Source: TrialSiteNews Author: Mary Beth Pfeiffer
She is a gynecologist. He is a surgeon. They are married and both 77 years old.
In mid-November, they were diagnosed with COVID-19, first her, then him. Their paths diverge at this point, but not to worry.
She took the drug hydroxychloroquine. He took ivermectin. They are both well now – walking, golfing, doing yoga — seven weeks later.
The couple’s brush with COVID might have ended very differently. In the United States, patients 75 to 84 years old die at 220 times the rate of adults under 30. But these two elderly, otherwise healthy physicians live in India. They were able to get early home treatment that is virtually, and unconscionably, unheard of in many western countries.
“Without any treatment, we know that the virus enters the cells and replicates there,” Dr. Makarand Paranjpe told me by phone from his home in Pune, where he had quarantined through a fever and other symptoms. “They can create disease that gets much more severe.” Which, of course, is the point of treating early. Stop the progression. ASAP.
From the outset, India, a nation of both economic vigor and poverty, knew it had to act decisively. It did. India locked down early and long; it promoted masks, tested millions, and, as with the Pune couple, treated the infected early.
Ten months into its battle with the SARS-CoV-2 virus, India is on track to become an unexpected warrior in the fight against this global pandemic. Although the densely populated nation has four times the population of the U.S., India has less than half the U.S. COVID deaths. And India isn’t just beating the poorly performing U.S. In all, 98 nations have higher death rates than India.
It may be tempting to attribute this startling news to imperfect data from a developing country. But doctors in India, Indian press reports, and even the Wall Street Journal have taken note of a sea change in COVID there. “In September, India was reporting almost 100,000 COVID-19 cases a day, with many predicting it would soon pass the U.S. in overall cases,” the WSJ wrote on Dec. 30. “Instead, its infections dropped and are now at one-fourth that level.”
Dr. Anil K. Chaurasia, a physician in Lucknow, in the state of Uttar Pradesh, watched this trend unfold. Starting about mid-September, “a clear decline in COVID cases and fatalities in India was noticeable,” he told me in a text message. The “steep decline in cases and fatalities is still continuing.”
Like a lot of western reporting, the WSJ article held fast to an accepted COVID theme. The Indian miracle was due to masks, it asserted, since they are worn by 88 to 95 percent of a population “bombarded” with public-service reminders. The article cited German research that showed masks work.
Fair enough. However, many factors are likely at play in India, including its painful yet supported national shutdown and individual state efforts at contact tracing and testing. But a pivotal role in any illness is surely the availability of treatments to resolve illness before crisis.
Late last March, as the U.S. argued over the merits of Trump-endorsed hydroxychloroquine and studies failed in late-stage patients, India decided to recommend the drug in its national guidelines. HCQ “should be used as early in the disease course as possible…and should be avoided in patients with severe disease,” the directives wisely state. As a precaution, authorities suggested an EKG to monitor for a rare heart arrhythmia that several COVID studies have since shown to be minimal.
The Power Of One State
But a crucial turn for India may have come in August when the Indian state of Uttar Pradesh recommended use of another drug: Ivermectin, which is coming on fast as a leading COVID treatment — without the baggage of at-turns effective but vilified hydroxychloroquine.
This was no small move. Were it a country, U.P.’s more than 230 million citizens would rank it fifth worldwide. As India’s largest state, its embrace of ivermectin may have changed the treatment landscape across India.
“This authentication of ivermectin revived the faith of people,” Dr. Chaurasia told me, “and net result was a massive inclination to take these drugs” — both ivermectin and hydroxychloroquine.
By the end of 2020, Uttar Pradesh — which distributed free ivermectin for home care — had the second-lowest fatality rate in India at 0.26 per 100,000 residents in December. Only the state of Bihar, with 128 million residents, was lower, and it, too, recommends ivermectin.
But Uttar Pradesh did more than treat 300,000 mild cases at home through 2020; it also opted to use ivermectin to prevent infection. It seems a young health officer’s COVID response teams had taken the drug and remained well – something prophylaxis studies support. U.P. then had contacts of COVID patients take it, with similar success. “Recognizing the sense of urgency,” Amit Mohan Prasad, a U.P. health official, wrote in a Dec. 30 article, “we decided to go ahead.”
Such urgency is in short supply in the U.S., where the single-minded focus is on vaccination. Nonetheless, a group of doctors called Frontline COVID Critical Care Alliance is pressing for adoption of ivermectin immediately as an adjunct and bridge to vaccination. Its logic is twofold: Ivermectin has a known safety profile, as a life-saving drug given to millions since the 1980s, and 46 COVID studies, including 18 peer-reviewed, have shown “high efficacy.”
However, even India is holding back, perhaps temporarily. The Indian Council of Medical Research declined in October to recommend ivermectin nationwide, citing, as other such entities have, the need for more data. Similarly, COVID guidelines in bordering Bangladesh make no mention of the drug, despite successful studies done there.
