<<If Neuro is out there, I'd be interested in his take on the likely "real" reason why the FDA shot down modafinil's (Sparlon) label expansion into ADHD. Didn't the skin rash issue seem like an extremely flimsy excuse? Could it simply be that they just don't want to see another abusable drug circulating through the nation's schools? As I understand it, Sparlon's clinical data strongly supported approval for ADHD.>>
Gfp, I've been giving this some thought--especially after hearing Frank Baldino on the CC discussing it. It was like a baseball player called out on strikes to end the game on an obviously bad call, seething and wanting to explode, but knowing that if he said what was on his mind, he would pay a bigger price later. Given how many hundreds of millions in revenue had just been taken away from Cephalon, it was remarkable that Frank Baldino--who has quite a temper (I've been on the receiving end)-did not blow up. But I wouldnt have wanted to be a pedestrian crossing the street in front of his Escalade as he drove home that night.
1) As you note, it shouldnt be the Stevens-Johnson safety issue. One case which appears to have been misdiagnosed, no increase in S-J in the many millions of people who have taken this very same drug, often at 400mg doses near what Sparlon is used at, over the past fifteen years (beginning in France in the early 90s).
2) I don't think it's the abuse issue--because Provigil is not an abuser's drug of choice. Kids who want to buy stimulants in school can easily obtain Ritalin or Adderall, Provigil simply isnt in the same league.
3) Baldino had come close to predicting approval, and had said publicly that the S-J case wasnt really one. Not a good tactic, discussing the safety issue in public before hearing from the FDA. Not a mistake Stoll is making.
4) One possible issue is that Cephalon has skirted the edges of the FDA regs in its marketing of Provigil in terms of off-label marketing. I was a little surprised they werent punished when they went for the shiftwork and sleep apnea expansions. Notice that Baldino claims that only 5-10% of Provigil scrips are written for ADHD, that's his attempt to downplay the off-label issue. My guess is that the ADHD use is more like 30-40%, and that the FDA isnt happy about that. Of course, they have now guaranteed continued high off-label use, but I never accused them of being logical.
5) Provigil is a useful drug for ADHD, certainly better than Strattera, less than Adderall/Ritalin (but without their baggage), This was not a good decision in terms of patient care.
6) This is, at its heart, a cover-your-ass decision. Let's say the FDA had approved it, and a genuine Stevens-Johnson case then occurred (there is a baseline rate of incidence, it doesnt have to be causal). They don't want headlines like: "8 year old dies of rare disease perhaps caused by drug approved by FDA--Grassley demands an explanation."
I actually think it is mostly #6, with a little #4 thrown in.
NeuroInvestment
