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/* What a joke */
:::Look, I'm not a fan of Bill Gates, either. Actually, personally, I view him as scum and would get rid of Microsoft if such didn't run the risk of making files I've made unusable (I'm really attached to my files, and if I move my files to open source, for example, I won't be able to use them anymore). However, he's never given any indication that he answered to Moscow during the Cold War, or for that matter to Beijing (though that being said, he probably IS one by 2017 at the earliest due to being inducted into that university), so no matter how much loathing I have for the man, I still need hard evidence that he's a communist. [[User:Pokeria1|Pokeria1]] ([[User talk:Pokeria1|talk]]) 15:36, 20 April 2020 (EDT)
::::Okay. Help me translate [https://www.quora.com/Is-it-true-that-Bill-Gates-faced-trial-in-India-for-illegally-testing-tribal-children-with-vaccines?share=1 Dr. Tirumalai Kamala's complete response into plain English] a layman can understand. [[User:RobSmith|RobS]]<sup>[[User talk:RobSmith|De Plorabus Unum]]</sup> 17:08, 20 April 2020 (EDT)
::::As to commie agitprop, what does the MS in MSNBC stand for? [[User:RobSmith|RobS]]<sup>[[User talk:RobSmith|De Plorabus Unum]]</sup> 17:15, 20 April 2020 (EDT)
:::::Microsoft. And for the record, I don't even WATCH MSNBC, nor do I ever plan to. [[User:Pokeria1|Pokeria1]] ([[User talk:Pokeria1|talk]]) 17:22, 20 April 2020 (EDT)
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Full text of Dr. Kamala's response:
'''Is it true that Bill Gates faced trial in India for illegally testing tribal children with vaccines?'''
http://articles.economictimes.indiatimes.com/2014-08-31/news/53413161_1_hpv-vaccine-cervarix-human-papilloma-virus
3 Answers
Tirumalai Kamala, Immunologist, Ph.D., Mycobacteriology
Answered December 3, 2015
No, that isn't completely accurate.
'''Who: Bill & Melinda Gates Foundation (BMGF), https://en.wikipedia.org/wiki/PATH_%28global_health_organization%29 (PATH) and Indian Council of Medical Research (ICMR)'''
The BMGF funds PATH, a Seattle-based NGO and main recipient of BMGF grant money for global public health initiatives. Since 1998, BMGF has funded PATH to the tune of ~$2 billion. The ICMR is the Indian Government's primary agency tasked with conducting biomedical research.
'''What: A Phase V human papilloma virus (HPV) Phase V vaccine trial in Andhra Pradesh & Gujarat, India'''
PATH carried out a large HPV Phase V vaccine trial in India. Phase V means using approved, not test, vaccines. Certain forms of HPV are associated with cervical cancer. The vaccines in question, Gardasil from Merck and Cervarix from GlaxoSmithKline, were granted marketing approval in India in 2008 while the PATH-sponsored trial began in 2009 as a joint project with the ICMR, using donated vaccines.
*The purpose of the trial was to generate data to support the inclusion of the HPV vaccine in India's Universal Immunization Programme (UIP).
*Specifically recruiting from low-income rural, largely tribal, households, the trial was conducted on girls aged 10 to 14 using Gardasil in Khammam district of Andhra Pradesh (AP) state (n=13000), and using Cervarix in Vadodara in Gujarat state (n=10000).
'''The Problems'''
Public recognition of problems with this trial started with the reported death of 7 girls. This led to immediate suspension of the trial in 2010 even though it was supposed to run until 2011. Investigations showed these deaths weren't directly connected to the vaccines (see table from the initial official investigation report, 1).
However, investigations triggered by these deaths instead uncovered serious violations of the process of informed consent (see official investigation reports below from 1, see also 2). Aged 10 to 15, girls in this trial were obviously below the age of consent meaning their participation in the trial required the consent of parents/guardians. In the course of Government of India (GOI) investigations, the trial investigators 'were asked to submit 100 consent forms, chosen randomly, for both AP and Gujarat for independent verification' (1). These consent forms turned out to have several problems (see reports below from 1).
Investigations (1) revealed that
*In Andhra Pradesh, 'Signatures of one parent were obtained on 9543 forms, thumb impression of one parent on 1948 forms and signatures of Hostel Warden/Head Master as Guardian in 2763 forms'
*The investigators noted, 'The legality of the signing by the Hostel Warden/Head Master in Andhra Pradesh needs to be examined by an appropriate authority'.
*In Gujarat, 'In Gujarat one parent has signed on 6217 forms, has provided thumb impression on 3944 forms and Legal guardian has signed or put thumb impression on 545 forms'.
*As a newspaper report summarized, signature of ~2800 consent forms had instead been signed by school teachers, principals or hostel wardens, even in cases where the girls had parents (2).
The Indian Parliament's Standing Committee on Health began its investigation in April 2010 and concluded that 'safety and rights of children were highly compromised and violated' (3).
The Committee's report (3) found
*The girls' consent was not fully informed.
*Post-vaccination adverse events weren't adequately monitored or reported.
*PATH and ICMR hadn't sought mandatory permission from the Drug Controller General of India (DCGI) or the Indian National Technical Advisory Group on Immunization (NTAGI).
*PATH wasn't even a registered legal entity when it began working with the ICMR.
*DGAI culpable for dereliction of duty.
The Committee's report stated, 'PATH resorted to an element of subterfuge by calling the clinical trial as 'observational studies' or 'demonstration project' and recommended legal action against PATH (3). However, the Union Government of India decided legal action couldn't proceed based on the its assessment of the country's prevailing laws. Instead in 2014, it issued a warning letter to PATH (4).
PATH's dubious and unconvincing defense was that this wasn't a clinical trial, only an observational study of an already approved vaccine. As such, it argued that neither provision, i.e., informed consent and monitoring/reporting of post-vaccination adverse events, was necessary (5). This is patently incorrect.
'''Bibliography'''
# http://icmr.nic.in/final/HPV%20PATH%20final%20report.pdf
# The Hindu, May 25, 2011. Editorial. A shockingly unethical trial
# Page on preventdisease.com
# The Hindu, August 25, 2012. Aarti Dhar. Government warns PATH
# LaMontagne, D. Scott, and Jacqueline D. Sherris. "Addressing questions about the HPV vaccine project in India." Lancet Oncology 12.14 (2013): e492; Statement from PATH: cervical cancer demonstration project in India
'''Further Reading'''
# Kumar, S., and D. Butler. "Calls in India for legal action against US charity. Nature News [Internet]. 2013 Sep 9 [cited 2013 Oct 22]." Calls in India for legal action against US charity
# sSharma, Dinesh C. "Rights violation found in HPV vaccine studies in India." The Lancet Oncology 14.11 (2013): e443.
Thanks for the A2A, Shivanshu Siyanwal.
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