Pharmaceutical product recall, part 2

Pharmaceutical product recall and educated hesitancy towards new drugs and novel vaccines

https://journals.sagepub.com/doi/10.1177/09246479241292008

Of many pharmaceutical products launched for the benefit of humanity, a significant number have had to be recalled from the marketplace due to adverse events.

A systematic review, 1953 – 2013

Recalls for 462 pharmaceutical products

In our current and remarkable period of medical history

Excess mortality figures are high in many countries,

often ignored or dismissed by mainstream news outlets.

This excess mortality may include adverse effects caused by novel pharmaceutical agents that use gene-code technology.

Results

Parallels with past drug withdrawals and gene-based vaccines,

include distortion of clinical trial data,

with critical adverse event data absent from high-impact journal publications.

Delayed regulatory action on pharmacovigilance data to trigger market withdrawal,

occurred with Vioxx (rofecoxib), rof e cox ib

and is apparent with the gene-based COVID-19 vaccines.

Conclusion

Public health requires access to raw clinical trial data,

improved transparency from corporations and heightened, active pharmacovigilance worldwide.

Introduction

Strong science, characterised by open mindedness, objectivity, curiosity and freedom of debate,

can be corrupted by capitalist opportunism, deception, political ideology and censorship.

The global pharmaceutical industry revenue

390 billion USD (2001)

1482 billion USD (2022)

From 1953 onwards

462 + medicinal products have had to be recalled

Median interval, first reported adverse reaction to year of first withdrawal, 6 years (IQR, 1–15)

Thalidomide

1957, marketed in Germany

1958, thalidomide was licensed and promoted in the UK as a “wonder drug” to treat headaches, insomnia, and nausea in pregnant women

Advertisements emphasised safety

catch phrases such as “non-toxic” and “no known toxicity”

1961, first publication on birth defect

1961, thalidomide withdrawn

2023, Australian Prime Minister announced a “formal national apology to all Australians impacted by the Thalidomide Tragedy”

FDA scientist Frances Kelsey

Demanded further safety trials prior to market authorisation,

thalidomide was never approved for release in the USA

Vioxx (rofecoxib), withdrawn, 2004

Concealed adverse cardiovascular events in the Vioxx arm of the study

American physicians, support and finance for research,

defamed, withdrew support, and tried to discredit or “neutralise” those who failed to promote use of Vioxx

(Federal Court in Melbourne, Australia)

Over 20 million people in the US are believed to have taken vioxx,

of whom an estimated 88,000 to 139,000 suffered myocardial infarctions, with 30–40% fatality rate

(testimony of Dr Graham to the US Senate), https://www.finance.senate.gov/imo/media/doc/111804dgtest.pdf

Merck had created a settlement fund of $4.85 billion

COVID-19 gene-based vaccines

The key failure is to have mandated injections in young and healthy adults;

these mandates correlate with excess mortality.

BMJ Public Health
https://bmjpublichealth.bmj.com/content/2/1/e000282

Excess mortality January 2020 to December 2022

47 Western nations,

over three million excess deaths,

the highest number of excess deaths was reported in 2021

(the year in which mass vaccination began)

Use of the term “vaccine” for novel experimental agents that deploy gene codes may convey a false sense of assurance.

Key failures

Coercion and mandates, ridicule of educated hesitancy

Western Australia was essentially free of the SARS-CoV-2 virus in 2021.

Medical research

The crisis rests on pressure to publish,

failure to publish negative and/or unfavourable data,

lack of data transparency, “burial” of data

poor methodological design of studies,

statistical errors, carelessness,

inexperience of peer reviewers and editors,

commercial interest, ideological biases, failure to declare conflicts of interest and fraud.

Distorted data, particularly due to commercial bias, is regularly published in medical journals.

“marketing-based medicine” that is at odds with “evidence-based medicine”.

Illusion of evidence-based medicine

Lack of recognition of pharmacovigilance data

A polio vaccine was withdrawn after just 10 death reports,

the Swine Flu vaccine of 1976 was recalled after just 25 of the ultimate 53 death reports.

Pharmacovigilance underestimation factor

Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.

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Friday Night Frolics returns with some much needed FUN to get your weekend started off right! Tonight Harvey returns with more horrific jokes from The Necronomicorn, Hank Hill sings about caulk (with Harvey on guitar), and we have more of the goofy celebrity impressions and song parodies you love! Join me, Harvey, Sabu, and the Usual Suspects for a night of fun and frolics!

Pharmaceutical product recall

Pharmaceutical product recall and educated hesitancy towards new drugs and novel vaccines

https://journals.sagepub.com/doi/10.1177/09246479241292008

Of many pharmaceutical products launched for the benefit of humanity, a significant number have had to be recalled from the marketplace due to adverse events.

A systematic review, 1953 – 2013

Recalls for 462 pharmaceutical products

In our current and remarkable period of medical history

Excess mortality figures are high in many countries,

often ignored or dismissed by mainstream news outlets.

This excess mortality may include adverse effects caused by novel pharmaceutical agents that use gene-code technology.

Results

Parallels with past drug withdrawals and gene-based vaccines,

include distortion of clinical trial data,

with critical adverse event data absent from high-impact journal publications.

Delayed regulatory action on pharmacovigilance data to trigger market withdrawal,

occurred with Vioxx (rofecoxib), rof e cox ib

and is apparent with the gene-based COVID-19 vaccines.

Conclusion

Public health requires access to raw clinical trial data,

improved transparency from corporations and heightened, active pharmacovigilance worldwide.

Introduction

Strong science, characterised by open mindedness, objectivity, curiosity and freedom of debate,

can be corrupted by capitalist opportunism, deception, political ideology and censorship.

