Coronavirus | Opeds and editorials

Misinformed and misleading

This Monday, April 6, 2020, photo shows an arrangement of Hydroxychloroquine pills in Las Vegas. President Donald Trump and his administration are keeping up their out-sized promotion of the anti-malaria drug not yet officially approved for fighting the new coronavirus, but scientists say more testing is needed before it's proven safe and effective against COVID-19. (AP Photo/John Locher)

The Health Ministry released its first COVID-19 management guidelines about a year ago. The initial treatment guidelines included hydroxychloroquine, which led to panic buying of the drug. Little was known in those initial months. In the last one year, multiple studies have proven the lack of efficacy of hydroxychloroquine. While most practitioners have moved away from prescribing hydroxychloroquine, it still remains in the guidelines released by the Health Ministry on April 22.

While formulating national-level guidelines, the most important factors are strength of evidence, pricing, cost-effectiveness and social relevance. These guidelines not only disregard evidence, but also show the unawareness of policymakers about the struggles of the common populace and the importance of the aforementioned factors.

Disregarding lack of evidence

While hydroxychloroquine is one example that stands the test of time in terms of disregarding evidence, there are several others. The Indian Council of Medical Research (ICMR) completed a trial on convalescent plasma (of 464 patients), which proved that plasma does not save the lives of those with COVID-19. This was bolstered by further evidence from the U.K. (more than 10,000 patients). The only benefit of convalescent plasma was shown in a small study from Argentina which demonstrated that plasma prevented progression to severe disease in mild cases when high-titre plasma was infused within three days of disease onset. This strict timeline of three days lends plasma little to no translational value in India as plasma titres are seldom available and are expensive. Plus, there is a lag of 2-5 days in RT-PCR results now. Yet, convalescent plasma is mentioned in the Ministry’s guidelines. Similarly, Ivermectin, a drug used against parasites, has been recommended in the guidelines. With no good clinical trials to support its use and the World Health Organization (WHO) recommending against its routine use, one wonders what led to its inclusion.

While evidence was ignored, the importance of pricing and cost-effectiveness was also overlooked. Remdesivir, in shortage now, is being black-marketed across India, although it has no value in saving lives. The only marginal benefit it may have is in reducing the hospital stay, with a trade-off of increasing the cost of hospitalisation by the steep price of the drug in the black market.

Last year, when hydroxychloroquine was touted as the wonder drug, it ran out of stocks in the market, precipitating a crisis for patients who needed it chronically. Similarly, this year, budesonide inhalers have been included as an option for mild patients based on results of two clinical trials. With more than 80% of COVID-19 patients having only mild symptoms, patients with asthma and chronic obstructive pulmonary disease (COPD) may run out of inhalers. Moreover, according to the PRINCIPLE trial, a trial only in pre-print, budesonide improves only self-reported symptoms in mildly sick patients. It does not yet translate into saving lives or reducing hospital admissions. The larger social relevance of budesonide is still in question. Policymakers should have waited for the final publication, worked with industry to scale-up production of budesonide, and bolstered supply chains till the final results came in, rather than hastily making recommendations that may trigger panic buying and a crisis for patients who actually need it.


Missing from guidelines

What is missing from the guidelines is the lack of guidance on drugs being used for COVID-19. Misused drugs include Azithromycin, Doxycycline, Favipiravir, Itolizumab and Coronil . These are not mentioned in the guidelines, but practitioners are busy prescribing them. This may cause more harm than good.

Also read | No traditional medicine cleared for COVID-19, says WHO

Lastly, absence of any mention of monoclonal antibodies from Regeneron or Eli Lilly in the guidelines, recommended by the National Institutes of Health, U.S., the most efficacious antivirals in COVID-19 till date, is baffling. COVID-19 is an administrative nightmare. A stark difference in messaging on COVID-19 management compared to the messaging of the WHO or other trusted sources like the Center for Disease Control and Prevention and the National Institutes of Health, U.S. will only create confusion. With the available evidence, and keeping cost-effectiveness and the social relevance of the Indian health system in context, the focus of COVID-19 treatment guidelines should be on oxygen delivery, steroids and anti-coagulants. More treatment does not necessarily lead to better outcomes but will definitely lead to higher out-of-pocket expenditure and healthcare-related bankruptcies and debts. The guidelines should be re-written in cognisance of the current strains on the healthcare system.

Anup Agarwal was the lead author of the ICMR-led Trial on convalescent plasma (PLACID trial) and is a physician at Rehoboth Mckinley Christian Hospital Healthcare Services, Gallup, New Mexico, U.S.

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Printable version | Apr 19, 2022 3:31:01 pm |