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For further reading:
http://www.drug-dissolution-testing.com/?p=3650
http://www.drug-dissolution-testing.com/?p=3587

A reference or link:

1. of having seen or possessing a pure virus’s physical specimen, not an isolate or a picture of a mixture/gunk (commonly referred to as cell culture).
   
2. To an experimental/scientific study showing that the suggested vaccines kill the virus in humans. A physical sample of the dead-virus in the presence of a vaccine or its derivative.
   
3. Showing that face-masks (any type) stop or significantly reduce the virus’s passage (in or out). The study must include a virus sample (not droplets or aerosols only as a virus substitute).

Dear scientists, experts, and authorities, please help. These should be easy questions to answer with all the fundings you have obtained and claims you made. Otherwise, what is the point?
.
.

PS: FYI, the answer is, such links or studies do not exist.

(link)

Could someone find a virology version of this on Amazon or anywhere else? Sorry, you will not have such luck because it does not exist (link)!

A couple of days ago, I participated in a Zoom meeting with a UK panel (physicians and others) on the situation (link). The meeting was very long; however, if interested, consider watching at 12:47 and 58:15 (in the latter part, I did not participate as I was not aware that the meeting continued after the disconnect).

It indeed appears that confusion is there, or created, to gain some advantages. Also, it remains questionable practice, at least to me, to treat people, the healthy ones in particular, with a new treatment, which is still in a developmental phase.

As noted here (link), I believe that we may be seriously in a misdiagnosis and mistreatment situation. This situation should not continue.

(Link to the first part of meeting/discussion)

I have been highlighting for some time that the virus (SARS-CoV-2) has never been isolated or positively identified [1,2,3,4]. Therefore, it cannot be claimed that the virus exists, and by extension, the story of the COVID pandemic cannot be considered science-based or factual.

This idea of non-isolation of the virus has been gaining traction. A recent report further emphasized that the SAR-CoV-2 has not been isolated, along with any other viruses in the coronavirus family [5].

The use of the word “isolate,” with the implied meaning or representation of the term isolation of the virus, misled everyone, including physicians, scientists, experts. They assumed that the virus or viruses are real and have been physically isolated.

The article mentioned [5] above also clearly discredit the PCR test’s relevance and usefulness, as I have been saying for quite some time [6,7,8]. A prestigious international expert on the subject, Dr. Stephen Bustin, is quoted, describing both the arbitrariness of criteria for RNA results and choosing the number of cycles leading to anyone testing positive for COVID.  The mentioned article [5] discusses the flaws of PCR tests and methodology for its use as a diagnostic tool.

On the other hand, as I have repeatedly described, the PCR test is a chemical test that has never been validated for its intended use. It is a blatant violation of the fundamental principle of science-based chemical/clinical testing. Such a test can never provide relevant and valid results. Surprisingly, such testing is accepted by the regulatory authorities, including the FDA. The test and its associated results should be withdrawn immediately.

In short, claims of isolation of the virus (SARS-CoV-2) and the PCR test are shown to be scientifically invalid and irrelevant.

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Yesterday, I posted my view on the recent FDA guidance documents for chloroquine and hydroxychloroquine (link). I do not think people realize the long term impact of this development where BE studies have been replaced/substituted with drug dissolution testing. Let me explain:

1. Saying that guidances are product specific is not correct, because chloroquine and hydroxychloroquine are drugs not products. Products are tablets, or capsules, with often unknown and proprietary composition of a drug, excipients and manufacturing attributes (i.e. formulation and manufacturing attributes). Hence, guidances cannot be product specific as assumed or suggested.
2. A drug dissolution test is conducted for products not drugs. As product attributes are mostly unknown and propriety, as noted above, hence a dissolution test (or guidance) cannot be product specific but has to be independent “standard or universal”.
3. Furthermore, it is to be noted that in principle product specific guidance concept is an invalid concept. Drug dissolution testing is a scale used to measure dissolution characteristics of a product. By definition it (scale) has to be independent to the tested items. Point being that the guidance documents cannot be restricted one or two drug products. These have to be applicable to ALL highly soluble drug products. It would not be possible for authorities, at least scientifically, to defend restricting to only one or two products. This decision could easily be challenged and won.
4. In addition, such a decision cannot be one time decision, as many believe, may it be taken under an emergency situation. It would not be possible to withdraw such a decision once taken i.e. if dissolution test alone can provide quality assessment of the products, then why would BE studies be needed and required on what basis especially when BE studies are known to be irrelevant (link).
5. This new development is a gift from heaven for the underdeveloped countries where because of lack of BE studies, products and their manufacturing have always been labelled inferior. However, with the requirement of dissolution testing only, everyone can manufacture and promote (for local and/or international markets) their quality products with confidence.

