February 2012

Magic Cancer Bullet: Behind the scenes

With our GIST 2010: A Decade of Difference gala event approaching, we decided to look back ten years and ask the question, “What’s the fuss about?” The following excerpt was reprinted from Magic Cancer Bullet: How a Tiny Orange Pill Is Rewriting Medical History by Daniel Vasella, M.D., Chairman of Novartis Pharmaceuticals.

Why was there such a fuss about Gleevec?

After all, other breakthrough drugs have surfaced over the years, but none received the massive media attention this drug did; an American cabinet member had never called a news conference to announce FDA approval for any other drug. Research scientists and physicians alike have never rallied behind a drug with such public enthusiasm as did those who were Gleevec’s official cheerleaders from the day of its FDA approval. Company employees rarely give up their weekends and vacations to help expedite a product’s journey to market, as was the case with Novartis personnel.

Why did the media demonstrate almost universal praise and awe for this drug at the time of its “victory in May”? Usually quick to join critics, normally proud of its fiery independence, the media this time joined Gleevec’s other cheerleaders, and happily proclaimed this tiny orange capsule a “magic bullet” of sorts.

No editor of a major news organization thought it too early to do in-depth stories on the drug. In those first days after FDA approval, no editor thought it worthwhile to criticize Department of Health and Human Services Secretary Tommy Thompson or Acting FDA Commissioner Bernard Schwetz for parading Gleevec in public as a drug that could well be the breakthrough drug we have all been waiting for in cancer therapy.

Why all the fuss?

Plain and simple: the early results were nothing short of spectacular and the mechanism of action opens new horizons of cancer-targeted treatment.

Still, none of us at Novartis could have predicted such an outpouring of goodwill and enthusiasm for Gleevec as occurred in those early days after FDA approval in May 2001. Of course, from the very first hours that we saw the stunning results of the Phase I patient trials in April 1999, we began to believe that STI571 might have some very interesting positive effects on cancer patients.

And now that we have all witnessed the outpouring of excitement for the drug, expectations for its future have grown dramatically. And that is not surprising either. Gleevec did not come to life in the dark shadows; it was swept to prominence by a giant wave of media exposure that increasingly exposed all of us to questions about its possibilities.

We were asked to read the future. We were asked to say precisely how this drug would work on other cancers. And of course we could not. We could only talk about the first four years of Gleevec and even then we felt an obligation to be exceedingly cautious. We were barraged with the same question: Which of the other cancers will Gleevec help? We had to say that we did not know, that we were intensely studying the question.