A recent study conducted by Yale University’s School of Medicine proves that the Food and Drug Administration’s (FDA) approval process for testing new drugs is extremely inconsistent. The study, published on January 21 in the Journal of the American Medical Association, exposes the agency’s anxiousness to get new drugs onto the market, many without adequate testing.
The study’s lead author, Dr. Nicholas Downing, said his objective was to educate patients and doctors who presume that all new drugs have undergone the same amount of testing before hitting the market. His experiment included the examination of close to 200 new drug approvals between 2005 and 2012. What he found: “Not all FDA approvals are created equally.”
According to the study, researchers found the FDA to be quite inconsistent when it came to their approval process for drugs and medical devices. For example, some drugs required “high-quality” clinical trials, while about a third received approval on the basis of just one clinical trial.
The Washington Post reports that numerous trials involved some groups of patients and short durations, and only approximately 40 percent included trials in which the new drug was compared with existing drugs on the market.
Interestingly, when it came to upgrades on medical devices, the approval process became even more lacking, and arguably sporadic. Researchers found that upgrades to already approved implantable cardiac devices, such as pacemakers and defibrillators, failed to require new research or clinical data, leaving lots of room for mistakes on upgraded equipment.
Philly.com reports, “Since the first device received approval in 1979, the FDA has approved 5,829 changes to 77 devices, an average of about 50 changes per device. Over one-third of these changes involved the devices’ design or materials, and in the majority of these cases, the FDA deemed that new clinical data were not necessary for approval.”
As the authors of the study pointed out, this less regulative process by the FDA makes it easier for manufacturers to update devices; however, it leaves room for devices with life-threatening defects to make their way onto the market.
As reported by Dennis Thompson, senior investigator Dr. Aaron Kesselheim, an assistant professor of medicine in the pharmacoepidemiology and pharmacoeconomics division at Brigham and Women’s Hospital, said in a news release, “‘Key cardiac devices recalled in recent years — such as the St. Jude Medical Riata and Medtronic Sprint Fidelis defibrillator leads — were approved’ as adaptations to existing devices.”
Responding to the agency’s inconsistent approval process, Dr. Steven Goodman, a Stanford professor of medicine, said, “The FDA walks a tightrope, and until now we haven’t had a huge amount of information about how they’re doing that balancing act. The criteria they are using could be perfect, in that they are being flexible and allowing innovation and getting lifesaving drugs through to market. The other side is they could be making decisions too precipitously and allowing potentially dangerous medications through. It’s a difficult balancing act that requires constant monitoring.”
The documents made publicly available found that the FDA:
• Does not apply the same standard of evidence to all drugs going through clinical trial, approving medications based on criteria that vary widely case by case.
• Often approves upgraded versions of existing heart devices without requiring a clinical trial.
• Regularly overlooks early problems in drug trials that later cause significant delays in the approval of new medications.
This study confirms what many of us have already known about the government’s relationship with big corporations, and in this case, the pharmaceutical industry. Hunter Lewis’ book entitled Crony Capitalism in America 2008-2012 reveals the “government’s incestuous relationship with the drug industry.”
In his book, Lewis points out that getting a drug approved by the FDA can costs an average of $1 billion, and also requires having the “right people on your side.” Political and private interests create financial ties which encourage a “wink and a nod” relationship between involved parties.
“Pharmaceutical companies bury clinical trials which show bad results for a drug and publish only those that show a benefit. The trials are often run on small numbers of unrepresentative patients, and the statistical analyses are massaged to give as rosy a picture as possible. Entire clinical trials are run not as trials at all, but as under-the-counter advertising campaigns designed to persuade doctors to prescribe a company’s drug,” writes the Economist.
In other words, Big Pharma would much rather spend its $1 billion on advertising than on clinical trials designed to protect consumers’ health. The drug industry, also referred to as the patent medicine industry, devotes its time to developing man-made drugs in the lab, as opposed to utilizing naturally occurring molecules, because anything naturally occurring in the environment cannot be patented, and therefore not profited from.
This prevents Americans from learning about natural supplements, or other forms of alternative medicine that can be far more effective, inexpensive and overall safer than prescription drugs.
This is not just another FEMA camp article which can be easily debunked. This article deals with the fact that a recent government manual, leaked to the public, details the plans for mass arresting dissident Americans and stripping them of their citizenship so as to be able to violate the Constitution and the Geneva Convention for the treatment of prisoners.
