Families grapple as India’s health bodies change COVID guidelines

Health ministry last month dropped several popular drugs from its clinical protocol, sparking debate and confusion.

India's Health Minister Harsh Vardhan holds a dose of Bharat Biotech's COVID-19 vaccine called Covaxin at All India Institute of Medical Sciences hospital in New Delhi [File: Adnan Abidi/Reuters]

New Delhi, India – Late last month, the Indian government made far-reaching changes to the COVID-19 treatment protocol for hospitals, leading to much debate and confusion after drugs people knew almost by rote were dropped.

For months, I had read and reread my family’s prescriptions, remembering what to administer to whom, goading the local pharmacies to send it fast. Like thousands of others, I had also read hundreds of social media pleas for these drugs.

So why did the government drop them? As I Googled and searched, I also remembered that ivermectin, one of the drugs now dropped and under much scrutiny, was first prescribed to me by my dermatologist in July last year.

“Just one pill, tonight,’’ said the doctor. I was told it is an anti-parasitic drug, used for deworming and scabies.

But little did I know that two months on, I would be prescribed ivermectin as part of my COVID treatment.

During a telephone consultation, the doctor prescribed five days of doxycycline (anti-bacterial drug) and one day of ivermectin.

Later that day, when government health workers made a compulsory call to our doorstep, my husband, who was COVID-19 negative, and I were given a pack of hydroxychloroquine and told to take the pill for seven days.

Both of us skipped it.

A popular drug at that time, its demand spiked after former US President Donald Trump threatened to stop medical supplies if India curtailed its export to the United States.

This was still the first wave. While there were endless tragedies of Indian migrants walking home, people losing their livelihood and a massive economic slowdown triggered by the lockdown, death rates were low, and hospitals and oxygen were not in short supply.

The second wave, which we all thought by most accounts would be weaker, was yet to ravage us.

In April, the second wave hit our home. My whole family – my husband, my mother and my in-laws – got COVID-19, some despite being vaccinated. We were caught in the middle of the ferocious outbreak when hospital beds, oxygen and medicines were in short supply.

My father-in-law who was COVID positive was given ivermectin for about a week. He was also given the ani-viral drug, favipiravir, more commonly known as fabiflu.

By the time he reached the hospital on May 2 for lung pneumonia, he had already been given ivermectin, doxycycline, azithromycin and favipiravir. In hospital, they further administered remdesivir and plasma therapy – twice.

We had worked the phone lines to get him a hospital bed and an oxygen concentrator. We did the same for my mother when she was admitted on May 11.

The only difference: by the time she reached hospital for lung pneumonia, plasma therapy had been dropped from the government’s health protocol for the coronavirus.

But this was April 2021. The Indian Council of Medical Research (ICMR), the country’s top scientific body, had flagged the “inappropriate use of plasma therapy” way back in November 2020.

ICMR letter dated November 17, 2020 on plasma therapy to fight COVID [Al Jazeera]

In a news release on November 17, 2020, ICMR said “PLACID, the world’s largest plasma trial, had shown no benefit of CPT in patients”.

On June 10 this year, Samiran Panda, head of the ICMR’s epidemiology and communicable diseases division, confirmed to me that plasma therapy has been flagged as showing no benefit by the ICMR.

On other drugs such as ivermectin, he said all evidence was based on observational studies, which indicated that it might be helpful but there was “no double-blind placebo-controlled randomised clinical trial for its efficacy”.

“Neither was evidence robust enough for the use of doxycycline, favipiravir and hydroxychloroquine,” he said.

Many of these drugs were part of the health ministry’s clinical guidelines for COVID-19 until May 27. But they were not approved by the World Health Organization or the Food and Drug Administration (FDA) of the US.

However, many doctors believe plasma therapy did save lives.

Dr Manoj Luthra, director of the department of cardiac surgery at Jaypee Hospital in Noida, a city outside New Delhi, told me that “while plasma therapy may have been struck off by the government, there is enough anecdotal evidence with doctors about its efficacy as a treatment method for COVID-19”.

“Some of us have also written to the government on this,” he said, sharing an article titled Emerging Evidence Demonstrating the Efficacy of Ivermectin in Prophylaxis and Treatment of COVID-19, published in the American Journal of Therapeutics.

The American Journal of Therapeutics article shared by Dr Manoj Luthra [Al Jazeera]

But by April, concerns were widespread about other drugs such as the extensive use of steroids to treat coronavirus. Both my mother and my father-in-law were given steroids for more than a month.

In May, we learned that the government’s new guidelines would advise hospitals to use steroids for no more than 10 days or until the time of hospitalisation, whichever was earlier.

Steroids, which have been essential in reducing lung inflammation in COVID-19 patients, are considered life-saving if given to patients at the right time and for the right duration. But they also reduce immunity and elevate blood sugar levels.

