Tag: FDA

Reviewing a book blacklisted by Amazon because it dared say things Amazon doesn’t like

1:35 pm

The Plague of Models, blacklisted by Amazon
The Plague of Models, blacklisted by Amazon

They’re coming for you next: Last week I posted an essay on the over-use and misuse of computer modeling in today’s scientific community, focused specifically on the unreliability of all climate models to successfully predict any actual climate trends.

One of the individuals who read my essay, Kenneth Green, immediately commented here on Behind the Black to note that he had just published a book on this very subject, entitled The Plague of Models: How Computer Modeling Corrupted Environmental, Health, and Safety Regulations, describing how the misuse of models has resulted in the proliferation of government regulations based not on actual data but on computer models that in many ways are nothing more than the opinions of the computer programs.

Green also noted that Amazon has refused to make his book available for sale, essentially banning it for no justifiable reason. As he explained to me in an email,

My publisher, who is a start-up small Canadian publisher specializing in public policy books, tried to upload The Plague of Models to Amazon, as he had previously done with half a dozen other books while working at previous institutions as in-house publisher.

This time, unlike his previous experiences, the book was taken down shortly after it was uploaded (and we know the upload process worked, since the book was available briefly for preview, so there was no technical issue with the manuscript file). The publisher got a form-letter email saying that the book had been taken down because it may have violated some (non-specific) Amazon Term of Service. When he sent a note back requesting clarification/appeal, he got another form letter, this one repeating that the book may have violated some term of service, and warning that any attempt to re-upload would get his entire account terminated.
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The evidence continues to pile up: The government’s strongarm policies against COVID were utter failures

2:05 pm

The modern basis of medical research in the dark age
Health policy during the Wuhan panic

Since my last COVID update in June, the number of research papers has continued to show, with increasing force, the total and utter failure of every single one of the draconian edicts imposed on the pubic by leftist governments both in Democratic Party controlled states in the U.S. as well as worldwide.

Below are a small sampling of this accumulating research. Read it and weep.

My sorrow however comes from knowing that this knowledge was patently obvious from day one. This new research really isn’t new, it confirms what was well known, and was confirmed quickly as early as March 2020. However, when skeptics like myself, mostly on the right, desperately tried to stem the panic, it was all to no avail. The government’s edicts were always wrong, but no one wanted to listen. The data below merely confirms what all the data, before and during the Wuhan panic, was already telling us.
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Connecting the dots of the COVID lie

1:40 pm

What our leaders want us to be
What our leaders want us to be

There were many reasons the world panicked in 2020 when COVID appeared and spread from China. Some of that panic was motivated by natural fear of an unknown disease. Some of it was motivated by a desire for power, harnessing that fear to nullify the Bill of Rights and the legal restraints on dictatorship. Some of it was inspired by a simple blind hatred of Donald Trump, and saw an opportunity to use the virus as a tool for getting him out of power. And some of the actions of our leaders was motivated by pure and simple greed, willing to let millions die so that they could personally get rich, or richer.

To connect the dots to understand the worst players in this terrible story, we need to look at more than one story or report, each telling us something that the fear-mongers have tried to hide from us so that their dishonest and sometimes quite evil motives might not be recognized.

To begin, there are these two stories, showing that we now have solid evidence that the military committed fraud in order to hide data that showed the COVID shots were causing a terrible number of health injuries and deaths to soldiers being ordered to take them.

From the first story, describing a lawsuit that claims the Defense Department committed fraud:
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Pushback: Blacklisted doctors opposed to present Biden/CDC/FDA policies testify to Congress

12:55 pm

Do not comply: A large group of highly qualified doctors and nurses, almost all of whom have been blacklisted, fired, suspended, or prevented from treating patients simply because either they opposed the COVID shot mandates or wished to treat their patients as they saw fit, testified on January 24, 2022 in Congress, describing in horrible detail the many times they were forced to watch as their patients died because their hospitals had forbidden them from providing the treatments they knew would work.

Below is a 38 minute-long video showing the most dramatic testimony during the five hour hearing. If you want to watch the full hearing, go here.
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Nebraska AG report blasts FDA and NIH positions on COVID treatment

5:51 pm

In a ruling [pdf] making it clear that doctors are doing nothing wrong if they prescribe ivermectin or hydroxycholoroquine as part of their treatment for patients with COVID-19, the Nebraska attorney general not only provided detailed documentation demonstrating the reasonableness of prescribing those drugs — based on extensive peer-review research by scientists — he blasted the FDA, the NIH, and WHO for their somewhat ignorant hostility to those drugs.

