Offit and His Critics: Part 2
Dachel Wake Up: Robert Kennedy Jr Interview with Tucker Carlson

FDA’s Vaccine Safety Lie: Why Buildings Have Stricter Quality Controls than Pediatric Vaccine Trials

Safety first buildingNOTE: Thank you to Skyhorse author James Grundvig for the link to his important post about vaccine safety.  If you don't know James, he's the guy who found the ex-CDC current US fugitive Poul Thorsen and wrote about it in his book Master Manipulator.  Unless you are Mother Teresa (wink wink),  you do NOT want one James Grundvig sniffing around your life.

By James Grundvig

Imagine President Donald Trump, in his past life as a real estate developer, learning that his new building had its structure compromised — the concrete didn’t meet design strength. Wanting to get to the bottom of the issue, he would direct his team to investigate the problem and report back to him. The findings, however, would shock him.

The contractor followed the “guidance” of the design team, but not the minimal code set by the city or the concrete industry. Trump would learn such guidance gave the contractor leeway to follow his whims on the design criteria of the specifications. That would cost Trump’s project time and money in remediation, and lawsuits would fly out the door.

But since no construction project in North America gives the contractor only “guidance” on what codes to follow — they must follow all that apply — then it’s truly stunning to learn this is what the FDA has been directing vaccine manufacturers to do for decades: Follow agency guidance, not a strict code, minimal requirements, specifications or regulations when it comes to the design and execution of vaccine safety studies.

Vaccine manufacturers are free as a bird. They can virtually do what they want. But how can that be?

It’s all in the FDA’s Biologics Division, in the words that gives “Guidance” for the different vaccine clinical trials, such as, “Guidance for Industry: For the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies.” Or how about, “Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines.”

If an architect or engineer ever used the word “consideration” in their specification on what design criteria to build to, the contractor would take liberties and not worry about exact compliance with any specification or regulation. They would just build fast, cheap, and dirty. And that is what vaccine makers have been doing for years.

So why does the FDA not write real codes and specifications, with strict standards and protocols for the vaccine makers to follow, achieve, and adhere to when conducting vaccine clinical trials?

Vaccine Clinical Trial Propaganda 101

According to the FDA, the word “placebo” can get bandied about on vaccine safety studies. A placebo for vaccines is not the same placebo used in drug trials. Vaccine makers are not obligated to use a real placebo, like saline, since guidance gives them an option and not a firm standard to follow. This leeway allows Big Pharma to use an “active comparator” vaccine, such as another similar vaccine or the clinical trial vaccine with the deactivated disease removed, as a “control” instead of a true placebo (saline).

Worse, the FDA allows — perhaps encourages — vaccine makers to freely use the word “placebo,” when in fact they should be forced to use the word “control” when they use the comparative vaccine during safety trials. But time and again, when one reviews the literature, such as the 28-page Gardasil package insert that states only “320 people” were given the saline placebo, or less than 9% of the control group, with the only reactions monitored for the true placebo group being mild, local reactions, such as redness or swelling.

So the Gardasil clinical trial is a sham. Out of the 3,690 “controls,” only 320 received the saline placebo. That meant 3,370, or 91.33%, were jabbed with the comparative vaccine, which was laden with aluminum at “double the amount in every other vaccine.”

No wonder New York moms are suing the state on forced Gardasil injections and that Judicial Watch and other law firms have jumped into the fray.

If only the lawyers understood the nuances of quality control inspections and quality assurance programs they would see what the vaccine safety trials really are — a ruse under the FDA guidance platform.  Read the rest at Medium.com.

Comments

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Jeannette Bishop

https://www.youtube.com/watch?v=KzIgqQPrqpc

Speaking of quality control, RFK Jr. went into the all cause mortality publication(s) by Aaby regarding DTP administration in Guinea-Bissau. I hope it was not lost on viewers that this is the only vaccine for which we have data compared with something like a true control group looking at a vaccine's actual impact on life and death, and it only took 30 years to publish it!

Mr. Washington

no mention of aluminum nuerotoxicity/immune activation by RFK Jr tonight?

someone here with more influence than me really needs to get in touch with RFK Jr and get him up to speed on alum/immune activation IL-6 studies. JB Handley and friends, that means you!

https://healthcareinamerica.us/did-chinese-scientists-find-autisms-missing-puzzle-piece-2d50be5b9122

go Trump

Perhaps Representative Jason Chaffetz not running for office again could be a good thing. He might be much more free to do what is right, rather then looking for money for the next two years for his next campaign.

Is there some simple committee vote which is preventing Dr. Thompson from coming to Congress ?

Not sure when the President will play the ‘Autism card” as it is such an endless, huuugge, public fraud. Who is the most dangerous to American children, the Russians or the AAP ???

The people we elect to Congress are really not the ones in charge anymore. We only have a few years to change a great number of things or it will be “lights out for the freedoms” we have taken for granted far too long.

Aimee Doyle

@Bob - about "draining the swamp" - seems to me like he's adding to the alligators.

