Globalists Prove Me Right: They’re Nuts! And They Love to Censor Truth Speakers
For those of us trying to figure out whether the globalists really are as nuts as I have been saying they are, we owe a debt of gratitude to an up-and-coming Labor Party politician in Australia. Take it from me, she is really nuts. She’s also a member of Parliament in Victoria, Australia and the mother of an autistic child.
. She is loudly supporting a bill to capture every child in Australia and force them all to be vaccinated regardless of the parents’ desires, and violating their Informed Consent. In this matter she asserted, publicly, and in Parliament, that she would prefer having an autistic child to nursing one with a “vaccine preventable disease“. Does that mean she is advising new mothers to forego nursing to assure babies are vaxed as young as possible? Brast-feeding transfers natural immunity to the infant thereby decreasing any alleged benefit. It is for that reason that the CDC recommends vaccinating, but not breast feeding, infants. The CDC is nuts too. There is strong indication in the literature that nursing mothers pass natural immune factors to their babies, and we cannot have that, can we?
. Here’s a very partial list of supposedly “vaccine preventable diseases”: measles, mumps, whooping cough, German measles… So this super compassionate mom and upstanding Member of Parliament would rather poison every child in the nation than spend 3 days soothing a cranky, itchy, slightly feverish kid (measles, mumps, German measles, chicken pox) or, for a whole week, having to take a toddler with a croupy cough into the bathroom and turn on the hot shower to ease the child’s breathing?
. And no one rose from the benches to question her or her wretched grip on the life sciences and common sense?? For shame!
. Read my so far unanswered letter to her, here: http://www.opensourcetruth.com/dr-rima-responds-to-mp/. I replied to her when our esteemed Australian colleague, Adam Crabb, of the highly informative Crazz Files sent me the report of her foolish and illegal stance. We are working with our Aussie allies to make sure everyone in the Vaccine Choice Movement understands just how far from rational, humane and lawful behavior the vax pushers are willing to go. Will there have to be another Nuremberg Trial, like the Nazi Doctor’s Trial, which enshrined the Nuremberg Code and our universal right to Informed Consent, declaring its violation a crime against humanity?
. As a psychiatrist, I must tell you, I consider this political woman not only dishonest, dangerous and a willing participant in a crime against humanity, but possibly clinically impaired.
. Those of us who do not agree with her mad coercive intent know what we need. We need Nano Silver 10 PPM to protect our own immune integrity, and each of us needs an Advance Vaccine Directive to protect our legal Informed Consent right to refuse all vaccination. Link: https://NSFmarketplace.com
. General Bert warned us that Informed Consent is the defining issue of the 21st Century. The absolute Madness of the Globalists guarantees the truth of his insight. Oh, by the way, Bill Gates’ former family doctor tells us he and Melinda do not vaccinate their kids, only ours. Where do you stand?
. Stand with us. Share this link with your entire circle of influence – https://www.facebook.com/NaturalSolutionsFoundation/
Use this link to share this message widely on social media – http://drrimatruthreports.com/globalists-prove-me-right-theyre-nuts/
Yours in health and freedom,
. Dr. Rima
. PS from Counsel Ralph:
. Curiously, when I tried to post Dr. Rima’s response to the Aussie MP Emma, Facebook blocked the link. I can post any other story we have on Open Source Truth, but not this one! So you know how important it is to get out the word. Share this link: http://drrimatruthreports.com/globalists-prove-me-right-theyre-nuts/
. Here is a screen shot of Facebook’s “endorsement” of Dr. Rima’s letter:
WE ACCUSE THE FDA!
The Citizens Commission for Health & Food Freedom
J’Accuse … Indictment of the FDA
Dr. Ron Paul: the FDA engages in “abuse of power…”
This Citizens’ Indictment is Presented to the Court of Public Opinion
Permalink: http://drrimatruthreports.com/?p=8073 Action Item: Demand Redress of Grievances! Tell Congress to Protect our Rights! http://tinyurl.com/4r5rr6w
You of the United States Food and Drug Administration (FDA) leadership are little more than political hacks, which means that you are little more than prostitutes for the Multi-National Corporate Persons who would poison you and your children while they poison us and ours.
You have blood on your hands, FDA officers and agents, blood mixed with chemicals. Your scientists tell you that mercury amalgams have no place in children and you choose to ignore their pleas telling you that patients need protection; instead you aid and abet mass poisoning of children and adults with toxic mercury and with toxic fluoride; you merely offer to cover-up the harm by having people sign more abusive waivers to protect the dental and corporate interests who poison their brains and bodies.
Your experts told you that “GMO” genetic modification of plants and animals was tinkering with life itself and, once released, this particularly malignant genie could never be re-contained in its flask. “Do not do this!” they said, but you rushed not to judgment, but to the condemnation of our biosphere, one nuclear DNA bundle of precious genes at a time, throwing out bouquets of infertility, cancer, brand new lethal allergies, strangely mutated bacteria, weeds that will not die, babies that cannot live and a plague of contagious genes never before seen – or experienced – on this planet. You have conspired to allow the poisoning of the biosphere.
Your bloody hands, hearts and heads have no capacity to contain all the guilt for deaths and suffering, losses and heartbreak caused by poorly tested (or in the case of flu vaccines, not safety tested at all), deceptively reported and dishonestly labeled drugs and vaccines which you had every reason to know will kill and main, but from which you make money or receive research position and money. Such a small amount of money, FDA, for so many lives despoiled and destroyed.
You are baby-killers. We accuse you of purchasing, approving, recommending, allowing, distributing and promoting the 2009 H1N1 Swine Flu Vaccine which has resulted in thousands of miscarriages. See our Citizens Petition demanding that you enforce the law against vaccine drug pushers: http://drrimatruthreports.com/?p=7418
Your dishonest and self-serving regulations make food the stuff of death and drugs the stuff of suffering. The fluoride in the water which you criminally flood us with – for genocide and mind control is a crime against humanity – is not there for us and our well being. It is there for the profit of those who would poison us and the comfort of those who would dominate us through apathy and slack-witted mindlessness.
