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I received this excellent comment on today’s Vioxx post. I will hopefully add my own comments either later tonight or tomorrow morning. In the meantime:

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I wrote a detailed comment about the Vioxx situation a few days ago, but the Internet ate it. Seeing that you’re still on topic, I’ll try again.

I agree that the Vioxx problem has a lot to do with aggressive marketing by Merck. I also agree that the prescribing docs deserve some blame, mitigated partly by being susceptible to marketing themselves, and partly by the time and effort required to convince patients they shouldn’t really switch to Merck’s new “wonder drug.”

You also note that the drug was marketed as if it was more effective. I’m not part of the marketing demographic (being neither an MD nor a candidate for Vioxx), but I had the same impression. So I imagine many patients on ibuprofen wanted to switch to Vioxx because they thought it would be better for their pain, not because ibuprofen caused them GI problems. That must have put a lot of pressure on the prescribing docs.

Another problem with Vioxx, as I understand it, is that early indications of possible cardio problems were downplayed. In retrospect, that was obviously the wrong approach, but it’s unclear to me whether that was “objectively” wrong at the time.

Unfortunately, I fail to see how any of these problems would be effectively addressed by taking clinical trial design and conduct out of the hands of the drug developers. *IF* it was objectively clear that more cardio safety studies were needed pre-approval, FDA should have required them. Why didn’t they?

FDA could easily have told Merck, “We’re concerned about cardiovascular risk. You need to run a trial in this many patients, from these populations, looking at these endpoints, etc.” I don’t see that an “arm’s-length” trial process (for want of a better term) can automatically do that better.

Some argue FDA has become too beholden to pharma, and is not sufficiently objective. If so, the arm’s-length approach might temporarily improve things just by bringing in a different batch of overseers. But in the longer run, why wouldn’t this new group be susceptible to the same fate? Pharma could easily direct some of their legendary lobbying might at the trial designers. What will keep them from succumbing they way FDA supposedly has? Whatever it is, wouldn’t it be easier to apply the same fix to FDA? (Perhaps not, but I’d prefer to at least consider that before implementing the arm’s length approach.)

Similarly, I don’t see that the arm’s length approach would have impacted the way Vioxx was marketed. We already know that Vioxx isn’t better for relieving most people’s pain. (At least, that’s my understanding.) Yet, intentionally or not, that impression was conveyed to millions of users.

So I don’t (yet) see that this approach will offer much benefit. I do see some significant drawbacks, but I’ll save that for another post, as this one is already rather long.

In the meantime, if you think I’m missing the benefits of your proposal, maybe you’ll be willing to explain in more detail. I freely admit that I’m looking from a drug developer’s perspective. (I’m in biotech, not pharma, but still.) But I still try to maintain some pretense of open-mindedness. Hopefully it’s not complete self-delusion.

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First, I would like to document that I wrote in 2002 that I thought we were using too much Vioxx and should have used cheaper NSAIDs – consumer-driven insurance

I will address the cardiac risk issue directly. The cardiac risk was clearly a surprise. We had reason to think that Cox-2 drugs might be cardiac protective.

I could think of no physiologic rationale for the FDA to suspect this side effect.

However, if we had independent studies, we would probably include post marketing surveillance studies looking for a wide variety of possible side effects.

I do believe that most physicians would agree that our current system does nothing to encourage high quality study designs for new drugs. The pharmaceutical company must conduct standard, vanilla studies to meet FDA standards.

An independent study process would encourage a wider variety of inquiry (at least I believe that it would). The current system does not provide physicians or patients with the highest quality data. The system thus is broken. We need creativity to fix it.

Related posts:

1. A comment on Vioxx
2. An interesting perspective on the Vioxx damage award
3. More on Vioxx
4. Risks and benefits – what if Merck starts selling Vioxx again?
5. Vioxx recalled

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