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DBL%20Hendrix%20small.png College chemistry, 1983

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: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

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June 1, 2006

That Fount of Information We Call ASCO

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Posted by Derek

Well, the American Society for Clinical Oncology (ASCO) meeting is almost upon us, and it's time for the annual blizzard of misinformation. I'm not talking about the presentations at the meeting, which are no better or worse than the usual scientific meeting. No, I mean the press releases and subsequent press reports, of which the Reuters item I'm going to highlight today is a depressingly good example.

The headline reads "Big Pharma Expected to Dominate Key Cancer Meeting", which isn't such a good start. Any time you see the industry being divided up into "Big Pharma" and "Biotech", as this piece does, an alarm bell should go off in your head. We need to get clear on what "biotech" means, or dump the term altogether. I'm in favor of the second choice, although that's not going to happen, because all the categories are mixed up, anyway. The tiny-DNA-and-protein versus big-chemical-drug storyline doesn't work so well these days. If Genentech and Amgen aren't Big Something, I'd like to know who is. And on the other end of the scale, was Sugen a "biotech" because they were small (even though they make small organic molecules instead of protein-based drugs?) How about Vertex, or OSI?

My favorite part of the article is this one:

Big pharma's interest in cancer comes about five years after Novartis' launch of the targeted leukemia drug Gleevec.

Gleevec was initially expected to be a niche product, but its effectiveness and benign side-effect profile led to sales last year of $2.2 billion.

Let's take those in order. "Big Pharma's interest in cancer" has, in fact, been pretty constant. It's our success that comes in fits and starts. The article would makes it seem as if we can turn on the clinical research tap at will - when we finally get around to it, anyway. But there are no sudden waves of interest that show up in clinical research meetings - you're seeing the end result of decisions taken eight or ten years ago. When do you think we started the projects that are now being presented at ASCO, anyway?

And as for Gleevec, which is a fine drug that does well by its small intended patient population, let me say (again) that I think that a good amount of it is being wasted. There are, to the best of my knowledge, not enough people with GIST or CML (the two cancers that it's been approved to treat) to account for its sales, not even nearly enough. Gleevec was indeed expected to be a niche product. In terms of the people it can effectively treat, it still is.

It's not for lack of trying. Here are a few attempts from just the last few months: endocrine tumors, renal cell carcinoma, metastatic melanoma, germ cell tumors, refractory myeloma, and advanced hepatocellular carcinoma. In some types of tumor, Gleevec may actually make things worse.

Again, I'm not going off on Gleevec because it's a bad drug,. It isn't. It's pretty typical of what we have to offer these days in cancer: very good effects in a small number of people, some help for a slightly larger number, and nothing much for most. Talk of a "benign side effect profile" is ridiculous for many of the newer agents, because they can only be considered benign with compared to the old ones, which were toxicologically the scourge of the earth. Compared to cisplatin, sure we look good. Who doesn't?

There were surely be more of this kind of thing over the next few days. My advice is to ignore the cancer news until things calm down a bit and we can get a better read on what's really happening. There's going to be too much dust in the air for that this weekend.

Comments (10) + TrackBacks (0) | Category: Cancer


COMMENTS

1. Abel Pharmboy on June 1, 2006 8:29 PM writes...

Derek, just saw on WSJ.com this afternoon that BMS's potent but non-selective Src/Abl kinase inhibitor, dasatinib, will be recommended by the ODAC tomorrow for approval in Gleevec-refractory CML. A great win for my esteemed BMS chemistry and pharmacology colleagues, but I was a little surprised to learn that the ODAC meeting was moved to Atlanta to coincide with the ASCO meeting.

Anyway, interesting news for those of us that get killed on NIH grant applications for being cancer phenotype-directed instead of molecular target-directed. Dasatinib was an almost thrown-away kinase inhibitor that had just enough promiscuity to have potent inhibitory activity on imatinib-resistant Bcr-Abl kinase. But, never fear, we pharmacologists have already generated dasatinib-resistant mutations to make way for the next, even less-targeted inhibitor.

We've already gotten the ASCO abstract book at home but I'll be staying tuned to In the Pipeline and the Wall Street Journal for the real stories!

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2. Derek Lowe on June 1, 2006 9:43 PM writes...

There are a number of other Bcr-Abl compounds coming down the chute for imatinib-resistant tumors, which sort of makes me wonder about what market share everyone is thinking they'll get. And that only shows what an odd thing it is that Gleevec is an orphan drug - since when is it worth trying to carve parts off an orphan's market?

I noticed that committee meeting in Atlanta, too - I guess the FDA realized that everyone they needed was going to be there, but it's an interesting decision to have the meeting there instead of postponing it.

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3. JenG on June 1, 2006 10:12 PM writes...

The reason that Gleevec has racked up so much in sales off of a smallish market is obvious: The enormous expense. A standard dose is nearly $3,000 a month, and many people must take more than the standard. Also, of course it can be prescribed off-label, which you don't mention.

In addition, as a CML patient who has experienced um, somewhat more than "benign" side effects, and also knows of many others who have had very serious side effects, I want to remind you that you really ought to learn about the side effects before suggesting that they are harmless. Heart problems, bone loss, pulmonary emboli, severe bone pain, severe skin infections & rashes, intolerable nausea and diarrhea, lung problems and even death -- those don't strike me as "benign."

