Blatant Violation of Evidence-based Medicine: Ignorance or Corruption or both?

The SARS-CoV-2 pandemic have unmasked a widespread violation of the ideals of medical practice. The violation has been observed in all fronts – accumulation of data, interpretation of data, drug approval by regulatory authorities and most unfortunately from the healthcare institutions and medical professionals. To make things worse we have seen overt politicization of medicine right in front of our eyes with therapies pushed into approval pending analysis and results.

Scene I: Data generation and interpretation – the backbone of any stream of science.

  • Doubts are generated whenever extraordinary claims are made in any sphere of life. That is probably why the skeptical methods of data analysis with the null hypothesis i.e. your hypothesis is wrong by default is probably the best way of data evaluation available to us as of now.
  • However, if the data is fudged how would you interpret it? We have been doubtful of the retrospective and observational studies for long. What are the screening methods in place to identify fudged data entry into the excel sheet prior to analysis? None as of now.
  • To compound matters we have come across withdrawal of SARS-Cov-2 related articles from reputed journals after the data collection was found to be grossly interfered with in an independent audit. With a defective backbone how hopeful can we be of the future endeavors except for falling back on randomized controlled studies which are monitored by independent adjudication committees.

Scene II: drug approval by regulatory authorities.

  • It is impossible to evaluate the quality and safety of a medicine at the level of the treating physician or the patient.
  • We are entirely dependent upon the regulatory bodies to ensure quality and safety, especially of the generic drugs.
  • On one hand we have wonderful agents capable of altering important outcomes related to chronic diseases. While on the other, most of these drugs are under patent protection resulting in high prices which majority of the patients cannot afford in an out-of-pocket payment scenario. To circumvent this problem, we find approval of cheaper agents by authorities whose raw materials are imported from other north-Asian countries and available for sale without any bioequivalence studies, standardized safety and efficacy data. It’s a catch 22 situation for the physicians – choose between excellent but extremely costly products and medications which are cheap but of questionable quality.
  • What was most scary during the SARS-CoV-2 pandemic was approval of numerous agents without any robust studies conducted. The fallout could be disastrous in the time to come with antibiotic resistance, hypervitaminosis syndromes, drug-related adverse effects overwhelming the deleterious effects of SARS-CoV-2 per se.

Scene III: Violation of the first principle of medicine – “do no harm.”

  • Armed with non-evidence-based guidelines from the regulatory authorities, physicians on a large scale have endorsed and prescribed a plethora of medicines with no data to back them up. Guidelines are guidelines. The final decision lies with the physician. What encouraged physicians to embrace such a trigger happy attitude prescribing antibiotics (more than one) in a viral disease routinely without any evidence of secondary bacterial infection, different types of vitamins (some more expensive than the outcomes altering medicines used in diabetes and heart disease), ivermectin (anti-parasitic – not anti-viral), HCQS, plasma therapy, remdesivir, etc.?
  • What made the individual decision-making ability go for a toss?
  • Ego?
  • Conflict of interest?
  • Ignorance?

Did we harm more patients with unnecessary medications than SARS-CoV-2?

With the 17th December WHO management advisory published and made available free online, declaring all the above-mentioned medicined harmful, is it time to go ahead with an extensive audit?

What about all the unnecessary adverse effects induced by the medications (steroid induced new-onset diabetes, hypervitaminosis, probable cardiac compromise, etc.) endorsed by recommending bodies & prescribed by physicians without any proof that they work?

Who are to be held responsible?

What compensation should be handed over to those being erroneously prescribed these medications?

Who is going to evaluate those sitting in position of power and recommending these agents in an unscrupulous manner?

How difficult is it to practice medicine?

  • Ethically?
  • Without conflict of interest?
  • Following the first principle of being a physician?
  • Jettisoning one’s ego?

The whole system needs an overhaul. The question is who or which association is going to do so?

Published by samitghosal

I am a consultant endocrinologist practising in Nightingale Hospital Kolkata, India. My recent interests includes 1. Experience in data science, 2. Quantum reality, 3. Delivery of online diabetes courses, 4. Challenging the present polarised environment especially the hypocrites masquerading as liberals.

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