Should Zyprexa Be Approved For Teens? No
1 CommentBy Ed Silverman // October 1st, 2007 // 12:33 pm
Last week, we posted an item that an FDA official, Tom Laughren, overruled his own medical reviewers and recommends that Lilly’s antipsychotic be approved for teenagers. You can read more about that here. The decision isn’t final, but certainly carries a lot of weight, given his role as the agency’s overseer of psychiatric meds.
However, FDA approval of Zyprexa is likely to cause still more controversy. Already, Lilly has settled lawsuits accusing the drugmaker of hiding side effect data about weight gain and diabetes. And a growing number of states are also pursuing suits, alleging their state Medicaid programs overpaid for a drug that was, in effect, improperly marketed. Psychiatrists, meanwhile, are already scared off the drug over the side effects.
For Lilly, pediatric approval can be a big boost in sales for a drug that’s losing market share. But many docs worry the side effects are worse in kids than adults. Given all this, we asked what you think the FDA should do. The vote was was overwhelmingly against approval. Please note that this wasn’t a scientific measure, but does provide some insight into what some think of the scenario.
Should Zyprexa Be Approved For Teens?
No - 1,199 votes, or 99 percent;
Yes - 15 votes, or 1 percent.
Total Voters: 1,214
Ellen
I have been praying for weeks that the FDA would, for once, do something right and , officially anyway, keep this worst of lethals from children. I wonder what’s in it for Tom if he overrules his own advisory committee? Maybe we can take up a collection and match it.
Where’s the transparency; the data; that conclusively shows this is not harmful for kids?