The letter dated July 2, 2020 by the Indian government’s apex medical research body ICMR (Indian Council of Medical Research) with a directive to begin and finish all human clinical trials of COVAXIN- an indigenously developed vaccine for COVID-19- by 15 August 2020 (India’s Independence Day) so that the vaccine can be launched for “public health use” on that day (preceding midnight?), has raised critical questions of whether science has got seriously compromised.

ICMR gave a clarification later that the letter was intended to cut red-tapism and avoid delays. But the burning question remains: Why did ICMR, knowing very well that it is fundamentally unethical to pre-determine research outcomes and also that it is principally impossible to do a robust clinical trial in 5-6 weeks, try to force researchers to begin and finish research and make a vaccine available for “public health use” by Independence Day? This letter stated that vaccine research is “being monitored at the topmost level of the government”. So, was it the Prime Minister’s Office that made such a demand with a scant regard for the rigours of science? Was it not the duty of ICMR to uphold the highest levels of science and integrity and decline such unjustifiable requests?

The news initially gave us tremendous hope that ICMR is working towards producing India’s first indigenous vaccine against COVID-19. However, a lot of questions remain unanswered: how will a safe and effective vaccine against COVID-19 be available as early as August 15,  2020?
 

There is a scientifically validated and accepted protocol for conducting clinical trials to provide strong evidence on the safety, efficacy and effectiveness of the medicine, vaccine or any other medical product under study, before it can be put to public use. To ensure that the product under study is safe for humans (phase1study), and effective against a disease for the general populations and no harm to their health is caused by it (phases 2 and 3 studies), it is of utmost importance to adhere to all scientific and ethical considerations in the protocol and guidelines of the clinical trials.

As per the study design registered in CTRI (Clinical Trials Registry of India), the duration of this study (for phases 1 and 2) for COVAXIN is stated to be one year three months (15 months). In other words even if (and that is a big IF) all goes well in phases one and two human clinical trials, it will not be before September 2021 that we will learn if the vaccine is safe and effective, and ready to enter phase-3 (or for conditional roll-out like new anti-TB drug Bedaquiline while phase-3 study progresses ahead).

Human clinical trials have had a very bad history of abuse and human rights violations in the past century.That is why scientific protocols, guidelines and processes are well-established now worldwide to ensure that study/ trial participants give their informed consent to be part of the study, and all their rights are well protected and respected. We all want a vaccine at the earliest, it is equally important to ensure science is respected and all protocols and safeguards are in place so that neither the study participants nor the general population are harmed in any way.

The vaccine candidate COVAXIN has currently cleared only animal studies (or the pre clinical stage) and human clinical trials have yet to begin. This is a very initial stage and declaring a date for its “public health use” is assuming that the clinical trial outcomes will be positive, which is principally unethical for a scientific study. Such declarations will not only raise undue expectations but can also result in complacency in implementing ‘what-we-know-works’ (including prevention measures) in containing the spread of the virus.

In an interview, Dr Soumya Swaminathan, WHO Chief Scientist and former DG of ICMR, raised serious questions about this timeline (of August 15, 2020) and cautioned that speed may be important but could not come at the cost of scientific and ethical standards

If the ICMR is so confident of producing a vaccine within a month and a half why did it not announce such a measure in March itself so that the vaccine could have been developed at the earliest and saved much human suffering? The history of Indian medicine research is not very encouraging with only one Nobel prize in this field to Har Gobind Khorana for his research done in United States when he had become US citizen.

Another important question is that though the strain of coronavirus was isolated by ICMR National Institute of Virology, then why is a government entity not doing further research and development of the vaccine? Why (as per the letter of ICMR) has it joined hands with a private biotech company (Bharat Biotech) for preclinical and clinical research development of the vaccine? If it is joint research project between the of ICMR and Bharat Biotech then why is ONLY Bharat Biotech listed as the Principal Investigator, trial coordinator, primary sponsor (there is no other secondary sponsor), source of monetary or material support, scientific query lead, etc? If a private company (let’s say a soft drink company) is the only sponsor, funder, principal investigator etc of a research which shows benefit of its product, then will we not call it junk science?

Also, it is important to note that no ICMR institute is included in the list of the 12 centres of this multi-centric study. Instead, we see a host of private centres too. Why is ICMR not collaborating with only public healthcare institutions when it is the public healthcare centres that have been majorly managing COVID-19 and non-COVID-19 illnesses since the lockdown? Also, why has the government not leveraged the Epidemic Act to nationalize all health services including biotechs?