FDA, you know that we know how to control disease and remove its underlying causes and you know that such removal and control strikes deeply at the heart of the Uber Cartel, those drug lords who will sell their contaminating agra-chemicals and provide their death-dealing seeds in order to make short term money, gain long-term control and accomplish forever-term depopulation of those of us deemed unnecessary, the “Useless Eaters”.
So J’Accuse FDA. We accuse you of murder, of graft, of extermination, of inhuman acts committed against the civilian population of the Earth, the military population of the Nation, unborn generations of the planet. I accuse you of Crimes Against Humanity through knowingly perpetrating these acts. I accuse you of fast-tracking death because it brings fast-track profits and because it brings fast-track infertility, suffering, disease and death.
We accuse you of having neither shame, compassion nor any humanity worthy of the name. You have sold your soul, FDA leadership, for a mess of guilt, crime and money.
For the brothers, sisters, mothers, fathers, sons, daughters and others of the Earth, We accuse you of genocide.
The International Criminal Court statute (echoing the Nuremberg Code) provides, in Article 7 of the Rome Treaty that Crimes Against Humanity, even when practiced against one’s own people, include “Other inhumane acts … intentionally causing great suffering, or serious injury to body or to mental or physical health.”
We therefore accuse the FDA and its officers and agents of conspiracy to cause “serious injury to body or to mental or physical health…”
FDA: how do you plead?
The Trustees will announce the membership of the Citizens’ Commission over the next few weeks and will then develop the case against the FDA for presentation to the Commission and their Moral Decision. We need a lawyer to volunteer to defend the FDA. Any volunteers?
Half of All FDA Approved Drugs are Quietly Withdrawn Within 5 Years of Approval
“FDA approved” drugs means “safe”, right? Clinical trials show that drugs and vaccines are safe or they wouldn’t be allowed to be marketed, right? Drug companies have to report what actually happens in a clinical trial, right? Once a drug is approved by the FDA for market release it stays available for a long time, right?
Lethal and potentially lethal side effects from FDA approved drugs are rare, right?
The answer to these questions is one big collective, “NO!!!!!”
Here are the facts: Drug companies are free to suppress negative clinical trial information with impunity. That is not how the system is designed to work, at least on paper, but it is the way things work in the real world.
Drugs, all drugs and vaccines, enter Phase IV clinical trials when they are released for general use. Depending on how many people they kill, maim, blind or cause to suffer once doctors start prescribing the drug for whatever the FDA has approved it for, although they can use the drug for anything they want to (called “off label prescribing”). Even the callous, corrupt and conflict-of-interest-riddled FDA withdraws approximately 50% of all approved drugs within 5 years of approval because they are just too toxic to continue on the market.
How did they get approved in the first place? Well, as you will see when you read the articles below, drug companies disregard the requirements to be honest in reporting data as they choose. Given that it can cost up to a billion dollars (yes, you read that right, a billion US dollars) to research a drug and bring it to market, there is an enormous amount of pressure to get the drug into the patients’ hands by putting it in the doctor’s mind and getting it onto his/her prescription pad – no matter what.
One of the may ways drug companies accomplish what they want – drug sales, is to lie about how many people die or drop out in drug trials.
Another way is by literally purchasing the decision-makers for stock options, research grants and other inducements plucked fresh from the abundant and ever self-replenishing FDA Corruption Tree.
The results? Pharmaceutical Mayhem. Drugs are the leading cause of death in the US and every other “developed” nation. But, not to worry, the FDA is on the job.! Oh, good. I was worried there for a moment!
You know, insultingly enough, the FDA expects you to believe that these deadly drugs released to the public to see what happens (and what happens is mayhem and murder much of the time) could possibly be an accident? Neither do I. Remember, these same drug companies are big players at Codex. They are the heirs and legatees of the German genocidalists who created Codex Alimentarius, now degrading the world’s food supply as a stepping side to “the Great Culling”, the death of 90% of the world’s population.
Bottom line, from where I stand? If you are not in an Emergency Room, there is, in my experience and belief, no reason to take drugs when inexpensive, gentle, effective and powerful natural options exist through orthomolecular medicine, homeopathy, naturopathy, chiropractic, acupuncture, Bio Acoustics, NeuroBioFeedback, Frequency Medicine, chelation, detoxification and a host of other helpful, safe techniques await your decision-making. But that is the very point, isn’t it? If you are an immensely powerful drug company and you know that your drugs are toxic, expensive, dangerous, poorly conceived and poorly tested, grossly dishonestly marketed what would you do? Jeopardize your cash bonus and tell the truth, wasting a billion bucks? Probably not. Probably you would do what the drug companies (and the BioTech companies which make GMOs and are usually one and the same as the drug companies!). You would lie, and lie big!
“These drugs are safe.” “The clinical trials show it.” “People do not get sick from our drugs.” “We followed the rules.” “You can trust us!”
Stuff and nonsense!
Yours in health and freedom,
Rima E. Laibow, MD
Ana Cantu was a Human Guinea Pig in a Drug Trial for $4,800
Vera Hassner Sharav
Monday, 26 July 2010
“The study started out with 20 subjects…For about a week there were 14 subjects. Then they started dropping…Now, we’re down to 7.”
Below, a testimonial by Ana Cantu who was one of the healthy volunteers –“a human guinea pig” as she describes herself– in a month long study that tested the effects of Norvir, an HIV drug made by Abbott Laboratories, when coupled with the antidepressant Wellbutrin, made by GlaxoSmithKline.”
Her first-hand experience provides insight about the immense “pressure for positive results in clinical trials,” the level of discomfort a human subject is expected to endure from the adverse effects of the tested drug (or combination of drugs), and the dilemma for drug manufacturers whose drug causes adverse effects so severe, the test subjects in pre-marketing trials drop out in droves. The FDA accepts study results–even if only 7 of 20 subjects complete the study. Companies are loathe to scrap a negative study: they hold on to the last 7 subjects despite severe adverse effects. The “volunteers” suffer for the payment which they would forfeit if they quit.
Ana describes how and why corporate sponsors–in her case, GSK and Abbott Labs–conceal adverse event data that may damage a drug’s chances for approval.
Despite federal law requiring companies to fully disclose to the FDA all adverse events in pre-marketing clinical trials, drug companies have repeatedly violated the law with impunity: they have failed to include in their submission of data to the FDA, the worst adverse events suffered by subjects who, as a result, dropped out of the trials.
