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Controlled Human Infection Method: ‘Unethical’ clinical trials of vaccines pose threat to human lives

TuskegeeIn the USA, we might call this "The Tuskegee method."  As I watched Vaxxed II last week, it was the Gardasil stories that affected me the strongest. The fact that the placebo in testing was not by even the lowest scientific standards a placebo haunts me. As for CHIM - controlled human infection method, it's astounding how easily those in medicine can pencil in the ethics line under the guise of science for the greater good.  We have featured Dr. Puliyel's writing many times. We thank him for his diligent, surely lonely, work.

‘Unethical’ clinical trials of vaccines pose threat to human lives

By Dr. Jacob Puliyel, Pediatrican
Published 11/11/19 in Sunday Guardian Live, an Indian e-paper

Primum non nocere—“first, do no harm”—is a basic tenet of medical ethics. That is about to change in India. “Controlled Human Infection Method” (CHIM) studies are planned to be introduced here. Humans are to be deliberately infected with diseases to test the efficiency of experimental vaccines. It will provide a shortcut to vaccine licencing and reduce costs to manufacturers.

At Hotel Taj Palace, from 19 -21 November, under the rubric of the “World Conference on access to medicinal products”, the ICMR and the DBT plan to introduce CHIM studies. According to the Economic Times, even vaccine manufacturers are advising caution before allowing such a radical departure from standard practice.

The Translational Health Science and Technology Institute (THSTI), under the DBT, is spearheading the efforts under the banner of a mysterious “India Volunteer Infection Research Consortium”. Dr Y.K. Gupta, principal advisor, THSTI, has said that “initially, such studies should only be allowed in high-quality academic institutions… Similarly, at least initially, only healthy, educated adults should be included in a CHIM study”. The promoters are clear that such concessions are needed only initially.

So, the “initial” studies are to be done on drug-responsive malaria, typhoid and flu (which is self-limiting). It is claimed that CHIM volunteers are to be infected with a weakened strain of the pathogen. However according to biologics development consultant Dr K.B. Walker “a safe, well characterised strain will lose some semblance to the real “challenge” organism and so weaken the relevance of CHIM in informing further clinical development”. This defeats the main objective of doing such studies. Read more at Sunday Guardian Live.

 

Comments

MorningStar

The 'Tuskegee Method'?
We need to consider that mandatory vaccines are more liken to the 'Jones Town Method'.

Angus Files

Controlled? so when it goes wrong what control will they have?how will they correct and undo if it goes wrong?Answer they cant so it isnt controlled.The only control they have is to control and manipulate the bad results.Humans treated as lab rats, worse than the way normal humans treat animals.

Many thanks for the article Jacob Pulliyel


John Stone

Dr Puliyel

We also recall that the previous Drug Controller General of India, Dr S Eswara Reddy was already happy to see people die from medical experiments in large numbers:

https://www.ageofautism.com/2018/05/1250-deaths-in-drug-trials-considered-acceptable-by-indian-controller.html

25,000 deaths was embarrassing but 1,250 was just fine! It seems as if the nations of the earth are engaged in a Dutch auction for the lowest ethical standards for drug trialing - with perhaps India outbidding.

Jacob Puliyel

Bob,
I am posting the referenced version so the references are available to the readers.
I wonder if it will come in full in the comments section
Jacob Puliyel

Exploitative and Unethical Trials in India - The CHIM Story

Primum non nocere "first, do no harm" is a basic tenet of medical ethics. That is about to change in India. It is planned to introduce “Controlled Human Infection Method” (CHIM) studies here. Humans are to be deliberately infected with diseases to test the efficiency of experimental vaccines. It will provide a short cut to vaccine licencing and reduce costs to manufacturers.

At Hotel Taj Palace, from November 19 -21, under the rubric of the ‘World Conference on access to medicinal products’, the ICMR and the DBT plan to introduce CHIM studies (1). According to the Economics Times (2) even vaccine manufacturers are advising caution before allowing such a radical departure from standard practice.