The previously mentioned document which has been leaked online, is entitled FM 3-39.40 Internment and Resettlement Operations (PDF). The document was originally to be kept secret, but everyone in the military command structure, as we know, is not on board with the encroaching tyranny sweeping across this country.
There are two terms which should concern you, namely, Internment and Resettlement (I/R). As if this needs any further elaboration, the two terms simply mean that you will be snatched from your home and sent to a detention camp for an undetermined period of time and treated in a manner which will not be defined by any law.
The Authorities Practice Targeting Second Amendment Supporters
There exists solid evidence that our illegitimate government, hijacked by the banksters, possesses a detailed plan to mass arrest Americans and it has moved from the pages of government documents and it is actually being practiced by authorities on American soil.
Jesse Hathaway wrote for MediaTrackers in which he said that a recent Ohio State National Guard exercise “reveal the details of a mock disaster where Second Amendment supporters with ‘anti-government’ opinions were portrayed as domestic terrorists.” Hathaway’s article went on to say that the “Ohio National Guard Communications Director James Sims II, MediaTrackers claims, told the website that it was “not relevant” as to why conservatives may feel targeted by being portrayed as anti-government extremists”. “Okay, I’m gonna stop ya there. I’m going to quit this conversation,” Sims told the site when reached for comment. “You have a good day.”
Then there is the ’fake” $96 million dollar Northern Virginia town which is being used to train the military to enforce martial Law. Of course, the government says that this is a foreign town being used to train our troops to occupy a foreign town. If this is true, then someone needs to explain why the town has a Christian church, handicap parking spots, Washington DC subway logos, loading zone signs and road signs in English. A picture is worth a thousand words as you will see in the following video.
In the Words of the Government
Straight from the Internment/Resettlement article (12 February 2010 FM 3-39.40 1-5) it states the following:
“…I/R operations may place Soldiers in continuous contact with or near insurgents, terrorists, or criminals who will exploit every opportunity to escape and kill or injure U.S. personnel or multinational partners“.
Whether you believe there are Russian troops training on our soil, along with other UN “Peacekeeping” troops is an irrelevant argument at this point. The above excerpt makes it clear regarding the INTENT to use “multinational partners” to round up and detain American citizens.
The following is a list of involved agencies involved in the soon-to-be roundups of American citizens who are not drinking from globalist Kool-Aid.
AGENCIES CONCERNED WITH INTERNMENT AND RESETTLEMENT
1-40. External involvement in I/R missions is a fact of life for military police organizations. Some government and government-sponsored entities that may be involved in I/R missions include—
International Committee of the Red Cross (ICRC).
International Organization of Migration.
Local U.S. embassy.
Department of Homeland Security.
U.S. Immigration and Customs Enforcement (ICE).
Federal Emergency Management Agency.
There can be no doubt as to the meaning of the above quote from the manual. This government plans to enlist the aid of foreign troops in conjunction with the UN, DHS and FEMA for the purpose of rounding up and detaining American civilians.
Segregation of Civilian Detainees
I have previously been told my military sources that when families are transported to the I/R camps, husbands will be segregated from wives and children from parents.
“Detainees may also be segregated by ethnic and family groups and further segregated to protect vulnerable individuals. Additionally, detainees may be categorized by behavior (cooperative, neutral, or combative) to accurately resource guards and facilities”. Juveniles within the I/R population are typically segregated from the general population. (See DODD 3115.09.)
You Are An Enemy Combatant
Most of us who are detained in these I/R camps will be classified as enemy combatants. The following reads like the MIAC Report on steroids.
1-15. An enemy combatant is, in general, a person engaged in hostilities against the United States or its coalition partners during an armed conflict. (JP 3-63) Enemy combatant includes EPWs and members of armed groups.
1-16. Enemy combatants are divided as follows:
An enemy prisoner of war is a detained person who, while engaged in combat under orders of his or her government, was captured by the armed forces of the enemy.
Member of an armed group is a person who engages in or supports acts against the United States or its multinational partners in violation of the laws and customs of war during a named conflict that do not meet the criteria of a prisoner of war as defined within the Geneva Convention Relative to the Treatment of Prisoners of War”
The last sentence is frightening. It says that anyone who supports acts against the United States or its foreign mercenaries, is not entitled to humane treatment under the Geneva Convention. An offense against the US government could include the failure to turn in your gun or to not pay your taxes. This also opens the door to torture and summary extermination as you will not likely have any rights. For those who think this is an exaggeration, ask yourself what does “do not meet the criteria defined within the Geneva Convention relative to the treatment of prisoners of war”, actually mean?