Bishnu Panigrahi, group head of medical strategies at Fortis, one of India’s largest private hospital groups, said “as far as steroids are concerned, they have been misused”.

He said steroids were used “very early during the treatment, in higher doses and for prolonged periods, resulting in secondary infections”.

“Black fungus is a fallout of inappropriate use of steroids,” he said.

Black fungus, or mucormycosis, is a rare but life-threatening infection with a mortality rate of 50 percent. It affects the sinuses, brain and lungs and can be fatal in severely immunocompromised patients.

In India, the disease has seen a 150 percent rise, with 31,216 infections and 2,109 deaths reported during the second wave so far.

Black fungus has now been listed as an epidemic under the Epidemic Diseases Act by the Indian government.

As worries rose about the overuse of prescribed drugs, the government made sweeping changes to the health protocol late last month.

On May 27, the Directorate General of Health Services (DGHS), which comes under the health ministry, effectively dropped all drugs that the doctors had been routinely prescribing, including ivermectin, azithromycin, doxycycline, zinc, favipiravir and plasma therapy.

The DGHS recommended only antipyretics (medication used to prevent or reduce fevers) and antitussives (to relieve or suppress coughing) for mild patients, and no medication or investigation for asymptomatic patients.

Steroids and anticoagulants were advised for moderate cases, and immediate oxygen therapy, intubation, ventilation and immune-modulators were added for severe cases.

The medical body retained remdesivir (for moderate to severe cases) and tocilizumab, an off-label immunosuppressant for severe to critically ill patients.

The DGHS’s new guidelines were welcomed by many, including the WHO whose Chief Scientist Soumya Swaminathan tweeted: “Evidence-based guidelines from @mohfw DGHS – simple, rational and clear guidance for physicians.”

Swaminathan said the guidelines “can be updated as and when new evidence becomes available”.

However, guidelines issued by the health ministry and the ICMR continue to recommend both ivermectin and hydroxychloroquine for mild to moderate cases. They have not been updated or changed until the publication of this report.

At present, COVID-19 guidelines are given out by the DGHS, federal health ministry, ICMR and state medical councils. And they are not always the same.

COVID guidelines issued by India’s Directorate General of Health Services (DGHS) [Al Jazeera]
Guidelines issued by Indian Council of Medical Science (ICMR) [Al Jazeera]

So, while almost all common drugs in use so far against COVID-19 have been dropped, remdesivir, which is a broad-spectrum anti-viral drug used in Hepatitis C treatment, has been retained by the DGHS in its health protocol. The drug has also been approved by the FDA and is in use in several other countries to treat coronavirus.

But like everything else, there is no broad consensus on it either.

Panigrahi of Fortis Hospitals says there has been “rampant use of remdesivir, which is a result of big pharma pushing this drug aggressively, despite literature not showing any significant reduction in mortality”.

However, DS Rana, medical superintendent at New Delhi’s Sir Ganga Ram Hospital, one of the largest COVID facilities in the capital, says it is an effective anti-viral drug.

“Well-conducted trials showed that if this drug is used early in the viral phase, it can have a positive effect on early recovery from COVID in terms of hospitalisation. DGHS has recommended its judicious use,” he said.

The ICU at Sir Ganga Ram Hospital in New Delhi [Courtesy of Sir Ganga Ram Hospital]

While no treatment mechanism can be perfect in the current scenario, and trial and error are part of fighting an unknown virus, evidence must be looked at repeatedly to modify treatment decisions to reduce the long-term effects of experimental drugs.

By the government’s own admission, a third wave of the virus is “inevitable”.

Experts say precedents and examples set in the US and Europe suggest that vaccination of at least 30-40 percent of the population by the end of the year can be an effective deterrent against the virus.

So far, less than five percent of India’s 950 million adult population has been fully vaccinated.

The country’s total COVID-19 caseload currently stands at nearly 30 million, while 381,903 deaths were recorded until Thursday. Close to 200,000 deaths took place during the second COVID wave.

Therefore, concerns are growing over reinfections, rehospitalisations and secondary infections even though the daily caseload has fallen substantially in the last two weeks.

Indians are hoping the government’s new centralised policy of vaccination, announced on June 7, should further ease the caseload.

Under the new policy, effective from June 21, the federal government will directly procure 75 percent of the manufactured vaccine doses and administer them for free. The remaining 25 percent of shots will be available in private hospitals.

While global trends show that transmission and death rates drop with increased vaccinations, the Indian government must streamline its clinical treatment protocols for COVID-19 and bring them in line with global trends.

As for my family, my mother is still recovering from a secondary infection and my father-in-law continues to suffer from post-COVID complications.

Source: Al Jazeera