FDA Approved Drugs – One of the ‘Top Killers’ In America
None of what you are about to read is new, and the saddest part of all this is the stark ignorance the general public has with relation to this topic. What if you were told well over one hundred thousand people die every single year from drugs? Most people wouldn’t be surprised, or bat an eyelash at this statement. You would probably think, Well, they are druggies who overdosed on illegal drugs, or abused prescription drugs for recreational purposes.
Well, the above statement about yearly drug deaths is unfortunately true … but this statement is in reference to the well over one hundred thousand people who die every year from FDA-approved prescription pharmaceutical drugs … prescribed properly by a licensed doctor.
This makes these drugs one of the highest ranking killers of Americans on a yearly basis. How is this even possible in a country that spends more on healthcare and its associated government agencies than any other country on this planet … by a huge margin?
If well over 100,000 Americans die each year from prescription drugs (the actual number is higher and varies year to year, but we use this number for simplicity of calculation), that is well over twice as many who die in auto related accidents per year (about 40,000). This is also three to four (depending on the year) times more than the number of people who die as a result of gun violence or accidents each year (about 30,000). So where is the government or public concern, or outrage, we see from these auto or gun deaths … ?
So are these prescription drugs being abused … or is this indicative of pharmaceutical drugs gone seriously wrong?
Let’s delve deeper into the mechanics of this catastrophic reality …
United States health agencies are funded at a massive and steadily increasing level to protect the health of the American people. Yet it is obviously still not enough to keep you and I safe … by their own admission. This denotes severe ineptitude in the – Request for funds – The use of funds requested – Or a level of complicity that is beyond doubt criminal by any definition of the word.
The Annual budget for the Food and Drug Administration (FDA) is approximately $4,700,000,000 ($4.7 Billion).
How is this agency responsible to the American people.
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.
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. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
Let’s focus on the FDA’s effectiveness in accomplishing its mandate.
New drugs are constantly being introduced via FDA approval and some, as a result of public harm are taken off the market because of the safety net put in place to protect us. This process is a four phase system. What you are about to find out in the video below should make you very uncomfortable … Especially if your doctor says:
“We have a brand new drug to treat that”
If you ever hear that statement, turn and run (don’t walk) to the nearest exit and don’t ever look back!
Don’t Take the ‘New Prescription Drugs’ !!!
Dr. Timothy Scott goes through the four stages of approving and patenting a drug. He explains how it takes years to complete this process. He explains why stage four is almost always overlooked and never done or completed. He also discusses the ill effects this can have on patients.
What Are the Different Stages (Phases) of Clinical Trials?
Clinical trials are conducted in a series of four steps or phases. Each step or phase builds on the results of the phase before it.
Phase I trials: Is it safe?
Phase I trials are the first trials to involve people. (Preclinical studies in petri dishes and animals already have been done.) Phase I trials are small, with usually between 15 to 50 people participating. In phase I trials, researchers are figuring out:
- the best way to give a new treatment (as an injection or as a pill)
- the highest dose that can be given safely, without serious side effects
In phase I trials, researchers closely monitor the participants and adjust the dose a little at time until they find the amount that works the best with acceptable side effects. This dose is usually the one used for further testing.
Phase II trials: Does it work?
Phase II trials look at how effective the new treatment is. Phase II trials are slightly larger than phase I trials and usually involve 25 to 100 people. Researchers start with the dose and method of giving the new treatment that were found to be best in phase I. The phase II participants are given the new treatment and the researchers watch to see if the treatment has some benefit. The benefits the researchers look for can be different, depending on the goals of the research:
- cancer tumor gets smaller
- cancer stops growing
- longer time before the cancer comes back
- longer survival time
- better quality of life
If a certain percentage of participants benefit from the treatment and the side effects are still acceptable, the new treatment will probably go on to a phase III trial.
Phase III trials: Is it better than what we have now?
Phase III trials compare the safety and effectiveness of the new treatment to the current standard of care. Phase III trials are usually large (some involve tens of thousands of participants) and are done at many places in the United States and sometimes around the world. A phase III trial is the last step a new treatment goes through before the U.S. Food and Drug Administration considers approving it for general use.
Participants are usually randomly assigned to receive the current standard treatment or the new treatment. If possible, the trial is double-blinded, which means neither the researchers nor the participants know who’s getting which treatment. Double-blinded clinical trials help researchers see the actual benefits and side effects of a treatment without bias or outside influence. Results from a randomized, double-blinded trial are considered more credible than results from a trial that isn’t randomized or double-blinded.
Just like phase I and phase II trials, phase III trial participants are watched closely to see if any serious side effects develop. Treatment is stopped if side effects appear to be dangerous.
Phase IV trials: Are there any other uses or benefits?
Phase IV trials usually look at whether the treatment offers benefits or produces long-term side effects that weren’t studied or seen in the phase II or phase III trials. Phase IV trials usually are done after a treatment has been approved for use by the U.S. Food and Drug Administration. Phase IV trials are less common than phase I, II, or III trials and may involve hundreds of thousands of people.
