Tag Archives: fda
By: Susan Patterson, The Alternative Daily |
The Food and Drug Administration (FDA), you know that group of good guys that are charged with protecting the health and welfare of Americans, has just approved the first ever genetically modified animal to be sold in American supermarkets. And that is not the worst of it… this Franken-salmon won’t even be labeled. WHAT????
I am so sick and tired of these regulating agencies speaking out of both sides of their mouth. How can they sleep at night making such a decision? How can they be for us when their actions clearly indicate they are for something, anything, other than us?
Here is the mission of this regulating agency, in case you are not familiar with it:
“FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”
We reported in 2013 about AquaBounty Technologies that claims its monster fish are safe to eat. Of course, we were all hoping it would never come to be.
If approved, AquaBounty’s GMO salmon would be the first genetically engineered animal to be sold for human consumption and could appear in restaurants and supermarkets as early 2015.
Farmed salmon are raised in pens in coastal waters along Washington, Maine and British Columbia. The fish being raised are Atlantic salmon and when they escape they will compete with already endangered native stocks. Between 400,000 and 1 million Atlantic salmon have already escaped into the wild from the 75 operations in British Columbia.
A Purdue University study showed that if 60 transgenic fish bred in a population of 60,000 wild fish, the wild fish would be extinct in 40 generations.
“We’ve seen assurances in the past from industry and regulators that there won’t be catastrophic consequences like the Gulf oil spill,” said George Kimbrell, a senior staff attorney for the Center for Food Safety. “We have a cultural amnesia about these things.”
No one gets excited at a genetically raised fish. Why put a different genetic makeup into your body? Some scientists don’t see it this way.
AquaBounty, which calls its super salmon an “advanced hybrid” rather than a transgenic fish, said the fish are safe to eat and would be raised in contained farming operations that could be based inland rather than along coastal waters. And the modified fish, all females, would be sterile so that they couldn’t breed with wild fish if any escaped, the company said.
Very comforting, sterility.
AquaBounty’s fish grow faster but not bigger than normal Atlantic salmon. The company says that genetically modified salmon are identical to regular salmon in every way except for the genes that have been added.
That’s not identical!
The difference between males and females is the Y chromosome. The company has added a growth hormone gene from the Chinook salmon as well as a gene from the ocean pout, a distant relative of the salmon, to a normal Atlantic salmon’s roughly 40,000 genes. Salmon normally feed only during the spring and summer, but when the on-switch from the pout’s gene is triggered, they eat year round.
We have another oil-rig-like catastrophe waiting to happen in our oceans.
The result is a transgenic salmon that grows to market size in about half the time as a normal salmon – 16 to 18 months, rather than three years.
The FDA doesn’t comment on pending applications, though a public hearing on the AquaBounty application could come as early as this fall. Such public hearings can signal the FDA is close to a decision.
How many times has the FDA’s decisions affected the lives of millions of people?
There have been no independent, long-term scientific studies of AquaBounty’s patented salmon. The human health impacts of GMO salmon are not known. The FDA has relied on scant scientific documents provided by AquaBounty itself. In fact, some of the FDA’s own assessment of AquaBounty’s studies to determine whether GMO salmon are safe for human consumption states that the studies contain “technical flaws” and provide “insufficient data.”
For two of the studies submitted, AquaBounty used sample sizes so small that they have no scientific credibility, with only 12 fish tested for one study, while another study on possible allergic reactions in humans involved only 6 fish.
Still, the FDA is currently on the verge of approving the company’s GMO salmon.
What will happen to people who eat the engineered fish over time? How far can genetically manipulated traits impact human health?
Once approved, AquaBounty said it could start marketing the eggs from transgenic salmon within two or three years. The company also is reportedly developing transgenic tilapia and trout. Ask for it in your favorite restaurant.
Once again, unknowing humans will be tested and the product in question will be recalled after many ill effects on humans. But in this case, genetically modified organisms can’t be recalled from the wild.
In 2014, we reported that the two largest national grocery stores, Kroger and Safeway, had announced that they would not sell the salmon should it receive FDA approval. I sure hope that they hold fast to this.
Kroger is the largest grocery chain in the United states, with 2,424 stores nationwide. Safeway follows in second place with 1,406 stores. Many other grocers have publicly stated that they will not sell Frankensalmon, including Target, Meijer, Giant Eagle, Marsh and H-E-B. Three of the first retailers to refuse the salmon were Whole Foods, Trader Joe’s and Aldi, who announced their decisions in July 2013.
To date, over 60 different food retailers have taken a stand against selling GM salmon, totaling over 9,000 stores across the U.S. Additionally, millions of people have protested the FDA’s consideration of the salmon in writing.
The FDA has cotton in its ears
It’s astounding to me that the FDA could turn such a deaf ear to the cries from environmentalists, health officials, researchers and consumer groups. The research just isn’t there to bring any assurance that these monster fish are safe. No one knows the long-term impact of eating genetically modified fish on human health. However, once again… common sense has evaded the FDA — this time in a massive way.
A glimmer of hope: The Center for Food Safety has not let any grass grow under its feet — it has announced it would file a lawsuit challenging the approval.
More Franken-fish to come
There are currently at least 35 other species of GM fish in various stages of engineering — and this is a truly disturbing fact for many people who do not want GMOs in circulation, especially if they are not labeled.
It’s just wrong… my two cents
I believe in Creation… I believe that the natural world was created and that our job is to be stewards of this Creation. However, we continue to mess where we don’t belong, impose our so-called advanced and “good” technology for the betterment of mankind.
If we just left things the way they were meant to be, cared for the land, cared for the plants, cared for the animals, and stopped exploiting the Earth for our desire to be bigger, better and wealthier… we would have enough for everyone. But… we want more and more. Our greedy tendencies drive the desire to rule over a Creation that was made to work harmoniously in partnership with us, to keep delicate ecosystems balanced and humankind healthy.
Why does anyone even think that raping Creation will yield anything more than trouble?
It’s time for the FDA to pull its head out of the sand and do the job it is called to do!
Susan Patterson is the Content Director at The Alternative Daily, a Certified Health Coach, Certified Metabolic Typing Advisor and Master Gardener. With an extensive knowledge of whole foods and wellness, Susan enjoys educating others on how to live healthy and sustainable lives. She presently lives off grid in the middle of the New Mexican high desert with her three children and numerous animals.
True healing and true health are deep concepts which by their very definition imply oneness and unity (the word heal is etymologically derived from various words such as the Old English hælan meaning “to make whole”). True healing includes the many levels within you beyond just the physical – the integration of the emotional, sexual, mental, spiritual and other selves or layers. True healing is far beyond just “managing”, “treating” and “curing” disease, which Big Pharma and its lapdog the FDA like to focus so exclusively upon. Western medicine has its place in society as an excellent tool for specialized surgical or other emergency interventions – however it came into being from the Rockefeller-Big Pharma cartel, whose business model thrives on repeat customers who can’t get off the hamster wheel of drug after drug after drug. On a deeper level, is it really any wonder that Western medicine can’t deliver true healing, when its approach is narrow and materialistic, rather than broad and holistic – when it’s fixated on managing, treating and curing, rather than healing?
Big Pharma and Western Medicine: Hooked on “Treating” Disease
If you’re wondering where the notion of “treating” come from, look no further than the FDA-mandated disclaimer that many natural health and holistic practitioners and companies are forced to use on their products. It states that “this product is not intended to diagnose, treat, cure or prevent any disease” because only a drug can legally make such a claim. And, in a great example of FDA circular logic, if a substance does have an effect on the human body such as preventing or curing a disease – then it must be drug and not a food!
Guess what? The moment something becomes a drug and not a food, it’s regulated differently. If you’re a producer of a food that wants to state its natural effects on the body, now you have to jump through all sorts of expensive hoops just to state the truth. This is despite the fact that scientific studies have shown, for instance, that cherries have a positive effect on gout and arthritis, coconut oil on Alzheimer’s, and turmeric, spirulina, graviola/soursop on cancer. It is an upside-down, outrageous situation where people are being silent about the clear and scientifically provable effects of foods and other natural medicines out of fear of being sued into poverty, taken down or taken out. Ignorant people defend the Big Pharma system by claiming it’s backed by “science”; meanwhile, insiders and experts state categorically that most scientific research is fraudulent, and most science is actually corporate junk science that is paid to produce the results its funders want.
Managing Disease: A Big Pharma Specialty
The truth is that managing disease is a Big Pharma specialty. The most profitable customers are those patients who are going to be reliant on prescription drugs – just to exist – for the rest of their lives. In those cases it’s all about managing disease. How interesting that the word itself management is a very corporate word. Another aspect of the managing of disease is all the unnecessary (but very fancy and impressive sounding) testing that is done to people, under the guise of “early detection”. In his revealing book Confessions of a Medical Heretic, Dr. Robert Mendolsohn quotes an article entitled “Cleveland’s Marvelous Medical Factory” which boasted of the Cleveland Clinic’s “accomplishments last year: 2,980 open-heart operations, 1.3 million laboratory tests, 73,320 electrocardiograms, 7,770 full-body x-ray scans, 24,368 surgical procedures.”
Seems wonderful … except for the very obvious point that none of these procedures has been proven to have anything to do with restoring health or true healing. When people get screened for a disease, they are being subjected to dangerous radiation (more money for the Rockefellers) which harms tissue and can end up causing the exact disease it is supposed to be protecting against – as happens daily with the mammogram scam, designed to drum up new breast cancer clients.
Healing vs. Curing
At this stage you may be thinking: well, Big Pharma and Western medicine do a lot of “managing” and “treating”, but aren’t they also in the business of “curing”? Yes – but even in this case, Western medicine is falling short of the ultimate goal of healing. Curing a disease and healing a disease are different things. As this website Healing Through The Arts states:
“Curing is what medical science attempts to do through medication, treatment and external intervention. It usually is the result of a series of treatments that hopefully lead to an event – the absence of disease.
Healing is an internal process you do for yourself. Healing restores the balance and harmony to the body, mind and spirit. It can be done without a cure. Healing activities are essential when the negative influences of illness, loss or life changes encompass your life.”
The website MindBodyGreen states:
“Curing is a restoration of health, an absence of symptoms, and a remedy of disease. Healing, on the other hand, is a restoration of wholeness — not the level of wholeness before the diagnosis, but a restoration of wholeness that is new, different, and comparatively better than before the onset of disease. Healing is not the removal or cessation of symptoms, but rather an integrative process that transcends the physical and includes mental, emotional, and spiritual vitality and wellness.”
Others have defined curing as the “elimination of all evidence of disease” and healing as “becoming whole”. There are many ways to conceive and verbalize the difference between curing and healing, but the overall point is that healing is a deeper concept which includes the understanding that we are not just physical beings. If we want to attain true health, we must address all the levels of our being. Often a “disease” is merely an outer physical manifestation of a psychological, energetic or spiritual blockage which is taking place at a much deeper level.
Big Pharma has (rightly) been accused of making drugs that just mask symptoms without healing the underling cause. In many cases, they transfer the disease or imbalance from one part of the body to another. From a holistic perspective, this is only minorly helpful or not helpful at all, because as long as you have some imbalance, you’ve still got a health problem you have to deal with. So, even if Big Pharma actually cures your disease, rather than just treating it or managing it, you still aren’t really at a place of true healing, or real health and balance. If the cause of your disease is happening on an energetic level, how can drugs, surgery or radiation ever address it?
