Power, politics, and economics are alive and well in India as apparently as quickly as select national health authorities in the world’s most second populated nation and fifth largest economy as measured by gross domestic product (GDP) included ivermectin in the national guidelines, the recommendation was just as quickly rescinded despite what appears to be tremendous success in states such as Uttar Pradesh, as TrialSite has recently reported. TrialSite has chronicled a remarkable turnaround that’s included the use of ivermectin and doxycycline-based home medicine kits in Uttar Pradesh and a few other states. On April 22, the use of ivermectin was formalized at the national level by All Institute of India Medical Science (AIIMS) and the Indian Council of Medical Research (ICMR) as reported in TrialSite. But in a national movement to hatchet that recommendation, the Union Health Ministry and Family Welfare’s directorate general of health services known as DGHS changed the guidelines again to cease use of Ivermectin and Doxycycline for COVID-19 treatment, dropping all medicines except for antipyretic and antitussives for asymptomatic and mild cases, reports local media. But this seeming power play perhaps represents a significant fissure between authorities and experts as it reveals monumental economic, political and medicinal tensions as the ICMR, the nation’s main health agency in the war against SARS-CoV-2, hasn’t approved of these changes as of yet.
The DGHS also shared that “Remdesivir is a reserved drug approved by DCG(I) under Emergency Use Authorization only based on limited scientific evidence globally. It is to be used only in select moderate/severe hospitalized COVID-19 patients on supplemental oxygen within 10 days of onset of disease.” As remdesivir has been shown to produce harmful side effects, DGHS cautioned physicians to use with “extreme caution” as shared in multiple media, including India Today.
But What About the Dramatic Decline in Cases?
TrialSite has chronicled a dramatic turnaround in Uttar Pradesh where ivermectin was used as part of a population-wide regimen and will continue to be used so more than likely. But this move at the national level is significant as, undoubtedly, pressures have mounted as cases are now on the wane everywhere to stop the use of these generic drugs and supplements, from ivermectin and doxycycline to hydroxychloroquine and multivitamins and zinc.
A few states were reporting success as TrialSite has recorded with what’s known in Bangladesh as “the “people’s medicine” that is combining ivermectin, doxycycline, and zin. In India, only about 6% of the population, the second largest in the world, has been vaccinated and these treatments have been vital in the turnaround.
But the government was essentially balking at the advice of the World Health Organization (WHO) and powerful other countries that undoubtedly are swayed by a rigid academic world view not to mention economic pressures from mature, sophisticated industry.
For those interested in the details, TrialSite is a treasure trove of information as many of the ivermectin studies, as well as the progress that resulted from population-wide programs in India, are chronicled, including the daily affairs leading to positive impacts of these treatments.
Now at least DGHS edicts that in cases with no symptoms, there is no need for medication. For those people with mild COVID-19, they declare the new norm of self-monitoring for fever, breathlessness, oxygen saturation (SpO2), and Roche’s Tocilizumab. Although Roche itself has admitted the drug doesn’t work that well and the study data is not strong, they recently declared, “Tocilizumab is an immunosuppressant drug and it has been approved by DCG(I) for use as an off-label only in severe and critically ill patients of COVID-19.” But last summer, Roche reported after a study that tocilizumab “failed to meet endpoints in the Phase 3 COVACTA study involving COVID-19 pneumonia.” While some trials show some success, other trials show failure.
Moreover, DGHS shares steroids should only be used for those hospitalized with COVID-19, facing moderate, severe or critical symptoms. They, of course, continue to recommend appropriate behaviors, from use of masks to hand sanitizers and of course social distancing when possible.
Call to Action: What does the TrialSite Community think about this? Is this change by DHGS due to pressure from external sources (e.g. World Health Organization, others)? or perhaps some other rationale? Perhaps they secured the maximum benefit while they could and axed the formal recommendation for leverage in other strategic discussions?