In terms of scientific reviews, this story is important around the globe.

This story is about a medication which has cost governments billions of dollars to put it in national stockpiles for emergencies.

Today, the British Medical Journal (BMJ) published online an updated review of clinical trials for Tamiflu.

Tamiflu  has been recommended as the first line drug for seasonal and pandemic H1N1 influenza by the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO)—- to name only two leading public health organizations which have done so.

The startling news, unless some researchers produce more and stronger data, is that Tamiflu may not do what experts have thought it did: Spare patients complications of influenza, such as pneumonia. Many patients die each year from seasonal influenza.

As the pandemic unfolded, governments reassured citizens that their stockpiles of anti-virals should be adequate to meet their needs.

This may be a pharmaceutical example of the emperor who has no clothes.

Here is how we got here. The reason the questions are coming up about Tamiflu now is that in 2006, eight studies were included in a review of the drug. In 2009, the researchers found  these studies insufficient to assess the drug properly. Those eight were tossed out. The remaining 12 studies did not produce evidence strong enough to justify stockpiling Tamiflu.

• An analysis of 20 trials for Tamiflu was performed but there was a “paucity of good data” to use in assessing the drug’s performance.
• A “paucity of good data” is a red flag whipping in the wind when the drug is so commonly relied upon and recommended. There should be data sufficient to fill every nook and cranny of the National Library of Medicine. No, it is not there. Why not?
• The lack of good data is attributed to the authors of the 20 studies and the manufacturer, Roche. Lacking data from the manufacturer is a common problem. Lacking data from independent researchers is not.
• In the meantime, if Tamiflu is not the wonder drug it is supposed to be, is the next choice effective? There are other anti-viral medications available.
• All around the world, governments urgently need to know the answer to this question and so do individuals at higher risk for influenza and its complications.

U. S. News and World Report

…”Claims about the effectiveness of the antiviral drug against flu-related complications have influenced governments worldwide to stockpile Tamiflu (oseltamivir) as part of their preparations for a global pandemic, the review authors said.

“Governments around the world have spent billions of [dollars] on a drug that the scientific community now finds itself unable to judge,” said Dr. Fiona Godlee, editor-in-chief of the British Medical Journal, which published the article online Wednesday. The review was done by BMJ and Channel 4 News in Great Britain. (Emphasis added)

“The authors of the new review, which updates a review published in 2006, analyzed 20 published clinical trials of Tamiflu that examined prevention, treatment and adverse reactions. However, the analysis was hampered by the “paucity of good data” available from the trial authors and Roche, the maker of Tamiflu, the study authors said.

“This meant the review authors couldn’t verify the results of eight important trials that were never fully published. These eight trials, which were included in the previous review, were omitted from the new review.”

Source: British Medical Journal, Online, December 8, 2009