For example, one phase IV trial is interested in participation from women diagnosed with breast cancer who are taking an aromatase inhibitor. Aromatase inhibitors are known to cause joint pain and bone loss. This phase IV trial is looking at whether the joint pain some women have while taking an aromatase inhibitor is linked to more defects in their cartilage compared to women not taking an aromatase inhibitor.
The third highest cause of death in the USA is FDA Approved Prescription Drugs!
Stop and consider this for a minute …
The issues and pitfalls of an agency (FDA) with such (very) close ties to the industry they are mandated to police do not stop there as you will find out …
According to a Yale School of Medicine study published in the January 22, 2014 issue of JAMA, reviewed 188 drugs and technologies from 2005-2012 and documented that more than 1/3 of the drugs were approved not only on the basis of a single clinical trial, but also were often small, short, and involved surrogate metrics rather than clear clinical endpoints. It is hard to have trust in these kinds of criteria.
The study also found that about 40% of drug approvals were brought to market without ever being compared to already existing approved drugs. The power of the FDA is remarkable, and makes one wonder if its conflicts of interest with the pharmaceutical and technology industries influence FDA approval.
Watch this video to find out more of the intimate relationship alluded to above …
And now for the Real Kick in the Proverbial Teeth …
Several years ago Congress became suspicious of the integrity of the FDA Approval Process, so they got together with the General Accountability Office (GAO) to set up a sting. They sent out an application for testing of a nonexistent product, Adhesiabloc, by a nonexistent company, Device Med-Systems. These are the results …
The First Sting
Congress became suspicious, so they got together with the General Accountability Office (GAO) to set up a sting. They sent out an application for testing of a nonexistent product, Adhesiabloc, by a nonexistent company, Device Med-Systems.
Subtlety is apparently not one of the GAO’s strong suits. Adhesiabloc was described as a gel that would be poured into a patient’s stomach after surgery to collect the bits and pieces left over from the operation. The instructions were to pour more than a liter into the wound.
Not one of the IRBs bothered to check the credentials of Device Med-Systems. Not one noted that the company’s headquarters was listed as a post office box in a shopping mall. The doctor who was supposed to have been leading development, Jonathan Q. Kruger, didn’t exist either. Not one checked to see if the product had ever been registered in development. Even so, two of the IRBs turned them down. Apparently, they actually read the testing protocol. The board member of one stated that it was the “riskiest thing I’ve ever seen on this board,” and an employee of the other simply called it “junk”.
Coast IRB LLC of Colorado Springs apparently didn’t see any value in reading the documentation. Their board members, several of whom were MDs, approved it unanimously, describing it as “probably very safe”.
The Second Sting
If that isn’t bad enough, the GAO did a second sting—and this one was on the Department of Health and Human Services (HHS), the parent of the FDA.
You have to wonder how an IRB as sloppy as Coast was licensed in the first place. This sting shows us. They put together an application to set up an IRB and sent it to HHS. They named their sting Trooper, after a three-legged dog of a congressional staffer. (Some reports state that the company name or the CEO was Trooper, but that doesn’t fit the scheme, as you’ll see.)
The name of the fake company was Phake Medical Devices. The names of the principles were April Phuls,Timothy Witless, and Alan Ruse. The company’s location was listed as Chetesville, Arizona.
The application sailed through.
Daniel Dueber, Coast IRB’s CEO, was subpoenaed to testify to congress. That must have clued him in that something might be wrong. Apparently, he or someone else in his company went through their files to search for irregularities. Adhesiabloc popped out. Oops! This was five months after the approval. They went into action. They reported the fraud. They ordered the immediate termination of the nonexistent trial …
Continue reading here: FDA Approves Nonexistent Product from Nonexistent Company for Human Testing
As should be readily apparent to you by now, the system is failing us in a massive way! How many people are harmed or dead over the last 3-4 decades (or longer) if you consider the average deaths per year greatly exceeds 100,000 due to FDA approved prescription drugs. Now try to justify the ineptitude of this government agency mandated with the protection of our health?
The questions that must be asked are: Is this nothing but bad management of this agency over generations? Is this a result of tasks too complex for this agency? Or is this (as many of us suspect) the result of Complicity and an ever more enticing revolving door with associated industries?
In any case with the number of Americans harmed (many for life), or deaths associated with the products (vaccines and drugs) of the Pharmaceutical industry and their intimate relationship with these “health agencies” (FDA, CDC, USDA) is astronomical and a red flag should be frantically and continuously waving!
My Parting Shot …
About the Author: Roger Landry (TLB) spent about three decades of his adult life either in, or working for the military, with about two decades working directly for the Military Industrial Complex facilitating DOD contracts. His awakening to Political, Economic, and Health realities was less than seven short years ago. Since that time he has founded The Liberty Beacon Project (TLB) consisting of over a dozen proprietary global websites, media projects such as TLBTV, and partner websites across the planet. He contributes regularly to multiple forums both in and outside of TLB Project. Most of his work can be found on the TLB Flagship website TheLibertyBeacon.com
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