Insightful newsletter of Drishtikone: Issue #218 - Quo usque tandem abutere, Catilina, patientia nostra?
India's CDSCO conditionally approved Covaxin for emergency situation in public interest as an abundant precaution in clinical trial mode! Indian political hyenas are at their game of sabotaging India!
“I seen hundreds of men come by on the road an’ on the ranches, with their bindles on their back an’ that same damn thing in their heads . . . every damn one of ’em’s got a little piece of land in his head. An’ never a God damn one of ’em ever gets it. Just like heaven. Ever’body wants a little piece of lan’. I read plenty of books out here. Nobody never gets to heaven, and nobody gets no land.” ― John Steinbeck, The Grapes of Wrath
Democracy and Freedom is not a license to abuse and kill. Or worse bring death to millions. Because you cannot deal with your irrelevance in the new world. The only way for yesterday’s despots who smothered all criticism and created a hegemonic structure by installing layers and strata of entitled and compromised hyenas is to sabotage India.
When despite otherwise following the normal procedure, Central Drugs Standard Control Organization (CDSCO) adapted the last step to create a special option for an emergency situation in the larger public interest and gave conditional approval for Bharat Biotech’s Covaxin, it was a case of government organization doing things given the situation at hand. Should it be done perfectly? Sure. But nothing about the COVID situation and the vaccine creation processes which take years has been normal and by the book.
It is so because, in case you haven’t noticed, nothing is normal now.
For someone to pretend and advocate otherwise when people are dropping dead is not just idiocy but criminal!
Enough of the filth full of hatred has flowed in the face of genuine efforts to do good, whether it was in the case of CAA (where the poor and persecuted were given refuge) or Article 370 (where the violent and terror-minded were put out of currency). It is time to stand up for humanity and not be pushed around by those whose only, and I really mean the ONLY objective is power at the cost of anyone and everyone’s life.
Know the facts. And, for the sake of your kids, demand some modicum of respect for yourself!
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Existential crisis and the Abuse of our patience
Vaccines are lying around as new flare-ups grow. A nurse died after the Pfizer vaccine. The cases are growing exponentially. And British PM has declined the Indian tour for Republic Day due to that as well. Three strong variants are now going around. Things are far from normal. If things are not brought under control and rapidly so, it could mean a greater disaster than one could have imagined!
That is the kind of extreme life-threatening crisis that we all are facing now. As it grows larger and more deadlier every day.
In 63 BC the legendary orator, Marcus Tullius Cicero, gave a set of speeches that have come to be known as the Catiline or Catilinarian Orations. Cicero was speaking against Lucius Sergius Catilina (Catiline) as he led a plot to overthrow the Roman Senate. Catiline was an unethical Roman senator known to bribe others in the Senate to get his way through. He hatched a conspiracy to murder Cicero when the orator had worked to bring a law that would prohibit election fraud. After a series of lost elections and conspiracies, a meeting of the Senate was called in the Temple of Jupiter Stator. Catiline and Cicero were also to attend. (Source)
That is where Cicero delivered his most famous oration which was about 3,400 words long. The opening of his address has survived for over 2000 years.
Quo usque tandem abutere, Catilina, patientia nostra? Quam diu etiam furor iste tuus nos eludet? Quem ad finem sese effrenata iactabit audacia?
When, O Catiline, do you mean to cease abusing our patience? How long is that madness of yours still to mock us? When is there to be an end of that unbridled audacity of yours, swaggering about as it does now?
Spinning fake yarns to block social good
The efficacy and safety of drugs in India are evaluated by the Central Drugs Standard Control Organization (CDSCO). They do it via its Subject Expert Committees (SECs).
The Central Drugs Standard Control Organization (CDSCO) plays an important role in safeguarding public health by ensuring efficacy, safety, and quality of drugs used in India. One of the important decision-making factors in the entire regulatory review process is Subject Expert Committees (SECs). A brief overview of evolution of SEC process and functioning would be helpful in further streamlining the regulatory review process. (Source)
This is the body that provides clinical trial oversight, approval, and inspections.
As set forth in the 2019 CTRules and the Hdbk-ClinTrial, the Central Drugs Standard Control Organization (CDSCO) is the regulatory authority responsible for clinical trial oversight, approval, and inspections in India. In accordance with the provisions of the 2019 CTRules, the Drugs Controller General of India (DCGI) heads CDSCO, and is responsible for granting permission for clinical trials to be conducted and for regulating the sale and importation of drugs for use in clinical trials. The DCGI is commonly referred to as the Central Licensing Authority in the Indian regulations. (Source)
Here are the notes from the CDSCO’s site (as of Jan 2, 2021) on their decision to go ahead with the restricted use of the vaccine for an emergency situation in “clinical trial mode.” 25,800 subjects were included in the trial, out of which the data was on 22,500 subjects. While the clinical trials continue, the vaccine is available for restricted use in order to have more options for vaccinations. (Source)
One major reason for the conditional approval was that this drug was also effective in handling the mutant strain of COVID.