Her observations, published in The American Statesman (below) are disturbing and insightful:
“The study started out with 20 subjects, but 6 were eliminated during the in-patient stay by the drug company sponsoring the trial for various reasons (including drinking caffeine within 24 hours of check-in). For about a week, there were 14 subjects. Then they started dropping. The first one to go was a girl with a pronounced Texas twang named Denise, who had severe jaw and tooth pain. Then extreme nausea and emesis (the clinical term for vomiting, I discovered) claimed April. Jo Kay, Paula, Amy, Alyssa and Carrie went one after another. Now we’re down to 7.”
Ana experienced severe black outs–clearly an adverse effect of the experimental drug–but she was kept in the trial against her best interest:
“The day got off to a bumpy start when I started to black out while reporting my side effects. Darkness closed in from my peripheral vision and then I saw nothing but big colored spots.
“That morning, we were standing around in the cafeteria waiting to dose. All of a sudden, I couldn’t see and lost the ability to balance. If I hadn’t been standing between two of my fellow subjects, who grabbed me and held me up, I would’ve slammed into the floor. I knew I hadn’t fainted; I could still hear just fine, but all I heard was chaos as everyone around me freaked out. I dropped into the nearest chair and put my head between my legs while the study coordinator called the on-site paramedics. While the coordinator frantically called the staff doctor, a paramedic checked and re-checked me. I did fine as long as I wasn’t on my feet for too long. The doctor cleared me to keep dosing.”
Ana explains why her continued “participation” in the trial–disregarding the danger the black outs posed to her well-being–was to accommodate the sponsoring company’s need to maintain a minimum of 7 subjects in the trial:
“The drug company had a dilemma. To submit trial results to the FDA, the study couldn’t fall below seven participants. But, unfortunately, one showed signs of serious side effects and if those results were submitted, approval was highly unlikely. If my results were dropped, the FDA would never know about the problem and the drug company could start fresh with a third trial. However, the first clinical trial had to be scrapped because too many subjects dropped out as a result of their side effects, and it looked like the second study could soon follow the same path. To gather enough healthy volunteers who fit the protocol for a third trial would require a lot of time and money, and it wasn’t something the sponsor was willing to do. So, in the end, my results and I stayed in the study.”
“Because the trial ended with the magic number of seven volunteers, the results could be submitted for review and the FDA had the opportunity to see the data. But what happens in the trials in which drug companies drop some of the subjects with the worst side effects?”
Ana Cantu’s first-hand experience confirms the finding reported by FDA’s safety officer, Dr. Thomas Marciniak, who analyzed the raw data from GSK’s Avandia trial, and found that the company concealed from the FDA the worst adverse event data, resulting in its approval precipitating preventable heart attacks and deaths.
An editorial in today’s New York Times, calls upon the FDA to revoke its questionable approval of Avastin for breast cancer because it failed to extend patients’ lives while it caused serious side effects. The drug had gained “accelerated approval” without adequate testing.
Cantú: Anatomy of a drug trial
By Ana Cantú
AMERICAN-STATESMAN Friday, July 23, 2010
Exactly five years ago, in exchange for the most miserable month of my life, I got paid $4,800 to test the effects of a drug made by GlaxoSmithKline.
You know where you’ve heard the name GlaxoSmithKline recently, right? That’s the company on the verge of losing the approval of the Food and Drug Administration for the diabetes medication Avandia after regulators discovered omissions in a key clinical trial report. On Wednesday, the FDA ordered Glaxo to stop enrolling people in another Avandia trial.
According to a review reassessing the drug’s safety by the FDA’s Dr. Thomas Marciniak, a number of patients taking Avandia appeared to have serious heart problems that were not counted in the study’s tally of adverse events, otherwise known as side effects.
Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” he wrote.
It can cost hundreds of millions of dollars — in some cases, close to a billion — in research and development for a drug company to secure FDA approval.
By the time a drug gets to point where it can be tested in humans, the pressure for positive results in clinical trials is immense. And I found that out first-hand when as one of the healthy volunteers — a human guinea pig — in a study that tested the effects of Norvir, an HIV drug made by Abbott Laboratories, when coupled with the antidepressant Wellbutrin, made by GlaxoSmithKline.
In exchange for that $4,800 paycheck, I spent about a month going in and out of a blocky silver building in an office park not far from Austin-Bergstrom International Airport, the site of a contract research lab that conducts medical studies.
During the lab’s second clinical trial of the Norvir-Wellbutrin combination, which I chronicled in a personal blog, I was known only subject No. 40.
July 12: I check in tomorrow for 4 days. I’ll be taking an antidepressant and an AIDS drug in combination for about a month.
July 13: The facility is freezing. We’re still waiting on blankets. I should’ve brought a hat and gloves. You can tell the people who do studies regularly by their baggage — they bring extra pillows and blankets and huge rolling suitcases. The building is pretty new and it’s painted in all kinds of “modern” colors like bile, which complement the black-and-white tiled floors nicely. Subjects sleep 8 to a room in bunk beds, though there are only 3 people in my room. …
My first dose of Wellbutrin is tomorrow. I hear it gives you crazy dreams.
July 14: I’ve been stuck so many times today I feel like a junkie. I had to be up by 6:12 a.m. to check vital signs and get a pre-dose blood draw. Then I had breakfast, which I had to finish: two potato, egg and cheese tacos with pico de gallo and a carton of 2% milk, which I don’t like. I took the Wellbutrin at 7:27, so precisely every hour after that I’ve been having blood drawn. For the rest of the day, it’s blood draws only every 2 hours. I carry around a clipboard that has all my procedures and meals scheduled — everything has to be done exactly as it says on the sheet or they can dock pay off your study-completion bonus.
Amusing sign near the toilets: Please do NOT use cellphones in urine monitoring stations.
July 15: Dinner was decent — teriyaki chicken, rice, salad with Italian dressing, a hunk of zucchini bread and a sugar cookie. I tried the cookie and didn’t like the aftertaste so I hid it in a spare napkin and arranged everything else on the tray to conceal it. The cafeteria workers check how much of our food we eat — we’re supposed to finish at least 50% of everything. Sometimes it’s hard, like with yesterday’s trail mix. I hope we get a good snack, which I will take my first bite of at precisely 9:32 p.m.
