Our Pharmaceutical Emperors Have No Clothes

Written by Saeed A Qureshi PhD (Edits by John O'Sullivan) on August 14, 2020. Posted in Current News

Readers are urged to be cautious over the claimed high quality of licensed Pharmaceutical Products.”Most of the claims made would be false and baseless at least scientifically,” says an internationally respected expert in pharmaceutical standards and testing.

Saeed A Qureshi PhD has spent most of his career conducting hands-on and multi-disciplinary laboratory research in pharmaceutical areas for regulatory assessment purposes while working with Health Canada. More than most scientists, he knows the pitfalls of the claims made by Big Pharma over safety of medicines and vaccines.

Over a thirty-year career Dr Qureshi has witnessed the whole process of testing and quality control riddled with subjectivity and favoritism, poor tests and accountability.

Consumers are provided with little, if any, objective, verifiable information to make rational decisions about the safety and reliability of the medicines being prescribed.

Qureshi writes:

“Regulatory authorities, in particular the FDA conduct observations and make statements following facility pharmaceutical facility inspections. These facility inspections are conducted under the requirements of Good Manufacturing Practices or GMP – usually part of any country’s laws and regulations giving the practices “authenticity” and enforcement ability.

The basis of GMP requirements and implementation is on the fundamental assumption that GMP requirements are enforced so that the end products from manufacturing are of quality, e.g. as per FDA “FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations”[1].

A quick survey of literature provides examples of some descriptions of observed deficiencies (often also knows as “observations”) of compliance requirements which could fall in one of the nine categories such as: organization and personnel; buildings and facilities; equipment; control of components and drug product containers and closures; production and process controls; packaging and labeling control; holding and distribution; laboratory controls; records and reports [2].

These deficiencies or observations are usually descriptive or narrative in nature, not objectively measurable or quantifiable. Therefore, these can be considered as subjective in nature, based on individual investigator’s personal judgement or inclination as noted by FDA as well e.g. “During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements [3].

Once such observations become public, people (often experts/consultants external as well as internal to agencies) blow these out of proportion arguably for their own personal and business advantages and benefits [e.g. see here 4]. These (“observations”) then become and/or promoted as “ills” of the manufacturing and/or the industry.

In short, the opinions expressed, formally or informally, by the investigators/inspectors mostly about operation are considered as “ills” of the industry and manufacturing.

It is important to note that, as per GMP requirements described above, inspections must establish or relate to the ability of the manufacturing of quality of products. However, as noted above as well, most of noted deficiencies are related to manufacturing and its operation not about quality of the products. For example, outcome of an inspection or warning letter is usually concluded as follows “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B)” [5,6]. Question is where is the evidence of manufacturing of substandard quality (or adulterated) product? The products quality can only be established by testing a product itself, which is mostly neither part of the inspections nor “observations” claims. It is like saying that as staff was not found properly cleaned and dressed (in the investigator’s view) hence staff would be considered lacking intelligence and/or competence for the job. For the validity of such a statement or conclusion, it must be based on evaluating and establishing their competence and intelligence and must be established independently.

However, experts/consultants would conclude and promote inspections/observations as product deficiencies or inability to manufacture “quality” products – these are simply false assumptions and conclusions, because observations are not linked or validated against the deficiencies of the product quality. Therefore, putting blame on the manufacturing or industry for poor manufacturing of quality products would in general be inaccurate. It is the practice of the current investigations or inspections which needs to be reassessed.

To make “observation” or inspections logical and scientifically valid agencies should define quality of the products with a measurable parameter. Samples should be collected at appropriate check points and evaluated against (strictest) pre-set standards and specifications for the quality of products.

On the other hand, manufacturers and their affiliated contract facilities should seek help in addressing and defending the current irrelevant conclusions drawn from the facilities assessments and removing the weaknesses of the regulatory (GMP) requirements and practices on a worldwide basis.”

In short, there is no point making suggestions to industry. The reason being FDA does not have even the most basic expertise in science and/or manufacturing. Therefore, it will always be hesitant to implement change because of fear of doing it wrong.  Hence Big Pharma practices are just the same as they were about 200 years ago. The COVID-19 screw up is a case in point.

The FDA/CDC declared a pandemic from a virus which does not exist. Their declaration of a pandemic is based on tests developed, approved or authorized by the FDA/CDC but without its validation – a cardinal sin in scientific practice.

Now they are expecting a vaccine which will be developed in less than a year with no available gold standard test/method to treat the virus and its associated disease. It really is the blind leading the blind. Unless, of course, they don’t really care because the pandemic was a scam from start to finish.

Read more at www.drug-dissolution-testing.com

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