The document is long, but everyone should read it, mostly to get a clear idea whether they or their doctor should consider using these two drugs should they come down with COVID. The answer appears to be an unqualified yes. Both drugs have different purposes, but both appear, if used properly, to be beneficial and reduce the severity of the virus.

The report also makes it clear that the hostility to these drugs by these American health agencies is irrational and somewhat alarming. See for example the one excerpt describing the FDA’s absurd statements in connection with ivermectin, a drug that doctors have been safely prescribing since the 1970s:

From Nebraska report

The report details at length the numerous research that makes these FDA statement so anti-science as to be quite horrifying, especially as this is the federal agency that is supposed to regulate food and drugs.

Once again, download this pdf and read it for yourself. You will find yourself significantly educated, based on actual peer-reviewed science.

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FDA hearing and comment period for giving COVID vaccines to children 5 to 11

10:14 pm

The FDA is going to hold a hearing on October 26, 2021 to discuss whether to allow the experimental vaccines to be given to children ages 5 to 11. From its webpage:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On October 26, 2021, the committee will meet in open session to discuss a request to amend Pfizer-BioNTech’s EUA for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age. [emphasis mine]

Prior to this meeting the FDA has a public comment period, allowing anyone to comment on this agenda. That five day comment period began today. If you want to comment you can do so here.

This meeting is clearly linked closely to the Biden administration’s announcement today that it is preparing to roll out a campaign to get every child in the country vaccinated, once the FDA approves.

The Biden administration has secured enough vaccine supply to vaccinate the 28 million children ages 5 to 11 who would become eligible for vaccination if the vaccine is authorized for that age group and will help equip more than 25,000 pediatric and primary care offices, hundreds of community health centers and rural health clinics as well as tens of thousands of pharmacies to administer the shots, according to the White House.

“We know millions of parents have been waiting for Covid-19 vaccine for kids in this age group. And should the FDA and (US Centers for Disease Control and Prevention) authorize the vaccine, we will be ready to get shots in arms,” White House Covid-19 response director Jeff Zients told reporters at a White House Covid-19 briefing on Wednesday. Zients continued: “Kids have different needs than adults and our operational planning is geared to meet those specific needs, including by offering vaccinations in settings that parents and kids are familiar with and trust.”

The administration is also launching a partnership with the Children’s Hospital Association “to work with over 100 children’s hospital systems across the country to set up vaccination sites in November and through the end of the calendar year,” the White House announced.

The administration also plans to help make vaccination available at school and other “community-based sites” with help from Federal Emergency Management Agency funding. The Department of Health and Human Services will also carry out a national public education campaign “to reach parents and guardians with accurate and culturally responsive information about the vaccine and the risks that COVID-19 poses to children.”

Though they are of course not saying so, I guarantee that once vaccines are approved for children, the Biden administration’s next step will be to mandate them for any child who wants to attend public school or be treated any of these hospitals. Expect such mandates to also come down from the various states controlled by the Democratic Party. Your children will no longer be yours at that point.

As I said, you can comment here. I have already done so. A quick look though the 645 comments so far submitted shows them largely against any vaccines for children.

I urge everyone to add their own comments. Let them know what you think. Don’t stand idly by as they not only rob you of your freedom, but your children’s freedom as well.

12 comments

The FDA and its regulation of genetic data purchased by Americans

11:46 am

Link here. The article is a detailed history of the company 23andMe, which offers individuals a way to get their personal genetic data. The company was growing and flourishing, providing data to its customers, until the FDA stepped in.

In 2009, the FDA started asking 23andme for evidence that the company’s products worked as advertised and wouldn’t harm customers. The agency was worried that people might take drastic medical measures on the basis of their test results, such as deciding to change the dosage of their medications without consulting a doctor or undergoing unnecessary surgery, such as a mastectomy, or treatment based on false positives. Regulators demanded evidence that the tests were accurate, and that customers were well informed what the results meant.

The next years were difficult ones for 23andme. It communicated with the agency on a few occasions and promised in January 2013 that data would be forthcoming. According to the FDA, it then ceased communicating with regulators entirely in May, even as it started a new advertising campaign. Fed up, the agency sent [Anne] Wojcicki [company CEO] a strongly worded warning letter on 22 November 2013 ordering her company to stop marketing its product.

It was a self-inflicted wound for the company. “There was a bit of arrogance,” says Richard Scheller, who was an executive at Genentech at the time. As a result, 23andme was forced to drastically cut its customer offerings, threatening its viability.