About half of the subjects have done trials before and say that ours isn’t so bad, even with all the blood draws. Apparently, there are some where you have them every 15 minutes. …The people who usually play Monopoly switched to Uno.
July 18: Yesterday I had my first bad blood draw.
July 20: Tomorrow I start my doses of Norvir, the AIDS drug. Fun, fun.
July 23: I started on the AIDS drug on Thursday — 300 mg twice a day. The dosage gets upped to 400 mg tomorrow. I don’t feel bad yet, though I’m sleeping less than normal. And today my stomach objected to the egg facsimile we had to eat.
July 25: I was pretty excited that I didn’t get sick after my dosings. … I think the secret is to not drink the milk. And not to eat more than 50% of the food. I’m becoming an expert in artfully rearranging things on my plate so it looks like I’ve eaten. They (try to) make us eat after taking the giant AIDS pills, but since we get the same few meals over and over, it’s gotten really hard to do. Plus, there’s a chance you’ll get sick after so you really don’t want to see nasty food twice, if you get my meaning.
July 28: I discovered that I feel better if I don’t eat after taking the horse pills. This morning, I refused to eat the breakfast tacos and felt fine. So I followed the same strategy at dinner — I did eat the peas and carrots and drank some caffeine-free root beer, but most of the meal was untouched.
Over the course of the trial, as a result of a near-constant state of nausea, I lost about 10 percent of my body weight.
To keep up my strength, for lunch, I’d go to a fast-food restaurant and order the heaviest combo on the menu (double bacon cheeseburger, fries and a huge non-caffeinated beverage) and eat as much as I could before I started to feel sick again.
Every night, insomnia cut my sleep to three hours.
Aug. 1: The study started out with 20 subjects, but 6 were eliminated during the in-patient stay by the drug company sponsoring the trial for various reasons (including drinking caffeine within 24 hours of check-in). For about a week, there were 14 subjects. Then they started dropping. The first one to go was a girl with a pronounced Texas twang named Denise, who had severe jaw and tooth pain. Then extreme nausea and emesis (the clinical term for vomiting, I discovered) claimed April. Jo Kay, Paula, Amy, Alyssa and Carrie went one after another. Now we’re down to 7. In what I view as biological injustice, none of the males have shown noticeable symptoms.
Aug. 2: I had to go see an opthamologist today, just for my safety, since I reported a migraine with aura a few days ago. Unfortunately, I’m fine. Curses. I was hoping I could get medically excused from the study — that way I’d still get paid. But it looks like I’m going to have to finish it. Only 10 more days of dosing to go. My current side effects include oral numbness and tingling in my extremities.
Aug. 6: It’s another day in lockup: cloudy skies (I think) and cold air conditioning. The day got off to a bumpy start when I started to black out while reporting my side effects. Darkness closed in from my peripheral vision and then I saw nothing but big colored spots.
That morning, we were standing around in the cafeteria waiting to dose. All of a sudden, I couldn’t see and lost the ability to balance. If I hadn’t been standing between two of my fellow subjects, who grabbed me and held me up, I would’ve slammed into the floor. I knew I hadn’t fainted; I could still hear just fine, but all I heard was chaos as everyone around me freaked out. I dropped into the nearest chair and put my head between my legs while the study coordinator called the on-site paramedics. While the coordinator frantically called the staff doctor, a paramedic checked and re-checked me. I did fine as long as I wasn’t on my feet for too long. The doctor cleared me to keep dosing.
A few days after my first blackout episode, during a scheduled outpatient visit, one of the study coordinators said I had to be examined by the on-staff doctor. “Why?” “The sponsor is concerned about your side effects,” she said.
The drug company had a dilemma. To submit trial results to the FDA, the study couldn’t fall below seven participants. But, unfortunately, one showed signs of serious side effects and if those results were submitted, approval was highly unlikely. If my results were dropped, the FDA would never know about the problem and the drug company could start fresh with a third trial. However, the first clinical trial had to be scrapped because too many subjects dropped out as a result of their side effects, and it looked like the second study could soon follow the same path. To gather enough healthy volunteers who fit the protocol for a third trial would require a lot of time and money, and it wasn’t something the sponsor was willing to do. So, in the end, my results and I stayed in the study.
Aug. 21: So yesterday I had the exit screening/physical for my drug study. I had to have my blood pressure checked 3 times because it was low, even for me. The paramedic checked me, but I was asymptomatic. She asked how I was feeling. “Fine, especially now that I’m off the drugs.” She said, “Well, it was for the good of mankind.” “I guess … and the money.”
Because the trial ended with the magic number of seven volunteers, the results could be submitted for review and the FDA had the opportunity to see the data. But what happens in the trials in which drug companies drop some of the subjects with the worst side effects?
Actually, we’ve seen what happens — with Avandia.
When a Drug Fails
THE NEW YORK TIMES July 25, 2010
The flameout of an enormously expensive drug to treat advanced breast cancer will pose a critical test for the Food and Drug Administration. Will the agency have the courage to reverse course when a medical treatment that it approved based on preliminary evidence flops badly in follow-up studies?
Two years ago, the F.D.A. gave Avastin, which is made by the Genentech unit of Roche, “accelerated approval” as a treatment for breast cancers that have spread to other parts of the body. Such cancers are essentially incurable so the best that current treatments can do is extend a patient’s life.
The hurry-up mechanism allows approval of a drug that has not yet been proved safe and effective in thorough clinical trials but has shown promise that it might benefit patients with life-threatening diseases. Rather than make such patients wait, they are treated with the drug while the manufacturer completes additional tests.
When Avastin was granted “accelerated approval” to treat advanced breast cancer, the primary evidence was a single clinical trial. It found that Avastin, when used with another drug, slowed progression of the disease but did not significantly extend patients’ lives.
Now two follow-up trials by the manufacturer have failed to confirm even those meager gains. In the initial trial, Avastin held tumor progression at bay for five and a half months. In the two new trials, pairing Avastin with different chemotherapy drugs, the delay in tumor worsening was much shorter: up to three months in one trial and less than a month in the other. The Avastin combinations also caused serious side effects.