Meanwhile, Indian Council of Medical Research (ICMR) Director General Dr Balram Bhargava had said on Sunday that Covaxin is based on an inactivated whole virus, having potential to target mutated coronavirus strains including the UK variant, and it was a major reason for giving it a conditional nod. (Source)
Let us remember that the SECs of CDSCO which go into the clinical trial results are comprised of professionals.
Subject Expert Committee (SEC) comprises of 8 medical experts (01 Pharmacologist and 07 medical specialists) shall be constituted to select names of the experts from the respective panels approved by the Ministry. If an expert fails to attend the SEC meeting, another expert from the same panel shall be invited to attend the meeting. (Source)
Now critics are harping on the clinical trial results be shared in the public domain. Here is one article by some Indian journalist in Science mag.
Some critics would also like to see India’s regulators to do more to promote transparency. They note that the national government does not disclose the names and institutional relationships of the experts present during each clinical trial proposal meeting for COVID-19 vaccines and drugs. These subject expert committees review the proposals and send recommendations to the government’s Central Drugs Standard Control Organisation (CDSCO), which decides on their approval. The opacity makes it impossible to evaluate any potential conflicts of interest. (Source)
A study was done about the publication of clinical trial results in the public domain in the US. [public disclosure of results (PDOR)]
Among the 400 clinical trials, 118 (29.5%) failed to achieve PDOR within four years of completion. The median day from study completion to PDOR among 282 studies (70.5%) that achieved PDOR was 602 days (mean 647 days, SD 454 days). Studies were less likely to achieve PDOR if at earlier stages (phase 2 vs. phase 3/4, adjusted HR 0.60, 95% CI 0.47-0.78), if they only included adult subjects (adjusted HR 0.61, 95% CI 0.45-0.83), involved randomization (adjusted HR 0.62, 95% CI 0.46-0.83), or had smaller sample sizes (≤50 subjects vs. >50, adjusted HR 0.60, 95% CI 0.44-0.83). Industry-funded studies were significantly less likely to be published than non-industry or blended studies (adjusted HR 0.49, 95% CI 0.36-0.66). (Source)
PDOR in FOUR YEARS! Not before the release of the drug!
In the case of COVID vaccines, experts have argued for confidentiality and against the release of trial results!
No one disputes the urgent need for safe and effective COVID-19 vaccines. But confidentiality within the processes of vaccine development is also essential. Ensuring rapid availability of COVID-19 vaccines will depend on rigorous evidence of their safety and efficacy. That rigour is threatened if emerging data from trials of candidate COVID-19 vaccines are disclosed in ways that allow them to influence the design or conduct of trials and potentially bias the results. It is widely recognized that emerging data by intervention group from clinical trials must be kept confidential—ie, accessible only to the trial Data Monitoring Committee (DMC). However, less well recognized are the risks to trial integrity from the release of data pooled across vaccine and placebo groups. (Source)
So, all this debate that has been stirred up is mere politicization of the whole issue.
Experts in the Indian body CDSCO have given a conditional nod for emergency use of Bharat Biotech’s COVAXIN vaccine, which will be administered under very strict and restrictive conditions. Not to everyone in the public! But, politicians being the morons they are will come out and give statements like these juvenile ones and the servile media which has little credibility will keep making these rants sound like weighty truisms!
Talking of journalists - in that Science Mag article, one of the organizations that the writer mentions as being some important group is AIDAN.
The All India Drug Action Network (AIDAN), an alliance of advocacy groups, has sent CDSCO three letters asking it to release details about review panel members, but has met with little success. After AIDAN’s first letter in June, the panel did start to release meeting minutes, but they were brief and lacked detail explaining decisions, Jesani says. (Source)
One look at its amateur free website shows a list of its institutional members. (Source) Two of those are Jan Swasthya Sahoyog (JSS) and Lawyers Collective.
It is interesting to note that Jan Swasthya Sahoyog has Dr. Saibal Jana as its President and his comrade Dr. Binayak Sen as part of the Guiding person’s list. Saibal Jana was arrested in 2016 for his Naxal activities (Source). He was one of first doctors from Bengal to have joined the Naxal movement. (Source). Binayak Sen obviously got life imprisonment in 2010 for helping Maoists (Source) but got bail from the Supreme Court in 2011.
The Lawyers Collective and its trustees like Indira Jaisingh have been known for anti-Modi vitriol and using their UPA-regime entitlements to push the envelope between crime and legality. Some of their advocates were in the cross-hairs of Enforcement Directorate for a petition filed by the CBI for the violation of the Foreign Contribution Regulation Act (FCRA) against Lawyers Collective. (Source)
So is it just a coincidence that the actors who have had allegiance to the old corrupt regimes and gained their entitled lifestyles thanks to them have risen up again to create a story on something as critical as a vaccine for COVID?
The Indian political system of the last 70 years was a hegemonic system where the main actors were aligned with the outside forces that could call the shots. Anyone like Lal Bahadur Shastri - who would not fall in line with the powers-that-be at these decades was either eliminated or disgraced. (please do read how the CIA admitted to killing Homi Bhabha and Shastri Issue #217 - The Surreptitious Killer)
Interestingly an Italian leftist had written something interesting on hegemonies and how those systems perpetuate themselves. “Every social group creates together with itself, organically, one or more strata of intellectuals, which give it homogeneity and an awareness of its function, not only in the economic but also in the social and political fields” (Source)
Any hegemonic coloniality that is practiced in, an often unsuspecting and willing, societies is done on the back many strata and layers of intellectual players who are aligned to one ideological framework. And, this framework and clique brooks no challenge. You challenge one of them and the entire edifice croaks and pushes you out. The tentacles are within the society and outside.