Towards True Healing
In conclusion, if you want true healing, look at all aspects of your entire life. Are you indulging in negative thought patterns? Are you involved in toxic relationships? Are you getting the right type, frequency and duration of exercise? Are you sleeping well? Is your lifestyle too sedentary? Are you allowing questionable food items into your diet? How are you dealing with stress? Even if you are doing a good job on most of these, being weak in one of these areas may be enough to throw your system off balance and lead to disease. We’re all on a journey of remembering our true selves, and reclaiming our wholeness through true healing is an inseparable part of it.
Makia Freeman is the editor of The Freedom Articles and senior researcher at ToolsForFreedom.com, writing on many aspects of the global conspiracy, from vaccines to Zionism to false flag operations and more, and also including info on natural health, sovereignty and higher consciousness.
There are over 2,000 studies on the GreenMedInfo database demonstrating the power of turmeric to heal, but this time-tested, safe, and affordable healing substance still has not received FDA approval to “prevent, treat, or cure” disease despite the fact that it is capable of doing exactly that.
One of the greatest if not the greatest triumph of biomedical science today is its role in validating ancient healing modalities that long before the advent of science, and even recorded history itself, were passed down “orally” from generation to generation in the vast body of folkloric medical knowledge that still forms the basis for the majority of the world’s primary health care system. These so-called “natural” or “alternative” modalities, which our species owes its present day survivorship to after eons of dependency on them, are increasingly gaining the attention of men and women in white lab coats intent on unlocking the mysteries of how they work, and in many cases, why they work better than patented, synthetic, chemical-based medications.
No better example of this today exists than turmeric…
Over the course of the past seven years, we have indexed over 2,000 studies investigating the health benefits of turmeric (or its components) in disease prevention and treatment, discovering an astounding 750 different diseases that it may be of value in ameliorating. The complexity of this substance in modulating over 150 biological pathways in the body, simultaneously, in a way that almost invariably produces positive results is simply astounding, and could be interpreted as exemplifying a type of plant intelligence if not also inter-species compassion between the plant and animal kingdoms.
The research continues to pile up, with a new published study added to Medline every few days; as of the writing of this article, there are over 9,000 published studies on the topic. In fact, our database on turmeric has grown so large that it takes an entire server just to load the data for professional members performing dynamic filtering by study type, date, etc.
Our regular followers know we report extensively on the evidence indicating that turmeric, and particularly the golden-hued polyphenol known as curcumin it contains, is superior to a wide range of pharmaceuticals both in safety and effectiveness. Some of the most compelling examples are listed below:
- Alzheimer’s Disease: Turmeric Produces ‘Remarkable’ Recovery in Alzheimer’s Patients
- Antibiotic-Resistant Infection: Could Turmeric Save Us From The CDC’s ‘Nightmare Bacteria’?
- Oral Health: Turmeric Superior to Chemical Mouthwash In Improving Oral Health
- Well-Being Support: Turmeric: A Wellness Promoting Tonic At Low Doses, Research Reveals
- Rheumatoid Arthritis: Turmeric Extract Found Superior To Blockbuster Drug for Rheumatoid Arthritis
- Cancer Malignancy: Turmeric Extract Strikes To The Root Cause of Cancer Malignancy
- Cardiovascular Disease: Turmeric’s Heart-Saving Properties Confirmed In New Diabetes Study
- HPV Infections: Natural Herbal HPV “Cure” Discovered
- Chemical Weapons Injury: Turmeric Compounds Alleviate Chemical Weapons Injury
- Suboptimal Brain Function: Turmeric Extract Improves Brain Function In One Dose
- Ebola Infection: Turmeric Neutralizes Deadly Viral Infections, Study Suggests
This is only a small subset of studies available that demonstrate the exceptional versatility of turmeric (curcumin) in disease prevention and treatment. You can search through more such research on our Turmeric Research database.
Why Turmeric Has Not Received FDA Approval
Considering the sheer density of data available today to support the health promoting effects of this safe and time-tested culinary ingredient, you would think the government would allow its use to “prevent, treat, or cure disease” — the technical criteria for something to be defined as a legitimate “drug” by the FDA. Indeed, the FDA mission statement includes the following objective:
FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.”
When something so safe, so affordable, so thoroughly time-tested across a multitude of cultures, has so much evidence behind it demonstrating its ability to alleviate suffering, isn’t it highly unethical not to use it, especially in cases where conventional treatments fail?
Sadly, the FDA requires prohibitively expensive clinical trials to be conducted in order to grant the legal right for the populace to be treated by medicinal substances of any kind. In fact, the average FDA-approved drug on the market today required between four to eleven billion dollars in capital to be invested on the front-end. Non-patented substances, no matter how well they work to produce positive health outcomes, are obviously not capable of producing a return on investment as they grant no market exclusivity. Economic considerations (i.e. profit motives), therefore, are the primary reason why natural medicine is still only being practiced outside the medical industrial establishment’s mile high walls.
How did we arrive at this clearly cognitively dissonant place in time? I addressed some of these issues in a previous article, Why The Law Forbids The Medicinal Use of Natural Substances,” looking at one of the historical roots of the impasse:
It is an interesting footnote in history that shortly after the Declaration of Independence, Congress declared that natural substances, e.g. water or salt, were God’s gift to mankind and that therefore products of nature should be limited in their patent protection. While this was a noble declaration, it has actually been used against those whose rights it would protect. It has forced private interests to synthetically alter natural substances — for instance the burgeoning biotech field of recombinant DNA technology, i.e. genetically modified organisms (GMOs) — for the sole reason that it guarantees them ownership/patent rights.”
And so, because natural substances are a God-given gift [insert the word “Nature-given” if you prefer], freely available without adulteration to be used to treat and even cure disease, the medical system — whose present day focus is profiting off of disease instead of alleviating suffering — goes out of its way to avoid their use, even ostracizing and/or punishing those medical professionals who do incorporate their use in their practice. Likewise, capitalized pharmaceutical interests tinker with natural lead compounds to alter them in such a way that they are converted into xenobiotic chemicals, virtually guaranteeing their toxicity, and making their subsequent FDA drug approval as a novel patentable chemical compound the equivalent of the kiss of death.
This situation has created a great rift between those who believe the government should have the authority to tell us what we can and cannot do medically speaking, and those who believe it is our inborn right to choose food or natural substances to prevent or treat disease regardless of what the state deems legal. Obviously, I stand on the side of health freedom. As long as what you choose to do for yourself does no harm to anyone else, that right to choose should be considered inviolable and sacrosanct. Truth be told, turmeric harms no one but the bottom of line of drug companies. Ultimately it is highly unethical for the medical establishment to pay lip service to evidence-based medicine, and turn a blind eye to the accumulating research that this spice, and the 1,700 other natural substances we have indexed on our database, have no legitimate value as treatments for the wide range of ailments that now plague members of our society.
To learn more about my philosophy of medicine and nutrition, check out my upcoming appearance in 8 of 9 episodes of the Truth about Cancer, where I will be covering this and many other topics which you may find helpful. Register for free access to this event here.
Article Contributed by Sayer Ji, Founder of GreenMedInfo.com.
Sayer Ji is an author, researcher, lecturer, and advisory board member of the National Health Federation. He founded Greenmedinfo.com in 2008 in order to provide the world an open access, evidence-based resource supporting natural and integrative modalities. It is internationally recognized as the largest and most widely referenced health resource of its kind.
You’ve heard it over and over again from Monsanto’s public relations machine: GMOs have been thoroughly tested and proven safe.
You know it isn’t true. But unfortunately, many people—and many U.S. lawmakers—have heard only that side of the story. And they’ve heard it so often it’s engrained in their psyches.
It’s up to us to counter Monsanto’s message. In the media. In meetings with Congress members. In phone calls and emails to Congress members.
Thankfully, Steven M. Druker, executive director of the Alliance for Bio-Integrity and author of “Altered Genes, Twisted Truth, How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public,” has made it easier for you to become a messenger of the truth. Druker has taken key points from his 528-page book and created a short 30-point argument for why the U.S. Food & Drug Administration’s decision to allow GMO foods, untested and unlabeled, into the marketplace was fraudulent and illegal. Druker says:
In reality, FDA decision-makers disregarded the input of the agency’s own scientists, covered up their warnings about the risks, lied about the facts and, despite pretensions to the contrary, have failed to conduct any genuine scientific reviews at all (a fact even acknowledged by FDA officials). Without such frauds, GE foods could never have come to market; and they could not remain there if the frauds became widely known. Moreover, the FDA’s policy on GE foods violates federal food safety law, and these novel products are on the market illegally.
Read Druker’s 30-point argument
Order “Altered Genes, Twisted Truth, How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public”
The FDA has been on a crusade against natural medicine that has spanned decades. Their skepticism and perhaps disdain for natural medicine could simply be because, at the moment, they are untouchable. In 1938, a U.S. senator (and homeopath) named Royal Copeland passed a law classifying homeopathic treatments as drugs. Since then, these products are deemed wholly natural and cannot be patented or regulated in any way, thus acting as a thorn in side for the FDA.
In fact, under the law, the FDA is required to regulate homeopathic remedies as drugs, but at the same time acknowledges that there is no evidence showing that homeopathy works. As such, you can expect that the vast majority of scientists and mainstream healthcare practitioners to never get behind the idea that natural medicine (essential oils, herbal tinctures, teas, etc.) as being a type of medical treatment in any form. Although there have been studies done on natural medicine in Australia, Britain and the United States that found little evidence that homeopathic remedies work, many believe more studies have not been performed because of the patents. Since natural medicine cannot be patented, drug companies will not waste their money studying them which truly limits our understanding of how powerful they could be.
Changes Are On the Horizon
Historically, regulators have generally looked the other way. Since 1988, the FDA allowed remedies to be sold, however, they needed to meet certain FDA manufacturing guidelines and can be marketed over the counter only for “self-limiting” conditions, meaning illnesses like colds that go away on their own. But changes are on the horizon, with the an increase in homeopathy and natural medicine popularity, the FDA has decided to reevaluate their stance on this subject and look into a regulatory processes, and would look into whether consumers “have adequate information to make informed decisions” about such remedies.
“That stance may be poised to change: The Food and Drug Administration (FDA) is this week holding a public meeting to evaluate “whether and how to adjust the current enforcement policies” to keep up with the growing homeopathic industry and a corresponding increase in safety problems. Since 2009, the FDA has sent nearly 40 warning notices to homeopathic manufacturers and has overseen three recalls. Pulled products include zinc cold remedies that caused people to lose their sense of smell and “teething tablets” with toxic levels of the plant belladonna.”
Whether or not you believe natural medicine is pure or just snake oil masked behind a marketable term, the FDA wants to make big changes and it can affect you.
Tess Pennington is the editor for ReadyNutrition.com. After joining the Dallas chapter of the American Red Cross in 1999, Tess worked as an Armed Forces Emergency Services Center specialist and is well versed in emergency and disaster management and response. Tess is the author of The Prepper’s Cookbook: 300 Recipes to Turn Your Emergency Food into Nutritious, Delicious, Life-Saving Meals. When a catastrophic collapse cripples society, grocery store shelves will empty within days. But by following Tess’s tips for stocking, organizing, and maintaining a proper emergency food supply, your family will have plenty to eat for weeks, months, or even years.
By: Jon Rappaport | No More Fake News –
There are several reasons why the medical cartel is too big to fail: the enormous amount of money at stake; its aim to control populations.
In this article, I want to examine a related reason.
Suppose it was discovered that thousands of bridges around the US were in imminent danger of collapsing? Not because maintenance and repair were lacking, not because the materials used to build them were cheap and shoddy. But because the original designs were inadequate and broke basic rules of engineering.