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4. James Powell on June 2, 2006 12:25 AM writes...

In ref to JenG's comment,
I think Derek posted exactly right- it is "benign" only in comparison to the previous best available drugs. It is benign only because it is the best available drug for effectiveness...not because it is harmless, but because it works better than everything else that there is available. It's a crappy choice, but better to have a choice available than not.

James Powell

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5. Derek Lowe on June 2, 2006 7:11 AM writes...

JenG, off-label use is exactly the reason that Gleevec sells at the levels it does. That's what I meant by saying that there are not enough patients in its approved categories to account for its sales.

I've addressed the off-label issue in cancer therapies several times over the last few years - scroll in the "Cancer" category over on the right and you're bound to find some.

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6. Fejes on June 2, 2006 8:58 AM writes...

I've been reading your blog for about half a year, now, Derek, but this is the first time I've really taken exception to something you've written. (Otherwise, I'm a tremendous fan of your writting.)

In fact, I'd like to agree with your point that "We need to get clear on what "biotech" means, or dump the term altogether." Frankly, I don't think that anyone in the pharma quite understands how much they are abusing the term "biotech," which just serves to confuse the non-technical public.

Biotech encompases so much more than just "small pharma", that it's just not correct to use the terms interchangably. What about all of those companies that are exploiting biological phenomenon to produce products that have nothing to do with medical devices and health care? Do they not fall under the same heading of biotechnology?

At any rate, I don't want this to turn into a rant, but the pharma mentality that biotech and pharma are the same thing really does all of the biotech industry a disservice. Why deliberately try to shape the public opinion that the only application of biology that exists is for improving health care? Biotech has been classified into three categories; agricultural, industrial and pharmaceutical. Two of them are being linguisticly swept under the carpet.

Permalink to Comment

7. secret milkshake on June 2, 2006 9:56 AM writes...

I was at SUGEN at the time we were shut down by Pfizer. What a way to waste good compounds - but you could say the same thing for Kalamazoo, the other Pharmacia site. We had much better compounds than Sutent and I would like to see what happens to them now.

Permalink to Comment

8. MolecularGeek on June 2, 2006 1:40 PM writes...

Fejes:
Amen. Biotech is a distinct industry from pharmaceuticals and conflating them is, IMNSHO, a way for the Pharmaceutical industry to show how much research "they" are doing and draw attention from the fact that they are fast beoming, if not already, consumer products corporations with R&D being a necessary evil on the balance sheet.

By the same token, however, describing companies as biotechs vs. pharmaceutical is fundementally a non-orthagonal basis set. the former designation tends to refer to the technology utilized to produce the product, while the latter refers to the product itself.

My personal belief is that it would make the most sense to speak of all the companies that produce molecules (including big nasty biological macromolecules) for human health as the pharmaceutical industry. Likewise, companies producing molecules to grow big healthy animals and crops should probably be refered as the agrochemical industry (or veterinary or animal health, or whatever term works for the people to whom it matters). If one wants to speak of the biotech industry, I think that should be limited to the companies that actually produce the tools for biotechnology, but that's just me.

I think business drivers, corporate culture, and developmental stages make far more sense to classify pharmaceutical companies than their choice of technology for product development. To paint with a very broad brush, the companies labeled "biotechs" in the pharmaceutical industry tend to be younger, smaller, and still driven very much by research results and valuing the culture that comes from being research-centric. What gets labeled "Big Pharma" are the corporate institutions where marketing ans sales have taken over and it's often seen as safer to buy the best research from the former class of company. They may be financially more stable (though this is no longer as certain as it was) but this may come at the cost of being unwilling to take risks in R&D as we have beaten into the ground in past discussions.

Just my ramblings,

MG

Permalink to Comment

9. Doc Bushwell on June 4, 2006 8:04 PM writes...

Just a little snippet here: Josh Boger, the CEO & President of Vertex Pharma, takes great umbrage at ClubV being referred to as a "biotech."

Permalink to Comment

10. Steve Low on June 12, 2006 10:44 AM writes...

I'm new here but will jump right in.

JenG is right. 'Benign' is misleading. You can add thymic carcnoma/thymoma to your list. In our yahoo support group for thymic carcinoma (my wife has the condition), a few participants were advised to try Gleevec with nothing but terrible side-effects to show for the effort before they abandoned the drug.

Fairly new to the whole world of cancer therapies, I'm very angry and sad to discover cancer drugs used for off-label purposes in such a haphazard way, with very little science to support the decision.

Gleevec was developed originally for CML and was the fastest fast-tracked drug ever -- 2.5 months (http://www.dfci.harvard.edu/abo/news/
publications/pop/fall-winter-2001/gleevec.asp).
Thymic carcinoma is a rare cancer of the thymus(many doctors surprisingly confuse it with thyroid). As GIST is also a rare solid tumor cancer, I'm assuming oncs are making a connection that its worth a shot. Seems to me though that the stomach is far more accessible to an ingested drug than the thymus.

Derek your link to 'worse' (unexpected metastasis) in your post is shocking and I'll blog about it as well post this info for the thymic group.

BTW, inflation must be far higher than some think as the linked article said the monthly cost of Gleevec was just US$2000 in 2000!

The article also said that a GIST patient could expect to be on Gleevec the rest of their lives. Biotech or big Pharma - its about profits.

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