Perils of politically-driven scientific research

Will Prime Minister Narendra Modi, in his Independence Day address from the ramparts of New Delhi’s Red Fort, announce that India has developed a COVID-19 cure?

Speculation on the subject was rife last week after the Indian Council of Medical Research asked investigators involved in clinical trials on a drug developed by a Hyderabad firm to speed up the process and provide results not later than August 15, the 73rd anniversary of Independence.

India has reasons to look for a breakthrough in the race for a cure for COVID-19 since it is now the third worst-hit country in the world.

However, many suspect a political motive behind the ICMR decision to advance the trial deadline.

At the root of the suspicion are misgivings about Modi’s understanding of scientific research and the tendency to convert governance into public relations exercises.

From Jawaharlal Nehru’s time, the Prime Minister has inaugurated the annual session of the Indian Science Congress. Modi caused amusement and consternation when he first addressed the Science Congress by suggesting in all seriousness that the popular Hindu god Ganesha got his elephant-head through organ transplant.

Bharat Biotech International Limited, the Hyderabad firm working on a COVID-19 drug, is a research-led company that boasts of creating vaccines and therapeutics for challenging diseases for more than two decades. Its products are sold in 65 countries.

Its vaccine candidate, named Covaxin, is just entering the stage of trial in humans. The trial is to be conducted at 12 institutions across the country.

In its submission to the Clinical Trial Registry of India, the company had indicated the trial would last 15 months.

The trial protocol requires follow-ups on Day 14, Day 28, Day 104 and Day 194. This means at the very minimum the trial will last over more than six months. The trial calendar envisaged enrolment of the first batch of participants on July 13.

In a letter to the principal investigators of the trial at the 12 institutions, ICMR Director-General Balram Bhargava asked them to obtain all necessary approvals from internal committees by July 7 and warned that failure to do so would be viewed very seriously.

“It is envisaged to launch the vaccine for public health use latest by 15 August 2020 after completion of all clinical trials,” he wrote.

Seven Indian firms are working on COVID-19 vaccines. So far only two, Bharat Biotech and Ahmedabad-based Zydus Cadila, have been given clearance for trial on humans.

The Zydus product is named ZyCoV-D.

As scientists criticised the deadline set for Bharat Biotech, ICMR claimed its action was in line with efforts going on worldwide to fast-track COVID-19 vaccine development.

The Department of Science and Technology, in a press release on measures to combat the pandemic, issued on Sunday, said a cure for the disease was unlikely to be ready for mass use before 2021.  Within hours it deleted the reference to 2021.

This suggests an August 15 announcement may still be on the cards.

Baba Ramdev, a Yoga guru with links to the ruling establishment, entered the market recently with what was said to be a Covid drug based on the indigenous system of medicine. The government asked him to stop advertising it as a Covid cure.However, it allowed him to sell it as an immunity booster.

Ramdev’s company has been marketing various consumer products, said to be based on traditional Indian practices, for a few years.

In February the World Health Organisation had brought together scientists from different countries at its Geneva headquarters to assess the level of knowledge about the new virus and evolve suitable strategies to combat it.

The WHO said later it did not expect a COVID-19 vaccine to become available in less than 18 months.

Across the world several hundred drug companies, biotechnology firms, university research groups and health organisations are working on 194 vaccine candidates and about 300 potential therapies for COVID‑19.

Intrusion of political considerations can pose a threat to the rigours of scientific research.

Trial of new vaccines on humans is conducted in two phases. In the first of these, the candidate vaccine is tested on small groups of patients. In the second phase, it is tested on large groups.

It is after the successful completion of these two phases that the vaccine is approved and its mass use permitted.  

India needs to avoid the temptation to short-circuit the process, motivated by exterior considerations, lest it should damage its reputation in the fields of science and technology.