“Safe and Effective”

Nov 18, 2005 4:43pm

Monday, 11:35 AM

To make a long story short, we didn’t make air Friday with our bird flu story. But I got a quick education in the meantime.

Read my post below if you’re concerned about bird flu, then please come back.

The issue is how ready the country is if the virus turns into a pandemic.  Most public-health specialists agree there’s a very small chance of a very big crisis, but multiply the small number by the big one and you get a consensus that it’s prudent to make some protective moves.

But should stocking up on Tamiflu be part of that?  The doctors we interviewed were practically on different planets. 

This, first from Dr. Robert Nelson, a pediatrician at Children’s Hospital of Philadelphia, who chairs the FDA’s Pediatric Advisory Committee:

"Tamiflu at this point I think is safe and effective for the treatment of children who have the flu," he said.  He attributed the twelve deaths in Japan to the flu itself, not the drug.  "More side effects are seen with more people taking the drug.  In my view, that doesn’t really change the safety of the drug to treat influenza as it’s already approved.  It’s impossible at this point to speculate on what would happen in a pandemic, should that occur."

Now here’s Dr. Jerry Avorn, who’s on the faculty of Harvard Medical School, and author of Powerful Medicines, a book about the pitfalls of new medications:

"Influenza is not normally a fatal disease in kids," he said, "and so immediately, that should have raised somebody’s eyebrows in Washington."  He says the F.D.A. dropped the ball.

Tamiflu, he said, is not an unusually risky drug–but not a very effective one either.  If one catches a more routine strain of influenza, Tamiflu shortens the course of one’s symptoms by a day or two.  All of a sudden its sales have jumped because doctors think it may have some effect against avian flu–and because there’s nothing else, at least not for a virus that doesn’t even exist in a form that transmits from one person to another.

"And so, if you have thousands of people taking a drug they don’t need," he concluded, "almost certainly the side effects are going to end up being worse than the benefit that they may or may not achieve from the drug."

So what are we supposed to think?  Nice little virus, just stay away from us…and you all in the lab, please keep working on a vaccine.

- Ned

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