A well-oiled machine. They were in tandem and unison at the same time.
The common man be damned.
market corner: 10 quick bytes
World Bank warns global recovery could erode if virus worsens - more
UPI transactions in 2020 break record, grow by more than 100 percent. From Rs 2,02,000 crores in 2019 to Rs 4,16,000 crores in 2020 - more
India gears up to supply 0.3 million healthcare workers across nine countries US, UK, Germany, and Canada among others till 2022 to help them better prepare for any future pandemic. - more
Income Tax refunds worth Rs 1.64 lakh cr issued to 1.41 cr taxpayers till January 4 - more
Dependent on India, the world’s top sugar trader expects two years of shortages ahead - more
Indian skilled workers to get job opportunities in 14 sectors in Japan such as nursing, construction, etc - more
Indian startups end dependence on Chinese money. Immediately after the ban, many startups had to reconfigure funding plans and look at different options overnight - more
Housing sales in Delhi NCR dip by half year-on-year in 2020 compared to 2019. Greater Noida accounts for 39% of the total residential sales followed by Gurugram at 29% - more
B2B marketplace for MSMEs Udaan gets $280M from existing, new investors; valuation up from around $2.6B - more
Govt considers creating a bank with $13.7 bn equity to fund roads, ports / the finance ministry has prepared a note for Modi's cabinet to discuss the proposal - more
Despite 2 approved Vaccines, 69% want to wait: The Drugs Controller General of India (DCGI), on Sunday, announced the approval of two vaccines -- Oxford-AstraZeneca's Covishield manufactured by Serum Institute of India and Bharat Biotech's Covaxin -- against coronavirus infection for restricted emergency use. The survey conducted by 'LocalCircles' in January has concluded that Indians' hesitancy over Covid-19 vaccines remains unchanged in November and December 2020, with 69 percent maintaining that they will not rush to take it. (Source)
Chinese Apps for Fraud and Espionage: The year 2020 ended with a shocking revelation about fraudulent activities being carried out through several mobile-based instant loan apps available on Google Play Store. During raids in Hyderabad and Gurugram in the last week of December 2020, Hyderabad and Cyberabad Police busted the call centers of fraudulent instant loan apps such as Cash Mama, Dhan, and Loan Zone, etc. According to the police investigation, these loan apps and call centers are run on behalf of Chinese-controlled private limited companies registered in Bengaluru like Liufang Technologies, Hotful Technologies, Nabloom Technologies, and Pinprint Technologies. These companies run under the control of Chinese nationals. (Source)
Chinese Govt shuts Alibaba Music: Chinese billionaire Jack Ma’s Alibaba Group, which is currently under scrutiny by the Chinese government for alleged monopoly practices is set to shut its music streaming service in a bid to scale down its businesses. The streaming platform is called Xiami Music and will cease operations next month. "Due to operational adjustments, we will stop the service of Xiami Music from February 5," the platform announced on Tuesday on its Weibo account. (Source)
Avian/Bird Flu in MP?: After Indore, bird flu has been confirmed as the cause of mass death of crows in Mandsaur and Agar Malwa districts of Madhya Pradesh, an official said on Tuesday. The presence of H5N8 virus (a variant of avian influenza or bird flu) was found in the carcasses of crows in Mandsaur and Agar Malwa districts, he said, citing test results of samples sent for laboratory analysis. (Source)
Ancient India thwarted malaria: When the first humans started moving out of Africa some 350,000 years ago, they looked for dry areas — the savannah grasslands, the deserts of southwest Asia. Because tropical regions, while bountiful with food and water, were also home to malaria-carrying mosquitoes. So, why prehistoric humans entered India — where it was wet, warm, and humid — about 70,000 years ago has puzzled scientists. But a new study offers an answer. The malarial parasite in prehistoric India is likely to have been the more benign variant. “Nor should we forget that India’s own medical system was able to take up the fight against diseases thousands of years ago, while in other malaria-affected areas of the world, a similarly effective, Ayurveda-like medicine system did not exist,” Dr. Attila J Trájer, lead author of the study published in ‘Quaternary International’, told TOI. (Source)
video corner: Scots selling sand to the Saudis
It seems that the Scots and Aussies are selling sand to - well - the Saudis! Crazy right? Well, maybe not.
A Scottish farmer said Wednesday he is selling sand to Saudi Arabia even though that arid country is mostly desert. ″The Saudis have a lot of sand but it is the wrong shape,″ said the farmer, John Keddie. The Saudis want tons of Keddie’s sand to use in filtration systems for water supplies and swimming pools. ″Their sand is too round. Ours is cuboid with the corners rubbed off. Ours is also very hard so it doesn’t break down in the filters,″ said the farmer. (Source)
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