Scott Gottlieb, Trump's FDA pick, is pro-vaccine. He is also a physician who is an industry insider.

From an interview in early April (link below quote) - "Gottlieb took very public issue with one of President Donald Trump’s high-profile grievances. Gottlieb was unequivocal that the anti-vaccine movement, newly emboldened by Trump’s vaccine skepticism, was tilting at windmills."

“This has been one of the most exhaustively studied questions in scientific history,” Gottlieb said. “We need to come to the point where we can accept no for an answer and come to the conclusion that there is no causal link between vaccination and autism. We’ve invested, and Congress has invested, enormous resources in studying this question.”

http://www.xconomy.com/national/2017/04/05/fda-nominee-scott-gottlieb-to-anti-vaccine-crowd-get-over-it/#

Tom Price, Trump's HHS choice, has rejected the claim that vaccines cause autism. He has said that the states should decide vaccine mandates, but unless all the states opt not to have mandates, tens of thousands of kids will continue to be at risk.

Do you think Trump is likely to appoint a CDC Director who will buck these two individuals? To me it doesn't seem like he really cares about the vaccine issue - despite his rhetoric. He certainly doesn't care about programs that our kids need once they've been vaccine injured, like appropriate special education, funding for supports and services, funding for therapy and treatment, funding for scientific research into cause and cure, etc.

Jeannette Bishop

Thank you, Bob Moffitt. Under Social Media on this page it says 9:40pm EDT tonight:

https://worldmercuryproject.org

Bob Moffit

Just read that RFK will be interviewed by Tucker Carlson on Foxnews at 9:00 tonight. As I understand it .. the interview is about VACCINES!!!!!!!!!!!!!!!!

angusfiles

The Globalists are under attack and dont they know it Their la la land is coming to an end and prison time for the perpetrators. Lets hope Trump acts with haste.

Pharma for Prison

MMR RIP

annie

As anti-Trump advocates gear up for their "science" rally this weekend I hope someone is there to explain to people that infantcide is not science.

Lisa

I, too, wondered if Chaffetz' decision not to run again had anything to do with the Thompson scandal. I think that when this all comes out, Chaffetz could rightly be accused of obstruction of justice. He had the documents in his possession for way too long and apparently did little or nothing with them.

The revolution is coming, and when it does, it won't be broadcast on (FAKE NEWS) television.

I, too, am very concerned with Trump's FDA appointment. Looks like a total insider who will do everything possible to protect the industry. Very sad.

HarvardMD

As a physician who worked in pharma for 10 years in drug development, I was shocked to learn of the lax standards for vaccines. Things aren't perfect for drugs but at least true placebos are mandated (unless good reason otherwise), 1 year cumulative safety data in a minimum number of people, animal tox studies, including long-term juvenile and adult carcinogenic studies are required - any red flags that isn't properly scientifically explained would end the drug and finally demonstration that the drug works as claimed.
This means just showing reduction in blood sugar or cholesterol is not good enough (think serologically positive conversion), you need to demonstrate a clinical benefit like decrease in heart attacks (think cervical cancer, or even acquiring asymptomatic pertussis).
I never imagined vaccines were any different, most vaccines would not meet drug standards and I suggest the standards should be higher as vaccines are injectable, use a preventative measure in healthy individuals, for mass use, often in the most vulnerables (i.e., infants).

kws

I'm saddened that the FDA permits flawed studies to support vaccine marketing applications. Given the post marketing experience, other drugs would have been pulled from the shelves long ago. Furthermore, autism and related spectrum disorders would be a measured endpoints on all vaccine trials, they would be powered to detect differences in populations, prospective, randomized, blinded, and use honest placebo's.

The industry will counter with "its not ethical to use real placebo's" since they might actually get the disease. Well, its not ethical to maim people with "controls" either.

They will dish out more retrospective epidemiology studies from Denmark or Kaiser which are a load of data mined crap.

The political corruption at the CDC and FDA will continue until we remove them.

Bob - I'm glad Chaffetz is out and I'm not optimistic about Trump's FDA appointee, he looks like a total insider.

Bob Moffit

'The longer President Trump waits to launch a Vaccine Safety Commission the more the vaccine clinical trial lie will continue to be used to sell and cajole the American people that all is well with the latest vaccine that has been tested and found “safe” for consumer use, when in fact it has not."

The FDA is just one ... of many other .. federal regulatory agencies .. that have been captured by the industries they are supposed to be "regulating". Instead .. the industries are "regulating" the federal bureaucracies .. is this a great country or what?

THIS IS THE SWAMP THAT TRUMP HAS PROMISED TO DRAIN! WE SHALL SEE

(off topic) ... Yesterday ... Representative Jason Chaffetz, the powerful chairman of the House oversight committee, told supporters on Wednesday that he would not seek re-election to Congress — or run for any office — in 2018.

Could this be the main reason for Cjaffetz's sudden decision to retire:

http://www.jeffereyjaxen.com/blog/house-oversight-committee-now-investigating-cdc-whistleblower-dr-william-thompson

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