We already know that the present administration holds the US Constitution in complete disdain and utter contempt. Do you remember the domestic terrorist designations which are contained in the MIAC Report? An authority not recognized by this criminal government would include Libertarians, Constitutionalists, a former Ron Paul supporter, a Bible believing Christian, a Second Amendment supporter and a veteran. If you belong to any of these groups, you are a domestic terrorist, an enemy combatant, a sovereign citizen and a stateless person.
The Legal Justification to Snatch You From Your Home
The following definition of an “evacuee” should concern all Americans. The definition of the term indicates the right of the military to remove a citizen from their home.
“Evacuee. An evacuee is a civilian removed from a place of residence by military direction for reasons of personal security or the requirements of the military situation.” (JP 3-57)
Do you remember when the globalists began to use the term “sovereign citizen”? This term was applied by DHS to Americans who claimed that they followed the Constitution, but not the “legitimate” governmental authority. The first time that I saw the term utilized by the government was in the Stacy Lynne case in which this anti-Agenda 21 activist had her son stolen by a NWO Judge, Julie Kunce Field, without so much as an allegation of parental wrong doing. This former World Bank and IMF consultant, turned judge, referred to Stacy as a “sovereign citizen”. As a result, Stacy was not allowed to call witnesses or object to the illegal practices she was subjected to while in Fields’ courtroom on the basis of any of the “constitutional violations” of law. This is because Field labeled Stacy as a noncitizen, a stateless person. The following defines a sovereign citizen as a stateless person.
Stateless Person. A stateless person is a civilian who has been denationalized or whose country of origin cannot be determined or who cannot establish a right to the nationality claimed.
If one is a stateless person, they are, by default, an enemy combatant. I have been assisting the Larimer County resident, Stacy Lynne, for 26 months. Stacy has not been able to see her son in almost a year and a half. I always wondered what kind of chicken outfit could steal someone’s child without cause. When I read this I/R manual, my eyes were opened and chills went up and down my spine. What was done to Stacy was accomplished because she was an anti-Agenda 21 advocate. And through the complicity of this globalist judge, Stacy was declared to not be a citizen and, as such, was not entitled to any Constitutional protections because a “sovereign citizen” is in effect a stateless person.
When martial law comes to our land, we will be snatched from our homes because of our collective verbal and behavioral resistance to the tyranny that is sweeping our land. We will be met by the likes of the self-appointed authority that globalist judges like Julie Kunce Field represent. These despots will use their unconstitutional powers to declare a wide swath of Americans to be stateless, or sovereign citizens. This mentality already exists in places like Ft. Collins, CO., and in Austin, TX. Soon, the entire nation will be declaring any perceived dissident to be a sovereign citizen.
Do I have to spell it out for you? All of us are Stacy Lynne. The NDAA is for you and for me. By virtue of the fact that you have visited this website, or a website that linked into this website, your every keystroke has been cataloged by the NSA and you and your family have been declared to be non-citizens and are targeted for forced Internment/Resettlement at some future date. This will most likely occur following a false flag event.
In the eyes of this criminal administration, we are all enemy combatants. We are all “sovereign citizens”. We are all stateless people not protected by either the Constitution, in the pre-arrest period, or, by the Geneva Convention, in the post-arrest period.In the next part of this series, I will spell out what losing your Geneva Convention rights will mean to you and your family.
You will never stand before a judge and jury and have your freedom stripped from you. You will likely be taken from your home at 3AM, loaded into a transport vehicle with other designated sovereign citizens with only the clothes on your back, and shipped to your final designated I/R camp.
Also in the next part of this series, I will expose more details on the upcoming mass incarcerations and what the dead banksters and fired generals have to do with all of this.
THE doctors were out of ideas to help 5-year-old Charlotte Figi. As a last resort her mother called medical marijuana shops to ease the 300 seizures her daughter was having every week.
Suffering from a rare genetic disorder, she had as many as 300 grand mal seizures a week, used a wheelchair, went into repeated cardiac arrest and could barely speak. As a last resort, her mother began calling medical marijuana shops.
