Evidence map›Paper›PMID 25821304›Full record

ArticleIndian journal of pharmacology

The Tamiflu fiasco and lessons learnt.

Yogendra Kumar Gupta, Meenakshi Meenu, Prafull Mohan

Open access · greenAbstract read
In one paragraph

Article in Indian journal of pharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.0field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 51 citations in OpenAlex.

  1. Article
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  4. Ensuring Prevention Science Research is Synthesis-Ready for Immediate and Lasting Scientific Impact.Prevention science : the official journal of the Society for Prevention Research · 2022
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  5. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Yogendra Kumar GuptaDepartment of Pharmacology, AIIMS, Ansari Nagar, New Delhi, India.
Meenakshi MeenuDepartment of Pharmacology, AIIMS, Ansari Nagar, New Delhi, India.
Prafull MohanDepartment of Pharmacology, AIIMS, Ansari Nagar, New Delhi, India.
All India Institute of Medical Sciences · INAll India Institute of Medical Sciences Bhopal · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Oseltamivir (Tamiflu), a neuraminidase inhibitor, was approved for seasonal flu by US Food and Drug Administration in 1999. A number of randomized controlled trials, systematic reviews, and meta-analysis emphasized a favorable efficacy and safety profile. Majority of them were funded by Roche, which also first marketed and promoted this drug. In 2005 and 2009, the looming fear of pandemic flu led to recommendation by prominent regulatory bodies such as World Health Organization (WHO), Centers for Disease Control and Prevention, European Medicines Agency and others for its use in treatment and prophylaxis of influenza, and it's stockpiling as a measure to tide over the crisis. Serious Adverse Events, especially neuropsychiatric events associated with Tamiflu started getting reported leading to a cascade of questions on clinical utility of this drug. A recent Cochrane review and related articles have questioned the risk-benefit ratio of the drug, besides raising doubts about the regulatory decision of approving it. The recommendations for stockpiling the said drug as given by various international organizations viz WHO have also been put to scrutiny. Although many reviewers have labeled the Tamiflu saga as a "costly mistake," the episode leaves us with some important lessons. This article takes a comprehensive relook on the subject, and we proceed to suggest some ways and means to avoid a similar situation in the future.

Indexed as

Antiviral AgentsCost-Benefit AnalysisDrug ApprovalDrug CostsHealth Services AccessibilityHumansInfluenza, HumanModels, OrganizationalOseltamivirPandemicsPublic OpinionRisk AssessmentRisk FactorsScientific MisconductStrategic StockpileAntiviral AgentsOseltamivirCochrane reviewflu pandemicH1N1rochestockpilingTamiflu

Identifiers

PMID25821304
PMCPMC4375804
OpenAlexW1965928140

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.