Tag: big pharma

More Big Pharma/Big Government Attacks Coming – Arepanrix: Package Insert & Approval Letter

By now, readers know this writer is a staunch advocate for proper informed consent following the informed consent process. Previously, the injectable vaccine AUDENZ for H5N1 manufactured by Seqirus was reviewed to inform the public about the product. While it was a long read, the package insert for AUDENZ proved there were not enough participants to represent the population, placebo-controlled trials were only conducted in one study, and the one-year follow-up was not long enough to uncover potential serious adverse events relating to development of autoimmune diseases. Understandably, reading package inserts is not particularly “attention-grabbing” and can be quite boring and tedious. However, it is the only way you will receive all the information you need to give proper informed consent, which includes denying taking a product. Because of the volume of data to be covered in the AREPANRIS package insert, it will be covered in two parts.

In this article, the approval letter and package insert for AREPANRIX will be reviewed. The only approval letter for AREPANRIX on the Food and Drug Administration (FDA) website is dated October 18, 2024. This letter references another letter dated April 19, 2024, which requested a supplement to their license regarding packaging to include the proprietary name of AREPANRIX. There should be another letter indicating the initial FDA approval for this vaccine. Without the initial approval letter, there is no additional information to be gleaned besides the package insert.

AREPANRIX, manufactured by GlaxoSmithKline (GSK), is approved for active immunization for the prevention of disease caused by the Influenza A virus H5N1 subtype contained the vaccine for individuals 6 months and older. AREPANRIX comes in two vials that must be mixed before administration: one contains the H5N1 antigen and the other contains the AS03 adjuvant. The AS03 adjuvant will be explained in Part II. For individuals ages 6 months through 17 years, two doses of 0.25 ml are injected intramuscularly 21 days apart. For individuals ages 18 years and older, two doses of 0.5 ml are injected intramuscularly 21 days apart. (Sections 1 through 2.2)

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2012 Whistleblower of the Year Exposed Psycho Pharma Corruption: Continues to Call for Unyielding Accountability

With the recent nomination of Robert F. Kennedy, Jr., to lead the Department of Health and Human Services, (HHS) the nation’s premier federal health agency, it’s important to remember Kennedy’s rising star began decades ago by exposing fraudulent medical/corporate research and food safety issues. In a sense, Kennedy is a kind of whistleblower on a national level.

But he’s not the only one and, with Kennedy’s rise to power, AbleChild is reminded of another whistleblower, Allen Jones, whose exposure of dirty dealing between the pharmaceutical industry and state mental health agencies needs to be remembered and recognized.

Afterall, it takes courage to stand up to corruption and Jones, not one to shy away from controversy or be strong-armed into walking away, stood up to the behemoth pharmaceutical industry and ultimately protected children in ways they will never fully understand.

In a nutshell, Jones, as an investigator with the Pennsylvania Office of the Inspector General, was tasked with investigating the State’s chief pharmacist, Steve Fiorello, who was reported to have been receiving payments from drug companies. A clear violation of Pennsylvania law. But Jones uncovered a much deeper financial scheme where the money flowing into Fiorello’s unregistered account was also flowing out of it and into an account belonging to the Director of the Texas Department of Mental Health and Mental Retardation. Jones had no idea that he was about to run head-first into the then controversial Texas Medication Algorithm Project (TMAP).

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Two undisclosed deaths in Pfizer Covid vaccine trials

Pfizer-BioNTech did not disclose the deaths of two participants in its COVID-19 vaccine clinical trials before the FDA granted emergency use authorization (EUA) in December 2020. Documents released nearly three years later revealed the deaths of a 63-year-old Kansas woman and a 58-year-old Georgia woman, both classified as “sudden cardiac death.” Researchers have criticized Pfizer for failing to report these incidents within the required 24-hour timeframe, with one case taking 37 days to be filed.

Dr. Jeyanthi Kunadhasan, an Australian anesthesiologist and researcher with the watchdog group Daily Clout, called for an investigation by Kansas Attorney General Kris Kobach. She raised concerns that withholding this information may have impacted the perception of the vaccine’s safety profile.

