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The public is focused on drug safety, but the real issue isn't approval standards. It's the way drugs expand to unapproved new indications. Are you listening, Acomplia?
In this issue of Pharm Exec we look to the future. Senior Editor Ron Feemster reports on the drug development pipeline, focusing on 40 compounds that are attracting the attention of analysts, clinicians, and others. And our second annual industry forecast turns to more than 20 industry experts and thought leaders, looking for their take on the most important issues, events, and trends of the coming year.
My own pick for the event to watch this year is Sanofi-Aventis' expected launch of the weight loss and anti-smoking drug Acomplia (rimonabant). Here is an important product, squarely aimed at a major global medical issue. Early accounts show it to be impressively effective.
But all drugs have side effects—and many these days have side effects for the companies that make medicines as well as the patients who take them. And Acomplia bears a strong resemblance to the drugs that have rocked the industry in recent years—maybe not pharmacologically, but in the way that it is likely to be treated by patients.
For all the public attention focused on drug safety these days, the truth is that, whether they know it or not, most industry critics are focusing on a far narrower issue: drugs that are approved because they have a favorable risk/benefit ratio in a particular indication but find their greatest use in less serious conditions—for which they may not meet a reasonable safety standard. Vioxx is the poster child for this sort of drug. As an alternative to severe gastric problems it might well be worth the risk. But what happens when it starts getting used by folks with tummies that feel fine? And think of the drugs on FDA dissident David Graham's list of brands he'd like to see withdrawn: Accutane, Meridia, Crestor, and so forth. Most fit the same pattern. So did most of the drugs mentioned in Jerry Avorn's editorial in the New England Journal of Medicine this past September. He said he was writing about research standards. But his best points were about the double standard.
There's no doubt that double-standard drugs like these create problems for FDA. Should drugs be approved based on the risks and benefits of the indications companies apply for—or for the indications patients actually use them for? And when a drug seems likely to expand far beyond its approved indications, how should that process be managed?
That's exactly the sort of challenge that Acomplia is going to pose. It seems likely to win approval for obesity—presumably, health-threatening obesity—and smoking cessation. But it seems clear that people interested in purely cosmetic weight loss are going to want the drug, and many consumers will be eager to try out Acomplia's other possible benefits, including treatment for addiction and relief of some cognitive problems. There's no question that Acomplia is going to expand beyond its approved indications. That sort of expansion is the root of today's debate on drug safety. All the players, from the company to FDA to industry critics, know that it's going to happen. Isn't it time they got together and talked about that process and how to make it work in the patient's best interests?
Here's a prediction: Whatever else happens, Acomplia will almost certainly be the case that points out what an enormous effect unofficial, unregulated, Internet-based information can have on a drug. The product isn't even approved and already hundreds of Acomplia Web sites have popped up: newsletters, discussion boards, and yet-to-open stores. Especially if Sanofi decides to delay DTC advertising, they could easily become the principal source of information on the drug, and they are uncontrollable. Did you think the gray-market campaigns for Viagra were scary? You ain't seen nothing yet.
Patrick Clinton is Pharmaceutical Executive's editor-in-chief and can be reached at firstname.lastname@example.org