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From the Editor


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-03-01-2005

In the drug safety debate, we're hearing plenty of potential solutions. They're smart and advance desirable goals. There's just one thing wrong with them: They don't solve the problem.

Everybody knows about "mission creep"—the way an organization tends to gradually expand its vision of what it's supposed to do in the world, often losing focus and effectiveness in the process. These days I think I see something similar happening in the debate over drug safety. Let's call it "solution creep."

Patrick Clinton

Here's an example: As this issue was going to press, Sandra Kweder, deputy director of CDER's Office of New Drugs at FDA, testified before a Senate committee. According to news accounts, she proposed that FDA be given additional power to add warnings to drug labels—in order to avoid the sort of protracted negotiation that kept cardiac warnings off of Vioxx's labels for many months after the agency became aware of potential problems.

On the surface, that seems pretty reasonable. Safety warnings need to be prompt. When they're not, patients face needless risks. What's more, as we saw in the Vioxx case, delays in delivering warnings can undercut the credibility of FDA, pharma companies, and the industry as a whole. Companies may not be happy to see FDA get unilateral power to impose labeling changes post-approval. (The biggest worry is that the power to change labels would reside with FDA's new safety office, and that the safety office would see its primary mission as busting the chops of the folks who approve drugs.) All in all, though, it sounds like a reasonable solution.

But solution to what? Remember, Merck and FDA may have been slow in putting revised safety information on Vioxx's label, but they did eventually put it there. The question is whether patients and doctors actually read and used it the way they're supposed to.

If they didn't—which is how it looks to me—then getting the warning into people's hands a little earlier will do next to nothing to improve patient safety. Kweder has proposed a good solution, but to the wrong problem.

That's how solution creep works. As we start to deal with a complex problem, people start putting solutions on the table. The solutions make sense, they advance goals we believe in, and before we know it, we're committed to them, whether they solve the problem or not. Full disclosure of clinical trials? Let's go for it. Drug safety office? Why not? Pretty soon, the solutions are driving the discussion. We forget what we were trying to accomplish.

The assumption behind many of the "solutions" I'm hearing these days is that we have a drug safety problem, and that people need more information. I think the real problem is different: We have a drug safety system based on the idea of letting patients and doctors decide how much risk they want to face. And for whatever reason, that system isn't working. Legislators, patients, and doctors alike all show signs that they don't understand it, don't like it, and aren't living up to the level of personal responsibility it requires.

That's a big problem that we're not going to solve by throwing solutions at the wall and seeing which ones stick.

It's tough to say no to solution creep. The credibility of pharma and FDA has clearly taken a hit, making it hard for either of them to get up in front of the public and say, "Wait, these proposals are fine, but they don't do the job we need to do now." But someone needs to start taking that stand.

The stakes are high. The states are clearly unhappy about drug regulation and are starting to write laws regulating marketing. (A list appears) Louisiana, troubled by the Vioxx advisory panel's decision, plans to introduce its own prescribing rules for the drug. Centralized drug regulation is vital for pharma. So is the informed-risk approach behind the current system. If we let them creep away, the industry may find itself with problems to which there are no solutions at all.

Patrick Clinton is Pharmaceutical Executive’s editor-in-chief and can be reached at pclinton@advanstar.com

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