With Tamiflu, the FDA is headed in the wrong direction — as usual
Doing a 180
As usual, the FDA is going in the wrong direction.
They kind of have a genius for that, don’t they?
And to make matters worse, they might be putting children at risk. But not just any children — infants as young as two weeks.
Even the FDA usually doesn’t get it THIS wrong.
Bring in the beans
A few days ago, the FDA expanded the use of Tamiflu to include all children who are older than two weeks.
Tamiflu, of course, is the notorious anti-viral medication. When it works, it’s supposed to shorten the duration of flu symptoms by about one day.
But there are different varieties of flu. And every case of the flu is different. So how can you possibly tell if this drug actually cuts your flu short? And then, even if it works, the most common side effects are nausea and vomiting. Which would make you feel like you have the flu.
And in terms of actual protection, Tamiflu is a bust.
Tamiflu has not been shown to reduce hospitalizations. It has not been shown to reduce risk of flu-related complications. It has not been shown to inhibit flu transmission. It has not been shown to reduce the severity of flu symptoms.
Kind of sounds like someone is trying to sell us magic beans, doesn’t it?
And yet, with this new FDA action, the agency is validating Tamiflu at the very moment that the rest of the medical world is putting the drug at arm’s length. Because it appears that Tamiflu might, in fact, actually be worth less than magic beans.
Here’s a quick review of the Tamiflu meltdown…
* Two ghostwriters admitted that they wrote several Tamiflu studies. They say they were instructed to embed a pro-Tamiflu message in their work.
* This revelation prompted Cochrane Collaboration researchers to reopen a review of Tamiflu clinical studies. But Roche (the maker of Tamiflu) refused to hand over all the trial data. About 60% of the data is unreleased.
* This past November, British Medical Journal editors called on Roche to turn over all unpublished data from Tamiflu trials. Until they do, BMJ says there’s no evidence that Tamiflu actually works.
* Last month, UK officials launched a Tamiflu investigation. Their concern is that the National Health Service spent a half-billion pounds to stockpile Tamiflu. The big question: Was there any assessment of the drug’s effectiveness? Or did they just take Roche’s word that the drug worked? (U.S. officials should be asking these same questions. In 2006, the U.S. spent $2 billion to stockpile Tamiflu.)
But for me, this is the real stunner…
Nobody is talking about the MedPage Today revelation that I’ve raised again and again. MedPage reports that in many Tamiflu trials the placebo contained two unknown chemicals that weren’t in the Tamiflu capsules. Roche has refused to reveal the placebo contents.
It’s pretty simple. If the placebos were shams, then the trials were shams. They’re out the window.
It’s an outrage that in the midst of one of the worst flu seasons on record, the FDA is validating and expanding the market of this very likely useless drug.
I’d rather take my chances with the magic beans.
Sources:
“FDA expands Tamiflu’s use to treat children younger than 1 year” FDA News Release, 12/21/12, fda.gov
“MPs call for investigation into £500m spent on Tamiflu drug” Nicholas Watt, The Guardian, 12/13/12, guardian.co.uk
“Tamiflu: the battle for secret drug data” British Medical Journal, Vol. 345, 10/29/12, bmj.com
“British Medical Journal says Roche’s Tamiflu won’t stop flu” Associated Press, 11/12/12, ap.org
“New Analysis Challenges Tamiflu Efficacy” Michael Smith, MedPage Today, 1/17/12, medpagetoday.com
