Questions that hang over remdesivir

AMERICAN DRUG giant Gilead, patron saint of the voluntary licence (VL), has handed out five licences to Indian and Pakistani pharma companies to manufacture its experimental anti-viral drug remdesivir. The drug, which was developed by Gilead to treat the Ebola virus but failed to do so, found a new lease of life when Chinese health authorities—scrambling to contain the deadly outbreak in Wuhan—found it effective in treating COVID-19 when used in combination with chloroquine. Since then, the drug has dominated the headlines as the most likely treatment for the disease, despite a clutch of trials failing to prove conclusively that it had a significant effect in containing the virus.

Since January, remdesivir has seldom been out of the news; every development— even if negative—only went on to push up Gilead’s stock prices and hopes of a cure. The irony is that most of the news on clinical trials on the drug should have acted as a dampener. First was the publication of what was titled the “Compassionate use of remdesivir for patients with severe COVID-19”. The trial was conducted on just 53 patients by the company itself and was neither a randomised nor a controlled test, which is the standard to assess a drug’s efficacy. It revoked a sharp reaction from pharmacologists and medical experts, one of whom described the data as “almost uninterpretable” and said it was unethical of the to have published it.

Then came the leaked results of a muchawaited clinical trial conducted in China. This showed remdesivir had failed to speed up the improvement of patients with COVID-19 or prevent them from dying. The data was

“inadvertently” posted on the the World Health Organization website and then pulled down. Although Gilead said it was an incomplete study, terminated prematurely, but claimed the trends indicated there was “potential benefit” for patients treated early with the drug.

It is against this backdrop that the US Food and Drug Administration (FDA) issued an emergency use authorisation for the drug on May 1, just two days after the National Institutes of Health’s (NIH) clinical trial “showed promising results”. It was swift and surprising to say the least. With this official stamp of approval for a drug that the company was till recently describing as “an investigational product that has not been approved anywhere globally”, and cautioning that “the safety and efficacy of remdesivir for the treatment of COVID-19 is not yet known” Gilead is on a roll.

So are Indian generic companies selected for the VLs. That’s Cipla, Hetero Labs, Jubilant Lifesciences and Mylan—the fifth is Ferozsons Laboratories in Lahore—among them some of them old partners of Gilead. They have been given royalty-free VLs and also the technology to make this ‘difficult’ drug. Other terms of the VL are also more agreeable than in the past. The companies are free to set their own prices and can export to 120 countries, mostly in Africa and Asia. Meanwhile, US clinical analysts are cautiously optimistic. They say the NIH trial results seem promising, but want details. They have reminded FDA that it is important to look at the overall results from other trials of remdesivir and of other treatments as is the usual case. But these are not normal times.

Indian drug firms have signed voluntary licences with Gilead, even though trials are yet to prove the drug is effective against COVID-19

Contagion

The Rules of

HORRIFIED WITH the stories of workers walking thousands of kilometres to their homes, it occurred to me that the best way to document their hardship was to join them and see it for myself. I started on May 16 without a destination in mind. A friend had told me that a large number of people were on the Delhi-Ghaziabad-Amroha road; so I decided to take that route. As I file this report on May 21, I am about 100 km from Bahraich, a district in eastern Uttar Pradesh, roughly 600 km from Delhi.

MAY 16: DELHI TO HAPUR

I left home in Mayur Vihar for the Anand Vihar Interstate Bus Terminus near Ghaziabad in the hope of finding people headed in the direction I had chosen. Close to the bus station, I saw a middleaged worker and thought of striking up a conversation:

(What do you do)?” I asked.

He responded in a disinterested and irritated manner. “Welder (I am a welder).”

India has about 100 million migrants who have lost jobs due to the lockdown

(Where is home)?” I posed a second question. “Farrukhabad,” he grumbled. (Why did you depart suddenly)?” I said.

ration (What do I eat? I’ve no money, no food),” he snapped.

I reached Anand Vihar at around 12 noon, tried to cross over to Uttar Pradesh via the Ghaziabad border, which was sealed and where migrants were being herded around by the police, sometimes with the help of lathis, to nowhere. I met Vinod Kumar, who was headed towards Bahraich, with his 11-year-old brother-in-law. The child was carrying luggage that weighed more than him. Vinod, even more. We took several detours, walked through a

and along a to avoid the police to enter Uttar Pradesh via the Ghaziabad overbridge at around 6 pm.

(I will not return),” Vinod remarked.

He had been in Delhi for 15 years, working at a sock factory that was now shut. “I have land. I will farm in my village,” he said.

We moved ahead and saw about 70 migrants at a police checkpoint. The police stopped us too and put Vinod, along with the other migrants, on a bus to return to Delhi. All his day’s walk gone waste. I too couldn’t do anything. Being a reporter, I was allowed to leave. I continued moving with a group headed to Banda.

After having walked about 30 km in the day, we reached Lal Kuan (see ‘The route’). The group decided to spend the night there, but I along with three others took the highway, crossed Hapur and stopped at one Haryana Dhaba around 4 in the morning. I wanted to sleep but could not as I had to guard my mobile phone while charging it. Still, I could rest for a couple of hours.

MAY 17: TO AMROHA

I left for Amroha district and must have walked about 10 km when I learnt that thousands of migrants can be seen near one Baba-Mama Yadav Dhaba in Hapur. I returned and found that the administration was arranging for buses to send them to Uttar Pradesh and Bihar. From there, I moved towards Brij Ghat, another location where I had heard migrants were stranded. I reached Brij Ghat at around 10 pm and found that the police had barricaded the route and the migrants were told they would be taken ahead in buses. But there was no arrangement for their stay. They were just asked to stay put on an open ground that had concrete surface. I stayed the night to talk to them and heard unbelievable stories of hardships. I saw a woman trying to arrange milk for her month-old baby; two men making the journey with their families in their cycle-rickshaws; and a group that had been duped of R17,000 by a driver.

MAY 18: SHAHJAHANPUR

My interactions with the people at Brij Ghat the previous day had made the police suspicious. I was also asking officials to help out migrants. To get rid of me, the police made me take a bus to Shahjahanpur. On the bus, I met Brij Kishore and Jagdish, brothers travelling from Panipat with their families and relatives—a group of eight. Both worked as dailywage labourers. I asked if I could accompany them to their village. I wanted to see how the village was treating its migrants. They agreed.

The bus dropped us at Sadar in Shahjahanpur where a cousin was waiting. Our group had two children who left for the village, Ratanpur Kunda, with the cousin on his motorcycle. We were told by officials at the bus station to collect the ration being provided by the government at the quarantine centre at Punaya, about 22 km from Sadar and about 5 km from our village. Completely drained out but without option, we walked to Punaya. The family received five kits of wheat, rice, pulses, potato, refined oil and spices, each kit weighing about 40 kg. Since they were too heavy to be carried, we arranged for an ambulance to drop them home, while we walked.

Reached Ratanpur Kunda. There was no electricity. As Jagdish’s wife unlocked the house, their relatives from adjacent houses came out. Over 40 members of the family live in the village. Among them was their uncle Ram Bharose, the eldest member, who said he was glad they had all made it back. There was no overt display of emotion. Noticing a stranger in their midst, one of the relatives addressed me:

(You’ll stay here tonight).” It did not sound like a question.