Why won’t drug companies give up all the data they have on flu medications?

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Back in November I wrote about the drug oseltamivir (Tamiflu), and specifically the fact that its manufacturer (Roche) has steadfastly refused to give up data on the drug that would allow independent researchers to assess its effectiveness and safety.

The British Medical Journal if waging a campaign for Roche to cough up the relevant information, and provided an update on the situation recently [1]. It is reported that on 2 April Roche informed researchers that it would give them 74 clinical study reports on Tamiflu over the next few months. To date, though, none of them have materialised.

If an when then critical information is yielded, then it may still prove difficult for researchers to perform a full analysis. I say this, because as the recent BMJ report details, another drug company has recently given up some data on its own flu drug, and the nature of this information has left a lot to be desired.

Drug company GlaxoSmithKline (GSK) gave researchers 30 reports relating to its flu drug zanamivir (Relenza) at the end of April. These reports hold vast amounts of information on the conduct of Relenza trials, outcomes and adverse events. The only problem is GSK has chosen to redact much critical information, including descriptions of serious adverse events and the start and stop dates of the trials.

The researchers who received the data have written to GSK and asked:

What type of independent research does GSK think this kind of release enables?

The true answer, I think, is probably: “Research that cannot reveal the full truth about the safety and effectiveness of Relenza.”

What we appear to have here is two drug companies making similar flu drugs that appear to be doing their damndest to ensure independent researchers are unable to assess these drugs properly.

Meanwhile, it has recently come to light that, partly due to poor record-keeping by the UK Department of Health, £74 million was wasted on Tamiflu.

This drug has been stockpiled by the British Government even though (as detailed above) the Government does not have all the data on it and what data we have shows that it really doesn’t work very well.

One might ask how it seems authorities have (literally) bought into flu drugs that aren’t particularly effective and on which the relevant data has not been made available. Back in 2010, the BMJ revealed potential conflicts of interest in the World Health Organization that may go some way to explain these anomalies. Here’s an extract from the report:

A joint investigation by the BMJ and the Bureau of Investigative Journalism has uncovered evidence that raises troubling questions about how WHO managed conflicts of interest among the scientists who advised its pandemic planning, and about the transparency of the science underlying its advice to governments. Was it appropriate for WHO to take advice from experts who had declarable financial and research ties with pharmaceutical companies producing antivirals and influenza vaccines? Why was key WHO guidance authored by an influenza expert who had received payment for other work from Roche, manufacturers of oseltamivir, and GlaxoSmithKline, manufacturers of zanamivir? And why does the composition of the emergency committee from which Chan sought guidance remain a secret known only to those within WHO? We are left wondering whether major public health organisations are able to effectively manage the conflicts of interest that are inherent in medical science.

The more one delves into the politics of flu medication, the murkier it get, it seems. One wonders what the drug companies might have to hide.


BMJ 2013;346:f3190[hr]

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