Britain’s National Institute for Health and Clinical Excellence, a pace-setter in evaluating medical advances, issued draft guidance this month against using Avastin for advanced breast cancer patients in the National Health Service. It called the clinical trial data “disappointing” and the cost “too high for the limited and uncertain benefit it may offer patients.”
By a 12-to-1 vote last week, an F.D.A. advisory committee quite sensibly urged the agency to revoke Avastin’s approval for breast cancer. That would not affect its other approvals, gained through the standard regulatory process, for treating colon, lung, kidney and brain cancers. Avastin would remain available to doctors for off-label use against breast cancer. Many insurers, however, might refuse to cover an unapproved use.
The cost of Avastin has always seemed outrageously high for the medical benefits it confers. The wholesale price for a typical breast cancer patient is about $88,000 a year. Genentech has been capping annual spending at $57,000 for patients with incomes below $100,000.
The F.D.A. has rarely removed drugs that were given accelerated approval and sometimes has failed even to compel completion of follow-up studies. But there are signs it may get tougher. In June, the agency finally forced a leukemia drug off the market that had been given accelerated approval a decade ago, after a long- delayed follow-up study showed no clinical benefit and an increased risk of death. With Avastin, the follow-up studies were completed in a timely manner — with such meager results that withdrawal seems the right response.
Cassandra, the daughter of King Priam and Queen Hecuba of Troy was cursed by Apollo, whom she offended, with always being right but never being believed. She warned her father not to open the gates to the Trojan Horse but no one listened. The horse was brought in and, the story goes, in the dead of night, its huge belly was opened and the warriors hidden within destroyed Troy. Being right did not make Cassandra happy.
Being right does not make me happy when I am writing about things like deceiving, diagnosing and drugging an entire population for the benefits of anyone but the patient.
Being right when I wrote, decades ago, that the use of psychiatric drugs, especially in children, was a disastrous, brain-damaging and insane social and medical policy. These drugs are untested, toxic and will create a society of pharmaceutically damaged people rather than ill people being well treated. Being right when I said that the Diagnostic and Statistical Manuals for Psychiatry were dangerous and would lead to the expansion of diagnoses and treatment to the point where there were none who dared resist and non who were not diagnosed. Being right when I wrote that Psychiatric diagnoses rested in marketing, not in science and that treating CFL (corporate financial lust) was fundamentally insane, but that the insanity did not lie with the patient.
And being right when I wrote that possible drugging would inevitably become mandated drugging, although neither the science or the treatments were any better.
Alas, like Cassandra, my predictions did not ring real when I wrote them but we have arrived where I saw us collectively headed. Dangerous drugs for everything that even smacks of real life and universal mandating just around the corner – if we turn that corner.
First, an admission: I am, by training, a Psychiatrist, encouraged by that training to treat children, adolescents and adults. But I was, I believe, saved from violating the basic ethical standard of medicine (and, with decency, every activity which involves any of us): Primum non nocere – Latin for “First Do No Harm”.
It is my considered belief, after considerable study, clinical practice and observation, that it is literally impossible to BE a practicing Psychiatrist, FOLLOWING THE PRACTICE GUIDELINES AND “STANDARD OF CARE IN THE COMMUNITY” PRACTICES, and NOT do harm, first, middle and last. That is why I have never treated anyone for anything using medication with two exceptions: a wildly psychotic 19 year old patient of mine in a State Hospital locked ward was suffering the torments of the damned (which is what he believed himself to be) as he unendingly hallucinated his inner terror. I prescribed for him enough sedation to allow him to stop screaming after 9 days of 24 hour nightmare. I was a First Year Resident at the time and knew nothing of orthomolecular psychiatry (the use of nutrients for mental relief and health), but I knew that I had to do something to help this young man by allowing him to reach into our world and us to reach into his. Once the madness-fear-madness cycle was broken, our work began. Ironically, my Chief Resident had just returned from a sojourn with the British Psychiatrist R. E. Liang, who saw schizophrenia as a glorious adventure so I had to go toe to toe with my superior and his superior and HIS superior to provide some respite for my young patient. I did and I won that battle.
Today, neither my Chief Resident, the well-known Dr. James Gordon, nor I would medicate that patient, both of us for very different reasons.
The other patient was a lady who had been addicted to Xanax(R) by her General Practitioner. I had to write a prescription for a small amount to complete weaning her from that intentionally highly addictive, and therefore highly profitable, psychoactive drug.
That takes care of my prescription history for psychiatric drugs over a 40 year career practicing medicine and psychiatry with some of the most seriously ill patients in the world. Successfully. Very Successfully.
So you can see that the article below chills me to the bone. It announces another step down the path of subservient lunacy for the disgraced profession of Psychiatry, a profession devoted to poisoning a specific target organ in the face of better, safer, cheaper, kinder and more effective options like nutrition and NeuroBioFeedback, appropriate therapies and social and health supports.
It is my considered view after 40 years of practice, that there is no place, that’s right, no place whatsoever, for psychiatric drugs. None. But, then, it is also my considered opinion that there is no place for any drugs in the Doctor’s office, although there is a place for them in the Emergency Room or ambulance while a patient is being transported there.
Psychiatrists no longer learn to talk to, and therefore, to listen to people. They are trained to look for flags that trigger this drug being prescribed or that one. The “literature” in their journals is mostly junk, paid for, authored by, and owned by the drug companies. But then, the “scientific journals” that publish them are, in reality, little more than advertising circulars for their magnificent, deceptive and callously dishonest advertisements. Just ask Marcia Angel, who resigned in protest as Editor of the [supposedly] prestigious New England Journal of Medicine because of the deep, dark and deadly corruption of the “peer review” system and the staggering lies upon which drug studies, and therefore prescription practices, rest.
In the Reuters article below you will see a future emerging in which there are no normals any more. Normal means having problems and problems are given names which suggest drug treatments. Suggest? Did I say suggest? Today, for most of us, most of the time, it is a suggestion. But it is a MUCH better business model if the suggestion is rhetorical and the requirement is absolute. More drugs sold. More side effects. More drugs added to the regimen. More side effects. More brain damage which looks exactly like the condition for which the drugs were given in the first place.