Two years later, Charlotte is largely seizure-free and able to walk, talk and feed herself after taking oil infused with a special pot strain. Her recovery has inspired both a name for the strain of marijuana she takes that is bred not to make users high — Charlotte’s Web — and an influx of families with seizure-stricken children to Colorado from states that ban the drug.
“She can walk, talk; she ate chilli in the car,’’ her mother, Paige Figi, said as her dark-haired daughter strolled through a cavernous greenhouse full of marijuana plants that will later be broken down into their anti-seizure components and mixed with olive oil so patients can consume them. “So I’ll fight for whoever wants this.’’
Doctors warn there is no proof that Charlotte’s Web is effective, or even safe.
In the frenzy to find the drug, there have been reports of non-authorised suppliers offering bogus strains of Charlotte’s Web. In one case, a doctor said, parents were told they could replicate the strain by cooking marijuana in butter. Their child went into heavy seizures.
“We don’t have any peer-reviewed, published literature to support it,’’ Dr. Larry Wolk, the state health department’s chief medical officer, said of Charlotte’s Web.
Still, more than 100 families have relocated since Charlotte’s story first began spreading last summer, according to Mrs Figi and her husband and the five brothers who grow the drug and sell it at cost through a non-profit. The relocated families have formed a close-knit group in Colorado Springs, the law-and-order town where the dispensary selling the drug is located. They meet for lunch, support sessions and hikes.
“It’s the most hope lots of us have ever had,’’ said Holli Brown, whose 9-year-old daughter, Sydni, began speaking in sentences and laughing since moving to Colorado from Kansas City and taking the marijuana strain.
Amy Brooks-Kayal, vice president of the American Epilepsy Society, warned that a few miraculous stories may not mean anything — epileptic seizures come and go for no apparent reason.
Few dispensaries stock CBD-heavy weed that has the THC removed because the THC is what gets you high. CBD, or cannabidiol, lacks the psychoactive effects of smoking pot but retains many of the medicinal benefits, including its anti-seizure and anti-inflammatory effects.
Luckily enough, Paige Figi found Joel Stanley.
One of 11 siblings raised by a single mother and their grandmother in Oklahoma, Mr Stanley and four of his brothers had found themselves in the medical marijuana business after moving to Colorado. Almost as an experiment, they bred a low-THC, high-CBD plant after hearing it could fight tumours.
Mr Stanley went to the Figis’ house with reservations about giving pot to a child.
“But she had done her homework,’’ Mr Stanley said of Paige Figi. “She wasn’t a pot activist or a hippy, just a conservative mim.’’
Now, Mr Stanley and his brothers provide the marijuana to nearly 300 patients and have a waitlist of 2000.
The CBD is extracted by a chemist who once worked for drug giant Pfizer, mixed with olive oil so it can be ingested through the mouth or the feeding tube that many sufferers from childhood epilepsy use, then sent to a third-party lab to test its purity.
Charlotte takes the medication twice a day. “A year ago, she could only say one word,’’ her father said. “Now she says complete sentences.’’
The recovery of Charlotte and other kids has inspired the Figis and others to travel the country, pushing for medical marijuana laws or statutes that would allow high-CBD, low-THC pot strains.
Donald Burger recently urged a New York State legislative panel to legalise medical marijuana while his wife, Aileen, was in the family’s new rental house in Colorado Springs, giving Charlotte’s Web to their daughter Elizabeth, 4. The family only relocated to Colorado after neurologists told them Elizabeth’s best hope — brain surgery — could only stop some of her seizures.
“It’s a very big strain being away from the rest of our family,’’ Aileen Burge said recently while waiting for her husband to return from a trip to sell their Long Island house. “But she doesn’t have to have pieces of her brain removed.’’
Ray Mirazabegian, an optician in Glendale, California, brought Charlotte’s Web to his state, where medical marijuana is legal. He convinced the Stanley brothers to give him some seeds he could use to treat his 9-year-old daughter Emily, who spent her days slumped on the couch. Now, she’s running, jumping and talking. Mirazabegian is cloning the Charlotte’s Web seeds and has opened the California branch of the Stanleys’ foundation.
Mr Mirazabegian has begun to distribute the strain to 25 families and has a waitlist of 400. It includes, he said, families willing to move from Japan and the Philippines.