Suppose five or six major manufacturers built their automobiles so the vast majority of power derived from the engines was transferred to one wheel?
Suppose the US Dept. of Agriculture recommended that all farmers spray their crops with heavy chlorine instead of water?
In other words, the science itself is fraudulent.
This revelation, above all, is what the medical cartel tries to guard against. Their profession has shoved in all its chips on the propaganda proposition that it does impeccable science.
Science sells. The appearance of it sells. It’s the foundation stone of many industries.
Were that stone to crack and shatter, all bets would be off. A titanic fraud would come to light. The kind of fraud that would both freeze people’s minds and blow them away.
Science is the most powerful rationalization in the modern world. Consensus reality would fail and disperse without it.
As I’ve covered before, the most conservative mainstream estimate of medically caused death in America is 225,000 people per year. Every credential behind that figure is immaculate.
The author of the paper that presented the statistics was the late Dr. Barbara Starfield, a revered public health expert who worked for many years at the Johns Hopkins School of Public Health.
Her review, “Is US health the best in the world?”, was published on July 26th, 2000, in the Journal of the American Medical Association.
Starfield’s breakdown was as follows: the medical system kills 119,000 people a year in the US as a result of maltreatment in hospitals. The other 106,000 people are killed by FDA-approved medicines.
The FDA must approve every drug as safe and effective before it is released for public use.
It’s the medicines I want to focus on in this article. 106,000 deaths a year translates to an astonishing 1,060,000 deaths per decade.
How are these drugs approved?
Clinical trials are conducted. Reports of those trials are written. The reports, the studies, are published in peer-reviewed medical journals. The studies ARE the science.
If a million people per decade are being killed by the drugs, then a huge number of published studies proclaiming the drugs are safe are sheer fraud. There is no other way to put it.
This statement from Marcia Angell, former editor of the New England Journal of Medicine, echoes the fact:
“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”
(Marcia Angell, MD, The New York Review of Books, January 15, 2009, “Drug Companies & Doctors: A Story of Corruption”)
The medical cartel rests on cataclysmic fraud, scientific fraud.
Imagine what would happen if just one major media outlet decided to take on this story and push it for all it’s worth. Not merely an article or two—an ongoing campaign of relentless exposure.
The silence from that quarter speaks volumes about the controlled press and what it stands for.
Over the years, I’ve written much about the the FDA. I thought I’d assemble a small fraction of it in one place, to reveal what this federal agency is really all about and why it should be dismantled, amid a blizzard of prosecutions and convictions for negligent homicide and, yes, murder.
the drugs it certifies as safe have been killing Americans, at the rate of 100,000 per year.
The FDA website page is available under the heading, “Why Learn About Adverse Drug Reactions.” You can search for it using the Startpage.com search engine.
The FDA takes no blame, no responsibility for its own actions, and yet it admits the death statistics are accurate.
Understand this very clearly. No medical drug in America can be released for public use until and unless the FDA states it is safe. The FDA is the agency that makes every such decision on every drug. The buck stops there.
Yes, the FDA has a “special relationship” with the pharmaceutical industry. Yes, the FDA utilizes doctors on their drug-approval panels that have ties to the pharmaceutical industry. But, in the end, it is the FDA official seal that opens the gate and permits a drug to be prescribed by doctors and sold in the US.
In all my research on this medical-drug holocaust, I have never found a case in which any FDA employee was censured, fired, or criminally prosecuted for the killing effects of these drugs.
That is a track record Organized Crime would be proud of, and the comparison is not frivolous.
On this FDA website page, the FDA also readily admits that medical drugs are the fourth leading cause of death in America, ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents, and automobile fatalities.
The FDA website page also states there are 2 million serious adverse reactions (ADRs) from the ingestion of medical drugs, annually, in the US. That would be 20 million ADRs per decade.
When the FDA says “serious,” they aren’t talking about headaches or slight dizziness or temporary nausea. “Serious” means stroke, heart attack, neurological damage; destruction of that magnitude.
Examining these figures for death and debilitation, can you find any comparable documented crime in the American landscape? This is the kind of story that would make Watergate look like a Sunday-school picnic.
If a paper like the New York Times let loose their hounds to relentlessly explore the horror, I assure you that, in time, doctors and medical bureaucrats and even drug-company employees would come out of the woodwork with confessions, and the resultant explosions and outcries would shake the medical/pharmaceutical foundations of America and the planet.
It would shake and destroy the SCIENCE.
But these major media outlets are an intrinsic part of the Matrix that protects and sustains the crimes and the criminals. It isn’t just drug-advertising profits that keep the leading newspapers and television networks silent. It’s collusion to protect “a revered institution”—the medical system.
Also at stake is Obamacare. The connection is vivid and unmistakable. Millions more Americans, previously uninsured, will be drawn into the system and subjected to the very drugs are killing and maiming people at such a horrific rate.
Where has the US Department of Justice been all these years? Is there any way, under the sun, that a million deaths per decade can be excused? Is there any way the FDA and the drug companies can float safely in the upper atmosphere of privilege, while the concept of justice retains any meaning? Where are criminal prosecutions?
Meanwhile, the FDA pursues an agenda of attacking nutritional supplements, and the latest federal regulations classify these supplements as “potentially dangerous”—despite the fact that supplements have a record of safety that is astonishing.
It is time for the public to realize that 100,000 people dying every year in the US, because they take medical drugs, is the equivalent of 33 airliner crashes into the Twin Towers, every year, year after year.
If you were a medical reporter for a major media outlet in the US, and you knew the above fact, wouldn’t you make it a priority to say something, write something, do something?
And with that, let’s get to another smoking gun. The citation is: BMJ June 7, 2012 (BMJ 2012:344:e3989), Anticoagulants cause the most serious adverse events, finds US analysis. Author, Jeanne Lenzer.
Lenzer refers to a report by the Institute for Safe Medication Practices:
“It calculated that in 2011 prescription drugs were associated with two to four million people in the US experiencing ‘serious, disabling, or fatal injuries, including 128,000 deaths.’”
The report called this “one of the most significant perils to humans resulting from human activity.”
And here is the final dagger. The report was compiled by outside researchers who went into the FDA’s own database of “serious adverse [medical-drug] events.”
Therefore, to say the FDA isn’t aware of this finding would be absurd. The FDA knows.
Since the Department of Homeland Security is working its way into every nook and corner of American life, hyper-extending its mandate to protect all of us from everything, maybe DHS should stop tracking every move we make and simply raid and arrest all employees of the FDA as terrorists. The details could be sorted out later.
How many smoking guns do we need before a sitting president shuts down the FDA buildings, fumigates them, and builds a monument to dead Americans the FDA has driven into their graves?
Do we need 100,000 smoking guns? Do we need relatives of the people who’ve all died, in the span of, say, merely a year, from the poisonous effects of FDA-approved medical drugs, to bring their corpses and coffins to the doors of FDA headquarters?
And let me ask another question. If instead of drugs like warfarin, dabigatran, levofloxacin, carboplatin, and lisinopril (the five leading killers in the FDA database), the 100,000 deaths per year were led by gingko, ginseng, vitamin D, niacin, and raw milk, what do you think would happen?
I’ll tell you what would happen. SEALS, Delta Force, DHS-HSI SRT, SWAT teams, snipers, predator drones, tanks, and infantry would be attacking every health-food store in America. The resulting fatalities would be written off as necessary collateral damage in the fight to keep America safe and healthy.
BTW, who are the video editing specialists that DHS hired to ‘sex up’ this video?
But you see, the routine deaths of 100,000 Americans a year, after the FDA has certified the drugs are SAFE, isn’t a “recognized political issue.”
Such is the power of the medical cartel. All those phony stories in the press, reported dutifully by so-called medical reporters? The stories about maybe-could-be-possible-miracle breakthroughs just over the horizon of state-of-the-art research? Those stories are there to obscure the very, very hard facts of medically-caused death on the ground.
The buck stops at the FDA.
Imagine this. You go to an FBI web page and read the following: “Killings committed by FBI agents are the third leading cause of death in America every year.”
Yet somehow, the FDA gets away with its crimes, its homicides. There are no alarm bells, no arrests, no hearings, no public statements, no press reactions, no shakeups at the Agency.
The power of the medical cartel is gigantic.
When I was running for a Congressional seat from the 29th District of California, in 1994, and during my participation in the Health Freedom movement of that period, I insisted we had to take the attack to the FDA. We had to make their crimes public.
I was told by the people who were leading the charge for Health Freedom that priority had to be given to passing a law that would protect us all from attacks on nutritional supplements. Then, when we had that law, we could think about going after the FDA.
Well, we got the law, which only gave us temporary protection, and afterward there was no “going after the FDA.” It was suddenly a dead issue.
I remember the people who said, “Don’t attack the FDA.” I remember their attitudes, their faces, their words. They were not my friends, and they weren’t your friends. Some of them were yuppies selling “let’s be nice” New Age sentiment. A few were most likely plants who had infiltrated the Health Freedom movement to water it down.
Various liars sell their lies through various strategies.
I assure you, there are doctors out there who know the statistics on medically caused death in the US. They know about the drugs that kill. They know what’s going on. They know the FDA is accountable. They remain silent. They feel no pressure to make a public statement. They’re living under the umbrella of protection provided by the government and the press and the medical system.
These doctors are silent witnesses to ongoing mass murder. Just as the FDA is a silent witness to its own mass-murdering practices. And of course, the doctors write the prescriptions for the drugs.
Obama, Bush, Clinton; none of these men have indicated the slightest awareness of the “problem.” Did they know? Do they know? Just as I predicted, correctly, that the FDA knows, I say these men do know. They prefer to remain silent as well. They don’t want to touch this genocidal crime. They don’t have the character or the courage.
Presidents and deans of medical schools know. Teachers at these schools know. Pharmaceutical executives know. Medical researchers know. The CDC knows. The World Health Organization knows. Editors and reporters at major press outlets know. The DEA knows. The US Dept. of Justice knows.
As far as the public is concerned, a matrix of hypnotic effect and cognitive dissonance is the obstacle. People find it extremely difficult to believe that a federal agency, in broad daylight, year after year, countenances and sustains the unnecessary deaths of 100,000 people.
People find it extremely difficult to believe that, were such a story true, they would not have heard about it already.
People want to believe that a crime of this boggling magnitude would already have been prosecuted to the full extent of the law.
People want to believe the secular religion known as Medicine is devoted to healing in all its forms.
People want to believe that, since doctors can put accident victims back together in one piece and can set broken bones and temporarily reduce inflammation, the practice of medicine must be uniformly successful across the board.
People want to believe in SCIENCE.
In a stunning 2012 interview with Truthout’s Martha Rosenberg, former FDA drug reviewer, Ronald Cavanagh, exposed the FDA as a relentless criminal mafia protecting its client, Big Pharma, with a host of mob strategies.
Cavanagh: “…widespread [FDA] racketeering, including witness tampering and witness retaliation.”
“I was threatened with prison.”
“One [FDA] manager threatened my children…I was afraid that I could be killed for talking to Congress and criminal investigators.”
Cavanagh reviewed new drug applications made to the FDA by pharmaceutical companies. He was one of the holdouts at the Agency who insisted the drugs had to be safe and effective before being released to the public.
But honest appraisal wasn’t part of the FDA culture, and Cavanagh swam against the tide, until he realized his life and the life of his children was on the line.
What was his covert task at the FDA? “Drug reviewers were clearly told not to question drug companies and that our job was to approve drugs.” In other words, rubber stamp them. Say the drugs were safe and effective when they were not.
