I started reading Alex Prud'Homme's "The Cell Game" this week—the story of Erbitux, ImClone, Sam Waksal, and Martha Stewart, you remember that mess. It starts out ominously with "The Cell Game was reported and written in nine months …", not the kind of line you want to introduce such a book with, it hardly inspires confidence in its journalism or accuracy. In fact my first impression is that this book was not given enough editorial attention (at one point Waksal quotes "John Stewart Mill").
By sheer coincidence, right before the book arrived in the mail (compliments of the fun at paperbackswap.com), I came across the class action lawsuit filed against Cell Therapeutics (CTI) by its shareholders which accuses its CEO, Dr. James Bianco, and its CMO, Dr. Jack Singer, of making several false or misleading statements regarding the company's leading NHL drug candidate, pixantrone.
Recall, an FDA advisory committee squashed pixantrone last February after evaluating the pathetic data from its pivotal EXTEND trial. CTI has made the repulsive decision to appeal the ruling.
Anyway the similarities are mounting: an oncologic drug candidate brought along amidst lots of hype, the company's share price rising, then the drug falling short of FDA expectations followed by accusations of lies, manipulation, artificially inflating stock prices, insider trading, and more.
Erbitux (cetuximab), Waksal's drug, did in fact make it to market and is available today, despite underwhelming trial data. The chances that pixantrone will follow aren't as good. I'm only half way through The Cell Game, but so far there's no indication that some of the participants in the Erbitux trial didn't even have cancer—which is one of the allegations against CTI. If true, it's the most appalling of them all.
By Ross Bonander
See also:
"The other 70 percent"
"A desperate biotech preying on desperate patients"
