Why Ramdev, vaccine producing pharma companies and government are all at fault

By Colin Gonsalves* 
It was perhaps Ramdev’s closeness to government which made him over-confident. According to reports he promoted a cure for Covid, thus directly contravening various provisions of The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. Persons convicted of such offences may not get away with a mere apology and would suffer imprisonment.
Ramdev’s case has wider ramifications. It applies to allopathy too. The role of big pharma across the world making false or exaggerated claims of the drugs they produce and the effect of these claims on the health of millions of persons is now well documented in published academic research. Big pharma constitute a significant component of international corporate crime.
Section 4 (b) of The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954; makes it an offence for anyone to assert a false claim for any drug, and makes the punishment a prison sentence upto 6 months. There is no provision in the law for an apology to replace a prison sentence.
When the vaccine Covishield was given emergency clearance in India without completing the elaborate protocols of clinical trials, the protests were brushed aside on the ground of necessity occasioned by the nature of the virus. But that does not justify why even today the full disclosure of the clinical trial data has not been made and why the full protocol of clinical trials rather than the truncated protocol could not be done.
This article is about people in authority in India both in the government and in private sector flying to the defence of the vaccine manufacturers and saying that the vaccine “was 100% safe”. How different were they from Ramdev?

Adverse events deliberately underestimated

It doesn’t take rocket science to calculate the serious adverse events (SAE) and deaths on account of the vaccine in India. This can be done by perusing the data collected in the UK where the same vaccine was used. The UK reported about 4 lakhs individuals injured and that about 2,400 persons died. Doing a pro rata adjustment for India by comparing the number of persons vaccinated in both countries, the number of persons injured in India would be 21 lakhs. Government admits of only 80,000 individuals. Similarly, the number of deaths estimated in India would be 30,000. Astonishingly, government admits only 1148!

Active surveillance? Even passive surveillance was not done

This cover up was done by government not adhering to the world recognised guidelines for monitoring. 

First, all newspapers in the country were to be scanned for information. Thereafter, government investigators were to check every single media report. Civil society organisations took up this task abandoned by the government and submitted more than 19,000 media reports of severe and fatal AEFI cases. Even then the government refused to investigate saying that the vaccine was 100% safe. 

Secondly, the government was to do active surveillance under the revised guidelines, as compared to passive surveillance which required the people of India – poor and illiterate to get through on the government helplines and report their adverse events. Active surveillance require the mobilisation of the entire Asha network and the Anganwadi network and all health workers everywhere to fan out in the villages and slums and document adverse events. This was not done. Why? Because the vaccine was 100% safe!
Not surprisingly though the law required active monitoring of every single adverse effect following vaccination this was rarely done. Government did not care to broadcast in the country the possible adverse effects and deaths of the vaccine and what the hospitals should do if their patients have a vaccine related adverse event. Phone calls made to government helplines were difficult to get through and received indifferent responses. 

The end result is that even today government puts forward an unbelievably low level of vaccine related adverse events and deaths.

Free and informed consent not taken

The Union of India already has a system in place for taking the beneficiary’s signature on consent forms as in the case of yellow fever. Apart from the general well established requirement in law, “prior, free and informed consent based on adequate information,” is a requirement of Article 6 of the Universal Declaration on Bio Ethics and Human Rights, 2005 which is binding upon India since it is a signatory.

List of adverse events known to the world: But not India

Millions of Indians went into the vaccination programme without knowing the possible adverse events which included “blood and lymphatic system disorders, cardiac disorders, congenital, familial and genetic disorders, ear and labyrinth disorders, endocrine disorders, eye disorders, gastrointestinal disorders, hepatobiliary, immune system disorders, infections and infestations, metabolism and nutrition disorders, musculoskeletal and connective tissue disorders, nervous system disorders, pregnancy puerperium and perinatal conditions, psychiatric disorders, renal and urinary disorders, reproductive system and breast disorders, respiratory thoracic and mediastinal disorders, skin and subcutaneous tissue disorders and vascular disorders. All this according to the European Medical Agency Data Base, Eudra Vigilance.

Vaccines 100% safe: Statement as wrong as Ramdev’s 'cure'

Some vaccine manufacturers gave a warning in the insert sold along with the vaccines that pregnant women and lactating mothers and persons suffering from diabetes and hypertension may not take the vaccine. RTI replies of government suggest that vaccine manufacturers may not have sought permission for safety trials on pregnant and lactating women. 

Ramdev’s case has wider ramifications. It applies to allopathy, too, especially big pharma making false or exaggerated claims 

Despite this, it appears that, pregnant women in India began receiving the vaccine in June 2021, with no data available on the number vaccinated. Government appears to have gone ahead with the vaccination programme even before clinical trials were done. Only fully disclosure of all the records by government and the vaccine manufacturers can confirm this unusual development.

Then, the Heads of Departments and other eminent persons such as the Professor, Centre for Community Medicines, AIIMS, New Delhi and the National President of the Indian Public Health Association, sent letters to the Prime Minister pleading that monitoring and surveillance ought to be done properly as was being done across the world. The Prime Minister did not have time to reply.

Conflict of interest in the watchdogs

Instead government set up the Immunisation Technical Support Unit (ITSU) and the National Technical Advisory Group on Immunisation (NTAGI) but it was riddled with vaccine manufacturers, funders of vaccines and persons having conflict of interest who did not so declare their conflict and kept silent.
“There is no side effect that would result in death,” said the Director of a leading central government hospital at Delhi. “The vaccines are 110 percent safe,” said the Drug Controller General of India. In the Frequently Asked Questions (FAQs) published by Ministry of Health it was stated that “the common side effects in some individuals could be mild fever, pain at the site of injection”.

Young girls' deaths post vaccination

The deaths of a number of young girls soon after receiving the vaccine are particularly heart breaking. 18 year old “R” suffered rapid decrease in her platelet count, intense headache, vomiting and seizures and died soon after the administration of the vaccine. 

Since adverse reaction of the vaccine had not been disclosed by government the family doctor gave her paracetamol. A senior doctor at a leading hospital at Delhi prescribed Avil for allergic reaction and Calpol for pain. Even at that stage the doctors said it was a viral infection and told the parents not to worry. When her condition worsened she was rushed to a leading hospital where the MRI disclosed a clot in her brain. The post mortem report said that the bleeding was “consequent to vaccination with Covishield”. Subsequently government accepted that the reaction was “Covid vaccine product related”. 20 year old “K” had a similar anguished death.

Ayurvedic drugs important during Covid

Though Ramdev was wrong in saying that he had a cure for Covid, his other utterances about the importance of resorting to ayurved during the Covid period to build internal resistance and lessen the adverse impacts of the vaccine may have been spot on. 

On this issue the Prime Minister of India who recently campaigned for yoga internationally seemed to have missed the bus. What he ought to have done after consulting with senior practitioners of Ayurved was to similarly campaign in India and abroad for the disciplined taking of ayurved medicines thus teaching the world about the marvels of Ayurved. Instead this government went whole hog in favour of allopathy and the vaccine. Misadventure after misadventure took place as in the case of plasma therapy. India’s Covid response was pathetic in the extreme.
Today there are large and influential institutions that guide the destiny of India who are committed to continue stifling any independent inquiry into adverse events including death and into the cosy relationship between vaccine manufactures and government which have a hint of improper conduct.

So what should the government have done?

Simple, tell the people the truth that the vaccine may help according to the government but the possible adverse reactions are many and the medical treatment for them exist. Then let the people decide! 

But telling the truth is not something this government is good at.

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*Senior advocate, Supreme Court of India