Wojcicki was stunned. “It became clear that we had pissed them off,” she says. “I really didn’t know that we had done so many things that angered them.”

Soon after the letter arrived, Wojcicki called Kathy Hibbs, a lawyer then working for Genomic Health, a gene-testing company in nearby Redwood City, California. “Can I get my whole company back in one year?” Wojcicki asked Hibbs.

“You can get it back, but it will take years,” Hibbs replied. And to get there, she counselled, Wojcicki would have to cooperate with regulators.

It was a tough adjustment for Wojcicki; she didn’t think that the FDA should be able to stop customers from learning their own genetic information. But Hibbs and others convinced her that capitulating to the FDA’s demands was the fastest way to rescue her company. [emphasis mine]

The FDA’s high and mighty attitude here really offends me. It appears that before and after their demands, nothing really changed. All that had happened was that a government agency took control of a private company’s operation, coming between it and its customers. Right now it limits the data that the company can release to its customers, the people that pay for the service in order to obtain their own genetic data.

In other words, the FDA doesn’t think ordinary people are smart enough to see their own data. If that doesn’t capture the arrogance of government, I don’t know what does.

2 comments

Government to ban cheese

10:33 am

We’re here to help you: New FDA regulations will make the import of certain very well known European cheeses forbidden.

New FDA restrictions on the levels of harmless bacteria found in imported cheese have effectively banned a number of artisan French cheeses, including Roquefort, Morbier, and Tomme de Savoie. The restricted bacteria already exist in the human stomach, and the banned cheeses have not changed their recipes for years. [emphasis mine]

Why is the FDA wasting time banning French cheeses when the deadly bacteria can be found in the human stomach? Shouldn’t the FDA instead ban the human stomach?

2 comments

More forgotten vials of deadly diseases discovered

8:56 pm

FDA officials now admit that when they discovered six undocumented vials of smallpox in a facility in Maryland they also found 327 additional vials that contained dengue, influenza and rickettsia.

FDA scientists said they have not yet confirmed whether the newly disclosed vials actually contained the pathogens listed on their labels. The agency is conducting a nationwide search of all cold storage units for any other missing samples.

Investigators destroyed 32 vials containing tissue samples and a non-contagious virus related to smallpox. Several unlabeled vials were sent to the Centers for Disease Control and Prevention for testing and the remaining 279 samples were shipped to the Department of Homeland Security for safekeeping.

The FDA’s deputy director is quoted with what might be the understatement of the year. “The reasons why these samples went unnoticed for this long is something we’re actively trying to understand.” You think so, eh?

Let’s just make a quick list of the alphabet soup of federal agencies that we have discovered in the last few months to be either corrupt, incredibly incompetent, or spendthrifts: FDA, CDC, IRS, VA, HHS, NIH, GAO, DHS, TSA. We can add the State Department for its wonderful work in Benghazi, as well as the Border Patrol for their stellar effort in securing the border. I also know that the management at NASA leaves much to be desired.

We can also be sure that this is a partial list. It suggests something that any reasonably intelligent person should quickly see: The federal government is a corrupt mess, and should be overhauled so aggressively that when we are done we shouldn’t recognize it anymore. Certainly its size should be slashed by half, if only to cut off the excess funds that are being funneled to an uncountable number of corrupt practices.

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The Obama administration has been caught tracking the emails of a group of scientists critical of certain FDA actions.

9:28 am

George Orwell would be proud! The Obama administration has been caught reading the emails and personal files of a group of scientists who were critics of the FDA.

The agency, using so-called spy software designed to help employers monitor workers, captured screen images from the government laptops of the five scientists as they were being used at work or at home. The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show.

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Six former and current employees have sued the FDA agency under the Obama administration over its secret surveillance of their private emails.

3:25 pm

How Obama encourages transparency: Six former and current employees have sued the FDA agency under the Obama administration over its secret surveillance of their private emails.

According to a release by the law firm representing the group, the FDA targeted the employees with a “covert spying campaign” that lasted for two years after it learned they had written a letter to President-Elect Obama in early 2009. … The plaintiffs allege the agency used spyware to read the their personal emails and take screenshots while they used government computers. But whether such reconnaissance is illegal is not quite clear. According to the Washington Post, “the startup screen on FDA computers warns employees, ‘you have no reasonable expectation of privacy,’ ” including any communication accessed or sent from the machine.”

According to the law firm representing the current and former FDA employees, the monitoring continued even after the Health and Human Services Office of Inspector General “denied the FDA’s request to take any criminal and/or administrative action against the whistleblowers” and noted the whistleblowers’ communications with Congress were protected under law.

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