If this reminds you of the influenza shot for “protection” which turns out to be the CAUSE of the influenza “epidemic” each year which then leads to more calls for more vaccines “against” the influenza “epidemic” and drugs to “treat” what was induced by the shots: flu, cancer, autism, ALS, infertility, diabetes, etc., etc., etc., then you are paying attention. The business model is identical.
And just as the flu shot is transitioning from voluntary to mandatory, so the use of psychoactive drugs, all of them, for “diseases” and “conditions” that any decent human being would be ashamed to label another person with, let alone “treat” them for, will soon be mandatory unless we collectively say “NO!”, as we did to the Swine Flu vaccination (now included in this year’s dangerous seasonal flu shot.
Here’s you bit: Help support the Stop the Shot lawsuit against the FDA. Now that H1N1 vaccine will be added to the seasonal flu shot, the women who lost their babies after they took it are especially important plaintiffs in this case. Click here, http://drrimatruthreports.com/?page_id=189, to set up your recurring tax deductible donation, large or small. Act now, before the Diagnostic and Statistical Manual declares caring about your life and your body a mental disorder, as caring about a healthy diet and clean food has become. There are, by the way, two names for this “disorder”:
1. “Orthorexia| from “Ortho” meaning correct and “orexis” meaning appetite
2. Complete, total and unmitigated garbage.
Yours in health and freedom,
Rima E. Laibow, MD
(Reuters) – An updated edition of a mental health bible for doctors may include diagnoses for “disorders” such as toddler tantrums and binge eating, experts say, and could mean that soon no-one will be classed as normal.
Leading mental health experts gave a briefing on Tuesday to warn that a new edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM), which is being revised now for publication in 2013, could devalue the seriousness of mental illness and label almost everyone as having some kind of disorder.
Citing examples of new additions like “mild anxiety depression,” “psychosis risk syndrome,” and “temper dysregulation disorder,” they said many people previously seen as perfectly healthy could in future be told they are ill.
“It’s leaking into normality. It is shrinking the pool of what is normal to a puddle,” said Til Wykes of the Institute of Psychiatry at Kings College London.
The DSM is published by the American Psychiatric Association (APA) and contains descriptions, symptoms, and other criteria for diagnosing mental disorders. It is seen as the global diagnostic bible for the field of mental health medicine.
The criteria are designed to provide clear definitions for professionals who treat patients with mental disorders, and for researchers and pharmaceutical drug companies seeking to develop new ways of treating them.
Wykes and colleagues Felicity Callard, also of Kings’ Institute of Psychiatry, and Nick Craddock of Cardiff University’s department of psychological medicine and neurology, said many in the psychiatric community are worried that the further the guidelines are expanded, the more likely it will become that nobody will be classed as normal any more.
“Technically, with the classification of so many new disorders, we will all have disorders,” they said in a joint statement. “This may lead to the belief that many more of us ‘need’ drugs to treat our ‘conditions’ — (and) many of these drugs will have unpleasant or dangerous side effects.”
The scientists said “psychosis risk syndrome” diagnosis was particularly worrying, since it could falsely label young people who may only have a small risk of developing an illness.
“It’s a bit like telling 10 people with a common cold that they are “at risk for pneumonia syndrome” when only one is likely to get the disorder,” Wykes told the briefing.
The American Psychiatric Association did not immediately respond to a request for comment.
The scientists gave examples from the previous revision to the DSM, which was called DSM 4 and included broader diagnoses and categories for attention deficit hyperactivity disorder (ADHD), autism and childhood bipolar disorders.
This, they said, had “contributed to three false epidemics” of these conditions, particularly in the United States.
“During the last decade, how many doctors were harangued by worried parents into giving drugs like Ritalin to children who didn’t really need it?,” their statement asked.
Millions of people across the world, many of them children, take ADHD drugs including Novartis’ Ritalin, which is known generically as methylphenidate, and similar drugs such as Shire Plc’s Adderall and Vyvanse. In the United States alone, sales of these drugs was about $4.8 billion in 2008.
Wykes and Callard published a comment in The Journal of Mental Health expressing their concern about the upcoming DSM revision and highlighting another 10 or more papers in the same journal from other scientists who were also worried. DSM 5 is due to be published in May 2013.
(Editing by Peter Graff)
BAN GMOs! Most plants are genetically modified to withstand (and thus encourage) high levels of dangerous agricultural chemicals like glyphosate, the active ingredient of Monsanto’s Roundup(c). The chemicals are toxic and the GMOs themselves are not tested for safety before FDA approves them, are forbidden to be labeled as GMO by the FDA and are associated with cancer, infertility, autoimmune diseases, fetal death and permanent changes to DNA in very cell of people who eat GMOs! More than 90% of the US food supply is either GMO or contains ingredients made from DNA. It’s time to end “FRANKEN-FOODS”! Click here, http://salsa.democracyinaction.org/o/568/p/dia/action/public/?action_KEY=2049, to demand a total ban on GMOs and a scientific effort to find out how bad the genetic damage has been and how to correct it while there is still time.
Valley of the Moon™ Eco Demonstration Project, www.NaturalSolutionsFoundation.org If clean, unadulterated food is important to you, you’ll want to know about, support, and perhaps participate in the Valley of the Moon Eco Demonstration Project in the beautiful, bountiful, temperate Highlands of Panama!
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GMO CASE DECIDED FOR CONSUMERS, ORGANIC FARMERS. MONSANTO SAYS NO, THEY WON. THE TRUTH IS THAT PUSH BACK WORKS, AND WORKS AND WORKS BECAUSE YOU, THE HEALTH FREEDOM NET ROOTS, WORK AND WORK AND WORK!
The US Supreme Court gave us a tremendous win by making it clear, as the article below shows, that consumers – that’s us – have the right to sue corporations and government agencies to stop poor regulations from going into effect.
That’s exactly what the Natural Solutions Foundation is doing in our Stop the Shot case against the FDA and in our Ear Candling case against the same corrupt, multinational-corporation-controlled FDA.
In the first case, we are now preparing to file for the third time. Each of the first two times that we filed this case which says that US law clearly and unambiguously says that vaccines must be tested and shown to be BOTH safe and effective before they can be released to the public. No flu vaccine has passed those two tests. For that matter, no vaccine has passed those tests.