“If the additional two deaths had been disclosed at the time of the EUA, it would have shown that the BNT162b2 mRNA COVID vaccine intervention provided no reduction in deaths.”
— Dr. Jeyanthi Kunadhasan, Anesthesiologist, Daily Clout

These revelations are part of a broader controversy surrounding transparency. In 2022, a federal court ordered the FDA to release 1.2 million pages of clinical trial documents after rejecting a 75-year delay request. This included the trial data that Pfizer had an opportunity to disclose to the FDA’s Vaccines and Related Biological Products Advisory Committee but did not.

Kansas Attorney General Kobach has also filed a lawsuit against Pfizer, accusing the company of misleading the public about the vaccine’s safety and effectiveness. The suit alleges the company failed to disclose risks like myocarditis, pericarditis, failed pregnancies, and deaths while promoting the vaccine as “safe and effective.”

Pfizer classified the deaths as unrelated to the vaccine and omitted them from a December 2020 New England Journal of Medicine paper that lauded the vaccine’s safety and efficacy. Critics say this omission reflects a troubling pattern of selective reporting.

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Moderna Creates new mRNA Vaccine

If the aftermath of the first widespread mRNA vaccine was not enough to deter the public, the government and the Centers for Disease Control and Prevention (CDC) partnered with Moderna to create a new DNA-altering vaccination for the bird flu.

And here we go again – Moderna said that their most recent vaccine is specifically for this variant (2.3.4.4b) of the flu, which has not spread from person-to-person contact. The Science Translational Medicine published Moderna’s study of the vaccine in which they exposed ferrets to the virus. Moderna won a $176 million federal funding package back in JULY to develop this vaccination.

There are only 60 known cases of this virus among humans, and nearly everyone who contracted it was exposed to infected cattle. California has already declared a state of emergency, and every politician and pharmaceutical company that enjoyed the power grab of the first pandemic is eager for the next. I cannot fathom why anyone would take this vaccine when the last mRNA vaccination FAILED. It failed to prevent the spread or transmission of the virus and injured far more people than it helped. This is why the current investigations into COVID must remain ongoing — we cannot afford a repeat of 2020.

We seriously need MAJOR political reform. Anyone who supports the absolute immunity for the Pharmaceutical Industry should be removed from office – NOW! If one in every 10,000 General Motors cars blew up when you just turned the key but has absolute immunity from lawsuits, why fix the problem? These people know that even with normal vaccines, there is also a portion of people who will die. That is just a matter of fact. That is why they bribed our politicians for absolute immunity. Why ask for that unless you were getting sued?

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FDA Updates Recall On Blood Pressure Medication Due To Possible Carcinogen

A third blood pressure medication was recalled across the United States in the past several weeks, according to a notice updated on the U.S. Food and Drug Administration’s (FDA) website on Dec. 16.

The notice said that New Jersey-based Aurobindo Pharma USA Inc. is recalling Nebivolol tablets in 2.5 milligram doses in 30-count bottles, which are only available by prescription. Nebivolol, a type of beta blocker, is used to treat high blood pressure.

The reason for the recall is because of the “presence of nitrosamine drug substance related impurity,” adding that discovered N-nitroso nebivolol levels are above the “acceptable intake limit,” it said. N-nitroso nebivolol is a nitrosamine and is considered mutagenic.

It was first initiated by Aurobindo earlier this month. The FDA classified the recall as Class II on Dec. 16, which occurs when there is a low chance of injury or death, and a possibility of “adverse events” that may have irreversible effects. They are issued if the product can cause medically reversible or temporary health problems—or if there is a small chance of serious health consequences.

The lot numbers being recalled are: NB0224001A and NB0224001B. It has an expiration date of April 2027 and a National Drug Code, or NDC, of 59651-137-30, according to the FDA.

Nitrosamines are compounds that can increase the risk of cancer in individuals if exposed to them above levels established by the FDA, or for long periods of time, the agency says on its website.