We should remember that right at the onset of lockdown in India, ICMR had landed itself in a controversial manner, negotiating a maximum price cap for the private sector for COVID-19 test which was way too high, allowing the private sector to reap profits when the nation was reeling under a public health emergency and a cascading humanitarian crisis. With this background, ICMR must come out clean on the intellectual property rights and price negotiations, if at all the vaccine sees the light of the day. In addition to this, the government of India must fully support the proposal of government of Costa Rica, for the development of a ‘global COVID-19 commons’ for all research, data, technology, treatments and vaccines relating to COVID-19 as a non-proprietary shared global resource.

While ensuring that there is no avoidable delay in scientific research, ICMR should not forget that it is also the vanguard for protecting the integrity of science and scientific rigour in the country.

In 2015 only 62% of newborn children received basic vaccinations in India. It is important to realize that vaccine-preventable illnesses are a significant cause of unnecessary human suffering and untimely deaths. We have failed to ensure zero-delay in making even the existing healthcare technologies (diagnostics, drugs, vaccines and other healthcare lifesaving procedures and care) available to everyone. While ICMR must ensure absolute adherence to all scientific norms and standards in conducting all research studies, the government also has to ensure that once these scientific breakthroughs come out of the research pipeline, they reach the people in need without any delay – where the ‘last person in the queue’, as per Mahatma Gandhi’s talisman, must come first.

(ShobhaShukla is the founding head of Citizen News Service,SandeepPandeyis national Vice President of Socialist Party (India) and Bobby Ramakant is both with CNS and Socialist Party (India). Follow the authors on Twitter: @Shobha1Shukla, @Sandeep4Justice, @bobbyramakant)

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Is the situation dismal? In a survey of experts done in 2018, India ranks as the world’s most dangerous country for women. It had ranked 4th in the same survey done 7 years ago. The Global Gender Gap Index 2017 by the World Economic Forum placed India at 108 position out of 144 countries benchmarked on the basis of gender parity in the fields of economic participation, education, health and political empowerment. India ranked 131 out of 153 countries in the global Women, Peace, and Security Index 2017-18, that is based upon 11 indicators incorporating inclusion, justice, and security. Despite women accounting for 49% of India’s population, only 12% of the seats in the national legislature are held by them. The female labour force participation rate in India fell from 37% in 2006 to 27% in 2017, as per World Bank report, ranking India at 163 out of 181 countries.

Some sparks of light
More women are getting educated and coming out of their cocooned existence. They are entering professions that were till recently considered to be the domain of males. They are flying planes, driving e-rickshaws and trains, wielding the surgeon’s knife and winning Olympic medals. It is heartening to know that amongst the top 79 global airlines, Indigo Airlines employs maximum percentage of women pilots (14%) followed closely by AirIndia (nearly 10%). Even rural women are becoming more independent, working outside of their homes and exhibiting active leadership at local government level. The Economic Survey 2018 shows that 43% of all gram panchayats (village councils) in India are headed by women.

Two young female staffers at a 5 star hotel told me that though they come from humble backgrounds, their education and job has given them the courage to take their own decisions and to raise their voice against gender injustice. Some domestic helpers said that there are more job opportunities for them today. And though gender equality is a distant dream, they feel more confident than before. A domestic violence survivor said that girls are now becoming more self sufficient and raising their voices against male dominance. She herself took bold decisions to walk out of an abusive marriage through sheer determination and strong will. Her courage has inspired her daughters to take life’s challenges head on and not bow down to the whims of a patriarchal society. Very gratifying indeed!

Problems at ground level
Renu Mishra, Executive Director, Association for Advocacy and Legal Initiatives (AALI) rues that the number of women in the work force is dismally low and even those who are working do not get equal wages as compared to their male counterparts. Women do not even have the right to take personal decisions; they do not have the right to enter into matrimony or walk out of a relationship of their own choice.