Cavanagh’s recalls a meeting where a drug-company representative flat-out stated that his company had paid the FDA for a new-drug approval. Paid for it. As in bribe.
He remarks that the drug pyridostigmine, given to US troops to prevent the effects of nerve gas, “actually increased the lethality” of certain nerve agents.
Cavanagh recalls being given records of safety data on a drug—and then his bosses told him which sections not to read. Obviously, they knew the drug was dangerous and they knew exactly where, in the reports, that fact would be revealed.
As I mentioned above, the original study-review on medically caused death in America was written by Dr. Barbara Starfield and published in the Journal of the American Medical Association.
Three years ago, shortly before her death, I interviewed Dr. Starfield. I asked her whether any government agency had ever contacted her about her findings, in the nine years since publication
“No,” she said.
I asked her whether she was aware of any federal agency undertaking action to remedy the horrific killing effects of the US medical system.
“No,” she said.
Try this image: you are a gatekeeper. Your job, on the first day of every year, is to unlock the gate and leave it open, so people can pass through. But you know that, when you open the gate, 100,000 people who pass through will die in the following year. Yet, every January 1, you keep opening the gate.
That’s what the FDA is. That particular gatekeeper.
But of course, the people at the FDA are just like us. They wouldn’t do THAT, they wouldn’t do THAT, they wouldn’t do that…
But they did. They do. They continue to do it.
Jon Rappoport is the author of three explosive collections, THE MATRIX REVEALED, EXIT FROM THE MATRIX, and POWER OUTSIDE THE MATRIX, Jon was a candidate for a US Congressional seat in the 29th District of California. He maintains a consulting practice for private clients, the purpose of which is the expansion of personal creative power. Nominated for a Pulitzer Prize, he has worked as an investigative reporter for 30 years, writing articles on politics, medicine, and health for CBS Healthwatch, LA Weekly, Spin Magazine, Stern, and other newspapers and magazines in the US and Europe. Jon has delivered lectures and seminars on global politics, health, logic, and creative power to audiences around the world. You can sign up for his free emails at NoMoreFakeNews.com or OutsideTheRealityMachine.
Original article: https://jonrappoport.wordpress.com/2015/04/19/the-medical-cartel-too-big-to-fail-too-evil-to-expose-2/
According to the FDA’s legal definition, a drug is anything that “diagnoses, cures, mitigates, treats, or prevents a disease.”
The problem with this definition is that there are numerous substances, as readily available and benign as found on our spice racks, which have been proven by countless millennia of human experience to mitigate, prevent and in some cases cure disease, and which cannot be called drugs according to the FDA.
How can this be? Well, the FDA has assumed for itself Godlike power, requiring that its official approval be obtained before any substance can legally be used in the prevention and treatment of disease.
The FDA’s legal-regulatory control therefore is totalitarian and Napoleonic in construct; what it does not explicitly permit as a medicine is implicitly forbidden.
Historically the FDA has required new drugs undergo expensive and elaborate multi-phased clinical trials, which are out of the grasp of any ordinary interest who might want to demonstrate the efficacy of a non-patentable (and therefore unprofitable) herb, food or spice.
The average out-of-pocket cost for obtaining a new drug approval is US$ 802 million dollars, and therefore an investor putting capital into bringing to market a substance that does not lend itself to market exclusivity and therefore cannot produce a return on investment, is committing economic suicide, if not also breaking the law. The investor actually has a legally-binding fiduciary responsibility to its shareholders to make a profit. And therefore, capital will not flow into any would-be commodity that can be produced or obtained with ease, including most things that grow freely on this Earth.
It is an interesting footnote in history that shortly after the Declaration of Independence, Congress declared that natural substances, e.g. water or salt, were God’s gift to mankind and that therefore products of nature should be limited in their patent protection. While this was a noble declaration, it has actually been used against those whose rights it would protect. It has forced private interests to synthetically alter natural substances — for instance the burgeoning biotech field of recombinant DNA technology, i.e. genetically modified organisms (GMOs) — for the sole reason that it guarantees them ownership/patent rights.
In fact, a medical system that legally requires it make a profit threatens to destroy and/or incriminate itself if non-patented, non-profitable natural substances or therapies are employed. It also results in so much collateral damage to those it purports to serve that it could rightly be called a modern form of human sacrifice.
As a result, instead of choosing prospective medicines logically: because they work, are easily accessible, and safe, billions of dollars flow in the exact opposite direction, capitalizing only those substances which are unnatural, and therefore while proprietary are almost invariably unsafe, and whose access and administration can be intensively controlled.
Has The Attempt To Co-opt Medicine Through the Drug-Based Model Undone Itself?
And yet, there is a silver lining to the story. Due to the fact that our bodies are ultimately constructed from the natural things (food, air and water), and obey very strict natural laws such as the well-known principle of chirality (handedness) – the fact that all amino acids in our body turn a beam of polarized light in the left-handed direction (L-lysine) and sugars to the right-handed direction (D-ribose)– one cannot simply create biologically active, synthetic drugs arbitrarily, as a mistake in handedness (or similar property) could be fatal. Nature, therefore, still provides an elegant biomolecular architecture of irreproducible intelligence and complexity, from which synthetic analogs are modeled and/or derivatives are spun.
As a result, billions of dollars of drug industry and government money (i.e. tax payer money) flow into finding lead compounds for drug development. Nature is put on the rack, if you will, and her secrets teased from her through innumerable animal and test tube experiments, in order to find compounds that can then be converted into synthetic, patented drugs.
Inadvertently, some of the very same companies and interests which require that natural substances not receive the same drug-approval status as synthetic ones, are funding research that prove basic vitamins, foods and spices are as effective or more effective – and usually much safer – than the drugs they are developing to replace or supplant them.
This means that tens of thousands of studies do exist showing that natural substances may prevent and/or treat disease, at least in the in vitro (test tube) and animal models. These results often confirm traditional uses in Ayurvedic, Chinese and other traditional systems of medicine, and therefore may be compelling enough for individuals or healthcare practitioners to use the information to inform their treatment decisions.
The Case For Curcumin In the Prevention and Treatment of Disease
The government biomedical and life sciences database known as Medline contains over 21 million published study citations, and is accessible to search through engines such as Pubmed.gov. 2.6 million of them contain reference to cancer. 115,000 of them remain after applying the “Complementary Medicine” filter. There are 2,625 topics on cancer which can be found indexed on the GreenMedInfo.com database, referencing 612 natural substances of potential value.
Turmeric, and particularly its polyphenolic constituent known as curcumin, which gives the spice its golden hue, is one of the most extensively studied natural compounds of all time, with 4588 references to it on the National Library of Medicine’s bibliographic database known as Medline [as of 2.25.2012]. And yet, despite having been shown to have therapeutic value in over 500 disease states in animal and in vitro studies, it still has not been the subject of extensive human clinical research – for the reasons stated above.
GreenMedInfo.com, an open source natural medicine database, has indexed curcumin’s anti-cancer properties in over 50 cancers, with the top 10 most cancers researched in association with curcumin listed below.
|Cancer||Number of Articles|
|Cancers: Drug Resistant||40|
As one can see curcumin holds great promise. It has been repeatedly demonstrated to possess simultaneously both chemoprotective/chemosensitizing and radioprotective/radiosensitizing properties, meaning it is capable of reducing the adverse effects on healthy cells caused by chemotherapy and radiotherapy, as well as enhance the cancer-killing properties of these conventional therapies. It also has an exceptionally high margin of safety, at least an order of magnitude greater than commonly used conventional chemotherapy agents such as 5-fluoruracil. Given these facts curcumin, at the very least, should be considered an ideal candidate for use as an adjuvant in integrative cancer care, and perhaps as a first-line treatment alternative to conventional chemo-agents.
For additional information on the remarkable research supporting the use of Turmeric and Curcumin in medicine, watch the video below. Join our Facebook research page on Turmeric for updates: Turmeric — What The Research Reveals
 Curcumin’s LD50 (lethal dose, 50%) in mice is at least 2,000 mg/kg, versus 5-fluorouracil 115 mg/kg, or
Article Contributed by Sayer Ji, Founder of GreenMedInfo.com.
Sayer Ji is an author, researcher, lecturer, and advisory board member of the National Health Federation. He founded Greenmedinfo.com in 2008 in order to provide the world an open access, evidence-based resource supporting natural and integrative modalities. It is internationally recognized as the largest and most widely referenced health resource of its kind.
By: Dean Garrison | DCClothesline –
Brian Shilhavy is reporting that relatives of the Stanley family in Garland County Arkansas have reached out to MedicalKidnap.com to notify the public that the 7 homeschool children of Hal and Michelle Stanley were removed during the night by DHS and fully armed sheriffs this past week, simply because they reportedly found a supplement in the home that was not approved by the FDA.
The FDA v. MMS
The supplement in question is MMS (Miracle Mineral Solution). The FDA has been at war with this product and its distributors for several years. It seems like the Stanley family was unfortunate enough to get caught in the middle of that. In 2010 the FDA posted this consumer alert to FDA.gov:
Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach
AUDIENCE: Consumers, Emergency Medicine
ISSUE: FDA warned consumers not to consume or use Miracle Mineral Solution, an oral liquid solution also known as “Miracle Mineral Supplement” or “MMS.” The product, when used as directed, produces an industrial bleach that can cause serious harm to health. The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.
BACKGROUND: MMS is distributed on Internet sites and online auctions by multiple independent distributors. MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.
RECOMMENDATIONS: Consumers who have MMS should stop using it immediately and throw it away. The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Some in the alternative health field disagree with the FDA assessment. Here is a video plea from the originator of MMS:
Daniel Smith is facing up to 37 years in prison for his role in distributing MMS.
Is this product really dangerous to the consumer?
Are the Stanleys Simply Collateral Damage in the FDA Fight Against MMS?
Regardless of the effectiveness of the MMS product, one has to wonder what right the police state feels it has to rip these 7 children from the Stanley home.
It does not appear that the Stanleys were distributing the product but merely attempting to keep it on hand for personal use.
Does anyone else see a problem here?
Arkansas Matters reports:
The substance in question is referred to as “MMS” or Miracle Mineral Solution. The FDA has weighed in on the substance citing serious health concerns reporting that it can turn into a potent bleach and cause nausea, vomiting and diarrhea if taken.
The Stanley family however say it wasn’t grounds for the way they were treated during a search Monday (1/12) night that ended with their seven children taken away.
“Policemen here, policemen here,” Hal Stanley pointed, standing on his front porch. “Over here, on the side roads full of policemen.”
Stanley opened his door Monday afternoon to find a warrant waiting for him and his home surrounded by State and Garland County agents.
“It said we’re here to search your house,” Stanley explained.
Hal and his wife Michelle were kept outside for hours while officers searched the home with their seven children inside.
Hal said, “If they had asked me if I had MMS, I’d say yes and give it to them.”
Hal insists that only he takes the supplement and he uses MMS as a water purifier for his garden.
The garden is part of the Stanley’s way of life.
They avoid most contact with the government. The parents have home schooled their nine children, two of which have graduated and gone on to college.
The Stanley’s keep to themselves, are generally self-sustained and consider themselves “preppers”.
There you have it. Big Brother has just cracked down on more of those dangerous preppers that dare try to live without total reliance on government from cradle to grave. The only crime here appears to be that our government has grown way too invasive and this is further evidence that they aim to enslave us all.
