Tag Archives: Drug Information

Informed Consent Action Network: Merk VARIVAX – Chicken Pox Vaccine

Reposted by permission from The Highwire with Del Bigtree

Merck sells the first and only chicken pox vaccine (VARIVAX) sold in the United States. VARIVAX is produced by growing chicken pox virus on the cell strain from aborted fetal tissue and was licensed by the FDA in 1995 for people aged 12 months and older.

Prior to FDA licensure of a new experimental vaccines, such as VARIVAX, are expected to undergo long-term placebo-controlled clinical trials with typically tens of thousands of participants to assure their safety.

To evaluate whether Merck met any of these criteria, ICAN, through its attorneys, headed by Aaron Siri, demanded that the FDA produce copies of all the clinical trial reports relied upon to license Merck’s chicken pox vaccine. After the FDA stonewalled ICAN for 14 months, failing to produce even a single document, ICAN sued the FDA in federal court to receive the clinical trial reports for this vaccine.

In this lawsuit, the FDA finally capitulated and began its production of the requested clinical trial reports, the last of which were recently received. A total of 10,796 pages were produced encompassing all the clinical trial reports submitted by Merck to get the VARIVAX license approved. A complete copy of the production is available here.

What do these documents show? They show that this product should never have been licensed.

Only one trial relied upon to license this vaccine included a placebo control. Buried deep in the reports, however, it admits that this “placebo” is an injection of lyophilized stabilizer containing approximately 45 mg of neomycin per milliliter. This is not a placebo! A placebo is an inert substance like saline — it is not another drug! Worse, this trial only contained 956 children, of which 491 received VARIVAX and 465 received the alleged “placebo.” Compounding its fake placebo and miniscule number of participants, these children were only monitored for clinical complaints for 56 days and then for an additional 14 days thereafter for serious adverse reactions.

Nonetheless, even in this shoddy, underpowered study, four serious adverse events (including seizure, ulcer, and viral enteritis) were reported in the group of children receiving VARIVAX and none were reported in the group receiving the alleged placebo. That differential was deemed acceptable by the FDA because Merck’s paid investigator did not consider these serious adverse events to be related to VARIVAX.

Nine months after this study began, the children from the “placebo” group were administered VARIVAX. This assured that any differences in the longer-term reaction profile between those that received VARIVAX and those that received the “placebo” in this miniscule trial could never be uncovered.

There was also one study that involved just 61 children in which 32 received VARIVAX and 29 received nothing. At the 8-week mark, the control group (the children who did not receive an injection) were vaccinated with VARIVAX. During that 8-week period, the children receiving VARIVAX had triple the rate of temperatures above 102 ̊F, nearly double the rate of ear infections, 50% increased rate of upper respiratory illness, and 33% increased rate of systemic clinical complaints.

The rest of the trials produced by the FDA were not blinded, not randomized, nor did they include a control group. These trials could therefore not provide scientifically valid data to support the product’s safety for licensure.

The FDA’s basis for licensing VARIVAX is incredible when considering that: (i) states mandate by law that millions of children receive VARIVAX every year; (ii) Merck cannot be sued for most injuries caused by this product under federal law; and (iii) Merck’s sales of this product, alone or in combination with another of its products, was $2.275 billion in 2019. But yet, the FDA licensed this product based on one fake “placebo” controlled trial, with less than 1,000 children, that reviewed safety for only around 2 months, and then vaccinated the “placebo” group at nine months!

The FDA should be ashamed to call itself a regulatory agency. ICAN will be taking additional formal legal action regarding the lack of safety relied upon to license this product.

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The Informed Consent Action Network (ICAN) is dedicated to ensuring the public is informed about consumer safety issues. As part of this, ICAN dug deep into NIAID’s recent trial of the drug, Remdesivir and found deviations in study protocol, study size, and inclusion and exclusion criteria. ICAN has sent a letter to NIAID Director, Dr. Tony Fauci, who has claimed that this drug will be “the standard of care’ for COVID-19,” demanding answers to the serious irregularities within the study.

