Author Archive

Do FDA and USP lie? Of course, all the time!

For example:

FDA claims that it establishes and monitors quality of pharmaceutical products such as tablet and capsule. A lie – FDA neither defines quality of the products nor its measurable parameter hence it does not, or cannot, determine quality of the products.

FDA claims that it establishes safety and efficacy (as well as quality) of pharmaceutical products using valid clinical testing (e.g. bioequivalence assessment) and in vitro (drug dissolution) testing using USP apparatuses. A lie – these tests, along with associated testers, have never been validated for the intended purpose. In fact, these tests have been shown to be scientifically invalid and irrelevant for their intended purpose.

USP claims that it provides reference standards for establishing quality of the pharmaceutical products such as tablets and capsules. A lie – USP never provides reference standards for any product. It provides powder or liquid samples of pure chemical compounds, not the products which patients use, however falsely promotes as reference standards of medicines.

USP claims that it provides a valid analytical test for the assessment drug release characteristics of the products for establishing and monitoring quality of the products. A lie – the test has never been validated for the intended purpose. The test cannot determine drug dissolution/release characteristics of any product. It has been shown experimentally that the test provides irrelevant and highly unpredictable results/data with no relevance to product quality.

For more examples please visit here. Manufacturers and patients should be cautious in accepting such claims from FDA and USP as well as other national and international authorities which often follow FDA/USP claims and guidances.

Please consider accepting the Citizen Petition (under review with FDA for more than a year and a half, link) for addressing the underlying lies concerning products development, manufacturing and their regulatory approval.

Pharmaceutical products quality assessments – future!

What should one expect, after FDA completely destroyed, and rightly so, the credibility and usefulness as well as need for bioequivalence assessment (aka clinical trials) by removing its requirement from ANDA approvals, at least for hydroxychloroquine (HCQ) and chloroquine (CQ) products to start with [1, 2]? It is to be noted that bioequivalence assessments have been shown to be scientifically invalid and irrelevant to establish the quality of the products based on their drug release assessment [3]. Not only such studies put large burden, financial and personnel, on the industry as well regulatory authorities for the development, manufacturing and approval of products but also expose healthy human subjects, in particular young adults, to potent chemicals (a serious unethical practice).

Products can easily and accurately be assessed using drug dissolution testing. However, to implement its (drug dissolution testing) valid use authorities, including FDA and USP, need to implement appropriate and scientifically valid dissolution testers and methods. Until then authorities’ claims regarding monitoring and establishing products quality will remain false and invalid.

COVID-19 pandemic exposed the burdensome and unnecessary regulatory practices and requirements. It also provides an opportunity to simplify the product development and manufacturing. Please consider the under-review Citizen Petition for removing the use of non-validated/non-qualified, hence non-GMP, USP drug dissolution testers/tests from regulatory requirements [4] and replace them with appropriate and scientifically valid tests and testers [5].

What is wrong with the following scenario?

We, the authorities and experts, are extremely sorry to let you know that we made a colossal mistake in declaring the Corona virus (COVID-19) pandemic. It is one of such rare situations where we found out at an extremely high cost (human and financial) that our scientific understanding of the subject was flawed and failed us. We honestly carried away with our projections and fear of huge number of anticipated deaths by the potential spread of this variant flu which clearly did not come out to be correct. We sincerely regret this unfortunate situation and ask for your forgiveness. Please accept our apologies. We hope that public will forgive us and will start its usual daily life. In addition, we hope that public would avoid the use and/or development of new medicines based on our falsely classified disease and pandemic hence reducing any further damages which may occur.

Once again, we sincerely apologise and hope that we will be forgiven.

Clinical trials – credibility issue?

In general clinical trials are important and necessary. It is like in any other area that one has to show that the “things” (in this case, medicines/treatments) work as expected – clinical trials serve such purpose.

However, in medicines area, underlying scientific concepts and practices are extremely poor hence “clinical trials” practices face credibility issue. For example, developing products (tablet/capsule) clinical trials (bioequivalence test – regulatory requirement) are conducted which indeed lack clinical relevance and usefulness. Therefore, it could be argued that such tests indeed expose subjects, often healthy human volunteers, needlessly to potent chemicals in the name of medicines development. (link)

Similarly, relating to Corona virus pandemic, there appears to be rush towards development of medicines/vaccines. It may be argued that as the underlying analytical science is not well-established to monitor virus and/or its “disease” it would be very difficult to conduct appropriate and validated “clinical trials” (link)

In short, running clinical trials is a good idea, however, conducting appropriate and useful clinical trials remains challenging that is where the confusion is.

Can we say?

  1. Flu came and gone!
  2. Why it was called a pandemic – not clear
  3. Discredited the bench top science – as disease state monitored with charts and their shapes (humpy or dumpy) with protocol/testing developed on the fly
  4. Discredited the medicines approval system with the approval of medicines without requiring established protocols
  5. Treatments could be suggested and implemented without having knowledge or expertise in the area of medicine.
  6. Exposed the great weakness, perhaps more accurately ignorance, of “science” at the authorities!
  7. Hope we learnt something not to repeat in future

(1)Coronavirus pandemic: Public/patients deserve better! (link)

(2)Authorities (including FDA) and pharmacopeias (including USP) never establish quality of products! (link)

(3) Is Coronavirus really causing abnormally higher number of deaths? (link)

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