Tuesday, December 8, 2009

Tamiflu: Benefitting from being in the right place at the right time/ BMJ

"We had to do something about swine flu!" And so the makers of Tamiflu (oseltamvir) are several billion dollars richer.

As the BMJ (a.k.a. British Medical Journal) put it in 2005: "From a bit of a dud to the world's most sought after drug in the space of six months, surely Roche cannot believe its luck with oseltamivir (Tamiflu)."

Then last month, the BMJ reported on researchers from Oxford, noting, "Children should not be given the anti-viral drug Tamiflu to combat swine flu, Oxford University researchers said today.
They urged the British Department of Health to urgently rethink its policy on giving the drugs to youngsters affected by the current flu pandemic."

Can someone develop a short seminar for politicians and public health decision-makers that teaches them that sometimes it's really okay (even best) to do nothing? Explain that the country won't collapse if they leave it to those in the trenches to decide when and how to administer drugs to patients (the way we always have done). They probably won't be voted out of office, either. Maybe support groups can be established for "Decision-Addicted" public servants.

In other words, just because they work inside the Beltway, they don't always have to "decide" everything for the rest of us, and they needn't always spend our money to "help" us.

Tamiflu is a prime example. When the drug was licensed, as I've noted previously, the best that could be said about it was that it reduced the duration of flu symptoms by about one day. At $10/tablet or $100/ten-day course it was an expensive marginal benefit. The drug may also cause a range of unpleasant side effects, include suicidality. Yet it might make a big difference in some cases of severe viral illnesses.

The reason people go to doctors is to receive an individual assessment that provides them a diagnosis, a determination of illness severity, and in the context of their overall medical condition, including the other medications they are using, a personalized therapy.

As one could have predicted, when Tamiflu was given out after a brief phone consultation (and the patient's medical provider was NOT the person on the other end of the phone) the results included nasty side effects in those who turned out not to have swine flu, and Tamiflu prescriptions for people with other serious conditions (including cases of life-threatening meningitis), delaying appropriate diagnosis and treatment, even causing reported deaths in the UK.

Tamiflu was given a PREP Act liability waiver in October 2008 for pandemic influenza use. It is very likely that this allowed the US government to purchase it at a reduced price for the 2009 swine flu pandemic... and also likely that those suffering from serious side effects are therefore barred from seeking damages from the manufacturer.

UPDATE Dec. 29: Letter from FDA to CDC permits outdated Tamiflu to be used under emergency use authorization. Was the fact that some Tamiflu in the Strategic National Stockpile was expired or expiring a factor in CDC recommendations to use stockpiled drug widely for swine flu, without testing patients to see if they had the virus?

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