Let this be our warning. These people did nothing wrong. They were not distributing this product, just using it. If it didn’t work then it’s no different then the closets full of products that we have all wasted money on throughout our lives. The FDA’s claims of harmful effects do not seem to be life threatening.
So what is really going on here?
This is about control and intimidation.
They could have seized the MMS and left.
Instead they took the children.
And people wonder why I can rarely say anything good about our government?
Tyrants have infiltrated all levels, all the way down to our local law enforcement.
Think about that.
The Mother, Michelle Stanley, has asked for our help:
The family has requested that the public call the following people:
- State Police Headquarters: 501-767-8836
- Kathy Finnegan 501-767-8550 (head investigator at State police department of our case.)
- DHS Department 501-321-2583 on menu choose Dept. of Children and Family
- Garland County Sheriff office Main Office Phone: (501) 622-3660 ask why did Mike Write make the decision to hold the Stanley kids?
Please keep this family in your thoughts and prayers, and please make some phone calls if you are able. There might be a day when you are the one that is seeking help.
The FDA Gets In Women’s Panties: Reusuable Menstrual Pads To Be Subject To $4000 A Year In Extortion Fees
Well, our good friends at the FDA are looking out for us again. Thank goodness we have them to fine us, charges us fees, regulate perfectly natural things, and keep us safe. Heck, who knew that women couldn’t even safely menstruate without them?
The FDA has decided that reusable menstrual pads are Class I Medical Devices. That means those who manufacture these products must pay an annual fee of THREE TO FOUR THOUSAND DOLLARS to continue doing so. Not only must these ladies armed with sewing machines pay taxes on their income, they must pay a fealty charge to the FDA to continue making a living this way. FDA Regulation #884.5435 states that a reusable menstrual pad maker must be “FDA compliant” – which means they must pay a yearly registration fee of $3,646 to remain in business for 2015 and a fee of $3,872 for 2016.
This is part of the Medical Device User Fee and Modernization Act…also known as “The government gets a piece or they put you out of business.” As people strive for more independence from Big Business, this will serve to put them firmly in their places. Self-sufficiency creates a competitive model and provides options other than paying for the lavish vacations and 19 bedroom homes of the CEOs and major stockholders of corporations who find the fees a nominal cost of doing business – if they are even subject to them at all.
Go read the mindblowing list of things that will be exempted: included are the little lights that go on urethral catheters and esophagal dilators. These things don’t require oversight but a cloth pad does????????????? The FDA is terribly concerned for women, because reusable pads are considered “gynecological or obstetrical devices” that require their intervention. And fees. Don’t forget the fees.
Women opt for natural reusable menstrual products for a variety of reasons:
- These products are non-toxic, unlike the bleached white, chemical-laden store-bought varieties.
- These products aren’t piling up in landfills.
- These products allow women to be self-sufficient – they don’t have to rely on a trip to Walmart every month.
Let’s talk about Class I Medical Devices. According to the FDA:
Class I means the class of devices that are subject to only the general controls authorized by or under sections 501 (adulteration), 502 (misbranding), 510 (registration), 516 (banned devices), 518 (notification and other remedies), 519 (records and reports), and 520 (general provisions) of the act. A device is in class I if (i) general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, or (ii) there is insufficient information from which to determine that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but the device is not life-supporting or life-sustaining or for a use which is of substanial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness of injury. (source)
Are you freakin’ kidding me? For that, people involved in cottage industries must pay thousands of dollars per year? Why are they trying to medicalize the regular shedding of uterine tissue, something that has been occurring since the beginning of time?
If you want to talk about something that needs oversight, how about the feminine hygiene products you can purchase at the store? Do you have any idea what carcinogenic materials those things contain? Here’s a quick primer on the contents of sanitary napkins:
In August Women’s Voices for the Earth (WVE) commissioned STAT Analysis to analyze volatile and semi-volatile organic compounds in scented, unscented, and Infinity versions of ultra-thin pads sold under the Always brand, which is manufactured by consumer-product giant Procter & Gamble (P&G).
The results of the testing indicate that both scented and unscented Always pads emit toxic chemicals, including chemicals identified by the U.S. Department of Health and Human Services’ National Toxicology Program, the Agency for Toxic Substances and Disease Registry, and the State of California Environmental Protection Agency, as carcinogens and reproductive and developmental toxins. The manufacturer discloses none of these chemicals on the product.
Some chemicals of concern detected include styrene (a human carcinogen), chloromethane (a reproductive toxicant), chloroethane (a carcinogen), chloroform (a carcinogen, reproductive toxicant, and neurotoxin), and acetone (an irritant). These chemicals also have industrial uses such as in the manufacturing of car tires, nail-polish remover, and Styrofoam, as well as in petroleum refining. (source)
This doesn’t even get into the vast amount of plastic in intimate contact with your body:
Each conventional sanitary pad contains the equivalent of about four plastic bags! With everything we now know about the hazardous nature of plastic chemicals, this alone is cause for concern.
For example, plasticizing chemicals like BPA and BPS disrupt embryonic development and are linked to heart disease and cancer. Besides crude oil plastics, conventional sanitary pads can also contain a myriad of other potentially hazardous ingredients, such as odor neutralizers andfragrances. Synthetics and plastic also restrict the free flow of air and can trap heat and dampness, potentially promoting the growth of yeast and bacteria in your vaginal area. (source)
For women who use tampons instead of pads, the content of those is even more grim:
Furthermore, to give tampons and pads that pristine, “clean” white look, the fibers used must be bleached. Chlorine is commonly used for this, which can create toxic dioxin and other disinfection-by-products (DBPs) such as trihalomethane. Studies show that dioxin collects in your fatty tissues, and according to a draft report by the US Environmental Protection Agency (EPA), dioxin a serious public health threat that has no “safe” level of exposure! Published reports show that even low or trace levels of dioxins may be linked to:
- Abnormal tissue growth in the abdomen and reproductive organs
- Abnormal cell growth throughout the body
- Immune system suppression
- Hormonal and endocrine system disruption
Meanwhile, the FDA’s official stance regarding trace amounts of dioxins is that there are no expected health risks associated with trace amounts of dioxins in tampons…
So wait a minute…according to our noble guardians at the FDA, dioxin is okay, but by golly, they’ve got to monitor those women who use flannel and organic cotton!!!! They must keep those women safe – and of course, dependent on a monthly trip to pay their dues at the altar of Proctor and Gamble, and companies like them. (Learn more from the World Health Organization about the dangers of the dioxin they say is okay to place in your private areas.)
Sellers of these products have been notified that they must scramble to come up with over $3600 by December 31 to remain in business.
Prices of these products are sure to rise in order for the makers to be able to stay in business. Support them by checking out this set of 5 pads or going for the gusto and getting a supply of 20 pads. You can also keep the FDA out of your panties by making your own pads – here are simple instructions.
If you agree that this is a ridiculous example of overreach that supports the interests of Big Business over the cottage industries that allow families to be independent and help to build a healthy economy, please sign this petition on the We the People website.
Daisy Luther is a freelance writer and editor who lives in a small village in the Pacific Northwestern area of the United States. She is the author of The Pantry Primer: How to Build a One Year Food Supply in Three Months. On her website, The Organic Prepper, Daisy writes about healthy prepping, homesteading adventures, and the pursuit of liberty and food freedom. Daisy is a co-founder of the website Nutritional Anarchy, which focuses on resistance through food self-sufficiency. Daisy’s articles are widely republished throughout alternative media. You can follow her on Facebook, Pinterest, and Twitter, and you can email her at [email protected]
Farmers know all about clearing and leveling out fields in order to plant crops.
But the U.S. Food & Drug Administration (FDA) seems determined to keep the playing field for small farmers decidedly unlevel. If we don’t intervene, the FDA could put countless small farmers out of business.
It all has to do with something called the Food Safety Modernization Act (FSMA). The FSMA is geared toward applying one-size-fits-all regulations to farms, regardless of how large or small those farms are.
Last year this time, in response to complaints from consumers, farmers and other groups, the FDA announced plans to revisit the rules. Fast forward a year, and the issue now is the Tester-Hagan amendment which would exempt small-scale, direct-marketing farms and artisan food producers from the most burdensome aspects of the FSMA.
But now the FDA, instead of respecting the intent of the Congressionally mandated Tester-Hagan amendment, is proposing to implement the amendment in a way that will allow the agency to target small farms and food producers one-by-one and put them out of business—with little or no recourse for the farmers. Small farms that produce healthy food are the key to healthy, economically sustainable communities. We should do everything in our power to make them flourish. So why is the FDA writing rules guaranteed to do just the opposite?
By: Carey Wedler | The Anti Media –
Last Thursday, the Food and Drug Administration approved a new painkiller that claims to combat the nation’s widespread, lethal addiction to painkillers.
In 2010, anywhere from half to three-quarters of drug overdoses in America were from painkillers. 12 million people abused them for non-medical reasons and addiction is also surging among teenagers. According to the CDC, prescription opioid abuse sends 420,000 people to the emergency room every year and death from opioid abuse is greater than heroin and cocaine combined. 46 Americans die every day from painkillers—more than one individual every hour.
Naturally, the FDA
–which has approved these deadly prescription painkillers – stepped in to help. After fighting change for years (alongside the American Medical Assocation), last year it announced it would tighten restrictions on prescribing pills to combat doctors who over-prescribed painkillers.
But that was not enough. Faced with outrage over the growing epidemic, the FDA approved Purdue Pharmaceuticals Hysingla last week. Hysingla contains a potent dose of highly addictive hydrocodone
–120 mg –but lacks acetaminophen, a mild painkiller found in products like Tylenol (that is not without its own side effects). Hysingla is taken once a day and releases over a 24-hour period.
Purdue spokesman, Raul Damas, bragged that
“This is coming on to a market that is currently flooded with products that do not have abuse-deterrent options.”
Still, the FDA advises the 120 mg dose of hydrocodone “should not be prescribed to people who have not previously taken an opioid medication,” and that any dose over 80 mg for a new patient is unsuitable (exposing how powerful the new drug actually is).
Nevertheless, the new pill’s manufacturer, Purdue Pharmaceuticals claims Hysingla is an “abuse-deterrent” because it is difficult to crush or dissolve in water. Apparently forgetting that drug addicts will consume their drug of choice in any way possible, Dr. David Haddox, the company’s chief of health policy, said the pill is a
“gelatinous, gooey mass that doesn’t pull into a syringe easily.”
The FDA parroted these claims:
“For patients who benefit from hydrocodone alone for the treatment of pain severe enough to need an opioid, this offers the advantage of once-a-day dosing in a formulation that we expect will reduce abuse and misuse.”
But addiction experts disagree. The New York Times reported:
“Dr. Andrew Kolodny, the chief medical officer at Phoenix House, a group of nonprofit addiction-treatment centers, said he was disturbed by the drug’s approval and disappointed that the F.D.A. did not seek input from an advisory committee of experts.
Dr. Kolodny said that addicts knew how to break down abuse-deterrent products for oral use, and that the 120-milligram tablets were particularly dangerous because they ‘pack an enormous amount of hydrocodone.’”
Last year, the FDA approved Targiniq, another Purdue “abuse deterrent” that like Hysingla, experts warned could still cause dependency. It, like Hysingla, was approved without the consult of an expert review board.
It is no secret that the FDA could have long ago approved other substances for the treatment of serious pain. Pain relief is one of the most commonly accepted uses of marijuana, but because the plant does not enjoy a powerful corporate lobby, it has long been barred from legal use (even though the government holds a patent on its medicinal qualities).