“A person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” the FDA adds.

People who are taking medications with possible “nitrosamine impurities should not stop taking their medications” and should instead speak with a health care professional.

Nitrosamines can be found in small levels in the environment and foods, including “meat, vegetables, and dairy products,” the FDA says.

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C19 HAS TAUGHT US DOCTORS DON’T UNDERSTAND HOW MEDICINES ARE MADE

If doctors did know how medicines are made, the SARS-CoV-2 injections would never have found their way into people’s arms.

Doctors would have shouted “Nine-months to develop and make an injection? Pull the other one, matey!”

In the world of medicines, the doctor is equivalent to the pilot of an aircraft, where passenger lives are in their hands. So it is with treating disease—patient lives are in doctors’ hands.

Could you imagine a pilot allowing his aircraft to take off, knowing it had been developed and made at least ten-times faster that ever before?

The manufacturer would need to explain in great detail what it had done differently to achieve such a miraculous outcome. Questions would be:

  • How were all the component parts designed and sourced so quicky?
  • How were manufacturing and supply contracts negotiated and signed-off so quickly?
  • How much testing were the wings, engines and other safety-critical components subjected to?
  • There are lots more, feel free to insert your own questions here…

The other thing, of course, is that the physical condition of the aircraft would undoubtedly give the game away. A wonky wing maybe, the odd bump in the fuselage, wires poking out from the cockpit?

A deathtrap for all to see…

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Study Links Ozempic To Blindness, Adding To Growing List Of Side Effects

Diabetes patients who took Ozempic were more than twice as likely to develop an eye condition that causes vision loss than patients using a different diabetes drug, according to a new study.

The study linked semaglutide, the active ingredient in Ozempic and Wegovy — which in addition to treating diabetes are widely used to lose weight — to non-arteritic anterior ischemic optic neuropathy (NAION).

The study, published last week on a preprint server, is undergoing peer review.

NAION can result in sudden vision loss due to loss of blood flow to the optic nerve. It is a major cause of severe vision loss and blindness in adults and the second-most common form of optic nerve damage after glaucoma. There is no effective treatment for the condition.

Doctors have recommended that patients considering taking these drugs should be informed of the risk, Bloomberg reported.

While the absolute risk of the disorder remains low, the authors of the study said, they found 1.4 additional cases per 10,000 among patients who took Ozempic.

Researchers analyzed data from the national healthcare registries in Denmark and Norway, comparing the rates of NAION between people taking semaglutide (Ozempic) versus those taking SGLT-2s, an older class of drugs used to treat Type 2 diabetes.

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Just how far does the malfeasance of the FDA extend? Clinical trials of psychiatric drugs show negative outcomes – more chemical drugs are required to treat side effects

The Reality of Psychiatric Medications

Mental health conditions are often treated with pharmaceuticals, but are these products really as “safe and effective” as public health officials, healthcare professionals and drug manufacturers claim them to be?

David Wayne, psychiatric nurse, returns to “Pediatric Perspectives” to spill the beans on the true risks associated with common medications for depression, anxiety and related diagnoses.

The information contained in this episode is for informational purposes only. No material is intended to be a substitute for professional medical advice, diagnosis or treatment.”

The interview is wide-ranging and covers treatments such as anti-psychotic and anti-depressant drugs, as well as SSRI’s and Serotonin (and impotency).

Of note are the failed clinical trials and side effects that require ever more chemical drugs that are just as bad, with their own harmful side effects.

Aaron Siri pointed out the clinical trial detail in the package inserts of vaccines such as Hep B.

It looks like the same information on bad trial outcomes applies to psychiatric drugs.

The information is in the package inserts – from (dodgy) memory – I think these details are in section 6,

There are many reports of the deteriorating mental health of Americans. These “leaves rustling in the wind” could mean that these mental health issues and other physical issues, are caused by chemicals in psychiatric drugs.

All “approved” by the FDA as “safe and effective”.

