WHO downgrades oseltamivir on drugs list after reviewing evidence
BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2841 (Published 12 June 2017) Cite this as: BMJ 2017;357:j2841
All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
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.”[1]
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.[2] 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.[3] 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.[4]
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.[5]
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.
References
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
apart from pharmacovigilance, vaccinevigilance is needed to save money and harm
Similarly, there should be scrutiny of vaccine side-effects.
All the usual research that is done in relation to pharmacovigilance, is non-existent for vaccines. http://www.bmj.com/content/352/bmj.i867/rr-7
Apart from the fact that proper academic vaccinevigilance doesn't exist, the industry can not be held accountable either.
The global omission of critically appraising vaccine-side-effects might well be the result that there is now a greater burden of disease due to chronic (life long) non-communicable diseases (NCD), as compared to vaccine prevented acute (short episode) infectious diseases. http://www.bmj.com/content/355/bmj.i5170/rr-2
Dr Adhanom Ghebreyesus should collect data on current NCD, as the developing world might also start to see endemics of NCD as those now affecting the developed, highly vaccinated, world.
The following are only 3 examples of morbidity (life long!) and mortality due to NCD:
1) "Food allergies are a growing public health issue—about 15 million Americans have food allergies. And food allergic reactions are responsible for about 30,000 emergency room visits and 150-200 deaths a year." https://blogs.cdc.gov/yourhealthyourenvironment/2017/05/17/going-out-to-...
2) In the UK there are 1500 asthma deaths a year and this trend is increasing http://www.pulsetoday.co.uk/clinical/cardiovascular/asthma-advice-in-tur... 5.4 million people in the UK are currently receiving treatment for asthma https://www.asthma.org.uk/about/media/facts-and-statistics
3) Chronic allergic diseases in Europe - "the current prediction is that by 2025 half of the entire EU population will be affected (EAACI, 2016)" https://www.allergyuk.org/information-and-advice/statistics
National schemes like VAERS are not good enough. Active research is needed. http://www.bmj.com/content/352/bmj.i867/rr-7
The WHO is hopefully resistant to lobbyists who are influencing national governments, as took place in the UK parliament last year. http://www.abpi.org.uk/media-centre/newsreleases/2016/Pages/World-Immuni...
With rhetoric like "patient-centered", new laws have been made, like in Italy, that "recognises patient safety as a fundamental right".
http://www.bmj.com/content/357/bmj.j2277
In Italy this "patient-centered" law was swiftly followed by a loss of individual freedom, loss of shared decision making (SDM) and the introduction of mandatory, compulsory vaccination.
Vaccinevigilance is essential and needs to benefit from an even greater scrutiny than pharmacovigilance, as vaccines (in contract to medicines) are potentially administered to every person on the planet.
@wouterhavinga
wouter.havinga@gmail.com
Competing interests: No competing interests