To me, those numbers look pretty encouraging. People understood that the Vioxx news identified a potential risk. They paid attention and took personal responsibility—just the way they're supposed to.
Our drug regulatory system depends on people paying attention to risk. It has to: No drug is completely safe, and every decision to take or not take a medication is a matter of balancing one danger against another. That's why it's good to see people reacting appropriately to the news about Vioxx.But what were these folks and their doctors doing for the past two years? It's hardly news that there are questions about Vioxx's effects on the heart. Since 2002 the drug's prescribing information has included the results of the VIGOR trial—in which patients taking Vioxx experienced about twice as many "serious cardiovascular thrombotic adverse events" as patients taking naproxen. In the current version of the prescribing information, more than 700 words are devoted to describing the cardiovascular side effects of Vioxx—more words than appear on this page.
Now, I'm well aware that a warning on a PI isn't as forceful as an article in the morning newspaper that says a drug has been withdrawn from the market. I realize that the Vioxx PI muddied the water by providing data on other trials that partly contradicted VIGOR's findings. I also know that PIs are a colossal pain to read and that many patients lack the scientific literacy to use them well.
That said, I think the Vioxx PI was clear enough. Anyone capable of understanding the newspaper stories about the withdrawal should have been able to read the PI well enough to know that there was a risk. (Don't take my word for it; you can still read the document at http://www.vioxx.com/) It's hard to believe a patient would read those warnings and not ask about them. It's hard to believe a physician would read them and not bring them to a patient's attention.
But apparently that's exactly what happened. And that is a disaster, not just for pharma, but for patients. It seems pretty clear that, Congressional grandstanding aside, most people want a system in which patients and physicians make key decisions about risk. But if patients and doctors opt out, we'll be left with a system in which only the "safest" products will be acceptable. That may sound great in a speech on the Hill, but it translates to fewer treatment options, more expensive drugs, and more patients suffering or dying because they're not allowed to make their own bet on their own lives.
Will some irate congressman launch an investigation into the distressing failures of doctors and patients in the Vioxx case? Probably not. There are too many easier targets. But those failures took place, and they endanger pharma's future. The industry devotes an amazing amount of energy to analyzing what makes doctors prescribe a drug. Maybe it's time to devote part of that energy to finding out what makes them think twice. Docs who fuss over side effects, docs who feel good about saying no, may not be pharma's idea of the ideal customer, but at the moment, they may be the industry's salvation. We need to know what makes them tick.
Patrick Clinton is Pharmaceutical Executive's editor-in-chief and can be reached at [email protected]