But the FDA continues to support the use of more, and more toxic, vaccines for children and adults in the absence of a single shred of evidence that vaccines work or are safe.
Each time we filed the Stop the Shot case, the standing of the plaintiffs (us) was undermined when the agency which was meancing our defendants with job loss or worse backed off on the eve of the trial going forward. Both times the judge said, “Well, you’ve won!” and sent us out of the Court House to go celebrate. But that was not the win we were looking for. We don’t just want the corrupt Department of Health Commissioner in New York State and the Governor to back down, we want all influenza vaccine banned. The next time, it was the mandate for all children under 5 in New Jersey to be vaccinated before they could be enrolled in a state-licensed day care center.
That is not what we are looking for although we congratulate the parents of young New Jersey children on having that mandate lifted.
We want a full and total ban on vaccines which have not been tested to prove their safety OR their effectiveness, as required by US law. That means that ALL influenza vaccines (and all other vaccines, but our standing is for influenza vaccine complaints right now) are, in fact, illegal, untested drugs in the US! That includes the absurd and dangerous H1N1 vaccines.
Yesterday, the FDA called the Natural Solutions Foundation asking us to withdraw our Citizens Petition about the dangers and illegality of the H1N1 vaccines! Why? Well, perhaps because about 5 months ago, just after a health emergency had been declared, they told us they would respond to us within 6 months since they were too busy to respond to our emergency petition [sic!] and the 6 months is almost up. Now they have to deal with us and they would clearly rather not. It is a great time for your to sign that Citizens Petition here: http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27791.
So the FDA appears to be asking us NOT to go forward with our campaign to get dangerous vaccines off the market and out of our bodies. That seems to us the very best indication that we are definitely on the right track.
What does that have to do with GMOs? Everything. First, the principle of the Uber-Cartel. The companies which make genetically modified organisms (GMOs) do so to make sure that they tolerate and/or require very high levels of the highly profitable and enormously toxic herbicides and pesticides which destroy the balance of nature and create sick plants and super weeds and pests, requiring yet more of the toxic chemicals. In fact, when GMO crops are planted, the average use of toxic agrochemicals increases by 400% or more.
Of course, these toxin chemicals, such as the new generation of Monsanto’s Roundup(c), containing 70% Agent Orange [dioxin] get into your body, the environment and, tragically, the unprotected bodies of the unsuspecting farm workers whose cancers, infertility, fetal and infant death mimic those of the general population which eats these foods. Codex Alimentarious, the International Food Code, habitually sets permissible limits for foods so high that any limitation is meaningless.
When eaten, these toxic, genetically altered foods literally change the DNA of every cell of the eater – you – and any children that are in the womb or that come after you will also have permanently altered DNA. And so will the plants and animals whose DNA is contaminated by the contaminated DNA of these dangerous foods.
Cancer, permanent genetic alteration, decreased immune function, infertility, sterility, fetal and infant death, auto immune disease, gut, kidney and other organ damage are the rule in every study NOT sponsored by industry which looks at GMO ingestion. But the FDA and USDA do not, and, in fact, MAY not examine the safety or dangers of these patented organisms.
More than 90% of US food is now either genetically modified or contains ingredients derived from GMOs or both.
When you get sick, the very same companies that made money from the sale of the GMOs which required increasing amounts of toxic chemicals to grow AND manufactured and marketed the toxic chemicals are the companies that make the drugs that you are supposed to take when you get sick from their GMOs and toxic chemicals.
The model is circular. The effect is disastrous. That cycle of profit and death is what I call the “Uber-Cartel”.
We all understand that GMOs are untested and that they hide within our food supply since they MAY NOT be labeled, thanks to the every industry-friendly, corrupt and dangerous FDA. We all also understand that the manufacturer of 95% of the genetically modified seed and animal stock in the world, Monsanto, is as ruthless as any corporation in the world in contaminating farmers’ fields, controlling markets regardless of the tragic consequences of such control (e.g., starvation, farmers being driven off their land, increased cancer, infertility, deaths, starvation, crop failure, etc.).
Alfalfa is the 4th largest crop grown in the US after corn (almost entirely GMO in the US), soy (nearly all GMO) and wheat (emerging as a GMO crop now that Japan and other countries have dropped their ban on US wheat if GMO varieties were developed). Fed to cows, organic alfalfa is essential or organic dairy and beef production. It is also impossible to produce organic alfalfa if GMO alfalfa is grown anywhere in the area because of short and long distance contamination.
The USDA approved alfalfa for general planting and use with the usual lack of caution or sense. But this time, when they did so in the absence of the required Environmental Impact Statement, the Center for Food Safety sued. A lower court found that the approval of Roundup Ready(C) alfalfa seeds in the absence of the necessary studies was legal and Monsanto announced victory. But push back is a funny thing: dedicated people and groups are willing to fight the long fight, slog the long slog, to make sure that the right thing is done, that lawful outcomes are the result. The District Court ruled that the planing could not go forward and the case was appealed.
The Supreme Court ruled recently on the case and both Monsanto and the Center for Food Safety declared victory, Monsanto because the total ban on planing GMO alfalfa was reversed and the Center for Food Safety because the Supreme Court did not disagree that the USDA had mistakenly approved GMO alfalfa prematurely AND, even ore importantly, because the Supreme Court, for the first time, affirmed the concept that has also now ruled for the very first time ‘that “environmental harm” includes economic effects such as reduced agricultural yield or loss of market due to genetic contamination, as well as the concept of what biologists refer to as “gene flow” (in practice, the idea that genetically engineered material may get into conventional plants through cross-pollination). The Supreme Court now accepts that this phenomenon in and of itself is harmful and illegal under current environment protections.’
As Michael Hansen of Consumer’s Union says, “That’s a huge win for our side … That’s gigantic!” Future lawsuits can now confidently use the gene-flow argument against approval and use of genetically engineered crops.
So although Monsanto is focusing on the reversal of the total ban of GMO alfalfa, we, the People of the PushBack, see it differently. We see that litigation is essential to this health freedom process we are engaged in and that it can be a very powerful strategy.
That is why our Ear Candle suit, to prevent the FDA from declaring any and everything they do not like as an unapproved medical drug or device, whether it is or not, and demanding that it be removed from the market immediately, and our Stop the Shot case, to prevent illegal, untested, unnecessary, unsafe and uninsurable influenza vaccines from being deployed are so important.
