Evidence of the Minimal Benefit of Oseltamivir (Tamiflu) is Now 18 Years Old
In the BMJ News article, “WHO downgrades oseltamivir on drugs list after reviewing evidence”; posted June 12, 2017, the editor in chief welcomed the move as a victory for the journal’s campaign for evidence based medicine. She said, “WHO’s decision is a vote for evidence based policy making, which will save money and harm. It is also an important milestone in the continuing fight for access to clinical trial data and independent research.”
The BMJ expressing credit for WHO’s action on oseltamivir and evidence based medicine, at least in part, is surprising. The evidence of the marginal value of oseltamivir in managing and preventing the complications of influenza is approaching being 2 decades old.
Oseltamivir was first marketed in the US in 1999. The original US Food and Drug Administration (US FDA) approved professional product label indicated only a modest clinical benefit for the drug in reducing the duration of flu symptoms, a little more than a day. The marketing authorization application submitted by the drug’s manufacturer did not contain information on its effectiveness in preventing complications due to influenza such as hospitalization, secondary bacterial infections, or mortality. Oseltamivir’s professional product label was amended in 2000 to reflect that there was no evidence that the drug would prevent the complications of influenza.
The Cochrane Review cited by the BMJ only confirmed the information that was available from the US FDA oseltamivir’s professional product label since 1999.
Acclaim for the WHO decision is misplaced. There are no champions, only losers, the public, when those responsible for selecting drugs that claim compliance with evidence based principles are unaware, or chose to ignore evidence that is freely available to the public on the Internet.
1. Kmietowicz Z. WHO downgrades oseltamivir on drugs list after reviewing evidence. BMJ 2017;357:j2841 doi: 10.1136/bmj.j2841. (Published 2017 June 12)
2. Gilead Sciences, Inc. Professional Product Label Oseltamivir (Tamiflu), October 1999. At http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21087lbl.pdf. Accessed June 12, 2017.
3. Jolson HM. United States Food and Drug Administration, Division Director Memo. At https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21087_Tamiflu_medr.... Accessed June 12, 2017.
4. Gilead Sciences, Inc. Professional Product Label Oseltamivir (Tamiflu), November 2000. At http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21087S002lbl.pdf. Accessed June 12, 2017.
5. Jefferson T, Jones M, Doshi P, Spencer EA, Onakpoya I, Heneghan CJ. Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments. BMJ 2014;357:g2545. doi:10.1136/bmj.g2545 pmid:24811411.
Competing interests: No competing interests