Pharmaceutical product recall, part 2

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

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1961, thalidomide withdrawn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Vioxx (rofecoxib), withdrawn, 2004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),

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

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.