The Vytorin debate isn’t going away anytime soon. A key question, however, is what, if anything, might the FDA do concering the labeling for the cholesterol pill. Any negative change would, of course, further affect already declining prescription writing and could easily prompt insurers to reduce reimbursement. In an interview with FDAWeb, Janet Woodcock, the new head of the Center for Drug Evaluation and Research, is deliberately coy, but seems to suggest lowering LDL is a well-validated surrogate. And the controversial Enhance trial did show Vytorin could do that much.

FDAWeb: With regard to the public uncertainty that seems to have arisen about LDL cholesterol lowering in the wake of the Vytorin/Zetia situation, how does FDA respond, if it chooses to, to such perceptional issues that may not be correct? Or should FDA confine itself to the hard science?
Woodcock: We have to be careful how we weigh in. We have to maintain our independence, and not appear to be defensive in any one direction or another. With Vytorin, you have people criticizing our use of an extremely well-validated and multiply-vindicated surrogate because of results with an experimental surrogate with unknown validity. We have no idea about the carotid intimal thickness surrogate, as far as its performance goes, and it looked kind of strange in that trial because on the statin it also progressed. Something was not as expected in the entire trial. I don’t know to what extent we should wade into these scientific melees. I believe people are piling-on right now on one side of the argument. Independent reporters and media, if they really want to have some reasoned approach, ought to step back from that. But what we see right now is everybody just piling on to the same message.

FDAWeb: But the editorial that accompanied the main NEJM article on Vytorin raised questions about the value of LDL lowering.
Woodcock: But if you look at those things closely, they’re talking about something else. It’s like global warming - you can always find some scientist who’d say, ‘Well, it isn’t exactly like that.’ But they didn’t mean that the climate wasn’t getting warmer - they just had some little nit-pick with the current model. And most of these, if you look at them, whether it is on hemoglobin A1C or on LDL cholesterol, or whatever it is, it’s the scientist saying ‘Well, in this subgroup it may not be as valid,’ or whatever. But anyone who questions the lowering of LDL cholesterol overall is probably, like Bob Temple said, trying to kill the population!

FDAWeb: Is this an opportunity for FDA say something publicly, or should you just wait for it to die down naturally?
Woodcock: I don’t know the answer to that…

…Because there’s such a piling-on right now, it might be seen as FDA being defensive. In this case, I think the data really ought to speak for itself. You’re not going to see cardiologists abandoning treatment with statins, for example, because they know the data. There have been about 50 studies showing not just decreased mortality but decreased claudication, decreased heart attacks, other things, over and over without any real question. What happens with these is there is some little point that the scientists are arguing about, and then the media get on it, and they start throwing the baby out with the bathwater.

FDAWeb: That’s what’s been happening. Every news broadcast on TV is interviewing patients who are disturbed about the medicines they have been prescribed.
Woodcock: People don’t like to take medicine. A lot of people may well stop taking their statins because of this. What that will do is cause increased mortality. This gives people an excuse to stop taking their preventive medicines.

FDAWeb: Nevertheless, FDA shouldn’t say so?
Woodcock: Well, we would, if we thought it would make a difference, given the current environment. If people think we’re just being defensive, we wouldn’t make a difference, in this environment. We have to think about it. If we could be effective, we would say something.

Hat tip to FDAWeb (subscription required)