Australasian Science: Australia's authority on science since 1938

The Tamiflu saga shows why all research data should be public

By Chris Del Mar

Attempts to evaluate whether the antiviral drug Tamiflu is effective have been stymied by lack of access to the data from clinical trials.

The full text of this article can be purchased from Informit.

There’s a dispute going on at the moment, a war of words with lots of public relations manoeuvring. It’s all about the disclosure of trials undertaken in the past. And it is between Cochrane reviewers (of which I am one) and Big Pharma (in this case, Hoffman-La-Roche of Switzerland).

To understand the dispute, it’s necessary to go back a bit in history.

Tamiflu (oseltamivir) is a drug, cleverly-designed in 2000 to attack a molecule in the influenza virus. It prevents the influenza virus bursting infected human cells to spread more virus in the body.

It works rather like antibiotics on bacteria, except that it’s very specific to viruses or, rather, one virus exclusively – the one that causes influenza. It looked as if this class of drug was going to revolutionise treating this virus' infections, in much the same way that antibiotics have made treatment of once-dreaded bacterial infections routine.

Roche performed trials and the results were used to get approval from different regulatory authorities for it to be used routinely. The agencies include the US FDA (Federal Drug Administration), Europe’s EMA (European Medicines Authority), and Australia’s TGA (Therapeutic Drug Administration).

The trial reports supplied to regulatory authorities are called clinical study reports, and they are massive documents with added volumes of appendices,...

The full text of this article can be purchased from Informit.