Supreme Court’s ruling on Monsanto’s GE alfalfa: Who won?
by Tom Laskawy
June 21, 2010
The sustainable agriculture world is abuzz today with news of the Supreme Court’s ruling regarding an earlier lawsuit, brought by alfalfa farmers, that sought to stop any planting of Monsanto’s genetically engineered Roundup Ready alfalfa seed. While the press coverage heralds the ruling as a decisive victory for Monsanto, a close reading shows that, in fact, it’s a fairly significant win for opponents of biotech crops.
Hay dudes, not so fast
The background: As the fourth most-planted U.S. crop behind corn, soybeans, and wheat, alfalfa is worth $9 billion a year — the dairy industry is the biggest consumer — with annual seed sales valued at $63 million, according to a USDA study. Monsanto’s Roundup Ready alfalfa seed has been genetically engineered to be tolerant of glyphosate, the active ingredient of Monsanto’s herbicide Roundup.
Earlier this year, the U.S. District Court in San Francisco found that the USDA had illegally approved Roundup Ready alfalfa for planting — which the agency refers to as “deregulating” — by allowing Monsanto to sell and farmers to plant the seeds without the USDA completing a required full Environmental Impact Statement. (A preliminary one was under way.)
In response to a lawsuit filed by GMO-opposed alfalfa farmers along with the Center for Food Safety on behalf of consumers, the District Court halted all planting of Roundup Ready alfalfa until the USDA completes the EIS, which could take years. It also issued two injunctions: one that prevented the USDA from performing a so-called “partial deregulation” of Roundup Ready alfalfa, i.e. allowing restricted and otherwise limited planting, while it prepared the final environmental statement; the other stopping farmers from planting any Roundup Ready alfalfa starting with the 2010 crop year. (For a deeper look into the lead-up to the case, read Matt Jenkins’ excellent 2007 feature “Brave New Hay” from High Country News.)
Today, in a 7-1 opinion written by Justice Samuel Alito, the Supreme Court reversed both District Court injunctions, saying that the Court had overreached itself procedurally in halting the plantings. (Both Justices Steven Breyer and Clarence Thomas had conflicts of interest in the case — Breyer’s brother was the District Court judge on the case, while Thomas was corporate counsel for Monsanto earlier in his career, but only Breyer saw fit to recuse himself.)
Despite the news reports claiming victory for Monsanto, the Supreme Court did not overturn the central tenet of the case: that the USDA prematurely approved Roundup Ready alfalfa. The District Court, in effect, made it once again illegal to plant Roundup Ready alfalfa — and the Supreme Court endorsed that ruling. While the Justices did declare that the USDA, if it wants to, has the right to give the seed a preliminary approval (i.e. for limited, restricted planting), the Supreme Court decision does not by itself give Roundup Ready alfalfa the green light.
And it’s important to note that the USDA has not yet formally announced any intention to re-authorize the restricted plantings, which would come in the form of a rule for “partial deregulation” of Roundup Ready alfalfa. In fact, the agency and Monsanto had preciously submitted such a plan to the District Court in hopes that it would be incorporated into the final ruling, and instead, they received an injunction.
To some, that move appeared to be an attempt at an end run around the official rulemaking process. It’s not clear if the USDA will move forward with anything other than the “final” environmental review.
[Update:] The USDA office that oversees biotech crops, the Animal and Plant Health Inspection Service (APHIS), just released a brief statement via email in response to the Supreme Court’s ruling. In it, the agency leaves the door open to some sort of preliminary approval for the alfalfa seed, without indicating its intention one way or the other: “APHIS is carefully reviewing the Supreme Court ruling before making decisions about its next regulatory actions related to the deregulation of Roundup Ready alfalfa.” It also announced its intention to complete the full environmental impact statement “in time for the spring planting of alfalfa crops in 2011.” That start date presumes they get through the process without any more lawsuits or injunctions — not a safe bet, at all.
No mo’ gene flow?
More importantly, the Supreme Court has also now ruled for the very first time that “environmental harm” includes economic effects such as reduced agricultural yield or loss of market due to genetic contamination, as well as the concept of what biologists refer to as “gene flow” (in practice, the idea that genetically engineered material may get into conventional plants through cross-pollination). The Supreme Court now accepts that this phenomenon in and of itself is harmful and illegal under current environment protections.
“That’s a huge win for our side … That’s gigantic!” Michael Hansen, senior staff scientist of Consumers Union, told me. Future lawsuits can now confidently use the gene-flow argument against approval and use of genetically engineered crops.
Others share his glee. The Center for Food Safety called the ruling “a victory for the Center for Food Safety and the farmers and consumers it represents.”
For its part, Monsanto is spinning the ruling positively. In a statement posted on its website, the company said: “This is exceptionally good news received in time for the next planting season. Farmers have been waiting to hear this for quite some time. We have Roundup Ready alfalfa seed ready to deliver and await USDA guidance on its release. Our goal is to have everything in place for growers to plant in fall 2010.”
Well, from all appearances Monsanto has this flat wrong. Farmers can’t plant Roundup Ready alfalfa just yet. And even if the USDA tries for that preliminary approval, the Supreme Court made very clear that today’s ruling does not presume that any preliminary approval is (or isn’t) legal.
Indeed, the legal issues at the heart of the ruling aren’t over the rights of corporations or the science behind genetically engineered seed, but about the separation of powers between co-equal branches of government. The Supreme Court today stopped a District Court from telling a federal agency that it couldn’t make regulatory rules. For the judiciary to stop the government from doing its job requires meeting a very rigorous set of standards. After the Supreme Court decided to make this point the crux of its ruling, all the other issues fell by the wayside. Another way of looking at it is that the supposed “overreach” by the District Court was against the USDA, not Monsanto.
The Supreme Court has also made the point very clearly that outside groups have the ability to file lawsuits in order to stop any poorly conceived or improperly executed rule that a federal agency passes. And surprisingly enough, the Court — with its expansion of the definition of “environmental harm” to include things like gene flow — just gave consumer groups a whole new set of legal weapons to wield against the same companies currently crowing over the implications of today’s events.