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