At this point, few Americans are fooled by the FDA’s false claims that it protects the health of the population. Simply disregarding or failing to seek the opinions of experts they hire would be enough to prove this point. That they disregard these experts to routinely side with corporations on matters that are literally life or death makes their true motives even more obvious.
However, with the growing awareness of these addictive “medicines,” there is hope that individuals will look to alternative forms of medicine to treat their ailments, avoiding “FDA-approved” solutions whenever possible.
By: Dr. Mercola, mercola.com –
It should be obvious that patients need unbiased advice when it comes to making decisions that can impact their health.
With that in mind, it stands to reason that physicians and scientists with financial ties to the drug industry should not be permitted to participate in broad policy and public health recommendations. But this is exactly what happens, and it happens more or less routinely.
In fact, conflict of interest is rampant in the field of medicine, even when it comes to recommendations from supposedly independent authorities like the federal government, which makes it very difficult to trust conventional health advice.
This issue was recently highlighted in a study published in the Milbank Quarterly,1 a multidisciplinary journal of population health and health policy.
The author, Genevieve Pham-Kanter, reviewed how financial interests affected the voting behavior of nearly 1,400 Food and Drug Administration (FDA) advisory committee members who took part in the decision process for Center for Drug and Evaluation Research between 1997 and 2011.
FDA advisory committees are created to help the agency make approval decisions on drugs, and the presence of external experts is supposed to ensure that decisions are unbiased and grounded in sound science. Alas, Pham-Kanter’s findings show this system can result in significant bias when conflicts of interest are ignored, as they typically are.
Conflicts of Interest Rampant Among FDA Advisors
In all, the 1,400 FDA advisory committee members cast nearly 15,740 votes between 1997 and 2011. After carefully examining the financial relationships between these committee members and drug makers, Pham-Kanter’s study2 showed that:
- On average, 13 percent of the members in any given committee had financial interest in the company whose drug was up for a review by that committee.
- About one-third of financial interests involved consulting for a drug maker; 25 percent involved ownership interest; 14 percent involved serving on an industry advisory board or steering committee.
- Committee members with financial ties to the company sponsoring the drug under review voted in favour of approval 63 percent of the time, while members who did not have financial ties had a 52 percent chance of favouring approval.
- Committee members who served on a sponsoring firm’s advisory board had a whopping 84 percent chance of voting in favour of the drug’s approval.
- Committee members with financial ties to several competing drug firms did not, on average, show pro-industry bias in their voting behaviour.
Quid Pro Quo May Be at Work in Your Doctor’s Office
As noted by the New York Times,3 the same kinds of conflicts of interest occur between prescribing doctors and drug firms.
The irony is that most doctors perceive themselves as being immune to influence, even though statistics clearly show that when a drug company provides a doctor with a gift of some kind, the doctor’s prescribing behavior is typically affected:
“Physicians sometimes travel to nice resorts for education. A study published some time ago in the journal Chest4 followed doctors who went to two all-expenses-paid symposia on new drugs.
Eighty-five percent of the physicians interviewed stated that accepting such invitations would not influence their use of the drugs. Nevertheless, their prescriptions for those drugs nearly tripled after the meetings, far above increases in the use of those drugs nationally.
Other studies5 have shown that physicians who meet with and accept gifts from drug companies are significantly more likely to ask that their drugs be added to hospital formularies…
A study6 of radiation oncologists found that only five percent thought that they might be affected by gifts. But a third of them thought that other radiation oncologists would be affected.”
Yes, Transparency IS a Deterrent…
To combat the undue influence drug companies have on doctors’ prescription behavior by way of gifts, the Physician Payments Sunshine Act7 was passed and went into effect last year.
This payment transparency program requires drug companies to report payments, including non-cash payments, made to doctors, which are posted in a public database. Payments that must be reported include:
- Speaking honorariums
- Research grants
- Company shares or ownership
In August, ProPublica8 used this database to reveal that nearly half of the doctors who billed Medicare for the expensive drug HP Acthar Gel9 were speakers, researchers, or consultants for the drug company in question. This included all of the top four prescribers.
This drug, despite there being questions about its effectiveness, has an average price tag of more than $41,700 per prescription, making it one of the most expensive drugs on the market. (It’s authorized as a treatment for a total of 19 different diseases, including multiple sclerosis.) As noted in the featured article:10
“The doctors mentioned by name in that article probably did not appreciate their loss of anonymity. Many others have begun to limit their acceptance of gifts, knowing that they will be made public.”
‘Doctored’—a Look at the Business of Medicine from the Inside
Dr. Jauhar, author of the book, Doctored: The Disillusionment of an American Physician, was recently described as “a compelling writer and an astute critic of the wasteful, mercenary, cronyistic and often corrupt practice of medicine today.”11
“He is brutally honest, not just about his own shortcomings, but about those of colleagues, bosses and institutions. There is the cardiologist who pressures him to perform expensive, unneeded diagnostic tests; the hospital, which wants him to see patients for ever-shorter sessions; the pharmaceutical company that pays him on the side to give ‘lectures’ but will let him use only its slides and data,” the New York Times book reviewer notes.
Indeed, such complaints have been well documented before. Too much cancer screening, too many heart tests, too many cesarean sections—mounting evidence suggests that Americans are basically being overtreated to death… A number of polls also show that doctors are truly struggling—mentally, emotionally, and physically. Like Dr. Jauhar, a vast majority report being disillusioned and dissatisfied with their work. In one 2008 survey,12 a mere six percent of 12,000 US doctors rated their work morale as positive…
There are many reasons for this, including the fact that doctors’ hands are tied by insurance companies when it comes to treatment decisions. But I think that the root of the problem goes back to the fact that doctors enter the field wanting to truly help people get well, but find that the system works against disease resolution at every turn.
Most all fail to appreciate the massive collusion between multinational corporations, peer reviewed journals, professional advisory committees, and federal regulatory agencies that decimate any hope of objective honest recommendations. Medicine has become a for-profit business, and this automatically promotes waste and less-than-optimal treatment options.
Doctors Over-Prescribe Antibiotics While Study Finds Honey May Work Better
A major part of medical waste is using profitable treatment options rather than what’s most effective. Case in point: recent research13 shows that many hospitals prescribe too many antibiotics, while other research finds that honey may actually outperform antibiotics for a number of serious infections—including antibiotic-resistant ones. According to Capital OTC,14 data from 500 American hospitals suggest that 78 percent of cases in which multiple antibiotics were prescribed to treat an infection between 2008 and 2011 may have been prescribed unnecessarily, costing the health care system a whopping $163 million:
“Director of the Premier Safety Institute, Premier, Inc Leslie Schultz, who is also the lead author of the study said, ‘Sometimes in an effort to ‘do whatever it takes’ to fight a serious infection, clinicians use multiple antibiotics to treat the same infection. This practice can contribute to antimicrobial resistance, put patient safety at risk and increase costs. We hope these findings help to enhance the antimicrobial stewardship initiatives that the majority of US hospitals already have in place today.'”
Meanwhile, Swedish scientists have concluded that honey contains a wide variety of active ingredients that make it a potent ally against infections.15 Honey was actually a conventional therapy in fighting infection up until the early 20th century, at which time its use slowly vanished with the advent of penicillin. Today, in light of the rapidly rising threat of antibiotic-resistant pathogens, alternative tools are sorely needed, and medical scientists are now taking a second look at this ancient remedy. According to the authors:
“Natural products such as honey have been applied against human’s infections for millennia without sufficient scientific evidence. A unique lactic acid bacterial (LAB) microbiota was discovered by us, which is in symbiosis with honeybees and present in large amounts in fresh honey across the world… [W]e tested the LAB against severe wound pathogens such as methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and vancomycin-resistant Enterococcus (VRE) among others.
We demonstrate a strong antimicrobial activity from each symbiont and a synergistic effect, which counteracted all the tested pathogens. The mechanisms of action are partly shown by elucidating the production of active compounds such as proteins, fatty acids, anaesthetics, organic acids, volatiles and hydrogen peroxide. We show that the symbionts produce a myriad of active compounds that remain in variable amounts in mature honey.”
Manuka Honey Can Be Used for Therapeutic Wound Care
As long as you use the right kind of honey, science does back up its use for wound treatment, which is especially relevant today as antibiotic-resistant bacterial infections are on the rise. Hospitals have become particularly notorious for spreading lethal infections. According to the US Centers for Disease Control and Prevention (CDC), hospital-acquired infections now affect one in 25 patients. GreenMedInfo.com16 lists a number of clinical studies showing Manuka honey’s effectiveness against a wide variety of diseases and conditions, including:
Leg Ulcer Dental Caries Dental Plaque MRSA Periodontal Infection and Gingivitis Ulcerative Colitis and Inflammatory Bowel Disease Helicobacter Pylori Infection Wound Healing Bacterial Infections
The US FDA authorized the first honey-based medical product in 2007. Derma Sciences uses Manuka honey for their Medihoney wound and burn dressings, which can be found online from medical supply stores. Amazon.com also sells them. These products can also be found in Great Britain, Australia, New Zealand, and Canada.
What Can You Do to Take Control of Your Health?
Virtually every measurable index indicates that despite the ever-increasing amounts of money invested, if you live in the United States your chance of achieving optimal health through the conventional medical system is getting progressively worse. As just one example, while the US spends more than twice the amount on health care as other developed nations, we rank 49th in life expectancy worldwide—far lower than most other developed nations…The time is ripe for you to take control of your health, and my site is chock full of free comprehensive recommendations that can serve as an excellent, truly independent starting point.
When it comes to your health, you simply cannot accept claims at their face value… Quite often—definitely too frequently for comfort—treatment recommendations are biased in favor of a specific drug simply because people making the decisions stand to profit from it. Whatever your health problem might be, I strongly recommend digging below the surface using all the resources available to you; including your own commonsense and reason, true independent experts’ advice and others’ experiences to determine what medical treatment or advice will be best for you.
Ultimately, you are responsible for your and your family’s health — not me, not your physician, and certainly not any researchers or government health agencies on a drug manufacturer’s payroll. I cannot stress enough how important it is to become an active participant in your own care, and make sure you are making decisions that correspond with your own best judgment, knowledge, and experiences. Most of us live in free enough countries where we still have the ability to take back control of our health, but we need to grab the initiative.
If I had a cure for Ebola, I could never sell it to you. I don’t have a cure for Ebola of course, but even if I did I could never promote it. And if you have a cure for Ebola and you start promoting it on the Internet, men with guns could soon show up at your door. Unfortunately, I am not kidding. Even if you have made a discovery that could potentially save millions of lives, that will not earn you an ounce of mercy from the FDA. In fact, the FDA has just issued a statement that contains a chilling warning for anyone that is claiming that they know how to prevent or cure Ebola. And without a doubt, FDA bureaucrats are scouring the Internet right now for any sign of an Ebola cure or treatment. When they find one, they are likely to crack down very hard based on their history. So if you do have a cure for Ebola, you might want to be very, very careful. You could end up having men with automatic weapons conducting a military-style raid on your home when you least expect it.
I wish that things were not this way in America.
I wish that this nation was not being transformed into a Big Brother police state.
I wish that we could feel free to share information with one another without the fear of men with guns coming to our homes.
But the cold, hard reality of the matter is that this is 2014 and we live at a time when our government is being run by paranoid control freaks.
On August 14th, the FDA published a warning that is specifically targeted at those that are claiming to know how to prevent or cure Ebola. The following is an excerpt from that warning…
The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection.