For Dr Pooja Ramakant, breast cancer and endocrine surgeon, striking a balance between family and career is a huge problem for women of her age. “As a female surgeon, I have to struggle more than my male counterparts. Why is a woman expected to fit in the framework designed by a patriarchal society and conform to the social norms laid down by others, even if they are detrimental for her own well being? I have come across many financially independent women also who suffer in silence and stay in abusive marriages. Perhaps, due to emotional weakness, they are scared of what others will say”, shares Pooja.
Even though more and more girls are going to school, education of the girl child is still beset with problems, thinks educationist Dr Chitra Singh. “This is more so in rural areas where girls’ schools are still not a plenty and parents do not feel safe for their daughters to travel long distances. Also most rural schools have poor toilet facilities, which is another deterrent for girls. Patriarchal mindsets when coupled with poor economical status, make matters worse. They think it is a waste of their meagre resources to spend on the daughter’s education, as she will have to be married off. They would rather educate the sons who they think would support them financially later on”, she says.

The way forward
Life cannot be a bed of roses, but neither does it have to be a throne of thorns. Renu is emphatic that at a personal level each woman should ensure that she would not allow herself and her family to abide by any patriarchal value system. “All of us will have to, and can, contribute to bringing about gender equality in our own life. Let us not do anything that helps propagate patriarchy. We must also contribute to have an enabling environment at home, in schools and outside where girls/women can speak openly and fearlessly”.

Pooja exhorts women to speak up and not remain silent- “I do not remain silent if I see any injustice being done to a woman. Rather I make it a point to speak and make my voice heard and I face such situations very often in my professional life. I encourage my young girl students (interns) to not get de- motivated by society, but make their own informed choices regarding their professional and family life. Also, women should insist on an equitable distribution of work between all members of the family. Men will have to contribute equally to household work and responsibilities. Let us not forget that all women are working women, whether employed or not.”

Chitra wants all girls to get at least some basic education plus job oriented skills to make them employable. They should not be married till they are economically independent.

Renu, who is also a lawyer, is happy that India has several women friendly laws on girls’ education, prohibition of child marriage, equal inheritance of property, curbing of sexual and domestic violence, etc. However, lack of political will power and a deeply entrenched patriarchal society makes their implementation very poor. Moreover, most women- even the educated and working women- do not have much knowledge about them and many are clueless even about their existence.

She wants these laws to be part of the education curriculum, to make women, as well as men, informed about them. Also, the government’s Information and Broadcasting Ministry needs to play a more proactive role in spreading awareness around these laws and government welfare schemes for women/girls, through channels like radio, television, newspapers, and billboards. It is the onus of the government to disseminate all this information, and then act on speedy delivery of redressals if it is really keen for women to benefit from them. One reason for rise in the number of sexual offences is no quick redressal—the case could drag on for long and/or accused goes scot free in most cases.

Recognising that women in today’s world have to balance multiple responsibilities at home as well as outside, Dr Soumya Swaminathan, Deputy Director General for Programmes at the World Health Organization (WHO), urges women to take care of their own health-both physical and mental health. In an exclusive interview given to CNS, she said that “Women play a very big role in healthcare delivery. Not only do women constitute the majority workforce in nursing and community healthcare work, they are also the main caregivers within households and communities. But their efforts are often taken for granted and are not publicly recognised. I would like to put the spotlight on these women who are providing healthcare either in formal or informal settings. We should appreciate this unrecognised army of women healthcare providers, and ensure that they are able to provide these services in a labour and time saving manner.”
India is a vast country, which, despite the skewed up sex ratio (945 females per 1000 males), is home to 65 crore women. That is a huge woman power, who should neither bow down in fear nor remain silent, but be brave and snatch their rights to exercise their choices- be it their education, marriage, profession, or health (including sexual and reproductive health).

The International Women’s Day 2019 campaign theme of #BalanceforBetter also calls for driving gender balance across the world- gender-balanced boardrooms, a gender-balanced governments, gender-balanced media coverage, a gender-balance of employees, more gender-balance in wealth.
So, let us celebrate our womanhood everyday and fight till we win. In solidarity we stand together!

Note: In response to this message I had posted on my FaceBook page- ‘To all the male readers of this post: Please share at least one action you have taken in your personal life to advance gender equality’ I got just one response and that was from a retired Professor of IIT Kanpur. He wrote-‘I have been instrumental in getting the PhD Degree to 3 males and 10 females. Hope this justifies my contribution’. Indeed it does.

Shobha Shukla is the Managing Editor at CNS (Citizen News Service) and a noted gender justice activist. Follow her on Twitter @Shobha1Shukla or visit www.citizen-news.org

Courtesy: Counter Current

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