Finally, Roche Studies Tamiflu And Suicide
9 CommentsBy Ed Silverman // June 19th, 2007 // 7:32 am
What took so long? Last fall, the FDA required Roche last fall to add psychiatric warnings to the Tamiflu label. And over the last few years, at least 183 cases were reported in Japan of youngsters acting strangely, including 26 who jumped off balconies (see photo) or buildings after taking the pill. Now, Roche and its Chugai unit in Japan are agreeing to conduct studies - in rats and humans - to figure this out.
The drugmaker continues to say there’s no ‘causal’ relationship, but will run metabolic and toxicity studies in rats to look at the effect Tamiflu has on the brain. There will also be a study involving up to 30 human volunteers, which will be finished by December, with interim results released in September. And Roche will conduct epidemiologic reviews.
“It is Chugai’s intention is to analyze information received until now in further detail, and investigate under what circumstances serious events might occur and how to best avoid their occurrence if any,” Roche’s Chugai unit says in a statement today.
It’s about time. On one hand, Roche and Chugai should be commended for agreeing to explore the problem. Yet the controversy has been growing and, until now, the drugmaker has sat on its hands, arguing there’s no evidence to suggest that Tamiflu causes teenagers to leap off tall buildings in a single bound. In an era when drugmakers are regularly accused of downplaying problems, Roche’s action is welcome, but…the delay was completely unnecessary.
Here’s an update: To view the FDA November 2006 presentation to the agency’s pediatric advisory committee, look here. You’ll see that Tamiflu was given to children in Japan more than any other country. Larry Sasich, a pharmacy professor at Lake Erie College of Osteopathic Medicine who sat on the panel, notes that doctors in Japan are permitted to sell drugs directly to patients.
Lisa Van Syckel
Only 30!!!! A study must be, much larger than this….
Also, metabolic and toxicology tests could eliminate those at a potential risk for a behavioural event.
Final outcome..It wasnt the drug…….
Chris
Have there been any similar cases outside Japan? The drug has been available, although not widely used, since the early 2000s. Is it that no similar cases occurred or were they not reported.
Anybody help me understand how metabolic and tox tests can rule out a risk for a behavioral event?
tks
Ed Silverman
Hi Chris,
I don’t know the answer to your question. I do know that just last week, a doctor in the UK urged caution over Tamiflu for this reason.
http://www.pharmalot.com/2007/06/tamiflu-prompts-warning-from-uk-doc/
I’m also curious to hear responses to your question about the tests?
Regards
ed
Laurie
“Anybody help me understand how metabolic and tox tests can rule out a risk for a behavioral event?”
And there in lies the problem. There is no way to definitively document a causal link, since there are no tests that would determine this. Drugs that alter behavior have no physiological “marker” to determine efficacy or adverse reaction related to that behavior, so causation can never be proven, except by behavioral patterns. Behavioral reactions to a drug can happen regardless of the dosing…it doesn’t have to be a toxic level.
Rudy Van Donkelaar
Bird Flu 191 deaths; Tamiflu 71 deaths.
Maybe it has something to do with the benzene ring which is the base structure of tamiflu. This was the only way Gilead-Roche could get around the Biota-GSK patent (Relenza).
Johnny Stettin
Rudy, You’re thinking of Biocryst’s neuraminidase inhibitor. Tamiflu is a classic patent busting exercise based on Glaxo/Biota’s Relenza and a couple of analog papers published by GSK. GSK published carbocylic analogs of Relenza in one paper and glycerol sidechain replacements in another paper. These could be used to redesign the molecule. Tamiflu has a carbocylic structure with the ring containing a single double bond designed to mimic the oxonium ion formed when sialic acid acid is cleaved by neuraminidase.
J
Lisa Van Syckel
Johnny,
Would you please restate what you just said and please put it in consumer friendly language.
Thank You
Kay
I’m wondering if anyone knows if Tamiflu is being especially pushed more than previously. My niece got this stuff, supposedly for the flu, and my sister was given no idea what she was getting her into. No one said, this may shave a day or two off the time she’s sick, and oh, if she has mono instead of the flu, may send her into liver failure and 10 days in the hospital. No lawsuit anticipated, I hasten to add; no way to prove it wasn’t just a bad case of mono. Unless there’s a push to broaden the use, you have to wonder why a doctor, even at a doc-in-a-box, would prescribe it at all.
Sales of Tamiflu for the first 1/4 of the year are up 47%, according to this:
http://www.pharmalot.com/2007/04/roche_strikes_an_optimistic_po/
CV
What does tamiflu do to the liver. How would it affect a patient with Hep-C