Medicines – What does research tell us about them? Why use them rationally?

For a lay person who has no scientific background, we have heard many a times,

“We do not understand the research”,
“Why should we try to understand them, our doctor will give it to us”,
“We trust that since it has come in the market, it must be for our good”.

But for a person from the science background, a researcher or a scientist who is busy working in his/her area, trying to discover more, alas it is like:

“I trust the science behind them“,
“I read a few papers about the medicine and they do work”.

Is it too much of blind trust?

Yes indeed! Having reviewed some of the trusted medicines, which we have heard about so much, it was difficult to digest how we are sometimes fooled by the greed of some others!

To start with, we have tried to gather information and write what research has told us about a very popular medicine, which each one of us must have heard and some would have even used, Tamiflu.

Is <Tamiflu> effective? Do we actually need it for flu?

Tamiflu (Oseltamivir), an antiviral medication for H1N1 influenza, was launched by Roche, a pharmaceutical company in 1999 after it was approved by US FDA. The approval came after a number of randomized controlled trials (majority funded by Roche) stated the efficacy of the medicine for seasonal flu. The H1N1 influenza scare that spread across the world in 2009, led the major regulatory bodies such as WHO, CDC and EMA to recommend its use for treatment. This led governments across the globe to stock Tamiflu in preparedness against H1N1 pandemic in 2009.1Maximizing the value of drug stockpiles for pandemic influenza. Emergency Infection Dis. 2009 octv15(10):1686-1687. India too stockpiled 30 million doses of it, placed orders for 900,000 doses from Ranbaxy Laboratories, gave a contract order of 740,000 doses to Strides Arcolab, procured 9 million doses from Hetero Drugs, the only Indian company that had a manufacturing agreement with Roche.2Gupta, YK., Padhy, BM, (2010) Issues in pharmacotherapy of 2009 H1N1 influenza infection. 56, 4, 321-327.

All this work, did help one of the biggest pharmaceutical giant become even bigger, but did it actually help anyone else is a big question. The abnormal neurological behavior in children and a few deaths reported in Japan led Japanese to do an independent analysis of the drug.3Half of children taking Tamiflu have side-effects 4Gupta, Y K, Meenu, M., Mohan, P. The Tamiflu fiasco and lessons learnt (2015) Indian Journal of Pharmacology. 47, 11-16The results of the analysis led them to insert a package warning against giving the medicine to children and overall restricted usage.5FDA Safety Changes: Lexiva, Tamiflu, Pexeva – Medscape Education 6Gupta, Y K, Meenu, M., Mohan, P. The Tamiflu fiasco and lessons learnt (2015) Indian Journal of Pharmacology. 47, 11-16Similar results were also reported from children in UK who had been given the medicine as a prophylactic treatment.7Half of children taking Tamiflu have side-effects 8Kitching A, Roche A, Balasegaram S, Heathcock R, Maguire H. Oseltamivir adherence and side effects among children in three London schools affected by influenza A (H1N1) v, May 2009 – an internet-based cross-sectional survey.(2009) Euro Surveill 14:19287 9Gupta, Y K, Meenu, M., Mohan, P. The Tamiflu fiasco and lessons learnt (2015) Indian Journal of Pharmacology. 47, 11-16 Following these studies, the Cochrane collaboration did a complete analysis of the clinical trial data (majority of which was not made accessible earlier to the regulatory authorities) and published the data analysis on April10, 2014.10Jefferson T, Jones MA, Doshi P, Del Mar CB, Hama R, Thompson MJ, Spencer EA, Onakpoya IJ, Mahtani KR, Nunan D, Howick J, Heneghan CJ. Neuraminidase inhibitors for preventing and treating influenza in adults and children. (2014) Cochrane Database of Systematic Reviews Issue 4

The Cochrane study showed:

  1. Tamiflu had small, non‐specific effects on reducing the time to alleviation of flu symptoms in adults (by a couple of hours) but not in asthmatic children.
  2. There was no clarity with respect to reduction of influenza complications such as pneumonia, bronchitis, sinusitis and otitis media or hospitalizations.
  3. However, the increased the risk of adverse effects were certain. These included nausea, vomiting, psychiatric effects and renal events in adults and vomiting in children.


Thus, the authors of the Cochrane study after 5 years of Tamiflu use across the globe recommended that doctors should critically consider the benefit and possible harms before prescribing Tamiflu. The findings of the Cochrane study also provided a reason to question the stockpiling of the medicine, it’s inclusion in the WHO essential drug lists and it’s use in clinical practice as an anti influenza drug.

Finally in 2017, WHO decided to downgrade Tamiflu.11WHO downgrades status of oseltamivir (2017) BMJ 358:j3266

Although the effectiveness of the drug is being debated across the globe, different pharmaceutical companies started making the generic forms of the drug (Antiflu/Fluvir/Starflyer/Natflu/Fluhalt) in India. Also, the medicine was removed from the schedule X drugs list in 2017 and so all pharmacies are now allowed to stock and sell it in India.12Swine flu drugs available at all chemists after India eases restrictions on sale

But the question remains, sell it for what? And that too at a price ranging from Rs470-520/10 capsules?!!?

The question is, did the regulatory authority of India do any analysis independently before introducing it into the market? Is there any post marketing surveillance Indian data available for the drug? While the world is still debating about its effectiveness and the side effects, is there any data supporting its usage in Indian population?


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