The Translational Health Science and Technology Institute (THSTI) under the DBT, is spearheading the efforts under the banner of a mysterious ‘India Volunteer Infection Research Consortium’ (2). Dr Y K Gupta, principal advisor THSTI, has said that “initially such studies should only be allowed in high-quality academic institutions…. Similarly, at least initially , only healthy, educated adults should be included in a CHIM study” (2). The promoters are clear that such concessions are needed only initially.

So, the ‘initial’ studies are to be done on drug-responsive malaria, typhoid and flu (which is self-limiting). It is claimed that CHIM volunteers are to be infected with a weakened strain of the pathogen. However according to biologics development consultant, Dr KB Walker “a safe, well characterised strain will lose some semblance to the real ‘challenge’ organism and so weaken the relevance of CHIM in informing further clinical development (3)”. This defeats the main objective of doing such studies.

Also, what is the use of doing studies on easily treated disease? The real need is for vaccines against dangerous diseases like Ebola. After the initial human revulsion against CHIM has been overcome, we can expect trials with Ebola infection and similar plagues. After the ‘initial’ stages, we can expect these studies will not be limited to academic institutions and contract research organisations (CROs) will do these studies more efficiently. This is a slippery slope. Once the Rubicon is crossed, there may be no coming back.

The country remembers what happened when the government tried to encourage the inflow of foreign exchange for clinical trials from abroad with tax cuts and relaxing local laws. The cost of doing clinical trials in India was half of what it cost in other countries in the West, even counting kickbacks to local doctors. There was a spurt in such trials. However the lax governmental regulation had to be tightened after 1725 deaths among trial participants was reported (4). Justice R M Lodha commented about these trials saying, “Human beings are being treated like animals”.

Writing in Business Standard (6) a group of ethicists and legal experts have raised a number of questions about these CHIM that need to be answered. Who are the industry collaborators? Who are the funders? Who will own patents obtained through CHIM? Will there be disclosure about the incentive paid to volunteers? Will there be an open registry of adverse events and results?

In a country, where adverse events during a government funded rotavirus trial are yet to be disclosed in spite of repeated appeals going up to the Supreme Court, open disclosures regarding CHIM trials seems very unlikely.

The poor in India are known to enter studies not for altruism but for healthcare, better healthcare services for themselves — or for money. Even in developed countries participants are known to join multiple trials for the high payments, despite the discomfort and the risks posed by repeated infections, according to the article in Business Standard.

The Alliance for Human Research Protection (AHRP) is presided over by Vera Sharav, a survivor from Hitler’s holocaust. The AHRP has called the proposed studies on human volunteers in India, “a vaccine experiment atrocity” (6).

CHIM studies cannot be done in countries like India where research regulation is poor and research transparency is non-existent. One must prevent exploitation of the public by vested interests.

Jacob Puliyel

puliyel@gmail.com

Puliyel is a paediatrician and the opinions expressed are personal

References

1. https://www.worldsdg2030.org/registration-form.aspx

2. //economictimes.indiatimes.com/articleshow/71496865.cms?from=mdr&utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

3. https://www.iabs.org/documents/conferences/2019/focus-on-quality-requirements-for-challenge-agents/abstracts-2/749-abstract-p-kremsner/file
4. http://www.jcdr.net/articles/pdf/2389/jcdr-6-1367.pdf

5.
https://www.thehindubusinessline.com/specials/pulse/chim-method-of-vaccine-testing-is-no-shot-in-the-arm-for-india/article29805631.ece
6.
https://ahrp.org/vaccine-experiment-atrocity-human-infection-model/

Bob Moffit

For some reason I cannot access full article … but .. the information already offered by Dr Puliyel is enough to warrant recognition of the continuing collapse of basic "ethical standards" when the product being marketed is a vaccine.

The truly sad part is the fact the entire vaccine industry is built upon unethical methods and policies that shield the vaccine industry from being held accountable for the continuing damage to generation after generation .. unethical methods and policies that were exposed by sworn testimony of Dr Plotkin .. the acknowledged guru of vaccine science .. who acknowledged participating in similar "experiments" on carefully chosen VICTIMS .. be they mentally challenged or in countries where "population control" is prioritized over the supposed prevention of diseases.

One can only imagine how often these types of "experiments' on uniformed, unsuspecting populations have been sacrificed over the decades of vaccine tyranny.

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