March 11, 2004

Sympathy for Sam

I suppose not many people have it. But I have sympathy for Sam Waksal. When ImClone System's cancer drug was approved, Professor Bainbridge blogged that Dr. Waksal would be kicking himself. But I think there's another well deserved kick that should be coming (but won't). And that it should be administered to the FDA. About 27 months after the agency's (now notorious) rejection of ImClone's application for approval of Erbitux, the FDA approved the drug.
That suggests that Erbitux was already proven at the time of its rejection. (From what I've seen another successful trial was concluded in Europe in the meantime.)
Imagine, now that you're Sam Waksal. You've staked your career on a drug. Your family, who believes in you supports you and invests in you. You find out that the FDA is about to reject that drug for reasons having nothing to do with scientific merit. What do you do? Do you let your friends and relatives suffer? Or do you let them know that the FDA will reject your drug for unwarranted (to your mind) reasons? Would you lose hope and start dumping your shares too? I'm not going to defend Waksal and say that what he did was legal. It's pretty clear that he violated the law.
What I am asking is:was the reason the Erbutix application legitimate? The FDA claimed that the application was incomplete. If it was, was there some way the FDA could have softened the blow? The FDA does need to be investigated here. It must be established that the FDA was correct in rejecting ImClone's 2001 application. Since Erbutix works there's a measure of vindication here for Sam Waksal. It would suggest that he was running his company successfully and doing good research to have developed a cancer drug. But his skills, for the next seven years, will remain dormant. His skills will help no one because he's in jail. If the world will be deprived of his talent, there better be a good reason for it.

Posted by SoccerDad at March 11, 2004 01:32 PM | TrackBack
Comments

Hold on there, chief.

Selling stock on insider information means that you are taking someone else's money dishonestly. Framing it as some maudlin "I didn't want my family to suffer," completely misses the point. If you believe in your drug, you engage the FDA, and you tell your family to hang on to their shares while you straighten the gummint out. You don't rip off some other completely innocent person to further fatten your daughter's (!) bank account in the interim. This isn't some bad law that he had to deal with, it's his own greed.

He is, of course, able to educate people while imprisoned, if your assertions of his magnanimity bear any relationship with reality. I remain somewhat skeptical myself.

Posted by: zalmy at March 11, 2004 02:59 PM

I acknowledged that he violated the law. I'm just arguing that the FDA decision should be subject to scrutiny. And I don't think he acted in a calculated, greedy fashion but in a panicked fashion. That's where we differ.

Posted by: David Gerstman at March 12, 2004 04:28 AM

We may differ there, but that's because you're wrong. According to SEC filings, Sam Waksal pulled in over $5.7 million in income between 1998 and 2000, in addition to owning over 4.5 million shares of Imclone as of March 28, 2001. At $10 a share (one-sixth of Martha Stewart's alleged floor price), that translates to assets of over $45 million.

So we're not talking about someone concerned about being chucked into the street, we're talking about avarice. Particularly since the application was denied for being incomplete, which is remedied easily enough. I fail to see how that translates into any excusable panic. "Oh no, I'll only have $100 million instead of $200 million!"

Please.

Posted by: zalmy at March 12, 2004 07:59 AM