Keep these thoughts in mind and proceed accordingly.

Recently FDA provided 1- and 2-pager guidance documents for chloroquine and hydroxychloroquine, respectively (link).

The most interesting part is that one can get product approval based on dissolution testing alone. This is what has recently been suggested in one of my recent published articles i.e. products (“quality”) assessment can easily and accurately be established with drug dissolution testing alone (link). There is really no need of conducting bioequivalence (BE) assessments. These (BE) assessments procedures have never been validated of the intended purpose. In fact BE are scientifically invalid and can provide false conclusions and assurance about product quality. In addition, such testing exposes healthy human volunteers to highly potent chemicals under the disguise of medicine development.

On the other hand, switching to dissolution testing alone using currently recommended USP apparatuses is not valid either, at least scientifically. The recommended apparatuses are non-GMP compliant and can provide false and irrelevant results because of their intrinsic design and operation problems. Simpler and scientifically valid options are available and could be used (link).

Mortality in the United States, 2018 (as of January 2020, link).

“The age-adjusted death rate decreased by 1.1% from 731.9 deaths per 100,000 standard population in 2017 to 723.6 in 2018.” i.e. death rate is about 0.7236%

For the USA, having population of 331 million (link), normal/standard death (attrition) rate should be 199,593 deaths/month. Now compare this number with the reported number of deaths caused by Coronavirus pandemic, which are 21,435 in about a month’s time as of April 12, 2020 (link) which is far less than normal/standard death (attrition) rate.

The death rate, therefore, does not appear to support the thesis that the pandemic is killing people with abnormally high numbers.

Just this morning I received the following query (my response is included as well) about the manufacturing aspect of the above mentioned drug product. It is hoped that authorities will take a note and address the issue faced by the industry to manufacture this important pharmaceutical product as per my year and half old Citizen Petition (link).

Query:
“Regarding dissolution of HYDROXYCHLOROQUINE SULPHATE TABLETS, the disso medium specified in IP & USP is water. The formulation sometimes fail to conform to IP and even USP parameters

I have tried replacing water with 0.1 M hydrochloric acid as dissolution medium and achieved a disso of above 90 %. I know the api is water soluble, but since this is an instant release formulation and the approximate pH of stomach is being maintained in disso medium, can we recommend change of disso medium from water to 0.1 M H Cl to IP & USP.

Response:

Scientifically speaking water is an appropriate dissolution medium not the HCl (link).

In reality, your suggestion of changing the medium from water to HCl is for obtaining desired dissolution results, which is neither scientific nor logical.

In general, the issue you are describing is not of medium choice but choice of the dissolution apparatus. USP apparatuses are known to provide slower and irrelevant results; most likely you are observing this flaw. Such an issue can only be addressed by changing the tester not the medium, rpm etc. Considering USP apparatuses flaws and limitations, I have proposed a new stirrer, precisely to address this issue. Perhaps consider using this suggested spindle and simpler dissolution method not only for this product but also avoiding future issues with the use of USP apparatuses. There is a stronger argument available in using an alternate dissolution tester than changing dissolution medium i.e. the USP apparatuses are non-GMP compliant (link, link).

I hope you will find suggestion useful and best of luck.

PS: Please request the authorities, in particular FDA and USP, to withdraw the requirement of using non-GMP (i.e. non-validated/non-qualified testers/methods) and allow the use of scientifically valid testers and methods to develop and manufacture urgently needed pharmaceutical products.

… provides in depth discussion on establishing and monitoring quality of pharmaceutical products in particular tablet and capsule. I hope you will find the chapter useful.

Chapter title: “Quality” of pharmaceutical products for human use – underlying concepts and required practices, published in

Drug Delivery Trends: Expectations And Realities Of Multifunctional Drug Delivery Systems Volume 3 Edited by Ranjita Shegokar, PhD., Available from Amazon (March 18, 2020), link.

Author Archive

Click on the picture to play the video

If you prefer to read from the text, it is available here (link)

Please donate (by clicking the button below). Thanks.

COVID-19 is a recently-labeled illness presumably caused by a virus named SARS-CoV-2. The illness is considered contagious, i.e., assuming that the virus spreads from person to person directly or indirectly. It is believed that COVID-19 caused the pandemic resulting in a large number of deaths.

This article reflects an exercise in summarizing the data in seeking a potential trend from COVID-19 deaths to guide addressing the pandemic issue. (Continue here)

People should realize that reducing the Ct (cycle threshold) of the PCR test, as some suggest, may reduce the number of test-positive results. This will certainly help reduce the so-called pandemic—a trickery approach to bring the pandemic under control that never existed in the first place.

