research has surfaced showing Monsanto was wrong and plant RNAs from food do have direct impacts on human genome/epigenome expression — it is highly irresponsible for them to continue to claim that food manipulation technologies will not have unintended, adverse effects in principle. Sadly, with the EPAs approval of four new RNAi forms of corn already completed, and likely many more on the way, we may be stuck with secondary and much slower forms of recourse: post-marketing, epidemiological surveillance of exposed populations, where patterns of disease can take decades if not generations to surface — and then with so many confounding factors at play, not with any certainty.

That said, I believe education and the awareness it generates is our best bet at countermanding the widespread acceptance of this highly experimental and obviously dangerous form of genetic engineering. As has been the case recently with glyphosate being classified as a carcinogen by the California EPA, and a growing mainstream movement to fight the forced feeding of non-labeled GMO laden products (March Against Monsanto), the tides are turning. Please help us spread this information far and wide.

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*This work is reproduced and distributed with permission of GreenMedInfo LLC. Want to learn more from GreenMedInfo? Sign up for the newsletter here: http://www.greenmedinfo.com/greenmed/newsletter

References

Heinemann JA, Agapito-Tenfen SZ, Carman JA. A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments. Environ Int. 2013 May;55:43-55. doi: 10.1016/j.envint.2013.02.010. Epub 2013 Mar 20. PubMed PMID: 23523853.

 

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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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