DOES TAMIFLU REALLY WORK

The British Medical Journal (BMJ) was dominated in 2009 by a cluster of articles on oseltamivir
(Tamiflu). Between them the articles conclude that the evidence that oseltamivir reduces
complications in otherwise healthy people with pandemic influenza is now uncertain and that we
need a radical change in the rules on access to trial data.

The use of meta-analysis is governed by the Cochrane review protocol. Cochrane Reviews investigate
the effects of interventions for prevention, treatment and rehabilitation in a healthcare setting. They
are designed to facilitate the choices that doctors, patients, policy makers and others face in health
care. Most Cochrane Reviews are based on randomized controlled trials, but other types of evidence
may also be taken into account, if appropriate.

If the data collected in a review are of sufficient quality and similar enough, they are summarized
statistically in a meta-analysis, which generally provides a better overall estimate of a clinical effect
than the results from individual studies. Reviews aim to be relatively easy to understand for non-
experts (although a certain amount of technical detail is always necessary). To achieve this,
Cochrane Review Groups like to work with “consumers”, for example patients, who also contribute
by pointing out issues that are important for people receiving certain interventions. Additionally, the
Cochrane Library contains glossaries to explain technical terms.

Briefly, in updating their Cochrane review, published in late 2009. Tom Jefferson and colleagues
failed to verify claims, based on an analysis of 10 drug company trials, that oseltamivir reduced the
risk of complications in healthy adults with influenza. These claims have formed a key part of
decisions to stockpile the drug and make it widely available.

Only after questions were put by the BMJ and Channel 4 News has the manufacturer Roche
committed to making “full study reports” available on a password protected site. Some questions
remain about who did what in the Roche trials, how patients were recruited, and why some
neuropsychiatric adverse events were not reported. A response from Roche was published in the
BMJ letters pages and their full point by point response is published online.

Should the BMJ be publishing the Cochrane review given that a more complete analysis of the
evidence may be possible in the next few months? Yes because Cochrane reviews are by their nature
interim rather than definitive. They exist in present tense always to be superseded by the next
update. They are based on the best information available to the reviewers at the time they complete
the review. The Cochrane reviewers have told the BMJ that they will update their review to
incorporate 8 unpublished Roche trials when they are provided with individual patient data.

Where does this leave oseltamivir, on which governments around the world have spent billions of
pounds? The papers in the last years journal relate only to its use in healthy adults with influenza.
But they say nothing about its use in patients judged to be at high risk of complications- pregnant
woman, children under 5, and those with underlying medical conditions; and uncertainty over its
role in complications in healthy adults still leaves it as a useful drug for reducing the duration of
symptoms. However as peter Doshi points out on this outcome it has yet to be compared in head to
head trials with Non-Steroidal inflammatory drugs or paracetamol. And given the drugs known side-
effects, the risk-benefit profile shifts considerably if we were talking only in terms of symptoms
relief.
We don’t know yet whether this episode will turnout to be a decisive battle or merely a skirmish in
the fight for greater transparency in drug evaluation. But it is legitimate scientific concern that data
used to support important health policy strategies are held only by a commercial organization and
have not been subject to full external scrutiny and review. It can’t be right that public should have to
rely on detective work by academics and journalists to patch together the evidence for such a widely
prescribed drug. Individual patient data from all trials of drugs should be readily available for
scientific scrutiny.

1. A cluster of articles on Oseltamivir in the British medical journal conclude………….

a. Complication are reduced in healthy people by Oseltamivir

b. The efficacy of Tamiflu is now in Doubt

c. Complications from pandemic influenza are currently uncertain.

d. A series of articles supporting Tamiflu

2. Cochrane reviews are designed to

a. A set of randomized control trial to specific values

b. Compile literature meta-analysis

c. Peer review articles

d. Influence doctor’s choice of prescription

3. According to the article which one of the following statement about Tamiflu is false

a. The use of randomized control trial is suspect?

b. The efficacy of Tamiflu is certain

c. Oseltamivir induces complication in healthy people

d. Cochrane reviews are useful when examining the efficacy of Tamiflu

4. According to the article Cochrane review groups……….

a. Like to work for consumers

b. Are being over hauled

c. Use language suitable for expert to expert communication

d. Evaluate a clinical effect better than individual studies

5. Which would make best heading for paragraph 4

a. Analysis of 10 drug company trials

b. The stock piling of Oseltamivir

c. Risk of complications in healthy adults

d. Tamiflu claims fail verification

6. According to the article which one of the following claim about Roche is true?
 a. Full study reports were made freely made available over the internet

b. Patient were recruited through a double-blind trial

c. The identities of the role of researcher in the Roche trial are not fully accounted for

d. Not all Neuropsychiatric adverse events were reported

7. Cochrane review should………

a. Use a more complete analysis

b. Not be published until final data is available

c. Be considered interim rather than definitive advice

d. Be superseded by a more reliable method of reporting result

8. Which would make the best heading for paragraph 7

e. a. Risk- benefit profile of Tamiflu

f. b. Studies limited to healthy adults

g. c. High risks of complications

h. d. Oseltamivir only for high risk patients