What the Tamiflu saga tells us about drug trials and big pharma

We have been subscribers to the All Trials network since founded by physician Ben Goldacre in Jan 2013. The mission statement is simple “All Trials Registered | All Results Reported”. The above-captioned article by Dr. Goldacre will make it clear why this initiative is so important:

Today we found out that Tamiflu doesn’t work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia.

That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story.

And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment.

Tamiflu being made by Roche

 

(…snip…)

This is a pivotal moment in the history of medicine. Trials transparency is finally on the agenda, and this may be our only opportunity to fix it in a decade. We cannot make informed decisions about which treatment is best while information about clinical trials is routinely and legally withheld from doctors, researchers, and patients. Anyone who stands in the way of transparency is exposing patients to avoidable harm. We need regulators, legislators, and professional bodies to demand full transparency. We need clear audit on what information is missing, and who is withholding it.

Finally, more than anything – because culture shift will be as powerful as legislation – we need to do something even more difficult. We need to praise, encourage, and support the companies and individuals who are beginning to do the right thing. This now includes Roche. And so, paradoxically, after everything you have read above, with the outrage fresh in your mind, on the day when it feels harder than any other, I hope you will join me in saying: Bravo, Roche. Now let’s do better.

• Ben Goldacre is a doctor and the author of Bad Pharma.

You can help the All Trials mission. Join and sign the petition here. Spread the word, lean on your politicians, get involved.

2 thoughts on “What the Tamiflu saga tells us about drug trials and big pharma

  1. Fred Cox

    I wonder how long it will take for all of the professional organizations that now recommend Tamiflu for the routine treatment of uncomplicated influenza to change their positions. It is now very difficult for a practicing physician not to prescribe this drug for every patient with clinically- suspected influenza or who has a positive flu test. Worse yet Tamiflu is now recommended for clinically well contacts of patients with influenza. Worse yet after the recommendations are changed how long will patients continue to demand this drug the way they demand antibiotics for viral infections?

    Fred

    — Sent from Mailbox for iPad

  2. Steve Darden Post author

    >Worse yet Tamiflu is now recommended for clinically well contacts of patients with influenza
    Thanks – it is actually much worse than I realized. What is the source of “now recommended”? USGov agency, specialty professional society, …?

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