In India, premier medical centers have, nonetheless, adopted it. In Bangladesh, doctors are using combination ivermectin/doxycycline therapy for home care, as are major hospitals in Dhaka for inpatients.
“The economy is flying,” Dr. Tarek Alam, who led several studies on the drug’s efficacy, told me in an email. “Hospitals have empty COVID beds and the initial demand for ICU has come down.” Indeed, Bangladesh – the world’s most densely populated country — has an even lower fatality rate than India, ranking 126th globally.
Significantly, ivermectin received a tentative endorsement recently in research funded by the World Health Organization-hosted program Unitaid. After analyzing 11 randomized control studies, Dr. Andrew Hill concluded: “If we see these same trends consistently across more studies, then this really is going to be a transformational treatment.”
The agency is publicly acknowledging movement. “Preliminary data is promising,” Herve Verhoosel, a spokesman, wrote in a statement, “but there is the need to await the results of further trials before determining next steps.”
More information is always better. But at what point, in a pandemic, is there enough?
Last spring, when COVID was new, Dr. Dhananjay Bakhle, an M.D. in pharmacology in Pune, observed something. “Many doctors were afraid to use HCQ,” he told me. “I was appalled since the solution was available.” He began treating infections among 15,000 workers of the pharmaceutical company where he directs medical research. Just 3 of 270 patients were hospitalized; he said, and none died.
“I trusted HCQ from the beginning,” Bakhle told me, “and I didn’t trust ivermectin.” He was unsure both of dosing and how the anti-parasitic drug worked. So he did studies in his own laboratory, to test the drug’s anti-viral mechanism, that he hopes to publish. “I changed my mind about Ivermectin in the last three to four months.”
Still, he sees HCQ as his top choice, while adding ivermectin frequently. He uses the drug alone when HCQ is contraindicated.
That was the case with his cousin Dr. Paranjpe, who Bakhle treated in consultation with another physician.
Did the drug make the difference for him, I asked Dr. Paranjpe.
“I can’t pinpoint if it was because of ivermectin,” he said. He also took doxycycline, zinc, aspirin, quercetin and, starting on day nine, the steroid dexamethasone for inflammation. While his wife, Meera, had a mild and quickly resolved infection with HCQ, he suffered through days of low fever and body pain. Paranjpe may not know for sure what worked, but he does know this: He was happy to get early treatment at home In India. “Definitely, it is helping,” he said.
A few days later he emailed an update. “Meera and myself, we both are feeling completely normal,” he wrote. “There are no residual symptoms.”
I’ll end this with the Worldometer COVID statistics for Jan. 7, 2021.
- New Cases: 18,106
- New Deaths: 234
- New Cases: 279,154
- New Deaths: 4,207
Mary Beth Pfeiffer is an investigative journalist and book author. Read her other COVID articles here. Follow her on Twitter: @marybethpf.
TrialSite Editor Comment
Importantly, the national laws, cultures and approaches are in fact, quite different between India and the United States. As TrialSite is a United States-based digital media platform, importantly we share that the proper path forward for acceptance of a new treatment approach is via the National Institutes of Health (NIH) COVID-19 Protection Treatment Guidelines. TrialSite doesn’t endorse any particular approach but rather seeks to provide unbiased, independent news, information and opportunity to bring more transparency and accessibility to research, with the aim of advancing biomedical research to benefit all humanity.
Currently, Ivermectin is recommended only for research and has a rating of AIII. Although we have been constructively critical of what is a national research treasure, TrialSite recently commended the Panel for inviting members of the Front Line COVID-19 Critical Care Alliance (FLCCC) and Dr. Andrew Hill, a consultant associated with the University of Liverpool in the UK, to present their findings to date.
This was an important milestone as the Panel associated with that apex national research agency now looks into the accumulating data. The NIH’s Panel will hopefully consider risk-based approaches (much like they have done with highly novel monoclonal antibodies), seeking a way to ensure early-stage treatment in combination with the vaccine rollout over the next year.
In parallel, other mission-critical agencies such as the Department of Defense could potentially benefit from economical approaches to both pre-exposure prophylaxis (PrEP) as well as post-exposure prophylaxis (PEP). We encourage multiple pathways toward that end, from promising research from AstraZeneca (AZD7442—originating from some brilliant researchers at Vanderbilt and the company) to innovative approaches such as the large United Health and Lilly home-based clinical trial to the potential of Ivermectin as a generic treatment.
Fully overcoming COVID-19 in the USA necessitates a combination of more harmonized behavior (e.g., social distancing, masks, etc., across the 50 states) plus effective early stage as well as later-stage treatments and, of course, the vaccines. With two vaccines currently authorized on an emergency basis, other promising ones could be underway sooner rather than later.
The broader economy, society as well as health and vitality of the nation—one that importantly sets a precedent for so many positive forces around the world— benefits from an open, proactive, and progressive approach that includes a dynamic interchange between research, regulatory, the clinic and caregiver—driven by an unbiased recognition of the accumulating data inspired by the most rational of decision making. The NIH made such a move the other day.