However, the fact remains that the PCR test is scientifically invalid, no matter how low Ct value one would set. To have a valid test, it requires to meet four well establish validation criteria: (i) specificity; (2) selectivity; (3) reproducibility; and (4) use of independently characterized reference standard. The first three criteria cannot be met if the reference standard (the #4) is not available. If the claim is that the PCR test monitors the presence or absence of the virus. Then reference virus must be available in its pure form. On the other hand, if virus RNA or its fragment is to be monitored, RNA or its fragment must be available as the reference standard and positively shown to be extracted from the virus (further details here).

Considering that the tests or testing are based on confirming the RNA sequencing only from an aliquot of media/culture/isolate, hence is a valid test, is pure nonsense. Such tests have no relevance to the virus, illness, and pandemic monitoring, and these PCR tests must be stopped immediately and preferably withdrawing all related results/data as false. This will be the legitimate and scientifically valid approach for getting out of the pandemic state.

It is hoped that science will prevail.

COVID-19 is an illness presumably caused by a virus named SARS-CoV-2. The illness is considered contagious, i.e., the virus spreads from person to person directly or indirectly. The virus is commonly viewed as a particle. For it to spread, the particle has to exist.

The problem is that such virus particles do not exist because no one has isolated them or positively identified them (details here).

If something does not exist, how it will transfer from one person to another. It can’t.

Therefore, wearing masks or keeping a distance becomes irrelevant. It is that simple!

As a part of a LinkedIn discussion (link), I provided the following (below) response to a query. The visitors of this blog may find my response informative and useful as well.

_________________________________________________________________________________________

Steve:

Thanks for your kind words about my article and also for asking the questions.

First, to be clear that I am not a microbiologist or virologist. I am a chemist and have worked in the pharmaceuticals area for 30+ years (as a scientist with Health Canada). I gained significant experience and expertise in critically evaluating pharmaceutical products.

Regarding the claim of virus isolation, I am saying that the experiments microbiologists/virologists perform and describe, such as virus characterization, identification, belongs to the chemistry discipline. However, the chemistry work has not been conducted accurately; hence claims made are incorrect.

There are many ways to describe and explain the inaccuracies. One of which is that of isolation of a substance, in this case, a virus. If one needs to isolate a virus, one must go through multiple steps, such as extraction, purification, identification, and structure determination, resulting in a pure sample of the virus. Nothing of this sort has been done for the virus isolation, in particular, SARS-CoV-2. Therefore, it cannot be said that the virus has been isolated and identified, or even it exists.

On the other hand, microbiologists and virologists (among others) work with a modified definition and description of the term isolation, for their purpose, as taking a swab sample (i.e., separating virus from the host). That is not a good scientific practice.  Therefore, in reality, a virus never gets isolated in its true or pure form.

On the other hand, to appear scientific, the DNA/RNA sequencing is considered as a claim of “identifying” the virus in a swab sample without truly “isolating” it (we chemists call it a clean-up step). Some chemical steps using enzymes (commonly known as polymerization, again a chemistry step) are conducted, followed by taking some pictures of the soup with an electron microscope. Observing spherical bodies with spikes are considered to reflect the existence of coronavirus.

From this soup (note everything is from the soup, nothing from pure virus), DNA or RNA or its fragments are extracted to establish their sequences. There is no evidence that this DNA or RNA is from anything specific, including the virus – it is an assumption. Based on computer analysis and comparison with previously obtained “reference” sequence (usually obtained from WHO depository), which is also “isolated” in a similar manner (without isolating the virus), virus existence is established. If the sequence did not match the “reference” sequence (not a virus), it would become a new virus or new strain.

The publications, links you provided all follow the same or similar protocol as I summarized above. I have critically reviewed two such publications, one from Australia (the one you noted in your post as well), the other from the USA (CDC), where I explained: “science” behind “isolation” of the virus. Links are provided (link1, link2) please have a look.

I have been arguing for some time that nowhere I can find an isolated virus, so why people keep claiming isolated virus. My recent discussion with a microbiologist made it clear that the virus has never been isolated but misrepresented by incorrect definition of the word “isolation.”  That makes it clear why I could never find the sample and specimen of the pure virus because it does not exist. One may imagine my shock after hearing this – so I wrote the article.

I hope I answered your query adequately. Otherwise, let me know. I will explain it further. I like to make another point, without going into technical details, the sequencing (chemistry) part is pretty iffy.  It is well known to the people in the area that sequencing steps can produce highly unpredictable results. The PCR test, which in reality is based on sequencing, suffers this weakness. Hence one sees so many false positive or negative outcomes that make the lack of “virus existence” claim even stronger. (edited)