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Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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In the Pipeline

« Law and Disorder | Main | COX-2 Aftermath »

February 18, 2005

Waiting for the FDA

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Posted by Derek

Well, we're finally coming to the end of the FDA's COX-2 marathon. My predictions will be overtaken by reality soon, but I know that a lot of people are following this, so I'll take a crack at it:

I don't think we're going to see any drugs pulled outright from the US market, but if there is one, it'll probably be Bextra. Assuming it stays on the market, I think that it and Celebrex will pick up additional warnings, along with guidance to prescribe it only to patients who can't tolerate the more traditional anti-inflammatories. The FDA has been trying to do that already, and I think we'll see it emphasized again.

And if those two drugs and Vioxx all suffer from the same risks, which I think is likely the case, then why shouldn't Vioxx come back on the market, as Merck's Peter Kim said the other day? He has a point. After all, the recall was voluntary, not FDA-mandated, and as far as I know, there's nothing keeping Merck from bringing the drug back.

As for Merck's follow-up COX-2 (Arcoxia) and Novartis's Prexige, neither of which is available in the US yet, I think that the FDA will want to see major cardiovascular data. Perhaps they'll let them through, eventually, with the same set of warnings and guidelines I expect to see attached to the current drugs. But if the companies want better terms, they're going to have to show some evidence why they should have them.

So we might end up, after all the mud is washed off the walls, with more COX-2 drugs on the market than we have now. Odd, eh? They'll be fighting inside what's supposed to be (and probably will be, in fact) a smaller market, though. The real financial damage has already been done, because this class of drugs will never be what it was a few months ago. Makes you wonder if a big launch of Arcoxia, et al., is even going to be worth the effort.

Which brings up one more point: in the above, I mentioned prescribing COX-2 drugs "only to patients who can't tolerate the more traditional anti-inflammatories", and I'll bet that many people read that and added ". . .just like they should have all along." And it's true that we probably wouldn't have even seen the cardiovascular side effects in that smaller patient population (nor would we have been bombarded with COX-2 ads, for that matter.)

But that's what companies do - try to broaden their market as much as possible. I think that Merck and Pfizer overdid it in the pain market, true. But keep in mind that some of the bad news about these drugs came from trials of them against other possible targets (colon cancer, for example.) The only way we're going to find out if they work in these indications is to run those trials, and finding bad news instead of good is the risk that we in the industry take. I think it's better to try and lose than to never try. Some may disagree. . .

Comments (4) + TrackBacks (0) | Category: Business and Markets | Cardiovascular Disease | Toxicology


1. jeet on February 18, 2005 6:57 PM writes...

I would agree, but only if the companies acted in good faith and not in the "smoking doesn't cause lung cancer" model of inconclusive evidence.

This industry is full of people that can take a batch of clinical trial data and tell you if there is a strong trend towards efficacy. They can do the same for safety.

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2. DV Henkel-Wallace on February 18, 2005 7:23 PM writes...

It's not just the companies themselves, it's the "Ooh -- shiny!" effect on the part of the patients and the doctors.

Somehow the new product is more exciting than the old standbys, even for the bulk of the patient population for whom the old standbys are perfectly appropriate (and cheaper). It's the same reason people buy new cars or new iPods when the old ones are perfectly satisfactory.

The companies of course knowingly take advantage of this.

Sure we wouldn't have had a large enough Phase 3 population to identify the cardiovascular risk unless the Pharmas had been trying to expand their market....but turn that around: if they'd only been medicating (let alone) testing the patients who really _needed_ to switch to a cox-2 inhibitor, then the cardio risk would have been swamped in the noise precisely because it was irrelevant.

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3. Chris on February 19, 2005 4:01 PM writes...

What do you think of Mobic, Boehringer Ingelheim's relatively new NSAID which has pretty good COX-2 specificity. It is said to be gaining popularity.

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4. Ed P on February 23, 2005 9:02 PM writes...

There are so many sides to this story. The more time spent looking into what they knew, the more angry I get. I have suffered with a form of arthritis called ankylosing spondylitis [AS] for over 30 years. When Vioxx first came on the market, i asked my physican about using it because my stomach was beginning to suffer from all the years of OTC pain meds. I was told that Viox was not inteneded for AS. Fast forward to 2001. My doctor asked if I would be interested in participating in a clinical trial for an AS specific Cox-2. I knew the risks and went for it. The clincal trial was for Arcoxia. I definetly had the "good stuff" during the trial. I hadn't felt that good in years. I did query as to what would happen at the end of the year trial. Doc said that I was on the third trial because Merck "just needed a little more info", it would probably be OK'd for sale before the trial was over. If it wasn't, Merck has a "compasinent extention" and they would continue to give me the drug. Fast forward, year over, no extention, Merck gave no reason why which the doc questioned as "they have never done this before". They would give me Vioxx for free. Fast forward 6 months, 9/10/01. Heart attack. Doctors don't know why I had the heart attack. Suggest I never take cox-2 again. I now know what caused my attack. The same reason Merck took it off the market.
From someone whos been there, be afraid, be very afraid, trust no one. The greed for money overpowers large companies. Arcoxia must never make to market in US.

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