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There is no scientific definition of vaccine in US biological product law.

Reader question:

Is there a formal definition of vaccine in law?

My reply:

There is no scientific definition of vaccine in statute or regulation.

That’s why I urged Kirk Moore to ask DOJ to provide proof that what they supplied to his office was a vaccine.

DOJ can’t provide that proof, because the proof doesn’t exist.

Congress added the term ‘vaccine’ to the biological products law in 1970 for the first time but did not define the term or direct the executive agencies to adopt or promulgate scientific definitions in regulations.

There is a financial definition of ‘vaccine’ and a definition based on the design intention, adopted by Congress in 1987.

1987/12/22 – Congress and President Reagan passed Omnibus Budget Reconciliation Act of 1987, PL 100-203, 101 Stat. 1330, including Sec. 9201, Manufacturers Excise Tax on Certain Vaccines, to establish an excise tax on vaccines ordered and purchased by US government and manufactured by private companies, to fund the Vaccine Injury Compensation Trust Fund established in 1986.

This act is the only act through which Congress has ever defined the term ‘vaccine,’ defining ‘vaccine’ as “any vaccine (A) which is listed in the table contained in [26 USC 4131(b)(1)], and (B) which is manufactured or produced in the United States or which entered into the United States for consumption, use or warehousing.”

Congress in 1987 defined vaccine in the form that now appears at 26 USC 4132a(2) — “any substance designed to be administered to a human being for the prevention of 1 or more diseases” — but has never defined the term “vaccine” in physical, chemical or pharmacological terms, and neither has the HHS-FDA.

See Dean v. HHS, No. 16–1245V, 2018 WL 3104388, at * 9 (Fed. Cl. Spec. Mstr. May 29, 2018), cited in 86 FR 6249, HHS Final Rule, National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, “(defining ‘‘vaccine’’ as ‘‘any substance designed to be administered to a human being for the prevention of 1 or more diseases’’) (quoting 26 U.S.C. 4132(a)(2)).”

The lack of scientific definition for vaccine was reinforced/corroborated in 2011 by the US Supreme Court in Bruesewitz v. Wyeth, when the majority opinion stated at p. 13:

“Design defects…do not merit a single mention in the [1986 National Childhood Vaccine Injury Act] or the FDA’s regulations. Indeed, the FDA has never even spelled out in regulations the criteria it uses to decide whether a vaccine is safe and effective for its intended use.”

Justice Scalia did not write, but it is also true, that FDA has never spelled out in regulations the criteria it uses to identify a product as a vaccine.

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Big Pharma Eli Lilly Announces $3B Manufacturing Expansion in Kenosha Following Strategic Meeting with Trump and RFK Jr. at Mar-a-Lago

Kenosha, Wisconsin, is poised for an economic revival, thanks to a groundbreaking $3 billion investment from pharmaceutical giant Eli Lilly.

This announcement comes just days after a high-stakes meeting at Mar-a-Lago between President-elect Donald Trump, his nominee for Secretary of Health and Human Services Robert F. Kennedy Jr., and top executives from major pharmaceutical companies, including Eli Lilly and Pfizer.

The meeting, which also included Trump’s incoming chief of staff Susie Wiles and representatives from the Pharmaceutical Research and Manufacturers of America (PhRMA), signals a potential realignment of U.S. health policy.

While the specifics remain under wraps, insiders suggest the discussions centered on finding cures for cancer, among other topics, according to Axios.

This development is being hailed as a masterstroke by Trump, who has long championed bringing jobs back to the U.S. and revamping the pharmaceutical industry to prioritize American innovation and production.

Eli Lilly’s decision to expand its Kenosha facility is being lauded by Trump supporters as a direct result of the strategic discussions in Mar-a-Lago.

According to the company’s press release, the $3 billion investment will not only enhance the production of injectable medicines but also create 750 high-paying jobs in Kenosha County.

The expansion will also generate more than 2,000 construction jobs, making it one of the largest economic boosts in the region’s history.

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