The global pharmaceutical industry revenue

390 billion USD (2001)

1482 billion USD (2022)

From 1953 onwards

462 + medicinal products have had to be recalled

Median interval, first reported adverse reaction to year of first withdrawal, 6 years (IQR, 1–15)

Thalidomide

1957, marketed in Germany

1958, thalidomide was licensed and promoted in the UK as a “wonder drug” to treat headaches, insomnia, and nausea in pregnant women

Advertisements emphasised safety

catch phrases such as “non-toxic” and “no known toxicity”

1961, first publication on birth defect

1961, thalidomide withdrawn

2023, Australian Prime Minister announced a “formal national apology to all Australians impacted by the Thalidomide Tragedy”

FDA scientist Frances Kelsey

Demanded further safety trials prior to market authorisation,

thalidomide was never approved for release in the USA

Vioxx (rofecoxib), withdrawn, 2004

Concealed adverse cardiovascular events in the Vioxx arm of the study

American physicians, support and finance for research,

defamed, withdrew support, and tried to discredit or “neutralise” those who failed to promote use of Vioxx

(Federal Court in Melbourne, Australia)

Over 20 million people in the US are believed to have taken vioxx,

of whom an estimated 88,000 to 139,000 suffered myocardial infarctions, with 30–40% fatality rate

(testimony of Dr Graham to the US Senate), https://www.finance.senate.gov/imo/media/doc/111804dgtest.pdf

Merck had created a settlement fund of $4.85 billion

COVID-19 gene-based vaccines

The key failure is to have mandated injections in young and healthy adults;

these mandates correlate with excess mortality.

BMJ Public Health
https://bmjpublichealth.bmj.com/content/2/1/e000282

Excess mortality January 2020 to December 2022

47 Western nations,

over three million excess deaths,

the highest number of excess deaths was reported in 2021

(the year in which mass vaccination began)

Use of the term “vaccine” for novel experimental agents that deploy gene codes may convey a false sense of assurance.

Key failures

Coercion and mandates, ridicule of educated hesitancy

Western Australia was essentially free of the SARS-CoV-2 virus in 2021.

Medical research

The crisis rests on pressure to publish,

failure to publish negative and/or unfavourable data,

lack of data transparency, “burial” of data

poor methodological design of studies,

statistical errors, carelessness,

inexperience of peer reviewers and editors,

commercial interest, ideological biases, failure to declare conflicts of interest and fraud.

Distorted data, particularly due to commercial bias, is regularly published in medical journals.

“marketing-based medicine” that is at odds with “evidence-based medicine”.

Illusion of evidence-based medicine

Lack of recognition of pharmacovigilance data

A polio vaccine was withdrawn after just 10 death reports,

the Swine Flu vaccine of 1976 was recalled after just 25 of the ultimate 53 death reports.

Pharmacovigilance underestimation factor

Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.

Lucasfilm Director LASHES OUT at Americans! Gina Carano & Elon Musk WIN BIG Versus Kathleen Kennedy!

Lucasfilm Director LASHES OUT at Americans! Gina Carano & Elon Musk WIN BIG Versus Kathleen Kennedy!

#disney #disneynews #lucasfilm #starwars #starwarsnews #kathleenkennedy #ginacarano #elonmusk #lawsuit #entertainmentnews

Art by @JFG
Ad by @FloralFromUnderARock

Reference:

@ThatParkPlace
https://thatparkplace.com/lucasfilm-creative-director-goes-on-ugly-tirade-against-majority-of-americans-that-could-influence-gina-carano-lawsuit/

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DISCLAIMER: Some videos featured on this channel contain rumor and speculation. All videos are forms of editorialized news coverage. Please view these videos as the subjective material they are intended to convey. No harm is intended to any party discussed or mentioned in any video.

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La Reina Creole is a an American writer, content creator, and pop culture analyst. She is known for her witty and insightful commentary on science fiction, fantasy, and theme parks. She also hosts the YouTube channel La Reina Creole, where she discusses a variety of topics related to pop culture and fandom.

La Reina Creole started her YouTube channel in 2019. Her videos have been viewed over 1 million times. She has also been featured in publications such as The Huffington Post, The Nerdist, and The Verge.

La Reina Creole is a rising star in the world of pop culture criticism and commentary. She is a witty, insightful, and thought-provoking voice. She is known for her sharp wit, her deep knowledge of pop culture, and her willingness to speak her mind. She is a refreshing voice in a world that is often too afraid to challenge the status quo. She is sure to continue to be a force in the industry for years to come.

Here are some links to her social media accounts:

Twitter: https://twitter.com/LaReinaCreole
YouTube: https://www.youtube.com/channel/UC2-WFEeMZEQw3BF8hKeA20A
Instagram: https://www.instagram.com/lareinacreole/

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Lucasfilm and Disney have announced an alleged brand new Star Wars trilogy…from Simon Kinberg, who just announced he's doing a new Star Trek reboot? Is this thing real? Is Kinberg working on Star Wars AND Star Trek? What about the Rey movie Lucasfilm hasn't been able to get off the ground? Is this trilogy as real as Rian Johnson's trilogy? Or as real as Benioff and Weiss' trilogy? Here are our thoughts! #disney #starwars #lucasfilm

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FAIR USE NOTICE. WDW Pro videos may contain copyrighted material, the use of which may not always be specifically authorized by the copyright owner. In such cases, the material is displayed for commentary and educational purposes. It is included under the sincere belief this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. If you wish to use copyrighted material from this video for purposes of your own, you must obtain permission from the copyright owner.

DISCLAIMER: Some videos featured on this channel contain rumor and speculation. All videos are forms of editorialized news coverage. Please view these videos as the subjective material they are intended to convey. No harm is intended to any party discussed or mentioned in any video.

The WDW Pro Channel is wholly owned and operated by Prelude Studios LLC.