There are currently no FDA-approved vaccines or drugs to prevent or treat Ebola. Although there are experimental Ebola vaccines and treatments under development, these investigational products are in the early stages of product development, have not yet been fully tested for safety or effectiveness, and the supply is very limited. There are no approved vaccines, drugs, or investigational products specifically for Ebola available for purchase on the Internet. By law, dietary supplements cannot claim to prevent or cure disease.
Individuals promoting these unapproved and fraudulent products must take immediate action to correct or remove these claims or face potential FDA action.
It is important to note that according to the Centers for Disease Control and Prevention (CDC), Ebola does not pose a significant risk to the U.S. public. Unfortunately, during outbreak situations, fraudulent products that claim to prevent, treat, or cure a disease all too often appear on the market. The FDA monitors for these fraudulent products and false claims and takes appropriate action to protect consumers.
So what prompted all of this?
Well, the New York Times has given us a clue. According to the Times, the government is particularly concerned about a product known as NanoSilver that is being promoted by the National Solutions Foundation…
While discussing the shipment to Liberia of an experimental drug the panel did endorse, ZMapp, Nigeria’s health minister, Onyebuchi Chukwu, said an unidentified Nigerian scientist living overseas had arranged for Nigeria to get a different experimental medicine, according to Nigerian news outlets. They identified it as NanoSilver, a supplement offered by the Natural Solutions Foundation, which said that it contains microscopic silver particles, although, as a food supplement, it is not tested by regulatory agencies. Silver kills some microbes on surfaces and in wounds, but it can be toxic and is not F.D.A.-approved for systemic use against viruses.
Personally, I have a lot of respect for the National Solutions Foundation. And Dr. Rima Laibow has been working very hard to share what she knows with the global community over the Internet…
Recently, the foundation’s medical director, Dr. Rima E. Laibow, posted an “open letter to heads of Ebola-impacted states,” dated July 29, claiming that NanoSilver cured Ebola. She also claimed to have addressed 47 African health ministers at a 2007 conference and to be in touch with “West African governments and their advisers.”
Dr. Laibow could not be reached for comment. On Friday afternoon, after The New York Times emailed her a series of questions, two of her websites briefly became unavailable, then reappeared with headlines saying they were “under attack” and directing readers to other sites selling a different product, Silver Solution.
But in the end, it is not going to matter to the FDA at all whether what Dr. Laibow is saying is true or not.
The only thing that is going to matter is that she is promoting alternatives that have not come from the pharmaceutical drug cartel.
And when you cross the FDA, they don’t just send you a threatening letter in the mail.
As I mentioned above, men with guns could show up at your door.
The following are just a few examples from the past few years…
-The FDA raided an Amish farmer at 5 AM in the morning because he was committing the “crime” of selling raw milk.
-The FDA raided Morningland Dairy in the Missouri Ozarks because they were committing the “crime” of selling raw cheese.
-The FDA raided a cancer clinic in Oklahoma that was offering patients natural alternatives to chemotherapy and radiation.
So right now, this is where we stand. The FDA says that there is no way to prevent or cure Ebola, and you better not say that there is a way to cure of prevent Ebola either.
Meanwhile, it looks like Ebola has potentially spread to even more countries and the outbreak continues to grow at an exponential rate. In fact, the World Health Organization just released a statement in which it said that “the numbers of reported cases and deaths vastly underestimate the magnitude of the outbreak.”
If you have not been taking Ebola seriously, you need to start doing so.
The turning point for me was when so many health workers started getting the virus. So far, more than 170 health workers have become infected with Ebola. And remember, these health workers go to extraordinary lengths to keep from being exposed to the disease. For example, you can see some photos of what an Ebola isolation ward looks like right here.
If they are catching the disease so easily, what chance are the rest of us going to have?
Sadly, it looks like this crisis is going to continue to get worse for an extended period of time.
And you better not mention that you might have a solution, because if you do, men with guns might just show up at your door.
Michael T. Snyder is a graduate of the McIntire School of Commerce at the University of Virginia and has a law degree and an LLM from the University of Florida Law School. He is an attorney that has worked for some of the largest and most prominent law firms in Washington D.C. and who now spends his time researching and writing and trying to wake the American people up. You can follow his work on The Economic Collapse blog, End of the American Dream and The Truth Wins. His new novel entitled “The Beginning Of The End” is now available on Amazon.com.
A New study compared warning and withdrawal rates for drugs released before and after the drug industry increased funding to the FDA to expedite drug approvals
What’s safer: a newly approved drug or one that has been on the market much longer? Newer drugs have a one in three chance of acquiring a black box warning or being withdrawn for safety reasons within 25 years of their approval, according to a new study by researchers from Cambridge Health Alliance /Harvard Medical School, Boston Medical Center (BMC)/Boston University School of Medicine (BUSM), City University of New York School of Public Health, and Public Citizen.
The study, published today in the August issue of Health Affairs, is the largest on this topic, encompassing all of the drugs approved by the U.S. Food and Drug Administration (FDA) over a 35-year period.
Black box warnings are part of the prescription medication label intended to alert consumers and health care professionals about important safety concerns, such as serious side effects or life-threatening risks. They are the most serious medication warnings required by the FDA.
The study compared warning and withdrawal rates for drugs released before and after 1992. The approval process for medications changed in 1992 with the Prescription Drug User Fee Act (PDUFA), which allowed the FDA to collect fees to expedite drug approvals. Congress passed PDUFA after heavy lobbying by the pharmaceutical industry, and PDUFA has been reauthorized by Congress several times. Since the law’s enactment, the average drug approval time for all drugs has fallen from 34 months to 16 months.
Very few of the 32 drugs withdrawn for safety reasons had clearly unique benefits at the time of approval, but all had unique risks that eventually led to their withdrawal.
The researchers discovered that drugs released after the PDUFA passed were more likely to be withdrawn or have a black box warning, with 26.7 percent of these drugs receiving such a warning compared to 21.2 percent in the pre-PDUFA drugs that underwent the longer approval process. Half of all black box warnings appeared after a drug had been on the market for 12 years, and safety withdrawals have occurred as late as 30 years after a drug’s initial release.
The authors suggest that the expedited process may have led to the release of drugs before they could be adequately evaluated for safety issues.
“The FDA is under constant pressure to rush new drugs through the pipeline to approval. In its hurry, the FDA is apparently failing to distinguish useful drugs from toxic ones, and more dangerous drugs are slipping through,” said study lead author Cassie Frank, MD, a physician at Cambridge Health Alliance and an instructor in medicine at Harvard Medical School. “By the time many drugs receive serious safety warnings, millions of Americans have already been exposed to their side effects, which can sometimes be fatal. As a doctor, I try to keep my patients safe by avoiding new drugs, when there are similar, older ones available.”
“Our findings raise concern that the FDA is rushing its review of new drugs and allowing potentially unsafe medicines onto the market. As a primary care doctor, I’m wary of prescribing brand new drugs unless they’re really a breakthrough, since their full risks are often unknown. And patients should be wary too,” said senior author Karen Lasser, MD, MPH, associate professor of medicine at BUSM who practices internal medicine at BMC.
“The FDA’s resources for reviewing drugs have increased dramatically since the passage of PDUFA, amounting to $760 million this fiscal year from pharmaceutical companies, about two-thirds of the agency’s drug review budget,” said study co-author Sidney Wolfe, MD, founder of Public Citizen’s Health Research Group and author of “Worst Pills, Best Pills.” “Since PDUFA, the review times for the drugs that are eventually banned have decreased enormously. From an average, prior to PDUFA, of about three years from receipt of the drug application to FDA approval, the interval has dropped sharply to about one year, following PDUFA. These shorter review times, combined with increased FDA authority to require further studies after approval – rather than settling safety issues before approval – possibly contributes to the increased rate of withdrawals and black box warnings.”
Folate. It’s the naturally occurring form of the water-soluble vitamin B9, found in black-eyed peas, chickpeas and other beans, lentils, spinach, turnip greens, asparagus, avocado and broccoli. It synthesizes and repairs your DNA, is critical during infancy and pregnancy, and is required to produce healthy red blood cells and prevent anemia.
You can’t live without it. That’s why it’s available as a supplement. But now the U.S. Food & Drug Administration (FDA) wants to reserve the natural form of folate for monopoly drug companies, leaving only the synthetic form for supplements. According to the FDA’s new labeling guidance, the word “folate” will be banned from the Supplement Fact labels—only the term “folic acid” will be allowed.
The OCA has joined the Alliance for Natural Health and the Weston A. Price Foundation to argue that this action is illegal. And we need your help to get the message across.
FDA aims to sterilize our food through the Food Safety Modernization Act
After two years of delay, the Food Safety Modernization Act is finally about to go into effect. The FDA is moving forward with rules that are supposed to make food in the United States the safest in the world.
Hailed as the most sweeping overhaul of farm and food policy since the Great Depression, some fear the law will actually make our food supply less safe by regulating small, organic farmers out of business and leaving it in the hands of a few mega farmers and processors.
“So what exactly is the government going to do to make our food safer?” I was wondering the other day. While I hoped for the labeling of GMOs and the removal and the word “natural” from products that aren’t natural, I knew the FDA would come up with an idea like putting port-a-potties with sinks in the middle of farm fields. And sure enough, that’s exactly what they did. With that, they also want food heated at higher temperatures to kill any bacteria that may be present, good or bad, and a host of other ill-conceived ideas that will prevent us from accessing nutrient-dense foods.
I recently spoke with Judith McGeary, founder of Farm and Ranch Freedom Alliance, a non-profit organization dedicated to protecting the rights of independent farmers, ranchers, and homesteaders. Judith is also an attorney, a farmer, and a Weston A. Price Foundation chapter leader in Austin, Texas.
McGeary has been following the Food Safety Modernization Act since it was first proposed a couple of years ago. Initially she feared the coming food safety regulations would be so costly for small farmers that they’d go out of business. Since then, farms with less than half a million dollars in annual sales have been exempted from the legislation.
But after reviewing the FDA’s proposed rules, she is still leery for several reasons.
Pay up, I’ll protect you
First, half a million dollars in sales might sound like a lot, but farmers only keep 10 to 15 percent of that in profits. That means it could cost farmers making as little as $50,000 a year as much as $10,000 annually to comply with the new rules. That’s a fifth of their income eaten up by regulation.
Second, the state, with all its power, could wave its magic wand and declare an “outbreak or emergency” and “un”exempt farmers earning even less than $50,000.
Third, on top of the cost in dollars, the law will cost farmers time. Farmers, especially small farmers who can’t afford legal counsel, don’t have time to mull through and comply with 1200 pages of new rules and regulations, many of which are vague and poorly written. Tracking the origin and destination of every crop sold, for example, isn’t going to benefit the farmer or the consumer of local foods. It may help the government hire another unnecessary worker to come and check the farmers’ books though, so why not?
As if filling out paperwork wasn’t bad enough, the agency wants to tell farmers what they can and cannot use to fertilize their crops, right down to the type of compost they can use.
The FDA seems to be scared of anything that was ever part of an animal. If you don’t follow their instructions to the letter, which includes extensive documentation of how the compost was made, you have to treat compost — including worm castings — as if it were raw animal manure and wait 9 months in between putting the compost down and harvesting the crop. In practice, this is a death knell for the use of many types of compost, which are vital to growing food sustainably.
This intrusive, restrictive approach to compost is a stark contrast to the agency’s attitude about the spraying of toxic chemicals on food, which doesn’t seem to concern it much at all.
What does all this mean for consumers? Well, expect local, sustainable food prices to go up. Thanks FDA, for making their lives harder and mine more expensive.