Just what we do here at the informed consent Action Network?
That’S our parent company, that’s the nonprofit!
That makes the highwire possible.
We not only report on the news.
We are making news.
We have won lawsuits against the FDA, CDC National Institute of Health and Health and Human Services, and I want to bring your attention really quickly if you want to know what we do.
This is a brand new letter that we’ve drafted up and sent out.
We are starting an investigation into who Anthony pouchy.
This letter is specifically about REM, desi beer.
If you watched our show a couple of weeks ago, we have serious questions about the manipulation.
The old only study now remember what Dolores was saying.
Hydroxychloroquine is showing success all around the world it works.
Yet Tony pouchy has come out against hydroxychloroquine.
It’S not being used appropriately upon diagnosis in hospitals in New York, where elderly are dying, and I think that that’s a real problem instead he’s come out.
He’S excited about REM, desi beer, which is the exact flip of the coin, the opposite side of the coin.
When I’m desert beer is failing in studies, all around studies been dropped out.
We talked about this two weeks ago, if you’re gonna watch that show but they’re dropping out of trials, because people are dying at higher rates that are taking REM, deser, be while we’re beginning an investigation.
This letter is going out to Tony pouchy.
Let me read some of the excerpts right now.
Can we bring that up?
This is dear doctor, foul to the informed consent Action Network is reporting to you on April 29 2020.
You stated that the data shows that REM dezer beer has a clear-cut, significant positive effect in diminishing the time to recovery.
This study appears to have many serious irregularities as detailed below prior to sending these concerns to the appropriate federal ethics and oversight committees.
We wanted to provide you an opportunity to respond.
The study at issue a multicenter randomized clinical trial, commenced on February 24th.
Like all such studies before it commenced, a detailed study protocol was established.
It is critical that the protocol be set in stone before a study begins.
This assures the validity of the study.
Despite the importance of adhering the study protocol, there were numerous substantive deviations in Nyad study of REM, desi beer, the one you yourself for doing all the failed studies you’re about to override it.
With one study that you were doing, we go through all of the issues: they changed the amount of people in the study they went on and you know, despite the study protocol, they started changing categories.
They even removed death as one of the categories so that we know how many people died.
All of this, while they’re in the middle of the study, you’re changing it while you’re seeing results come in this by almost every definition in science is scientific fraud.
Therefore, we end this letter this way and you can read it.
This is up on our website.
I will not speculate as to your motives and seeking to have REM.
Does it be a license and pushed out to the public so quickly?
What I will say is that you and I ad can do better.
The American people deserve better.
They deserve science, that is on solid footing, not a sales pitch based on a single study in which every material element of its protocol was changed after patient outcomes were observed.
Please provide a response on or before May 22 2022 the serious irregularities regarding the Nyad REM, dezer beer studied detailed above.
If we do not receive a response by then we intend to pursue ethics and related claim with the appropriate federal agencies.
Very truly yours, Dell, big tree CEO of the informed consent Action Network.
You can mark your words.
We are not just started, stop being a letter.
I hope that doctor foul she decides to respond to us and explain what’s going on with this group II study, I also want to let you know that we have 34 requests.
Freedom of Information Act, request for materials from Falchi people at HHS, CDC the NIH.
We are under a full-tilt shock-and-awe investigation of our government, and this ridiculous thing that’s been going on with coab in nineteen.
If you want to support these efforts along with this amazing show where we’re bringing in the best scientists around the world, I really need your help.
These lawsuits are going to cost a lot having this legal team put forward these letters and do these FOIA requests.
It is non-stop.
Please donate 20 for 2020 right now.
You can make a difference.
You can stop this, not only me putting up a tweet.
Stop and cheer at County for taking your kids away.
Imagine what we can do if we can stop Tony pouchy from manipulating studies to push through bad drugs to erase good drugs or make us wait on vaccines while they destroy our economy, the highwire is directly active.
Maybe I’m not a news reporter, maybe on activists I’m called all sorts of different things in newspapers all over the world.
All I can say is I work for you.
We are here for you.
We are fighting for the issues that matter and we are discussing the issues that matter and we were reporting on everything we find and if we find a problem, we don’t just report on it, we investigate it, we send letters and ultimately, we bring lawsuits.
You are making that possible if you want to try and imagine who else is doing exactly that.
I’D like to know and I would also celebrate them too, but we are here for this is sponsored by the informed consent action Network.
You are a part of that network, you were making it happen, and all of this is to make sure that this entire planet does not turn into a circus that our country and government is not some circus game.
But it’s run by intelligent people that actually care about us.
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Drug Information Update- New FDA Drug Safety Communication on tramadol

Drug Information Update- New FDA Drug Safety Communication on tramadol FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration (FDA) is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. We are evaluating all available information and will communicate our final conclusions and recommendations to the public when our review is complete.

Tramadol is not FDA-approved for use in children; however, data show it is being used “off-label” in the pediatric population. Health care professionals should be aware of this and consider prescribing alternative FDA-approved pain medicines for children.

Parents and caregivers of children taking tramadol who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness should stop tramadol and seek medical attention immediately by taking their child to the emergency room or calling 911. Parents and caregivers should talk with their child’s health care professional if they have any questions or concerns about tramadol or other pain medicines their child is taking.

For more information, please visit: tramadol

Drug Information Update- New Drug Safety Communication on Avycaz (ceftazidime & avibactam)

Drug Information Update- New Drug Safety Communication on Avycaz (ceftazidime & avibactam)
FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.