If it’s alive, they want it dead
The FDA’s solution to eliminating any possibility of dangerous pathogens is to kill everything. In addition to pasteurizing juices and other processed and packaged foods, the agency would like all “fresh” fruits and vegetables to be irradiated. Yes, that means zapped with radiation. While potentially killing deadly bacteria, this process also kills living enzymes and good bacteria that help build our immune systems. Is this what consumers really want? A bunch of irradiated bags of lettuce that have gone through a giant processing plant, leaving green leaves stripped of the nutrients they once contained? I for one, don’t.
It seems, as usual, the government is making things worse instead of better. A simple way to curb contamination would be to stop subsidizing the mega farms that are causing the problem. Let the free markets figure it out. I think I know what type of farm would win. The local, sustainable farmers have more incentive to do what is right for the consumer and the environment, because they rely on the consumer – not government subsidies – for their paychecks.
If more people took ownership of themselves, and the food they were eating, we wouldn’t need government officials intervening. Yes, that means, getting up off of your ass and visiting the farmer, or at least giving him a call to discuss how your food is being made. If more consumers started talking to their farmers directly and holding them accountable, they’d have more of an incentive to provide good quality, nutrient-dense foods. I mean if I walked on to the farm and saw chemicals being sprayed on the crops, I wouldn’t buy his products. If, after talking to a few people who worked on the farm, I learned the smell in the air was coming from a shit lagoon up around the bend, I wouldn’t buy his products. See where I’m going?
It all starts with food
After reading Harry Brown’s book this weekend, How I Found Freedom in an Unfree World, I realize bold action is required in order for change to occur in our lives. So, if you’re eating irradiated, chemically fabricated, pre-packaged foods, take action today, and start eating nutrient dense, non-processed, whole foods. Visualize how it will feel and taste eating homemade stews made from real bone stock, butter from freshly milked grass-fed cows, and pasture raised chicken eggs cooked in lard on your cast iron skillet. My mouth is watering just thinking about it. If you can’t visualize how fantastic these foods will taste, visualize a Lean Cuisine cooking away in your microwave, with its rubber stamped FDA approval. Then ask yourself if bold action is required. Is it time for a change? Is it time to eat free or die?
If your answer is yes to any of the following, do some research, find out where you can get raw milk (email me, if you have to) and pasture-raised chicken eggs. Once you have these items, take a deep breath, and realize your life is about to change. Crack open an egg and disregard the white that surrounds the golden orange yolk, and put that yolk in a blender, add another if you’re feeling wild. Pour in a couple cups of fresh, grass fed, milk from your bottle, where the cream sits a couple inches on top. Blend up some of nature’s most perfect foods.
Now, pour that concoction into a glass and walk in front of mirror. Put on a podcast from foodriotradio.com. I recommend the Mark Baker interview, for extra inspiration. Now look at yourself, with your own eyes. Realize this is the beginning. This is the first day of the rest of your life. Grab that glass with both hands because they’ll be sweaty and you’ll be anxious and you don’t want to drop what you’ve worked so hard for. Throw that drink back and take a big swallow. Set it down and look at yourself again. See the sparkle in your eye? Feel the change taking place in your body? Now you feel the power of food. It feels good, doesn’t it? You feel alive for the first time in years. The awakening has occurred. You’ve been baptized into the real food movement. Now go spread the word to others and grow the revolution because its message is finally here. Freedom baby, freedom.
Listen to Brad’s interview with Judith McGeary here.
Brad Jordan hosts a podcast called Food Riot Radio. He and his co-host Sara Burrows work to expose how a collusion between government, big agriculture, big pharma and big food has determined what ends up on our plates and offer ideas for how to fight back.
The World Health Organization, or WHO, was officially established in 1948 by the United Nations. It was created with the goal of standardizing international health policies and practices to achieve “the attainment by all peoples of the highest possible level of health.”
WHO is the organization behind the curtain (or one of such) that pushes flouridation around the world as a means of eugenics. Since the organization is so large and has public support around the world, they have been very successful.
The WHO is very corrupt – the global mother of USA’s AMA. You see, big pharma, FDA, CDC, USDA, DHS (Department of Human Services) are becoming entwined and somewhat merged, causing a complete breakdown of our medical, health and human services systems.
I speculate that the deterioration of all of these organizations from the top down, is due to the WHO’s influence and control in round-about ways. The WHO is just another moving part of the New World Order (NWO); a branch of it, if you will – of which I am sure many will come to me and call me a conspirator for saying such ‘nonsense’. Any organization that seeks global dominance in any way is a dangerous organization, which we should all scrutinize. Not only does WHO wish to control our healthcare, they also wish to control our food supply. This is one avenue where Monsanto comes in. Monsanto is much bigger than most people think and the history goes way back.
As every nation in the world marches forward to a completely integrated and globalized society, the control of food is an absolute necessity for those who seek to accelerate amalgamation. It is for this reason that we see an increase in domestic legislation that mirrors the guidelines and demands of international standard-setting organizations. These attempts at harmonization of national laws, specifically those regarding food, are coming in daily from all sides of the globe.
Whether it’s the GMO fight in the United States, as well as other countries, or the question of the level of vitamins and minerals in supplements, the Biotech Corporations are continually winning most of their battles with the help of mass ignorance, national governments, the World Trade Organization (WTO) and similar entities.
Indeed, when one begins to examine many of the debates regarding food and food regulation, one name appears over and over – Codex Alimentarius.
For those who may be unaware of what Codex Alimentarius is, I refer you to a book called Codex Alimentarius – The End of Health Freedom, or you can read it, via this website. Briefly speaking, however, Codex Alimentarius is an agency created under the Food and Agricultural Organization (FAO) and the WHO, and thereby functions under direction of the United Nations (UN).
Codex Alimentarius sets the standards by which the World Trade Organization implements its dispute settlements and international trade policies. Codex Guidelines, once agreed upon, are enforced by the WTO and other related treaties. Essentially, Codex Alimentarius sets the standards for the world regarding food, vitamins and minerals, GMO’s, and almost everything else that humans consume.
Although the influence of Codex Alimentarius can be seen the world over, New Zealanders were targets of the international standard-setting organization via a food bill titled Food Bill 160-2 in 2011.
Similar to legislation passed in the United States, the New Zealand Food Bill essentially turns the right to grow food and share it with others into a regulated and controlled privilege. Food Bill 160-2 would also allow for the control of seeds (specifically heirloom seeds), and the creation of Food Safety Officers that would serve to police the newly designated and loosely termed “food producers.” It would also effectively end the ability of individuals to become and remain self-sufficient. “Control the food supply; control the people”.
For instance, the bill defines food so as to include any plant or animal (living or dead by the definitions set forth in the bill) intended for human consumption, as well as: any ingredient or nutrient or other constituent of any food or drink, whether that ingredient or nutrient or other constituent is consumed or represented for consumption on its own by humans, or is used in the preparation of, or mixed with or added to, any food or drink; and anything that is or is intended to be mixed with or added to any food or drink.
Furthermore, giving broad and alarming levels of power to the Governor-General, “anything that is declared by the Governor-General, by Order in Council made under section 355, to be food for the purposes of this Act” will also fall under the jurisdiction of Bill 160-2.
So much is included in just the “Definitions” section of the bill one could almost write a twenty-page article just on the connotations provided by Section 8 alone. Regardless, as one can clearly see from reading the small portion of the bill quoted above, the terms of the bill are all-encompassing.
Herein, food is defined literally as anything that can be consumed by humans and it retains this definition at whatever the stage of its development.
Therefore, corn may be considered food whenever it is being sold at a market. It may be considered food when it is being shucked, and it may be considered food when it is being grown. It is also considered food before being grown — in seed form.
Not only that, but because many seeds themselves are consumed by humans, seeds naturally fall under this tyrannical legislation as much as anything else.
As a result of the new policies to be implemented as a result of Food Bill 160-2, anyone then engaged in producing and distributing food would be subject to the regulation and monitoring of the new authorization program. Of course, the classification of “food producer,” applies to individuals who grow two or three tomato plants for their own consumption as much as it does to major Agri-businesses.
That being said, there are clearly financial concerns with the new bill, as well. Obviously, Big-Agra would easily be able to pay the monitoring fees for the new Soviet program while small farmers, where they still exist, could not. In addition, individuals would certainly no longer be able to continue selling their food at the local farmers market, local restaurants, or even to other individuals.
True to form, the questions regarding the new legislation are being brushed off by the New Zealand government, particularly those individuals in the New Zealand government who have been pushing the bill from the start.
For instance, Kate Wilkinson, New Zealand Minister of Food Safety stated that concerns over the Food Bill were part of some kind of “conspiracy theory” and that she didn’t understand where all this “conspiracy theory” was coming from.
Before I continue, I must ask if all this doesn’t sound eerily familiar. It certainly does to me. (That phrase is getting so played out by now)
In 2010 when the United States Congress was busy passing S.510, a bill that was very similar if not identical in scope to the New Zealand Food Bill, we heard the same cat calls of “conspiracy theory” launched at anyone who criticized the impending legislation. Now, after the U.S. government is constantly publicly raiding organic food shops, raw milk distributors, the Amish, small farmers, nutrition supplement shops, etc. etc. with guns drawn by clownish looking SWAT teams, the name-calling is a bit harder to justify.
The similarities between the law in the United States and New Zealand are quite striking, so much in fact that they can scarcely be considered a coincidence — especially when both of these bills are themselves disturbingly similar to Codex Alimentarius Guidelines and recommendations. Indeed, upon closer examination it appears that there is more of a pattern than some members of national governments would have us believe. No doubt this is almost always the case.
But, back to Miss “Conspiracy Theory” Kate Wilkinson for a moment. To answer her question as to where all the “conspiracy theories” have come from, perhaps she should look at her own statements.
In a letter to Green MP, Sue Kedgley, who has expressed some attenuated level of criticism toward the bill, Wilkinson wrote:
“The barter or selling of propagation food seeds and food seedlings is in scope [of the Bill] . . . However the sale or exchange of seeds for propagation, and seedlings (whether this occurs in the context of a garden center, a market, or between those in a community of interest), is not intended to be captured.”
Wilkinson openly admits that seeds can and will be controlled under the new food bill. Hardly a conspiracy theory when the antagonist actually admits it to be true.
Of course, before one gets their hopes up in regards to the Green Party, one should bear in mind that politics are politics and the theater of public opinion is much the same in New Zealand as it is in the United States. The Green Party itself initially voted for this bill. The organization states, “Ignore the Green Party dog-and-pony show propaganda. The Greens, who voted for the Bill at first reading, know the truth is coming out now and are dissembling for extra election votes).” Obviously, the political climate is exactly the same in every country with exactly the same result.
In the end, there should be no mistake as to the goal of these new laws, whether they be in the United States, New Zealand, or anywhere else for that matter. As the world marches faster and faster toward totalitarianism, the ability of individuals to become self-sufficient must be destroyed before the control system can fully assert itself. This, in fact, is an integral part of the system in the first place. This is causing manufactured famines in areas and thus leading people to believe we are running out of resources, due to overpopulation. Just what the green parties and our governments want you to believe, to condone the eugenics programs.
The UN’s Agenda 21 is already making its way into every city, under the guise of “sustainable development”, also being pushed by the green parties, eco-friendly organizations and the Centers for biodiversity. Next, we will lose our rights to own property and procreate – it will be left to those with certain bloodlines. These organizations are merely the domestic ground-level implementation of international policy handed down from Codex Alimentarius, the WTO, WHO, and the United Nations, entities that are themselves nothing more than tools in the Great Work known as the New World Order.